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J Thorac Cardiovasc Surg 2000;119:251-259
© 2000 Mosby, Inc.
CARDIOPULMONARY SUPPORT AND PHYSIOLOGY |
From the Department of Surgery, Columbia University, College of Physicians and Surgeons, New York, NY.
Address for reprints: David L. S. Morales, MD, Department of Cardiothoracic Surgery, MHB 7-435, 177 Fort Washington, New York, NY 10032 (E-mail: dlm36{at}Columbia.edu) .
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Abstract |
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Introduction |
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TopAbstractIntroductionMethodsResultsDiscussionAppendix: DiscussionReferences |
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Fortunately, prolonged hospital discharge for patients with an LVAD has become possible for several reasons: First, confidence in the devices has allowed patients, their families, and health care providers to be more comfortable with outpatient therapy. Second, the devices have become durable enough to allow extended durations of support. Third, the perception of the LVAD has changed from a last-resort therapeutic option to that of a rehabilitation-enhancing, patient-empowering device.
1 As LVAD technology has matured, programs are now being asked to evaluate patients’ outcomes such as satisfaction, functional capabilities, and quality-of-life issues, as well as to assess the raw survival statistics of their programs. 2-7
The literature on LVAD outpatients is sparse, with the largest reported experience of LVAD patients discharged home consisting of 21 patients accumulated from the 4 most experienced LVAD programs. 8 The LVAD is not widely recognized in the medical community as a device reliable enough to support a patient at home. We reviewed our 6-year experience with LVAD outpatients to assess the safety and the cost-effectiveness of such a program.
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Methods |
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1,9,10 Discharging a patient to a rehabilitation center, to medically supervised housing, on a day trip, or home overnight did not qualify patients for this study. Inclusion of only patients discharged home without restriction allowed us to assess the safety and economics of outpatient LVAD care as though a permanent device had been implanted.
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Costs of all supplies were priced according to a Drug Topics Redbook written by Medical Economics Company (Montvale, NJ, 1998). 11 Items not included in this book were priced by averaging their cost at 3 surgical supply stores in the New York City area. The professional fees represent the prices set by the American Medical Association in the 1999 current procedural terminology codes. 12 In-hospital costs were gathered from the financial and billing departments at Columbia-Presbyterian Medical Center. All data on sexual activity, working, and driving were collected by personal interview. Results on the incidence of these three activities used the number of people engaging in these activities before LVAD implantation as the denominator.
All results are reported as a mean ± the standard error. The 95% confidence intervals for the incidence per outpatient were calculated by the Exact Method for Binomial Proportions. The 95% confidence intervals for the incidence of event per outpatient month were calculated by the Exact Method for Poisson Parameters.
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Results |
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The outcomes of the 44 patients with LVADs discharged home and the remaining 46 patients with LVADs not discharged home are listed in Table II. No LVAD outpatients died. All outpatients were successfully bridged to transplantation or planned explantation.
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Complications.
A rapid response mechanism created in case of an outpatient catastrophic event was rarely implemented, because the frequency of these events or any outpatient complications in our experience has been minimal (Table III). This includes the 9 patients allowed day trips only, who had no complications while out of the hospital or as a result of being out of the hospital.
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Neurologic/thromboembolic events.
Despite no systemic anticoagulation, no strokes or transient ischemic attacks occurred in this cohort of patients. However, 1 patient did have a microembolization to the retina, causing a transient scotoma of the left eye 83 days after implantation. This patient was admitted for 3 days of observation during which there was no intervention or anticoagulation since no source of emboli was found. This deficiency resolved almost completely and did not inhibit the patient from such activities as snowboarding.
Device-related infections.
