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Ann Thorac Surg 1996;62:646-652
© 1996 The Society of Thoracic Surgeons
Departments of Surgery and Medicine, and Division of Circulatory Physiology, College of Physicians & Surgeons, Columbia University, New York, New York
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Abstract |
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 TopFootnotes Abstract IntroductionMaterial and MethodsResultsCommentAcknowledgmentsReferences |
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Methods. During January 1993 to November 1995, 12 male and 2 female patients with an average age of 47 ± 17 years were supported for an average of 117 ± 24 days with the Thermo Cardiosystems VE wearable left ventricular assist device. Seven patients were discharged home an average of 35 ± 4 days after implantation.
Results. No device failures occurred, although 29 controller malfunctions were identified during 1,640 total support days. All patients were able to safely maintain their devices. Outflow graft bleeding and driveline infection were responsible for two readmissions. No long-term anticoagulation treatment was used; one small thromboembolic episode occurred, but without significant long-term sequelae.
Conclusions. None of the 7 patients released from the hospital died, and all were able to successfully maintain their devices at home. Hospital discharge of patients supported with left ventricular assist devices has allowed long-term evaluation of this technology, and the findings should prompt study of their use as a long-term alternative treatment to medical management for congestive heart failure.
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Introduction |
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TopFootnotesAbstractIntroductionMaterial and MethodsResultsCommentAcknowledgmentsReferences |
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The left ventricular assist device (LVAD) bridge-to-transplantation experience has established the efficacy of these devices for short- and medium-term mechanical support and has demonstrated the viability of discharging patients with these devices home to await transplantation [1, 2]. Early designs of the LVAD required patients to be tethered to bulky external consoles, but now the control and power systems for these devices have been miniaturized, making these units wearable and thus allowing unrestricted ambulation and independent patient function despite the need for extracorporeal connections.
Although these devices can restore virtually normal resting hemodynamics and exercise tolerance and normalize hepatic, renal, and neurohormonal function [3], a review of the outpatient experience during the circulatory assistance period is needed to determine the clinical feasibility of mechanical support as an alternative to medical therapy or transplantation for congestive heart failure. To this end, we evaluated the initial investigational experience with outpatient LVAD support at our institution, with particular emphasis on patient selection, release protocol, exercise testing, problems encountered in the out-patient setting, and quality-of-life (QOL) measures.
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Material and Methods |
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TopFootnotesAbstractIntroductionMaterial and MethodsResultsCommentAcknowledgmentsReferences |
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The VE device is powered by two batteries, which provide 6 to 8 hours of charge time and are usually worn in a shoulder holster (Fig 1
). The device is typically operated in the "automatic" mode, so that the pump ejects when it is 90% filled. In this way LVAD flow increases when patient activity increases and LVAD flow decreases during periods of relative inactivity (eg, sitting, sleeping).
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Three levels of fail-safe rescue exist with the currently available HeartMate (TCI, Woburn, MA) wearable electric device. First, the native heart usually recovers enough function to keep the patient alive if no pump function exists. Second, the extracorporeal nature of the electronic control unit allows for easy access; should software, chip, or electronic failure occur, the damaged portion of the device can be easily replaced. Third, with pusher-plate technology, the device can be pneumatically actuated using a hand-held portable pneumatic pump if the electric motor of the device fails.
Patient Selection
All patients in this cohort were approved transplant candidates who met the United States Food and Drug Administration (FDA) requirements for implantation. Inclusionary criteria for entry into the study included a pulmonary capillary wedge pressure of 20 mm Hg or more, unweanable inotropic agent support, and either a systolic blood pressure of 80 mm Hg or less or a cardiac index of 2.0 L•min-1•m-2 or less.
Numerous additional considerations have arisen regarding potential candidates for wearable VE devices. First, a suitable 24-hour companion, or companions, must be identified. Second, a subjective preoperative assessment of the patient's ability to care and manage the device is essential. Third, there must be more space in the preperitoneal area to accommodate the thickness of the VE pump; thus, small adults and children may preferably receive the pneumatic LVAD. Fourth, patients who have a high panel reactive antibody profile and type O blood are likely to wait a long time for transplantation [5], and may benefit from a device that would provide long-term outpatient support.
