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https://www.readbyqxmd.com/read/28339299/the-10th-gcc-closed-forum-rejected-data-gcp-in-bioanalysis-extract-stability-bav-processed-batch-acceptance-matrix-stability-critical-reagents-eln-and-data-integrity-and-counteracting-fraud
#1
Stephanie Cape, Rafiq Islam, Corey Nehls, John Allinson, Afshin Safavi, Patrick Bennett, James Hulse, Chris Beaver, Masood Khan, Shane Karnik, Maria Cruz Caturla, Steve Lowes, Adriana Iordachescu, Luigi Silvestro, Rabab Tayyem, Ron Shoup, Stephanie Mowery, Anahita Keyhani, Andrea Wakefield, Yinghe Li, Jennifer Zimmer, Javier Torres, Philippe Couerbe, Ardeshir Khadang, James Bourdage, Nicola Hughes, Kayode Awaiye, Brent Matthews, Saadya Fatmi, Rhonda Johnson, Christina Satterwhite, Mathilde Yu, Jenny Lin, Laura Cojocaru, Michele Fiscella, Eric Thomas, Kai Kurylak, John Kamerud, Zhongping John Lin, Wei Garofolo, Natasha Savoie, Mike Buonarati, Nadine Boudreau, Clark Williard, Yansheng Liu, Dominic Warrino, Prashant Kale, Neil Adcock, Radha Shekar, Edward O'Connor, Hanna Ritzen, Christina Sanchez, Roger Hayes, Mohammed Bouhajib, Simona Rizea Savu, Bruce Stouffer, Edward Tabler, Jing Tu, Chad Briscoe, Barry van der Strate, Paul Rhyne, Phyllis Conliffe, Ira DuBey, Jim Yamashita, Daniel Tang, Elizabeth Groeber, Jenifer Vija, Michele Malone, Mohamed Osman
The 10th Global CRO Council (GCC) Closed Forum was held in Orlando, FL, USA on 18 April 2016. In attendance were decision makers from international CRO member companies offering bioanalytical services. The objective of this meeting was for GCC members to meet and discuss scientific and regulatory issues specific to bioanalysis. The issues discussed at this closed forum included reporting data from failed method validation runs, GCP for clinical sample bioanalysis, extracted sample stability, biomarker assay validation, processed batch acceptance criteria, electronic laboratory notebooks and data integrity, Health Canada's Notice regarding replicates in matrix stability evaluations, critical reagents and regulatory approaches to counteract fraud...
March 24, 2017: Bioanalysis
https://www.readbyqxmd.com/read/28329312/first-experience-with-transfemoral-transcatheter-aortic-valve-implantation-without-prior-balloon-pre-dilatation-using-a-latest-generation-repositionable-and-retrievable-transcatheter-heart-valve%C3%A2
#2
Andreas Schaefer, Eva Harmel, Moritz Seiffert, Daniel Reichart, Florian Deuschl, Niklas Schofer, Yvonne Schneeberger, Stefan Blankenberg, Hermann Reichenspurner, Ulrich Schaefer, Lenard Conradi
OBJECTIVES: : The aim of this study was to prove technical feasibility and document haemodynamic and clinical outcomes of transcatheter aortic valve implantation (TAVI) with the latest generation repositionable and retrievable Lotus™ transcatheter heart valve (THV) without prior balloon-aortic valvuloplasty (BAV). It has been demonstrated for self-expandable and balloon-expandable THV that implantation without prior BAV is not only feasible and safe but also results in lower fluoroscopy times and amounts of contrast agent while yielding non-inferior haemodynamic and clinical outcome...
February 6, 2017: Interactive Cardiovascular and Thoracic Surgery
https://www.readbyqxmd.com/read/28318856/balloon-aortic-valvuloplasty-in-the-transcatheter-aortic-valve-implantation-era-a-single-center-registry
#3
Ana Rita G Francisco, Miguel Nobre Menezes, Pedro Carrilho Ferreira, Cláudia Jorge, Doroteia Silva, Eduardo Infante de Oliveira, Fausto J Pinto, Pedro Canas da Silva
INTRODUCTION: Percutaneous balloon aortic valvuloplasty (BAV) has been limited by the risk of complications and restenosis. However, growing use of transcatheter aortic valve implantation (TAVI) has revived interest in this technique. We analyzed the current indications for BAV and outcomes in a single center. METHODS: Acute results and long-term outcomes were analyzed in a retrospective single-center registry of patients undergoing BAV between January 2013 and January 2016...
