Rodrigo Modolo1, Chun Chin Chang2, Mohammad Abdelghani3, Hideyuki Kawashima4, Masafumi Ono4, Hiroki Tateishi5, Yosuke Miyazaki6, Michele Pighi7, Joanna J Wykrzykowska4, Robbert J de Winter4, Andreas Ruck8, Alaide Chieffo9, Martijn S van Mourik4, Kyohei Yamaji10, Gert Richardt11, Fabio S de Brito12, Pedro A Lemos13, Baravan Al-Kassou14, Nicolo Piazza5, Didier Tchetche15, Jan-Malte Sinning14, Mohamed Abdel-Wahab16, Osama Soliman17, Lars Søndergaard18, Darren Mylotte17, Yoshinobu Onuma17, Nicolas M Van Mieghem2, Patrick W Serruys19. 1. Department of Cardiology, Amsterdam UMC, Amsterdam Cardiovascular Sciences, University of Amsterdam, Amsterdam, the Netherlands; Department of Internal Medicine, Cardiology Division. University of Campinas, Campinas, Brazil. 2. Department of Cardiology, Erasmus Medical Center, Rotterdam, the Netherlands. 3. Department of Cardiology, Amsterdam UMC, Amsterdam Cardiovascular Sciences, University of Amsterdam, Amsterdam, the Netherlands; The Heart Center, Segeberger Kliniken, Bad Segeberg, Germany. 4. Department of Cardiology, Amsterdam UMC, Amsterdam Cardiovascular Sciences, University of Amsterdam, Amsterdam, the Netherlands. 5. Division of Cardiology, Department of Clinical Science and Medicine, Yamaguchi University Graduate School of Medicine, Ube, Yamaguchi, Japan. 6. Department of Cardiology, Erasmus Medical Center, Rotterdam, the Netherlands; Division of Cardiology, Department of Clinical Science and Medicine, Yamaguchi University Graduate School of Medicine, Ube, Yamaguchi, Japan. 7. Division of Cardiology, McGill University Health Centre, Montreal, Quebec, Canada. 8. Department of Aortic Valve Disease, Karolinska University Hospital, Stockholm, Sweden. 9. Interventional Cardiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy. 10. Department of Cardiology, Kokura Memorial Hospital, Kokurakita-ku, Kitakyushu, Japan. 11. The Heart Center, Segeberger Kliniken, Bad Segeberg, Germany. 12. The Heart Institute, University of São Paulo Medical School, São Paulo, Brazil. 13. The Heart Institute, University of São Paulo Medical School, São Paulo, Brazil; Department of Interventional Cardiology, Hospital Israelita Albert Einstein, São Paulo, Brazil. 14. Medizinische Klinik und Poliklinik II, Universitätsklinikum Bonn, Bonn, Germany. 15. Groupe CardioVasculaire Interventionnel, Clinique Pasteur, Toulouse, France. 16. The Heart Center, Segeberger Kliniken, Bad Segeberg, Germany; Cardiology Department, Heart Center Leipzig at the University of Leipzig, Leipzig, Germany. 17. Galway University Hospital, SAOLTA Health Care Group, and National University of Ireland, Galway, Ireland. 18. The Heart Center, Rigshospitalet, University of Copenhagen, Denmark. 19. Galway University Hospital, SAOLTA Health Care Group, and National University of Ireland, Galway, Ireland; Department of Cardiology, Imperial College of London, London, United Kingdom. Electronic address: patrick.w.j.c.serruys@gmail.com.
