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Sapien valve

Cheng He, Gregory Scalia, Darren L Walters, Andrew Clarke
We describe a successful transcatheter, transapical mitral valve implant within a failed mitral bioprosthesis (valve-in-valve) in a symptomatic 86-year-old patient with prohibitive surgical risks, using the new Sapien 3 balloon-expandable valve. Post-deployment echocardiographic profile of the valve-in-valve was satisfactory and the patient was discharged from hospital uneventfully. This is the first reported case of the Sapien 3 valve used in the mitral valve-in-valve setting.
June 21, 2016: Heart, Lung & Circulation
Roland Hilling-Smith, James Cockburn, Maureen Dooley, Jessica Parker, Andrea Newton, Andrew Hill, Uday Trivedi, Adam de Belder, David Hildick-Smith
: Transcatheter aortic valve implantation (TAVI) and balloon aortic valvuloplasty (BAV) are now well established percutaneous procedures. These procedures almost always require bursts of rapid ventricular pacing to temporarily reduce cardiac output to facilitate the procedure, usually done via a temporary pacing wire inserted into the right ventricle. We describe a case series of 132 cases of TAVI and 76 BAV done using ventricular pacing via the left ventricular lead by simply connecting one electrode to the patient's skin and one electrode through the left ventricular (LV) wire...
October 11, 2016: Catheterization and Cardiovascular Interventions
Yigal Abramowitz, Hasan Jilaihawi, Tarun Chakravarty, Yoshio Maeno, Hiroyuki Kawamori, Yoshio Kazuno, Geeteshwar Mangat, Tanya Rami, Zev Allison, David Anderson, Larry Chan, Wen Cheng, Raj R Makkar
OBJECTIVES: Aortic valve preparation with balloon aortic valvuloplasty (BAV) has been previously considered mandatory during transcatheter aortic valve implantation (TAVI) procedures. BAV-inherent risks including stroke, conduction abnormalities, and reduced device profile size established the rationale for safe valve deployment without the need for aggressive valve preparation. We investigate the feasibility and safety of performing Sapien 3 (S3; Edwards Lifesciences) balloon-expandable TAVI with moderate or without predilation (PD)...
October 2016: Journal of Invasive Cardiology
Pranav Loyalka, Angelo Nascimbene, Michael Schechter, Marija Petrovic, Ajay Sundara Raman, Igor D Gregoric, Biswajit Kar
INTRODUCTION: Transcatheter aortic valve implantation (TAVI) in patients with degenerated bioprosthetic aortic valve has been successfully performed as an alternative to surgery. We describe our initial experience of valve-in-valve TAVI in five patients, using new generation Edwards Sapien 3 transcatheter heart valves implanted into degenerated 19 mm bioprosthetic valves. 20-mm Edwards S3 valves were offered for compassionate use. All patients had significant aortic valve stenosis. METHODS AND RESULTS: The main vascular access was achieved and pre-closed with two Proglide closure devices in one patient and Prostar closure devices in four patients...
October 3, 2016: Catheterization and Cardiovascular Interventions
Uri Landes, Alexander Sagie, Ran Kornowski
Sutureless aortic bioprostheses (SAB) are increasingly being used to provide shorter cross-clamp time. Valve-in-valve transcatheter aortic valve replacement (VIV-A) is shown to be effective and safe in the vast majority of patients with degenerated bioprosthetics, yet its' use in SAB failure is infrequent. We present a case of balloon-expandable VIV-A in an 80-year-old woman who suffered severe symptomatic aortic regurgitation in a failed Perceval S 21-mm valve. Computed tomography scan demonstrated a deformed valve...
October 3, 2016: Catheterization and Cardiovascular Interventions
Subasit Acharji, Arvind Agnihotri, Joseph Carrozza
Unicuspid aortic valve (UAV) offers unique challenges to transcatheter aortic valve replacement (TAVR), due to asymmetric expansion and apposition of the prosthesis during implantation. Although TAVR in bicuspid is now a well described experience, TAVR in unicuspid valve has not yet been described. A challenging case is described with TAVR in UAV using a Edwards Sapiens prosthesis via transapical approach. © 2016 Wiley Periodicals, Inc.
