Implantable Cardioverter Defibrillators and Survival in Continuous-Flow Left Ventricular Assist Device Patients.

The association of an implantable cardioverter defibrillator (ICD) with survival in patients with left ventricular assist devices (LVADs) is not well understood. We evaluated all-cause mortality by the presence of an ICD at the time of LVAD implantation, or by ICD implantation after LVAD placement in 191 patients, using Kaplan-Meier survival analyses and Cox models with multivariate adjustment. During the median follow-up of 23 months, 33 of 129 patients (26%) with an ICD and 17 of 62 patients (27%) without an ICD died. Patients had similar all-cause mortality with or without an ICD before LVAD, after censoring for post-LVAD ICD implantation (log-rank p = 0.889). Multivariate models after adjustments revealed no statistically significant survival benefit from an ICD before LVAD (hazard ratio [HR]: 0.65, 95% CI: 0.27-1.57, p = 0.340). Thirty-one of 62 (50%) patients without an ICD before LVAD implantation subsequently received an ICD after LVAD, although these patients did not have significantly better survival when compared with those with no ICD in a time-dependent analysis (HR: 0.70, 95% CI: 0.25-1.95, p = 0.497). Among LVAD patients, neither a previously implanted ICD nor a new ICD implantation after LVAD yielded statistically significant survival benefit. Further studies are warranted to investigate the role of ICD implantation in LVAD patients.

Readmission Patterns During Long-Term Follow-Up After Left Ventricular Assist Device Implantation.

As more patients are supported for longer periods by a left ventricular assist device (LVAD), hospital readmission is becoming a growing problem. However, data about temporal changes in readmission rates and causes for patients with prolonged LVAD support are limited. We aimed to evaluate rates, causes, and predictors of any and long-term readmission after LVAD placement at our institution. We followed 177 HeartMate II LVAD patients for a mean of 1.90 ± 1.33 years post initial discharge after implantation. A marginal rate model was used to evaluate readmission rates, accounting for mortality. During the first year, the readmission rate was 1.79 (95% confidence interval 1.51 to 2.10) readmissions per year. The readmission rate was 1.54 (95% confidence interval 1.07 to 1.93) 2 to 3 years after initial discharge. There was a further decrease in readmission rate in the 3- to 4-year interval. The most common causes of readmission during the first year and even after 3 to 4 years of LVAD support were bleeding (excluding intracranial bleeding) and infection. Female gender was associated with an increased risk of readmission in multivariable analyses, while blood urea nitrogen was predictive of long-term readmissions. In conclusion, readmission after LVAD implantation is common, but readmission rates decrease during long-term follow-up. Bleeding and infection remain leading causes of readmission during longer follow-up and strategies to decrease these complications may reduce readmission rates. Female patients and patients with renal dysfunction have increased risk of readmission and further studies are needed to improve outcomes in these groups.

Influence of Diabetes Mellitus on Outcomes in Patients After Left Ventricular Assist Device Implantation.

BACKGROUND: Despite previous studies, the mortality risk of patients with diabetes mellitus after left ventricular assist device (LVAD) implant remains unclear. In addition, the relationship between the degree of glycemic control and long-term mortality risk in LVAD patients with diabetes has not been established. METHODS: Ninety-five nondiabetic patients and 96 diabetic patients from the University of Rochester Medical Center who received a HeartMate II (Thoratec, Pleasanton, CA) continuous-flow LVAD between May 2008 and June 2014 were included in this study. The primary outcome was all-cause mortality. Secondary outcomes included rates of infection, neurologic dysfunction, renal dysfunction, and rehospitalization. Kaplan-Meier survival analyses and Cox models were utilized. RESULTS: During follow-up, 32 diabetic patients (33%) and 15 nondiabetic patients (16%) died after LVAD implantation. Cumulative probability of death was higher for diabetic patients when compared with nondiabetic patients (42% versus 21% at 3 years, p = 0.013). There were no significant differences in overall rates of infection, neurologic dysfunction, and rehospitalization between the two groups. However, after an initial secondary outcome event, diabetic patients continued to have a higher mortality rate when compared with nondiabetic patients. There was no statistically significant difference in the risk of death between diabetic patients with pre-LVAD hemoglobin A1c less than 7.0% and diabetic patients with pre-LVAD hemoglobin A1c 7.0% or greater (hazard ratio 1.71, 95% confidence interval: 0.72 to 4.08, p = 0.223). CONCLUSIONS: Diabetic patients who underwent LVAD implantation had a higher risk of death compared with nondiabetic patients. Adverse event rates did not differ between the two groups. Finally, the degree of glycemic control in diabetic patients before LVAD was not found to influence mortality.

