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Right arrow Congestive Heart Failure
Right arrow Mechanical Circulatory Assistance
Right arrow Transplantation - heart

Eur J Cardiothorac Surg 2004;25:971-977
© 2004 Elsevier Science NL

Implantable left ventricular assist device for treatment of pulmonary hypertension in candidates for orthotopic heart transplantation—a preliminary study

Juergen Martina*, Michael P. Siegenthalera, Ortwin Friesewinkela, Tina Fadera, Andreas van de Loob, Georg Trummera, Michael Berchtold-Herza, Friedhelm Beyersdorfa

a Department of Cardiovascular Surgery, Albert-Ludwigs-University Medical Center, Hugstetter Str. 55, D-79106 Freiburg, Germany
b Department of Cardiology, Albert-Ludwigs-University Medical Center, Freiburg, Germany

Received 21 October 2003; received in revised form 26 January 2004; accepted 28 January 2004.

* Corresponding author. Tel.: +49-761-270-2818; fax: +49-761-270-2550
e-mail: martin{at}ch11.ukl.uni-freiburg.de


   Abstract
Top
 Abstract
1. Introduction
 2. Methods
 3. Results
 4. Discussion
 References
 
Objectives: Elevated pulmonary vascular resistance (PVR) unresponsive to pharmacological intervention is a major limitation in heart transplantation (HTX). The post-operative course of these patients is associated with an increased risk of life-threatening right heart failure. We evaluated the efficiency of an implantable left ventricular assist device (LVAD) to decrease PVR by unloading the left ventricle and to lower the risk of later orthotopic HTX. Methods: Six patients with end-stage heart failure (NYHA class IV) and ’fixed‘ pulmonary hypertension (PVR 5.7±0.7, range 4.4–6.5 Wood units) were analyzed. Despite maximal pharmacological intervention at initial evaluation (oxygen inhalation, nitrates, alprostadil infusion) PVR could not be reduced to under 2.5 Wood units. Four patients received a TCI Heartmate, one patient a Novacor, and one patient a Jarvik 2000. Results: All patients survived the LVAD implantation, four patients could be discharged from hospital. Cardiac index and pulmonary artery pressure values returned to normal during the early post-operative phase. After a mean support time of 191±86 days PVR had fallen to 2.0±1.2 (range 0.8–3.6) Wood units. All patients could be bridged to transplantation, one patient died 3 months after transplant, five patients are still alive after a mean follow-up of 16.2±10.5 months. Conclusions: Mechanical support using an implantable LVAD is a very efficient approach with an acceptable risk to treat severe pulmonary hypertension in end-stage heart failure patients before HTX. Adequate reduction of PVR can be expected within 3–6 months. Subsequent HTX is associated with a good outcome.

Key Words: Heart failure • Pulmonary hypertension • Transplantation • Ventricular assist device


   1. Introduction
Top
 Abstract
 1. Introduction
2. Methods
 3. Results
 4. Discussion
 References
 
Pulmonary hypertension associated with ‘unresponsive’ increased pulmonary vascular resistance (PVR) is a severe problem in candidates for orthotopic heart transplantation (HTX). The donor heart's right ventricle is unable to overcome the high afterload, leading to a high risk of lethal right ventricular failure after transplantation. Pharmacological interventions such as oxygen inhalation, nitroglycerine, milrinone, prostaglandins, and nitric oxide (NO) have been recommended to evaluate the reversibility of pulmonary hypertension [1–3]. This medical treatment can usually reduce PVR by approximately 30–50%. But in cases of long-lasting pulmonary hypertension, pharmacological interventions often fail to decrease PVR sufficiently to allow for safe HTX. Other patients with good response of pulmonary hypertension to drug interventions fail to respond adequately after HTX and have a long and complicated course, requiring high doses of inotropes and long-term mechanical ventilation.

We have observed a continuous decrease in PVR during mechanical circulatory support in patients with a left ventricular assist device (LVAD). Adamson and colleagues [4] made a similar observation in a single patient. Recently, Petrofski [5] reported on a patient with a congenitally corrected transposition of the great vessels associated with a ventricular septal defect and a PVR of 12 WU (Wood-Unit). This patient was listed for heart–lung transplantation and received a biventricular assist device due to acute cardiac decompensation. Even after 24 days of mechanical support PVR had fallen to 3.1 WU.

