Elective Generator Replacement Research Articles

Considerations involved in elective generator replacement of implantable cardioverter-defibrillators: balancing risks, benefits, and individual factors

Considerations involved in elective generator replacement of implantable cardioverter-defibrillators: balancing risks, benefits, and individual factors

Successful defibrillation testing in patients undergoing elective subcutaneous implantable cardioverter-defibrillator generator replacement.

After implantation of a subcutaneous implantable cardioverter-defibrillator (S-ICD), a defibrillation test (DFT) is performed to ensure that the device can effectively detect and terminate the induced ventricular arrhythmia. Data on DFT efficacy at generator replacement are scarce with a limited number of patients and conflicting results. This study evaluates conversion efficacy during DFT at elective S-ICD generator replacement in a large cohort from our tertiary centre. Retrospective data of patients who underwent an S-ICD generator replacement for battery depletion with subsequent DFT between February 2015 and June 2022 were collected. Defibrillation test data were collected from both implant and replacement procedures. PRAETORIAN scores at implant were calculated. Defibrillation test was defined unsuccessful when two conversions at 65 J failed. A total of 121 patients were included. The defibrillation test was successful in 95% after the first and 98% after two consecutive tests. This was comparable with success rates at implant, despite a significant rise in shock impedance (73 ± 23 vs. 83 ± 24 Ω, P < 0.001). Both patients with an unsuccessful DFT at 65 J successfully converted with 80 J. This study shows a high DFT conversion rate at elective S-ICD generator replacement, which is comparable to conversion rates at implant, despite a rise in shock impedance. Evaluating device position before generator replacement may be recommended to optimize defibrillation success at generator replacement.

A novel simple and safe approach to frozen pacemaker leads

Elective pulse generator replacement remains a mainstay procedure in any contemporary electrophysiology laboratory. Frozen pacemaker leads, where the leads fail to disengage from the pacemaker resulting in lead entrapment within the header, have been well described. We report on 2 cases where the pacemaker (IS-1) bipolar lead failed to detach from the device header and describe a novel solution to this unique and old problem involving the use of a procedural glove to effectively release a frozen lead and avoid the need for mechanical and electrical devices.

Procalcitonin as a biomarker of cardiac implantable electronic device pocket infection: a prospective validation study

Abstract Funding Acknowledgements Type of funding sources: None. Introduction The implantation of cardiac implantable electronic devices (CIEDs) such as pacemakers and implantable cardioverter-defibrillators is increasing along with the complexitly of these devices. CIED infection is an uncommon, but severe complication associated with the presence of a device and is associated with a high mortality and morbidity. Lead-related infections and frank endocarditis are associated with a systemic inflammatory response and, in general, are readily identified. Isolated pocket infections do not produce such a systemic response and are thus more complex to diagnose. There is a reliance on clinical accumen and examination of local signs of infection. There is thus a need for a reliable biomaker to help identify cases of pocket infection. Aim Our group have previously shown procalcitonin (PCT) to be a potentially useful biomaker in the clinial situation of possible pocket infection. We aim to prospectively validate the proposed cut-off value of 0.05ng/ml for the procalcitonin (PCT) biomaker in an independent cohort, which we have previously identified as showing promise in this clinical situation. Methods In this prospective case-control validation study the PCT levels of 81 patients with confirmed pocket infections were compared to 81 controls, matched for age and renal function, presenting for elective generator replacement or lead revision unrelated to infection. Exclusion criteria included: concomitant infectious or inflammatory diseases, end-stage renal failure, active malignancy or receiving immunosuppressive therapy. Results A PCT over 0.05 ng/ml was found in 68% (n= 55) of pocket infections and 24% (n= 19) of controls. Using the pre­defined cut-off value of 0.05 ng/ml PCT had a sensitivity of 68% and a specificity of 77% for diagnosing pocket infections. ROC analysis revealed area under the curve of 0.752 (standard error 0.039, p &amp;lt;0.001 ) for PCT. In patients presenting with minimal infective signs the sensivity remained high (67% vs 70% with extensive inflammation) and similarly remained high in thus who had received anti-biotic therapy prior to PCT sampling (65% vs 69%). Conclusion PCT is a potentially useful biomarker to aid the diagnosis of a pocket infection when used with the prospecitvely validated cut-off value of 0.05ng/ml. The sensitivity of the PCT positive result remained high even in patients pre-treated with antibiotics or with minimal clinical signs of inflammation.

