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Ann Thorac Surg 2002;73:1489-1494
© 2002 The Society of Thoracic Surgeons

Original article: cardiovascular

Treatment of end-stage heart disease with outpatient ventricular assist devices

William L. Holman, MD*a, James E. Davies, MDa, Barry K. Rayburn, MDb, David C. McGiffin, MDa, Brian A. Foley, MDc, Raymond L. Benza, MDc, Robert C. Bourge, MDb, Peggy Blood, RNc, James K. Kirklin, MDa

a Department of Surgery, University of Alabama at Birmingham, Birmingham, Alabama, USA
b Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA
c Department of Nursing, University of Alabama at Birmingham, Birmingham, Alabama, USA

* Address reprint requests to Dr Holman, Department of Surgery, University of Alabama at Birmingham, Birmingham, AL 35294-0007 USA
e-mail: wholman{at}its.uab.edu

Presented at the Forty-eighth Annual Meeting of the Southern Thoracic Surgical Association, San Antonio, TX, Nov 8–10, 2001.


   Abstract
Top
 Abstract
Introduction
 Material and methods
 Results
 Comment
 Discussion
 References
 
Background. Initiating outpatient therapy with ventricular assist devices (VAD) was important in the progress of mechanical circulatory support. This article reviews our experience with VAD therapy from the start of our outpatient program until the present.

Methods. Medical records of patients who received a Thoratec para-corporeal VAD, HeartMate vented electrical VAD, or HeartMate pneumatic VAD between 12/1/97 and 9/1/01 were reviewed. Variables included age, type of devices, total duration of VAD support, discharge status, duration of outpatient support, outcome (transplanted, died on support, ongoing), in-hospital length of stay after transplantation, and complications during VAD support.

Results. There were 53 device implants in 46 patients. The cumulative patient-days of VAD support was 7,468 (mean duration of support, 138 ± 195 days; median, 95 days; range, 2 to 948 days). Twenty of the 46 patients were discharged with a VAD. The cumulative outpatient days was 3,600 (mean outpatient duration, 157 ± 164 days; median, 83 days; maximum, 560 days). Of the 20 outpatients, 11 received cardiac transplantation, 5 died, and 4 are ongoing as of 9/1/01. Major complications that occurred in the outpatient setting included 5 deaths after hospital readmission (1 sepsis, 1 conduit tear, 3 neurologic events); 4 device infections (3 sepsis, 1 pouch infection); and 3 device malfunctions that required reoperation for pump replacement (1 HeartMate pneumatic and 2 HeartMate vented electrical). No deaths occurred in an outpatient setting.

Conclusions. Ventricular assist devices effectively support outpatients for months to years. The anticipated time for postoperative recovery and VAD training before discharge is approximately 14 to 21 days, although shorter times may be possible in the future. Establishing a successful outpatient VAD program is a crucial step toward VAD as definitive therapy for end-stage heart disease.


   Introduction
Top
 Abstract
 Introduction
Material and methods
 Results
 Comment
 Discussion
 References
 
Ventricular assist devices (VAD) have been in use for more than a decade and several versions have received approval for use as a bridge to cardiac transplantation. During this developmental phase, investigational protocols were developed to test the safety and efficacy of outpatient VAD therapy. The Novacor left VAD (World Heart Corporation, Ottawa, Canada) [1, 2] and Thoratec HeartMate vented electrical (VE) left VAD (Thoratec Corporation, Pleasanton, CA) [3] have completed this phase of testing and are Food and Drug Administration-approved for outpatient bridging to transplantation. Most recently, multicenter trials of the HeartMate VE and Novacor VAD were undertaken to evaluate their use as permanently implanted pumps that allow patients to life at home. The REMATCH Trial [4], a Food and Drug Administration/National Institutes of Health/industry co-sponsored trial of the HeartMate VE left VAD, has been completed [5]. In the REMATCH Trial, patients who were randomized to permanent VAD use had a 48% reduction in the risk of death from any cause as compared to patients randomized to optimal medical therapy. Moreover, the quality of life was significantly improved in the VAD-treated group. These results suggest that VAD use will rapidly expand as increasing numbers of patients who are not transplant candidates receive mechanical circulatory assist devices to treat their end-stage heart disease.

