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Ann Thorac Surg 1996;61:396-398
© 1996 The Society of Thoracic Surgeons
Department of Surgery, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
Abstract
Background. There is interest in expanding ventricular assist device use from short-term bridging to transplantation to long-term and permanent support.
Methods. We have reviewed the outcome of 162 patients who had a mechanical bridge to transplantation that lasted at least 60 days. Eighty-five patients received the HeartMate, 40 the Novacor, and 37 the Thoratec device.
Results. Of the 162 patients, 125 received transplants, and 115 survived after transplantation (93%). Within the group there were 174 complications including 54 infections of the driveline, 73 other infections, and thromboembolic strokes in 47. Infections of the driveline were considered major in 24 of 54 cases, and other infections were major in 36 of 73 cases. Twenty-seven of those who sustained thromboembolic events had residual effects. Of 11 patients with a major stroke and infection, only 1 survived transplantation. Eighty-two patients were supported between 60 and 100 days, 63 patients between 101 and 200 days, 12 patients between 201 and 300 days, and only 5 patients in excess of 300 days. A greater percentage of candidates died waiting between 101 and 200 days than between 60 and 100 days (25% versus 10%). The incidence of complications also rose in those patients bridged more than 100 days.
Conclusions. The data reinforce the excellent results obtained in the bridge to transplantation trials that reported a shorter duration of support. For those interested in extended bridge to transplantation or permanent use of the currently available devices, the results suggest reasonable success can be anticipated, but the serious infections and strokes tend to be more common with longer duration of support.
The directive from The Society of Thoracic Surgeons' Ad Hoc Committee on mechanical circulatory support to discuss outcome and complications in patients with prolonged bridge toward transplantation is timely. Most centers with large programs in transplantation have adopted either the HeartMate (Thermo Cardiosystems, Woburn, MA) Novacor (Novacor Division, Baxter Healthcare Corp, Oakland, CA) or Thoratec (Berkeley, CA) ventricular assist device to support patients with morbid congestive heart failure while awaiting heart transplantation. Somewhat subtly but not surprisingly, the increasing need for transplantation and stable levels of donor hearts available have not only translated into longer waiting times for all patients on the United Network for Organ Sharing heart transplant list but also have resulted in a progressively increasing duration of support for those requiring a mechanical circulatory bridge. The problem of long waiting times has in fact provided an opportunity to evaluate the performance of the investigational ventricular assist devices and permits a projection of what likely would be the results of these devices as isolated therapy without a cardiac transplant option. The National Heart, Lung and Blood Institute trial designed to test a totally implantable device compared with medical therapy for end-stage heart failure was discontinued after a year of protocol development, not because of a reluctance to proceed, but because of a lack of pump availability [1]. Surgeons experienced with available ventricular assist devices that are vented and energized via a percutaneous cord are rightfully asking whether it is reasonable to proceed now without the use of a totally implantable device. The current devices use external power sources that require percutaneous tethers. The risk of infection of the drivelines must be weighed against the risk of death due to progressive heart failure. The purpose of this article is to review the experience of patients supported with one of the three ventricular assist devices for at least 60 days. An emphasis has been made on outcomes, including likelihood of transplantation and its success, the incidence of death while supported, and the likelihood and impact of wound, blood, or driveline infection or stroke.
Material and Methods
The evaluation was restricted to the HeartMate, Novacor, and Thoratec ventricular assist devices (Table 1
). The total artificial heart was excluded because there had been few contemporary long-term uses of the device in comparison with the ventricular assist devices. A list of clinical investigators was obtained from the three manufacturers of these ventricular assist devices, and a questionnaire was sent to each relative to outcome and complications in patients bridged for at least 60 days. The questionnaire was simplified to obtain a high rate of response. It included age, number of days the device was implanted (excluding all patients who received the device for less than 60 days), the presence of infection and stroke, and outcomes, including successful transplantation, death while awaiting transplantation, or death after transplantation. Infections were generally categorized as major or minor, and major infections not of the driveline included those in the blood, wound, or lung. It was left to the investigator to decide the difference between major and minor. A minor stroke included transient ischemic attacks, and a major stroke included a cerebral infarction with clinical residual. Successful transplantation was defined as the patient being well and discharged from the hospital after the procedure. The outcome was divided by duration of implantation between 60 and 100 days, 101 to 200 days, and greater than 200 days. Although it was possible to identify the presence of a complication at the various intervals, the postoperative day on which the complication occurred was not recorded, and the actuarial incidence and linearized rate of complication could not be calculated. Because this was an entirely volunteer response and the data could not be independently verified, device-specific information was not tabulated.
