February 17, 2006

Device offers critically ill heart patients new option

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The TandemHeart device can be inserted without surgery.

Device offers critically ill heart patients new option

The TandemHeart, here on patient Nikki Jones, is made up of a pump, cannula and system controller.

The TandemHeart, here on patient Nikki Jones, is made up of a pump, cannula and system controller.

Vanderbilt University Medical Center is the first in the region to offer a potentially life-saving treatment option for severe heart failure patients too sick to undergo surgical interventions.

The treatment is the TandemHeart, a fist-sized ventricular assist device that is inserted percutaneously in the most critically ill cardiac patients.

The primary advantage of this device is that it does not require surgery.

“Conventional left ventricular assist devices (LVADs) require surgery,” said David Zhao, M.D. director of the Cardiac Catheterization Lab and Interventional Cardiology. “In the past we cut the chest open, exposed the heart and inserted the LVAD. Now this device can be inserted using a percutaneous technique in the Cath Lab without doing surgery.

“We are able to use this device as a temporary bridge so that a patient can recover some heart function. Previously, with no other options, a patient who is too sick for a surgical implantation of an LVAD or another invasive procedure would die. This allows us to give them a chance,” Zhao said.

TandemHeart is a short-term support device that allows the body to regain a normal blood circulation in minutes. The three-part system includes a pump, a cannula set and a system controller.

Through a small incision in the groin, two cannula are threaded into the heart via the femoral vein and into the aorta through the femoral artery. The pump, which is strapped around the patient's leg, provides the circulating power to pull oxygenated blood from the left atrium of the heart and return it to the abdominal aorta. Acting as the brain of the device, the pump is able to support the heart's job of distributing blood through the body. The controller, which is attached to a pole, powers the pump and provides automated monitoring and alarm systems.

The device is normally inserted using a catheterization procedure, but can also be placed in an OR setting with a small incision if needed.

Zhao led a team of cardiologists and cardiac surgeons that recently used the technique on 20-year-old Nikki Jones, who would have died within days without the procedure, he said.

“She was not a candidate for transplant because she was too sick,” Zhao said. “After implanting the device, she was placed on the transplant list and received her new heart within days of the procedure.”

Thomas DiSalvo, M.D., medical director, Vanderbilt Heart & Vascular Institute and director of the Heart Failure, Transplant Program, called the achievement a “tour de force.”

“This was a heroic effort,” he said. “This is the kind of outcome we see at the best heart failure/transplant programs in the world. This will prove to be very valuable for patients in the future.

“TandemHeart expands our repertoire of devices and provides reliable short-term support for many patients with life-threatening cardiac illnesses. There are specific indications for the device and not all patients will be candidates, but for many it will give them support until we can stabilize them to move on to the next step of treatment.”

Vanderbilt will adhere to strict guidelines for usage, implanting the device on a patient-by-patient basis.

The most prevalent uses will be in patients who have bypass, heart valve or open heart surgery, patients who need very short-term bridging before receiving a longer-term LVAD and for patients undergoing high-risk angioplasty or stenting, to help rest the heart and provide a margin of safety during the procedure.

DiSalvo, the attending physician for Vanderbilt's first TandemHeart recipient, commended the multidisciplinary team effort as a “testament to Vanderbilt's commitment to innovation in cardiovascular disease that will help our patients have better outcomes.”

Zhao, Pablo Saavedra, M.D., assistant professor of Medicine, and James Greelish, M.D., assistant professor of Cardiac Surgery, placed the device in about one hour.

“This is truly an example of the very best that Vanderbilt has to offer with cutting-edge technology and high-level academic collaboration,” Greelish said. “Anytime you can save a patient from a large operation it's progress.”

“This kind of collaboration is impressive and opened my eyes to the common ground that now exists between interventional cardiologists and cardiac surgeons.”

The TandemHeart, which has the capability of assuming about 85 percent of the heart's pumping function, is made by Cardiac Assist.

Vanderbilt's pioneer recipient, Nikki Jones, is currently recovering from her heart transplant and improving daily.

Other members of the team included Allen Naftilan, M.D., associate professor of Cardiovascular Medicine; Rebecca Hung, M.D., assistant professor of Cardiovascular Medicine; Frank Scholl, M.D., assistant professor of Cardiac Surgery; Shelly Scholl, transplant coordinator; and Cindy Giullian, acute care nurse practitioner.