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

Eustaquio Maria Onorato, Manuela Muratori, Grzegorz Smolka, Magdalena Malczewska, Aleksejus Zorinas, Diana Zakarkaite, Abdurashid Mussayev, Christous P. Christos, Fabrice Bauer, Thomas Gandet, Gian Luca Martinelli, Anna Maria Costante, Antonio L. Bartorelli

Research output: Contribution to journalArticlepeer-review

Abstract

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. Allcause 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.

Original languageEnglish
Pages (from-to)1251-1259
Number of pages9
JournalEuroIntervention
Volume15
Issue number14
DOIs
Publication statusPublished - Feb 2020

Keywords

  • Imaging modalities
  • Specific closure device/technique
  • Transoesophageal echocardiogram
  • Transthoracic echocardiogram

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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