Axel Kloppe1, Alessandro Proclemer1, Angel Arenal1, Maurizio Lunati1, José Bautista Martìnez Ferrer1, Ahmad Hersi1, Marcin Gulaj1, Maurits C E F Wijffels1, Elisabetta Santi1, Laura Manotta1, Lorenza Mangoni1, Maurizio Gasparini2. 1. From Medizinische Klinik II, Kardiologie und Angiologie, Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil, Ruhr Universität Bochum, Bochum, Germany (A.K.); Azienda Ospedaliero Universitaria S. Maria della Misericordia, Udine, Italy (A.P.); Hospital General Universitario Gregorio Marañón, Madrid, Spain (A.A.); Azienda Ospedaliera Niguarda Ca' Granda, Milano, Italy (M.L.); Hospital de Txagorritxu, Vitoria (Álava), Spain (J.B.M.F.); College of Medicine, King Saud University, Riyadh, Saudi Arabia (A.H.); MSWiA Hospital, Bialystok, Poland (M. Gulaj); St. Antonius Ziekenhuis Hospital, Nieuwegein, Netherlands (M.C.E.F.W.); Medtronic Clinical Research Institute, Rome, Italy (E.S., L. Mangoni); Medtronic Clinical Research Institute, Sesto San Giovanni, Italy (L. Manotta); and Humanitas Research Hospital, Rozzano-Milano, Italy (M. Gasparini). 2. From Medizinische Klinik II, Kardiologie und Angiologie, Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil, Ruhr Universität Bochum, Bochum, Germany (A.K.); Azienda Ospedaliero Universitaria S. Maria della Misericordia, Udine, Italy (A.P.); Hospital General Universitario Gregorio Marañón, Madrid, Spain (A.A.); Azienda Ospedaliera Niguarda Ca' Granda, Milano, Italy (M.L.); Hospital de Txagorritxu, Vitoria (Álava), Spain (J.B.M.F.); College of Medicine, King Saud University, Riyadh, Saudi Arabia (A.H.); MSWiA Hospital, Bialystok, Poland (M. Gulaj); St. Antonius Ziekenhuis Hospital, Nieuwegein, Netherlands (M.C.E.F.W.); Medtronic Clinical Research Institute, Rome, Italy (E.S., L. Mangoni); Medtronic Clinical Research Institute, Sesto San Giovanni, Italy (L. Manotta); and Humanitas Research Hospital, Rozzano-Milano, Italy (M. Gasparini). maurizio.gasparini@humanitas.it.
Abstract
BACKGROUND: Three trials demonstrated recently that a long detection window reduces implantable cardioverter-defibrillator (ICD) therapy in primary prevention patients. Avoid Delivering Therapies for Nonsustained Arrhythmias in ICD Patients III (ADVANCE III) was the only trial that enrolled both primary and secondary prevention patients. METHODS AND RESULTS: Of the 1902 patients enrolled in the ADVANCE III trial, 477 received a defibrillator for secondary prevention; 248 patients were randomly assigned to a long detection setting (30 of 40 intervals) and 229 to the nominal setting (18 of 24 intervals) for ventricular arrhythmias with cycle length ≤ 320 ms. Eight-five percent of patients were men, with a mean age of 65 ± 12 years, a previous history of ventricular fibrillation in 37% of the cases, and a mean ejection fraction of 38 ± 13%. The ICD device mix was 37% single chamber, 47% dual chamber, and 16% triple chamber. Over a median period of 12 months, the long detection period was associated with a 25% reduction in the number of overall therapies (115.6 versus 86.8 per 100 patient-years; incidence rate ratio, 0.75; 95% confidence interval, 0.61-0.93; P=0.008) and a 34% reduction in the number of shocks (rate per 100 patient-years, 51.2 versus 38.1; incidence rate ratio, 0.66; 95% confidence interval, 0.48-0.89; P=0.007). Appropriate therapies (89.7 versus 67.7; incidence rate ratio, 0.77; 95% confidence interval, 0.60-0.97; P=0.029) and appropriate shocks (37.1 versus 28.1; incidence rate ratio, 0.64; 95% confidence interval, 0.45-0.93; P=0.018) were also reduced. CONCLUSIONS: ADVANCE III is the first randomized trial to assess a long detection window setting in ICDs in both primary and secondary prevention populations and demonstrates a reduction of overall therapies and shocks in the subgroup of secondary prevention patients. These data suggest that even the secondary prevention population may benefit from programming that combines a long detection period with antitachycardia pacing during charging. CLINICAL TRIAL REGISTRATION URL: http://www/clinicaltrials.gov. Unique identifier: NCT00617175.
RCT Entities:
BACKGROUND: Three trials demonstrated recently that a long detection window reduces implantable cardioverter-defibrillator (ICD) therapy in primary prevention patients. Avoid Delivering Therapies for Nonsustained Arrhythmias in ICDPatients III (ADVANCE III) was the only trial that enrolled both primary and secondary prevention patients. METHODS AND RESULTS: Of the 1902 patients enrolled in the ADVANCE III trial, 477 received a defibrillator for secondary prevention; 248 patients were randomly assigned to a long detection setting (30 of 40 intervals) and 229 to the nominal setting (18 of 24 intervals) for ventricular arrhythmias with cycle length ≤ 320 ms. Eight-five percent of patients were men, with a mean age of 65 ± 12 years, a previous history of ventricular fibrillation in 37% of the cases, and a mean ejection fraction of 38 ± 13%. The ICD device mix was 37% single chamber, 47% dual chamber, and 16% triple chamber. Over a median period of 12 months, the long detection period was associated with a 25% reduction in the number of overall therapies (115.6 versus 86.8 per 100 patient-years; incidence rate ratio, 0.75; 95% confidence interval, 0.61-0.93; P=0.008) and a 34% reduction in the number of shocks (rate per 100 patient-years, 51.2 versus 38.1; incidence rate ratio, 0.66; 95% confidence interval, 0.48-0.89; P=0.007). Appropriate therapies (89.7 versus 67.7; incidence rate ratio, 0.77; 95% confidence interval, 0.60-0.97; P=0.029) and appropriate shocks (37.1 versus 28.1; incidence rate ratio, 0.64; 95% confidence interval, 0.45-0.93; P=0.018) were also reduced. CONCLUSIONS: ADVANCE III is the first randomized trial to assess a long detection window setting in ICDs in both primary and secondary prevention populations and demonstrates a reduction of overall therapies and shocks in the subgroup of secondary prevention patients. These data suggest that even the secondary prevention population may benefit from programming that combines a long detection period with antitachycardia pacing during charging. CLINICAL TRIAL REGISTRATION URL: http://www/clinicaltrials.gov. Unique identifier: NCT00617175.
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