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Ann Thorac Surg 2000;70:59-66
© 2000 The Society of Thoracic Surgeons
a Division of Cardiothoracic Surgery, University of California Medical Center, Los Angeles, California, USA
Address reprint requests to Dr Marelli, Division of Cardiothoracic Surgery, UCLA School of Medicine, 10833 Le Conte Ave, 62-238 CHS, Box 951741, Los Angeles, CA 90095-1741
e-mail: dmarelli{at}mednet.ucla.edu
| Abstract |
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Methods. Nineteen status I patients failing inotropic support were treated with the BVS 5000i with the intention of short-term bridge to transplant. Fourteen patients received left ventricular support whereas 5 received biventricular support. Cardiopulmonary bypass was used in less than 50% of patients.
Results. Median support time was 7 days. The 2 myocarditis patients were weaned from support. Twelve patients were transplanted and there were 5 deaths on support. Overall 14 of 19 were transplanted or weaned. One-year survival was 79%. Median hospital stay was 31 days.
Conclusions. The BVS 5000i can be used for short-term mechanical assist toward transplantation in selected patients for whom a donor can be expected soon. The device may provide a cost-effective, short-term strategy to optimize end-organ function before orthotopic heart transplant, particularly for patients who are predictably not ideal to be discharged with implantable left ventricular assist device treatment.
| Introduction |
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The BVS 5000i external pulsatile VAD is typically used for short-term mechanical support in postcardiotomy patients with cardiogenic shock or in other situations when myocardial recovery is expected [5]. It has a small console that can provide biventricular support and does not require specialized bedside personnel. Two attractive features of this assist device are its low cost and the option to institute support without CPB. Theoretically, avoiding CPB should lead to shorter postoperative recovery of end-organ function. We hypothesized that this device would be ideal for certain heart failure patients with limited end-organ dysfunction and who would not require long waiting times for a donor heart.
We report our experience with the BVS 5000i as a bridge to orthotopic heart transplant (OHT) for smaller patients with severe congestive heart failure (CHF) and end-organ dysfunction, who require short-term optimization before OHT.
| Material and methods |
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BVS 5000i device
The BVS 5000i device is an external pulsatile pump that is pneumatically driven [6]. It consists of a polyurethane chamber in a polycarbonate housing. The atrium of the pump is filled by gravity and empties passively after the ventricle contracts. It supplies blood to a ventricle from which it is separated by a one-way valve. When the ventricle fills with 80 mL of blood, it generates a pressure that is sensed by the console that immediately sends compressed air back to the pumping chamber, causing the bladder to eject its volume. Unidirectional flow is ensured by the presence of one-way valves similar to a human heart.
Left ventricular (LV) assist is achieved using a cannula graft with an extension sewn onto the aorta. The ascending aorta is dissected at its distal portion and a side-biting clamp is applied after heparin is given to achieve an activated clotting time of 300 seconds if the procedure is to be done off bypass. Previous coronary grafts are carefully preserved. The arterial inflow graft is then anastomosed in an end-to-end fashion to the aorta with a running 4 to 0 Prolene suture and reinforced with a pericardial strip (Fig 1). In most cases, the left atrial cannula is inserted into the right superior pulmonary vein. We have occasionally used the left atrial appendage (in younger patients) or the dome of the left atrium when it is very large. The cannulas are positioned away from the heart and tunneled through the abdominal wall to allow for chest closure without compression of the right ventricle (Fig 2). Two patients had LV apical cannulation. One of these patients, with severe dilated cardiomyopathy (CM), had the cannula placed off CPB via a small left anterior thoracotomy in addition to a sternotomy. The other had an LV apical cannulation on CPB following a failed revascularization for chronic ischemic CM. Our preference is to use the malleable 36F open-end cannula for all intracardiac cannulations, making sure the bevel is pointing away from the septum of the chamber of insertion.
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The devices internal rate is set by cyclic filling and it self-adjusts to maintain a stroke volume of 80 mL. It is usually slightly slower than the patients native rate. The blood chambers are suspended on a pole so that preload and afterload can be optimized for maximal output, which is usually greater than 5 L/min. In the ICU, filling pressures are adjusted to 8 to 12 mm Hg. Afterload is controlled with vasodilators. We aim for a mean systemic arterial blood pressure of 75 mm Hg to minimize the risk of cerebrovascular bleeding complications. Postoperatively, patients can be weaned off mechanical ventilation, can receive physiotherapy, and can receive normal diets. When pulmonary function recovers, they can ambulate within the ICU with assistance.
