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Ann Thorac Surg 1999;68:678-683
© 1999 The Society of Thoracic Surgeons

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Description Of Devices And Surgical Techniques

Temporary pulsatile ventricular assist devices and biventricular assist devices

^a Department of Thoracic and Cardiovascular Surgery, Heart Center North Rhine-Westphalia, Ruhr University of Bochum, Bad Oeynhausen, Germany

Address reprint requests to Dr Körfer, Herzzentrum NRW, Klinik für Thorax- und Kardiovaskularchirurgie, Georgstr 11, D-32545 Bad Oeynhausen, Germany

Presented at the Fourth International Conference on Circulatory Support Devices for Severe Cardiac Failure, Houston, TX, Oct 3–5, 1997.

Abstract

Background. During the past years several systems for mechanical circulatory support have become available. In this study we describe our experience with short-term and mid-term application of the ABIOMED and Thoratec device.

Methods. Since 1990 the ABIOMED BVS and since 1992 the Thoratec VAD have been applied to 75 and 103 patients, respectively, with postcardiotomy heart failure, as a bridge-to-transplant procedure, and with different other indications.

Results. In the ABIOMED collective 25 of 50 patients (50%) with postcardiotomy heart failure and 1 of 4 patients with miscellaneous other indications could be discharged from hospital, 7 of 14 bridge-to-transplant patients (50%) underwent transplantation with a post-transplant survival of 86%. In the Thoratec collective 6 of 10 patients (60%) with postcardiotomy heart failure and 4 of 8 patients (50%) with miscellaneous indications could be discharged from hospital, 48 bridge-to-transplant patients (74%) underwent transplantation with a post-transplant survival of 90%.

Conclusions. The results show the versatility of the Thoratec VAD for short-term and mid-term application in patients with postcardiotomy heart failure and as a bridge-to-transplant procedure. The use of the ABIOMED device is not indicated for bridging patients to transplantation. Although in case of postcardiotomy heart failure, Thoratec is also superior to ABIOMED, the high costs of the Thoratec VAD limits its wide acceptance in this patient cohort.

During the past years several systems for mechanical circulatory support have been developed to a stage where they are no longer investigational devices. Food and Drug Administration approval has been granted for the ABIOMED BVS 5000 (ABIOMED Inc, Danvers, MA) to be applied in patients with postcardiotomy heart failure, for the pneumatically driven TCI HeartMate (Thermo Cardiosystems Inc, Woburn, MA) in patients bridged to heart transplantation, and for the Thoratec VAD (Thoratec Laboratories Corp, Berkeley, CA) in both of these indications. The incidence of postcardiotomy heart failure refractory to both pharmacologic therapy and intraaortic balloon pumping is reported to be 0.2% to 1.2% [1–6]. Many publications have advocated the use of mechanical circulatory support in these patients, providing acceptable results in view of the poor situation of the patients [1–12]. The application of these devices as a bridge-to-transplant procedure has also been described extensively with even better outcomes than in patients with postcardiotomy heart failure [9, 11, 13–17].

In this study we describe our experience with short-term and mid-term application of the ABIOMED and the Thoratec devices.

Material and methods

Since our mechanical circulatory support program was started in September 1987 until September 1997, 366 implantations of six different devices in 337 patients with different indications have been performed at our Center. The ABIOMED system has been inserted in 75 patients since October 1990, the Thoratec VAD in 103 patients since March 1992 for short-term and mid-term ventricular assistance.

System selection
At our Center patients with early postcardiotomy heart failure are initially scheduled for ABIOMED support, because implantation in the operating room is easy and pump does not require special postoperative care. In patients with late postcardiotomy failure (implantation on the intensive care unit) we prefer centrifugal pump assistance, because it can be inserted without the institution of extracorporeal circulation. In postcardiotomy patients with a preoperatively reduced ejection fraction or severe cardiac damage in which the native heart is unlikely to recover, the implantation of the Thoratec VAD is recommended, provided there is no contraindication for cardiac transplantation. In transplant candidates needing biventricular mechanical circulatory support as a bridging procedure the Thoratec device is selected for implantation because it is more suitable for an extended duration of support than the ABIOMED system, providing a certain degree of mobility for the patients. Some of our patients had also been bridged to transplantation using ABIOMED support at a time when the Thoratec VAD had not yet been available at our Center. Patients are scheduled for Thoratec biventricular support if one of the following conditions are present: central venous pressure > 20 mm Hg and positive airway pressure–central venous pressure gradient < 4 mm Hg, increased pulmonary vascular resistance (> 500 dynes · s · cm^-5), multiple organ dysfunction, or severe malignant arrhythmias refractory to medical therapy. Otherwise, the patients receive Thoratec left ventricular support or an implantable ventricular assist device. Patients who would normally be supported with an implantable left ventricular assist device (Novacor or HeartMate) but have a body surface area less than 1.5 m² always receive the Thoratec system.

