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Heart valve design criteria

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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
#1
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
#2
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
#3
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
#4
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
#5
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...
May 16, 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
#6
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
#7
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
#8
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
#9
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
#10
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
#11
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
#12
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
#13
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
#14
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
#15
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
https://www.readbyqxmd.com/read/27026750/contemporary-outcomes-after-surgical-aortic-valve-replacement-with-bioprostheses-and-allografts-a-systematic-review-and-meta-analysis
#16
REVIEW
Simone A Huygens, Mostafa M Mokhles, Milad Hanif, Jos A Bekkers, Ad J J C Bogers, Maureen P M H Rutten-van Mölken, Johanna J M Takkenberg
Many observational studies have reported outcomes after surgical aortic valve replacement (AVR), but there are no recent systematic reviews and meta-analyses including all available bioprostheses and allografts. The objective of this study is to provide a comprehensive and up-to-date overview of the outcomes after AVR with bioprostheses and allografts reported in the last 15 years. We conducted a systematic literature review (PROSPERO register: CRD42015017041) of studies published between 2000-15. Inclusion criteria were observational studies or randomized controlled trials reporting on outcomes of AVR with bioprostheses (stented or stentless) or allografts, with or without coronary artery bypass grafting (CABG) or valve repair procedure, with study population size n ≥ 30 and mean follow-up length ≥5 years...
October 2016: European Journal of Cardio-thoracic Surgery
https://www.readbyqxmd.com/read/26843026/natural-history-of-107-cases-of-fetal-aortic-stenosis-from-a-european-multicenter-retrospective-study
#17
H M Gardiner, A Kovacevic, G Tulzer, T Sarkola, U Herberg, J Dangel, A Öhman, J Bartrons, J S Carvalho, H Jicinska, V Fesslova, I Averiss, M Mellander
OBJECTIVES: Fetal aortic valvuloplasty (FV) aims to prevent fetal aortic valve stenosis progressing into hypoplastic left heart syndrome (HLHS), which results in postnatal univentricular (UV) circulation. Despite increasing numbers of FVs performed worldwide, the natural history of the disease in fetal life remains poorly defined. The primary aim of this study was to describe the natural history of fetal aortic stenosis, and a secondary aim was to test previously published criteria designed to identify cases of emerging HLHS with the potential for a biventricular (BV) outcome after FV...
September 2016: Ultrasound in Obstetrics & Gynecology
https://www.readbyqxmd.com/read/26656602/fibrous-scaffolds-for-building-hearts-and-heart-parts
#18
REVIEW
A K Capulli, L A MacQueen, Sean P Sheehy, K K Parker
Extracellular matrix (ECM) structure and biochemistry provide cell-instructive cues that promote and regulate tissue growth, function, and repair. From a structural perspective, the ECM is a scaffold that guides the self-assembly of cells into distinct functional tissues. The ECM promotes the interaction between individual cells and between different cell types, and increases the strength and resilience of the tissue in mechanically dynamic environments. From a biochemical perspective, factors regulating cell-ECM adhesion have been described and diverse aspects of cell-ECM interactions in health and disease continue to be clarified...
January 15, 2016: Advanced Drug Delivery Reviews
https://www.readbyqxmd.com/read/25814425/a-review-of-the-key-clinical-trials-of-2014
#19
Peter McKavanagh, Claire McCune, Ian B Menown
INTRODUCTION: Over the last year, multiple, potentially practice-changing, cardiology trials or studies have been published or presented at international meetings including the American College of Cardiology, European Association for Percutaneous Cardiovascular Interventions, European Society of Cardiology, Transcatheter Cardiovascular Therapeutics, Heart Failure Congress, Heart Rhythm Society, Heart Failure Society of America, American Society of Hypertension and the American Heart Association...
June 2015: Cardiology and Therapy
https://www.readbyqxmd.com/read/25490297/infective-endocarditis-and-complications-a-single-center-experience
#20
Olcay Ozveren, Mehmet Akif Oztürk, Cihan Sengül, Ruken Bengi Bakal, Taylan Akgün, Cemil Izgi, Zekeriya Küçükdurmaz, Atiye Elif Eroğlu Büyüköner, Muzaffer Değertekin
OBJECTIVES: The aim was to investigate the microbiological characteristics and complications of infective endocarditis (IE) in 119 patients treated in our center for IE, diagnosed by modified Duke criteria. STUDY DESIGN: The archive records of 119 patients (82 [69%] males; 37 [31%] females; mean age 39 ± 16 years) with a definite diagnosis of IE between January 1997 and November 2004 were systematically reviewed for clinical and microbiological properties and complications...
October 2014: Türk Kardiyoloji Derneği Arşivi: Türk Kardiyoloji Derneğinin Yayın Organıdır
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