Clinical utility of sonication for diagnosing infection and colonization of cardiovascular implantable electronic devices.

Our study aimed to evaluate the sensitivity of the sonication tool for the microbiological diagnosis of cardiovascular implantable electronic device infections (CIEDIs). The extracted cardiac implants of 52 patients were assessed: 19 with CIEDI and 33 with elective generator replacement or revision without clinical infection. Sonication fluid culture of explanted CIEDs yielded higher numbers of microorganisms than pocket tissue or swab cultures. The sensitivity of sonication fluid culture was significantly higher than that of pocket swab and tissue culture for microbiological diagnosis of CIEDI. The microorganisms isolated most frequently via sonication of explanted CIEDs were Gram-positive cocci (70%), of which 50% was coagulase-negative Staphylococcus. Sonication fluid culture detected colonization in 36.4% of the non-infected patients. Sonication fluid culture represents a promising diagnostic strategy with increased sensitivity compared to conventional culture methods for microbiological diagnosis of cardiac devices associated with infection and colonization.

Reassessment of clinical variables in cardiac resynchronization defibrillator patients at the time of first replacement:Death after replacement of CRT (DARC) score.

IntroductionCardiac resynchronization defibrillator (CRT‐D) as primary prevention is known to reduce mortality. At the time of replacement, higher age and comorbidities may attenuate the benefit of implantable cardioverter‐defibrillator (ICD) therapy. The purpose of this study was to evaluate the progression of comorbidities after implantation and their association with mortality following CRT‐D generator replacement. In addition, a risk score was developed to identify patients at high risk for mortality after replacement.Methods and ResultsWe identified patients implanted with a primary prevention CRT‐D (n = 648) who subsequently underwent elective generator replacement (n = 218) from two prospective ICD registries. The cohort consisted of 218 patients (median age: 70 years, male gender: 73%, mean left ventricular ejection fraction [LVEF]: 36 ± 11% at replacement). Median follow‐up after the replacement was 4.2 years during which 64 patients (29%) died and 11 patients (5%) received appropriate ICD shocks. An increase in comorbidities was observed in 77 patients (35%). The 5‐year mortality rate was 41% in patients with ≥2 comorbidities at the time of replacement. A risk score incorporating age, gender, LVEF, atrial fibrillation, anemia, chronic kidney disease, and history of appropriate ICD shocks at time of replacement accurately predicted 5‐year mortality (C‐statistic 0.829). Patients with a risk score of greater than 2.5 had excess mortality at 5‐year postreplacement compared with patients with a risk score less than 1.5 (57% vs. 6%; p < .001).ConclusionA simple risk score accurately predicts 5‐year mortality after replacement in CRT‐D patients, as patients with a risk score of greater than 2.5 are at high risk of dying despite ICD protection.

Long-Term Outcome of Patients With Congenital Heart Disease Undergoing Cardiac Resynchronization Therapy.

