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Ann Thorac Surg 1998;65:1625-1630
© 1998 The Society of Thoracic Surgeons

Original articles: cardiovascular

HeartMate Left Ventricular Assist Device as Bridge to Heart Transplantation

Bansi Koul, MD, PhDa, Jan-Otto Solem, MD, PhDa, Stig Steen, MD, PhDa, Henrik Casimir-Ahn, MD, PhDb, Hans Granfeldt, MDb, Urban J. Lönn, MDb

a Department of Thoracic and Cardiovascular Surgery, University Hospitals in Lund, Sweden
b Department of Thoracic and Cardiovascular Surgery, University Hospitals, Linköping, Sweden

Accepted for publication January 21, 1998.

Address reprint requests to Dr Koul, Department of Thoracic and Cardiovascular Surgery, University Hospital, 221 85 Lund, Sweden


   Abstract
Top
 Footnotes
 Abstract
Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
 References
 
Background. Because of the limited supply of donor hearts, prospective recipients continue to die while on the waiting list for heart transplantation. Use of long-term mechanical circulatory support devices as a bridge to transplantation may reduce this mortality. However, with the present state of technology, continued clinical evaluation of the various long-term, mechanical circulatory support devices available is mandatory.

Methods. Sixteen patients were bridged with the HeartMate left ventricular assist device (LVAD) to heart transplantation for New York Heart Association functional class IV cardiac failure. Twelve pneumatic and six electric devices were used. The mean cardiac index and the mean pulmonary vascular resistance of the patient cohort were 1.7 1 · min-1 · m-2 and 3.1 Wood units, respectively.

Results. The mean LVAD support time per transplanted patient was 237 days, with a cumulative LVAD support time of about 7.2 years. Bleeding was the main operative and postoperative complication. Two patients suffered from neurologic complications and there were two major incidents of device malfunction. Twelve patients (75%) now have received a transplant, 3 (19%) are awaiting a transplant, and in 1 patient (6%), the device was explanted after spontaneous left ventricular recovery. Eleven of the 12 patients who received a transplant are alive and doing well. The HeartMate LVAD gave adequate circulatory support over extended periods of time and reversed the vital organ dysfunction. Since the start of the LVAD program, only 1 patient has died on our heart transplantation waiting list, compared to nine deaths in the 2 preceding years.

Conclusions. The HeartMate LVAD bridge to heart transplantation can be performed with low post-LVAD implantation and posttransplantation mortality and offers 1- and 2-year posttransplantation actuarial survival rates comparable to those for nonbridged heart transplant recipients.


   Introduction
Top
 Footnotes
 Abstract
 Introduction
Material and methods
 Results
 Comment
 Acknowledgments
 References
 
Several North American studies have shown that the HeartMate (Thermo Cardiosystems Inc, Woburn, MA) left ventricular assist device (LVAD) is effective in relieving heart failure in patients resistant to medical therapy, who deteriorate rapidly while awaiting heart transplantation [1–4]. As of May 23, 1997, 995 patients worldwide have received this device, 753 patients the HeartMate Implantable Pneumatic Left Ventricular Assist System (IP LVAS) and 242 patients the HeartMate Vented Electric Left Ventricular Assist System (VE LVAS) [5]. Sixty-three percent of patients supported with the pneumatic system and 51% of those supported with the electric system underwent transplantation. The clinical results with other cardiac support systems, used as a bridge to transplantation, namely the Novacor LVAS (Baxter Health Care Corporation, Novacor Division, Oakland, CA), the Thoratec left, right, or biventricular assist device (Thoratec Laboratories, Berkeley, CA), and the CardioWest total artificial heart (TAH; CardioWest Inc, Tucson, AZ), are very similar to those with the HeartMate LVAD [6–8]. The University Hospitals in Lund and Linköping, located about 400 km from each other, embarked on a cooperative HeartMate LVAD program in early 1993. Transplantation candidates deteriorating rapidly on the heart transplantation waiting list had the HeartMate LVAD implanted at the respective centers and all patients subsequently underwent transplantation at the hospital in Lund. Before the start of this joint LVAD program, from 1991 to the early part of 1993, 9 patients died of cardiac causes while waiting for heart transplantation. During the same period 19 patients underwent heart transplantation at our hospital. This article summarizes our experience with the HeartMate LVAD in the context of a bridge to heart transplantation. Two patients who received the HeartMate LVAD as an alternative to heart transplantation are not included in this retrospective study.


