Primary Results From the Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction (UNTOUCHED) Trial.

Gold, Michael R. ; Lambiase, Pier D. ; El-Chami, Mikhael F. ; Knops, Reinoud E. ; Aasbo, Johan D. ; Bongiorni, Maria Grazia ; Russo, Andrea M. ; Deharo, Jean-Claude ; Burke, Martin C. ; Dinerman, Jay ; Barr, Craig S. ; Shaik, Naushad ; Carter, Nathan ; Stoltz, Thomas ; Stein, Kenneth M. ; Brisben, Amy J. ; Boersma, Lucas V.A. ; Phelan, Timothy ; Al-Ameri, Hazim ; Albirini, Abdulhay ; Alimohammad, Rizwan ; Arias, Miguel ; Badenco, Nicolas ; Bertaux, Geraldine ; Bhakta, Deepak ; Bindra, Sanjay ; Blangy, Hugues ; Boveda, Serge ; Brock, Johansen ; Busch, Mathias ; Calvo, Naiara (Universidad de Zaragoza) ; Cassidy, Christopher ; Chauvin, Michel ; Marzak, Halim ; Chinitz, Jason ; Ciuffo, Allen ; Clancy, Jude ; Crossen, Karl ; De Filippo, Paolo ; Devecchi, Fausto ; Karanam, Sreekanth ; Doshi, Rahul ; Eckardt, Lars ; Fedor, Matthew ; Freedman, Roger ; Gehi, Anil ; Goethals, Peter ; Gosau, Nils ; Gottlieb, Charles ; Granrud, Gregory ; Greenstein, Radmira ; Hamdan, Firas ; Hanon, Sam ; Hassankhani, Alborz ; Henderson, Rick ; Hohnloser, Stefan ; Huang, David ; Irles, Didier ; Kalahasty, Gautham ; Kazemian, Pedram ; Khairallah, Farhat ; Kim, Brian ; Kim, Edward ; Klein, Christoph ; Knight, Bradley ; Koide, Niuton ; Kuk, Richard ; Leclercq, Christophe ; Lee, Michael ; Lee, Shang-Chiun ; Lenz, Corinna ; Lewis, Nigel ; Lewis, Robert ; Mark, George ; Marquie, Christelle ; McDonnell, Kelly ; Mckenzie, John ; Merchant, Faisal ; Mobarek, Sameh ; Moccetti, Tiziano ; Molin, Franck ; Philliopon, Francois ; Morani, Giovanni ; Morin, Daniel ; Ng, G. ; Nsah, Emmanuel ; Panday, Manoj ; Pasquie, Jean-Luc ; Castellano Perez, Nicasio ; Perez-Gil, Francisco ; Ptaszynski, Pawel ; Rajendra, Anil ; Rhodes, Troy ; Roberts, Paul ; Rowe, Steven ; Saba, Samir ; Sagi, Venkata ; Sarter, Brian ; Schoenhard, John ; Schutzman, John ; Scott, Luis ; Segerson, Nathan ; Shakir, Ali ; Smelley, Matthew ; Steffel, Jan ; Sturdivant, J. Lacy ; Tabbal, Ghiyath ; Tendler, Drory ; Theuns, Dominic ; Timmers, Liesbeth ; Trojan, Matthew ; Tsai, Shane ; Upadhyay, Gaurav ; Varkey, Santosh ; Viani, Stefano ; Weiner, Stanislav ; Weiss, Raul ; Wiggins, Sherman ; Wright, David ; Zadeh, Andrew ; Zitron, Edgar

Resumen: Background:
The subcutaneous (S) implantable cardioverter-defibrillator (ICD) is safe and effective for sudden cardiac death prevention. However, patients in previous S-ICD studies had fewer comorbidities, had less left ventricular dysfunction, and received more inappropriate shocks (IAS) than in typical transvenous ICD trials. The UNTOUCHED trial (Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction) was designed to evaluate the IAS rate in a more typical, contemporary ICD patient population implanted with the S-ICD using standardized programming and enhanced discrimination algorithms.

Methods:
Primary prevention patients with left ventricular ejection fraction ≤35% and no pacing indications were included. Generation 2 or 3 S-ICD devices were implanted and programmed with rate-based therapy delivery for rates ≥250 beats per minute and morphology discrimination for rates ≥200 and <250 beats per minute. Patients were followed for 18 months. The primary end point was the IAS-free rate compared with a 91.6% performance goal, derived from the results for the ICD-only patients in the MADIT-RIT study (Multicenter Automatic Defibrillator Implantation Trial–Reduce Inappropriate Therapy). Kaplan-Meier analyses were performed to evaluate event-free rates for IAS, all-cause shock, and complications. Multivariable proportional hazard analysis was performed to determine predictors of end points.

Results:
S-ICD implant was attempted in 1116 patients, and 1111 patients were included in postimplant follow-up analysis. The cohort had a mean age of 55.8±12.4 years, 25.6% were women, 23.4% were Black, 53.5% had ischemic heart disease, 87.7% had symptomatic heart failure, and the mean left ventricular ejection fraction was 26.4±5.8%. Eighteen-month freedom from IAS was 95.9% (lower confidence limit, 94.8%). Predictors of reduced incidence of IAS were implanting the most recent generation of device, using the 3-incision technique, no history of atrial fibrillation, and ischemic cause. The 18-month all-cause shock-free rate was 90.6% (lower confidence limit, 89.0%), meeting the prespecified performance goal of 85.8%. Conversion success rate for appropriate, discrete episodes was 98.4%. Complication-free rate at 18 months was 92.7%.

Conclusions:
This study demonstrates high efficacy and safety with contemporary S-ICD devices and programming despite the relatively high incidence of comorbidities in comparison with earlier S-ICD trials. The inappropriate shock rate (3.1% at 1 year) is the lowest reported for the S-ICD and lower than many transvenous ICD studies using contemporary programming to reduce IAS.

Idioma: Inglés

DOI: 10.1161/circulationaha.120.048728

Año: 2021

Publicado en: Circulation 143, 1 (2021), 7-17
ISSN: 0009-7322

Factor impacto JCR: 39.922 (2021)

Categ. JCR: PERIPHERAL VASCULAR DISEASE rank: 1 / 67 = 0.015 (2021) - Q1 - T1
Categ. JCR: CARDIAC & CARDIOVASCULAR SYSTEMS rank: 2 / 143 = 0.014 (2021) - Q1 - T1

Factor impacto CITESCORE: 40.5 - Medicine (Q1)

Factor impacto SCIMAGO: 8.281 - Physiology (medical) (Q1) - Cardiology and Cardiovascular Medicine (Q1)

Tipo y forma: Article (Published version)

Área (Departamento): Area Medicina (Dpto. Medicina, Psiqu. y Derm.)