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Sapien 3

Niklas Schofer, Florian Deuschl, Gerhard Schön, Moritz Seiffert, Matthias Linder, Andreas Schaefer, Johannes Schirmer, Edith Lubos, Hermann Reichenspurner, Stefan Blankenberg, Lenard Conradi, Ulrich Schäfer
BACKGROUND: The balloon-expandable Sapien 3 (Edwards Lifesciences, Irvine, CA, USA) and the mechanically-expandable Lotus valve (Boston Scientific, Marlborough, MA, USA) are established devices for transcatheter aortic valve implantation. We sought to compare both transcatheter heart valves (THV) under consideration of the extent of THV landing zone calcification. METHODS: This retrospective analysis includes consecutive patients with severe aortic stenosis treated with Sapien 3 (S3; n=212) or Lotus (n=61) THV via transfemoral access...
March 13, 2018: Journal of Cardiology
Unzue Leire, García Eulogio, Rodríguez Rodrigo Francisco José, Parra Jiménez Francisco Javier, Medina Peralta Juan, Díaz-Antón Belen, Rodríguez Del Río Miguel, Fontenla Adolfo, Teijeiro Rodrigo, Rubio-Alonso Belén
OBJECTIVES: The aim of this study is to describe electrocardiographic changes and conduction abnormalities in patients undergoing transcatheter aortic valve implantation (TAVI). METHODS: 76 patients who underwent TAVI using Edwards Sapien 3 prosthesis were included, comparing electrocardiographic registries at admission, post-procedure and before discharge. RESULTS: Patients after TAVI presented a longer PR interval, a wider QRS, and a longer corrected QT, with a left deviation of QRS axis and T waves; reversible changes that tended to correct in the following days after TAVI...
February 20, 2018: Journal of Electrocardiology
W Toppen, W Suh, O Aksoy, P Benharash, C Bowles, R J Shemin, M Kwon
OBJECTIVE: With the introduction of the latest generation Sapien 3 transcatheter aortic valve, there has been a reduction in the usage of transapical (TA) approach for TAVRs in many centers. However, despite the smaller sheath size and more stream-lined delivery system, vascular complications continue to occur, especially in patients with peripheral vascular disease. Thus, our institution has maintained a stringent TA protocol aiming to prevent these complications. We hypothesize that this protocol has helped to reduce vascular complications and improve outcomes at our institution even in the Sapien 3 era...
March 6, 2018: Seminars in Thoracic and Cardiovascular Surgery
Amnon Eitan, Julian Witt, Jan Stripling, Timo Haselbach, Friedrich-Christian Rieß, Joachim Schofer
BACKGROUND: Evolut-R 34 mm (received CE mark in January 2017) and Sapien-3 29 mm are the only options for transcatheter aortic valve replacement (TAVR) in patients with annulus ≥26 mm. We compared the short-term outcomes of these valves in these patients. METHODS: Data was collected prospectively from consecutive patients with severe aortic stenosis and annulus diameter larger than 26 mm treated by femoral approach TAVR. RESULTS: Between February 1, 2014 to August 19, 2017 Sapien-3 29 mm was implanted in 55 and Evolut-R 34 mm in 37 consecutive patients...
March 9, 2018: Catheterization and Cardiovascular Interventions
Evan M Zahn, Jennifer C Chang, Dustin Armer, Ruchira Garg
Current balloon expandable transcatheter valves have limited applicability to patients with "native" right ventricular outflow tracts (RVOT), meaning those who have had previous surgery and are left with large, compliant, irregular RVOT. The Alterra Adaptive PrestentTM is a self-expanding, partially covered stent that was designed to internally reconfigure these types of RVOT, making them suitable for implantation of a commercially available balloon expandable heart valve, the SAPIEN 3. Herein, we describe the first human implant of this device...
March 9, 2018: Catheterization and Cardiovascular Interventions
Katsuo Sekiguchi, Tomokazu Ushitani, Kosuke Sawa
Landmark-based goal-searching tasks that were similar to those for pigeons (Ushitani & Jitsumori, 2011) were provided to human participants to investigate whether they could learn and use multiple sources of spatial information that redundantly indicate the position of a hidden target in both an open field (Experiment 1) and on a computer screen (Experiments 2 and 3). During the training in each experiment, participants learned to locate a target in 1 of 25 objects arranged in a 5 × 5 grid, using two differently colored, arrow-shaped (Experiments 1 and 2) or asymmetrically shaped (Experiment 3) landmarks placed adjacent to the goal and pointing to the goal location...
March 8, 2018: Journal of Comparative Psychology
El Molto, Peter Sheldrick
This article describes six cases of cancer from the Dakhleh Oasis, Egypt. A mummy had a confirmed 'primary' diagnosis of adenocarcinoma of the rectum. The remaining diagnoses were based on the distribution and types of skeletal lesions in conjunction with age, sex, and/or the molecular phylogeny of the Human Papillomavirus (HPV). HPV is a confirmed cause of cancer of the uterine cervix (UC) and testes (TC) and it evolved in Africa long before Homo sapiens emerged. Today these cancers are common in young adult females and males, a fact which was pivotal in respectively including them in the differential diagnosis of UC and TC...
