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Published on: July 18, 2014
Outcomes in Patients With Congenital Heart Disease Receiving the Subcutaneous Implantable-Cardioverter Defibrillator:
Benjamin A D'Souza1, Andrew E Epstein1, Fermin C Garcia1
1Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Insights
The subcutaneous implantable cardioverter-defibrillator (S-ICD) is safe and effective for congenital heart disease (CHD) patients at high risk for sudden cardiac death. This study found comparable complication rates and successful defibrillation testing in CHD patients compared to non-CHD patients.
Area of Science:
- Cardiology
- Medical Devices
- Electrophysiology
Background:
- The subcutaneous implantable cardioverter-defibrillator (S-ICD) offers an alternative for congenital heart disease (CHD) patients unsuitable for transvenous devices.
- Efficacy of S-ICD in CHD patients remains under-investigated despite its potential benefits.
Purpose of the Study:
- To evaluate the safety and efficacy of S-ICD implantation in patients diagnosed with congenital heart disease (CHD).
- To compare S-ICD performance in CHD patients versus non-CHD patients.
Main Methods:
- Pooled analysis of data from the EFFORTLESS registry and a U.S. Investigational Device Exemption study.
- Inclusion of 19 CHD patients and 846 non-CHD patients with median follow-up periods of 567 and 639 days, respectively.
Main Results:
- No deaths or appropriate shocks for ventricular tachycardia/fibrillation were observed in the CHD cohort.
- Complication rates were similar between CHD and non-CHD groups (10.5% vs. 9.6%), with T-wave oversensing causing inappropriate shocks in 2 CHD patients.
- Successful defibrillation testing at 80J was comparable (100% in CHD vs. 98.5% in non-CHD).
Conclusions:
- S-ICD is a safe and effective option for CHD patients at high risk of sudden cardiac death without pacing indications.
- Further research is needed to precisely define sudden cardiac death risk across diverse CHD anatomical substrates.
Objectives:
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.
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