BY PAM MCGRATH

In the past two decades or so, minimally invasive surgery has become widely used for many operations: gallbladder removal, appendix removal and hernia repair, just to name a few. The benefits of several small incisions versus a large, single one are well documented: reduced pain, faster recovery, fewer complications. Some heart surgeries, too, have gone the way of minimally invasive surgery, making standard open-heart surgery one option among several instead of the only option available.

THE FDA RECENTLY APPROVED TRANSCATHETER AORTIC VALVE REPLACEMENT FOR A NEW GROUP OF PATIENTS WITH AORTIC STENOSIS, FURTHER WIDENING THE REACH OF THIS MINIMALLY INVASIVE ALTERNATIVE TO OPEN-HEART SURGERY.
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But, until recently, only a relatively small group of people with aortic stenosis—a narrowing of the heart’s aortic valve that restricts blood flow—were eligible for a minimally invasive procedure called transcatheter aortic valve replacement, also known as TAVR. The Food and Drug Administration (FDA) had approved the innovative procedure for those in need of valve replacement who might not survive open-heart surgery. But people who were generally healthy enough to undergo open-heart surgery didn’t have the option to instead have the minimally invasive procedure.

Now, that has changed. The FDA recently approved TAVR for people at low risk for complications caused by open-heart surgery, meaning they, too, may benefit from this minimally invasive treatment. Physicians at the Washington University and Barnes-Jewish Heart & Vascular Center participated in the Placement of Aortic Transcatheter Valve (PARTNER) clinical trial, testing the effectiveness of TAVR treatment in patients who were otherwise healthy. They also participated in previous PARTNER studies for high-risk and intermediate-risk patients, those for whom open-heart surgery presented a variety of significant risks.

“The clinical trials began with high-risk patients because they had no other treatment options; medical complications made it impossible for them to undergo open-heart surgery,” says Marc Sintek, MD, Washington University interventional cardiologist and member of the Heart & Vascular Center team. “When minimally invasive outcomes proved comparable to those of people who underwent open-heart surgery, the PARTNER II and III studies were initiated. With just a few exceptions—for example, people born with two valve leaflets instead of three—this less invasive treatment is now potentially available to all patients needing aortic valve replacement.”

WITH JUST A FEW EXCEPTIONS...THIS LESS INVASIVE TREATMENT IS NOW POTENTIALLY AVAILABLE TO ALL PATIENTS NEEDING AORTIC VALVE REPLACEMENT.

Here’s how the procedure works: A wire, loaded with a replacement aortic valve, is passed through an artery, usually in the leg, and maneuvered into the heart, where it is positioned inside the defective valve. The surgeon then activates a release mechanism that anchors the new valve in place and pushes the old valve out of the way. “The procedure takes about an hour, and patients usually leave the hospital in a day or two. Within about 10 days, they often are feeling quite well,” says Hersh Maniar, MD, Washington University cardiothoracic surgeon at Barnes-Jewish Hospital. “In contrast, patients undergoing open-heart surgery remain in the hospital for about a week and require at least six weeks to recover.”

The Heart & Vascular Center team uses a collaborative method to determine whether this minimally invasive procedure is appropriate for a person needing valve replacement. Each patient is evaluated by an interventional cardiologist and a cardiothoracic surgeon before a treatment recommendation is made.

“In addition,” Sintek says, “patients undergo a CT scan that gives us a clear picture of the heart and helps us determine whether we can position a new valve properly.” Additionally, all candidates undergo heart catheterization, which will reveal the presence of any artery blockages that may need to be addressed. “We consider a number of factors as a team to determine what approach—TAVR or open-heart surgery— is the best option.”