Paraprosthetic cardiac valve leaks are a progressive complication after after surgical or percutaneous heart valve replacement. These leaks can lead to heart failure and/or life-threatening hemolysis.
Percutaneous closure of para-prosthetic leaks has been developed as an alternative to surgery in high-risk patients. These procedures remain technically challenging with a significant risk of failure and complications, but this risk is improved since the development of dedicated prostheses and the increased experience of the operators. The data in the literature concerning percutaneous leak closure remain limited and disparate and mostly retrospective.The impact of the procedures on the quality of life of patients is not known. Beyond the technical aspects and the follow-up of major cardiovascular events, investigators also wonder what is the impact of these procedures on the quality of life of patients. Investigators hypothesize that even a partial reduction in paraprosthetic leakage may be associated with an improvement in quality of life through reduction of transfusion needs and/or reduction of dyspnea. A prospective study is warranted to assess the technical and clinical and clinical results of these procedures, together with the evaluation of the the possible benefit on the quality of life of the patients.
≥16 years of age No opposition from the patient or the representative of the parental authority if the patient is a minor Patient referred for a percutaneous paraprosthetic leak closure procedure
< 16 years old Refusal of the patient to participate in the observatory or of the legal representative if the patient is a minor
Included patients are included as part of their routine clinical care. The percutaneous intervention is not indicated for the purpose of the study but according to each centre policy after a medico-surgical meeting. Prior to percutaneous intervention, a large investigation of functional status, quality of life, biological exam and echocardiography is performed. This investigation is done again at 1 and 2 years
Cohort
Prospective
percutaneous paravalvular leak closure
Procedure/Surgerythe procedure consists of deployment of an occluder or a vascular plug within the cardiac paravalvular leak. The device is inserted percutaneously from a femoral vascular approach or from a trans-apical approach. The device is deployed through a delivery sheath within the leak. Stability and efficacy to occlude the leak are assessed by transoesophageal echocardiography prior to device release. Type of devices to be inserted varied : * Amplatzer vascular plug 3 * occlutech paravalvular leak device * amplatzer vascular plug 2 * amplatzer muscular ventricular septal defect * amplatzer vascular plug 4 Devices to be implanted are under the responsability of the local investigator and are not based on the study design.
clinical success
Device success is a composite criteria including all of the following conditions: No rehospitalizations or reinterventions for hemolysis No rehospitalizations or reinterventions for Heart Failure Improvement versus baseline in symptoms defined as decrease in NYHA functional class of at least one class vs. baseline
clinical success
Clinical success will be assessed on a composite endpoint at 2 years including the following conditions: * no death * no hospitalization for heart failure, * no blood transfusion for hemolysis, * no surgical or percutaneous re-intervention on the treated valve.
quality of life
evolution of quality of life between baseline and 3 months after the procedure on the EQ5D-5L score
Click on the lead sponsor to view all of their trials.
Centre Chirurgical Marie Lannelongue
Lead sponsor
Easy-CRF
Collaborator
