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Eur J Cardiothorac Surg 2010;37:350-356. doi:10.1016/j.ejcts.2009.03.071
Copyright © 2010, European Association for Cardio-thoracic Surgery. Published by Elsevier. All rights reserved.
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Right arrow Mechanical Circulatory Assistance

Destination therapy with a rotary blood pump and novel power delivery

Stephen Westabya,*, Michael Siegenthalerb, Friedhelm Beyersdorfc, Massimo Massettid, John Peppere, Andre Khayatd, Roland Hetzerf, Oscar Howard Frazierg

a Department of Cardiothoracic Surgery, John Radcliffe Hospital, Headley Way, Headington, Oxford OX3 9DU, UK
b Department of Cardiothoracic Surgery, UMPC Presbytarian, Pittsburgh, Philadelphia, PA, USA
c Department of Cardiovascular Surgery, Albert-Ludwigs-University Freiburg, Freiburg, Germany
d Department of Thoracic and Cardiovascular Surgery, University Hospital, Caen, France
e National Heart and Lung Institute, Imperial College, London, UK
f German Heart Institute, Berlin, Germany
g Texas Heart Institute, Houston, TX, USA

Received 11 September 2008; received in revised form 12 March 2009; accepted 17 March 2009.

* Corresponding author. Tel.: +44 1865 220269; fax: +44 1865 220268. (Email: swestaby{at}ahf.org.uk).


   Abstract
Top
 Abstract
1. Introduction
 2. Patients and methods
 3. Results
 4. Discussion
 Appendix A
 References
 
Objective: We tested the hypothesis that a miniaturised axial flow pump with infection-resistant power delivery could improve longevity and quality of life (QOL) in advanced heart failure patients deemed unsuitable for transplantation. Methods: The study included all non-United States Jarvik 2000 patients (n = 46), where a skull-pedestal-based power line was employed with the intention of long-term support. Patient age ranged from 29 to 80 years. Of the 46 patients, 42 were male. All were New York Heart Association (NYHA) IV predominantly with idiopathic dilated (n = 22) or ischaemic (n = 18) cardiomyopathy. The experience (2000–2008) included the learning curve of 10 centres. Results: The internal components are imperceptible. The power/control system is user friendly, allowing excellent QOL. There has been no pump malfunction. The Kaplan–Meier survival analysis is shown. The longest event-free survival is 7.5 years. Support exceeded 3 years in five cases. The cumulative experience exceeds 50 years. Three patients were transplanted, and two pumps were replaced at 90 and 203 days. Nineteen cases are ongoing (mean: 663 days), while 22 died during support (mean survival: 402 days), of which five from non-device-related diseases. Temporary local infection occurred in three pedestals, and there has been no pump infection. Incidence of thrombo-embolic events showed wide variation between centres. Conclusions: From this learning-curve experience, both left ventricular assist device (LVAD) and power delivery are reliable and promising for destination therapy. Early mortality is similar to other studies and relates to the severity of illness. Pump infection has not occurred and prolonged event-free survival is clearly possible with expert medical management.

Key Words: Heart failure • Assist device • Jarvik • Long term


   1. Introduction
Top
 Abstract
 1. Introduction
2. Patients and methods
 3. Results
 4. Discussion
 Appendix A
 References
 
Severely symptomatic heart failure is an expanding problem with poor prognosis and limited treatment options [1]. Heart failure treatment costs are driven by hospital admissions with a major escalation when patients reach the New York Heart Association (NYHA) Class IV. In the USA and UK, there are approximately 25 000 and 12 000 patients under 65 years of age with chronic pre-terminal heart failure, of whom half have systolic dysfunction. Set against these numbers are 2000 and 150 donor hearts, respectively. Cardiac allotransplantation does not address the epidemiological situation and lacks a firm evidence base, particularly for ambulatory United Network for Organ Sharing (UNOS) Status II candidates [2]. Mechanical blood pumps were developed to sustain life in patients with cardiogenic shock during heart surgery, and then they were used in selected patients to preserve life until cardiac transplantation. The Randomised Evaluation of Mechanical Assistances for the Treatment of Congestive Heart Failure (REMATCH) trial provided a firm, though inauspicious, evidence base for the use of blood pumps as an alternative to medical therapy in patients not eligible for transplantation [3].

