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Heart valve design criteria

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https://www.readbyqxmd.com/read/29017461/feasibility-and-safety-of-early-discharge-after-transfemoral-transcatheter-aortic-valve-implantation-rationale-and-design-of-the-fast-tavi-registry
#1
Marco Barbanti, Jan Baan, Mark S Spence, Fortunato Iacovelli, Gian Luca Martinelli, Francesco Saia, Alessandro Santo Bortone, Frank van der Kley, Douglas F Muir, Cameron G Densem, Marije Vis, Martijn S van Mourik, Lenka Seilerova, Claudia M Lüske, Peter Bramlage, Corrado Tamburino
BACKGROUND: There is an increasing trend towards shorter hospital stays after transcatheter aortic valve implantation (TAVI), in particular for patients undergoing the procedure via transfemoral (TF) access. Preliminary data suggest that there exists a population of patients that can be discharged safely very early after TF-TAVI. However, current evidence is limited to few retrospective studies, encompassing relatively small sample sizes. METHODS: The Feasibility And Safety of early discharge after Transfemoral TAVI (FAST-TAVI) registry is a prospective observational registry that will be conducted at 10 sites across Italy, the Netherlands and the UK...
October 10, 2017: BMC Cardiovascular Disorders
https://www.readbyqxmd.com/read/28952468/balloon-angioplasty-as-a-modality-to-treat-children-with-pulmonary-stenosis-secondary-to-complex-congenital-heart-diseases
#2
Yan Gu, Mei Jin, Xiao-Fang Wang, Bao-Jing Guo, Wen-Hong Ding, Zhi-Yuan Wang, Ya-Hui Zhang
BACKGROUND: Pulmonary stenosis is common in children with complex congenital heart diseases. Proper management of this problem, especially postoperatively, is still controversial. This study was designed to assess the rate and determinants of success or failure of balloon angioplasty for such lesions. METHODS: Clinical and hemodynamic data from 40 pediatric patients (24 boys and 16 girls) with complex congenital heart diseases who underwent balloon angioplasty were reviewed retrospectively from January 2012 to December 2016...
September 27, 2017: Chinese Medical Journal
https://www.readbyqxmd.com/read/28826848/preoperative-aspirin-does-not-increase-transfusion-or-reoperation-in-isolated-valve-surgery
#3
Jordan E Goldhammer, Corey R Herman, Mark W Berguson, Marc C Torjman, Richard H Epstein, Jian-Zhong Sun
OBJECTIVE: Preoperative aspirin has been studied in patients undergoing isolated coronary artery bypass graft surgery. However, there is a paucity of clinical data available evaluating perioperative aspirin in other cardiac surgical procedures. This study was designed to investigate the effects of aspirin on bleeding and transfusion in patients undergoing non-emergent, isolated, heart valve repair or replacement. DESIGN: Retrospective, cohort study. SETTING: Academic medical center...
October 2017: Journal of Cardiothoracic and Vascular Anesthesia
https://www.readbyqxmd.com/read/28797431/implantation-and-30-day-follow-up-on-all%C3%A2-4-valve-sizes-within-the-portico-transcatheter-aortic-bioprosthetic-family
#4
Helge Möllmann, Axel Linke, David M Holzhey, Thomas Walther, Ganesh Manoharan, Ulrich Schäfer, Karl Heinz-Kuck, Ad J Van Boven, Simon R Redwood, Jan Kovac, Christian Butter, Lars Søndergaard, Alexander Lauten, Gerhard Schymik, Stephen G Worthley
OBJECTIVES: The aim of this study was to evaluate the short-term safety and performance of the full range of valve sizes offered within the Portico transcatheter aortic valve replacement system. BACKGROUND: The Portico transcatheter aortic heart valve is a fully resheathable, repositionable, and self-expanding bioprosthesis designed to achieve optimal valve position and hemodynamic performance and limit conduction disturbances. METHODS: Patients (n = 222) with symptomatic (New York Heart Association functional class ≥II) severe aortic stenosis considered by a multidisciplinary heart team to be at high surgical risk were recruited between December 2011 and September 2015 in this prospective, nonrandomized, multicenter study...
