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Procedure: Heart Valve Surgery
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Total 31 results found since Jan 2013.

Claret Medical touts Sentinel data in TAVR study
Claret Medical today released results from a study of its Sentinel cerebral protection system, touting reduced early occurrence of stroke associated with transcatheter aortic valve replacement procedures and lowered mortality rates. The study of the device was recently published in the Journal of the American College of Cardiology: Cardiovascular Interventions, the Santa Rosa, Calif.-based company said. The Sentinel embolic protection device is designed to trap blood clots and prevent stroke during heart valve replacement procedures, which Claret Medical touts as the 1st and only FDA-cleared device to do so. “In pat...
Source: Mass Device - September 18, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Catheters Clinical Trials Neurological Claret Medical Inc. Source Type: news

Risk factors and outcome of postoperative delirium after transcatheter aortic valve replacement
ConclusionsPatients with POD after TAVR are at increased risk for in-hospital mortality. However, after adjusting for postoperative events and comorbidities, stroke and bleeding, but not POD, are independent mortality predictors.
Source: Clinical Research in Cardiology - April 13, 2018 Category: Cardiology Source Type: research

Sex-specific differences in outcome of transcatheter or surgical aortic valve replacement
Conclusions This nation-wide analysis of sex-specific outcomes after aortic-valve replacement procedures showed that women are higher-risk for bleeding, but lower-risk for stroke, mechanical ventilation, and TF-TAVR mortality. Understanding these differences and their basis may help improve outcomes. Teaser We analyzed baseline characteristics and outcomes of all isolated TAVR or SAVR procedures performed in Germany between 2011 and 2014. In comparison to male patients, females were preferentially treated with TF-TAVR rather than SAVR due to their generally older age and higher EuroSCORE. Females suffered from more relevan...
Source: Canadian Journal of Cardiology - April 13, 2018 Category: Cardiology Source Type: research

Sex-Specific Differences in Outcome of Transcatheter or Surgical Aortic Valve Replacement
ConclusionsThis nation-wide analysis of sex-specific outcomes after aortic-valve replacement procedures showed that women are higher-risk for bleeding, but lower-risk for stroke, mechanical ventilation, and TF-TAVR mortality. Understanding these differences and their basis may help improve outcomes.RésuméContexteLes différences anatomiques et celles au niveau des caractéristiques initiales entre patients de sexe masculin et féminin présentant une sténose valvulaire aortique pourraient influencer l’issue après un remplacement valvulaire aortique par voie chirurgicale et transcathéter. Nous avons évalué l’effe...
Source: Canadian Journal of Cardiology - July 24, 2018 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

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

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

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

ICU Readmission after Cardiac Surgery —Still a Matter of Concern?
Conclusions In conclusion, readmission to the ICU after cardiac surgery is a rare complication that is still associated with excessive mortality. Establishment of an intermediate care unit proved to be an excellent means to reduce ICU stay without endangering post-surgery patients and significantly reduced the ICU readmission rate. [...] Georg Thieme Verlag KG Stuttgart · New YorkArticle in Thieme eJournals: Table of contents  |  Abstract  |  Full text
Source: The Thoracic and Cardiovascular Surgeon - May 1, 2018 Category: Cardiovascular & Thoracic Surgery Authors: Kolat, Philipp Guttenberger, Patricia Ried, Michael Kapahnke, Julia Haneya, Assad Schmid, Christof Diez, Claudius Tags: Original Cardiovascular Source Type: research

ICU Readmission after Cardiac Surgery-Still a Matter of Concern?
CONCLUSIONS:  In conclusion, readmission to the ICU after cardiac surgery is a rare complication that is still associated with excessive mortality. Establishment of an intermediate care unit proved to be an excellent means to reduce ICU stay without endangering post-surgery patients and significantly reduced the ICU readmission rate. PMID: 29715703 [PubMed - as supplied by publisher]
Source: The Thoracic and Cardiovascular Surgeon - May 1, 2018 Category: Cardiovascular & Thoracic Surgery Authors: Kolat P, Guttenberger P, Ried M, Kapahnke J, Haneya A, Schmid C, Diez C Tags: Thorac Cardiovasc Surg Source Type: research

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

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

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

Incidence and in-hospital Safety Outcomes of Patients undergoing Percutaneous Mitral Valve Edge-to-Edge Repair Using MitraClip ® - 5 year German national patient sample including 13,575 implants.
CONCLUSIONS: MitraClip® implantations increased markedly 5.4-fold between 2011 and 2015, with a constant in-hospital mortality and MACCE rate. Our data indicate that edge-to-edge mitral valve repair in MitraClip® technique has acceptable in-hospital safety outcomes in a real world scenario. PMID: 30666965 [PubMed - as supplied by publisher]
Source: EuroIntervention - January 24, 2019 Category: Cardiovascular & Thoracic Surgery Tags: EuroIntervention Source Type: research