Renal Function Changes Following Left Ventricular Assist Device Implantation.

Limited data assessing the clinical significance of post-left ventricular assist device (LVAD) in renal function are available. We aimed to investigate the impact of changes in renal function after LVAD implantation on subsequent long-term outcomes. We followed 184 patients with HeartMate II LVADs implanted between May 2008 and November 2014. Serial assessment of renal function, was performed at baseline and at day 1, day 7, 1 month, 3 months, 6 months, 1 year, and 2 years after implantation. Effects of 1-month GFR and changes in GFR from baseline to 1 month on long-term mortality and hospital re-admission were evaluated. There were 30 patients with GFR <45 (low), 44 with GFR 45 to 59 (intermediate), and 110 with GFR ≥60 (normal) at baseline. Only patients with baseline GFR <45 experienced significant improvement in GFR after 2 years of follow-up (p = 0.012). At 1 month, a higher GFR category was significantly associated with a 31% reduction in mortality (hazard ratio [HR] 0.69, CI 0.49 to 0.98, p = 0.036), but not re-admission. Patients with baseline low and intermediate GFR who had no improvement in renal function category at 1 month experienced significantly greater risk of mortality (HR 1.95, CI 1.10 to 3.43, p = 0.022) and re-admission (HR 1.75, CI 1.07 to 2.84, p = 0.025), relative to patients whose GFR was normal at baseline and 1 month. In conclusion, renal function after LVAD implantation improves in patients with GFR <45. Change in renal function from baseline to 1 month after implantation is a powerful marker of long-term outcomes.

Effect of Gender on the Risk of Neurologic Events and Subsequent Outcomes in Patients With Left Ventricular Assist Devices.

Previous studies have shown that women with continuous-flow left ventricular assist devices (LVADs) are at greater risk of neurologic events. However, the relation between neurologic events and subsequent outcomes by gender is not well understood. We aimed to identify gender differences in the risk of neurologic events in patients with LVAD and the impact of time-dependent neurologic event on all-cause mortality by gender. Our study included 34 women and 157 men who received a HeartMate II LVAD at the University of Rochester Medical Center, Rochester, New York, from May 5, 2008, to June 5, 2014. Neurologic event was defined as a transient ischemic attack or cerebrovascular accident (hemorrhagic or ischemic). During a median follow-up of 25 months, 16 women (47%) and 20 men (13%) had neurologic events. Among patients with neurologic events, 7 women (44%) and 9 men (45%) died. Women had a 4.67-fold greater risk of neurologic events (hazard ratio [HR] 4.67, 95% confidence interval [CI] 2.26 to 9.66, p <0.001) compared with men. Women with neurologic events had an increased risk of all-cause mortality compared to women without neurologic event (HR 4.84, 95% CI 1.33 to 17.55, p = 0.017). Similarly, men with neurologic events had an increased risk of all-cause mortality compared to men without neurologic event (HR 4.20, 95% CI 1.93 to 9.17, p <0.001, interaction p = 0.854). In conclusion, among patients with LVAD, women are at greater risk of neurologic event compared to men. Both women and men after LVAD have similar high risk of all-cause mortality after neurologic events.