Long-term Outcome Following Transcatheter Para-Valvular Leak Closures: An International Retrospective Multicenter Registry

Paravalvular leak (PVL) of cardiac valve prostheses is a frequent complication after surgical valve replacement. The incidence varies according to the type of prosthesis and location, ranging from 2-15% for aortic prostheses and 7-17% for mitral prostheses, with an increasing incidence over time. PVL may also be observed after percutaneous valve replacement. After transcatheter aortic valve implantation (TAVI) the incidence of PVL at 1 year is 6%, regardless of the type of prosthesis placed.

The majority of these leaks do not lead to symptoms but they are sometimes responsible for hemolytic anemia, heart failure and infectious endocarditis, thus posing an indication for closure. The reference technique for PVL closure (PVLc) is redo cardiac surgery despite significant morbidity and mortality.

Percutaneous PVLc techniques have been developed since 1992. Several small case series have been published since then, highlighting the different closure techniques and the modalities for evaluating PVL by 3D ultrasound and CT scan. Several multicenter registries have also been published that trace current practices and also identify prognostic factors for success in the short to medium term.

However, despite improvements in available techniques and prostheses, the long-term evolution of patients after percutaneous PVLc remains poorly understood. The objective of this study is to evaluate the long-term outcome of patients after percutaneous PVLc and to identify factors predictive of survival.

The investigators designed a retrospective multicentre observational registry entitled FFPP (e.g. "Fermeture des Fuites Para-Prothétiques" in French). Seventeen centres from France, Poland, Turkey and Belgium enrolled retrospectively at least one PVLc procedure on aortic, mitral, tricuspid or pulmonary valves without limit in its delay of performance.Enrolment started on January 1st, 2017. Study database was closed on december 31st, 2019. The study was financially supported by Marie Lannelongue Hospital, without any financial support from the industry. This research was conducted according to Declaration of Helsinki. The study protocol was approved by an independent review board (CCTIRS, 6th January 2017, n°16-622). An electronic case report form was created (easy-crf®). Each local investigator entered data using a secure access. Data quality control was performed by Marie-Lannelongue research assistants.