Abstract 4660: Death Due to Pacemaker or ICD Device Failure is Rare: Implications for the Management of Recalls

Knowledge of major adverse clinical events (MACE) associated with ICD and pacemaker (PM) pulse generator (PG) and lead performance may be important for managing patients who have these devices. The aim of our study was to assess MACE in our Multicenter Registry. Participating centers prospectively reported ICD and PM PG and lead failures, and PG replaced for normal battery depletion (NBD). Data included dates of implant and removal, failure signs including the elective replacement indicator (ERI), clinical consequences, and reason for removal. MACE were death, inappropriate shocks (IAS), syncope, heart failure, ischemia, sustained tachyarrhythmias, and replacement of a normally functioning PG or lead due to a manufacturers recall. Since 1998, 6,291 ICD and PM PG and leads were removed from service. Of 5,212 ICD and PM PGs, 4,562 (88%) were removed for NBD, 346 (7%) for a recall, and 304 (5%) for component defects. MACE are shown in the Table . The deaths (n=2) were due to component defects causing an ICD PG to short-circuit and a PM PG to deliver high rate pacing. Thus, of the 304 component defects in our database, 2 resulted in death (0.7%). No deaths were associated with ICD or PM lead failure, but 2 deaths occurred following PM lead extraction. The ERI, signifying NBD, resulted in 48 MACE, primarily syncope (67%). Most MACE are due to replacement of normally functioning recalled devices. However, our experience suggests that death due to ICD and PM PG component or lead failure is rare; this finding may be important for managing patients who have recalled devices. Overall, MACE may be substantially reduced by improving high voltage lead reliability, and by providing physiologic ERIs.

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A single-centre experience concerning the safety of Sprint Fidelis defibrillator lead extraction at the time of pulse generator replacement or in case of evidence of lead failure

Archives of Cardiovascular Diseases ◽

10.1016/j.acvd.2012.01.007 ◽

2012 ◽

Vol 105 (4) ◽

pp. 203-210 ◽

Cited By ~ 4

Author(s):

Antoine Da Costa ◽

Carine Da Cruz ◽

Cécile Romeyer-Bouchard ◽

Loucif Abdellaoui ◽

Abdallah Nadrouss ◽

...

Keyword(s):

Pulse Generator ◽

Lead Extraction ◽

Single Centre ◽

Lead Failure ◽

Single Centre Experience ◽

Sprint Fidelis ◽

Defibrillator Lead ◽

Generator Replacement

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RIATA LEAD EXTRACTION: LEAD FAILURE DOES NOT INCREASE DIFFICULTY

Journal of the American College of Cardiology ◽

10.1016/s0735-1097(16)30816-6 ◽

2016 ◽

Vol 67 (13) ◽

pp. 815

Author(s):

Ankur Tiwari ◽

Faiz Subzposh ◽

Ashwani Gupta ◽

Eduard Koman ◽

James McCaffrey ◽

...

Keyword(s):

Lead Extraction ◽

Lead Failure

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Abstract 11945: Indications and Outcomes Following Transvenous Extraction of ICD versus Pacemaker Leads

Circulation ◽

10.1161/circ.132.suppl_3.11945 ◽

2015 ◽

Vol 132 (suppl_3) ◽

Author(s):

Eric W Black-Maier ◽

Sean D Pokorney ◽

Robert K Lewis ◽

Alexander Christian ◽

Ruth A Greenfield ◽

...

