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Transcatheter aortic valve replacement (TAVR) was approved for use in the U.S. in November 2011. Today, about 250 clinical sites report post-TAVR outcomes to the Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapy Registry as a condition of Medicare reimbursement. We now have initial results from 7710 patients (median age, 84; 51% men) who underwent TAVR at 224 hospitals before June 2013; about 20% were deemed “inoperable,” and the remaining 80% were at high estimated operative risk.
The median STS-predicted risk for operative mortality at 30 days was 7%, with wide variation among sites. Most TAVR approaches were transfemoral (64%) or transapical (29%). The majority of procedures (57%) were performed in a hybrid operating room, and nearly all (98%) involved general anesthesia. The implantation success rate was 92%. Conversion to open surgery (1% of patients) was associated with a 49% in-hospital death rate.
Overall in-hospital mortality was 5.5%. Other complications included stroke (2.0%), major vascular injury (6.4%), and acute renal insufficiency (5.5%). Median length of stay was 6 days, and 8.5% of patients were found to have moderate or severe aortic insufficiency just before discharge. Thirty-day mortality, reported by only about half of participating hospitals, was 7.6%.
Mack MJ et al. Outcomes following transcatheter aortic valve replacement in the United States. JAMA 2013 Nov 20; 310:2069. (http://jama.jamanetwork.com/article.aspx?articleid=1779535)
Bonow RO.Improving outlook for elderly patients with aortic stenosis. JAMA 2013 Nov 20; 310:2045. (http://dx.doi.org/10.1001/jama.2013.281825)
Comment
This first glimpse of the commercial use of early-generation TAVR in the U.S. reveals success and complication rates similar to those in published randomized trials and to those documented outside the U.S. with later-generation devices. The national registry data suggest that a heart-team approach, a controlled rollout, and a high level of site training and case supervision by a sponsor can achieve post-approval results similar to those of clinical trials. However, the possibility of “indication creep” to a lower STS-predicted risk for operative mortality than in randomized trials cannot be excluded as an explanation for the excellent outcomes. Further analyses must explore that issue as well as the wide variability among centers in procedural volume and patient selection.