Learning from this experience, we have changed our strategy in transplant candidates with severe pulmonary hypertension to reduce PVR. If pharmacological interventions fail to lower PVR to less than 2.5 WU, the patients are treated with an implantable LVAD as a bridge to HTX. The aim of this preliminary study was to evaluate the effect of left ventricular mechanical support in transplant candidates with ‘unresponsive’ pulmonary hypertension.


   2. Methods
Top
 Abstract
 1. Introduction
 2. Methods
3. Results
 4. Discussion
 References
 
2.1. Patient population
Between November 1999 and February 2002, 17 patients underwent implantation of an LVAD. Six of these patients with end-stage heart failure had severe pulmonary hypertension not responsive to pharmacological interventions with PVR of 5.7±0.7 WU (range 4.4–6.5 WU) and were treated with an implantable LVAD as bridge-to-HTX (Tables 1 and 2). The indications for HTX were dilated cardiomyopathy (n=5) and ischemic heart disease (n=1). In four patients with a baseline PVR of 4.4–6.2 WU pharmacological interventions resulted in only insufficient reversibility of pulmonary hypertension (PVR >3 WU despite maximal medical intervention). The remaining two patients had excessive increased baseline values of 5.8 and 6.5 WU and did not tolerate the pharmacological interventions. All patients were in NYHA class IV despite optimal medical therapy and had a heart failure survival score [6] <7.0 (mean 6.2±0.5) associated with a poor prognosis.


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  		Table 1. Demographic profile and patients characteristics of the entire cohort (n=6)

 

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  		Table 2. Hemodynamic parameters before LVAD implantation and prior to orthotopic heart transplantation

 
2.2. Testing reversibility of pulmonary hypertension
Three consecutive hemodynamic measurements using a Swan–Ganz catheter were carried out at baseline. Patients with a PVR of >2.5 WU at baseline received 5 l/min oxygen by face mask for 10 min prior to the second evaluation. Thereafter, nitroglyceryin was applied at 2–6 mg/h over 10 min. Then, prostaglandine E was given intravenously at increasing doses of 25, 50, and 100 µg/kg per min for 10 min each.

2.3. LVAD implantation
To predict the chance of a successful early outcome after LVAD implantation we used the risk score described by Oz et al. [7]. The predicted survival of our cohort was 92.4% according to a mean score of 1.7±1.5 (range 0–4).

Five patients received a pulsatile implantable LVAD (4 TCI Heartmate VE, ThermoCardiosystems/Thoratec Laboratories Corporation, Pleasanton, CA, and 1 Novacor N100, World Heart Corporation, Ottawa, ON, Canada). In the sixth patient a Jarvik 2000 axial pump was implanted initially. That patient required a device-switch to a TCI Heartmate after 90 days (Fig. 1 , see case report No 6 below).



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  		Fig. 1. Treatment and outcome of all patients. HTX, heart transplantation.

 
After device implantation weaning from extracorporeal circulation was performed using 40 ppm of nitric oxygen and inotropic right ventricular support as required. The patients received routine post-operative care. Medical therapy included beta-blocker, ACE inhibitors, diuretics, and antiarrhythmic drugs to support right heart function. A special medication to lower PVR after LVAD implantation was not given.

2.4. Statistical analysis
Statistical analysis was performed with a statistical computer program (Prism, Graph Pad Software, San Diego, CA, USA). Post-operative data were compared to baseline using a paired t-test. Data are presented as mean±SD. A P-value <0.05 was considered statistically significant.


   3. Results
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
4. Discussion
 References
 
3.1. LVAD implantation and post-operative recovery
All patients survived LVAD implantation. Right heart function was adequate to provide a pump output beyond 4 l/min at the end of the operation. Data on the post-operative course are given in Table 3. Four of the six LVAD patients could be discharged from hospital after 144.0±12.7 days. They were trained in the routine care and handling of the assist system.


