Senior Heart Help: New Option for the Inoperable -- Research Summary

BACKGROUND: TAVR or Transcatheter Aortic Valve Replacement is a first-of-its-kind cardiac surgery device being called by some as a "game-changer" in the world of cardiac valve surgery. It allows patients who are at high risk for traditional surgery to have their damaged heart valve replace without surgery.

HOW IT WORKS: Instead of open heart surgery, which most older patients aren’t eligible for, a team of doctors inserts a catheter through a vein in the groin area and feed it to the heart. The catheter carries a replacement heart valve made of a steel frame and parts of a cow heart. Once at the heart, the TAVR is put in place with a balloon, instantly replacing the faulty valve.

THE RESEARCH: A study published in the New England Journal of Medicine concludes: "Among appropriately selected patients with severe aortic stenosis who were not suitable candidates for surgery, TAVR reduced the rates of death and hospitalization, with a decrease in symptoms and an improvement in valve hemodynamics that were sustained at 2 years of follow-up. The presence of extensive coexisting conditions may attenuate the survival benefit of TAVR."

(Source: http://www.ncbi.nlm.nih.gov)

But, the PARTNER Trial which shows many of the benefits of TAVR also shows major strokes were higher for TAVR at both 30 days (3.8% vs. 2.1%) and one year (5.1% vs. 2.4%). At 30 days major vascular complications also were much more common after TAVR (11% vs. 3.2%), but the TAVR group’s rates were much lower for major bleeding (9.3% vs. 19.5%) and new-onset irregular heart rhythms of atrial fibrillation (8.6% vs. 16%).

(Source: http://mdd.blogs.medicaldevicedaily.com )

PAYING FOR IT: In May, The Centers for Medicare & Medicaid Services (CMS) issued its national coverage decision (NCD) for transcatheter aortic valve replacement (TAVR). CMS offers reimbursement for TAVR, but only if a number of criteria are first met:

-The use of an FDA approved device for an FDA approved indication.

-Evaluation of the patient by 2 cardiac surgeons.

-Performance of the procedure at an institution with sufficient surgical and interventional cardiology experience and expertise, including participation in a prospective national TAVR study and a commitment to the heart team concept. (The memo provides details on two sets of qualifications: one for hospitals without previous TAVR experience and the second for hospitals with TAVR experience.)

-Performance by physicians with sufficient experience and expertise.

-The patient must be enrolled in, and the physician must participate in a national TAVR registry. MORE

Senior Heart Help: New Option for the Inoperable -- Research Summary | Medical News and Health Information

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