852Lead abandonment and subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation in a cohort of patients with ICD lead malfunction

Abstract Funding Acknowledgements NO FUNDING OnBehalf Rhythm Detect Registry Background Currently, when an implantable-cardioverter defibrillator (ICD) lead becomes nonfunctional, a class IIa recommendation exists for either lead abandonment or for removal. The benefits of removal include creation of an access for insertion of a new lead. However, the subcutaneous ICD (S-ICD) does not require the insertion of any leads into the cardiovascular system, and may represent an additional option for patients not requiring pacing. Purpose To report outcomes associated with a strategy of lead abandonment and S-ICD implantation in the setting of lead malfunction. Methods We analyzed all consecutive patients who underwent S-ICD implantation after abandonment of malfunctioning leads and we compared outcomes with those of patients who underwent transvenous extraction and subsequent reimplantation of a single-chamber transvenous ICD (T- ICD). Results 43 patients were implanted with an S-ICD after abandonment of malfunctioning leads, while in 62 patients extraction and subsequent reimplantation of a T-ICD. The two groups were comparable (Age 55 ± 16 vs. 54 ± 33years, BMI 26 ± 3 vs. 24 ± 4kg/m2, LVEF 43 ± 15 vs. 48 ± 8%). S-ICD defibrillation test success rate at implantation was 96% at 65J. In the extraction group, no major complications were reported during extraction, while the procedure failed and an S-ICD was implanted in 4 patients. During a median follow-up of 21 months, the rate of major complications was not higher in the S-ICD group than in the T-ICD group (HR 1.07; 95%CI 0.29–3.94; P = 0 .912; Figure), as well as the rate of minor complications (HR 2.13; 95%CI 0.49–9.24; P = 0 .238). Conclusions In case of ICD lead malfunction, extraction prevents potential long-term risks of abandoned leads, e.g. increased complications for a possible future mandatory extraction indication such as infection, and allows magnetic resonance imaging. Nonetheless in this series, the strategy of lead abandonment and S-ICD implantation appeared to be feasible and safe with no significant increase in adverse outcomes for patients not requiring pacing and may represent an option in selected clinical settings (very high risk or failed extractions, older patients, etc.). Longer follow-up studies are needed to fully understand the potential risks of lead abandonment. Abstract Figure

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Lead Abandonment and Subcutaneous Implantable Cardioverter-Defibrillator (S-ICD) Implantation in a Cohort of Patients With ICD Lead Malfunction

Frontiers in Cardiovascular Medicine ◽

10.3389/fcvm.2021.692943 ◽

2021 ◽

Vol 8 ◽

Author(s):

Vincenzo Russo ◽

Stefano Viani ◽

Federico Migliore ◽

Gerardo Nigro ◽

Mauro Biffi ◽

...

Keyword(s):

Implantable Cardioverter Defibrillator ◽

Adverse Outcomes ◽

Clinical Settings ◽

Icd Implantation ◽

Clinical Trial Registration ◽

Cardioverter Defibrillator ◽

Major Complications ◽

Potential Risks

Background: When an implantable-cardioverter defibrillator (ICD) lead becomes non-functional, a recommendation currently exists for either lead abandonment or removal. Lead abandonment and subcutaneous ICD (S-ICD) implantation may represent an additional option for patients who do not require pacing. The aim of this study was to investigate the outcomes of a strategy of lead abandonment and S-ICD implantation in the setting of lead malfunction.Methods: We analyzed all consecutive patients who underwent S-ICD implantation after abandonment of malfunctioning leads and compared their outcomes with those of patients who underwent extraction and subsequent reimplantation of a single-chamber transvenous ICD (T-ICD).Results: Forty-three patients underwent S-ICD implantation after abandonment of malfunctioning leads, while 62 patients underwent extraction and subsequent reimplantation of a new T-ICD. The two groups were comparable. In the extraction group, no major complications occurred during extraction, while the procedure failed and an S-ICD was implanted in 4 patients. During a median follow-up of 21 months, 3 major complications or deaths occurred in the S-ICD group and 11 in the T-ICD group (HR 1.07; 95% CI 0.29–3.94; P = 0.912). Minor complications were 4 in the S-ICD group and 5 in the T-ICD group (HR 2.13; 95% CI 0.49–9.24; P = 0.238).Conclusions: In the event of ICD lead malfunction, extraction avoids the potential long-term risks of abandoned leads. Nonetheless the strategy of lead abandonment and S-ICD implantation was feasible and safe, with no significant increase in adverse outcomes, and may represent an option in selected clinical settings. Further studies are needed to fully understand the potential risks of lead abandonment.Clinical Trial Registration: URL: ClinicalTrials.gov Identifier: NCT02275637

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Abstract 20158: Long-Term Device-Related Adverse Events After Implantable Cardioverter-Defibrillator Therapy

Circulation ◽

10.1161/circ.130.suppl_2.20158 ◽

2014 ◽

Vol 130 (suppl_2) ◽

Author(s):

Isuru Ranasinghe ◽

Craig Parzynski ◽

James V Freeman ◽

Rachel P Dreyer ◽

Joseph S Ross ◽

...

