Helping High Risk Hearts


Ironing is not exactly Barbara Roy's favorite activity, but it's something she's glad she can do again.

"I'd probably iron a couple pieces and then have to come out here and sit down and rest," Roy told Ivanhoe.

Her doctor diagnosed her with severe aortic stenosis.

"I didn't think I was going to make it," she said. "I couldn't breathe."

Because of her age, 82, and other health problems, she was considered a high risk patient.

"[They] said no way could I ever be operated on," she said.

Left untreated, Augusto Villa, MD, Interventional Cardiologist at Palm Beach Gardens Medical Center and Medical Director of the Valve Clinic in Palm Beach Gardens, Fla. says 50 percent of patients will die within two years.

"Their prognosis is extremely poor," Dr. Villa told Ivanhoe. "It's as poor as lung cancer. In five years, only 4 percent will survive."

Now there's a new option for patients who can't have open heart surgery, known as transcatheter aortic valve replacement or TAVR. A balloon catheter is placed through either the groin or ribs. Once in position, it inflates, placing the artificial heart valve and restoring blood flow.

"I think it's an amazing, amazing technology," Dr. Villa said.

Unlike traditional surgery, the heart continues to beat during the TAVR procedure and there's no need to place a patient on a heart-lung machine. Patients can go home in four to five days and expect to get back to normal activities in one to two weeks.

A month after surgery, Roy is back doing chores, thankful that she can.

"I cook. I do dishes. I do laundry," she said.

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 replaced without surgery. The Centers for Medicare & Medicaid Services (CMS) issued its national coverage decision for TAVR in May of 2012. CMS offers reimbursement for TAVR, but only if a number of criteria are first met: evaluation of the patient by two 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 patient must be enrolled in, and the physician must participate in a national TAVR registry. (Source: http://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/Transcatheter-Aortic-Valve-Replacement-TAVR-.html)


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. (Source: http://www.uclahealth.org/site.cfm?id=2139)


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 two years of follow-up. The presence of extensive coexisting conditions may attenuate the survival benefit of TAVR." 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://www.ncbi.nlm.nih.gov, http://mdd.blogs.medicaldevicedaily.com)




Ryan Lieber

PR Manager

Delray Medical Center



What exactly is aortic stenosis?  

Dr. Villa: Aortic stenosis is a condition where the aortic valve narrows due to different reasons, the main one being calcification of the valves usually seen in patients in their late 70's or 80's. And when it becomes severe and the patient develops symptoms, either of congestive heart failure, chest pain, or blackouts, their prognosis is very poor.  Just to give you an example, in recent studies it showed that 50 percent of those patients die within a year.  

So in the past, what have been the options for those folks?  

Dr. Villa: The only real good option was open heart surgery; to replace the valve with open heart surgery.  With medical therapy, as I mentioned before, the studies have shown that mortality within a year is 50 percent.  

For many of those patients though, going under the knife really wasn't an option?

Dr. Villa: That's right and also as I mentioned before, many of these patients are in their 80's, with many other co-morbidities and open heart surgery was also not a very good option, but since they are at high risk some of them will not make it during surgery. 

So the thought was to just let them live out their days? 

Dr. Villa: Well, there is something that came out almost 20 years ago that we've been doing it here, called the balloon valvuloplasty, but this is something that will not last that long or might make them better for the next few months, but in the long run really will not make big impact.

So where does the TAVR procedure come in?

Dr. Villa: The TAVR came out a couple of years ago. They have the idea that instead of placing the valve by opening up the chest, why don't we try to place the valve through a balloon. They mounted the valve in a balloon and that's how the valve is delivered, similar to the stents that we do in the coronary arteries, it's just a much bigger device. 

How does that work though?

Dr. Villa: Studies have shown that there is a 50 percent decrease in mortality compared to conventional medical therapy. And the way it's done, there are now three approaches: one is through the skin through the groin, like when we do a cardiac catheterization. The only problem with that is the device, the first generation device that we have been approved here is still big, so you have to have big vessels in the legs. The second generation, which hopefully will be approved within the next few months, is much smaller. The third generation that they are already using in Europe is even smaller. So in the future, my guess is within a year, the majority of the cases are going to be through the groin which is the minimally invasive technique. And in the future, also the patients are going to be done just with sedation, local anesthesia. Right now, it's done in many other places under general anesthesia. 

Without this patients probably would die?

Dr. Villa: Absolutely. Yeah, as I said their prognosis is extremely poor. It's as poor as lung cancer.  In five years, only 4 percent will survive; almost everybody dies.   

How big of a breakthrough would you say this is? 

Dr. Villa: I think it's an amazing, amazing technology. I think it's making big difference in terms of outcomes, saving lives, and improving quality of life, which is also very important. It's not just about living longer, but also being able to enjoy life. The studies have also shown that it's a big difference in patients that undergo this intervention, their quality of life improved significantly compared to the ones who just underwent medical therapy.