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Self-expanding valve

Timm Schäfer, Christian Doose, Buntaro Fujita, Marc Utzenrath, Sandrine Egron, Christoph Schmitz, Smita Scholtz, Maximilian Kütting, Kavous Hakim-Meibodi, Jochen Börgermann, Jan Gummert, Ulrich Steinseifer, Stephan Ensminger
AIMS: The aim was to determine the best functional position of a transcatheter heart valve (THV) implanted as a valve-in-valve (ViV) procedure in small rapid deployment valves (RDV) in an in vitro model. METHODS AND RESULTS: A 21mm Perceval™, Enable™ or INTUITY™ RDV was mounted into a pulse duplicator and a 23mm balloon-expandable or a self-expanding THV was deployed (valve-in-valve) in two different positions. Under physiological hydrodynamic conditions, performance of the THV was characterized by mean transvalvular pressure gradient (MPG), effective orifice area (EOA) and regurgitation volume (RV)...
October 18, 2016: EuroIntervention
Ismail Bouhout, Amine Mazine, Lena Rivard, Aly Ghoneim, Ismail El-Hamamsy, Yoan Lamarche, Michel Carrier, Philippe Demers, Denis Bouchard
BACKGROUND: Sutureless self-expandable aortic bioprostheses rely on radial forces for stabilization, raising concern that these devices may increase the risk of postoperative conduction disease. The purpose of this study was to determine the incidence of conduction disorders after sutureless aortic valve replacement (AVR) with the Perceval S (Sorin Group, Saluggia, Italy) bioprosthesis. METHODS: Between June 2011 and March 2013, 108 consecutive patients underwent sutureless AVR with the Perceval S prosthesis...
October 4, 2016: Annals of Thoracic Surgery
Rodrigo Bagur, Patrick J Teefy, Bob Kiaii, Pantelis Diamantouros, Michael W A Chu
BACKGROUND: Transcatheter aortic valve implantation (TAVI) has become a therapeutic alternative for patients presenting with severe symptomatic aortic stenosis and considered at high-surgical risk. Paravalvular leak (PVL), conduction disorders, and coronary obstruction remain unresolved procedure-related complications. The aim of this manuscript was to report the first North American experience with the ACURATE-neo(TM) aortic bioprosthesis and its ACURATE-TF(TM) delivery system (Symetis S...
September 28, 2016: Catheterization and Cardiovascular Interventions
Nicolas Amabile, Konstantinos Zannis, Aurélie Veugeois, Christophe Caussin
No abstract text is available yet for this article.
August 29, 2016: Journal of Thoracic and Cardiovascular Surgery
Maurizio Taramasso, Azeem Latib, Paolo Denti, Fabian Nietlispach, Kevin Lynn, Nikola Cesarovic, Alessandro Addis, Maximilian Y Emmert, Andrea Guidotti, Hugo Vanermen, Francesco Maisano
AIMS: The aim of this study was to evaluate the safety, technical feasibility and performance of a new trans-catheter tricuspid repair system. METHODS AND RESULTS: Thirty-one adult swine underwent implantation of a transcatheter tricuspid remodelling system under general anaesthesia. The steerable transcatheter device was introduced through a 24 Fr femoral sheath into the right femoral vein and delivered to the tricuspid annulus on the beating heart. A fixation element was implanted into the tricuspid annulus...
September 18, 2016: EuroIntervention
Benyamin Rahmani, Spyros Tzamtzis, Rose Sheridan, Michael J Mullen, John Yap, Alexander M Seifalian, Gaetano Burriesci
AIMS: The aim of this study was to introduce and demonstrate the feasibility in an acute preclinical model of a new transcatheter heart valve concept with a self-expanding wire frame, polymeric leaflets and a sealing component. METHODS AND RESULTS: The TRISKELE valve was developed based on a previously validated polymeric leaflet design, an adaptive sealing cuff and a novel nitinol wire frame which reduces stress on the leaflets and radial pressure on the surrounding tissue...
September 18, 2016: EuroIntervention
Ditte Dencker, Mikkel Taudorf, N H Vincent Luk, Michael B Nielsen, Klaus F Kofoed, Torben V Schroeder, Lars Søndergaard, Lars Lönn, Ole De Backer
Vascular access and closure remain a challenge in transcatheter aortic valve replacement (TAVR). This single-center study aimed to report the incidence, predictive factors, and clinical outcomes of access-related vascular injury and subsequent vascular intervention. During a 30-month period, 365 patients underwent TAVR and 333 patients (94%) were treated by true percutaneous transfemoral approach. Of this latter group, 83 patients (25%) had an access-related vascular injury that was managed by the use of a covered self-expanding stent (n = 49), balloon angioplasty (n = 33), or by surgical intervention (n = 1)...
