Advertisement

Postoperative opioid prescription patterns and new opioid refills following cardiac implantable electronic device procedures

Published:October 20, 2019DOI:https://doi.org/10.1016/j.hrthm.2019.08.011

      Background

      Prescription opioids are a major cause of the opioid epidemic. Despite the invasive nature of cardiac implantable electronic device (CIED) procedures, data on opioid prescription patterns after CIED procedures are lacking.

      Objective

      The purpose of this study was to assess opioid prescribing patterns and the rates of new opioid refills (refills in previously opioid naïve patients) among patients undergoing CIED procedures.

      Methods

      We performed a retrospective analysis of all patients undergoing CIED procedures from January 1, 2010, to March 30, 2018, at the Mayo Clinic (Minnesota, Arizona, and Florida). Procedures were categorized into new implant, generator change, device upgrade, lead revision or replacement, and subcutaneous implantable cardiac defibrillator (S-ICD) procedures. The rates of postoperative opioid prescription and new opioid refills were analyzed. Wilcoxon rank sum and χ2 tests assessed variations.

      Results

      A total of 16,517 patients (mean age 70 ± 15; 36% female) underwent CIED procedures. Opioids were prescribed to 20.2% of the patients, among whom 80% were opioid naïve. Among opioid naïve patients who received opioids, 9.4% (95% confidence interval [CI] 8.3%–10.5%) had subsequent opioid refills. The percentage of patients who received more than 200 oral morphine equivalents of prescription was 38.8% (95% CI 37.2%–40.5%). Temporal trends revealed increasing rates of any opioid prescription, peaking in 2015 at 25.9%, with subsequent downtrend to 14.6% in 2018 (P <.001).

      Conclusion

      Postoperative opioid prescription rate after CIED procedures was 20.2%, with most patients being opioid naïve. Among opioid naïve patients who received opioids, 9.4% had subsequent opioid refills. This finding suggests that perioperative pain management in CIED procedures warrants meticulous attention.

      Keywords

      Introduction

      Prescription opioid abuse is an epidemic in the United States.
      • Murthy V.H.
      Ending the opioid epidemic—a call to action.
      There has been an increase in pain medication prescriptions since the installment of pain as the "fifth vital sign" by the Joint Commission on Accreditation of Healthcare Organizations.
      • Jones M.R.
      • Viswanath O.
      • Peck J.
      • Kaye A.D.
      • Gill J.S.
      • Simopoulos T.T.
      A brief history of the opioid epidemic and strategies for pain medicine.
      • Baker D.W.
      History of The Joint Commission's pain standards: lessons for today's prescription opioid epidemic.
      This has led to increase in prescription opioid abuse, addiction, and deaths due to prescription opioid overdose, which has now surpassed those of cocaine and heroin.
      Painkillers fuel growth in drug addiction. Harvard Mental Health Letter. January 2011.
      • Bohnert A.S.B.
      • Ilgen M.A.
      Understanding links among opioid use, overdose, and suicide.
      Multiple factors are associated with the increase in opioid prescriptions by health care providers. A conceptual framework rooted in the theory of planned behavior was created to understand the factors related to increase in opioid prescriptions (Figure 1).
      • Ajzen I.
      From intentions to actions: a theory of planned behavior.
      Provider attitudes about pain control may be influenced by pain management training and previous experiences. Patient factors, such as expectations of pain control, underlying comorbidities, and personal sensitivity to pain, are intertwined with the social norms about pain control and the perceived ability of the health care provider to provide pain control. All of these factors influence the provider's decision to prescribe opioids. Depending on the ease of prescribing, this may ultimately lead to prescription of opioids.
      Figure thumbnail gr1
      Figure 1A: Provider–patient relationship leading to decision for opioid prescription. (Used with permission of Mayo Foundation for Medical Education and Research. All Rights Reserved.) B: Conceptual framework of opioid prescriptions.
      Opioid prescription following cardiac implantable electronic device (CIED) procedures has not been studied. The primary objective of this study was to gain an understanding of opioid prescription pattern following CIED procedures at a tertiary academic practice with sites across the United States. The secondary objectives were to understand various factors associated with opioid prescriptions and to evaluate continued opioid prescription rates (refills) after initial device surgery. This is a first step toward improving nonopioid-based pain management following CIED procedures and potentially reduce prescription opioid abuse.

      Methods

      We performed a retrospective cohort study of all patients undergoing device procedures at the Mayo Clinic Enterprise Heart Rhythm Practice. The study included patients at the 3 academic campuses in Rochester, Minnesota; Phoenix, Arizona; and Jacksonville, Florida. The study was exempt from the Mayo Clinic Institutional Review Board.

      Study population

      Adult patients (age ≥18 years) who underwent CIED procedures and were discharged between January 1, 2010, and March 30, 2018, were included in the study (Figure 1). Administrative billing data were used to identify patients who underwent CIED procedures using Current Procedural Terminology (CPT) codes (Supplemental Material). Procedures were categorized into 5 broad categories: new CIED implantation, generator change, device upgrade, lead revision/replacement, subcutaneous implantable cardiac defibrillator (ICD), and other CIED procedures. Patients younger than 18 years, in-hospital deaths, and transfers to another hospital were excluded. Lead and device extraction or removal procedures without reimplantation also were excluded, as patients may have more pocket revision surgeries and surgical debridement. Leadless pacemakers were not included.