Abstract
OBJECTIVES: The aim of this study was to assess acute regurgitation following transcatheter aortic valve replacement, comparing different implanted transcatheter heart valves. BACKGROUND: Regurgitation following transcatheter aortic valve replacement influences all-cause mortality. Thus far, no quantitative comparison of regurgitation among multiple commercially available transcatheter heart valves has been performed. METHODS: Aortograms from a multicenter cohort of consecutive 3,976 transcatheter aortic valve replacements were evaluated in this pooled analysis. A total of 2,258 (58.3%) were considered analyzable by an independent academic core laboratory using video densitometry. Results of quantitative regurgitation are shown as percentages. The valves evaluated were the ACURATE (n = 115), Centera (n = 11), CoreValve (n = 532), Direct Flow Medical (n = 21), Evolut PRO (n = 95), Evolut R (n = 295), Inovare (n = 4), Lotus (n = 546), Lotus Edge (n = 3), SAPIEN XT (n = 239), and SAPIEN 3 (n = 397). For the main analysis, only valves with more than 50 procedures (7 types) were used. RESULTS: The Lotus valve had the lowest mean regurgitation (3.5 ± 4.4%), followed by Evolut PRO (7.4 ± 6.5%), SAPIEN 3 (7.6 ± 7.1%), Evolut R (7.9 ± 7.4%), SAPIEN XT (8.8 ± 7.5%), ACURATE (9.6 ± 9.2%) and CoreValve (13.7 ± 10.7%) (analysis of variance p < 0.001). The only valves that statistically differed from all their counterparts were Lotus (as the lowest regurgitation) and CoreValve (the highest). The proportion of patients presenting with moderate or severe regurgitation followed the same ranking order: Lotus (2.2%), Evolut PRO (5.3%), SAPIEN 3 (8.3%), Evolut R (8.8%), SAPIEN XT (10.9%), ACURATE (11.3%), and CoreValve (30.1%) (chi-square p < 0.001). CONCLUSIONS: In this pooled analysis stemming from daily clinical practice, the Lotus valve was shown to have the best immediate sealing. This analysis reflects the objective evaluation of regurgitation by an academic core laboratory (nonsponsored) in a real-world cohort of patients using a quantitative technique.
OBJECTIVES: The aim of this study was to assess acute regurgitation following transcatheter aortic valve replacement, comparing different implanted transcatheter heart valves. BACKGROUND:Regurgitation following transcatheter aortic valve replacement influences all-cause mortality. Thus far, no quantitative comparison of regurgitation among multiple commercially available transcatheter heart valves has been performed. METHODS: Aortograms from a multicenter cohort of consecutive 3,976 transcatheter aortic valve replacements were evaluated in this pooled analysis. A total of 2,258 (58.3%) were considered analyzable by an independent academic core laboratory using video densitometry. Results of quantitative regurgitation are shown as percentages. The valves evaluated were the ACURATE (n = 115), Centera (n = 11), CoreValve (n = 532), Direct Flow Medical (n = 21), Evolut PRO (n = 95), Evolut R (n = 295), Inovare (n = 4), Lotus (n = 546), Lotus Edge (n = 3), SAPIEN XT (n = 239), and SAPIEN 3 (n = 397). For the main analysis, only valves with more than 50 procedures (7 types) were used. RESULTS: The Lotus valve had the lowest mean regurgitation (3.5 ± 4.4%), followed by Evolut PRO (7.4 ± 6.5%), SAPIEN 3 (7.6 ± 7.1%), Evolut R (7.9 ± 7.4%), SAPIEN XT (8.8 ± 7.5%), ACURATE (9.6 ± 9.2%) and CoreValve (13.7 ± 10.7%) (analysis of variance p < 0.001). The only valves that statistically differed from all their counterparts were Lotus (as the lowest regurgitation) and CoreValve (the highest). The proportion of patients presenting with moderate or severe regurgitation followed the same ranking order: Lotus (2.2%), Evolut PRO (5.3%), SAPIEN 3 (8.3%), Evolut R (8.8%), SAPIEN XT (10.9%), ACURATE (11.3%), and CoreValve (30.1%) (chi-square p < 0.001). CONCLUSIONS: In this pooled analysis stemming from daily clinical practice, the Lotus valve was shown to have the best immediate sealing. This analysis reflects the objective evaluation of regurgitation by an academic core laboratory (nonsponsored) in a real-world cohort of patients using a quantitative technique.