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European Journal of Heart Failure 2007 9(5):525-530; doi:10.1016/j.ejheart.2006.12.003
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© 2007 European Society of Cardiology

The feasibility of left ventricular mechanical support as a bridge to cardiac recovery

Hans Lidena, Kristjan Karasonb, Claes-Håkan Berghb, Folke Nilssona, Bansi Koulc and Lars Wiklunda,*

a Department of Cardiothoracic Surgery, Sahlgrenska University Hospital S-413 45 Gothenburg, Sweden
b Department of Cardiology, Sahlgrenska University Hospital Gothenburg, Sweden
c Department of Cardiothoracic Surgery, Lund University Hospital Lund, Sweden

* Corresponding author. Tel.: +46 31 3427502; fax: +46 31 417991. E-mail address: lars.wiklund{at}vgregion.se


   Abstract
Top
 Abstract
1. Introduction
 2. Methods
 3. Results
 4. Discussion
 5. Conclusion
 References
 
Objective: To study the achievability of device weaning in patients receiving left ventricular assist devices (LVADs) as a bridge to transplantation.

Methods: Eighteen consecutive patients receiving a LVAD between September 1997 and June 2002 were included in the study. During a four-month follow-up, patients were repeatedly evaluated with right heart catheterization and echocardiography and, if functional improvement was observed, studied with the device turned off. Cardiac recovery was defined as off-pump LVEF≥40% together with a significant improvement in invasive haemodynamic measurements (CI≥2.5 and PCWP≤10–12 mm Hg). Patients fulfilling these criteria were considered for weaning.

Results: Three patients fulfilled the predefined criteria for cardiac recovery and were subjected to device explantation. In one patient, a young female with acute myocarditis, the following course was uneventful. In the second patient, a male with dilated cardiomyopathy, heart failure reoccurred only a few days later. The third patient had a relapse of giant cell myocarditis and was transplanted. One patient underwent transplantation before follow-up evaluation could be performed.

Conclusion: In our experience, patients with severe advanced heart failure are unlikely to show significant cardiac recovery following treatment with LVAD, in contrast to previous suggestions.

Key Words: Heart transplantation • Left ventricular assist device • Mechanical support • Recovery

Received October 4, 2006; Accepted December 4, 2006


   1. Introduction
Top
 Abstract
 1. Introduction
2. Methods
 3. Results
 4. Discussion
 5. Conclusion
 References
 
Heart transplantation is currently the most effective therapy for end-stage heart disease. Transplantation is, however, associated with morbidity related to immunosuppressive treatment and somewhat sub-optimal survival. Furthermore, despite various efforts to increase the number of donors, the availability of organs is still insufficient.

Cardiac mechanical assist devices are widely used for circulatory support. Implantable left ventricular assist devices (LVADs) have been shown to serve effectively as a bridge to transplantation [1,2] and have been used to bridge patients with post-cardiotomy heart failure and acute myocarditis to myocardial recovery.

More recently, patients with chronic end-stage heart failure, due to dilated cardiomyopathy, have been reported to show cardiac recovery during treatment with LVADs. In many cases the restoration of cardiac function has been sufficient to enable explantation of the device, thereby, rendering heart transplantation unnecessary [3-5].

Therefore, if LVAD support in chronic end-stage heart disease would result in cardiac recovery, the need for heart transplantation could be reduced.

The purpose of this study was therefore to prospectively investigate the feasibility of device weaning in an unselected group of heart failure patients receiving mechanical circulatory support as a bridge to transplantation at two Swedish centres.


   2. Methods
Top
 Abstract
 1. Introduction
 2. Methods
3. Results
 4. Discussion
 5. Conclusion
 References
 
2.1. Patients
Eighteen consecutive patients receiving a LVAD as a bridge to transplantation, between September 1997 and June 2002 at Sahlgrenska and Lund University Hospitals, were included in the study. The study population consisted of 4 women and 14 men, with a mean age of 41±3 (range 19-61) years. The causes of heart failure were: idiopathic dilated cardiomyopathy (IDCM) (n=9), myocarditis (n=5), ischaemic cardiomyopathy (n=3) and hypertrophic cardiomyopathy (n=1). Of the five patients with myocarditis, two displayed myocardial histology consistent with giant cell myocarditis. All patients were in NYHA functional class IV, despite optimal medical treatment, with signs of deteriorating renal and/or liver function. A pre-transplantation evaluation revealed no significant contraindications for heart transplantation (Htx) in any patient.