February 27, 2018: International Journal of Paleopathology
Majd Ibrahim, Keattiyoat Wattanakit, Marco Barzallo, Sudhir Mungee
To our knowledge, this is the first documented case of successful TAVI for severe quadricuspid aortic valve (QAV) stenosis performed in the U.S. and the first documented Sapien 3 valve implantation in a severely stenotic QAV.
March 2018: Journal of Invasive Cardiology
Christian A Tryon, Jason E Lewis, Kathryn L Ranhorn, Amandus Kwekason, Bridget Alex, Myra F Laird, Curtis W Marean, Elizabeth Niespolo, Joelle Nivens, Audax Z P Mabulla
The archaeology of East Africa during the last ~65,000 years plays a central role in debates about the origins and dispersal of modern humans, Homo sapiens. Despite the historical importance of the region to these discussions, reliable chronologies for the nature, tempo, and timing of human behavioral changes seen among Middle Stone Age (MSA) and Later Stone Age (LSA) archaeological assemblages are sparse. The Kisese II rockshelter in the Kondoa region of Tanzania, originally excavated in 1956, preserves a ≥ 6-m-thick archaeological succession that spans the MSA/LSA transition, with lithic artifacts such as Levallois and bladelet cores and backed microliths, the recurrent use of red ochre, and >5,000 ostrich eggshell beads and bead fragments...
2018: PloS One
Gilbert H L Tang, Syed Zaid, Samuel R Schnittman, Hasan Ahmad, Ryan Kaple, Cenap Undemir, Tanya Dutta, Angelica Poniros, Joanne Bennett, Cheng Feng, Martin Cohen, Steven L Lansman
AIMS: Paravalvular leak(PVL) remains an important issue in TAVI. The Edwards Sapien3(S3) valve has reduced PVL but up to one-third of patients remain with mild leak. Our study aims to identify predictors of mild PVL after TAVI with S3 valve. METHODS AND RESULTS: From 10/2015 to 5/2017, 122 consecutive patients underwent S3 TAVI for symptomatic severe aortic stenosis. 33 patients with mild PVL on transthoracic echocardiography at 30-day follow-up were compared to 89 with none/trace PVL...
February 27, 2018: EuroIntervention
Giorgia M Bosi, Claudio Capelli, Mun Hong Cheang, Nicola Delahunty, Michael Mullen, Andrew M Taylor, Silvia Schievano
Patient-specific computational models are an established tool to support device development and test under clinically relevant boundary conditions. Potentially, such models could be used to aid the clinical decision-making process for percutaneous valve selection; however, their adoption in clinical practice is still limited to individual cases. To be fully informative, they should include patient-specific data on both anatomy and mechanics of the implantation site. In this work, fourteen patient-specific computational models for transcatheter aortic valve replacement (TAVR) with balloon-expandable Sapien XT devices were retrospectively developed to tune the material parameters of the implantation site mechanical model for the average TAVR population...
February 20, 2018: Journal of Biomechanics
Andy C Kiser, Thomas G Caranasos, Mark D Peterson, David M Holzhey, Philipp Kiefer, L Wiley Nifong, Michael A Borger
OBJECTIVE: Recently, the PARTNER 2A trial reported results of transcatheter aortic valve replacement versus surgical aortic valve replacement in 2032 intermediate-risk patients at 2 years. Two hundred thirty-six patients (24%) required an access route other than transfemoral. Compared with transfemoral and surgical aortic valve replacement, nontransfemoral transcatheter aortic valve replacement was associated with a numerically higher rate of death and disabling stroke at 30 days. This underscores the need for a better alternative surgical approach for patients with marginal femoral access...
February 17, 2018: Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery
Jonathon P Fanning, Allan J Wesley, Darren L Walters, Andrew A Wong, Adrian G Barnett, Wendy E Strugnell, David G Platts, John F Fraser
BACKGROUND: Transcatheter aortic valve implantation (TAVI) is associated with a high incidence of cerebrovascular injury. As these injuries are thought to be primarily embolic, neuroprotection strategies have focused on embolic protection devices. However, the topographical distribution of cerebral emboli and how this impacts on the effectiveness of these devices have not been thoroughly assessed. Here, we evaluated the anatomical characteristics of magnetic resonance imaging (MRI)-defined cerebral ischemic lesions occurring secondary to TAVI to enhance our understanding of the distribution of cardioembolic phenomena...
