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TAVI With or Without Predilation: Trends From a Large, Propensity-Score Weighted German Aortic Valve Registry (GARY) Population
CONCLUSIONS: The safety and efficacy of d-TAVI vs b-TAVI depends on the type of THV implanted. For balloon-expandable valves, d-TAVI provides an advantage, while self-expanding valves offer a similar safety profile for d-TAVI compared with b-TAVI. However, increased mPG post intervention with both valve types and more significant PVL in self-expanding THVs emphasize the importance of proper patient selection and evaluation of valve anatomy to identify suitable cases for d-TAVI.PMID:36416901
Source: The Journal of Invasive Cardiology - November 23, 2022 Category: Cardiology Authors: Brunilda Alushi Alexander Lauten Umniye Balaban Eva Herrmann Andreas Schaefer Timm Bauer Andreas Beckmann Sabine Bleiziffer Christian Frerker Helge M öllmann Thomas Walther Raffi Bekeredjian Stephan Ensminger Lenard Conradi Source Type: research

In-hospital outcomes of self-expanding and balloon-expandable transcatheter heart valves in Germany
ConclusionsWe find broadly equivalent outcomes in contemporary TF-TAVR procedures, regardless of the valve type used. Incidence of major complications is very low for both types of valve.
Source: Clinical Research in Cardiology - September 21, 2021 Category: Cardiology Source Type: research

A Blood Filter Fights Deadly Inflammatory Response
A new blood filtration technology may prove to be life-saving for patients whose normally healthy inflammatory response to injury or illness has gone into overdrive, resulting in fatally high levels of cytokines in their blood. In an interview with MD+DI, Dr. Phillip Chan, MD, PhD, CEO of CytoSorbents Corp., explained that inflammation, and the production of substances called cytokines that drive inflammation, are the body’s natural response to heal injury or infection. But sometimes, the inflammatory response is so severe in such conditions as sepsis and infection, burn injuries, trauma, pancreatitis, li...
Source: MDDI - October 9, 2019 Category: Medical Devices Authors: Susan Shepard Tags: Cardiovascular Source Type: news

Safety and efficacy of a self-expanding versus a balloon-expandable bioprosthesis for transcatheter aortic valve replacement in patients with symptomatic severe aortic stenosis: a randomised non-inferiority trial
Publication date: Available online 27 September 2019Source: The LancetAuthor(s): Jonas Lanz, Won-Keun Kim, Thomas Walther, Christof Burgdorf, Helge Möllmann, Axel Linke, Simon Redwood, Christian Thilo, Michael Hilker, Michael Joner, Holger Thiele, Lars Conzelmann, Lenard Conradi, Sebastian Kerber, Gerhard Schymik, Bernard Prendergast, Oliver Husser, Stefan Stortecky, Dik Heg, Peter JüniSummaryBackgroundTranscatheter aortic valve replacement (TAVR) is the preferred treatment option for older patients with symptomatic severe aortic stenosis. Differences in the properties of available TAVR systems can affect clinical outcom...
Source: The Lancet - September 28, 2019 Category: General Medicine Source Type: research

A Comparison of Three Different Bioinformatics Analyses of the 16S –23S rRNA Encoding Region for Bacterial Identification
Conclusion The higher resolution at the species level identification provided by 16S–23S rRNA encoding region NGS makes its use in routine diagnostic microbiology potentially attractive. Particularly, data analysis is one of the most important steps of a diagnostic workflow, which requires an optimal pipeline for the interpretation of the sequencing data in a short time. This study demonstrates that de novo assembly and subsequent BLASTN analysis using an in-house developed database compared to OTU clustering and mapping approaches is the most accurate and fastest approach for identification of bacterial pathogens....
Source: Frontiers in Microbiology - April 15, 2019 Category: Microbiology Source Type: research

Edwards & #039; Sapien 3 Ultra Valve Wins CE Mark
As expected, Edwards Lifesciences has secured a CE mark for its Sapien 3 Ultra device, but the company won't be able to release the new transcatheter aortic valve replacement (TAVR) system in Germany due to a recent preliminary injunction from Boston Scientific. The CE mark allows Edwards to market the device in Europe for patients with severe, symptomatic aortic stenosis. "Edwards is disappointed in Boston Scientific's tactic to limit access of this new therapy," the company said in a press release. The Germany case involves a European patent  Boston Scientific acquired in 2017 when it boughtÂ...
Source: MDDI - November 16, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

Edwards Lifesciences wins CE Mark for Sapien 3 Ultra TAVR
Edwards Lifesciences (NYSE:EW) said today it won CE Mark approval in the European Union for its Sapien 3 Ultra transcatheter aortic valve replacement system intended for patients with severe, symptomatic aortic stenosis. Despite winning a CE Mark, Edwards said that the new valve will not be launched in Germany due to a preliminary injunction from rival Boston Scientific (NYSE:BSX). The company said that “the German court will hold a full hearing on the merits of the dispute” mid-next year, and that it is hopeful it will prevail. The company said it will introduce the Sapien 3 Ultra in the rest of Europe as pa...
Source: Mass Device - November 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Featured Regulatory/Compliance Replacement Heart Valves Edwards Lifesciences Source Type: news

Neovasc touts Tiara TMVR success rate in study
A small study of the Neovasc (NSDQ:NVCN) Tiara transcatheter mitral valve replacement (TMVR) in high-risk patients revealed a 100% procedural success rate and immediate elimination of mitral regurgitation. Published in Circulation: Cardiovascular Interventions, the study also showed no death, myocardial infarction, stroke, major bleeding, or access site complications at 30 days. The twelve patients in the study had had a previous aortic valve replacement. Such patients have been excluded from most TMVR trials because of the potential risks of left ventricular outflow tract obstruction or interaction between the TMVR anch...
Source: Mass Device - October 16, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Cardiac Implants Cardiovascular Featured Replacement Heart Valves Research & Development Mayo Clinic neovasc Neovasc Inc. Source Type: news

Use of oral anticoagulants in German nursing home residents: drug use patterns and predictors for treatment choice
ConclusionsNOACs are increasingly used in German nursing homes, both for initial anticoagulation but also in VKA pre‐treated patients. Switching from VKA to NOAC was substantially influenced by aspects such as intended higher effectiveness and safety but probably also practicability due to less blood monitoring.
Source: British Journal of Clinical Pharmacology - January 11, 2018 Category: Drugs & Pharmacology Authors: Kathrin Jobski, Falk Hoffmann, Stefan Herget ‐Rosenthal, Michael Dörks Tags: PHARMACOEPIDEMIOLOGY Source Type: research

Oral Anticoagulants in German nursing home residents – Drug use patterns and predictors for treatment choice
ConclusionsNOACs are increasingly used in German nursing homes, both for initial anticoagulation but also in VKA pre‐treated patients. Switching from VKA to NOAC was substantially influenced by aspects such as intended higher effectiveness and safety but probably also practicability due to less blood monitoring.
Source: British Journal of Clinical Pharmacology - November 1, 2017 Category: Drugs & Pharmacology Authors: Kathrin Jobski, Falk Hoffmann, Stefan Herget ‐Rosenthal, Michael Dörks Tags: PHARMACOEPIDEMIOLOGY Source Type: research

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