Author + information
- Received February 18, 2020
- Revision received March 5, 2020
- Accepted March 6, 2020
- Published online June 1, 2020.
- Rodrigo Modolo, MDa,b,
- Chun Chin Chang, MDc,
- Mohammad Abdelghani, MD, PhDa,d,
- Hideyuki Kawashima, MDa,
- Masafumi Ono, MDa,
- Hiroki Tateishi, MDe,
- Yosuke Miyazaki, MD, PhDc,e,
- Michele Pighi, MDf,
- Joanna J. Wykrzykowska, MD, PhDa,
- Robbert J. de Winter, MD, PhDa,
- Andreas Ruck, MD, PhDg,
- Alaide Chieffo, MD, PhDh,
- Martijn S. van Mourik, PhDa,
- Kyohei Yamaji, MD, PhDi,
- Gert Richardt, MDd,
- Fabio S. de Brito Jr., MDj,
- Pedro A. Lemos, MD, PhDj,k,
- Baravan Al-Kassou, MDl,
- Nicolo Piazza, MD, PhDe,
- Didier Tchetche, MD, PhDm,
- Jan-Malte Sinning, MD, PhDl,
- Mohamed Abdel-Wahab, MDd,n,
- Osama Soliman, MD, PhDo,
- Lars Søndergaard, MD, PhDp,
- Darren Mylotte, MD, PhDo,
- Yoshinobu Onuma, MD, PhDo,
- Nicolas M. Van Mieghem, MD, PhDc and
- Patrick W. Serruys, MD, PhDo,q,∗ ()
- aDepartment of Cardiology, Amsterdam UMC, Amsterdam Cardiovascular Sciences, University of Amsterdam, Amsterdam, the Netherlands
- bDepartment of Internal Medicine, Cardiology Division. University of Campinas, Campinas, Brazil
- cDepartment of Cardiology, Erasmus Medical Center, Rotterdam, the Netherlands
- dThe Heart Center, Segeberger Kliniken, Bad Segeberg, Germany
- eDivision of Cardiology, Department of Clinical Science and Medicine, Yamaguchi University Graduate School of Medicine, Ube, Yamaguchi, Japan
- fDivision of Cardiology, McGill University Health Centre, Montreal, Quebec, Canada
- gDepartment of Aortic Valve Disease, Karolinska University Hospital, Stockholm, Sweden
- hInterventional Cardiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy
- iDepartment of Cardiology, Kokura Memorial Hospital, Kokurakita-ku, Kitakyushu, Japan
- jThe Heart Institute, University of São Paulo Medical School, São Paulo, Brazil
- kDepartment of Interventional Cardiology, Hospital Israelita Albert Einstein, São Paulo, Brazil
- lMedizinische Klinik und Poliklinik II, Universitätsklinikum Bonn, Bonn, Germany
- mGroupe CardioVasculaire Interventionnel, Clinique Pasteur, Toulouse, France
- nCardiology Department, Heart Center Leipzig at the University of Leipzig, Leipzig, Germany
- oGalway University Hospital, SAOLTA Health Care Group, and National University of Ireland, Galway, Ireland
- pThe Heart Center, Rigshospitalet, University of Copenhagen, Denmark
- qDepartment of Cardiology, Imperial College of London, London, United Kingdom
- ↵∗Address for correspondence:
Prof. Patrick W. Serruys, National University of Ireland, Galway (NUIG), University Road, Galway H91 TK33, Ireland.
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.
Dr. Modolo has received research grants from Biosensors and Sahajanand Medical Technologies, not related to the present work. Dr. Rück has received lecture honoraria, research grants, and proctor fees from Boston Scientific and Edwards Lifesciences. Dr. de Brito is a proctor for Medtronic and Edwards Lifesciences. Dr. Piazza is a consultant and proctor for Medtronic, Microport, and HighLife. Dr. Sinning is a proctor for Medtronic and Boston Scientific; and receives speaking honoraria and research grants from Abiomed, Abbott, Medtronic, Edwards Lifesciences, and Boston Scientific. Dr. Mylotte is a proctor and consultant for Medtronic and Microport; and is a consultant for Boston Scientific. Dr. Van Mieghem has received institutional research grants from Abbott, ACIST Medical Systems, Boston Scientific, Medtronic, Edwards Lifesciences, and PulseCath; and has received advisory fees from Abbott, ACIST Medical Systems, Boston Scientific, Medtronic, and PulseCath. Prof. Serruys has received personal fees from Abbott Laboratories, AstraZeneca, Biotrinik, Cardialysis, GLG Research, Medtronic, Sino Medical Sciences Technology, Société Europa Digital Publishing, and Stentys. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Bernard Prendergast, DM, served as guest editor for this paper.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Cardiovascular Interventions author instructions page.
- Received February 18, 2020.
- Revision received March 5, 2020.
- Accepted March 6, 2020.
- 2020 American College of Cardiology Foundation
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