Despite the evidence, destination therapy has been slow to progress largely due to the cardiologists’ misconceptions about complication rates in contemporary blood pumps [4]. Publications about first-generation left ventricular assist devices (LVADs) reported substantial incidences of device failure, infection and thrombo-embolism [3]. LVAD abdominal power lines pass through subcutaneous fat and are subject to continuous movement in relation to the skin. Pathogenic organisms are able to breach the skin layer, colonise the foreign materials and cause antibiotic-resistant LVAD pocket infection. Sepsis accounted for 37% of deaths in the REMATCH trial. In HeartMate LVAD patients, Holman reported a 42% incidence of sepsis by 12 months and 52% by 2 years. Septic patients had only 39% 1-year and 8% 2-year survival compared with 60% and 38%, respectively, for uninfected patients [5].

In the past 10 years, blood pump technology has improved markedly following the revelation that pulse pressure is not a fundamental requirement in the human circulation [6]. Moreover, it is clear that modest increases in blood flow (in the range of 3–4 l min–1) can relieve symptoms and reverse both the humoral and cytokine changes associated with heart failure. The new rotary blood pumps are smaller and more patient friendly than pulsatile LVADs. In an attempt to avoid transcutaneous cable infection, we developed a new method for power delivery for the Jarvik 2000 axial flow pump (Fig. 1 ). The system is based upon cochlear implant technology [7]. A titanium pedestal is screwed into the temporal bone behind the ear and conveys the electrical system through highly vascular scalp skin (Fig. 2 ). Our hypothesis was that immobility (in relation to the skin) and absence of subcutaneous fat would prove infection resistant. In turn, the percutaneous site remote from the device prevents infection from reaching the blood pump situated in the apex of the left ventricle. The first patient was implanted in 2000 and achieved 7.5 years event-free survival [8]. We now present the entire series of patients with alternative power delivery, specifically designed for long-term use.


Figure 1
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  		Fig. 1. The Jarvik 2000.

 

Figure 2
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  		Fig. 2. Skull pedestal power delivery. (a) The pedestal screwed to the skull. (b) Titanium pedestal with external power cable removed. (c) External cable plugged into the pedestal.

 

   2. Patients and methods
Top
 Abstract
 1. Introduction
 2. Patients and methods
3. Results
 4. Discussion
 Appendix A
 References
 
This cohort included 46 adult patients who underwent Jarvik 2000 implants with post-auricular power delivery between June 2000 and July 2008. Long-term therapy was intended for all patients at the time of surgery. Contraindications to destination therapy have been discussed elsewhere [3]. The only contraindications to skull pedestal use were a skull thickness less than 5 mm or a skin disease affecting the post-auricular area. Forty-two patients were male and four female. Ages at implant ranged from 27 to 80 years (mean: 57 ± 10.2 years). Body surface area of the patients ranged from 1.51 m2 to 2.33 m2 (mean: 1.96 ± 0.21 m2). All patients were NYHA IV despite maximum medical therapy. The projected survival was less than 12 weeks in every case, but less than 7 days in the majority of pre-CE mark (2005) patients. Twenty-four patients had idiopathic dilated cardiomyopathy and 19 ischaemic cardiomyopathy. Three had other conditions. Transplantation was not performed because of age or co-morbidities such as pulmonary hypertension or renal impairment.