Patients
From February 1, 1993, to November 1, 1995, 14 patients at Columbia Presbyterian Medical Center underwent implantation of the Thermo Cardiosystems VE wearable LVAD. This group consisted of 12 male and 2 female patients with a mean age (± standard deviation) of 47 ± 17 years (range, 16–62 years). The cause of end-stage heart failure was ischemic cardiomyopathy in 8 patients (57%), idiopathic cardiomyopathy in 5 patients (36%), and idiopathic hypertrophic subaortic stenosis in 1 patient (7%).
At the time of implantation, all patients were in cardiogenic shock, with a mean cardiac index (± standard error of the mean) of 1.96 ± 0.11 L • min-1 • m-2 (range, 1.06–2.77), mean arterial blood pressure (± standard error of the mean) of 61.7 ± 2.3 mm Hg, and mean pulmonary capillary wedge pressure (± standard error of the mean) of 26 ± 0.85 mm Hg. All patients were receiving high doses of ß-agonists or phosphodiesterase inhibitors, or both, and 7 patients (50%) required intraaortic balloon pump support before LVAD insertion. All patients except for the first one underwent preperitoneal placement of the LVAD, as described elsewhere [6].
Evaluation of Adverse Clinical and Mechanical Events
The incidences of the following adverse events after implantation of the VE LVAD were assessed prospectively: (1) significant bleeding was defined as a blood loss necessitating surgical reexploration or causing death; (2) right ventricular failure was defined as the need for placement of a right ventricular assist device; (3) thromboembolism was defined as the manifestation of clinical symptoms of stroke or evidence of any neurologic, pulmonary, renal, hepatic, or peripheral vascular deficit, which was sudden in onset and occurred during LVAD support, and excluding intraoperative events; (4) significant infections were defined as those associated with leukocytosis or fever, or both, in the presence of positive culture results necessitating treatment with antimicrobial agents during mechanical support; and (5) equipment malfunctions were defined as those involving problems with the pump, the system controller, the power base unit or cable, or the batteries or battery clips.
Patient Release Protocol
The patient release protocol is a stepwise program for the discharge of patients with the VE HeartMate to their homes. This four-stage program includes training patients and their companions to operate and troubleshoot the system as well as making five day trips and five 3-day trips before discharge. This program was originally designed to respond to the psychological needs of patients during the long wait for transplantation. Several other considerations also govern the decision to release patients:
This protocol has allowed us to evaluate this technology as a destination for patients with end-stage heart failure and to study related QOL measures. Patients participating in the release program have access to a dedicated 24-hour emergency phone line. All patients carry wallet-sized identification cards with emergency telephone numbers and contact information. In addition, local emergency medical staff have been trained to respond to device emergencies. Patients are assessed weekly in the LVAD outpatient clinic, and this includes routine physical examinations and blood work and an assessment of their compliance with the study protocol.
Quality-of-Life Protocol
We measured a broad spectrum of relevant QOL attributes after LVAD implantation and discharge home to assess whether the VE LVAD confers an acceptable QOL for long-term management. Data are rendered in terms of the time from hospital discharge.
The health-related QOL, as assessed by the Nottingham health profile (NHP) [7], the sickness impact profile (SIP) [8], and the global rating scale (Williams, personal communication, 1996), was measured before LVAD implantation and after discharge home. (See Table 1 for a summary of the findings.)
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Six-Minute Walk Test Protocol
Besides subjective measures of patients' QOL, patients performed a 6-minute walk test to determine their functional ability as an index of QOL. All patients underwent one practice test. They were instructed to walk as far as they could during 6 minutes in a 30-m-long unobstructed corridor. Patients were encouraged (eg, to "keep up the good work") at 30-second intervals. Heart rate was monitored continuously by telemetry or with a transcutaneous monitoring system (Polar, Port Washington, NY). Blood pressure was measured by cuff sphygmomanometry at rest and at the end of exercise. All tests were performed in the auto mode of the device.
Statistical Analysis
Data were analyzed using the Statistical Analysis System software (SAS Institute, Cary, NC). Hemodynamic profiles before and after LVAD support were compared using the paired Student's t test. The Wilcoxon signed-rank sum test for different scores of the NHP, the SIP, and the global rating scale were rated before LVAD implantation and after discharge home. A two-tailed p value of less than 0.05 was considered statistically significant.
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Results |
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TopFootnotesAbstractIntroductionMaterial and MethodsResultsCommentAcknowledgmentsReferences |
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. The mean duration of support was 117 ± 24 days. Nine of the 14 patients (64%) were eligible for release. Two patients underwent transplantation early (postoperative day 24 and 40), and 3 patients died.