October 15, 2016: American Journal of Cardiology
Mattia Lunardi, Gabriele Pesarini, Carlo Zivelonghi, Anna Piccoli, Giulia Geremia, Sara Ariotti, Andrea Rossi, Alessia Gambaro, Leonardo Gottin, Giuseppe Faggian, Corrado Vassanelli, Flavio Ribichini
OBJECTIVE: The use of transcatheter aortic valve implantation (TAVI) is growing rapidly in countries with a predominantly elderly population, posing a huge challenge to healthcare systems worldwide. The increment of human and economic resource consumption imposes a careful monitoring of clinical outcomes and cost-benefit balance, and this article is aimed at analysing clinical outcomes related to the TAVI learning curve. METHODS: Outcomes of 177 consecutive transfemoral TAVI procedures performed in 5 years by a single team were analysed by the Cumulative Sum of failures method (CUSUM) according to the clinical events comprised in the Valve Academic Research Consortium (VARC-2) safety end point and the VARC-2 definition of device success...
2016: Open Heart
Birgid Gonska, Julia Seeger, Justus Baarts, Christoph Rodewald, Dominik Scharnbeck, Wolfgang Rottbauer, Jochen Wöhrle
BACKGROUND: Residual paravalvular moderate or severe aortic regurgitation (AR) has been an independent risk factor for mortality after transcatheter aortic valve implantation (TAVI). The design of the third generation Edwards Sapien 3 (ES3; Edwards Lifesciences, Irvine, CA, USA) valve was optimized with an outer skirt to address the issue of paravalvular AR. METHODS AND RESULTS: We compared 100 consecutive patients treated with the ES3 for severe aortic stenosis with 100 patients treated with the Medtronic CoreValve (CV; Medtronic, Minneapolis, MN, USA) (Clinical Trial Registration: NCT02162069)...
September 7, 2016: Journal of Cardiology
A A Sakrana, M M Nasr, G A Ashamallah, R A Abuelatta, H A Naeim, M E Tahlawi
AIM: To investigate the determinants of paravalvular leak (PVL) occurring after transcatheter aortic valve implantation (TAVI). MATERIALS AND METHODS: One hundred and eight patients with severe symptomatic aortic stenosis (mean age 75.5±11.8 years, 72.2% male) underwent contrast-enhanced electrocardiogram (ECG)-gated multidetector computed tomography (MDCT) then successful TAVI. The following parameters were determined in the late systolic phase: annular and left ventricular outflow tract (LVOT) diameters, annular perimeter, ellipticity index, annular area, indexed annular area, LVOT perimeter, annulus/LVOT perimeter difference ratio, the LVOT to ascending aorta angle (< LVOT-AO)...
November 2016: Clinical Radiology
Neal S Kleiman, Brijeshwar J Maini, Michael J Reardon, John Conte, Stanley Katz, Vivek Rajagopal, James Kauten, Alan Hartman, Raymond McKay, Robert Hagberg, Jian Huang, Jeffrey Popma
BACKGROUND: The risk for stroke after transcatheter aortic valve replacement (TAVR) is an important concern. Identification of predictors for stroke is likely to be a critical factor aiding patient selection and management as TAVR use becomes widespread. METHODS AND RESULTS: Patients enrolled in the CoreValve US Extreme Risk and High Risk Pivotal Trials or Continued Access Study treated with the self-expanding CoreValve bioprosthesis were included in this analysis...
September 2016: Circulation. Cardiovascular Interventions
Francesco Giannini, Matteo Montorfano, Vittorio Romano, Neil Ruparelia, Richard J Jabbour, Susanna Benincasa, Azeem Latib, Antonio Colombo
Valve embolization during transcatheter aortic valve implantation is a rare but potentially fatal complication of first generation transcatheter valves. As a result, second generation valves were designed to be fully retrievable and minimize this complication. We report a first case of embolization with a second-generation fully-retrievable and repositionable Lotus valve. In this case, the presence of severe left ventricular hypertrophy and a sigmoid septum may have contributed to prosthesis embolization with the initial 23mm Lotus valve...
November 15, 2016: International Journal of Cardiology
E Coron, G David, S Lecleire, J Jacques, A Le Sidaner, T Barrioz, D Coumaros, C Volteau, B Vedrenne, P Bichard, C Boustière, Y Touchefeu, J Brégeon, F Prat, M Le Rhun
INTRODUCTION: Self-expanding metal stents (SEMS) are commonly used in the palliation of dysphagia in patients with inoperable esophageal carcinoma. However, they predispose to gastroesophageal reflux when deployed across the gastroesophageal junction. The aims of this study were to: 1) assess the influence of the antireflux valve on trans-prosthetic reflux (primary outcome); and 2) compare the results of SEMS with and without antireflux valve in terms of reflux symptoms, quality of life (QOL), improvement of dysphagia and adverse events (secondary outcomes)...
June 2016: Endoscopy International Open
Manolis Vavuranakis, Konstantinos Kalogeras, Maria Lavda, Michail-Aggelos Kolokathis, Theodoros Papaioannou, Euaggelos Oikonomou, Mursini Stasinopoulou, Dimitrios Vrachatis, Carmen Moldovan, Maria Kariori, Evelina Bei, Sophia Vaina, Georgios Lazaros, Ourania Katsarou, Gerasimos Siasos, Dimitrios Tousoulis
BACKGROUND: 'Cover index' has been proposed to appraise the congruence between the aortic annulus and the device, with the assumption of not taking into account the actual device implantation depth. The aim of this study was to investigate whether the annulus-prosthesis mismatch, as expressed with the new proposed 'true cover index' according to actual implantation depth, can predict aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI). METHODS: Patients who had undergone TAVI with the self-expandable CoreValve device, were retrospectively studied...