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  		Table 3. Post-operative data after LVAD implantation and after orthotopic heart transplantation

 
PVR decreased to <2.5 WU in four patients after a mean support time of 191±86 days (Table 2). We observed a remarkable decrease in PVR in the two remaining patients (Fig. 2) , but due to device-specific complications, they had to be transplanted prior to the complete normalization of PVR.



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  		Fig. 2. Pulmonary vascular resistance (PVR) before implantation of the left ventricular assist device and at the time of orthotopic heart transplantation. The decrease in PVR was significant (P<0.01). Note: patient No 6 was switched from a Jarvik 2000 to TCI Heartmate after 84 days. Despite inadequate myocardial recovery, PVR decreased continuously in this patient during mechanical support.

 
Recovery of kidney and liver functions could be observed during device support (Fig. 3) .



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  		Fig. 3. Improvement in liver and kidney functions during mechanical support. Pre-VAD, baseline values prior to the implantation of the LVAD; pre-HTX, values at the time of heart transplantation. *P<0.05: compared to baseline.

 
3.2. Heart transplantation
All patients underwent successful orthotopic HTX using the biatrial standard technique. Ischemia time was 201±24 min (range 177–222 min). Three patients required NO after transplantation for 7–25 days. In two of those patients PVR had decreased only incompletely after LVAD support. One patient suffered from intracranial bleeding after 21 days of mechanical support and had to be urgently transplanted with a PVR of 3.6 WU (see case report No 1). The PVR in the other patient had decreased from 5.9 to 3.3 WU 180 days after implantation of the TCI Heartmate when he required urgent HTX due to progressive insufficiency of the TCI's inflow conduit valves (case report No 6). The third patient had normal PVR at the time of transplantation but NO was given for 6 days due to a severe contractile dysfunction of the donor heart.

The average follow-up period after HTX was 16.2±10.5 months (range 1–32 months). Five patients were discharged from hospital after 36.0±17.2 days (range 15–54 days), four had an uneventful post-operative course and are in NYHA class I. One patient had a prolonged course due to impaired initial graft function (see case report No 5). Another patient suffered humoral rejection and expired 3 months after transplantation (see case report No 6).

3.3. Case reports
3.3.1. Patient 1
A Novacor LVAD was implanted in this 43-year-old male with dilated CMP. Early post-operative course was uneventful. On post-operative day 21 intracranial bleeding required neurosurgical intervention. The patient could be transplanted successfully on day 73 after LVAD implantation. He recovered with no substantial neurological deficits and could be discharged from hospital 55 days after orthotopic HTX; he is now in NHYA class I.

3.3.2. Patient 2
This patient with dilated cardiomyopathy had to undergo urgent LVAD implantation due to severe cardiac decompensation. His post-operative course was uneventful and he could be discharged from hospital. After a support period of 228 days, urgent HTX was necessary due to progressive device failure of the TCI. Upon explantation of the device we found a severe destruction of the inflow conduit's biological heart valve.

3.3.3. Patient 3
Patient with dilative cardiomyopathy and PVR of 4.4 WU. Six weeks after implantation of the TCI Heartmate the patient contracted a purulent infection of the device pocket. After surgical revision and antibiotic treatment, the symptoms of acute inflammation receded, but chronic purulent secretion required removal of the device and HTX after a support period of 85 days. The PVR at the time of transplantation was 2.3 WU. The patient had an uneventful post-operative course and is in NYHA class I now.

3.3.4. Patient 4
A 17-year-old male suffering from dilative CMP after viral infection. While waiting for HTX his PVR rose to 5.5 WU and his NYHA class to IV. His course following LVAD implantation was uneventful. After 4 weeks he could be discharged and was an outpatient for 280 days prior to receiving a donor organ. Post-operative course was uneventful. After transplantation he is in NHYA class I.

3.3.5. Patient 5
A 46-year-old man with ischemic heart disease and PVR of 6.5 WU. He received a TCI Heartmate and was treated as an outpatient for 116 days. After a total support time of 272 days PVR had fallen to 0.8 WU and he underwent successful HTX. He required an intraaortic balloon pump and nitric oxygen for 6 days due to impaired initial graft function and prolonged mechanical ventilation. He also suffered a cerebral stroke caused by intracranial carotid artery stenoses.