2.1 Operative technique
The implant technique for the Jarvik 2000 with post-auricular power supply has been described in detail by both left thoracotomy and median sternotomy [9,10]. Left thoracotomy was used in 44 of the 46 patients described. In brief, the post-auricular incision was made and the surface of the skull prepared. Left thoracotomy was performed through the sixth intercostal space. Meanwhile, percutaneous left femoral artery and vein cannulas were inserted using the Seldinger technique, should cardiopulmonary bypass be required. The pump was tested and then the power cable delivered through the pleural cavity to the first intercostal space posteriorly. It was then conveyed to the post-auricular position through small incisions on the posterior aspect of the neck (Fig. 2). The electric pins were inserted through the titanium skull pedestal and the pedestal screwed into place on the outer table of the temporal bone (Fig. 2). The pedestal was then passed through a perforation in the skin flap and the scalp wound closed. The external power cable was plugged into the pedestal and the pump tested again in a bowl of saline. The length of the vascular graft was carefully determined and the anastomosis made to the descending thoracic aorta using a side clamp. The restraining cuff was then sewn to the apex of the left ventricle aiming to align the device parallel to the septum and towards the mitral orifice. Teflon pledgetted sutures were inserted into the beating heart. Amiodarone was used to suppress ventricular ectopic activity. With the cuff sewn in place, a coring knife was used to excise apical muscle and the pump was inserted through the cuff to stop bleeding. The vascular graft was carefully de-aired before switching on LVAD power. This process was achieved without important blood loss or haemodynamic deterioration. Cardiopulmonary bypass was used in the event of ventricular fibrillation or borderline cardiac output. This occurred in 12 patients (Fig. 3 ).


Figure 3
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  		Fig. 3. Plain X-ray showing the power cable passing from the blood pump through the pleural cavity and exiting through the first intercostal space posteriorly. It then passes through the neck to the post-auricular pedestal which is screwed into the external table of the temporal bone.

 
Anticoagulation with warfarin was started on the first postoperative day. Target INR was between 2.0 and 3.0. Supplementary anticoagulation differed between centres and included aspirin or clopidogrel. In the early postoperative period, the external power cable was disconnected for short periods for cleaning. Acetycholinesterase inhibitors were recommenced to control pump afterload. Betablockers, diuretics and anti-dysrhythmic drugs were re-introduced as necessary. The patients were discharged from hospital when they and the family were confident in managing of the external components.

2.2 Statistical methods
Time zero was defined as the date of device implant, and patients were censored at the time of death or last contact. We calculated event rates and hazard ratios using Cod proportional hazards models with time to death as the outcome and age and baseline diagnosis (presence or absence of idiopathic dilated cardiomyopathy) as covariates. We checked the proportional assumption using a standard test based on the scaled Schoenfeld residuals [11], but no failure was noted. We also computed Kaplan–Meier estimates of the cumulative event rates over time. We truncate the Kaplan–Meier plots when fewer than 10% of the patients remain at risk in either treatment arm.


   3. Results
Top
 Abstract
 1. Introduction
 2. Patients and methods
 3. Results
4. Discussion
 Appendix A
 References
 
Duration of support ranged from 8 to 2714 days (mean: 402 ± 587). This provided a total experience of 18 509 days (50.7 years). There have been 22 deaths during support and 19 patients are ongoing. Three patients converted to cardiac transplantation, of which two are alive. Two patients had the LVAD replaced. The first suffered progressive biventricular failure and had the Jarvik 2000 replaced with a pulsatile HeartMate I LVAD at 90 days. Biventricular function continued to deteriorate and the patient died. The second patient suffered life-threatening gastrointestinal haemorrhage and warfarin was discontinued during surgery. Pump thrombosis followed and was managed by thrombolysis. A second gastric operation was required and the pump clotted again when anticoagulation was reversed. The first LVAD was then replaced with a second Jarvik 2000 on post-implant day 203. The patient is alive and well 12 months later.