September 23, 2016: Catheterization and Cardiovascular Interventions
Divya Ratan Verma, Yash Pershad, Ashish Pershad, Kenith Fang, George Gellert, Michael F Morris
BACKGROUND: Computed tomography (CT) has become the standard imaging modality for pre-procedural aortic annular sizing prior to transcatheter aortic valve replacement (TAVR). We hypothesized that the accuracy of CT derived annular measurements would be greater at sites with higher TAVR procedural volume. METHODS: Within a large integrated health system, TAVR was performed at low (<40 cases), intermediate (40-75 cases), and high-volume sites (>75 cases). 181 patients underwent TAVR with a Sapien XT transcatheter heart valve (THV)...
August 27, 2016: Cardiovascular Revascularization Medicine: Including Molecular Interventions
Matheus Simonato, Ali N Azadani, John Webb, Jonathon Leipsic, Ran Kornowski, Alec Vahanian, David Wood, Nicolo Piazza, Susheel Kodali, Jian Ye, Brian Whisenant, Diego Gaia, Mina Aziz, Tilak Pasala, Julinda Mehilli, Harindra C Wijeysundera, Didier Tchetche, Neil Moat, Rui Teles, Anna Sonia Petronio, David Hildick-Smith, Uri Landes, Stephan Windecker, Yaron Arbel, Oscar Mendiz, Raj Makkar, Elaine Tseng, Danny Dvir
AIMS: Transcatheter heart valve (THV) implantation in failed bioprosthetic valves (valve-in-valve [ViV]) offers an alternative therapy for high-risk patients. Elevated post-procedural gradients are a significant limitation of aortic ViV. Our objective was to assess the relationship between depth of implantation and haemodynamics. METHODS AND RESULTS: Commercially available THVs used for ViV were included in the analysis (CoreValve Evolut, SAPIEN XT and the Portico valve)...
September 18, 2016: EuroIntervention
Hardy Baumbach, Samir Ahad, Stephan Hill, Tim Schäufele, Sara Adili, Kristina Wachter, Ulrich F W Franke
An increasing number of patients with severe aortic stenosis and concomitant critical coronary artery disease were referred to our hospital. Some of those patients were classified as high-risk patients qualifying for a transcatheter therapy with the additional need for coronary revascularization. As a consequence of their comorbidities, the established transapical as well as transfemoral approach were either not possible or not favored owing to the indispensable need for coronary revascularization. We present 4 successfully combined off-pump procedures consisting of a transcatheter aortic valve implantation (Edwards SAPIEN XT) via the transaortic approach and an off-pump coronary artery bypass grafting...
September 15, 2016: Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery
Ran Kornowski
The Sapien 3 (S3) balloon expandable aortic valve equipped with an outer skirt to minimize paravalvular leakage (PVL) was built upon the predecessor Sapien XT (SXT) valve. There is scant comparative data of transcatheter aortic valve replacement using S3 versus SXT valve. The study shows that S3 valve is associated with reduced PVL rate compared with SXT, which is an important clinical advantage.
September 2016: Catheterization and Cardiovascular Interventions
Donald J Hagler
Current delivery systems for the Sapien XT valve for the native pulmonary valve are unacceptable stiff and poorly design for implantation in the pulmonary outflow tract. This report details improvisation of the Melody Ensemble for easier pulmonary outflow tract delivery of the Sapien XT valve. The unacceptable cost of the utilization of two delivery systems for valve implantation, requires industry development of an safe, effective delivery system appropriate for the pulmonary outflow tract.
