Author + information
- Received April 28, 2017
- Revision received May 17, 2017
- Accepted May 26, 2017
- Published online September 25, 2017.
- Jennifer A. Cowger, MD, MSa,∗ (, )
- John M. Stulak, MDb,
- Palak Shah, MD, MSc,
- Todd F. Dardas, MD, MSd,
- Francis D. Pagani, MD, PhDe,
- Shannon M. Dunlay, MD, MSf,
- Simon Maltais, MDb,
- Keith D. Aaronson, MD, MSg,
- Ramesh Singh, MDh,
- Nahush A. Mokadam, MDi,
- James K. Kirklin, MDj and
- Christopher T. Salerno, MDk
- aCardiovascular Medicine, Henry Ford Medical Center, Detroit, Michigan
- bSurgery, Mayo Clinic, Rochester, Minnesota
- cCardiovascular Medicine, Inova Heart and Vascular Institute, Fairfax, Virginia
- dCardiovascular Medicine, University of Washington, Seattle, Washington
- eCardiac Surgery, University of Michigan, Ann Arbor, Michigan
- fCardiovascular Medicine, Mayo Clinic, Rochester, Minnesota
- gCardiovascular Medicine, University of Michigan, Ann Arbor, Michigan
- hCardiac Surgery, Inova Heart and Vascular Institute, Falls Church, Virginia
- iCardiovascular Surgery, University of Washington, Seattle, Washington
- jCardiothoracic Surgery, University of Alabama at Birmingham, Birmingham, Alabama
- kCardiac Surgery, St. Vincent Heart Center, Indianapolis, Indiana
- ↵∗Address for correspondence:
Dr. Jennifer A. Cowger, Division of Cardiovascular Medicine, Advanced Heart Failure/Transplant, Henry Ford Hospital, 2799 Grand Boulevard, K14, Detroit, Michigan 48202.
Objectives This study examined patient outcomes after left ventricular assist device (LVAD) implantation across a range of center surgical volumes.
Background In order for a center to qualify for reimbursement, Centers for Medicare and Medicaid Services (CMS) requires it to implant ≥10 LVADs or total artificial hearts over a 3-year period. The impact of center LVAD surgical volumes on patient outcomes has not been thoroughly scrutinized.
Methods Center volumes were provided for 7,416 patients undergoing LVAD implantation who were enrolled in INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support). Center LVAD volume was categorized as either very low (≤10 implants/year, n = 617), low (11 to 30 implants/year, n = 2,561), medium (31 to 50 implants/year, n = 2,458), or high (>50 implants/year, n = 1,750). The main outcome of interest was patient survival based on center volume derived from Kaplan-Meier and multivariate Cox regression.
Results Overall survival was associated with center volume (p = 0.003), as follows: 71 ± 1.8% (very low volume), 81 ± 0.8% (low volume), 83 ± 0.8% (medium volume), and 79 ± 1.0% (high volume) at 1 year. Compared with medium volume centers, the 90-day mortality was higher in very low volume (odds ratio [OR]: 1.35; p = 0.04) and high volume (OR: 1.28; p = 0.018) VAD centers. The adjusted hazard ratios (HRs) for mortality were 1.32 (95% confidence interval [CI]: 1.11 to 1.56), 1.07 (95% CI: 0.95 to 1.21), and 1.17 (95% CI: 1.03 to 1.30) for very low, low, and high volume centers, respectively. Center volume did not predict mortality (p = 0.25; n = 3,688) in INTERMACS profile 1 patients (patients who had sustained cardiogenic shock) and profile 2 patients (patients with progressive hemodynamic decline despite inotropes).
Conclusions Center volume correlates with post-VAD survival, with worse survival noted at very-low volume centers. These findings suggest that current U.S. VAD center standards warrant reconsideration.
This work was funded in part by National Heart, Lung, and Blood Institute/National Institutes of Health/Department of Health and Human Services contract HHSN268201100025C.
Dr. Cowger has received support from Abbott, Medtronic, and HeartWare through her institution. Dr. Shah has received grant support from Medtronic and Haemonetics; and has received support from HeartWare and Abbott through his institution. Dr. Dardas has received grant support from the ISHLT (International Society For Heart & Lung Transplantation); and has received support from HeartWare and Abbott through his institution; and is a recipient of an International Society for Heart and Lung Transplantation award. Dr. Aaronson has received support from Abbott, Medtronic, HeartWare, and Abbott through his institution. Dr. Singh is a consultant for Baxter. Dr. Mokadam is a consultant for Abbott and Medtronic; is an investigator for Abbott, Medtronic, and SynCardia; has received support from Syncardia, HeartWare, and Abbott through his institution; and is a consultant for HeartWare and Abbott. Dr. Salerno has received support from Heartware (Medtronic) and Thoratec (Abbott) through his institution; is a speaker for Abbott and Medtronic; and is a consultant for Abbott. Drs. Stulak, Maltais, and Pagani have received support from HeartWare and Abbott through their institutions. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received April 28, 2017.
- Revision received May 17, 2017.
- Accepted May 26, 2017.
- 2017 American College of Cardiology Foundation