Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2013 Feb 12;127(6):691-702.
doi: 10.1161/CIRCULATIONAHA.112.128132. Epub 2013 Jan 11.

Prospective, multicenter study of ventricular assist device infections

Rachel J Gordon  1 , Alan D Weinberg, Francis D Pagani, Mark S Slaughter, Pat S Pappas, Yoshifumi Naka, Daniel J Goldstein, Walter P Dembitsky, Julie C Giacalone, Jennifer Ferrante, Deborah D Ascheim, Alan J Moskowitz, Eric A Rose, Annetine C Gelijns, Franklin D Lowy; Ventricular Assist Device Infection Study Group
Collaborators, Affiliations
Clinical Trial

Prospective, multicenter study of ventricular assist device infections

Rachel J Gordon et al. Circulation. .

Abstract

Background: Ventricular assist devices (VADs) improve survival and quality of life in patients with advanced heart failure, but their use is frequently complicated by infection. There are limited data on the microbiology and epidemiology of these infections.

Methods and results: One hundred fifty patients scheduled for VAD implantation were enrolled (2006-2008) at 11 US cardiac centers and followed prospectively until transplantation, explantation for recovery, death, or for 1 year. Eighty-six patients (57%) received HeartMate II devices. Data were collected on potential preoperative, intraoperative, and postoperative risk factors for infection. Clinical, laboratory, and microbiological data were collected for suspected infections and evaluated by an infectious diseases specialist. Thirty-three patients (22%) developed 34 VAD-related infections with an incidence rate of 0.10 per 100 person-days (95% confidence interval, 0.073-0.142). The median time to infection was 68 days. The driveline was the most commonly infected site (n=28); 18 (64%) were associated with invasive disease. Staphylococci were the most common pathogen (47%), but pseudomonas or other Gram-negative bacteria caused 32% of infections. A history of depression and elevated baseline serum creatinine were independent predictors of VAD infection (adjusted hazard ratio=2.8 [P=0.007] and 1.7 [P=0.023], respectively). The HeartMate II was not associated with a decreased risk of infection. VAD infection increased 1-year mortality (adjusted hazard ratio=5.6; P<0.0001).

Conclusions: This prospective, multicenter study demonstrates that infection frequently complicates VAD placement and is a continuing problem despite the use of newer, smaller devices. Depression and renal dysfunction may increase the risk of VAD infection. VAD infection is a serious consequence because it adversely affects patient survival.

Clinical trial registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01471795.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Patient outcomes.
Figure 2
Figure 2
Instantaneous risk (hazard) of VAD infection with 95% Cls.
Figure 3
Figure 3
Pulsatile vs. continuous-flow VADs and probability of infection.
Figure 4
Figure 4
History of depression vs. no depression and probability of infection.
Figure 5
Figure 5
Baseline serum creatinine <1.8 and >1.8 mg/dL and probability of infection (1.8 is the 75th percentile). Two subjects with missing data are excluded.
Figure 6
Figure 6
The cumulative incidence (%) of VAD surgery outcomes (red=alive, green=transplanted, blue=dead, grey=explanted) in patients with (6A) and without (6B) VAD infections.
Figure 6
Figure 6
The cumulative incidence (%) of VAD surgery outcomes (red=alive, green=transplanted, blue=dead, grey=explanted) in patients with (6A) and without (6B) VAD infections.
See this image and copyright information in PMC

References

    1. Frazier OH, Rose EA, Oz MC, Dembitsky W, McCarthy P, Radovancevic B, Poirier VL, Dasse KA. Multicenter clinical evaluation of the heartmate vented electric left ventricular assist system in patients awaiting heart transplantation. J Thorac Cardiovasc Surg. 2001;122:1186–1195. - PubMed
    1. Rose EA, Gelijns AC, Moskowitz AJ, Heitjan DF, Stevenson LW, Dembitsky W, Long JW, Ascheim DD, Tierney AR, Levitan RG, Watson JT, Meier P, Ronan NS, Shapiro PA, Lazar RM, Miller LW, Gupta L, Frazier OH, Desvigne-Nickens P, Oz MC, Poirier VL. Long-term mechanical left ventricular assistance for end-stage heart failure. N Engl J Med. 2001;345:1435–1443. - PubMed
    1. Kirklin JK, Naftel DC, Kormos RL, Stevenson LW, Pagani FD, Miller MA, Ulisney KL, Baldwin JT, Young JB. Second intermacs annual report: More than 1,000 primary left ventricular assist device implants. J Heart Lung Transplant. 2010;29:1–10. - PMC - PubMed
    1. Holman WL, Park SJ, Long JW, Weinberg A, Gupta L, Tierney AR, Adamson RM, Watson JD, Raines EP, Couper GS, Pagani FD, Burton NA, Miller LW, Naka Y. Infection in permanent circulatory support: Experience from the rematch trial. J Heart Lung Transplant. 2004;23:1359–1365. - PubMed
    1. Miller LW, Pagani FD, Russell SD, John R, Boyle AJ, Aaronson KD, Conte JV, Naka Y, Mancini D, Delgado RM, MacGillivray TE, Farrar DJ, Frazier OH. Use of a continuous-flow device in patients awaiting heart transplantation. N Engl J Med. 2007;357:885–896. - PubMed

Publication types

MeSH terms

Associated data