Fourteen patients died within 1 year of implant. The second patient to receive the skull pedestal sustained a sub-dural haematoma, which required surgery. Weighing more than 120 kg, this patient eventually died from right heart failure secondary to pulmonary hypertension 95 days after the implant. Four patients died from sepsis and multi-organ failure at 9, 13, 25 and 85 days after the implants. Two patients died from heart failure progression, predominantly right ventricular failure at 93 and 190 days. There was one death from isolated renal failure at 57 days and another from torrential acute haemoptysis at 12 days. Four patients suffered a stroke at 8, 33, 81 and 110 days post implant, which eventually resulted in death. One patient died at 162 days during a battery change.

Late deaths (after 12 months) occurred in eight patients. Two patients died from systemic sepsis at 819 and 1182 days, neither related to the drive line. One patient died at 1126 days when he left home without a spare battery and his existing battery ran out. Another patient died from progressive right ventricular failure 762 days after implantation. There were four late non-device or heart failure deaths from head injury (382 days), renal carcinoma (540 days), chronic obstructive airways disease (1041 days) and renal failure following profuse epistaxis (2714 days) in a patient whose INR was carefully controlled at 2.5. This was the first Jarvik 2000 destination therapy patient who enjoyed almost 7.5 years good-quality event-free survival until the terminal event.

A second patient has reached 7 years survival with the same LVAD, but has required replacement and re-location of the skull pedestal due to corrosion of the connecting pins, possibly mediated by contaminants. This was also one of three pedestal infections. The other two were managed successfully with topical antiseptic solutions and systemic antibiotics. One further patient suffered corrosion of the connecting pins, which have now been plated with gold, and five patients suffered external cable malfunction due to wear and tear. Device thrombus was suspected and managed by thrombolysis in five patients. There were three other non-fatal strokes, one of which occurred within the first 3 months of the implant. The others occurred at 195 and 225 days postoperatively. In addition, there were three transient ischaemic attacks all within 180 days of surgery. One patient sustained an embolus to the femoral artery and four patients suffered anticoagulant-related bleeding.

The learning curve for the use of this system had an important bearing on clinical outcomes. Overall survival in the 46 patients at 2 years was 52% (Fig. 4 ). At 2 years, overall freedom from LVAD failure, drive-line infection and skull-pedestal infection was 100%, 100% and 94%, respectively. In no case did infection at the pedestal site travel down the electrical system or reach the pump. Freedom from thrombo-embolism at 2 years was 83% (38 of 46 patients). For the first 21 patients implanted before CE mark approval (in 2005), the 2-year survival was 37% (Fig. 5 ). In contrast, for 25 patients implanted since the CE mark, the 2-year survival was 74%. In this group, there were five deaths (20%), with 18 patients ongoing. One patient converted to transplantation and another was replaced after device thrombosis following cessation of anticoagulation due to surgery. Both are alive.


Figure 4
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  		Fig. 4. Survival in all patients.

 

Figure 5
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  		Fig. 5. Survival difference between patients operated during learning curve.

 
Notably, there has been no bearing failure of the axial flow pump in any of the 46 patients, or in more than 200 bridge-to-transplant patients where an abdominal cable has been employed. All but two hospital survivors were restored to NYHA I or II. Quality of life has been exceptionally good for many of these patients. Most found the implanted components imperceptible. The skull pedestal was unobtrusive and not visible in most when the hair grew back (Fig. 6 ). International air travel, driving, skiing, fishing and farming were resumed by some. A number have declined transplant wait listing following improvement in renal function or a fall in pulmonary vascular resistance.


Figure 6
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  		Fig. 6. The skull pedestal is unobtrusive when hair grows back after surgery.

 

   4. Discussion
Top
 Abstract
 1. Introduction
 2. Patients and methods
 3. Results
 4. Discussion
Appendix A
 References
 
The Jarvik 2000 post-auricular power system adopts the principles used successfully by Parkin for artificial hearing technology [12]. Parkin's cochlear implant operations achieved reproducible long-term freedom from infection by combining an exit site through highly vascular scalp skin with immobility through rigid fixation of a biocompatible pedestal to the underlying skull. Immobility in relation to the skin promotes secure healing. The principle was first tested in laboratory experiments where the skull pedestal remained free from infection in contrast to failure to heal and sepsis in conventional transcutaneous drive lines [7]. These experiments suggested that similar principles could be translated to LVAD power cables for patients who required long-term circulatory support.

