JACC. Clinical electrophysiology · 2020
Targeted Left Ventricular Lead Implantation Strategy for Non-Left Bundle Branch Block Patients: The ENHANCE CRT Study.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Singh Jagmeet P, Berger Ronald D, Doshi Rahul N, Lloyd Michael, Moore Douglas, Stone James, Daoud Emile G, ENHANCE CRT Study Group
Аннотация
OBJECTIVES: This study compared clinical outcomes between an increased electrical delay in the left ventricular region (QLV)-based LV lead implantation approach (QLV arm) and anatomical implantation approach (control arm) in patients with non-left bundle branch block.
BACKGROUND: Limited data exist on cardiac resynchronization therapy effectiveness in patients with non-left bundle branch block. Clinicians generally deliver cardiac resynchronization therapy through an anatomical implantation approach; however, targeting the QLV may serve as an individualized implantation strategy in non-left bundle branch block patients.
METHODS: The study enrolled 248 subjects at 29 U.S. centers. Subjects were randomized in a 2:1 ratio between a QLV-based implantation approach and anatomical implantation approach and were implanted with a St. Jude Medical quadripolar cardiac resynchronization therapy defibrillator system. The primary endpoint was the clinical composite score after 12 months of follow-up.
RESULTS: The study analyzed 191 available subjects at 12 months of follow-up (128 QLV arm, 63 control arm). Of these, 39 subjects (26 in the QLV arm and 13 in the control arm) had heart failure events (8 cardiac deaths and 31 heart failure hospitalizations). Aside from New York Heart Association functional class, there were no other significant differences in baseline characteristics between the 2 arms. The responder rate at 12 months measured by the clinical composite score was 67.2% in the QLV arm and 73.0% in the control arm (p = 0.506).
CONCLUSIONS: Although patient-tailored left ventricular lead placement guided by QLV is promising, we observed no difference in outcome between the QLV-based implantation approach and the conventional anatomical implantation approach.
BACKGROUND: Limited data exist on cardiac resynchronization therapy effectiveness in patients with non-left bundle branch block. Clinicians generally deliver cardiac resynchronization therapy through an anatomical implantation approach; however, targeting the QLV may serve as an individualized implantation strategy in non-left bundle branch block patients.
METHODS: The study enrolled 248 subjects at 29 U.S. centers. Subjects were randomized in a 2:1 ratio between a QLV-based implantation approach and anatomical implantation approach and were implanted with a St. Jude Medical quadripolar cardiac resynchronization therapy defibrillator system. The primary endpoint was the clinical composite score after 12 months of follow-up.
RESULTS: The study analyzed 191 available subjects at 12 months of follow-up (128 QLV arm, 63 control arm). Of these, 39 subjects (26 in the QLV arm and 13 in the control arm) had heart failure events (8 cardiac deaths and 31 heart failure hospitalizations). Aside from New York Heart Association functional class, there were no other significant differences in baseline characteristics between the 2 arms. The responder rate at 12 months measured by the clinical composite score was 67.2% in the QLV arm and 73.0% in the control arm (p = 0.506).
CONCLUSIONS: Although patient-tailored left ventricular lead placement guided by QLV is promising, we observed no difference in outcome between the QLV-based implantation approach and the conventional anatomical implantation approach.