March 2018: American Heart Journal
Alexander Lauten, Hans R Figulla, Axel Unbehaun, Neil Fam, Joachim Schofer, Torsten Doenst, Joerg Hausleiter, Marcus Franz, Christian Jung, Henryk Dreger, David Leistner, Brunilda Alushi, Anja Stundl, Ulf Landmesser, Volkmar Falk, Karl Stangl, Michael Laule
BACKGROUND: Transcatheter caval valve implantation is under evaluation as a treatment option for inoperable patients with severe tricuspid regurgitation (TR). The procedure involves the catheter-based implantation of bioprosthetic valves in the inferior vena cava and superior vena cava to treat symptoms associated with TR. This study is the first to evaluate the feasibility, safety, and efficacy of this interventional concept. METHODS AND RESULTS: Twenty-five patients (mean age, 73...
February 2018: Circulation. Cardiovascular Interventions
Patrick Bovio, Deborah Roidl, Stefanie Heidrich, Tanja Vogel, Henriette Franz
Brain development is a complex process, which is controlled in a temporo-spatial manner by gradients of morphogens and different transcriptional programs. Additionally, epigenetic chromatin modifications, like histone methylation, have an important role for establishing and maintaining specific cell fates within this process. The vast majority of histone methylation occurs on the flexible histone tail, which is accessible to histone modifiers, erasers, and histone reader proteins. In contrast, H3K79 methylation is located in the globular domain of histone 3 and is implicated in different developmental functions...
January 26, 2018: Journal of Visualized Experiments: JoVE
Mark Webster, Sanjeevan Pasupati, Nigel Lever, Martin Stiles
OBJECTIVE: This first-in-human study evaluated the safety and technical feasibility of the Tempo temporary cardiac pacing lead (BioTrace Medical), which includes a novel fixation mechanism and soft tip. BACKGROUND: Complications of temporary pacing leads include dislodgment, arrhythmias, and ventricular perforation. Temporary pacing applications have increased with transcatheter aortic valve replacement (TAVR) growth, for rapid pacing during balloon valvuloplasty (BAV) and valve deployment, and for periprocedural bradyarrhythmia support...
February 15, 2018: Journal of Invasive Cardiology
Philippe J van Rosendael, Victoria Delgado, Jeroen J Bax
Aims: The incidence of new-onset conduction abnormalities requiring permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI) with new-generation prostheses remains debated. This systematic review analyses the incidence of PPI after TAVI with new-generation devices and evaluates the electrical, anatomical, and procedural factors associated with PPI. In addition, the incidence of PPI after TAVI with early generation prostheses was reviewed for comparison...
February 6, 2018: European Heart Journal
Jeroen Vendrik, Floortje van Kesteren, Martijn S van Mourik, Jan J Piek, Jan G Tijssen, Jose P S Henriques, Joanna J Wykrzykowska, Rob J de Winter, Antoine H G Driessen, Abdullah Kaya, M Marije Vis, Karel T Koch, Jan Baan
Over the years increasing experience and technical device improvements in transcatheter aortic valve implantation (TAVI) have led to treatment of patients with lower surgical risks. Specifically for this population, device performance and longer term outcome are of great importance. In this single center, we performed a retrospective analysis of 515 consecutive patients with low- to intermediate surgical risk (STS-PROM ≤8), who underwent transfemoral TAVI between January 2009 and February 2017 with the SXT and ES3 prostheses, and we assessed procedural outcome and procedural and 3-year survival...
January 11, 2018: American Journal of Cardiology
Norio Tada, Teruo Inoue, Takashi Matsumoto, Mie Sakurai, Yukiko Mizutani, Yusuke Enta, Kazunori Ishii, Hiroshi Inoue, Masataka Taguri, Masaki Hata, Masashi Sakuma, Shigeru Toyoda, Tatsushi Ootomo
A narrow and calcified sinotubular junction (STJ) represents a risk for ascending aortic dissection after balloon-expandable transcatheter aortic valve implantation (TAVI). The aim of this study was to assess computed tomography (CT)-based aortic root morphology in patients with aortic stenosis (AS), and to evaluate the feasibility of a two-step inflation technique that we devised for TAVI using the SAPIEN 3 in patients with a narrow and calcified STJ. We retrospectively analyzed the STJ diameter (STJD) as well the as aortic annulus diameter (AAD) and STJ calcification using CT imaging in 412 patients undergoing TAVI...
January 31, 2018: Heart and Vessels
Adham Elmously, Berhane Worku, Katherine D Gray, Arash Salemi
BACKGROUND: Transapical transcatheter mitral valve-in-valve implantation (TA-MVIVI) for bioprosthetic valve failure is an emerging alternative to re-operation in high risk patients. We report our outcomes in a patient population with a high proportion of cardiogenic shock. METHODS: Retrospective review was performed of all patients undergoing TA-MVIVI with an Edwards SAPIEN (Edwards Life sciences, Irvine, CA) prosthesis at our center between the years of 2013-2017...
January 27, 2018: Annals of Thoracic Surgery
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