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Transcatheter Versus Surgical Aortic-Valve Replacement in High-Risk Patients
Study Questions:
What are the outcomes for the high-risk subgroup of patients in the PARTNER trial who were still candidates for surgical valve replacement and who were randomly assigned to undergo either transcatheter or surgical replacement of the aortic valve?
Methods:
At 25 centers, the investigators randomly assigned 699 high-risk patients with severe aortic stenosis to undergo either transcatheter aortic valve replacement with a balloon-expandable bovine pericardial valve (either a transfemoral or a transapical approach) or surgical replacement. The primary endpoint was death from any cause at 1 year. The primary hypothesis was that transcatheter replacement is not inferior to surgical replacement. Time-to-event analyses, based on all available follow-up data, were performed with the use of Kaplan-Meier estimates and were compared between groups with the use of the log-rank test.
Results:
The rates of death from any cause were 3.4% in the transcatheter group and 6.5% in the surgical group at 30 days (p = 0.07) and 24.2% and 26.8%, respectively, at 1 year (p = 0.44), a reduction of 2.6 percentage points in the transcatheter group (upper limit of the 95% confidence interval, 3.0 percentage points; predefined margin, 7.5 percentage points; p = 0.001 for noninferiority). The rates of major stroke were 3.8% in the transcatheter group and 2.1% in the surgical group at 30 days (p = 0.20) and 5.1% and 2.4%, respectively, at 1 year (p = 0.07). At 30 days, major vascular complications were significantly more frequent with transcatheter replacement (11.0% vs. 3.2%, p < 0.001); adverse events that were more frequent after surgical replacement included major bleeding (9.3% vs. 19.5%, p < 0.001) and new-onset atrial fibrillation (8.6% vs. 16.0%, p = 0.006). More patients undergoing transcatheter replacement had an improvement in symptoms at 30 days, but by 1 year, there was not a significant between-group difference.
Conclusions:
The authors concluded that in high-risk patients with severe aortic stenosis, transcatheter and surgical procedures for aortic valve replacement were associated with similar rates of survival at 1 year.
Perspective:
In this study, transcatheter aortic-valve implantation (TAVI) was similar to surgical replacement with respect to rates of death from any cause at 1 year among patients with aortic stenosis who were at high risk for increased operative complications and death. Clinical benefits of TAVI included significantly shorter stays in the intensive care unit and in the hospital. However, the approximate doubling in the rate of all new neurologic events (including major strokes) after TAVI, as compared with surgical replacement, remains a concern and is consistent with previous findings in the PARTNER trial. Overall, these findings indicate that TAVI is an alternative to surgical replacement in a well chosen, high-risk subgroup of patients with aortic stenosis, and recommendations to individual patients must balance the known risks of open heart surgery against the transcatheter approach, which may have different risks, particularly with respect to stroke.
Keywords: Heart Valve Prosthesis, Intensive Care Units, Stroke, Follow-Up Studies, Cardiac Surgical Procedures
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