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Sapien valve

François Huchet, Fanny d'Acremont, Vincent Letocart, Patrice Guerin, Gael Grimandi, Thibaut Manigold
BACKGROUND: Transcatheter aortic valve replacement (TAVR) has revolutionized the prognosis of inoperable patients with severe aortic valve stenosis. Yet, the implantation of expensive prostheses in patients with comorbidities may be questionable in an era when healthcare costs are becoming a major concern. AIM: The objective of this study was to assess whether the TAVR procedure is profitable in a high-volume French hospital. METHODS: Consecutive patients eligible for transfemoral TAVR using the SAPIEN bioprostheses (Edwards Lifesciences, Irvine, CA, USA) were included retrospectively in this single-centre study between September 2014 and December 2015...
March 15, 2018: Archives of Cardiovascular Diseases
Niklas Schofer, Florian Deuschl, Gerhard Schön, Moritz Seiffert, Matthias Linder, Andreas Schaefer, Johannes Schirmer, Edith Lubos, Hermann Reichenspurner, Stefan Blankenberg, Lenard Conradi, Ulrich Schäfer
BACKGROUND: The balloon-expandable Sapien 3 (Edwards Lifesciences, Irvine, CA, USA) and the mechanically-expandable Lotus valve (Boston Scientific, Marlborough, MA, USA) are established devices for transcatheter aortic valve implantation. We sought to compare both transcatheter heart valves (THV) under consideration of the extent of THV landing zone calcification. METHODS: This retrospective analysis includes consecutive patients with severe aortic stenosis treated with Sapien 3 (S3; n=212) or Lotus (n=61) THV via transfemoral access...
March 13, 2018: Journal of Cardiology
Yutaka Tanaka, Shigeru Saito, Saeko Sasuga, Azuma Takahashi, Yusuke Aoyama, Kazuto Obama, Mitsuo Umezu, Kiyotaka Iwasaki
BACKGROUND: Quantitative assessment of post-transcatheter aortic valve replacement (TAVR) aortic regurgitation (AR) remains challenging. We developed patient-specific anatomical models with pulsatile flow circuit and investigated factors associated with AR after TAVR. METHODS: Based on pre-procedural computed tomography (CT) data of the six patients who underwent transfemoral TAVR using a 23-mm SAPIEN XT, anatomically and mechanically equivalent aortic valve models were developed...
May 1, 2018: International Journal of Cardiology
Unzue Leire, García Eulogio, Rodríguez Rodrigo Francisco José, Parra Jiménez Francisco Javier, Medina Peralta Juan, Díaz-Antón Belen, Rodríguez Del Río Miguel, Fontenla Adolfo, Teijeiro Rodrigo, Rubio-Alonso Belén
OBJECTIVES: The aim of this study is to describe electrocardiographic changes and conduction abnormalities in patients undergoing transcatheter aortic valve implantation (TAVI). METHODS: 76 patients who underwent TAVI using Edwards Sapien 3 prosthesis were included, comparing electrocardiographic registries at admission, post-procedure and before discharge. RESULTS: Patients after TAVI presented a longer PR interval, a wider QRS, and a longer corrected QT, with a left deviation of QRS axis and T waves; reversible changes that tended to correct in the following days after TAVI...
February 20, 2018: Journal of Electrocardiology
W Toppen, W Suh, O Aksoy, P Benharash, C Bowles, R J Shemin, M Kwon
OBJECTIVE: With the introduction of the latest generation Sapien 3 transcatheter aortic valve, there has been a reduction in the usage of transapical (TA) approach for TAVRs in many centers. However, despite the smaller sheath size and more stream-lined delivery system, vascular complications continue to occur, especially in patients with peripheral vascular disease. Thus, our institution has maintained a stringent TA protocol aiming to prevent these complications. We hypothesize that this protocol has helped to reduce vascular complications and improve outcomes at our institution even in the Sapien 3 era...
March 6, 2018: Seminars in Thoracic and Cardiovascular Surgery
Amnon Eitan, Julian Witt, Jan Stripling, Timo Haselbach, Friedrich-Christian Rieß, Joachim Schofer
BACKGROUND: Evolut-R 34 mm (received CE mark in January 2017) and Sapien-3 29 mm are the only options for transcatheter aortic valve replacement (TAVR) in patients with annulus ≥26 mm. We compared the short-term outcomes of these valves in these patients. METHODS: Data was collected prospectively from consecutive patients with severe aortic stenosis and annulus diameter larger than 26 mm treated by femoral approach TAVR. RESULTS: Between February 1, 2014 to August 19, 2017 Sapien-3 29 mm was implanted in 55 and Evolut-R 34 mm in 37 consecutive patients...
