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Eur J Cardiothorac Surg 2003;23:748-755
© 2003 Elsevier Science NL

The Jarvik 2000 is associated with less infections than the HeartMate left ventricular assist device1

M.P. Siegenthaler*, J. Martin, K. Pernice, T. Doenst, S. Sorg, G. Trummer, O. Friesewinkel, F. Beyersdorf

Department of Cardiovascular Surgery, Albert-Ludwigs University Freiburg, Hugstetterstrasse 55, 79106 Freiburg, Germany

Received 26 September 2002; received in revised form 22 January 2003; accepted 23 January 2003.

* Corresponding author. Tel.: +49-761-270-6138; fax: +49-761-270-2550
e-mail: siegenth{at}ch11.ukl.uni-freiburg.de


   Abstract
Top
 Abstract
1. Introduction
 2. Materials and methods
 3. Results
 4. Discussion
 5. Conclusions
 Appendix A. Conference...
 References
 
Objectives: Device-related infections remain a considerable problem of left-ventricular support. We compared the device-related-infections between the HeartMate left ventricular assist device (LVAD) and the Jarvik 2000 permanent LVAD, a device with a novel retroauricular power-supply. Methods: Between December 2000 and September 2002 we implanted the HeartMate-vented, electrical-system in 11 patients and the permanent Jarvik 2000 in six patients. Total support time was 1626 patient-days (HeartMate, 26–271 days) versus 1246 patient-days (Jarvik 2000, 8–411 days). As potential risk factors for infection we analyzed age, preoperative hospital-days, total protein, cardiac index, maximal oxygen uptake, use of inotropes, LVAD risk-score-index and Aaronson-Mancini-score, intubation time, and intensive care unit stay. We used the Center of Disease Control definitions for surgical site infections. Results: HeartMate-patients were younger than Jarvik 2000 patients (46±13 versus 58±6 years, P=0.056), there were no other differences in the risk factors. Four HeartMate-patients needed late (>=48 h) surgical revisions for bleeding/hematomas versus no revisions in the Jarvik 2000 patients. In the HeartMate-patients, there were seven (64%) driveline-infections, five (45%) device-pocket infections, and three (27%) bloodstream-infections, or 0.43 device-related infections/100 patient-days. Infections occurred early (34±31 days). Three patients required urgent transplantation due to bloodstream infection. There were no adverse outcomes in the HeartMate-group due to infection. In the Jarvik 2000 patients, there was one driveline-infection (16%) after 270 days of support (0.08 device-related infections/100 patient-days), significantly less than in the HeartMate-group (P=0.044). Driveline infections resolved with antibiotics and local wound care in the Jarvik 2000 patient, but only in one of seven HeartMate-patients. Conclusions: Implantation of the Jarvik 2000 is associated with less device-related infections than the HeartMate-LVAD. The power-supply of the permanent Jarvik 2000 is suitable for long-term mechanical support.

Key Words: Heart failure • Left ventricular assist device • TCI Heartmate • Jarvik 2000 • Infection


   1. Introduction
Top
 Abstract
 1. Introduction
2. Materials and methods
 3. Results
 4. Discussion
 5. Conclusions
 Appendix A. Conference...
 References
 
Infection,device-failure, bleeding and emboli are the principal reasons precluding widespread use of long-term mechanical circulatory support [1]. Infections are associated with significant morbidity and cost, even though the impact on outcomes after heart transplantation has been surprisingly small [2]. In patients ineligible for transplantation, device-related infection can usually not be cleared, as device removal is required for curative treatment. The recently published Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure-study shows that infection is the leading cause of death in such patients [1]. Thus, any assist-device for long-term use has to stand the test of infection. The Jarvik 2000 LVAD is an axial flow pump designed for permanent use [3]. As the large abdominal driveline of conventional vented systems is the most frequent site of infection, the novel power-supply of this device is connected to a small percutaneous retroauricular skull-mounted pedestal (Fig. 1) . Similar percutaneous systems were used for intracochlear implants and had low infection rates [4]. We evaluated infectious complications associated with the Jarvik 2000 LVAD and compared them with our cohort of HeartMate-LVADs.



