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https://www.readbyqxmd.com/read/28104716/source-3-registry-design-and-30-day-results-of-the-european-post-approval-registry-of-the-latest-generation-of-the-sapien-3tm-transcatheter-heart-valve
#1
Olaf Wendler, Gerhard Schymik, Hendrik Treede, Helmut Baumgartner, Nicolas Dumonteil, Leo Ihlberg, Franz-Josef Neumann, Giuseppe Tarantini, José L Zamorano, Alec Vahanian
BACKGROUND: -The SOURCE 3 Registry is a European multicentre, observational registry of the latest generation of transcatheter heart valve, the SAPIEN 3(TM) (Edwards Lifesciences, Irvine, CA/USA). Its purpose is to document outcomes of clinical safety and performance after European approval was given. METHODS: -In this manuscript we present the 30-day outcome of the SOURCE 3 Registry. All data is self-reported and all participating centres have committed to support their consecutive experience with the SAPIEN 3(TM) transcatheter heart valve, dependent on patients consent, before the start of the study...
January 19, 2017: Circulation
https://www.readbyqxmd.com/read/28100340/-outcome-comparison-of-different-therapy-procedures-in-surgical-high-risk-elderly-patients-with-severe-aortic-stenosis
#2
Y Q Ye, Y T Wang, Z Li, M Y Wang, H Y Xu, W J Zhang, Q R Liu, G N Niu, Y J Wu
Objective: To compare the outcome of surgical high-risk elderly patients with severe aortic stenosis(SAS) treated by different therapy procedures, including transcatheter aortic valve implantation(TAVI), surgical aortic valve replacement(SAVR), and drug therapy. Methods: We retrospectively analyzed the clinical data of 242 surgical high-risk elderly (age ≥65 years old) SAS patients hospitalized in Fuwai Hospital between September 2012 and June 2015. According to the treatment method, patients were divided into TAVI group (81 cases), SAVR group (59 cases) and drug therapy group (102 cases)...
January 25, 2017: Zhonghua Xin Xue Guan Bing za Zhi
https://www.readbyqxmd.com/read/28092726/pathophysiology-incidence-and-predictors-of-conduction-disturbances-during-transcatheter-aortic-valve-implantation
#3
Marco Barbanti, Simona Gulino, Giuliano Costa, Corrado Tamburino
Over the past decade, transcatheter aortic valve implantation (TAVI) has evolved rapidly toward an extremely reproducible, safe and effective procedure, with a marked reduction of its related complications. However, the occurrence of conduction disturbances and the need for permanent pacemaker implantation (PPI) after TAVI remains a concern. Areas covered: In this article review, we will go through the mechanisms involved in conduction disturbances after TAVI, and we will discuss the key aspects of pathophysiology, incidence and predictors of conduction disturbances following Transcatheter Aortic Valve Implantation...
January 16, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28089455/comparison-of-transcatheter-aortic-valve-implantation-with-the-newest-generation-sapien-3-vs-direct-flow-medical-valve-in-a-single-center-cohort
#4
Eberhard Schulz, Alexander Jabs, Alexander Tamm, Patrick Herz, Andreas Schulz, Tommaso Gori, Stephan von Bardeleben, Walter Kasper-König, Ulrich Hink, Christian-Friedrich Vahl, Thomas Münzel
BACKGROUND: The latest generation transcatheter heart valves including Edwards Sapien 3 (ES3) and Direct Flow Medical (DFM) were designed to allow precise implantation at the intended position and to minimize prosthesis dysfunction as well as procedural complications. Our aim was to compare short-term functional and clinical outcomes of these 2 transcatheter aortic valve systems. METHODS: Of 174 patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) at our institution between August 2013 and June 2015, 113 were treated with ES3 and 61 with DFM...
