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J Am Coll Cardiol. 2014 May 20;63(19):1972-81. doi: 10.1016/j.jacc.2014.02.556. Epub 2014 Mar 19.

Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery.

Collaborators (430)

Kleiman NS, Reardon M, Ramchandani M, Lawrie G, Brinegar P, Arredondo J, Joseph J, Green L, Hermiller J, Heimansohn D, Ball M, Hall J, Elsner G, Walts P, Hanan S, Robison R, Salerno C, Burkert L, Powell P, Gall J, Gallagher S, Harrison J, Hughes G, Wang A, Glower D, Vavalle J, Halim S, Yang J, Swisher C, Pierce C, Cowhig D, Arthur M, Wootton S, Kato N, Gilchrist J, Diez J, Coselli J, Ott D, Gregoric I, Cohn W, Jafar M, Dean J, Parenti J, Jones S, Orsi S, Williamson D, Schreiber T, Kafi A, Choksi N, Munir A, Dabir R, Carl H, Huang H, Aurakzai H, Kreydi G, Byrne T, Caskey M, Pershad A, Loli A, Brady K, Fang K, Payne J, Franz D, Tkach A, Hollabaugh J, Kishimoto I, Yakubov S, Watson D, Kander N, Blossom G, Duff S, George B, Robb G, Popelas L, Hunter K, Engle C, Terry T, Paul B, Hartley C, Tadros P, Zorn G, Wiley M, Muehlebach G, Page S, Karson J, Sharma S, Adams DH, Kini A, Dangas G, Anyanwu A, Stelzer P, Fusilero M, Bhat A, Vallabhajosyula K, Bajwa T, O'Hair D, Allaqaband S, Werner P, Schmidt W, Waller D, Seaton D, de Marchena E, Salerno T, Ferreira A, Moscucci M, Alfonso C, Martinez-Clark P, Panos A, Marin y Kall C, Marincic Sanchez X, Querales E, Atapattu S, Popma JJ, Khabbaz K, Laham R, Burke D, Pinto D, Liu D, Senthilnathan V, Kaufman J, Guibone K, Tjoa V, Chen M, Skelding K, Casale A, Singh D, Carter R, Stewart B, Grana V, Stella J, Long D, Reddy C, Temple A, Scalzo L, Burgess B, Chetcuti S, Deeb G, Grossman M, Patel H, Romano M, LaBounty T, Migda E, Allen A, Diener A, Clair KS, Ranella M, DeBenedictus C, Nulty P, Rohlf M, Petrossian G, Robinson N, Berke A, Colangelo R, Stevens P, Haag E, Santiago L, McLaughlin J, Sands M, Katz M, Costa M, Markowitz A, Simon D, Boova R, Geraghty M, Mazzurco S, Davis A, Gorbey D, Hricik M, Panchik N, Melis A, Ward D, Ring M, Siwek L, Reynolds B, Batkoff B, Crawford K, Merhi W, Heiser J, Patzelt L, Van Over B, Postema K, Cannestra J, Moelker T, Dutkiewicz A, Helm E, Lee JS, Gleason TG, Anderson W, Henry L, Navid F, Knollmann F, Lacomis J, Deible C, Schindler J, Jadhav A, Enlow M, Baxendell L, Valchar K, Matthews R, Starnes V, Shavelle D, Cunningham M, Sanossian N, Lopez B, Bart C, Stoler R, Hebeler R, Graybum P, Hamman B, Henry C, Labile E, Waters K, Wilcott L, Rajagopal V, Kauten J, Karmpaliotis D, Gott J, Dean D, Rinehart S, Holt S, Amoroso E, Picardi K, Daugherty J, Cadic N, Kipperman R, Brown J, Cohen B, Magovern C, Slater J, Xydas S, Rosenberg R, Ciprich C, Benner A, Maini B, Mumtaz M, Bachinsky W, Martella A, Todd A, Rice Hollister R, Cheatham J, Crestanello J, Mazzaffarri E Jr, Firstenberg M, Sai-Sudhakar C, Jones D, Liptrot R, Applegate R, Kon N, Gandhi S, Kincaid E, White W, Young T, O'Donnell L, Heller L, Macheers S, Lieppe W, Reingold J, Frohwein S, King S, Langford D, Snyder A, Campbell R, Mathewson S, Skrifvars C, Leya F, Bakhos M, Lewis B, Dieter R, Tuchek JM, Schwartz J, Kartji C, Del Priore J, Klein W, Sawicki K, Kliger C, Fontana G, Subramanian V, Cohen H, Patel N, Ruiz C, Bonomo R, Plestis K, Manapat A, Joye J, Gaudiani V, Vial C, Rammohan C, DeBettenCourt B, Hebig A, Ruiz M, Sumner R, Resar J, Conte J, Shah A, Brinker J, Beohar N, Marsh E, Citro K, Herr M, Lamelas J, Londoño JC, Nascimento F, Pineda A, Valdez G, Chandra R, Povegliano L, Acevedo B, Garcia H, Mon A, Perez K, Aharonian V, Pfeffer T, Browning R, Ad N, Hall C, Blake M, Keyte S, Mansukhani P, Yun K, Tolentino J, Mejia P, Raybuck B, Speir A, Neblett P, Katz S, Banks S, Hartman A, Rutkin B, Esposito R, Dellilune D, Scorcia Y, Thompson C, Elefteriades J, Forrest J, Cleman M, Sugeng L, Yun D, Lansky A, Geirsson A, Hashim S, Levesque L, Shaddinger D, McCarthy M, Chawla A, Hockmuth D, Iannone L, Marcus R, Jensen B, Klein M, Verhofste MA, Barnes H, Gaulke P, Prouty D, Evans D, Bloom E, Waksman R, Bafi A, Satler L, Lowery R, Kent K, Deville M, Hemantha D, Griffin S, Okubagzi P, Hendrix C, Slater J, Galloway A, Attubato M, Jacobs J, Grossi E, Siller K, Loulmet D, McElhinney D, Yung CL, Fail P, Feinberg E 2nd, Abben R, Dearman R, Allam M, Tedesco V 4th, Robert M, Benoit DK, Arceneaux K, Parfait V, Montero S, Aucoin J, Dauerman H, Schmoker J, Terrien E, Coyle D, Ittleman F, Gorman M, Commichau C, Worgan B, Straight F, Henderson A, McKay R, Underhill D, Hagberg R, Fuhrman J, Kiernan F, Sadiq I, Mendes B, Cloutier J, Davis T, Jaconson T, Morin R, Robbins R, Batra S, Yamasaki H, Martin J, Bess R, Campau C, Giacomini J, Buchbinder M, Fann J, Burdon T, Baer J, Zhao D, Ball S, Byrne J, Robbins M, Fredi J, Crenshaw M, Blair-Anton L, Watts C, Haynes ML, Kirshner N, O'Duffy A, Hermann L.

