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.)
You must give appropriate credit, provide a link to the license, and indicate if changes were made. You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use. You may not use the material for commercial purposes. If you remix, transform, or build upon the material, you may not distribute the modified material.
Exportado de SIDERAL (2024-01-22-15:28:14)
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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.)
You must give appropriate credit, provide a link to the license, and indicate if changes were made. You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use. You may not use the material for commercial purposes. If you remix, transform, or build upon the material, you may not distribute the modified material. Exportado de SIDERAL (2024-01-22-15:28:14)
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