Transcatheter Para-Valvular Leak Closures
Condition: Paravalvular Aortic Regurgitation; Paravalvular Mitral Regurgitation; Cardiac Valve Disease; Cardiac Catheterization
MeSH terms: Mitral Valve Insufficiency; Aortic Valve Insufficiency; Heart Valve Diseases
Study type: Observational

Summary: 
      Despite improvements in available techniques and prostheses, the long-term evolution of
      patients after transcatheter paravalvular leak closure remains poorly understood. The
      objective of this study is to evaluate the long-term outcome of patients after transcatheter
      paravalvular leak closure 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.Follow-up of
      at least one year was expected
    

Detailed description: 
      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.

      Past medical history, cardiac surgery details, clinical, biological and echocardiographic
      parameters were collected. EUROSCORE II risk scale (http://euroscore.org) was assessed with
      the assumption that a surgical valve replacement would be performed. Both technical success
      and clinical success were defined according to the Paravalvular Leak Academic Research
      Consortium. Technical success was implantation of at least one device within the leak, with
      an at least 1-grade decrease in the echocardiographic leak-severity grade, no valve
      dysfunction, and no surgical conversion of the procedure. Clinical success was survival at
      one month without re-admission for heart failure, blood transfusion, or open-heart valvular
      surgery. The investigators distinguished per procedural complications, in-hospital
      complications (index hospitalization) and complications occurring during follow-up.
      Complication's severity was graded using a five levels scale.For each patient, the latest
      follow-up data at the time of the inclusion period was collected. Follow-up of at least one
      year was expected. New valvular surgery, new PVLc procedure, death and its causes were
      collected through the patients themselves or their cardiologist by each local investigator.
    

Intervention name(s): transcatheter paravalvular leak closure
Intervention type(s): Device
Intervention description(s): transcatheter paravalvular leak closure on cardiac valve
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        An electronic case-report form (eCRF, Easy-crf.com) was completed for each patient. The
        medical history (notably regarding heart surgery), symptoms, physical findings, laboratory
        test results, and echocardiographic parameters were collected. The EUROSCORE II risk score
        (http://euroscore.org) was determined, since surgical valve replacement was among the
        treatment options. Creatinine clearance below 60 mL/min defined renal failure and below 30
        mL/min severe renal failure. Heart failure was defined according to the European Society of
        Cardiology as the presence of symptoms (dyspnoea, orthopnoea, asthenia) with physical signs
        of heart failure (limb oedema, hepato-jugular reflux, crackles on pulmonary auscultation)
        linked to the valvular disease. Anaemia was defined as haemoglobin <13 g/dL in men and <12
        g/dL in women and haemolytic anaemia as anaemia with lactic dehydrogenase elevation and/or
        schistocytes and/or low haptoglobin, in the absence of other causes of anaemia.
      
Keywords: paravalvular leak; cardiac catheterization; cardiac valve; transcatheter; percutaneous