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Condition: Heart Valve Disease
Procedure: Heart Valve Surgery

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Total 376 results found since Jan 2013.

Propensity Score Matched Analysis of Mechanical vs. Bioprosthetic Valve Replacement in Patients With Previous Stroke.
CONCLUSIONS: In patients with previous stroke, bioprosthetic valves had a lower incidence of complications connected to major bleeding than did the mechanical valves. Survival and stroke recurrence rates, however, did not differ between the 2 groups. We recommend bioprosthetic valves for patients >60 years or who have a history of GI bleeding. PMID: 29794401 [PubMed - as supplied by publisher]
Source: Circulation Journal - May 24, 2018 Category: Cardiology Authors: Chen SW, Wu VC, Lin YS, Chen CC, Chen DY, Chang CH, Chu PH, Ting PC, Chou AH, Chen TH Tags: Circ J Source Type: research

Real World Data Could Give Edwards Edge in TAVR
Edwards Lifesciences is continuing to strengthen its position in the transcatheter aortic valve replacement(TAVR) market by revealing real world data for the Sapien 3 valve. The Irvine, CA-based company presented positive 30-data of the device at EuroPCR. The propensity-matched analysis compared real-world data collected from the Society of Thoracic Surgeons and American College of Cardiology (STS/ACC) Transcatheter Valve Therapy (TVT) Registry with outcomes of patients enrolled in the PARTNER II studies of the Sapien 3 valve. Nearly 2,000 patients were involved and treated in more than 450 commercial centers around the U....
Source: MDDI - May 22, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Business Source Type: news

MassDevice EuroPCR 2018 Roundup
Valve Tech Roundup – Transcath heart valves getting safer, seeing expanded use   Abbott touts initial data from Portico TAVR study Abbott (NYSE:ABT) today released 30-day data from a study of its Portico transcatheter aortic valve replacement, touting excellent clinical outcomes and low rates of death, disabling stroke and paravalvular leak. The real-world, multicenter, prospective, single-arm Portico I study aimed to explore the safety and efficacy of the Portico valve with independent adjudication of clinical events and independent echocardiography core-lab analysis. Investigators in the study will follow pa...
Source: Mass Device - May 22, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Replacement Heart Valves Abbott Edwards Lifesciences Esaote Source Type: news

Impact of Heart Rate on Flow Measurements in Aortic Regurgitation.
CONCLUSIONS: An increased heart rate leads to a decreased RV. The RF is more stable and may therefore be preferable for severity grading in AR. PMID: 29762918 [PubMed - in process]
Source: Journal of Heart Valve Disease - May 17, 2018 Category: Cardiology Tags: J Heart Valve Dis Source Type: research

‘Ten Commandments’ of the EHRA Guide for the Use of NOACs in AF
Non-vitamin K antagonist oral anticoagulants (NOACs) are an alternative for vitamin K antagonists (VKAs) to prevent stroke in patients with atrial fibrillation (AF), and have emerged as the preferred choice, particularly in patients newly started on anticoagulation. Both physicians and patients are becoming more accustomed to the use of these drugs in clinical practice. However, many unresolved questions on how to optimally use these agents in specific clinical situations remain. In 2013, the first “EHRA Practical Guide” was published to provide practical guidance for situations; an update was published in 2015. Below ...
Source: European Heart Journal - April 21, 2018 Category: Cardiology Source Type: research

Emboline raises $10m Series B for TAVR embolism filter
Emboline said today that it pulled in a $10 million Series B round for the namesake embolic protector it’s developing for heart valve replacement procedures. The Emboliner catheter is designed to prevent blood clots from passing into the cerebral vasculature during transcatheter aortic valve replacements. Santa Cruz, Calif.-based Emboline said the round includes $3 million from a consortium led by SV Tech Ventures and Shangbay Capital and $7 million in already-issued convertible notes. The cash is earmarked for Emboline’s SafePass clinical trial, submission for CE Mark approval and initial commercialization, ...
Source: Mass Device - April 19, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Funding Roundup Replacement Heart Valves Vascular Wall Street Beat Emboline Source Type: news

Mitralign raises $10m
Mitralign, which is looking to commercialize its namesake mitral valve treatment and pursue regulatory nods for its Trialign tricuspid valve device, said it raised nearly $10 million. The $9.8 million funding, of a hoped-for $30.2 million, came from 19 unnamed investors beginning last September, the Tewksbury, Mass.-based company said in a regulatory filing. Mitralign raised a $40 million Series E round in May 2016. The Mitralign and Trialign devices are designed to use wire and catheters to implant polyester anchors within the annulus of the mitral and tricuspid valves. The anchors are then cinched together to reduce v...
Source: Mass Device - February 21, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Funding Roundup Replacement Heart Valves Wall Street Beat Mitralign Inc. Source Type: news

Edwards Lifesciences wins CE Mark for Centera TAVR
Edwards Lifesciences (NYSE:EW) said today it won CE Mark approval in the European Union for its self-expanding transcatheter Centera aortic heart valve, with indications for treating symptomatic aortic stenosis patients at high risk of open-heart surgery. The Centera valve is designed to be repositionable and retrievable, and is delivered through the use of a 14 French motorized delivery system in which the valve is pre-attached to the mechanism for quick preparation, the Irvine, Calif.-based company said. “With the Edwards Centera valve, European clinicians and their patients may now benefit from a self-expanding ...
Source: Mass Device - February 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Regulatory/Compliance Replacement Heart Valves Edwards Lifesciences Source Type: news

