Utilization and outcomes of transcatheter aortic valve replacement in the United States shortly after device approval.
OBJECTIVE
The objective of this study was to assess the national uptake of TAVR, associated in-hospital outcomes, and the effect of procedural experience on outcomes in the first two years following device approval.


BACKGROUND
Transcatheter aortic valve replacement (TAVR) is a newly established therapy for high-risk patients with severe aortic stenosis. Evaluating the manner in which TAVR has disseminated into real-world practice is essential for understanding its impact on population health.


RESULTS
We identified patients undergoing TAVR from the National Inpatient Sample from January 2012 through December 2013. During this period, an estimated 21,185 cases were performed in the United States. Mean age was 81.1 years, 50.8% were male, 86.5% were Caucasian, and 89.6% were Medicare patients. The number of TAVRs performed and of hospitals performing the procedure nationally grew linearly throughout the study period. The most frequent complications included bleeding (26.9%), respiratory failure (19.3%), and renal/metabolic issues (17.2%). Median hospital length of stay was 6 days (IQR 4-10). In-hospital mortality was estimated to be 4.9%. A majority of cases were performed in large (80.8%) and in urban teaching (87%) hospitals. In the first year post-market approval, prior institutional experience with TAVR was associated with significantly reduced risk-adjusted, in-hospital mortality (OR 0.82 per 25 additional TAVRs performed, CI 0.70-0.951, P = 0.009).


CONCLUSIONS
Following device approval, the number of TAVRs and hospitals performing TAVR grew dramatically. Procedural complications were frequent and in-hospital mortality was approximately 4.9%. Finally, increased procedural experience was strongly associated with a reduction in inpatient mortality. © 2017 Wiley Periodicals, Inc.
Cardiology Division, Massachusetts General Hospital, Boston, Massachusetts.
Michael N
MN
Young
Cardiology Division, Massachusetts General Hospital, Boston, Massachusetts.
Sammy
S
Elmariah
Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, Missouri.
Kevin F
KF
Kennedy
Cardiology Division, Massachusetts General Hospital, Boston, Massachusetts.
Ignacio
I
Inglessis
Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
Robert W
RW
Yeh
D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D016009:Chi-Square Distribution; D002983:Clinical Competence; D016208:Databases, Factual; D018795:Device Approval; D005260:Female; D006350:Heart Valve Prosthesis / Q000706:statistics & numerical data; D017052:Hospital Mortality; D006801:Humans; D059032:Learning Curve; D007902:Length of Stay; D016015:Logistic Models; D008297:Male; D015999:Multivariate Analysis; D016017:Odds Ratio; D011183:Postoperative Complications / Q000209:etiology; D010818:Practice Patterns, Physicians' / Q000639:trends; D017064:Process Assessment, Health Care / Q000639:trends; D011358:Product Surveillance, Postmarketing; D012042:Registries; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D065467:Transcatheter Aortic Valve Replacement / Q000295:instrumentation / Q000401:mortality / Q000706:statistics & numerical data* / Q000639:trends; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration
aortic valve disease; health care outcomes; percutaneous intervention; percutaneous valve therapy; transcatheter valve implantation