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2015 HRS/EHRA/APHRS/SOLAECE expert consensus statement on optimal implantable cardioverter-defibrillator programming and testing

Published:November 19, 2015DOI:https://doi.org/10.1016/j.hrthm.2015.11.018

      Abbreviations:

      aCRT (adaptive cardiac resynchronization therapy), AF (atrial fibrillation), ATP (antitachycardia pacing), CI (confidence interval), CL (cycle length), CRT (cardiac resynchronization therapy), CRT-D (cardiac resynchronization therapy–defibrillator), DT (defibrillation testing), EEG (electroencephalography), EGM (electrogram), HF (heart failure), HR (hazard ratio), ICD (implantable cardioverter-defibrillator), LV (left ventricle), LVEF (left ventricular ejection fraction), MI (myocardial infarction), MVP (managed ventricular pacing), NCDR (National Cardiovascular Data Registry), NYHA (New York Heart Association), OR (odds ratio), PEA (peak endocardial acceleration), PVC (premature ventricular contraction), RCT (randomized clinical trial), RV (right ventricle), SCD (sudden cardiac death), S-ICD (subcutaneous implantable cardioverter-defibrillator), SVT (supraventricular tachycardia), TIA (transient ischemic attack), VF (ventricular fibrillation), VT (ventricular tachycardia)

      Keywords

      Document Reviewers: Giuseppe Boriani, MD, PhD (Italy); Michele Brignole, MD, FESC (Italy); Alan Cheng, MD, FHRS (USA); Thomas C. Crawford, MD, FACC, FHRS (USA); Luigi Di Biase, MD, PhD, FACC, FHRS (USA); Kevin Donahue, MD (USA); Andrew E. Epstein, MD, FAHA, FACC, FHRS (USA); Michael E. Field, MD, FACC, FHRS (USA); Bulent Gorenek, MD, FACC, FESC (Turkey); Jin-Long Huang, MD, PhD (China); Julia H. Indik, MD, PhD, FACC, FAHA, FHRS (USA); Carsten W. Israel, MD (Germany); Mariell L. Jessup MD, FACC, FAHA, FESC (USA); Christophe Leclercq, MD, PhD (France); Robert J. MacFadyen, MD, PhD (UK); Christopher Madias, MD, FHRS (USA); Manlio F. Marquez, MD, FACC (Mexico); Brian Olshansky, MD, FACC, FAHA, FHRS (USA); Kristen K. Patton, MD (USA); Marwan M. Refaat, MD, mMBA, FACC, FAHA, FHRS, FASE, FESC, FACP, FAAMA (USA); Cynthia M. Tracy, MD, FACC, FAHA (USA); Gaurav A. Upadhyay, MD (USA); Diego Vanegas, MD, FHRS (Colombia); Paul J. Wang, MD, FHRS, CCDS (USA)

      Introduction

      Implantable cardioverter-defibrillator (ICD) therapy is clearly an effective therapy for selected patients in definable populations. The benefits and risks of ICD therapy are directly impacted by programming and surgical decisions. This flexibility is both a great strength and a weakness, for which there has been no prior official discussion or guidance. It is the consensus of the 4 continental electrophysiology societies that there are 4 important clinical issues for which there are sufficient ICD clinical and trial data to provide evidence-based expert guidance. This document systematically describes the greater than 80% (83%–100%, mean 96%) required consensus achieved for each recommendation by official balloting in regard to the programming of (1) bradycardia mode and rate, (2) tachycardia detection, (3) tachycardia therapy, and (4) the intraprocedural testing of defibrillation efficacy. Representatives nominated by the Heart Rhythm Society (HRS), European Heart Rhythm Association (EHRA), Asian Pacific Heart Rhythm Society (APHRS), and the Sociedad Latinoamericana de Estimulacion Cardiaca y Electrofisiologia (SOLAECE-Latin American Society of Cardiac Pacing and Electrophysiology) participated in the project definition, the literature review, the recommendation development, the writing of the document, and its approval. The 32 recommendations were balloted by the 35 writing committee members and were approved by an average of 96%.
      The classification of the recommendations and the level of evidence follow the recently updated ACC/AHA standard.
      • Jacobs A.K.
      • Anderson J.L.
      • Halperin J.L.
      • et al.
      The evolution and future of ACC/AHA clinical practice guidelines: a 30-year journey: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines.
      • Anderson J.L.
      Evolution of the ACC/AHA Clinical Practice Guidelines in Perspective.
      Class I is a strong recommendation, denoting a benefit greatly exceeding risk. Class IIa is a somewhat weaker recommendation, with a benefit probably exceeding risk, and Class IIb denotes a benefit equivalent to or possibly exceeding risk. Class III is a recommendation against a specific treatment because either there is no net benefit or there is net harm. Level of Evidence A denotes the highest level of evidence from more than 1 high-quality randomized clinical trial (RCT), a meta-analysis of high-quality RCTs, or RCTs corroborated by high-quality registry studies. Level of evidence B indicates moderate-quality evidence from either RCTs with a meta-analysis (B-R) or well-executed nonrandomized trials with a meta-analysis (B-NR). Level of evidence C indicates randomized or nonrandomized observational or registry studies with limited data (C-LD) or from expert opinions (C-EO) based on clinical experience in the absence of credible published evidence. These recommendations were also subject to a 1-month public comment period. Each society then officially reviewed, commented, edited, and endorsed the final document and recommendations. All author and peer reviewer disclosure information is provided in Appendix A.
      The care of individual patients must be provided in context of their specific clinical condition and the data available on that patient. Although the recommendations in this document provide guidance for a strategic approach to ICD programming, as an individual patient’s condition changes or progresses and additional clinical considerations become apparent, the programming of their ICDs must reflect those changes. Remote and in-person interrogations of the ICD and clinical monitoring must continue to inform the programming choices made for each patient. The recommendations in this document specifically target adult patients and might not be applicable to pediatric patients, particularly when programming rate criteria.
      Please consider that each ICD has specific programmable options that might not be specifically addressed by the 32 distinctive recommendations in this document. Appendix B, published online (http://www.hrsonline.org/appendix-b), contains the writing committee’s translations specific to each manufacturer and is intended to best approximate the recommended behaviors for each available ICD model.

       Bradycardia Mode and Rate Programming

       Single- or Dual-Chamber Pacing Mode

       Evidence

      Because the ICD is primarily indicated for tachycardia therapy, there might be some uncertainty regarding optimal bradycardia management for ICD patients. Data from clinical studies adequately address only the programmed mode rather than the number of leads implanted, the number of chambers stimulated, or how frequently the patients required bradycardia support. It is of note that most information on pacing modes has been collected from pacemaker patients, and these patients are clinically distinct from ICD recipients. Dual-chamber pacing (atrial and ventricular) has been compared with single-chamber pacing (atrial or ventricular) in patients with bradycardia in 5 multicenter, parallel, randomized trials, in 1 meta-analysis of randomized trials, and in 1 systematic review that also included 30 randomized crossover comparisons and 4 economic analyses.
      • Nielsen J.C.
      • Thomsen P.E.B.
      • Hojberg S.
      • et al.
      A comparison of single-lead atrial pacing with dual-chamber pacing in sick sinus syndrome.
      • Connolly S.J.
      • Kerr C.R.
      • Gent M.
      • et al.
      Effects of Physiologic Pacing versus Ventricular Pacing on the Risk of Stroke and Death Due to Cardiovascular Causes.
      • Lamas G.A.
      • Lee K.L.
      • Sweeney M.O.
      • et al.
      Ventricular Pacing or Dual-Chamber Pacing for Sinus-Node Dysfunction.
      • Lamas G.A.
      • Orav E.J.
      • Stambler B.S.
      • et al.
      Quality of Life and Clinical Outcomes in Elderly Patients Treated with Ventricular Pacing as Compared with Dual-Chamber Pacing.
      • Toff W.D.
      • Camm A.J.
      • Skehan J.D.
      Single-Chamber versus Dual-Chamber Pacing for High-Grade Atrioventricular Block.
      • Healey J.S.
      Cardiovascular Outcomes With Atrial-Based Pacing Compared With Ventricular Pacing: Meta-Analysis of Randomized Trials, Using Individual Patient Data.
      • Castelnuovo E.
      • Stein K.
      • Pitt M.
      • Garside R.
      • Payne E.
      The effectiveness and cost-effectiveness of dual-chamber pacemakers compared with single-chamber pacemakers for bradycardia due to atrioventricular block or sick sinus syndrome: systematic review and economic evaluation.
      Meta analyses comparing dual-chamber to single-chamber ICDs did not evaluate pacing modes.
      • Theuns D.A.
      • Klootwijk A.P.
      • Goedhart D.M.
      • Jordaens L.J.
      Prevention of inappropriate therapy in implantable cardioverter-defibrillators: results of a prospective, randomized study of tachyarrhythmia detection algorithms.
      • Chen B.W.
      • Liu Q.
      • Wang X.
      • Dang A.M.
      Are dual-chamber implantable cardioverter-defibrillators really better than single-chamber ones? A systematic review and meta-analysis.
      Compared with single-chamber pacing, dual-chamber pacing results in small but potentially significant benefits in patients with sinus node disease and/or atrioventricular block. No difference in mortality has been observed between ventricular pacing modes and dual-chamber pacing modes. Dual-chamber pacing was associated with a lower rate of atrial fibrillation (AF) and stroke.
      • Wilkoff B.L.
      • Cook J.R.
      • Epstein A.E.
      • et al.
      Dual-chamber pacing or ventricular backup pacing in patients with an implantable defibrillator: the Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial.
      The benefit in terms of AF prevention was more marked in trials comprised of patients with sinus node disease. Although trends in favor of dual-chamber pacing have been observed in some trials, there was no benefit in terms of heart failure (HF). In patients without symptomatic bradycardia, however, the Dual Chamber and VVI Implantable Defibrillator (DAVID) trial in ICD recipients showed that one specific choice of dual-chamber rate-responsive (DDDR) programming parameters led to poorer outcomes than VVI backup pacing, most likely secondary to unnecessary right ventricular (RV) pacing. The fact that RV stimulation was responsible was reinforced in the DAVID II trial, in which AAI pacing was demonstrated to be noninferior to VVI backup pacing.
      • Wilkoff B.L.
      • Kudenchuk P.J.
      • Buxton A.E.
      • et al.
      The DAVID (Dual Chamber and VVI Implantable Defibrillator) II trial.
      Approximately a quarter of patients with either sinus node disease or atrioventricular block develop “pacemaker syndrome” with VVI pacing usually associated with retrograde (ventricular to atrial) conduction, which in turn is associated with a reduction in the quality of life.
      • Castelnuovo E.
      • Stein K.
      • Pitt M.
      • Garside R.
      • Payne E.
      The effectiveness and cost-effectiveness of dual-chamber pacemakers compared with single-chamber pacemakers for bradycardia due to atrioventricular block or sick sinus syndrome: systematic review and economic evaluation.
      In crossover trials, symptoms of pacemaker syndrome (dyspnea, dizziness, palpitations, pulsations, and chest pain) were reduced by reprogramming to a dual-chamber mode.
      • Castelnuovo E.
      • Stein K.
      • Pitt M.
      • Garside R.
      • Payne E.
      The effectiveness and cost-effectiveness of dual-chamber pacemakers compared with single-chamber pacemakers for bradycardia due to atrioventricular block or sick sinus syndrome: systematic review and economic evaluation.
      Dual-chamber pacing is associated with better exercise performance compared with single-chamber VVI pacing without rate adaptation, but produces similar exercise performance when compared with rate-responsive VVIR pacing. Because of the additional lead, dual-chamber devices involve longer implantation times, have a higher risk of complications, and are more expensive. However, because of the additional clinical consequences of pacemaker syndrome and AF (and its sequelae), the overall cost difference between single- and dual-pacing systems is moderated.
      In patients with persistent sinus bradycardia, atrial rather than ventricular dual-chamber pacing is the pacing mode of choice. There is evidence for superiority of atrial-based pacing over ventricular pacing for patients who require pacing for a significant proportion of the day. The evidence is stronger for patients with sinus node disease, in whom dual-chamber pacing confers a modest reduction in AF and stroke, but not in hospitalization for HF or death compared with ventricular pacing. In patients with acquired atrioventricular block, large randomized parallel trials were unable to demonstrate the superiority of dual-chamber pacing over ventricular pacing with regard to hard clinical endpoints of mortality and morbidity.
      • Connolly S.J.
      • Kerr C.R.
      • Gent M.
      • et al.
      Effects of Physiologic Pacing versus Ventricular Pacing on the Risk of Stroke and Death Due to Cardiovascular Causes.
      • Lamas G.A.
      • Orav E.J.
      • Stambler B.S.
      • et al.
      Quality of Life and Clinical Outcomes in Elderly Patients Treated with Ventricular Pacing as Compared with Dual-Chamber Pacing.
      • Toff W.D.
      • Camm A.J.
      • Skehan J.D.
      Single-Chamber versus Dual-Chamber Pacing for High-Grade Atrioventricular Block.
      • Healey J.S.
      Cardiovascular Outcomes With Atrial-Based Pacing Compared With Ventricular Pacing: Meta-Analysis of Randomized Trials, Using Individual Patient Data.
      The benefit of dual-chamber over ventricular pacing is primarily due to the avoidance of pacemaker syndrome and to improved exercise capacity.
      • Castelnuovo E.
      • Stein K.
      • Pitt M.
      • Garside R.
      • Payne E.
      The effectiveness and cost-effectiveness of dual-chamber pacemakers compared with single-chamber pacemakers for bradycardia due to atrioventricular block or sick sinus syndrome: systematic review and economic evaluation.
      Even if it is a softer endpoint, pacemaker syndrome is associated with a reduction in quality of life that justifies the preference for dual-chamber pacing when reasonable; thus, there is strong evidence for the superiority of dual-chamber pacing over ventricular pacing that is limited to symptom improvement. Conversely, there is strong evidence of nonsuperiority with regard to survival and morbidity. The net result is that the indications for programming the dual-chamber modes are weaker and the choice regarding the pacing mode should be individualized, taking into consideration the increased complication risk and costs of dual-chamber devices. Because ICD patients usually do not require bradycardia support, with the exception of patients who require cardiac resynchronization, programming choices should avoid pacing and in particular avoid single ventricular pacing, if possible.
      • Magrì D.
      • Corrà U.
      • Di Lenarda A.
      • et al.
      Cardiovascular mortality and chronotropic incompetence in systolic heart failure: the importance of a reappraisal of current cut-off criteria.
      • Sims D.B.
      • Mignatti A.
      • Colombo P.C.
      • et al.
      Rate responsive pacing using cardiac resynchronization therapy in patients with chronotropic incompetence and chronic heart failure.

      Programming of Rate Modulation

      The benefit of rate response programming has been evaluated in patients with bradycardia in 5 multicenter, randomized trials and in 1 systematic review that also included 7 single-center studies.
      • Padeletti L.
      • Pieragnoli P.
      • Di Biase L.
      • et al.
      Is a Dual-Sensor Pacemaker Appropriate in Patients with Sino-Atrial Disease? Results from the DUSISLOG Study.
      • Sulke N.
      • Chambers J.
      • Dritsas A.
      • Sowton E.
      A randomized double-blind crossover comparison of four rate-responsive pacing modes.
      • Lamas G.A.
      • Knight J.D.
      • Sweeney M.O.
      • et al.
      Impact of rate-modulated pacing on quality of life and exercise capacity—Evidence from the Advanced Elements of Pacing Randomized Controlled Trial (ADEPT).
      • Lau C.P.
      • Rushby J.
      • Leigh-Jones M.
      • et al.
      Symptomatology and quality of life in patients with rate-responsive pacemakers: A double-blind, randomized, crossover study.
      • Oto M.A.
      • Muderrisoglu H.
      • Ozin M.B.
      • et al.
      Quality of Life in Patients with Rate Responsive Pacemakers: A Randomized, Cross-Over Study.
      • Dell’Orto S.
      • Valli P.
      • Greco E.M.
      Sensors for rate responsive pacing.
      Most of these data were obtained from pacemaker studies and must be interpreted in that light.
      Although there is evidence of the superiority of VVIR pacing compared with VVI pacing in improving quality of life and exercise capacity, improvements in exercise capacity with DDDR compared with DDD have been inconsistent. In 2 small studies on patients with chronotropic incompetence comparing DDD and DDDR pacing, the latter had improved quality of life and exercise capacity; however, a larger, multicenter randomized trial (Advanced Elements of Pacing Randomized Controlled Trial [ADEPT]) failed to show a difference in patients with a modest blunted heart rate response to exercise.
      • Padeletti L.
      • Pieragnoli P.
      • Di Biase L.
      • et al.
      Is a Dual-Sensor Pacemaker Appropriate in Patients with Sino-Atrial Disease? Results from the DUSISLOG Study.
      • Sulke N.
      • Chambers J.
      • Dritsas A.
      • Sowton E.
      A randomized double-blind crossover comparison of four rate-responsive pacing modes.
      • Lamas G.A.
      • Knight J.D.
      • Sweeney M.O.
      • et al.
      Impact of rate-modulated pacing on quality of life and exercise capacity—Evidence from the Advanced Elements of Pacing Randomized Controlled Trial (ADEPT).
      In addition, DDDR programming in cardiac resynchronization therapy (CRT) patients has the potential to impair AV synchrony and timing. It should be noted that trials evaluating CRT generally did not use rate-responsive pacing, and many in fact avoided atrial stimulation using atrial sensed and ventricular paced pacing modes with a lower base rate. However, the Pacing Evaluation-Atrial Support Study in Cardiac Resynchronization Therapy (PEGASUS CRT) trial is the exception and did not demonstrate adverse impact on mortality and HF events.
      • Martin D.O.
      • Day J.D.
      • Lai P.Y.
      • et al.
      Atrial support pacing in heart failure: results from the multicenter PEGASUS CRT trial.

