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

被引：56

作者：

Mangieri, Antonio ^{[1
,2
]}

Tchetche, Didier ^{[3
]}

Kim, Won-Keun ^{[4
]}

Pagnesi, Matteo ^{[2
]}

Sinning, Jean-Malte ^{[5
]}

Landes, Uri ^{[6
]}

Kornowski, Ran ^{[6
]}

De Backer, Ole ^{[7
]}

Nickenig, Georg ^{[5
]}

Ielasi, Alfonso ^{[8
]}

De Biase, Chiara ^{[3
]}

Sondergaard, Lars ^{[7
]}

De Marco, Federico ^{[9
]}

Montorfano, Matteo ^{[2
]}

Chiarito, Mauro ^{[10
]}

Regazzoli, Damiano ^{[10
]}

Stefanini, Giulio ^{[10
]}

Presbitero, Patrizia ^{[10
]}

Toggweiler, Stefan ^{[11
]}

Tamburino, Corrado ^{[12
]}

Imme, Sebastiano ^{[13
]}

Tarantini, Giuseppe ^{[14
]}

Sievert, Horst ^{[15
,16
]}

Schaefer, Ulrich ^{[17
]}

Kempfert, Joerg ^{[18
]}

Woeehrle, Jochen ^{[19
]}

Gallo, Francesco ^{[1
]}

Laricchia, Alessandra ^{[1
]}

Latib, Azeem ^{[20
]}

Giannini, Francesco ^{[1
]}

Colombo, Antonio ^{[1
,21
]}

机构：

[1] Maria Cecilia Hosp, GVM Care & Res, Cotignola, Ravenna, Italy

[2] Ist Sci San Raffaele, Milan, Italy

[3] Clin Pasteur, Grp Cardiovasc Intervent, Toulouse, France

[4] Kerckhoff Heart Ctr, Dept Cardiol, Bad Nauheim, Germany

[5] Univ Hosp Bonn, Dept Cardiol, Bonn, Germany

[6] Rabin Med Ctr, Dept Cardiol, Petah Tiqwa, Israel

[7] Rigshosp, Heart Ctr, Copenhagen, Denmark

[8] Ist Clin St Ambrogio, Milan, Italy

[9] Ist Clin San Donato, Dept Cardiol, Milan, Italy

[10] Humanitas Univ, Dept Biomed Sci, Milan, Italy

[11] Luzerner Kantonsspital, Heart Ctr Lucerne, Luzern, Switzerland

[12] Univ Catania, Div Cardiol, CAST Policlin Hosp, Catania, Italy

[13] Ctr Cuore Morgagni, Catania, Italy

[14] Univ Padua, Intervent Cardiol Unit, Padua, Italy

[15] Cardiovasc Ctr, Frankfurt, Germany

[16] Anglia Ruskin Univ, Chelmsford, England

[17] UKE, Hamburg, Germany

[18] Charite, Deutsch Herzzentrum Berlin, Berlin, Germany

[19] Ulm Univ, Ulm, Germany

[20] Montefiore Med Ctr, Dept Cardiol, New York, NY USA

[21] GVM Care & Res, Ctr Cuore Columbus, Milan, Italy

来源：

CIRCULATION-CARDIOVASCULAR INTERVENTIONS | 2020年 / 13卷 / 07期

关键词：

aortic valve; bicuspid valve; pacemaker; propensity score; surgeons; transcatheter aortic valve replacement; EARLY OUTCOMES; EVOLUT PRO; TRANSCATHETER; REPLACEMENT; IMPLANTATION; GENERATION; SYSTEM;

D O I：

10.1161/CIRCINTERVENTIONS.119.008714

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.

引用

页数：11

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