Unrecognized venous injuries after cardiac implantable electronic device transvenous lead extraction

Published:November 12, 2017DOI:https://doi.org/10.1016/j.hrthm.2017.11.008

      Background

      The major complication rate of transvenous lead extraction (TLE) is estimated to be 1%–2%. Laceration of the central veins can be fatal.

      Objectives

      To define the incidence and extent of venous injuries on a microscopic level after TLE and compare these data with those of clinically documented events of venous laceration.

      Methods

      We studied all patients who underwent TLE at our tertiary center within 30 months via a variety of techniques. Extracted leads and tissue around them were fixed in formalin. Pathologic examination was standardized to examine the leads identifying the areas covered by tissue cuffs along the length of the lead. The cuffs were removed and sectioned transversely to their longitudinal axis. Microscopic examination was performed using hematoxylin and eosin stains and Movat stains to identify the presence of vein tissue.

      Results

      In all, 861 leads (585 pacemaker and 272 defibrillator leads) were extracted from 461 patients (median age 63 years, standard deviation 15 years), with an average of 1.9 leads per patient and a median lead age of 2546 days. On microscopic review, 80 leads (9.3%) in 72 of 461 patients (15.6%) showed segments of vein, most of which were transmural (venous tissue including adventitia). Despite this finding, only 5 catastrophic complications (1.1%) occurred that required emergent surgical intervention. Risk factors for venous injury included implantable cardioverter defibrillator lead, age of lead, and the use of laser sheath.

      Conclusions

      Microscopic venous injuries during lead extraction are common but often not recognized clinically.

      Graphical abstract

      Keywords

      Introduction

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      The expanding indications for cardiac implantable electronic devices (CIEDs) has led to significant growth in the number of implanted devices.
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      • Patel J.D.
      • Lau E.
      • Ochoa J.A.
      • Frisch D.R.
      • Ho R.T.
      • Pavri B.B.
      • Kurtz S.M.
      Trends in permanent pacemaker implantation in the united states from 1993 to 2009: increasing complexity of patients and procedures.
      • Tarakji K.G.
      • Wilkoff B.L.
      Management of cardiac implantable electronic device infections: the challenges of understanding the scope of the problem and its associated mortality.
      With an aging population and a growing mismatch between patient and device longevity,
      • Hauser R.G.
      The growing mismatch between patient longevity and the service life of implantable cardioverter-defibrillators.
      there has been increasing need for transvenous lead extraction (TLE) for different indications: infection,
      • Voigt A.
      • Shalaby A.
      • Saba S.
      Continued rise in rates of cardiovascular implantable electronic device infections in the united states: temporal trends and causative insights.
      lead malfunction,
      • Liu J.
      • Brumberg G.
      • Rattan R.
      • Jain S.
      • Saba S.
      Class I recall of defibrillator leads: a comparison of the sprint fidelis and riata families.
      need for system upgrade, or venous system occlusion.
      • Wazni O.
      • Epstein L.M.
      • Carrillo R.G.
      • et al.
      Lead extraction in the contemporary setting: The lexicon study: an observational retrospective study of consecutive laser lead extractions.
      • Wilkoff B.L.
      • Love C.J.
      • Byrd C.L.
      • Bongiorni M.G.
      • Carrillo R.G.
      • Crossley 3rd, G.H.
      • Epstein L.M.
      • Friedman R.A.
      • Kennergren C.E.
      • Mitkowski P.
      • Schaerf R.H.
      • Wazni O.M.
      Heart Rhythm Society; American Heart Association. Transvenous lead extraction: Heart Rhythm Society expert consensus on facilities, training, indications, and patient management: This document was endorsed by the American Heart Association (AHA).
      Major complications, including cardiac perforation, vascular tear, hemothorax, and death, may occur but at a low incidence rate of approximately 1%–2%
      • Wazni O.
      • Epstein L.M.
      • Carrillo R.G.
      • et al.
      Lead extraction in the contemporary setting: The lexicon study: an observational retrospective study of consecutive laser lead extractions.
      • Brunner M.P.
      • Cronin E.M.
      • Duarte V.E.
      • et al.
      Clinical predictors of adverse patient outcomes in an experience of more than 5000 chronic endovascular pacemaker and defibrillator lead extractions.
      • Brunner M.P.
      • Cronin E.M.
      • Wazni O.
      • Baranowski B.
      • Saliba W.I.
      • Sabik J.F.
      • Lindsay B.D.
      • Wilkoff B.L.
      • Tarakji K.G.
      Outcomes of patients requiring emergent surgical or endovascular intervention for catastrophic complications during transvenous lead extraction.
      The low incidence rate of these complications has made it difficult to predict when leads will be difficult to extract and when complications may occur. Whereas many studies have evaluated clinical variables and their association with outcomes during TLE, endovascular and myocardial injury have not been evaluated on a microscopic level. Our goal in this study was to better understand the pathophysiology of cardiovascular injuries with lead extraction on a microscopic level.

