Author + information
- Received January 26, 2017
- Revision received April 17, 2017
- Accepted April 19, 2017
- Published online June 26, 2017.
- John D. Carroll, MDa,∗ (, )
- Sreekanth Vemulapalli, MDb,
- Dadi Dai, PhDc,
- Roland Matsouaka, PhDd,
- Eugene Blackstone, MDe,
- Fred Edwards, MDf,
- Frederick A. Masoudi, MD, MSPHa,
- Michael Mack, MDg,
- Eric D. Peterson, MD, MPHb,
- David Holmes, MDh,
- John S. Rumsfeld, MD, PhDa,
- E. Murat Tuzcu, MDe and
- Frederick Grover, MDi
- aDivision of Cardiology, Department of Medicine, University of Colorado Denver, Aurora, Colorado
- bDivision of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, North Carolina
- cOutcomes Department, Duke Clinical Research Institute, Duke University, Durham, North Carolina
- dDepartment of Biostatistics and Bioinformatics & Duke Clinical Research Institute, Duke University, Durham, North Carolina
- eDepartment of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio
- fDepartment of Surgery, University of Florida, Jacksonville, Florida
- gBaylor Scott & White Health, Plano, Texas
- hDepartment of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota
- iDivision of Cardiothoracic Surgery, Department of Surgery, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, Colorado
- ↵∗Address for correspondence:
Dr. John D. Carroll, University of Colorado, Anschutz Medical Campus, Mail Stop B132, Leprino Office Building, 12401 East 17th Avenue, Room 524, Aurora, Colorado 80045.
Background Transcatheter aortic valve replacement (TAVR) has been introduced into U.S. clinical practice with efforts to optimize outcomes and minimize the learning curve.
Objectives The goal of this study was to assess the degree to which increasing experience during the introduction of this procedure, separated from other outcome determinants including patient and procedural characteristics, is associated with outcomes.
Methods The authors evaluated the association of hospital TAVR volume and patient outcomes for TAVR by using data from 42,988 commercial procedures conducted at 395 hospitals submitting to the Transcatheter Valve Therapy Registry from 2011 through 2015. Outcomes assessed included adjusted and unadjusted in-hospital major adverse events.
Results Increasing site volume was associated with lower in-hospital risk-adjusted outcomes, including mortality (p < 0.02), vascular complications (p < 0.003), and bleeding (p < 0.001) but was not associated with stroke (p = 0.14). From the first case to the 400th case in the volume–outcome model, risk-adjusted adverse outcomes declined, including mortality (3.57% to 2.15%), bleeding (9.56% to 5.08%), vascular complications (6.11% to 4.20%), and stroke (2.03% to 1.66%). Vascular and bleeding volume–outcome associations were nonlinear with a higher risk of adverse outcomes in the first 100 cases. An association of procedure volume with risk-adjusted outcomes was also seen in the subgroup having transfemoral access.
Conclusions The initial adoption of TAVR into practice in the United States showed that increasing experience was associated with better outcomes. This association, whether deemed a prolonged learning curve or a manifestation of a volume–outcome relationship, suggested that concentrating experience in higher volume heart valve centers might be a means of improving outcomes. (STS/ACC Transcatheter Valve Therapy Registry [TVT Registry]; NCT01737528)
Dr. Carroll is a local site investigator in transcatheter aortic valve replacement studies sponsored by Edwards Lifesciences and Medtronic. Dr. Vemulapalli has received grants from the American College of Cardiology, the Society of Thoracic Surgeons, the Patient-Centered Outcomes Research Institute, Abbott Vascular, and the Agency for Healthcare Quality and Research; and has served as a consultant for Novella. Dr. Blackstone has received a grant through MedStar to independently analyze PARTNER trial data provided by Edwards Lifesciences for investigator-initiated research as one of the branches of the PARTNER Publication Office. Dr. Masoudi served as chief science officer of the National Cardiovascular Data Registry programs. Dr. Mack was a trial co–principal investigator for Edwards Lifesciences and Abbott Vascular; and was on the trial steering committee for Medtronic. Dr. Rumsfeld was chief science officer for the National Cardiovascular Data Registry during the conduct of this study. Drs. Carroll, Mack, Holmes, Tuzcu, and Grover are members of the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry Steering Committee. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received January 26, 2017.
- Revision received April 17, 2017.
- Accepted April 19, 2017.
- 2017 American College of Cardiology Foundation