Our report includes the learning curve from 10 centres with this system during which both surgical techniques and aspects of pre- and postoperative management were refined. Careful measurements of skull thickness and improved instruments for skull pedestal implantation prevented another penetration of the internal skull table. A change in the metallic composition of the power cable pins prevented further problems with corrosion. The external power cables were strengthened, and a change of external components is now recommended every 6 months. Brief disconnection and cleaning of the pedestal connections is undertaken in hospital during the early postoperative period. After a patient died through error during a battery change, a dual cable was produced so that the replacement battery could be connected before the spent battery was removed. Given these improvements, which occurred before CE mark approval, it is clearly advantageous to have completely exchangeable external components for a destination therapy patient living an active life in the community. These changes contributed to the substantial differences in outcome between pre- and post-CE mark patients and resulted in better survival. A major weakness of this collective experience is that many centres had small numbers of patients, which automatically limits outcome. In REMATCH, Park et al. observed that high-volume implant centres achieved 85% 1-year and 65% 2-year survival, substantially better than the average for all participating centres [13]. Irrespective of patient numbers, the current study is notable for 100% mechanical reliability and 100% freedom from LVAD or power cable infection. In no case did skull pedestal infection travel down the power cable, and in no patient did bacteraemia or septicaemia result in device endocarditis.

Pre-CE mark implants performed between 2000 and 2005 typically occurred in REMATCH type end-of-life candidates with multiple co-morbidities, deemed unsuitable for transplantation. Accordingly hospital mortality occurred in many through inability of an LVAD to alter the course of terminal heart failure. In the words of the REMATCH principal investigator Eric Rose, ‘even a perfect LVAD could not have improved outcomes in these patients.’ For the post-CE mark destination therapy cohort, selection shifted towards chronic severely symptomatic heart failure patients who were non-transplant eligible through age or co-morbidity, but who were not dependent on intravenous inotropes or a balloon pump. The result was 75% 2-year survival and excellent quality of life in the majority of patients. Clearly, ‘destination therapy’ is most economically viable and effective when provided electively (for symptomatic relief) at low surgical risk and not for salvage during multiple organ failure [14]. Similar improved outcomes were achieved with the HeartMate XVE LVAD towards the end of the REMATCH trial when adjustments in patient selection, better infection prophylaxis and the use of drive line restraining belts improved 2-year survival from 21% to 43%. Current destination therapy outcomes are now comparable with those achieved by haemodialysis in end-stage renal disease (The United States Renal Data System 2004 Annual Data Report. Available at http://www.usrds.org/).

Other investigations support the finding that continuous-flow-pump patients suffer fewer complications than those with a pulsatile LVAD. The largest bridge-to-transplant investigation using the HeartMate II axial flow LVAD recorded 0.37 cases of drive-line infection per patient year vs 3.49 in REMATCH [15]. Similarly, there were 0.19 vs 0.44 strokes per patient year, 0.26 vs 0.67 non-stroke neurological events per patient year and 0.08 vs 0.30 cases of right heart failure requiring a right ventricular assist device per patient year. Resolution of heart failure symptoms and of cytokine and humeral change occurred in the same time frame with continuous LVADs as for pulsatile systems. The major outstanding issue is thrombo-embolism, the incidence of which differed widely between centres in our study. The reasons for this were difficult to define but may well be patient rather than device related.