Eight patients had a device-related infection while at home. Three of the 5 patients with driveline infections were admitted to the hospital because of fevers and increased white cell counts while receiving oral antibiotics. After successful intravenous antibiotic therapy, 2 of these patients resumed their outpatient LVAD care and 1 patient underwent transplantation on the 7th day in the hospital. The other 2 patients with a driveline infection were treated with oral antibiotics as outpatients with no further complications. One patient had a pocket infection associated with high fevers and drainage from the abdominal wound. He was admitted and successfully treated with a 7-day course of intravenous antibiotics. Two patients with LVAD endocarditis 13 were admitted with bacteremia and fever but the fever abated with intravenous antibiotic therapy. Both LVADs were explanted on those admissions, one for functional improvement of the native heart and the other for a transplant. Positive pseudointimal lining cultures at explant and pre-explant blood cultures for Pseudomonas aeruginosa and Staphylococcus epidermidis confirmed our suspicions of LVAD endocarditis.
Non–device-related infections.
The immune function of patients receiving long-term LVAD support has been theorized to become deficient by the prolonged and ongoing stimulation of the immune system by the LVAD, a large antigen. Therefore we evaluated whether these LVAD outpatients contracted a higher frequency of other types of infections (ie, pneumonia, urinary tract) not directly involving the device. 14,15 Only 4 non–device-related infections were identified. Two were central line infections, both necessitating admission, in patients receiving immunoglobulin G for positive panel reactive antibody tests. These infections resolved with line removal and intravenous antibiotics. The third incident was a Streptococcus throat infection treated on an outpatient basis and the fourth, a urinary tract infection, also treated on an outpatient basis. There was no case of pneumonia or urosepsis.
Malfunctions.
A total of 66 minor malfunctions affected 20 of 44 outpatients (46%). These included batteries not fully charging, alarms continuously sounding, and controllers malfunctioning. The vast majority of these events were managed by the patient or in the outpatient clinic. Only one of these events necessitated admission to the hospital, and this was to observe a new controller for 48 hours.
All three of the major malfunctions in our experience were recognized in the outpatient setting early and addressed in an efficient manner that avoided any clinical ramifications. There was no mortality from major malfunctions. The LVADs malfunctioned in three ways, all resulting in deficient forward flow: (1) The cam slope had broken loose, thus inhibiting the pusher plate from fully compressing the blood chamber; (2) the LVAD’s ball bearings had worn after 270 days of support, making the resistance too great for the motor to work efficiently; and (3) a static shock mistakenly delivered to the LVAD system damaged the power conductor, sending the LVAD into a basal rate at 40 cycles/min. After LVAD replacement, all patients recovered without complications, were discharged, and successfully underwent transplantation after a period of outpatient support. Thus the fear that the LVAD can stop, causing sudden death at home, was not realized.
Unscheduled hospitalizations.
There were 18 unscheduled hospitalizations affecting 12 of 44 (27%) outpatients with a median hospital stay of 7 days and a range of 3 to 25 days for a total of 171 readmission days. These days were not included in the 4546 outpatient LVAD support days. These readmissions were caused by the complications discussed earlier. There were 8 scheduled admissions, lasting 1 to 4 days. All were for immunoglobulin G therapy for a positive panel reactive antibody test except for one that was for a scheduled angioplasty. All of the patients who were readmitted were discharged. The 18 unscheduled readmissions resulted in discharge (15), transplantation (2), or explantation (1). None of the unscheduled hospitalizations resulted in death. Until transplantation or explantation, LVAD outpatients spent 96% of their outpatient support time at home and healthy.
Outpatient costs.
The costs associated with caring for an outpatient with an LVAD are listed in Table IV, and the analysis in Table V shows the estimated cost of outpatient care over 1 week and over our average outpatient support time of 103 days. In our experience, the incidence of readmission per outpatient over this average time of outpatient support is 0.41 and over a week is 0.028. The mean cost to readmit an LVAD outpatient in our hospital is $25,653. 16 Using the weekly supply cost, our typical schedule for follow-up visits, and our readmission cost, we can estimate the expense of bridging our LVAD patients to transplantation or explantation once an outpatient as $13,200. If we exclude readmissions, the cost to take care of a healthy LVAD outpatient for 1 month, including weekly clinic visits and laboratory tests, is $750. If the FDA requirement for weekly visits is eliminated, as it has been since September of 1998, the anticipated cost per month assuming one clinic visit a month would be $600. One day of room and board on our nonacute surgical floor costs $1604.