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). The mean in-hospital stay (± standard error of the mean) before the first release was 35 ± 3.67 days (range, 29–59 days). The total out-of-hospital time, including day trips, was 877 days.
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Second, 1 patient (7%) experienced profound right-sided circulatory failure in the setting of significant bleeding that necessitated short-term right ventricular assist device support. The device was explanted 5 days later, without incident. A second patient required the intraoperative administration of inhaled nitric oxide for treatment of right-sided circulatory failure and separation from cardiopulmonary bypass. Both patients were eventually discharged.
Despite the fact that anticoagulation treatment was not used, the incidence of device-related thromboembolic events was low (7%). Early in the experience, some patients were maintained on one aspirin per day. With the exception of 1 patient who temporarily received warfarin for the treatment of atrial fibrillation, none of the patients received warfarin or heparin postoperatively. The only clinically significant thromboembolic event occurred in a patient who noted amaurosis fugax 83 days after implantation. Further evaluation revealed a microembolus to his left retina, resulting in partial loss of peripheral vision.
With regard to clinical infections, only 1 patient had a device (driveline)-related infection (Acinetobacter and Staphylococcus sp). During the entire follow-up period, clinically significant non-device-related infections developed in 4 patients, including two Clostridium difficile diarrheas and two urinary tract infections (Citrobacter freundii and Candida sp). Of the 10 patients who underwent explantation of the LVAD, no cultures were positive for organisms.
Several mechanical malfunctions were observed during the postoperative course of these patients. A total of 29 controller malfunctions were documented during 1,640 patient-support days (an average of 0.0178 malfunctions per day). In most cases of controller malfunction, a new controller device had to be replaced. Briefly, this involves disconnecting the electric lead and reinserting it into a new controller and initiating power again. This was usually performed by hospital staff, but patients and companions are intimately familiar with this procedure. In one instance, the battery clip, which secures the batteries to the controller, was defective and had to be replaced. In another instance, a battery charging panel in the power base unit of the device had to be replaced. None of these mechanical malfunctions threatened the ability of the device to provide adequate blood flow, however.
Three patients (21%) died after LVAD implantation, all during our early VE experience. The first patient underwent intraperitioneal device implantation and subsequently suffered a small-bowel obstruction. He succumbed to a sudden massive aspiration pneumonitis 11 days after implantation. The second patient suffered a left cerebrovascular accident during reoperation for repair of a late aortic tear and died 20 days after the institution of mechanical support. The third patient had a large left ventricular aneurysm with subendocardial thrombus that was not appreciated on a preoperative echocardiogram. Although the aneurysm was successfully resected, a large stroke resulted from fragmentation of the thrombus and a vegetative state resulted. This patient died after 13 days of support.
Quality of Life
QUALITY-OF-LIFE INSTRUMENTS.
Four of the 9 patients meeting discharge-to-home criteria underwent QOL interviews before LVAD implantation and immediately after discharge home. Four of the patients not included in this analysis were hemodynamically compromised and unable to complete all of the study questionnaires before LVAD implantation, and the other patient underwent LVAD implantation and explantation before the initiation of this protocol. The questionnaire findings at baseline before LVAD implantation and those after discharge home at 4 weeks (0.13 ± 11.4 days after discharge; range, -11–18 days) and at 12 weeks (53.3 ± 20.4 days after discharge; range, 13–77 days) were compared. Four patients completed the NHP at baseline and at 4 and 12 weeks after implantation, whereas these same patients were only able to complete the SIP at 4 and 12 weeks after implantation. The SIP proved too difficult and lengthy for all but 2 patients to complete before LVAD implantation.
Comparison of the NHP score at baseline and 4 weeks after implantation showed no significant improvement in the QOL. However, comparison of the baseline scores with those obtained 12 weeks after implantation showed that all domains of functioning, except social isolation, were improved (p = 0.06 for all domains). The mean scores for each domain, as depicted in Figure 3, reflect these improvements over time. For all questionnaires, higher scores represent the amount of QOL displaced; lower scores indicate the amount of QOL restored. The fact that none of these differences in the scores were statistically significant at the 0.05 level is most likely due to the small number of patients assessed. Similarly, there was an improvement in the mean SIP scores from 4 to 12 weeks after LVAD implantation, as shown in Figure 4. However, the overall SIP score (p = 0.5), including physical (p = 0.08) and psychological (p = 0.13) domains of health, again did not yield statistical significance at the 0.05 level, presumably because of an underpowered sample size. The global rating scale reflected improvements in the patient's rating of their health in terms of general (p = 0.02) and mental comfort (p = 0.03) from baseline to the time of hospital discharge.
