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Condition: Heart Valve Disease
Procedure: Heart Valve Surgery

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Total 376 results found since Jan 2013.

ACC 2017 Roundup: Medtronic ’ s CoreValve as good as surgery in intermediate-risk trial
The team at MassDevice.com and Drug Delivery Business News will be updating this post periodically as news comes out of ACC 2017, the annual American College of Cardiology meeting in Washington March 17-19. Medtronic’s CoreValve as good as surgery in intermediate-risk trial A study comparing surgical valve replacement with transcatheter aortic valve replacement using the CoreValve device made by Medtronic (NYSE:MDT) showed that the TAVR device was as safe as surgery in intermediate-risk patients, according to data presented today at ACC 2017. Two-year data from the 1,657-patient Surtavi study, presented at ACC 2017 a...
Source: Mass Device - March 17, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Clinical Trials Replacement Heart Valves ACC 2017 Medtronic Source Type: news

Keystone Heart, Venus Medtech ink Asian TAVR stroke partnership deal
Keystone Heart and Chinese heart valve maker Venus Medtech said today they inked a partnership deal covering China and other Asian markets. Through the deal, the companies will provide Venus Medtech’s transcatheter aortic valve replacement system along with Keystone’s TriGuard cerebral embolic protection device. TriGuard is a cerebral embolic protection device designed to reduce the amount of embolic material entering blood circulation to the brain during TAVR procedures, by allowing blood to pass through while catching potentially dangerous embolic debris. “Providing brain protection for every TAVR pat...
Source: Mass Device - March 2, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Cardiovascular Catheters Replacement Heart Valves Keystone Heart Venus Medtech Source Type: news

FDA panel supports Claret Medical ’ s Sentinel, despite efficacy questions
The FDA’s Circulatory System Devices Panel this week gave its support to de novo clearance for Claret Medical’s Sentinel embolic protection device despite weak efficacy data for the device. The Santa Rosa, Calif.-based company’s Sentinel device is designed to use a pair of temporary arterial filters during trans catheter aortic valve replacement procedures to trap blood clots before they reach the brain. Members of the panel said that while current efficacy data on the device was not strong enough to assess its ability to prevent stroke, the device may be worth allowing due to its safety profile and the possibl...
Source: Mass Device - February 24, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves Vascular Claret Medical Inc. Source Type: news

Boston Scientific touts no deaths, low PVL rates in Lotus TAVR trial
Boston Scientific (NYSE:BSX) this week presented new data from the Respond extension study of its Lotus transcatheter aortic valve replacement with its Depth Guard technology, touting no deaths and low rates of paravalvular regurgitation. Data from the study was presented at the Cardiovascular Research Technologies CRT 2017 annual meeting in Washington D.C. The 50-patient Respond Extension study aimed to assess clinical and device performance outcomes with its Lotus Valve in combination with the Depth Guard technology. The Marlborough, Mass.-based company’s Depth Guard tech is designed to optimize valve deployment by an...
Source: Mass Device - February 21, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Replacement Heart Valves Boston Scientific Source Type: news

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.
CONCLUSIONS: -Results from the SOURCE 3 Registry demonstrate contemporary European trends and good outcomes of TAVI in daily practice when using this third generation TAVI device. PMID: 28104716 [PubMed - as supplied by publisher]
Source: Circulation - January 18, 2017 Category: Cardiology Authors: Wendler O, Schymik G, Treede H, Baumgartner H, Dumonteil N, Ihlberg L, Neumann FJ, Tarantini G, Zamorano JL, Vahanian A Tags: Circulation Source Type: research

A Left-to-Right Shunt After Transfemoral TAVR Using Edwards SAPIEN 3.
Authors: Steffen J, Köhler A, Schwarz F, Sadoni S, Hagl C, Massberg S, Greif M Abstract Transcatheter aortic valve replacement (TAVR) is used for the treatment of aortic stenosis (AS). Besides major bleeding, conduction blocks, stroke or atrial fibrillation, complications include cardiac perforation with possible left-to-right-shunts. Herein is reported the sixth case of a left-to-right shunt in an 87-year-old man who underwent TAVR using a 29 mm Edwards SAPIEN S3 prosthesis to treat AS. Soon after the procedure, a small channel evolving from the right coronary cusp could be detected on echocardiography. The patie...
Source: Journal of Heart Valve Disease - December 25, 2016 Category: Cardiology Tags: J Heart Valve Dis Source Type: research

A Patient with Quadricuspid Aortic Valve and Ischemic Stroke.
Authors: Krisper M, Köhncke C, Escher F, Morris DA, Tschöpe C, Pieske B Abstract Quadricuspid aortic valve (QAV) is a rare congenital cardiac defect. Aortic regurgitation is the predominant hemodynamically relevant abnormality in patients with QAV, and the main reason for patients requiring valve surgery. Calcific valve disease of the left heart valves is classified as 'low embolic risk' according to current guidelines. However, it remains an important risk factor of cardiovascular events, including ischemic stroke. A 71-year-old woman presented with new-onset aphasia and hemiparesis of the right side of her body...
Source: Journal of Heart Valve Disease - December 25, 2016 Category: Cardiology Tags: J Heart Valve Dis Source Type: research