   Material and methods
Top
 Footnotes
 Abstract
 Introduction
 Material and methods
Results
 Comment
 Acknowledgments
 References
 
Patients
Between February 1993 and February 1997, 16 patients received the HeartMate LVAD as mechanical bridge to heart transplantation. Indications for LVAD implantation and patient demography are summarized in Table 1. All these patients were being treated with various inotropics for low cardiac output syndrome before the LVAD was implanted. One patient with dilated cardiomyopathy and another with ischemic cardiomyopathy, both prospective transplant candidates, were first operated on under cardiopulmonary bypass with conventional surgical methods and needed postoperative support with a Hemopump for 2 and 4 days, respectively. One patient with fulminating acute myocarditis was transferred from another cardiac surgical center in Sweden with ongoing venoarterial extracorporeal membrane oxygenation. Six patients (37%) were on ventilator support before LVAD implantation. Five procedures (31%) were reoperations and two rereoperations (Table 2). Twelve of the patients were on the waiting list for heart transplantation when HeartMate LVAD implantation was contemplated. The remaining 4 patients, with diagnoses of postcardiotomy cardiac failure (n = 1), doxorubicin cardiomyopathy (n = 1), dilated cardiomyopathy (n = 1), and acute myocarditis (n = 1) deteriorated rapidly and underwent implantation with the HeartMate LVAD before being enrolled in the heart transplant program.


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  		Table 1. Left Ventricular Assist Device Indications and Patient Demography (n = 16)

 

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  		Table 2. Previous Surgical Interventions Before Left Ventricular Assist Device Implantation

 
Implantation
Patients and their close relatives were informed in detail about the nature of the surgical procedure and verbal consent was obtained. HeartMate LVAD implantation was performed through a midline sternoabdominal incision using conventional cardiopulmonary bypass and mild to moderate hypothermia. The techniques of HeartMate LVAD implantation have been described elsewhere [10, 11]. In 1 patient with massive ascites, the HeartMate LVAD was deliberately positioned preperitoneally. In 3 patients, previously implanted mechanical valves were changed to biological ones at the time of HeartMate LVAD implantation. Other surgical details are summarized in Table 3. Eight patients received aprotinin (Trasylol; Bayer, West Haven, CT) at the time of LVAD implantation. In the earlier part of the series, patients were treated postoperatively with acetylsalicylic acid and persantin. In the later part of the series, in response to cerebellar embolism occurring in one of the patients, both acetylsalicylic acid and warfarin sodium were used for all patients (prothrombin time maintained at the upper therapeutic level in patients with no cardiac valve prostheses). At the time of cardiac transplantation, midline sternoabdominal incision was again used and the device removed with the patient on cardiopulmonary bypass. In 1 patient, the outflow Dacron graft connected to the aorta was damaged at the time of resternotomy. At the beginning of the series, the conventional orthotopic heart transplantation technique (n = 8) was used, but later a modified, bicaval technique (n = 4) was used.


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  		Table 3. Left Ventricular Assist Device Implantation (n = 16)

 
Statistics
Postoperative data were analyzed statistically using the signed rank test. Wilcoxon rank sum test was used to test the difference in various bleeding-related parameters between the patient group receiving aprotinin and the one not receiving aprotinin. Probability values less than 0.05 are considered statistically significant.


   Results
Top
 Footnotes
 Abstract
 Introduction
 Material and methods
 Results
Comment
 Acknowledgments
 References
 
The total LVAD support time in this study amounts to 2,644 days (7.2 years). The pneumatic system was used for 1,922 days altogether (mean, 160 days; range, 54 to 310 days) and the electric system for 722 days (mean, 120 days; range, 55 to 261 days). The mean LVAD support times for individual patient categories are summarized in Table 4.


