Transcatheter closure of paravalvular leaks using a paravalvular leak device – a prospective Polish registry

Grzegorz Smolka; Piotr Pysz; Michał Kozłowski; Marek Jasiński; Radosław Gocoł; Tomasz Roleder; Agnieszka Kargul; Andrzej Ochała; Wojciech Wojakowski

doi:10.5114/aic.2016.59363

eISSN: 1897-4295
ISSN: 1734-9338

Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej

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Original paper

Transcatheter closure of paravalvular leaks using a paravalvular leak device – a prospective Polish registry

Grzegorz Smolka

,

Piotr Pysz

,

Michał Kozłowski

,

Marek Jasiński

,

Radosław Gocoł

,

Tomasz Roleder

,

Agnieszka Kargul

,

Andrzej Ochała

,

Wojciech Wojakowski

Adv Interv Cardiol 2016; 12, 2 (44): 128–134

DOI: https://doi.org/10.5114/aic.2016.59363

Online publish date: 2016/05/11

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AMA

Smolka G, Pysz P, Kozłowski M, et al. Transcatheter closure of paravalvular leaks using a paravalvular leak device – a prospective Polish registry. Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej. 2016;12(2):128-134. doi:10.5114/aic.2016.59363.

APA

Smolka, G., Pysz, P., Kozłowski, M., Jasiński, M., Gocoł, R.,  & Roleder, T. et al. (2016). Transcatheter closure of paravalvular leaks using a paravalvular leak device – a prospective Polish registry. Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej, 12(2), 128-134. https://doi.org/10.5114/aic.2016.59363

Chicago

Smolka, Grzegorz, Piotr Pysz, Michał Kozłowski, Marek Jasiński, Radosław Gocoł, Tomasz Roleder,  and Agnieszka Kargul et al. 2016. "Transcatheter closure of paravalvular leaks using a paravalvular leak device – a prospective Polish registry". Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej 12 (2): 128-134. doi:10.5114/aic.2016.59363.

Harvard

Smolka, G., Pysz, P., Kozłowski, M., Jasiński, M., Gocoł, R., Roleder, T., Kargul, A., Ochała, A.,  and Wojakowski, W. (2016). Transcatheter closure of paravalvular leaks using a paravalvular leak device – a prospective Polish registry. Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej, 12(2), pp.128-134. https://doi.org/10.5114/aic.2016.59363

MLA

Smolka, Grzegorz et al. "Transcatheter closure of paravalvular leaks using a paravalvular leak device – a prospective Polish registry." Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej, vol. 12, no. 2, 2016, pp. 128-134. doi:10.5114/aic.2016.59363.

Vancouver

Smolka G, Pysz P, Kozłowski M, Jasiński M, Gocoł R, Roleder T et al. Transcatheter closure of paravalvular leaks using a paravalvular leak device – a prospective Polish registry. Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej. 2016;12(2):128-134. doi:10.5114/aic.2016.59363.

Introduction: Transcatheter paravalvular leak closure (TPVLC) has become an established treatment option but is mostly performed with off-label use of different non-dedicated occluders. The first one specifically designed for TPVLC is the paravalvular leak device (PLD – Occlutech).

Aim: We present initial short-term results of a prospective registry intended to assess the safety and efficacy of TPVLC with PLD.

Material and methods: We screened patients with paravalvular leak (PVL) after surgical valve replacement (SVR). Heart failure symptoms and/or hemolytic anemia were indications for TPVLC. Patients were selected according to PVL anatomy by RT 3D TEE. Only those considered appropriate for closure with a single PLD were enrolled. The procedures were performed via transvascular or transapical access using type W (waist) PLDs only.

Results: Thirty patients with 34 PVLs (18 aortic, 16 mitral) were included. We implanted 35 PLDs with a total device success rate of 94.3% (100% for aortic, 88.2% for mitral). The procedural success rate, encompassing device success without in-hospital complications, was 94.1% (100% for aortic, 93.8% for mitral). During the follow-up period we recorded an increase of hemoglobin concentration (3.9 to 4.1 g/dl), red blood count (11.6 to 12.2 M/mm3) and functional improvement by NYHA class.

Conclusions: Paravalvular leak device type W is a promising TPVLC device, but meticulous preselection of patients based on imaging of PVL anatomy is a prerequisite. A PLD should only be chosen for channels shorter than 5 mm. Size of the device should match the PVL cross-sectional area without any oversizing. Such an approach facilitates high device and procedural success rates.

keywords:

Transcatheter closure of paravalvular leaks using a paravalvular leak device – a prospective Polish registry

Grzegorz Smolka , Piotr Pysz , Michał Kozłowski , Marek Jasiński , Radosław Gocoł , Tomasz Roleder , Agnieszka Kargul , Andrzej Ochała , Wojciech Wojakowski

percutaneous closure, paravalvular leak, occluder, prosthetic heart valve

Grzegorz Smolka

,

Piotr Pysz

,

Michał Kozłowski

,

Marek Jasiński

,

Radosław Gocoł

,

Tomasz Roleder

,

Agnieszka Kargul

,

Andrzej Ochała

,

Wojciech Wojakowski