Alexander C Fanaroff1, Pratik Manandhar2, David R Holmes2, David J Cohen2, J Kevin Harrison2, G Chad Hughes2, Vinod H Thourani2, Michael J Mack2, Matthew W Sherwood2, W Schuyler Jones2, Sreekanth Vemulapalli2. 1. From the Duke Clinical Research Institute, Durham, NC (A.C.F., P.M., M.W.S., W.S.J., S.V.); Division of Cardiology (A.C.F., J.K.H., W.S.J., S.V.) and Division of Cardiovascular and Thoracic Surgery (G.C.H.), Duke University, Durham, NC; Division of Cardiology, Mayo Clinic, Rochester, MN (D.R.H.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City (D.J.C.); Division of Cardiothoracic Surgery, Emory University, Atlanta, GA (V.H.T.); The Heart Hospital Baylor Plano, TX (M.J.M.); and Inova Heart and Vascular Institute, Falls Church, VA (M.W.S.). alexander.fanaroff@duke.edu. 2. From the Duke Clinical Research Institute, Durham, NC (A.C.F., P.M., M.W.S., W.S.J., S.V.); Division of Cardiology (A.C.F., J.K.H., W.S.J., S.V.) and Division of Cardiovascular and Thoracic Surgery (G.C.H.), Duke University, Durham, NC; Division of Cardiology, Mayo Clinic, Rochester, MN (D.R.H.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City (D.J.C.); Division of Cardiothoracic Surgery, Emory University, Atlanta, GA (V.H.T.); The Heart Hospital Baylor Plano, TX (M.J.M.); and Inova Heart and Vascular Institute, Falls Church, VA (M.W.S.).
Abstract
BACKGROUND: Peripheral artery disease (PAD) is associated with increased cardiovascular mortality, and PAD risk factors overlap with those for aortic stenosis. The prevalence and outcomes associated with PAD in a population undergoing transcatheter aortic valve replacement (TAVR) are unknown. METHODS AND RESULTS: Using the Society of Thoracic Surgeons/Transcatheter Valve Therapy Registry linked to Medicare claims data, we identified patients ≥65 years old undergoing TAVR from 2011 to 2015. We calculated hazard ratios for 1-year adverse outcomes, including mortality, readmission, and bleeding, for patients with PAD compared with those without, adjusting for baseline characteristics and postprocedure medications. Analyses were performed separately by access site (transfemoral and nontransfemoral). Of 19 660 patients undergoing transfemoral TAVR, 4810 (24.5%) had PAD; 3730 (47.9%) of 7780 patients undergoing nontransfemoral TAVR had PAD. In both groups, patients with PAD were significantly more likely to have coronary and carotid artery diseases. At 1-year follow-up, patients with PAD undergoing TAVR via transfemoral access had a higher incidence of death (16.8% versus 14.4%; adjusted hazard ratio, 1.14; P=0.01), readmission (45.5% versus 42.1%; hazard ratio, 1.11; P<0.001), and bleeding (23.1% versus 19.7%; hazard ratio, 1.18; P<0.001) compared with patients without PAD. Patients with PAD undergoing TAVR via nontransfemoral access did not have significantly higher rates of 1-year mortality or readmission compared with patients without PAD. CONCLUSIONS: PAD is common among patients undergoing commercial TAVR via transfemoral and nontransfemoral access. Among patients undergoing transfemoral TAVR, PAD is associated with a higher incidence of 1-year adverse outcomes compared with absence of PAD. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01737528.
BACKGROUND:Peripheral artery disease (PAD) is associated with increased cardiovascular mortality, and PAD risk factors overlap with those for aortic stenosis. The prevalence and outcomes associated with PAD in a population undergoing transcatheter aortic valve replacement (TAVR) are unknown. METHODS AND RESULTS: Using the Society of Thoracic Surgeons/Transcatheter Valve Therapy Registry linked to Medicare claims data, we identified patients ≥65 years old undergoing TAVR from 2011 to 2015. We calculated hazard ratios for 1-year adverse outcomes, including mortality, readmission, and bleeding, for patients with PAD compared with those without, adjusting for baseline characteristics and postprocedure medications. Analyses were performed separately by access site (transfemoral and nontransfemoral). Of 19 660 patients undergoing transfemoral TAVR, 4810 (24.5%) had PAD; 3730 (47.9%) of 7780 patients undergoing nontransfemoral TAVR had PAD. In both groups, patients with PAD were significantly more likely to have coronary and carotid artery diseases. At 1-year follow-up, patients with PAD undergoing TAVR via transfemoral access had a higher incidence of death (16.8% versus 14.4%; adjusted hazard ratio, 1.14; P=0.01), readmission (45.5% versus 42.1%; hazard ratio, 1.11; P<0.001), and bleeding (23.1% versus 19.7%; hazard ratio, 1.18; P<0.001) compared with patients without PAD. Patients with PAD undergoing TAVR via nontransfemoral access did not have significantly higher rates of 1-year mortality or readmission compared with patients without PAD. CONCLUSIONS: PAD is common among patients undergoing commercial TAVR via transfemoral and nontransfemoral access. Among patients undergoing transfemoral TAVR, PAD is associated with a higher incidence of 1-year adverse outcomes compared with absence of PAD. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01737528.
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