      Methods

      We retrospectively analyzed consecutive patients who underwent TLE of pacemaker or implantable cardioverter defibrillator (ICD) leads at the Cleveland Clinic's tertiary care center between July 2013 and January 2016. We included leads that were >1 year old or required additional tools for removal, therefore fulfilling the criteria for the definition of lead extraction.
      • Wilkoff B.L.
      • Love C.J.
      • Byrd C.L.
      • Bongiorni M.G.
      • Carrillo R.G.
      • Crossley 3rd, G.H.
      • Epstein L.M.
      • Friedman R.A.
      • Kennergren C.E.
      • Mitkowski P.
      • Schaerf R.H.
      • Wazni O.M.
      Heart Rhythm Society; American Heart Association. Transvenous lead extraction: Heart Rhythm Society expert consensus on facilities, training, indications, and patient management: This document was endorsed by the American Heart Association (AHA).
      Demographic, historical, and procedural data were obtained from the electronic medical records and prospectively collected in institutional databases. Leads were removed via a variety of techniques per operator preference and as dictated by the procedure. All operators were electrophysiologists experienced in TLE. The study was approved by the institutional review board of the Cleveland Clinic.
      The extracted leads were sent to our pathology laboratory, where the leads and tissue around them were fixed in formalin. Pathologic examination was standardized to identify the areas covered by tissue cuffs along the length of the lead. The length of every tissue cuff was measured before removal. Because multiple points of contact between the lead and vascular or cardiac tissue can occur along the lead's course, there was frequently >1 segment of fibrous cuff per lead (Figure 1). Therefore, in every case, the distal tip of the lead was identified, and the distance of every cuff from the distal end of the lead was recorded for possible correlation to the anatomic location of contact of the lead with myocardium, valve, or vein wall structures. After they were dissected from the lead, the fibrous cuffs were transversely sectioned and embedded to show a lumen where the lead used to be. Microscopic examination was performed using hematoxylin and eosin and Movat pentachrome stains. Venous wall injury was identified by the presence of tunica media containing smooth muscle cells and thin elastic fibers or tunica adventitia containing coarse elastic fibers and collagen bundles. The venous injury was considered transmural when the adventitial layer was identified around the extracted lead. We also defined any cardiovascular injury as either vein injury or the presence of atrial or ventricular myocardial tissue on histopathologic examination. Clinical catastrophic complications were defined as any cardiovascular injury at time of extraction that required surgical or percutaneous intervention.
      Figure thumbnail gr1
      Figure 1Fibrous cuffs around extracted leads.

