A Novel Method to Bridge Failing Fontan Patients to Heart Transplantation: The Re-Give Study

Objectives: Successful surgical palliation in children with a single ventricle morphology (SV) led to an increasing number of patients suffering from failing of the Fontan circulation. The absence of a subpulmonary (SP) ventricle leads to protein-losing enteropathy, hepatic, and renal dysfunction and plastic bronchitis. The only long-term therapeutic option so far is heart transplantation (HTX) which carries a high risk due to the impaired functional status. The lack of an approved device for SP support has so far limited the clinical application.

Methods: To fill this gap, a novel venous cannula (VC) for SP support as an additional component of a paracorporeal VAD has been designed. The VC is connecting the upper and lower vena cava and leads the blood flow to a paracorporeal pump which is connected to the pulmonary artery. The VC will facilitate a standardized implantation of a VAD for support of the SP circulation in SV patients for the first time. The device will be able to provide supraphysiological and pulsatile pulmonary blood flow and decongest the venous system. The VC was flow optimized in terms of computerized fluid dynamics (CFD) and particle imaging velocimetry (PIV) and went to several animal studies and virtual fitting. The system recently gained CE mark and can be used for SP support alone or in combination with a systemic VAD. An observational, prospective, international, multicenter, nonrandomized registry (Re-Give Study; Registry to assess the safety and the SP support of the novel Venous Cannula in patients with venous connection abnormalities) is planned to observe the clinical outcome of the patients treated with this device. The study investigates safety by means of adverse events rate, and performance by means of secondary organ function in 20 patients in a BTT setting with a maximal follow-up of 12 months.

Conclusion: The Re-Give Study will be the first prospective clinical register of a standardized surgical MCS procedure to help failing Fontan patients via immediate improvement of cardiac output and improved Fontan related end-organ dysfunction.

No conflict of interest has been declared by the author(s).

Publication History

Article published online:
19 February 2021