August 14, 2017: JACC. Cardiovascular Interventions
https://www.readbyqxmd.com/read/28676065/prior-balloon-valvuloplasty-versus-direct-transcatheter-aortic-valve-implantation-directavi-study-protocol-for-a-randomized-controlled-trial
#5
Florence Leclercq, Pierre Robert, Jessica Labour, Benoit Lattuca, Mariama Akodad, Jean-Christophe Macia, Richard Gervasoni, Francois Roubille, Thomas Gandet, Laurent Schmutz, Erika Nogue, Nicolas Nagot, Bernard Albat, Guillaume Cayla
BACKGROUND: Balloon predilatation of the aortic valve has been regarded as an essential step during the transcatheter aortic valve implantation (TAVI) procedure. However, recent evidence has suggested that aortic valvuloplasty may cause complications and that high success rates may be obtained without prior dilatation of the valve. We hypothesize that TAVI performed without predilatation of the aortic valve and using new-generation balloon-expandable transcatheter heart valves is associated with a better net clinical benefit than TAVI performed with predilatation...
July 4, 2017: Trials
https://www.readbyqxmd.com/read/28633375/final-5-year-clinical-and-echocardiographic-results-for-treatment-of-severe-aortic-stenosis-with-a-self-expanding-bioprosthesis-from-the-advance-study
#6
Ulrich Gerckens, Corrado Tamburino, Sabine Bleiziffer, Johan Bosmans, Peter Wenaweser, Stephen Brecker, Jia Guo, Axel Linke
Aims: The ADVANCE study was designed to evaluate the safety and effectiveness of transcatheter aortic valve implantation (TAVI) with a self-expanding bioprosthesis in real-world patients with symptomatic, severe aortic stenosis at high surgical risk for valve replacement. Methods and results: Study participants were enrolled from 44 experienced centres in 12 countries. Patient eligibility, treatment approach, and choice of anaesthesia were determined by the local Heart Team...
June 13, 2017: European Heart Journal
https://www.readbyqxmd.com/read/28555592/repositionable-percutaneous-aortic-valve-implantation-with-the-lotus-valve-30-day-and-1-year-outcomes-in-250-high-risk-surgical-patients
#7
Ian T Meredith, Nicolas Dumonteil, Daniel J Blackman, Didier Tchétché, Darren L Walters, David Hildick-Smith, Ganesh Manoharan, Jan Harnek, Stephen G Worthley, Gilles Rioufol, Thierry Lefèvre, Thomas Modine, Nicolas M Van Mieghem, Ted Feldman, Dominic J Allocco, Keith D Dawkins
AIMS: The REPRISE IIE trial evaluated outcomes following transcatheter aortic valve implantation of the fully repositionable and retrievable Lotus Valve with a unique seal designed to minimize paravalvular leak (PVL). METHODS AND RESULTS: This prospective, multicentre study enrolled 250 patients with severe aortic stenosis considered high-risk for surgery by a multidisciplinary Heart Team. An independent Clinical Events Committee adjudicated events per Valve Academic Research Consortium criteria...
May 30, 2017: EuroIntervention
https://www.readbyqxmd.com/read/28544834/in-vitro-pulsatile-flow-measurement-in-prosthetic-heart-valves-an-inter-laboratory-comparison
#8
Stephen M Retta, Jeff Kepner, Salvador Marquez, Bruce A Herman, Mark C S Shu, Laurence W Grossman
BACKGROUND AND AIM OF STUDY: One of the first steps in qualifying a new prosthetic valve for eventual clinical use is preclinical flow performance testing in vitro. Such testing is typically performed in an in-vitro test system that simulates the pumping mechanics of the left ventricle of the heart, generally referred to as a pulse duplicator or duplicator. Historically, test results in these systems have varied from duplicator to duplicator. This collaborative effort between heart valve manufacturers and the Food and Drug Administration (FDA) was designed to evaluate the variability of the pulse duplicator test technology for pulsatile flow performance measurement in an interlaboratory round robin...
