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magna ease

Sina Stock, Hans-Hinrich Sievers, Doreen Richardt, Michael Scharfschwerdt
OBJECTIVES: : Small aortic annuli are challenging in aortic valve replacement. Prosthesis-patient mismatch, accompanied by high transvalvular gradients and small orifice area, is an often faced problem impairing postoperative outcome. The new TRIBIO bioprosthesis aims to enable enhanced haemodynamics, being increasingly important with decreasing annular size. This study compares ex vivo hydrodynamics of TRIBIO with 2 established bioprostheses in small annuli at different stroke volumes, simulating 'rest' and 'exercise', and evaluates haemodynamics of TRIBIO in a sheep model...
June 20, 2017: Interactive Cardiovascular and Thoracic Surgery
John D Puskas, Joseph E Bavaria, Lars G Svensson, Eugene H Blackstone, Bartley Griffith, James S Gammie, David A Heimansohn, Jerzy Sadowski, Krzysztof Bartus, Douglas R Johnston, Jacek Rozanski, Todd Rosengart, Leonard N Girardi, Charles T Klodell, Mubashir A Mumtaz, Hiroo Takayama, Michael Halkos, Vaughn Starnes, Percy Boateng, Tomasz A Timek, William Ryan, Shuab Omer, Craig R Smith
OBJECTIVES: The COMMENCE trial was conducted to evaluate the safety and effectiveness of a novel bioprosthetic tissue for surgical aortic valve replacement (AVR). METHODS: Patients underwent clinically indicated surgical AVR with the Carpentier-Edwards PERIMOUNT™ Magna Ease™ aortic valve with RESILIA™ tissue (Model 11000A) in a prospective, multinational, multicentre ( n  = 27), single-arm, FDA Investigational Device Exemption trial. Events were adjudicated by an independent Clinical Events Committee; echocardiograms were analysed by an independent Core Laboratory...
June 10, 2017: European Journal of Cardio-thoracic Surgery
Yuta Kume, Tomoyuki Fujita, Satsuki Fukushima, Hiroki Hata, Yusuke Shimahara, Yorihiko Matsumoto, Kizuku Yamashita, Junjiro Kobayashi
BACKGROUND: Prosthesis-patient mismatch (PPM) is associated with increased mid-term and long-term mortality rates after aortic valve replacement (AVR). This study aimed to evaluate the efficacy of the Carpentier-Edwards Perimount Magna and Magna Ease (CEPMs) aortic bioprostheses to reduce the incidence of PPM.Methods and Results:Altogether, 282 consecutive patients (113 women, mean age 69.9±9.9 years) underwent AVR with a CEPMs between 2008 and 2015. They were divided into 3 groups based on the risk of PPM as a result of their body surface area and aortic annular diameter (BSA/AnnD ratio): low-risk (LR) group: 0...
March 24, 2017: Circulation Journal: Official Journal of the Japanese Circulation Society
Sina Stock, Michael Scharfschwerdt, Roza Meyer-Saraei, Doreen Richardt, Efstratios I Charitos, Hans-Hinrich Sievers, Thorsten Hanke
BACKGROUND: Transcatheter aortic valve-in-valve implantation (TAVI-ViV) is an evolving treatment strategy for degenerated surgical aortic valve bioprostheses (SAVBs). However, there is some concern regarding coronary obstruction, especially after TAVI-ViV in calcified SAVBs with externally mounted leaflets. We investigated in vitro coronary flow and hydrodynamics after TAVI-ViV using 2 modern SAVBs with externally and internally mounted leaflets. METHODS: Aortic root models including known risk factors for coronary obstruction served for the implantation of SAVBs with either externally mounted leaflets (St Jude Trifecta, size 25) or internally mounted leaflets (Edwards Perimount Magna Ease, size 25)...