After implantation, patients continued to receive optimal medical treatment for heart failure, including beta-blockers, ACE-inhibitors and spironolactone. During a four-month follow-up period, patients were repeatedly evaluated with echocardiography and right heart catheterization. If criteria for cardiac recovery were not fulfilled during this period, patients were activated on the Htx waiting list. The investigation conforms with the principles outlined in the "Declaration of Helsinki" (Br Med J 1964; ii:177). The study was approved by the Ethics Committees at the Universities of Göteborg and Lund and all patients gave informed consent.

2.2. Cardiac assist devices
Fifteen patients were supported with HeartMate VE (Thoratec Corporation, Plesanton, CA) and three patients received Jarvik 2000 (Jarvik Inc., NY). Study patients who received a HeartMate device [6] obtained a vented electrical model to facilitate patient mobility and promote outpatient care. The implantation technique has previously been described [7]. In the first two patients the LVAD was placed in a preperitoneal pocket, but in subsequent patients an intraperitoneal implantation was performed to reduce the risk of pocket infection. In five patients, implanted early in the program, the heart was arrested during implantation.

The Jarvik 2000 VAD® [8] consists of a blood pump, controller and batteries. The patient can adjust the speed between 8000 and 12,000 revolutions/minute (rpm). The power cable can be placed either abdominally, through the right upper quadrant, or in a post-auricular pedestal [9]. The cable was tunnelled in the apex region of the left chest and subcutaneously through the neck to the exit site behind the left ear. The exit site was determined using a CT scan of the skull and the thickest part of the region behind the left ear was used. Holes in the skull were drilled using special equipment and the pedestal was placed on the skull behind the left ear with screws. The pumps were implanted through a left thoracotomy incision, where the outflow graft was connected to the descending aorta using a partial occlusion clamp. The implantation technique has been described elsewhere [8].

2.3. Right heart catheterization
Right heart catheterization was performed at rest using the internal jugular vein approach with a Swan-Ganz pulmonary artery catheter (Baxter Health Care Corp., Edwards Div., Santa Ana, CA). An arterial line was obtained through the radial artery. Pulmonary artery pressure, pulmonary capillary wedge pressure (PCWP) and cardiac output were measured, the latter by thermodilution technique. The cardiac index was derived from cardiac output divided by the body surface area. During follow-up, when applicable, a supine bicycle exercise test was performed with the same measurements as in the resting position. The workload was fixed at 50% of the maximal workload as determined by a sitting bicycle exercise tolerance test. After 4 min of exercise, pressure and flow measurements were undertaken. Pump-off measurements, at rest and during exercise, were performed in four patients, who had showed signs of myocardial improvement. During this procedure patients were fully heparinized (300 U/kg).

2.4. Doppler echocardiography
Doppler echocardiography studies were performed on each subject, contemporarily with right heart catheterization, using a commercially available ultrasound system. Two-dimensional guided M-mode measurements of left ventricular end-diastolic dimension (LVEDD) were performed at the level of the chordae tendinae just beyond the mitral leaflet tips. Furthermore, two-dimensional (2D) echocardiography registrations were performed using a 2.5 MHz transducer. Left ventricular diastolic and systolic volumes were estimated from the apical four- and two-chamber views using the disc summation method (modified Simpson's rule) and left ventricular ejection fraction was calculated.

2.5. Definition of improvement
Cardiac recovery was defined as off-pump LVEF≥40% both at rest and during exercise by echocardiography along with significant improvements in invasive haemodynamic measurements including CI≥2.5 L/min/m2 and PCWP≤10-12 mm Hg.

2.6. Statistics
All data are expressed as the mean±standard error of the mean (SEM). Comparisons between values before implantation and during follow-up were performed with the Wilcoxon matched-paired signed rank-test. A p-value less than 0.05 was considered statistically significant.


