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Condition: Heart Valve Disease
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Total 330 results found since Jan 2013.

Edwards launches US pivotal Centera self-expanding TAVR study
Edwards Lifesciences (NYSE:EW) said yesterday it launched a U.S.-based pivotal trial of its self-expanding Centera transcatheter aortic valve, exploring its use in treating severe symptomatic aortic stenosis in intermediate risk patients. 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 Edwards said. The Irvine, Calif.-based company said it hopes to enroll approximately 1,000 patients in the trial, which will include a bicuspid registry. The endpoint fo...
Source: Mass Device - October 9, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Catheters Clinical Trials Replacement Heart Valves Edwards Lifesciences Source Type: news

Transfemoral aortic valve implantation with new-generation devices: the repositionable Lotus vs. the balloon-expandable Edwards Sapien 3 valve
Background New-generation transcatheter heart valves have been developed to reduce complications of transcatheter aortic valve implantation (TAVI). With this study we sought to compare procedural and 30-day outcomes of the new-generation repositionable Boston Scientific Lotus (Lotus) and the balloon-expandable Edwards Sapien 3 (ES3) transcatheter heart valves. Methods A total of 315 patients with severe symptomatic aortic stenosis undergoing transfemoral TAVI with Lotus or ES3 included in two large Italian registries were considered for this analysis. After propensity matching, 93 matched pairs of patients were includ...
Source: Journal of Cardiovascular Medicine - October 9, 2018 Category: Cardiology Tags: Research articles: Interventional cardiology Source Type: research

Rivaroxaban versus Warfarin in Patients with Mechanical Heart Valve: Rationale and Design of the RIWA Study
DiscussionWarfarin and similar VKAs are standard therapy for patients with an MHV. Even with the appropriate use of therapy, the incidence of thromboembolic events is high at 1 –4% per year. Furthermore, bleeding risk is significant, ranging from 2 to 9% per year. The new frontier to be overcome in relation to use of the new oral anticoagulants is undoubtedly in patients with MHV. A significant portion of people with MHV worldwide will benefit if noninferiority of these new agents is confirmed.Trial RegistrationClinicalTrials.gov identifier:NCT03566303. Recruitment Status: Recruiting. First Posted: 25 June 2018. Last Upd...
Source: Drugs in R&D - October 6, 2018 Category: Drugs & Pharmacology Source Type: research

Red Cell Distribution Width as a Prognostic Marker in Patients Undergoing Valve Surgery.
CONCLUSIONS: An elevated RDW is associated with a worse outcome following valve surgery. The predictive ability of the RDW, when assessed by the area under the ROC curve, improved the predictive ability of the EuroSCORE II calculator. PMID: 30207123 [PubMed - in process]
Source: Journal of Heart Valve Disease - September 13, 2018 Category: Cardiology Tags: J Heart Valve Dis Source Type: research

Boston Scientific touts Acurate Neo2 CE Mark study
Boston Scientific (NYSE:BSX) yesterday touted results from a European study of the Acurate Neo2 replacement heart valve it acquired along with Symetis last year. Thirty-day results from a 120-patient trial backing a bid for CE Mark approval for the transcatheter aortic valve replacement, acquired for $435 million in May 2017, were presented at the annual PCR London Valves conference, Marlborough, Mass.-based Boston Scientific said. Patients treated in the single-arm study showed a 97% rate of mild or less-than-mild paravalvular leakage and a procedural success rate of 97.5%, the company said. All-cause mortality (the p...
Source: Mass Device - September 11, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Replacement Heart Valves Boston Scientific Source Type: news

INR Control of Patients with Mechanical Heart Valve on Long-Term Warfarin Therapy
ConclusionsDespite a majority of patients having <60% TTR, there were low incidences of bleeding and stroke events in this center. There were no factors found to be associated with INR control in this study.
Source: Global Heart - September 11, 2018 Category: Cardiology Source Type: research

Abbott Makes Strong Statement in TMVR Space with SUMMIT
Abbott Laboratories has hit a substantial milestone in its plan to bring the Tendyne transcatheter mitral valve replacement (TMVR) system to the U.S. market. The Abbott Park, IL-based company said it has initiated SUMMIT, a pivotal clinical study of the TMVR system. Up to 1,010 patients will be enrolled in up to 80 sites in the pivotal trial. Abbott said the investigational Tendyne device is the first and only mitral valve replacement that can be repositioned and fully retrieved, allowing the surgeon to precisely place the device during implantation, which could improve patient outcomes. Tendyne is a tri-leaflet, bioprost...
Source: MDDI - July 26, 2018 Category: Medical Devices Authors: Omar Ford Tags: Implants Cardiovascular Source Type: news

Aortic Valve Predilatation with a Small Balloon, without Rapid Pacing, prior to Transfemoral Transcatheter Aortic Valve Replacement.
Conclusion: In TAVR, AVPD with a small, nonocclusive balloon can be safely performed. By avoiding rapid pacing, this technique may be a valid alternative to traditional BAV. Whether or not the use of APVD without rapid pacing translates into less periprocedural complications needs to be assessed in future studies. PMID: 29854723 [PubMed - in process]
Source: Biomed Res - June 3, 2018 Category: Research Authors: Shivaraju A, Thilo C, Sawlani N, Ott I, Schunkert H, von Scheidt W, Kastrati A, Kasel AM Tags: Biomed Res Int Source Type: research

Non-vitamin K antagonist oral anticoagulants in atrial fibrillation patients with bioprosthetic valves.
Authors: Andrade JG, Meseguer E, Didier R, Dussault C, Weitz JI Abstract INTRODUCTION: The non-vitamin K antagonist oral anticoagulants (NOACs), which include dabigatran, apixaban, edoxaban and rivaroxaban, are preferred over vitamin K antagonists for stoke prevention in most patients with non-valvular atrial fibrillation. The NOACs are contraindicated in atrial fibrillation patients with rheumatic mitral stenosis or mechanical heart valves. There is evidence that bioprosthetic heart valves are less thrombogenic than mechanical heart valves, but it is unknown whether the risk of thromboembolism in atrial fibrillati...
Source: Expert Review of Cardiovascular Therapy - May 25, 2018 Category: Cardiology Tags: Expert Rev Cardiovasc Ther Source Type: research

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

An Egg A Day Might Reduce Your Risk Of Heart Disease, Study Says
In this study however, they didn’t assess the risk of developing diabetes, which may be because diabetes is a newer disease in the Chinese population and there is not good documentation of who has it,” Richard said. Still, she noted, “this will be very important data for helping develop dietary prevention guidelines in China.” Cardiovascular disease, which takes the lives of 17.7 million people every year, is the leading cause of death and disability worldwide, according to the World Health Organization. Cardiovascular disease causes nearly a third — 31% — of all global deaths each year....
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - May 22, 2018 Category: Consumer Health News Authors: Health – CBS Boston Tags: Health News Eggs Heart Disease Local TV 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

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