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  		Table 4. Implanted Left Ventricular Assist Device Data Profile (n = 18, devices)a

 
Various early and late postoperative complications are summarized in Table 5. A transient postoperative hemiparesis developed in 1 patient with a preoperative history of cerebral dysfunction, who was supported for 2 days with a Hemopump before final bridging with the HeartMate LVAD. Almost all patients bled more than usual at the initial LVAD implantation. Use of aprotinin at the time of HeartMate LVAD implantation influenced neither the perioperative bleeding nor the amount of blood products transfused (Table 6). Five of the 16 patients (31%) received transfusions, on an average with 289 mL of blood products (range, 425 to 1,800 mL) after transfer from the intensive care unit to the general ward. Blood platelet counts remained essentially unchanged after the LVAD operation (pre-LVAD, 186 ± 22 x 109/L; on LVAD and before transplantation, 183 ± 22 x 109/L; p = 0.23). However, after cardiac transplantation and at the time of discharge from the hospital, the platelet counts were significantly higher (303 ± 51 x 109/L; p = 0.0024). Twelve patients have now received a heart transplant, 3 are currently being supported with the device, and 1 patient with acute myocarditis recovered spontaneously and the device explanted (Table 4).


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  		Table 5. Complications After Left Ventricular Assist Device (n = 16)

 

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  		Table 6. Bleeding-Related Parameters and Aprotinin After Left Ventricular Assist Device Implantation (mean ± SEM, n = 16)

 
Several cases of major and minor HeartMate LVAD pump malfunctions were encountered, as shown in Table 7. None of the patients with the HeartMate IP LVAS were discharged from the hospital until after transplantation. Three patients with the HeartMate VE LVAS were at home for 157, 101, and 175 days, respectively, before they received transplants. All 3 enjoyed an active physical and social life during their stay at home, and 1 of them participated in sports to an extent comparable with what is normal for his age group. The 2 remaining patients with the HeartMate VE LVAS are presently awaiting discharge from the hospital.


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  		Table 7. Left Ventricular Assist Device Performance (n = 18)a

 
A cerebellar embolus developed in 1 patient 110 days after HeartMate IP LVAS implantation. She was treated with partial cerebellar resection and has some visual field defects. At the time of the stroke, the patient was being treated with acetylsalicylic acid and dipyridamole, and after cerebellar resection she was switched to low molecular weight heparin (Fragmin; Pharmacia & Upjohn, Uppsala, Sweden). This patient also suffered from intraabdominal HeartMate drive-line rupture 310 days after LVAD implantation, and this time the device was changed without any complication. There were no signs of macroscopic thrombosis in the explanted device.

Several indices of heart failure showed significant improvement after HeartMate LVAD implantation (Table 8). All patients registered a slow but progressive weight gain, after an initial postoperative weight loss due to decreasing edema. After LVAD implantation all the patients could be adequately mobilized, irrespective of the type of HeartMate LVAD device used.


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  		Table 8. Indices of Heart Failure Before and After Left Ventricular Assist Device Bridge to Heart Transplantation (Mean + SEM)

 
One patient with combined preoperative cardiac and renal failure was still in renal failure 56 days after LVAD implantation. Two of the 12 patients who received a transplant (17%) needed temporary ultrafiltration or dialysis after the transplantation. One patient (8%) needed additional treatment with photochemotherapy for recurrent posttransplantation acute rejection (grade IIIA). Two patients were operated on for subacute diaphragmatic hernia into the left hemithorax several months after the transplantation. The herniation occurred at the site of the entry of the HeartMate left ventricular inflow cannula through the diaphragm.

Eleven of the 12 patients who received a transplant are alive and doing well. Three of them required treatment for backache due to osteoporosis. None of the patients undergoing LVAD implantation seroconverted for cytomegalovirus before transplantation. After transplantation, however, 2 patients suffered a primary infection within 3 months of the operation.