Keyword(s):

Adverse Events ◽

Dwell Time ◽

Clinical Success ◽

Lead Extraction ◽

Index Hospitalization ◽

Lead Failure ◽

Icd Leads ◽

Pacemaker Leads ◽

Pacing Lead ◽

Major Adverse Events

Introduction: Percutaneous transvenous lead extraction of cardiovascular implantable electronic devices (CIEDs) is increasingly common. Although ICD leads are widely considered to be more difficult to extract than pacemaker leads, there are few direct comparisons. Methods/Results: Using a cohort of 368 consecutive patients undergoing lead extraction (dwell time >1 year) between 2005-2012, we compared baseline characteristics/outcomes in extractions involving pacing versus ICD leads. We defined major adverse events (MAE) as any events/complications that required procedural intervention, transfusion, or that resulted in death or serious harm during index hospitalization. Median age was 60.6 yrs and 29.6% were women. There were 136 (37%) pacing lead extractions and 232 (63%) ICD lead extractions. Pacing leads had a longer dwell time (6.14 yrs [IQR 1.2-10.9 ] versus 4.4 yrs [IQR 1.1-6.4], p<0.001) and higher median LVEF (55% [IQR 35-55] vs. 30% [IQR 20-40], p<0.001) compared with ICD lead patients. Indications for pacing and ICD lead extractions included sepsis/endocarditis (21.3% vs. 24.6%, p=0.48), pocket infection (40.4% vs. 34.9%, p=0.29), and lead failure (15.4% vs. 38.8%, p<0.001). There were no significant differences between pacing and ICD lead extractions in median fluoroscopy time (5.5 vs. 8.5 minutes, p=0.86) or femoral bailout rate (4.4% vs. 5.2%, p=0.73). There were similar rates of all-cause MAE during index hospitalization (5.1% vs. 5.6%), death (2.2% vs 3.2%) and clinical success (97.0% vs. 97.0%, p=0.55) in pacemaker and ICD extractions, respectively. Conclusions: ICD leads are more commonly extracted relative to pacemaker leads, and this difference is driven by larger numbers of lead failure within ICD leads. Despite much longer dwell times, major adverse events were similar in pacing lead cases compared with ICD extractions.

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Abstract 13531: Coronary Artery Disease Predicts Venous Occlusion in Patients Undergoing Lead Extraction

Circulation ◽

10.1161/circ.142.suppl_3.13531 ◽

2020 ◽

Vol 142 (Suppl_3) ◽

Author(s):

Kris Kumar ◽

Stacey Howell ◽

Saket Sanghai ◽

George Giraud ◽

Peter Jessel ◽

...

Keyword(s):

Coronary Artery Disease ◽

Coronary Artery ◽

Odds Ratio ◽

Nyha Class ◽

Vascular Occlusion ◽

Venous Occlusion ◽

Lead Extraction ◽

Lead Failure ◽

Increased Risk ◽

Artery Disease

Introduction: Pacemaker and ICD lead failure or vascular occlusion can require lead extraction. Predictors of a need for lead extraction due to venous occlusion are not well characterized. Hypothesis: Coronary artery disease (CAD) is an independent predictor of lead extraction due to venous occlusion. Methods: We performed a retrospective study of consecutive patients in a prospectively collected registry at a single center undergoing lead extraction due to either venous occlusion or lead failure from 10/2011 to 02/2020. Patients requiring lead extraction due to infection were excluded. Continuous variables are reported as mean ± standard deviation or total number reported as a percentage (%). Chi square test and logistic regression were used to estimate difference in rates and Odds Ratio. Statistically significant findings were identified with a p valve < 0.05. Results: Of 384 procedures included in the database, 131 patients met inclusion criteria for venous occlusion (17%) or lead failure (83%) (Table 1). Average age of the cohort was 55.1 ± 16.4 years and 51% were female. Baseline ejection fraction was 44.6 ± 15.5% and 19.7% of patients had NYHA class III or IV symptoms. 29.7% had a history of CAD. Average number of leads extracted was 1.3 ± 0.57 compared to 2.1 ± 0.82 leads in situ. Patients with CAD had a statistically significant increased risk for extraction as a result of venous occlusion Odds Ratio of 6.80, 95% CI 2.47-18.6, p = 0.0001. Conclusions: Identification of predictors of venous occlusion and risk stratification of these patients is an important component of procedural planning and shared decision making. CAD is a predictor of venous occlusion in patients undergoing lead extraction and should be assessed as a risk factor for complex lead management decisions. Further study is warranted to identify mechanisms by which this relationship can be used to predict need for extraction due to vascular occlusion.

