Author + information
- Received January 28, 2018
- Revision received May 14, 2018
- Accepted May 14, 2018
- Published online September 3, 2018.
- Amit N. Vora, MD, MPHa,b,∗ (, )
- Dadi Dai, MSb,
- Roland Matsuoka, PhDb,
- J. Kevin Harrison, MDa,
- G. Chad Hughes IV, MDa,
- Matthew W. Sherwood, MD, MHSc,
- Jonathan P. Piccini, MD, MHSa,b,
- Bhaskar Bhardwaj, MDd,
- Renato D. Lopes, MD, PhDa,
- David Cohen, MDe,
- David R. Holmes Jr., MDf,
- Vinod H. Thourani, MDg,
- Eric Peterson, MD, MPHa,b,
- Ajay Kirtane, MDh,
- Samir Kapadia, MDi and
- Sreekanth Vemulapalli, MDa,b
- aDuke Clinical Research Institute, Durham, North Carolina
- bDuke University Medical Center, Durham, North Carolina
- cInova Heart and Vascular Institute, Fairfax, Virginia
- dUniversity of Missouri–Columbia, Columbia, Missouri
- eSaint Luke’s Mid America Heart Institute, University of Missouri–Kansas City School of Medicine, Kansas City, Missouri
- fMayo Foundation, Rochester, Minnesota
- gMedStar Heart and Vascular Institute/Georgetown University, Washington, District of Columbia
- hColumbia University Medical Center/NewYork-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, New York
- iDepartment of Cardiology, Cleveland Clinic, Cleveland, Ohio
- ↵∗Address for correspondence:
Dr. Amit N. Vora, Duke Clinical Research Institute, 2400 Pratt Street, Durham, North Carolina 27705.
Objectives The aim of this study was to evaluate incidence, care patterns, and clinical outcomes in patients developing new-onset atrial fibrillation (AF) following transcatheter aortic valve replacement (TAVR).
Background Pre-procedural AF has been associated with adverse outcomes in patients undergoing TAVR, but the incidence of new-onset AF, associated anticoagulant management, and subsequent clinical outcomes are unclear.
Methods Using the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry linked with Medicare claims, patients undergoing TAVR from 2011 to 2015 who developed post-procedural AF were evaluated. Patients with known AF prior to TAVR were excluded. Outcomes of interest included in-hospital mortality and stroke and all-cause mortality, stroke, and bleeding at 12 months. Multivariate adjustment was then performed to determine differences in 1-year outcomes among those with and without new post-procedural AF, stratified by anticoagulation status.
Results We identified 1,138 of 13,556 patients (8.4%) who developed new onset AF (4.4% of transfemoral [TF]–access patients, 16.5% of non-TF-access patients). Patients developing AF were older, more likely female, had higher Society of Thoracic Surgeons risk scores, and were often treated using non-TF access. Despite having a median CHA2DS2-VASc score of 5 (25th and 75th percentile: 5 to 6), only 28.9% of patients with new AF were discharged on oral anticoagulation. In-hospital mortality (7.8% vs. 3.4%; p < 0.01) and stroke (4.7% vs. 2.0%; p < 0.01) were higher among patients who developed post-procedural AF compared with those who did not. At 1 year, rates of death (adjusted hazard ratio [HR]: 1.37; 95% confidence interval [CI]: 1.19 to 1.59), stroke (adjusted HR: 1.50; 95% CI: 1.14 to 1.98), and bleeding (adjusted HR: 1.24; 95% CI: 1.10 to 1.40) were higher among patients with new-onset AF. One-year mortality rates were highest among patients who developed new-onset AF but were not discharged on anticoagulation.
Conclusions Post-TAVR AF occurred in 8.4% of patients (4.4% with TF access, 16.5% with non-TF access), with fewer than one-third of patients receiving anticoagulation at discharge, and was associated with increased risk for in-hospital and 1-year mortality and stroke. Given the clinical significance of post-TAVR AF, additional studies are necessary to delineate the optimal management strategy in this high-risk population.
Dr. Harrison has received institutional research funding from Boston Scientific, Edwards, Medtronic, and St. Jude/Abbott Medical. Dr. Sherwood has received consulting fees from Janssen. Dr. Piccini has received funding for clinical research from Abbott Medical, ARCA Biopharma, Boston Scientific, Gilead, and Janssen Pharmaceuticals; and serves as a consultant to Allergan, Bayer, Johnson & Johnson, Medtronic, Sanofi, and Spectranetics. Dr. Lopes has received research funding from Bristol-Myers Squibb and GlaxoSmithKline; and is a consultant for Bayer, Boehringer Ingelheim, Bristol-Myers Squibb (modest), Merck (modest), Pfizer (significant), and Portola. Dr. Cohen has received research grant support from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott Vascular; and consulting income from Edwards Lifesciences and Medtronic. Dr. Thourani has received grant support from Edwards Lifesciences; and is a consultant for Edwards Lifesciences and Medtronic. Dr. Peterson has received research funding from the American College of Cardiology, the American Heart Association, Eli Lilly & Company, Janssen Pharmaceuticals, and the Society of Thoracic Surgeons (all significant); and is a consultant (including continuing medical education) for Merck (modest), Boehringer Ingelheim, Genentech, Janssen Pharmaceuticals, and Sanofi (all significant). Dr. Kirtane has received institutional grants to Columbia University and/or the Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, Cardiovascular Systems Inc., CathWorks, Siemens, Philips, and ReCor Medical. Dr. Vemulapalli has received research funding from the American College of Cardiology, the Society of Thoracic Surgeons, Abbott Vascular, the Patient-Centered Outcomes Research Institute, and Boston Scientific; is a consultant for Premiere and Novella; and is a member of the Speakers Bureau for Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received January 28, 2018.
- Revision received May 14, 2018.
- Accepted May 14, 2018.