Heart rhythm · 2025
Acute results of the ASCEND EV study: A new modality of parasternal extravascular implantable cardioverter-defibrillator therapy including antitachycardia pacing.
СтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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van der Stuijt Willeke, Friedman Paul A, Deshmukh Abhishek J, Daly Matthew, Downey Ross, Aasbo Johan D, Jurišić Zrinka, Anić Ante, Ebner Adrian, Olde Nordkamp Louise R A, Doshi Shephal K, Knops Reinoud E, Burke Martin C
Аннотация
BACKGROUND: Extravascular implantable cardioverter-defibrillators (EV-ICDs) are being developed to overcome limitations of current implantable cardioverter-defibrillators (ICDs). The AtaCor parasternal EV-ICD system uses an extravascular lead along the left parasternum to deliver defibrillation and pacing therapy from outside the heart.
OBJECTIVE: This pilot study analysis evaluates implant success, acute performance, and 30-day safety of the parasternal EV-ICD system.
METHODS: Patients with a class I or IIa indication for ICD therapy were implanted with the parasternal EV-ICD system and underwent acute defibrillation testing. End points included acute defibrillation success and 30-day freedom from major complications.
RESULTS: 19 patients were enrolled, of whom 79% had a primary ICD indication. The majority (56%) had an ischemic cardiomyopathy, and the mean left ventricular ejection fraction was 47% ± 18%. The lead was successfully deployed in 19 of 19 attempted implant procedures (100%). Defibrillation testing was performed in 18 patients and was successful in 17 patients (94%). Freedom from major complications was 95% (95% confidence interval 74% to >99%) at 30 days. Intraprocedural pacing capture with the dedicated bipolar pacing vector was achieved in 17 of 17 chronically implanted subjects (100%). Pacing was well tolerated among patients at the predischarge visit.
CONCLUSION: These results show that the AtaCor parasternal EV-ICD system is feasible and safe, with high defibrillation efficacy in induced ventricular arrhythmias and a low occurrence of major complications within 30 days. By combining an extravascular approach with the ability to deliver antitachycardia pacing and defibrillation, the parasternal EV-ICD may provide a viable alternative to conventional ICD therapy.
OBJECTIVE: This pilot study analysis evaluates implant success, acute performance, and 30-day safety of the parasternal EV-ICD system.
METHODS: Patients with a class I or IIa indication for ICD therapy were implanted with the parasternal EV-ICD system and underwent acute defibrillation testing. End points included acute defibrillation success and 30-day freedom from major complications.
RESULTS: 19 patients were enrolled, of whom 79% had a primary ICD indication. The majority (56%) had an ischemic cardiomyopathy, and the mean left ventricular ejection fraction was 47% ± 18%. The lead was successfully deployed in 19 of 19 attempted implant procedures (100%). Defibrillation testing was performed in 18 patients and was successful in 17 patients (94%). Freedom from major complications was 95% (95% confidence interval 74% to >99%) at 30 days. Intraprocedural pacing capture with the dedicated bipolar pacing vector was achieved in 17 of 17 chronically implanted subjects (100%). Pacing was well tolerated among patients at the predischarge visit.
CONCLUSION: These results show that the AtaCor parasternal EV-ICD system is feasible and safe, with high defibrillation efficacy in induced ventricular arrhythmias and a low occurrence of major complications within 30 days. By combining an extravascular approach with the ability to deliver antitachycardia pacing and defibrillation, the parasternal EV-ICD may provide a viable alternative to conventional ICD therapy.