Novel Extracorporeal Continuous-Flow Ventricular Assist System for Patients with Advanced Heart Failure

Purpose Ventricular Assist devices are essential but challenging therapeutic options for advanced heart failure patients with critical conditions including cardiogenic shock. In such cases, bridge to decision (BTD) strategies using temporary mechanical circulatory (MCS) support should be introduced to stabilize the systemic conditions and to connect to the next therapeutic stages. We conducted a clinical study (NCVC-BTD_01, National Cerebral and Cardiovascular Center-Bridge to Decision_01) to assess the safety and effectiveness of the novel developed extracorporeal continuous-flow ventricular assist system employing a disposable and hydrodynamically leviated centrifugal pump (BR16010) for BTD strategies. Methods NCVC-BTD_01 is a single-center, single-arm, open-label, exploratory, medical device, investigator-initiated clinical study. The study was planned using Simon's minimax two-stage phase design. The primary endpoint is a composite of survival free of device-related serious adverse events and complications during device support. Results A total of nine patients (6 males, average 47.7±8.1 years) were enrolled for the study. Study subjects included 3 dilated cardiomyopathy, 3 fulminant myocarditis, 2 acute myocardial infarction and 1 chronic ischemic cardiomyopathy. Six patients were interagency registry for mechanically circulatory support (INTERMACS) profile 1 with temporary MCS and all remaining were INTERMACS profile 2. Eight patients received left ventricular support of which 3 initially received concomitant right ventricular support using extracorporeal membrane oxygenation circuit due to severe respiratory failure. One patient with fulminant myocarditis received biventricular support both using BR16010. After average of 19.0±13.5 days of support (Range, 9 to 48 days), 3 patients weaned from BR16010 because of native cardiac recovery, whereas 6 patients without cardiac recovery required conversion to durable implantable LVAD for bridge to transplantation. Although 1 patient developed non-disabling ischemic stroke, no patient died during the study period. Conclusion From the result of NCVC-BTD_01, BTD strategies using BR16010 safely and successfully bridged patients with advanced heart failure to the next therapeutic stages.