The successful outpatient use of VADs is considered a crucial step in the progression to mechanical circulatory support as permanent therapy [6–12]. This article reviews a single center experience with outpatient VAD therapy. All the patients who received VAD during the study interval at this institution are included. The outcome of patients who were discharged while on VAD support and the hospital course of VAD patients who were never discharged are described. Inferences regarding the future course of outpatient VAD therapy and potential directions for the design of novel circulatory support devices based on this experience are presented.


   Material and methods
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 Abstract
 Introduction
 Material and methods
Results
 Comment
 Discussion
 References
 
Patients who are included in this analysis received a Thoratec para-corporeal VAD, HeartMate VE left VAD, or HeartMate pneumatic (IP) left VAD as a bridge to cardiac transplantation or as a permanent implant between 12/1/97 and 9/1/01. Those patients who received an Abiomed BVS 5000 VAD (Abiomed; Danvers, MA) or who had extracorporeal membrane oxygenation support are only included in the study if they subsequently received one of the previously mentioned VAD.

Data were retrieved retrospectively from hospital records. Variables in this analysis included age, cardiac pathology, type of devices, implant and explant dates, total duration of VAD support, discharge status, duration of outpatient support, outcome (transplanted, died on support, ongoing), in-hospital length of stay after transplantation, and complications during VAD support.

Indications for the use of a Thoratec para-corporeal VAD include right ventricular failure during left VAD support despite medical therapy, refractory ventricular arrhythmias, small size (body surface area less than 1.5 to 1.7 m2), and high potential for mediastinal/pocket infection. The HeartMate IP left VAD was used if the HeartMate VE left VAD was not available (ie, before local Institutional Review Board approval for the HeartMate VE VAD or when hardware [eg, power base unit] was not available), or if discharge was unlikely for social or other reasons. Extracorporeal membrane oxygenation was used in patients with combined cardiac and pulmonary failure or in extremely grave situations (ie, salvage cases as a bridge-to-a bridge to cardiac transplantation [13]). All other patients had HeartMate VE left VAD.


   Results
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 Abstract
 Introduction
 Material and methods
 Results
Comment
 Discussion
 References
 
There were 53 device implants in 46 patients in the period under study (Table 1). The indication for mechanical circulatory support was bridge to transplantation in 43 patients and permanent use for nontransplant candidates in 3 patients. The 7 secondary VAD implants included 4 reimplants for VAD mechanical failure. Mechanical failures included pneumatic driveline dehiscence from the pump (HeartMate IP left VAD; 1 patient treated successfully by replacement of the pneumatic left VAD with a HeartMate VE left VAD); inflow valve failure (1 patient with a HeartMate VE left VAD treated successfully by VAD replacement); and conduit perforation (2 patients; 1 HeartMate VE left VAD [patient died due to air embolization at time of diagnosis and repair], 1 Thoratec para-corporeal VAD [treated successfully by replacement with implanted HeartMate VE left VAD]). Two patients with HeartMate VE left VAD underwent Thoratec para-corporeal right VAD placement at a second operation. The indications for addition of right ventricular support were intractable ventricular arrhythmias in 1 patient and right heart failure in 1 patient (both patients survived to transplantation). One patient was converted from extracorporeal membrane oxygenation support to biventricular Thoratec para-corporeal VAD support with subsequent death due to multiorgan failure. The cumulative patient-days of VAD support for our patients during this time interval was 7,468 (mean duration of support, 138 ± 195 days; median, 95 days; range, 2 to 948 days).


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  		Table 1. Summary of Patients in Outpatient Era

 
Twenty of the 46 patients were discharged with a VAD. The cumulative number of outpatient days was 3,600 (mean outpatient duration, 157 ± 164 days; median, 83 days; maximum, 560 days). The first VAD outpatient had a HeartMate IP left VAD. A special IRB study and fabrication of custom portable pneumatic drivers were required for this patient to leave the hospital. She was an inpatient for 369 days before discharge. This long duration of hospitalization before discharge was necessary to resolve regulatory issues and was not included in Figure 1. The duration of hospitalization before discharge for the remainder of the patients is displayed in Figure 1. The mean number of hospital days from implant to discharge was 45 ± 37 days, with a median of 41 days and a minimum of 13 days. During the study interval, a care map for the discharge of VAD patients was formulated by a local committee. This care map has been in place since October 1, 2000, and has improved the process for education of the patient and family by making it a uniform stepwise procedure with a checklist to ensure thorough training before discharge. Before 10/1/2000 the mean duration of hospitalization before discharge was 59 ± 39 days (minimum, 18 days). After initiating the care plan, the mean duration of hospitalization was 32 ± 21 days (minimum, 13 days). However, as shown in Figure 1, there has not been a consistent effect on the length of hospitalization after VAD implant. This persisting variability in the length of postimplant hospitalization is due primarily to prolonged convalescence after VAD placement rather than problems with patient education.



