Percutaneous paravalvular leak closure after TAVI: A demanding approach (original) (raw)

Transcatheter Paravalvular Leak Closure : Diagnosis , Devices , Techniques , and Outcomes

2019

P aravalvular leak (PVL) is a common condition in which an unintended gap between a prosthetic heart valve and native annular tissue allows for regurgitation of blood from a downstream to an upstream chamber, similar to valvular regurgitation. The most common causes of PVL are native annular tissue friability, annular calcification, and endocarditis. PVL occurs in 5% to 17% of surgically implanted prosthetic valves, affecting both mechanical and biologic prostheses, and patients can present with multiple simultaneous PVL defects.1-3 After valve surgery, PVL is more common in the mitral valve position than the aortic valve position2; however, PVL occurs more frequently after transcatheter aortic valve replacement (TAVR) than surgical aortic valve replacement (SAVR).4,5 Although the incidence of PVL has been historically high following TAVR, rates of moderate or severe PVL have been substantially reduced with improved sizing techniques and newer iterations of transcatheter valves.5-7 ...

Performance of valve-in-valve for severe para-prosthetic leaks due to inadequate transcatheter aortic valve implantation

Catheterization and Cardiovascular Interventions, 2011

Objectives: This study reports on mid-term safety and performance of valve-in-valve implantation as rescue strategy to overcome acute PPL after TAVI. Background. Moderate to severe para-prosthetic leaks (PPL) after transcatheter aortic valve implantation (TAVI) have been described with both self-expandable and balloon-expandable device.-Methods: We analyzed data regarding patients who underwent valve-in-valve implantation, enrolled in the ongoing single-center prospective registry of TAVI, the Padova University REVALVing experience Registry. All procedures were performed by a totally percutaneous approach, using the self-expanding Medtronic CoreValve (Medtronic, Minneapolis, MN). Results: Out of 87 patients who underwent TAVI, six received valvein-valve implantation because of persisting severe PPL, due to prosthesis malposition. In all patients, the second device was successfully deployed, with a significant reduction in aortic regurgitation: PPL was no longer appreciable in two of six patients, and it decreased from severe to mild or trivial in four patients. Four patients developed atrioventricular block requiring pace-maker implantation. At follow-up (6-24 months) two patients died, whereas no prosthesis-related death occurred. Transprosthesis pressure gradient, effective orifice area, and aortic regurgitation did not change at serial echocardiograms throughout the follow-up. Conclusions: Valve-in-valve implantation using self-expandable bioprosthesis seems safe and highly effective to overcome severe PPL due to prosthesis malposition early after TAVI. Moreover, the implantation of two valves does not affect the performance of prosthesis at follow-up. V C 2011 Wiley Periodicals, Inc.

Paravalvular leak closure after transcatheter aortic valve replacement with a self‐expanding prosthesis

Catheterization and Cardiovascular Interventions, 2013

Introduction: Paravalvular leak (PVL) after percutaneous transcatheter aortic valve replacement (TAVR) is associated with significant morbidity and mortality. Percutaneous PVL closure has been reported for balloon-expandable valves but not self-expandable valves. Methods: We conducted a review of cases at our center where patients who received TAVR with self-expandable valves and went on to develop severe PVL underwent percutaneous closure. Baseline demographic, TAVR procedural, PVL procedural, and follow-up data were collected. Results: A total of five patients with severe PVL after TAVR with a self-expanding valve underwent percutaneous PVL closure. Four of five patients had a trial of balloon postdilatation after valve deployment and had significant persistent PVL. In all five patients, PVL went from moderate-severe to mildmoderate PVL. There were no adverse events. Conclusion: Percutaneous PVL closure for severe PVL self-expanding valve for TAVR is a safe and efficacious procedure. Procedural technique involves transesophageal guidance, a high approach through the valve struts, deployment of an appropriate size device, and careful monitoring. This method may be part of the algorithm for severe PVL after TAVR. V

Clinical Trial Principles and Endpoint Definitions for Paravalvular Leaks in Surgical Prosthesis: An Expert Statement

European heart journal, 2017

The VARC (Valve Academic Research Consortium) for transcatheter aortic valve replacement set the standard for selecting appropriate clinical endpoints reflecting safety and effectiveness of transcatheter devices, and defining single and composite clinical endpoints for clinical trials. No such standardization exists for circumferentially sutured surgical valve paravalvular leak (PVL) closure. This document seeks to provide core principles, appropriate clinical endpoints, and endpoint definitions to be used in clinical trials of PVL closure devices. The PVL Academic Research Consortium met to review evidence and make recommendations for assessment of disease severity, data collection, and updated endpoint definitions. A 5-class grading scheme to evaluate PVL was developed in concordance with VARC recommendations. Unresolved issues in the field are outlined. The current PVL Academic Research Consortium provides recommendations for assessment of disease severity, data collection, and e...

A new technique for vascular access management in transcatheter aortic valve implantation

Catheterization and Cardiovascular Interventions, 2010

Objectives: To describe results from a novel percutaneous technique designed to minimize the risk of hemorrhage in the event of a major complication during transcatheter aortic valve implantation. Background: Vascular access management is a major challenge in transfemoral TAVI due to the large introducer sheathes required. Methods: Fifty-two pts underwent TAVI between November 2007 and March 2009. Of these, 37 received an Edwards-Sapien Valve (23 mm valve: 17/37; 26 mm valve: 20/37) whilst 15 patients received a CoreValve (26 mm valve: 6/15; 29 mm valve: 9/15). Using a crossover technique, the opposing femoral artery was cannulated with a 7Fr long sheath. This allowed contralateral passage of a balloon and inflation in the proximal iliac. The sheath was then removed and Prostar sutures tied in a dry field. Balloon optimization of the puncture site was performed as required. Results: In three subjects, elective surgical repair was undertaken due to excessive femoral arterial calcification. In the remaining 49, the crossover technique was employed and closed with two Prostar devices (Edwards-Sapien) or one (CoreValve). There were serious ''on-table'' complications in seven patients, six due to the large introducer sheathes used in the TAVI procedure-iliac avulsion, two iliac dissections, iliac perforation, common femoral perforation and scrotal hematoma. All were repaired safely by combined surgical and endovascular techniques, using the crossover technique to ensure patient stability. All made a good recovery and were independently ambulant at discharge. Conclusion: Using crossover balloon inflation as an adjunct to Prostar closure may be helpful for managing TAVI vascular access sites. V C 2009 Wiley-Liss, Inc.

Two-stage percutaneous closure of paravalvular leak in a patient with stentless aortic bioprosthesis

Catheterization and Cardiovascular Interventions, 2012

We report a case of successful 2-stage percutaneous closure of severe paravalvular leak (PVL) in a patient with stentless aortic bioprosthesis. Threat of pliable prosthesis compression and long course of PVL posed main considerations. Accordingly, Amplatzer vascular plug (AVP) 2 was chosen as occluder. It was delivered transfemorally under fluoroscopy and transesophageal echocardiography guidance. No prosthesis distortion was provoked at the expense of moderate residual leak. Its symptoms after 3 months spurred another AVP 2 implantation, which lead to PVL closure with no effect on valve area. Marked reduction of left ventricle cavity size and NT-proBNP plasma concentration was promptly noted and remains stable in 12-month follow-up. V