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A total of 261 patients have been sent home with a TCI LVAD, 205 patients with a Novacor LVAD (Novacor Division, Baxter Healthcare Corporation, Oakland, Calif), and 5 patients with a Thoratec LVAD (Thoratec Laboratories, Pleasanton, Calif).
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Discussion |
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4,17,18 This is not surprising since the literature on the safety and reliability of outpatient LVAD care is sparse. The largest single outpatient program experience was reported by Columbia-Presbyterian Hospital and consisted of only 19 patients. 1 Therefore published proof of the safety and reliability of outpatient LVADs is not overwhelming, as seen by a review of the literature (Table VIII). 1,8,17-19 However, data for outpatient LVADs do exist, even though not reported. To this end, the FDA, after studying all the outpatient data from the manufactures, approved the only two available portable LVADs in the United States, the TCI VE HeartMate and the Novacor 100 W LVAD, for outpatient use in September of 1998. A third device, the Thoratec TLC II, which can serve as a right, left, or biventricular assist device, has been available for outpatient use in Canada since November 1998 and in Europe since May 1998 (personal communication from G. Marchesani, December 1998). The worldwide LVAD outpatient experience of 471 patients with a total of 168 support-years out of the hospital and a 1.2% per patient-year mortality is impressive, but unpublished.* This mortality is a significant improvement when compared with the 66% 1-year mortality of a transplant status I patient with class IV heart failure or with the 30% 1-year mortality of all patients on the cardiac transplant list. 20,21 There are also significant improvements in regard to freedom from hospitalization. Most LVAD recipients are United Network for Organ Sharing (UNOS) status I, receiving inotropic support, and waiting in the intensive care unit with class IV heart failure. Even if these patients improve and are sent home, an average group of 44 patients with class III or IV heart failure supported for the same amount of time as our outpatient cohort would be admitted 50 times (4 times per patient-year), 22 whereas our LVAD outpatients were admitted 18 times (1.4 times per patient-year). Outpatient LVAD care is not a therapy of the future but a safe therapy for patients with end-stage heart failure that currently is being practiced in the United States and around the world.
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13,23 Second, if they did occur, the outpatient’s LVAD education, the LVAD personnel access and communication systems, and the physiologic discharge criteria of adequate left ventricular function served as safety nets. 9,10 These nets allowed early detection of all complications followed by a swift and seamless plan of therapy, avoiding frantic or emergency situations out of the hospital and resulting in no outpatient mortality. Third, no complications of clinical significance occurred as a result of being an outpatient; all complications could have occurred in the hospital. Thus, whether the patients were in or out of the hospital made no difference in regard to safety. However, being an outpatient did have several benefits in terms of cost and quality of life.
Reallocation away from the inpatient setting, the most costly component of the $35 billion spent on heart failure treatment every year, to the outpatient setting is becoming a necessity in the ever increasingly cost-conscious health care system. 20,22 Outpatient mechanical support may be one option in deferring hospital costs. Although the initial cost of mechanical circulatory support is expensive, the ability to streamline patients to discharge and maintain them on an out-of-hospital basis may lessen the economic burden this type of illness places on society.
An outpatient LVAD program ameliorates two main economic burdens of inpatient LVADs: one is the cost of in-hospital care and the other is the use of hospital resources, especially personnel. The latter is important because our program, especially when just beginning, had a maximum number of LVAD inpatients that could be cared for adequately because of a finite quantity of resources and of LVAD-trained personnel. The wait for donor hearts is 148 days in our overall experience, and when LVAD patients were not routinely discharged, a difficult to manage patient load would accumulate. Discharging LVAD patients when appropriate has allowed us to focus on new and critically ill LVAD patients and has allowed patients undergoing long-term LVAD support to enter into an independent phase of rehabilitation.
