How to Run an Outpatient VAD Program: Overview

During the past decade, patients with implanted left ventricular assist devices (VADs) began to leave the hospital environment under Food and Drug Administration (FDA) sponsored Investigational Device Exemption trials. These trials culminated in the approval of two VADs (HeartMate VE [Thoratec Laboratories, Inc., Pleasanton, CA] and Novacor [World Heart Corporation, Ottawa, Ontario, Canada) for use in out-patients as a bridge to cardiac transplantation. A variety of other new assist devices, including axial flow VADs and total artificial hearts, are now entering out-patient trials as a bridge to cardiac transplantation or as a permanent implant. 1–3 Out-patient programs have been designed according to the needs and requirements of each participating center. In general they follow examples provided by the FDA sponsored out-patient trial designs and the information published from individual programs. 4–13 However, there has not yet been a national symposium to present the details of administering an out-patient VAD program. The purpose of this symposium was to present information on various aspects of out-patient VAD management, followed by a question and discussion period. Symposium participants were from centers with active out-patient VAD programs (the University of Iowa [Dr. Richenbacher and Ms. Seemuth], the University of Minnesota [Ms. Ormaza], Pennsylvania State University [Dr. Boehmer], and the University of Alabama at Birmingham [Dr. Holman]). A review of out-patient VAD programs indicates that roughly 40% to 60% of patients with implanted left VADs pending cardiac transplantation are discharged. However, at the University of Iowa 12/14 bridge to transplant patients were discharged during the past two years. 14 An 86% discharge rate may too high to set as a benchmark for all bridge to transplant programs, but it does serve as an example of what can be achieved with appropriate patient selection and an education program that is highly focused on returning patients to their homes. The importance of the Iowa experience is that similar rates of discharge will be necessary, together with a low re-admission rate, to justify the use of VADs as permanent implants. Training of the patient and their care givers was the subject of a presentation from the University of Minnesota. Their approach incorporates early initiation of education (preimplant or immediate postimplant) to minimize the duration of postimplant hospitalization. The goals of their program are to provide the information necessary for successful out-patient existence together with counseling that reduces apprehension of the patient and his or her support group. An interesting aspect of the Minnesota program is its attention to the patient’s neuropsychiatric status, including stress management and assessment of postimplant cognitive function. A program for patient and care giver education was outlined that can be completed in 7 days and includes 1:1 instruction reinforced with computer-based self-examination. The computer-based module was developed by Thoratec [Thoratec Laboratories, Inc; Pleasanton, California; USA] as a CD-ROM explaining use of the HeartMate VE system. Other details of educating the community health care and utility providers for the in-patient to out-patient transition were discussed. 15 At the University of Iowa, letters are sent to the power and phone providers to notify them of the patient’s need for these services, and to request high priority for service in the event of an outage. It was noted in the discussion that power and phone providers (depending on location) may be under no legal obligation to provide this coverage. Thus, alternative plans for managing outages must be formulated if the providers are unwilling to give the VAD patient living at home top priority for restoring service in the event of an outage. Other providers included in the educational effort include: local physicians and dentists, emergency medical service (EMS) personnel, physical therapists, emergency room (ER) staff and transport personnel, friends and relatives, visiting nurses, employers, and educational facility personnel (e.g., school nurses). This level of education requires a large commitment from university based personnel. At the University of Iowa this is largely the responsibility of the VAD coordinator, Kate Seemuth, R.N., M.S.N. 15 The discussion brought up several problems facing out-patient VAD programs and questions regarding the details of designing these programs. The training of local EMS and ER personnel is problematic because incomplete attendance at training sessions and staff turnover make it possible for a patient with an urgent problem to encounter EMS or ER personnel who are unfamiliar with VADs. The approach to this problem at other centers has been to supply these providers with videotaped presentations that can be used repeatedly (University of Alabama at Birmingham) or computer-based distance learning courses (University of Iowa) that can be taken at any time of the day or night. Training the patient and their family to direct the actions of EMS and ER personnel in collaboration with personnel at the implant center is another approach that was advocated by several centers. An informal survey of attendees at the meeting indicated that restrictions on out-patient activity are easing as experience with out-patient VAD therapy increases. This includes, most notably, allowing patients to live at increasing distances from the implant center, and allowing the patient to spend periods of time without a trained care giver within sight or earshot. The patient is provided with a cell phone or other communication device, and plans are made for immediate response in the event of an emergency. The experience of automatic cardioverter-defibrillator patients provides a useful precedent for developing strategies to give progressively greater freedom to VAD patients. There was general agreement that VAD patients should begin out-patient life with weekly visits to clinic. If this goes well, most centers lengthen the time between clinic visits to 1 month. Procuring funds to supply out-patients with disposable items (e.g., vent filters and dressing supplies) remains an unresolved problem for many programs. The use of day trips and overnight visits as a prelude to full discharge is embraced by many centers, but this is not universal. Several VAD-related problems, including infection of percutaneous drive line sites and inflow valve disruption in the HeartMate VE left VAD have been successfully managed, at least for periods of time, in patients at great distances from the implant center. The safe limits to such out-patient therapy have not yet been clearly defined. Out-patient therapy has progressed from investigational status to an accepted component of VAD support for patients bridged to transplantation. The details of running such a program vary from center to center, partly in response to local conditions and partly because of incomplete information regarding the optimal approach. The major challenge facing out-patient VAD therapy at the present time is managing patients with permanently implanted devices.

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