Patients included in this analysis were part of the Placement of Aortic Transcatheter Valves trial, a multicenter, randomized trial comparing transcatheter aortic-valve implantation (TAVI) with standard care in high-risk severe aortic stenosis patients. TAVI is a relatively new procedure involving insertion of a bioprosthetic valve through a catheter for implantation in the diseased aortic valve.

The cohort included those considered unsuitable for surgery because of complicating coexisting conditions that increase their likelihood of dying or, in some cases, developing a serious irreversible condition. The 358 patients were randomly assigned to undergo TAVI or receive standard treatment. A total of 179 patients were assigned to undergo TAVI; 173 did so. Within 30 days after receiving TAVI, 11 patients died. Of the 179 patients in the standard-therapy group, 150 received balloon aortic vavuloplasty, 12 received aortic-valve replacement, five received a conduit from the left ventricular apex to the descending aorta plus aortic-valve replacement, and four received TAVI (surgery was performed despite patients having been deemed unsuitable for surgery, and the four TAVI procedures were done at a nonparticipating site).

At one year, the rate of death from all causes was lower in the TAVI group than in the standard-therapy group (31% versus 51%, respectively), as were the rate of death from cardiovascular causes (21% versus 45%, respectively) and the percentage of repeated hospitalizations (22% versus 44%, respectively). TAVI significantly reduced cardiac symptoms: 75% in the TAVI group were asymptomatic or had mild symptoms at one year, compared with 42% in the standard-therapy group. However, TAVI was associated with more neurologic events (such as strokes) and often resulted in mild paravalvular regurgitation. Although the authors recommend additional research into the frequency of strokes after TAVI, they also conclude that TAVI should be the standard of care in patients with aortic stenosis who are unable to undergo surgery.

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