First implant of ChordArt TMVR system completed Nov. 24, 2023, 11:06 p.m.
The system was used in the treatment of a patient suffering from severe degenerative mitral regurgitation due to mitral leaflet flail, and was successfully treated as part of CoreMedic’s first-in-human trial for percutaneous mitral chordae tendineae replacement with the ChordArt transcatheter mitral valve repair (TMVR) system.
Percutaneous Left Atrial Appendage Occlusion—Current Evidence and Future Directions Nov. 24, 2023, 11:05 p.m.
LAAO has emerged over the past 2 decades as a safe and effective procedure with remarkable procedural success rates for patients with AF unsuitable for long-term OAC. This has been evaluated in the “real-world” data from large registries and the follow-up evidence from landmark trials. Continued development of imaging modalities and accumulated operator and institutional experience, as well as technical advancements in the occlusion devices, have contributed to the increasing implementation of this therapy. However, many questions regarding adequate patient selection, optimal antithrombotic regimen after the intervention, and management of postprocedural complications remain unanswered. Numerous ongoing trials addressing these issues will expand our knowledge and possibly broaden the indication for LAAO in patients with AF and increased risk for stroke and bleeding.
Physicians forecast Edwards’ 5-year data will have limited impact on low-risk TAVR market Nov. 24, 2023, 10:37 p.m.
Edwards Lifesciences’ upcoming five-year data on transcatheter aortic valve replacement (TAVR) for low-risk patients is unlikely to have a big effect on market share or growth, according to several physicians. The physicians expect TAVR to be statistically non-inferior to open-chest surgery. Some doctors think TAVR may perform numerically worse but see little impact on the market unless there is a statistically significant result in PARTNER 3 or a trial run by Medtronic, Edwards’ main TAVR rival.
In vivo remodeling of human cell-assembled extracellular matrix yarns Nov. 17, 2023, 3:17 p.m.
This is the first study to formally demonstrate that devitalized human CAM is very long-lived in vivo and does not trigger a degradative response, but rather is very slowly remodeled. This data supports a strategy to produce human textiles from CAM yarn for regenerative medicine applications where a scaffold with low inflammation and long-term mechanical properties are critical.
Edwards Lifesciences’ Mitris Resilia valve receives CE mark for mitral replacement surgeries Nov. 6, 2023, 12:12 p.m.
The valve is made with bovine pericardial tissue technology that is designed to reduce calcium build up on the valve. According to the company, this technology enables the valve to potentially last longer than conventional bioprosthetic valves. Mitris Resilia has a saddle-shaped sewing cuff that mimics the asymmetric shape of the native mitral valve. The low-profile valve is based on the Edwards Perimount valve design with a nitinol wireform, which allows it to fold inward during implantation. The Mitris Resilia valve is visible under fluoroscopy, which facilitates potential future transcatheter interventions for patients.
Transcatheter Mitral Valve Replacement Using Transcatheter Aortic Valve or Dedicated Devices Nov. 5, 2023, 5:04 p.m.
There is an unmet clinical need for definitive treatment options for patients with mitral valve disease who are ineligible for surgery or TEER. TMVR represents a pioneering interventional solution for this underserved patient population. TMVR with TAV has demonstrated its safety and effectiveness, particularly in patients with failing mitral bioprostheses. However, outcomes have been less favorable in patients with MAC or those with previously failed surgical repairs. Therefore, a meticulous evaluation of patients by experienced heart teams should be considered a prerequisite before embarking on ViMAC and ViR procedures.
Fabricating Heart Valve in Minutes With a Marshmallow Machine and A Air Dryer Nov. 5, 2023, 5:01 p.m.
Researchers at Harvard University have developed a technique to create biomaterial heart valves in a matter of minutes. The method is called "Focused Rotary Jet Spinning," and the researchers describe it as "a marshmallow machine with a hair dryer in the back." Basically, the technique uses air jets to orient polymer fibers onto a framework in the shape of a heart valve. This forms a porous scaffold that allows heart cells to enter and grow. These formed structures also have mechanical properties that act as one-way valves within the heart. These scaffolds contain nanoscale signals that stimulate cell entry and proliferation, with the ultimate goal of gradually replacing the biomaterial scaffold by cells to regenerate the heart valve.
New Double Lumen Catheter at TCT 2023 Nov. 2, 2023, 5:22 p.m.
The novel platform for structural heart interventions is now in human use, with ability to improve patient recovery and reduce anesthesia and hospital stays, according to a statement on the session. “A Double Lumen Catheter to Facilitate Atrial Septal Procedure and the Transseptal Delivery of Catheters: Dib UltraNav Transseptal Catheter System/Catheter-Based Treatment of Congenital Heart Disease: ASD, PFO, and RVOT Obstruction II,” was presented as a Moderated Abstract: Emerging Clinical Science & Research today during the annual Cardiovascular Research Foundation (CRF) TCT conference.
Edwards Lifesciences secures CE mark for Mitris Resilia valve Nov. 2, 2023, 5:21 p.m.
Mitris Resilia is a low-profile valve, designed based on the company’s Perimount valve design with a nitinol wireform, which allows the valve to fold inward during implantation
Edwards Evoque Transcatheter Tricuspid Valve Replacement System Receives CE Mark Oct. 25, 2023, 1:02 a.m.