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  		Fig 1. Duration of hospitalization before discharge. (DC = discharge.) Note: The first outpatient was excluded; see text.

 
Of the 20 outpatients, 11 received cardiac transplantation, 5 died, and 4 are ongoing as of 9/1/01. Major complications that occurred in the outpatient setting included 5 deaths after hospital readmission (1 sepsis, 1 conduit tear, 3 neurologic events [2 intracranial hemorrhage and 1 air embolus]); 4 device infections (3 sepsis, 1 pouch infection); and 3 device malfunctions that required reoperation for pump replacement (1 HeartMate IP and 2 HeartMate VE). There were no deaths that occurred in an outpatient setting. Event-free survival of discharged VAD patients up to 400 days postimplant is shown in Figure 2.



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  		Fig 2. Event-free survival of 20 discharged patients on 22 ventricular assist devices up to 400 days after implant.

 
It is important to consider the patients who were never discharged while on VAD support, although the outpatient program was in place, because these issues will remain with us as we progress into the era of outpatient VAD therapy. Twenty-six VAD patients were never discharged. Ten of these patients died on support, whereas 16 of these patients were otherwise eligible for discharge. Six of the 16 patients had Thoratec para-corporeal VAD before local IRB approval of a protocol for outpatient use of the TLC-II portable drive unit (Thoratec Corporation). Currently, these patients would be offered discharge under the study protocol. Five patients were transplanted before discharge training had been completed. Three patients with HeartMate IP left VAD declined the opportunity for discharge. All of the refusals were due to patient fears regarding pneumatic VAD use outside of the hospital setting. Two patients with HeartMate VE left VADs declined the opportunity for discharge. One patient did not have a caregiver available during the majority of the day, whereas another declined due to anxiety. Patient reluctance has diminished over time as more experience is gained with outpatient VAD therapy. There were no statistically important differences between discharged and nondischarged patients with regard to age or type of underlying cardiac pathology.


   Comment
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 Abstract
 Introduction
 Material and methods
 Results
 Comment
Discussion
 References
 
The most important findings of this study are that patients with end-stage heart disease who are on VAD support can live at home with an acceptably low incidence of complications and are unlikely to die out of the hospital while on VAD support. There is no way to meaningfully compare inpatient to outpatient complication rates because of the inherently higher chance for complications during the early phase after VAD implant [6], but it is noteworthy that there was not a single death during the time that patients were actually outside the hospital. This may change as patients live progressively further from the hospital where the VAD was implanted; however, the risk-to-benefit ratio still seems favorable given the benefits of outpatient life. In the present report, patients bridged to transplantation were required to live within roughly 1 hour’s travel from the hospital. Patients with permanent implants do not have this restriction and can live further away from the implanting hospital. One patient in this series with a permanent implant lives 370 miles away from this hospital and has been at home for 2 years. Her only complication thus far is inflow valve insufficiency in her HeartMate VE left VAD. Her VAD was electively replaced and she continues to live at home.

The duration of postimplant hospital stay depends on the speed of the patient’s postsurgical recovery as well as the time required for patient and family training. It is possible that implanting a VAD before the onset of profound circulatory failure and end organ dysfunction will shorten the postimplant length of hospital stay by minimizing the time required for postsurgical recovery. However, we are also working to shorten the inpatient stay by starting the educational process at the earliest possible time after VAD implant and expressing to the patient and family the expectation that discharge will occur within approximately 2 weeks after implant. Implementing a care plan that sets deadlines and assigns tasks helped us to organize this effort. The care plan coordinates consultative services, teaches patient self-monitoring of health status and VAD maintenance skills, and arranges outpatient services. Last, postsurgical recovery time may be shorter with the newest generation of VAD (axial flow and centrifugal devices), which are smaller than the currently available pulsatile implanted VAD [14–16].

