This article is more than 5 years old. Information may no longer be current.
EFFORTLESS data illustrate long-term safety, efficacy of subcutaneous ICD
Click Here to Manage Email Alerts
Real-world data from the EFFORTLESS S-ICD registry indicate that the Boston Scientific subcutaneous implantable cardioverter defibrillator demonstrates appropriate performance and has comparable rates of clinical events and inappropriate shocks as conventional implantable cardioverter defibrillators.
Researchers reported interim results of the EFFORTLESS registry published in the European Heart Journal. The nonrandomized, multicenter registry was designed to collect long-term, real-world patient outcome data from patients implanted with the subcutaneous ICD since June 2009.
The current analysis focuses on outcomes from 472 patients (72% men; mean age, 49 years; mean left ventricular ejection fraction, 42%) at 29 facilities in Europe and New Zealand who had a mean follow-up duration of 558 days.
The complication-free rate was 97% at 30 days and 94% at 1 year.
During follow-up, 317 spontaneous episodes were recorded in 85 patients. Of those, 169 episodes received therapy (93 for ventricular tachycardia/fibrillation).
Sustained ventricular tachycardia/fibrillation was recorded on 91 occasions in 33 patients, including 51 discrete episodes in 29 patients and 40 episodes during “storms” (three or more treated episodes within 24 hours). One death due to recurrent ventricular fibrillation and severe bradycardia occurred during follow-up.
Among discrete episodes of ventricular tachycardia/fibrillation, researchers observed 100% overall successful clinical conversion after a maximum of five shocks with first shock conversion efficacy of 88%. The inappropriate shock rate was 7% at 1 year, with the majority resulting from oversensing of cardiac signals. The researchers noted a lower inappropriate shock rate among patients implanted with a device with dual zone programming (n=357 evaluable patients) compared with single zone programming (n=74 evaluable patients; 6.4% vs. 12%; P=.09).
No participants experienced lead fractures or breakages. Documented or suspected infections related to the procedure were reported in 18 patients, on 20 occasions and at 10 sites, including 10 cases of serious infection resulting in removal of the subcutaneous ICD system.
“This data set is important as it is the first long-term real world experience demonstrating safe and effective performance of the S-ICD system,” Pier Lambiase, PhD, consultant electrophysiologist at Heart Hospital in London, said in a press release. “This should further establish the S-ICD system as a worthwhile option for a considerable portion of the ICD-indicated population that is eligible for the S-ICD system.”
Disclosure: See the full study for a list of relevant financial disclosures.
Click Here to Manage Email Alerts