Employment centrifugal pump associated with the use of cannulas long stay for ventricular assist as bridge to transplantation

• Grant number: 16/01572-6
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Start date: November 01, 2016
• End date: October 31, 2017
• Field of knowledge: Health Sciences - Medicine - Surgery
• Principal Investigator: Luiz Fernando Canêo
• Grantee: Rafael Ceconi
• Host Institution: Instituto do Coração Professor Euryclides de Jesus Zerbini (INCOR). Hospital das Clínicas da Faculdade de Medicina da USP (HCFMUSP). Secretaria da Saúde (São Paulo - Estado). São Paulo , SP, Brazil

Abstract

Although heart transplantation is considered the gold standard therapy for the advanced heart failure, donor shortage, especially in pediatric patients, is the main limitation for this procedure. The mortality ratio on the waiting list is higher than 32% inpatients status I. The use of any kind of mechanical circulatory support improves hemodynamically these patients, contributing to the reduction of mortality before and after the pediatric heart transplantation. In our country the high cost of these devices, especially for the pulsatile par corporeal ventricular assist device (VAD), limits its indication. The use of centrifugal pump and long term implantable VAD cannulas has been shown an effective and less costly short-term device when used as a bridge to transplantation in selected patients. Although considered to be a short-term device, the mean waiting list time in our country justifies their use. Objective: to analyze the impact on the survival ratio for those patients waiting a heart transplantation using centrifugal pump and long term implantable VAD cannulas. Material and Methods: this study is a prospective, not randomized, clinical trial, in a group of patients with cardiomyopathy and cardiogenic shock (Interagency Registry for Mechanically Assisted Circulatory Support - INTERMACS levels 1 and 2). Centrifugal pump (Centrimag: PedVas, Thoratech, USA and Rotaflow: Maquet, German) and long-term implantable VAD cannulas (developed for the use with the pulsatile para corporealInCor VAD, Bioengineering Division - InCor-HC-USP) will be used as bridge to transplantation. Patients listed for cardiac transplantation and not eligible to the device implantation, either by family refusal or unavailability of equipment, will be used as control group in this study. Will be considered as the primary endpoint: success full transplantation or removal from the waiting list due to recovery, death or clinical deterioration that compromises the transplantation result. Will be considered as secondary endpoint any hospitalar death occurred during the post transplantation period. Expected results: we expect a reduction of 50% in the waiting list mortality ratio during the first 30 days (patients INTERMACS 1 and 2). Survival greater than 30% in the group who underwent VAD implantation compared to the patients transplanted on an emergency basis.