Abstract
Background: Left ventricular assist device (LVAD) implantation leads to substantial and sustained improvement in health-related quality of life (HRQOL) among patients. Infection following device implantation remains an important and frequent complication and adversely affects patient-reported HRQOL. Methods: Patients in The Society of Thoracic Surgeons’ Interagency Registry for Mechanically Assisted Circulatory Support receiving a primary LVAD between April 2012 to October 2016 were included. The primary exposure was one-year post-implant infection, characterized by: (1) any infection; (2) total number of infections and (3) type (LVAD-specific, LVAD-related, non-LVAD). The association between infection and the primary composite adverse outcome (defined as EuroQoL Visual Analog Scale< 65, too sick to complete the survey, or death at 1-year) was estimated using inverse probability weighting and Cox regression. Results: The study cohort included 11,618 patients from 161 medical centers with 4,768 (41.0%) patients developing an infection, and 2,282 (19.6%) patients having> 1 infection during the follow up period. The adjusted odds ratio for the primary composite adverse outcome was 1.22 (95% CI, 1.19–1.24, p < 0.001) for each additional infection. Each additional infection was associated with a 3.49% greater probability of the primary composite outcome and was associated with worse performance across multiple dimensions of HRQOL as assessed by the EQ-5D for patients who survived to 1 year. Conclusions: For patients undergoing LVAD implantation, each additional infection within the first post-implantation year was associated with an incremental negative effect on survival free of impaired HRQOL.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 1307-1315 |
| Number of pages | 9 |
| Journal | Journal of Heart and Lung Transplantation |
| Volume | 42 |
| Issue number | 9 |
| DOIs | |
| State | Published - Sep 2023 |
Funding
This study involved analysis of data from the Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs), a North American prospective registry of U.S. Food and Drug Administration approved durable implantable mechanical circulatory support devices. Data for this study were: (1) provided by the Intermacs Data Coordinating Center with permission from the National Heart, Lung, and Blood Institute prior to the administration of Intermacs by Society of Thoracic Surgeons in January, 2018 (previously funded, in part, by the National Heart, Lung, and Blood Institute, under Contract No. HHSN268201100025C). Informed consent for registrant participation in the Intermacs data collection was required until Protocol v4.0 implementation (February 27, 2014). The use of these data was approved by Michigan Medicine’s Institutional Review Board (HUM00155687, approved 2/4/2019). Data use agreements restrict distribution of raw study-related data files. Requests for summary statistics will be shared upon review and approval by the study team. The authors have no relevant conflicts of interest to disclose. This work was supported by funding from the Agency for Healthcare Research and Quality (R01HS026003 AHRQ). Outside of this work, Dr. Donald S. Likosky receives additional research funding from the AHRQ and the National Institutes of Health and serves as a consultant for the American Society of Extracorporeal Technology. Dr. Likosky receives partial salary support from Blue Cross Blue Shield of Michigan (BCBSM) to advance quality in Michigan in conjunction with the Michigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative (MSTCVS-QC). Dr. Francis D. Pagani is a noncompensated ad hoc scientific advisor for Abbott, Medtronic, FineHeart and CH Biomedical and noncompensated medical monitor for Abiomed. He is also a member of the Data Safety Monitoring Board for Carmat and the National Heart, Lung, and Blood Institute, PumpKIN Study, and is Chair of The Society of Thoracic Surgeons Intermacs Task Force, and receives partial salary support from BCBSM to advance quality in Michigan in conjunction with the MSTCVS-QC. Dr. Keith D. Aaronson receives an honorarium from Medtronic as a member of the Independent Physician Quality Panel. Dr. James W. Stewart II is funded through Veterans Affairs as a National Clinician Scholars Program (NCSP) research fellow at the University of Michigan. The authors have no relevant conflicts of interest to disclose. This work was supported by funding from the Agency for Healthcare Research and Quality ( R01HS026003 AHRQ). Outside of this work, Dr. Donald S. Likosky receives additional research funding from the AHRQ and the National Institutes of Health and serves as a consultant for the American Society of Extracorporeal Technology. Dr. Likosky receives partial salary support from Blue Cross Blue Shield of Michigan ( BCBSM ) to advance quality in Michigan in conjunction with the Michigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative ( MSTCVS-QC ). Dr. Francis D. Pagani is a noncompensated ad hoc scientific advisor for Abbott, Medtronic, FineHeart and CH Biomedical and noncompensated medical monitor for Abiomed. He is also a member of the Data Safety Monitoring Board for Carmat and the National Heart, Lung, and Blood Institute, PumpKIN Study, and is Chair of The Society of Thoracic Surgeons Intermacs Task Force, and receives partial salary support from BCBSM to advance quality in Michigan in conjunction with the MSTCVS-QC. Dr. Keith D. Aaronson receives an honorarium from Medtronic as a member of the Independent Physician Quality Panel. Dr. James W. Stewart II is funded through Veterans Affairs as a National Clinician Scholars Program ( NCSP ) research fellow at the University of Michigan.
Keywords
- health-related quality of life
- infection
- mechanical circulatory support
- ventricular assist device
ASJC Scopus subject areas
- Surgery
- Pulmonary and Respiratory Medicine
- Cardiology and Cardiovascular Medicine
- Transplantation