   3. Results
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
4. Discussion
 5. Conclusion
 References
 
All patients survived the surgical procedure. Four patients underwent additional surgery due to excessive bleeding. The mean LVAD-support time was 201±55 days (range 25-998 days). During LVAD support liver and renal function was normalized in all patients (Table 1). Sixteen patients were discharged from the hospital; however the remaining two patients remained hospitalised during LVAD support (Table 2). Of these two patients, one was transplanted after 20 days and the other underwent successful LVAD explantation at 83 days. Two patients died during LVAD support. One of these patients with a HeartMate VE® died after 97 days due to a malignant ventricular arrhythmia. The other patient a 33-year old man with IDCM, who received a Jarvik 2000 VAD®, with uneventful pre- and postoperative course, died after 90 days to a due to a technical failure in the pump system. The patient was considered to be completely pump-dependent, since no flow could be detected over the aorta at the lowest speed of the pump (8000 rpm). The external power cable was attached to the system through a connection mounted on a post-auricular pedestal and the patient had experienced heat from this area. When the cable was disconnected a broken pin was revealed, which also hindered re-attachment to the pedestal. The connection was quickly repaired, but due to the temporary loss of circulation during this process, the patient developed multiorgan failure and died 19 days later. The postmortem technical investigation revealed metal corrosion as the cause of the broken pin.


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  		Table 1 Measured variables before implantation and at the time of final evaluation for Htx/explantation of LVAD

 


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  		Table 2 Postoperative variables

 
3.1. Evaluation of heart function
Three patients did not undergo evaluation of heart function during mechanical support. In one patient Htx was performed before the evaluation could take place. One patient developed significant inflow insufficiency with regurgitation of blood from the pump, which inhibited rest of the heart and therefore improvement in myocardial function was not expected. One patient with a Jarvik 2000 was totally pump-dependent and showed no signs of recovery.

The mean time to evaluation of heart function in the remaining 15 patients was 76 days (range, 42-122 days) following implantation of the LVAD.

Right heart catheterization: The mean cardiac index increased from 1.6±0.1 L/min/m2 before implantation to 1.9±0.2 L/min/m2 at the time of evaluation with the LVAD (Fig. 1a). No statistically significant differences between patients with IDCM and patients with other diagnoses were found. PCWP was 22±1.5 mm Hg before implantation of LVAD and 19±2.3 mm Hg at evaluation (Fig. 1b) with no statistically significant difference between the two time periods.


Figure 01
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  		Fig. 1 (a) Cardiac index in patients (n=15) with non-ischaemic aetiology at admission before implantation of the device and at evaluation for Htx/explantation of LVAD. (b) Pulmonary capillary wedge pressure (PCWP) in patients (n=15) with non-ischaemic aetiology at admission before implantation of the device and at evaluation for Htx/ explantation of LVAD.

 
Doppler echocardiography: There was a significant decrease in LVEDD measured by Doppler echocardiography before implantation and at the time of evaluation with the pump on (75±0.5 mm and 57±0.6 mm, respectively) (p<0.005). There was a significant increase in LVEF from 15.5±1.5% to 32±5.7% with the pump on, p<0.001.

It was only possible to consider turning off the LVAD in four patients, as described in detail below.