January 2017: Journal of Heart Valve Disease
https://www.readbyqxmd.com/read/28511453/pregnancy-outcome-of-abnormal-nuchal-translucency-a-systematic-review
#9
Nasibeh Roozbeh, Maryam Azizi, Leili Darvish
INTRODUCTION: Nuchal Translucency (NT) is the sonographic form of subcutaneous gathering of liquid behind the foetal neck in the first trimester of pregnancy. There is association of increased NT with chromosomal and non-chromosomal abnormalities. AIM: The purpose of this systemic review was to review the pregnancy outcome of abnormal nuchal translucency. MATERIALS AND METHODS: The present systematic review was conducted by searching English language articles from sources such as International Medical Sciences, Medline, Web of science, Scopus, Google Scholar, PubMed, Index Copernicus, DOAJ, EBSCO-CINAHL...
March 2017: Journal of Clinical and Diagnostic Research: JCDR
https://www.readbyqxmd.com/read/28510720/effects-of-a-3d-segmental-prosthetic-system-for-tricuspid-valve-annulus-remodelling-on-the-right-coronary-artery-a-human-cadaveric-coronary-angiography-study
#10
Mohsen Riki-Marishani, Arash Gholoobi, Ghasem Sazegar, Mathias H Aazami, Aria Hedjazi, Maryam Sajjadian, Mahmoud Ebrahimi, Ahmad Aghaii-Zade Torabi
OBJECTIVES: A prosthetic system to repair secondary tricuspid valve regurgitation was developed. The conceptual engineering of the current device is based on 3D segmental remodelling of the tricuspid valve annulus in lieu of reductive annuloplasty. This study was designed to investigate the operational safety of the current prosthetic system with regard to the anatomical integrity of the right coronary artery (RCA) in fresh cadaveric human hearts. METHODS: During the study period, from January to April 2016, the current prosthetic system was implanted on the tricuspid valve annulus in fresh cadaveric human hearts that met the study's inclusion criteria...
September 1, 2017: Interactive Cardiovascular and Thoracic Surgery
https://www.readbyqxmd.com/read/28449479/early-results-of-the-sorin-%C3%A2-perceval-s-sutureless-valve-systematic-review-and-meta-analysis
#11
Karan Sian, Sheila Li, Daneish Selvakumar, Ross Mejia
BACKGROUND: Minimally invasive aortic valve replacement (MAVR) has demonstrated a benefit with respect to increased patient satisfaction due to minimised pain and earlier recovery. Sutureless valves may benefit MAVR and conventional aortic valve replacement (AVR) by reducing operative times and blood transfusion requirements. The Perceval valve (Sorin, Salluggia, Italy) is a self-expanding prosthesis made from bovine pericardium mounted in a nitinol stent, designed to simplify the implantation of an aortic valve...
March 2017: Journal of Thoracic Disease
https://www.readbyqxmd.com/read/28104716/source-3-registry-design-and-30-day-results-of-the-european-postapproval-registry-of-the-latest-generation-of-the-sapien-3-transcatheter-heart-valve
#12
MULTICENTER STUDY
Olaf Wendler, Gerhard Schymik, Hendrik Treede, Helmut Baumgartner, Nicolas Dumonteil, Leo Ihlberg, Franz-Josef Neumann, Giuseppe Tarantini, José Luis Zamarano, Alec Vahanian
BACKGROUND: The SOURCE 3 Registry (SAPIEN Aortic Bioprosthesis European Outcome) is a European multicenter, observational registry of the latest generation of transcatheter heart valve, the SAPIEN 3 (Edwards Lifesciences, Irvine, CA). Its purpose is to document outcomes of clinical safety and performance after European approval was given. METHODS: Here, we present the 30-day outcome of the SOURCE 3 Registry. All data are self-reported, and all participating centers have committed to support their consecutive experience with the SAPIEN 3 transcatheter heart valve, dependent on patient consent, before the start of the study...