      CIED procedures

      CIED procedures were performed per American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines.
      • Russo A.M.
      • Stainback R.F.
      • Bailey S.R.
      • et al.
      ACCF/HRS/AHA/ASE/HFSA/SCAI/SCCT/SCMR 2013 appropriate use criteria for implantable cardioverter-defibrillators and cardiac resynchronization therapy: a report of the American College of Cardiology Foundation appropriate use criteria task force, Heart Rhythm Society, American Heart Association, American Society of Echocardiography, Heart Failure Society of America, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, and Society for Cardiovascular Magnetic Resonance.
      • Tracy C.M.
      • Epstein A.E.
      • Darbar D.
      • et al.
      2012 ACCF/AHA/HRS focused update of the 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. [corrected].
      The procedures may be performed as inpatient or outpatient procedures. Local anesthesia and intraprocedural opioids were administered per the discretion of the provider. The patients underwent procedures using standard techniques. Starting 2014, it was common for the Mayo Clinic Rochester practice to administer liposomal bupivacaine (Exparel; Pacira Pharmaceuticals, San Diego, CA) for all subcutaneous ICD implants. Postprocedure, patients were evaluated by the health care provider team, which included physicians and allied health providers. Typically, patients had standing orders for pain medications on an as-needed basis per electronic medical record order entry, which usually include nonopioid-based medications as first line and opioids-based medications as second line. For inpatient procedures, patients were evaluated the next day after CIED implantation. Upon discharge from the inpatient or outpatient procedure, opioids were prescribed based on the health care provider team's discretion, following all applicable state and federal laws. There is no fixed institutional practice guideline on opioid prescription. During the study period, there was also no change in provider requirements or limitations on prescribing opioids.

      Data collection

      Patient demographic parameters and comorbidities were collected. Comorbidities were identified using International Classification of Diseases, Ninth Revision (ICD-9) and International Classification of Diseases, Tenth Revision (ICD-10) codes (Supplemental Material).
      Medications in the pharmaceutical subclass of "opioid agonist," "opioid partial agonist," and "opioid combinations" with a Drug Enforcement Administration schedule II or III were considered prescription opioid medications. Data on opioid prescription written in the 90 days before the procedure and up 30 days after discharge were collected, such as characteristics of the opioid prescription, including type, dosage, frequency, quantity, and oral morphine equivalents (OME).
      Discharge opioid prescriptions were defined as outpatient opioid prescriptions written during admission and on the day of discharge. Comparable with previous studies, opioid prescriptions provided preoperatively for postoperative pain control were accounted for by including opioid prescription written 7 days before surgery as discharge prescriptions.
      • Hill M.V.
      • McMahon M.L.
      • Stucke R.S.
      • Barth Jr., R.J.
      Wide variation and excessive dosage of opioid prescriptions for common general surgical procedures.
      • Brummett C.M.
      • Waljee J.F.
      • Goesling J.
      • et al.
      New persistent opioid use after minor and major surgical procedures in US adults.
      Patients were categorized into opioid naïve and preoperative users. Opioid naïve was defined based on patients who did not receive any opioid prescription 90 days before the CIED procedure (up to 7 days before surgery).
      • Swarm R.A.
      • Abernethy A.P.
      • Anghelescu D.L.
      • et al.
      Adult cancer pain.
      • Thiels C.A.
      • Anderson S.S.
      • Ubl D.S.
      • et al.
      Wide variation and overprescription of opioids after elective surgery.
      Patients who received opioids before that time period were considered preoperative users. Refills were defined based on any opioid prescribed from 1 to 30 days after discharge. Opioid naïve patients who received opioid prescriptions and subsequently refilled their opioids were defined as new opioid refills. Opioid prescriptions were converted to OME in milligrams (Supplemental Material). High-dose opioid prescription was defined as discharge prescription with OME >200. The cutoff of 200 was based on the State of Minnesota guidelines for acute postoperative pain released in 2017, with recommendations to limit the entire prescription of opioids for postacute pain to no more than 200 OME (approximately 1 week of opioids or 26 tablets of 5 mg oxycodone).
      Minnesota Department of Human Services
      Opioid Prescribing Improvement Program. September 2017.
      The primary outcome was opioid prescription following discharge from the device procedure. Secondary outcomes were rates of opioid prescription among the 5 categories of CIED procedures, rate of new opioid refills, patient variables associated with opioid prescription, association between CIED complication rates and opioid refills, 30-day readmission rates, regional variation, and temporal trends of opioid prescription.

