Dataset Information

Questionable utility of digoxin in left-ventricular assist device recipients: A multicenter, retrospective analysis.

ABSTRACT:

Background

While clinical experience with left ventricular assist devices (LVAD) continues to grow and evolve, little is known regarding the ongoing use of certain medications in this population. We sought to evaluate the utility of digoxin in LVAD recipients and its association with outcomes.

Methods

A total of 505 patients who underwent continuous-flow LVAD implantation at 5 centers from 2007-2015 were included. Patients were divided into 4 groups: not on digoxin at any time (ND; n = 257), received digoxin pre implant (PreD; n = 144), received digoxin pre and post implant (ContD; n = 55), and received digoxin only post implant (PostD; n = 49). Survival and all-cause readmission were compared between the 4 groups.

Results

There was no difference in survival at 1 year nor at 3 years between groups (ND = 88%, 66%, respectively; PreD = 85%, 66%; ContD = 86%, 57%; PostD = 90%, 51%; p = 0.7). Readmission per 100 days also was not different between groups (ND = 0.5, PreD = 0.6, ContD = 0.5, PostD = 0.7; p = 0.1).

Conclusions

In this large, multicenter cohort, use of digoxin was not associated with any significant benefit in regard to mortality or hospitalization in patients supported with a continuous-flow LVAD. Importantly, its discontinuation post implant did not worsen all-cause hospitalization or survival.

SUBMITTER: Ahmed MM

PROVIDER: S-EPMC6876793 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Publications

Questionable utility of digoxin in left-ventricular assist device recipients: A multicenter, retrospective analysis.

Ahmed Mustafa M MM Roukoz Henri H Trivedi Jaimin R JR Bhan Adarsh A Ravichandran Ashwin A Dhawan Rahul R Cowger Jennifer J Bhat Geetha G Birks Emma J EJ Slaughter Mark S MS Gopinathannair Rakesh R

PloS one 20191125 11

<h4>Background</h4>While clinical experience with left ventricular assist devices (LVAD) continues to grow and evolve, little is known regarding the ongoing use of certain medications in this population. We sought to evaluate the utility of digoxin in LVAD recipients and its association with outcomes.<h4>Methods</h4>A total of 505 patients who underwent continuous-flow LVAD implantation at 5 centers from 2007-2015 were included. Patients were divided into 4 groups: not on digoxin at any time (ND ...[more]

PMID: 31765397

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Project description:ImportanceWhile wide-scale adoption of durable left ventricular assist devices (LVADs) can be attributed to favorable randomized clinical trial outcomes, restrictive selection criteria may be associated with a lack of generalizability to real-world experience.ObjectiveTo estimate the proportion of LVAD recipients who are eligible for clinical trials and to assess whether an association exists between trial eligibility and mortality.Design, setting, and participantsThis cohort study examined 14 679 patients undergoing primary, intracorporeal continuous-flow LVAD implantation (with or without a right ventricular assist device) in 181 North American centers from January 1, 2012, to June 30, 2017, identified in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). To simulate a trial population, trial criteria from the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Therapy With HeartMate 3 (MOMENTUM 3) were mapped to INTERMACS variables. Patients were categorized as eligible for trial inclusion or ineligible for trial inclusion and by number of ineligibility criteria met. Follow-up in INTERMACS was complete for all patients through October 31, 2017. Data were analyzed from July 2019 through November 2020.ExposuresUndergoing durable LVAD implantation.Main outcomes and measuresTrial eligibility and postimplant mortality were analyzed using Kaplan-Meier estimates and Cox proportional hazards models.ResultsAmong 14 679 recipients, mean (SD) age was 57 (13) years, 11 503 individuals (78.4%) were men, and 11 406 individuals (77.7%) presented with New York Heart Association class IV heart failure. A total of 6429 recipients (43.8%) were ineligible for trial inclusion, of whom 4226 individuals (65.7%) met 1 ineligibility criterion, 1442 individuals (22.4%) met 2 criteria, and 761 individuals (11.8%) met 3 or more criteria. Estimated mortality for recipients who were trial-ineligible was higher than for recipients who were trial-eligible (1-year mortality: 25.3% [95% CI, 24.2%-26.5%] vs 16.2% [95% CI, 15.4%-17.1%]; 3-year mortality: 42.8% [95% CI, 41.3%-44.4%] vs 36.4% [95% CI, 35.0%-37.8%]; log-rank P < .001 for both). Patients who were trial-ineligible had increased risk of mortality compared with patients who were trial-eligible if they met 1 trial ineligibility criterion (hazard ratio [HR], 1.16 [95% CI, 1.08-1.24]; P < .001), 2 trial ineligibility criteria (HR, 1.51 [95% CI, 1.36-1.67]; P < .001), or 3 or more trial ineligibility criteria (HR, 2.09 [95% CI, 1.84-2.39]; P < .001). Among patients meeting only 1 ineligibility criterion, 4 criteria were independently associated with mortality: prior or ongoing mechanical circulatory support (HR, 1.63 [95% CI, 1.23-2.16]; P = .001), elevated creatinine level (HR, 1.42 [95% CI, 1.17-1.72]; P < .001), elevated bilirubin level (HR, 1.39 [95% CI, 1.17-1.66]; P < .001), and low albumin or prealbumin level (HR, 1.18 [95% CI, 1.05-1.33]; P = .007).Conclusions and relevanceThese findings suggest that while treatment for patients who are ineligible for LVAD trial inclusion should be weighed against medical management, more consideration could be given to designing trials with eligibility criteria that reflect real-world experience.

Project description:BackgroundLeft ventricular assist device (LVAD) implantation significantly impacts on a recipient's symptoms and quality of life. Capturing their experiences and post implant journey is an important part of clinical practice, research and device design evolution. Patient reported outcome measures (PROMs) are a useful tool for capturing that experience. However, patient reported outcome measures need to reflect recipients' experiences. Discussions with a patient partner group found that none of the frequently used cardiology PROMs captured their unique experiences.AimsTo capture the experiences and important issues for LVAD recipients. Develop a conceptual map of domains and items that should be reflected in patient reported outcomes.MethodsGroup concept mapping (GCM) web-based software was used to remotely capture and structure recipients' experiences across a wide geographical area. GCM is a semi-quantitative mixed method consisting of 3 stages: item generation, item sorting and rating (importance, relevance and frequency). Patient partners were involved in all aspects of the study design and development.Results18 LVAD recipients consented to take part. 101 statements were generated and multi-dimensional scaling, and hierarchical cluster analysis identified 9 clusters. Cluster themes included: Activities, Partner/family support, Travel, Mental wellbeing, Equipment and clothing, Physical and cognitive limitations, LVAD Restrictions, LVAD Challenges and positive impact of the LVAD (LVAD Positives). LVAD Positives were scored highest across all the rating variables, e.g., frequency (2.85), relevance (2.44) and importance (2.21). Other domains rated high for importance included physical and cognitive limitations (2.19), LVAD restrictions (2.11), Partner/family support (2.02), and Equipment and clothing (2.01).ConclusionOnline GCM software facilitated the inclusion of geographically dispersed recipients and provided useful insights into the experiences of LVAD recipients. The conceptual framework identifies important domains and items that should be prioritised and included in patient reported outcomes in future research, LVAD design evolution, and clinical practice.

Dataset Information

Questionable utility of digoxin in left-ventricular assist device recipients: A multicenter, retrospective analysis.

Background

Methods

Results

Conclusions

Publications

Questionable utility of digoxin in left-ventricular assist device recipients: A multicenter, retrospective analysis.

Similar Datasets

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