      Statistical analysis

      Demographics, medical history, and lead-related characteristics were presented as frequency (%) for categorical variables and as mean plus or minus standard deviation for normally distributed continuous variables or median and interquartile range for nonnormally distributed continuous variables. Histopathologic outcomes were summarized across lead-age groups. Lead and procedural characteristics among the identified patients (lead type, median age of leads, use of laser extraction, and procedural complications) were compared based on the presence or absence of vein injury and on the presence or absence of any cardiovascular injury using generalized linear mixed-effects modeling (a mixed-effects logistic regression model with a binomial link function), whereas the variable of reason of lead extraction was assessed using the Fisher exact test. In the mixed-effects models, individual patients were set as a random effect, considering the fact that the same patient could have multiple lead extractions. A multivariable generalized mixed-effects logistic model was developed for vein injury and for any cardiovascular injury, respectively, to identify clinical predictors of the pathologic outcomes.

      Results

      In all, 461 consecutive patients who underwent TLE were included in the study. Demographics and clinical characteristics of these patients are provided in Table 1. The mean age of patients was 63 years (standard deviation 15 years) and 70% were male. A total of 861 leads were extracted (272 defibrillator leads [31.6%] and 585 pacemaker leads [68%]; 3 leads were unidentified). The average number of leads removed per patient was 1.9 leads. The median age of leads removed was 2546 days. Twenty-one percent of the leads were extracted using only manual traction, and the remainder required additional tools. Sixty-eight percent of leads required the use of a laser extraction system (Spectranetics, Colorado Springs, CO), and 11% required mechanical extraction tools (Evolution or Evolution RL system, Cook Medical, Bloomington, IN) (Table 2).
      Table 1Baseline characteristics of 461 consecutive patients who underwent cardiac implantable electronic device extraction
      DemographicsPatients, nPatients, %
      Age, y, mean ± SD, y62.6 ± 15.1
      Gender
       Male32470.3
      Ethnicity
       White40086.8
       African American449.5
       Asian/Native American/Alaska Native61.3
       Other112.4
      Medical history
       Coronary artery disease20243.8
       Congestive heart failure15734.1
       Hypertension27058.6
       Diabetes13128.4
       Atrial fibrillation19041.2
       Chronic renal insufficiency (creatinine concentration >1.7 mg/dL)6013.0
       Dialysis173.7
       Peripheral arterial disease429.1
       Chronic obstructive pulmonary disease5912.8
      Table 2Lead and procedural characteristics
      Type of lead
       Defibrillator272 (31.6)
       Pace/sense585 (67.9)
      Leads extracted per patient
       1198 (43)
       2165 (36)
       ≥398 (21)
      Leads extracted per patient mean ± SD1.87 ± 0.98
      Age of leads, d, median IQR2545.5 (1336.0–3691.0)
      Indication for lead extraction
       Infection507 (58.6)
       Lead failure / malfunction251 (29.0)
       Device upgrade42 (4.9)
       Venous access29 (3.4)
       Other29 (3.4)
      Lead traction only (and lead age >1 y)184 (21.3)
      Locking stylet653 (75.5)
      Extraction sheath585 (67.6)
       Laser + mechanical63 (7.3)
       Laser522 (60.6)
       Mechanical32 (3.7)
       None244 (28.3)
      Laser sheath size
       12F95 (11.0)
       14F257 (29.7)
       16F236 (27.3)
      Location of laser application
       Axillary subclavian vein404 (46.7)
       Brachiocephalic417 (48.2)
       Superior vena cava416 (48.1)
       Superior vena cava–right atrial junction48 (5.6)
       Right atrium221 (25.6)
       Right ventricle196 (22.7)
      N = 861 leads extracted from 461 consecutive patients.
      Cell values are n (%) unless otherwise specified.
      IQR = interquartile range; SD = standard deviation.