January 7, 2017: International Journal of Cardiology
https://www.readbyqxmd.com/read/28070241/comparison-between-the-sapien-s3-and-the-sapien-xt-transcatheter-heart-valves-a-single-center-experience
#5
Fadi J Sawaya, Marco Spaziano, Thierry Lefèvre, Andrew Roy, Phillippe Garot, Thomas Hovasse, Antoinette Neylon, Hakim Benamer, Mauro Romano, Thierry Unterseeh, Marie-Claude Morice, Bernard Chevalier
AIM: To investigate the clinical outcomes of transcatheter aortic valve implantation (TAVI) with the SAPIEN 3 transcatheter heart valve (S3-THV) vs the SAPIEN XT valve (XT-THV). METHODS: We retrospectively analyzed 507 patients that underwent TAVI with the XT-THV and 283 patients that received the S3-THV at our institution between March 2010 and December 2015. RESULTS: Thirty-day mortality (3.5% vs 8.7%; OR = 0.44, P = 0.21) and 1-year mortality (25...
December 26, 2016: World Journal of Cardiology
https://www.readbyqxmd.com/read/28067197/comparison-of-procedural-and-clinical-outcomes-with-evolut-r-versus-medtronic-corevalve-a-swiss-tavi-registry-analysis
#6
Stephane Noble, Stefan Stortecky, Dik Heg, David Tuller, Raban Jeger, Stefan Toggweiler, Enrico Ferrari, Fabian Nietlispach, Maurizio Taramasso, Francesco Maisano, Jürg Grünenfelder, Peter Jüni, Christoph Huber, Thierry Carrel, Stephan Windecker, Peter Wenaweser, Marco Roffi
AIMS: Data on procedural and clinical outcomes after transcatheter aortic valve implantation (TAVI) with the new generation self-expanding Medtronic Evolut-R prosthesis in comparison with its predecessor, the Medtronic CoreValve, are scarce. METHODS AND RESULTS: In a nationwide, prospective, multi-center cohort study outcomes of consecutive transfemoral TAVI patients treated with the new- generation Medtronic Evolut-R (September 2014 - February 2016) and the Medtronic CoreValve (February 2011 - February 2016) were investigated...
January 10, 2017: EuroIntervention
https://www.readbyqxmd.com/read/28045412/transcatheter-aortic-valve-implantation-with-the-edwards-sapien-3-valve-first-experiences-in-turkey
#7
Abdullah Nabi Aslan, Serdal Baştuğ, Hacı Ahmet Kasapkara, Hüseyin Ayhan, Hakan Süygün, Telat Keleş, Tahir Durmaz, Nihal Akar Bayram, Emine Bilen, Engin Bozkurt
OBJECTIVE: Transcatheter aortic valve implantation (TAVI) has shown promising results in patients with severe aortic stenosis (AS) at high risk for open heart surgery. We aimed to evaluate outcomes of patients who underwent TAVI with Edwards SAPIEN 3 Transcatheter Heart Valve (S3), a second-generation TAVI device. METHODS: Between November 2014 and June 2016, 31 high-risk patients received balloon-expandable S3 valve at Atatürk Training and Research Hospital that has the largest case series in Turkey...
December 2016: Türk Kardiyoloji Derneği Arşivi: Türk Kardiyoloji Derneğinin Yayın Organıdır
https://www.readbyqxmd.com/read/28034684/thirty-day-outcome-following-corevalve-evolut-r-transcatheter-aortic-valve-implantation-an-all-comers-prospective-study
#8
Nils Perrin, Marco Roffi, Angela Frei, Anne-Lise Hachulla, Christoph Ellenberger, Hajo Müller, Mustafa Cikirikcioglu, Marc Licker, Stephane Noble
INTRODUCTION AND OBJECTIVES: There are scarce clinical outcomes data on the new generation recapturable and repositionable CoreValve Evolut R. METHODS: Data on all-comer patients undergoing transcatheter aortic valve implantation (TAVI) with the Evolut R for severe symptomatic aortic stenosis at a single center were prospectively collected between February 2015 and April 2016. Clinical endpoints were independently adjudicated according to the Valve Academic Research Consortium-2 criteria...
December 26, 2016: Revista Española de Cardiología
https://www.readbyqxmd.com/read/27990197/transcatheter-aortic-valve-implantation-for-treatment-of-aortic-valve-stenosis-a-health-technology-assessment
#9
(no author information available yet)
BACKGROUND: Surgical aortic valve replacement (SAVR) is the gold standard for treating aortic valve stenosis. It is a major operation that requires sternotomy and the use of a heart-lung bypass machine, but in appropriately selected patients with symptomatic, severe aortic valve stenosis, the benefits of SAVR usually outweigh the harms. Transcatheter aortic valve implantation (TAVI) is a less invasive procedure that allows an artificial valve to be implanted over the poorly functioning valve...