      Statistical analysis

      Categorical variables are expressed as percentages, whereas continuous variables are expressed as mean ± SD. Univariate analysis of demographic characteristics, comorbidity, and discharge prescriptions was performed using χ
      • Jones M.R.
      • Viswanath O.
      • Peck J.
      • Kaye A.D.
      • Gill J.S.
      • Simopoulos T.T.
      A brief history of the opioid epidemic and strategies for pain medicine.
      tests for categorical variables and Wilcoxon rank sum tests for continuous variables. All P values were 2-sided, and P <.05 was considered significant. All statistical analysis was performed using SAS statistical software, version 9.4 (SAS Institute, Cary, NC).

      Results

      A total of 16,517 patients (mean age 70 ± 15 years; 36.5% female) underwent CIED procedures during the 9-year study period (Figure 2).
      Figure thumbnail gr2
      Figure 2Patient inclusion and categorization CONSORT (CONsolidated Standards Of Reporting Trials) flow diagram. CPT = Current Procedural Terminology; ICD = implantable cardiac defibrillator.
      Overall, 20.2% of patients who underwent CIED procedures were discharged with an opioid prescription following the procedure. Of the patients who received an opioid prescription, 79.7% were opioid naïve. Among opioid naïve patients who received an opioid prescription, 9.4% had new opioid refills (opioid naïve patients who refilled their opioid prescriptions).
      Compared to patients who were not prescribed opioids, patients who were opioid naïve and were prescribed opioids were younger, were more likely to be female, and had fewer comorbidities (Table 1). This included lower rates of hypertension, coronary artery disease, chronic kidney disease, chronic obstructive pulmonary disease, peripheral vascular disease, and diabetes.
      Table 1Demographic, clinical characteristics, and outcomes of patients who underwent cardiac electronic device implantation
      OverallNo opioids prescribedOpioids prescribedP value
      Opioid naïvePreoperative opioid users
      Number16,51713,1822657678
      Age (y)70.5 ± 15.172.1 ± 14.363.7 ± 16.666.4 ± 15.8<.0001
      Female gender6017 (36.4)4663 (35.4)4056 (39.7)298 (44.0)<.0001
      Hypertension12930 (78.3)10421 (79.1)1947 (73.3)562 (82.9)<.0001
      CAD10567 (64.0)8449 (64.1)1646 (61.9)472 (69.6).0008
      CHF9857 (59.7)7813 (59.3)1589 (59.8)455 (67.1).0003
      CKD3666 (22.2)3002 (22.8)461 (17.4)203 (29.9)<.0001
      COPD2839 (17.2)2288 (17.4)381 (14.3)170 (25.1)<.0001
      PVD2519 (15.3)2082 (15.8)300 (11.3)137 (20.2)<.0001
      Diabetes5086 (30.8)4093 (31.0)718 (27.0)275 (40.6)<.0001
      Opioid prescription outcomes
       Opioid prescription3335 (20.2)NA2657 (79.7)678 (20.3)
       New opioid refillsNANA250 (9.4)NA
       OME prescription243.2 ± 346.0NA219.8 ± 237.3335.0 ± 598.4<.0001
       Opioid prescriptions with OME >2001295 (38.8)NA981 (36.9)314 (46.3)<.0001
      Values are given as n, mean ± SD, or n (%) unless otherwise indicated.
      CAD = coronary artery disease; CHF = congestive heart failure; CKD = chronic kidney disease; COPD = chronic obstructive pulmonary disease; OME = oral morphine equivalent; NA = not applicable; PVD = peripheral vascular disease.
      Among patients who received an opioid prescription, the mean OME prescribed was 243 ± 346. The average OME was higher in patients who were preoperative opioid users compared to patients who were opioid naïve (335 vs 219; P <.001). Overall, 38.8% of patients who were prescribed opioids received a high-dose opioid prescription (OME >200). About one-third (36.9%) of new opioid users (opioid naïve patients who received opioids) were prescribed a high-dose opioid prescription. The proportion of patients who received a high-dose opioid prescription was higher among patients with preoperative opioid use (46.3%).
      Among all CIED procedures, patients who underwent subcutaneous ICD implantation had the highest rate of opioid prescription (25.0%), followed by new implants (23.2%), lead revision or replacement (22.4%), device upgrade (18.3%), and generator change (11.6%) (P <.001) (Table 2). The rates of opioid refills were also higher in patients who had complications from CIED procedures (14.4% vs 9.9%; P <.001) (Supplemental Material). Opioid refill rates were higher in patients with pneumothorax (2.4% vs 1.7%; P = .043), lead dislodgment (8.0 vs. 5.2%; P <.001), pericardial effusion (4.6% vs 3.3%; P = .01), and who required lead revision after the CIED procedure (2.5% vs 1.2%; P <.001). Patients who received opioid prescriptions at discharge also had higher 30-day readmission rates compared to patients who did not receive opioid prescriptions at discharge (9.5% vs 7.7%; P <.001).
      Table 2Prescription of opioids following various categories of CIED procedures
      NumberOpioid prescription rateOME
      Overall16,5173335 (20.2)243.2 ± 346.0
      Subcutaneous ICD504126 (25.0)194.0 ± 122.8
      New implants96242234 (23.2)244.6 ± 300.3
      Lead revision or replacement728163 (22.4)215.7 ± 206.4
      Device upgrade
      Device upgrade includes procedure in which an existing pacemaker system is upgraded to a dual-chamber, cardiac resynchronization therapy, or defibrillator system.
      1309240 (18.3)254.9 ± 486.2
      Generator change3862448 (11.6)249.7 ± 485.8
      Others490124 (25.3)259.7 ± 463.0
      Values are given as n, n (%), or mean ± SD.
      CIED = cardiac implantable electronic device; ICD = implantable cardiac defibrillator; OME = oral morphine equivalent.
      Device upgrade includes procedure in which an existing pacemaker system is upgraded to a dual-chamber, cardiac resynchronization therapy, or defibrillator system.
      From 2010 to 2015, the rate of opioid prescription showed an increasing trend. At the peak in 2015, 25.9% of patients who underwent device procedures were discharged with opioids (Figure 3). The rate subsequently decreased to 14.6% in 2018 (P = <.001). However, the rate of opioid prescription for subcutaneous ICD continued to increase to 39.1% in 2018.
      Figure thumbnail gr3
      Figure 3Temporal trends of opioid prescription rate following cardiac implantable electronic device procedures. The overall opioid prescription rate peaked in 2015 and decreased since then (P <.001). The opioid prescription rate following subcutaneous implantable cardiac defibrillator (ICD) continued to increase (P <.001). Data in 2018 represent data from January 1, 2018, to March 30, 2018.
      Regional variation in opioid prescription was observed (Table 3). The opioid prescription rate was 15.7%, 17.2%, and 56.6% in Rochester, Minnesota; Phoenix, Arizona; and Jacksonville, Florida, respectively. The average OME among patients who received opioids was 255, 267, and 204 in Minnesota, Arizona, and Florida respectively. The rate of opioid refills in previously opioid naïve patients was 8.1%, 12.1%, and 10% in Minnesota, Arizona, and Florida respectively.
      Table 3Regional variation in opioid prescription
      MinnesotaArizonaFloridaP value
      Number11,02138291667
      Percentage of opioid naïve patients9721 (88.2)3270 (85.4)1387 (83.2)<.0001
      Opioid prescription rate1735 (15.7)657 (17.2)943 (56.6)<.0001
      Opioid naïve patients prescribed opioids1394 (14.4)495 (15.1)768 (55.4)<.0001
      New opioid refills113 (8.1)60 (12.1)77 (10.0).02
      OME prescription255.1 ± 330.3267.4 ± 497.2204.6 ± 220.4<.0001
      Opioid prescriptions with OME >200774 (44.6)277 (42.2)244 (25.9)<.0001
      Values are given as n, n (%), or mean ± SD unless otherwise indicated.
      OME = oral morphine equivalent.

