Impact of fracture‐prone implantable cardioverter defibrillator leads on long‐term patient mortality

Author:

Koike Toshiharu1ORCID,Shoda Morio12ORCID,Ejima Koichiro12ORCID,Yagishita Daigo12,Suzuki Atsushi1,Hasegawa Shun1,Kataoka Shohei1,Yazaki Kyoichiro1ORCID,Higuchi Satoshi1ORCID,Kanai Miwa1,Yamaguchi Junichi1

Affiliation:

1. Department of Cardiology Tokyo Women's Medical University 8‐1 Kawada‐cho, Shinjuku‐ku Tokyo 162‐8666 Japan

2. Clinical Research Division for Heart Rhythm Management, Department of Cardiology Tokyo Women's Medical University 162‐8666 Tokyo 8‐1 Kawada‐cho, Shinjuku‐ku Japan

Abstract

AbstractBackgroundThe long‐term relationship between fracture‐prone implantable cardioverter‐defibrillator (ICD) leads and poor prognosis remains unclear in Japanese patients.MethodsWe conducted a retrospective review of the records of 445 patients who underwent implantation of advisory/Linox leads (Sprint Fidelis, 118; Riata, nine; Isoline, 10; Linox S/SD, 45) and non‐advisory leads (Endotak Reliance, 33; Durata, 199; Sprint non‐Fidelis, 31) between January 2005 and June 2012 at our hospital. The primary outcomes were all‐cause mortality and ICD lead failure. The secondary outcomes were cardiovascular mortality, heart failure (HF) hospitalization, and the composite outcome of cardiovascular mortality and HF hospitalization.ResultsDuring the follow‐up period (median, 8.6 [4.1–12.0] years), there were 152 deaths: 61 (34%) in patients with advisory/Linox leads and 91 (35%) in those with non‐advisory leads. There were 32 ICD lead failures: 27 (15%) in patients with advisory/Linox leads and five (2%) in those with non‐advisory leads. Multivariate analysis for ICD lead failure demonstrated that the advisory/Linox leads had a 6.65‐fold significantly greater risk of ICD lead failure than non‐advisory leads. Congenital heart disease (hazard ratio 2.51; 95% confidence interval 1.08–5.83; p = .03) could also independently predict ICD lead failure. Multivariate analysis for all‐cause mortality demonstrated no significant association between advisory/Linox leads and all‐cause mortality.ConclusionsPatients who have implanted fracture‐prone ICD leads should be carefully followed up for ICD lead failure. However, these patients have a long‐term survival rate comparable with that of patients with non‐advisory ICD leads in Japanese patients.

Publisher

Wiley

Subject

Cardiology and Cardiovascular Medicine

Reference31 articles.

1. A Comparison of Antiarrhythmic-Drug Therapy with Implantable Defibrillators in Patients Resuscitated from Near-Fatal Ventricular Arrhythmias

2. Amiodarone or an Implantable Cardioverter–Defibrillator for Congestive Heart Failure

3. US Food and Drug Administration.Class 1 Device Recall Medtronic Sprint Fidelis Lead. [cited 2022 Aug 20].https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65383

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