Given the number of patients with advanced heart failure LVAD deployment has the potential to exceed cardiac transplantation by a factor of 20:1. For non-transplant eligible patients, there are no satisfactory treatment alternatives. Cardiac re-synchronisation therapy (CRT) and implantable cardioverter-defibrillators are both widely employed at substantial cost but have limited value in severely symptomatic patients [16]. Boyle presented a direct comparison of functional outcomes in NYHA Class IV patients after CRT or an LVAD implant [17]. At 6 months CRT patients achieved an additional 46 m in the 6-min walk test. In contrast, the LVAD patients who attempted the walk test beforehand improved by 225 yards (fourfold over CRT). The study was not randomised because 90% of LVAD recipients were bed-bound on intravenous inotropes beforehand. This group improved by 373 yards. Advanced age, pulmonary hypertension and renal impairment are not absolute contraindications to LVAD deployment. Moore et al. reported comparative survival and symptomatic relief for LVAD patients older than 75 years [18].

It is reasonable to conclude that an ‘off the shelf’ solution already exists for transplant ineligible patients or for those who wish to avoid immunosuppression [19]. Data from the UK Cardiothoracic Transplant Audit presented at the International Society for Heart Lung Transplantation (2008) showed that donor hearts allocated to coronary artery disease patients have fallen from 46% to 21% over 10 years, largely due to alternative therapies [20]. Fifty-eight per cent of transplants are now for idiopathic dilated cardiomyopathy where LVAD unloading may improve native heart function. The Berlin Group now show 78% 8-year survival following LVAD removal in idiopathic dilated cardiomyopathy patients whose myocardial contractility was improved by unloading [21]. Predictors of sustainable improvement were younger age, symptoms for less than 5 years and rapid improvement in ejection fraction. So why has long-term LVAD therapy failed to progress further with the new rotary blood pumps? There are several reasons. First is the perceived difficulty in identifying patients who are progressing towards an early death but who are not yet dying [22]. The UNOS Status II patients who derive limited benefit from cardiac transplantation are an example [23]. Many of these patients would choose LVAD support for symptomatic relief irrespective of survival benefit or their prospects of receiving a donor heart. To allow the younger of these patients (less than 75 years) to deteriorate to a chachectic state with multiple organ dysfunctions before considering an LVAD could now be considered neglectful. Secondly, in the absence of a well-powered prospective trial of destination therapy with a rotary blood pump, it is difficult to persuade cardiologists and the regulators of health-care resources of the clear benefits of an LVAD. In addition, the use of LVADs for long-term therapy is largely limited to transplant centres. Patients who are clearly not eligible for transplant and who could be candidates for destination therapy are not currently referred to these hospitals. Given the potential demand from these patients, LVAD therapy should be performed in tertiary referral cardiac centres that perform non-transplant heart failure surgery [24]. This approach is already endorsed in the USA and regulatory guidelines for such centres are established. To date, rotary blood pumps have not been licensed for destination therapy in the USA and research funding for meaningful randomised clinical trials has not been forthcoming in Europe. This provides an inequitable situation whereby renal patients benefit from dialysis irrespective of age, whereas heart failure patients are not provided with a mechanical solution clearly demonstrated to relieve symptoms and provide life by equivalent amounts. Lastly, for the 7.5-year survivor, the LVAD sustained the systemic circulation and palliated symptoms for more than 10% of his overall life span [8]. The cost per annum of $40 000, which included the cost of the LVAD and operation, did not exceed the benchmark $50 000 per added life year accepted by most health-care systems for renal dialysis patients.

Given the effectiveness and reliability of rotary blood pumps in appropriately selected patients, it is difficult to justify further trials with randomisation against medical therapy for severely symptomatic patients. Indeed, for those who wish to avoid the side effects of immunosuppression or the risk of death on the waiting list, a rotary blood pump may already provide a realistic alternative to a donor heart. In the meantime, blood pumps can offer symptomatic relief for the many heart failure patients who will never reach a transplant waiting list.


   Appendix A
Top
 Abstract
 1. Introduction
 2. Patients and methods
 3. Results
 4. Discussion
 Appendix A
References
 
Conference discussion

Dr Beyersdorf: The Jarvik 2000 is a pump which functions extremely well. There has been no malfunction up to 7 years, which makes this device so important. This almost compares to the survival rate which we have just seen with haemodialysis raising the question if even prophylactic implantation could be done maybe 1 day, surely not right now.

