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Heart valve design criteria

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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/28100277/stress-echo-2020-the-international-stress-echo-study-in-ischemic-and-non-ischemic-heart-disease
#2
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
#3
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
#4
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
#5
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
#6
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
#7
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...
October 23, 2016: 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
#8
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
#9
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
#10
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
#11
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
#12
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
#13
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
#14
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
https://www.readbyqxmd.com/read/25439467/a-randomized-assessment-of-an-advanced-tissue-preservation-technology-in-the-juvenile-sheep-model
#15
Willem Flameng, Hadewich Hermans, Erik Verbeken, Bart Meuris
BACKGROUND: Despite improved anticalcification technology, bioprosthetic heart valves still cannot be used in younger patients because of progressive structural valve degeneration. A novel advanced tissue preservation technology was developed that uses stable functional group capping and preservation by glycerolization. Valves incorporating this novel technology can be stored in a dry condition and do not require rinsing before use. The aim of the study was to assess the effects of this new technology in terms of valve function and durability in a chronic sheep model of orthotopic implantation...
January 2015: Journal of Thoracic and Cardiovascular Surgery
https://www.readbyqxmd.com/read/25257635/transcatheter-aortic-valve-replacement-for-severe-symptomatic-aortic-stenosis-using-a-repositionable-valve-system-30-day-primary-endpoint-results-from-the-reprise-ii-study
#16
MULTICENTER STUDY
Ian T Meredith Am, Darren L Walters, Nicolas Dumonteil, Stephen G Worthley, Didier Tchétché, Ganesh Manoharan, Daniel J Blackman, Gilles Rioufol, David Hildick-Smith, Robert J Whitbourn, Thierry Lefèvre, Rüdiger Lange, Ralf Müller, Simon Redwood, Dominic J Allocco, Keith D Dawkins
BACKGROUND: Transcatheter aortic valve replacement provides results comparable to those of surgery in patients at high surgical risk, but complications can impact long-term outcomes. The Lotus valve, designed to improve upon earlier devices, is fully repositionable and retrievable, with a unique seal to minimize paravalvular regurgitation (PVR). OBJECTIVES: The prospective, single-arm, multicenter REPRISE II study (REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System: Evaluation of Safety and Performance) evaluated the transcatheter valve system for treatment of severe symptomatic calcific aortic valve stenosis...
September 30, 2014: Journal of the American College of Cardiology
https://www.readbyqxmd.com/read/25135236/bayesian-stopping-guidelines-for-heart-valve-premarket-approval-studies
#17
Gary L Grunkemeier, YingXing Wu, Lian Wang, Cody Hamilton
OBJECTIVES: The Data Monitoring Committee (DMC) for the premarket approval (PMA) study of a new heart valve prosthesis convenes periodically to review the accumulating results of the study, and determines, among other things, whether there is enough concern with safety to stop the study. Their deliberations are largely subjective, based on their combined experience and expertise, but an objective aid to evaluating complication rates, usually called a stopping rule, is desirable. METHODS: The US Food and Drug Administration has designated objective performance criteria (OPC) for 7 heart valve complications...
December 2014: Journal of Thoracic and Cardiovascular Surgery
https://www.readbyqxmd.com/read/25046483/association-between-cardiovascular-vs-non-cardiovascular-co-morbidities-and-outcomes-in-heart-failure-with-preserved-ejection-fraction
#18
MULTICENTER STUDY
Lars H Lund, Erwan Donal, Emmanuel Oger, Camilla Hage, Hans Persson, Ida Haugen-Löfman, Pierre-Vladimir Ennezat, Catherine Sportouch-Dukhan, Elodie Drouet, Jean-Claude Daubert, Cecilia Linde
AIMS: The prevalence of cardiovascular and non-cardiovascular co-morbidities and their relative importance for outcomes in heart failure with preserved ejection fraction (HFPEF) remain poorly characterized. This study aimed to investigate this. METHODS AND RESULTS: The Karolinska-Rennes (KaRen) Study was a multinational prospective observational study designed to characterize HFPEF. Inclusion required acute HF, defined by the Framingham criteria, LVEF ≥ 45%, and NT-pro-BNP ≥ 300 ng/L or BNP ≥ 100 ng/L...
September 2014: European Journal of Heart Failure
https://www.readbyqxmd.com/read/24914874/spectrum-of-cyanotic-congenital-heart-disease-diagnosed-by-echocardiographic-evaluation-in-patients-attending-paediatric-cardiology-clinic-of-a-tertiary-cardiac-care-centre
#19
Soumya Patra, Usha M K Rama Sastry, J Mahimaiha, Anand P Subramanian, Ravindranath K Shankarappa, Manjunath C Nanjappa
BACKGROUND: Cyanotic CHD comprises up to 25% of cases of all causes of CHD. RATIONALE: There is lack of data about the present spectrum of congenital cyanotic heart disease in the paediatric age group. OBJECTIVE: The present study was undertaken to determine the spectrum of patients with congenital cyanotic heart disease in the paediatric age group in tertiary paediatric cardiac care clinic. DESIGN: Prospective observational study...
June 2015: Cardiology in the Young
https://www.readbyqxmd.com/read/24703628/surgical-pulmonary-valve-replacement-a-benchmark-for-outcomes-comparisons
#20
E Dean McKenzie, Muhammad S Khan, Thomas W Dietzman, Francisco A Guzmán-Pruneda, Andres X Samayoa, Aimee Liou, Jeffrey S Heinle, Charles D Fraser
BACKGROUND: Patients with right heart obstructive lesions develop residual or recurrent right ventricle outflow tract pathology as a result of native or implanted pulmonary valve (PV) dysfunction. Until recently, the standard of care has been surgical placement of a PV or valved right ventricle to pulmonary artery conduit. Catheter-based options are being increasingly applied in patients with PV dysfunction. The purpose of our study was to evaluate outcomes of surgical pulmonary valve/conduit replacement (PVR) at a large pediatric hospital to provide contemporary benchmark data for comparison with developing technologies...
October 2014: Journal of Thoracic and Cardiovascular Surgery
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