One patient died about 3 months after heart transplantation of combined sepsis and acute rejection. This patient, with a Hemopump–HeartMate hybrid bridge to heart transplantation, had a pump pocket infection at the time of transplantation. He was discharged from the hospital after the transplantation and was doing well. During the first 3 months after transplantation he had two episodes of acute rejection. This patient did not have any lymphocytotoxic antibodies in his blood before heart transplantation. Donor–recipient direct cross-matching of blood performed after the heart transplantation was also negative.

One female patient with dilated cardiomyopathy, arrhythmogenic right ventricular dysfunction, and with an automatic implantable cardiac defibrillator continued to suffer from repeated episodes of ventricular tachycardias and was defibrillated by the automatic implantable cardiac defibrillator several times after the HeartMate LVAD implantation. These tachyarrhythmias recurred despite maximal treatment with various antiarrhythmics (digoxin, sotalol, and mexiletine). The current threshold for the defibrillator increased successively and after 109 days of LVAD support she received a transplant on an urgent basis. The donor heart (ischemic time, 273 min) failed to support the circulation. The patient was supported for 24 hours with a Carmeda heparin-coated venoarterial extracorporeal membrane oxygenator (Med- tronic, Minneapolis, MN) and then with an Abiomed BVS 5000 Biventricular Support System (Abiomed, Danvers, MA) for another 6 days before successful retransplantation. Microscopy of the first donor heart showed no signs of rejection. The patient’s posttransplantation hospital stay was prolonged because of exacerbation of previously existing anxiety neurosis and depression. She is now at home and doing well.

After HeartMate LVAD implantation, on average patients needed 7 days of ventilator support and 14 days of care in the intensive care unit. After the heart transplantation, these periods were significantly reduced to 4 and 7 days, respectively (p = 0.02 and p = 0.002, respectively).

In the entire series, during the first 3 months after heart transplantation, the mean number of acute rejections requiring treatment, per patient, was 0.73 (range, 0 to 3).

These patients have now been followed up after their heart transplantation for an average of 654 days (range, 33 to 1,402 days) with actuarial 1- (n = 7), 2- (n = 5), and 3- (n = 2) year survival rates of 94%. Since the start of LVAD program, only 1 patient from our heart transplant waiting list has died, probably of arrhythmia, at home.


   Comment
Top
 Footnotes
 Abstract
 Introduction
 Material and methods
 Results
 Comment
Acknowledgments
 References
 
The patient cohort who was offered LVAD implantation as a bridge to heart transplantation was severely ill and had advanced therapy-resistant cardiac failure. Their mean cardiac index was 1.7 L · min-1 · m2, with all of them on inotropic support and all belonging to New York Heart Association class IV. Six patients (37%) were on a ventilator, 2 (12%) on a Hemopump, and 1 (6%) on a venoarterial extracorporeal membrane oxygenator. All had elevated serum creatinine and bilirubin levels. In 12 patients (75%) acute cardiac failure supervened on preexisting chronic failure, whereas the remaining 25% presented with a rapidly progressing heart failure of short duration. Five procedures (31%) were reoperations and 2 rereoperations. Moreover, in addition to LVAD implantation, 4 patients (25%) underwent a valve change. The mean Higgins score in this series was nine. In our present circumstances, with a limited supply of donor hearts, the probability of survival in this patient category without long-term circulatory support would be low; our mean LVAD support time was about 8 months before transplantation (Table 4).

Despite the high-risk category of patient, the HeartMate LVAD implantation could be performed with no perioperative mortality. This may be ascribed to three factors: an efficient LVAD, which is able to decompress the left heart effectively (mean pulmonary capillary wedge pressure of 1 mm Hg) (see Table 8); relatively low pulmonary vascular resistances and low transpulmonary pressure gradients; and the fact that a majority of these patients were on regular laboratory and clinical surveillance since being enrolled in the heart transplant program. The only patient who had a high pulmonary vascular resistance and a high transpulmonary pressure gradient (10.4 Wood units and 25 mm Hg, respectively) was the one with acute myocarditis on venoarterial extracorporeal membrane oxygenation. This patient was previously healthy and the duration of her heart failure was short. Incorporation of an implantable LVAD in our transplantation program has, with one exception, prevented patients from dying while waiting for heart transplantation.