      Histologic examination showed that the tissue cuff was composed of dense fibrous tissue surrounding the lead as a result of organized thrombus. Other common findings, including the presence of calcification, attached trabecular myocardium with endocardial fibroelastosis, and the presence of skeletal muscle and adipose tissue, are illustrated in Figure 2. No arterial tissue was identified. Vein wall was identified by the presence of tunica media containing smooth muscle cells and thin elastic fibers and tunica adventitia containing coarse elastic fibers and collagen bundles (Figure 3).
      Figure thumbnail gr2
      Figure 2Findings from histologic examination of fibrous cuffs surrounding cardiac implantable electronic device leads (Movat pentachrome stains). A: A section of the tissue cuff around the lead shows a thin rim of dense fibrous tissue stained in yellow with attached organizing thrombus stained in red (asterisk). The empty space in the center is the space occupied by the lead. B: Calcification (arrows) is common in the fibrous cuffs (with higher frequency in the areas over defibrillator coils), as shown in this example. C: This tissue cuff shows granulation tissue surrounding the empty space previously occupied by the lead. The tissue cuff is adherent to a transmural section of vein on the right side. Adjacent to the vein is a segment of skeletal muscle (asterisk). This finding is most consistent with tissue close to the pocket access site. D: The fibrous cuff shown in this section is focally surrounded by myocardial tissue with the myocytes stained in red (asterisk). This finding is common in the right ventricular apical leads and less common in the areas of contact with atrial myocardium. E: A thick fibrous cuff is densely adherent to the endocardium. A higher magnification of the boxed area of the endocardium is shown in F. A high-resolution version of the image is available as eSlide: VM04596 . F: The endocardium is thickened with a band of smooth muscle cells, fibrosis, and proliferation of abundant elastic fibers stained black (asterisk). Note the presence of a few blood vessels in the deeper layer and cautery artifact with the tissue at the edge staining dark brown black. Endocardial fibroelastosis could be mistaken for a segment of vein. However, in most instances, there are subtle differences in the characteristics of the elastic fibers that are finer in caliber and denser with a wavy pattern in endocardial fibroelastosis.
      Figure thumbnail gr3
      Figure 3Histology of vein injury associated with lead extraction (Movat pentachrome stains). A: A fibrous cuff is firmly attached to the wall of a vein. Note that the portion of the fibrous cuff adherent to the vein is very thin. The tissue at the edges of the section is stained darker as a result of thermal injury. A greater magnification of the boxed area is shown in B. A high-resolution version of the image is available as eSlide: VM04597 . B: A transmural segment of vein is present adjacent to the fibrous cuff. The tunica media contains circularly arranged layer of smooth muscle cells with the cytoplasm stained a light red or magenta. The tunica adventitia contains elastic fibers stained black interspersed with the collagen bundles stained yellow. The brown-black staining at the tissue edge is secondary to thermal injury. C: A segment of fibrous cuff has an attached partial thickness of vein wall. A higher magnification image of the boxed area is shown in D. D: The tunica media can be identified with a few smooth muscle cells and scattered elastic fibers. A distinct tunica adventitia is not identified as this specimen represents a gracing cut through the media/adventitia interface.
      Vein tissue was identified in 80 of the 861 extracted leads (9.3%) and among 72 of the total 461 patients (15.6%). The sections of vein wall were further classified into transmural, where the adventitia was identified, in 65 leads and partial, where only the media was identified, in 15 leads. Moreover, skeletal and adipose tissue were present in 16 of the 65 leads with transmural injury; this latter finding was most consistent with vein tissue close to the pocket access site. Only 28 of 80 extracted leads came with the distal tip that allowed assessment of the position of the fibrous cuff with vein. Most of the vein tissue was identified within 15–22 cm of the tip (average 17 cm).
