Dataset Information

Causes and Consequences of Missing Health-Related Quality of Life Assessments in Patients Who Undergo Mechanical Circulatory Support Implantation: Insights From INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support).

ABSTRACT: Missing health-related quality of life (HRQOL) data in longitudinal studies can reduce precision and power and bias results. Using INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support), we sought to identify factors associated with missing HRQOL data, examine the impact of these factors on estimated HRQOL assuming missing at random missingness, and perform sensitivity analyses to examine missing not at random (MNAR) missingness because of illness severity.INTERMACS patients (n=3248) with a preimplantation profile of 1 (critical cardiogenic shock) or 2 (progressive decline) were assessed with the EQ-5D-3L visual analog scale and Kansas City Cardiomyopathy Questionnaire-12 summary scores pre-implantation and 3 months postoperatively. Mean and median observed and missing at random-imputed HRQOL scores were calculated, followed by sensitivity analyses. Independent factors associated with HRQOL scores and missing HRQOL assessments were determined using multivariable regression. Independent factors associated with preimplantation and 3-month HRQOL scores, and with the likelihood of missing HRQOL assessments, revealed few correlates of HRQOL and missing assessments (R2 range, 4.7%-11.9%). For patients with INTERMACS profiles 1 and 2 and INTERMACS profile 1 alone, missing at random-imputed mean and median HRQOL scores were similar to observed scores, before and 3 months after implantation, whereas MNAR-imputed mean scores were lower (?5 points) at baseline but not at 3 months.We recommend use of sensitivity analyses using an MNAR imputation strategy for longitudinal studies when missingness is attributable to illness severity. Conduct of MNAR sensitivity analyses may be less critical after mechanical circulatory support implant, when there are likely fewer MNAR data.

SUBMITTER: Grady KL

PROVIDER: S-EPMC5737781 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

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Causes and Consequences of Missing Health-Related Quality of Life Assessments in Patients Who Undergo Mechanical Circulatory Support Implantation: Insights From INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support).

Grady Kathleen L KL Jones Philip G PG Cristian-Andrei Adin A Naftel David C DC Myers Susan S Dew Mary Amanda MA Idrissi Katharine K Weidner Gerdi G Wissman Sherri A SA Kirklin James K JK Spertus John A JA

Circulation. Cardiovascular quality and outcomes 20171201 12

<h4>Background</h4>Missing health-related quality of life (HRQOL) data in longitudinal studies can reduce precision and power and bias results. Using INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support), we sought to identify factors associated with missing HRQOL data, examine the impact of these factors on estimated HRQOL assuming missing at random missingness, and perform sensitivity analyses to examine missing not at random (MNAR) missingness because of illness sever ...[more]

PMID: 29246883

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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: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.

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Dataset Information

Causes and Consequences of Missing Health-Related Quality of Life Assessments in Patients Who Undergo Mechanical Circulatory Support Implantation: Insights From INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support).

Publications

Causes and Consequences of Missing Health-Related Quality of Life Assessments in Patients Who Undergo Mechanical Circulatory Support Implantation: Insights From INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support).

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