Multiplug paravalvular leak closure using Amplatzer Vascular Plugs III: A prospective registry

Smołka, Grzegorz; Pysz, Piotr; Jasiński, Marek; Roleder, Tomasz; Peszek-Przybyła, Ewa; Ochała, Andrzej; Wojakowski, Wojciech

doi:10.1002/ccd.25992

Cited by 45 publications

(33 citation statements)

References 18 publications

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“…It was semi-quantitatively defined as a reduction of paravalvular flow by at least one degree and might correspond to our device success. Another paper on the efficacy of multi-plug TPVLC technique using AVP III reported procedural success, demandingly defined as a reduction of regurgitation to not more than mild, of 76.5% for mitral and 100% for aortic PVLs [ 9 ]. Those results were similar to these currently achieved with PLD.…”

Section: Discussionmentioning

confidence: 99%

“…Transcatheter PVL closure, with proven beneficial effect on HF symptoms and hemolysis [ 4 ], has been recently granted a class IIa recommendation by the AHA/ACC [ 5 ]. Transcatheter PVL closure was initially performed as an “off-label” indication with ASD/VSD/PDA occluders and later with vascular embolization devices [ 6 – 9 ].…”

Section: Introductionmentioning

confidence: 99%

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

Smołka¹,

Pysz²,

Kozłowski³

et al. 2016

pwki

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IntroductionTranscatheter 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).AimWe present initial short-term results of a prospective registry intended to assess the safety and efficacy of TPVLC with PLD.Material and methodsWe 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.ResultsThirty 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.ConclusionsParavalvular 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.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

Smołka¹,

Pysz²,

Kozłowski³

et al. 2016

pwki

Self Cite

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“…It was first reported by Hourihan et al in 1992 [9]. Over the subsequent years its safety and feasibility were documented both in children [10] and adults [11–14]. Despite the lack of randomized trials, consistent data from case series and registries resulted in the TPVLC class IIa recommendation being granted by the American Heart Association/American College of Cardiology [15].…”

Section: Introductionmentioning

confidence: 99%

Transcatheter paravalvular leak closure and hemolysis – a prospective registry

Smołka¹,

Pysz²,

Ochała³

et al. 2017

aoms

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IntroductionParavalvular leak (PVL) related to a surgical prosthetic valve may be associated with clinically significant hemolysis. The influence of transcatheter PVL closure (TPVLC) on hemolysis remains uncertain.Material and methodsThe prospective registry included patients undergoing TPVLC due to PVL-related heart failure and/or hemolysis. Procedural data, laboratory markers of hemolysis and heart failure status were recorded at baseline, discharge and at 1- and 6-month follow-up.ResultsOf 116 patients from all those qualified for TPVLC, 79 fulfilled the inclusion/exclusion criteria. Hemolysis was significantly more frequent in patients with mitral location of PVL and with calcifications in its channel. After TPVLC prompt reduction of lactate dehydrogenase activity (617.0 (342.0–899.0) vs. 397 (310.0–480.5) IU/l, p < 0.05) and gradual resolution of anemia (hemoglobin (HGB) 11.7 (10.4–13.8) vs. 13.4 (12.9–13.8) g%, p < 0.05) over 6 months were noted. Effective closure of PVL (> 90% reduction of PVL cross-sectional area) resulted in a more prominent increase of red blood cell count and HGB than in patients with residual regurgitation. The TPVLC-related exacerbation of hemolysis was recorded in 14 patients. Its risk was aggravated by presence of significant hemolysis at baseline or residual flow either by a partially uncovered channel or across the occluder. Reduction of hemolysis after successful TPVLC was sustained in 6-month follow-up.ConclusionsRisk factors for PVL-related hemolysis were the presence of calcifications in the defect and mitral location of PVL. The TPVLC effectively reduced hemolysis if at least 90% reduction of PVL cross sectional area was achieved. The effect was sustained in 6-month follow-up. Incomplete closure of PVL may increase the magnitude of hemolysis after TPVLC, but it occurred rarely.

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“…We decided to perform paravalvular leak closure first to have more space for plugs. Indeed, the size of the leak made us plan in advance the implantation of multiple plugs, which has shown excellent long‐term results in a recent study . In our case the deployment of multiple plugs was made possible by the use of an arterial–venous loop which was able not only to increase support, but also to let us deploy each plug from a different route (the first one from arterial access, the second one from the transseptal sheath), with a fully satisfactory final result.…”

Section: Discussionmentioning

confidence: 83%

Successful percutaneous paravalvular leak closure followed by transfemoral aortic lotus valve‐in‐valve implantation in a degenerated surgical bioprosthesis

Nerla

Cremonesi

Castriota

2016

Cathet Cardio Intervent

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Bioprosthesis degeneration is a relevant clinical issue that is increasingly developing with the higher expectancy of life. Its treatment may be further complicated by the presence of paravalvular leaks, which are usually consequence of tissue friability, annular calcification, and infection. The surgical treatment of such complex conditions may be too risky, so percutaneous techniques in selected centers are becoming an attracting option. We report the case of a 65-year-old gentleman with a previous aortic valve replacement (Perimount n.25) who was admitted with worsening heart failure and transoesophageal evidence of severe intraprosthetic regurgitation and a large paravalvular leak. Since he was judged at too high risk for surgery, he was treated by a fully percutaneous approach. First, he had his large paravalvular leak closed by implantation of two plugs from both retrograde and anterograde routes (arterial-venous loop created). After one month, he underwent a "valve-in-valve" transcatheter aortic valve implantation with a fully repositionable Lotus 23 mm valve, which was able to restore a completely normal aortic valve function and let to a dramatic improvement of his functional status at 6-month follow-up (from NYHA IV to NYHA I), when a transthoracic echocardiogram also confirmed the absence of any aortic regurgitation. This case shows how a tailored step-by-step fully percutaneous strategy is safe and feasible in high-risk patients with both bioprosthesis degeneration and large paravalvular leaks. This novel opportunity would need to be better evaluated in properly addressed long-term clinical studies. © 2016 Wiley Periodicals, Inc.

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Multiplug paravalvular leak closure using Amplatzer Vascular Plugs III: A prospective registry

Cited by 45 publications

References 18 publications

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

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

Transcatheter paravalvular leak closure and hemolysis – a prospective registry

Successful percutaneous paravalvular leak closure followed by transfemoral aortic lotus valve‐in‐valve implantation in a degenerated surgical bioprosthesis

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