      The characteristics of leads with and without vein injury are presented in Table 3. Vein injuries tended to be more frequent with defibrillator leads compared with pacemaker leads. Defibrillator leads accounted for 32% of all leads but represented 49% of all leads with vein injuries. Leads with vein injuries were significantly older. The median age of the extracted leads with vein injury was 3197 days (IQR 2445–3899 days), whereas the median age of those leads without vein injury was 2463 days (IQR 1253–3682), P = .019. The laser sheath was used in the vast majority of leads with vein injury (95%) compared with 65% of leads without vein injury (P < .001). There was no statistical difference in the history of prior open heart surgery or indication for extraction between the 2 groups. A total of 507 leads were extracted because of CIED infection (294 with pocket infection [58%] and 213 with endovascular infection [42%]). There was no statistical difference in the presence or absence of vein injury between infected and noninfected leads (P =.93) or between the type of infection, whether pocket or endovascular infection (P =.26) Among the leads with vein injuries, 73 (91%) were >5 years old, 7 (9%) were 1–5 years old, and none was <1 year old, despite using extra tools for extraction (Supplemental Table 1). Among the pacemaker leads, the incidence of vein injury was 2.3% among leads that were ≤5 years old and 9.9% for leads >5 years old. Among the defibrillator leads, the incidence of vein injury was 2.9% among leads that were ≤5 years old and 18.2% among leads that were >5 years old. We encountered similar findings when we compared the group of leads with any cardiovascular injury (defined as vein injury or the presence of atrial or ventricular trabecular myocardial tissue on histopathologic examination) to the group without any injury (Table 4). Cardiovascular injuries were identified in 153 of the 861 extracted leads (17.7%) and among 134 patients of the total 461 patients (29%). Similarly, leads with any injury tended to be older, and injury was more frequently encountered in defibrillator leads and when the laser sheath was used.
      Table 3Lead and procedural characteristics based on the presence or absence of vein injury
      No vein injury (n = 781)Vein injury (n = 80)P value
      Except reason for lead extraction, variables are compared using generalized linear mixed-effects modeling (a mixed-effects logistic regression model with a binomial link function) with individual patient set as a random effect, considering the fact that multiple lead extractions could occur within the same patient.
      Lead type.001
       Pace/sense544 (70.0)41 (51.3)
       Defibrillator
      In the implantable cardioverter defibrillator lead type, within 205 patients, there were 41 single coils vs 183 dual coils when the leads had no vein injury, and 4 single coils vs 30 dual coils when there was a vein injury, with a P value of .35.
      233 (30.0)39 (48.8)
      Lead age, d, median (IQR)2463.0 (1253.0–3682.0)3197.0 (2445.5–3899.5).019
      Use of laser extraction509 (65.2)76 (95.0)<.001
      Procedural complications16 (2.0)4 (5.0).19
      Indication for lead extraction.92
      From the Fisher exact test.
       Infection460 (59.1)47 (58.8)
       Lead failure225 (28.9)26 (32.5)
       Device upgrade39 (5.0)3 (3.8)
       Venous access27 (3.5)2 (2.5)
       Other27 (3.5)2 (2.5)
      Prior open heart surgery262 (34)33 (41).18
      N = 861 leads from 461 patients.
      Except reason for lead extraction, variables are compared using generalized linear mixed-effects modeling (a mixed-effects logistic regression model with a binomial link function) with individual patient set as a random effect, considering the fact that multiple lead extractions could occur within the same patient.
      In the implantable cardioverter defibrillator lead type, within 205 patients, there were 41 single coils vs 183 dual coils when the leads had no vein injury, and 4 single coils vs 30 dual coils when there was a vein injury, with a P value of .35.
