TY - JOUR

T1 - Balloon Versus Self-Expandable Valve for the Treatment of Bicuspid Aortic Valve Stenosis

T2 - Insights From the BEAT International Collaborative Registrys

AU - Mangieri, Antonio

AU - Tchetchè, Didier

AU - Kim, Won-Keun

AU - Pagnesi, Matteo

AU - Sinning, Jean-Malte

AU - Landes, Uri

AU - Kornowski, Ran

AU - De Backer, Ole

AU - Nickenig, Georg

AU - Ielasi, Alfonso

AU - De Biase, Chiara

AU - Søndergaard, Lars

AU - De Marco, Federico

AU - Montorfano, Matteo

AU - Chiarito, Mauro

AU - Regazzoli, Damiano

AU - Stefanini, Giulio

AU - Presbitero, Patrizia

AU - Toggweiler, Stefan

AU - Tamburino, Corrado

AU - Immè, Sebastiano

AU - Tarantini, Giuseppe

AU - Sievert, Horst

AU - Schäfer, Ulrich

AU - Kempfert, Jörg

AU - Wöehrle, Jochen

AU - Gallo, Francesco

AU - Laricchia, Alessandra

AU - Latib, Azeem

AU - Giannini, Francesco

AU - Colombo, Antonio

PY - 2020

Y1 - 2020

N2 - 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.

AB - 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.

U2 - 10.1161/CIRCINTERVENTIONS.119.008714

DO - 10.1161/CIRCINTERVENTIONS.119.008714

M3 - Journal article

C2 - 32646304

VL - 13

JO - Circulation: Cardiovascular Interventions

JF - Circulation: Cardiovascular Interventions

SN - 1941-7640

IS - 7

M1 - e008714

ER -