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).

BACKGROUND: 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. METHODS AND RESULTS: 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. CONCLUSIONS: 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.

Change in health-related quality of life from before to after destination therapy mechanical circulatory support is similar for older and younger patients: analyses from INTERMACS.

BACKGROUND: Destination therapy left ventricular assist devices (DT LVADs) are being implanted in older adults on an increasing basis. Older patients have a higher risk for mortality and morbidity post-LVAD, which may impact their health-related quality of life (HRQOL). We aimed to determine the change in HRQOL by age from before implant to 1 year after DT LVAD implant and identify factors associated with the change. METHODS: Data were collected from 1,470 continuous-flow DT LVAD patients at 108 institutions participating in INTERMACS from January 21, 2010 to March 31, 2012. Patients were divided into three cohorts: <60 years of age (n = 457); 60 to 69 years of age (n = 520); and ≥70 years of age (n = 493). HRQOL was measured using the generic EuroQol instrument (EQ-5D-3L). Data were collected pre-implant and 3, 6 and 12 months post-implant. Statistical analyses included descriptive statistics, Kaplan-Meier survival analyses and multivariable regression analyses. RESULTS: HRQOL improved in all patients. Generally, older patients reported better HRQOL than younger patients pre-implant (≥70 years: mean 40; 60 to 69 years: mean 33; and <60 years: mean 31; p < 0.0001) and 1 year post-implant (≥70 years: mean 77; 60 to 69 years: mean 72; <60 years: mean 70; p = 0.01) using the EQ-5D visual analog scale (VAS), with 0 = worst imaginable health state and 100 = best imaginable health state. The magnitude of improvement in EQ-5D scores from pre-implant to 1-year post-LVAD implant was similar in all age groups (≥70 years: mean change 33; 60 to 69 years: mean change 35; <60 years: mean change 35; p = 0.77). Factors associated with improvement in HRQOL from before to 1 year after implant were a lower VAS score pre-implant and fewer rehospitalizations post-implant (R(2) = 61.3%, p < 0.0001). CONCLUSIONS: Older patients reported better HRQOL than younger patients before and after LVAD implantation. The magnitude of improvement was similar for all age groups, with >70% of all patients showing clinically significant increases (>10 points on the VAS). Rehospitalization appears to reduce the magnitude of improvement.

Changing trends in mechanical circulatory assistance:.

BACKGROUND: The success of long-term implantable ventricular assist devices has led to their increased use in patients previously thought to be unsuitable for mechanical support. As a result, the demographic profile of patients presenting for LVAD support has changed over time. We reviewed our institutional experience to identify emerging risk factors and changing trends in patients who received the HeartMate VE LVAD. METHODS: The clinical records were reviewed of 131 consecutive LVAD recipients between 1996 and 2001. All perioperative data were collected prospectively and entered into an institutional database. All patients received a preoperative risk stratification score based upon published criteria. The cohort was arbitrarily divided into early (n = 45), mid (n = 45), and late groups (n = 41). RESULTS: Overall operative mortality was 25% with no difference between groups. The mean risk score increased significantly over time (early 3.5 +/- 0.4 vs. late 5.3 +/- 0.3, p < 0.05). The proportion of patients at high risk for mortality (score >5) was significantly higher in the late group (51% vs. 29%, p < 0.05). Although ventilation time and ICU stay was similar for all groups, hospital stay was longer in the late group (43 days vs. 23 days, p < 0.05). Mean duration of support fell from 90 to 59 days, but this failed to achieve statistical significance. Out-patient therapy decreased from 73% in the early group to 15% in the late group (p < 0.001). Multivariate analysis identified right heart failure (odds ratio 4.1, 95% CI 2-11) and risk score (OR 1.4, 95% CI 1.2-1.6) as independent predictors of death. CONCLUSIONS: Despite an increasingly high risk patient population, the mortality associated with LVAD therapy has remained constant. Duration of LVAD support has decreased with a trend toward transplantation before hospital discharge. These data continue to support the aggressive institution of mechanical assistance for acute or chronic heart failure.