A Comparison of Novel Developed Centrifugal-Flow and Conventional Pulsatile-Flow Extracorporeal Left Ventricular Assist Devices as Bridging Strategy in Patients with Refractory Heart Failure; Sub-Analysis of NCVC-BTD_01 Trial

Abstract

Purpose An extracorporeal centrifugal-flow left ventricular assist device (CF-E-LVAD) system (BR16010) was newly developed. Since implantation of the durable implantable LVAD (I-LVAD) is still controversial in patients with cardiogenic shock or refractory heart failure because of its significant inferiority of outcomes as compared with higher INTERMACS profile patients, short-term E-LVADs have been still clinically important for bridging strategy for the next definitive treatment. Our aim of this study was to evaluate the influence of the novel developed CF-E-LVAD on the clinical prognosis in patients with bridging strategy, as compared with conventional extracorporeal pulsatile flow LVAD (PF-E-LVAD). Methods We retrospectively reviewed the medical records of 62 patients who were implanted E-LVAD as bridging strategy from April 2011 to January 2019. Six patients (9.7%) were implanted CF-E-LVAD. The clinical prognosis until 30 days after E-LVAD implantation, and the change of cardiac function and laboratory data at the early follow up were evaluated. Results Improvement of left ventricular ejection fraction was significantly greater in the CF-E-LVAD group than in the PF-E-LVAD group (217.9 [147.8 to 335.3] vs 38.3 [-21.7 to 128.8] %, P=0.010). Serum total bilirubin level significantly improved in CF-E-LVAD group than in the PF-E-LVAD group (-7.9 [-33.3 to 82.4] vs 68.8 [10.0 to 202.1] %, P=0.041). Although clinical courses, including death, cerebrovascular accidents and re-thoracotomy due to removal of mediastinal hematoma, were no significant difference between two groups, almost half (54.5%) in the PF-E-LVAD group was still ongoing the E-LVAD support at the 30 days post-E-LVAD implantation while only one patient (16.7%) was supported with E-LVAD in the CF-E-LVAD group. Conclusion The novel developed CF-E-LVAD system might influence on the earlier recovery of cardiac function and the multiple organ failure, and lead to the earlier decision for next definitive strategy.