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Rigshospitalet - en del af Københavns Universitetshospital
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Balloon Versus Self-Expandable Valve for the Treatment of Bicuspid Aortic Valve Stenosis: Insights From the BEAT International Collaborative Registrys

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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  • 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 Tamburino
  • Sebastiano Immè
  • Giuseppe Tarantini
  • Horst Sievert
  • Ulrich Schäfer
  • Jörg Kempfert
  • Jochen Wöehrle
  • Francesco Gallo
  • Alessandra Laricchia
  • Azeem Latib
  • Francesco Giannini
  • Antonio Colombo
Vis graf over relationer

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.

OriginalsprogEngelsk
TidsskriftCirculation. Cardiovascular interventions
Vol/bind13
Udgave nummer7
Sider (fra-til)e008714
ISSN1941-7640
DOI
StatusUdgivet - jul. 2020

ID: 62241750