2016: Ontario Health Technology Assessment Series
https://www.readbyqxmd.com/read/27989053/conventional-and-novel-predictors-of-permanent-pacemaker-after-tavi-in-atrial-fibrillation-patients
#10
Guilherme Portugal, Lino Patrício, Ana Abreu, Duarte Cacela, Mário Oliveira, Rui Ferreira
BACKGROUND: Atrial fibrillation (AF) is common in patients submitted for transcatheter aortic valve implantation (TAVI), and these patients are at higher risk of developing conduction system disturbances requiring pacemaker (PM) implantation. Conventional predictors for PM use in this population have limited applicability. It was hypothesized that a post-procedural heart rate reduction could gauge the degree of atrioventricular (AV) node injury, and that this would be a clinically useful predictor of a need for PM...
May 2016: Journal of Heart Valve Disease
https://www.readbyqxmd.com/read/27987072/the-value-of-electrophysiologic-study-in-decision-making-regarding-the-need-for-pacemaker-implantation-after-tavi
#11
Oholi Tovia-Brodie, Yael Ben-Haim, Erel Joffe, Ariel Finkelstein, Aharon Glick, Raphael Rosso, Bernard Belhassen, Yoav Michowitz
PURPOSE: The purpose of this study was to evaluate electrophysiologic study (EPS) in risk stratification of relative indications for pacemaker implantation (PMI) after transcatheter aortic valve implantation (TAVI). METHODS: We reviewed files of all patients who had a left bundle branch block (LBBB) and underwent EPS after TAVI between 3/2009 and 5/2015. The indications for EPS were new-onset LBBB and the presence of an old or a new-onset LBBB associated with either PR prolongation after TAVI (∆PR >20 ms) or with "slow" atrial fibrillation (<100/min)...
December 17, 2016: Journal of Interventional Cardiac Electrophysiology: An International Journal of Arrhythmias and Pacing
https://www.readbyqxmd.com/read/27943488/electrocardiographic-predictors-of-long-term-cardiac-pacing-dependency-following-transcatheter-aortic-valve-implantation
#12
Sivan Naveh, Gidon Y Perlman, Yair Elitsur, David Planer, Dan Gilon, David Leibowitz, Chaim Lotan, Haim Danenberg, Ronny Alcalai
BACKGROUND: Conduction disorders requiring permanent pacemaker (PPM) implantation are a known complication of trans-catheter aortic valve implantation (TAVI). Indications for permanent pacing in this setting are still controversial. The study aim was to characterize the natural history of conduction disorders related to TAVI, and to identify predictors for long term pacing dependency. METHODS: Consecutive patients who underwent TAVI were included in this prospective observational study...
December 12, 2016: Journal of Cardiovascular Electrophysiology
https://www.readbyqxmd.com/read/27934611/a-multicentre-european-registry-to-evaluate-the-direct-flow-medical-transcatheter-aortic-valve-system-for-the-treatment-of-patients-with-severe-aortic-stenosis
#13
Christoph K Naber, Stylianos A Pyxaras, Hüseyin Ince, Peter Frambach, Antonio Colombo, Christian Butter, Fernando Gatto, Ulrich Hink, Georg Nickenig, Giuseppe Bruschi, Guus Brueren, Didier Tchétché, Peter Den Heijer, Wolfgang Schillinger, Smita Scholtz, Jan Van der Heyden, Thierry Lefèvre, Martine Gilard, Karl-Heinz Kuck, Joachim Schofer, Dimitar Divchev, Helmut Baumgartner, Federico Asch, Daniel Wagner, Azeem Latib, Federico De Marco, Stephan Kische
AIMS: Our aim was to assess the clinical outcomes of the Direct Flow Medical Transcatheter Aortic Valve System (DFM-TAVS), when used in routine clinical practice. METHODS AND RESULTS: This is a prospective, open-label, multicentre, post-market registry of patients treated with DFM-TAVS according to approved commercial indications. Echocardiographic and angiographic data were evaluated by an independent core laboratory and adverse events were adjudicated and classified according to VARC-2 criteria by an independent clinical events committee...
