Prospective, multicenter study of ventricular assist device infections

Rachel J Gordon, 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, Sarah Fox, Christina L Leventhal, Colleen Gallagher, Katharine Idrissi, Margaret Flannery, Rosie Te-Frey, Roger Swayze, Robert M Adamson, Brian E Jaski, Gina Gravitt, Chris Kohlmyer, Suzanne Chillcott, Marcia Stahovich, Timothy B Icenogle, Mark Puhlman, Alfred Tector, Maggie Miller, Niloo M Edwards, Jan Yakey, Jim Long, Michael Acker, Joseph P Donnelly, Deb Dougherty, Robert Dowling, Pam Adkisson, Rachel J Gordon, 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, Sarah Fox, Christina L Leventhal, Colleen Gallagher, Katharine Idrissi, Margaret Flannery, Rosie Te-Frey, Roger Swayze, Robert M Adamson, Brian E Jaski, Gina Gravitt, Chris Kohlmyer, Suzanne Chillcott, Marcia Stahovich, Timothy B Icenogle, Mark Puhlman, Alfred Tector, Maggie Miller, Niloo M Edwards, Jan Yakey, Jim Long, Michael Acker, Joseph P Donnelly, Deb Dougherty, Robert Dowling, Pam Adkisson

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.

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 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.

Source: PubMed

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