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Cost-Effectiveness of SAPIEN  3 Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in German Severe Aortic Stenosis Patients at Low Surgical Mortality Risk
ConclusionsTAVI with SAPIEN  3 appears to be a clinically meaningful, cost-effective treatment option over SAVR for patients with severe symptomatic aortic stenosis and low risk for surgical mortality in Germany.Clinical Trial Registration Numberwww.clinicaltrials.gov identifier: NCT02675114.
Source: Advances in Therapy - January 9, 2023 Category: Drugs & Pharmacology Source Type: research

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

Prognostic value of the H2FPEF score in patients undergoing transcatheter aortic valve implantation
ConclusionsThe H2FPEF score serves as an independent predictor of adverse CV and heart failure outcome among TAVI patients with preserved EF. A high H2FPEF score is associated with the presence of paradoxical low ‐flow, low‐gradient AS, the HFpEF in patients with AS. By identifying patients in advanced stages of HFpEF, the H2FPEF score might be useful as a risk prediction tool in patients with preserved EF scheduled for TAVI.
Source: ESC Heart Failure - January 25, 2021 Category: Cardiology Authors: Sebastian Ludwig, Costanza Pellegrini, Alina Gossling, Tobias Rheude, Lisa Voigtl änder, Oliver D. Bhadra, Matthias Linder, Daniel Kalbacher, Benedikt Koell, Lara Waldschmidt, Johannes Schirmer, Moritz Seiffert, Hermann Reichenspurner, Stefa Tags: Original Research Article Source Type: research

Risk of mortality following transcatheter aortic valve replacement for low-flow low-gradient aortic stenosis
ConclusionIn patients with LF-LG AS, history of myocardial infarction, renal dysfunction, tricuspid regurgitation, a low stroke volume index, self-expandable device, and non-femoral approach were associated with increased 1-year mortality after TAVR. The RRS might serve as a helpful tool for risk prediction and patient selection for TAVR in patients with LF-LG AS.
Source: Clinical Research in Cardiology - October 14, 2020 Category: Cardiology Source Type: research

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

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

Medtronic launches post-market study of CoreValve Evolut Pro heart valve
Medtronic (NYSE:MDT) said today it launched a post-market clinical study of its CoreValve Evolut Pro valve, looking to evaluate performance out to 5 years for the self-expanding transcather aortic valve implantation system. The multi-center, prospective single-arm study aims to enroll 600 patients across 35 European sites to evaluate the safety of the CoreValve Evolut Pro, including all-cause mortality and all stroke at 30 days and clinical performance including valve hemodynamics and paravalvular regurgitation. “We look forward to replicating the excellent clinical outcomes demonstrated by the Evolut Pro valve in a...
Source: Mass Device - September 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Replacement Heart Valves Medtronic Source Type: news