Update: Now you can get the same treatment as Mick Jagger
In an early Rolling Stones hit, Mick Jagger boasted that he had a “heart of stone” – but even that heart eventually needed some repair.
Jagger recently underwent a minimally invasive cardiac procedure called Transcatheter Aortic Valve Replacement (or TAVR, for short), an alternative to open heart surgery. Lots of other people will now be getting satisfaction from TAVR, as the procedure with SAPIEN 3 technology was just approved by the federal Food and Drug Administration for use in low surgical risk patients with severe symptomatic aortic stenosis.
TAVR is a treatment for aortic valve stenosis, a narrowing of the aortic valve. The narrowing, usually due to an accumulation of calcium, restricts the flow of blood from the heart’s left ventricle to the entire body. Symptoms include breathlessness, chest pain, fainting and palpitations.
Aortic valve stenosis afflicts about 7 percent of people 65 and older. Left untreated, it has a worse survival rate than metastatic breast, lung, colon and prostate cancers.
“TAVR has transformed the lives of many patients, who can get back to their normal activities in just a week after having the procedure, rather than months after open heart surgery,” said Richard B. Zelman, MD, FACC, an interventional cardiologist and Chief of Cardiology for Cape Cod Healthcare.
In the TAVR procedure, the doctor uses a catheter tube, inserted in the upper leg and guided by X-ray and ultrasound technology, to place a new valve inside the diseased valve. The procedure takes less than two hours, and patients go home within 48 hours and resume normal activities in about a week. Patients who have open heart surgery stay in the hospital longer, continue recuperating at home for about two months and might not resume normal activities for six months.
“Most of our patients are having TAVR procedures that are done under local anesthetic and with mild sedation,” said Dr. Zelman. “They're up and walking around six hours after the procedure and many are home the next day. It’s definitely an amazing technology. It has taken the world of aortic valve surgery and turned it upside down.”
The FDA had formerly approved the procedure for those patients who were too sick or frail for open heart surgery, only. But two large, clinical trials demonstrated that TAVR is effective for lower-risk patients and gives them better outcomes (lower rates of death or disabling strokes).
The FDA had been expected to approve that expanded use, according to the New York Times . The approval means that an additional 20,000 patients a year will be eligible for TAVR (about 60,000 intermediate- and high-risk patients per year undergo the procedure now).
“Pretty much all patients with aortic valve stenosis are now candidates for the catheter valve technology,” said Dr. Zelman. “It’s been widely positively received in all the trials, and patients who have undergone the procedure are extremely enthusiastic about it.”
There has been a steady progression of evidence supporting TAVR, he added.
“A study published about a dozen years ago looked at the use of this technology in patients who would have been refused for surgery. Those studies showed that the catheter technology was superior in those high-risk and extreme-risk groups. Then there were the intermediate-risk trials that were published about two and a half years ago. Again, those studies showed the catheter technology to be at least as good, if not better,” Dr. Zelman said.
The low-risk trials (published recently in the New England Journal of Medicine and presented at the American College of Cardiology’s annual meeting) “are again showing the catheter technology to be at least as good, if not better,” he said.
Dr. Zelman and his team performed their 500th TAVR procedure in July. He expects the team now will begin treating low-risk patients.
“We have very excellent outcomes,” he said. “The patients are incredibly satisfied. They're very grateful that we have the program here on the Cape and that they and their families don't need to go to Boston. They're very grateful that our outcomes are comparable, if not better, to any of the programs that they've read about. It's been a very enthusiastic response.”