BackgroundCardiac resynchronization therapy (CRT) is rarely used in patients with congenital heart disease, and reported follow‐up is short. We sought to evaluate long‐term impact of CRT in a single‐center cohort of patients with congenital heart disease.Methods and ResultsThirty‐two consecutive patients with structural congenital heart disease (N=30) or congenital atrioventricular block (N=2), aged median of 12.9 years at CRT with pacing capability device implantation, were followed up for a median of 8.7 years. CRT response was defined as an increase in systemic ventricular ejection fraction or fractional area of change by >10 units and improved or unchanged New York Heart Association class. Freedom from cardiovascular death, heart failure hospitalization, or new transplant listing was 92.6% and 83.2% at 5 and 10 years, respectively. Freedom from CRT complications, leading to surgical system revision (elective generator replacement excluded) or therapy termination, was 82.7% and 72.2% at 5 and 10 years, respectively. The overall probability of an uneventful therapy continuation was 76.3% and 58.8% at 5 and 10 years, respectively. There was a significant increase in ejection fraction/fractional area of change (P<0.001) mainly attributable to patients with systemic left ventricle (P=0.002) and decrease in systemic ventricular end‐diastolic dimensions (P<0.05) after CRT. New York Heart Association functional class improved from a median 2.0 to 1.25 (P<0.001). Long‐term CRT response was present in 54.8% of patients at last follow‐up and was more frequent in systemic left ventricle (P<0.001).ConclusionsCRT in patients with congenital heart disease was associated with acceptable survival and long‐term response in ≈50% of patients. Probability of an uneventful CRT continuation was modest.

Abstract 14091: Outcomes of Patients With Recalled Defibrillator Leads: Results From the NCDR-ICD Registry

Introduction: Whether to reuse, abandon, or extract functioning, recalled ICD leads at the time of generator replacement is an area of uncertainty as lead failure is more common following generator replacement, and long term failure rates of recalled ICD leads are unknown. We sought to evaluate outcomes following various lead management strategies at the time of generator replacement. Hypothesis: Functional St. Jude Riata and Medtronic Sprint Fidelis leads at the time of elective generator replacement are more frequently reused than replaced, and extracting them poses significant procedural risk. Methods: We queried the NCDR ICD Registry for Medicare patients undergoing elective generator replacement with a normal Fidelis or Riata lead from 2010-2016 and categorized patients based on the fate of the recalled lead: reused, abandoned, or extracted. We report pre-discharge complications by group. Results: There were 9937 generator replacement patients between 2010-2016 with a functioning Riata or Fidelis lead in which lead management was reported. The lead was reused in 9806 (98%) patients, extracted in 55 (0.6%), and abandoned in 76 (0.8%). Compared with the reused group, extracted patients were &gt;10 years younger, had less heart failure and fewer comorbidities. In-hospital death occurred in 4 (7.3%) patients in the extracted group and 7 (0.07%) in the reused group (P&lt;0.0001). The combination of death or any pre-discharge event occurred in 11% of extracted patients compared with 0.3% and 0% in the reused and abandoned groups, respectively.(Table) Conclusions: At the time of generator replacement, a small percentage of functional Riata and Fidelis leads were extracted. Even in this highly selected extraction population, extraction posed significant risk of in-hospital mortality and severe complications. Future work will help clarify whether these peri-procedural risks may be justified by improved medium and long term outcomes.

Complications related to elective generator replacement of the subcutaneous implantable defibrillator.

AimsTo guarantee uninterrupted function of the subcutaneous implantable cardioverter-defibrillator (S-ICD), the pulse generator needs to be surgically replaced before the battery is depleted. The risks related to this replacement substantially impact long-term outcome for S-ICD recipients, as the majority will undergo one or several of these procedures in their lifetime. We aim to describe the procedural characteristics of the replacement procedure and to provide an insight in the complications associated with these replacements.Methods and resultsIn this retrospective analysis, data from replacement procedures and follow-up visits were collected from all patients who underwent elective S-ICD generator replacement in our tertiary centre from June 2014 until November 2019. Original device position was assessed using the PRAETORIAN score. Complications were defined as those requiring surgical intervention, systemic antibiotic treatment, or device extraction. Seventy-two patients were included, with a median follow-up of 1.9 years (IQR 0.6–3.3 years) after replacement. Battery depletion occurred after 5.9 ± 0.7 years. The pulse generator was repositioned in patients with a PRAETORIAN score ≥90 to minimize the defibrillation threshold. Although there was an increase in impedance compared to the implant procedure, first shock conversion rate during defibrillation testing was 91.4% with a success rate of 100% after multiple attempts. Two patients developed a complication after, respectively, 9 and 21 months, resulting in a complication rate of 1.4% per year.ConclusionWith a median follow-up of 1.9 years, this study shows a low complication rate after S-ICD replacement, with a first shock conversion rate of 91.4%.