      Sinus Node Disease

      In patients with persistent or intermittent sinus node dysfunction or chronotropic incompetence, the first choice is DDDR with algorithms responding to intermittent atrioventricular conduction. There is sufficient evidence for the superiority of VVIR compared with VVI in improving quality of life and exercise capacity. The evidence is much weaker in dual-chamber pacing (DDDR vs DDD).
      Although only an issue when there is some concomitant AV block, the upper rate limit should be programmed higher than the fastest spontaneous sinus rhythm to avoid upper rate limit behavior. To avoid symptomatic bradycardia, the lower rate should be programmed on an individual basis, according to the clinical characteristics and the underlying cardiac substrate of the patient.

      Atrial Fibrillation and Atrioventricular Block

      Patients with permanent AF and either spontaneous or AV junctional ablation-induced high-degree atrioventricular block have little to no chronotropic response to exercise; thus, VVIR pacing is associated with better exercise performance, improved daily activities, improved quality of life, and decreased symptoms of shortness of breath, chest pain, and heart palpitations, compared with VVI.
      • Lau C.P.
      • Rushby J.
      • Leigh-Jones M.
      • et al.
      Symptomatology and quality of life in patients with rate-responsive pacemakers: A double-blind, randomized, crossover study.
      • Oto M.A.
      • Muderrisoglu H.
      • Ozin M.B.
      • et al.
      Quality of Life in Patients with Rate Responsive Pacemakers: A Randomized, Cross-Over Study.
      • Dell’Orto S.
      • Valli P.
      • Greco E.M.
      Sensors for rate responsive pacing.
      • Leung S.-K.
      • Lau C.-P.
      Developments in sensor-driven pacing.
      • Van Campen LCMC De Cock CC
      • Visser F.C.
      • Visser C.A.
      The effect of rate responsive pacing in patients with angina pectoris on the extent of ischemia on 201-thallium exercise scintigraphy.
      • Brignole M.
      • Auricchio A.
      • Baron-Esquivias G.
      • et al.
      2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy: The Task Force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association (EHRA).
      Therefore, rate-adaptive pacing is the first choice of pacing mode; fixed-rate VVI pacing should be abandoned in patients with permanent AF and atrioventricular block. It is the experts’ opinion that the minimum rate can be programmed higher (e.g., 70 bpm) than for sinus rhythm patients, in an attempt to compensate for the loss of active atrial filling. In addition, the maximum sensor rate should be programmed restrictively (e.g., 110–120 bpm) to avoid “overpacing” (i.e., pacing with a heart rate faster than necessary), which can be symptomatic, particularly in patients with coronary artery disease. In a small study, however, it was found that rate-responsive pacing could be safe and effective in patients with angina pectoris, without an increase in subjective or objective signs of ischemia.
      • Van Campen LCMC De Cock CC
      • Visser F.C.
      • Visser C.A.
      The effect of rate responsive pacing in patients with angina pectoris on the extent of ischemia on 201-thallium exercise scintigraphy.
      The lower rate should be programmed on an individual basis, according to the clinical characteristics and the underlying cardiac substrate of the patient. The clinical benefit of programming a lower resting rate at night based on internal clocks has not been evaluated in ICD patients. There is some concern that atrioventricular junction ablation and permanent ventricular pacing might predispose the patient to an increased risk of sudden cardiac death (SCD) related to a bradycardia-dependent prolongation of the QT interval. This risk might be overcome by setting the ventricular pacing rate to a minimum of 80 or 90 bpm for the first 1–2 months following the atrioventricular junction ablation, then reducing it to a conventional 60–70 bpm.
      • Geelen P.
      • Brugada J.
      • Andries E.
      • Brugada P.
      Ventricular Fibrillation and Sudden Death After Radiofrequency Catheter Ablation of the Atrioventricular Junction.
      • Nowinski K.
      • Gadler F.
      • Jensen-Urstad M.
      • Bergfeldt L.
      Transient proarrhythmic state following atrioventricular junction radiofrequency ablation: pathophysiologic mechanisms and recommendations for management.
      Not all patients with AF and milder forms of atrioventricular block will require a high percentage of ventricular pacing or have a wide QRS. Physicians should consider the risk of increasing preexisting left ventricular (LV) dysfunction with RV pacing vs improved chronotropic responsiveness and the potential value of CRT.

       Intact Atrioventricular Conduction

       Right Ventricular Pacing

      The results of a number of large-scale, prospective randomized trials demonstrated a significant reduction in AF in pacemaker patients with atrial-based pacing (AAI or DDD) compared with patients with ventricular-based pacing.
      • Connolly S.J.
      • Kerr C.R.
      • Gent M.
      • et al.
      Effects of Physiologic Pacing versus Ventricular Pacing on the Risk of Stroke and Death Due to Cardiovascular Causes.
      • Healey J.S.
      Cardiovascular Outcomes With Atrial-Based Pacing Compared With Ventricular Pacing: Meta-Analysis of Randomized Trials, Using Individual Patient Data.
      • Andersen H.R.
      • Nielsen J.C.
      • Thomsen P.E.B.
      • et al.
      Long-term follow-up of patients from a randomised trial of atrial versus ventricular pacing for sick-sinus syndrome.
      In the Mode Selection Trial, which enrolled 2010 patients with sick sinus syndrome, the risk of AF increased linearly with the increasing percentage of RV pacing.
      • Sweeney M.O.
      Adverse Effect of Ventricular Pacing on Heart Failure and Atrial Fibrillation Among Patients With Normal Baseline QRS Duration in a Clinical Trial of Pacemaker Therapy for Sinus Node Dysfunction.
      At the same time, deleterious effects of RV pacing in patients with LV dysfunction (left ventricular ejection fraction [LVEF] ≤40%) implanted with dual-chamber ICD systems were observed in the Dual Chamber and VVI Implantable Defibrillator (DAVID) trial, which included 506 ICD patients without indications for bradycardia pacing. Patients within the DDDR-70 group (with paced and sensed atrioventricular delays of 170 and 150 ms, respectively, in most of the DDDR group patients) showed a trend toward higher mortality and an increased incidence of HF compared with the patients programmed to ventricular backup pacing—the VVI-40 group. Within the DDDR-70 group, there were more cardiac events when the percentage of ventricular pacing exceeded 40% (P = .09) compared with patients with <40% of RV pacing, although almost all the patients had >95% RV stimulation (DDDR-70) or <5% RV stimulation (VVI-40).
      The DTI
      Dual-Chamber Pacing or Ventricular Backup Pacing in Patients With an Implantable Defibrillator.
      • Sharma A.D.
      • Rizo-Patron C.
      • Hallstrom A.P.
      • et al.
      Percent right ventricular pacing predicts outcomes in the DAVID trial.
      However, a more detailed post hoc analysis of the Inhibition of Unnecessary RV Pacing With Atrial-Ventricular Search Hysteresis in ICDs (INTRINSIC RV) trial revealed that the most favorable clinical results were not in the VVI groups with the least percentage of RV pacing but in the subgroup that had DDD pacing with longer atrioventricular delays and 11%–19% of ventricular pacing. This parameter selection probably helped patients to avoid exceedingly low heart rates while preserving intrinsic atrioventricular conduction most of the time.
      The DTI
      Dual-Chamber Pacing or Ventricular Backup Pacing in Patients With an Implantable Defibrillator.
      • Olshansky B.
      • Day J.D.
      • Moore S.
      • et al.
      Is dual-chamber programming inferior to single-chamber programming in an implantable cardioverter-defibrillator? Results of the INTRINSIC RV (Inhibition of Unnecessary RV Pacing With AVSH in ICDs) study.
      In the Second Multicenter Automated Defibrillator Implantation Trial (MADIT II), a higher risk of HF was observed in patients who had a greater than 50% burden of RV pacing.
      • Steinberg J.S.
      • Fischer A.V.I.
      • Wang P.
      • et al.
      The Clinical Implications of Cumulative Right Ventricular Pacing in the Multicenter Automatic Defibrillator Trial II.
      In another large observational study of 456 ICD patients without HF at baseline, a high RV pacing burden (RV pacing more than 50% of the time) was associated with an increased risk of HF events and appropriate ICD shocks.
      • Smit M.D.
      • Van Dessel PFHM
      • Nieuwland W.
      • et al.
      Right ventricular pacing and the risk of heart failure in implantable cardioverter-defibrillator patients.
      Optimally, RV stimulation should be avoided, but the precise tradeoff between the percentage of ventricular pacing and atrioventricular timing is unclear in non-CRT patients.

      Non-CRT Devices: Algorithms to Reduce Right Ventricular Stimulation

      The importance of reducing or avoiding RV pacing in ICD patients with LV dysfunction was illustrated in the DAVID trial.
      The DTI
      Dual-Chamber Pacing or Ventricular Backup Pacing in Patients With an Implantable Defibrillator.
      The feasibility of algorithms designed to decrease the burden of unnecessary ventricular pacing has been demonstrated in patients with dual-chamber pacemakers.
      • Gillis A.M.
      • Purerfellner H.
      • Israel C.W.
      • et al.
      Reducing Unnecessary Right Ventricular Pacing with the Managed Ventricular Pacing Mode in Patients with Sinus Node Disease and AV Block.
      • Kolb C.
      • Schmidt R.
      • Dietl J.U.
      • et al.
      Reduction of Right Ventricular Pacing with Advanced Atrioventricular Search Hysteresis: Results of the PREVENT Study.
      • Akerström F.
      • Arias M.A.
      • Pachón M.
      • Puchol A.
      • Jiménez-López J.
      • Rodríguez-Padial L.
      The reverse mode switch algorithm: How well does it work?.
      These algorithms usually provide functional AAI pacing with monitoring of atrioventricular conduction and an automatic mode switch from AAI to DDD during episodes of atrioventricular block. Some studies directly compared various algorithms to decrease ventricular pacing, showing that a “managed ventricular pacing” (MVP) algorithm resulted in greater ventricular pacing reduction than an “atrioventricular search” algorithm
      • PüRerfellner H.
      • Brandt J.
      • Israel C.
      • et al.
      Comparison of Two Strategies to Reduce Ventricular Pacing in Pacemaker Patients.
      • Murakami Y.
      • Tsuboi N.
      • Inden Y.
      • et al.
      Difference in percentage of ventricular pacing between two algorithms for minimizing ventricular pacing: results of the IDEAL RVP (Identify the Best Algorithm for Reducing Unnecessary Right Ventricular Pacing) study.
      : however, no randomized studies comparing these two algorithms with respect to important cardiovascular endpoints (e.g., HF, cardiac death) have been performed. The results of the studies on these pacing algorithms are summarized in Table 1.
      Table 1Influence of pacing modes and algorithms on clinical endpoints
      StudyPatients (PM/ICD)Results and remarks
      SAVE PACe, randomized multicenter (2007)
      • Sweeney M.O.
      • Bank A.J.
      • Nsah E.
      • et al.
      Minimizing Ventricular Pacing to Reduce Atrial Fibrillation in Sinus-Node Disease.
      1065 (PM)40% relative risk reduction of AF in the MVP group compared with DDD pacing (4.8% absolute risk reduction).
      MVP, randomized multicenter (2011)
      • Sweeney M.O.
      • Ellenbogen K.A.
      • Tang A.S.L.
      • et al.
      Atrial pacing or ventricular backup–only pacing in implantable cardioverter-defibrillator patients.
      1030 (ICD)No superiority of MVP over VVI-40 in terms of AF, VT/VF, quality of life, HF.
      Steinbach et al, retrospective single-center (2011)
      • Steinbach M.
      • Douchet M.-P.
      • Bakouboula B.
      • Bronner F.
      • Chauvin M.
      Outcome of patients aged over 75 years who received a pacemaker to treat sinus node dysfunction.
      102 (PM)In patients over 75 years of age, MVP showed lower rates of HF episodes and all-cause mortality than conventional DDD pacing
      long-MinVPACE, randomized single-center (2011)
      • Veasey R.A.
      • Arya A.
      • Silberbauer J.
      • et al.
      The relationship between right ventricular pacing and atrial fibrillation burden and disease progression in patients with paroxysmal atrial fibrillation: the long-MinVPACE study.
      66 (PM)Less RV pacing, less AF burden in MinVP group patients compared with DDDR (mean 12.8 vs 47.6%). Chosen AV/PV delay (150/130 ms) was probably too short in the DDDR (control) group.
      Generation MVP, observational multicenter (2012)
      • Rey J.-L.
      • Quenum S.
      • Hero M.
      Effect of a Pacing Mode Preserving Spontaneous AV Conduction on Ventricular Pacing Burden and Atrial Arrhythmias.
      220 (PM)Significantly fewer atrial arrhythmias when programmed to MVP compared with DDD.
      PreFER MVP, randomized multicenter (2014)
      • L. Botto G.
      • Ricci R.P.
      • Bénézet J.M.
      • et al.
      Managed ventricular pacing compared with conventional dual-chamber pacing for elective replacement in chronically paced patients: Results of the Prefer for Elective Replacement Managed Ventricular Pacing randomized study.
      605 (556 PM, 49 ICD)No difference between cardiovascular hospitalization, AF, and the composite of death and hospitalization between the MVP and DDD groups. The authors stated that “patients were enrolled upon elective replacement of the device, and were healthy enough to survive the first device without experiencing a significant decrease in LV function.”
      MINERVA, randomized multicenter (2014)
      • Boriani G.
      • Tukkie R.
      • Manolis A.S.
      • et al.
      Atrial antitachycardia pacing and managed ventricular pacing in bradycardia patients with paroxysmal or persistent atrial tachyarrhythmias: the MINERVA randomized multicentre international trial.
      1300 (PM)AF burden: no superiority of MVP pacing compared with the DDDR mode (AV/PV delay >180/210 ms in greater than 60% of patients, 53% of RV pacing). MVP in combination with atrial antitachycardia pacing was superior to both DDDR and MVP-only.
      COMPARE, randomized multicenter (2014)
      • Chen S.
      • Chen K.
      • Tao Q.
      • et al.
      Reduction of unnecessary right ventricular pacing by managed ventricular pacing and search AV+ algorithms in pacemaker patients: 12-month follow-up results of a randomized study.
      385 (PM)Lower percentage of ventricular pacing (%VP) in the MVP group compared with the SearchAV+ group. A trend in the correlation between %VP and AT/AF burden.
      AT = atrial tachycardia; HF = heart failure; MVP = Managed Ventricular Pacing; PM = pacemaker.
      Unnecessary RV pacing should be minimized by using specific algorithms or programming longer atrioventricular delays, and this process is more important for patients with a higher risk of AF or who already have poorer LV function.
      • Gillis A.M.
      • Russo A.M.
      • Ellenbogen K.A.
      • et al.
      HRS/ACCF Expert Consensus Statement on Pacemaker Device and Mode Selection.
      Patients with longer baseline PR intervals have a higher risk of AF regardless of the percentage of ventricular pacing or the length of the programmed atrioventricular interval.
      • Nielsen J.C.
      • Thomsen P.E.B.
      • Hojberg S.
      • et al.
      Atrial fibrillation in patients with sick sinus syndrome: the association with PQ-interval and percentage of ventricular pacing.
      Use of the AAIR pacing mode with exceedingly long atrioventricular conduction times can lead to “AAIR pacemaker syndrome” and actually increases the risk of AF compared with the DDDR mode, as was shown in the Danish Multicenter Randomized Trial on Single Lead Atrial versus Dual-Chamber Pacing in Sick Sinus Syndrome (DANPACE).
      • Nielsen J.C.
      • Thomsen P.E.B.
      • Hojberg S.
      • et al.
      A comparison of single-lead atrial pacing with dual-chamber pacing in sick sinus syndrome.
      • Den Dulk K.
      • Lindemans F.W.
      • Brugada P.
      • Smeets J.L.R.M.
      • Wellens H.J.J.
      Pacemaker Syndrome with AAI Rate Variable Pacing: Importance of Atrioventricular Conduction Properties, Medication, and Pacemaker Programmability.
      Therefore, excessively long atrioventricular delays resulting in nonphysiologic atrioventricular contraction patterns should be avoided. The potential harm of atrial pacing with a prolonged atrioventricular delay was also demonstrated in the MVP trial. In the MVP trial, dual-chamber pacing with the MVP algorithm was not superior to ventricular backup pacing (VVI 40 bpm) with respect to HF events. After a follow-up of 2.4 years, there was an apparent increase in HF events that was limited primarily to patients with a baseline PR interval of >230 ms (mean PR of 255–260 ms).
      • Sweeney M.O.
      • Ellenbogen K.A.
      • Tang A.S.L.
      • et al.
      Atrial pacing or ventricular backup–only pacing in implantable cardioverter-defibrillator patients.
      Long atrioventricular intervals also predispose the patient to repetitive atrioventricular reentrant rhythms, “repetitive nonreentrant VA synchrony,” or “atrioventricular desynchronization arrhythmia,” which manifest as mode switching but which also cause sustained episodes with poor hemodynamics.
      • Sweeney M.O.
      Novel Cause of Spurious Mode Switching in Dual-Chamber Pacemakers: Atrioventricular Desynchronization Arrhythmia.
      Thus, based on the available data, it appears that atrial pacing with excessively long atrioventricular delays should be avoided.
      Algorithms that minimize ventricular pacing sometimes lead to inadvertent bradycardia or spontaneous premature, beat-related short-long-short RR interval sequences with proarrhythmic potential.
      • Pascale P.
      • Pruvot E.
      • Graf D.
      Pacemaker Syndrome During Managed Ventricular Pacing Mode: What is the Mechanism?.
      • Sweeney M.O.
      • Ruetz L.L.
      • Belk P.
      • Mullen T.J.
      • Johnson J.W.
      • Sheldon T.
      Bradycardia Pacing-Induced Short-Long-Short Sequences at the Onset of Ventricular Tachyarrhythmias.
      • Vavasis C.
      • Slotwiner D.J.
      • Goldner B.G.
      • Cheung J.W.
      Frequent Recurrent Polymorphic Ventricular Tachycardia during Sleep Due to Managed Ventricular Pacing.
      However, in a study retrospectively analyzing the onset of ventricular tachycardia (VT) in ICD patients, the MVP mode was less frequently associated with the onset of VT compared with the DDD and VVI modes.
      • Sweeney M.O.
      • Ruetz L.L.
      • Belk P.
      • Mullen T.J.
      • Johnson J.W.
      • Sheldon T.
      Bradycardia Pacing-Induced Short-Long-Short Sequences at the Onset of Ventricular Tachyarrhythmias.
      Atrioventricular decoupling (greater than 40% of atrioventricular intervals exceeding 300 ms) was observed in 14% of the ICD patients in the Marquis ICD MVP study, which might have a negative effect on ventricular filling.
      • Sweeney M.O.
      • Ellenbogen K.A.
      • Tang A.S.L.
      • Johnson J.
      • Belk P.
      • Sheldon T.
      Severe Atrioventricular Decoupling, Uncoupling, and Ventriculoatrial Coupling During Enhanced Atrial Pacing: Incidence, Mechanisms, and Implications for Minimizing Right Ventricular Pacing in ICD Patients.
      In ICD patients with structural heart disease, spontaneous atrioventricular conduction can become prolonged instead of shortening, with increased atrial paced heart rates.
      • Olshansky B.
      • Day J.D.
      • Moore S.
      • et al.
      Is dual-chamber programming inferior to single-chamber programming in an implantable cardioverter-defibrillator? Results of the INTRINSIC RV (Inhibition of Unnecessary RV Pacing With AVSH in ICDs) study.
      This outcome frequently leads to a higher percentage of ventricular paced complexes. In view of the results of the ADEPT trial, which failed to demonstrate the clinical superiority of combined rate modulation and DDD pacing, the need for and aggressiveness of sensor-driven rate responses should be individualized or eliminated.
      • Lamas G.A.
      • Knight J.D.
      • Sweeney M.O.
      • et al.
      Impact of rate-modulated pacing on quality of life and exercise capacity—Evidence from the Advanced Elements of Pacing Randomized Controlled Trial (ADEPT).
      Rate-dependent shortening of atrioventricular delay could have the same effect and should usually be avoided.
      Patients with hypertrophic cardiomyopathy represent a small but intricate subset of the ICD population for whom pacing has not been demonstrated to be a consistently effective treatment for outflow tract obstruction. However, according to the 2011 ACCF/AHA Hypertrophic Cardiomyopathy Guideline, dual-chamber ICDs are reasonable for patients with resting LV outflow tract gradients more than 50 mm Hg, and who have indications for ICD implantation to reduce mortality.
      • Gersh B.J.
      • Maron B.J.
      • Bonow R.O.
      • et al.
      2011 ACCF/AHA Guideline for the Diagnosis and Treatment of Hypertrophic Cardiomyopathy: Executive Summary: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines.
      In these patients, atrioventricular delays should be individually programmed to be short enough to achieve RV preexcitation and decrease LV outflow tract gradient, but not too short, which would impair LV filling; usually in the ranges of 60–150 ms.
      • Nishimura R.A.
      • Hayes D.L.
      • Ilstrup D.M.
      • Holmes D.R.
      • Jamil Tajik A.
      Effect of dual-chamber pacing on systolic and diastolic function in patients with hypertrophic cardiomyopathy Acute doppler echocardiographic and catheterization hemodynamic study.
      • Topilski I.
      • Sherez J.
      • Keren G.
      • Copperman I.
      Long-Term Effects of Dual-Chamber Pacing With Periodic Echocardiographic Evaluation of Optimal Atrioventricular Delay in Patients With Hypertrophic Cardiomyopathy >50 Years of Age.
      There are few studies of pacing modes in these patients, and they are limited by small numbers and the failure to quantify important cardiac outcomes.
      In conclusion, atrioventricular interval programming and choosing between DDDR and MVP or other atrioventricular interval management modes should be performed on an individual basis. The goal is to minimize the percentage of RV pacing and to avoid atrial-based pacing with atrioventricular intervals exceeding 250–300 ms leading to atrioventricular uncoupling. In patients with prolonged PR intervals and impaired LV function, biventricular pacing can be considered.