The EVOQUE system is comprised of a nitinol self-expanding frame, intra-annular sealing skirt, and tissue leaflets made from the same bovine pericardial tissue as the company's market-leading heart valves. The EVOQUE valve will be available in three sizes, all delivered through a low-profile transfemoral 28F system.
Valvular Heart Disease: Symptoms, Causes, and Treatment Oct. 17, 2023, 7:32 a.m.
Valvular heart disease refers to a group of conditions in which one or more of the heart’s four valves (the aortic valve, mitral valve, tricuspid valve, and pulmonary valve) do not function properly. These valves play a crucial role in regulating blood flow through the heart, ensuring that blood moves in the correct direction as the heart contracts and relaxes.
$10.2M NIH grant awarded to study risk factors for malignant arrhythmias in mitral valve prolapse Oct. 1, 2023, 4:31 p.m.
It is crucial to bring together a multidisciplinary research team to advance our understanding of this complex disease. The development of heart failure and arrhythmia may present differently in different patients with mitral valve prolapse. Developing new indicators that are specific to predicting malignant arrhythmias and understanding what they mean over the long term will allow us to better care for our patients."
Chinese Cardiovascular Medical Device Maker MitrAssist Bags USD100 Million in Series C Fundraiser Oct. 1, 2023, 4:19 p.m.
Founded in 2017, MitrAssist has developed products such as interventional heart valve therapy, interventional coronary drug balloon, and interventional heart failure treatment. It has research and development centers in China, Israel, and Germany.
Combined Minimally Invasive Mitral Valve Surgery and Percutaneous Coronary Intervention: A Hybrid Concept for Patients with Mitral Valve and Coronary Pathologies Sept. 2, 2023, 3:42 p.m.
A hybrid concept of PCI and MIMVS is feasible in patients with mitral valve pathology and single vessel coronary disease and can be considered if the team members have sufficient expertise in MIMVS. Future studies should also evaluate whether this recommendation is feasible for patients with multivessel disease, so that for patients with combined mitral valve and coronary pathologies, with the availability of adequate expertise in MIMVS, the choice of revascularization strategy can be evaluated independent from the mitral valve pathology.
Cardiac reverse remodeling in primary mitral regurgitation: mitral valve replacement vs. mitral valve repair Aug. 19, 2023, 3:40 a.m.
In primary MR, MVR with chordal preservation may offer comparable cardiac reverse remodeling benefits at 6-months compared to MVr. Larger, multicenter CMR studies are required, which if the findings are confirmed, may have implications for future surgical practice.
COAPT at 5 Years: MitraClip Still Ahead, but Deaths and Crossovers Cast Shadows Aug. 19, 2023, 3:39 a.m.
Despite the favorable risk-benefit profile of the MitraClip in this setting, adverse events continued to accrue,” said Gregg Stone, MD (Icahn School of Medicine at Mount Sinai, New York, NY), who presented the 5-year data here at the American College of Cardiology/World Congress of Cardiology (ACC/WCC) 2023 meeting. Results were simultaneously published in the New England Journal of Medicine.
Abbott pulls Trifecta heart valves off the market due to early deterioration Aug. 19, 2023, 3:27 a.m.
The FDA said in its February letter to providers that information from published literature suggests a higher cumulative incidence of early SVD for Trifecta valves compared to other commercially available surgical bioprosthetic aortic valves. Early deterioration of a heart valve is defined by the FDA as five years or less. In February, the FDA said it was working with the manufacturer to evaluate information from all available sources on this issue. The Trifecta valve features leaflets externally mounted to the valve frame, which are a point of difference and might contribute to the valve issue.
Mitral regurgitation in the critically ill: the devil is in the detail Aug. 19, 2023, 3:25 a.m.
Critical care echo is an expanding subspecialty that allows recognition and management of MR during acute illness. The intensivist is uniquely positioned to apply advanced valvular assessment at the bedside to optimise cardiorespiratory physiology and identify patients requiring percutaneous or surgical intervention. MR is dynamic and repeated assessment is key. Comprehensive assessment in the ICU should integrate loading factors and clearly describe the mechanism, severity and the upstream/downstream complications.
Transapical Mitral Valve-in-Ring Replacement Using the Innovative System under 3-Dimensional Printing Guidance Aug. 19, 2023, 3:22 a.m.
This case report highlights the successful utilization of the Mi-thos system in a TMVR procedure, specifically following the failed mitral annuloplasty ring via the transapical approach. The remarkable ease of control and intraoperative patient stabilization demonstrated in this case signifies the potential need of minimally invasive methods in carefully selected cases. Furthermore, one of the key advantages of this device is its ability to minimize complications associated with TMVR procedures. The incorporation of 3D printing guidance in surgical planning enhances the feasibility and safety of TMViR, providing a valuable tool for developing effective surgical strategies.
Transcatheter edge-to-edge mitral valve repair in patients with mitral annulus calcification Aug. 19, 2023, 3:20 a.m.
MAC is commonly found in patients affected with MR, and it is associated with high morbidity, mortality and worse cardiac surgical outcomes. Transcatheter edge-to-edge repair could be an alternative treatment, although there is little evidence in this population.