  1. A 29-year old man presented with acute decompensation due to IDCM and was on mechanical ventilation and maximal inotropic support. A HeartMate VE was implanted. Haemodynamic evaluation after 2 months revealed a dramatic improvement in CI, 3.3 L/min/m2, and LVEF was 45% with low PCWP (Fig. 2a-b). Stroke volume was 63 mL. During supine exercise on 40 W workload, CI was 3.5 L/min/m2, PCWP 19 mm Hg and the stroke volume was 64 mL. The patient had borderline haemodynamic data for weaning but after discussion it was decided that the device should be explanted. Three days after a successful explantation the patient developed cardiogenic shock and a biventricular Abiomed BVS 5000 was implanted in an urgent procedure. After another 10 days on temporary support the patient underwent a successful Htx.
  2. A 22-year old male presented with acute giant cell myocarditis and circulatory collapse. He received a HeartMate VE and displayed improvement of heart function during the follow-up period. After 65 days of support, CI had risen to 3.3 L/min/m2 at rest and increased to 4.5 L/min/m2 during 40 W supine exercises. Further measurements showed a decrease in PCWP to 10 mm Hg and normalisation of stroke volume to 65 mL, Fig. 2a-b. The patient fulfilled the criteria for weaning. However, despite treatment with cyclosporin, the patient developed a relapse of giant cell myocarditis resulting in Fontan circulation. The patient therefore underwent successful Htx.
  3. A 19-year old, previously healthy woman, developed neurological signs of multiple sclerosis and shortly thereafter heart failure due to acute myocarditis [10]. The patient required mechanical ventilation and a HeartMate VE® was implanted in an emergency situation. The early postoperative period was uneventful, except for repeated periods of septicaemia. At evaluation, heart function showed significant recovery. Resting CI, 1.8 L/min/m2 at admission, had increased to 3.4 L/min/m2 (pump off) 2 months after implantation of the device. LVEF had during the same period increased from <20% to over 50% at evaluation. During supine exercise with a workload of 40 W the CI measured 4 L/min/m2 and PCWP 20 mm Hg, Fig. 2a-b. The patient fulfilled the criteria for weaning and the device was successfully explanted. After 8 years of follow-up, heart function remains normal with the patient on treatment with beta-blockers and ACE-inhibitors.
  4. This patient with a Jarvik 2000 who showed signs of recovery refused weaning and remained on the pump for 998 days. Due to deterioration later on, a successful Htx was performed.


Figure 02
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  		Fig. 2 (a) Three patients, one with dilated cardiomyopathy (IDCM), one with giant cell myocarditis and one with myocarditis show increased CI at the time of evaluation. Supine exercise of 40 W workload resulted in a further increase in CI. (b) Three patients, one with dilated cardiomyopathy (IDCM), one with giant cell myocarditis and one with myocarditis show decreased PCWP at the time of evaluation. Supine exercise of 40 W workload did not result in a significant increase in filling pressure.

 

   4. Discussion
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
5. Conclusion
 References
 
Haemodynamic unloading with LVADs in severe advanced heart failure has been shown to be associated with reverse remodelling including favourable changes on a structural, cellular and molecular level [11-14]. In addition, reports have emerged showing sufficient improvement in myocardial function to allow explantation of the supporting device [14]. Consequently, it has been suggested that it may be feasible to use LVADs to bridge selected patients with severe advanced heart failure to myocardial recovery, thereby reducing the need for heart transplantation.

In the present study, the occurrence of significant cardiac recovery during LVAD support was low. Despite optimal medical therapy for heart failure during mechanical unloading, none of the patients with chronic advanced heart failure could be subjected to successful weaning from the device. One patient, who suffered from dilated cardiomyopathy, fulfilled predefined criteria for myocardial recovery and underwent explantation, but had a relapse a few days later and required re-institution of mechanical support. The only patient, who could be successfully weaned from the device, was a young female, who presented with acute cardiogenic shock due to fulminate myocarditis.

Sustained cardiac recovery following mechanical support in patients with dilated cardiomyopathy has been described [5,14]. In 1995, Muller et al. reported functional improvement in 5 (29%) out of 17 patients, enabling device explantation [5]. In 2005, Dandel et al. reported successful weaning in 32 (24%) out of 131 patients, with a 5-year survival rate of 78% after explantation [14]. All patients received optimal medical therapy for heart failure during unloading. A heart failure duration of less than 5 years before LVAD implantation, off-pump LVEDD<55 mm and/or LVEF≥45% before LVAD removal were all predictive of stable recovery.

In contrast to these findings from the Berlin group, our results do not support the concept of LVADs as a bridge to recovery in patients with severe advanced heart failure. Differences in post-implant treatment cannot explain this discrepancy, since all of our LVAD patients received optimal medical therapy for heart failure, similar to that given by the Berlin group. On the other hand, it is possible that the patient population referred for mechanical support may have differed between centres. In the present study population, every possible effort was made to treat patients with maximally tolerated doses of neurohormonal inhibitors before a decision to refer for mechanical support was made. This may have lead to selection of patients with a greater degree of irreversible myocardial damage as pump recipients.