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Comment |
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TopFootnotesAbstractIntroductionMaterial and MethodsResultsCommentAcknowledgmentsReferences |
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At the same time, the donor organ shortage, always a limitation to the success of organ transplantation programs, has worsened. Over the past 5 years, the annual number of donor organs has not varied significantly from approximately 2,500 per year [13]. With an estimated 40,000 patients in severe congestive heart failure [13], organ transplantation can have only an epidemiologically limited impact. In addition to stimulating research on long-term alternatives to transplantation, the donor organ shortage has also forced centers to maintain patients on LVAD support for prolonged periods, thus generating an extensive clinical experience.
Simultaneously, technological advances have led to the development of portable, battery-powered units that have multiple safety backups and are appropriate for long-term support in outpatients. Given these advances and the low incidence of thromboemboli reported for the device, despite the avoidance of anticoagulation, these devices could be considered for permanent use if the clinical experience with the devices as an extended bridge to transplantation is successful. Our experience involving a total of 1,640 days of LVAD support highlights and reinforces the dramatic effect these devices have had in patients to date.
All our patients underwent aggressive physical rehabilitation and serial exercise physiology testing. No deaths or serious device malfunctions occurred in the 7 patients released from the hospital. One patient is retired, 1 patient has chosen not to work, 2 patients are currently attending school, and 1 patient has returned to work full time. All patients admitted to driving automobiles while on device support. Additional activities enjoyed by these patients include showering, playing tennis, bicycling, gardening, and ballroom dancing. Sexual activity was resumed in all but 1 patient, who was young and not sexually active. Variations in sexual functioning have been reported for patients with coronary artery disease and congestive heart failure [14], but no reports of sexuality in LVAD patients have been identified.
All patients and their companions were able to safely maintain their devices during malfunctions of the controller and power systems. The problem most likely to prompt the patient to contact our team were controller malfunctions. This alarm on this sensitive device was often triggered and the device had to be changed, but patient lives were not endangered. At times, interrogation of the system required evening or semiemergent visits to the hospital as a result of patient or staff concerns; no critical problems were detected, and changing of the controller usually corrected the problem.
There were few patient-related adverse events. The single small thromboembolism proved clinically minor. The single LVAD driveline infection was effectively treated with antibiotics. The most threatening complication was an outflow graft hemorrhage, which necessitated late reexploration and suture repair. The only right ventricular failure to prove life-threatening occurred after perioperative hemorrhage and was successfully managed by the implantation of an Abiomed BVS 5000 (Danvers, MA) right ventricular assist device, with support maintained for 5 days.
Our data in patients with a VE LVAD discharged home indicate that, before patients undergo implantation of the device, they often experience notable difficulties in their physical, psychosocial, and overall QOL. As early as 4 weeks after LVAD implantation and discharge home, these same patients show minimal dysfunction in most areas of QOL examined. Although some improvement in QOL is noted at the time of discharge, more pronounced improvements are noted once the patient has been at home for a few weeks. However, we are unable to discern from our results whether these improvements reflect a positive response to being at home or are an effect of the time after LVAD implantation.
In their study of 2 patients on the Novacor device who were transferred to a "home-like" halfway house setting out of the hospital to await transplantation, Dew and colleagues [15] noted findings similar to ours. They found that QOL in the physical, emotional, and social domains more closely resembled that of transplant recipients than of candidates. In another study, 11 patients with a pneumatic TCI LVAD were prospectively evaluated using the NHP and a disease-specific instrument, the HeartMate-QOL [16]. When compared with a "normal" NHP score for patients with peripheral vascular disease, the scores for patients with an LVAD were found to be moderately elevated. Interestingly, noise from the LVAD and worry about mechanical failure were rarely a concern. Patients with a pneumatic LVAD were most bothered by confinement and tethering. Both studies provide useful information but, like our study, involve small numbers of patients and measurement of only a few QOL domains. Although the QOL questionnaires do not assess all facets of life that can be affected in a patient with a VE LVAD, the data yielded do provide an overall rating of QOL. A disease-specific measure of QOL in patients with an LVAD may provide more meaningful data.
Although encouraging, these data reflect the subjective responses of a select group of patients who are well enough to meet discharge-to-home criteria. Our results do not encompass the QOL ratings of those patients with a VE LVAD who experience significant complications and morbidity and cannot be discharged home. This limits the generalizability of our results to only those patients who make good progress in terms of the surgical and aftercare requirements of the VE LVAD. Although we would like to be able to attribute these improvements to the effects of being discharged home, as already noted, we cannot make this assumption because we are unable to determine whether the changes are the result of this or the time after LVAD implantation.