      Discussion

      Our analysis of 16,517 patients who underwent CIED procedure showed that (1) 20.2% had opioid prescription after device procedure; (2) 80% of patients who received opioids were opioid naïve and 9.4% of opioid naïve patients had opioid refills; (3) 38.8% of patients who were prescribed opioids received a high-dose opioid prescription; and (4) temporal and regional variations in opioid prescription patterns were observed.
      Our study showed that 20.2% of patients were prescribed opioids following CIED procedures. In comparison with other studies on postoperative opioid use, the opioid prescription rate was 59% after endovascular aneurysm repair
      • Colton I.B.
      • Fujii M.H.
      • Ahern T.P.
      • et al.
      Postoperative opioid prescribing patterns and use after vascular surgery.
      and 77% after hand surgery procedures.
      • Paulozzi L.J.
      • Budnitz D.S.
      • Xi Y.
      Increasing deaths from opioid analgesics in the United States.
      In another study among general surgical procedures, ranging from partial mastectomy to open inguinal hernia repair, 90.5% of patients were prescribed an opioid.
      • Hill M.V.
      • McMahon M.L.
      • Stucke R.S.
      • Barth Jr., R.J.
      Wide variation and excessive dosage of opioid prescriptions for common general surgical procedures.
      The rates of opioid prescription following CIED seems to be lower than after other surgical procedures. This may be due to the relatively less invasive nature of CIED procedures compared to other surgical procedures. However, it may be higher compared to interventional radiology procedures. In a study of opioid prescribing behaviors of interventional radiologists, the average annual prescription of opioids was only 5.4 prescriptions per interventional radiologist.
      • Rosenkrantz A.B.
      • Prologo J.D.
      • Wang W.
      • Hughes D.R.
      • Bercu Z.L.
      • Duszak Jr., R.
      Opioid prescribing behavior of interventional radiologists across the United States.
      Among opioid naïve patients who were prescribed opioids, patients were younger, were more likely to be female, and had fewer comorbidities. This group of patients generally is more active, and providers may have a lower threshold for prescribing opioids for better pain relief so that these patients can return to their baseline physical functioning. Another possible explanation could be provider perception of a lower pain tolerance in this group of patients. Other studies have shown that women were more likely to be prescribed opioids than men.
      • Hirschtritt M.E.
      • Delucchi K.L.
      • Olfson M.
      Outpatient, combined use of opioid and benzodiazepine medications in the United States, 1993–2014.
      • Mazure C.M.
      • Fiellin D.A.
      Women and opioids: something different is happening here.
      We found that patients with a subcutaneous ICD had the highest rate of postoperative opioids prescription (Table 2). This is likely because of the larger device footprint of the subcutaneous ICD, highly innervated midaxillary chest wall, and the procedural technique, which typically requires 2 or 3 incisions, dissection of tissue planes, and tunneling from the pocket for parasternal positioning of the lead.
      In our study, most patients who received opioids were opioid naïve, and 9.4% of patients had new opioid refills. The rate of opioid refills in our study is similar to that in other studies, ranging from 13% following hand surgery procedures to 15.7% among various elective surgical procedures ranging from total knee arthroplasty to parathyroidectomy.
      • Thiels C.A.
      • Anderson S.S.
      • Ubl D.S.
      • et al.
      Wide variation and overprescription of opioids after elective surgery.
      • Paulozzi L.J.
      • Budnitz D.S.
      • Xi Y.
      Increasing deaths from opioid analgesics in the United States.
      The rate of new persistent opioid use, defined as use of opioids between 90 and 180 days, was 5.9% following minor surgery.
      • Brummett C.M.
      • Waljee J.F.
      • Goesling J.
      • et al.
      New persistent opioid use after minor and major surgical procedures in US adults.
      The temporal trend in opioid prescription reveals a peak in 2015, with a subsequent decrease in prescription rate since then. Recent studies have shown similar patterns of recent decrease in opioid prescription rates, probably reflecting the increased provider and health care practice awareness of the opioid epidemic.
      • Adams J.M.
      • Giroir B.P.
      Opioid Prescribing Trends and the Physician’s Role in Responding to the Public Health Crisis.
      • Piper B.J.
      • Shah D.T.
      • Simoyan O.M.
      • McCall K.L.
      • Nichols S.D.
      Trends in medical use of opioids in the U.S., 2006–2016.
      Our study also showed regional variation in opioid prescription, which reflected data from the Centers for Disease Control and Prevention, showing the highest to lowest opioid prescription rate being Duval County, Florida; Maricopa County, Arizona; and Olmsted County, Minnesota.
