Multiple trials, for which data was presented at the Heart Rhythm Society (HRS) Heart Rhythm 2022 conference, backed Marlborough, Massachusetts-based Boston Scientific’s subcutaneous implantable cardiac defibrillators (S-ICD) against transvenous ICDs (TV-ICD) — and the Watchman FLX left atrial appendage closure (LAAC) device against an earlier generation of the system.
The Atlas trial for the S-ICD system met its primary endpoint with a statistically significant 92% reduction in serious lead-related complications at six months for the Emblem S-ICD system compared to TV-ICDs. The trial observed no significant differences between the S-ICD and TV-ICD arms in rates of failed appropriate shocks and arrhythmic death.
In-hospital outcomes for Watchman FLX compared with Watchman 2.5, there was a 43% lower rate of in-hospital major adverse events with the newer generation FLX. That included lower rates of pericardial effusion requiring intervention and major bleeding.
Major in-hospital major adverse events included a composite of death, cardiac arrest, stroke, transient ischemic attack, intracerebral hemorrhage, systemic embolism, major bleeding, major vascular complication, myocardial infarction, pericardial effusion requiring intervention, and device embolization.
The new data for Watchman FLX follows strong results from February, when Boston Scientific shared real-world data for Watchman FLX from more than 16,000 patients with non-valvular atrial fibrillation (AFib) within the National Cardiovascular Data Registry (NCDR) Left Atrial Appendage Occlusion (LAAO) Registry, demonstrating only a 0.37% rate of major adverse events at seven days following a Watchman FLX implant or the time of hospital discharge (whichever came later).