A Novel Strategy for the Mechanical Subpulmonary Support in Failing Fontan Patients

Eleonora Dal Sasso, Thomas Schöndorf, Kim-John Schlüter, Oliver Miera, Fabrizio De Rita, Ares K Menon, European EXCOR® Pediatric Investigator Group (EEPIG), Eleonora Dal Sasso, Thomas Schöndorf, Kim-John Schlüter, Oliver Miera, Fabrizio De Rita, Ares K Menon, European EXCOR® Pediatric Investigator Group (EEPIG)

Abstract

Background: The number of single ventricle patients undergoing Fontan palliation and surviving to adulthood worldwide has steadily increased in recent years. Nevertheless, the Fontan circulation is destined to fail. Ultimately, heart transplantation (HTx) remains the definitive treatment option. Due a shortage of organs, mechanical circulatory support in the form of ventricular assist devices (VADs) is widely used to bridge heart failure patients to HTx, but these devices have been mainly developed to address the needs of normal anatomies. A novel venous cannula has been developed as part of the EXCOR® VAD to provide subpulmonary support in these patients. Its clinical application is investigated in the "Registry to Assess the Safety and Feasibility of the Subpulmonary Support with the Novel Venous Cannula in Patients with Failing/Absence of the Right Heart" (RegiVe study, NCT04782232).

Methods: RegiVe is a multicenter, international, observational, prospective, non-randomized registry aiming to collect the routine clinical data of up to 20 patients. The primary endpoints address device performance and safety, while the secondary endpoints target organ status and overall safety (according to the Interagency Registry for Mechanically Assisted Circulatory Support - INTERMACS - definitions). Data analysis will be performed by means of descriptive statistics.

Results: RegiVe has received the favorable opinion of an independent ethics committee and enrollment has recently started.

Conclusion: RegiVe is the first study evaluating the use of a medical device specifically developed for subpulmonary support of failing Fontan patients. The study will provide important insight and further information on this cohort and help to improve a dedicated VAD strategy.

Conflict of interest statement

E. D. S., T. S., K.-J. S., and A. K. M. are employees of Berlin Heart GmbH. O. M. and F. D. R. received fees as EEPIG chairs. F. D. R. is proctor of Berlin Heart GmbH.

The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).

Figures

Fig. 1
Fig. 1
The venous cannula consists of a body made from silicone and suture rings for anastomosis to the vascular grafts connecting the superior and inferior vena cavae, and it is intended for single ventricle patients with failing Fontan palliation. (A ) EXCOR® Revive approach illustrating the use of the EXCOR® VAD with the venous cannula as isolated subpulmonary support. ( B, C ) Venous cannula in situ. (images B and C are provided by courtesy of Bernd H. Schnitzer, Berlin Heart GmbH, and have been taken at the Ludwig Maximilian University of Munich on the occasion of the first case 16 ).

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Source: PubMed

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