Author + information
- 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 Sondergaard, 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 (UNICAMP). 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, QC, 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, 3-2-1 Asano, Kokurakita-ku, Kitakyushu, 802-0001, Japan
- jThe Heart Institute (InCor), University of São Paulo Medical School, São Paulo, Brazil
- kDepartment of Interventional Cardiology, Hospital Israelita Albert Einstein, Sao 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: Professor Patrick W. Serruys, MD, PhD. Professor of Cardiology (hon) - Imperial, College London London, The United Kingdom, P.O. Box 2125 3000 CC Rotterdam, the Netherlands
Background Regurgitation following transcatheter aortic valve replacement (TAVR) impacts all-cause mortality. Thus far, no quantitative comparison of regurgitation amongst multiple commercially available transcatheter heart valves (THV) has been performed.
Objectives We sought to assess the acute regurgitation following TAVR comparing different implanted THV.
Methods Aortograms from a multicenter cohort of consecutive 3,976 TAVR were evaluated in this pooled analysis. A total of 2,258 (58.3%) were considered analyzable by an independent academic core lab using videodensitometry. Results of quantitative regurgitation are shown in percentage. Valves evaluated were: 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 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%, ANOVA p-value<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 a 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-value <0.001.
Conclusion In this pooled analysis stemming from daily clinical practice, the Lotus valve showed to have the best immediate sealing. This analysis reflects the objective evaluation of regurgitation by an academic core lab (non-sponsored) in a real-world cohort of patients using a quantitative technique.
Rodrigo Modolo: Received research grant from Biosensors and SMT, not related to the present work.
Andreas Rück: has received lecture honoraria, research grants and proctor fees from Boston Scientific and Edwards Lifesciences.
Fabio S de Brito Jr: Proctor for Medtronic and Edwards LifeSciences. Nicolo Piazza: consultant and proctor for Medtronic, Microportand HighLife.
Jan-Malte Sinning: proctor for Medtronic and Boston Scientific and receives speaker honoraria and research grants from Abiomed, Abbott, Medtronic, Edwards Lifesciences, and Boston Scientific.
Darren Mylotte: proctor and consultant for Medtronic and Microport and a consultant for Boston Scientific.
Nicolas Van Mieghem: received institutional research grants from Abbott, ACIST, Boston Scientific, Medtronic, Edwards and PulseCath BV, and received advisory fees from Abbott, ACIST, Boston Scientific, Medtronic, and PulseCath BV.
Prof. Serruys: reports personal fees from Abbott Laboratories, personal fees from AstraZeneca, personal fees from Biotrinik, personal fees from Cardialysis, personal fees from GLG Research, personal fees from Medtronic, personal fees from Sino Medical Sciences Technology, personal fees from Société Europa Digital Publishing, personal fees from Stentys.
The other authors have no disclosures.
Tweet/handle: @R_Modolo; In this study, Modolo et al. performed an independent core lab analysis of PVL after TAVR in a large “real-world” cohort, finding lower regurgitation rate with newer devices.
- Received February 18, 2020.
- Revision received March 5, 2020.
- Accepted March 6, 2020.
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