Left ventricular apical pacing in children: feasibility and long-term effect on ventricular function

Left ventricular apical pacing (LVAP) has been reported to preserve left ventricular (LV) function in chronically paced children with complete atrioventricular block (CAVB). We sought to evaluate long-term feasibility of LVAP and the effect on LV mechanics and exercise capacity as compared to normal controls. Thirty-six consecutive paediatric patients with CAVB and LVAP in the absence (N = 22) or presence of repaired structural heart disease (N = 14, systemic LV in all) and 25 age-matched normal controls were cross-sectionally studied after a median of 3.9 (interquartile range 2.1-6.8) years of pacing using echocardiography and exercise stress testing. Pacemaker implantation was uneventful and there was no death. Probability of the absence of pacemaker-related surgical revision (elective generator replacement excluded) was 89.0% at 5 years after implantation. Left ventricular apical pacing patients had lower maximum oxygen uptake (P = 0.009), no septal to lateral but significant apical to basal LV mechanical delay (P < 0.001) which correlated with decreased LV contraction efficiency (P = 0.001). Left ventricular ejection fraction and global longitudinal LV strain were, however, not different from controls. Results were similar in both the presence and absence of structural heart disease. Left ventricular apical pacing is technically feasible with a low reintervention rate. Mechanical synchrony between LV septum and free wall is maintained at the price of an apical to basal mechanical delay associated with LV contraction inefficiency as compared to healthy controls. Global LV systolic function is, however, not negatively affected by LVAP.

Prevalence and prognosis of lead masses in patients with cardiac implantable electronic devices without infection.

Finding of intracardiac lead masses in patients with cardiac implantable electronic devices remains controversial, as such masses have been observed in cases of exclusively local infections whereas they have not been recognized in patients with positive cultures of intravascular lead fragments. In this study, we aim to describe the prevalence of intracardiac lead masses in true asymptomatic patients with cardiac implantable electronic devices, to identify their predictive factors and to define their prognostic impact at long-term follow-up. Seventy-eight consecutive patients admitted over a 6-month period for elective generator replacement without clinical evidence of infection were evaluated by transthoracic and transesophageal echocardiography and prospectively followed at in-clinic follow-up visits. Lead masses were found in 10 patients (12.8%). These patients had more frequently right ventricular dysfunction at univariate analysis (OR 2.71, P = 0.010) and after baseline variables adjustment (hazard ratio 6.25, P = 0.012). At 5-year follow-up without any specific therapy, none of the patients suffered from any cardiac device infections, or developed clinical signs of infections. There is an evidence of clinical lead masses in asymptomatic patients with cardiac implantable electronic devices. The value of these findings is still debated for aetiological interpretation and for therapeutic strategy, but they are not necessarily associated with an infection.

Incidence of appropriate implantable cardioverter-defibrillator therapy and mortality after implantable cardioverter-defibrillator generator replacement: results from a real-world nationwide cohort.