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  		Fig. 1. Photography of a patient with the percutaneous, skull-mounted pedestal of the Jarvik 2000 permanent left ventricular assist device; picture taken 8 months after implantation. The exit-site for the power-supply does not interfere with his daily activities and even allows the patient to take a shower.

 

   2. Materials and methods
Top
 Abstract
 1. Introduction
 2. Materials and methods
3. Results
 4. Discussion
 5. Conclusions
 Appendix A. Conference...
 References
 
We retrospectively reviewed the data of patients receiving the Jarvik 2000 and the HeartMate-LVAD at our institution. Between December 2000 and September 2002, a total of 37 devices were implanted for mechanical circulatory support. The HeartMate (TCI) single lead, vented, electrical LVAD (Thoratec Corporation, Pleasanton, CA, USA) was implanted in 11 patients and the Jarvik 2000 permanent LVAD (Jarvik Heart, Inc., NY, USA) was implanted in six patients. Total support time on the HeartMate-system was 1626 patient-days (mean 148±84, range 26–271), versus 1264 patient-days on the Jarvik 2000 (mean 211±151, range 8–411). There were three surgeons performing all the procedures. The surgical approach for the HeartMate-device included a sternotomy. The device was placed in a preperitoneal position with the driveline skin exit-site above the right iliac crest. The Jarvik 2000 was implanted on femoro-femoral bypass using a lateral thoracotomy approach [5,6]. Indications whether to implant a HeartMate or a Jarvik 2000 device varied with time. Initially, the Jarvik 2000 was not available and all patients in need for LVAD support were treated with the HeartMate LVAD. Once both devices were available, the Jarvik 2000 was offered only to patients in need of circulatory support who were either ineligible for transplantation at the time of device implantation (e.g. high pulmonary vascular resistance, amyloidosis of the heart or unwillingness to be transplanted) or were too small for implantation of the HeartMate LVAD.

One patient with a Jarvik 2000 required a device-switch to a HeartMate-system after 90 days on the device. He had a high pulmonary vascular resistance (PVR), a body surface area of 2.1 m2 and poor intrinsic left ventricular function with no myocardial recovery after implantation of the Jarvik 2000, despite maximal medical therapy. The Jarvik 2000 device pumped 5–5.5 l/min at 12,000 rpm. He remained in NYHA class 3–4 on the device with a non-pulsatile blood pressure and finally underwent a device-switch to the HeartMate-system, which was able to entirely replace his left ventricular function. On this device, he required 8–9 l of flow for the first few weeks.

Preoperative, operative, and postoperative parameters, possibly associated with an increased risk of infection were analyzed. Infection was defined using the Center of Disease Control (CDC) criteria for surgical site infections [7,8]. No routine cultures of the device surfaces at the time of explantation were performed, therefore, the incidence of device endocarditis could not be evaluated in this series. Infections in patients on the device with a positive blood culture but without central-line were categorized as a device-related bloodstream infection [7]. A driveline infection was classified as a superficial surgical site infection (superficial SSI). To diagnose a superficial SSI, we required wound drainage, local signs of infection, as well as at least one positive wound culture. The term deep surgical site infection (deep SSI) was used for device-pocket infections. This diagnosis required either a positive culture or an unequivocal finding of the surgeons involved at the time of transplantation or surgical revision. Differences in outcomes related to infection were recorded.

All microbiology laboratory data were reviewed, including wound, respiratory, blood, catheter, and all other cultures. Use of antibiotics and cost was monitored. We calculated the cost of antibiotic therapy with the actual drug cost as well as €6.25 of nursing costs for each i.v. administration. Table 1 shows the cost of the most frequently used antibiotics. Cost for re-admissions were calculated with a daily cost of €615 for each day on the surgical ward, and €1583 for each day in the intensive care unit.


