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Randomized Controlled Trial Comparative Study
Propensity-matched comparisons of clinical outcomes after transapical or transfemoral transcatheter aortic valve replacement: a placement of aortic transcatheter valves (PARTNER)-I trial substudy.
- Eugene H Blackstone, Rakesh M Suri, Jeevanantham Rajeswaran, Vasilis Babaliaros, Pamela S Douglas, William F Fearon, D Craig Miller, Rebecca T Hahn, Samir Kapadia, Ajay J Kirtane, Susheel K Kodali, Michael Mack, Wilson Y Szeto, Vinod H Thourani, E Murat Tuzcu, Mathew R Williams, Jodi J Akin, Martin B Leon, and Lars G Svensson.
- From Cleveland Clinic, Cleveland, OH (E.H.B., J.R., S.K., E.M.T., L.G.S.); Mayo Clinic, Rochester, MN (R.M.S.); Emory University, Atlanta, GA (V.B., V.H.T.); Duke University Clinical Research Institute and Duke University Medical Center, Durham, NC (P.S.D.); Stanford University Medical Center, Stanford, CA (W.F.F., D.C.M.); Columbia University Medical Center/New York-Presbyterian Hospital, New York (R.T.H., A.J.K., S.K.K., M.B.L.); Baylor Scott & White Health, Plano, TX (M.M.); Hospital of the University of Pennsylvania, Philadelphia (W.Y.S.); and New York University Langone Medical Center, New York (M.R.W.). J.J. Akin is self-employed. blackse@ccf.org.
- Circulation. 2015 Jun 2;131(22):1989-2000.
BackgroundThe higher risk of adverse outcomes after transapical (TA) versus transfemoral (TF) transcatheter aortic valve replacement (TAVR) could be attributable to TA-TAVR being an open surgical procedure or to clinical differences between TA- and TF-TAVR patients. We compared outcomes after neutralizing patient differences using propensity score matching.Methods And ResultsFrom April 2007 to February 2012, 1100 Placement of Aortic Transcatheter Valves (PARTNER)-I patients underwent TA-TAVR and 1521 underwent TF-TAVR with Edwards SAPIEN balloon-expandable bioprostheses. Propensity matching based on 111 preprocedural variables, exclusive of femoral access morphology, identified 501 well-matched patient pairs (46% of possible matches), 95% of whom had peripheral arterial disease. Matched TA-TAVR patients experienced more adverse procedural events, longer length of stay (5 versus 8 days; P<0.0001), and slower recovery (New York Heart Association class I, 31% versus 38% at 30 days, equalizing by 6 months at 51% versus 47%); stroke risk was similar (3.4% versus 3.3% at 30 days and 6.0% versus 6.7% at 3 years); mortality was elevated for the first 6 postprocedural months (19% versus 12%; P=0.01); but aortic regurgitation was less (34% versus 52% mild and 8.9% versus 12% moderate to severe at discharge, P=0.001; 36% versus 50% mild and 10% versus 15% moderate to severe at 6 months, P<0.0001).ConclusionsThe likelihood of adverse periprocedural events and prolonged recovery is greater after TA-TAVR than TF-TAVR in vasculopathic patients after accounting for differences in cardiovascular risk factors, although stroke risk is equivalent and aortic regurgitation is less. As smaller delivery systems permit TF-TAVR in many of these patients, we recommend a TF-first access strategy for TAVR when anatomically feasible.Clinical Trial RegistrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894.© 2015 American Heart Association, Inc.
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