      Cardiac Resynchronization Therapy: Consistent Delivery of Ventricular Pacing

      CRT in combination with a defibrillator device (CRT-D) improves survival and cardiac function in patients with LV systolic dysfunction, prolonged QRS duration, and mild-to-severe HF.
      • Moss A.J.
      • Hall W.J.
      • Cannom D.S.
      • et al.
      Cardiac-Resynchronization Therapy for the Prevention of Heart-Failure Events.
      • Tang A.S.L.
      • Wells G.A.
      • Talajic M.
      • et al.
      Cardiac-Resynchronization Therapy for Mild-to-Moderate Heart Failure.
      • Chen S.
      • Ling Z.
      • Kiuchi M.G.
      • Yin Y.
      • Krucoff M.W.
      The efficacy and safety of cardiac resynchronization therapy combined with implantable cardioverter defibrillator for heart failure: a meta-analysis of 5674 patients.
      The beneficial effect of CRT-D compared with ICD is likely to be derived from biventricular pacing, with a decrease in dyssynchrony and an improvement in cardiac function. The percentage of biventricular pacing capture in the ventricles can be negatively influenced by a number of factors, including atrial tachyarrhythmias, premature ventricular complexes, and programming of the atrioventricular delay, giving way to the intrinsic conduction of the patient and a reduced percentage of biventricular pacing. Some large observational studies have investigated the optimal level of biventricular pacing percentage and found a higher percentage to be associated with more pronounced CRT benefits. An optimal CRT benefit was observed with a biventricular pacing percentage as close to 100% as possible.
      • Koplan B.A.
      • Kaplan A.J.
      • Weiner S.
      • Jones P.W.
      • Seth M.
      • Christman S.A.
      Heart Failure Decompensation and All-Cause Mortality in Relation to Percent Biventricular Pacing in Patients With Heart Failure.
      • Hayes D.L.
      • Boehmer J.P.
      • Day J.D.
      • et al.
      Cardiac resynchronization therapy and the relationship of percent biventricular pacing to symptoms and survival.
      • Gasparini M.
      • Auricchio A.
      • Regoli F.
      • et al.
      Four-Year Efficacy of Cardiac Resynchronization Therapy on Exercise Tolerance and Disease Progression.
      • Ousdigian K.T.
      • Borek P.P.
      • Koehler J.L.
      • Heywood J.T.
      • Ziegler P.D.
      • Wilkoff B.L.
      The Epidemic of Inadequate Biventricular Pacing in Patients With Persistent or Permanent Atrial Fibrillation and Its Association With Mortality.
      In the analysis of the left bundle branch block population in the MADIT-CRT trial, those patients with less than 90% biventricular pacing had similar rates of HF and death compared with the patients randomized to no CRT. By contrast, biventricular pacing exceeding 90% was associated with a benefit of CRT-D in terms of HF or death when compared with ICD patients and no CRT. Biventricular pacing 97% and greater was associated with a further reduction in HF or death and a significant reduction in death alone. Consistently, every 1% increase in biventricular pacing percentage was associated with a 6% risk reduction in HF or death, a 10% risk reduction in death alone, and an increase in LV reverse remodeling.
      • Ruwald A.C.
      • Kutyifa V.
      • Ruwald M.H.
      • et al.
      The association between biventricular pacing and cardiac resynchronization therapy-defibrillator efficacy when compared with implantable cardioverter defibrillator on outcomes and reverse remodelling.
      Therefore, in ICD patients with biventricular pacing, it can be beneficial to adjust the therapy to produce the highest achievable percentage of ventricular pacing, preferably above 98%, to improve survival and reduce HF hospitalization. Approaches to increasing the percentage of biventricular pacing include programming shorter but hemodynamically appropriate atrioventricular delays and minimizing atrial and ventricular ectopic activity and tachyarrhythmias.
      Optimizing the location of ventricular pacing sites and the timing of the pacing pulses can significantly improve cardiac hemodynamics in CRT patients. Echocardiographic optimization of atrioventricular delays in CRT patients can alleviate HF symptoms and increase exercise capacity compared with nominal programming, particularly when approaching nonresponding populations.
      • Mullens W.
      • Grimm R.A.
      • Verga T.
      • et al.
      Insights From a Cardiac Resynchronization Optimization Clinic as Part of a Heart Failure Disease Management Program.
      However, echocardiographic optimization in the PROSPECT study did not support this approach in a randomized trial, and the Frequent Optimization Study Using the QuickOpt Method (FREEDOM) trials failed to provide evidence supporting the benefit of CRT optimization and did not demonstrate superiority of the respective algorithms over nominal or empiric programming.
      • Ellenbogen K.A.
      • Gold M.R.
      • Meyer T.E.
      • et al.
      Primary Results From the SmartDelay Determined AV Optimization: A Comparison to Other AV Delay Methods Used in Cardiac Resynchronization Therapy (SMART-AV) Trial: A Randomized Trial Comparing Empirical, Echocardiography-Guided, and Algorithmic Atrioventricular Delay Programming in Cardiac Resynchronization Therapy.
      • Abraham W.T.
      • Gras D.
      • Yu C.M.
      • Guzzo L.
      • Gupta M.S.
      Rationale and design of a randomized clinical trial to assess the safety and efficacy of frequent optimization of cardiac resynchronization therapy: The Frequent Optimization Study Using the QuickOpt Method (FREEDOM) trial.
      • Bax J.J.
      • Gorcsan J.
      Echocardiography and Noninvasive Imaging in Cardiac Resynchronization Therapy.
      There are limited data supporting the use of LV-only stimulation in a small subset of patients who fail to respond to biventricular stimulation.
      • Thibault B.
      • Ducharme A.
      • Harel F.
      • et al.
      Left ventricular versus simultaneous biventricular pacing in patients with heart failure and a QRS complex >/ = 120 milliseconds.
      Adaptive CRT (aCRT) is an algorithm that periodically measures intrinsic conduction and dynamically adjusts CRT pacing parameters. The algorithm withholds RV pacing when intrinsic electrical conduction to the RV is normal and provides adjustment of CRT pacing parameters based on electrical conduction. A prospective, multicenter, randomized, double-blind clinical trial demonstrated the safety and efficacy of the aCRT algorithm.
      • Martin D.O.
      • Lemke B.
      • Birnie D.
      • et al.
      Investigation of a novel algorithm for synchronized left-ventricular pacing and ambulatory optimization of cardiac resynchronization therapy: Results of the adaptive CRT trial.
      This algorithm can increase the longevity of the implantable device and replace a manual device optimization process with an automatic ambulatory algorithm, although echo optimization might still be needed, at least in nonresponders. The Clinical Evaluation on Advanced Resynchronization (CLEAR) study assessed the effects of CRT with automatically optimized atrioventricular and interventricular delays, based on a peak endocardial acceleration (PEA) signal system. PEA-based optimization of CRT in patients with HF significantly increased the proportion of patients who improved with therapy during follow-up, mainly through an improved New York Heart Association (NYHA) class.
      • Ritter P.
      • Delnoy P.P.H.
      • Padeletti L.
      • et al.
      A randomized pilot study of optimization of cardiac resynchronization therapy in sinus rhythm patients using a peak endocardial acceleration sensor vs. standard methods.
      Tabled 1
      Bradycardia Mode and Rate Programming RecommendationsClass of RecommendationLevel of Evidence
      In ICD patients who also have sinus node disease and guideline-supported indications for a bradycardia pacemaker, it is beneficial to provide dual-chamber pacing to reduce the risk of AF and stroke, to avoid pacemaker syndrome, and to improve quality of life.IB-R
      In single- or dual-chamber ICD patients without guideline-supported indications for bradycardia pacing, adjusting the pacing parameters is recommended so that ventricular stimulation is minimized to improve survival and reduce HF hospitalization.IB-R
      In ICD patients who have sinus rhythm, no or only mild LV dysfunction, and atrioventricular block where ventricular pacing is expected, it is reasonable to provide dual-chamber pacing in preference to single-chamber ventricular pacing to avoid pacemaker syndrome and to improve quality of life.IIaB-R
      In ICD patients who have sinus rhythm, mild-to-moderate LV dysfunction, and atrioventricular block where ventricular pacing is expected, it is reasonable to provide CRT in preference to dual-chamber ventricular pacing to improve the combination of HF hospitalization, LV enlargement, and death.IIaB-R
      In ICD patients who have chronotropic incompetence, it can be beneficial to program the ICD to provide sensor-augmented rate response, especially if the patient is young and physically active.IIaB-NR
      In dual-chamber ICD patients with native PR intervals of 230 ms or less, it can be beneficial to program the mode, automatic mode change, and rate response so that the patient’s native atrioventricular conduction minimizes ventricular pacing.IIaB-R
      In biventricular pacing ICD patients, it can be beneficial to adjust the therapy to produce the highest achievable percentage of ventricular pacing, preferably above 98%, to improve survival and reduce HF hospitalization.IIaB-NR
      In biventricular pacing ICD patients, it can be reasonable to activate the algorithms providing automatic adjustment of atrioventricular delay and/or LV-RV offset to obtain a high percentage of synchronized pacing and reduce the incidence of clinical events.IIbB-R

       Tachycardia Detection Programming

      Following significant technological changes in ICDs in recent years, the concept of optimal ICD programming has changed dramatically. From the dawn of this therapy in the early 1980s to the first decade of the 21st century, the rapid detection and treatment of VT and ventricular fibrillation (VF) have been stressed. The argument for rapid detection of VT and VF derived from a number of factors. Initial skepticism regarding the feasibility of sudden death prevention with ICDs, the fact that early ICD patients had all survived one or more cardiac arrests, concern for undersensing and underdetection (of VF in particular), demonstration of an increasing defibrillation threshold with prolonged VF duration, and the increased energy requirement of monophasic defibrillation all created a culture of programming for rapid tachycardia detection and the shortest possible time to initial therapy.
      • Lown B.
      Implanted Standby Defibrillators.
      • Mirowski M.
      • Reid P.R.
      • Mower M.M.
      • et al.
      Termination of malignant ventricular arrhythmias with an implanted automatic defibrillator in human beings.
      • Gradaus R.
      • Bode-Schnurbus L.
      • Weber M.
      • et al.
      Effect of ventricular fibrillation duration on the defibrillation threshold in humans.
      The initial generations of ICDs did not record and save electrograms (EGMs), leading to a reduced appreciation for the frequency and impact of inappropriate shocks. With the advent and then dominance of primary prevention indications, avoidable shocks assumed a relatively larger proportion of total therapy.
      • Moss A.J.
      • Zareba W.
      • Hall W.J.
      • et al.
      Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction.
      • Moss A.J.
      • Hall W.J.
      • Cannom D.S.
      • et al.
      Improved Survival with an Implanted Defibrillator in Patients with Coronary Disease at High Risk for Ventricular Arrhythmia.
      • Bardy G.H.
      • Lee K.L.
      • Mark D.B.
      • et al.
      Amiodarone or an Implantable Cardioverter–Defibrillator for Congestive Heart Failure.
      • Klein R.C.
      • Raitt M.H.
      • Wilkoff B.L.
      • et al.
      Analysis of implantable cardioverter defibrillator therapy in the Antiarrhythmics Versus Implantable Defibrillators (AVID) Trial. J.
      • Daubert J.P.
      • Zareba W.
      • Cannom D.S.
      • et al.
      Inappropriate implantable cardioverter-defibrillator shocks in MADIT II: frequency, mechanisms, predictors, and survival impact.
      • Poole J.E.
      • Johnson G.W.
      • Hellkamp A.S.
      • et al.
      Prognostic importance of defibrillator shocks in patients with heart failure.
      Gradually, publications have increased awareness of the frequency and the diverse range of adverse outcomes associated with avoidable ICD therapy, and have demonstrated that avoidable ICD shocks can be reduced by evidence-based programming of the detection rate, detection duration, antitachycardia pacing (ATP), algorithms that discriminate supraventricular tachycardia (SVT) from VT, and specific programming to minimize the sensing of noise.
      • Klein R.C.
      • Raitt M.H.
      • Wilkoff B.L.
      • et al.
      Analysis of implantable cardioverter defibrillator therapy in the Antiarrhythmics Versus Implantable Defibrillators (AVID) Trial. J.
      • Daubert J.P.
      • Zareba W.
      • Cannom D.S.
      • et al.
      Inappropriate implantable cardioverter-defibrillator shocks in MADIT II: frequency, mechanisms, predictors, and survival impact.
      • Poole J.E.
      • Johnson G.W.
      • Hellkamp A.S.
      • et al.
      Prognostic importance of defibrillator shocks in patients with heart failure.
      • Grimm W.
      • Flores B.T.
      • Marchlinski F.E.
      Shock occurrence and survival in 241 patients with implantable cardioverter-defibrillator therapy.
      • Luderitz B.
      • Jung W.
      • Deister A.
      • Marneros A.
      • Manz M.
      Patient acceptance of the implantable cardioverter defibrillator in ventricular tachyarrhythmias.
      • Rosenqvist M.
      • Beyer T.
      • Block M.
      • den Dulk K.
      • Minten J.
      • Lindemans F.
      Adverse Events With Transvenous Implantable Cardioverter-Defibrillators: A Prospective Multicenter Study.
      • Gold M.R.
      • Peters R.W.
      • Johnson J.W.
      • Shorofsky S.R.
      Complications Associated with Pectoral Implantation of Cardioverter Defibrillators.
      • Kron J.
      Clinical significance of device-related complications in clinical trials and implications for future trials: Insights from the Antiarrhythmics Versus Implantable Defibrillators (AVID) trial.
      • Schron E.B.
      • Exner D.V.
      • Yao Q.
      • et al.
      Quality of life in the antiarrhythmics versus implantable defibrillators trial: impact of therapy and influence of adverse symptoms and defibrillator shocks.
      • Vollmann D.
      • Luthje L.
      • Vonhof S.
      • Unterberg C.
      Inappropriate therapy and fatal proarrhythmia by an implantable cardioverter-defibrillator.
      • Sweeney M.O.
      • Wathen M.S.
      • Volosin K.
      • et al.
      Appropriate and Inappropriate Ventricular Therapies, Quality of Life, and Mortality Among Primary and Secondary Prevention Implantable Cardioverter Defibrillator Patients: Results From the Pacing Fast VT REduces Shock ThErapies (PainFREE Rx II) Trial.
      • Pinski S.L.
      • Fahy G.J.
      The proarrhythmic potential of implantable cardioverter-defibrillators.