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  		Table 1. Price of the most frequently used Antibiotics

 
Data are presented as mean values±standard deviation for quantitative variables and as absolute and relative frequencies for qualitative variables. Group comparisons were performed with Student t tests and Wilcoxon rank-sum tests for quantitative data as appropriate and with Fisher's exact test for qualitative data. Infection-free survival was analyzed by the method of Kaplan–Meier using time from implantation to the occurrence of an infection. The time of patients with no infections was censored at the date of the last contact. The difference between corresponding infection free survival-curves was tested by a log rank test [9]. All significance tests were two-sided and a P value of less than 0.05 was considered to indicate statistical significance. Data analysis was performed using SAS software (SAS Institute Inc., Cary, NC, USA).


   3. Results
Top
 Abstract
 1. Introduction
 2. Materials and methods
 3. Results
4. Discussion
 5. Conclusions
 Appendix A. Conference...
 References
 
3.1. Preoperative risk factors
Table 2 shows the demographical data and preoperative risk factors of the Jarvik 2000 and the HeartMate-patients. None of the parameters demonstrated differences between the groups, possibly due to the small sample size, as the patients receiving the HeartMate-LVAD appeared to be slightly more ill. The Jarvik patients tended to be older (P=0.056).


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  		Table 2. Demographics and preoperative risk factors of HeartMate and Jarvik 2000 patients

 
3.2. Operative data
Operative times were similar (Table 3). Bypass times were shorter in the Jarvik 2000 group (59±10 versus 99±20 min, P=0.004). There were no early surgical complications in either group. The chest of all HeartMate-patients was primarily closed and none of the patients had to be revised for bleeding in the immediate postoperative period. There were no bleeding complications or surgical revisions required in the Jarvik group. In the HeartMate-group, there were four late surgical revisions. One patient experienced an episode of bleeding from an arroded diaphragmatic artery on postoperative day #5 and had to be surgically revised. He remained free of infection. One patient had a dehiscence of his aortic outflow-graft anastomosis on postoperative day #19 leading to massive bleeding. He could be surgically revised and survived, but developed a device-pocket infection later on. Two patients developed hematomas in their device-pocket, which had to be drained. One of them developed a superficial SSI and the other a deep SSI.


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  		Table 3. Operative and postoperative risk factors of HeartMate and Jarvik 2000 patients

 
3.3. Device-related infection – HeartMate LVAD
In the HeartMate-patients, there were seven (64%) driveline-infections, five (45%) device-pocket infections, and three (27%) bloodstream-infections, leading to a device-related infection rate of 0.43 infections/100 patient-days.

Seven patients (64%) had a driveline infection (superficial SSI). These infections occurred early (34±31 days). In one patient the SSI resolved without leading to a deep SSI. Over a 4 week course of antibiotics, the drainage subsided. This patient lived subsequently at home without antibiotics and underwent a successful transplantation 3 months later. Two patients are currently on the HeartMate-device, one of them with a superficial SSI treated with antibiotics, the presence of a deep SSI in this patient is unknown.

There were five patients (45%) in the HeartMate-group that met criteria for a LVAD Pocket-infection (deep SSI). All these patients were treated with intravenous antibiotics. Three patients with a deep SSI developed a blood stream infection despite intravenous antibiotics. They had to be urgently transplanted due to infection. There were no adverse outcomes in the HeartMate-group related to infection. Seven of eight transplanted HeartMate-patients survived the transplantation. One patient died due to acute rejection. There was no death related to infection. The patient who required the device-switch from the Jarvik 2000 to the HeartMate-system developed a superficial and later a deep SSI. This patient was initially not a candidate for transplantation due to a greatly elevated pulmonary vascular resistance. Chronic unloading during mechanical circulatory support decreased his pulmonary vascular resistance and allowed transplantation and removal of his infected device.