      From the Fisher exact test.
      Table 4Lead and procedural characteristics based on the presence or absence of any cardiovascular injury
      No evidence of any cardiovascular injury (n = 708)Evidence of any cardiovascular injury (n = 153)P value
      Except reason for lead extraction, variables are compared using generalized linear mixed-effects modeling (a mixed-effects logistic regression model with a binomial link function) with individual patient set as a random effect, considering the fact that multiple lead extractions could occur within the same patient.
      Lead type<.001
       Pace/sense519 (73.7)66 (43.1)
       Defibrillator
      In the implantable cardioverter defibrillator lead type, within 205 patients, there were 33 single coils vs 146 dual coils when the participants had no cardiovascular injury, and 12 single coils vs 67 dual coils when there was a cardiovascular injury, with a P value of .53.
      185 (26.3)87 (56.9)
      Age of leads, d, median (IQR)2324.0 (1162.0–3669.0)3171.0 (2420.0–3900.0).002
      Use of laser extraction445 (62.9)140 (91.5)<.001
      Procedural complications14 (2.0)6 (3.9).26
      Reason for lead extraction<.001
      From the Fisher exact test.
       Infection433 (61.3)74 (48.7)
       Lead failure185 (26.2)66 (43.4)
       Device upgrade36 (5.1)6 (4.0)
       Venous access25 (3.5)4 (2.6)
       Other27 (3.8)2 (1.3)
      Prior open heart surgery262 (34)56 (37).56
      Cell values are n (%) unless otherwise specified.
      N = 861 leads within 461 patients.
      IQR = interquartile range.
      Except reason for lead extraction, variables are compared using generalized linear mixed-effects modeling (a mixed-effects logistic regression model with a binomial link function) with individual patient set as a random effect, considering the fact that multiple lead extractions could occur within the same patient.
      In the implantable cardioverter defibrillator lead type, within 205 patients, there were 33 single coils vs 146 dual coils when the participants had no cardiovascular injury, and 12 single coils vs 67 dual coils when there was a cardiovascular injury, with a P value of .53.
      From the Fisher exact test.
      Despite these findings, among the total cohort, only 5 patients had catastrophic complication (1.1%) that required emergency surgical intervention. Of these 5 patients, 4 had ICD leads and only 1 had previously undergone open heart surgery. Four of these patients had superior vena cava (SVC) tears, and in 1, the injury location could not be accurately located as the patient deteriorated quickly and was not a candidate for emergency thoracotomy. On histopathologic examination, 1 patient had evidence of atrial tissue along with coronary sinus venous wall, 1 had evidence of ventricular tissue, and 1 had an ICD lead that could not be removed and therefore the pathology results were not available. Two patients had fibrous cuff over the extracted leads without microscopic venous wall injury despite clear evidence of SVC tear on thoracotomy. These injuries resulted in 3 deaths, and 2 patients were salvaged with emergency surgical repair. After adjusting for all other variables and using a multivariable prediction model, risk factors for vein injury included defibrillator lead (vs pacemaker lead), older lead age, use of the laser sheath, hypertension, and diabetes (Table 5).
      Table 5Multivariable prediction model for vein injury
      CovariatesOdds ratio (95% confidence interval)P value
      Defibrillator vs pace/sense lead2.02 (1.20–3.50).009
      Age of leads (log transformed)1.75 (1.11–2.97).024
      Use of laser extraction5.69 (2.13–19.99).002
      Hypertension2.47 (1.37–4.77).004
      Diabetes0.48 (0.24–0.90).026
      The dependent variable is vein injury yes/no. The multivariable model is a generalized linear mixed-effects model (a mixed-effects logistic regression model with a binomial link function), with individual patient set as a random effect, considering the fact that multiple lead extractions could occur within the same patient.

