Percutaneous Device Closure of Paravalvular Leak

Calvert, Patrick A.; Northridge, David B.; Malik, Iqbal; Shapiro, Leonard M.; Ludman, Peter; Qureshi, Shakeel A.; Mullen, Michael; Henderson, Robert A.; Turner, Mark; Been, Martin; Walsh, Kevin; Casserly, Ivan P.; Morrison, Lindsay; Walker, Nicola L.; Thomson, John; Spence, Mark S.; Mahadevan, Vaikom S.; Hoye, Angela; MacCarthy, Philip; Daniels, Matthew J.; Clift, Paul; Davies, William R.; Adamson, Philip D; Morgan, Gareth J.; Aggarwal, Suneil; Ismail, Yasmin; Ormerod, Julian O M; Khan, Harun; Chandran, Sudhakar; Giovanni, Joseph De; Rana, Bushra S.; Ormerod, Oliver; Hildick‐Smith, David

doi:10.1161/circulationaha.116.022684

Cited by 117 publications

(46 citation statements)

References 16 publications

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“…For this reason some conclude that the transapical approach could be considered as a first line therapy [ 23 , 24 ] . Other authors state that this approach allows access to defects in all anatomic locations of the mitral prosthesis [ 3 ]. Furthermore, the analysis by Jelnin et al showed that a planned transapical approach resulted in shorter fluoroscopy and procedural times compared with the converted and combined trans-septal procedures [ 25 ].…”

Section: Discussionmentioning

confidence: 99%

“…Due to a lack of definitions to establish disease severity and endpoints for the safety and efficacy of PVL treatment there is currently an absence of outcomes for PVL treatment modalities in the literature [ 2 ]. Available data are very heterogeneous, with different devices being used, various access sites being employed for different valve prostheses, and mostly short-term outcomes are presented [ 3 – 5 ]. The specifically designed and manufactured Occlutech PLD Occluder for PVL closure has been introduced into clinical practice.…”

Section: Introductionmentioning

confidence: 99%

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

Zorinas¹,

Janušauskas²,

Davidavičius³

et al. 2018

pwki

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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.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

Zorinas¹,

Janušauskas²,

Davidavičius³

et al. 2018

pwki

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“…Various percutaneous and hybrid techniques have been developed over the last years to address paravalvular regurgitation avoiding redo sternotomy, CPB, and aortic cross-clamp ( 14 , 17 ). Randomized controlled trials comparing surgical and catheter closure of PVL are not currently available; however, early mortality in elective cases was reported to be 2.9% in a recent large series from UK and Irish centers ( 18 ). To our knowledge, there are no published series reporting results of transcatheter PVL closure in adults with previous diagnosis of atrioventricular septal defect.…”

Section: Discussionmentioning

confidence: 99%

Hybrid Surgery Options for Complex Clinical Scenarios in Adult Patients with Congenital Heart Disease: Three Case Reports

et al. 2017

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The strategy for the management of adult patients with congenital heart disease (CHD) often represents a challenge for cardiac surgeons and cardiologists due to complex anatomy, wide range of clinical presentations, and a high-risk profile. However, hybrid approach may represent an attractive solution. We report three cases of adult patients previously operated for CHD and recently treated with a hybrid approach in our institution. Case 1: a 76-year-old woman with permanent atrial fibrillation, lung disease, chronic kidney disease, microcytic anemia, and type II diabetes mellitus, previously operated for atrial septal defect closure and pulmonary valvotomy, presented with severe pulmonary regurgitation and advanced right ventricular failure. In order to minimize the surgical risk, a hybrid approach was used: an extensive right ventricular outflow tract (RVOT) plication was followed by implantation of an Edwards Sapien XT prosthesis in the RVOT through the right ventricular apex, without cardiopulmonary bypass. Case 2: a 64-year-old man with previous atrial septum excision and pericardial baffle for partial anomalous pulmonary venous drainage with intact interatrial septum, presented with worsening dyspnea, right ventricular failure, and pulmonary hypertension caused by baffle stenosis. His comorbidities included coronary artery disease, atrial flutter, and previous left pneumonectomy. After performing a redo longitudinal median sternotomy, a 20-mm stent was implanted in the baffle with access through the superior vena cava. Case 3: a 50-year-old man, with previous atrioventricular septal defect repair, followed by mitral valve replacement with a mechanical prosthesis, subsequently developed a paravalvular leak (PVL) with severe mitral regurgitation and severe left ventricular dysfunction. He underwent a transapical PVL device closure with two Amplatzer Vascular Plugs. In our opinion, hybrid surgery is a promising therapeutic modality that increases the available treatment options for this patient population. A multidisciplinary and patient-tailored approach is crucial in these complex clinical scenarios.

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“…While PVL can affect any valve, it is more common with mitral mechanical prostheses . Recent reports suggest that successful percutaneous repair of mitral PVL is associated with long term survival benefit and with less major adverse cardiovascular events . The 2014 American College of Cardiology/American Heart Association guidelines for the management of valvular heart disease recommended percutaneous repair of PVL (Class IIa) for high‐risk surgical patients with either intractable hemolysis or New York Heart Association (NYHA) class III or IV heart failure .…”

Section: Introductionmentioning

confidence: 99%

Left atrial pressure and predictors of survival after percutaneous mitral paravalvular leak closure

Maor

Raphael

Panaich

et al. 2017

Cathet Cardio Intervent

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Percutaneous Device Closure of Paravalvular Leak

Abstract: Percutaneous closure of PVL is an effective procedure that improves PVL severity and symptoms. Severity of persisting leak at follow-up is independently associated with both MACE and death. Percutaneous closure should be considered as an alternative to repeat surgery.

Cited by 117 publications

References 16 publications

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

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

Hybrid Surgery Options for Complex Clinical Scenarios in Adult Patients with Congenital Heart Disease: Three Case Reports

Left atrial pressure and predictors of survival after percutaneous mitral paravalvular leak closure

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