3.4. Device-related infection – Jarvik 2000 LVAD
There was one driveline-infection in the Jarvik 2000 group (16%) accounting for 0.08 device-related infections/100 patient-days. This infection rate was significantly lower than the rate of device-related infection in the HeartMate-group (Fig. 3; P=0.045). The patient developed clinical signs of progressive right-heart failure. After 270 days of support, he developed a driveline-infection, which clinically presented as a sharp pain over the drive-line in his posterior neck. He later developed drainage from his retroauricular site. Culture of the drainage was positive for Staphylococcus aureus. Treatment included intravenous antibiotics and local wound care. His infection subsequently resolved. He was later urgently transplanted due to progressive heart failure.



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  		Fig. 3. Kaplan–Meier curve for freedom of driveline infection (superficial surgical site infection, A) and freedom of device-pocket infection (deep surgical site infection, B) for patients with the Jarvik 2000 and the HeartMate LVAD. P-values were 0.045 for A, and 0.088 for B.

 
3.5. Antibiotic use and cost
Antibiotic use in all HeartMate-patients is shown in Fig. 2a , for the Jarvik 2000 patients in Fig. 2b. Antibiotic use was extensive. Often, empiric therapy was administered based on clinical grounds without positive culture results. HeartMate-patients were given antibiotics for a mean duration of 55±43 days (52±33% of total support-time). With a mean period of 18±14 days (18±20% of total support time), the Jarvik patients received less antibiotics (P=0.039). There were significantly higher cost for antibiotics in the HeartMate-group (€2816±2778) than in the Jarvik group (€508±429, P=0.018).



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  		Fig. 2. Support time of HeartMate patients (a); and Jarvik 2000 patients (b) with (open areas) and without (shaded areas) use of Antibiotics. Note: The Jarvik 2000 patients received significantly less antibiotics (P=0.039).

 
3.6. Microbiology results
A total of 430 cultures were taken from all the patients. Of these, 146 were positive. Fig. 4a shows the distribution of all positive cultures between HeartMate-patients and Jarvik 2000 patients. The incidence of any positive culture was 12.0±9.2 per 100 patient-days in the HeartMate-group and 1.6±2.6 per 100 patient-days in the Jarvik group (P=0.020). In the HeartMate group (1626 patient-days), a total of 380 cultures were sent, 129 were positive. In the Jarvik 2000 group (1264 patient-days) a total of 50 cultures were sent, 17 were positive. The difference in positive cultures was significant (P=0.02)



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  		Fig. 4. Cumulative incidence of positive cultures from all sites, i.e. respiratory, blood, catheter, urine, wound and other cultures (a); and from wounds alone (b) for patients with the Jarvik 2000 (•) and the HeartMate ({blacktriangleup}) LVAD. P-values were 0.020 for all cultures and 0.008 for wound cultures.

 
There were a total of 91 wound-cultures taken from all the patients. Fig. 4b shows all the positive wound-cultures obtained from both patient cohorts. In the HeartMate group a total of 89 wound-cultures were sent, 58 were positive. In the Jarvik 2000 group only two cultures were sent, one was positive. The difference in positive wound cultures was significant (P=0.008). HeartMate-patients had 4.7±3.6 positive wound-cultures per 100 patient-days, Jarvik 2000 patients had 0.06±0.14 positive wound cultures per 100 patient-days (P=0.008). Table 4 shows the organisms isolated in all wound cultures. There was a trend towards more positive blood cultures and respiratory infections in the HeartMate-group (2.0±3.1 versus 0.18±0.45 positive blood cultures/100 patient-days, P=0.073 and 3.5±4.0 versus 0.9±1.3 positive respiratory cultures/100 patient-days, P=0.170). No difference was found between catheter, urine, and all other cultures.


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  		Table 4. The isolated organisms (N=74) in all positive wound cultures (N=59)

 
3.7. Readmissions due to infection
There were eight re-admissions due to infection in the HeartMate-group and one re-admission in the Jarvik group. The average cost for each re-admission was €12,849, regardless of the device.


