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Cardica C-Port Flex A

When Dr. Louis A. Brunsting and his team performed a closed-chest cardiac bypass at Centennial Medical Center in late August, it was unlike any heart-vessel bypass they had done before — or that any other surgeon in Tennessee had done before. In fact, the surgery had been performed only one other time, just a few days earlier, at Bon Secours St. Mary’s Hospital in Richmond, Va.

“What made this extraordinary was that it was one of the first applications of a new kind of device to create that connection between the internal mammary artery and the coronary artery. It’s a linear stapling device,” explained Brunsting, a member of the five-physician Heart & Vascular Team in Nashville.

That’s right, a stapler, and quite a stapler it is. Designed by California-based Cardica Inc., the C-Port Flex A eases for cardiothoracic surgeons the process of anastomosis, which is the connection of blood vessels. When it comes to heart surgery, that usually means connecting a graft vessel, most times from the leg, to the aorta and to small-diameter coronary vessels, thus creating the bypass around a severely narrowing or blocked route. The blood is rerouted through the healthy vessel, and blood flow is restored to the heart muscle.

Conventional bypass surgery requires the surgeon to hand-sew these connections, a process that is tedious and takes 10 to 15 minutes per suture. The Flex A “staples” the grafted vein in place, and it only takes about two minutes for each anastomosis.

According to Brunsting, here’s how the Flex A works: “You load the end of the mammary artery onto this device — and just like your stapler has a top part that comes down and a bottom part that bends the staple, called the anvil, this has a very small anvil that fits through a little hole in the heart artery that you make. Then the stapler actually creates a circular row of staples and makes a cut right through the middle of it, so it automatically — bang! — makes your anastomosis, just like pushing on your stapler. It’s CO2 driven. Then you remove the anvil and you have a linear, one-millimeter hole, and you put a little stitch in that hole to close, and you have created the bypass instead of having to laboriously whip-stitch all the way around. This thing does it for you, and it does it in a fraction of the time.”

Brunsting’s ground-breaking surgery makes use of Intuitive Surgical’s da Vinci robot, which allows for a minimally invasive, closed-chest procedure. Accessing the heart through four fingertip-size incisions, the surgeon precisely guides the robot’s movements. As opposed to standard laparoscopy, Brunsting said the da Vinci has two major advantages: surgeons view the surgical site in 3-D rather than just two dimensions, and the surgeon’s movements with respect to the robot’s operations are intuitive. “Using the joystick-type controls, you move the hand just like you want the end of the instrument to move inside the body,” he said.

The combination of the da Vinci and the Flex A anastomosis system allows the surgeon to more quickly complete a heart bypass with minimal trauma, Brunsting said. “This is a new step forward that I believe will help make this something that is more widely accepted, and it will allow us to significantly reduce the operative time and expand the number of patients who would be candidates,” he said. While Brunsting said he has used “a version of” the da Vinci to complete bypasses since 2002, the one-two punch of the robot and the Flex A is a boon for patients. Brunsting’s first surgery in August was on a 64-year-old male patient who had undergone hip-replacement surgery one week earlier. The patient actually resumed physical therapy for his hip the next day. Brunsting said patients undergoing this procedure may be discharged in 24 to 48 hours following surgery, and often return to normal activity levels within one to two weeks.

Brunsting recalled when laparoscopic surgery was first introduced that many physicians were critical of the new technology, calling it “a marketing tool” or “a fad.” Yet as laparoscopic techniques and instruments were refined, laparoscopy became commonplace. “Now 60 percent of all surgery is done laporascopically, and the procedures in general are shorter than the open procedures, and the patients recover much quicker — all good things,” he said, predicting that robotic heart surgery using an anastomosis stapler will become relatively routine as well. “This is going to, I think, make a big difference. It does require a significant platform of learning experience and investment,” he said.

Brunsting added that “it has become real apparent to me over the last five to 10 years” that a patient’s discomfort and length of recovery time correlate with the size of the surgical incision. “We used to believe it was the heart and lung machine that made people so sick and swollen and take so long to recover after heart surgery and not the size of the incision,” he said. “I’ve come to believe 180 degrees the opposite, based on my experience, that it’s the magnitude of the stress you induce surgically on somebody by making those big incisions.”

What’s next? “We’re starting at the safest level — one single bypass,” Brunsting said. “But as we gain experience and as the equipment continues to be refined, one of my goals — before I need this procedure myself potentially in the future — is to address multiple bypasses all with just port sites.”



November 2007

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