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Responses were combined for 162 patients who had been bridged to transplantation for at least 60 days (HeartMate, 85; Novacor, 40; Thoratec, 37). Of the 162 patients 125 received transplants and 115 survived (93%), 7 were waiting for transplantation, and 25 died during support. Surprisingly, 6 patients were weaned and 4 survived. In the group there were 174 complications, including driveline infections in 54, other infections in 73, and strokes in 47. Driveline infections in 24 of 54 were considered major. Other infections were major in 36 of 73 instances, and strokes with residual defects were noted in 29 of 47 (Table 2).
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). Outcome by implantation interval includes a 75% incidence of transplantation with a 92% survival between 60 and 100 days, a 76% incidence of transplantation with 93% survival at 101 to 200 days, and a 92% incidence of transplantation with a 91% survival between 201 and 300 days. A greater percentage of candidates died waiting between 101 and 200 days than between 60 and 100 days (25% versus 10%). The incidence of complication recognized at various implantation intervals suggests a higher incidence of driveline infections (49% versus 25%; p < 0.002) after 100 days; likewise, other infections were observed more commonly in the group of patients who had been bridged more than 100 days (Fig 2). Between 60 and 100 days, 33 (37%) had other infections compared with 32 (55%) of those supported for 101 to 200 days (p < 0.05). Stroke occurred in 18 (21%) of the 60- to 100-day patients and was more common thereafter, occurring in 20 (34%) of the 101- to 200-day patients (p < 0.05).
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). Of the 36 patients who had other major infections, 20 received transplants and 17 survived whereas 3 died, and 15 died waiting transplantation. One patient required the device to be removed and died. A major stroke occurred in 29 patients: 12 of 14 of those patients survived transplantation, and 1 of 15 has died waiting. Of 11 patients with a major stroke and infection, only 1 survived after transplantation. Comment
This review is limited because the data were acquired by voluntary consent of investigators or their surrogates and could not be verified further. In the interest of pushing for a high rate of response, the queries were simple and did not require extensive chart review. Although device-specific data were acquired, the purpose of this report was not to compare devices but to give a general snapshot of expectation for those interested in the results of prolonged mechanical circulatory support. To be sure, there were differences in the rate of certain complications between devices, but these differences were not of such a magnitude to change the collective impression for all devices. Exclusion of proprietary information can help to ensure cooperation from device manufacturers.
We were impressed that the incidence of transplantation and its subsequent success was so high in these extended bridge patients. Although several serious complications occurred, they generally were limited and by and large did not eliminate the possibility of benefiting from the mechanical support and subsequent transplantation. Of 162 patients supported, only 36 died and successful transplantation was possible in greater than 90% regardless of time on support between 60 and 340 days. Infections of the wound, driveline, blood, and lung were common and occurred more frequently after 100 days. Major driveline infection occurred in 24 patients and was associated with death in 7 awaiting transplantation but with successful transplantation in 13 of 17. Similarly, 47 patients had major (29) or minor (18) strokes and these too were more common the longer the duration of support. As many candidates died after major stroke as underwent successful transplantation with them. The combination of major infection and stroke was associated with an extremely poor outcome (10/11 died).
This report reinforces the excellent results obtained in the bridge to transplantation trials that reported a shorter duration of support. For those interested in extended bridge to transplantation or permanent use of the currently available devices, the results suggest reasonable success can be anticipated but that serious infections and strokes tend to be more common with longer duration of support.
Footnotes
Presented at The Third International Conference on Circulatory Support Devices for Severe Cardiac Failure, Pittsburgh, PA, Oct 28--30, 1994.
Address reprint requests to Dr Griffith, Division of Cardiothoracic Surgery, University of Pittsburgh School of Medicine, C700 Presbyterian University Hospital, 200 Lothrop St, Pittsburgh, PA 15213.
Reference
This article has been cited by other articles:
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  J. O. Robertson, C. Lober, N. G. Smedira, J. L. Navia, N. Sopko, and G. V. Gonzalez-Stawinski One hundred days or more bridged on a ventricular assist device and effects on outcomes following heart transplantation. Eur. J. Cardiothorac. Surg., August 1, 2008; 34(2): 295 - 300. [Abstract] [Full Text] [PDF]
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