      Centers for Disease Control and Prevention
      Opioid Overdose: U.S. Opioid Prescribing Rate Maps. October 2018.
      This may be due to variations in patient population, hospital protocols, and provider practice patterns.
      The management of postoperative pain should begin preoperatively (Table 4). Patients should be evaluated with a thorough history and physical examination, which includes history of chronic pain and previous postoperative treatment regimens and responses.
      • Chou R.
      • Gordon D.B.
      • de Leon-Casasola O.A.
      • et al.
      Management of postoperative pain: a clinical practice guideline from the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council.
      Patients also should be educated on treatment options for management of postoperative pain and goals of postoperative pain management. Oral gabapentin (600 or 1200 mg) or pregabalin (150 or 300 mg) administered 1–2 hours before the procedure has been associated with reduced opioid requirements postsurgery.
      • Chou R.
      • Gordon D.B.
      • de Leon-Casasola O.A.
      • et al.
      Management of postoperative pain: a clinical practice guideline from the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council.
      • Agarwal A.
      • Gautam S.
      • Gupta D.
      • Agarwal S.
      • Singh P.K.
      • Singh U.
      Evaluation of a single preoperative dose of pregabalin for attenuation of postoperative pain after laparoscopic cholecystectomy.
      Similarly, preoperative oral celecoxib 200 to 400 mg administered 30 minutes to 1 hour before the procedure has been associated with reduced opioid requirements.
      • Chou R.
      • Gordon D.B.
      • de Leon-Casasola O.A.
      • et al.
      Management of postoperative pain: a clinical practice guideline from the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council.
      • Ekman E.F.
      • Wahba M.
      • Ancona F.
      Analgesic efficacy of perioperative celecoxib in ambulatory arthroscopic knee surgery: a double-blind, placebo-controlled study.
      However, celecoxib may not be appropriate for many patients undergoing device implantation who often have significant cardiovascular history.
      Table 4Outline of strategies to improve postoperative pain management
      Preoperative
       Preoperative evaluationObtain comprehensive history, which includes medical and psychiatric comorbidities, chronic pain, substance abuse, and previous treatment regimens and responses
       Patient educationProvide information and discuss treatment options for postoperative pain; establish goals for postoperative pain management
       Preoperative medicationsAdminister oral gabapentin or pregabalin 1–2 hours before the procedure, or oral celecoxib 30 minutes to 1 hour before the procedure
      Intraprocedural
       Operative techniquePlacement of generator in the fascial plane and meticulous hemostasis to prevent postoperative hematoma
       Local anesthesiaUse of long-acting local anesthetic (liposomal bupivacaine)
       Regional anesthesiaUse of site-specific peripheral regional anesthetic
      Postoperative
       Multimodal analgesiaUse of variety of analgesic medication may have additive and synergistic effects; nonopioid medications includes acetaminophen, NSAID, and gabapentin or pregabalin
       EducationAppropriate degree and duration of arm restriction for prevention of both lead dislodgment and adhesive capsulitis
      NSAID = nonsteroidal anti-inflammatory drug.
      Intraprocedurally, the main factors to consider are operative technique, local medication, and regional anesthesia.
      • Biocic M.
      • Vidosevic D.
      • Boric M.
      • et al.
      Anesthesia and perioperative pain management during cardiac electronic device implantation.
      Meticulous technique with placement of the device in the fascial layer as opposed to near the skin as well as adequate control of hemostasis will reduce postoperative pain (Figures 4A and 4B). Liposomal bupivacaine is an extended release bupivacaine that may have a clinical effect for 72 hours after a single infiltration (Figure 4C).
      • Malik O.
      • Kaye A.D.
      • Kaye A.
      • Belani K.
      • Urman R.D.
      Emerging roles of liposomal bupivacaine in anesthesia practice.
      Combined use of lidocaine and liposomal bupivacaine for local anesthetic infiltration may help achieve short- and longer-term local pain relief. Regional anesthesia techniques, such as truncal plane blocks (Figure 4D), also may be a feasible alternative to general anesthesia for subcutaneous ICD implantation.
      • Miller M.A.
      • Garg J.
      • Salter B.
      • et al.
      Feasibility of subcutaneous implantable cardioverter-defibrillator implantation with opioid sparing truncal plane blocks and deep sedation.
      For transvenous pacemakers or defibrillators, local anesthetic infiltration is adequate, although cervical and pectoral nerve block may be an alternative option.
