Time in Therapeutic Range Significantly Impacts Survival and Adverse Events in Destination Therapy Patients.

The study aim was to examine the impact time in therapeutic range (TTR, International Normalized Ratio [INR] 2.0-3.0) has on survival and adverse events in patients receiving the HeartWare HVAD System in the ENDURANCE and ENDURANCE Supplemental Trials. Evaluable subjects (n = 495) had >1 INR value recorded 1-24 months postimplant and were categorized as: low TTR (10-39%), moderate TTR (40-69%), and high TTR (≥70%). Baseline characteristics, adverse events, and survival were analyzed. Low TTR patients experienced higher rates of major bleeding (1.69 vs. 0.54 events per patient year [EPPY]; p < 0.001), GI bleeding (1.22 vs. 0.38 EPPY; p < 0.001), stroke (0.47 vs. 0.17 EPPY; p < 0.001), thrombus requiring exchange (0.05 vs. 0.01 EPPY; p = 0.02), infection (1.44 vs. 0.69 EPPY; p < 0.001), and renal dysfunction (0.23 vs. 0.05 EPPY; p < 0.001) compared with high TTR. Moderate TTR had higher rates of major bleeding (0.75 vs. 0.54 EPPY; p < 0.001), thrombus requiring exchange (0.05 vs. 0.01 EPPY; p = 0.007), cardiac arrhythmia (0.32 vs. 0.24 EPPY; p = 0.04), and infection (0.90 vs. 0.69 EPPY; p = 0.001) compared with high TTR. Two year survival was greater among moderate and high versus low cohorts (Log-rank p = 0.001). The significant reduction in morbidity and mortality in destination therapy (DT) HVAD patients with well-controlled TTR (≥70%) emphasizes the importance of vigilant anticoagulation management.

Multicenter experience with durable biventricular assist devices.

BACKGROUND: Severe right ventricular failure necessitating a right ventricular assist device (RVAD) complicates 6% to 11% of left ventricular assist device (LVAD) implants. Patient outcomes for those receiving durable continuous-flow VADs in a biventricular configuration (i.e., BiVAD) have been reported in limited case series. METHODS: Data from United States centers with ≥ 6 BiVAD implants were collected. Characteristics and outcomes of patients receiving contemporaneous (i.e., same surgery) vs staged implantation of the HVAD as a BiVAD were compared. RESULTS: From 2011 to 2017, 46 patients received durable BiVADs and had the following characteristics: median age, 46 years (interquartile range [IQR], 19-67 years), non-ischemic cardiomyopathy (80%), bridge to transplant (83%), Interagency Registry for Mechanically Assisted Circulatory Support Profile 1 or 2 (92%), use of temporary circulatory support (37%), right atrial pressure 19 mm Hg (IQR, 14-23 mm Hg), and cardiac index of 1.6 liters/min/m2 (IQR, 1.2-2.1 liters/min/m2). Operative mortality was 33%. Equal numbers of patients received a right atrial or right ventricular implant. Contemporaneous BiVAD implantation occurred in 31 patients (67%), and compared with 15 patients (33%) with staged implants, these patients had a shorter intensive care unit length of stay of 12 days (IQR, 7-23 days) vs 42 days (IQR, 28-48 days, p = 0.035) and were more likely to be discharged from the hospital on BiVAD support (61% vs 27%, p = 0.04). RVAD thrombosis developed in 17 patients (37%). Patients with contemporaneous BiVAD implants had a 1-year survival of 74% compared with 40% in staged BiVAD patients (p = 0.11). CONCLUSIONS: Patients receiving durable BiVADs represent a critically ill patient population with severe biventricular failure who have high operative mortality and RVAD thrombosis rates. The 1-year survival for patients receiving contemporaneous BiVADs in experienced centers mirrors other contemporary durable biventricular support strategies.