Supra ‐annular structure assessment for self‐expanding transcatheter heart valve size selection in patients with bicuspid aortic valve
ConclusionsA supra‐annular structure based sizing strategy is feasible for TAVR in patients with bicuspid AS.
Source: Catheterization and Cardiovascular Interventions - February 5, 2018 Category: Cardiovascular & Thoracic Surgery Authors: Xianbao Liu, Yuxin He, Qifeng Zhu, Feng Gao, Wei He, Lei Yu, Qijing Zhou, Minjian Kong, Jian'an Wang Tags: ORIGINAL STUDIES Source Type: research

LivaNova launches post-market study of bioprosthetic aortic heart valves
LivaNova (NSDQ:LIVN) announced today that the first patient has been enrolled in a post-market trial evaluating the overall incidence of reduced leaflet motion identified by CT imaging in patients receiving a bioprosthetic aortic heart valve. Four-dimensional CT scans will be taken of the trial’s 230 participants at least 30 days after they stop anticoagulation or dual antiplatelet therapy, according to LivaNova. The study will also include one year of follow-up. “Thrombus formation on valve leaflets has been shown to occur in some patients receiving prosthetic tissue valve replacement via transcatheter or ope...
Source: Mass Device - January 11, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiovascular Clinical Trials Imaging Wall Street Beat LivaNova Source Type: news

3 Reasons TAVR Will Continue to Prosper
The transcatheter aortic valve replacement (TAVR) market has already seen rapid growth, and today represents a $3 billion market globally. But the leading TAVR companies say the current technology and approved indications barely scratches the surface in terms of the true growth potential of the space. Michael Mussallem, CEO of Edwards Lifesciences, told J.P. Morgan Healthcare Conference attendees on Monday that the global TAVR market is expected to exceed $5 billion by 2021, and that number does not include certain indications that are currently being explored, like treatment for patients with asymptomatic aortic stenosi...
Source: MDDI - January 9, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Source Type: news

Long-Term Results of Aortic Root Surgery in Marfan Syndrome Patients: A Single-Center Experience.
CONCLUSIONS: The Bentall and David operations are both associated with satisfactory long-term results in MFS patients. The low rate of valve prosthesis-related complications suggested that the Bentall operation would continue to be a standard surgical treatment. The reimplantation technique, adopted for less-dilated aortas, provides satisfactory freedom from reoperation. Careful attention should be paid to the reimplantation technique in patients affected by a serious familiar genetic phenotype. PMID: 29302938 [PubMed - in process]
Source: Journal of Heart Valve Disease - January 7, 2018 Category: Cardiology Tags: J Heart Valve Dis Source Type: research

Nonvitamin K Antagonist Oral Anticoagulants Use in Patients with Atrial Fibrillation and Bioprosthetic Heart Valves/Prior Surgical Valve Repair: A Multicenter Clinical Practice Experience
Semin Thromb Hemost DOI: 10.1055/s-0037-1615261This is an observational study to investigate the efficacy and safety of nonvitamin K antagonist oral anticoagulants (NOACs) in atrial fibrillation (AF) patients with bioprosthetic valves or prior surgical valve repair in clinical practice. A total of 122 patients (mean age: 74.1 ± 13.2; 54 females) with bioprosthetic heart valve or surgical valve repair and AF treated with NOACs were included in the analysis. The mean CHA2DS2-VASc (Congestive heart failure, Hypertension, Age >75 years, Diabetes mellitus, prior Stroke or transient ischemic attack, Vascular disease) and...
Source: Seminars in Thrombosis and Hemostasis - January 5, 2018 Category: Hematology Authors: Russo, Vincenzo Attena, Emilio Mazzone, Carmine Esposito, Francesca Parisi, Valentina Bancone, Ciro Rago, Anna Nigro, Gerardo Sangiuolo, Raffaele D' Onofrio, Antonio Tags: Original Article Source Type: research

Suprasternal Transcatheter Aortic Valve Replacement in Patients With Marginal Femoral Access
Conclusions These data demonstrate the early clinical feasibility of suprasternal transcatheter aortic valve replacement. Key advantages of this approach include direct access to the innominate artery and ascending aorta, precise sheath control, and confident arterial closure. Additional experience is warranted to confirm these favorable results.
Source: Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery - January 1, 2018 Category: Cardiovascular & Thoracic Surgery Tags: Original Articles Source Type: research

Thirty-Day Outcomes in 100 Consecutive Patients Undergoing Transfemoral Aortic Valve Replacement With the Portico Valve on an All-Comer Basis.
CONCLUSIONS: Our immediate and 30-day post-TAVR results support favorable survival comparable to other studies, and significant clinical improvement with the Portico valve in non-selected patients in a real-world setting, with short-term complications being uncommon. PMID: 29207365 [PubMed - in process]
Source: The Journal of Invasive Cardiology - December 6, 2017 Category: Cardiology Tags: J Invasive Cardiol Source Type: research