      Duration Criteria for the Detection of Ventricular Arrhythmia

      Until recently, default device programming used short-duration “detection” criteria that varied by manufacturer and a tachycardia rate of approximately 2.8 to 5 seconds before either ATP or charging (including detection time plus duration or number of intervals).
      • Daubert J.P.
      • Zareba W.
      • Cannom D.S.
      • et al.
      Inappropriate implantable cardioverter-defibrillator shocks in MADIT II: frequency, mechanisms, predictors, and survival impact.
      • Wathen M.S.
      • DeGroot P.J.
      • Sweeney M.O.
      • et al.
      Prospective randomized multicenter trial of empirical antitachycardia pacing versus shocks for spontaneous rapid ventricular tachycardia in patients with implantable cardioverter-defibrillators: Pacing Fast Ventricular Tachycardia Reduces Shock Therapies (PainFREE Rx II) trial results.
      With increased awareness of the potential harm from inappropriate shocks and the realization from stored pacemaker EGMs that even long episodes of VT can self-terminate, a strategy of prolonged detection settings has been explored. This strategy allows episodes to self-terminate without requiring device intervention and reduces inappropriate therapy for nonmalignant arrhythmias. The benefit of programming a prolonged detection duration (30 of 40 beats) was first reported in the Prevention Parameters Evaluation (PREPARE) study on exclusively primary prevention subjects (n = 700), and compared outcomes to a historical ICD cohort programmed at “conventional detection delays” with about half programmed to 12 of 16 intervals within the programmed detection zone and half to 18 of 24 intervals.
      • Wilkoff B.L.
      • Williamson B.D.
      • Stern R.S.
      • et al.
      Strategic programming of detection and therapy parameters in implantable cardioverter-defibrillators reduces shocks in primary prevention patients: results from the PREPARE (Primary Prevention Parameters Evaluation) study.
      The programming in PREPARE demonstrated a significant reduction in inappropriate shocks for supraventricular arrhythmia and in avoidable shocks for VT. In addition, a composite endpoint was reduced as well: the morbidity index, which consists of shocks, syncope, and untreated sustained VT. Within the limitations of a nonrandomized study, it was concluded that extending detection times reduces shocks without increasing serious adverse sequelae.
      In 2009, the Role of Long-Detection Window Programming in Patients with Left Ventricular Dysfunction, Non-Ischemic Etiology in Primary Prevention Treated with a Biventricular ICD (RELEVANT) study confirmed and expanded the results of the PREPARE trial in a cohort of 324 primary prevention CRT-D patients with nonischemic cardiomyopathy.
      • Gasparini M.
      • Menozzi C.
      • Proclemer A.
      • et al.
      A simplified biventricular defibrillator with fixed long detection intervals reduces implantable cardioverter defibrillator (ICD) interventions and heart failure hospitalizations in patients with non-ischaemic cardiomyopathy implanted for primary prevention: the RELEVANT [Role of long dEtection window programming in patients with LEft VentriculAr dysfunction, Non-ischemic eTiology in primary prevention treated with a biventricular ICD] study.
      The subjects were treated with simplified VT management, which implies much longer detection for VF episodes (30 of 40) compared with the control group (12 of 16) and a monitor-only window for VT. As in PREPARE, the RELEVANT study group experienced a significantly reduced burden of ICD interventions (81% reduction) without increasing the incidence of syncope. Fewer inappropriate shocks and HF hospitalizations were reported in the RELEVANT study group compared with the control group.
      The Multicenter Automatic Defibrillator Implantation Trial: Reduce Inappropriate Therapy (MADIT-RIT), a 3-arm study, compared a conventional programming strategy (a 1-second delay for VF [equivalent to approximately 12 intervals including detection plus delay] and a 2.5-second delay for VT detection [equivalent to approximately 16 intervals including detection plus delay]) (Arm A) to both a high-rate cutoff with a VF zone starting at 200 bpm (Arm B) (discussed in section Rate Criteria for the Detection of Ventricular Arrhythmia and discussed as referenced in reference
      • Moss A.J.
      • Schuger C.
      • Beck C.A.
      • et al.
      Reduction in Inappropriate Therapy and Mortality through ICD Programming.
      .) and to a delayed therapy strategy with a 60-second delay for rates between 170 and 199 bpm, a 12-second delay at 200 to 249 bpm, and a 2.5-second delay at 250 bpm (Arm C).
      • Moss A.J.
      • Schuger C.
      • Beck C.A.
      • et al.
      Reduction in Inappropriate Therapy and Mortality through ICD Programming.
      The MADIT-RIT population was exclusively primary prevention and included approximately an equal proportion of nonischemic and ischemic cardiomyopathy patients. All the patients were implanted with either a dual-chamber ICD or a CRT-D programmed to deliver ATP before charging. After a mean 1.4-year follow-up, the prolonged detection group (Arm C) was associated with a reduction in treated VT/VF leading to a 76% reduction in the primary endpoint of the first inappropriate therapy (P <.001), as well as a significant reduction in the first appropriate therapy, appropriate ATP, and inappropriate ATP, but not in appropriate or inappropriate shock.
      The Avoid Delivering Therapies for Non-Sustained Arrhythmias in ICD Patients III (ADVANCE III) trial reported that a long detection was associated with a highly significant reduction of overall therapies (appropriate and inappropriate ATP and/or shocks), inappropriate shocks, and all-cause hospitalizations.
      • Gasparini M.
      • Proclemer A.
      • Klersy C.
      • et al.
      Effect of long-detection interval vs standard-detection interval for implantable cardioverter-defibrillators on antitachycardia pacing and shock delivery: the ADVANCE III randomized clinical trial.
      Importantly, like PREPARE, RELEVANT, and MADIT-RIT, the extended detection duration used in the ADVANCE III trial (30 of 40) did not negatively impact the rate of syncopal events. There was no significant difference in mortality between the optimal and the conventional programming groups. Compared with the MADIT-RIT trial, the ADVANCE III control group had a longer detection duration (primarily in the VF zone), and enrolled a larger cohort of subjects covering all ICD types (single, dual, and CRT with ATP delivered during charging) for both primary and secondary prevention indications. Finally, the Programming Implantable Cardioverter-Defibrillators in Patients With Primary Prevention Indication (PROVIDE) trial randomized 1670 patients to conventional programming (12-beat detection in each of 2 zones) or experimental programming (2 VT and 1 VF zone requiring 25-, 18-, and 12-beat detection, respectively).
      • Saeed M.
      • Hanna I.
      • Robotis D.
      • et al.
      Programming implantable cardioverter-defibrillators in patients with primary prevention indication to prolong time to first shock: results from the PROVIDE study.
      PROVIDE observed a significant 36% reduction in the 2-year all-cause shock rate and an improved survival (hazard ratio [HR] 0.7; 95% confidence interval [CI] 0.50–0.98; P = .036).
      Whereas PREPARE, RELEVANT, MADIT-RIT, and PROVIDE only enrolled primary prevention patients, a subset of the ADVANCE III study evaluated the efficacy and safety of a long-detection approach in secondary prevention patients who have a known higher burden of arrhythmic episodes. In this particular subset of 25% of the enrolled patients, ADVANCE III reported that a long detection duration reduced the overall therapies delivered, primarily due to a significant 36% reduction in appropriate shocks.
      • Kloppe A.
      • Proclemer A.
      • Arenal A.
      • et al.
      Efficacy of long detection interval ICD settings in secondary prevention population: Data from the Advance III trial.
      Syncopal episodes related to arrhythmic events and deaths were similar between the 2 groups.
      Following shortly on the heels of these trials, 2 meta-analyses including the above studies were published in 2014. Tan et al presented the data from the RELEVANT, PREPARE, MADIT-RIT, ADVANCE III, PROVIDE, and EMPIRIC trials.
      • Tan V.H.
      • Wilton S.B.
      • Kuriachan V.
      • Sumner G.L.
      • Exner D.V.
      Impact of Programming Strategies Aimed at Reducing Nonessential Implantable Cardioverter Defibrillator Therapies on Mortality: A Systematic Review and Meta-Analysis.
      • Wilkoff B.L.
      • Ousdigian K.T.
      • Sterns L.D.
      • et al.
      A comparison of empiric to physician-tailored programming of implantable cardioverter-defibrillators: results from the prospective randomized multicenter EMPIRIC trial.
      A 30% reduction in the risk of death was found in the therapy reduction group when including all 6 studies; however, similar results were observed when separately considering the 4 randomized trials and the 2 observational studies. Data on the appropriateness of shocks were available only for RELEVANT, MADIT-RIT, ADVANCE III, and PROVIDE, and a 50% reduction in inappropriate shock was observed without an increased risk of syncope and appropriate shock.
      A meta-analysis evaluated the impact of a prolonged arrhythmia detection duration on outcome
      • Scott P.A.
      • Silberbauer J.
      • McDonagh T.A.
      • Murgatroyd F.D.
      The Impact of Prolonged ICD Arrhythmia Detection Times On Outcomes: A Meta-analysis.
      —thus excluding the EMPIRIC trial (which used 18 of 24 intervals for VF detection), the PREPARE trial (which used a historical control group), and the high-rate therapy arm of the MADIT-RIT. Analyzing the cohort of patients enrolled in RELEVANT, Arm C of MADIT-RIT, ADVANCE III, and PROVIDE, the meta-analysis reported a reduction of overall burden of therapies, driven by the greater than 50% reduction in appropriate and inappropriate ATP and the 50% reduction in inappropriate shocks. A reduction in all-cause mortality was observed without an increase in the risk of syncope.
      All the reports above clearly stress the necessity to consider a long detection window setting as a “default” strategy for ICD programming. Moreover, they underline the importance of choosing to reprogram the ICD rather than using the manufacturers’ out-of-the-box settings. A summary of the large comparative datasets of tachycardia detection is presented in Table 2.
      Table 2Tachycardia detection evidence
      StudyParticipants (N)Short detection controlsProlonged detection interventionFindings
      PREPARE139112 of 16 (58%)30 of 40Reduction in inappropriate shocks (SVT), avoidable shocks (VT), and ”morbidity index”
      Nonrandomized18 of 24 (42%)
      Primary prevention
      RELEVANT32412 of 1630 of 40Reduction in inappropriate shocks (SVT), avoidable shocks (VT), and HF hospitalizations
      Nonrandomized
      Primary prevention
      MADIT-RIT15002.5 s (170–199 bpm)60 s (170–199 bpm)Reduction in first inappropriate therapy, first appropriate therapy, appropriate ATP, and inappropriate ATP; improved survival
      Randomized1 s (≥200 bpm)12 s (200–249 bpm)
      Primary prevention2.5 s (≥250 bpm)
      ADVANCE-III190218 of 2430 of 40Reduction in overall therapies, inappropriate shocks, and all-cause hospitalizations
      Randomized
      Primary & secondary prevention
      PROVIDE167012 beats25 beats (180–214 bpm)Reduction in all-cause shock rate; improved survival
      Randomized18 beats (214–250 bpm)
      Primary prevention12 beats (>250 bpm)

      Limitations of Data on the Duration of Tachycardia Required for Detection

      Although the findings on the effect of tachycardia detection duration are based on roughly 7000 patients, there are limitations. Data on secondary prevention patients are limited to 25% of the 1902 patients enrolled in the ADVANCE III trial (n = 477). Although this proportion is a fair representation of the real-world population receiving an ICD, more data are needed to fully understand the impact of a long-detection strategy in this subgroup of patients. MADIT-RIT and RELEVANT did not include single-chamber ICDs, and MADIT-RIT excluded patients with permanent AF. The PROVIDE and MADIT-RIT trials were designed to assess the time to first therapy and not the overall rate of therapies. MADIT-RIT, ADVANCE III, RELEVANT, and PROVIDE used devices from 3 different manufacturers with detection strategies leading to different detection times, intervals, and definitions. Some manufacturers of ICDs are not represented at all in these trials. Programming in the trial control groups was highly heterogeneous, with time until ATP or charging for VF as varied as about 11–12 intervals (approximately 3.4 seconds at 200 bpm) in MADIT-RIT and PROVIDE and 18 intervals (approximately 5.4 seconds) in ADVANCE III. An approximate translation of the impact of the number of intervals to detection and tachycardia cycle length (CL) are listed in Table 3. A further limitation is the relatively short duration and lack of inclusion of the patients with the most severe illness receiving an ICD. This limitation minimizes the exposure to relatively rare events that might occur in nonclinical trial, “real-world” patients. Lastly, as ICD batteries deplete, the charge time lengthens. The effect of such a delay to shock therapy in addition to prolonged detection times has not been studied.
      Table 3Approximating the time taken to detect 30 intervals using fixed 8 of 10 interval detection plus adding a time delay, for a range of heart rates
      Arrhythmia characteristicInterval-based detection8 of 10 interval detection, then delay
      Beats per minuteCycle length (ms)Time to detect 30 intervals (s)Time to detect 8 intervals (s)Subsequent delay to approximate a 30-interval detection time
      18033310.02.77.0
      2003009.02.46.5
      2202738.22.26.0
      2402507.52.05.5
      2602316.91.85.0
      2802146.41.74.5
      3002006.01.64.5

      Rate Criteria for the Detection of Ventricular Arrhythmia

      Ventricular tachyarrhythmia detection by implantable devices is primarily based on heart rate. Heart rates can be extremely rapid during ventricular tachyarrhythmias, and it is less likely that such rates are achieved during supraventricular tachyarrhythmias—thus making rate a powerful component of arrhythmia discrimination. However, VT can also present slower rates in the range of those of supraventricular tachyarrhythmias or even of sinus tachycardia. Therefore, any rate cutoff will always imply a tradeoff between maximizing sensitivity for ventricular tachyarrhythmia detection at the expense of inappropriate detection of fast supraventricular tachyarrhythmias and maximizing specificity at the expense of some slow VTs going undetected.
      • Bansch D.
      • Steffgen F.
      • Gronefeld G.
      • et al.
      The 1+1 trial: a prospective trial of a dual- versus a single-chamber implantable defibrillator in patients with slow ventricular tachycardias.
      Because ICD therapy was initially employed in secondary prevention patients, the cutoff rate was usually tailored to a rate slightly below that of the observed VT. With the development of ICD use in primary prevention, the detection rate came into question because there is no history of sustained tachycardia in these patients. The recognition of a significant rate of inappropriate therapies in primary prevention studies, and their potentially deleterious consequences, prompted the development of studies that tested whether programming faster rate criteria reduced avoidable ICD therapies, particularly shocks. In many of these studies, however, testing also involved programming parameters other than rate, and those have been discussed as described below.
      In the MADIT-RIT trial of primary prevention patients, conventional therapy (rate cutoff 170 bpm, n = 514) was compared with a “high-rate group” in which rate cutoff was 200 bpm (n = 500).
      • Moss A.J.
      • Schuger C.
      • Beck C.A.
      • et al.
      Reduction in Inappropriate Therapy and Mortality through ICD Programming.
      The primary endpoint of first occurrence of inappropriate therapy was observed in 20% of the conventional group and in 4% of the high-rate group (P <.001) over a mean follow-up of 1.4 years. ICD shocks occurred in 4% and 2% of patients in the conventional and high-rate groups, respectively. The proportion of patients with appropriate therapies was also significantly different (22% vs 9% in the conventional and high-rate groups, respectively). It is important to note that all-cause mortality in the conventional group (6.6%) was approximately double that of the high-rate group (3.2%, P = .01).
      In a single-center observational study, 365 primary prevention patients were prospectively studied, with programming including a single shock-only zone over 220 bpm.
      • Clementy N.
      • Pierre B.
      • Lallemand B.
      • et al.
      Long-term follow-up on high-rate cut-off programming for implantable cardioverter defibrillators in primary prevention patients with left ventricular systolic dysfunction.
      During a mean follow-up of 42 months, 11% of the patients (7% in the first 2 years) experienced appropriate shocks, and only 6.6% experienced inappropriate shocks. It was notable that in the monitoring zone over 170 bpm, self-limiting VT episodes were detected in 12% of the patients but were symptomatic in only 1.9%. The mortality rate was 17%, with one case of unexplained sudden death.
      A recent primary prevention study revealed that there was considerable overlap between the ventricular rates of supraventricular and ventricular arrhythmias, and the majority of inappropriate shocks occurred at rates between 181 and 213 bpm.
      • Saeed M.
      • Hanna I.
      • Robotis D.
      • et al.
      Programming implantable cardioverter-defibrillators in patients with primary prevention indication to prolong time to first shock: results from the PROVIDE study.
      These data also support the notion that for primary prevention patients it is safe to increase the rate cutoff up to 200 bpm to reduce these potentially avoidable therapies, a practice that was also supported by the results of the MADIT-RIT trial.
      In secondary prevention patients, no trial has randomized the detection rate and compared outcomes. However, the ADVANCE III Secondary Prevention substudy confirmed the safety of not programming therapy for rates <188 bpm; syncope was rare at 2 to 3 episodes per 100 patient-years.
      • Kloppe A.
      • Proclemer A.
      • Arenal A.
      • et al.
      Efficacy of long detection interval implantable cardioverter-defibrillator settings in secondary prevention population: data from the Avoid Delivering Therapies for Nonsustained Arrhythmias in ICD Patients III (ADVANCE III) trial.
      Previously published recommendations suggest a VT zone starting at 10 to 20 bpm slower than the observed tachycardia rate, usually including a 2- or 3-zone arrhythmia detection scheme (as discussed elsewhere).
      • Webber M.R.
      • Stiles M.K.
      Recommendations for the programming of implantable cardioverter-defibrillators in New Zealand.
      Clinicians should allow a larger rate differential when starting a patient on an antiarrhythmic drug that might slow the clinical tachycardia rate (e.g., amiodarone).

