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

Abstract

IntroductionDue 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.AimTo analyze a single center’s experience of mitral PVL closure in a surgical transapical catheter-based fashion with a purpose-specific device.Material and methodsThis 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.ResultsNineteen 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.ConclusionsSurgical transapical catheter-based mitral PVL closure with the Occlutech PLD Occluder is a safe and clinically effective treatment.

Percutaneous Transapical approach in the Treatment of Paravalvular Leak

“…On the other hand, Zorinas et al published outcomes of 19 patients who underwent surgical TA catheter-based mitral PVL closure. 1 (5.2%) patient with hemothorax due to surgical retractor blade injury to the rib with subsequent severe bleeding required surgical revision (17). In our study, 1(8.3%) patients had hemodynamically insigni cant pericardial effusion, after the procedure.…”

EchoNavigator® technology facilitates transapical mitral paravalvular leak closure: a case report

“…Important advantages of the hybrid approach are (i) coaxiality to the mitral plane, direct engagement to the leak, and crossing on the same direction of the regurgitant flow; (ii) better wire pushability and easier access to leakages particularly for posteroseptal ones; and (iii) controlled surgical closure of the ventricular puncture. 10 , 11 The disadvantage is represented by a more invasive approach. Further studies comparing different access sites for percutaneous PVL closure are needed.…”

First Experience Using a Nonfenestrated Cardioform Septal Occluder for Closure of Giant Mitral Paravalvular Leak

“…Although a variety of endovascular plugs have been tested, none are approved by the FDA for PVL closure. Among commercially available products, the Amplatzer family of plugs (St Jude Medical/Abbott Vascular) have been used most commonly with variable success and operator experience ( 1 , 3 , 5 , 7 , 8 ). Incomplete PVL closure resulting in heart failure and refractory hemolysis remains the most important limitation; this is particularly true among large complex PVL defects, in which multiple plugs are required.…”

“…Incomplete PVL closure resulting in heart failure and refractory hemolysis remains the most important limitation; this is particularly true among large complex PVL defects, in which multiple plugs are required. Despite ongoing efforts to develop PVL-specific plugs, such as the Occlutech PVL Device (Occlutech, Helsingborg, Sweden) ( 1 , 3 , 5 , 7 , 8 ), the existing limitations and failure rates are best explained by the inherent semirigid multifenestrated nitinol mesh design that results in device underexpansion, malapposition, and incomplete closure, which allows blood to travel across fenestrations at a high velocity resulting in either heart failure or residual hemolysis ( 4 ). Predicting post-operative hemolysis is challenging, as even the smallest residual jet may result in severe refractory hemolysis.…”