If base line panel reactive antibodies (PRA) are negative, transplantation without a donor/recipient crossmatch can occur within a week. After a week, however, a repeat PRA analysis is performed with a prospective crossmatch needed if treated PRAs are greater than 10%.
In all cases but one, the BVS 5000i was implanted via sternotomy. A thoracotomy was used in 1 patient as a precaution to avoid the risk of injuring patent bypass grafts inserted 1 year earlier. All patients underwent transesophageal echocardiography intraoperatively to rule out the presence of a patent foramen ovale. We attempted to insert the device off CPB in all patients when a patent foramen ovale was absent.
| Results |
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Twelve patients were transplanted after an average support time of 7 days. Four of these 12 received marginal donor hearts (see Comment). One patient died postoperatively of acute rejection and 1 of graft failure. The patient who died of graft failure received a marginal donor heart with myocardial contusion. This patient had received urgent BIVAD support after receiving cardiopulmonary resuscitation continuously on the way to the operating room. He had biventricular failure due to muscular dystrophy and was considered a poor candidate for an implantable LVAD.
The 12 survivors were discharged after an average hospital stay of 24 days postsupport (6 to 61 days). For the 14 patients who were transplanted or weaned, 30-day and 1-year actuarial survival was 85% and 79%, respectively (Fig 3).
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Six patients developed renal failure and required dialysis, 4 of whom who died. Seven patients were extubated while on support. Seventeen of 19 patients achieved flows of 5 L/min while 1 patient had flows of 4 L/min, due to using the earlier generation BVS 5000i; flows were limited to 3 to 3.5 L/min in the small pediatric patient. Nine patients underwent reexploration for bleeding.
Creatinine levels were monitored daily to evaluate renal function (Fig 4). Over the duration of support, levels decreased or remained stable for 14 of 19 patients.
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| Comment |
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McCarthy and coworkers [3] reported on the use of the Heartmate implantable LVAD in 100 patients. Sixty-nine percent of their patients had ischemic CM. The mean duration of support was 70 ± 41 days (up to 206 days) and overall survival to heart transplantation was 76%. Overall, 1-year survival for the 100 patients was 67%. Fifty-eight percent of patients were found to have positive blood cultures whereas 28% had driveline infection. They concluded that the device provided excellent hemodynamic support but because of technical issues with the device and other postinsertion complications, cost was very high. Elevated creatinine before the insertion of the Heartmate was one of two significant risk factors for death before transplantation in multivariate analysis (1.8 versus 1.4 mg/dL, p = 0.05, odds ratio 2.4). The other risk factor that was significant was the use of extracorporeal membrane oxygenation (ECMO) preoperatively for resuscitation (33% versus 16%, p = 0.08, odds ratio 3.6).
Sun and coworkers [4] also recently reported the use of 100 Heartmate LVADs in 95 patients. Fifty-two patients received the pneumatic LVAD (five device changes) and 43 received the vented electrical model (four device changes). The mean duration of support was 108 days (0 to 605 days). Seventy percent were transplanted and 4% were weaned. Overall, mortality was 25%.
Recently, the Food and Drug Administration approved implantable electrical LVADs that allow for hospital discharge and are currently widely used. Nonhemodynamic criteria for insertion of these include a body surface area (BSA) of more than 1.5 m2, and patients ability to manage the device. A 24-hour companion capable of managing the device is a prerequisite [7]. This treatment has several limitations in addition to the high device cost. Implantable devices required extensive surgery, including CPB, which may be too risky for certain patients such as those on ECMO or with secondary renal insufficiency, reflecting a late stage of CHF. Also, although most chronic heart failure patients can be treated only with a LVAD, as seen in this series, certain patients require BiVAD. Such patients therefore require external assist systems or a total artificial heart. Lastly, not all patients are candidates for discharge on an LVAD, especially those living in remote areas away from transplant centers. Body size to accommodate current implantable VADs has also been a concern in the past.