      Single- or Multi-Zone Detection

      Modern ICDs allow the rate to be classified into single or multiple zones. This classification permits different criteria to be applied for detection (e.g., number of intervals) and for tiered therapy (e.g., different adaptive CLs for slower vs faster VTs and more sequences of ATP for slower and presumably hemodynamically more stable VTs). Additionally, because some manufacturers tie SVT discrimination algorithms to specific VT zones, programming more than one tachycardia zone allows for greater specificity in discriminating VT from SVT (see online Appendix B). Although there are trials in which arms differ in whether a single zone or multiple zones are used, this is typically performed to allow programming of various detection, discrimination, or therapies for comparison. Thus, the number of zones was not the randomization variable being directly compared. Therefore, the concept of single- vs multizone programming as a head-to-head comparison is not well tested. The MADIT-RIT study randomized primary prevention ICD patients into 1 of 3 arms with single-, dual-, or triple-zone programming (the single-zone arm also had a monitoring zone). Although the trial’s aim was to compare conventional therapy with high-rate and delayed therapy, the outcome for the single-zone arm (high-rate) was comparable to the triple-zone (delayed) arm and superior to the dual-zone (conventional) arm, with regard to inappropriate shock.
      • Moss A.J.
      • Schuger C.
      • Beck C.A.
      • et al.
      Reduction in Inappropriate Therapy and Mortality through ICD Programming.
      This study is consistent with multiple studies in ICD programming in which the use of multiple-zone programming has allowed for flexibility in programming strategies with regard to detection, discrimination, and therapy. Additionally, there are observational data from the ALTITUDE Real World Evaluation of Dual-Zone ICD and CRT-D Programming Compared to Single-Zone Programming (ALTITUDE REDUCES) study that show that dual-zone programming is associated with fewer shocks than single-zone programming, at least for rates <200 bpm.
      • Hayes D.L.
      • Boehmer J.P.
      • Day J.D.
      • et al.
      Cardiac resynchronization therapy and the relationship of percent biventricular pacing to symptoms and survival.
      Therefore, the authors conclude that using more than 1 detection zone can be useful for modern ICD programming. It should be noted that ATP before or during charging was used in the majority of studies described in both the tachycardia detection and therapy sections and thus is recommended for longer detection.

      Discrimination Between Supraventricular and Ventricular Arrhythmia

      The SVT-VT discrimination process classifies a sequence of sensed EGMs that satisfies rate and duration criteria as either SVT (therapy withheld) or VT/VF (therapy given). Discriminators are individual algorithm components that provide a partial rhythm classification or a definitive classification for a subset of rhythms. Discrimination algorithms combine individual component discriminators to produce a final rhythm classification. Discrimination algorithms vary among manufacturers and between individual ICD models (see online Appendix B). The final rhythm classification can differ depending on the technical details of how each individual discriminator is calculated, the nominal or programmed threshold for each discriminator, the order in which discriminator components are applied, and the logical connections between them (e.g., “and” vs “or”). In some ICDs, rhythms classified as VT/VF undergo a subsequent sensing-verification step to confirm that EGMs represent true cardiac activation.

       SVT-VT Discriminator Components

      Individual discriminators can be considered in relation to the EGMs analyzed as ventricular-only or both atrial and ventricular, by the rhythm that they identify (e.g., AF, sinus tachycardia, VT), or by the type of EGM information analyzed (intervals vs morphology). Note that ventricular rate alone is a mandatory discriminator, as discussed in the section above. We summarize the most commonly used discriminators. More comprehensive discussions are available in the literature.
      • Gard J.J.
      • Friedman P.A.
      Strategies to Reduce ICD Shocks: The Role of Supraventricular Tachycardia–Ventricular Tachycardia Discriminators.
      • Aliot E.
      • Nitzsche R.
      • Ripart A.
      Arrhythmia detection by dual-chamber implantable cardioverter defibrillators. A review of current algorithms.
      • Koneru J.N.
      • Swerdlow C.D.
      • Wood M.A.
      • Ellenbogen K.A.
      Minimizing inappropriate or “unnecessary” implantable cardioverter-defibrillator shocks: appropriate programming.
      • Mansour F.
      • Khairy P.
      Programming ICDs in the Modern Era beyond Out-of-the Box Settings.
      • Swerdlow C.
      • Gillberg J.
      • Khairy P.
      Sensing and detection.

       Rejection of Sinus Tachycardia by Onset

      Several interval-based discriminators focus on differences in the onset of sinus tachycardia (gradual and parallel acceleration of atrial and conducted ventricular intervals) compared with VT (typically abrupt, with at least transient atrioventricular dissociation). Sudden (abrupt) onset was one of the first single-chamber, interval-based discriminators. It withholds therapy if acceleration across the sinus-VT rate boundary is gradual. Because onset discriminators classify the rhythm only once, and thus cannot correct misclassifications, they are now used infrequently and only with an override feature and/or other discriminators.
      • Brugada J.
      • Mont L.
      • Figueiredo M.
      • Valentino M.
      • Matas M.
      • Navarro-Lopez F.
      Enhanced detection criteria in implantable defibrillators.
      • Weber M.
      • Bocker D.
      • Bansch D.
      • et al.
      Efficacy and safety of the initial use of stability and onset criteria in implantable cardioverter defibrillators.
      • Swerdlow C.D.
      • Ahern T.
      • Chen P.S.
      • et al.
      Underdetection of ventricular tachycardia by algorithms to enhance specificity in a tiered-therapy cardioverter-defibrillator.
      • Swerdlow C.D.
      • Chen P.S.
      • Kass R.M.
      • Allard J.R.
      • Peter C.T.
      Discrimination of ventricular tachycardia from sinus tachycardia and atrial fibrillation in a tiered-therapy cardioverter-defibrillator.
      Chamber of onset is a related, interval-based, dual-chamber discriminator that classifies a 1:1 tachycardia as SVT if the atrial rhythm accelerates at the device-defined onset. A related “Sinus Tachycardia®” discriminator classifies a tachycardia as VT if either the RR or the PR intervals deviate sufficiently from the range of the immediately preceding sinus intervals.
      • Stadler R.W.
      • Gunderson B.D.
      • Gillberg J.M.
      An adaptive interval-based algorithm for withholding ICD therapy during sinus tachycardia.

       Rejection of AF by Ventricular Interval Regularity

      Ventricular interval regularity (interval stability) is an explicit single-chamber, interval-based discriminator that classifies the rhythm as AF if the ventricular intervals are sufficiently irregular. Because interval variability in conducted AF decreases at faster rates, stability becomes unreliable in discriminating VT from conducted AF at ventricular rates greater than 170 bpm.
      • Brugada J.
      • Mont L.
      • Figueiredo M.
      • Valentino M.
      • Matas M.
      • Navarro-Lopez F.
      Enhanced detection criteria in implantable defibrillators.
      • Swerdlow C.D.
      • Chen P.S.
      • Kass R.M.
      • Allard J.R.
      • Peter C.T.
      Discrimination of ventricular tachycardia from sinus tachycardia and atrial fibrillation in a tiered-therapy cardioverter-defibrillator.
      Interval stability can also fail if drugs (e.g., amiodarone) cause monomorphic VT to become irregular or induce polymorphic VT to slow into the SVT-VT discrimination zone.
      • Swerdlow C.D.
      • Ahern T.
      • Chen P.S.
      • et al.
      Underdetection of ventricular tachycardia by algorithms to enhance specificity in a tiered-therapy cardioverter-defibrillator.
      • Neuzner J.
      • Pitschner H.F.
      • Schlepper M.
      Programmable VT detection enhancements in implantable cardioverter defibrillator therapy. Pacing Clin.

       Diagnosis of VT by Dual-Chamber Components: Atrial vs Ventricular Rate and Atrioventricular Association

      In contrast to the single-chamber discrimination algorithms above that diagnose SVT when their criteria are fulfilled, 2 separate, interval-based, dual-chamber discrimination algorithms diagnose VT. First, atrial rate vs ventricular rate diagnoses VT if the ventricular rate exceeds the atrial rate.
      • Dorian P.
      • Philippon F.
      • Thibault B.
      • et al.
      Randomized controlled study of detection enhancements versus rate-only detection to prevent inappropriate therapy in a dual-chamber implantable cardioverter-defibrillator.
      Second, atrioventricular dissociation identifies isorhythmic VT during sinus tachycardia. Inversely, the atrioventricular association discriminator diagnoses SVT in the presence of N:1 (e.g., 2:1, 4:1) atrioventricular association consistent with atrial flutter at a fixed conduction ratio.

       The Ventricular Electrogram Morphology Discriminator

      This versatile, single-chamber discriminator is the only algorithm component that does not rely on inter-EGM intervals. It classifies tachycardias as SVT if the morphology (shape) of the ventricular EGM is sufficiently similar to the morphology during a conducted baseline rhythm. It can potentially discriminate any SVT from VT, including SVTs that challenge other discriminators, such as abrupt-onset 1:1 SVTs and irregular VT during AF. Contemporary ICDs (including subcutaneous ICD [S-ICD]) analyze EGMs from the shock electrodes, which record a larger field of view than EGMs from pace-sense electrodes.
      • Requena-Carrion J.
      • Vaisanen J.
      • Alonso-Atienza F.
      • Garcia-Alberola A.
      • Ramos-Lopez F.J.
      • Rojo-Alvarez J.L.
      Sensitivity and spatial resolution of transvenous leads in implantable cardioverter defibrillator.
      They operate using a common series of steps and are susceptible to common failure modes.
      • Swerdlow C.
      • Gillberg J.
      • Khairy P.
      Sensing and detection.
      • Swerdlow C.D.
      • Brown M.L.
      • Lurie K.
      • et al.
      Discrimination of ventricular tachycardia from supraventricular tachycardia by a downloaded wavelet-transform morphology algorithm: a paradigm for development of implantable cardioverter defibrillator detection algorithms.
      • Theuns D.A.
      • Rivero-Ayerza M.
      • Goedhart D.M.
      • van der Perk R.
      • Jordaens L.J.
      Evaluation of morphology discrimination for ventricular tachycardia diagnosis in implantable cardioverter-defibrillators.
      • Klein G.J.
      • Gillberg J.M.
      • Tang A.
      • et al.
      Improving SVT discrimination in single-chamber ICDs: A new electrogram morphology-based algorithm.
      • Swerdlow C.D.
      • Friedman P.A.
      Advanced ICD troubleshooting: Part I. Pacing Clin.
      The first common step is acquisition of a baseline rhythm template by mathematically extracting EGM features and storing them. Both the acquisition of the initial template and the subsequent template updating are automated in most ICDs. Nevertheless, physicians should confirm that the conducted baseline beats match the template both at implant and during follow-up. For CRT patients, the template must be manually collected. If the wavelet signal during template acquisition appears clipped, adjustments specific to the manufacturer might be necessary.

       SVT-VT Discrimination Algorithms

      Discrimination algorithms combine component discriminators to provide a final rhythm classification of VT/VF or SVT. The morphology discriminator frequently forms the primary component of single-chamber algorithms with stability playing a secondary role and sudden onset used sparingly. By contrast, the cornerstone of most dual-chamber algorithms is explicit or implicit comparison of atrial vs ventricular rates. Because the ventricular rate is greater than the atrial rate in more than 80% of VTs, algorithms that compare atrial and ventricular rates as their first step apply additional SVT discriminators to fewer than 20% of VTs, reducing the risk that they will misclassify VT as SVT.
      • Wilkoff B.L.
      • Kuhlkamp V.
      • Volosin K.
      • et al.
      Critical analysis of dual-chamber implantable cardioverter-defibrillator arrhythmia detection: results and technical considerations.
      • Glikson M.
      • Swerdlow C.D.
      • Gurevitz O.T.
      • et al.
      Optimal combination of discriminators for differentiating ventricular from supraventricular tachycardia by dual-chamber defibrillators.
      Most dual-chamber algorithms further restrict single-chamber discriminators to tachycardias for which they offer the greatest benefit; thus, stability is applied only if AF is confirmed by direct calculation of the atrial rate or the atrial rate is greater than the ventricular rate. Similarly, sudden onset, chamber of onset, or 1:1 atrioventricular association are applied only if the atrial rate equals the ventricular rate. The use of discriminators in redetection varies among manufacturers and has not been systematically studied.

       Assessing Clinical Benefits and Risks

       What Evidence Supports a Benefit?

      • 1.
        The annual rate of inappropriate shocks has fallen dramatically from 37%–50% for SVT alone in early studies to 1%–5% for all causes in modern clinical trials.
        • Gasparini M.
        • Proclemer A.
        • Klersy C.
        • et al.
        Effect of long-detection interval vs standard-detection interval for implantable cardioverter-defibrillators on antitachycardia pacing and shock delivery: the ADVANCE III randomized clinical trial.
        • Dorian P.
        • Philippon F.
        • Thibault B.
        • et al.
        Randomized controlled study of detection enhancements versus rate-only detection to prevent inappropriate therapy in a dual-chamber implantable cardioverter-defibrillator.
        • Moss A.J.
        • Schuger C.
        • Beck C.A.
        • et al.
        Reduction in inappropriate therapy and mortality through ICD programming.

        Meijer A, Auricchio A, Kurita T, et al. Inappropriate shock rates in patients with single chamber ICDs using a novel suite of detection algorithms. Europace. 152013: ii116-ii117.

        • Grimm W.
        • Flores B.F.
        • Marchlinski F.E.
        Electrocardiographically documented unnecessary, spontaneous shocks in 241 patients with implantable cardioverter defibrillators.
        This decrease is likely due to differences in both clinical populations and the programming of multiple ICD parameters, including longer detection time and higher rate cutoffs. Thus, it is difficult to isolate the differential effect of SVT-VT discrimination algorithms using clinical data. These studies have programmed discrimination algorithms to ON, however, so it seems reasonable to use them.
      • 2.
        Although clinical trials that reported dramatic reductions in shocks for SVT programmed discrimination algorithms consistently, they have been programmed inconsistently in clinical practice, and the rate of inappropriate shocks for SVT has been higher in observational studies of remote-monitoring ICD databases. In the ALTITUDE REDUCES study on 15,991 patients in the Latitude® database, SVT was the most common cause of shocks when the detection rate was ≤180 bpm.
        • Gilliam F.R.
        • Hayes D.L.
        • Boehmer J.P.
        • et al.
        Real world evaluation of dual-zone ICD and CRT-D programming compared to single-zone programming: the ALTITUDE REDUCES study.
        For detection rates ≤170 bpm, the rate of inappropriate shocks at 1 year was significantly lower with dual-zone programming, which permits SVT-VT discrimination, than single-zone programming, which does not (9.6% vs 4.3%). Similarly, Fischer et al
        • Fischer A.
        • Ousdigian K.T.
        • Johnson J.W.
        • Gillberg J.M.
        • Wilkoff B.L.
        The impact of atrial fibrillation with rapid ventricular rates and device programming on shocks in 106,513 ICD and CRT-D patients.
        analyzed shocks in 106,513 patients in the CareLink® database; programming SVT-VT discrimination ON was associated with a 17% reduction in all-cause shocks.
      • 3.
        Sophisticated simulations indicate that SVT-VT discrimination algorithms have substantial benefit. For example, the SCD-HeFT study on primary prevention patients did not use discriminators. A validated Monte Carlo simulation predicted that use of single- or dual-chamber SVT-VT discriminators alone would have reduced inappropriate shocks for SVT by 75.5% and 78.8%, respectively.
        • Volosin K.J.
        • Exner D.V.
        • Wathen M.S.
        • Sherfesee L.
        • Scinicariello A.P.
        • Gillberg J.M.
        Combining shock reduction strategies to enhance ICD therapy: a role for computer modeling.