September 2016: Catheterization and Cardiovascular Interventions
Augusto D'Onofrio, Laura Besola, Giulio Rizzoli, Eleonora Bizzotto, Erica Manzan, Chiara Tessari, Roberto Bianco, Giuseppe Tarantini, Luigi P Badano, Massimo Napodano, Chiara Fraccaro, Demetrio Pittarello, Gino Gerosa
BACKGROUND: This single-center retrospective study assessed the variation of left ventricular ejection fraction (LVEF) after transapical transcatheter aortic valve implantation and its effect on survival. We also evaluated the effect of sheath diameter on LVEF. METHODS: We analyzed data of all consecutive patients who underwent transapical transcatheter aortic valve implantation with the Sapien (Edwards Lifesciences, Irvine, CA) device (and its evolutions) between 2009 and 2015...
September 7, 2016: Annals of Thoracic Surgery
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
Sung-Han Yoon, Thierry Lefèvre, Jung-Ming Ahn, Gidon Y Perlman, Danny Dvir, Azeem Latib, Marco Barbanti, Florian Deuschl, Ole De Backer, Philipp Blanke, Thomas Modine, Gregor Pache, Franz-Josef Neumann, Philipp Ruile, Takahide Arai, Yohei Ohno, Hidehiro Kaneko, Edgar Tay, Niklas Schofer, Erik W Holy, Ngai H V Luk, Gerald Yong, Qingsheng Lu, William K F Kong, Jimmy Hon, Hsien-Li Kao, Michael Lee, Wei-Hsian Yin, Duk-Woo Park, Soo-Jin Kang, Seung-Whan Lee, Young-Hak Kim, Cheol Whan Lee, Seong-Wook Park, Hyo-Soo Kim, Christian Butter, Omar K Khalique, Ulrich Schaefer, Fabian Nietlispach, Susheel K Kodali, Martin B Leon, Jian Ye, Bernard Chevalier, Jonathon Leipsic, Victoria Delgado, Jeroen J Bax, Corrado Tamburino, Antonio Colombo, Lars Søndergaard, John G Webb, Seung-Jung Park
BACKGROUND: Few studies have evaluated the clinical outcomes of transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve stenosis (AS). Particularly, limited data exist comparing the results of TAVR with new-generation devices versus early-generation devices. OBJECTIVES: This study sought to evaluate the clinical outcomes of TAVR for bicuspid AS with early- and new-generation devices. METHODS: The Bicuspid TAVR Registry is an international multicenter study enrolling consecutive patients with bicuspid AS undergoing TAVR between April 2005 and May 2015...
September 13, 2016: Journal of the American College of Cardiology
Vinayak Bapat, Derk Frank, Ricardo Cocchieri, Dariusz Jagielak, Nikolaos Bonaros, Marco Aiello, Joel Lapeze, Mika Laine, Sidney Chocron, Douglas Muir, Walter Eichinger, Matthias Thielmann, Louis Labrousse, Kjell Arne Rein, Jean-Philippe Verhoye, Gino Gerosa, Hardy Baumbach, Peter Bramlage, Cornelia Deutsch, Martin Thoenes, Mauro Romano
OBJECTIVES: The Registry of the Utilization of the TAo-TAVR approach using the Edwards SAPIEN Valve (ROUTE) was established to assess the effectiveness and safety of the use of transaortic (TAo) access for transcatheter aortic valve replacement (TAVR) procedures (NCT01991431). BACKGROUND: TAVR represents an alternative to surgical valve replacement in high-risk patients. Whereas the transfemoral access route is used commonly as the first-line approach, transapical access is an option for patients not suitable for transfemoral treatment mainly due to anatomic conditions...
September 12, 2016: JACC. Cardiovascular Interventions
Peter Dankerl, Matthias Hammon, Hannes Seuss, Monique Tröbs, Annika Schuhbaeck, Michaela M Hell, Alexander Cavallaro, Stephan Achenbach, Michael Uder, Mohamed Marwan
PURPOSE: To evaluate the performance of computer-aided evaluation software for a comprehensive workup of patients prior to transcatheter aortic valve implantation (TAVI) using low-contrast agent and low radiation dose third-generation dual-source CT angiography. METHODS: We evaluated 30 consecutive patients scheduled for TAVI. All patients underwent ECG-triggered high-pitch dual-source CT angiography of the aortic root and aorta with a standardized contrast agent volume (30 ml Imeron350, flow rate 4 ml/s) and low-dose (100 kv/350 mAs) protocol...