   4. Discussion
Top
 Abstract
 1. Introduction
 2. Materials and methods
 3. Results
 4. Discussion
5. Conclusions
 Appendix A. Conference...
 References
 
Infection remains a considerable problem of left-ventricular support. Device-related infection rates ranging from 17 to 55% have been reported [1,2,10–13]. Reported series are difficult to compare due to various definitions used for infection, different devices studied, and often limited periods of mechanical support. We used the definitions of the CDC for surgical site infection, which potentially allows for a better comparison of nosocomial infections between different institutions [7]. This classification has the advantage of including objective criteria, i.e. culture or pathology results as well as subjective criteria, i.e. the finding of an attending surgeon.

We evaluated infections associated with the permanent Jarvik 2000 LVAD. This data was compared to our patients who received the HeartMate LVAD. In our HeartMate-patients, we found a driveline infection rate of 65% and a device-pocket infection rate of 45%. This rate is similar to other recently published series with longer support times [1,10,11]. We found no adverse outcomes in the HeartMate-patients due to infection. Others have made similar findings [12]. In one recent series with 25 patients, a negative influence of infection on survival was found [11]. Even if such a difference had been present in our series, it could not be substantiated due to small sample size.

It might be argued, that the patient with the device-switch was at a particular high risk of infection. The indication for the device-switch was based on hemodynamic reasons alone and the switch was performed at a time when there was no sign of infection. In addition, the HeartMate device was implanted in a ‘virgin’ operative field through a sternotomy. The Jarvik 2000 had been implanted more than 3 months previously through a left thoracotomy approach and was fully healed-in. There is no evidence in the literature that such a device switch increases the risk of infection. All potential risk factors associated with an increased risk of infection have been considered in this patient (Tables 2 and 3). The infection of the HeartMate-device remained localized to the device-pocket. After transplantation and removal of the infected device, the percutaneous skull-mounted pedestal of the Jarvik 2000 LVAD and the powercable have been left in place and remain without any sign of infection despite an aggressive immunsuppressive regimen for his course complicated by several episodes of rejection.

The infection rate of the Jarvik 2000 LVAD with the retroauricular power-supply designed for permanent use was significantly lower than the rate of the HeartMate-LVAD. The risk of infection was lower than any other series of LVADs with abdominal drivelines. We found no major difference in risk factors between the Jarvik 2000 and HeartMate-patients, including preoperative risk scores. The only difference we found was that the Jarvik 2000 patients tended to be older, which is negatively associated with survival [1]. Only a prospective randomized study can truly control for risk factors between patient groups. Differences could have been missed due to small sample size and due to the nature of the retrospective review. Despite these limitations, the observed difference in infection rates is most likely due to the different devices. Several aspects of the permanent Jarvik 2000 might lead to the low device-related infection rate. The head-and-neck area appears to be immunologically privileged. We could not find any reports in the literature of infected hardware for osteosynthesis after maxillofacial surgery for trauma. Long-term experiences with similar percutaneous pedestals used for cochlear implants were associated with a low infection rate[4]. Other factors preventing infection might be the completely immobile skin exit-site of the pedestal and its much smaller size compared to a driveline of vented devices. The intraventricular position of the device, with lack of a large pseudo-capsule forming around the device, might account for the observed absence of deep surgical site infection.

Even though we found no influence on patient outcome due to infection in our patients, device-related infection was associated with significant morbidity and an average hospital cost of €12,843 per hospital re-admission. Antibiotic use was significantly higher in the HeartMate-patients. Three patients with the HeartMate-system had to be urgently transplanted due to bloodstream infection. These patients were at an increased risk for a serious complication [12]. The Jarvik 2000 permanent LVAD might reduce re-admission rates due to infection, lower the infection-associated cost, and also lead to a reduction of urgent transplantation due to infection. This device truly assists the left ventricle with flow rates of 1–5 l. However, as shown in our patient who required a device-switch from the Jarvik 2000 to the HeartMate-LVAD, it cannot completely replace left-ventricular function and can not be used in all patients in need for mechanical support.