       Which Patients are Most Likely to Benefit, and Which are Least Likely to Benefit?

      Despite limited direct evidence, it seems clear that patients will benefit most if the rates of their VTs and SVTs overlap. This includes patients with slower monomorphic VT, those at risk for AF with rapid ventricular rates, or those capable of exercising to sinus rates in the VT zone.
      • Bansch D.
      • Steffgen F.
      • Gronefeld G.
      • et al.
      The 1+1 trial: a prospective trial of a dual- versus a single-chamber implantable defibrillator in patients with slow ventricular tachycardias.
      • Nanthakumar K.
      • Dorian P.
      • Paquette M.
      • et al.
      Is inappropriate implantable defibrillator shock therapy predictable?.
      In secondary prevention patients with slower VT, older discrimination algorithms reduced shocks for SVT compared with rate-only detection. The benefit is less for primary prevention patients, secondary prevention patients at risk only for VF, and those who cannot sustain rapid atrioventricular conduction. Patients with permanent complete atrioventricular block do not benefit.

       What are the Risks?

      The risk of the misclassification of either VT or VF as SVT by the discrimination algorithms can either prevent VT detection or delay the time to therapy (underdetection), as documented in clinically significant situations.
      • Brugada J.
      • Mont L.
      • Figueiredo M.
      • Valentino M.
      • Matas M.
      • Navarro-Lopez F.
      Enhanced detection criteria in implantable defibrillators.
      • Weber M.
      • Bocker D.
      • Bansch D.
      • et al.
      Efficacy and safety of the initial use of stability and onset criteria in implantable cardioverter defibrillators.
      • Swerdlow C.D.
      • Chen P.S.
      • Kass R.M.
      • Allard J.R.
      • Peter C.T.
      Discrimination of ventricular tachycardia from sinus tachycardia and atrial fibrillation in a tiered-therapy cardioverter-defibrillator.
      • Glikson M.
      • Swerdlow C.D.
      • Gurevitz O.T.
      • et al.
      Optimal combination of discriminators for differentiating ventricular from supraventricular tachycardia by dual-chamber defibrillators.
      When modern algorithms are programmed to recommended parameters, clinically significant underdetection is rare. Large clinical trials on multiple shock-reduction strategies (including SVT-VT discrimination) report no or minimal and statistically insignificant increases in syncope.
      • Gasparini M.
      • Menozzi C.
      • Proclemer A.
      • et al.
      A simplified biventricular defibrillator with fixed long detection intervals reduces implantable cardioverter defibrillator (ICD) interventions and heart failure hospitalizations in patients with non-ischaemic cardiomyopathy implanted for primary prevention: the RELEVANT [Role of long dEtection window programming in patients with LEft VentriculAr dysfunction, Non-ischemic eTiology in primary prevention treated with a biventricular ICD] study.
      • Gasparini M.
      • Proclemer A.
      • Klersy C.
      • et al.
      Effect of long-detection interval vs standard-detection interval for implantable cardioverter-defibrillators on antitachycardia pacing and shock delivery: the ADVANCE III randomized clinical trial.
      • Moss A.J.
      • Schuger C.
      • Beck C.A.
      • et al.
      Reduction in inappropriate therapy and mortality through ICD programming.
      • Wilkoff B.L.
      • Williamson B.D.
      • Stern R.S.
      • et al.
      Strategic programming of detection and therapy parameters in implantable cardioverter-defibrillators reduces shocks in primary prevention patients: results from the PREPARE (Primary Prevention Parameters Evaluation) study.
      Most reports do not include the causes of syncope and thus do not permit identification of whether discrimination algorithms contributed to any of the syncopal episodes by prolonging detection. However, in the PREPARE study, no syncopal episode was caused by untreated tachycardia.
      • Wilkoff B.L.
      • Williamson B.D.
      • Stern R.S.
      • et al.
      Strategic programming of detection and therapy parameters in implantable cardioverter-defibrillators reduces shocks in primary prevention patients: results from the PREPARE (Primary Prevention Parameters Evaluation) study.
      In general, discriminators that re-evaluate the rhythm classification during ongoing tachycardia reduce the risk of underdetection compared with those that withhold therapy if the rhythm is misclassified by the initial evaluation (e.g., onset, chamber of origin algorithms).

       Additional Considerations

       SVT Limit

      SVT-VT discrimination applies from the VT detection rate to the SVT limit rate, which is programmable independently of the VT/VF therapy zones with some manufacturers (preferable), but which might be linked to one of the zone boundaries in others. The minimum CL for SVT-VT discrimination should be set to prevent clinically significant delays in the detection of hemodynamically unstable VT. PREPARE, EMPIRIC, and MADIT-RIT all support the safety of empirical programming at 200 bpm.
      • Moss A.J.
      • Schuger C.
      • Beck C.A.
      • et al.
      Reduction in Inappropriate Therapy and Mortality through ICD Programming.
      • Wilkoff B.L.
      • Ousdigian K.T.
      • Sterns L.D.
      • et al.
      A comparison of empiric to physician-tailored programming of implantable cardioverter-defibrillators: results from the prospective randomized multicenter EMPIRIC trial.
      • Weiss R.
      • Knight B.P.
      • Gold M.R.
      • et al.
      Safety and efficacy of a totally subcutaneous implantable-cardioverter defibrillator.
      In MADIT-II, approximately 50% of SVT episodes were faster than 170 bpm, and a few were as fast as 250 bpm.
      • Daubert J.P.
      • Zareba W.
      • Cannom D.S.
      • et al.
      Inappropriate implantable cardioverter-defibrillator shocks in MADIT II: frequency, mechanisms, predictors, and survival impact.
      In INTRINSIC RV, SVT comprised 19% of episodes, with rates between 200 and 250 bpm.
      • Sullivan R.M.
      • Russo A.M.
      • Berg K.C.
      • et al.
      Arrhythmia rate distribution and tachyarrhythmia therapy in an ICD population: results from the INTRINSIC RV trial.
      More limited and preliminary data from PainFree SST support programming up to 222–230 bpm.
      • Stadler R.W.
      • Gunderson B.D.
      • Gillberg J.M.
      An adaptive interval-based algorithm for withholding ICD therapy during sinus tachycardia.
      • Auricchio A.
      • Schloss E.J.
      • Kurita T.
      • et al.
      Low inappropriate shock rates in patients with single- and dual/triple-chamber implantable cardioverter-defibrillators using a novel suite of detection algorithms: PainFree SST trial primary results.
      We suggest the SVT limit not exceed 230 bpm in adults without a patient-specific indication, based on the low incidence of SVTs in this rate range among ICD patients and the potential—however small—for misclassifying hemodynamically unstable VT.

       Duration-Based “Safety-Net” Features to Override Discriminators

      These features deliver VT/VF therapy if a tachycardia satisfies the ventricular rate criterion for a sufficient duration, even if the discrimination algorithm indicates SVT. The premise is that the ventricular rate during transient sinus tachycardia or AF will decrease to below the VT rate boundary before the override duration is exceeded. In one study, an override duration of 3 minutes delivered inappropriate therapy to 10% of SVTs.
      • Brugada J.
      • Mont L.
      • Figueiredo M.
      • Valentino M.
      • Matas M.
      • Navarro-Lopez F.
      Enhanced detection criteria in implantable defibrillators.
      Because SVT is much more common than VT, programming an override duration of less than 5–10 minutes results primarily or solely in inappropriate SVT therapy.
      • Klein G.J.
      • Gillberg J.M.
      • Tang A.
      • et al.
      Improving SVT discrimination in single-chamber ICDs: A new electrogram morphology-based algorithm.
      Although more data would be useful, in the absence of a documented benefit, we recommend programming this feature OFF or long (minutes) without a patient-specific or device-specific indication.

       Dual-Chamber vs Single-Chamber Algorithms

      Clinical trials and simulated testing of induced arrhythmias that compared single- vs dual-chamber discriminators have reported inconsistent results.
      • Theuns D.A.
      • Klootwijk A.P.
      • Goedhart D.M.
      • Jordaens L.J.
      Prevention of inappropriate therapy in implantable cardioverter-defibrillators: results of a prospective, randomized study of tachyarrhythmia detection algorithms.
      • Olshansky B.
      • Day J.D.
      • Moore S.
      • et al.
      Is dual-chamber programming inferior to single-chamber programming in an implantable cardioverter-defibrillator? Results of the INTRINSIC RV (Inhibition of Unnecessary RV Pacing With AVSH in ICDs) study.
      • Friedman P.A.
      • McClelland R.L.
      • Bamlet W.R.
      • et al.
      Dual-Chamber Versus Single-Chamber Detection Enhancements for Implantable Defibrillator Rhythm Diagnosis: The Detect Supraventricular Tachycardia Study.
      • Almendral J.
      • Arribas F.
      • Wolpert C.
      • et al.
      Dual-chamber defibrillators reduce clinically significant adverse events compared with single-chamber devices: results from the DATAS (Dual chamber and Atrial Tachyarrhythmias Adverse events Study) trial.
      • Friedman P.A.
      • Slusser J.
      • Hodge D.O.
      • et al.
      Prospective Randomized Trial Of Dual Chamber Vs. Single Chamber ICDs To Minimize Shocks In Optimally Programmed Devices.
      Two meta-analyses found no superiority of dual-chamber ICDs in terms of mortality or inappropriate therapies.
      • Chen B.W.
      • Liu Q.
      • Wang X.
      • Dang A.M.
      Are dual-chamber implantable cardioverter-defibrillators really better than single-chamber ones? A systematic review and meta-analysis.
      • Goncalves J.
      • Pereira T.
      Inappropriate shocks in patients with ICDs: single chamber versus dual chamber.
      Any benefit of dual-chamber discrimination is likely restricted to specific patient groups.
      • Bansch D.
      • Steffgen F.
      • Gronefeld G.
      • et al.
      The 1+1 trial: a prospective trial of a dual- versus a single-chamber implantable defibrillator in patients with slow ventricular tachycardias.
      • Almendral J.
      • Arribas F.
      • Wolpert C.
      • et al.
      Dual-chamber defibrillators reduce clinically significant adverse events compared with single-chamber devices: results from the DATAS (Dual chamber and Atrial Tachyarrhythmias Adverse events Study) trial.
      For example, the Dual Chamber and Atrial Tachyarrhythmias Adverse Events (DATAS) trial of predominantly secondary prevention patients with slower VTs reported modest benefit from dual-chamber discrimination, while the recent Reduction and Prevention of Tachyarrhythmias and Shocks Using Reduced Ventricular Pacing with Atrial Algorithms (RAPTURE) trial of primary prevention patients programmed to a fast detection rate (>182 bpm) and long detection duration (30/40 intervals) did not.
      • Bansch D.
      • Steffgen F.
      • Gronefeld G.
      • et al.
      The 1+1 trial: a prospective trial of a dual- versus a single-chamber implantable defibrillator in patients with slow ventricular tachycardias.
      • Almendral J.
      • Arribas F.
      • Wolpert C.
      • et al.
      Dual-chamber defibrillators reduce clinically significant adverse events compared with single-chamber devices: results from the DATAS (Dual chamber and Atrial Tachyarrhythmias Adverse events Study) trial.
      • Friedman P.A.
      • Slusser J.
      • Hodge D.O.
      • et al.
      Prospective Randomized Trial Of Dual Chamber Vs. Single Chamber ICDs To Minimize Shocks In Optimally Programmed Devices.
      Inappropriate therapy for SVT occurred in only 2% of the patients in each group. Recent data from PainFree SST notes very low rates of inappropriate shocks (3.7% for single chamber; 2.8% for dual and triple chamber after 2 years). The choice of device was not randomized, suggesting that when physicians chose a dual- or triple-chamber device (perhaps due to known atrial arrhythmia or bradycardia), inappropriate shock rates were minimized.
      • Auricchio A.
      • Schloss E.J.
      • Kurita T.
      • et al.
      Low inappropriate shock rates in patients with single- and dual/triple-chamber implantable cardioverter-defibrillators using a novel suite of detection algorithms: PainFree SST trial primary results.
      The Optimal Anti-Tachycardia Therapy in Implantable Cardioverter-Defibrillator Patients Without Pacing Indications (OPTION) trial randomized 462 patients to single- or dual-chamber programming and noted inappropriate shock rates of 10.3% for single chamber vs 4.3% for dual chamber after 27 months (P = .015). Atrial lead-related complications were 1.3%, therapy was delivered from 170 bpm (VT) and 200 bpm (VF), and no difference in ventricular pacing percentage was noted.
      • Kolb C.
      • Sturmer M.
      • Sick P.
      • et al.
      Reduced risk for inappropriate implantable cardioverter-defibrillator shocks with dual-chamber therapy compared with single-chamber therapy: results of the randomized OPTION study.
      Dual-chamber algorithms probably reduce the risk of underdetection compared with single-chamber algorithms because more than 80% of VTs with a ventricular rate greater than the atrial rate undergo no further analysis.
      • Bansch D.
      • Steffgen F.
      • Gronefeld G.
      • et al.
      The 1+1 trial: a prospective trial of a dual- versus a single-chamber implantable defibrillator in patients with slow ventricular tachycardias.
      • Wilkoff B.L.
      • Kuhlkamp V.
      • Volosin K.
      • et al.
      Critical analysis of dual-chamber implantable cardioverter-defibrillator arrhythmia detection: results and technical considerations.
      • Glikson M.
      • Swerdlow C.D.
      • Gurevitz O.T.
      • et al.
      Optimal combination of discriminators for differentiating ventricular from supraventricular tachycardia by dual-chamber defibrillators.
      However, the rate of clinically significant underdetection with modern programming is so low that this difference is rarely of clinical significance. In most patients, improved SVT-VT discrimination should not be considered an indication for a dual- vs single-chamber ICD. Even if a dual-chamber ICD is implanted, dual-chamber discrimination should be programmed only if the atrial lead becomes chronic or if atrial sensing is unreliable. Accurate sensing of atrial EGMs is essential for dual-chamber SVT-VT discrimination. Atrial lead dislodgments, oversensing of far-field R waves, or undersensing due to low-amplitude atrial signals can cause misclassification of VT/SVT. On implant, it is important to position the atrial lead to minimize far-field R waves.

       Ventricular Oversensing

      Excluding recalled leads, ventricular oversensing accounts for less than 10% of inappropriate shocks, but it often results in repetitive shocks and severe symptoms.
      • Daubert J.P.
      • Zareba W.
      • Cannom D.S.
      • et al.
      Inappropriate implantable cardioverter-defibrillator shocks in MADIT II: frequency, mechanisms, predictors, and survival impact.
      • Powell B.D.
      • Asirvatham S.J.
      • Perschbacher D.L.
      • et al.
      Noise, Artifact, and Oversensing Related Inappropriate ICD Shock Evaluation: ALTITUDE NOISE Study.
      • Sears S.F.
      • Hauf J.D.
      • Kirian K.
      • Hazelton G.
      • Conti J.B.
      Posttraumatic stress and the implantable cardioverter-defibrillator patient: what the electrophysiologist needs to know.
      • Swerdlow C.D.
      • Gunderson B.D.
      • Ousdigian K.T.
      • et al.
      Downloadable algorithm to reduce inappropriate shocks caused by fractures of implantable cardioverter-defibrillator leads.
      Recently introduced features reduce inappropriate therapies from oversensing of physiologic T waves and nonphysiologic signals related to pace-sense lead failures as discussed below.

      Programming to Reduce T-Wave Oversensing

      The problem of T-wave oversensing relates to the basic requirement that ICDs reliably sense VF, which is characterized by RR intervals shorter than the normal QT interval and some EGMs with low amplitudes and slew rates. Approaches to minimizing T-wave oversensing include reprogramming ventricular sensitivity, altering sensing bandwidth, and changing the sensing bipole.
      • Koneru J.N.
      • Swerdlow C.D.
      • Wood M.A.
      • Ellenbogen K.A.
      Minimizing inappropriate or “unnecessary” implantable cardioverter-defibrillator shocks: appropriate programming.
      • Swerdlow C.D.
      • Friedman P.A.
      Advanced ICD troubleshooting: Part I. Pacing Clin.
      • Ellenbogen K.A.
      • Gunderson B.D.
      • Stromberg K.D.
      • Swerdlow C.D.
      Performance of Lead Integrity Alert to assist in the clinical diagnosis of implantable cardioverter defibrillator lead failures: analysis of different implantable cardioverter defibrillator leads.
      One manufacturer provides an algorithm that withholds therapy after rate and duration criteria for VT/VF are fulfilled if a specific pattern of T-wave oversensing is identified.
      • Cao J.
      • Gillberg J.M.
      • Swerdlow C.D.
      A fully automatic, implantable cardioverter-defibrillator algorithm to prevent inappropriate detection of ventricular tachycardia or fibrillation due to T-wave oversensing in spontaneous rhythm.
      T-wave oversensing rates vary based on device design; using an appropriate high band-pass filter results in very low rates of T-wave oversensing.
      • Powell B.D.
      • Asirvatham S.J.
      • Perschbacher D.L.
      • et al.
      Noise, Artifact, and Oversensing Related Inappropriate ICD Shock Evaluation: ALTITUDE NOISE Study.
      Because T-wave oversensing is unpredictable, features that minimize T-wave oversensing should be enabled proactively at implant, providing they do not cause undersensing in VF.
      • Cao J.
      • Gillberg J.M.
      • Swerdlow C.D.
      A fully automatic, implantable cardioverter-defibrillator algorithm to prevent inappropriate detection of ventricular tachycardia or fibrillation due to T-wave oversensing in spontaneous rhythm.