February 2017: Journal of Thoracic and Cardiovascular Surgery
Glenn R Barnhart, Kevin D Accola, Eugene A Grossi, Y Joseph Woo, Mubashir A Mumtaz, Joseph F Sabik, Frank N Slachman, Himanshu J Patel, Michael A Borger, H Edward Garrett, Evelio Rodriguez, Patrick M McCarthy, William H Ryan, Francis G Duhay, Michael J Mack, W Randolph Chitwood
BACKGROUND: The TRANSFORM (Multicenter Experience With Rapid Deployment Edwards INTUITY Valve System for Aortic Valve Replacement) trial (NCT01700439) evaluated the performance of the INTUITY rapid deployment aortic valve replacement (RDAVR) system in patients with severe aortic stenosis. METHODS: TRANSFORM was a prospective, nonrandomized, multicenter (n = 29), single-arm trial. INTUITY is comprised of a cloth-covered balloon-expandable frame attached to a Carpentier-Edwards PERIMOUNT Magna Ease aortic valve...
October 15, 2016: Journal of Thoracic and Cardiovascular Surgery
Giuseppe Santarpino, Jurij M Kalisnik, Theodor Fischlein, Steffen Pfeiffer
Aortic valve bioprostheses are commonly implanted in the current era (also in younger patients) as they may obviate the need for anticoagulation while providing better hemodynamic performance and a more favorable quality of life. The steady increase in the use of biological valves has prompted the development of several different models of conventional stented bioprostheses. At present, there are four main types of stented aortic bioprostheses that compete in the market: the LivaNova Crown PRT (LivaNova Group, Burnaby, Canada), the St...
October 2016: Minerva Cardioangiologica
Naritomo Nishioka, Akira Yamada, Kosuke Ujihira, Yutaka Iba, Ryushi Maruyama, Eiichiro Hatta, Yoshihiko Kurimoto, Katsuhiko Nakanishi
OBJECTIVE: We sought to compare the outcomes of Carpentier-Edwards PERIMOUNT (CEP), Magna and Magna Ease valves in Japanese elderly patients with severe aortic valve stenosis (AS). METHODS: We retrospectively identified 136 patients (mean age 76.61 ± 5.5 years old) who had undergone isolated surgical aortic valve replacement (SAVR) using CEP, Magna, and Magna Ease valves at a single institution, from January 2001 to December 2013. We compared the valves according to their survival rates, freedom from major adverse cardiovascular and cerebrovascular events (MACCE), and durability and hemodynamic performance by echocardiographic data...
December 2016: General Thoracic and Cardiovascular Surgery
Fraser D Rubens, Yen-Yen Gee, Janet M C Ngu, Li Chen, Ian G Burwash
OBJECTIVES: We sought to assess the effect of 2 contemporary pericardial valves on left ventricular mass regression and clinical outcomes after aortic valve replacement (AVR) in patients with aortic stenosis (AS). METHODS: Patients were followed postoperatively in a dedicated valve clinic. A propensity score was derived for each patient and used to adjust all analyses. Longitudinal analysis was performed using a repeated measures growth curve model. Survival analysis was assessed with a Cox proportional hazards model...
November 2016: Journal of Thoracic and Cardiovascular Surgery
Giordano Tasca, Gianfranco Beniamino Fiore, Andrea Mangini, Claudia Romagnoni, Amando Gamba, Alberto Redaelli, Carlo Antona, Riccardo Vismara
Pericardial and porcine stented aortic valves have different leaflet kinematics. To study the biomechanics of a prosthesis thoroughly, the in vitro setting is the most appropriate. The aim of our study was to find out whether the prosthesis design in which the pericardial sheet is outside the stent post might influence the opening and closing patterns of the leaflets. Four pericardial prostheses (Magna Ease [MG] 21, Trifecta [TRI] 21, Soprano-Armonia [SA] 20 and Mitroflow [MF] 23) that fitted aortic roots with a native annulus diameter of 2...
