Safety Profile of an Intra-Annular Self-Expanding Transcatheter Aortic Valve and Next-Generation Low-Profile Delivery System

被引：29

作者：

Fontana, Gregory P. ^{[1
]}

Bedogni, Francesco ^{[2
]}

Groh, Mark ^{[3
]}

Smith, David ^{[4
]}

Chehab, Bassem M. ^{[5
]}

Garrett, H. Edward ^{[6
]}

Yong, Gerald ^{[7
]}

Worthley, Stephen ^{[8
,9
]}

Manoharan, Ganesh ^{[10
]}

Walton, Antony ^{[11
]}

Hermiller, James ^{[12
]}

Dhar, Gaurav ^{[13
]}

Waksman, Ron ^{[14
]}

Ramana, Ravi K. ^{[15
,16
]}

Mahoney, Paul ^{[17
]}

Asch, Federico M. ^{[18
]}

Chakravarty, Tarun ^{[19
]}

Jilaihawi, Hasan ^{[20
]}

Makkar, Raj R. ^{[19
]}

机构：

[1] Los Robles Reg Med Ctr, Cardiovasc Inst, Thousand Oaks, CA 91360 USA

[2] IRCCS Policlin San Donato, Milan, Italy

[3] Mission Hlth & Hosp, Asheville, NC USA

[4] Morriston Hosp, Swansea Bay Univ Hlth Board, Swansea, W Glam, Wales

[5] Univ Kansas, Ascens Via Christi Hosp, Wichita, KS USA

[6] Univ Tennessee, Dept Surg, Memphis, TN USA

[7] Fiona Stanley Hosp, Murdoch, WA, Australia

[8] Royal Adelaide Hosp, Adelaide, SA, Australia

[9] Genesis Care, Sydney, NSW, Australia

[10] Royal Victoria Hosp, Belfast, Antrim, North Ireland

[11] Alfred Hosp, Melbourne, Vic, Australia

[12] St Vincent Heart Ctr, Indianapolis, IN USA

[13] Sparrow Clin Res Inst, Lansing, MI USA

[14] Medstar Washington Hosp Ctr, Sect Intervent Cardiol, Washington, DC USA

[15] Advocate Christ Med Ctr, Oak Lawn, IL USA

[16] Heart Care Ctr Illinois, Palos Pk, IL USA

[17] Sentara Norfolk Gen Hosp, Norfolk, VA USA

[18] MedStar Hlth Res Inst, Washington, DC USA

[19] Cedars Sinai Med Ctr, Smidt Heart Inst, Los Angeles, CA 90048 USA

[20] NYU Langone Hlth, New York, NY USA

来源：

JACC-CARDIOVASCULAR INTERVENTIONS | 2020年 / 13卷 / 21期

关键词：

aortic stenosis; high risk; TAVR; transfemoral access; vascular complications; RISK PATIENTS; EXTREME RISK; REPLACEMENT; IMPLANTATION; STENOSIS;

D O I：

10.1016/j.jcin.2020.06.041

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

OBJECTIVES The aim of this study was to characterize the safety profile of an intra-annular self-expanding valve with a next-generation low-profile delivery system (DS). BACKGROUND Key design modifications to the FlexNav DS include the addition of a hydrophilic-coated, integrated sheath and stability layer to facilitate gradual, controlled deployment in vessels with diameter >= 5 mm. METHODS Patients were pooled from 2 concurrent prospective, multicenter, single-arm studies (FlexNav DS arm of PORTICO IDE [Portico Re-Sheathable Transcatheter Aortic Valve System U.S. IDE Trial] [n = 134] and the FlexNav EU CE Mark Study [n = 46]) for the analysis. The primary endpoint was Valve Academic Research Consortium-2-defined major vascular complications at 30 days. Clinical outcomes and valve performance were assessed through 30 days by an independent clinical events committee and an echocardiography core laboratory, respectively. RESULTS One hundred forty high-risk and 40 extreme-risk subjects enrolled between October 15, 2018, and December 10, 2019, from 28 sites in the United States, Australia, and Europe who underwent attempted transfemoral Portico valve implantation were included. The mean age was 85.1 +/- 5.6 years, 60% were women, the mean Society of Thoracic Surgeons score was 5.3%, and 96.1% presented with >= 1 frailty factor. Technical device success was 96.7%. At 30 days, the rate of major vascular complications was 5.0%, with 4.4% of complications adjudicated as access site-related (3.3% transcatheter aortic valve replacement DS access site-related). Death (0.6%) and disabling stroke (1.1%) were rare. The rate of new permanent pacemaker implantation was 15.4%. Echocardiography revealed a mean gradient of 7.1 +/- 3.2 mm Hg, mean valve area of 1.77 +/- 0.41 cm(2), and a 4.1% rate of moderate paravalvular leak at 30 days. CONCLUSIONS Portico valve implantation with the FlexNav DS was associated with an excellent safety profile at 30 days. (C) 2020 Published by Elsevier on behalf of the American College of Cardiology Foundation.

引用

页码：2467 / 2478

页数：12

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