Among the multiple changes that occur within the myocardium after prolonged mechanical support, not all appear to be favourable. An observed decrease in myocyte area after LVAD implantation [15] has raised concerns over a possible risk of myocardial atrophy [16]. Furthermore, LVAD treatment has been shown to be associated with increased myocardial fibrosis resulting in augmented chamber stiffness. These findings suggest that cell death with replacement fibrosis continues to take place during mechanical support.

The observations of the present study are more in line with the findings of Mancini et al., who in a retrospective study identified only 5 (5%) successful explantations among 111 LVAD recipients [17]. Likewise, our experience is in accordance with the report of Helman et al. who reported that heart failure reoccurred shortly following explantation in two patients, a phenomenon they termed recurrent remodelling [18]. Thus, in our opinion patients with long-term advanced heart failure, resistant to adequate medical therapy, are unlikely to display significant recovery following treatment with a LVAD.

The LVAD Working Group Recovery Study was established in response to the conflicting reports of functional recovery during LVAD support [19]. In this study patients were prospectively assessed each month by echocardiography during LVAD support. Despite observed improvements in cardiac function, none of the patients with chronic heart failure demonstrated sufficient cardiac restoration to be weaned from LVAD support.

The possible application of novel pharmacological therapy to facilitate cardiac recovery during mechanical support is of interest. The Harefield group has, in addition to customary neurohormonal blockade, treated LVAD patients with the β2 agonist clenbuterol, which has been shown to induce physiological hypertrophy in the myocardium [13]. It has been suggested that such treatment might improve contractile function by changing calcium metabolism at a cellular level. Another potential approach would be to develop strategies to modulate the regenerative potential of the heart. Such interventions would require implantation of cardiac stem cells and promotion of their differentiation into myocytes and coronary vessels, an exciting future challenge.

The role of mechanical circulatory support as a bridge to recovery has not been defined. The success rate of such treatment is likely to depend on the degree of irreversible myocardial damage at the time of implantation. It is plausible that patients with reversible causes of heart failure, such as acute myocarditis, myocardial ischaemia or therapy-resistant arrhythmia will show sustained recovery following mechanical unloading and, possibly, also patients with heart failure of short duration showing signs of ongoing myocardial inflammation. On the other hand, patients with heart failure of long duration, not responding to adequate medical treatment or resynchronization therapy, are unlikely to display cardiac recovery following mechanical circulatory support. Whether novel pharmacological therapy during mechanical unloading may facilitate cardiac healing and/or regeneration remains to be established.


   5. Conclusion
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
 5. Conclusion
References
 
LVADs can be effectively and safely used to bridge patients with severely advanced heart failure to Htx and to bridge patients with acute reversible causes of heart failure, such as acute myocarditis, to recovery. However, in our experience, and in contrast to previous suggestions, LVAD support in patients with chronic end-stage heart failure unresponsive to medical therapy, is unlikely to result in significant recovery of cardiac function.


   References
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
 5. Conclusion
 References
 

