Eugene H Blackstone1, Rakesh M Suri2, Jeevanantham Rajeswaran2, Vasilis Babaliaros2, Pamela S Douglas2, William F Fearon2, D Craig Miller2, Rebecca T Hahn2, Samir Kapadia2, Ajay J Kirtane2, Susheel K Kodali2, Michael Mack2, Wilson Y Szeto2, Vinod H Thourani2, E Murat Tuzcu2, Mathew R Williams2, Jodi J Akin2, Martin B Leon2, Lars G Svensson2. 1. 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. 2. 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.
Abstract
BACKGROUND: The 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 RESULTS:From 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). CONCLUSIONS: The 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 REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894.
RCT Entities:
BACKGROUND: The 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 RESULTS: From 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). CONCLUSIONS: The 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 REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894.
Authors: Susheel Kodali; Vinod H Thourani; Jonathon White; S Chris Malaisrie; Scott Lim; Kevin L Greason; Mathew Williams; Mayra Guerrero; Andrew C Eisenhauer; Samir Kapadia; Dean J Kereiakes; Howard C Herrmann; Vasilis Babaliaros; Wilson Y Szeto; Rebecca T Hahn; Philippe Pibarot; Neil J Weissman; Jonathon Leipsic; Philipp Blanke; Brian K Whisenant; Rakesh M Suri; Raj R Makkar; Girma M Ayele; Lars G Svensson; John G Webb; Michael J Mack; Craig R Smith; Martin B Leon Journal: Eur Heart J Date: 2016-03-31 Impact factor: 29.983