Long-Term Outcomes of Inoperable Patients With Aortic Stenosis Randomly Assigned to Transcatheter Aortic Valve Replacement or Standard Therapy

被引：133

作者：

Kapadia, Samir R. ^{[1
]}

Tuzcu, E. Murat ^{[1
]}

Makkar, Raj R. ^{[2
]}

Svensson, Lars G. ^{[1
]}

Agarwal, Shikhar ^{[1
]}

Kodali, Susheel ^{[3
]}

Fontana, Gregory P. ^{[4
]}

Webb, John G. ^{[5
]}

Mack, Michael ^{[6
]}

Thourani, Vinod H. ^{[7
]}

Babaliaros, Vasilis C. ^{[7
]}

Herrmann, Howard C. ^{[8
]}

Szeto, Wilson ^{[8
]}

Pichard, Augusto D. ^{[9
]}

Williams, Mathew R. ^{[3
]}

Anderson, William N. ^{[10
]}

Akin, Jodi J. ^{[10
]}

Miller, D. Craig ^{[11
]}

Smith, Craig R. ^{[3
]}

Leon, Martin B. ^{[3
]}

机构：

[1] Cleveland Clin Fdn, Cleveland, OH 44195 USA

[2] Cedars Sinai Med Ctr, Los Angeles, CA 90048 USA

[3] Columbia Univ, Med Ctr, New York Presbyterian Hosp, New York, NY USA

[4] Lenox Hill Hosp, New York, NY 10021 USA

[5] St Pauls Hosp, Vancouver, BC V6Z 1Y6, Canada

[6] Baylor Healthcare Syst, Plano, TX USA

[7] Emory Univ, Sch Med, Atlanta, GA USA

[8] Hosp Univ Penn, Philadelphia, PA 19104 USA

[9] Medstar Washington Hosp Ctr, Washington, DC USA

[10] Edwards Lifesci, Irvine, CA USA

[11] Stanford Univ, Stanford, CA 94305 USA

来源：

CIRCULATION | 2014年 / 130卷 / 17期

关键词：

aortic valve; aortic valve stenosis; outcome assessment (health care); HIGH-RISK PATIENTS; IMPLANTATION; EXPERIENCE; PREDICTORS; REGISTRY; SURGERY; TAVI;

D O I：

10.1161/CIRCULATIONAHA.114.009834

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Background-The long-term outcomes of transcatheter aortic valve replacement (TAVR) in inoperable patients with severe aortic stenosis remain unknown. Methods and Results-In the Placement of Aortic Transcatheter Valves (PARTNER) study, 358 patients were randomly assigned to TAVR or standard therapy. We report the 3-year outcomes on these patients, and the pooled outcomes for all randomly assigned inoperable patients (n=449) in PARTNER, as well, including the randomized portion of the continued access study (n=91). The 3-year mortality rate in the TAVR and standard therapy groups was 54.1% and 80.9%, respectively (P<0.001; hazard ratio, 0.53; 95% confidence interval, 0.41-0.68; P<0.001). In survivors, there was significant improvement in New York Heart Association functional class sustained at 3 years. The cumulative incidence of strokes at 3-year follow-up was 15.7% in TAVR patients versus 5.5% in patients undergoing standard therapy (hazard ratio, 2.81; 95% confidence interval, 1.26-6.26; P=0.012); however, the composite of death or strokes was significantly lower after TAVR versus standard therapy (57.4% versus 80.9%, P<0.001; hazard ratio, 0.60; 95% confidence interval, 0.46-0.77; P<0.001). Echocardiography showed a sustained increase in aortic valve area and decrease in transvalvular gradient after TAVR. Analysis of the 449 pooled randomly assigned patients (TAVR, n=220; standard therapy, n=229) demonstrated significant improvement in all-cause mortality and functional status during early and 3-year follow-up. The results of the pooled cohort were similar to the results obtained from the pivotal PARTNER trial. Conclusions-TAVR resulted in better survival and functional status in inoperable patients with severe aortic stenosis with durable hemodynamic benefit on long-term follow-up. However, high residual mortality, even in successfully treated TAVR patients, highlights the need for more strategic patient selection.

引用

页码：1483 / U106

页数：13