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Friday March 24, 2017

Expanding Life-Saving Options in Aortic Valve Replacements

Expanding Life-Saving Options in Aortic Valve Replacements

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Rutgers Robert Wood Johnson's Medical School and University Hospital perform nation’s first transcarotid valve-in-valve TAVR

Photo: Kim Sokoloff
Brenda Rossi’s heart issues put her in the unique position of being the first person in the United States to undergo a transcarotid valve-in-valve TAVR procedure.

‘ The idea that there is nothing we can do, there are no options for you, is really an obsolete discussion.'
 
– Zoltan G. Turi
 

Identifying the Problem
The symptoms of aortic stenosis often present very late in the disease process, so individuals can be very asymptomatic for years. Eventually, however, the tightness will get to a point where symptoms begin to manifest. Symptoms may include:
 
· Chest pain/tightness with exertion
 
· Shortness of breath with exertion
 
· Lightheadedness or syncope – nearly passing out as a consequence of not enough blood getting through to the brain
 
· Fatigue, especially when particularly active
 
· Rapid or irregular heartbeat, or heart palpitations
 

When Brenda Rossi told her primary care doctor about the fatigue that had been plaguing her for weeks, she never expected her heart was the cause – or that the situation was dire enough to put her in the emergency room.

“I kept feeling tired and was very weak. Everything was an effort. I told my doctor about it during my annual physical, and he said, ‘Brenda, you need to go to the hospital; your pulse is 120!’” Rossi recalls.

That trip to the emergency department of her local hospital and subsequent testing revealed the toll her hypertension and other cardiopulmonary issues had taken. Rossi was experiencing congestive heart failure related to valvular heart disease, her pacemaker was failing, and the aortic valve replacement she had received approximately 15 years earlier had degenerated, leading to significant aortic stenosis.

Her cardiologist recommended she seek the expertise of the team at Rutgers Robert Wood Johnson Medical School and Robert Wood Johnson University Hospital, which specializes in cases such as hers. Their additional tests and examinations confirmed that Rossi needed another aortic valve replacement, and time was of the essence.

But while Rossi had originally had traditional open surgery to replace her aortic valve in 2000, that option was no longer viable nor were some of the more traditional access routes for transcatheter aortic valve replacement (TAVR), one of the newest modalities for treating aortic stenosis, says Leonard Y. Lee, professor and interim chair of the Department of Surgery, James W. Mackenzie Endowed Chair in Surgery, and chief of the division of cardiothoracic surgery, Robert Wood Johnson Medical School.

Aortic stenosis is a condition whereby the valve at the top of the heart, which controls blood flow being pumped to the rest of the body, becomes extremely tight, forcing the heart to pump harder and resulting in some blood going backward through the heart, Lee explains. Without surgical treatment, individuals who have aortic stenosis survive only about two to five years after symptoms present, he says.

TAVR – a procedure that enables specialists to replace the aortic valve using fluoroscopic-guided, catheter-based technology – is performed by making a small incision into an artery, and then feeding a catheter with a tiny balloon at the end of the tip through the artery to the aortic valve. The balloon is inflated to push the damaged valve open, then deflated and removed. The new replacement valve is delivered the same way, placed in position in the middle of the old valve, and begins working immediately. Unlike some surgical procedures that require cardiopulmonary bypass and stopping the heart, the TAVR procedure is performed while the heart is still beating and provides an option for individuals who could not otherwise tolerate surgery.

Taking a Novel Approach

Rossi’s issues, not only because of the previous surgery but also the inability to use some of the traditional TAVR access points (such as the femoral artery), put her in the unique position of being the first person in the United States to undergo a transcarotid valve-in-valve TAVR procedure -- that is, inserting a new replacement valve through an incision in the carotid artery at the neck. The frame of the degenerated replacement valve acts as the anchor for the TAVR valve, Lee explains.

