Assist devices offer heart patients independence

Implantable pumps improve quality of life

Many patients with late-stage heart disease linger for months in intensive care units waiting for a donor heart to become available. With average costs nationwide of more than $2,000 a day for an ICU bed, excluding additional costs for such items as medications and laboratory tests, the need for alternative treatments is obvious.

"A patient awaiting a heart transplant can easily rack up costs of $5,000 a day for as long as six months. Not only is it expensive, but there is a great strain on the patient and the family due to the patient’s need to remain in the hospital indefinitely," notes Kathy E. Magliato, MD, a cardio-thoracic surgeon at Cedars-Sinai Hospital in Los Angeles. Magliato is one of a growing number of cardiothoracic surgeons nationwide who routinely implant ventricular-assist devices (VADs) in patients awaiting heart transplants.

"The assist devices are expensive, but they offer the patient a degree of independence. Depending on the type of device and the health of the patient, the patient can either be stepped down from the ICU to other units of the hospital or discharged home and even returned to the workplace while awaiting transplant," she says.

Several companies now have Food and Drug Administration-approved VADs on the market. (See chart, p. 34, for information on three companies that market VADs.) The devices can cost as much as $70,000, which, although stagg ering, still saves money in the long run due to decreased ICU costs and improved quality of life.

The high cost of the devices causes some payers to question their cost/benefit ratio. Most payers are aware of the FDA’s approval of the devices and routinely reimburse for them. How ever, there are several reimbursement issues to be resolved. "Since 1998, Medicare has reimbursed for the device, but there are still reimbursement barriers. There is no billing and coding method ology in place to deal with outpatient charges associated with the system — supplies and equip ment," says Virginia Curcio, RN, MBA, reimbursement manager for Thermo Cardio systems in Woburn, MA.

"I had two payers just recently who did not offer LVAS [left ventricular assist device] coverage as part of their reimbursement plan," she notes. "One company, even in light of the FDA approvals, still considered the device investigational. When case managers requested coverage for LVAS implantation, it was denied. Then they appealed to the health plan medical director and received coverage. In many instances, these devices are considered on an individual basis. I suggest case managers always appeal denials."

Many VAD manufacturers hold seminars on reimbursement, adds Magliato. "In general, these devices are well-reimbursed. Facilities considering use of VADs would probably benefit from asking the various manufacturers in for a seminar on reimbursement."

Most late-stage heart patients awaiting transplants are possible candidates for VAD implantation. However, several conditions make some patients less suitable, Magliato says. "These are relative and not absolute contraindications which might make some heart patients an exception."

Those conditions include:

• bleeding disorders;

• severe liver or kidney dysfunction;

• existence of a mechanical valve.

For appropriate patients, VADs greatly improve survival odds for patients with late-stage heart disease, notes James W. Long, MD, PhD, cardiothoracic surgeon at LDS Hospital, assistant clinical professor of cardiothoracic surgery at the University of Utah in Salt Lake City and director of the Utah Artificial Heart Program. "One of the greatest benefits of these devices is that they improve survivorship for late-stage heart patients. The use of the device changes the mortality rate from 90% mortality for patients awaiting transplant to a 85% survi -val rate to transplant with an implanted VAD."

In clinical trials of its Novacor LVAS, Baxter Healthcare in Oakland, CA, found the overall survival rate to transplant was 78% for patients receiving a Novacor LVAS, compared with a 35% survival rate to transplant for patients not receiving a LVAS, says Linda Strauss, vice president and director of communications for the Novacor division of the Baxter Healthcare Cardiovascular Group. That survival rate has improved since FDA approval allowed surgeons to implant the device in healthier patients. Survival rate to transplant is now roughly 85% for all of the VAD systems currently available.

Due to the similarity in the success rates, surgeons say selecting the correct VAD for an individual patient depends upon patient size, desire for independence, and whether the heart failure is left-sided, right-sided, or both. "The Thoratec system can be used in the widest range of patients because it can be used for the right side, the left side, or both sides of the heart," Strauss says. "It also fits a wider range of patients and has even been approved for use in small children."

However, a very large patient may need a larger pump, she notes. "If I have a really big man with left-sided heart failure, I’m more likely to chose the Novacor or Heart Mate system."

The greatest single benefit of VADs is their ability to improve a patient’s quality of life, agree Magliato and Long. That is even more true as VADs become increasingly reliable and are implanted in healthier patients.

"We’re becoming more confident in the reliability of these systems," says Long. "Up until the recent past, we insisted every patient with an implant have a constant 24-hour companion who could contact the center and institute emergency response measures. We never allowed these patients to drive and insisted they remain within a very short distance of the hospital."

Long says he’s now starting to push the envelope. LDS Hospital has begun evaluating patients for their ability to enjoy a greater degree of independence. "We now have patients who are driving themselves long distances and flying as far away as San Diego, California, and Washington, DC."

To measure a patient’s ability for greater independence, LDS Hospital evaluates the following:

Patient has sufficient cardio-reserves to carry out emergency measures if the pump fails. "We run three-minute tests," explains Long. "We watch the patient to see how they react during that three-minute period. Do they stay in control of their faculties? Do they remember what to do?"

Patient has an adequate emergency response system in the community. "If the patient lives in a smaller community, we train paramedics and emergency room physicians on the technology and explain the patient’s specific needs. We also set up a communication system so that we are notified immediately about any complications."

Although the survival rate to transplant is high in centers nationwide, Long and Magliato say there are several factors case managers must consider when selecting a surgeon and facility for VAD implantation. Those include:

Center handles a large volume of VAD implants. "Look for a center that implants at least one of these devices every two months — six a year, minimum. You need volume to gain the necessary experience that leads to better survival rates," says Long, adding that case managers should look for a facility with a survival rate to transplant of no less than 75%.

Support staff are familiar with the implants. "You need not only volume, but a strong support staff of clinicians — not just surgeons. You have to have nurses, anesthesiologists, pulmonologists, cardiologists, and engineers who are all familiar and comfortable with these systems," he says.

Magliato says trained nursing staff are vital to a facility’s success with VADs. "Many nurses are intimidated by these patients. The patients have a metal device coming out of their body that’s keeping them alive. People don’t want to touch the device. They’re afraid to touch the patient. The nursing staff must be trained that the patients not only can but should be moved. Nurses must be reassured that patients can be taken off the ventilator and walked around."

VAD implant patients require psychological support as well as medical and technical support, she says. "These patients are scared . . . You must have a special passion to work with these patients give them the support they need."

Most VAD implant patients suffer few complications. However, centers nationwide are still struggling to reduce instances of infection associated with VADs, says Long. "We believe that the instances of infection can be reduced with meticulous care of the percutaneous leads in the outpatient setting," he says, adding that patients and their families must receive training in proper care of percutaneous leads.