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. 2018;14(2):167-175.
doi: 10.5114/aic.2018.76408. Epub 2018 Jun 19.

Retrospective analysis of single-center early and midterm results of transapical catheter-based mitral paravalvular leak closure with a purpose-specific device

Aleksejus Zorinas  1 , Vilius Janušauskas  1 , Giedrius Davidavičius  1 , Rokas Šimakauskas  2 , Lina Puodžiukaitė  1 , Diana Zakarkaitė  1 , Valdas Bilkis  1 , Rasa Joana Čypienė  1 , Robertas Stasys Samalavičius  3 , Eustaquio M Onorato  4 , Audrius Aidietis  1 , Kęstutis Ručinskas  1
Affiliations

Retrospective analysis of single-center early and midterm results of transapical catheter-based mitral paravalvular leak closure with a purpose-specific device

Aleksejus Zorinas et al. Postepy Kardiol Interwencyjnej. 2018.

Abstract

Introduction: Due to the recent lack of definitions to establish the severity of paravalvular leak (PVL) and endpoints for its treatment, the effectiveness and safety of a new device for PVL closure have not been comprehensively analyzed.

Aim: To analyze a single center's experience of mitral PVL closure in a surgical transapical catheter-based fashion with a purpose-specific device.

Material and methods: This is a retrospective cohort study of patients following transapical catheter-based mitral PVL closure with a purpose-specific device. Data were analyzed at baseline, perioperatively, at discharge, at six months and annually after the procedure.

Results: Nineteen patients underwent surgical transapical catheter-based mitral PVL closure with the Occlutech PLD Occluder. Mean follow-up time was 20 ±7 (range: 9-33) months. The patients' mean age was 64 ±7 years, and 11 (58%) were male. Technical, device and individual patient success at follow-up was achieved in 18 (95%), 16 (84%) and 16 (84%) patients respectively. Median intensive therapy unit stay was one day (1-4) and mean hospital stay was 11 ±4 days. A reduction of paravalvular regurgitation to a mild or lesser degree was achieved in 18 (95%) patients. There were no strokes or myocardial infarctions at follow-up. There were no deaths at 30 days after the procedure. One (5%) patient expired due to progression of heart failure 12 months after surgery. None of the patients required immediate conversion to full sternotomy.

Conclusions: Surgical transapical catheter-based mitral PVL closure with the Occlutech PLD Occluder is a safe and clinically effective treatment.

Keywords: heart failure; mitral regurgitation; paravalvular leak; prosthetic heart valve; transcatheter closure.

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Conflict of interest statement

Dr. Eustaquio Maria Onorato is a Consultant for Occlutech, the manufacturer of the PVL closure device used and described in this manuscript. He also is Co-Principal Investigator for an international, multi-center follow-up study monitoring the efficacy and safety of Occlutech PLD in patients with mitral or aortic PVL. The other authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Distribution of PVLs along perimeter of mitral valve, presented in clock-like fashion (6). III, VI, IX and XII – hours of the clock; A1, A2, A3, P1, P2, P3 – mitral valve scallops (segments). 1 (4%), 2 (8%), 6 (26%), 8 (35%) – number of defects and percentage in our cohort of patients
Figure 2
Figure 2
A – Delivery catheter introduced in to the left ventricle. B – Tourniquets securing the “U” shape sutures at the apex of the heart. C – Entry site of the delivery catheter into the left ventricle. D – “U” shape sutures reinforced with pledgets on the apex of the left ventricle
Figure 3
Figure 3
Intraoperative pictures of the PLD occluder in patient with worsened anemia. 1: PLD occluder at the A2 aspect of the mitral valve annulus. A – PLD occluder in situ at the A2 aspect of the mitral valve annulus, B – cuff of the mitral valve prosthesis, C – interatrial septum, D – left atrium. 2: PLD occluder removed. Arrows point to scarce “islands” of epithelium
See this image and copyright information in PMC

References

    1. Hourihan M, Perry SB, Mandell VS, et al. Transcatheter umbrella closure of valvular and paravalvular leaks. J Am Coll Cardiol. 1992;20:1371–7. - PubMed
    1. Ruiz CE, Hahn RT, Berrebi A, et al. Clinical trial principles and endpoint definitions for paravalvular leaks in surgical prosthesis: an expert statement. Eur Heart J. 2017;69:2067–87. - PubMed
    1. Calvert PA, Northridge DB, Malik IS, et al. Percutaneous device closure of paravalvular leak: combined experience from the United Kingdom and Ireland. Circulation. 2016;134:934–44. - PMC - PubMed
    1. Lampropoulos K, Aggeli C, Megalou A, et al. Diagnosis and treatment of left-sided prosthetic paravalvular regurgitation. Cardiology. 2016;133:27–34. - PubMed
    1. Smolka G, Pysz P, Kozlowski M, et al. Transcatheter closure of paravalvular leaks using a paravalvular leak device – a prospective Polish registry. Adv Interv Cardiol. 2016;12:128–34. - PMC - PubMed

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