1. Primary Results From the Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction (UNTOUCHED) Trial
- Author
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Gold, Michael, Lambiase, Pier, El-Chami, Mikhael, Knops, Reinoud, Aasbo, Johan, Bongiorni, Maria Grazia, Russo, Andrea, Deharo, Jean-Claude, Burke, Martin, Dinerman, Jay, Barr, Craig, Shaik, Naushad, Carter, Nathan, Stoltz, Thomas, Stein, Kenneth, Brisben, Amy, Boersma, Lucas, 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, 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, Cardiology, ACS - Heart failure & arrhythmias, Clinical sciences, Medical University of South Carolina [Charleston] (MUSC), University College of London [London] (UCL), Amsterdam UMC - Amsterdam University Medical Center, Cooper Medical School of Rowan University [Camden] (CMSRU), Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research (C2VN), and Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)
- Subjects
Male ,[SDV]Life Sciences [q-bio] ,primary prevention ,heart failure ,Ventricular tachycardia ,MESH: Stroke Volume ,Sudden cardiac death ,Defibrillators/standards ,defibrillators ,Prospective Studies ,MESH: Cohort Studies ,MESH: Treatment Outcome ,MESH: Aged ,Ejection fraction ,MESH: Middle Aged ,MESH: Follow-Up Studies ,Middle Aged ,Primary Prevention/methods ,defibrillators, implantable ,MESH: Arrhythmias, Cardiac ,Treatment Outcome ,Cardiology ,Cohort studies ,Female ,ventricular tachycardia ,Cardiology and Cardiovascular Medicine ,arrhythmias ,Adult ,medicine.medical_specialty ,implantable ,cardiac ,MESH: Defibrillators, Implantable ,Defibrillators, Implantable/standards ,sudden cardiac death ,Physiology (medical) ,Primary prevention ,Internal medicine ,medicine ,Humans ,Death, Sudden, Cardiac/epidemiology ,Aged ,MESH: Humans ,business.industry ,Stroke Volume ,MESH: Adult ,MESH: Death, Sudden, Cardiac ,Arrhythmias, Cardiac/physiopathology ,arrhythmias, cardiac ,medicine.disease ,ventricular fibrillation ,MESH: Prospective Studies ,MESH: Male ,Death, Sudden, Cardiac ,MESH: Primary Prevention ,Stroke Volume/physiology ,Heart failure ,Ventricular fibrillation ,MESH: Defibrillators ,business ,MESH: Female ,Follow-Up Studies - Abstract
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 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. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02433379.
- Published
- 2021
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