March 16, 2017: Portuguese Journal of Cardiology: An Official Journal of the Portuguese Society of Cardiology
https://www.readbyqxmd.com/read/28318133/transcatheter-aortic-valve-implantation-with-the-self-expandable-venus-a-valve-and-corevalve-devices-preliminary-experiences-in-china
#4
Yan-Biao Liao, Zhen-Gang Zhao, Xin Wei, Yuan-Ning Xu, Zhi-Liang Zuo, Yi-Jian Li, Ming-Xia Zheng, Yuan Feng, Mao Chen
BACKGROUND: Transcatheter aortic valve implantation (TAVI) has been demonstrated to be an effective alternative to surgical aortic valve replacement (SAVR) in patients with aortic stenosis who are deemed high risk or inoperable. Currently, TAVI procedures in China mostly make use of the domestic Venus A-Valve and the CoreValve; however, there is no data on their comparative performance. METHODS: Consecutive patients undergoing TAVI with the aforementioned devices were included...
March 2017: Catheterization and Cardiovascular Interventions
https://www.readbyqxmd.com/read/28314673/can-we-perform-rotational-atherectomy-in-patients-with-severe-aortic-stenosis-substudy-from-the-ocean-tavi-registry
#5
Toru Naganuma, Hiroyoshi Kawamoto, Kensuke Takagi, Hiroto Yabushita, Satoru Mitomo, Yusuke Watanabe, Shinichi Shirai, Motoharu Araki, Norio Tada, Futoshi Yamanaka, Masanori Yamamoto, Hirokazu Onishi, Sunao Nakamura, Akihiro Higashimori, Minoru Tabata, Kazuki Mizutani, Hiroshi Ueno, Kentaro Hayashida
PURPOSE: The aim of this study was to report the safety of coronary rotational atherectomy (RA) in patients with severe aortic stenosis (AS). RA in the clinical setting seems challenging because coronary slow flow leads to hemodynamic instability. METHODS: Between October 2013 and May 2016, 1401 patients in the Optimized transCathEter vAlvular iNtervention (OCEAN) registry in Japan underwent transcatheter aortic valve implantation (TAVI). The primary study endpoint was procedural success, defined as residual stenosis <20% with final Thrombolysis in Myocardial Infarction flow 3...
February 28, 2017: Cardiovascular Revascularization Medicine: Including Molecular Interventions
https://www.readbyqxmd.com/read/28303684/aortic-valvuloplasty-via-the-radial-artery-case-reports-and-review-of-the-literature
#6
Elizabeth M Rau, Mohammad El-Hajjar
The use of balloon aortic valvuloplasty (BAV) has increased with the development of transcatheter aortic valve implantation (TAVI) to medically optimize patients prior to procedure. It has been traditionally done by a retrograde approach via the femoral artery or an antegrade approach via the femoral vein. Large sheaths have been required with traditional balloons which require large vessel access. Use of a low profile compliant valvuloplasty balloon has been demonstrated to have adequate BAV results with smaller sheath sizes...
March 17, 2017: Catheterization and Cardiovascular Interventions
https://www.readbyqxmd.com/read/28299882/systolic-ejection-click-versus-split-first-heart-sound-are-our-ears-deceiving-us
#7
Natalie M Hoeting, Courtney E McCracken, Michael McConnell, Denver Sallee, Glen J Iannucci, Matthew E Oster
OBJECTIVE: Bicuspid aortic valve (BAV) disease is associated with potential lifetime complications, but auscultation of a BAV click is commonly missed or mistaken for a benign split first heart sound. Our objective was to determine whether pediatric cardiologists could reliably distinguish between BAV clicks and benign split first heart sounds. DESIGN: Quality evaluation project using de-identified recordings from an outpatient pediatric cardiology clinic. OUTCOME MEASURES: Twenty-one cardiologists listened to five de-identified recordings of pediatric heart sounds (three with BAV clicks, two with mitral components of benign split first heart sounds) and indicated whether they believed each recording was a BAV or split first heart sound...
