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

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Τίτλος: Primary Results From the Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction (UNTOUCHED) Trial
Συγγραφείς: Gold, MR, Lambiase, PD, El-Chami, MF, Knops, RE, Aasbo, JD, Bongiorni, MG, Russo, AM, Deharo, J-C, Burke, MC, Dinerman, J, Barr, CS, Shaik, N, Carter, N, Stoltz, T, Stein, KM, Brisben, AJ, Boersma, LVA, UNTOUCHED Investigators*
Πηγή: Circulation , 143 (1) pp. 7-17. (2021)
Έτος έκδοσης: 2021
Συλλογή: University College London: UCL Discovery
Θεματικοί όροι: arrhythmias, cardiac, defibrillators, implantable, heart failure, primary prevention, sudden cardiac death, ventricular fibrillation, ventricular tachycardia
Περιγραφή: 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. ...
Τύπος εγγράφου: article in journal/newspaper
Περιγραφή αρχείου: text
Γλώσσα: English
Relation: https://discovery.ucl.ac.uk/id/eprint/10120730/1/CIRCULATIONAHA.120.048728.pdf; https://discovery.ucl.ac.uk/id/eprint/10120730/
Διαθεσιμότητα: https://discovery.ucl.ac.uk/id/eprint/10120730/1/CIRCULATIONAHA.120.048728.pdf
https://discovery.ucl.ac.uk/id/eprint/10120730/
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  Data: Primary Results From the Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction (UNTOUCHED) Trial
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  Data: Circulation , 143 (1) pp. 7-17. (2021)
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  Data: 2021
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– Name: Abstract
  Label: Description
  Group: Ab
  Data: 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 &lt;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&#177;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&#177;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. ...
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  Data: https://discovery.ucl.ac.uk/id/eprint/10120730/1/CIRCULATIONAHA.120.048728.pdf; https://discovery.ucl.ac.uk/id/eprint/10120730/
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      – SubjectFull: defibrillators
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      – SubjectFull: heart failure
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      – SubjectFull: sudden cardiac death
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      – TitleFull: Primary Results From the Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction (UNTOUCHED) Trial
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