      Lead-Related Oversensing

      Oversensed signals caused by pace-sense lead failure have specific interval patterns and EGM characteristics.
      • Ellenbogen K.A.
      • Gunderson B.D.
      • Stromberg K.D.
      • Swerdlow C.D.
      Performance of Lead Integrity Alert to assist in the clinical diagnosis of implantable cardioverter defibrillator lead failures: analysis of different implantable cardioverter defibrillator leads.
      • Swerdlow C.D.
      • Sachanandani H.
      • Gunderson B.D.
      • Ousdigian K.T.
      • Hjelle M.
      • Ellenbogen K.A.
      Preventing overdiagnosis of implantable cardioverter-defibrillator lead fractures using device diagnostics.
      • Swerdlow C.D.
      • Ellenbogen K.A.
      Implantable cardioverter-defibrillator leads: design, diagnostics, and management.
      Present algorithms identify three features: (1) intervals can be too short to represent successive ventricular activations; (2) such short intervals are often transient and can be repetitive; and (3) in true bipolar leads, oversensed signals are absent on the shock EGM. Algorithms can provide warning alerts, withhold shocks after spurious detection of VT/VF, or both. All 3 criteria can provide alerts, but only the third is applied to withhold shocks. The present algorithms were developed to identify impending lead failures on recalled leads, notably the Sprint Fidelis. These algorithms might not be appropriate for detecting failures in other leads.
      • Swerdlow C.D.
      • Gunderson B.D.
      • Ousdigian K.T.
      • et al.
      Downloadable algorithm to reduce inappropriate shocks caused by fractures of implantable cardioverter-defibrillator leads.
      There is a high false-positive rate when using these algorithms, and caregivers must carefully review the device data that caused the alert to ensure the lead experienced a true failure.
      • Ellenbogen K.A.
      • Gunderson B.D.
      • Stromberg K.D.
      • Swerdlow C.D.
      Performance of Lead Integrity Alert to assist in the clinical diagnosis of implantable cardioverter defibrillator lead failures: analysis of different implantable cardioverter defibrillator leads.
      Alerts that combine both oversensing and abrupt changes in impedance trends provide earlier warning of lead failure than a fixed impedance threshold.
      • Swerdlow C.D.
      • Gunderson B.D.
      • Ousdigian K.T.
      • et al.
      Downloadable algorithm to reduce inappropriate shocks caused by fractures of implantable cardioverter-defibrillator leads.
      • Ellenbogen K.A.
      • Gunderson B.D.
      • Stromberg K.D.
      • Swerdlow C.D.
      Performance of Lead Integrity Alert to assist in the clinical diagnosis of implantable cardioverter defibrillator lead failures: analysis of different implantable cardioverter defibrillator leads.
      • Swerdlow C.D.
      • Gunderson B.D.
      • Ousdigian K.T.
      • Abeyratne A.
      • Sachanandani H.
      • Ellenbogen K.A.
      Downloadable software algorithm reduces inappropriate shocks caused by implantable cardioverter-defibrillator lead fractures: a prospective study.
      Such alerts can be delivered via wireless remote monitoring and/or by notifying the patient via vibration or an audible tone. Caregivers must respond rapidly to alerts to minimize inappropriate shocks.
      • Swerdlow C.D.
      • Gunderson B.D.
      • Ousdigian K.T.
      • et al.
      Downloadable algorithm to reduce inappropriate shocks caused by fractures of implantable cardioverter-defibrillator leads.
      • Swerdlow C.D.
      • Gunderson B.D.
      • Ousdigian K.T.
      • Abeyratne A.
      • Sachanandani H.
      • Ellenbogen K.A.
      Downloadable software algorithm reduces inappropriate shocks caused by implantable cardioverter-defibrillator lead fractures: a prospective study.
      Wireless remote monitoring has been reported to reduce response time.
      • Blanck Z.
      • Axtell K.
      • Brodhagen K.
      • et al.
      Inappropriate shocks in patients with Fidelis(R) lead fractures: impact of remote monitoring and the lead integrity algorithm.
      The principal disadvantage of lead alerts is false-positive triggers. The principal risk of shock-withholding algorithms is a failure to shock VF, which is extremely rare.
      • Gunderson B.D.
      • Gillberg J.M.
      • Wood M.A.
      • Vijayaraman P.
      • Shepard R.K.
      • Ellenbogen K.A.
      Development and testing of an algorithm to detect implantable cardioverter-defibrillator lead failure.
      In addition to algorithmic approaches, oversensing due to failure of the cable leading to the ring electrode can be prevented by changing the programming of the sensing configuration from true bipolar to integrated bipolar. This approach is appropriate prophylactically or as temporary programming after a ring electrode cable failure; it is not a permanent solution, however, because increased rates of high-voltage cable fractures have been documented after sensing cable fractures.

      Sprint Fidelis® Lead Patient Management Recommendations Update: Models 6949, 6948, 6931, 6930. 2011; http://www.medtronic.com/wcm/groups/mdtcom_sg/@mdt/documents/documents/fidelis-phys-ltr-2011-04.pdf. Accessed 4/21/2013, 2013.

      The Subcutaneous Defibrillator (S-ICD)

      The novel S-ICD follows many of the same principles as intravascular ICDs but is considered here separately for duration criteria, rate criteria, and discrimination algorithms. Candidates for the S-ICD must initially be screened with a modified tri-channel surface electrocardiogram that mimics the sensing vectors of the S-ICD system. This test is designed to assess the R-wave to T-wave ratio for appropriate signal characteristics and relationships. If the screening is not satisfactory for at least 1 of the 3 vectors supine and standing, an S-ICD should not be implanted. On implant, the S-ICD automatically analyzes and selects the optimal sensing vector.
      Detection of VT or VF by the S-ICD is programmable using a single or dual zone. In the single-zone configuration, shocks are delivered for detected heart rates above the programmed rate threshold: the “shock zone.”
      • Weiss R.
      • Knight B.P.
      • Gold M.R.
      • et al.
      Safety and efficacy of a totally subcutaneous implantable-cardioverter defibrillator.
      In the dual-zone configuration, arrhythmia discrimination algorithms are active from the lower rate: the “conditional shock zone.” In this latter zone, a unique discrimination algorithm is used to classify rhythms as either shockable or nonshockable. If they are classified as supraventricular arrhythmias or nonarrhythmic oversensing, therapy is withheld.
      With dual-zone programming, the shock zone uses rate as the sole method for rhythm analysis. In contrast, the conditional shock zone uses a stepwise discrimination algorithm to distinguish shockable from nonshockable rhythms. The conditional shock zone has a morphology analysis process based on a normal rhythm transthoracic QRS:T wave template. The template uses up to 41 fiduciary points to reconstruct morphology for the template as well as the programmed targeted heart rate zones. The comparison of the template to the high-rate rhythm electrocardiogram for discrimination constitutes the static waveform analysis. A good template match designates a sensed beat as supraventricular, thereby preventing a shock. A poor match to the static QRS:T morphology template moves the algorithm to a dynamic waveform analysis that compares single-beat morphologies in groups of 4 beats for uniformity. A consistent dynamic waveform match adjusts the sensing to evaluate QRS width. If a tachycardia has a prolonged QRS width compared with the template width (>20 ms) and is of sufficient duration, it will lead to a shock.
      The system uses an initial 18 of 24 duration criteria (nonprogrammable) prior to initiating capacitor charging; however, this duration is automatically extended following nonsustained ventricular tachyarrhythmia events. A confirmation algorithm is also used at the end of capacitor charging to ensure persistence of the ventricular arrhythmia prior to shock delivery. Shocks for spontaneous (noninduced) episodes are delivered at a nonprogrammable 80 J regardless of the therapy zone of origination.
      When programmed to include a conditional shock zone, the S-ICD VT detection algorithm has been demonstrated to be more effective than transvenous ICD systems programmed at nominal settings to prevent the detection of induced supraventricular arrhythmias.
      • Gold M.R.
      • Theuns D.A.
      • Knight B.P.
      • et al.
      Head-to-head comparison of arrhythmia discrimination performance of subcutaneous and transvenous ICD arrhythmia detection algorithms: the START study.
      Furthermore, in the clinical evaluation of the conditional shock zone, the S-ICD system was strongly associated with a reduction in inappropriate shocks from supraventricular arrhythmias and did not result in prolongation of detection times or increased syncope.
      • Gold M.R.
      • Weiss R.
      • Theuns D.A.
      • et al.
      Use of a discrimination algorithm to reduce inappropriate shocks with a subcutaneous implantable cardioverter-defibrillator.

      Integrating Tachycardia Detection Data Into Programming Recommendations

      When taking data from specific single-manufacturer studies and producing generic guidelines applicable across all ICDs, some compromises and potential pitfalls have been encountered. Nevertheless, it is our intention to convey the general principles of good quality evidence (e.g., extending detection time) to apply to ICD programming in general. Thus, attempts have been made to translate interval-based detection to time-based detection and to provide a range of reasonable heart rate cutoffs that are inclusive of those proven in good-quality trials. We encourage programming ICDs to manufacturer-specific therapies of proven benefit; however, when evidence is lacking, the guidelines provide a framework for programming within the evidence base. See online Appendix B for manufacturer-specific examples of optimal ICD programming.
      Tabled 1
      Tachycardia Detection Programming RecommendationsClass of RecommendationLevel of Evidence
      For primary prevention ICD patients, tachyarrhythmia detection duration criteria should be programmed to require the tachycardia to continue for at least 6–12 seconds* or for 30 intervals before completing detection, to reduce total therapies.IA
      *Tachyarrhythmia detection duration is directly related to the tachyarrhythmia rate. Direct evidence to support a delay >2.5 seconds for rates over 250 bpm is not available, but can be inferred from evidence that 30 detection intervals are safe at that rate.
      For primary prevention ICD patients, the slowest tachycardia therapy zone limit should be programmed between 185 and 200bpm*, to reduce total therapies.IA
      *Higher minimum rates for detection might be appropriate for young patients or for those in whom SVT-VT discriminators cannot reliably distinguish SVT from VT, provided there is no clinical VT below this rate.
      For secondary prevention ICD patients, tachyarrhythmia detection duration criteria should be programmed to require the tachycardia to continue for at least 6–12 seconds* or for 30 intervals before completing detection, to reduce total therapies.IB-R
      *Tachyarrhythmia detection duration is directly related to the tachyarrhythmia rate. Direct evidence to support a delay >2.5 seconds for rates over 250 bpm is not available, but can be inferred from evidence that 30 detection intervals are safe at that rate.
      Discrimination algorithms to distinguish SVT from VT should be programmed to include rhythms with rates faster than 200 bpm and potentially up to 230 bpm (unless contraindicated*) to reduce inappropriate therapies.IB-R
      *Discrimination algorithms and/or their individual components are contraindicated in patients with complete heart block or if the algorithm/component is known to be unreliable in an individual patient. Dual-chamber discriminators that misclassify VT as SVT if the atrial lead dislodges are discouraged in the perioperative period. Dual-chamber discriminators are contraindicated in patients with known atrial lead dislodgment, atrial undersensing or oversensing of far field R waves, and in those with permanent AF.
      It is recommended to activate lead-failure alerts to detect potential lead problems.IB-NR
      For secondary prevention ICD patients for whom the clinical VT rate is known, it is reasonable to program the slowest tachycardia therapy zone at least 10 bpm below the documented tachycardia rate but not faster than 200bpm*, to reduce total therapies.IIaC-EO
      *Higher minimum rates for detection might be appropriate for young patients or for those in whom SVT-VT discriminators cannot reliably distinguish SVT from VT, provided there is no clinical VT below this rate.
      It can be useful to program more than one tachycardia detection zone to allow effective use of tiered therapy and/or SVT-VT discriminators and allow for a shorter delay in time-based detection programming for faster arrhythmias.IIaB-R
      When a morphology discriminator is activated, it is reasonable to reacquire the morphology template when the morphology match is unsatisfactory, to improve the accuracy of the morphology discriminator.IIaC-LD
      It is reasonable to choose single-chamber ICD therapy in preference to dual-chamber ICD therapy if the sole reason for the atrial lead is SVT discrimination, unless a known SVT exists that may enter the VT treatment zone, to reduce both lead-related complications and the cost of ICD therapy.IIaB-NR
      For the S-ICD, it is reasonable to program 2 tachycardia detection zones: 1 zone with tachycardia discrimination algorithms from a rate ≤200 bpm and a second zone without tachycardia discrimination algorithms from a rate ≥230 bpm, to reduce avoidable shocks.IIaB-NR
      Programming a nontherapy zone for tachycardia monitoring might be considered to alert clinicians to untreated arrhythmias.IIbB-NR
      It may be reasonable to disable the SVT discriminator timeout function, to reduce inappropriate therapies.IIbC-EO
      It may be reasonable to activate lead “noise” algorithms that withhold shocks when detected VT/VF is not confirmed on a shock or other far-field channel to avoid therapies for nonphysiologic signals.IIbC-EO
      It may be reasonable to activate T-wave oversensing algorithms, to reduce inappropriate therapies.IIbC-LD
      It may be reasonable to program the sensing vector from bipolar to integrated-bipolar in true-bipolar leads at risk for failure of the cable to the ring electrode to reduce inappropriate therapies.*IIbC-EO
      *This is not intended as a long-term solution when a cable fracture has been identified.