Bleeding was a major intraoperative and early postoperative complication at LVAD implantation. Intraoperative administration of aprotinin had little effect on early postoperative bleeding or on the need for postoperative transfusion of blood products. Observations to the contrary have been made by Goldstein and colleagues [12], who recommend the use of aprotinin in this type of operation. Despite massive blood transfusions, cytomegalovirus seroconversions were few and the mean number of posttransplantation cardiac rejections occurring in the first 3 months was the same as for nonsupported patients.

The need for blood transfusion after discharge from the intensive care unit was low (mean, 289 mL) and was restricted to only 5 patients (31%). These data, in the light of the relatively long mean LVAD support time (165 days), suggest minimal pump-related hemolysis. After LVAD implantation, blood platelet counts remained essentially unchanged, at the lower end of the normal range. Jeevanandam [13] showed that patients with the HeartMate LVAD have constant low-grade disseminated intravascular coagulation activity, with consumption of platelets. After heart transplantation, however, the platelet counts increased significantly, suggesting that the platelets are constantly being consumed by the HeartMate LVAD.

The frequency of post-LVAD right heart failure (low LVAD output together with high central venous pressure and dilated, poorly contracting right ventricle) was about 19%, which compares well with other published series [1, 3, 4]. However, in all of these patients, the right heart failure responded well to conventional medical treatment, including nitric oxide, and no additional right ventricular assistance was required. The frequency of right heart failure seems to correlate with the amount and the type of blood products transfused [14].

After LVAD implantation the mean ventilator support time was 7 days and the mean stay in the intensive care unit was 14 days. These figures were significantly higher than those after subsequent biological heart transplantation. This may be ascribed to the reversal of vital organ dysfunction, near normalization of central and peripheral hemodynamics (see Table 8), and to adequate mobilization of the patients during LVAD support.

The reason for primary graft failure in the 1 patient was probably a combination of long donor heart ischemic time, donor left ventricular hypertrophy, and pretransplantation high-dose sotalol treatment in the recipient.

Thirty-six major and minor postoperative complications were encountered (see Table 5). Three inflow conduit valves showed signs of incipient or manifest valve dysfunction in our total experience of 7.2 patient-pump years. None of these patients suffered from pump endocarditis, and microscopy performed on one of these three valves was normal. Furthermore, two pumps (12%) were changed on account of major pump dysfunction (drive-line rupture and inflow conduit valve incompetence). Despite these and other pump and console-related problems (see Tables 5, 7) a 100% transplantation rate and a 100% in-hospital posttransplantation survival was achieved. Moreover, 1-, 2-, and 3-year posttransplantation actuarial survival rates of 94% were attained, which are better than for our own nonbridge heart transplantation population, and better than those of the International Heart & Lung Transplant Registry [15].

With increasing use of the HeartMate VE LVAS, these patients are being discharged from the hospital to await heart transplantation. From the perspective of the Swedish health services, where the referring hospital pays for treatment of its patients at the regional hospital, the domiciliary management of these patients has made this expensive treatment cost effective. This cooperative bridge to heart transplant program, between the two university hospitals has functioned well.

In conclusion, the HeartMate LVAD bridge to heart transplantation can be performed with low post-LVAD and posttransplantation mortality. Bridging with an LVAD reduces mortality on the transplantation waiting list and offers 1- and 2-year posttransplantation actuarial survival rates comparable with those for nonbridge heart transplant recipients. The LVAD gives patients effective and prolonged relief from heart failure and reverses vital organ dysfunction. The postoperative complication rate after LVAD implantation is relatively high, partly attributable to the poor preoperative clinical condition of the patients and partly due to the device itself. Biological valve dysfunction may become one of the major limiting factors in the use of this device as an alternative to heart transplantation.


