Edwards Lifesciences Corp., of Irvine, Calif., petitioned the Centers for Medicare & Medicaid Services to revise the Medicare coverage policy for transcatheter aortic valve replacement (TAVR) devices on two points, the combination of which would make a big difference for TAVR devices across manufacturers. Edwards requested that CMS explicitly cover TAVR for asymptomatic aortic stenosis patients, a notion well supported by recent data, and bring an end to the coverage with evidence development mandate.
Edwards Lifesciences Corp. released data from a health economics study done across nine countries in Europe which showed that early transcatheter aortic valve replacement in patients with asymptomatic severe aortic stenosis can deliver significant economic benefits alongside improved clinical outcomes.
Results of the Shortcut study, presented last week at the Transcatheter Cardiovascular Therapeutics meeting in San Francisco, indicated that cutting balloon angioplasty matched intravascular lithotripsy in coronary artery preparation of calcification for stent placement.
The prevalence of valvular heart disease in the U.S. is tough to peg with any great precision, but an extrapolation of data from a new study would put the number at roughly 10.6 million people, a staggering number when the clinical and fiscal implications are considered.
Stakeholders of all stripes have wondered whether transcatheter aortic valve replacement devices could match their surgically implanted cousins for device durability, but seven-year data from the Partner 3 trial seems to suggest that patients, physicians, payers and regulators need not fret as the topline numbers showed no statistically significant difference for outcomes such as mortality and morbidity.
Doctors and device makers are habituated to the notion that more devices equal better outcomes, but one presenter at this year’s Transcatheter Cardiovascular Therapeutics meeting in San Francisco argued that this is not always the case. James McCabe of Beth Israel Deaconess Medical Center in Boston said cardiologists may want to start thinking about whether a cardiology implant should stay implanted, a mindset that is anything but intuitively attractive to the modern practicing physician.
Total arterial revascularization (TAR) might not be the most popular approach to coronary artery bypass grafting (CABG), but it is gaining in popularity according to a new study appearing in the Journal of the American College of Cardiology. The authors said that TAR provides superior mortality outcomes compared to bypass grafting that relies on both veins and arteries for graft materials, a finding that might suggest lower rates of downstream angioplasty and stenting.
The U.K. National Institute for Health and Care Excellence has recommended that physicians in the U.K. use the least expensive, clinically appropriate TAVR device when possible, concluding a pricing review that commenced roughly a year ago.
Caranx Medical SAS secured clearance from the U.S. FDA for Tavipilot Soft, its AI-powered software which provides real-time intraoperative guidance during transcatheter heart valve replacement (TAVR) procedures. The software, which tracks anatomical and instrumental landmarks in real-time to enable precise and accurate heart valve positioning and delivery, will allow a broader number of cardiologists to perform this complex procedure.
The U.K. National Health Service may or may not deploy transcatheter aortic valve replacement devices as widely as in the U.S., but the National Institute for Health and Care Excellence officially staked out the position the data are not yet compelling for anyone other than high risk patients.
