Adverse neurologic events in patients bridged with long-term mechanical circulatory support: A device-specific comparative analysis.

BACKGROUND: Neurologic complications are among the principal causes of morbidity and mortality after continuous-flow left ventricular assist device (CF-LVAD) implantation. The aim of this study was to describe a focused "real-world" multicenter comparison of neurologic outcomes between HeartMate II (HMII) and HeartWare HVAD CF-LVAD recipients. METHODS: Between March 2009 and October 2014, 497 patients underwent primary CF-LVAD implantation as a bridge to transplantation at centers included in the Mechanical Circulatory Support Research Network; 314 patients (63%) received HMII, and 183 patients (37%) received HVAD. Ischemic cerebrovascular accident, hemorrhagic cerebrovascular accident, and transient ischemic attack were the neurologic outcomes assessed. RESULTS: Median follow-up time for HMII recipients was 0.95 years (0.48, 1.85, range) and for HVAD recipients was 0.44 years (0.19, 0.97, range) (p < 0.001). HMII recipients had significantly fewer neurologic events per patient year for ischemic cerebrovascular accident (0.071) and transient ischemic attack (0.012) compared with HVAD recipients (0.157 and 0.072, respectively). Univariate analysis showed that 51 HMII recipients (16%) had any neurologic event, whereas 34 HVAD recipients (19%) had any neurologic event (p = 0.504). After adjusting for pre-specified covariates (device type, age, sex, atrial fibrillation, diabetes, and Interagency Registry for Mechanically Assisted Circulatory Support profile), multivariable analysis showed only advanced age was able to predict neurologic events (p = 0.02). Neurologic events were comparable between HMII and HVAD recipients after multivariable analysis. CONCLUSIONS: CF-LVAD placement incurs a low but significant risk of neurologic complications in patients receiving CF-LVADs as a bridge to transplantation. Advancing age is a risk factor for any adverse neurologic outcome. This multicenter analysis demonstrated comparable hazard of adverse neurologic events among patients implanted with HMII or HVAD.

Predictors of death and transplant in patients with a mechanical circulatory support device: a multi-institutional study.

BACKGROUND: INTERMACS is a registry of FDA-approved durable mechanical circulatory support (MCS) devices used for the strategies of destination therapy (DT) and bridge to transplantation (BTT) or recovery. This study identifies predictors for death and transplantation based on initial results from INTERMACS. METHODS: From June 23, 2006 to December 31, 2007, 420 patients from 75 institutions were prospectively entered into the INTERMACS database in which pre-implant data, indication for MCS device use, adverse events, demographics, hemodynamics, laboratory values and outcomes were recorded. Using competing outcomes methodology, risk factors were identified for the events of death and transplantation. RESULTS: The devices included 314 left ventricular assist devices (LVADs), 5 right VADs (RVADs), 77 biventricular VADs (biVADs) and 24 total artificial hearts (TAHs) for a total of 497 pumps in 420 patients. Among the BTT patients at 6 months, 33% were alive with a device in place, 42% were transplanted, 22% had died, and 3% were explanted for recovery. Among the DT patients at 6 months, 68% were alive with a device in place, 5% were transplanted, 25% had died, and 2% were explanted for recovery. The risk factors identified for death across all patient groups include older age (relative risk [RR] = 1.41, p < 0.001), ascites (RR = 2.04, p = 0.003), increased bilirubin (RR = 1.49, p < 0.05) and INTERMACS Level 1 (cardiogenic shock) (RR = 1.59, p = 0.02). The most common causes of death were central nervous system (CNS) event (18.3% of deaths), multiple-organ failure (16.4%) and cardiac cause (right ventricular failure and arrhythmias, 15.4%). CONCLUSIONS: Cardiogenic shock, advanced age and severe right heart failure manifested as ascites or increased bilirubin are risk factors for death after MCS therapy. BTT patients who require biVAD support have a transplant rate similar to that of LVAD-only patients, but their mortality at 6 and 12 months exceeds that of LVAD-only patients. Consideration should be given to MCS referral before the sequelae of right ventricular failure dominate the advanced heart failure syndrome.