ORIGINAL CLINICAL SCIENCEStroke and death risk in ventricular assist device patients varies by ISHLT infection category: An INTERMACS analysis
Section snippets
Methods
INTERMACS is funded by the National Heart, Lung and Blood Institute (NHLBI, Contract No. HHSN268201100025C). The INTERMACS Data Access, Analysis and Publications Committee approved the analysis described in this report, and the analysis was conducted at the Inova Heart and Vascular Institute. The INTERMACS Data and Clinical Coordinating Center and each participating institution received international review board/ethics review board approval for active informed consent or a waiver of consent to
Patients’ characteristics for those with and without an infection
The analysis included 16,597 continuous-flow VAD recipients (Figure 1). Of this cohort, 9,551 patients were free of any post-implant infection, whereas 7,046 patients (42%) developed an infection after implant. The median time to development of any infection was 69 (interquartile range [IQR] 12 to 272) days. Characteristics of patients with and without an infection are compared in Table S1 (refer to Supplementary Material available online at www.jhltonline.org/). Patients with a
Discussion
We performed an analysis of continuous-flow LVAD patients within INTERMACS to characterize the epidemiology of infections in VAD recipients and to determine the risk of stroke and death. Infections in VAD recipients are a significant cause of morbidity and mortality and we discovered distinct differences in clinical outcomes based on the 2011 ISHLT categorization of infections.4 Our principal findings are as follows: (1) the incidence rate of infection was highest in the early post-implant
Limitations
We used INTERMACS for our analysis and, as with all registry data sets, not all data points are available for all patients and not all individual data points can be reviewed by the data coordinating center. Specific reporting standards are mandated by INTERMACS for each center with regard to data quality and completeness. Because many DLIs are managed in the ambulatory setting or by outlying providers, it is possible that milder infections are underreported in the registry compared with BSIs,
Disclosure statement
P.S. has received an American Heart Association Scientist Development Award, co-funded by the Enduring Hearts Foundation, and has done consulting work for NuPulse and Ortho Clinical Diagnostics. L.B.C. reports grant support from Abbott. J.A.C. is a member of the Medtronic steering committee and receives travel-related financial support and compensation for speaking from Abbott, Inc. The remaining authors have no conflicts of interest to disclose.
The authors thank the INTERMACS investigators,
Supplementary data
Supplementary data associated with this article can be found in the online version at www.jhltonline.org/.
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These authors have contributed equally to this work.