Functional capacity is an integral component of one's overall sense of well-being and satisfaction. The 6-minute walk test has been shown to be a reproducible and valid measure of submaximal exercise capacity in patients with chronic heart failure [17], and it has been widely applied in patients with heart failure. There are significant differences in the distance walked in 6 minutes among normal subjects, patients with class II, and those with class III or IV heart failure. The ranges are 2,000 to 2,400 feet (600–720 m), 1,300 to 1,800 feet (390–540 m), and 950 to 1,090 feet (285–327 m), respectively [9, 10, 18]. The advantages of this measure over conventional exercise testing that have been reported have been realized in our experience, including the fact that it is closely related to ordinary activities of daily living, the exercise tested is submaximal, and the work rate is controlled by the patient [19]. We have previously reported that the distances walked in 6 minutes by LVAD recipients are comparable with the distances walked by patients with mild to moderate congestive heart failure [9]. Improvements in the distance walked by those patients who are sequentially tested further independently affirms progress in the performance of ordinary activities of daily living. These improvements may be important indicators of the ability of the patient to take care of himself or herself upon discharge home.
Previous reports regarding the outpatient management of implantable LVADs are limited by the small numbers of patients studied and the cumulatively short support periods. Myers and associates [1] reported on 2 patients who made only day trips, and 1 patient who lived at home while awaiting transplantation. Kormos and colleagues [2] reported on 3 patients who were released to an "outpatient facility" for an average of 51 days. Both groups noted improved hemodynamics and functional capacity in their patients and proved to be ahead of their time by successfully maintaining patients for prolonged periods with devices designed for short-term use.
Several of these limitations also apply to our study. First, although the durations of support were long, the patients were still being bridged to transplantation, and this may have an effect on their perceived QOL. In addition, as patients are supported for periods longer than 1 year, further device malfunctions and psychological limitations may surface. The incidence of patient-related adverse events may also increase, as manifested by increased bleeding or infection rates. Second, our study only consisted of 9 dischargeable patients. Third, all patients were required to maintain a companion, a limitation that risks ruining the QOL for 2 people. From a programmatic perspective, abolition of this requirement is probably essential. Although the companion never had to perform a life-saving intervention during the time of the study, this may be needed eventually. Fourth, the device was designed originally to provide temporary support and is still evolving into a longer-term support vehicle. The changes required will require constant monitoring and will likely spawn additional modifications.
A final consideration is the financial implications. Early studies of our expenses [20] for device implantation support the contention that the implantation of LVADs involves approximately the same cost to society as heart transplantation. However, the number of heart transplantations is necessarily limited to approximately 2,200 per year by the number of donor organs available. Because LVADs can be produced to meet the potential demand of 40,000 to 60,000 patients currently, and because many of these patients are older, this could translate into substantial fiduciary repercussions.
The TCI long-term implantable LVAD has worked remarkably well in a small cohort of critically ill patients supported as out-patients for 877 days. The low incidence of device- and patient-related complications supports further investigation of these LVADs as an alternative to medical therapy in appropriately selected patients who are not candidates for the limited pool of donor hearts.
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Acknowledgments |
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TopFootnotesAbstractIntroductionMaterial and MethodsResultsCommentAcknowledgmentsReferences |
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Footnotes |
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TopFootnotesAbstractIntroductionMaterial and MethodsResultsCommentAcknowledgmentsReferences |
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Address reprint requests to Ms Catanese, Division of Cardiothoracic Surgery, Columbia University, 177 Fort Washington Ave, Milstein Hospital Building, Room 7–435, New York, NY 10032 (E-Mail: catanes{at}cucis.cis.columbia.edu).
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TopFootnotesAbstractIntroductionMaterial and MethodsResultsCommentAcknowledgmentsReferences |
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E. A. Rose, A. C. Gelijns, A. J. Moskowitz, D. F. Heitjan, L. W. Stevenson, W. Dembitsky, J. W. Long, D. D. Ascheim, A. R. Tierney, R. G. Levitan, et al. Long-Term Use of a Left Ventricular Assist Device for End-Stage Heart Failure N. Engl. J. Med., November 15, 2001; 345(20): 1435 - 1443. [Abstract] [Full Text] [PDF]
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