A Novel Extracorporeal Continuous-Flow Ventricular Assist System for Patients With Advanced Heart Failure　― Initial Clinical Experience ―

Abstract

Background: Bridge-to-decision (BTD) devices providing temporary mechanical circulatory support should be introduced to patients with advanced heart failure. This study evaluated the effectiveness and safety of a BTD device comprising an innovative extracorporeal continuous-flow temporary ventricular assist device (VAD) driven by a novel hydrodynamically levitated centrifugal flow blood pump.Methods and Results: Nine patients, comprising 3 with dilated cardiomyopathy, 3 with fulminant myocarditis, and 3 with ischemic heart disease, and 6 males, whose mean age was 47.7±8.1 years, were enrolled into the study. Six patients had Interagency Registry for Mechanically Assisted Circulatory Support profile 1, and 3 were profile 2. The primary endpoint was a composite of survival free from device-related serious adverse events and complications during circulatory support. Eight patients received left ventricular support, of whom 3 received concomitant right ventricular support using extracorporeal membrane oxygenation circuits, as a consequence of severe respiratory failure. One patient with fulminant myocarditis received biventricular support using the novel VAD system. After 19.0±13.5 days, 3 patients were weaned from circulatory support, because their native cardiac function recovered, and 6 patients required conversion to a durable device as a bridge-to-transplantation. One patient had non-disabling ischemic stroke episodes, and no patients died. Conclusions:This novel extracorporeal VAD system with a hydrodynamically levitated centrifugal pump can safely and successfully bridge patients with advanced heart failure to subsequent therapeutic stages.

Prognostic impact of lung computed tomography density in cardiogenic shock patients with veno‐arterial extracorporeal membrane oxygenation

“…14,15 The last reason is that our policy for MCS escalation has been updated recently and tailored to the condition of each patient. [16][17][18][19] For these reasons, our study population appeared to have a better survival rate. However, there is still room for improved patient management before MCS escalation, and our study provides important evidence for improving this management.…”

Mechanical circulatory support for adults in Japan: A 10‐year perspective

“…Furthermore, in cases of pulmonary hemorrhage due to severe preoperative pulmonary congestion, pulmonary perfusion provided by biventricular support may aggravate congestion and bleeding, which can be treated by switching the outflow cannula from the PA to the left atrium as veno‐left atrial ECMO 17 . A novel centrifugal pump with a hydrodynamically levitated impeller was recently developed and approved for use as extracorporeal system for mid‐term circulatory support (BIOFLOAT‐NCVC® Ventricular Assist Device System; NIPRO, Osaka, Japan) after a clinical trial in Japan 18 . As a less invasive approach for left ventricular support, a percutaneously placed axial‐flow pump catheter, Impella® (Abiomed, Danvers, MA, USA) was approved for cardiogenic shock in Japan in 2017.…”

“…17 A novel centrifugal pump with a hydrodynamically levitated impeller was recently developed and approved for use as extracorporeal system for mid-term circulatory support (BIOFLOAT-NCVC® Ventricular Assist Device System; NIPRO, Osaka, Japan) after a clinical trial in Japan. 18 As a less invasive approach for left ventricular support, a percutaneously placed axial-flow pump catheter, Impella® (Abiomed, Danvers, MA, USA) was approved for cardiogenic shock in Japan in 2017. In the 4 years since its approval, the Impella has been used in more than 4000 cases at 222 institutions in Japan with its usefulness reported for patients with fulminant myocarditis, 19 and those with a ventricular septal defect due to AMI, 20,21 as well as patients who received an Impella as a bridge to implantable LVAD.…”

JCS/JSCVS/JATS/JSVS 2021 Guideline on Implantable Left Ventricular Assist Device for Patients With Advanced Heart Failure

“…[45][46][47] Expansion of the indications for VADs or obtaining approval of long-term durable centrifugal pumps in BTD through physician-led trials is a critical necessity. 48,49 In children aged ≥10 years, who rarely present with respiratory failure, VAD therapy should be considered if signs of multiple organ failure such as hepatic and renal dysfunction, eating difficulty, and malnutrition progress under inotropic therapy.…”

“…101 In patients with left ventricular bypass using a centrifugal pump for temporary support, replacement with implantable LVAD is indicated as BTD in Europe and the USA, 102 and the development of such a BTD protocol is urgently needed in Japan as well. 49 IMPELLA, a pump catheter for assisted circulation, is also used for temporary circulatory support until LVAD implantation. 103 Because VA-ECMO uses an artificial lung, coagulation factors and platelets are consumed, and bleeding complications often occur.…”