ORLANDO, Fla. (Ivanhoe Newswire) - Many elderly people with a serious heart condition have been told they are too old for an operation. Now, a recently FDA approved procedure is offering the inoperable an opportunity for a longer life.
Duyane Hoffman puts his heart and soul into exotic flowers.
"It's a good hobby. Not a good business, but a good hobby," Duyane Hoffman, told Ivanhoe.
But the 92-year-old had to put his passion on pause because of his heart problems.
"I couldn't finish sentences. I had to start over again," Duyane said.
Duyane had a triple bypass decades ago, but this time it wasn't an option for his blocked valve.
"At my age, they didn't want to cut me open, " Duyane said.
Until recently, Duyane and older heart patients like him who were deemed inoperable probably would not last a year with the blockage.
"There was essentially no option other than continued medical therapy," Kevin Accola, M.D., a cardiovascular surgeon and valve center of excellence program director at Florida Hospital, explained.
"We're talking about a prognosis that without something being done is horrible," Andrew Taussig, M.D., a cardiovascular institute program director at Florida Hospital, said.
But now that prognosis is improving. Doctors Taussig and Doctor Accola are part of a multi-disciplinary team at Florida Hospital offering elderly patients TAVR or Transcatheter Aortic Valve Replacement.
Instead of opening the chest, the team inserts a catheter in the leg near the groin. They guide it to the heart. Then a new valve supported by a steel frame expands inside the faulty valve.
"I think it's excellent technology, "Dr. Accola said. "We see results immediately."
While there is an increased chance of stroke with TAVR, Doctor Taussig said for the inoperable the benefits greatly outweigh the risks. Five weeks after surgery and Duyane and his wife are getting back to their passion.
"That's what keeps us busy around here," Duyane said.
With a new valve in his old heart he hopes to see his orchids blossom for many years to come.
The TAVR procedure takes about two to four hours. The doctors said the process is still being refined and will eventually go quicker. A patient's hospital stay can range from a few days to a week. Along with the steel frame, the device is made with parts of a cow's heart.
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 percent vs. 2.1 percent) and one year (5.1 percent vs. 2.4 percent). At 30 days major vascular complications also were much more common after TAVR (11 percent vs. 3.2 percent), but the TAVR group's rates were much lower for major bleeding (9.3percent vs. 19.5 percent) and new-onset irregular heart rhythms of atrial fibrillation (8.6 percent vs. 16 percent). (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.