3.3.6. Patient 6
The 49-year-old male patient received a Jarvik 2000 axial pump. His body surface area measured 2.1 m2 and he presented poor intrinsic left ventricular function with no myocardial recovery after implantation of the Jarvik 2000, despite maximal medical therapy. The Jarvik 2000 pumped 5.0–5.5 l/min at 12,000 rev./min but he remained in NYHA class III and IV on the device. Finally, he underwent a device-switch to the TCI system after 84 days, 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. This patient could be mobilized and improved to NYHA class II. After 108 days he had to undergo urgent HTX due to progressive device failure of the TCI. The post-operative course after HTX was complicated by hematothorax and humoral rejection. The patient was treated with plasmapheresis, intravenous immunoglobuline, cyclophosphamide, and CD 20 specific antibody. Echocardiography 80 days after HTX revealed good contractile function of the donor heart without inotropic support. The patient had to undergo tracheotomy due to critical illness neuropathy. Further course was complicated by sepsis and multiorgan failure and he expired 3 months after transplantation.


   4. Discussion
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
References
 
Advanced drug therapy combined with a broader use of defibrillators and biventricular pacemakers has markedly improved the survival and quality of life in patients with end-stage heart failure [8,9]. The improved survival rates associated with long-term medical therapy may increase the number of patients with severe and ‘fixed’ secondary pulmonary hypertension.

Several studies have identified increased PVR >2.5 WU as important risk factor for early death after HTX [10–12]. About 30% of heart transplant recipients have increased PVR>2.5 WU, and for the majority of these patients (74%) these values could not be normalized by nitroprusside administration [11].

There have been various pharmacological tests recommended to evaluate reversibility of pulmonary hypertension and to decrease elevated PVR before and after HTX [13,14]. But even in case of reversible pulmonary hypertension the efficiency of pharmacological interventions may be inadequate. Zink et al. [2] tested urapidil and NO in patients with elevated PVR and found that PVR fell from 4.9±1.9 WU at baseline to 4.3±1.4 WU after inhalation of 15 ppm NO, and to 3.6±0.8 WU after intravenous application of urapidil. Pagano et al. [15] investigated 10 consecutive patients with increased PVR of 3.6±0.3 WU and found a decrease in PVR of 1.8±0.4 WU by 10 ppm of NO. The application of sodium nitroprusside and prostacycline in the same study resulted in a decrease of 1.5±0.4 WU.

These studies demonstrate that the PVR cannot be lowered to less than 3 WU in some patients despite all pharmacological interventions and will remain a major contraindication for orthotopic HTX [12]. Moreover, using pharmacological tests to predict the reversibility of pulmonary hypertension does not always reflect the response after orthotopic HTX. Cardiopulmonary bypass and blood product administration may lead to further increase in PVR [16,17]. This might explain that even those patients with ‘reversible’ pulmonary hypertension still have a markedly higher mortality compared to patients with normal PVR [11].

Heterotopic HTX and right ventricle-sparing transplant techniques [18,19] have been recommended as alternatives to orthotopic HTX in patients with severe pulmonary hypertension. But the survival rates of 76 and 59% 30 days and 1 year after heterotopic HTX are significantly lower compared to the overall survival after orthotopic cardiac transplantation.

Compared to the high risk of early graft failure after orthotopic HTX, the use of implantable LVADs as a bridge to transplant in patients with increased PVR seems a safe and efficacious therapeutic approach. The safety and efficacy of implantable LVADs for mid-term and long-term support have been demonstrated in several clinical trials. For long-term implantable devices such as the TCI Heartmate and the Novacor, survival to transplantation is approximately 65–75% and survival after transplantation approaches 90% [20]. Careful patient selection and VAD implantation under elective conditions, as feasible in patients with chronic heart failure, can further improve the survival rates. In our institution, more than 90% of all patients treated with a Heartmate (n=16) could be successfully bridged to orthotopic HTX. Probably, the advancing technology of circulatory devices may provide an alternative to HTX within the next years [21–23].