Anticoagulation protocol
In the first 24 hours postoperatively the patients (both ABIOMED and Thoratec) do not receive anticoagulation. Thereafter, therapy is started with heparin according to the activated clotting time (1.5 times baseline value). In Thoratec patients, Coumadin administration is started (dosage according to International Normalized Ratio [INR], 2.5 to 3.5) after removal of chest drains. In addition, patients with a platelet count of > 250,000 receive 1 mg/kg body weight aspirin. ABIOMED patients remain on heparin therapy.

Antibiotic protocol
Our antibiotic and infection management protocol consists of a prophylactic administration of cefazolin (2 g, three times a day) in all patients until all drains are removed. In patients with local exit site infections, only a culture is obtained to identify the pathogen; however, they do not receive specific systemic treatment. If they develop systemic signs of infection they are given antibiotics according to the antimicrobial sensitivity test. If the test is not available, therapy is started with vancomycin with the dosage depending on blood level (20 to 40 mg/L). In case the infection cannot be controlled by this antibiotic regime, either rifampicin (10 mg/kg body weight daily) or fosfomycin (5 mg three times a day), according to liver and renal function, is administered additionally. These additional antibiotic regimes are applied for at least 4 weeks.

Patients
ABIOMED experience
Seventy-five patients (52 men, 23 women) aged between 28 and 82 years (mean, 55 ± 10 years) were supported with the ABIOMED system. In 68 of them the ABIOMED system was applied exclusively, in 7 patients before or subsequently to other mechanical circulatory support devices. Five patients had been primarily supported with the centrifugal pump (in 4 patients as femoral-to-femoral cardiopulmonary bypass; in 1 patient as left ventricular assist device), which had to be replaced by the ABIOMED device for left ventricular assistance because of insufficient flow. The ABIOMED left ventricular support and ABIOMED biventricular support was replaced with the Thoratec biventricular assistance in 1 patient each. Fifty-five patients had suffered postcardiotomy heart failure, 14 patients were bridged to cardiac transplantation, and in 6 patients, miscellaneous other indications were present (Table 1). The type of support in patients with ABIOMED application is detailed in Table 2.

ABIOMED
Duration of support in the ABIOMED collective was 2 hours to 28 days (mean, 5.7 ± 6.9 days) with a flow of 2.8 to 5.5 L/min (mean, 3.87 L/min) being achieved. Thirty-two of 68 patients (47%) with exclusive ABIOMED application could be weaned from the device, with 22 patients (37%) being discharged from hospital. Thirteen patients underwent cardiac transplantation, 3 of them died after the procedure. Altogether, 32 patients (47%) of this subset were survivors. Of those 7 patients in whom the ABIOMED device was applied subsequently or before another system, 3 could be weaned from support, 2 of them underwent cardiac transplantation later, 1 of whom survived to be discharged home, the other patient died after the procedure from multiple organ failure and sepsis. The third weaned patient survived without being transplanted and could be discharged. The outcome of the ABIOMED patients by indication is described in Table 4. The highest incidence of complications among ABIOMED patients was observed to be bleeding in 28% and cerebral infarction in 13% (Table 5 ), the most frequent causes of death multiple organ failure and sepsis (Table 6).

Four of 17 patients (21%) with the application of more than one mechanical circulatory support device underwent cardiac transplantation, 3 of them are survivors (13%), 1 patient died from multiple organ failure and sepsis after the procedure. Another 2 patients are still waiting for a donor organ (Table 7). Main complications among Thoratec patients were multiple organ failure (28%), bleeding (27%), sepsis (25%), and liver failure (24%) (Table 8 ), main causes of death multiple organ failure and sepsis (Table 9).

At present in our Center with 10 years of experience with VAD support, 337 patients have been treated with mechanical circulatory assistance using six different devices for a variety of indications. We tried to outline the most appropriate indication for each system in this study for the ABIOMED and Thoratec VADs, which were implanted in 75 and 103 patients, respectively.

In patients with early postcardiotomy heart failure, expected to recover within a couple of days, we primarily apply the ABIOMED BVS because it is easy to implant, the pump requires no special postoperative care, and it provides pulsatile flow that is supposed to have a favorable effect on organ recovery. Although in our series, this flow was lower compared to the Thoratec device (3.87 versus 4.34 L · min · m^-2), low flow was not correlated to the incidence of multiple organ failure. Furthermore, the system is cheaper than the Thoratec VAD is. However, the ABIOMED device is only indicated for short-term application because long-term use is associated with high morbidity (40% multiple organ failure and sepsis). Patients with late postcardiotomy heart failure are generally supported with the centrifugal pump, which has been described elsewhere [18]. Of postcardiotomy patients 25% supported with ABIOMED had late postcardiotomy heart failure with previous multiple organ failure, episodes of cardiopulmonary resuscitation, and an unclear neurologic status, which also accounts for the high incidence of cerebral infarction and multiple organ failure. The use of the Thoratec in some patients with postcardiotomy heart failure and severe cardiac damage is justified because the system offers the possibility of long-term use with lower morbidity and provides more pump output and mobility for the patient. The issue why we do not use Thoratec in all patients with early postcardiotomy heart failure is only a matter of cost.