      • Martin R.
      • Dupuis J.Y.
      • Tetrault J.P.
      Regional anesthesia for pacemaker insertion.
      • Mittnacht A.J.C.
      • Shariat A.
      • Weiner M.M.
      • et al.
      Regional techniques for cardiac and cardiac-related procedures.
      Intravenous ketamine has been suggested to reduce postoperative opioid use.
      • Chou R.
      • Gordon D.B.
      • de Leon-Casasola O.A.
      • et al.
      Management of postoperative pain: a clinical practice guideline from the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council.
      However, this should be avoided in patients undergoing device implantation because it may cause myoclonus leading to oversensing and interference with pacemaker function or intraprocedural device testing.
      Figure thumbnail gr4
      Figure 4A: Identification of fascial plane during pacemaker insertion. B: Hematoma formation after pacemaker implantation. C: Injection of liposomal bupivacaine D: Regional anesthesia for cardiac implantable electronic device implantation includes transversus thoracic plane block (TTPB) and serratus anterior plane block (SAPB) for subcutaneous implantable cardiac defibrillator implantation, and cervical plexus block (CPB) and pectoralis block (PEC) for transvenous pacemaker implantation.
      (Used with permission of Mayo Foundation for Medical Education and Research. All Rights Reserved.)
      For postoperative pain management, the use of multimodality analgesia (ie, a variety of analgesic medications) to target a different mechanism of action in the peripheral and central nervous systems may have a synergistic effect and provide better pain relief compared to use of a single agent alone.
      • Chou R.
      • Gordon D.B.
      • de Leon-Casasola O.A.
      • et al.
      Management of postoperative pain: a clinical practice guideline from the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council.
      The use of around-the-clock nonopioid analgesic may be adequate for pain relief. Appropriate postoperative patient education on arm movement is important, as prolonged restricted arm movement may lead to adhesive capsulitis (frozen shoulder) leading to prolonged postoperative pain.
      • Naffe A.
      • Iype M.
      • Easo M.
      • et al.
      Appropriateness of sling immobilization to prevent lead displacement after pacemaker/implantable cardioverter-defibrillator implantation.
      Multiple statements on recommendations for opioid use in managing acute postoperative pain have been published.
      • Chou R.
      • Gordon D.B.
      • de Leon-Casasola O.A.
      • et al.
      Management of postoperative pain: a clinical practice guideline from the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council.
      Prescribing Opioids for Postoperative Pain–Supplemental Guidance. July 2018.
      The Dr. Robert Bree collaborative categorized procedures into various types, based on expected duration of recovery.
      Prescribing Opioids for Postoperative Pain–Supplemental Guidance. July 2018.
      In procedures in which rapid recovery is expected, such as inguinal hernia repair or breast lumpectomy, nonopioid analgesics are recommended as first-line therapy. If opioids are necessary, <3 days of short-acting opioids in combination with an nonsteroidal anti-inflammatory drug or acetaminophen is recommended.
      Multiple unintended consequences to the prescription of opioids for pain relief include an increase in opioid addiction and opioid-related death.
      • Volkow N.D.
      • McLellan A.T.
      Opioid abuse in chronic pain—misconceptions and mitigation strategies.
      Beyond the potential for addiction, the side effect profile of opioids includes constipation, sleep-disordered breathing, depression, somnolence, and dizziness leading to unintended consequences such as falls and fractures.
      • Baldini A.
      • Von Korff M.
      • Lin E.H.
      A Review of Potential Adverse Effects of Long-Term Opioid Therapy: A Practitioner's Guide.
      There is also the economic cost of prescription opioid overdose, abuse, and dependence, at an individual level and at a societal level, from increased health care costs, criminal justice costs, and loss of productivity costs.
      • Florence C.S.
      • Zhou C.
      • Luo F.
      • Xu L.
      The economic burden of prescription opioid overdose, abuse, and dependence in the United States, 2013.
      There is also a risk of opioid diversion, which is transfer of opioids by patients who received legitimately prescribed opioids to family members or friends who are trying to self-medicate.
      • Volkow N.D.
      • McLellan A.T.
      Opioid abuse in chronic pain—misconceptions and mitigation strategies.
      Diversion of opioids can be intentional or it can be unintentional in the form of theft, related to the improper storage or disposal of opioids.
      • Reddy A.
      • de la Cruz M.
      • Rodriguez E.M.
      • et al.
      Patterns of storage, use, and disposal of opioids among cancer outpatients.