  1. Frazier O.H., Rose E.A., Oz M.C., et al. Multicenter clinical evaluation of the HeartMate vented electric left ventricular assist system in patients awaiting heart transplantation. J Thorac Cardiovasc Surg (2001) 122:1186–1195.[Abstract/Free Full Text]
  2. Koul B., Solem J.O., Steen S., Casimir-Ahn H., Granfeldt H., Lonn U.J. HeartMate left ventricular assist device as bridge to heart transplantation. Ann Thorac Surg (1998) 65:1625–1630.[Abstract/Free Full Text]
  3. Levin H., Oz M., Catanese K., Rose E., Burkhoff D. Transient normalization of systolic and diastolic function after support with a left ventricular assist device in a patient with dilated cardiomyopathy. J Heart Lung Transplant (1996) 15:840–842.[Web of Science][Medline]
  4. Frazier O.H., Benedict C., Radovancevic B., et al. Improved left ventricular function after chronic left ventricular unloading. Ann Thorac Surg (1996) 62:675–682.[Abstract/Free Full Text]
  5. Müller J., Wallukat G., Weng Y., et al. Weaning from mechanical cardiac support in patients with dilated cardiomyopathy. Circulation (1997) 96:542–549.[Abstract/Free Full Text]
  6. Frazier O.H., Rose E.A., Oz M.C., et al. HeartMate LVAS investigators. Left Ventricular Assist System. Multicenter clinical evaluation of the HeartMate vented electric left ventricular assist system in patients awaiting heart transplantation. J Thorac Cardiovasc Surg (Dec 2001) 122(6):1186–1195.[Abstract/Free Full Text]
  7. Radovancevic B., Frazier O.H., Duncan J.M. Implantation technique for the HeartMate left ventricular assist device. J Card Surg (1992) 7:203–207.[Web of Science][Medline]
  8. Frazier O.H., Myers T.J., Jarvik R.K., et al. Research and development of an implantable axial-flow left ventricular assist device: the Jarvik 2000 heart. Ann Thorac Surg (2001) 71:S125–S132.[CrossRef][Web of Science][Medline]
  9. Jarvik R., Westaby S., Katsumata T., Pigott D., Evans R.D. LVAD power delivery: a percutaneous approach to avoid infection. Ann Thorac Surg (1998) 65:470–473.[Abstract/Free Full Text]
  10. Kjellman U., Hallgren P., Bergh C.-H., Lycke J., Oldfors A., Wiklund L. Weaning from mechanical support in a patient with acute heart failure and multiple sclerosis. Ann Thorac Surg (2000) 69:628–630.[Abstract/Free Full Text]
  11. Kumpati G.S., McCarthy P.M., Hoercher K.J. Left ventricular assist device as a bridge to recovery: present status. J Card Surg (2001) 16:294–301.[CrossRef][Web of Science][Medline]
  12. Bruckner B.A., Stetson S.J., Perez-Verdia A., et al. Regression of fibrosis and hypertrophy in failing myocardium following mechanical circulatory support. J Heart Lung Transplant (2001) 20:457–464.[CrossRef][Web of Science][Medline]
  13. Terracciano C.M., Hardy J., Birks E.J., Khaghani A., Banner N.R., Yacoub M.H. Clinical recovery from end-stage heart failure using left-ventricular assist device and pharmacological therapy correlates with increased sarcoplasmic reticulum calcium content but not with regression of cellular hypertrophy. Circulation (2004) 109:2263–2265.[Abstract/Free Full Text]
  14. Dandel M., Weng Y., Siniawski H., Potapov E., Lehmkuhl H.B., Hetzer R. Long-term results in patients with idiopathic dilated cardiomyopathy after weaning from left ventricular assist devices. (2005) (Suppl. I):I-37-I-45. Circulation.
  15. Kinoshita M., Takano H., Takaichi S., Taenaka Y., Nakatani T. Influence of prolonged ventricular assistance on myocardial histopathology in intact heart. Ann Thorac Surg (1996) 61:640–645.[Abstract/Free Full Text]
  16. Scheinin S., Capek P., Radovancevic B., Duncan J., McAllister J., Frazier O. The effect of prolonged left ventricular assist device support on myocardial histopathology in patients with end-stage cardiomyopathy. ASAIO J (1992) 38:M271–M274.[Medline]
  17. Mancini D.M., Beniaminovitz A., Levin H., et al. Low incidence of myocardial recovery after left ventricular assist device implantation in patients with chronic heart failure. Circulation (1998) 98:2383–2389.[Abstract/Free Full Text]
  18. Helman D.N., Maybaum S.W., Morales D.L., et al. Recurrent remodelling after ventricular assistance: is long-term myocardial recovery attainable? Ann Thorac Surg (2000) 70:1255–1288.[Abstract/Free Full Text]
  19. Maybaum S., et alon behalf of the LVAD Working Group. Cardiac recovery during 30 days of support with left ventricular assist device. J Am Coll Cardiol (2003) 41:165A.

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