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P1147Complications in young ICD patients - a retrospective analysis

EP Europace ◽

10.1093/europace/euaa162.143 ◽

2020 ◽

Vol 22 (Supplement_1) ◽

Author(s):

D Zweiker ◽

T Puntus ◽

F Egger ◽

R Kriz ◽

J Koch ◽

...

Keyword(s):

Retrospective Analysis ◽

Young Patients ◽

High Rate ◽

Complication Rates ◽

Active Lifestyle ◽

Icd Implantation ◽

Lead Failure ◽

Icd Therapy ◽

Ventricular Lead

Abstract Introduction In specific situations implantable cardioverter defibrillator (ICD) therapy is recommended for patients under the age of 40 years. Due to the active lifestyle of this patient population, complication rates in devices with conventional transvenous electrodes may be higher than for the remaining population. Methods The ICD-YOUNG study is a retrospective analysis of consecutive patients ≤ 40 years undergoing transvenous or subcutaneous ICD (s-ICD) implantation, device change or lead revision at our centre between July 2006 and December 2017. Rehospitalization for lead failure or device battery depletion was documented. Results Out of 586 patients undergoing ICD implantation, 35 patients (6.0%) were ≤ 40 years. Mean age was 30.0 ± 7.2 years, 48.6% were female, 37.1% received ICD therapy for primary prevention and 11.4% primarily received s-ICD. Median follow up was 7.3 (interquartile range, 1.8-12.0) years, with a lower follow up duration in s-ICD patients than conventional ICD patients (median, 2.9 vs. 9.0 years). Over the course of follow-up, 37.1% received successful anti-tachycardia therapy. 19.4% of patients in the conventional ICD group had right ventricular lead problems requiring intervention, while none of the s-ICD patients had to be revised. Time to first device change due to battery depletion and/or device upgrade was similar in young and remaining patients (median 5.4 vs 6.0 years, p = 0.23). Discussion Young patients requiring ICD have a high rate of lead problems. In most young patients, s-ICD therapy is an encouraging alternative to conventional ICD therapy with a lower lead failure rate.

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An adaptable UWB pulse generator for high-rate applications

IEICE Electronics Express ◽

10.1587/elex.4.232 ◽

2007 ◽

Vol 4 (8) ◽

pp. 232-237

Author(s):

Mehdi Salehi ◽

Abdolreza Nabavi

Keyword(s):

Pulse Generator ◽

High Rate

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MANAGEMENT OF FUNCTIONAL SPRINT FIDELIS IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR LEADS AT CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR GENERATOR REPLACEMENT: AN ALTERNATIVE APPROACH FOR PREVENTION OF INAPPROPRIATE SHOCKS CAUSED BY LEAD FAILURE

Journal of the American College of Cardiology ◽

10.1016/s0735-1097(16)30706-9 ◽

2016 ◽

Vol 67 (13) ◽

pp. 705

Author(s):

Dennis Zhu ◽

Matthew M. Chu ◽

Kristen A. Lavell ◽

Chad House

Keyword(s):

Cardiac Resynchronization Therapy ◽

Implantable Cardioverter Defibrillator ◽

Cardiac Resynchronization ◽

Resynchronization Therapy ◽

Lead Failure ◽

Cardioverter Defibrillator ◽

Inappropriate Shocks ◽

Alternative Approach ◽

Sprint Fidelis ◽

Generator Replacement

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Issue of Lithium-indium Anode in High Energy and Power All-Solid-State Lithium Batteries

10.21203/rs.3.rs-402674/v1 ◽

2021 ◽

Author(s):

Shuting Luo ◽

Zhenyu Wang ◽

Xuelei Li ◽

Xinyu Liu ◽

Haidong Wang ◽

...

