Transcatheter aortic valve implantation vs. surgical aortic valve replacement for treatment of symptomatic severe aortic stenosis: an updated meta-analysis

AbstractAims  Owing to new evidence from randomized controlled trials (RCTs) in low-risk patients with severe aortic stenosis, we compared the collective safety and efficacy of transcatheter aortic valve implantation (TAVI) vs. surgical aortic valve replacement (SAVR) across the entire spectrum of surgical risk patients.Methods and results  The meta-analysis is registered with PROSPERO (CRD42016037273). We identified RCTs comparing TAVI with SAVR in patients with severe aortic stenosis reporting at different follow-up periods. We extracted trial, patient, intervention, and outcome characteristics following predefined criteria. The primary outcome was all-cause mortality up to 2  years for the main analysis. Seven trials that randomly assigned 8020 participants to TAVI (4014 patients) and SAVR (4006 patients) were included. The combined mean STS score in the TAVI arm was 9.4%, 5.1%, and 2.0% for high-, intermediate-, and low surgical risk trials, respectively. Transcathet er aortic valve implantation was associated with a significant reduction of all-cause mortality compared to SAVR {hazard ratio [HR] 0.88 [95% confidence interval (CI) 0.78–0.99],P  = 0.030}; an effect that was consistent across the entire spectrum of surgical risk (P-for-interaction  = 0.410) and irrespective of type of transcatheter heart valve (THV) system (P-for-interaction  = 0.674). Transcatheter aortic valve implantation resulted in lower ...
Source: European Heart Journal - Category: Cardiology Source Type: research

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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 clinica...
Source: The Lancet - Category: General Medicine Source Type: research
The transcatheter aortic valve replacement market received one of the biggest jolts of the year when FDA expanded indications of both Edwards Lifesciences and Medtronic’s valves. FDA’s measure would open up the valves to be used in younger and low-risk patients. The agency said these transcatheter valves – Edwards’ Sapien 3, and Sapien 3 Ultra, with Medtronic’s CoreValve Evolut R and CoreValve Evolut PRO – were previously indicated only for patients at intermediate or higher risk for death or major complications duri...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Regulatory and Compliance Source Type: news
There has been a flurry of news recently about a procedure called trans-catheter aortic valve replacement (TAVR) for the treatment of the common heart condition aortic stenosis (AS). You may even know people who have had this procedure performed. What exactly is TAVR? And what’s all the excitement about? What is aortic stenosis? First, it’s important to understand the condition that TAVR is designed to treat, aortic stenosis. The aortic valve is the last structure of the heart through which blood passes before entering the aorta and circulating throughout the body. The aortic valve has three flaps, called leafl...
Source: Harvard Health Blog - Category: Consumer Health News Authors: Tags: Health Heart Health Surgery Source Type: blogs
Abstract Valvular heart diseases are one of the most frequent causes for heart failure. Degenerative diseases of the aortic and mitral valve as well as a dysfunctional tricuspid valve disease result in a worse clinical outcome if severe. Minimal-invasive, surgical and/or catheter-based structural heart disease (SHD) interventions have recently seen a dramatic increase. Transcatheter aortic valve implantation (TAVI) for severe aortic stenosis (AS) is a disruptive technology, and next generation devices and careful patient selection will minimize limitations of TAVI such as paravalvular leak, conductance disturbance...
Source: Journal of Cardiology - Category: Cardiology Authors: Tags: J Cardiol Source Type: research
ConclusionPreoperative ECG Strain was associated with higher risk of ME onset after TAVR for severe AS.
Source: Archives of Cardiovascular Diseases Supplements - Category: Cardiology Source Type: research
Results from trials of both Medtronic‘s (NYSE:MDT) and Edwards Lifesciences‘ (NYSE:EW) transcatheter aortic valve replacement systems exploring their use in low-risk patients indicated that the devices were as safe as open surgery, paving the way for possible new indications for TAVR technology. Data from the trials were presented over the weekend at the American College of Cardiology 68th Annual Scientific Session 2019 in New Orleans and simultaneously published in the New England Journal of Medicine. Currently, TAVR devices are only approved by the FDA for treating severe aortic valve stenosis in patients at ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiac Implants Cardiovascular Clinical Trials Featured Replacement Heart Valves Edwards Lifesciences Medtronic Source Type: news
Two-year results from a head-to-head study comparing transcatheter aortic heart valve replacement devices from both Boston Scientific (NYSE:BSX) and Medtronic (NYSE:MDT) indicated similar outcomes for the competing products. The study, published recently in the journal JAMA Cardiology, compared Marlborough, Mass.-based Boston Scientific’s Lotus valve to Fridley, Minn.-based Medtronic’s CoreValve system. Investigators in the study compared outcomes for 912 patients with high or extreme risk and severe, symptomatic aortic stenosis after treatment with one of the two devices. Patients, treated between Se...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiovascular Clinical Trials Featured Replacement Heart Valves Boston Scientific Medtronic Source Type: news
Authors: Del Val D, Ferreira-Neto AN, Asmarats L, Maes F, Guimaraes L, Junquera L, Wintzer J, Fischer Q, Barroso de Freitas Ferraz A, Puri R, Rodés-Cabau J Abstract INTRODUCTION: Transcatheter aortic valve replacement (TAVR) is a well-established treatment for patients with severe aortic stenosis and intermediate-to-high surgical risk. The increasing clinical experience along with technical and design iterations of transcatheter valve systems have contributed to reducing adverse events and improving clinical outcomes. Areas covered: Overview of the latest generation transcatheter heart valves (THVs), focusin...
Source: Expert Review of Medical Devices - Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research
Edwards Lifesciences received European CE Mark approval for its SAPIEN 3 Ultra transcatheter aortic heart valve. Indicated for valve replacement in patients with severe, symptomatic aortic stenosis, the device is available in three sizes (20 mm,...
Source: Medgadget - Category: Medical Devices Authors: Tags: Cardiac Surgery Cardiology Source Type: blogs
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 bo...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Source Type: news
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