Spectrum introducing latest generation heart pumps
Hundreds of hospitals nationwide have implanted the left ventricle assistance device, or LVAD, including University of Michigan Health System and Henry Ford Hospital. But major technological advances have made the machines smaller and more reliable. The devices now are being used as destination therapy for heart failure patients as well as a way to buy time until a donor heart becomes available for transplant.
The first LVAD implantation in Grand Rapids occurred at Spectrum Health’s Meijer Heart Center in April 2009, said Dr. Michael Dickinson, medical director for the heart failure program.
In January, the federal Food and Drug Administration approved the latest and most compact LVAD, the HeartMate II, as a permanent treatment. It was approved for use as a bridge to heart transplant in 2008.
The device is made by publicly traded Massachusetts company Thoratec Corp.
Dickinson said that Spectrum began planning for the LVAD program in 2008, as the hospital also worked toward the heart transplant program that received a state OK in February.
In heart failure, the heart becomes too weak to push blood out to the body. For advanced heart failure patients, the LVAD takes over part of the heart’s work, pushing oxygen-rich blood out of the left ventricle to the aorta.
About 5.7 million people in the U.S. have heart failure and it is implicated in 300,000 deaths annually, according to the National Heart Lung & Blood Institute at the National Institutes of Health. It’s more common in people over age 65, in men, in African-Americans and in people who are overweight.
The NHLBI estimated that treating heart failure will cost the U.S. health care system $39.2 billion in 2010. Heart failure accounts for more than 1 million hospitalizations annually.
In 2007, the Centers for Medicaid and Medicare Services started requiring LVAD programs across the nation to obtain certification from the Joint Commission. Medicare initiated coverage for LVADs as destination therapy in 2003.
LVADs cost about $200,000 in the first year, plus continued monitoring in subsequent years. Medicare requires a facility to have performed 10 implants before it will cover procedures done there. Medicare’s reimbursement approval usually triggers reimbursements from commercial insurers, as well. Dickinson said he has referred some LVAD patients to Chicago or elsewhere in Michigan because of the insurance issue.
Spectrum Health spokesman Bruce Rossman said two more open-heart surgeries for LVAD are anticipated soon and the local program is expected to qualify for certification perhaps as early as December. He said the cost of several procedures has been absorbed by the hospital as it waits for certification to qualify for reimbursement.
The cost needs to be viewed in light of the extra time and quality of life that destination LVADs provide, Dickinson said. The device can give new life to people with end-stage heart failure who may otherwise be hospital-bound or homebound with shortness of breath, overwhelming fatigue and fluid retention. In the clinical trial that led to FDA approval, the two-year survival rate for the HeartMate II was 58 percent, according to WebMD’s HeartWire.
“They feel wonderful with the pump,” Dickinson said. “They almost become normal, with no limit on exercise or tolerance. I’ve had patients go hunting, go to work, run businesses.
“People who were essentially bedridden and not able to do any activity, you can put them on an LVAD and it will keep them alive and give them a decent quality of life. Some patients are critically ill and dying in front of us. … Sometimes the heart recovers and you can remove the LVAD.”
Not all heart failure patients are candidates for an LVAD, he cautioned. Age, additional health problems or not being a heart transplant candidate for some other reason could mean the LVAD is not an option, he said.
Use of the device requires dedication on the part of the patient and supporters. The pump requires patients to carry a purse-sized battery pack and extra batteries, and sometimes they may need to plug into an outlet.
“It’s not magic. Patients can run into complications,” Dickinson said. LVAD patients face the potential for blood clots, pump failure and infection at the point in the abdomen where a wire exits the body to connect with the power source.
“It takes a firm commitment on the part of the patient,” Dickinson added. “Not every patient is willing to go through with that.”
Patients must go through not just physical exams, but psychological and social work assessments to determine whether they can cope with life on a portable pump and whether they have supportive family and friends to help, he said.
Cheney, 69, suffered a heart attack in February, his fifth since 1978. He has had bypass surgery, a stent, an implantable cardioverter defibrillator, and twice underwent cardioversion for atrial defibrillation. In July, he received an LVAD at Fairfax Heart and Vascular Institute in Virginia, near Washington, D.C., according to HeartWire.
In a statement, Cheney said his congestive heart failure was advancing, and he chose to take advantage of “a new technology,” although he didn’t indicate the exact device he received.
One quirk is that most patients with an LVAD don’t have a pulse, Dickinson said. Normally, blood ebbs and flows through the circulatory system, but the LVAD provides a continuous flow, eliminating the sudden surge that causes the pulse.
“How much contribution from their own heart determines whether they have a pulse,” Dickinson said. “They are still very much alive.”