Keyword(s):

Adverse Events ◽

Implantable Cardioverter Defibrillator ◽

End Of Life ◽

Adverse Outcomes ◽

Icd Implantation ◽

Cardioverter Defibrillator ◽

Risk Of Death ◽

Device Malfunction

Background: Long-term implantable cardioverter-defibrillator (ICD) adverse events are poorly documented. In the NCDR ICD Registry™, a nationally representative cohort, we calculated the rate of long-term post-discharge device related adverse events. Methods: We included first-time ICD implants from 2006-2010 that could be matched with Medicare fee-for-service claims data to identify outcomes. We excluded patients if they had a previous ICD or pacemaker, CABG during their procedure, or were not discharged alive. The primary outcome was device reoperation (involving the generator, leads, pocket, or a combination) for device malfunction, infection, other complications (wound disruption, cardiac perforation, etc.), or reoperation for battery end-of-life and/or device upgrade. Analysis was performed using unadjusted cumulative incidence functions taking into consideration the competing risk of death. Results: We identified 185,263 ICD implants of which 114,649 (19.7% single-chamber, 41.3% dual-chamber, 38.8% CRT-D) could be matched to Medicare data (mean age 74.8±6.2 years, 72.5% male).Of these, 83.5% were for primary prevention of sudden cardiac death. The median follow up was 2.7 yrs (max follow-up 6 yrs). At least 1 reoperation occurred in 15.5% of patients by 6 yrs and more than 80% of these reoperations occurred after the early (>90 days) post-implantation period (Figure). Reoperation rates for specific complications (per 1000 patient yrs) were device malfunction (14.3), infection (5.1), other device related complications (18.4) and reoperation for generator battery end-of-life and/or device upgrade (12.9). The crude reoperation rate (for any cause) was similar among device types (P=0.19). Conclusion: Patients continue to have adverse outcomes in the years post ICD implantation, predominately from device malfunction. Our next steps are to identify patient, device, and provider factors associated with these long-term adverse events.

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Cardioverter-related complications: observations from an institutional implantable cardioverter defibrillator registry

EP Europace ◽

10.1093/europace/euab116.478 ◽

2021 ◽

Vol 23 (Supplement_3) ◽

Author(s):

I Prepolec ◽

V Pasara ◽

E Ciglenecki ◽

J Putric Posavec ◽

JE Bogdanic ◽

...

Keyword(s):

Antibiotic Prophylaxis ◽

Implantable Cardioverter Defibrillator ◽

Needle Aspiration ◽

Left Ventricular ◽

Icd Implantation ◽

Cardioverter Defibrillator ◽

Vein Thrombosis ◽

Funding Sources ◽

Major Complications

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Implantable cardioverter defibrillator (ICD) is gold standard therapy for primary and secondary prevention of sudden cardiac death (SCD) and ventricular tachyarrhythmias. While reducing arrhythmic mortality in patients with left ventricular dysfunction of various causes, inherited primary arrhythmia syndromes and after aborted SCD, these devices can have serious adverse effects including inappropriate shocks and device-related infection. Purpose The aim of this study was to create an institutional ICD registry and to examine the major complications after ICD implantation. Methods We analysed the data concerning all newly implanted ICDs in our institution from 2011 to 2017. All patients received periprocedural antibiotic prophylaxis according to relevant guidelines. Follow-up data was collected from hospital electronic medical records. Results Total number of implanted ICDs was 507 (85.4% male, 57.6 ± 14.0 years-old) and mean follow-up was 34.3 ± 23.8 months. Major complications (infection, large haematoma/hemorrhage, lead displacement/dysfunction) occurred in 18 (3.6%) patients. In 9 (1.8%) cases patients were diagnosed with ICD infection (8 surgical wound/pocket infections and 1 confirmed endocarditis of the lead). Device was explanted in 5 cases (1.0%) while the rest were treated only with antibiotic therapy (empirically or according to swab/blood culture results). All of the infections were successfully resolved and no relapses were noted. Eventually, 3 of 5 devices were reimplanted. One death was recorded 5 month after the explanation. Second most common complication was lead displacement/dysfunction which occurred in 5 (1.0%) patients and was successfully repaired in all cases. Large haematoma and/or hemorrhage at the implantation site were present in 5 (0.8%) patients (2 required surgical revision and transfusion while 2 were managed by needle aspiration). Pneumothorax (2 cases, 0.4%) had to be drained in one patient. There was one case of subclavian vein thrombosis which was treated by anticoagulation. Conclusion Despite appropriate antibiotic prophylaxis, the rate of ICD infections in our institution was relatively higher than the one reported in similar registries. The prevalence of other major complications, including lead dysfunction was quite low. Institutional registries could help monitor and plan actions to resolve ICD-related complications to improve patient outcomes.

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