       Tachycardia Therapy Programming

      Although therapies delivered by the ICD can abort SCD, appropriate and inappropriate ICD shocks have been associated with a considerable increase in the risk of mortality.
      • Daubert J.P.
      • Zareba W.
      • Cannom D.S.
      • et al.
      Inappropriate implantable cardioverter-defibrillator shocks in MADIT II: frequency, mechanisms, predictors, and survival impact.
      • Poole J.E.
      • Johnson G.W.
      • Hellkamp A.S.
      • et al.
      Prognostic importance of defibrillator shocks in patients with heart failure.
      • Sweeney M.O.
      • Sherfesee L.
      • DeGroot P.J.
      • Wathen M.S.
      • Wilkoff B.L.
      Differences in effects of electrical therapy type for ventricular arrhythmias on mortality in implantable cardioverter-defibrillator patients.
      • Sood N.
      • Ruwald A.C.H.
      • Solomon S.
      • et al.
      Association between myocardial substrate, implantable cardioverter defibrillator shocks and mortality in MADIT-CRT.
      • Powell B.D.
      • Saxon L.A.
      • Boehmer J.P.
      • et al.
      Survival After Shock Therapy in Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy-Defibrillator Recipients According to Rhythm Shocked.
      • van Rees J.B.
      • Borleffs C.J.W.
      • de Bie M.K.
      • et al.
      Inappropriate Implantable Cardioverter-Defibrillator Shocks.
      In the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), the risk of mortality was 5-fold higher in patients who received appropriate ICD shocks and 2-fold higher in patients who received inappropriate shocks.
      • Poole J.E.
      • Johnson G.W.
      • Hellkamp A.S.
      • et al.
      Prognostic importance of defibrillator shocks in patients with heart failure.
      Similarly, pooling data from 4 studies of 2135 ICD patients, shocked VT was associated with a 32% increase in the risk of mortality. In that analysis, shocked patients had poorer survival than patients treated with ATP only.
      • Sweeney M.O.
      • Sherfesee L.
      • DeGroot P.J.
      • Wathen M.S.
      • Wilkoff B.L.
      Differences in effects of electrical therapy type for ventricular arrhythmias on mortality in implantable cardioverter-defibrillator patients.
      ICD shocks are likely a marker of more advanced heart disease and subsequent death, but defibrillation therapies have been associated with troponin release and increased LV dysfunction with the potential of further mortality risk.
      The incidence of appropriate and inappropriate ICD shocks depends on the patient’s characteristics, including the indication for the device, concomitant medical therapies including antiarrhythmic medications, programming of the ICD, and the duration of follow-up. With regard to ICD programming, faster VT/VF detection rates, longer detection durations, use of a single zone, use of SVT discriminators, and delivery of ATP have been shown to reduce both appropriate and inappropriate shocks and to improve quality of life.
      • Sweeney M.O.
      • Wathen M.S.
      • Volosin K.
      • et al.
      Appropriate and Inappropriate Ventricular Therapies, Quality of Life, and Mortality Among Primary and Secondary Prevention Implantable Cardioverter Defibrillator Patients: Results From the Pacing Fast VT REduces Shock ThErapies (PainFREE Rx II) Trial.
      • Wilkoff B.L.
      • Ousdigian K.T.
      • Sterns L.D.
      • et al.
      A comparison of empiric to physician-tailored programming of implantable cardioverter-defibrillators: results from the prospective randomized multicenter EMPIRIC trial.
      • Moss A.J.
      • Schuger C.
      • Beck C.A.
      • et al.
      Reduction in inappropriate therapy and mortality through ICD programming.
      • Gilliam F.R.
      • Hayes D.L.
      • Boehmer J.P.
      • et al.
      Real world evaluation of dual-zone ICD and CRT-D programming compared to single-zone programming: the ALTITUDE REDUCES study.
      • Fischer A.
      • Ousdigian K.T.
      • Johnson J.W.
      • Gillberg J.M.
      • Wilkoff B.L.
      The impact of atrial fibrillation with rapid ventricular rates and device programming on shocks in 106,513 ICD and CRT-D patients.
      • Wilkoff B.L.
      • Williamson B.D.
      • Stern R.S.
      • et al.
      Strategic programming of detection and therapy parameters in implantable cardioverter-defibrillators reduces shocks in primary prevention patients: results from the PREPARE (Primary Prevention Parameters Evaluation) study.
      • Gasparini M.
      • Proclemer A.
      • Klersy C.
      • et al.
      Effect of Long-Detection Interval vs Standard-Detection Interval for Implantable Cardioverter-Defibrillators on Antitachycardia Pacing and Shock Delivery.
      • González-Enríquez S.
      • Rodríguez-Entem F.
      • Expósito V.
      • et al.
      Single-chamber ICD, single-zone therapy in primary and secondary prevention patients: the simpler the better?.
      This programming might improve survival.
      • Moss A.J.
      • Schuger C.
      • Beck C.A.
      • et al.
      Reduction in inappropriate therapy and mortality through ICD programming.
      Indeed, several studies have shown that ATP is effective at terminating slow and fast VT with exceedingly low rates of adverse events like syncope.
      • Wathen M.S.
      • DeGroot P.J.
      • Sweeney M.O.
      • et al.
      Prospective randomized multicenter trial of empirical antitachycardia pacing versus shocks for spontaneous rapid ventricular tachycardia in patients with implantable cardioverter-defibrillators: Pacing Fast Ventricular Tachycardia Reduces Shock Therapies (PainFREE Rx II) trial results.
      • Sullivan R.M.
      • Russo A.M.
      • Berg K.C.
      • et al.
      Arrhythmia rate distribution and tachyarrhythmia therapy in an ICD population: results from the INTRINSIC RV trial.
      • Saeed M.
      • Neason C.G.
      • Razavi M.
      • et al.
      Programming Antitachycardia Pacing for Primary Prevention in Patients With Implantable Cardioverter Defibrillators: Results From the PROVE Trial.
      • Sivagangabalan G.
      • Eshoo S.
      • Eipper V.E.
      • Thiagalingam A.
      • Kovoor P.
      Discriminatory Therapy for Very Fast Ventricular Tachycardia in Patients with Implantable Cardioverter Defibrillators.
      • Schoels W.
      • Steinhaus D.
      • Johnson W.B.
      • et al.
      Optimizing implantable cardioverter-defibrillator treatment of rapid ventricular tachycardia: Antitachycardia pacing therapy during charging.
      • Wathen M.S.
      • Sweeney M.O.
      • DeGroot P.J.
      • et al.
      Shock Reduction Using Antitachycardia Pacing for Spontaneous Rapid Ventricular Tachycardia in Patients With Coronary Artery Disease.
      • Gasparini M.
      • Anselme F.
      • Clementy J.
      • et al.
      BIVentricular versus right ventricular antitachycardia pacing to terminate ventricular tachyarrhythmias in patients receiving cardiac resynchronization therapy: The ADVANCE CRT-D Trial.
      The initial bias of the ICD community was to reserve ATP therapy for those patients in whom the therapy was demonstrated to be effective, usually during an electrophysiologic study. However, the approach of physician-directed programming based on the knowledge of induced arrhythmias was found to be significantly inferior to the routine strategic (EMPIRIC) programming of ATP. It is not reflective of the arrhythmias experienced outside the electrophysiology laboratory for primary and secondary prevention patients with ischemic and nonischemic substrates.
      • Wilkoff B.L.
      • Ousdigian K.T.
      • Sterns L.D.
      • et al.
      A comparison of empiric to physician-tailored programming of implantable cardioverter-defibrillators: results from the prospective randomized multicenter EMPIRIC trial.
      • Yee R.
      • Birgersdotter-Green U.
      • Belk P.
      • Jackson T.
      • Christensen J.
      • Wathen M.S.
      The Relationship between Pacing Site and Induction or Termination of Sustained Monomorphic Ventricular Tachycardia by Antitachycardia Pacing.
      Although the ideal number of ATP bursts has not been definitively determined, current data support the use of up to 2 ATP attempts, given additional attempts yield very little additional efficacy.
      • Wathen M.S.
      • DeGroot P.J.
      • Sweeney M.O.
      • et al.
      Prospective randomized multicenter trial of empirical antitachycardia pacing versus shocks for spontaneous rapid ventricular tachycardia in patients with implantable cardioverter-defibrillators: Pacing Fast Ventricular Tachycardia Reduces Shock Therapies (PainFREE Rx II) trial results.
      • Sullivan R.M.
      • Russo A.M.
      • Berg K.C.
      • et al.
      Arrhythmia rate distribution and tachyarrhythmia therapy in an ICD population: results from the INTRINSIC RV trial.
      • Saeed M.
      • Neason C.G.
      • Razavi M.
      • et al.
      Programming Antitachycardia Pacing for Primary Prevention in Patients With Implantable Cardioverter Defibrillators: Results From the PROVE Trial.
      • Sivagangabalan G.
      • Eshoo S.
      • Eipper V.E.
      • Thiagalingam A.
      • Kovoor P.
      Discriminatory Therapy for Very Fast Ventricular Tachycardia in Patients with Implantable Cardioverter Defibrillators.
      • Schoels W.
      • Steinhaus D.
      • Johnson W.B.
      • et al.
      Optimizing implantable cardioverter-defibrillator treatment of rapid ventricular tachycardia: Antitachycardia pacing therapy during charging.
      • Wathen M.S.
      • Sweeney M.O.
      • DeGroot P.J.
      • et al.
      Shock Reduction Using Antitachycardia Pacing for Spontaneous Rapid Ventricular Tachycardia in Patients With Coronary Artery Disease.
      • Gasparini M.
      • Anselme F.
      • Clementy J.
      • et al.
      BIVentricular versus right ventricular antitachycardia pacing to terminate ventricular tachyarrhythmias in patients receiving cardiac resynchronization therapy: The ADVANCE CRT-D Trial.
      • Anguera I.
      • Dallaglio P.
      • SabatÉ X.
      • et al.
      The Benefit of a Second Burst Antitachycardia Sequence for Fast Ventricular Tachycardia in Patients with Implantable Cardioverter Defibrillators.
      • Martins R.P.
      • Blangy H.
      • Muresan L.
      • et al.
      Safety and efficacy of programming a high number of antitachycardia pacing attempts for fast ventricular tachycardia: a prospective study.
      In one study, up to 5 attempts were found to be safe.
      • Martins R.P.
      • Blangy H.
      • Muresan L.
      • et al.
      Safety and efficacy of programming a high number of antitachycardia pacing attempts for fast ventricular tachycardia: a prospective study.
      The most effective ATP duration is likewise uncertain; however, in the ATP Delivery for Painless ICD Therapy (ADVANCE-D) trial—a prospective RCT of 925 patients—8-pulse ATP was as effective and safe as 15-pulse ATP.
      • Santini M.
      • Lunati M.
      • Defaye P.
      • et al.
      Prospective multicenter randomized trial of fast ventricular tachycardia termination by prolonged versus conventional anti-tachyarrhythmia burst pacing in implantable cardioverter-defibrillator patients-Atp DeliVery for pAiNless ICD thErapy (ADVANCE-D) Trial results.
      The PITAGORA ICD clinical trial randomized 206 patients with an ICD to 2 ATP strategies: an 88% coupling interval burst vs a 91% coupling interval ramp. The results of the trial showed that over a median follow-up of 36 months and compared with ramp pacing, burst pacing was more effective for terminating fast VT episodes (between CL 240 and 320 ms).
      • Gulizia M.M.
      • Piraino L.
      • Scherillo M.
      • et al.
      A Randomized Study to Compare Ramp Versus Burst Antitachycardia Pacing Therapies to Treat Fast Ventricular Tachyarrhythmias in Patients With Implantable Cardioverter Defibrillators: The PITAGORA ICD Trial.
      In a prospective study of 602 patients, a strategy of tiered ATP and low-energy shock was efficacious and safe in patients with VT CL greater than 250 ms, with extremely low syncope rates.
      • Sivagangabalan G.
      • Chik W.
      • Zaman S.
      • et al.
      Antitachycardia Pacing for Very Fast Ventricular Tachycardia and Low-Energy Shock for Ventricular Arrhythmias in Patients With Implantable Defibrillators.
      However, a “real-world” retrospective study on 2000 patients with 5279 shock episodes from the LATITUDE remote monitoring system showed that the success rate of first shock as first therapy was approximately 90%, but the success rate was lower after failed ATP. Therefore, that study recommended programming a higher level of energy after ATP.
      • Kanal E.
      • Barkovich A.J.
      • Bell C.
      • et al.
      ACR guidance document on MR safe practices: 2013.
      Finally, a substudy of the Effectiveness and Cost of ICD Follow-Up Schedule with Telecardiology (ECOST) study, which randomly assigned 433 patients to remote monitoring (n = 221; active group) vs ambulatory follow-up (n = 212; control group), showed that remote monitoring was highly effective in the long-term prevention of inappropriate ICD shocks through early detection and prevention of AF with a rapid ventricular rate, nonsustained VT, or diverted VT episodes.
      • Guédon-Moreau L.
      • Kouakam C.
      • Klug D.
      • et al.
      Decreased Delivery of Inappropriate Shocks Achieved by Remote Monitoring of ICD: A Substudy of the ECOST Trial.

      Benefits and Risks

      The goal of ICD therapy is to prolong life while causing as little morbidity as possible. Although survival is quantifiably objective, morbidity is more subjective and includes both physical and emotional components. Clearly, shocks are usually painful to the patient, whereas ATP is typically not uncomfortable. However, there can be other morbidities related to both therapies, including mild to extreme emotional distress, syncope, palpitations, and proarrhythmia yielding more therapies and occasionally leading to death. Paradoxically, the need for life-saving therapies, including shocks and potentially ATP, might also be associated with increased mortality; however, the causal relationships are unclear. Also, the prevalence of tachycardia amenable to ATP or hemodynamic significance varies with the mechanism of the risk (e.g., long QT vs ischemic cardiomyopathy). In addition, although the risk of having a hemodynamically important or life-threatening arrhythmia can vary from patient group to patient group, the largest proportion of patients in whom ICD therapy is applied has yet to have a previously recorded arrhythmia, and we must therefore strategically choose on the basis of other factors how we will treat the first event and subsequent events.

      Classification of Therapy

      The literature uses definitions of therapies that differ from each other and that impact their results and conclusions. The occurrence rates of these events not only are dependent on their definition but also are highly dependent on the programming of the defibrillation system. Both shock and nonshock therapies can be categorized as being appropriate, inappropriate, and avoidable. Whereas appropriate and inappropriate therapies refer to therapies that were actually delivered, avoidable therapies are theoretical events in the future. These potential future tachycardia therapies, delivered for either appropriately or inappropriately detected events, can frequently be avoided by establishing programming to either prevent the initiation of the arrhythmia or to allow the condition to pass without therapy.

       Appropriate

      A response to a sustained ventricular arrhythmia (VT, VF) or hemodynamically poorly tolerated arrhythmias (e.g., associated with syncope, rate over 200 bpm, or hemodynamically compromising supraventricular arrhythmias).

       Inappropriate

      A response to signals generated by something other than sustained ventricular arrhythmias or hemodynamically poorly tolerated arrhythmias. Possible signals include supraventricular rhythms such as sinus tachycardia, AF, atrial flutter, reentrant SVT, atrial tachycardia, or instances of signal misinterpretation. Signal misinterpretation includes multiple counting of single events (e.g., atrial, T-wave or R-wave), environmental signals such as electromagnetic interference, frequent premature ventricular contractions (PVCs) and nonsustained ventricular arrhythmias, extracardiac physiologic signals (e.g., diaphragmatic or pectoral myopotentials), other implantable electronic devices (e.g., pacemakers, LV assist devices, nerve stimulators), inappropriate lead placement or dislodgment, conductor or insulation failures, header connection instability, and pulse generator failure.

       Avoidable

      Programming of detection and therapy parameters and algorithms so that shock or ATP therapy is withheld from arrhythmias that would be expected to be hemodynamically tolerated. Examples include self-terminating ventricular arrhythmias, ATP-susceptible ventricular arrhythmias, and overdrive suppression responsive rhythms. Many appropriate and most inappropriate therapies are also potentially avoidable.

       Phantom

      These are not true therapies; however, there is the patient’s perception that a therapy was delivered. Interrogation of the ICD and/or coincident rhythm monitoring does not identify a tachycardia or therapy.

       Unintended Consequences of ICD Therapy and ICD Therapy Programming

      In the SCD-HeFT and MADIT II trials, inappropriate shocks more than doubled the risk of death. Mortality rates were substantially higher after shocks: 10% within days after the first shock, 25% within 1 year, and 40% by 2 years. The leading cause of death was progressive HF. In an analysis of the MADIT-CRT trial, the patients with appropriate shocks experienced increased mortality when compared with the patients without ICD shocks, after accounting for mechanical remodeling effects; this was not the case for patients who received appropriate ATP only.
      • Sood N.
      • Ruwald A.C.H.
      • Solomon S.
      • et al.
      Association between myocardial substrate, implantable cardioverter defibrillator shocks and mortality in MADIT-CRT.
      ICD shocks have also been associated with independent predictors of mortality in the large ALTITUDE registry of 3809 ICD recipients and in a meta-analysis of ICD trials in which ATP was applied.
      • Sweeney M.O.
      • Sherfesee L.
      • DeGroot P.J.
      • Wathen M.S.
      • Wilkoff B.L.
      Differences in effects of electrical therapy type for ventricular arrhythmias on mortality in implantable cardioverter-defibrillator patients.
      • Powell B.D.
      • Saxon L.A.
      • Boehmer J.P.
      • et al.
      Survival After Shock Therapy in Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy-Defibrillator Recipients According to Rhythm Shocked.
      Emotional morbidities associated with ICD shocks are well recognized and include anxiety, depression, and posttraumatic stress disorders.
      • Camm A.J.
      • Sears S.F.
      • Todaro J.F.
      • Lewis T.S.
      • Sotile W.
      • Conti J.B.
      Examining the psychosocial impact of implantable cardioverter defibrillators: A literature review.
      • Sears S.F.
      • Vazquez L.D.
      • Matchett M.
      • Pitzalis M.
      State-of-the-art: anxiety management in patients with implantable cardioverter defibrillators.
      • Magyar-Russell G.
      • Thombs B.D.
      • Cai J.X.
      • et al.
      The prevalence of anxiety and depression in adults with implantable cardioverter defibrillators: A systematic review.
      Phantom shocks can result from fear and/or anxiety and have a reported incidence of 5% in a European study of ICD recipients over 35 months of follow-up.
      • Kraaier K.
      • Starrenburg A.H.
      • Verheggen R.M.
      • van der Palen J.
      • Scholten M.F.
      Incidence and predictors of phantom shocks in implantable cardioverter defibrillator recipients.
      If possible, and when safe, it is best to avoid both the discomfort and psychological impact of shocks for ventricular arrhythmias, supraventricular arrhythmias, noise events including lead failures, and for self-terminating arrhythmias, as is discussed in the section on tachycardia detection. The 1500-patient MADIT-RIT study demonstrated a mortality reduction by changing both tachycardia detection criteria and tachycardia therapy (shocks and ATP). Therefore, it is difficult to assign the outcome result to ATP, shocks, or both when compared with older, more conventional programming.
      • Moss A.J.
      • Schuger C.
      • Beck C.A.
      • et al.
      Reduction in inappropriate therapy and mortality through ICD programming.
      In addition, in a randomized study of remote follow-up of ICDs, home monitoring showed an incidence of 52% fewer inappropriate shocks, 72% fewer hospitalizations due to inappropriate shocks, 76% fewer capacitor charges, and a significant positive impact on battery longevity.
      • Guédon-Moreau L.
      • Lacroix D.
      • Sadoul N.
      • et al.
      A randomized study of remote follow-up of implantable cardioverter defibrillators: safety and efficacy report of the ECOST trial.

       ATP

      Several large clinical trials have established the safety and efficacy of ATP as a first-line therapy to treat even very fast VTs.
      • Wathen M.S.
      • DeGroot P.J.
      • Sweeney M.O.
      • et al.
      Prospective randomized multicenter trial of empirical antitachycardia pacing versus shocks for spontaneous rapid ventricular tachycardia in patients with implantable cardioverter-defibrillators: Pacing Fast Ventricular Tachycardia Reduces Shock Therapies (PainFREE Rx II) trial results.
      • Gasparini M.
      • Menozzi C.
      • Proclemer A.
      • et al.
      A simplified biventricular defibrillator with fixed long detection intervals reduces implantable cardioverter defibrillator (ICD) interventions and heart failure hospitalizations in patients with non-ischaemic cardiomyopathy implanted for primary prevention: the RELEVANT [Role of long dEtection window programming in patients with LEft VentriculAr dysfunction, Non-ischemic eTiology in primary prevention treated with a biventricular ICD] study.