The second, more concrete economic benefit is reduction of overall cost for taking care of an LVAD patient after implantation. Our estimated average cost to bridge a patient to transplantation or explantation once discharged, including the cost of readmissions, is $13,200. The cost of caring for an LVAD inpatient over the same length of time, charging only for room and board on the nonacute floor (thus excluding medicine, medical care, and professional fees), is $165,200. Also, to care for a healthy LVAD outpatient, which is how our cohort spent 96% of their outpatient support time, for 1 month ($750) is less expensive than the 1-day charge for room and board on our nonacute hospital service, $1600.
The other major benefit to an outpatient program is the improvement in the quality of life when patients are discharged home. The hospital serves as a haven for sick people to be dependent on others for their care and rehabilitation. However, once rehabilitation has reached a certain level, the confines of the hospital may inhibit the independent rehabilitation a person needs to achieve a personal perception of mental, social, and physical health. Patients with pneumatic LVADs, which are not FDA approved for outpatient care, are often supported in the hospital for extended periods of time while awaiting donor hearts and frequently feel stifled and "imprisoned" by the hospital. 18,24,25 However, the patients with an electrical LVAD are able to be discharged and have taken full advantage of this opportunity. All 44 LVAD outpatients performed activities of daily living independently. They also engaged in a host of activities, which included going to restaurants, the movies, and parties with friends, as well as caring for children, ice skating, bicycle riding, playing sports, playing in a band, and volunteer work. The high prevalence of the three activities listed in Table VI
and the breadth of the activities listed above compel one to believe that outpatient care allowed these patients to fully complete their social, mental, and physical rehabilitation.
The above observations are based on the perceptions and opinions of the caregivers. Recently, a thorough and formal quality-of-life study on LVAD outpatients was completed by Dew and associates. 26 Using the Sickness Impact Profile subclasses for physical function and for social interaction, as well as the self-report Symptom Checklist-90 (SCL-90), LVAD outpatients were demonstrated to improve in the physical, psychologic, emotional, and social aspects of their lives when discharged home and fared significantly better than transplant candidates at home or LVAD inpatients. In fact, LVAD outpatients closely resembled the transplant recipients 7 months after transplantation in physical, psychologic, and emotional well-being. 3,26 Interestingly, the transplant recipients felt more of a burden to their family than did the LVAD outpatients.
Substantial evidence now exists through patients’ actions and perceptions, caregivers’ observations, and some formal outcome/quality-of-life research by Dew and associates that outpatient LVAD care provides a better quality of life than inpatient care. 1,9,10,26
We believe that an outpatient LVAD program is safe and economical while being socially, physically, and psychologically beneficial to the patient. Our confidence in outpatient LVAD care has led to an 84% discharge rate and has resulted in a minimal complication incidence. Outpatient LVAD support is a necessary part of an LVAD program and should be sought by most cardiac mechanical assist programs.
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Appendix: Discussion |
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TopAbstractIntroductionMethodsResultsDiscussionAppendix: DiscussionReferences |
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Dr Morales. I agree. We do not usually advise such an activity for our patients.
Dr Reitz. These impressive results also include the fact that only 1 patient had a thromboembolic event despite the fact that no anticoagulants were given to these patients. Clearly this is very cost effective, as those of us who are involved in assist device and transplant programs can appreciate. I think your experience is now being duplicated, although in many fewer numbers, at a number of other centers.
I would like to ask you several questions and go into a little more of the detail that was in the manuscript. First, to understand how this outpatient group was determined, you do list approximately 10 criteria that patients have to meet to become an outpatient. For example, the aortic valve has to open during a time that the LVAD is turned down to show that the patient has some cardiac output should the device abruptly fail. Which of these criteria are the most frequent ones that prevent the patient from becoming an outpatient?
Dr Morales. Thank you for your comments. At first I think it was the 30-day restriction by the FDA. Several times, we thought we could have discharged patients sooner, but we did not because of the 30-day restriction. Also, the physiologic criterion is one of the critical safety nets for the outpatient program. In the 3 patients whose devices did fail, the ability for their native heart to give them some level of perfusion allowed them to get into the hospital, have the problem be diagnosed, and then have the device exchanged.
