Transcatheter Aortic Valve Replacement Using a Self-Expanding Bioprosthesis in Patients With Severe Aortic Stenosis at Extreme Risk for Surgery

被引：837

作者：

Popma, Jeffrey J. ^{[1
]}

Adams, David H. ^{[2
]}

Reardon, Michael J. ^{[3
]}

Yakubov, Steven J. ^{[4
]}

Kleiman, Neal S. ^{[3
]}

Heimansohn, David ^{[5
]}

Hermiller, James, Jr. ^{[5
]}

Hughes, G. Chad ^{[6
]}

Harrison, J. Kevin ^{[6
]}

Coselli, Joseph ^{[7
]}

Diez, Jose ^{[7
]}

Kafi, Ali ^{[8
]}

Schreiber, Theodore ^{[8
]}

Gleason, Thomas G. ^{[3
,9
]}

Conte, John ^{[3
,10
]}

Buchbinder, Maurice ^{[11
]}

Deeb, G. Michael ^{[12
]}

Carabello, Blase ^{[13
]}

Serruys, Patrick W. ^{[14
]}

Chenoweth, Sharla ^{[15
]}

Oh, Jae K. ^{[16
]}

机构：

[1] Beth Israel Deaconess Med Ctr, Boston, MA 02215 USA

[2] Mt Sinai Med Ctr, New York, NY 10029 USA

[3] Houston Methodist Debakey Heart & Vasc Ctr, Houston, TX USA

[4] Riverside Methodist Hosp, Columbus, OH 43214 USA

[5] St Vincents Med Ctr, Indianapolis, IN USA

[6] Duke Univ, Med Ctr, Durham, NC USA

[7] Texas Heart Inst, St Lukes Med Ctr, Houston, TX 77025 USA

[8] Detroit Med Ctr, Detroit, MI USA

[9] Univ Pittsburgh, Med Ctr, Pittsburgh, PA USA

[10] Johns Hopkins Med Ctr, Baltimore, MD USA

[11] Palo Alto Vet Adm Med Ctr, Palo Alto, CA USA

[12] Univ Michigan, Med Ctr, Ann Arbor, MI USA

[13] Baylor Coll Med, Houston, TX 77030 USA

[14] Erasmus Univ, Ctr Thorax, NL-3000 DR Rotterdam, Netherlands

[15] Medtronic Inc, Minneapolis, MN USA

[16] Mayo Clin Fdn, Rochester, MN USA

来源：

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY | 2014年 / 63卷 / 19期

关键词：

aortic stenosis; transcatheter aortic valve replacement; outcomes; PERMANENT PACEMAKER; CONDUCTION ABNORMALITIES; ELDERLY-PATIENTS; IMPLANTATION; OUTCOMES; BALLOON; VALVULOPLASTY; IMPACT; REQUIREMENTS; METAANALYSIS;

D O I：

10.1016/j.jacc.2014.02.556

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Objectives This study sought to evaluate the safety and efficacy of the CoreValve transcatheter heart valve (THV) for the treatment of severe aortic stenosis in patients at extreme risk for surgery. Background Untreated severe aortic stenosis is a progressive disease with a poor prognosis. Transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis is a potentially effective therapy. Methods We performed a prospective, multicenter, nonrandomized investigation evaluating the safety and efficacy of self-expanding TAVR in patients with symptomatic severe aortic stenosis with prohibitive risks for surgery. The primary endpoint was a composite of all-cause mortality or major stroke at 12 months, which was compared with a pre-specified objective performance goal (OPG). Results A total of 41 sites in the United States recruited 506 patients, of whom 489 underwent attempted treatment with the CoreValve THV. The rate of all-cause mortality or major stroke at 12 months was 26.0% (upper 2-sided 95% confidence bound: 29.9%) versus 43.0% with the OPG (p < 0.0001). Individual 30-day and 12-month events included all-cause mortality (8.4% and 24.3%, respectively) and major stroke (2.3% and 4.3%, respectively). Procedural events at 30 days included life-threatening/disabling bleeding (12.7%), major vascular complications (8.2%), and need for permanent pacemaker placement (21.6%). The frequency of moderate or severe paravalvular aortic regurgitation was lower 12 months after self-expanding TAVR (4.2%) than at discharge (10.7%; p = 0.004 for paired analysis). Conclusions TAVR with a self-expanding bioprosthesis was safe and effective in patients with symptomatic severe aortic stenosis at prohibitive risk for surgical valve replacement. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902) (C) 2014 by the American College of Cardiology Foundation

引用

页码：1972 / 1981

页数：10

共 40 条

[1] Gait Speed as an Incremental Predictor of Mortality and Major Morbidity in Elderly Patients Undergoing Cardiac Surgery [J].

