TY - JOUR
T1 - Continuous-flow devices and percutaneous site infections
T2 - Clinical outcomes
AU - Goldstein, Daniel J.
AU - Naftel, David
AU - Holman, William
AU - Bellumkonda, Lavanya
AU - Pamboukian, Salpy V.
AU - Pagani, Francis D.
AU - Kirklin, James
N1 - Funding Information:
Daniel J. Goldstein, MD, is the Site Principal Investigator for Thoratec HeartMate II and the HeartWare Bridge to Transplant and Destination Therapy Clinical Trials, is the Chair of the Adverse Event Committee of the Terumo DuraHeart Bridge to Transplant Clinical Trial, and is on the Medical Advisory Boards of Thoratec Inc and Berlin Heart Inc. William Holman, MD, is a Scientific Advisor for Sun Medical Inc (Evaheart) and is a member of the Data Safety and Monitoring Board of the HeartWare Bridge to Transplant Trial. Salpy V. Pamboukian, MD, is Site Principal Investigator for the Thoratec HeartMate II LVAD Bridge and Destination Therapy Trials and the DuraHeart and Evaheart Bridge to Transplant Trial. Francis D. Pagani, MD, is Site Principal Investigator for the Terumo DuraHeart Bridge and HeartWare Bridge to Transplant and Destination Therapy Trials and receives contract research support administered by the University of Michigan for Terumo Heart Inc, HeartWare Inc, and National Institutes of Health-National Heart, Lung Blood Institute. None of the other authors has a financial relationship with a commercial entity that has an interest in the subject of the presented manuscript or other conflicts of interest to disclose.
PY - 2012/11
Y1 - 2012/11
N2 - Background: Although continuous-flow left ventricular assist device (LVAD) support has become standard therapy, the complexities of device and patient management remain a challenge. In particular, percutaneous site infections (PSI) are a serious complication during the post-implant course. We sought to study the incidence, risk factors, and clinical effect of PSI. Methods: Data were obtained from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) Registry. All adult patients who received a primary intracorporeal continuous flow LVAD between June 2006 and September 2010 were included. Descriptive statistics, Kaplan-Meier depictions, and multivariable analysis in the parametric hazard domain were used for statistical analysis. Results: A total of 239 PSIs were documented in 197 of 2,006 recipients (9.8%) of a continuous-flow LVAD. Mean follow-up was 8.1 months. Mean time to development of a PSI was 6.6 months. At 1 year after implant, nearly 19% of continuous-flow LVAD recipients developed a PSI. Multivariate analysis showed younger age (hazard ratio, 1.20; p < 0.0001) was the only factor predicting a PSI. Continuous-flow LVAD recipients who did not develop a PSI had improved survival (p = 0.004). Twenty-three patients died after development of a PSI. Sepsis was the most common cause of death (26.1%). Conclusions: PSIs occur in approximately 19% of continuous-flow LVAD recipients by 12 months after implant. Young age is the only predictor of PSI. Importantly, development of a PSI adversely affects survival. Efforts to enhance driveline integration and to develop future totally implantable systems are warranted.
AB - Background: Although continuous-flow left ventricular assist device (LVAD) support has become standard therapy, the complexities of device and patient management remain a challenge. In particular, percutaneous site infections (PSI) are a serious complication during the post-implant course. We sought to study the incidence, risk factors, and clinical effect of PSI. Methods: Data were obtained from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) Registry. All adult patients who received a primary intracorporeal continuous flow LVAD between June 2006 and September 2010 were included. Descriptive statistics, Kaplan-Meier depictions, and multivariable analysis in the parametric hazard domain were used for statistical analysis. Results: A total of 239 PSIs were documented in 197 of 2,006 recipients (9.8%) of a continuous-flow LVAD. Mean follow-up was 8.1 months. Mean time to development of a PSI was 6.6 months. At 1 year after implant, nearly 19% of continuous-flow LVAD recipients developed a PSI. Multivariate analysis showed younger age (hazard ratio, 1.20; p < 0.0001) was the only factor predicting a PSI. Continuous-flow LVAD recipients who did not develop a PSI had improved survival (p = 0.004). Twenty-three patients died after development of a PSI. Sepsis was the most common cause of death (26.1%). Conclusions: PSIs occur in approximately 19% of continuous-flow LVAD recipients by 12 months after implant. Young age is the only predictor of PSI. Importantly, development of a PSI adversely affects survival. Efforts to enhance driveline integration and to develop future totally implantable systems are warranted.
KW - continuous flow
KW - driveline infection
KW - left ventricular assist device
KW - long term complication
KW - percutaneous site infections
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U2 - 10.1016/j.healun.2012.05.004
DO - 10.1016/j.healun.2012.05.004
M3 - Article
C2 - 22766022
AN - SCOPUS:84867582886
SN - 1053-2498
VL - 31
SP - 1151
EP - 1157
JO - Journal of Heart and Lung Transplantation
JF - Journal of Heart and Lung Transplantation
IS - 11
ER -