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Clinical implications of differences between real world and clinical trial usage of left ventricular assist devices for end stage heart failure.

ABSTRACT: Importance: Patient outcomes in heart failure clinical trials are generally better than those observed in real-world settings. This may be related to stricter inclusion and exclusion criteria in clinical trials.

Objective: We study sought to characterize the clinical implications of differences between patients in clinical trials and those in a real-world registry of patients receiving left ventricular assist devices (LVADs).

Design, setting, and participants: This retrospective cohort study included all patients in INTERMACS (the Interagency Registry for Mechanically Assisted Circulatory Support) who were implanted with an axial flow LVAD from 2010 to 2015 to allow for equivalent comparisons.

Main outcomes and measures: Differences in patient characteristics and 2-year rates of adverse outcomes with those reported in the ENDURANCE and MOMENTUM 3 clinical trials. Survival analyses were used to assess the relationships between prespecified patient factors and clinical outcomes.

Results: Of the 10,937 LVAD recipients identified in INTERMACS between 2010-2015, 44% met at least 1 clinical trial exclusion criterion. The 2-year incidence of stroke and death amongst LVAD recipients in INTERMACS and the landmark clinical trials differed significantly (P<0.04, both). Nevertheless, patients who would have been excluded from the clinical trials did not have dramatically different 2-year mortality outcomes in INTERMACS [2y survival estimate: 66.4%, 95% CI (64.9-67.9%) versus 71.9%, 95% CI (70.6-73.1%)]. Clinical interventions driving a significantly increased risk of death were relatively rare (<5% of implants) and included mechanical ventilation, ECMO, severe thrombocytopenia, and dialysis.

Conclusions and relevance: Most exclusion criteria used in LVAD clinical trials did not afford a substantially greater risk to patients in the real-world setting. In the relatively infrequent cases of end stage renal disease, thrombocytopenia, respiratory failure, and need for ECMO, the risks and benefits of LVAD therapy need careful weighting and further study.

SUBMITTER: Mezzacappa C

PROVIDER: S-EPMC7714148 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Clinical implications of differences between real world and clinical trial usage of left ventricular assist devices for end stage heart failure.

Mezzacappa Catherine C Ravindra Neal G NG Caraballo Cesar C Chouairi Fouad F Miller P Elliott PE Clarke John-Ross D JD Gruen Jadry J Mori Makoto M McCullough Megan M Mullan Clancy C Geirsson Arnar A Rogers Joseph G JG Anwer Mohammad M Desai Nihar N Ahmad Tariq T

PloS one 20201203 12

<h4>Importance</h4>Patient outcomes in heart failure clinical trials are generally better than those observed in real-world settings. This may be related to stricter inclusion and exclusion criteria in clinical trials.<h4>Objective</h4>We study sought to characterize the clinical implications of differences between patients in clinical trials and those in a real-world registry of patients receiving left ventricular assist devices (LVADs).<h4>Design, setting, and participants</h4>This retrospecti ...[more]

PMID: 33270648

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Project description:Importance:Left ventricular assist devices (LVADs) are widely used both as a bridge to heart transplant and as destination therapy in advanced heart failure. Although heart failure is common in patients with end-stage renal disease (ESRD), little is known about outcomes after LVAD implantation in this population. Objective:To determine the utilization of and outcomes associated with LVADs in nationally representative cohorts of patients with and without ESRD. Design, Setting and Participants:We described LVAD utilization and outcomes among Medicare beneficiaries after ESRD onset (defined as having received maintenance dialysis or a kidney transplant) from 2003 to 2013 based on Medicare claims linked to data from the United States Renal Data System (USRDS), a national registry for ESRD. We compared Medicare beneficiaries with ESRD to a 5% sample of Medicare beneficiaries without ESRD. Exposures:ESRD (vs no ESRD) among patients who underwent LVAD placement. Main Outcomes and Measures:The primary outcome was survival after LVAD placement. Results:Among the patients with ESRD, the mean age was 58.4 (12.1) years and 62.0% (96) were male. Among those without ESRD, the mean age was 62.2 (12.6) years and 75.1% (196) were male. From 2003 to 2013, 155 Medicare beneficiaries with ESRD (median and interquartile range [IQR] days from ESRD onset to LVAD placement were 1655 days [453-3050 days]) and 261 beneficiaries without ESRD in the Medicare 5% sample received an LVAD. During a median follow-up of 762 days (IQR, 92-3850 days), 127 patients (81.9%) with and 95 (36.4%) without ESRD died. more than half of patients with ESRD (80 [51.6%]) compared with 11 (4%) of those without ESRD died during the index hospitalization. The median time to death was 16 days (IQR 2-447 days) for patients with ESRD compared with 2125 days (IQR, 565-3850 days) for those without ESRD. With adjustment for demographics, comorbidity and time period, patients with ESRD had a markedly increased adjusted risk of death (hazard ratio, 36.3; 95% CI, 15.6-84.5), especially in the first 60 days after LVAD placement. Conclusions and Relevance:Patients with ESRD at the time of LVAD placement had an extremely poor prognosis, with most surviving for less than 3 weeks. This information may be crucial in supporting shared decision-making around treatments for advanced heart failure for patients with ESRD.

Dataset Information

Clinical implications of differences between real world and clinical trial usage of left ventricular assist devices for end stage heart failure.

Publications

Clinical implications of differences between real world and clinical trial usage of left ventricular assist devices for end stage heart failure.

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