September 7, 2016: International Journal of Computer Assisted Radiology and Surgery
Rainer Petzina, Georg Lutter, Christin Wolf, Constantin Kühl, Sandra Freitag-Wolf, Bernd Panholzer, Peter Bramlage, Norbert Frey, Jochen Cremer, Derk Frank
OBJECTIVES: To evaluate the efficacy and safety of Edwards SAPIEN-XT or SAPIEN-3 transcatheter heart valves via transaortic (TAo) access. METHODS: A total of 100 consecutive patients with severe symptomatic aortic stenosis undergoing TAo-transcatheter aortic valve implantation (TAVI) were included in this observational registry (November 2012-December 2014). Periprocedural and post-procedural outcomes were assessed. RESULTS: Of these 100 patients, 1 received a Medtronic CoreValve...
September 5, 2016: Interactive Cardiovascular and Thoracic Surgery
Mike Saji, D Scott Lim
Following the first successful transcatheter aortic valve replacement (TAVR) in 2002, TAVR has globally evolved to become a standard procedure in high-risk patients. Surgical aortic valve replacement in non-high-risk patients remains the gold standard for treatment of severe aortic stenosis. However, a paradigm shift appears to be occurring in the direction of treating lower-risk patients, and several studies have suggested its impact on clinical outcomes. In this review, we highlight the current status of TAVR in intermediate-risk patients and review major trials including Placement of AoRTic TraNscathetER (PARTNER) 2A randomized intermediate-risk trial using SAPIEN XT (Edwards Lifesciences Corp, Irvine, CA) recently presented with excellent outcomes and the lowest major complications rate at the American College of Cardiology's 65th Annual Scientific Session in Chicago...
October 2016: Current Cardiology Reports
Nicolas Debry, Arnaud Sudre, Ibrahim Elquodeimat, Cédric Delhaye, Guillaume Schurtz, Antoine Bical, Mohamad Koussa, Khalil Fattouch, Thomas Modine
BACKGROUND: Postprocedural aortic regurgitations following transcatheter aortic valve implantation (TAVI) procedures remain an issue. Benefit of oversizing strategies to prevent them isn't well established. We compared different level of oversizing in our cohort of consecutive patients to address if severe oversizing compared to normal sizing had an impact on post-procedural outcomes. METHODS: From January 2010 to August 2013, consecutive patients were referred for TAVI with preoperative Multislice-CT (MSCT) and the procedures were achieved using Edwards Sapien(®) or Corevalve devices(®)...
September 2016: Journal of Geriatric Cardiology: JGC
Nicolaj C Hansson, Erik L Grove, Henning R Andersen, Jonathon Leipsic, Ole N Mathiassen, Jesper M Jensen, Kaare T Jensen, Philipp Blanke, Tina Leetmaa, Mariann Tang, Lars R Krusell, Kaj E Klaaborg, Evald H Christiansen, Kim Terp, Christian J Terkelsen, Steen H Poulsen, John Webb, Hans Erik Bøtker, Bjarne L Nørgaard
BACKGROUND: There is increasing focus on transcatheter heart valve (THV) thrombosis. However, there are limited data on incidence, clinical implications and predisposing factors of THV thrombosis following transcatheter aortic valve replacement (TAVR). OBJECTIVES: We assessed the incidence, potential predictors, and clinical implications of THV thrombosis determined by contrast-enhanced multidetector computed tomography (MDCT) after TAVR. METHODS: Among 460 consecutive patients undergoing TAVR with the Edwards Sapien XT or Sapien 3 (Edwards Lifesciences, Irvine, CA, USA) valves, 405 (88%) underwent MDCT in addition to transthoracic and transesophageal echocardiography 1-3 months post-TAVR...
August 18, 2016: Journal of the American College of Cardiology
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