Outcomes in Patients With Congenital Heart Disease Receiving the Subcutaneous Implantable-Cardioverter Defibrillator: Results From a Pooled Analysis From the IDE Study and the EFFORTLESS S-ICD Registry

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• 作者：Benjamin A. D&rsquo ; Souza ; MD^a ; Andrew E. Epstein ; MD^a ; ^{andrew.epstein@uphs.upenn.edu" class="auth_mail" title="E-mail the corresponding author} ; Fermin C. Garcia ; MD^a ; Yuli Y. Kim ; MD^a ; ^b ; Sharad C. Agarwal ; MD^c ; Peter H. Belott ; MD^d ; Martin C. Burke ; DO^e ; Angel R. Leon ; MD^f ; John M. Morgan ; MD^g ; Kristen K. Patton ; MD^h ; Maully Shah ; MBBS^b
• 关键词：congenital heart disease ; subcutaneous implantable-cardioverter defibrillator ; sudden cardiac death
• 刊名：JACC: Clinical Electrophysiology
• 出版年：2016
• 出版时间：October 2016
• 年：2016
• 卷：2
• 期：5
• 页码：615-622
• 全文大小：518 K

文摘

This study was conceived to determine the safety and efficacy of the subcutaneous implantable cardioverter-defibrillator (S-ICD) in patients with congenital heart disease (CHD).

Background

The S-ICD is a treatment option for patients with CHD in which a transvenous device is contraindicated due to anatomic considerations. However, efficacy in this group has not been determined.

Methods

A pooled analysis of 865 patients in the EFFORTLESS (Evaluation of Factors Affecting the Clinical Outcome and Cost-Effectiveness) registry (an international observational database) and a U.S. Investigational Device Exemption study were reviewed.

Results

Nineteen CHD patients versus 846 non-CHD patients with a median follow-up of 567 days and 639 days, respectively, were included. There were no deaths and no appropriate shocks for ventricular tachycardia/ventricular fibrillation in the CHD cohort, versus 26 deaths (3.1%, p = 0.42) and 111 appropriate shocks in 59 patients (7.1%) in the non-CHD cohort (p = 0.23). There were similar complication rates for the CHD versus non-CHD groups (10.5 vs. 9.6% [p = 0.89]), with inappropriate shocks for T-wave oversensing as the only complication in the CHD group (n = 2). The rate of inappropriate shocks was similar for both groups (10.5% vs. 10.9% [p = 0.96]). Successful defibrillation testing at 80J was comparable for the CHD versus non-CHD groups (100% vs. 98.5%).

Conclusions

The overall analysis of the CHD cohort from the pooled data of the Investigational Device Exemption study and the EFFORTLESS registry shows that the S-ICD is a safe option in CHD patients deemed to be at high risk for sudden cardiac death who do not have pacing indications. Further research to accurately define sudden cardiac death risk in the diverse anatomic substrates of CHD patients is warranted.