Grupper, Avishay

Background: While implantation of left ventricular assist devices (LVAD) improves survival and quality of life in patients with advanced heart failure, very little is known about healthcare resource utilization, including hospital readmissions, post-LVAD. Methods: Administrative claims data from a large, national US health plan were used to identify privately insured and Medicare Advantage patients that received an LVAD (ICD-9-CM code 37.66) and survived to hospital discharge from January 1, 2006 through 31 August 31, 2013, and had at least six months coverage pre-LVAD. The individuals covered by this health plan, about 88 million in years 2003 to 2013, are geographically dispersed across the United States, with greatest representation in the South and Midwest census regions. Reasons for subsequent readmissions were categorized according to the AHRQ Clinical Classifications Software and risk factors for readmission analyzed using multiple failure Cox regression analysis. Patients were censored at the time of heart transplantation or end of coverage through November 30, 2013. Results: In total, 857 patients received an LVAD, of whom 693 (81%) survived to hospital discharge without undergoing heart transplantation (mean age 56 years, 77% male). After a median follow-up of 0.69 (interquartile range [IQR]: 0.31, 1.50) years, 1,659 readmissions occurred among 509 patients. Over this period, patients spent a median of 10.5 days (IQR: 0 -40 days) per followup year hospitalized. The number of readmissions per patient varied widely (0 to 20 per person), with 184 (26.6%) patients experiencing no readmissions, while 112 (16.2%) had 5 or more readmissions during follow-up. The most common reasons for readmission were device complications (291 readmissions in 155 patients), heart failure (246 readmissions in 135 patients), gastrointestinal bleeding (90 readmissions in 52 patients), and arrhythmia (88 readmissions in 55 patients). Readmission risk was higher in patients who had longer initial length of stay and more comorbid conditions. Discussion: There is tremendous variability in the readmission burden experienced post-LVAD, with some patients experiencing no readmissions while others are repeatedly hospitalized. LVAD therapy introduces a unique set of problems that often prompt readmission including device complications and gastrointestinal bleeding.

AbstractSoluble ST2 (sST2) is a novel biomarker of inflammation and fibrosis. Elevated sST2 levels (≥35 ng/mL) are associated with worse outcomes in patients with heart failure (HF). There are sparse data regarding the significance of sST2 levels after heart transplantation (HTx). The study aims were to evaluate trends in soluble ST2 levels after the resolution of HF status with HTx and association between post‐HTx sST2 levels and outcomes. Plasma sST2 levels were measured at baseline (median [IQR] of 118 days pre‐HTx) and 12 months post‐HTx in 62 subjects who were stratified into two groups by post‐HTx sST2 levels < or ≥35 ng/mL: “Group 1” or “Group 2,” respectively. Plasma sST2 levels were elevated in 58% of patients pre‐HTx and in 50% of patients post‐HTx. There was no association between elevated sST2 levels before and after HTx, and no significant differences in baseline characteristics between Group 1 and Group 2 patients. Group 2 as compared to Group 1 HTx recipients had significantly higher incidence of antibody‐mediated rejection (AMR) for the entire post‐transplant follow‐up period (32% vs 4%, P = 0.006). There was no association between post‐HTx sST2 level status and other post‐HTx outcomes including survival. In conclusion, elevated plasma sST2 levels after HTx are associated with increased risk for AMR.

Renal function improves early after left ventricular assist device (LVAD) implantation but later decline has been observed. We sought to determine the occurrence and evaluate possible causes for this decline. In 62 consecutive patients with HeartMateII LVAD with available calculated glomerular filtration rate (GFR, ml/min/1.73 m2) 1 year after implant, GFR was assessed repeatedly and possible predictors for decline from 3 to 12 months were investigated. Post-mortem renal specimens for patients supported with an LVAD were evaluated. GFR 54.5 ± 19.5 at admission increased to 66.4 ± 22.3 preoperatively and to 79.2 ± 30.1 ~1 month after implantation. Subsequently at ~3 months GFR declined to 74.7 ± 25.4, at ~6 months to 68.8 ± 23.1, and ~1 year after implant to 63.9 ± 17.7. Glomerular filtration rate at 1 year was significantly lower (p < 0.0001, p < 0.0001, p = 0.005) than GFR 1, 3, and 6 months after implant. Early rise in GFR after surgery was not associated with late decline. Shorter bypass time (β = −0.09, p = 0.048) and higher albumin 3 months after LVAD (β = 14.4, p = 0.025) were significantly associated with less later decline in GFR. Arteriosclerosis was identified in autopsy renal specimens. In conclusion, early gains in renal function after LVAD implant are not sustained in many patients. Patient, device, and operative factors may influence long-term renal function in these patients.

Background Pregnancies may result in antibodies against HLA, a risk factor for antibody-mediated rejection (AMR) and subsequent cardiac allograft vasculopathy (CAV) after heart transplantation (HTx). The aim of this study was to evaluate sex differences in the incidence of AMR events and subsequent risk of CAV among HTx recipients. Methods The study comprised 160 patients (51 [32%] women) who underwent HTx in 2008 to 2014. The cumulative effect of AMR events was calculated by AMR score (sum of myocardial biopsy grading divided by number of biopsies taken during 3 years post-HTx). Results Females had higher levels of anti-HLA I antibodies pre-HTx compared to males which was associated with a history of pregnancies, total number of children and with a higher AMR score at 6 months post-HTx (P < 0.05). Women demonstrated a significant increase in the total incidence of AMR events (27 vs. 7%, P = 0.001) and in AMR scores at 6, 12, 24 and 36 months post-HTx compared to men (P < 0.05). There were no differences in cellular rejection between the groups. A history of AMR events was associated with a significantly increased risk of severe CAV onset (hazard ratio, 7.0; 95% confidence interval, 1.5-31.5; P = 0.012). Conclusions Women are at higher risk for AMR post-HTx which subsequently increases their risk for CAV. Females recipients may benefit from closer surveillance to identify AMR at an earlier stage post-HTx, and targeted immunosuppressive therapy to attenuate the development of CAV.