The time necessary for convalescence after VAD placement has been difficult for us to accurately predict based on information available at the time of preimplant evaluation. For instance, patients with preimplant noncardiac organ dysfunction may have these abnormalities purely on the basis of poor perfusion. If there is a good response to VAD therapy, the patient’s organ function (eg, renal and hepatic) may normalize over the span of a week during which time the patient can actively participate in predischarge teaching. In contrast, patients with acute decompensation or cardiac arrest immediately before device implant may have normal measurements of renal and hepatic function at the time of implant, but may progress to multiorgan dysfunction with a prolonged and complex convalescence that precludes meaningful learning by the patient until recovery is nearly complete.

Other chronically ill patients may have relatively normal noncardiac organ function and few of the other commonly accepted risk factors for postimplant death (eg, intubation or infection at the time of implant), but still take longer than a less debilitated patient for wound healing and physical rehabilitation due to malnutrition and muscle wasting. The variables describing general heath and functional status are more difficult to measure than individual organ (eg, renal or hepatic) function. Furthermore, there are no studies to date that have quantified the effect of these potentially important general health factors on the duration of convalescence after VAD placement.

The patients in this study who received Thoratec para-corporeal VAD were never discharged. Discharge is now possible with this device because the portable pneumatic driver for the Thoratec VAD (TLC-II pneumatic drive unit) [17] is available to us for use in the outpatient setting under a Food and Drug Administration Investigational Device Exemption. We have received approval from our IRB and are beginning this service. The paracorporeal position of the Thoratec pump and need for coumadin anticoagulation pose challenges for outpatient life; however, the reported experience with outpatient TLC-II support as well as our own experience with the TLC-II for inpatient support have been encouraging. This is an important advance for small patients, patients who require support for biventricular failure, or patients who are at risk for episodes of recurrent and refractory ventricular fibrillation. In the future, outpatient therapy with total artificial hearts will be another option for some of these patients.

Other technological advances that have the potential to improve outpatient life for VAD patients include completely implanted devices that are expected to have less potential for infection [18–21] and will not require the daily dressing changes required for percutaneous drivelines. Although fully implanted VAD will be less prone to infection than current designs that have percutaneous connections [22], the large prosthetic surface available for bacterial colonization at the time of implantation remains an attractive surface for growth of biofilm-forming bacteria [23]. The prevention and eradication of such infections may require measures beyond the current regimen of sterile operative technique and perioperative antibiotic prophylaxis.

Another challenge for the more widespread use of VAD is providing for local patient support services. These services are arranged before discharge according to the care plan checklist, and range from provisions for emergency resumption of electrical power in case of an outage (an important consideration in our state that has large rural areas and seasonal tornadoes) to planning for emergency transport and care. Education of local providers is difficult due to the infrequent need for such service and staff turnover at local EMS providers and hospitals [24]. At present, we provide local support facilities with videotaped presentations on emergency care of VAD patients and ask that these patients be transferred to us as soon as possible in the event of an emergency, preferably using our institution’s critical care transport service.

Clinic visits for VAD patients are scheduled weekly until all wounds are well healed and the patient has shown competence in living outside the hospital. All clinic visits are scheduled to include a cardiologist with knowledge of VAD (typically a transplant cardiologist) and a surgeon with expertise in this field. When weekly clinic visits are no longer necessary, biweekly to monthly appointments are made. These patients do not require home nursing visits except under unusual circumstances. During the initial trial of the HeartMate VE left VAD, patients were required to have a trained caregiver within earshot at all times. This restriction has been eased in our practice to allow patients more freedom. They are asked to have a means of contacting a trained caregiver who is in the vicinity but not necessarily within earshot at all times. As device reliability and experience with outpatient life increases, we expect greater independence for the patients and their caregivers.

Outpatient use of VAD as a bridge to cardiac transplantation has blazed the trail for future patients who will receive these devices as permanent implants. Modifications of existing VAD and new device designs will make VAD increasingly reliable for longer periods of time. Thus, during the next decade we expect to see increased utilization of mechanical circulatory support primarily in patients who receive VAD as an alternative to medical therapy for end-stage heart disease rather than as a bridge to cardiac transplantation. Gathering of high quality data describing the outcome of these patients is crucial to the appropriate and optimal utilization of this expensive technology, and is another major challenge for the immediate future [25].


   Discussion
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 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Discussion
References
 
DR PETER K. SMITH (Durham, NC): Thanks for that nice report, Bill. I was wondering, most of us are in control of our lives, for the most part, except when we are on a plane flight nowadays. These patients obviously are tethered in one way or another to a hospital organization. I wonder if you have any comments on the psychological effectiveness of giving these patients modest control over their lives by being in their home environment, and then perhaps whether you would comment on the financial reimbursement aspects of setting up a program like this one.

