Interventions for valvular disease and heart failure

Midterm procedural and clinical outcomes of percutaneous paravalvular leak closure with the Occlutech Paravalvular Leak Device

EuroIntervention 2020;15:1251-1259. DOI: 10.4244/EIJ-D-19-00517

Eustaquio Maria Onorato
Eustaquio Maria Onorato1, MD; Manuela Muratori1, MD; Grzegorz Smolka2, MD, PhD; Magdalena Malczewska3, MD; Aleksejus Zorinas4, MD, PhD; Diana Zakarkaite4, MD; Abdurashid Mussayev5, MD; Christous P. Christos6, MD; Fabrice Bauer7, MD; Thomas Gandet8, MD; Gian Luca Martinelli9, MD; Anna Maria Costante10, MD; Antonio L. Bartorelli1,11
1. Centro Cardiologico Monzino, IRCCS, University School of Milan, Milan, Italy; 2. 3rd Division of Cardiology, Medical University of Silesia, Katowice, Poland; 3. Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University, Katowice, Poland; 4. Department of Cardiovascular Medicine, Vilnius University, Vilnius, Lithuania; 5. National Research Cardiac Surgery Center, Astana, Kazakhstan; 6. American Heart Institute, Nicosia, Cyprus; 7. Centre Hospitalier Universitaire “Charles Nicolle”, Rouen, France; 8. Centre Hospitalier Universitaire, Hôpital Arnaud de Villeneuve, Montpellier, France; 9. Clinica San Gaudenzio, Novara, Italy; 10. Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo, Alessandria, Italy; 11. Department of Biomedical and Clinical Sciences “Luigi Sacco”, University of Milan, Milan, Italy

Aims: The aim of this study was to assess the efficacy and safety of the Occlutech Paravalvular Leak Device (PLD) for the percutaneous closure of paravalvular leaks (PVL).

Methods and results: Patients with PVL were enrolled at 21 sites from nine countries. Indications for PVL closure were heart failure and/or haemolytic anaemia. Endpoint measures were changes in PV regurgitation grade, NYHA class and requirement for haemolysis-related transfusion. One-hundred and thirty-six patients with mitral (67.6%) or aortic (32.4%) leaks were included (mean age 66.7 years, 58% male); 31% had multiple PVLs. The proportion of patients with NYHA Class III/IV decreased from 77.3% at baseline to 16.9% at latest follow-up. The proportion of patients with need for haemolysis-related blood transfusion decreased from 36.8% to 5.9% and from 8.3% to 0% for ML patients and AL patients, respectively. All-cause mortality was 7.4%. Complications included interference with valve leaflets (0.7%), transient device embolisation (percutaneously solved) (0.7%), late device embolisation (0.7%), recurrent haemolytic anaemia (2.2%), new-onset haemolytic anaemia (0.7%), valve surgery (2.2%), need for repeat closure (0.7%), complications at femoral puncture site (0.7%) and arrhythmias requiring treatment (4.4%).

Conclusions: PVL closure with the Occlutech PLD demonstrated a high success rate associated with significant clinical improvement and a relatively low rate of serious complications.

Visual summary. PVL characteristics, leak approach, device types and midterm procedural and clinical outcomes of percutaneous paravalvular leak closure with the Occlutech® PLD. Transcatheter PVL closure with the specifically designed PLD was demonstrated to be effective with a relatively low rate of major complications. Procedural success for ML and AL closure was high with a low rate of residual or recurrent leaks. Significant improvement of NYHA class, and reduction of haemolytic anaemia and transfusion dependency were achieved.

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imaging modalitiesspecific closure device/techniquetransoesophageal echocardiogramtransthoracic echocardiogram
Interventions for valvular diseaseOther valvular and structural interventions
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