The BVS 5000i is a lower cost and less invasive potential alternative to implantable VADs. The average support time and total hospital length of stay for the transplanted/weaned patients in this series was 6.7 and 31 days, respectively. This time differs greatly from previous pneumatic Heartmate recipients at our institution who were supported for an average time of 115 days and had an average hospital length of stay of 150 days (unpublished data). These longer times pose greater costs and are partly attributed to longer transplant waiting times due to the typical use of the Heartmate in larger patients (average BSA 2.03 m2). In the present study, the overall wean/transplant rate was 74%. This rate suggests that in selected patients the BVS 5000i can provide comparable end results to implantable LVADs, with shorter total support time. By avoiding the need for abdominal wall dissection, and in many cases, CPB, the BVS 5000i may offer certain patients a decreased risk of postoperative complications. This advantage may translate into lower hospital costs, particularly if patients are to remain hospitalized until transplantation. The BVS 5000i may also shorten reactivation of UNOS status following a faster postoperative recovery. As discussed in the study by McCarthy and coworkers [3], a lower prechronic LVAD implant or preorgan transplant creatinine provides the patient a greater chance of survival. By optimizing end-organ function, including renal function, "off pump" BVS 5000i treatment may thus be useful in improving survival rates for high risk patients requiring mechanical support as a bridge to transplantation. Avoiding the heart-lung machine would prevent the aggravation of existing end-organ dysfunction. The requirement for anticoagulation therapy and limited patient mobility warrant the use of the BVS 5000i as a short-term device in a staging strategy for selected patients. This is well adapted to the current UNOS guidelines dividing status I patients into IA (short-term) or IB (long-term) subdivisions.
Other paracorporeal options for the patients presented in this study included centrifugal pumps and the Thoratec pulsatile system. A centrifugal pump does not provide pulsatile flow and requires specialized bedside personnel, thereby increasing the costs. The Thoratec system offers the possibility of both short-term and long-term support. However, as of this writing, outpatient treatment is currently not approved by the Food and Drug Administration and the cost of this device is significantly greater than that of the BVS 5000i.
The 5 deaths that occurred on support in this series were among patients who presented with severe cardiac dysfunction and worsening end-organ function. Patient "R.F." presented with renal and hepatic insufficiency. He had ischemic CM and several patent bypass grafts. The device was implanted off CPB via a lateral thoracotomy. At the time it was considered that he would have been a poor candidate for an implantable LVAD placed on CPB. He required reexploration for bleeding and the thoracotomy approach revealed itself to be cumbersome for this. We have since abandoned this approach and have been able to place the BVS 5000i off CPB in cases of redo sternotomy and previous coronary artery bypass graft surgery.
Patient "J.P.", aged 65 years, had a history of atrial fibrillation and a massive anterior wall myocardial infarction. After 3 weeks of unsuccessful medical treatment and worsening renal function in the ICU, the BVS 5000i was implanted. Unfortunately, at the time of implantation, the patient had dialysis-dependent renal failure. He was reexplored for tamponade on postoperative day 4 and died on postoperative day 6 as a result of MSOF.
Patient "W.M." presented an opportunity to be bridged to an implantable device. The patient was a 52-year-old man with dilated CM. Because he was referred with a creatinine level of more than 4.0 mg/dL, he underwent BVS 5000i placement off CPB. He was extubated and ambulatory (out of bed) postdevice implant, and exhibited improved end-organ function. Unfortunately, on day 9 of support, he experienced several cerebral vascular emboli postimplant due to heparin-induced thrombocytopenia. This precluded transplantation and he expired one day later. Because of his blood type B, our plan had been to support him for 14 days. If a donor heart had not become available during that time, we would have offered him an implantable LVAD.
Two patients underwent device placement due to postpartum CM and both died. Patient "S.S." was on multiple inotropic agents and an intraaortic balloon pump at time of LVAD insertion. An RVAD was later added. At time of withdrawal of support, the patient had pseudomonas pneumonia and liver dysfunction. Patient "E.S.," who also had only an LVAD initially, went into ventricular fibrillation. The patients chest was opened urgently and cardiopulmonary resuscitation was administered while a centrifugal RVAD was inserted. She was then converted to a BVS 5000i RVAD off CPB. She also developed heparin-induced thrombocytopenia presenting as disseminated intravascular coagulation, which required numerous transfusions of blood products. She developed respiratory distress syndrome and died of MSOF.