November 15, 2016: International Journal of Cardiology
Ganesh Manoharan, Axel Linke, Helge Moellmann, Simon Redwood, Christian Frerker, Jan Kovac, Thomas Walther
AIMS: The aim of this study was to evaluate the safety and performance of the resheathable and repositionable St. Jude Medical Portico self-expanding transfemoral TAVI system. METHODS AND RESULTS: This prospective, single-arm, multicentre study evaluated the 18 Fr Portico system with either a 23 or a 25 mm valve. Patient follow-up was at 30, 90, 180 days and one year. Results up to 30 days are presented. Adverse events were categorised by VARC definitions and adjudicated by an independent events committee...
August 20, 2016: EuroIntervention
Michael J Reardon, Neal S Kleiman, David H Adams, Steven J Yakubov, Joseph S Coselli, G Michael Deeb, Daniel O'Hair, Thomas G Gleason, Joon Sup Lee, James B Hermiller, Stan Chetcuti, John Heiser, William Merhi, George L Zorn, Peter Tadros, Newell Robinson, George Petrossian, G Chad Hughes, J Kevin Harrison, Brijeshwar Maini, Mubashir Mumtaz, John V Conte, Jon R Resar, Vicken Aharonian, Thomas Pfeffer, Jae K Oh, Jian Huang, Jeffrey J Popma
Importance: Transcatheter aortic valve replacement (TAVR) is now a well-accepted alternative to surgical AVR (SAVR) for patients with symptomatic aortic stenosis at increased operative risk. There is interest in whether TAVR would benefit patients at lower risk. Objective: The Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) has trended downward in US TAVR trials and the STS/American College of Cardiology Transcatheter Valve Therapy Registry. We hypothesized that if the Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) alone is sufficient to define decreased risk, the contribution to survival based on the degree of invasiveness of the TAVR procedure will decrease, making it more difficult to show improved survival and benefit over SAVR...
August 17, 2016: JAMA Cardiology
Yosuke Miyazaki, Takayuki Okamura, Akira Fujita, Akihito Mikamo, Tetsuro Oda, Yasuaki Wada, Atsuo Yamashita, Ryo Suzuki, Masaya Takahashi, Kimikazu Hamano, Masafumi Yano
No abstract text is available yet for this article.
November 15, 2016: International Journal of Cardiology
Carlos Ferrera, Luis Nombela-Franco, Eulogio Garcia, Pilar Jimenez-Quevedo, Corina Biagioni, Nieves Gonzalo, Ivan Nuñez-Gil, Ana Viana-Tejedor, Pablo Salinas, Jose Alberto de Agustin, Carlos Almeria, Fabian Islas, Leopoldo Perez de Isla, Cristina Fernandez-Perez, Javier Escaned, Antonio Fernández-Ortiz, Carlos Macaya
OBJECTIVES: To evaluate the safety and midterm hemodynamic results of direct transcatheter aortic valve replacement (TAVR) without pre-implantation balloon aortic valvuloplasty (BAV). BACKGROUND: BAV was considered a mandatory previous step in TAVR procedures. METHODS: A total of 339 consecutive patients who underwent transfemoral TAVR were prospectively selected. A 1:1 matching was conducted, pairing age, prosthesis type (self-expandable or balloon expandable) and size, and valve calcification grade (48% with moderate to severe valve calcification)...
August 12, 2016: Catheterization and Cardiovascular Interventions
Vincent Auffret, Ander Regueiro, María Del Trigo, Omar Abdul-Jawad Altisent, Francisco Campelo-Parada, Olivier Chiche, Rishi Puri, Josep Rodés-Cabau
BACKGROUND: Identifying transcatheter aortic valve replacement (TAVR) patients at high risk for cerebrovascular events (CVE) is of major clinical relevance. However, predictors have varied across studies. OBJECTIVES: The purpose of this study was to analyze the predictors of 30-day CVE post-TAVR. METHODS: A systematic review of studies that reported the incidence of CVE post-TAVR while providing raw data for predictors of interest was performed...
August 16, 2016: Journal of the American College of Cardiology
Alexander Sedaghat, Nils Neumann, Nadjib Schahab, Jan-Malte Sinning, Christoph Hammerstingl, Simon Pingel, Christian Schaefer, Fritz Mellert, Wolfgang Schiller, Armin Welz, Eberhard Grube, Georg Nickenig, Nikos Werner
BACKGROUND: Access-site and access-related vascular injury (ASARVI) is still a major limiting factor in transcatheter aortic valve implantation and affects the outcome of patients. Management strategies for ASARVI include manual compression, stent grafts, and vascular surgery. We hypothesized that the standard use of a self-expanding stent graft for the management of ASARVI is feasible and safe. METHODS AND RESULTS: Of 407 patients treated by transfemoral transcatheter aortic valve implantation, 110 experienced ASARVI (27...
August 2016: Circulation. Cardiovascular Interventions
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