   Acknowledgments
Top
 Footnotes
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
References
 
We acknowledge the help provided by Anna-Karin Morin, RN, in patient data collection. The clinical data were analyzed statistically by Jan Petersson, Clinical Data Care in Lund AB.


   Footnotes
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 Footnotes
Abstract
 Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
 References
 
This article has been selected for the open discussion forum on the STS Web site: http://www.sts.org/annals


   References
Top
 Footnotes
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
 References
 

  1. Frazier O.H., Rose E.A., Macmanus Q., et al. Multicenter clinical evaluation of the HeartMate 1000 IP left ventricular assist device. Ann Thorac Surg 1992;53:1080-1090.[Abstract/Free Full Text]
  2. Burton N.A., Lefrak E.A., Macmanus Q., et al. A reliable bridge to cardiac transplantation. The TCI left ventricular assist device. Ann Thorac Surg 1993;55:1425-1431.[Abstract/Free Full Text]
  3. McCarthy P.M., Savage R.M., Fraser C.D., et al. Hemodynamic and physiologic changes during support with an implantable left ventricular assist device. J Thorac Cardiovasc Surg 1995;109:409-418.[Abstract/Free Full Text]
  4. Frazier O.H., Rose E.A., McCarthy P.M., et al. Improved mortality and rehabilitation of transplant candidates treated with a long-term implantable left ventricular assist device. Ann Surg 1995;222:327-338.[Medline]
  5. Dasse K. Update of HeartMate experience. Ninth Annual HeartMate Investigators’ and Users’ Meeting, Scottsdale, AZ, October 17–19, 1996. Woburn, MA: TCI Thermo Cardiosystems Inc, 1996.
  6. Miller P.J., Billich T.J., LaForge D.H., et al. Initial clinical experience with a wearable controller for the Novacor left ventricular assist system. J ASAIO 1994;40:465-470.
  7. Farrar D.J., Hill J.D., Pennington D.G., et al. Preoperative and postoperative comparison of patients with univentricular and biventricular support with the Thoratec ventricular assist device as a bridge to cardiac transplantation. J Thorac Cardiovasc Surg 1997;113:202-209.[Abstract/Free Full Text]
  8. Copeland J.G., Pavie A., Duveau D., et al. Bridge to transplantation with the CardioWest total artificial heart: the international experience 1993–1995. J Heart Lung Transplant 1996;15:94-99.[Medline]
  9. Higgins T.L., Estafanous F.G., Loop F.D., et al. Stratification of morbidity and mortality outcome by preoperative risk factors in coronary artery bypass patients. JAMA 1992;267:2344-2348.[Abstract/Free Full Text]
  10. McGee M.G., Parnis S.M., Nakatani T., et al. Extended clinical support with an implantable left ventricular assist device. ASAIO Trans 1989;35:614-616.[Medline]
  11. McCarthy P., Wang N., Vargo R. Preperitoneal insertion of the HeartMate 1000 IP implantable left ventricular assist device. Ann Thorac Surg 1994;57:634-638.[Abstract/Free Full Text]
  12. Goldstein D.J., Seldomridge J.A., Jonathan M.C., et al. Use of aprotinin in LVAD recipients reduces blood loss, blood use, and perioperative mortality. Ann Thorac Surg 1995;59:1063-1068.[Abstract/Free Full Text]
  13. Jeevanandam V. Update: anticoagulation: bleeding management. Ninth Annual HeartMate Investigators’ and Users’ Meeting, Scottsdale, AZ, October 17–19, 1996. Woburn, MA: TCI Thermo Cardiosystems Inc, 1996.
  14. Kormos RL. The right heart on LVAD support. At the Heart Failure Summit, Cleveland, OH, October 11–12, 1996. Cleveland, OH: Cleveland Clinic Foundation, Department of Thoracic and Cardiovascular Surgery, 1996.
  15. Hosenpud JD, Novick RJ, Bennett LE, Keck BM, Fiol B, Daily OP. The Registry of the International Society of Heart and Lung Transplantation: thirteenth official report—1996. J Heart Lung Transplant 1996;15;7:655–74.



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