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Shortness of breath, fatigue, and edema: These hallmarks of congestive heart failure (CHF) frequently cause severely affected patients and their physicians to believe they have no alternative to the endless cycle of emergency department visits and hospital stays.
But several outpatient cardiac clinics around the country are providing patients with a controversial option: intermittent inotropic infusion therapy, a process that gives patients periodic intravenous doses of inotropes and diuretics to improve the overall performance of failing hearts.
This treatment is controversial because of a group of studies conducted in the late 1980s suggesting that inotropic infusion therapy increases mortality by causing arrhythmia in some patients, says Richard Kay, MD, a clinical cardiologist at the George E. Reed Heart Center in Hawthorne, NY.
"The obvious concern is that [inotropes] may be asking an extremely diseased heart to do more than it’s capable of doing," says Kay. He points out that one major study in which an oral inotrope was administered to CHF patients was terminated prematurely when the researchers detected a "definite increase" in mortality.
"I certainly would not advocate, nor would I use this therapy in people who have moderate heart failure that can be symptomatically controlled with other agents," says Kay.
He adds, however, that he and many other cardiology professionals use inotropic infusion therapy in patients with advanced and very symptomatic heart failure, people who would "have a pretty miserable and limited functional existence without it."
"You put them on inotropic infusion therapy, and it might be statistically that their mean prognosis is 10 months now instead of a year," says Kay. "But it’s ten months of being able to get a decent night’s sleep, being able to catch your breath, feel better, and have a little more energy."
Ask clinicians at Columbia Michael Reese Hospital and Medical Center in Chicago if the benefits of their outpatient infusion clinic outweigh risks, and you’ll get an emphatic "yes." Because the hospital is a pioneer in infusion therapy and one of the largest infusion clinics in the country, Columbia Michael Reese’s clinicians back their judgement with some strong statistics and stories of individual patients whose lives have been changed.
The hospital, which does more than 300 infusions a month, has reduced the admission rates of CHF patients in the infusion program by 74%, length of stay by 86%, and emergency department visits by 87%. Quality of life has been improved by 58% based on scores from the Minnesota Living With Heart Failure questionnaire, which patients complete each month, says Lori Heaney, RN, heart failure coordinator. Those numbers are even more dramatic, she says, when you consider that as the disease progresses, CHF admission rates are expected to increase.
One of Heaney’s favorite quality-of-life stories is about an 80-year-old woman who was constantly in the hospital and whose physician sent her to the Heart Failure Unit as a last resort. "All she wanted was to live long enough to go to her grandson’s wedding in four months," Heaney says. "Not only did she go, but she went without oxygen and walked there like everybody else. When the physician saw her two months later and saw how well she was doing, she paraded her all through the office and showed the other physicians what a difference we made."
Columbia Michael Reese’s program has attracted enough interest that it offers clinics through the Advanced Heart Failure Shared Clinical Experience Network twice a month for physicians around the country who want to start similar programs. "There have been a lot of converts," Heaney says. "We were one of the first hospitals to start doing this, and now they’re just springing up around every corner. Once the physicians see the great benefit in how these patients improve so dramatically, they want to do it too."
Patients accepted for infusion therapy at the Heart Failure Unit, which offered its first infusions in 1985 and has been doing infusion therapy exclusively since 1992, are classified as having New York Heart Association Class III or IV heart failure. Typical class III patients have been admitted to a hospital in the previous year at least twice and are taking maximum oral therapy with little symptom relief.
Basically, these patients have no alternative but continued hospital visits or hospice care, Heaney says. They participate in a comprehensive program of low-dose infusions with milrinone and dobutamine, intravenous diuretics, close monitoring of lab values, readjustment of oral medications, and extensive patient education and follow-up.
The drugs are tailored to each patient in consultation with the cardiologist, but most class IV patients start with four- to six-hour infusions two to three times a week until they improve to Class III heart failure, and then they receive infusions once a week. Once they’re stable, patients are weaned to once or twice a month. Some are able to completely stop the treatment for a while.
Clinical benefits include improved cardiac output, decreased peripheral vascular resistance, and decreased pulmonary-artery wedge pressure, as well as a marked reduction in symptoms. Many patients see relief from paroxysmal nocturnal dyspnea, pedal edema, extreme fatigue, shortness of breath, and loss of appetite within a month, Heaney says.
The key to the program is not just the infusions; it’s the total package. "People cannot just give infusions and ignore the other aspects of taking care of these patients," Heaney says. "You must have very intense patient education. You could give infusions forever and a day to somebody but if they’re not doing what they should at home, you’re not going to get very far."
Those four to six hours the patient spends in the chair getting the infusion are golden for patient education. The Heart Failure Unit has 14 cardiac chairs in one large room, promoting patient bonding and informal group therapy. Nurses encourage patient compliance with physician’s orders on medication, diet, and fluid restrictions, and teach patients how to recognize symptoms. The nurses place follow-up calls and keep in contact with physicians.
Christ Hospital and Medical Center in Oak Lawn, IL, started a similar infusion program last year after finding they had the 33rd largest number of CHF patient discharges in the nation and were losing at least $250,000 a year on CHF patients, says Carol Pisano, RN, BSN, CCRN, the hospital’s CHF coordinator. CHF, formerly one of the diagnosis-related groups with the biggest losses for the hospital, is no longer even on the loss list.
Infusion therapy costs about $500 per treatment, with patients going in for treatment an average of once per month after the first few visits. Anecdotal information on individual patients showed only one CHF hospital admission among 21 clinic patients in the first six months of the program. Preliminary studies show potential cost savings on admissions of $228,000 for the first six months.
Despite its cost-effectiveness, however, critics of infusion therapy remain skeptical. Melvin Weiss, MD, an interventional cardiologist at the George E. Reed Heart Center, points out that no studies have been done assessing the effects of inotropic infusion therapy on the mortality of patients with mild-to-moderate CHF. Until such evidence is available, he would have serious concerns about proceeding with infusion therapy for any but advanced CHF patients.
Pisano recognizes the reluctance of physicians like Weiss to start patients on these programs. "But you’re never going to see improved mortality with these patients," she says. "This is more like a tune-up, like changing the oil in your car instead of waiting until all the oil is totally gone. Besides, when these patients go to the emergency department, what kind of medicine do they give them? IV inotropes. We just do it on an outpatient basis before they ever have to go to the hospital."
[For more information about inotropic infusion therapy, contact the following sources: Carol Pisano, RN, BSN, CCRN, Christ Hospital and Medical Center, 4440 West 95th Street, Oak Lawn, IL 60453-2699. Telephone: (708) 346-4552; Lori Heaney, RN, Columbia Michael Reese Hospital and Medical Center, 2929 South Ellis Avenue, Chicago, IL 60616. Telephone: (312) 791-8368; Richard Kay, MD, and Melvin Weiss, MD, George E. Reed Heart Center, 19 Bradhurst Ave. Hawthorne, NY 10532. Telephone: (914) 593-5343.