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

A. Mangieri, D. Tchetchè, W.-K. Kim, M. Pagnesi, J.-M. Sinning, U. Landes, R. Kornowski, O. De Backer, G. Nickenig, A. Ielasi, C. De Biase, L. Søndergaard, F. De Marco, M. Montorfano, M. Chiarito, D. Regazzoli, G. Stefanini, P. Presbitero, S. Toggweiler, C. TamburinoS. Immè, G. Tarantini, H. Sievert, U. Schäfer, J. Kempfert, J. Wöehrle, F. Gallo, A. Laricchia, A. Latib, F. Giannini, A. Colombo

Research output: Contribution to journalArticlepeer-review

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. © 2020 Lippincott Williams and Wilkins. All rights reserved.
Original languageEnglish
JournalCirc. Cardiovasc. Interventions
Volume13
Issue number7
DOIs
Publication statusPublished - 2020

Keywords

  • aortic valve
  • bicuspid valve
  • pacemaker
  • propensity score
  • surgeons
  • transcatheter aortic valve replacement
  • aged
  • annular rupture
  • aortic regurgitation
  • aortic valve stenosis
  • Article
  • bicuspid aortic valve
  • cardiovascular mortality
  • clinical outcome
  • cohort analysis
  • comparative effectiveness
  • conversion to open surgery
  • device safety
  • echocardiography
  • female
  • human
  • major clinical study
  • male
  • multidetector computed tomography
  • paravalvular leak
  • priority journal
  • transcatheter aortic valve implantation
  • valvular heart disease

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