INTERMACS: Interval Analysis of Registry Data

Holman, William L.; Pae, Walter E.; Teutenberg, Jeffrey J.; Acker, Michael A.; Naftel, David C.; Sun, Benjamin C.; Milano, Carmelo A.; Kirklin, James K.

doi:10.1016/j.jamcollsurg.2008.11.016

« Previous Next »Journal of the American College of Surgeons
Volume 208, Issue 5 , Pages 755-761, May 2009

INTERMACS: Interval Analysis of Registry Data

Presented at the Southern Surgical Association 120^th Annual Meeting, Palm Beach, FL, November 30 to December 3, 2008.

William L. Holman, MD, FACS
- Department of Surgery, University of Alabama at Birmingham, Birmingham, AL
- Correspondence address: William L Holman, MD, University of Alabama at Birmingham, Room 719 ZRB, 703 19^th St South, Birmingham, AL 35294-0007
Walter E. Pae, MD, FACS
- Department of Surgery, Penn State University, Hershey, PA
Jeffrey J. Teutenberg, MD
- Department of Medicine, University of Pittsburgh, Pittsburgh, PA
Michael A. Acker, MD, FACS
- Department of Surgery, University of Pennsylvania, Philadelphia, PA
David C. Naftel, MD
- Department of Surgery, University of Alabama at Birmingham, Birmingham, AL
Benjamin C. Sun, MD, FACS
- Department of Surgery, Ohio State University, Columbus, OH
Carmelo A. Milano, MD, FACS
- Department of Surgery, Duke University, Durham, NC
James K. Kirklin, MD, FACS
- Department of Surgery, University of Alabama at Birmingham, Birmingham, AL

Received 14 November 2008; accepted 20 November 2008. published online 02 February 2009.

Background

The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) is an NIH-sponsored registry of US FDA−approved mechanical circulatory support devices (MCSDs) used for destination therapy, bridge to transplantation (BTT), or recovery of the heart. INTERMACS data were analyzed through the most recent quarter ending March 31, 2008.

Study Design

INTERMACS variables include demographics, patient outcomes (survival and adverse events), hemodynamic data, and laboratory values. Data were analyzed with competing outcomes methods. Risk factors were identified for death and transplantation.

Results

Ninety-four sites have prospectively enrolled 483 patients in INTERMACS (BTT, 80%; destination therapy, 15%; bridge to recovery, 5%). Forty-two percent of patients had critical cardiogenic shock before implantation, 38% had progressive circulatory decline despite inotropic agents, and 8% were stable but inotropic agent−dependent. The remaining 12% had recurrent advanced heart failure, severe exercise intolerance, or advanced class III heart failure. At 6 months postimplantation, the competing outcomes for the 483 patients included ongoing support (42%), cardiac transplantation (33%), cardiac recovery with pump removal (3%), or death (22%). The most common causes of death were central nervous system events (11%), cardiovascular failure (8%), or respiratory failure (8%). Less common causes were infection (4%), device malfunction (4%), and liver failure (3%). Survival for BTT and destination therapy were similar (p = 0.53). Patient profile at the time of implantation (critical cardiogenic shock versus others) influenced survival (p = 0.007), as did device configuration (left ventricular assist device versus biventricular ventricular assist device; p < 0.0001).

Conclusions

INTERMACS has increasing participation among domestic MCSD centers. The influence of preimplantation patient condition on survival underscores the importance of timely referral before critical cardiogenic shock occurs. As more devices achieve US FDA approval, INTERMACS will become useful for comparing MCSDs.

Abbreviations and Acronyms: BTT, bridge to transplantation, INTERMACS, Interagency Registry for Mechanically Assisted Circulatory Support, MCSD, mechanical circulatory support device, VAD, ventricular assist device