December 2016: Journal of Artificial Organs: the Official Journal of the Japanese Society for Artificial Organs
Giuseppe Santarpino, Jurij M Kalisnik, Theodor Fischlein, Steffen Pfeiffer
Aortic valve bioprostheses are commonly implanted in the current era - also in younger patients - as they may obviate the need for anticoagulation while providing better hemodynamic performance and a more favorable quality of life. The steady increase in the use of biological valves has prompted the development of several different models of conventional stented bioprostheses. At present, there are four main types of stented aortic bioprostheses that compete in the market: the LivaNova Crown PRT (LivaNova Group, Burnaby, Canada), the St...
April 20, 2016: Minerva Cardioangiologica
Martin Andreas, Stephanie Wallner, Andreas Habertheuer, Claus Rath, Martin Schauperl, Thomas Binder, Dietrich Beitzke, Raphael Rosenhek, Christian Loewe, Dominik Wiedemann, Alfred Kocher, Guenther Laufer
OBJECTIVES: Sutureless and rapid-deployment valves were recently introduced into clinical practice. The Edwards INTUITY valve system is a combination of the Edwards Magna pericardial valve and a subvalvular stent-frame to enable rapid deployment. We performed a parallel cohort study for comparison of the two valve types. METHODS: All patients receiving either an Edwards Magna Ease valve or an Edwards INTUITY valve system due to aortic stenosis from May 2010 until July 2014 were included...
June 2016: Interactive Cardiovascular and Thoracic Surgery
Giordano Tasca, Riccardo Vismara, Gianfranco Beniamino Fiore, Andrea Mangini, Claudia Romagnoni, Alberto Redaelli, Carlo Antona
BACKGROUND AND AIM OF THE STUDY: Many variables may affect the fluid dynamic of an implanted bioprosthesis. In-vitro studies have provided accurate data such that, when different prostheses are implanted in the same true aortic root, it should be possible to make a fair comparison. The study aim was to evaluate the fluid dynamic and geometric characteristics of the four most widely used stented pericardial bioprostheses. METHODS: Four types of pericardial prosthesis (Magna Ease 21, Trifecta 21, Soprano-Armonia 20, and Mitroflow 23) that fitted eight aortic roots with a native annulus diameter of 2...
September 2015: Journal of Heart Valve Disease
Vinayak Bapat, David Chambers
AIMS: Implantation of a transcatheter heart valve to treat valve failure is an attractive option which is being used more frequently. Despite large clinical experience there is a paucity of in vitro data to support this treatment. Our aim was to provide in vitro performance data on the SAPIEN XT transcatheter heart valve implanted within two types of pericardial surgical heart valve. METHODS AND RESULTS: A SAPIEN XT was implanted within multiple sizes, i.e., 21, 23, 25 of Magna Ease and explanted calcified PERIMOUNT valves...
February 2016: EuroIntervention
David S Bach, Himanshu J Patel, Theodore J Kolias, G Michael Deeb
OBJECTIVES: The purpose of this study was to compare haemodynamics at rest and during exercise after clinically indicated aortic valve replacement (AVR) for aortic stenosis among patients randomly assigned to one of three haemodynamically excellent bioprostheses. METHODS: In a single-centre, prospective trial, 60 patients undergoing clinically indicated AVR were randomly assigned to Freestyle, Magna Ease or Trifecta bioprostheses. Six months after surgery, patients underwent supine bicycle stress echocardiography for the assessment of aortic valve haemodynamics...
August 2016: European Journal of Cardio-thoracic Surgery
Vrishank Raghav, Ikechukwu Okafor, Michael Quach, Lynn Dang, Salvador Marquez, Ajit P Yoganathan
BACKGROUND: Durability and hemodynamic performance are top considerations in selecting a valve for valve replacement surgery. This study was conducted in order to evaluate the long-term mechanical durability and hydrodynamic performance of the Carpentier-Edwards PERIMOUNT Magna Ease Bioprostheses, through 1 billion cycles (equivalent to 25 years). METHODS: In vitro valve hydrodynamic performance, durability, and quantitative flow visualization were conducted in accordance with ISO 5840:2005 heart valve standard...