March 21, 2017: Circulation
https://www.readbyqxmd.com/read/28100277/stress-echo-2020-the-international-stress-echo-study-in-ischemic-and-non-ischemic-heart-disease
#13
MULTICENTER STUDY
Eugenio Picano, Quirino Ciampi, Rodolfo Citro, Antonello D'Andrea, Maria Chiara Scali, Lauro Cortigiani, Iacopo Olivotto, Fabio Mori, Maurizio Galderisi, Marco Fabio Costantino, Lorenza Pratali, Giovanni Di Salvo, Eduardo Bossone, Francesco Ferrara, Luna Gargani, Fausto Rigo, Nicola Gaibazzi, Giuseppe Limongelli, Giuseppe Pacileo, Maria Grazia Andreassi, Bruno Pinamonti, Laura Massa, Marco A R Torres, Marcelo H Miglioranza, Clarissa Borguezan Daros, José Luis de Castro E Silva Pretto, Branko Beleslin, Ana Djordjevic-Dikic, Albert Varga, Attila Palinkas, Gergely Agoston, Dario Gregori, Paolo Trambaiolo, Sergio Severino, Ayana Arystan, Marco Paterni, Clara Carpeggiani, Paolo Colonna
BACKGROUND: Stress echocardiography (SE) has an established role in evidence-based guidelines, but recently its breadth and variety of applications have extended well beyond coronary artery disease (CAD). We lack a prospective research study of SE applications, in and beyond CAD, also considering a variety of signs in addition to regional wall motion abnormalities. METHODS: In a prospective, multicenter, international, observational study design, > 100 certified high-volume SE labs (initially from Italy, Brazil, Hungary, and Serbia) will be networked with an organized system of clinical, laboratory and imaging data collection at the time of physical or pharmacological SE, with structured follow-up information...
January 18, 2017: Cardiovascular Ultrasound
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
#14
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/28071960/community-based-prevalence-study-of-rheumatic-heart-disease-in-rural-ethiopia
#15
Tadesse Gemechu, Hani Mahmoud, Eldryd Ho Parry, David Iw Phillips, Magdi H Yacoub
Background Chronic Rheumatic Heart disease (RHD) continues to be a health problem in many low and middle income countries and especially in sub-Saharan Africa. Echocardiography has shown that the disease is far more widespread than may be detected by clinical assessment, but data are lacking on the prevalence and epidemiological features in rural Africa. Design Community-based prevalence survey Methods We used transthoracic echocardiography to carry out a population-based study of RHD in a rural area of Ethiopia...
January 1, 2017: European Journal of Preventive Cardiology
https://www.readbyqxmd.com/read/28064153/comparison-of-valve-performance-of-the-mechanically-expanding-lotus-and-the-balloon-expanded-sapien3-transcatheter-heart-valves-an-observational-study-with-independent-core-laboratory-analysis
#16
Osama I I Soliman, Nahid El Faquir, Ben Ren, Ernest Spitzer, Lennart van Gils, Hans Jonker, Marcel L Geleijnse, Gerrit-Anne van Es, Jan G Tijssen, Nicolas M van Mieghem, Peter P T de Jaegere
AIMS: The Lotus and SAPIEN3 are second-generation transcatheter heart valves, which are designed to minimize paravalvular aortic regurgitation (PAR) after transcatheter aortic valve replacement (TAVR). We sought to compare both devices for valve performance and with emphasis on PAR by independent core laboratory analysis. METHODS AND RESULTS: A total of 162 (79 Lotus and 83 SAPIEN3) consecutive patients (51% female, 80 ± 8 years, Logistic EuroSCORE 14.8 ± 9...
