Cardiovascular revascularization medicine : including molecular interventions · 2025
Clinical and health status after permanent pacemaker implantation in patients undergoing transcatheter aortic valve replacement: Insights from the SCOPE I randomized trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Nakase Masaaki, Tomii Daijiro, Lanz Jonas, Prendergast Bernard, Heg Dik, Thiele Holger, Möllmann Helge, Kim Won-Keun, Burgdorf Christof, Linke Axel, Redwood Simon, Hilker Michael, Conradi Lenard, Kerber Sebastian, Thilo Christian, Toggweiler Stefan, Walther Thomas, Joner Michael, Windecker Stephan, Pilgrim Thomas, SCOPE I Investigators
Аннотация
BACKGROUND: The impact of new permanent pacemaker (PPM) implantation on prognosis after transcatheter aortic valve replacement (TAVR) is controversial.
OBJECTIVES: To investigate the impact of new PPM implantation on combined outcomes of vital and patient-reported health status after TAVR.
METHODS: Patients in the SCOPE (Safety and Efficacy of the ACURATE Neo/TF Compared to the SAPIEN 3 Bioprosthesis) trial were stratified according to new PPM implantation within 30 days of TAVR. In this trial, clinical endpoints were adjudicated according to the Valve Academic Research Consortium (VARC)-2 definition. The combined outcomes, including general outcomes and clinical efficacy, were retrospectively adjudicated according to the VARC-3 definition at 1 and 3 years of follow-up.
RESULTS: Among 640 patients without a PPM at baseline (mean age 82.8 ± 4.1 years, 58.1 % females, mean Society of Thoracic Surgeons predicted risk of mortality 4.2 ± 2.5), 69 (10.8 %) required PPM implantation within 30 days of TAVR. Patients requiring a PPM had higher rates of right ventricular dysfunction (33 % versus 15 %, P = 0.038) at 1 year. Improvement in patient-health status measures was similar between groups throughout the study period. Patients requiring a new PPM had similar rates of unfavorable clinical outcomes (Risk ratio [RR]adjusted 0.89 [95 % CI 0.68-1.16]) and clinical efficacy (RRadjusted 0.96 [95 % CI 0.76-1.22]) compared to those who did not require new PPM implantation.
CONCLUSIONS: In the SCOPE I trial, new PPM implantation complicating TAVR had no impact on an integrated endpoint of vital and disease-specific health status throughout 3 years of follow-up.
OBJECTIVES: To investigate the impact of new PPM implantation on combined outcomes of vital and patient-reported health status after TAVR.
METHODS: Patients in the SCOPE (Safety and Efficacy of the ACURATE Neo/TF Compared to the SAPIEN 3 Bioprosthesis) trial were stratified according to new PPM implantation within 30 days of TAVR. In this trial, clinical endpoints were adjudicated according to the Valve Academic Research Consortium (VARC)-2 definition. The combined outcomes, including general outcomes and clinical efficacy, were retrospectively adjudicated according to the VARC-3 definition at 1 and 3 years of follow-up.
RESULTS: Among 640 patients without a PPM at baseline (mean age 82.8 ± 4.1 years, 58.1 % females, mean Society of Thoracic Surgeons predicted risk of mortality 4.2 ± 2.5), 69 (10.8 %) required PPM implantation within 30 days of TAVR. Patients requiring a PPM had higher rates of right ventricular dysfunction (33 % versus 15 %, P = 0.038) at 1 year. Improvement in patient-health status measures was similar between groups throughout the study period. Patients requiring a new PPM had similar rates of unfavorable clinical outcomes (Risk ratio [RR]adjusted 0.89 [95 % CI 0.68-1.16]) and clinical efficacy (RRadjusted 0.96 [95 % CI 0.76-1.22]) compared to those who did not require new PPM implantation.
CONCLUSIONS: In the SCOPE I trial, new PPM implantation complicating TAVR had no impact on an integrated endpoint of vital and disease-specific health status throughout 3 years of follow-up.
Предметные рубрики MeSH
HumansFemaleTranscatheter Aortic Valve ReplacementMaleAged, 80 and overPacemaker, ArtificialTreatment OutcomeTime FactorsHealth StatusAortic Valve StenosisAgedRisk FactorsHeart Valve ProsthesisAortic ValveRetrospective StudiesProsthesis DesignCardiac Pacing, ArtificialRisk AssessmentRecovery of FunctionArrhythmias, CardiacBioprosthesisPatient Reported Outcome Measures