DR HOLMAN: Thanks, Peter. I think those are important questions. It is interesting that when the program started the insurance companies were loathe to have us send the patients out of the hospital, which I could not understand because it probably runs a thousand dollars a day or more to have a patient in the heart transplant unit. Also, the patients themselves thought, "I can’t leave the hospital with this device, I mean, my God, I would be out there with a machine, et cetera." But once the experience was started and people got comfortable with ventricular assist devices, I began to get calls from the insurance companies asking, "Why hasn’t this patient been discharged?" Similarly the patients, when they have a taste of freedom, really do not want to come back, even if I see they are developing an infection or something that requires a short in-hospital stay. So it is a tremendously enabling technology for the patients.

They really do enjoy being outpatients.

The patients who are being bridged to a transplant and cannot go all the way back to their home (eg, getting back in time for a donor heart), nevertheless enjoy being at our outpatient apartment building across the street from the hospital. The patients are back in control of their lives. They can go to the mall and walk. They can do pretty much everything except swim or get in a bathtub.

Financially we are still encountering problems with support for the outpatient effort. We are having a very hard time finding reimbursement for any supplies that are given to the patient. This typically includes vent filters and rechargeable batteries. Over time I expect this to be worked out with third party payers, but my advice to anyone beginning a program now is make sure all your charges are made up front in the operating room, because it is very hard to recoup these additional costs later.

DR IRVING L. KRON (Charlottesville, VA): Bill, that is a very nice series, and the truth is that these devices may be the future of cardiac surgery as the ventricular assist devices become more implantable and smaller and truly more efficient.

I have two quick questions. One is, what are you doing for bleeding prophylaxis these days? Obviously if you have less bleeding you can send them home sooner. And second, what has been the result of these devices in your program on preformed antibodies and suitability for transplantation? Thank you.

DR HOLMAN: Dr Kron, those are, again, important problems. The bleeding issues have been substantial. Many of these patients are in chronic heart failure with congestive hepatic insufficiency, and even if their INR is not elevated at the time of operation, they tend to have less hepatic reserve to generate new clotting factors. If at all possible, before operation we give them vitamin K. In the operating room we use replacement therapy, typically fresh frozen plasma, in the pump prime to correct any deficiencies. I routinely use aprotinin; other surgeons have used aminocaproic acid as well with benefit. Do not use the two together, because the blockade of two thrombolytic pathways may be somewhat too pro-thrombotic.

The other issue is to keep the operating room as warm as you can and remember to rewarm the patient thoroughly at the end of bypass. That is something that can be forgotten in the heat of battle. If you are perfusing the patient at 38°C for only a short time before you separate from cardiopulmonary bypass, you can get into trouble in the operating room with hypothermia.

The second question you asked had to do with preformed antibodies, which are a big problem. It is actually a very complex problem because of how one decides to measure these antibodies. If you are using flow cytometry, the problems with cross-reactivity as well as sensitivity become enormous in defining exactly what your preformed antibody titer is to donor antigens. Suffice it to say that we do not have a good answer other than to allow the patients as long as possible on the device if the PRA titer is elevated. They tend to have a decrease in their PRA over time. Exactly what triggers the formation of these antibodies is not clear. It seems that transfusions, especially if they have white cells in them, in other words, nonirradiated transfusions, can be one source of the antigen to stimulate PRA formation. However, that is not the only source; just the stress of the ventricular assist device implant seems to have something to do with it. Also, the time of onset for the PRA elevation is variable from one patient to another. So my advice is to test your patients at least every 6 weeks to determine whether they have developed a change in their PRA titer.

In terms of managing the patients immediately before transplantation, particularly in the face of a high PRA, although the cross-match is negative, we are using plasmapheresis, if we have the time, before they receive their heart. Then the patients receive a very aggressive prophylactic regimen against rejection after transplantation.

Again, thank you for the privilege of the floor and membership into the Society.


   References
Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Discussion
 References
 

  1. Loisance D.Y., Jansen P.G., Wheeldon D.R., Portner P.M. Long-term mechanical circulatory support with the wearable Novacor left ventricular assist system. Eur J Cardiothorac Surg 2000;18:220-224.[Abstract/Free Full Text]
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