      Discussion

      Because of expanding indications for CIED implantation and more frequent recognition of associated complications, lead extraction has become an essential part of lead management.
      • Wilkoff B.L.
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      • Friedman R.A.
      • Kennergren C.E.
      • Mitkowski P.
      • Schaerf R.H.
      • Wazni O.M.
      Heart Rhythm Society; American Heart Association. Transvenous lead extraction: Heart Rhythm Society expert consensus on facilities, training, indications, and patient management: This document was endorsed by the American Heart Association (AHA).
      The challenges and risks associated with lead extraction are mainly related to lead adherence and fibrosis that preclude lead removal through simple manual traction, as this method might cause avulsion, laceration, perforation, or death.
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      Predictors and degree of fibrosis are not well defined, but dwell time, hardware burden, and younger patient age tend to lead to more fibrosis and calcification.
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      TLE has become the standard of care for lead extraction, and when performed with the right tools and techniques, the procedure is effective with excellent results and low complication rates.
      • Wazni O.
      • Epstein L.M.
      • Carrillo R.G.
      • et al.
      Lead extraction in the contemporary setting: The lexicon study: an observational retrospective study of consecutive laser lead extractions.
      • Brunner M.P.
      • Cronin E.M.
      • Duarte V.E.
      • et al.
      Clinical predictors of adverse patient outcomes in an experience of more than 5000 chronic endovascular pacemaker and defibrillator lead extractions.
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      • Cronin E.M.
      • Wazni O.
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      • Saliba W.I.
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      • Lindsay B.D.
      • Wilkoff B.L.
      • Tarakji K.G.
      Outcomes of patients requiring emergent surgical or endovascular intervention for catastrophic complications during transvenous lead extraction.
      The number of TLEs performed is expected to reach 30,000 per year worldwide.
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      • Segreti L.
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      • Coluccia G.
      • Soldati E.
      Where is the future of cardiac lead extraction heading?.
      • Wazni O.
      • Wilkoff B.L.
      Considerations for cardiac device lead extraction.
      Catastrophic complications associated with lead extraction that require emergent surgical or endovascular intervention are not common but may still occur in approximately 1% of cases and could carry a 35%–50% mortality risk at 1 month.
      • Brunner M.P.
      • Cronin E.M.
      • Wazni O.
      • Baranowski B.
      • Saliba W.I.
      • Sabik J.F.
      • Lindsay B.D.
      • Wilkoff B.L.
      • Tarakji K.G.
      Outcomes of patients requiring emergent surgical or endovascular intervention for catastrophic complications during transvenous lead extraction.
      The low incidence rate of major complications makes it difficult to identify predictors for these outcomes and makes the discussion about risks and benefits for lead extraction challenging.
      To our knowledge, our study is the first to characterize the microscopic findings of extracted leads among a large cohort of patients. In this cohort, 5 patients had catastrophic complications that required emergency surgical intervention (1.1%), which is consistent with the findings prior studies.
      • Wazni O.
      • Epstein L.M.
      • Carrillo R.G.
      • et al.
      Lead extraction in the contemporary setting: The lexicon study: an observational retrospective study of consecutive laser lead extractions.
      • Brunner M.P.
      • Cronin E.M.
      • Wazni O.
      • Baranowski B.
      • Saliba W.I.
      • Sabik J.F.
      • Lindsay B.D.
      • Wilkoff B.L.
      • Tarakji K.G.
      Outcomes of patients requiring emergent surgical or endovascular intervention for catastrophic complications during transvenous lead extraction.
      To our surprise, we found that despite the absence of any clinical adverse event, vein injury was present on a microscopic level in 80 of the 861 extracted leads (9.3%) and among 72 of the total 461 patients (15.6%). When we included any cardiovascular injury (defined as vein injury or the presence of atrial or ventricular tissue on the extracted lead), the incidence was even higher: 153 of the 861 extracted leads (17.7%) and among 134 patients∖of the total 461 (29%). Among the 5 patients who had catastrophic complications, 2 did not have evidence of microscopic vein injury on their leads despite clear evidence of SVC tear on chest exploration, suggesting that some injuries are due to mechanical forces disrupting the fibrous tissue and might not result in the presence of venous tissue microscopically.
      The absence of significant clinical complications despite the finding of vein injury could be explained partly by a few observations. In 16 of the 80 extracted leads (20%), the vein injury most likely was located at or near the pocket access site, based on the presence of adjoining skeletal muscle and fibroadipose tissue. In 15 of the 80 extracted leads (18.8%), the vein injury involved a partial wall thickness that may not have resulted in a perforation. Lastly, the SVC contains an outer asymmetrical myocardial sleeve as it enters the right atrium.