Keyword(s):

Solid State ◽

Lithium Batteries ◽

Short Circuit ◽

High Energy ◽

High Rate ◽

Transmission Electron ◽

Scanning Transmission ◽

Attractive Option ◽

Vigorous Growth ◽

Electron Energy Loss

Abstract All-solid-state lithium batteries (ASSLBs) using sulfide solid electrolytes (SSEs) offer an attractive option for energy storage applications. Lithium anode is the ultimate goal for ASSLBs, but lithium-indium (Li-In) alloy anode is more widely utilized in lab testing owing to the quite stable interface and elimination for the risk of short circuit. However, vigorous growth of Li-In dendrites in SSE is discovered in the present work when a full cell (LiNbO3 coated LiNi0.6Co0.2Mn0.2O2//Li6PS5Cl//Li-In) is cycled in high loading and high rate. Our study demonstrates that Li-In anode is unstable towards SSEs at high current, which induces Li-In dendrite growth enclosing electrolyte particles and eventually results in cell death after a long cycling. The morphology and growth mechanism of Li-In dendrites are revealed by scanning transmission electron microscopy-electron energy loss spectroscopy (STEM-EELS) analysis and density function theory (DFT) calculations. Moreover, the differences between Li and Li-In dendrites are systematically compared.

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PROMET: The effect of operator profession on non-laser transvenous lead extraction

EP Europace ◽

10.1093/europace/euab116.493 ◽

2021 ◽

Vol 23 (Supplement_3) ◽

Author(s):

Z Akhtar ◽

MM Gallagher ◽

A Elbatran ◽

CT Starck ◽

L WM Leung ◽

...

Keyword(s):

Regression Analysis ◽

Multivariate Regression ◽

Dwell Time ◽

Clinical Success ◽

Systemic Infection ◽

High Volume ◽

Multivariate Regression Analysis ◽

High Rate ◽

Lead Extraction ◽

Cardiac Surgeons

Abstract Funding Acknowledgements Type of funding sources: None. OnBehalf PROMET group Background As implantation of cardiac implantable devices (CIED) rises globally, there is a paralleled need for extraction of these devices. Indications for transvenous lead extraction (TLE) is expanding, fuelling demand. This lifesaving procedure is performed by cardiologists and cardiac surgeons (CS). Cardiologists are familiar with transvenous methods whilst cardiac surgeons possess the skillset to address the significant complications associated with this procedure. We compared non-laser TLE outcomes performed by cardiologists and cardiac surgeons from six high-volume extraction centres across Europe. Methods Data was collected retrospectively from six major European TLE centres of 2205 patients and 3849 leads (PROMET). Propensity 1:1 score matching (PSM) was performed to account for confounding variables. PSM model with variables: lead dwell time, infection indication, biventricular system and defibrillator device, was best matched. This dataset was analysed to compare outcomes of TLE performed by the cardiologists and CS. Predictors of 30-day mortality and complications were identified using a multivariate regression analysis. Results Patients treated by CS and cardiologists were similar in age (64.7 vs 66.7 years, p = NS) and equally male (70.3% vs 72.3%, p = 0.39) with a parallel infectious indication (51.7% vs 47.6%, p = 0.1). Surgeons achieved a significantly higher proportion of clinical success than cardiologists (98.9% vs 96.4%, p = 0.001) and complete lead extraction (98% vs 95.9%, p < 0.01) with a higher rate of minor complications (4.1% vs 2.2%, p = 0.024); major complications were similar (0.9% vs 1.2%, respectively, p = 0.46) as was 30-day mortality (3.2% vs 2%, respectively, p = 0.28). Multivariate regression analysis revealed systemic infection (p < 0.001, OR 7.2 [CI 2.3-20.1]) and defibrillator system extraction (p = 0.025, OR 3.4 [CI 1.2-10.2]) increased the odds of 30-day mortality, whilst Evolution™ sheath use reduced the odds (p = 0.025, OR 0.34 [CI 0.13-0.88]); lead dwell time (p = 0.02, OR 1.005 [1-1.009] and Evolution™ sheath use (p = 0.023, OR 2.15[1.1-4.15]) increased the odds of complications. Conclusion Cardiac surgeons and cardiologists achieved a high rate of TLE procedural success and with a similar safety profile, replicating standards seen across Europe.

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