March 16, 2017: Congenital Heart Disease
https://www.readbyqxmd.com/read/28299607/comprehensive-4-stage-categorization-of-bicuspid-aortic-valve-leaflet-morphology-by-cardiac-mri-in-386-patients
#8
I G Murphy, J Collins, A Powell, M Markl, P McCarthy, S C Malaisrie, J C Carr, A J Barker
Bicuspid aortic valve (BAV) disease is heterogeneous and related to valve dysfunction and aortopathy. Appropriate follow up and surveillance of patients with BAV may depend on correct phenotypic categorization. There are multiple classification schemes, however a need exists to comprehensively capture commissure fusion, leaflet asymmetry, and valve orifice orientation. Our aim was to develop a BAV classification scheme for use at MRI to ascertain the frequency of different phenotypes and the consistency of BAV classification...
March 15, 2017: International Journal of Cardiovascular Imaging
https://www.readbyqxmd.com/read/28256067/transcatheter-aortic-valve-replacement-the-year-in-review-2016
#9
Kishore J Harjai, Cindy L Grines, Jean-Michael Paradis, Susheel Kodali
Transcatheter aortic valve replacement (TAVR) continued to make major strides in 2016, simultaneously expanding its application to lower risk patients as well as more technically challenging subsets of patients with aortic stenosis (AS). The two major accomplishments this year were the establishment of TAVR as the preferred treatment strategy over surgical aortic valve replacement (SAVR) in intermediate risk patients, and initial signals that TAVR and SAVR may be clinically equivalent in low-risk populations...
March 2, 2017: Journal of Interventional Cardiology
https://www.readbyqxmd.com/read/28251911/sex-differences-in-phenotypes-of-bicuspid-aortic-valve-and-aortopathy-insights-from-a-large-multicenter-international-registry
#10
William K F Kong, Madelien V Regeer, Arnold C T Ng, Louise McCormack, Kian Keong Poh, Tiong Cheng Yeo, Miriam Shanks, Sarah Parent, Roxana Enache, Bogdan A Popescu, James W Yip, Lawrence Ma, Vasileios Kamperidis, Enno T van der Velde, Bart Mertens, Nina Ajmone Marsan, Victoria Delgado, Jeroen J Bax
BACKGROUND: This large multicenter, international bicuspid aortic valve (BAV) registry aimed to define the sex differences in prevalence, valve morphology, dysfunction (aortic stenosis/regurgitation), aortopathy, and complications (endocarditis and aortic dissection). METHODS AND RESULTS: Demographic, clinical, and echocardiographic data at first presentation of 1992 patients with BAV (71.5% men) were retrospectively analyzed. BAV morphology and valve function were assessed; aortopathy configuration was defined as isolated dilatation of the sinus of Valsalva or sinotubular junction, isolated dilatation of the ascending aorta distal to the sinotubular junction, or diffuse dilatation of the aortic root and ascending aorta...
March 2017: Circulation. Cardiovascular Imaging
https://www.readbyqxmd.com/read/28248407/hemodynamic-changes-after-transcatheter-aortic-valve-implantation-during-sequential-follow-ups-in-patients-with-bicuspid-aortic-valve-compared-with-tricuspid-aortic-valve
#11
Tian-Yuan Xiong, Ming-Xia Zheng, Xin Wei, Yi-Jian Li, Yan-Biao Liao, Zhen-Gang Zhao, Yuan-Ning Xu, Hong Tang, Yuan Feng, Mao Chen
BACKGROUND: To investigate the individual sequential hemodynamic changes after transcatheter aortic valve implantation (TAVI), especially for patients with bicuspid aortic valve (BAV), in comparison with tricuspid aortic valve (TAV). METHODS: The study population comprised 85 patients with severe aortic stenosis who underwent TAVI for BAV (n = 49) or TAV (n = 36) with at least two serial echocardiographic follow-ups. Doppler echocardiography was scheduled to be performed at discharge and 1, 3, 6 months and 1 year after the procedure...