Indications for RVAD insertion at time of LVAD implant include CHF with pulmonary hypertension, rapidly progressive biventricular CHF (eg, giant cell myocarditis), or for patients with a history of cardiac arrest. Post-LVAD implant, flows less than 5 L/min indicate a failing right ventricle and necessitate the insertion of an RVAD, at least temporarily. In the 2 postpartum CM patients described above, RVADs were inserted post-LVAD insertion after evidence of right ventricular failure. We recommend to implant LVAD and RVAD simultaneously in postpartum CM patients to prevent the effects of a later failing right ventricle.
The use of the BVS 5000i for treatment of acute myocarditis was reported recently [9]. It was hypothesized that the device allows the heart to concentrate on using its metabolic energy for repair rather than work. In patients in whom the potential for recovery is not known, the BVS 5000i allows for the optimization of the patient in the event that transplantation becomes necessary. Because most myocarditis patients are not chronically ill, unlike many patients with CM, the device is useful for optimizing and maintaining end-organ reserves whereas long-term restoration is not typically needed. Such patients also present a particular technical challenge for insertion of large apical cannulas as their left ventricles are not enlarged. The 2 patients in the present series were listed for OHT. After 4 days of support, however, the patients appeared to have recovery of myocardial function, which improved steadily over the subsequent week, thus avoiding the need for transplantation.
Our strategy demonstrates that it is possible to bridge CHF patients with a potentially cost-effective, short-term strategy. When compared with a hospital stay that may be lengthened by a more complex implantable LVAD procedure, a short-term strategy with a total hospital stay of 30 days (including transplantation) is an attractive option, especially when there is advanced preoperative end-organ dysfunction. Our study did not compare the cost of short-term bridging in the ICU with the cost of long-term bridging out of the ICU, but in the hospital for several months. It is suggested, however, that in many cases it may be possible to shorten the process of mechanical bridge to transplant while maintaining equivalent results. Furthermore, our strategy avoids the delayed reoperation following chronic LVAD implant that can be complicated by severe adhesions. It also avoids the infectious complications associated with chronic LVAD therapy. UNOS has established new guidelines for the assignment of status codes for heart recipients [8]. Patients who have been on an LVAD or an RVAD or both for 30 days or less are considered to be status IA whereas those who have been on an assist device for more than 30 days are considered to be status IB. Figure 6 depicts a possible strategy for treating CHF, while maximizing organ usage. The BVS 5000i is ideal for use in critically ill status IA patients when a heart is expected soon. The advantage of the BVS 5000i can be assessed by taking into account body size, blood type, and regional status I listing. If a donor heart is not expected soon, the BVS 5000i can be used to optimize status IA patients before being converted to an implantable chronic LVAD for longer-term support, which results in a downgrade in UNOS status to IB after a total of 30 days of support. If a patient is in distress (status IB) and has preserved end-organ function an implantable chronic LVAD is the current accepted standard.
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Our results suggest that the BVS 5000i can be used to optimize patients before conversion to a chronic implantable LVAD. Our study did not include such patients. We demonstrated that the use of the BVS 5000i in an intermediate staging strategy leading to heart transplantation may provide survival rates comparable to those achieved with implantable LVADs in selected patients. This strategy may also significantly reduce overall hospital stay for patients who are not discharged with an implantable LVAD.
| Appendix A |
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BiVAD = biventricular assist device; CPB = cardiopulmonary bypass;LVAD = left ventricular assist device; OHT = orthotopic heart transplant.
BSA = body surface area; DCM = dilated cardiomyopathy;ICM = ischemic cardiomyopathy; MI = myocardial infarction;PPCM = postpartum cardiomyopathy.
| Appendix B |
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BiVAD = biventricular assist device; CPB = cardiopulmonary bypass;LVAD = left ventricular assist device; OHT = orthotopic heart transplant.
BSA = body surface area; DCM = dilated cardiomyopathy;ICM = ischemic cardiomyopathy; MI = myocardial infarction;PPCM = postpartum cardiomyopathy.
ALT = alanine transaminase; AST = aspartate transaminase; BiVAD = biventricular assist device; BUN = blood urea nitrogen; CPB = cardiopulmonary bypass; ECMO = extracorporeal membrane oxygenation; IABP = intraaortic balloon pump; LVAD = left ventricular assist device; OHT = orthotopic heart transplant.
| References |
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