December 10, 2016: EuroIntervention
https://www.readbyqxmd.com/read/27916776/favorable-clinical-outcomes-of-transcatheter-aortic-valve-implantation-in-japanese-patients%C3%A3-first-report-from-the-post-approval-k-tavi-registry
#14
Shinya Takimoto, Naritatsu Saito, Kenji Minakata, Shinichi Shirai, Akihiro Isotani, Yoshio Arai, Michiya Hanyu, Tatsuhiko Komiya, Takeshi Shimamoto, Tsuyoshi Goto, Yasushi Fuku, Natsuhiko Ehara, Yutaka Furukawa, Tadaaki Koyama, Atsuhi Nagasawa, Toshihiro Tamura, Makoto Miyake, Kazuo Yamanaka, Hisashi Sakaguchi, Koichiro Murata, Tomoya Onodera, Fumio Yamazaki, Masanao Nakai, Tomohiko Taniguchi, Ryuzo Sakata, Takeshi Kimura
BACKGROUND: Very limited data exist on the outcomes of transcatheter aortic valve implantation (TAVI) since Japanese marketing approval of the first TAVI device.Methods and Results:The Kyoto University-related hospital Transcatheter Aortic Valve Implantation (K-TAVI) registry includes prospectively collected data from 6 participating hospitals in Japan. We included 302 patients with severe aortic stenosis who underwent TAVI using the SAPIEN XT balloon-expandable valve via transfemoral (TF; n=203, 67%) or transapical (TA; n=99, 33%) approach between October 2013 and September 2015...
December 22, 2016: Circulation Journal: Official Journal of the Japanese Circulation Society
https://www.readbyqxmd.com/read/27899128/european-real-world-trans-catheter-aortic-valve-implantation-systematic-review-and-meta-analysis-of-european-national-registries
#15
REVIEW
G Krasopoulos, F Falconieri, U Benedetto, J Newton, R Sayeed, R Kharbanda, A Banning
OBJECTIVE: Transcatheter aortic valve implantation (TAVI) has been adopted rapidly in Europe. TAVI national registries can augment understanding of technologies and represent real-world experience, providing further clinical insights. We undertook a meta-analysis of published European national TAVI registries to assess current results following TAVI in Europe. METHODS: Electronic databases were searched. The review focused on the comparison of the following TAVI strategies: transfemoral (TF) and transapical (TA) SAPIEN and CoreValve implantation...
November 29, 2016: Journal of Cardiothoracic Surgery
https://www.readbyqxmd.com/read/27898500/patterns-and-trends-of-transcatheter-aortic-valve-implantation-in-italy-insights-from-rispeva
#16
Arturo Giordano, Nicola Corcione, Giuseppe Biondi-Zoccai, Sergio Berti, Anna Sonia Petronio, Carlo Pierli, Patrizia Presbitero, Pietro Giudice, Gennaro Sardella, Antonio L Bartorelli, Roberto Bonmassari, Ciro Indolfi, Alfredo Marchese, Elvis Brscic, Alberto Cremonesi, Luca Testa, Nedy Brambilla, Francesco Bedogni
AIMS: Clinical trials have shown that transcatheter aortic valve implantation for aortic stenosis compares favorably to surgical replacement in high-risk patients and is superior to medical therapy in those at prohibitive risk. There is uncertainty however on patterns and trends in transcatheter aortic valve implantation, especially focusing on Italy. METHODS: The RISPEVA study is a prospective Italian registry including 21 institutions. Patients have been enrolled since late 2012, and data collection includes several baseline, procedural, in-hospital, and follow-up details...