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      • Munger T.M.
      • Hammill S.C.
      • Packer D.L.
      • Asirvatham S.J.
      Myocardium of the superior vena cava, coronary sinus, vein of Marshall, and the pulmonary vein ostia: gross anatomic studies in 620 hearts.
      It is thus possible that a transmural vein injury detected microscopically will not always correspond with a perforation of the SVC, because of the presence of myocardium and adipose tissue support outside the vein proper.
      The predictors for vein injuries included older age, defibrillator leads, and the use of laser-powered sheaths. Defibrillator coils are almost always covered with fibrous cuff although it could be of varying length and thickness. These findings are consistent with predictors for clinically difficult extraction procedures.
      • Brunner M.P.
      • Cronin E.M.
      • Duarte V.E.
      • et al.
      Clinical predictors of adverse patient outcomes in an experience of more than 5000 chronic endovascular pacemaker and defibrillator lead extractions.
      • Epstein L.M.
      • Love C.J.
      • Wilkoff B.L.
      • et al.
      Superior vena cava defibrillator coils make transvenous lead extraction more challenging and riskier.
      CIED infection is a class I indication for TLE.
      • Wilkoff B.L.
      • Love C.J.
      • Byrd C.L.
      • Bongiorni M.G.
      • Carrillo R.G.
      • Crossley 3rd, G.H.
      • Epstein L.M.
      • Friedman R.A.
      • Kennergren C.E.
      • Mitkowski P.
      • Schaerf R.H.
      • Wazni O.M.
      Heart Rhythm Society; American Heart Association. Transvenous lead extraction: Heart Rhythm Society expert consensus on facilities, training, indications, and patient management: This document was endorsed by the American Heart Association (AHA).
      • Baddour L.M.
      • Epstein A.E.
      • Erickson C.C.
      • et al.
      Update on cardiovascular implantable electronic device infections and their management: a scientific statement from the American Heart Association.
      However, for noninfectious indications, lead extraction vs abandonment continues to be controversial.
      • Maytin M.
      • Epstein L.M.
      • Henrikson C.A.
      Lead extraction is preferred for lead revisions and system upgrades: when less is more.
      Randomized trials addressing this issue are lacking and would be difficult to accomplish. Abandoned leads add to the complexity of lead extraction, leading to higher failure rate in achieving complete removal, longer procedures, and higher 1-month mortality.
      • Hussein A.A.
      • Tarakji K.G.
      • Martin D.O.
      • et al.
      Cardiac implantable electronic device infections: Added complexity and suboptimal outcomes with previously abandoned leads.
      Therefore, these cases should be discussed on a case-by-case basis, taking into account the patient's age, comorbidities, and number and age of leads. It is difficult to assess the risk of extraction on an individual basis, because most of the data come from large cohorts with low event rates. Microscopic examination of extracted leads might provide us with a new perspective from which to assess cardiovascular injury. In our study, for example, there was a remarkable difference in the incidence of vein injuries in leads that are ≤5 years old vs older ones, and that was observed for both pacemaker and defibrillator leads. These findings may influence our decision-making process. A lead with a noninfectious indication for extraction might be better dealt with earlier than later (beyond 5 years).
      Optimizing lead technologies and developing new tools for lead extraction have improved the safety and outcomes of TLE. However, for a low incidence rate of major clinical complications, it would be difficult to assess the value of any new lead design or extraction tool or technique. Histopathology provides a framework with which to evaluate new lead design or extraction tools and could enable us to perform prospective longitudinal studies more efficiently.

      Study limitations

      Our center is a tertiary referral center, and our findings may not represent those at other centers because our patient population and the techniques used by the operators may differ. Our findings are also subject to the limitations inherent to retrospective studies, including the possibility of unknown confounders and bias in management strategy. Echocardiography is not routinely performed after extraction procedure, and therefore we have no data about subclinical pericardial effusion. When the lead is extracted for infection, the tip is usually cut and sent for cultures, and this action would affect the yield of microscopic examination of the lead tip to identify myocardial tissue. All leads removed were sent for histopathologic examination, but better correlation between the findings of vein injuries and lead anatomic location was limited when the tips were cut. Finally, on some occasions, the tissue cuffs were not firmly adherent to the lead and could have moved along the body of the lead during extraction.

      Conclusions

      Microscopic vein injuries during lead extraction are common but are often not recognized clinically. Microscopic examination of extracted leads may help with future lead design and development of new extraction tools.

      Appendix. Supplementary data

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