Afilalo, Jonathan ;

Eisenberg, Mark J. ;

Morin, Jean-Francois ;

Bergman, Howard ;

Monette, Johanne ;

Noiseux, Nicolas ;

Perrault, Louis P. ;

Alexander, Karen P. ;

Langlois, Yves ;

Dendukuri, Nandini ;

Chamoun, Patrick ;

Kasparian, Georges ;

Robichaud, Sophie ;

Gharacholou, S. Michael ;

Boivin, Jean-Francois .

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2010, 56 (20) :1668-1676

[2] Results of repeat balloon valvuloplasty for treatment of aortic stenosis in patients aged 59 to 104 years [J].

Agarwal, A ;

Kini, AS ;

Attanti, A ;

Lee, PC ;

Ashtiani, R ;

Steinheimer, AM ;

Moreno, PR ;

Sharma, SK .

AMERICAN JOURNAL OF CARDIOLOGY, 2005, 95 (01) :43-47

[3]

American College of Cardiology, 2006, J Am Coll Cardiol, V48, pe1, DOI 10.1016/j.jacc.2006.05.021

[4] Incidence, Predictors, and Outcomes of Aortic Regurgitation After Transcatheter Aortic Valve Replacement Meta-Analysis and Systematic Review of Literature [J].

Athappan, Ganesh ;

Patvardhan, Eshan ;

Tuzcu, E. Murat ;

Svensson, Lars Georg ;

Lemos, Pedro A. ;

Fraccaro, Chiara ;

Tarantini, Giuseppe ;

Sinning, Jan-Malte ;

Nickenig, Georg ;

Capodanno, Davide ;

Tamburino, Corrado ;

Latib, Azeem ;

Colombo, Antonio ;

Kapadia, Samir R. .

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2013, 61 (15) :1585-1595

[5] The Impact of Integration of a Multidetector Computed Tomography Annulus Area Sizing Algorithm on Outcomes of Transcatheter Aortic Valve Replacement A Prospective, Multicenter, Controlled Trial [J].

Binder, Ronald K. ;

Webb, John G. ;

Willson, Alexander B. ;

Urena, Marina ;

Hansson, Nicolaj C. ;

Norgaard, Bjarne L. ;

Pibarot, Philippe ;

Barbanti, Marco ;

Larose, Eric ;

Freeman, Melanie ;

Dumont, Eric ;

Thompson, Chris ;

Wheeler, Miriam ;

Moss, Robert R. ;

Yang, Tae-hyun ;

Pasian, Sergio ;

Hague, Cameron J. ;

Giang Nguyen ;

Raju, Rekha ;

Toggweiler, Stefan ;

Min, James K. ;

Wood, David A. ;

Rodes-Cabau, Josep ;

Leipsic, Jonathon .

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2013, 62 (05) :431-438

[6]

Bohannon Richard W, 2007, J Geriatr Phys Ther, V30, P28

[7] Impact of Permanent Pacemaker Implantation on Clinical Outcome Among Patients Undergoing Transcatheter Aortic Valve Implantation [J].

Buellesfeld, Lutz ;

Stortecky, Stefan ;

Heg, Dik ;

Hausen, Sven ;

Mueller, Ralf ;

Wenaweser, Peter ;

Pilgrim, Thomas ;

Gloekler, Steffen ;

Khattab, Ahmed A. ;

Huber, Christoph ;

Carrel, Thierry ;

Eberle, Balthasar ;

Meier, Bernhard ;

Boekstegers, Peter ;

Jueni, Peter ;

Gerckens, Ulrich ;

Grube, Eberhard ;

Windecker, Stephan .

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2012, 60 (06) :493-501

[8] 2-Year Follow-Up of Patients Undergoing Transcatheter Aortic Valve Implantation Using a Self-Expanding Valve Prosthesis [J].

Buellesfeld, Lutz ;

Gerckens, Ulrich ;

Schuler, Gerhard ;

Bonan, Raoul ;

Kovac, Jan ;

Serruys, Patrick W. ;

Labinaz, Marino ;

den Heijer, Peter ;

Mullen, Michael ;

Tymchak, Wayne ;

Windecker, Stephan ;

Mueller, Ralf ;

Grube, Eberhard .

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2011, 57 (16) :1650-1657

[9] Aortic stenosis [J].

Carabello, Blase A. ;

Paulus, Walter J. .

LANCET, 2009, 373 (9667) :956-966

[10] A NEW METHOD OF CLASSIFYING PROGNOSTIC CO-MORBIDITY IN LONGITUDINAL-STUDIES - DEVELOPMENT AND VALIDATION [J].

CHARLSON, ME ;

POMPEI, P ;

ALES, KL ;

MACKENZIE, CR .

JOURNAL OF CHRONIC DISEASES, 1987, 40 (05) :373-383

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