1 P eripheral artery disease (PAD) affects >200 million people worldwide, including >50 million people in Europe and North America, with symptoms ranging from none to critical limb ischemia. 1 Its prevalence is known to increase in those over the age of 50 years, especially in those with other vascu- lar risk factors, including diabetes mellitus, hyperlipidemia, smoking, and chronic renal insuffciency. 2 These risk factors overlap with those of aortic stenosis. 3 Given the shared risk factors, PAD is a frequent comor- bidity in patients referred for transcatheter aortic valve replacement (TAVR). 4 In clinical trials, the prevalence of PAD in patients undergoing TAVR ranged from 27.8% in the PARTNER B (prohibitive risk) trial (Placement of Aortic Transcatheter Valves, Cohort B) to 41.3% in the CoreValve US study. 5,6 However, the population studied in clinical trials may differ from the population undergoing commercial TAVR in important ways; commercial TAVR patients are more often men and have lower operative risk than patients enrolled in pivotal trials, for example. 7,8 Moreover, PAD has been associ- ated with increased cardiovascular mortality and stroke risk in the general population and in patients undergoing coro- nary artery bypass grafting 9–11 and may therefore represent an 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 identifed 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 signifcantly 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 signifcantly 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 identifer: NCT01737528. (Circ Cardiovasc Interv. 2017;10:e005456. DOI: 10.1161/CIRCINTERVENTIONS.117.005456.) Key Words: aortic valve stenosis ◼ peripheral vascular disease ◼ risk factors ◼ transcatheter aortic valve replacement © 2017 American Heart Association, Inc. Circ Cardiovasc Interv is available at http://circinterventions.ahajournals.org DOI: 10.1161/CIRCINTERVENTIONS.117.005456 Received May 3, 2017; accepted September 14, 2017. 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.). The Data Supplement is available at http://circinterventions.ahajournals.org/lookup/suppl/doi:10.1161/CIRCINTERVENTIONS.117.005456/-/DC1. Correspondence to Alexander C. Fanaroff, MD, Duke Clinical Research Institute, 2400 Pratt St, Durham, NC 27705. E-mail alexander.fanaroff@duke.edu Peripheral Artery Disease and Transcatheter Aortic Valve Replacement Outcomes A Report From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Therapy Registry Alexander C. Fanaroff, MD; Pratik Manandhar, MS; David R. Holmes, MD; David J. Cohen, MD, MSc; J. Kevin Harrison, MD; G. Chad Hughes, MD; Vinod H. Thourani, MD; Michael J. Mack, MD; Matthew W. Sherwood, MD, MHS; W. Schuyler Jones, MD; Sreekanth Vemulapalli, MD Structural Heart Disease Downloaded from http://ahajournals.org by on May 24, 2020