I have two questions for you. First, is there a minimum of cardiac index which is required for optimal device function?

And second, since we have already discussed before, were there patients included with fixed pulmonary hypertension and could they be improved with this device?

Mr Stuart McConchie (New York, United States): Professor Beyersdorf, The answer to the first question, I’m not aware of a minimum cardiac index requirement.

And, yes, there were patients included in the series who had high fixed pulmonary vascular resistance and improved subsequent to implantation.


   Footnotes
 
{star} Presented at the 22nd Annual Meeting of the European Association for Cardio-thoracic Surgery, Lisbon, Portugal, September 14–17, 2008.


   References
Top
 Abstract
 1. Introduction
 2. Patients and methods
 3. Results
 4. Discussion
 Appendix A
 References
 

  1. Redfield MM. Heart failure—an epidemic of uncertain proportions. N Engl J Med 2002;347:1442-1444.[Free Full Text]
  2. Hoercher KJ, Nowicki ER, Blackstore EH, Singh G, Alster JM, Gonzalez-Stawinski GV, Starling RC, Young JB, Smedira NG. Prognosis of patients removed from a transplant waiting list for medical improvement: implications for organ allocation and transplantation for Status 2 patients. J Thorac Cardiovasc Surg 2008;135:1159-1166.[Abstract/Free Full Text]
  3. Rose EA, Gelijns AC, Moskowitz AJ, Heitjan DF, Stevenson LW, Dembitsky W, Long JW, Ascheim DD, Tierney AR, Levitan RG, Watson JT, Meier P, Ronan NS, Shapiro PA, Lazar RM, Miller LW, Gupta L, Frazier OH, Desvigne-Nickens P, Ox MC, Poirier VL, Randomised Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) Study Group Long term mechanical left ventricular assistance for end-stage heart failure. N Engl J Med 2001;345:1435-1443.[Abstract/Free Full Text]
  4. Westaby S. Destination therapy. Time for real progress. Nat Clin Pract Cardiovasc Med 2008;5:477-483.[CrossRef][Medline]
  5. Holman WL, Park SJ, Long JW, Weinberg A, Gupta L, Tierney AR, Adamson RM, Watson JD, Raines EP, Couper GS, Pagani FD, Burton NA, Miller LW, Naka Y, REMATCH Investigators Infection in permanent circulatory support experience from the REMATCH trial. J Heart Lung Transplant 2004;23:1359-1365.[CrossRef][Medline]
  6. Haft J, Dyke DB, Aaronson KD, Koelling TM, Farrar DJ, Pagani FD. Hemodynamic and exercise performance with pulsatile and continuous flow left ventricular assist devices. Circulation 2007;116(Suppl. II):I8-I15.[CrossRef][Medline]
  7. Jarvik R, Westaby S, Katsumata T, Pigott D, Evans RD. LVAD power delivery: a percutaneous approach to avoid infection. Ann Thorac Surg 1998;65:470-473.[Abstract/Free Full Text]
  8. Westaby S, Banning A, Neil D, Poole-Wilson P, Frazier OH. Optimism derived from 7.5 years continuous flow circulatory support. J Thorac Cardiovasc Surg, doi:10.1016/jtcvs.2008.05.072.
  9. Siegenthaler MP, Martin J, Gutwald R, Bahr R, Westaby S, Schmelzeisen R, Beyersdorf F. Anterior approach to implant the Jarvik 2000 with retro-auricular power supply. Ann Thorac Surg 2005;80(August (2)):745-747.[Abstract/Free Full Text]
  10. Westaby S, Saito S, Frazier OH. Implant technique for the Jarvik 2000 heart. Ann Thorac Surg 2002;123:977-983.
  11. Grambsch P, Therneau T. Proportional hazards tests and diagnostics based on weighted residuals. Biometrika 1994;81:515-526.[Abstract/Free Full Text]
