TY - JOUR
T1 - Midterm procedural and clinical outcomes of percutaneous paravalvular leak closure with the Occlutech Paravalvular Leak Device
AU - Onorato, Eustaquio Maria
AU - Muratori, Manuela
AU - Smolka, Grzegorz
AU - Malczewska, Magdalena
AU - Zorinas, Aleksejus
AU - Zakarkaite, Diana
AU - Mussayev, Abdurashid
AU - Christos, Christous P.
AU - Bauer, Fabrice
AU - Gandet, Thomas
AU - Martinelli, Gian Luca
AU - Costante, Anna Maria
AU - Bartorelli, Antonio L.
N1 - Publisher Copyright:
© Europa Digital & Publishing 2020. All rights reserved.
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/2
Y1 - 2020/2
N2 - 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.
AB - 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.
KW - Imaging modalities
KW - Specific closure device/technique
KW - Transoesophageal echocardiogram
KW - Transthoracic echocardiogram
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U2 - 10.4244/EIJ-D-19-00517
DO - 10.4244/EIJ-D-19-00517
M3 - Article
AN - SCOPUS:85083337002
VL - 15
SP - 1251
EP - 1259
JO - EuroIntervention
JF - EuroIntervention
SN - 1774-024X
IS - 14
ER -