March 1, 2017: Cardiology Journal
https://www.readbyqxmd.com/read/28238238/bicuspid-aortic-valve-a-review-of-its-genetics-and-clinical-significance
#12
Lei Wang, Li Ming Wang, Wen Chen, Xin Chen
The aim of this review was to describe recent advancements in the understanding of bicuspid aortic valve (BAV). BAV is the most common congenital cardiac anomaly, and affects between 0.46% and 1.37% of the population. There is a male predominance of approximately 3:1.While isolated BAV is found in certain patients, it is often associated with other congenital cardiac lesions, including dilatation of the thoracic aorta, coarctation of the aorta and abnormalities of the coronary anatomy. In most cases, it remains undetected until the patient contracts infective endocarditis, or calcification occurs...
September 2016: Journal of Heart Valve Disease
https://www.readbyqxmd.com/read/28238234/markers-of-lipid-metabolism-do-not-correlate-with-the-expression-of-aortopathy-in-patients-with-bicuspid-aortic-valve-disease
#13
Tatiana M Sequeira Gross, Thomas Kuntze, Alexander Bernhardt, Hermann Reichenspurner, Yskert von Kodolitsch, Evaldas Girdauskas
BACKGROUND: Controversy exists regarding the potential effects of lipid metabolism on the expression of proximal aortopathy. The study aim was to compare the association between markers of lipid metabolism and the expression of proximal aortopathy in patients with either bicuspid aortic valve (BAV) or tricuspid aortic valve (TAV) disease. METHODS: A total of 458 consecutive patients (68% males) underwent aortic valve replacement (AVR) with or without concomitant aortic surgery between January 2008 and December 2014 at the authors' institution...
September 2016: Journal of Heart Valve Disease
https://www.readbyqxmd.com/read/28236629/increased-prevalence-of-bicuspid-aortic-valve-in-turner-syndrome-links-with-karyotype-the-crucial-importance-of-detailed-cardiovascular-screening
#14
Eva Klásková, Jiřina Zapletalová, Sabina Kaprálová, Marta Šnajderová, Jan Lebl, Zbyněk Tüdös, Jan Pavlíček, Jana Černá, Vladimír Mihál, Veronika Stará, Martin Procházka
BACKGROUND: Bicuspid aortic valve (BAV) represents one of the strongest risk factors for aortic dissection in Turner syndrome (TS). An exact relation between the occurrence of BAV and a particular karyotype has not been established yet. The aim of this study was to determine the association between karyotype and prevalence of BAV. METHODS: Sixty-seven TS patients aged between 6.6 and 32.5 years underwent cardiac magnetic resonance imaging (MRI) study. They were divided into four cytogenetic subgroups-45,X karyotype (n=27); 45,X/46,XX mosaicism (n=17); structural abnormalities of the X chromosome (n=10); and 45,X/structural abnormality of the X chromosome mosaicism (n=13)...
March 1, 2017: Journal of Pediatric Endocrinology & Metabolism: JPEM
https://www.readbyqxmd.com/read/28222756/proximal-aortic-stiffening-in-turner-patients-may-be-present-before-dilation-can-be-detected-a-segmental-functional-mri-study
#15
Daniel G H Devos, Katya De Groote, Danilo Babin, Laurent Demulier, Yves Taeymans, Jos J Westenberg, Luc Van Bortel, Patrick Segers, Eric Achten, Jean De Schepper, Ernst Rietzschel
BACKGROUND: To study segmental structural and functional aortic properties in Turner syndrome (TS) patients. Aortic abnormalities contribute to increased morbidity and mortality of women with Turner syndrome. Cardiovascular magnetic resonance (CMR) allows segmental study of aortic elastic properties. METHOD: We performed Pulse Wave Velocity (PWV) and distensibility measurements using CMR of the thoracic and abdominal aorta in 55 TS-patients, aged 13-59y, and in a control population (n = 38;12-58y)...
February 13, 2017: Journal of Cardiovascular Magnetic Resonance
https://www.readbyqxmd.com/read/28214795/pre-implantation-balloon-aortic-valvuloplasty-and-clinical-outcomes-following-transcatheter-aortic-valve-implantation-a-propensity-score-analysis-of-the-uk-registry
#16
Glen P Martin, Matthew Sperrin, Rodrigo Bagur, Mark A de Belder, Iain Buchan, Mark Gunning, Peter F Ludman, Mamas A Mamas
BACKGROUND: Aortic valve predilation with balloon aortic valvuloplasty (BAV) is recommended before transcatheter aortic valve implantation (TAVI), despite limited data around the requirement of this preprocedural step and the potential risks of embolization. This study aimed to investigate the trends in practice and associations of BAV on short-term outcomes in the UK TAVI registry. METHODS AND RESULTS: Eleven clinical endpoints were investigated, including 30-day mortality, myocardial infarction, aortic regurgitation, valve dysfunction, and composite early safety...