The safety of omitting implantable cardioverter-defibrillator (ICD) generator replacement in patients with no prior appropriate therapy, comorbid conditions, and advanced age is unclear. The aim was to investigate incidence of appropriate ICD therapy after generator replacement. We identified patients implanted with a primary prevention ICD (n = 4630) from 2007 to 2016, who subsequently underwent an elective ICD generator replacement (n = 670) from the Danish Pacemaker and ICD Register. The data were linked to other databases and evaluated the outcomes of appropriate therapy and death. Predictors of ICD therapy were identified using multivariate Cox regression analyses. A total of 670 patients underwent elective ICD generator replacement. Of these, 197 (29.4%) patients had experienced appropriate therapy in their 1st generator period. During follow-up of 2.0 ± 1.6 years, 95 (14.2%) patients experienced appropriate therapy. Predictors of appropriate therapy in 2nd generator period was low initial left ventricular ejection fraction (≤25%) [hazard ratio (HR) 1.87, confidence interval (CI) 1.13-1.95] and appropriate therapy in 1st generator period (HR 3.95, CI 2.57-6.06). For patients with appropriate therapy in 1st generator period, 4-year incidence of appropriate therapy was 50.6% vs. 16.4% in those without (P < 0.001). Among patients >80 years with no prior appropriate therapy 8.8% of patients experienced appropriate therapy after replacement. Comorbidity burden and advanced age were associated with reduced device utilization after replacement and a high competing risk of death without preceding appropriate therapy. A significant residual risk of appropriate therapy in the 2nd generator was present even among patients with advanced age and with a full prior generator period without any appropriate ICD events.

Incidence of appropriate anti-tachycardia therapies after elective generator replacement in patient with heart failure initially implanted with a defibrillator for primary prevention: Results of a meta-analysis

BackgroundImplantable cardioverter-defibrillator (ICD) is an effective therapy to reduce mortality in heart failure. When the ICD generator approaches the end of life, most of the patients undergo an elective generator replacement (GR) even if they no longer meet implantation criteria. Whether arrhythmic risk should be re-assessed at the time of GR is still an open question. The aim of our study was to assess, via a meta-analysis, the occurrence of appropriate ICD therapies after GR in patients stratified based on the presence/absence of ICD indication at the time of GR. MethodsVia a systematic literature search for primary prevention studies (January 2000-Sectember 2018), 2976 studies were analyzed. 6 studies were lastly included. Patients were categorized into two groups: “with ICD indication” in case of LVEF≤35% at the time of GR and/or appropriate therapies during the first ICD life; “without ICD indication” in case of a LVEF>35% and no previous ICD therapies. Incidences of appropriate ICD therapies were computed as number of events per 100 person-year. ResultWe included 478 pts. (65%) with and 255 patients (35%) without persistent ICD indication. The incidence of appropriate therapies was 12.3/100-person-year in patients with vs. 3.4 in patients without persistent ICD indication (2.98 fold higher risk of ICD therapies). ConclusionPatients who no longer meet ICD implantation criteria at the time of GR present a significantly lower risk of appropriate ICD therapies after GR. The results of this study underline the importance of an arrhythmic risk re-stratification at the time of GR.

Six-year follow-up of the initial Dutch subcutaneous implantable cardioverter-defibrillator cohort: Long-term complications, replacements, and battery longevity.

Experience with the subcutaneous implantable cardioverter-defibrillator (S-ICD) is expanding rapidly. However, data on long-term performance or complications related to elective generator replacement are lacking. Follow-up (FU) data of all patients implanted between December 2008 and April 2011 were collected. Complications were defined as those requiring surgical intervention. Kaplan-Meier estimates for complication and shock rates, with corresponding 95% confidence intervals (CI), were calculated. One hundred and eighteen patients were included. Median FU was 6.1 years (IQR 5.6-6.5 years). Short-term complication rate (0-30 days) was 3% (CI 0-6%). Long-term complication rate at 6 years was 19% (CI 12-26%), corresponding with an annual complication rate of 3%. One patient in this cohort developed a need for a transvenous ICD (TV-ICD) in order to provide pacing for bradycardia (1%). Six patients were implanted with a TV-ICD after experiencing an S-ICD complication for which extraction was necessary. In total, 10 S-ICDs were extracted; none resulted in a complication. Eight patients had a nonsystemic ICD-related infection and no lead failures were observed. The majority, 68 (58%) patients, received an elective generator replacement. Two patients had a complication related to generator replacement (3%). Battery longevity was 5.6 years (IQR 5.2-6.1). Appropriate and inappropriate shock rates of 6-year estimates were 17% (CI 9-25%) and 21% (CI 15-27%), respectively. This cohort represents the longest follow-up to date and shows a low annual complication rate without lead failures or systemic infections. Battery longevity of the first S-ICD generation results in relative early generator replacement procedures.