February 2017: Journal of Cardiovascular Medicine
https://www.readbyqxmd.com/read/27898433/transcatheter-aortic-valve-implantation-in-nonagenarians
#17
Adam Penkalla, Joerg Kempfert, Axel Unbehaun, Semih Buz, Thorsten Drews, Miralem Pasic, Volkmar Falk
OBJECTIVE: In this report, we assess the outcome of transcatheter aortic valve implantation (TAVI) in nonagenarians at our institution during a 6-year period. METHODS: Between April 2008 and July 2014, 40 patients with a mean ± SD age of 91.8 ± 2.3 years (range, 90-98 years) underwent TAVI. Thirty-three patients (82.5%) received transapical TAVI, and seven patients (17.5%) received transfemoral TAVI. Baseline characteristics were as follows: mean ± SD EuroSCORE II, 23...
November 2016: Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery
https://www.readbyqxmd.com/read/27883975/evaluation-of-current-practices-in-transcatheter-aortic-valve-implantation-the-written-worldwide-tavi-experience-survey
#18
Enrico Cerrato, Luis Nombela-Franco, Tamim M Nazif, Helene Eltchaninoff, Lars Søndergaard, Henrique B Ribeiro, Marco Barbanti, Fabian Nietlispach, Peter De Jaegere, Pierfrancesco Agostoni, Ramiro Trillo, Pilar Jimenez-Quevedo, Fabrizio D'Ascenzo, Olaf Wendler, Gabriel Maluenda, Mao Chen, Corrado Tamburino, Carlos Macaya, Martin B Leon, Josep Rodes-Cabau
BACKGROUND: Transcatheter aortic valve implantation (TAVI) has been adopted worldwide as the standard treatment for severe aortic stenosis in symptomatic patients at prohibitive or high surgical risk, but there are still several areas where consensus and evidence are lacking. The purpose was to obtain a global view of current practice related to TAVI with the potential to identify the main areas of consensus and divergence between centers. METHODS: An online questionnaire was distributed in centers performing TAVI including a total of 59 questions concerning pre-procedural evaluation, procedural practices and post-procedural management...
February 1, 2017: International Journal of Cardiology
https://www.readbyqxmd.com/read/27846458/predictive-factor-and-clinical-consequence-of-left-bundle-branch-block-after-a-transcatheter-aortic-valve-implantation
#19
Takahiko Nishiyama, Sho Tanosaki, Makoto Tanaka, Ryo Yanagisawa, Fumiaki Yashima, Takehiro Kimura, Takahide Arai, Hikaru Tsuruta, Mitsushige Murata, Yoshiyasu Aizawa, Takashi Kohno, Yuichiro Maekawa, Kentaro Hayashida, Seiji Takatsuki, Keiichi Fukuda
BACKGROUND: Atrioventricular conduction disturbances can develop after transcatherter aortic valve implantations (TAVIs) with balloon-expandable valves because the conduction system exists adjacent to the aortic valve. However, the clinical consequence of patients with new onset conduction disturbances is not clear. OBJECTIVE: This study aimed to assess the incidence and progress of new-onset conduction disturbances following TAVIs and the cardiac function evaluated by echocardiography...
January 15, 2017: International Journal of Cardiology
https://www.readbyqxmd.com/read/27832846/pre-existing-right-bundle-branch-block%C3%A2-increases-risk-for-death-after-transcatheter-aortic-valve-replacement-with-a-balloon-expandable-valve
#20
Yusuke Watanabe, Ken Kozuma, Hirofumi Hioki, Hideyuki Kawashima, Yugo Nara, Akihisa Kataoka, Fukuko Nagura, Makoto Nakashima, Shinichi Shirai, Norio Tada, Motoharu Araki, Kensuke Takagi, Futoshi Yamanaka, Masanori Yamamoto, Kentaro Hayashida
OBJECTIVES: The aim of this study was to determine the impact of pre-existing right bundle branch block (RBBB) on clinical outcomes after transcatheter aortic valve replacement (TAVR). BACKGROUND: The impact of pre-existing RBBB on clinical outcomes after TAVR is unknown. METHODS: Between October 2013 and August 2015, 749 patients undergoing TAVR using the Edwards SAPIEN XT prosthesis were prospectively enrolled in the OCEAN-TAVI (Optimized Transcatheter Valvular Intervention) registry from 8 Japanese centers...
November 14, 2016: JACC. Cardiovascular Interventions
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