  12. Parkin JL. Percutaneous pedestal in cochlear implantation. Ann Otol Rhinol Largyngol 1990;99:798-800.
  13. Park SJ, Tector A, Piccioni W, Raines E, Gelijns A, Moskowitz A, Rose E, Holman W, Furukawa S, Frazier OH, Dembitsky W. Left ventricular assist devices as destination therapy: a new look at survival. J Thorac Cardiovasc Surg 2005;129:9-17.[Abstract/Free Full Text]
  14. Leitz K, Long JW, Kfoury AG, Slaughter MS, Silver MA, Milano CA, Rogers JG, Naka Y, Mancini D, Miller LW. Outcomes of left ventricular assist device implantation as destination therapy in the post-REMATCH era: implications for patient selection. Circulation 2007;116:497-505.[Abstract/Free Full Text]
  15. Miller LW, Pagani FD, Russell SD, John R, Boyle AJ, Aaronson KD, Conte JV, Naka Y, Mancini D, Delgado RM, MacGillivray TE, Farrar DJ, Frazier OH, HeartMate II Clinical Investigators Use of a continuous flow device in patients awaiting heart transplantation. N Eng J Med 2007;357:885-896.[Abstract/Free Full Text]
  16. McAlister FA, Ezekowitz J, Hooton N, Vandermeer B, Spooner C, Dryden DM, Page RL, Hlatky MA, Rowe BH. Cardiac resynchronisation therapy for patients with left ventricular systolic dysfunction. A systematic review. JAMA 2007;297:2502-2514.[Abstract/Free Full Text]
  17. Boyle AJ, Russell SD, John R, Chen L, Aaronson KD, Farrar DJ, Rogers JG. Comparing improvements in functional capacity in NYHA Class IV patients between a continuous flow left ventricular device and cardiac resynchronisation therapy. J Am Coll Cardiol 2008;51(Suppl. A)A69(Abstr).
  18. Moore SA, Clark N, Madsen CN, Bishop CJ, Nelson K, Long JW. Destination left ventricular assist device therapy for advanced age patients with heart failure: is there an age limit. J Am Coll Cardiol 2008;51(Suppl. A)A68(Abstr).
  19. Westaby S. Advanced heart failure—an "off the shelf" solution?. Lancet 2008;371(9628):1898-1900.[CrossRef][Medline]
  20. Thekkudan J, Rogers C, Thomas HL, Bonser RS, Banner NR, Steering Group Trends in adult heart transplantation: a UK survey. J Heart-Lung Transplant 2008;27(Suppl. 2)S.122(Abstr).
  21. Hetzer R, Muller J, Weng Y, Wallukat G, Spiegelsberger S, Loebe M. Cardiac recovery in dilated cardiomyopathy by unloading with a left ventricular assist device. Ann Thorac Surg 1999;68:742-749.[Abstract/Free Full Text]
  22. Lee DS, Austin PC, Rouleau JL, Liu PP, Naimark D, Tu JV. Predicting mortality among patients hospitalized for heart failure: derivation and validation of a clinical model. JAMA 2003;290:2581-2587.[Abstract/Free Full Text]
  23. Leitz K, Miller LW. Improved survival of patents with end-stage heart failure listed for heart transplantation. J Am Coll Cardiol 2007;50:1282-1290.[Abstract/Free Full Text]
  24. Westaby S. Lifetime circulatory support must not be restricted to transplant centres. Heart Failure Clin 2007;3:369-376.[CrossRef]



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H. Argiriadou, K. Megari, P. Antonitsis, M. H. Kosmidis, C. Papakonstantinou, and K. Anastasiadis
Non-pulsatile circulation with axial-flow left ventricular assist device preserves neurocognitive function
Perfusion, July 1, 2010; 25(4): 225 - 228.
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