Dataset Information

Aortic Insufficiency During Contemporary Left Ventricular Assist Device Support: Analysis of the INTERMACS Registry.

ABSTRACT: OBJECTIVES:This study sought to evaluate the impact of moderate to severe aortic insufficiency (AI) on outcomes in patients with continuous flow left ventricular assist devices (CF-LVADs). BACKGROUND:Development of worsening AI is a common complication of prolonged CF-LVAD support and portends poor prognosis in single-center studies. Predictors of worsening AI and its impact on clinical outcomes have not been examined in a large cohort. METHODS:We conducted a retrospective analysis of patients with CF-LVAD in the INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) study. Development of significant AI was defined as the first instance of at least moderate AI. Primary outcomes of interest were survival after development of significant AI and time to adverse events, including device complications and rehospitalizations. RESULTS:Among 10,603 eligible patients, 1,399 patients on CF-LVAD support developed moderate to severe AI. Prevalence of significant AI progressively increased over time. Predictors of worsening AI included older age, female sex, smaller body mass index, mild pre-implantation AI, and destination therapy strategy. Moderate to severe AI was associated with significantly higher left ventricular end-diastolic diameter, reduced cardiac output, and higher levels of brain natriuretic peptide. Significant AI was associated with higher rates of rehospitalization (32.1% vs. 26.6%, respectively, at 2 years; p = 0.015) and mortality (77.2% vs. 71.4%, respectively, at 2 years; p = 0.005), conditional upon survival to 1 year. CONCLUSIONS:Development of moderate to severe AI has a negative impact on hemodynamics, hospitalizations, and survival on CF-LVAD support. Pre- and post-implantation management strategies should be developed to prevent and treat this complication.

SUBMITTER: Truby LK

PROVIDER: S-EPMC6217859 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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Aortic Insufficiency During Contemporary Left Ventricular Assist Device Support: Analysis of the INTERMACS Registry.

Truby Lauren K LK Garan A Reshad AR Givens Raymond C RC Wayda Brian B Takeda Koji K Yuzefpolskaya Melana M Colombo Paolo C PC Naka Yoshifumi Y Takayama Hiroo H Topkara Veli K VK

JACC. Heart failure 20181101 11

<h4>Objectives</h4>This study sought to evaluate the impact of moderate to severe aortic insufficiency (AI) on outcomes in patients with continuous flow left ventricular assist devices (CF-LVADs).<h4>Background</h4>Development of worsening AI is a common complication of prolonged CF-LVAD support and portends poor prognosis in single-center studies. Predictors of worsening AI and its impact on clinical outcomes have not been examined in a large cohort.<h4>Methods</h4>We conducted a retrospective ...[more]

PMID: 30384913

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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.

Project description:AimsDonor heart shortage leads to increasing use of left ventricular assist device (LVAD) as bridge-to-transplant or destination therapy. Prolonged LVAD support is associated with aortic valve insufficiency, representing a relevant clinical problem in LVAD patients. Nevertheless, the impact of LVAD support on inflammation, remodelling, and chondro-osteogenic differentiation of the aortic valve is still not clearly understood. The aim of the study is to evaluate the impact of LVAD support on structural and molecular alterations of the aortic valve.Methods and resultsDuring heart transplantation, aortic valves of 63 heart failure patients without (n = 22) and with LVAD support (n = 41) were collected and used for analysis. Data on clinical course as well as echocardiographic data were analysed. Calcification and markers of remodelling, chondro-osteogenic differentiation, and inflammation were evaluated by computed tomography, by mRNA analysis and by histology and immunohistochemistry. Expression of inflammation markers of the LVAD group was analysed with regard to levels of C-reactive protein and driveline infections. Calcium accumulation and mRNA expression of determined markers were correlated with duration of LVAD support. Data were also analysed relating to aortic valve opening and aortic valve insufficiency. There was no difference in the frequency of cardiovascular risk factors or comorbidities between the patient groups. Expression of matrix metalloproteinase-9 (P = 0.007), alpha-smooth muscle actin (P = 0.045), and osteopontin (P = 0.003) were up-regulated in aortic valves of LVAD patients. Histological appearance of the aortic valve was similar in patients with or without LVAD, and computed tomography-based analysis not yet revealed significant difference in tissue calcification. Expression of interferon gamma (P = 0.004), interleukin-1 beta (P < 0.0001), and tumour necrosis factor alpha (P = 0.04) was up-regulated in aortic valves of LVAD patients without concomitant inflammatory cell infiltration and independent from unspecific inflammation. Expression of matrix metalloproteinase-2 (P = 0.038) and transforming growth factor beta (P = 0.0504) correlated negatively with duration of LVAD support. Presence of aortic valve insufficiency led to a significantly higher expression of interferon gamma (P = 0.007) in LVAD patients. There was no alteration in the determined markers in relation to aortic valve opening in LVAD patients.ConclusionsLeft ventricular assist device support leads to signs of early aortic valve degeneration independent of support duration. Thus, the aortic valve of patients with LVAD support should be closely monitored, particularly in patients receiving destination therapy as well as in the prospect of using aortic valves of LVAD patients as homografts in case of bridge-to-transplant therapy.

Project description:ObjectivesThis study examined patient outcomes after left ventricular assist device (LVAD) implantation across a range of center surgical volumes.BackgroundIn order for a center to qualify for reimbursement, Centers for Medicare and Medicaid Services (CMS) requires it to implant ≥10 LVADs or total artificial hearts over a 3-year period. The impact of center LVAD surgical volumes on patient outcomes has not been thoroughly scrutinized.MethodsCenter volumes were provided for 7,416 patients undergoing LVAD implantation who were enrolled in INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support). Center LVAD volume was categorized as either very low (≤10 implants/year, n = 617), low (11 to 30 implants/year, n = 2,561), medium (31 to 50 implants/year, n = 2,458), or high (>50 implants/year, n = 1,750). The main outcome of interest was patient survival based on center volume derived from Kaplan-Meier and multivariate Cox regression.ResultsOverall survival was associated with center volume (p = 0.003), as follows: 71 ± 1.8% (very low volume), 81 ± 0.8% (low volume), 83 ± 0.8% (medium volume), and 79 ± 1.0% (high volume) at 1 year. Compared with medium volume centers, the 90-day mortality was higher in very low volume (odds ratio [OR]: 1.35; p = 0.04) and high volume (OR: 1.28; p = 0.018) VAD centers. The adjusted hazard ratios (HRs) for mortality were 1.32 (95% confidence interval [CI]: 1.11 to 1.56), 1.07 (95% CI: 0.95 to 1.21), and 1.17 (95% CI: 1.03 to 1.30) for very low, low, and high volume centers, respectively. Center volume did not predict mortality (p = 0.25; n = 3,688) in INTERMACS profile 1 patients (patients who had sustained cardiogenic shock) and profile 2 patients (patients with progressive hemodynamic decline despite inotropes).ConclusionsCenter volume correlates with post-VAD survival, with worse survival noted at very-low volume centers. These findings suggest that current U.S. VAD center standards warrant reconsideration.

Dataset Information

Aortic Insufficiency During Contemporary Left Ventricular Assist Device Support: Analysis of the INTERMACS Registry.

Publications

Aortic Insufficiency During Contemporary Left Ventricular Assist Device Support: Analysis of the INTERMACS Registry.

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