   5. Conclusions
Top
 Abstract
 1. Introduction
 2. Materials and methods
 3. Results
 4. Discussion
 5. Conclusions
Appendix A. Conference...
 References
 
The permanent Jarvik 2000 LVAD is associated with a low infection rate. In 1264 patient-days we found one driveline infection which was resolved with antibiotic treatment alone. The power-supply of the permanent Jarvik 2000 appears suitable for permanent mechanical support.


   Acknowledgments
 
We would like to thank C. Siegenthaler RPh, K. Brehm MS and K. Hausschild MS, for the assistance in preparing the manuscript. We wish to thank Mr M. Olschewski, MSc., Institute of Medical Biometry, University of Freiburg, for the statistical review.


   Footnotes
 
Presented at the 16th Annual Meeting of the European Association for Cardio-thoracic Surgery, Monte Carlo, Monaco, September 22–25, 2002.

1 The authors have contributed equally to the present paper, and the names are presented in random order. Back


   Appendix A. Conference discussion
Top
 Abstract
 1. Introduction
 2. Materials and methods
 3. Results
 4. Discussion
 5. Conclusions
 Appendix A. Conference...
References
 
Dr J. Pomar (Barcelona, Spain): How comfortable was the patient with this kind of transfer of energy here in the skull? Was it okay for the patient?

Dr Siegenthaler: The patients get completely used to the retroauricular power connection. They really do not feel it anymore, some sleep on that side and they have no problems with it. It is probably a similar mechanism to wearing glasses.

Dr C. Yankah (Berlin, Germany): Infection might be a source of thromboembolic complications or valve thrombosis. Did you observe any thromboembolic complications in your TCI groups?

Dr Siegenthaler: We observed one minor stroke in our HeartMate group. This patient had a driveline infection. We are aware of the association between infection and thromboembolism, but our series of 11 HeartMate patients is too small to conclusively substantiate this association.

Mr S. Westaby (Oxford, UK): I think it would be nice to leave this session with some grounds for optimism with a view to permanent mechanical circulatory support right now. I would say there are two features about the Jarvik that make it resistant to infection. One is the skull-mounted power delivery, which is novel, and very user friendly for the patients; they seem to be very happy with it.

The other aspect is that the pump itself sits within the left ventricle. Because it sits within the left ventricle it is surrounded by blood and is far less likely to become infected than devices which sit in a pocket. I think the alignment of the pump within the left ventricle also makes it less likely to suffer thrombotic problems. And certainly, as Dr Siegenthaler knows, we have patients now well beyond 2 years living at home and actually taking trans-Atlantic flights and living completely normal lives with this device.

So I do think if you select the patients properly, and the best patients are idiopathic dilated cardiomyopathy patients with a chance of recovery, in this group this particular device looks very good for destination therapy.

Dr C. Vaughn (Phoenix, AZ): I had the occasion in the early years to work with Dr Jarvik in the development of his heart, and he would be very excited to see these innovations and the promising results. However, lest anyone in this audience leave with the idea that infection will not have a negative effect on transplantation, I would offer one anecdote, in that the first time in the world that an artificial heart was used to treat acute rejection in the absence of a donor heart, the centrally-actuated Phoenix Heart performed satisfactorily for an appropriate time until a transplant could be done. The patient died several days after transplantation from an infection that was traced back to the original donor heart. So I just rise to stress the importance of infection.


   References
Top
 Abstract
 1. Introduction
 2. Materials and methods
 3. Results
 4. Discussion
 5. Conclusions
 Appendix A. Conference...
 References
 