Implantable cardioverter-defibrillator elective generator replacement: a procedure for all?

Six risk stratification scores have been developed to estimate mortality risk in patients receiving an implantable cardioverter-defibrillator (ICD). This study aims at validating and comparing these risk scores in patients having elective ICD generator replacement (GR) and assessing the outcome of patients submitted to this procedure. Two hundred twenty three consecutive patients with ischaemic or non-ischaemic dilated cardiomyopathy submitted to elective ICD GR and followed-up for 44 ± 19 months were included. We evaluated which of six previously developed risk scores could predict post-discharge all-cause mortality risk in this context with the highest efficacy. Comparisons between these scores were made using receiver-operating characteristic curves and the integrated discrimination improvement (IDI) index. We further assessed risk of appropriate ICD therapies and all-cause mortality following ICD GR. The prognostic utility of the six scores was assessed by calculating the AUC for follow-up all-cause mortality prediction: Goldenberg - 0.758 ± 0.042, p < 0.001; Parkash - 0.754 ± 0.042, p < 0.001; Bilchick - 0.813 ± 0.038, p < 0.001; Kraaier - 0.721 ± 0.043, p < 0.001; REPLACE DARE - 0.746 ± 0.048, p < 0.001; Providencia - 0.739 ± 0.043, p < 0.001. Through measures of risk reclassification (IDI and relative IDI), the score by Bilchick et al. was shown to outperform all other scores. Binary logistic regression identified pre-GR-appropriate ICD therapy as an independent predictor of post-GR ICD therapy (OR 6.2, CI 95% 3.0-12.7, p < 0.001), along with male gender (OR 6.6, CI 95% 0.8-55, p = 0.082) and history of atrial fibrillation (OR 2.28, CI 95% 1.1-4.5, p = 0.019). Current prediction scores are useful in predicting mortality risk of patients considered for ICD generator replacement and can potentially help identify patients who may not benefit from continuous ICD treatment due to high mortality rates regardless of the ICD.

Complications from prophylactic replacement of cardiac implantable electronic device generators in response to United States Food and Drug Administration recall: A systematic review and meta-analysis.

The number of cardiac implantable electronic device (CIED) recalls and advisories has increased over the past 3 decades, yet no consensus exists on how to best manage patients with these CIEDs, partially because rates of complications from prophylactic replacement are unknown. The purpose of this study was to establish rates of complications when recalled CIED generators are replaced prophylactically. We searched MEDLINE and the Cochrane Controlled Trials Register for reports of prophylactic replacement of recalled CIED generators. Studies with <20 subjects were excluded. We then conducted a meta-analysis of qualifying studies to determine the rates of combined major complications, mortality, and reoperation. We identified 7 citations that met our inclusion criteria and reported ≥1 end-points of interest. Four were single center, and 3 were multicenter. Six studies collected data retrospectively (n = 1213) and 1 prospectively (n = 222). Using a random effects model to combine data from all included studies, the rate of major complications was 2.5% (95% confidence interval [CI] 1.0%-4.5%). Combining data from 6 studies reporting mortality and reoperation, the rates were 0.5% (95% CI 0.1%-0.9%) and 2.5% (95% CI 0.8%-4.5%), respectively. Prophylactic replacement of recalled CIED generators is associated with a low mortality rate but nontrivial rates of other major complications similar to those reported when CIED generators are replaced for other reasons. Thus, when considering replacing a recalled CIED generator, known risks of elective generator replacement likely apply and can be weighed against risks associated with device failure.