January 6, 2017: European Heart Journal Cardiovascular Imaging
https://www.readbyqxmd.com/read/27931592/the-rationale-for-performance-of-coronary%C3%A2-angiography-and-stenting-before-transcatheter-aortic-valve-replacement-from-the-interventional-section-leadership-council-of-the-american-college-of-cardiology
#17
REVIEW
Stephen Ramee, Saif Anwaruddin, Gautam Kumar, Robert N Piana, Vasilis Babaliaros, Tanveer Rab, Lloyd W Klein
Transcatheter aortic valve replacement (TAVR) is an effective, nonsurgical treatment option for patients with severe aortic stenosis. The optimal treatment strategy for treating concomitant coronary artery disease (CAD) has not been tested prospectively in a randomized clinical trial. Nevertheless, it is standard practice in the United States to perform coronary angiography and percutaneous coronary intervention for significant CAD at least 1 month before TAVR. All existing clinical trials were designed using this strategy...
December 12, 2016: JACC. Cardiovascular Interventions
https://www.readbyqxmd.com/read/27773869/valve-in-valve-outcome-design-impact-of-a-pre-existing-bioprosthesis-on-the-hydrodynamics-of-an-edwards-sapien-xt-valve
#18
Christian Doose, Maximilian Kütting, Sandrine Egron, Pejman Farhadi Ghalati, Christoph Schmitz, Marc Utzenrath, Alexander Sedaghat, Buntaro Fujita, Thomas Schmitz-Rode, Stephan Ensminger, Ulrich Steinseifer
Objectives: Bioprosthetic aortic heart valves are increasingly implanted in younger patients. Therefore, a strategy for potential valve failure should be developed before implanting the 'first valve'. The goal of this in vitro study was to provide insight into the effects of the design of a bioprosthesis on a valve-in-valve implanted Sapien XT valve. Methods: The hydrodynamic performance of a 23-mm Sapien XT valve implanted in Vascutek Aspire, Edwards Perimount, Medtronic Mosaic and St...
March 1, 2017: European Journal of Cardio-thoracic Surgery
https://www.readbyqxmd.com/read/27544900/integration-of-flow-gradient-patterns-into%C3%A2-clinical-decision-making-for-patients-with-suspected-severe-aortic-stenosis-and-preserved-lvef-a-systematic-review-of-evidence-and-meta-analysis
#19
Chirag Bavishi, Kiruthika Balasundaram, Edgar Argulian
OBJECTIVES: This study was designed to evaluate the evidence base for the 2014 American Heart Association/American College of Cardiology (AHA/ACC) guidelines for severe aortic stenosis (SAS) and preserved left ventricular ejection fraction by comparing the natural history of the disease in subgroups of low-gradient (LG) aortic stenosis patients with high-gradient (HG) patients. BACKGROUND: The 2014 AHA/ACC valvular disease guidelines recommend estimation of stroke volume index by echocardiography in patients with suspected LG SAS and preserved left ventricular ejection fraction...
November 2016: JACC. Cardiovascular Imaging
https://www.readbyqxmd.com/read/27207627/epidemiology-health-systems-and-stakeholders-in-rheumatic-heart-disease-in-africa-a-systematic-review-protocol
#20
Annesinah Hlengiwe Moloi, David Watkins, Mark E Engel, Sumaya Mall, Liesl Zühlke
INTRODUCTION: Rheumatic heart disease (RHD) is a chronic disease affecting the heart valves, secondary to group A streptococcal infection (GAS) and subsequent acute rheumatic fever (ARF). However, RHD cure and preventative measures are inextricably linked with socioeconomic development, as the disease mainly affects children and young adults living in poverty. In order to address RHD, public health officials and health policymakers require up-to-date knowledge on the epidemiology of GAS, ARF and RHD, as well as the existing enablers and gaps in delivery of evidence-based care for these conditions...
2016: BMJ Open
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