May 2016: Annals of Thoracic Surgery
Satoru Domoto, Hiroshi Niinami, Kazuhiko Uwabe, Hiroyuki Koike, Mimiko Tabata, Kozo Morita, Masaru Kambe, Atsushi Iguchi
OBJECTIVES: A potential problem in aortic valve replacement (AVR) for patients with a small aortic annulus is prosthesis-patient mismatch (PPM). Although larger size prostheses have been well studied, the haemodynamics of 19-mm bioprostheses has been reported in only a small number of patients. The Trifecta valve is a novel bioprosthesis and its unique design is conceived to increase effective orifice area (EOA) and prevent PPM. This study aims at comparing the early haemodynamics of the new Trifecta valve with that of other conventional 19-mm valves...
January 2016: Interactive Cardiovascular and Thoracic Surgery
Daniel Wendt, Sebastian Stühle, Philipp Marx, Jaroslav Benedik, Hermann Wendt, Thomas Stühle, Martin Thoenes, Matthias Thielmann, Heinz Jakob, Wojciech Kowalczyk
OBJECTIVES: We aimed to investigate leaflet kinematics of bioprostheses with a novel high-speed imaging method. MATERIAL AND METHODS: High-speed-imaging (1000 Hz) was used to evaluate leaflet kinematics of the Carpentier-Edwards Perimount Magna (PM) and Magna Ease (PME) aortic bioprostheses. Both prostheses (diameter 23 mm) were placed inside a model aorta under pulsatile flow conditions. Frequencies (F) and different stroke volumes (S) were simulated. Maximum aortic valve area (AVA), total ejection time (TET), rapid valve opening time (RVOT) and rapid valve closing time (RVCT) as well as opening (OS) and closing (CS) speeds were evaluated...
2015: Minimally Invasive Therapy & Allied Technologies: MITAT
Shigehiko Tokunaga, Tomoki Cho, Ryo Izubuchi, Munetaka Masuda
Though the Carpentier Edwards PERIMOUNT Magna Ease valve is a bioprosthesis with documented excellent haemodynamics and easy implantability, this valve has a gap between the cobalt-chromium-nickel alloy stent and silicone sewing ring. This gap, which is widest just below each of the three commissural struts, lacks silicone and leaves the two-layer polytetrafluoroethylene fabric unsupported and unprotected. If the needle of a valve suture is placed in this structurally weak area of the sewing ring, the resultant fabric tear may result in a true cuff leakage, not the usual paravalvular leakage...
December 2015: Interactive Cardiovascular and Thoracic Surgery
Enrico R Barrozo, David A Fowler, Matthew L Beckman
Daphnia are freshwater crustaceans that have been used for decades in ecotoxicology research. Despite the important role that Daphnia have played in environmental toxicology studies, very little is known about the neurobiology of Daphnia. Although many studies have investigated the swimming movements of these "water fleas", few studies have examined the underlying neurochemical basis for these movements. To characterize the locomotor effect of drugs in Daphnia, a two-dimensional video imaging tool was developed and animal tracking was performed with freely available software, CTRAX...
October 2015: Pharmacology, Biochemistry, and Behavior
Kathrin Fiegl, Marcus-Andre Deutsch, Ina-Christine Rondak, Ruediger Lange, Ralf Guenzinger
Objective The aim of this retrospective study was to evaluate the hemodynamic performance of the St. Jude Medical Trifecta (SJM Trifecta; St. Jude Medical, St Paul, Minnesota, United States) and the Carpentier-Edwards Perimount Magna Ease (CEPM Ease; Edwards Lifesciences, Irvine, California, United States) bioprostheses early postoperative and at 1 year. Methods From October 2007 to October 2008, a total of 61 consecutive patients underwent aortic valve replacement (AVR) with the CEPM Ease prosthesis. From a prospective cohort of 201 patients (March 2011 to January 2012) who received AVR with the SJM Trifecta valve, a matched group of 51 patients was selected...
September 2015: Thoracic and Cardiovascular Surgeon
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