Pierre Deharo1,2,3, Arnaud Bisson4, Julien Herbert4,5, Thibaud Lacour4,5, Christophe Saint Etienne4, Leslie Grammatico-Guillon4, Alizée Porto, Frederic Collart6,2,3, Thierry Bourguignon7, Thomas Cuisset1,2,3, Laurent Fauchier5. 1. Département de Cardiologie (P.D., T.C.), CHU Timone, Marseille, France. 2. INSERM, INRA (P.D., F.C., T.C.), Aix Marseille Université, France. 3. Faculté de Médecine (P.D., F.C., T.C.), Aix Marseille Université, France. 4. Service de Cardiologie, Centre Hospitalier Universitaire Trousseau et Faculté de Médecine (A.B., J.H., T.L., C.S.E., L.F.), France. 5. Service d'information médicale, d'épidémiologie et d'économie de la santé, Unité d'épidémiologie hospitalière régionale (J.H., T.L., L.G.-G.), France. 6. Département de Chirurgie Cardiaque (F.C.), CHU Timone, Marseille, France. 7. Service de Chirurgie Cardiaque (T.B.), France.
Abstract
BACKGROUND: Two competing transcatheter aortic valve replacement (TAVR) technologies are currently available. Head-to-head comparisons of the relative performances of these 2 devices have been published. However, long-term clinical outcome evaluation remains limited by the number of patients analyzed, in particular, for recent-generation devices. METHODS: Based on the French administrative hospital-discharge database, the study collected information for all consecutive patients treated with a TAVR device commercialized in France between 2014 and 2018. Propensity score matching was used for the analysis of outcomes during follow-up. The objective of this study was to analyze the outcomes of TAVR according to Sapien 3 balloon-expandable (BE) versus Evolut R self-expanding TAVR technology at a nationwide level in France. RESULTS: A total of 31 113 patients treated with either Sapien 3 BE or Evolut R self-expanding TAVR were found in the database. After matching on baseline characteristics, 20 918 patients were analyzed (10 459 in each group with BE or self-expanding valves). During follow-up (mean [SD], 358 [384]; median [interquartile range], 232 [10-599] days), BE TAVR was associated with a lower yearly incidence of all-cause death (relative risk, 0.88; corrected P=0.005), cardiovascular death (relative risk, 0.82; corrected P=0.002), and rehospitalization for heart failure (relative risk, 0.84; corrected P<0.0001). BE TAVR was also associated with lower rates of pacemaker implantation after the procedure (relative risk, 0.72; corrected P<0.0001). CONCLUSIONS: On the basis of the largest cohort available, we observed that Sapien 3 BE valves were associated with lower rates of all-cause death, cardiovascular death, rehospitalization for heart failure, and pacemaker implantation after a TAVR procedure.
BACKGROUND: Two competing transcatheter aortic valve replacement (TAVR) technologies are currently available. Head-to-head comparisons of the relative performances of these 2 devices have been published. However, long-term clinical outcome evaluation remains limited by the number of patients analyzed, in particular, for recent-generation devices. METHODS: Based on the French administrative hospital-discharge database, the study collected information for all consecutive patients treated with a TAVR device commercialized in France between 2014 and 2018. Propensity score matching was used for the analysis of outcomes during follow-up. The objective of this study was to analyze the outcomes of TAVR according to Sapien 3 balloon-expandable (BE) versus Evolut R self-expanding TAVR technology at a nationwide level in France. RESULTS: A total of 31 113 patients treated with either Sapien 3 BE or Evolut R self-expanding TAVR were found in the database. After matching on baseline characteristics, 20 918 patients were analyzed (10 459 in each group with BE or self-expanding valves). During follow-up (mean [SD], 358 [384]; median [interquartile range], 232 [10-599] days), BE TAVR was associated with a lower yearly incidence of all-cause death (relative risk, 0.88; corrected P=0.005), cardiovascular death (relative risk, 0.82; corrected P=0.002), and rehospitalization for heart failure (relative risk, 0.84; corrected P<0.0001). BE TAVR was also associated with lower rates of pacemaker implantation after the procedure (relative risk, 0.72; corrected P<0.0001). CONCLUSIONS: On the basis of the largest cohort available, we observed that Sapien 3 BE valves were associated with lower rates of all-cause death, cardiovascular death, rehospitalization for heart failure, and pacemaker implantation after a TAVR procedure.
Authors: Peter E Umukoro; Paul Yeung-Lai-Wah; Sunil Pathak; Sabri Elkhidir; Deepa Soodi; Brooke Delgoffe; Richard Berg; Kelley P Anderson; Romel J Garcia-Montilla Journal: Clin Med Res Date: 2020-10-14
Authors: Alberto Alperi; Guillem Muntané-Carol; Afonso B Freitas-Ferraz; Lucia Junquera; David Del Val; Laurent Faroux; François Philippon; Josep Rodés-Cabau Journal: Ann Cardiothorac Surg Date: 2020-11
Authors: Damian Hudziak; Wojciech Wańha; Radosław Gocoł; Radosław Parma; Andrzej Ochała; Grzegorz Smolka; Joanna Ciosek; Tomasz Darocha; Marek A Deja; Wojciech Wojakowski Journal: Postepy Kardiol Interwencyjnej Date: 2021-03-27 Impact factor: 1.426