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Using left ventricular assist devices in advanced heart failure patients.

ABSTRACT: ABSTRACTAdvanced Heart Failure (AHF) is a complex syndrome that affects the physiology of the heart to maintain efficient blood circulation resulting in multiorgan failure and, eventually, death. Left Ventricular Assist Devices (LVADs) have become the cornerstone therapy for AHF patients, both as a bridge to transplantation and as a decisive therapy. Recently the results of the MOMENTUM 3 Trial were published. The trial compared HeartMate 3 LVAD with HeartMate II LVAD in a randomized trial in The Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3 (MOMENTUM 3). Of 366 patients, 190 were assigned to the centrifugal-flow pump group (HeartMate 3) and 176 to the axial-flow (HeartMate II) pump group. In the intention-to-treat population, the primary end point occurred in 151 patients (79.5%) in the centrifugal-flow pump group, as compared with 106 (60.2%) in the axial-flow pump group (P < 0.001 for noninferiority). Reoperation for pump malfunction was less frequent in the centrifugal-flow pump group than in the axial-flow pump group (P < 0.001).The results of the MOMENTUM 3 Trial are a big achievement in the cardiovascular world. Any improvement in LVADs that reduces the risk of stroke, perhaps the most feared complication of these devices, would be meaningful. Besides, given the observed lower rate of pump thrombosis and reoperation for pump malfunction, it already seems likely that the HeartMate 3 will supplant the HeartMate II in clinical practice. In addition, the risks that are associated with reoperation undoubtedly counterbalanced any unintentional bias in performing that intervention.

SUBMITTER: Shah SR

PROVIDER: S-EPMC6292364 | biostudies-other | 2018

REPOSITORIES: biostudies-other

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Project description:Importance:Left ventricular assist devices (LVADs) improve outcomes in patients with advanced heart failure, but little is known about the role of neurohormonal blockade (NHB) in treating these patients. Objective:To analyze the association between NHB blockade and outcomes in patients with LVADs. Design, Setting, and Participants:This retrospective cohort analysis of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) included patients from more than 170 centers across the United States and Canada with continuous flow LVADs from 2008 to 2016 who were alive with the device in place at 6 months after implant. The data were analyzed between February and November 2019. Exposures:Patients were stratified based on exposure to NHB and represented all permutations of the following drug classes: angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, ?-blockers, and mineralocorticoid antagonists. Main Outcomes and Measures:The outcomes of interest were survival at 4 years and quality of life at 2 years based on Kansas City Cardiomyopathy Questionnaire scores and a 6-minute walk test. Results:A total of 12?144 patients in INTERMACS met inclusion criteria, of whom 2526 (20.8% ) were women, 8088 (66.6%) were white, 3024 (24.9%) were African American, and 753 (6.2%) were Hispanic; the mean (SD) age was 56.8 (12.9) years. Of these, 10?419 (85.8%) were receiving NHB. Those receiving any NHB medication at 6 months had a better survival rate at 4 years compared with patients not receiving NHB (56.0%; 95% CI, 54.5%-57.5% vs 43.9%; 95% CI, 40.5%-47.7%). After sensitivity analyses with an adjusted model, this trend persisted with patients receiving triple therapy with an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker, ?-blocker, and mineralocorticoid antagonist having the lowest hazard of death compared with patients in the other groups (hazard ratio, 0.34; 95% CI, 0.28-0.41). Compared with patients not receiving NHB, use of NHB was associated with a higher Kansas City Cardiomyopathy Questionnaire score (66.6; bootstrapped 95% CI, 65.8-67.3 vs 63.0; bootstrapped 95% CI, 60.1-65.8; P?=?.02) and a 6-minute walk test (1103 ft; bootstrapped 95% CI, 1084-1123 ft vs 987 ft; bootstrapped 95% CI, 913-1060 ft; P?<?.001). Conclusions and Relevance:Among patients with LVADs who tolerated NHB therapy, continued treatment was associated with improved survival and quality of life. The optimal heart failure regimen for patients after LVAD implant may be the initiation and continuation of guideline-directed medical therapy.

Project description:BackgroundConcern has been raised about consequences of including patients with left ventricular assist device (LVAD) or heart transplantation in readmission and mortality measures.MethodsWe calculated unadjusted and hospital-specific 30-day risk-standardized mortality (RSMR) and readmission (RSRR) rates for all Medicare fee-for-service beneficiaries with a primary diagnosis of AMI or HF discharged between July 2010 and June 2013. Hospitals were compared before and after excluding LVAD and heart transplantation patients. LVAD indication was measured.ResultsIn the AMI mortality (n = 506,543) and readmission (n = 526,309) cohorts, 1,166 and 1,016 patients received an LVAD while 3 and 2 had a heart transplantation, respectively. In the HF mortality (n = 1,015,335) and readmission (n = 1,254,124) cohorts, 789 and 931 received an LVAD, while 212 and 202 received a heart transplantation, respectively. Less than 2% of hospitals had either ≥6 patients who received an LVAD or, independently, had ≥1 heart transplantation. The AMI mortality and readmission cohorts used 1.8% and 2.8% of LVADs for semi-permanent/permanent indications, versus 73.8% and 78.0% for HF patients, respectively. The rest were for temporary/external indications. In the AMI cohort, RSMR for hospitals without LVAD patients versus hospitals with ≥6 LVADs was 14.8% and 14.3%, and RSRR was 17.8% and 18.3%, respectively; the HF cohort RSMR was 11.9% and 9.7% and RSRR was 22.6% and 23.4%, respectively. In the AMI cohort, RSMR for hospitals without versus with heart transplantation patients was 14.7% and 13.9% and RSRR was 17.8% and 17.7%, respectively; in the HF cohort, RSMR was 11.9% and 11.0%, and RSRR was 22.6% and 22.6%, respectively. Estimations changed ≤0.1% after excluding LVAD or heart transplantation patients.ConclusionHospitals caring for ≥6 patients with LVAD or ≥1 heart transplantation typically had a trend toward lower RSMRs but higher RSRRs. Rates were insignificantly changed when these patients were excluded. LVADs were primarily for acute-care in the AMI cohort and chronic support in the HF cohort. LVAD and heart transplantation patients are a distinct group with differential care requirements and outcomes, thus should be considered separately from the rest of the HF cohort.

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Using left ventricular assist devices in advanced heart failure patients.

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