Quantitative Assessment of Acute Regurgitation Following TAVR: A Multicenter Pooled Analysis of 2,258 Valves

Rodrigo Modolo; Chun Chin Chang; Mohammad Abdelghani; Hideyuki Kawashima; Masafumi Ono; Hiroki Tateishi; Yosuke Miyazaki; Michele Pighi; Joanna J Wykrzykowska; Robbert J de Winter; Andreas Ruck; Alaide Chieffo; Martijn S van Mourik; Kyohei Yamaji; Gert Richardt; Fabio S de Brito Jr; Pedro A Lemos; Baravan Al-Kassou; Nicolo Piazza; Didier Tchetche; Jan-Malte Sinning; Mohamed Abdel-Wahab; Osama Soliman; Lars Søndergaard; Darren Mylotte; Yoshinobu Onuma; Nicolas M Van Mieghem; Patrick W Serruys

doi:10.1016/j.jcin.2020.03.002

Quantitative Assessment of Acute Regurgitation Following TAVR: A Multicenter Pooled Analysis of 2,258 Valves

JACC Cardiovasc Interv. 2020 Jun 8;13(11):1303-1311. doi: 10.1016/j.jcin.2020.03.002. Epub 2020 Mar 16.

Authors

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 Brito Jr¹², 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

Affiliations

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.

PMID: 32499020
DOI: 10.1016/j.jcin.2020.03.002

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.

Keywords: aortic regurgitation; paravalvular leak; transcatheter aortic valve replacement.

Publication types

Comparative Study
Multicenter Study

MeSH terms

Aortic Valve Insufficiency / diagnostic imaging
Aortic Valve Insufficiency / etiology*
Aortic Valve Stenosis / surgery*
Feasibility Studies
Heart Valve Prosthesis*
Humans
Retrospective Studies
Risk Factors
Severity of Illness Index
Transcatheter Aortic Valve Replacement / adverse effects*
Transcatheter Aortic Valve Replacement / instrumentation*
Treatment Outcome