February 18, 2017: Journal of the American Heart Association
https://www.readbyqxmd.com/read/28211605/end-stage-renal-disease-and-severe-aortic-stenosis-does-valve-replacement-improve-one-year-outcomes
#17
Jose F Condado, Aneel Maini, Bradley Leshnower, Vinod Thourani, Jessica Forcillo, Chandan Devireddy, Kreton Mavromatis, Eric L Sarin, James Stewart, Robert Guyton, Amy Simone, Patricia Keegan, Stamatios Lerakis, Peter C Block, Vasilis Babaliaros
BACKGROUND: Treatment for patients with end-stage renal disease (ESRD) and severe aortic stenosis (AS) includes balloon aortic valvuloplasty (BAV), surgical (SAVR), or transcatheter (TAVR) aortic valve replacement. We compared outcomes among these strategies. METHODS: A retrospective review of patients with ESRD undergoing treatment for severe AS between 07/2007 and 06/2015 was performed at our center. Patients were classified based on treatment: BAV-only, TAVR, or SAVR...
February 17, 2017: Catheterization and Cardiovascular Interventions
https://www.readbyqxmd.com/read/28209261/the-feasibility-of-transcatheter-aortic-valve-implantation-using-the-edwards-sapien-3-for-patients-with-severe-bicuspid-aortic-stenosis
#18
Takahide Arai, Thierry Lefèvre, Thomas Hovasse, Marie-Claude Morice, Mauro Romano, Hakim Benamer, Philippe Garot, Kentaro Hayashida, Erik Bouvier, Bernard Chevalier
BACKGROUND: There are currently only limited data focusing on transcatheter aortic valve implantation (TAVI) for bicuspid aortic valves (BAV) patients using the Edwards SAPIEN (Irvine, CA, USA) 3 (S3) valve. The aim of this study was to evaluate the feasibility and efficacy of TAVI using the S3 in patients with BAV. METHODS: A total of 153 TAVI cases performed with the S3 were included. BAV was detected by multidetector computed tomography (MDCT) in 10 (7%) patients...
February 10, 2017: Journal of Cardiology
https://www.readbyqxmd.com/read/28203207/morphotype-dependent-flow-characteristics-in-bicuspid-aortic-valve-ascending-aortas-a-benchtop-particle-image-velocimetry-study
#19
Andrew McNally, Ashish Madan, Philippe Sucosky
The bicuspid aortic valve (BAV) is a major risk factor for secondary aortopathy such as aortic dilation. The heterogeneous BAV morphotypes [left-right-coronary cusp fusion (LR), right-non-coronary cusp fusion (RN), and left-non-coronary cusp fusion (LN)] are associated with different dilation patterns, suggesting a role for hemodynamics in BAV aortopathogenesis. However, assessment of this theory is still hampered by the limited knowledge of the hemodynamic abnormalities generated by the distinct BAV morphotypes...
2017: Frontiers in Physiology
https://www.readbyqxmd.com/read/28198527/coexistence-of-bicuspid-aortic-valve-aberrant-right-subclavian-artery-and-common-origin-of-carotid-arteries
#20
Paweł Tyczyński, Ilona Michałowska, Aneta Fronczak, Rafał Wolny, Hubert Łazarczyk, Zbigniew Chmielak, Adam Witkowski
BACKGROUND: Prevalence of bicuspid aortic valve (BAV) and right aberrant subclavian artery (ASA) separately is relatively common in general population, and much higher in some disorders. Surprisingly, coexistence of both valve and vessel anomalies has only been reported in single cases. METHODS: From 2008 to 2016, in a single, high-volume tertiary cardiac center, patients who underwent chest computed tomography or magnetic resonance imaging for various reasons, were retrospectively screened for the presence of right ASA...
February 15, 2017: Folia Morphologica (Warsz)
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