Dr Reitz. You had 9 patients in a "day trip" mode. Do all of the patients who become outpatients go on day trips first, or to a supervised environment, before they become completely discharged to their home?
Dr Morales. Our protocol, which switched in September 1998 when the FDA approved the TCI LVADs, was that every patient would go through five 1-day trips with their companion and then five 3-day trips. After that, they could be completely discharged. Those were the patients who were eligible for this study.
Dr Reitz. I believe you said that the 9 patients who were taking day trips underwent transplantation, and that prevented them from getting to the outpatient status. Is that right?
Dr Morales. Yes, sir.
Dr Reitz. Among the 3 patients with major problems, 2 patients had graft disruptions and bleeding that necessitated reoperation. Was the graft disruption in any particular place, and is there something that could be done to prevent that?
Dr Morales. The hole developed probably as a result of wear. One was identified at 6 weeks and the other at almost a year. The Dacron graft of the TCI LVAD sometimes kinks or bends as it is going into the ascending aorta. Dr Oz believes it can rub against the thoracic cage, which then causes the graft to wear. Actually, in both of these patients the low hematocrit levels were identified during routine visits to the outpatient clinic. Further investigation, through imaging studies, showed collections of blood surrounding the grafts.
Dr Reitz. Are you saying that these were contained ruptures, and not symptomatic?
Dr Morales. Yes, sir.
Dr Reitz. The manuscript mentions that some of these patients became sensitized, with high panel reactive antibodies, which we know is a problem with some long-term LVADs. In the group that was at home, how many patients became sensitized, and what did you do to take care of that?
Dr Morales. I do not know the exact number because I considered this a scheduled admission. They would have had this same problem whether they were an inpatient or outpatient. What would usually occur in these patients is a 3-day admission for intravenous immunoglobulin G therapy to combat the positive panel reactive antibodies.
Dr Reitz. Your success with the outpatients clearly supports the rationale for the permanent trial that I believe has started at your institution and several others. What is the status of that particular trial? Have you had the same kind of results so far that you presented in this report?
Dr Morales. I do not know the data of the rematch trial. I do not believe that information has been released publically. Dr Rose and Dr Oz could better answer this question.
Dr Walter Dembitsky (San Diego, Calif). We all have gone through the stage of "how can we do it." We are passing through the stage of "how should we do it," and now we are all entering the phase of "how do we do it best." In that spirit, we are looking at the same things in San Diego and we have been very pleased with our outpatient LVAD population. Are you evaluating quality-of-life indicators in these patients?
Dr Morales. We published a study I believe 3 years ago, but that was a very small cohort. Actually, the best quality-of-life study has been done by the Pittsburgh group, which I mentioned as a reference in the article.26 In June 1999 in the ASAIO Journal they published a formal quality-of-life study using different mechanisms such as the Sickness Impact Profile and the self-report Symptom Checklist-90. They have shown that LVAD patients at home actually have the same quality of life as transplant patients 7 months after receiving their allograft and believe that their quality of life is much better than that of transplant candidates or inpatient LVAD patients.
Dr Dembitsky. Thank you. Finally, on that rematch, 42 patients have been randomized.
Dr Michael Reardon (Houston, Tex). In our LVAD program we are not sending people home, but right next door at the Texas Heart Institute Dr Frasier is. Your results are extraordinarily good. These people seem to be doing very well. What with the risks of heart transplantation and immunosuppression, do any of your patients tell you that they do not want the transplant operation?
Dr Morales. Yes. One patient, an ophthalmologist, really tried to refuse his transplant because he said he was operating better than he had for the past few years before receiving the LVAD. It was quite a fight to get the LVAD out, but there was no choice.
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Footnotes |
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*Jacobs D. Novacor out-of-hospital experience. Personal communication, December 1998.
Krauskopf T. Summary of patients in release program: vented electric LVAS. Personal communications, December 1998.
Marchesani G. TLC-II portable driver outpatient experience. Personal communications, December 1998.
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References |
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