Aortic Valve Replacement in Redo-Scenarios: A Comparison Between Traditional Aortic Valve Replacement (TAVR) and Transapical-TAVR from Two Real-World Multicenter Registries.
CONCLUSIONS: Outcome differences between RAVR and TaTAVR in redo-scenarios reflect methodological differences and different baseline risk profiles. Propensity-matched patients showed a better renal outcome after TaTAVR. *Drs. Onorati and D'Onofrio contributed equally to this article and should both be considered as first authors. PMID: 27997769 [PubMed]
Source: Journal of Heart Valve Disease - December 22, 2016 Category: Cardiology Tags: J Heart Valve Dis Source Type: research

Direct oral anticoagulant use in nonvalvular atrial fibrillation with valvular heart disease: a systematic review
In conclusion, subanalyses of DOAC landmark AF trials revealed that dabigatran, rivaroxaban, and apixaban may be safely used in AF patients with certain types of VHD: aortic stenosis, aortic regurgitation, and mitral regurgitation. More evidence is needed before routinely recommending these agents for patients with bioprosthetic valves or mild mitral stenosis. Patients with moderate to severe mitral stenosis or mechanical valves should continue to receive warfarin, as these patients were excluded from all landmark AF trials.
Source: Clinical Cardiology - December 21, 2016 Category: Cardiology Authors: Ryan E. Owens, Rajesh Kabra, Carrie S. Oliphant Tags: Reviews Source Type: research

Intravenous Recombinant Tissue Plasminogen Activator Therapy for Acute Basilar Artery Ischemic Stroke Following Transfemoral Transcatheter Aortic Valve Implantation.
Authors: Montarello NJ, Nelson AJ, Sidharta SL, Worthley SG Abstract Transcatheter aortic valve implantation (TAVI) can now be considered a standard of care for inoperable and high-risk surgical patients with severe aortic stenosis, and its uptake worldwide is rapidly increasing. Indeed, many centers performing the procedure have now moved towards treating intermediate-risk patients with TAVI rather than referring them for surgical aortic valve replacement. Although the incidence of peri-procedural acute and subacute stroke following TAVI has fallen to 2-5%, its occurrence can be life-threatening and life-changing,...
Source: Journal of Heart Valve Disease - December 21, 2016 Category: Cardiology Tags: J Heart Valve Dis Source Type: research

Acute Invasive Hemodynamic Effects of Transcatheter Aortic Valve Replacement.
CONCLUSIONS: Successful TAVR results in immediate and sizeable improvements in SV and CI, reductions in left and right ventricular filling pressures, and marked reductions in systemic and pulmonary vascular resistances. PMID: 27989060 [PubMed - in process]
Source: Journal of Heart Valve Disease - December 21, 2016 Category: Cardiology Tags: J Heart Valve Dis Source Type: research

Anticoagulation After Biological Aortic Valve Replacement: Is There An Optimal Regimen?
CONCLUSIONS: Plasma anticoagulation with warfarin during the early postoperative phase was shown statistically to be inferior to platelet aggregation inhibition by aspirin with regards to postoperative bleeding risk, cerebral ischemic events, and survival. PMID: 27989055 [PubMed - in process]
Source: Journal of Heart Valve Disease - December 21, 2016 Category: Cardiology Tags: J Heart Valve Dis Source Type: research

Pre-treatment clinical assessment in head and neck cancer: United Kingdom National Multidisciplinary Guidelines.
Authors: Robson A, Sturman J, Williamson P, Conboy P, Penney S, Wood H Abstract This is the official guideline endorsed by the specialty associations involved in the care of head and neck cancer patients in the UK. This paper provides recommendations on the pre-treatment clinical assessment of patients presenting with head and neck cancer. Recommendations • Comorbidity data should be collected as it is important in the analysis of survival, quality of life and functional outcomes after treatment as well as for comparing results of different treatment regimens and different centres. (R) • Patients with hypertens...
Source: Journal of Laryngology and Otology - November 15, 2016 Category: ENT & OMF Tags: J Laryngol Otol Source Type: research

The JUPITER registry: 1-year results of transapical aortic valve implantation using a second-generation transcatheter heart valve in patients with aortic stenosis ADULT CARDIAC
CONCLUSIONS In a high-risk cohort of patients undergoing TA-TAVR for AS, the use of the JenaValve THV is safe and effective. In patients at higher risk for coronary ostia obstruction, annular rupture or with limited aortic valve calcification, the JenaValve might be preferable for implantation due to its clipping-mechanism engaging native aortic valve cusps for fixation with reduced radial forces of the self-expanding stent.
Source: European Journal of Cardio-Thoracic Surgery - November 3, 2016 Category: Cardiovascular & Thoracic Surgery Authors: Silaschi, M., Treede, H., Rastan, A. J., Baumbach, H., Beyersdorf, F., Kappert, U., Eichinger, W., Rüter, F., de Kroon, T. L., Lange, R., Ensminger, S., Wendler, O. Tags: History, Basic research vascular ADULT CARDIAC Source Type: research

Report: Boston Scientific pauses Lotus Edge heart valve in Europe
Boston Scientific (NYSE:BSX) is reportedly pausing implantations of its next-generation Lotus Edge replacement heart valve in Europe to investigate a locking mechanism issue. Marlborough, Mass.-based Boston Scientific has implanted about 200 of the Lotus Edge transcatheter aortic valve replacements in Europe, according to Barclays analyst Matthew Taylor, encountering about a 4% rate of “some issues with [the] locking mechanism of the valve.” “In these cases (incidence rate of ~4%), the device was recaptured and a new valve was implanted with no major adverse events,” Taylor wrote today in a note to...
Source: Mass Device - October 31, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Replacement Heart Valves Boston Scientific TCT 2016 Transcatheter Cardiovascular Therapeutics symposium (TCT) Source Type: news