Transcatheter Aortic Valve Replacement With Intra-Annular Self-Expanding or Balloon-Expandable Valves The Multicenter International NAVULTRA Registry

被引：1

作者：

Cannata, Stefano ^{[1
,2
]}

Sultan, Ibrahim ^{[3
,4
]}

Van Mieghem, Nicolas ^{[5
]}

Giordano, Arturo ^{[6
]}

De Backer, Ole ^{[7
,8
]}

Byrne, Johnathan ^{[9
]}

Tchetche, Didier ^{[10
]}

Buccheri, Sergio ^{[11
,12
]}

Nombela-Franco, Luis ^{[13
]}

Teles, Rui Campante ^{[14
]}

Barbanti, Marco ^{[15
]}

Barbato, Emanuele ^{[16
]}

Santos, Ignacio Amat ^{[17
,18
]}

Blackman, Daniel J. ^{[19
]}

Maisano, Francesco ^{[20
]}

Lorusso, Roberto ^{[2
,21
]}

La Spina, Ketty

Millin, Antonella ^{[22
]}

Kliner, Dustin E. ^{[3
,4
]}

van den Dorpel, Mark ^{[5
]}

Acerbi, Elena ^{[23
]}

Lulic, Davorka

Divekar, Kaivalya

Cesario, Vincenzo

Solsol, Jorge Francisco Chavez

Brito, Joao ^{[14
]}

Costa, Giuliano ^{[24
]}

Casenghi, Matteo

Cordon, Clara Fernandez

Sherwen, Amanda

Buzzatti, Nicola

Pasta, Salvatore ^{[1
,25
]}

Turrisi, Marco ^{[1
]}

Minacori, Michele ^{[1
]}

Manca, Paolo ^{[1
]}

Nuzzi, Vincenzo ^{[1
]}

Tamburino, Corrado ^{[26
]}

Bedogni, Francesco ^{[23
]}

Gandolfo, Caterina ^{[1
]}

Latib, Azeem ^{[22
]}

机构：

[1] IRCCS ISMETT Mediterranean Inst Transplantat & Adv, Dept Cardiothorac Surg, Unit Intervent Cardiol, Palermo, Italy

[2] Cardiovasc Res Inst Maastricht, Maastricht, Netherlands

[3] Univ Pittsburgh, Dept Cardiothorac Surg, Pittsburgh, PA USA

[4] Univ Pittsburgh, UPMC Heart & Vasc Inst, Med Ctr, Pittsburgh, PA USA

[5] Erasmus MC, Dept Cardiol, Thoraxctr, Rotterdam, Netherlands

[6] Pineta Grande Hosp, Invas Cardiol Unit, Castel Volturno, Caserta, Italy

[7] Copenhagen Univ Hosp, Dept Cardiol, Rigshosp, Copenhagen, Denmark

[8] Univ Copenhagen, Dept Clin Med, Copenhagen, Denmark

[9] Kings Coll Hosp NHS Fdn Trust, London, England

[10] Clin Pasteur, Dept Cardiol, Toulouse, France

[11] Uppsala Univ Hosp, Dept Med Sci, Uppsala, Sweden

[12] Uppsala Univ Hosp, Uppsala Clin Res Ctr, Uppsala, Sweden

[13] Hosp Clin San Carlos, Cardiovasc Inst, Inst Invest Sanitaria San Carlos, Madrid, Spain

[14] Ctr Hosp Lisboa Ocidental, Hosp Santa Cruz, Carnaxide & Comprehens Hlth Res Ctr, NOVA Med Sch, Lisbon, Portugal

[15] Univ Enna Kore, Enna, Italy

[16] Sapienza Univ, Dept Clin & Mol Med, Rome, Italy

[17] Inst Salud Carlos III, Ctr Invest Biomed Red Enfermedades Cardiovasc, Madrid, Spain

[18] Hosp Clin Univ Valladolid, Valladolid, Spain

[19] Leeds Teaching Hosp NHS Trust, Dept Cardiol, Leeds, England

[20] Ist Sci San Raffaele, Div Cardiac Surg, Milan, Italy

[21] Maastricht Univ Med, Heart & Vasc Ctr, Cardiothorac Surg Dept, Maastricht, Netherlands

[22] Montefiore Med Ctr, Albert Einstein Coll Med, Montefiore Einstein Ctr Heart & Vasc Care, Bronx, NY USA

[23] Ist Ricovero & Cura Carattere Sci Policlin San Don, Div Cardiol, San Donato Milanese, Italy

[24] AOU Policlin G Rodol San Marco, Div Cardiol, Catania, Italy

[25] Univ Palermo, Palermo, Italy

[26] Ctr Cuore Morgagni, Div Cardiol, Catania, Italy

来源：

JACC-CARDIOVASCULAR INTERVENTIONS | 2025年 / 18卷 / 12期

关键词：

intra-annular; Navitor; SAPIEN; 3; Ultra; TAVR; PARAVALVULAR REGURGITATION; OUTCOMES; IMPLANTATION; IMPACT;

D O I：

10.1016/j.jcin.2025.03.015

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

BACKGROUND No comparative data exist with the self-expanding Navitor (NAV) and the balloon-expandable SAPIEN 3 Ultra (ULTRA) transcatheter heart valves (THVs). OBJECTIVES This study sought to investigate the 1-year outcomes of transcatheter aortic valve replacement using the intra-annular NAV and the ULTRA THVs. METHODS The NAVULTRA (Navitor and SAPIEN 3 Ultra) registry included consecutive patients who underwent trans-femoral transcatheter aortic valve replacement at 16 centers with NAV or ULTRA between November 2018 and April 2024. Propensity score matching was used for adjustment. The primary outcomes of interest were all-cause death and the composite of all-cause death, disabling stroke, and hospitalization for heart failure at 1 year. RESULTS The overall study cohort included 3,878 patients treated with NAV (n = 1,746) or ULTRA (n = 2,176). The propensity score-matched population resulted in 1,363 pairs. At 1 year, the rate of death from any cause was 9.7% with NAV and 9.9% with ULTRA (adjusted P = 0.585). Similarly, there were no significant differences in primary composite outcome (13.6% in the NAV group and 12.6% in the ULTRA group; adjusted P = 0.218). The rate of new permanent pacemaker implantation (20.6% vs 10.6%; adjusted P < 0.01) and heart failure rehospitalization (4.6% vs 2.8%; adjusted P < 0.05) was higher in NAV group. At 1 year, the use of NAV was associated with higher rates of mild paravalvular leak (OR: 1.53; 95% CI: 1.01 to 2.33; adjusted P <0.05) but lower mean transprosthetic gradients compared with ULTRA (mean change:-3.90, 95% CI:-4.47 to-3.34; adjusted P < 0.01). CONCLUSIONS Both intra-annular THVs were associated with similar 1-year clinical outcomes; however, differences were observed in secondary clinical endpoints and valve hemodynamic performance. (JACC Cardiovasc Interv. 2025;18:1557-1568) (c) 2025 by the American College of Cardiology Foundation.

引用

页码：1557 / 1568

页数：12

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