      Study limitations

      Our study analyzed data on opioid prescription but was not able to attain data on patient utilization of the prescribed opioids. A single or even repeated opioid refills do not necessarily signal addiction or dependence. Patient refill rates were also likely underestimated as we were unable to evaluate opioid refills outside of our health care systems. Data on use of nonopioid analgesic medications, such as acetaminophen or nonsteroidal anti-inflammatory drugs, were not captured due to the limited accuracy of these data as they are available over the counter. We also did not capture data on intraprocedural medications and therefore were not able to analyze associations between various kinds of intraprocedural analgesic medications and impact on opioid prescription rates at discharge. Furthermore, this study was based on data from 3 tertiary referral centers that are part of the same health system. There may be limited extrapolation to hospitals with a different patient population, hospital protocol, and procedural mix.

      Conclusion

      Among patients who underwent CIED procedures, the overall opioid prescription rate was 20.2%, with 80% of patients being opioid naïve. This study shows that perioperative pain management in CIED procedures warrants attention. More studies are needed to evaluate various methods to decrease opioid prescription rates following CIED procedures, such as development of protocols emphasizing nonopioid means of pain relief that can reduce the use of opioids following CIED procedures. Other studies on nonpharmacologic methods of pain relief, such as cognitive behavioral therapy, are important. Our study showed that 9.4% of opioid naïve patients who received opioids subsequently refilled their opioids. This highlights that short-term opioid prescription may have a longer-term impact on patients. More studies are needed to assess the link between prolonged opioid use and risk of addiction or dependence.