Electrocautery-induced ventricular fibrillation during routine implantable cardioverter-defibrillator generator replacement

A 78-year-old man with a primary-prevention implantable cardioverter-defibrillator (ICD) underwent an elective generator replacement. The pre-procedural lead parameters were normal and tachycardia detection was turned off during the procedure. During a 4.6 s application of unipolar electrocautery to the pocket, transient …

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Rate, causes, and impact on patient outcome of implantable device complications requiring surgical revision: large population survey from two centres in Italy

The long-term impact of implantable device-related complications on the patient outcome has not been thoroughly evaluated. The aims of this retrospective, bi-centre study were to analyse the rate and nature of device-related complications requiring surgical revision in a large series of patients undergoing device implantation, elective generator replacement and pacing system upgrade and to systematically assess the impact of such complications on patient outcome and healthcare utilization. Data from 2671 consecutive procedures (1511 device implantations, 1034 elective generator replacements, and 126 pacing system upgrades) performed between January 2006 and March 2011 were retrospectively analysed. The outcome measures recorded were complication-related mortality, number of re-operations, need for complex surgical procedures, number of re-hospitalizations, and additional hospital treatment days. Over a median follow-up of 27 months, the overall rate of complications was 2.8% per procedure-year [9.5% in cardiac resynchronisation therapy (CRT) device implantation, 6.1% in pacing system upgrade, 3.5% in implantable cardioverter defibrillator implantation, 1.7% in pacemaker implantation, and 1.7% in generator replacement). The procedure with the highest risk of complications was CRT device implantation (odds ratio: 6.6; P < 0.001); these complications primarily involved coronary sinus lead dislodgement and device infection. Patients with complications had a significantly higher number of device-related hospitalizations (2.3 ± 0.6 vs. 1.0 ± 0.1; P < 0.001) and hospital treatment days (15.7 ± 25.1 vs. 3.6 ± 1.1; P < 0.001) than those without complications. Device infection was the complication with the greatest negative impact on patient outcome. Cardiac resynchronisation therapy implantation was the procedure with the highest risk of complications requiring surgical revision. Complications were associated with substantial clinical consequences and a significant increase in the number and length of hospitalizations.

Sprint Fidelis Lead Fractures in Patients With Cardiac Resynchronization Therapy Devices

Background— Using data from the Resynchronization/Defibrillation for Ambulatory Heart Failure (RAFT) study, we examined whether Fidelis lead failure was more common in patients with implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy (ICD-CRT) than in patients with an ICD only. Methods and Results— All cases of patients who had a right ventricular defibrillation lead revision in the RAFT study were adjudicated for the presence of lead fracture. Criteria for fracture were at least 2 of the following: (1) Impedance rise (&gt;50% or &gt;500 Ω in 1 week), (2) short interval count &gt;10 times per day or 300 times per month, or (3) inappropriate shock caused by noise, verified by stored electrogram. A total of 1798 patients were enrolled into the RAFT study, with a mean follow-up of 40±20 months. There were 818 patients (45.5%) who received a Fidelis lead at the original implantation, 405 with an ICD only and 413 with an ICD-CRT. There were 47 confirmed defibrillation lead fractures; 45 were Fidelis leads (5.5% of Fidelis leads). The overall rate of fracture in the ICD group was 3.2% compared with 7.8% in the ICD-CRT group ( P =0.006; hazard ratio, 2.42; 95% confidence interval, 1.27–4.61). Significant correlates of lead fracture in this population were undergoing an ICD-CRT implantation and having ≥2 leads. Conclusions— In this analysis of the RAFT study, patients with an ICD-CRT were found to have a significantly higher fracture rate than patients with an ICD. This finding needs to be considered when these patients are assessed for possible lead revision at the time of an elective generator replacement.