March 9, 2018: Catheterization and Cardiovascular Interventions
Evan M Zahn, Jennifer C Chang, Dustin Armer, Ruchira Garg
Current balloon expandable transcatheter valves have limited applicability to patients with "native" right ventricular outflow tracts (RVOT), meaning those who have had previous surgery and are left with large, compliant, irregular RVOT. The Alterra Adaptive PrestentTM is a self-expanding, partially covered stent that was designed to internally reconfigure these types of RVOT, making them suitable for implantation of a commercially available balloon expandable heart valve, the SAPIEN 3. Herein, we describe the first human implant of this device...
March 9, 2018: Catheterization and Cardiovascular Interventions
Majd Ibrahim, Keattiyoat Wattanakit, Marco Barzallo, Sudhir Mungee
To our knowledge, this is the first documented case of successful TAVI for severe quadricuspid aortic valve (QAV) stenosis performed in the U.S. and the first documented Sapien 3 valve implantation in a severely stenotic QAV.
March 2018: Journal of Invasive Cardiology
Gilbert H L Tang, Syed Zaid, Samuel R Schnittman, Hasan Ahmad, Ryan Kaple, Cenap Undemir, Tanya Dutta, Angelica Poniros, Joanne Bennett, Cheng Feng, Martin Cohen, Steven L Lansman
AIMS: Paravalvular leak(PVL) remains an important issue in TAVI. The Edwards Sapien3(S3) valve has reduced PVL but up to one-third of patients remain with mild leak. Our study aims to identify predictors of mild PVL after TAVI with S3 valve. METHODS AND RESULTS: From 10/2015 to 5/2017, 122 consecutive patients underwent S3 TAVI for symptomatic severe aortic stenosis. 33 patients with mild PVL on transthoracic echocardiography at 30-day follow-up were compared to 89 with none/trace PVL...
February 27, 2018: EuroIntervention
Giorgia M Bosi, Claudio Capelli, Mun Hong Cheang, Nicola Delahunty, Michael Mullen, Andrew M Taylor, Silvia Schievano
Patient-specific computational models are an established tool to support device development and test under clinically relevant boundary conditions. Potentially, such models could be used to aid the clinical decision-making process for percutaneous valve selection; however, their adoption in clinical practice is still limited to individual cases. To be fully informative, they should include patient-specific data on both anatomy and mechanics of the implantation site. In this work, fourteen patient-specific computational models for transcatheter aortic valve replacement (TAVR) with balloon-expandable Sapien XT devices were retrospectively developed to tune the material parameters of the implantation site mechanical model for the average TAVR population...
February 20, 2018: Journal of Biomechanics
Doreen Richardt, Sherazade Luise Haban-Rackebrandt, Sina Stock, Michael Scharfschwerdt, Hans-Hinrich Sievers
OBJECTIVES: Transcatheter aortic valve implantation is a treatment strategy for degenerated aortic valve prostheses, but there is some concern regarding valve thrombosis. The optimal anticoagulation strategy for implantation of a transcatheter aortic valve prosthesis remains unclear. METHODS: Aortic root models with the Sapien-XT and S3 prostheses (sizes 23 and 26) fixed in a Perimount Magna Ease bioprosthesis (sizes 23 and 25) were constructed. The haemodynamics of the left ventricle were imitated in a proved in vitro model...
February 15, 2018: European Journal of Cardio-thoracic Surgery
Andy C Kiser, Thomas G Caranasos, Mark D Peterson, David M Holzhey, Philipp Kiefer, L Wiley Nifong, Michael A Borger
OBJECTIVE: Recently, the PARTNER 2A trial reported results of transcatheter aortic valve replacement versus surgical aortic valve replacement in 2032 intermediate-risk patients at 2 years. Two hundred thirty-six patients (24%) required an access route other than transfemoral. Compared with transfemoral and surgical aortic valve replacement, nontransfemoral transcatheter aortic valve replacement was associated with a numerically higher rate of death and disabling stroke at 30 days. This underscores the need for a better alternative surgical approach for patients with marginal femoral access...
February 17, 2018: Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery
Kevin D Accola, W Randolph Chitwood, Mubashir A Mumtaz, Glenn R Barnhart
PURPOSE: Rapid deployment/sutureless aortic valve replacement is aimed at minimizing the invasiveness of surgical aortic valve replacement. We describe the implantation techniques of a new rapid deployment aortic valve, focusing on its unique and challenging features. DESCRIPTION: The EDWARDS INTUITY Elite aortic valve (Edwards Lifesciences, Irvine, CA) represents a hybrid between the surgical PERIMOUNT Magna Ease (Edwards Lifesciences) pericardial valve, but with advanced features of the percutaneous SAPIEN valve system (Edwards Lifesciences)...