TAVR procedures in general are not unusual, notes Zoltan G. Turi, professor of medicine and associate director of the division of cardiovascular disease and hypertension, Rutgers Robert Wood Johnson Medical School, and director of the Structural Heart Program at Robert Wood Johnson University Hospital, who has been involved with the technique from its earliest days. Since November 2011, when the FDA approved TAVR for commercial use in treating severe aortic stenosis, more than 50,000 procedures have been performed worldwide.

However, valve-in-valve (i.e., new artificial valve inside previously placed surgical valve) procedures are quite uncommon, and use of the transcarotid approach is extremely rare, Turi says. Only about 20 transcarotid procedures have been performed nationally – two of which were performed here by Robert Wood Johnson specialists. Until Rossi’s surgery in June, none of them had involved a valve-in-valve procedure.

As a result, the procedure requires highly specialized expertise and what has been described in cardiac interventions literature as “a truly dedicated TAVR team approach.”

Robert Wood Johnson’s multidisciplinary team involves specialists in cardiothoracic surgery, vascular surgery and interventional cardiology, among others. During Rossi’s surgery, for example, approximately 15 individuals were present in the hybrid operating room, including cardiologist Hemal G. Gada, assistant professor of medicine; vascular surgeon Saum A. Rahimi, assistant professor of surgery and interim chief, division of vascular surgery; Lee and Turi, as well as cardiac anesthesiologists, nursing staff from the cardiac catheterization lab and operating room, and technicians.

Photo: John Emerson
Robert Wood Johnson’s multidisciplinary team involves specialists in cardiothoracic surgery, vascular surgery and interventional cardiology, among others.
Expanding Availability of Treatment

While surgery is still the procedure of choice for relatively healthy individuals in need of aortic valve replacement, the availability of TAVR and the ability to offer patients a transcarotid option here further expands the number of individuals who can receive life-saving treatment, says Lee.

“We can offer the full spectrum of care related to the aortic valve, including standard surgery, two different kinds of minimally invasive surgeries and several different kinds of TAVR procedures. As a result, we can really tailor the treatment to the patient’s needs and overall medical condition,” he says. “There is almost no circumstance in which we can’t treat a patient now.”

“The idea that ‘there’s nothing we can do, there are no options for you’ is really an obsolete discussion,” Turi agrees.

Changes in the availability of the TAVR technique and its technology have come rapidly, Turi notes. What once was a procedure exclusively for people who were absolutely inoperable has now been expanded to include individuals who are at high risk from surgery.

“We’re using it in healthier patients than before, because the data about outcomes have been compelling,”  Turi explains.

Since the first TAVR procedure was performed in 2002, Turi has seen the devices used getting smaller and smaller – about half the size they were originally, he says. More patients have expanded options, are ambulated and out of the hospital in days instead of weeks, and ongoing refinements are taking place in the technology, he adds.

Improving Outcomes

While the average age of patients undergoing the procedure here is in the late 80s, Turi has performed a TAVR procedure on a patient as young as 42. But because TAVR patients are typically older and more frail, the ability to have an alternative to open surgery has a lot of appeal to patients, Turi says. It’s a shorter procedure; involves deep sedation instead of general anesthesia; avoids having the chest open in invasive surgery; and there’s even a chance they will be able to sit in a chair that same night. It eliminates some of the fear people have about surgery in general.

As for Rossi, she has been pleased with the outcome.

“At first I was weak and couldn’t do much, but now I’m getting my strength back. There may be times when I get tired, but I’ll sit down for a few minutes and will be fine. Little by little, I’m getting better all the time,” she says. “The last three years had been an ordeal, but so far, it seems to be successful.”

Another positive outcome is the improvement in her appetite, she says. In the years prior to the surgery, she had lost more than 50 pounds, bringing her well below the acceptable weight range for a woman of her height. She would have a piece of chicken smaller than her palm and only be able to eat less than half of it, she recalls: “Now I’m able to eat more, which I’m really happy about. My appetite is still improving, and I’m hoping to gain more weight to get into the correct weight range.”

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