Baptist's HeartMate II Offers Years to End-Stage Heart Patients

JENNIFER BOULDEN

Baptist's HeartMate II Offers Years to End-Stage Heart Patients | Cardiology, Thoratec HeartMate II, Baptist Hospital in Little Rock, John Ransom,

Dale Fulmer being examined by Baptist Heart Health Transplant Program medical director Steve Hutchins, M.D

New Device May Become Destination Therapy

Though she hadn't heard of it a few months ago, Joyce Fulmer is now a big fan of the Thoratec HeartMate II. The device and the cardiology team at Baptist Hospital in Little Rock gave her back her husband Dale in October when his Texarkana physicians had given up hope of saving him.

"I've got him back now. It's amazing. He is getting stronger every day, lifting weights, exercising," she said. "I didn't think that would be possible ever again."

The HeartMate II is the newest generation of bridge-to-transplant left ventricle assist device (LVAD) technologies available for end-stage heart disease patients through Baptist Health System, approved by the FDA in April.

Baptist has the only adult heart transplant program in the state (Arkansas Children's Hospital has a pediatric transplant program) and has been doing successful transplants for 20 years. John Ransom, MD, is surgical director and Steve Hutchins, MD, is medical director of the Baptist heart transplant program. Both attended Joel "Dale" Fulmer, a retired field engineer with the Arkansas Highway Department.

"When we first saw Mr. Fulmer, his existence was extremely limited," Ransom said. "He couldn't lie down to sleep, couldn't eat and had lost a ton of weight. He was really near death at that point and wasn't a transplant candidate at that point because he was so far gone. He couldn't wait for a heart because he was about to die. We got him in a little bit better condition and implanted the HeartMate II. Within a week he was walking around outside Baptist with his wife."

Joyce Fulmer said that her husband, who was diagnosed with congestive heart failure in 2000, had received a pacemaker and defibrillator in February, but had gotten progressively worse and had multiple hospitalizations during the year. Local cardiologists were overbooked and they had told Dale that hospice care would be appropriate.

"He had seen a story on Channel 7 about this new pump, and we felt sure that maybe someone in Little Rock would be able to help, but we couldn't get through to the cardiologist," she said. "I had given up hope."

Then, in true Arkansas fashion, their minister heard about the problem when he visited Dale in the hospital and contacted the sister he knew of Little Rock cardiologist David Smith, who then helped Joyce reach Smith.

Smith had Dale Fulmer transferred to Baptist Hospital the next day. Fulmer was in the early stages of organ failure, and medical director Hutchins advised Joyce to call their family as he was moved to intensive care.

The Baptist Health team saved Fulmer's life that night with a temporary balloon pump. Seven days later, he was well enough for the HeartMate II surgery.

"If he hadn't happened to hear that piece of information and found out it was available here, he would not be alive now," Ransom said.

Baptist uses several types of LVAD devices for patients awaiting transplant, including a first-generation version of the Heart Mate II, called the HeartMate XVE. Ransom said that while the XVE was a great advancement when it was new, the HeartMate II is far more advanced.

"It's much, much, much more user-friendly, for the patients who are using it and the physicians who are implanting it," Ransom said. "It is smaller, quieter, more efficient, more durable, and just a tremendous step forward from anything we've had before."

The device can pump up to 10 liters of blood per minute, covering the full output of a healthy heart. It is implanted along side a patient's native heart and takes over the pumping ability of the weakened heart's left ventricle.

Ransom said that besides being a bridge-to-transplant therapy, a REMATCH clinical trial showed the first-generation XVE device to be effective as a destination therapy, meaning that patients who were not candidates for transplant could live longer, more fully and more cost-effectively using the HeartMate XVE than with medicine alone.

The XVE, though, was only good for 18 months. In contrast, the new HeartMate II lasts for 8 – 10 years.

The HeartMateII has not yet been approved as a destination therapy, but Ransom said he expects that a current clinical trial early this year will approve the device as a permanent option for end-stage patients who do not qualify for transplant.

Baptist Health implanted four HeartMate II devices in 2008 after it received FDA approval in April. Of those four, Ransom said one patient had received a new heart and had the device removed and the other three, including Fulmer, were home awaiting a transplant.

The clinical parameters of who is eligible for the HeartMate II vary by case and they are used only when all other modalities of treatment have been exhausted, but Ransom said that there is a "tremendous population" who can benefit from it. Plus, he said, the REMATCH trial showed that the HeartMate devices can be a significant cost-savings, as patients do not have to spend six months in and out of the hospital, dying.

"Especially as information is disseminated and people know more what's available, we're going to see more of these HeartMate II implants," Ransom predicted. "Maybe five or 10 years down the road, the devices will be refined even more."

The American Heart Association estimates that about five million Americans are affected by congestive heart failure, with 550,000 new cases diagnosed each year. Cardiovascular disease remains the No. 1 cause of death in the United States. Though transplants offer hope for approximately 2,000 advanced heart failure patients each year, over 250,000 patients have no viable treatment option and are considered at high risk for repeated hospitalizations, severely diminished quality of life and limited life expectancy.

The assist devices are the future of end-stage heart failure, he said.

"I think they will take the place of a lot of transplants," he said. "A lot of people will choose to have these devices rather than a transplant. After they have the device, they are fully functional, can exercise, do anything they want."

Joyce Fulmer said that there are some limitations since the battery pack should not be submerged and has to be plugged in at night, but that her husband's quality of life now is greatly improved.

"He was out there pushing the mower around, doing yard work today," she said. "I don't know how long it's been since he could do that. He can play with our young grandchildren, do so much more now. Once he gets a transplant, we're going to take advantage of the extra time we've been given and do some traveling."

She said the holidays were especially meaningful this year.

"It was so good to see him with his family here during Thanksgiving and Christmas, because he would not have made it without this device and the wonderful people at Baptist," she said. "He has his life again. We are so thankful for that."