      Appendix. Supplementary data

      References

        • Murthy V.H.
        Ending the opioid epidemic—a call to action.
        N Engl J Med. 2016; : 2413-2415
        • Jones M.R.
        • Viswanath O.
        • Peck J.
        • Kaye A.D.
        • Gill J.S.
        • Simopoulos T.T.
        A brief history of the opioid epidemic and strategies for pain medicine.
        Pain Ther. 2018; 7: 13-21
        • Baker D.W.
        History of The Joint Commission's pain standards: lessons for today's prescription opioid epidemic.
        JAMA. 2017; 317: 1117-1118
      1. Painkillers fuel growth in drug addiction. Harvard Mental Health Letter. January 2011.
        (Available at)
        • Bohnert A.S.B.
        • Ilgen M.A.
        Understanding links among opioid use, overdose, and suicide.
        N Engl J Med. 2019; 380: 71-79
        • Ajzen I.
        From intentions to actions: a theory of planned behavior.
        in: Kuhl J. Beckmann J. Action Control. SSSP Springer Series in Social Psychology. Springer, Berlin, Heidelberg1985 (Chap 2, pp 11 to 39)
        • Russo A.M.
        • Stainback R.F.
        • Bailey S.R.
        • et al.
        ACCF/HRS/AHA/ASE/HFSA/SCAI/SCCT/SCMR 2013 appropriate use criteria for implantable cardioverter-defibrillators and cardiac resynchronization therapy: a report of the American College of Cardiology Foundation appropriate use criteria task force, Heart Rhythm Society, American Heart Association, American Society of Echocardiography, Heart Failure Society of America, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, and Society for Cardiovascular Magnetic Resonance.
        J Am Coll Cardiol. 2013; 61: 1318-1368
        • Tracy C.M.
        • Epstein A.E.
        • Darbar D.
        • et al.
        2012 ACCF/AHA/HRS focused update of the 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. [corrected].
        Circulation. 2012; 126: 1784-1800
        • Hill M.V.
        • McMahon M.L.
        • Stucke R.S.
        • Barth Jr., R.J.
        Wide variation and excessive dosage of opioid prescriptions for common general surgical procedures.
        Ann Surg. 2017; 265: 709-714
        • Brummett C.M.
        • Waljee J.F.
        • Goesling J.
        • et al.
        New persistent opioid use after minor and major surgical procedures in US adults.
        JAMA Surg. 2017; 152: e170504
        • Swarm R.A.
        • Abernethy A.P.
        • Anghelescu D.L.
        • et al.
        Adult cancer pain.
        J Natl Compr Canc Netw. 2013; 11: 992-1022
        • Thiels C.A.
        • Anderson S.S.
        • Ubl D.S.
        • et al.
        Wide variation and overprescription of opioids after elective surgery.
        Ann Surg. 2017; 266: 564-573
        • Minnesota Department of Human Services
        Opioid Prescribing Improvement Program. September 2017.
        (Available at)
        • Colton I.B.
        • Fujii M.H.
        • Ahern T.P.
        • et al.
        Postoperative opioid prescribing patterns and use after vascular surgery.
        Vasc Med. 2019; 24: 63-69
        • Paulozzi L.J.
        • Budnitz D.S.
        • Xi Y.
        Increasing deaths from opioid analgesics in the United States.
        Pharmacoepidemiol Drug Saf. 2006; 15: 618-627
        • Rosenkrantz A.B.
        • Prologo J.D.
        • Wang W.
        • Hughes D.R.
        • Bercu Z.L.
        • Duszak Jr., R.
        Opioid prescribing behavior of interventional radiologists across the United States.
        J Am Coll Radiol. 2018; 15: 726-733
        • Hirschtritt M.E.
        • Delucchi K.L.
        • Olfson M.
        Outpatient, combined use of opioid and benzodiazepine medications in the United States, 1993–2014.
        Prev Med Rep. 2017; 9: 49-54
        • Mazure C.M.
        • Fiellin D.A.
        Women and opioids: something different is happening here.
        Lancet. 2018; 392: 9-11
        • Adams J.M.
        • Giroir B.P.
        Opioid Prescribing Trends and the Physician’s Role in Responding to the Public Health Crisis.
        JAMA Intern Med. 2019; 179: 476-478
        • Piper B.J.
        • Shah D.T.
        • Simoyan O.M.
        • McCall K.L.
        • Nichols S.D.
        Trends in medical use of opioids in the U.S., 2006–2016.
        Am J Prev Med. 2018; 54: 652-660
        • Centers for Disease Control and Prevention
        Opioid Overdose: U.S. Opioid Prescribing Rate Maps. October 2018.
        (Available at)
        • Chou R.
        • Gordon D.B.
        • de Leon-Casasola O.A.
        • et al.
        Management of postoperative pain: a clinical practice guideline from the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council.
        J Pain. 2016; 17: 131-157
        • Agarwal A.
        • Gautam S.
        • Gupta D.
        • Agarwal S.
        • Singh P.K.
        • Singh U.
        Evaluation of a single preoperative dose of pregabalin for attenuation of postoperative pain after laparoscopic cholecystectomy.
        Br J Anaesth. 2008; 101: 700-704
        • Ekman E.F.
        • Wahba M.
        • Ancona F.
        Analgesic efficacy of perioperative celecoxib in ambulatory arthroscopic knee surgery: a double-blind, placebo-controlled study.
        Arthroscopy. 2006; 22: 635-642
        • Biocic M.
        • Vidosevic D.
        • Boric M.
        • et al.
        Anesthesia and perioperative pain management during cardiac electronic device implantation.
        J Pain Res. 2017; 10: 927-932
        • Malik O.
        • Kaye A.D.
        • Kaye A.
        • Belani K.
        • Urman R.D.
        Emerging roles of liposomal bupivacaine in anesthesia practice.
        J Anaesthesiol Clin Pharmacol. 2017; 33: 151-156
        • Miller M.A.
        • Garg J.
        • Salter B.
        • et al.
        Feasibility of subcutaneous implantable cardioverter-defibrillator implantation with opioid sparing truncal plane blocks and deep sedation.
        J Cardiovasc Electrophysiol. 2019; 30: 141-148
        • Martin R.
        • Dupuis J.Y.
        • Tetrault J.P.
        Regional anesthesia for pacemaker insertion.
        Reg Anesth. 1989; 14: 81-84
        • Mittnacht A.J.C.
        • Shariat A.
        • Weiner M.M.
        • et al.
        Regional techniques for cardiac and cardiac-related procedures.
        J Cardiothorac Vasc Anesth. 2019; 33: 532-546
        • Naffe A.
        • Iype M.
        • Easo M.
        • et al.
        Appropriateness of sling immobilization to prevent lead displacement after pacemaker/implantable cardioverter-defibrillator implantation.
        Proc (Bayl Univ Med Cent). 2009; 22: 3-6
      2. Prescribing Opioids for Postoperative Pain–Supplemental Guidance. July 2018.
        (Available at)
        • Volkow N.D.
        • McLellan A.T.
        Opioid abuse in chronic pain—misconceptions and mitigation strategies.
        N Engl J Med. 2016; 374: 1253-1263
        • Baldini A.
        • Von Korff M.
        • Lin E.H.
        A Review of Potential Adverse Effects of Long-Term Opioid Therapy: A Practitioner's Guide.
        Prim Care Companion CNS Disord. 2012; 14 (PCC.11m01326)
        • Florence C.S.
        • Zhou C.
        • Luo F.
        • Xu L.
        The economic burden of prescription opioid overdose, abuse, and dependence in the United States, 2013.
        Med Care. 2016; 54: 901-906
        • Reddy A.
        • de la Cruz M.
        • Rodriguez E.M.
        • et al.
        Patterns of storage, use, and disposal of opioids among cancer outpatients.
        Oncologist. 2014; 19: 780-785