  1. Rose EA, Gelijns AC, Moskowitz AJ, Heitjan DF, Stevenson LW, Dembitsky W, Long JW, Ascheim DD, Tierney AR, Levitan RG, Watson JT, Ronan NS, Shapiro PA, Lazar RM, Miller LW, Gupta L, Frazier OH, Desvigne-Nickens P, Oz MC, Poirier VL, Meier P, the Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) Study Group. Long-term use of a left ventricular assist device for end-stage heart failure. N Engl J Med 2001;345:1435–1443.
  2. Argenziano M., Catanese K.A., Moazami N., Gardocki M.T., Weinberg A.D., Clavenna M.W., Rose E.A., Scully B.E., Levin H.R., Oz M.C. The influence of infection on survival and successful transplantation in patients with left ventricular assist devices. J Heart Lung Transplant 1997;16:822-831.[Medline]
  3. Westaby S., Banning A.P., Jarvik R., Frazier O.H., Pigott D.W., Jin X.Y., Catarino P.A., Saito S., Robson D., Freeland A., Myers T.J., Poole-Wilson P.A. First permanent implant of the Jarvik Heart. Lancet 2000;356:900-903.[CrossRef][Medline]
  4. Parkin J.L. Percutaneous pedestal in cochlear implantation. Ann Otol Rhinol Laryngol 1990;99:796-800.[Medline]
  5. Westaby S., Frazier O.H., Pigott D.W., Saito S., Jarvik R.K. Implant technique for the Jarvik 2000 Heart. Ann Thorac Surg 2002;73:1337-1340.[Abstract/Free Full Text]
  6. Siegenthaler M.P., Martin J., Frazier O.H., Beyersdorf F. Implantation of the permanent Jarvik-2000 left-ventricular-assist-device: surgical technique. Eur J Cardiothorac Surg 2002;21:546-548.[Abstract/Free Full Text]
  7. Garner J.S., Jarvis W.R., Emori T.G., Horan T.C., Hughes J.M. CDC definitions for nosocomial infections. Am J Infect Control 1988;16:128-140.[CrossRef][Medline]
  8. Horan T.C., Gaynes R.P., Martone W.J., Jarvis W.R., Emori T.G. CDC definitions of nosocomial surgical site infections, 1992: a modification of CDC definitions of surgical wound infections. Am J Infect Control 1992;20:271-274.[CrossRef][Medline]
  9. Altman D.G. Practical statistics for medical research. London: Chapman & Hall, 1991.
  10. Malani P.N., Dyke D.B., Pagani F.D., Chenoweth C.E. Nosocomial infections in left ventricular assist device recipients. Clin Infect Dis 2002;34:1295-1300.[CrossRef][Medline]
  11. Herrmann M., Weyand M., Greshake B., von Eiff C., Proctor R.A., Scheld H.H., Peters G. Left ventricular assist device infection is associated with increased mortality but is not a contraindication to transplantation. Circulation 1997;95:814-817.[Abstract/Free Full Text]
  12. Sinha P., Chen J.M., Flannery M., Scully B.E., Oz M.C., Edwards N.M. Infections during left ventricular assist device support do not affect posttransplant outcomes. Circulation 2000;102:7.[Abstract/Free Full Text]
  13. MacCarthy P.A., Schmitt S.K., Vargo R.L., Gordon S., Keys T.F., Hobbs R.E. Implantable LVAD infections: implications for permanent use of the device. Ann Thorac Surg 1996;61:359-365.[Abstract/Free Full Text]
  14. Oz M.C., Goldstein D.J., Pepino P., Weinberg A.D., Thompson S.M., Catanese K.A., Vargo R.L., McCarthy P.M., Rose E.A., Levin H.R. Screening scale predicts patients successfully receiving long-term implantable left ventricular assist devices. Circulation 1995;92:II169-II173.
  15. Aaronson K.D., Schwartz J.S., Chen T.M., Wong K.L., Goin J.E., Mancini D.M. Development and prospective validation of a clinical index to predict survival in ambulatory patients referred for cardiac transplant evaluation [see comments]. Circulation 1997;95:2660-2667.[Abstract/Free Full Text]



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Ann. Thorac. Surg., August 1, 2005; 80(2): 745 - 747.
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M. P. Siegenthaler, S. Westaby, O.H. Frazier, J. Martin, A. Banning, D. Robson, J. Pepper, P. Poole-Wilson, and F. Beyersdorf
Advanced heart failure: feasibility study of long-term continuous axial flow pump support
Eur. Heart J., May 2, 2005; 26(10): 1031 - 1038.
[Abstract] [Full Text] [PDF]

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