March 2018: Annals of Thoracic Surgery
Jonathon P Fanning, Allan J Wesley, Darren L Walters, Andrew A Wong, Adrian G Barnett, Wendy E Strugnell, David G Platts, John F Fraser
BACKGROUND: Transcatheter aortic valve implantation (TAVI) is associated with a high incidence of cerebrovascular injury. As these injuries are thought to be primarily embolic, neuroprotection strategies have focused on embolic protection devices. However, the topographical distribution of cerebral emboli and how this impacts on the effectiveness of these devices have not been thoroughly assessed. Here, we evaluated the anatomical characteristics of magnetic resonance imaging (MRI)-defined cerebral ischemic lesions occurring secondary to TAVI to enhance our understanding of the distribution of cardioembolic phenomena...
March 2018: American Heart Journal
Alexander Lauten, Hans R Figulla, Axel Unbehaun, Neil Fam, Joachim Schofer, Torsten Doenst, Joerg Hausleiter, Marcus Franz, Christian Jung, Henryk Dreger, David Leistner, Brunilda Alushi, Anja Stundl, Ulf Landmesser, Volkmar Falk, Karl Stangl, Michael Laule
BACKGROUND: Transcatheter caval valve implantation is under evaluation as a treatment option for inoperable patients with severe tricuspid regurgitation (TR). The procedure involves the catheter-based implantation of bioprosthetic valves in the inferior vena cava and superior vena cava to treat symptoms associated with TR. This study is the first to evaluate the feasibility, safety, and efficacy of this interventional concept. METHODS AND RESULTS: Twenty-five patients (mean age, 73...
February 2018: Circulation. Cardiovascular Interventions
Mark Webster, Sanjeevan Pasupati, Nigel Lever, Martin Stiles
OBJECTIVE: This first-in-human study evaluated the safety and technical feasibility of the Tempo temporary cardiac pacing lead (BioTrace Medical), which includes a novel fixation mechanism and soft tip. BACKGROUND: Complications of temporary pacing leads include dislodgment, arrhythmias, and ventricular perforation. Temporary pacing applications have increased with transcatheter aortic valve replacement (TAVR) growth, for rapid pacing during balloon valvuloplasty (BAV) and valve deployment, and for periprocedural bradyarrhythmia support...
February 15, 2018: Journal of Invasive Cardiology
Philippe J van Rosendael, Victoria Delgado, Jeroen J Bax
Aims: The incidence of new-onset conduction abnormalities requiring permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI) with new-generation prostheses remains debated. This systematic review analyses the incidence of PPI after TAVI with new-generation devices and evaluates the electrical, anatomical, and procedural factors associated with PPI. In addition, the incidence of PPI after TAVI with early generation prostheses was reviewed for comparison...
February 6, 2018: European Heart Journal
Jeroen Vendrik, Floortje van Kesteren, Martijn S van Mourik, Jan J Piek, Jan G Tijssen, Jose P S Henriques, Joanna J Wykrzykowska, Rob J de Winter, Antoine H G Driessen, Abdullah Kaya, M Marije Vis, Karel T Koch, Jan Baan
Over the years increasing experience and technical device improvements in transcatheter aortic valve implantation (TAVI) have led to treatment of patients with lower surgical risks. Specifically for this population, device performance and longer term outcome are of great importance. In this single center, we performed a retrospective analysis of 515 consecutive patients with low- to intermediate surgical risk (STS-PROM ≤8), who underwent transfemoral TAVI between January 2009 and February 2017 with the SXT and ES3 prostheses, and we assessed procedural outcome and procedural and 3-year survival...
January 11, 2018: American Journal of Cardiology
Alessia Faccini, Gianfranco Butera
Nowadays, percutaneous pulmonary valve implantation (PPVI) is a suitable alternative to surgical procedure in patients with right ventricle outflow tract dysfunction. Two valves are currently available for PPVI: the Melody valve and the Edwards Sapien valve. The following complications may occur: coronary artery compression, deformation of the aortic root, stent or valve embolization, damage of distal pulmonary arteries, access site injuries. Here, we report on three cases of severe tricuspid regurgitation due to valvular and subvalvular apparatus damage during Edwards Sapien XT valve implantation...
February 6, 2018: Catheterization and Cardiovascular Interventions
Sandeep Banga, Marco A Barzallo, Casey L Nighswonger, Sudhir Mungee
We report a challenging case of a 81-year-old male with history of severe calcific aortic valve stenosis and aneurysmal membranous interventricular septum. The presence of anomalies in the sub-annular area can lead to valve malpositioning and its consequences. transcatheter aortic valve implantation (TAVR) in patients with aneurysm of the perimembranous interventricular septum extending into the left ventricular outflow tract has not been previously reported. This case describes a successful transfemoral TAVR with an Edwards SAPIEN XT valve (Edwards Lifesciences, Irvine, CA, United States) with such anomaly...
January 26, 2018: World Journal of Cardiology
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