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Outcomes with ambulatory advanced heart failure from the Medical Arm of Mechanically Assisted Circulatory Support (MedaMACS) Registry.

ABSTRACT: BACKGROUND:The outlook for ambulatory patients with advanced heart failure (HF) and the appropriate timing for left ventricular assist device (LVAD) or transplant remain uncertain. The aim of this study was to better understand disease trajectory and rates of progression to subsequent LVAD therapy and transplant in ambulatory advanced HF. METHODS:Patients with advanced HF who were New York Heart Association (NYHA) Class III or IV and Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) Profiles 4 to 7, despite optimal medical therapy (without inotropic therapy), were enrolled across 11 centers and followed for the end-points of survival, transplantation, LVAD placement, and health-related quality of life. A secondary intention-to-treat survival analysis compared outcomes for MedaMACS patients with a matched group of Profile 4 to 7 patients with LVADs from the INTERMACS registry. RESULTS:Between May 2013 and October 2015, 161 patients were enrolled with INTERMACS Profiles 4 (12%), 5 (32%), 6 (49%), and 7 (7%). By 2 years after enrollment, 75 (47%) patients had reached a primary end-point with 39 (24%) deaths, 17 (11%) undergoing LVAD implantation, and 19 (12%) receiving a transplant. Compared with 1,753 patients with Profiles 4 to 7 receiving LVAD therapy, there was no overall difference in intention-to-treat survival between medical and LVAD therapy, but survival with LVAD therapy was superior to medical therapy among Profile 4 and 5 patients (p?=?0.0092). Baseline health-related quality of life was lower among patients receiving a LVAD than those enrolled on continuing oral medical therapy, but increased after 1 year for survivors in both cohorts. CONCLUSIONS:Ambulatory patients with advanced HF are at high risk for poor outcomes, with only 53% alive on medical therapy after 2 years of follow-up. Survival was similar for medical and LVAD therapy in the overall cohort, which included the lower severity Profiles 6 and 7, but survival was better with LVAD therapy among patients in Profiles 4 and 5. Given the poor outcomes in this group of advanced HF patients, timely consideration of transplant and LVAD is of critical importance.

SUBMITTER: Ambardekar AV

PROVIDER: S-EPMC6452871 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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Outcomes with ambulatory advanced heart failure from the Medical Arm of Mechanically Assisted Circulatory Support (MedaMACS) Registry.

Ambardekar Amrut V AV Kittleson Michelle M MM Palardy Maryse M Mountis Maria M MM Forde-McLean Rhondalyn C RC DeVore Adam D AD Pamboukian Salpy V SV Thibodeau Jennifer T JT Teuteberg Jeffrey J JJ Cadaret Linda L Xie Rongbing R Taddei-Peters Wendy W Naftel David C DC Kirklin James K JK Stevenson Lynne W LW Stewart Garrick C GC

The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation 20181001 4

<h4>Background</h4>The outlook for ambulatory patients with advanced heart failure (HF) and the appropriate timing for left ventricular assist device (LVAD) or transplant remain uncertain. The aim of this study was to better understand disease trajectory and rates of progression to subsequent LVAD therapy and transplant in ambulatory advanced HF.<h4>Methods</h4>Patients with advanced HF who were New York Heart Association (NYHA) Class III or IV and Interagency Registry for Mechanically Assisted ...[more]

PMID: 30948210

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Project description:BackgroundAn optimal blood pressure (BP) range to mitigate morbidity and mortality on left ventricular assist device (LVAD) support has not been clearly defined.MethodsAverage Doppler opening pressure, mean arterial pressure (MAP), and/or systolic blood pressure (SBP) were calculated in operative survivors (n = 16,155) of LVAD support in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). BP distributions were used to group patients into low (BP <25th percentile), normal (25-75th percentile), high (75th-95th percentile), and very high (>95th percentile). Associations between BP and adverse events were evaluated using Cox regression (hazard ratio[HR], 95% confidence interval).ResultsThe median (25th, 75th) MAP, Doppler, and SBP (mm Hg) during continuous flow LVAD support were 84 (77, 90), 85 (80, 92), and 99 (90, 107) mm Hg, respectively. BP had a bimodal risk association with survival. At 3 years, survival was 58% ± 1.8% in those with low MAP (≤75 mm Hg) vs 70% ± 0.9%, 71% ± 1.5%, and 63% ± 3.0% in the those with normal, high, or very high average MAP, respectively. Patients with chronically low MAP (≤75 mm Hg), Doppler (≤80 mm Hg), and SBP (<90 mm Hg) had 35%-42% higher adjusted hazards of death than patients with normal or high BP (p ≤ 0.0001). Patients with MAP >100 mm Hg, Doppler ≥105 mm Hg, and SBP ≥120 mm Hg had 17%-20% higher adjusted hazards of death than those with normal pressures (p < 0.05). In patients on axial flow LVADs, elevated SBP (HR 1.08 [95% confidence interval, 1.04-1.13] per 10 mm Hg increase) but not MAP correlated with increased incident of stroke.ConclusionsIn INTERMACS, BP extremes during LVAD support increase the risk for adverse events, supporting a MAP goal >75 mm Hg and <90 mm Hg. Hypotension conferred the highest risk for mortality. Excessive BP control should be avoided, and Doppler opening pressure should not be assumed to represent MAP in all patients.

Project description:Time course and predictors of myocardial recovery on contemporary left ventricular assist device support are poorly defined because of limited number of recovery patients at any implanting center. This study sought to investigate myocardial recovery using multicenter data from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). Thirteen thousand four hundred fifty-four adult patients were studied. Device explant rates for myocardial recovery were 0.9% at 1-year, 1.9% at 2-year, and 3.1% at 3-year follow-up. Independent predictors of device explantation for recovery were age <50 years (odds ratio [OR] 2.5), nonischemic etiology (OR 5.4), time since initial diagnosis <2 years (OR 3.4), suboptimal heart failure therapy before implant (OR 2.2), left ventricular end-diastolic diameter <6.5 cm (OR 1.7), pulmonary systolic artery pressure <50 mm Hg (OR 2.0), blood urea nitrogen <30 mg/dL (OR 3.3), and axial-flow device (OR 7.6). Patients with myocarditis (7.7%), postpartum cardiomyopathy (4.4%), and adriamycin-induced cardiomyopathy (4.1%) had highest rates of device explantation for recovery. Use of neurohormonal blockers on left ventricular assist device support was significantly higher in patients who were explanted for recovery. Importantly, 9% of all left ventricular assist device patients who were not explanted for recovery have demonstrated substantial improvement in left ventricular ejection fraction (partial recovery) and had remarkable overlap in clinical characteristic profile compared with patients who were explanted for recovery (complete recovery). Complete and partial recovery rates have declined in parallel with recent changes observed in device indications and technology. Myocardial recovery is a spectrum of improvement rather than a binary clinical end point. One in every 10 left ventricular assist device patients demonstrates partial or complete myocardial recovery and should be targeted for functional assessment and optimization.

Dataset Information

Outcomes with ambulatory advanced heart failure from the Medical Arm of Mechanically Assisted Circulatory Support (MedaMACS) Registry.

Publications

Outcomes with ambulatory advanced heart failure from the Medical Arm of Mechanically Assisted Circulatory Support (MedaMACS) Registry.

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