The use of implantable LVADs is still occasionally complicated by early perioperative right ventricular failure, leading to poor filling of the LVAD and low pump output. In about 10% of these cases treatment with inotropes and nitric oxygen may be insufficient and placement of a right ventricular assist device will be necessary [24]. Increased PVR alone is not a risk factor for early post-operative right heart failure after LVAD implantation. The analysis of 245 subsequent patients undergoing LVAD implantation at the Cleveland Clinic revealed that the pre-operative PVR in the patients with post-operative right heart failure after LVAD implantation was 271±194 dynes s cm–5 (3.4±2.4 WU) compared to 317±200 dynes s cm–5 (4.0±2.5 WU) in the patients requiring an additional RVAD. The difference was not significant indicating that increased PVR was not responsible for the post-operative deterioration in right ventricular function.

Using a screening scale one can identify patients with an increased perioperative risk of LVAD implantation including right ventricular failure [7]. In our cohort all patients had a risk score of <4 and were, therefore, suitable for LVAD support. Predicted outcome and the excellent post-operative course correlated convincingly. Our survival rate was 100%. Patients could be weaned from mechanical ventilation after 1.3±0.5 days, and inotropic support was required for only 4.5±4.6 days to support right ventricular function. NO was given in 4/6 patients but could be withdrawn until the second post-operative day. No surgical reintervention was necessary.

We observed a significant fall in PVR sufficient for HTX in our patients after 60–90 days. Despite severe complications, such as intracranial bleeding, device failure, and device pocket infection all patients survived and could be bridged to HTX. In two patients the post-operative course after HTX was complicated due to humoral rejection and impaired early graft function.

A very important issue is the selection of the device. One patient with a Jarvik 2000 had to be switched to a Heartmate because the Jarvik could not provide sufficient pump flow to ameliorate heart failure symptoms. Patients with a Jarvik require enough residual left ventricular function to enable opening of the aortic valve and generate some pulsatile blood flow. Especially, in large patients with poor residual contractility of the left ventricle the pump output of 6 l/min provided by the Jarvik may be to low to increase exercise tolerance and enable recovery of the patient. In our patient, pulsatile flow after switch to the Heartmate was 10–11 l/min in the automatic filling mode. Therefore, large patients with extremely poor left ventricular function should not be treated with the Jarvik. In general, axial flow pumps should not be excluded in the treatment of pulmonary hypertension. Comparison of the Mikromed-DeBakey-VAD vs. the Novacor in 22 patients with pulmonary hypertension revealed no difference between pulsatile and non-pulsatile devices [25].

Our results must be compared to the poor survival rates after orthotopic HTX in pulmonary hypertension. PVR of more than 5 WU or a transpulmonary gradient of more than 10 mmHg in transplant recipients was associated with a survival rate of 38% after 18 months compared to 72% in a cohort with lower PVR [26]. Chen et al. [11] found a 30-day mortality of 17.7% in patients with PVR >3 WU, compared to 5.1% in patients with PVR<2 WU.

In conclusion, patients presenting severe pulmonary hypertension suffer a high perioperative risk when undergoing orthotopic HTX. In this context their treatment with an implantable LVAD seems to be an efficacious approach to normalize PVR prior to cardiac transplantation, and to provide good conditions for successful HTX. However, this therapy can be associated with adverse effects, such as bleeding, infection, and device failure.

4.1. Limitations of the study
Reversibility of pulmonary hypertension was tested in the catheter laboratory by short-term infusion of vasodilators. With respect to the device-specific complications a decision to implant an LVAD should not be made without a 24 h monitoring and treatment with dobutamine, PDE inhibitors, and calcium sensitizers whenever possible. Eventually, borderline patients, such as patient No 3 may respond to this therapy and become eligible for HTX.

Our experience includes only a small number of patients. Further, randomized studies on larger patient cohorts are necessary to evaluate the patient's benefit in survival and life quality and to define evidence-based criteria for the implantation of LVAD to treat pulmonary hypertension.


   Acknowledgments
 
We wish to thank Ms Carole Cuerten for editorial suggestions and Manfred Olschewski MSc, Institute of Medical Biometry, University of Freiburg, for assistance with statistical analysis.


   Footnotes
 
Presented at the joint 17th Annual Meeting of the European Association for Cardio-thoracic Surgery and the 11th Annual Meeting of the European Society of Thoracic Surgeons, Vienna, Austria, October 12–15, 2003.


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

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