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Implementation of a CT-derived correction factor to refine the measurement of aortic valve area and stroke volume using Doppler echocardiography improves grading of severity and prediction of prognosis in patients with severe aortic stenosis
Aims: To assess rates of reclassification of severity and associated 5-year survival in patients with severe aortic stenosis (AS) and preserved left ventricular ejection fraction (LVEF) after application of a CT-derived correction factor (CF) to refine the measurement of aortic valve area (AVA) and stroke volume index (SVi) using Doppler echocardiography.Methods and Results: We enrolled 1450 patients with severe AS and preserved LVEF from a French registry. Multiplication of echocardiographic LV outflow tract diameter by a CT-derived CF of 1.13 to calculate the AVA and SVi using the continuity equation resulted in reclassi...
Source: International Journal of Cardiology - June 15, 2022 Category: Cardiology Authors: Attila Kardos, Dan Rusinaru, Sylvestre Mar échaux, Ebraham Alskaf, Bernard Prendergast, Christophe Tribouilloy Source Type: research

Valve-in-valve transcatheter aortic valve implantation after failed surgically implanted aortic bioprosthesis versus native transcatheter aortic valve implantation for aortic stenosis: Data from a nationwide analysis.
CONCLUSION: We observed that valve-in-valve TAVI was associated with good short- and long-term outcomes. No significant differences were observed compared with native valve TAVI regarding clinical follow-up. PMID: 32532695 [PubMed - as supplied by publisher]
Source: Archives of Cardiovascular Diseases - June 8, 2020 Category: Cardiology Authors: Deharo P, Bisson A, Herbert J, Lacour T, Saint Etienne C, Jaussaud N, Theron A, Collart F, Bourguignon T, Cuisset T, Fauchier L Tags: Arch Cardiovasc Dis Source Type: research

Transaxillary compared with transcarotid access for TAVR: a propensity-matched comparison from a French multicenter registry.
CONCLUSIONS: One-month mortality, 1-month stroke/TIA and 1-year mortality are similar with TAx and TC TAVR. However TC-TAVR is accompanied by more minor bleeding and main access hematoma compared with the transaxillary route. PMID: 32310129 [PubMed - as supplied by publisher]
Source: EuroIntervention - April 22, 2020 Category: Cardiovascular & Thoracic Surgery Tags: EuroIntervention Source Type: research

Outcomes in nonagenarians undergoing transcatheter aortic valve implantation (TAVI): data from a nationwide analysis.
CONCLUSIONS: Within nonagenarians with AS, patients treated with TAVI had lower risk of cardiovascular events than matched patients treated medically. The patients undergoing a TAVI at this age were often highly selected and the procedure was associated with acceptable long term outcomes. PMID: 31763981 [PubMed - as supplied by publisher]
Source: EuroIntervention - November 27, 2019 Category: Cardiovascular & Thoracic Surgery Tags: EuroIntervention Source Type: research

Analysis of length of hospital stay after Transfemoral Transcatheter Aortic Valve Implantation: Results from the FRANCE TAVI (FRench Transcatheter Aortic Valve Implantation) Registry
ConclusionLOS remain high after TF TAVI in France and extremely variable. As expected, co-morbidities and complications were predictive factors of late discharge after TAVI. Furthermore, our results suggest that the use of self-expandable prosthesis and general anesthesia also contributes to late discharge.
Source: Archives of Cardiovascular Diseases Supplements - March 22, 2019 Category: Cardiology Source Type: research

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 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

Edwards Adds Bold New Chapter to TAVR Story
Edwards Lifesciences just might have leaped-frogged over some of its competitors in the burgeoning  TAVR market. The undisputed TAVR pioneer has received CE mark for its Centera valve to treat severe, symptomatic aortic stenosis patients at high risk of open-heart surgery. The Edwards Centera valve is repositionable and retrievable and can be delivered through a low-profile, 14-French, motorized delivery system. The company said the device is packaged with the valve fully pre-attached to the delivery system, which helps with simple and rapid device preparation. Network with your colleagues in medtech at ADM Cleveland, ...
Source: MDDI - February 15, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Medical Device Business Source Type: news

Edwards Lifesciences wins CE Mark for Centera TAVR
Edwards Lifesciences (NYSE:EW) said today it won CE Mark approval in the European Union for its self-expanding transcatheter Centera aortic heart valve, with indications for treating symptomatic aortic stenosis patients at high risk of open-heart surgery. 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 Irvine, Calif.-based company said. “With the Edwards Centera valve, European clinicians and their patients may now benefit from a self-expanding ...
Source: Mass Device - February 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Regulatory/Compliance Replacement Heart Valves Edwards Lifesciences Source Type: news