Author information

1
Beth Israel Deaconess Medical Center, Boston, Massachusetts. Electronic address: jpopma@bidmc.harvard.edu.
2
Mount Sinai Medical Center, New York, New York.
3
Houston-Methodist-Debakey Heart and Vascular Center, Houston, Texas.
4
Riverside Methodist Hospital, Columbus, Ohio.
5
St. Vincent's Medical Center, Indianapolis, Indiana.
6
Duke University Medical Center, Durham, North Carolina.
7
Texas Heart Institute at St. Luke's Medical Center, Houston, Texas.
8
Detroit Medical Center, Detroit, Michigan.
9
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
10
Johns Hopkins Medical Center, Baltimore, Maryland.
11
Palo Alto Veterans Administration Medical Center, Palo Alto, California.
12
University of Michigan Medical Center, Ann Arbor, Michigan.
13
Baylor College of Medicine, Houston Texas.
14
Thoraxcenter, Rotterdam, the Netherlands.
15
Medtronic, Inc., Minneapolis, Minnesota.
16
Mayo Clinic Foundation, Rochester, Minnesota.

Abstract

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).

KEYWORDS:

aortic stenosis; outcomes; transcatheter aortic valve replacement

PMID:
24657695
DOI:
10.1016/j.jacc.2014.02.556
[Indexed for MEDLINE]
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