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Subcutaneous ICD Long-Term Efficacy and Outcomes
Quick Takes
- In the EFFORTLESS registry, the S-ICD maintained a high level of shock efficacy of 98% at 5 years.
- During the follow-up of 5 years, only 2% of patients needed a transvenous device for pacing indications.
Study Questions:
What are the 5-year outcomes of patients with early-generation subcutaneous implantable cardioverter-defibrillator (S-ICD) devices?
Methods:
The EFFORTLESS S-ICD registry is an observational, nonrandomized, standard of care registry for patients with S-ICD.
Results:
Nine hundred and eighty-four patients enrolled. Median follow-up was 5 years. All-cause mortality was 9.3% at 5 years. Of the explants, only 20 (2.0%) patients needed a transvenous device for pacing indications. First and final shock efficacy for discrete ventricular arrhythmias was 90% and 98%, respectively, with storm episode final shock efficacy at 95%. Time to therapy remained unaltered. Complication rates were 8.9% at 1 year and 15.2% at 5 years. Early complications did not predict later complications. There were no structural lead failures. Inappropriate shock rates at 1 and 5 years were 8.7% and 16.9%, respectively.
Conclusions:
The authors concluded that spontaneous shock efficacy remained consistently high over 5 years in this S-ICD registry and that very few patients needed a transvenous device for pacing.
Perspective:
This is the largest study to show long-term performance of S-ICD, and the devices performed very well for the duration of the follow-up. Of note is the fact that patients in this registry were younger and healthier than the broader ICD patient population (the annualized mortality rate was low at 1.9%). There was a high shock efficacy rate, low complication rate, relatively low inappropriate shock rate, and very few patients had to be converted to a transvenous device. This study confirms that S-ICD is a reasonable therapy for patients at increased risk of arrhythmic death.
Clinical Topics: Arrhythmias and Clinical EP, Heart Failure and Cardiomyopathies, Prevention, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Acute Heart Failure
Keywords: Arrhythmias, Cardiac, Death, Sudden, Death, Sudden, Cardiac, Defibrillators, Implantable, Heart Failure, Pacemaker, Artificial, Primary Prevention, Secondary Prevention, Shock, Standard of Care, Tachycardia, Ventricular
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