Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery.
BACKGROUND
Many patients with severe aortic stenosis and coexisting conditions are not candidates for surgical replacement of the aortic valve. Recently, transcatheter aortic-valve implantation (TAVI) has been suggested as a less invasive treatment for high-risk patients with aortic stenosis.


METHODS
We randomly assigned patients with severe aortic stenosis, whom surgeons considered not to be suitable candidates for surgery, to standard therapy (including balloon aortic valvuloplasty) or transfemoral transcatheter implantation of a balloon-expandable bovine pericardial valve. The primary end point was the rate of death from any cause.


RESULTS
A total of 358 patients with aortic stenosis who were not considered to be suitable candidates for surgery underwent randomization at 21 centers (17 in the United States). At 1 year, the rate of death from any cause (Kaplan–Meier analysis) was 30.7% with TAVI, as compared with 50.7% with standard therapy (hazard ratio with TAVI, 0.55; 95% confidence interval [CI], 0.40 to 0.74; P<0.001). The rate of the composite end point of death from any cause or repeat hospitalization was 42.5% with TAVI as compared with 71.6% with standard therapy (hazard ratio, 0.46; 95% CI, 0.35 to 0.59; P<0.001). Among survivors at 1 year, the rate of cardiac symptoms (New York Heart Association class III or IV) was lower among patients who had undergone TAVI than among those who had received standard therapy (25.2% vs. 58.0%, P<0.001). At 30 days, TAVI, as compared with standard therapy, was associated with a higher incidence of major strokes (5.0% vs. 1.1%, P=0.06) and major vascular complications (16.2% vs. 1.1%, P<0.001). In the year after TAVI, there was no deterioration in the functioning of the bioprosthetic valve, as assessed by evidence of stenosis or regurgitation on an echocardiogram.


CONCLUSIONS
In patients with severe aortic stenosis who were not suitable candidates for surgery, TAVI, as compared with standard therapy, significantly reduced the rates of death from any cause, the composite end point of death from any cause or repeat hospitalization, and cardiac symptoms, despite the higher incidence of major strokes and major vascular events. (Funded by Edwards Lifesciences; ClinicalTrials.gov number, NCT00530894.).
Leon
Martin B
MB
Columbia University Medical Center/NewYork–Presbyterian Hospital, New York, NY 10032, USA. ml2398@columbia.edu
Smith
Craig R
CR
Mack
Michael
M
Miller
D Craig
DC
Moses
Jeffrey W
JW
Svensson
Lars G
LG
Tuzcu
E Murat
EM
Webb
John G
JG
Fontana
Gregory P
GP
Makkar
Raj R
RR
Brown
David L
DL
Block
Peter C
PC
Guyton
Robert A
RA
Pichard
Augusto D
AD
Bavaria
Joseph E
JE
Herrmann
Howard C
HC
Douglas
Pamela S
PS
Petersen
John L
JL
Akin
Jodi J
JJ
Anderson
William N
WN
Wang
Duolao
D
Pocock
Stuart
S
D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000401:mortality / Q000601:surgery / Q000628:therapy*; D006328:Cardiac Catheterization; D002318:Cardiovascular Diseases / Q000401:mortality; D002404:Catheterization; D004452:Echocardiography; D005260:Female; D019918:Heart Valve Prosthesis Implantation / Q000379:methods*; D006760:Hospitalization; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D011446:Prospective Studies; D016896:Treatment Outcome