Outcomes following transcatheter aortic valve replacement in the United States.
OBJECTIVE
Transcatheter aortic valve replacement (TAVR) was approved by the US Food and Drug Administration for the treatment of severe, symptomatic aortic stenosis and inoperable status (in 2011) and high-risk but operable status (starting in 2012). A national registry (the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy [STS/ACC TVT] Registry) was initiated to meet a condition for Medicare coverage and also facilitates outcome assessment and comparison with other trials and international registries.


OBJECTIVE
To report the initial US commercial experience with TAVR.


METHODS
We obtained results from all eligible US TAVR cases (n=7710) from 224 participating registry hospitals following the Edwards Sapien XT device commercialization (November 2011-May 2013).


METHODS
Primary outcomes included all-cause in-hospital mortality and stroke following TAVR. Secondary analyses included procedural complications and outcomes by clinical indication and access site. Device implantation success was defined as successful vascular access, deployment of a single device in the proper anatomic position, appropriate valve function without either moderate or severe AR, and successful retrieval of the delivery system. Thirty-day outcomes are presented for a representative 3133 cases (40.6%) at 114 centers with at least 80% complete follow-up reporting.


RESULTS
The 7710 patients who underwent TAVR included 1559 (20%) cases that were inoperable and 6151 (80%) cases that were high-risk but operable. The median age was 84 years (interquartile range [IQR], 78-88 years); 3783 patients (49%) were women and the median STS predicted risk of mortality was 7% (IQR, 5%-11%). At baseline, 2176 patients (75%) were either not at all satisfied (1297 patients [45%]) or mostly dissatisfied (879 patients [30%]) with their symptom status; 2198 (72%) had a 5-m walk time longer than 6 seconds (slow gait speed). The most common vascular access approach was transfemoral (4972 patients [64%]), followed by transapical (2197 patients [29%]) and other alternative approaches (536 patients [7%]); successful device implantation occurred in 7069 patients (92%; 95% CI, 91%-92%). The observed incidence of in-hospital mortality was 5.5% (95% CI, 5.0%-6.1%). Other major complications included stroke (2.0%; 95% CI, 1.7%-2.4%), dialysis-dependent renal failure (1.9%; 95% CI, 1.6%-2.2%), and major vascular injury (6.4%; 95% CI, 5.8%-6.9%). Median hospital stay was 6 days (IQR, 4-10 days), with 4613 (63%) discharged home. Among patients with available follow-up at 30 days (n=3133), the incidence of mortality was 7.6% (95% CI, 6.7%-8.6%) (noncardiovascular cause, 52%); a stroke had occurred in 2.8% (95% CI, 2.3%-3.5%), new dialysis in 2.5% (95% CI, 2.0%-3.1%), and reintervention in 0.5% (95% CI, 0.3%-0.8%).


CONCLUSIONS
Among patients undergoing TAVR at US centers in the STS/ACC TVT Registry, device implantation success was achieved in 92% of cases, the overall in-hospital mortality rate was 5.5%, and the stroke rate was 2.0%. Although these postmarket US approval findings are comparable with prior published trial data and international experience, long-term follow-up is essential to assess continued efficacy and safety.


BACKGROUND
clinicaltrials.gov Identifier: NCT01737528.
Heart Hospital Baylor Plano, Baylor Healthcare System, Plano, Texas.
Michael J
MJ
Mack
J Matthew
JM
Brennan
Ralph
R
Brindis
John
J
Carroll
Fred
F
Edwards
Fred
F
Grover
David
D
Shahian
E Murat
EM
Tuzcu
Eric D
ED
Peterson
John S
JS
Rumsfeld
Kathleen
K
Hewitt
Cynthia
C
Shewan
Joan
J
Michaels
Barb
B
Christensen
Alexander
A
Christian
Sean
S
O'Brien
David
D
Holmes
D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery; D000082882:Bicuspid Aortic Valve Disease; D006328:Cardiac Catheterization; D015331:Cohort Studies; D005260:Female; D005263:Femoral Artery; D006330:Heart Defects, Congenital / Q000601:surgery*; D006349:Heart Valve Diseases / Q000601:surgery*; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods* / Q000401:mortality*; D017052:Hospital Mortality; D006801:Humans; D015994:Incidence; D007902:Length of Stay; D008297:Male; D017060:Patient Satisfaction; D018579:Patient Selection; D011358:Product Surveillance, Postmarketing; D012042:Registries / Q000706:statistics & numerical data; D020521:Stroke / Q000453:epidemiology*; D016896:Treatment Outcome