Balloon Versus Self-Expandable Valve for the Treatment of Bicuspid Aortic Valve Stenosis: Insights from the BEAT International Collaborative Registrys

Antonio Mangieri, Didier Tchetchè, Won Keun Kim, Matteo Pagnesi, Jean Malte Sinning, Uri Landes, Ran Kornowski, Ole De Backer, Georg Nickenig, Alfonso Ielasi, Chiara De Biase, Lars Søndergaard, Federico De Marco, Matteo Montorfano, Mauro Chiarito, Damiano Regazzoli, Giulio Stefanini, Patrizia Presbitero, Stefan Toggweiler, Corrado TamburinoSebastiano Immè, Giuseppe Tarantini, Horst Sievert, Ulrich Schäfer, Jörg Kempfert, Jochen Wöehrle, Francesco Gallo, Alessandra Laricchia, Azeem Latib, Francesco Giannini, Antonio Colombo

Research output: Contribution to journalArticlepeer-review

17 Scopus citations

Abstract

Background: Large data comparing the performance of new-generation self-expandable versus balloon-expandable transcatheter heart valves in bicuspid aortic stenosis are lacking. We aim to compare the safety and performance of balloon-expandable and self-expandable transcatheter heart valves in the treatment of bicuspid aortic stenosis. Methods: The BEAT (balloon versus self-expandable valve for the treatment of bicuspid aortic valve stenosis) registry included 353 consecutive patients who underwent transcatheter aortic valve implantation using new-generation Evolut R/PRO or Sapien 3 valves in bicuspid aortic valve. Results: A total of 353 patients (n=242 [68.6%] treated with Sapien 3 and n=111 [68.6%] treated with Evolut R (n=70)/PRO [n=41]) were included. Mean age was 77.8±8.3 years and mean Society of Thoracic Surgeons Predicted Risk of Mortality was 4.4±3.3%. Valve Academic Research Consortium-2 device success was similar between Sapien 3 and Evolut R/PRO (85.6% versus 87.2%; P=0.68). In the Sapien 3 group, 4 patients experienced annular rupture whereas this complication did not occur in the Evolut R/PRO group. After propensity score matching, Valve Academic Research Consortium-2 device success was similar between both groups (Sapien 3=85.7% versus Evolut R/Pro=84.4%; P=0.821). Both in the overall and in the matched population, no differences in the rate of permanent pacemaker implant were observed. At 1-year follow-up, the rate of overall death and cardiovascular death were similar between the 2 groups. In the unmatched population, the 1-year echocardiographic follow-up demonstrated similar rate of moderate-to-severe paravalvular aortic regurgitation (Evolut R/PRO 10.5% versus Sapien 3 4.2%, P=0.077); however, after propensity matching, the rate of moderate-to-severe paravalvular leak became significantly higher among patients treated with self-expandable valves (9.3% versus 0%; P=0.043). Conclusions: Our study confirms the feasibility of both Sapien 3 and Evolut R/PRO implantation in bicuspid aortic valve anatomy; a higher rate of moderate-severe paravalvular aortic regurgitation was observed in the Evolut R/PRO group at 1-year follow-up in the matched cohort, although patients treated with balloon-expandable valve had a higher rate of annular rupture.

Original languageEnglish (US)
Article numbere008714
JournalCirculation: Cardiovascular Interventions
Volume13
Issue number7
DOIs
StatePublished - Jul 1 2020

Keywords

  • aortic valve
  • bicuspid valve
  • pacemaker
  • propensity score
  • surgeons
  • transcatheter aortic valve replacement

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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