CC BY-NC-ND 4.0 · Thorac Cardiovasc Surg 2022; 70(S 03): e34-e41
DOI: 10.1055/s-0042-1757916
Pediatric and Congenital Cardiology

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

Eleonora Dal Sasso
1   Berlin Heart GmbH, Berlin, Germany
,
Thomas Schöndorf
1   Berlin Heart GmbH, Berlin, Germany
,
Kim-John Schlüter
1   Berlin Heart GmbH, Berlin, Germany
,
Oliver Miera
2   Department of Congenital Heart Disease – Pediatric Cardiology, German Heart Center Berlin (DHZB), Berlin, Germany
,
Fabrizio De Rita
3   Adult Congenital and Paediatric Heart Unit, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom
,
Ares K. Menon
1   Berlin Heart GmbH, Berlin, Germany
,
on behalf of the European EXCOR® Pediatric Investigator Group (EEPIG) › Author Affiliations
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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.

Keywords

circulatory assist devices - congenital heart disease - transplantation - heart

Note

The study concept has been presented at the 50th Annual Meeting of the German Society for Thoracic and Cardiovascular Surgery (DGTHG); online; February 26th to 28th, 2021 [Menon et al, Thorac Cardiovasc Surg 2021;69(S 01)].


Author's Contribution

O. M., F. D. R., and A. K. M. devised the medical rationale for this novel treatment option. E. D. S., T. S., K.-J. S., and A. K. M. elaborated the conceptual study design. The expert panel “European EXCOR® Pediatric Investigator Group” (EEPIG) contributed with intensive discussion and mutual agreement. E. D. S. prepared the manuscript, and all other authors contributed by thorough manuscript review. The authors thank Mr. Samuel Alberman for editing the manuscript.




Publication History

Received: 02 June 2022

Accepted: 05 September 2022

Article published online:
11 November 2022

© 2022. 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/)

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