Our institution is a very busy cardiac surgical center with about 4,000 open heart and nearly 100 heart transplant procedures per year with a 0.5% incidence of postcardiotomy heart failure requiring the use of ventricular assist devices. The discharge rates of 50% with ABIOMED and 60% with Thoratec in this patient group, however, are better than those described by Pae and colleagues [5] (24.6%) and Jett [8] (27%). However, the data presented by Pae and associates [5] are quite old referring to an experience with patients between 1985 and 1990. Furthermore, our approach seems to be different, because patients who cannot be weaned from support but have no organ failure and no contraindications for transplantation are listed for the transplant procedure (6 patients with Thoratec, 5 with ABIOMED in our collective). These investigators have not mentioned this option.

In our initial experience with bridging to transplantation the centrifugal pump was the only system available at our institution for mechanical circulatory support and was only applied in a few patients. Subsequently, ABIOMED and Thoratec were provided. In our opinion, the ABIOMED BVS is not suitable for bridging patients to transplantation because waiting times and thus VAD duration [19] are increasing, long-term support with ABIOMED is associated with high morbidity, and mobility of the patient is almost impossible.

The Thoratec VAD provides the possibility of biventricular assistance and is more suitable for an extended use than the ABIOMED because of a higher pump output, more mobility for the patient and less morbidity. In comparison to the implantable systems, Novacor and HeartMate (left ventricular assist devices), there is no pocket infection and thus a reduced infection rate. However, the disadvantage is the large console restricting its application to hospitalized patients and the lower pump outflow compared with Novacor and HeartMate. VAD support time of up to 6 months is ideal with this device.

During our initial experience with bridging to transplantation we applied Thoratec for left and biventricular assistance. Most recently, we use Thoratec primarily for biventricular support and in patients with multiple organ failure. Novacor and HeartMate are recommended for patients in need of a left ventricular assist device. Thoratec right ventricular assist device is also indicated in right heart failure after HeartMate or Novacor implantation. Seventy-four percent of patients bridged with Thoratec and 50% bridged with ABIOMED underwent cardiac transplantation; survival rates after transplantation were 90% and 86%, respectively.

In patients with miscellaneous indications mechanical circulatory support should only be applied in a selected group, as the results have proved to be very poor. However, due to the low number of patients, a final conclusion is not possible.

In several patients a system change became necessary, for example, because of insufficient flow or the use of an assist device as a resuscitative procedure (femoral-to-femoral cardiopulmonary bypass). In view of the disastrous preoperative situation of these patients, the results are acceptable with 20% (Thoratec) and 29% (ABIOMED) surviving to be discharged. However, a system change should be restricted to younger patients in whom organ recovery is more likely under support.

Our results recommend the restriction of ABIOMED BVS use to patients with early postcardiotomy failure and to accept a wider spectrum for the Thoratec VAD application, that is, biventricular assistance in bridging patients, right ventricular assistance after Novacor/HeartMate implantation, and in some cases of postcardiotomy heart failure.

Acknowledgments

We thank the German Association of Organ Recipients (Reg. Ass.) for grant support.

References

1. Golding L.A.R., Crouch R.D., Stewart R.W., et al. Postcardiotomy centrifugal mechanical ventricular support. Ann Thorac Surg 1992;54:1059-1064.[Abstract]
2. Lee W.A., Gillinov A.M., Cameron D.E., et al. Centrifugal ventricular assist device for support of the failing heart after cardiac surgery. Crit Care Med 1993;21:1186-1192.[Medline]
3. Miller C.A., Pae W.E., Pierce W.S. Combined registry for the clinical use of mechanical ventricular assist devices. ASAIO Trans 1990;36:43-46.[Medline]
4. Pae W.E., Pierce W.S., Pennock J.L., Campbell D.B., Waldhausen J.A. Long-term results of ventricular assist pumping in postcardiotomy cardiogenic shock. J Thorac Cardiovasc Surg 1987;93:434-441.[Abstract]
5. Pae W.E., Miller C.A., Metthew J., Pierce W.S. Ventricular assist devices for postcardiotomy cardiogenic shock. J Thorac Cardiovasc Surg 1992;104:541-553.[Abstract]
6. Parascandola S.A., Pae W.E., Davis P.K., et al. Determinants of survival in patients with ventricular assist devices. ASAIO Trans 1988;34:222-228.[Medline]
7. Körfer R., El-Banayosy A., Posival H., et al. Mechanical circulatory support with the Thoratec assist device in patients with postcardiotomy cardiogenic shock. Ann Thorac Surg 1996;61:314-316.[Abstract/Free Full Text]
8. Jett G.K. ABIOMED BVS 5000. Ann Thorac Surg 1996;61:301-304.[Abstract/Free Full Text]
9. Körfer R., El-Banayosy A., Posival H., et al. Mechanical circulatory support. Ann Thorac Surg 1995;59:S56-S62.
10. Minami K., Posival H., El-Banayosy A., et al. Mechanical ventricular support using pulsatile ABIOMED BVS 5000 and centrifugal Biomedicus pump in postcardiotomy shock. Int J Artif Organs 1994;17:492-498.[Medline]
11. Pae W.E., Jr Ventricular assist devices and total artificial hearts. Ann Thorac Surg 1993;55:295-298.[Abstract]
12. Guyton R.A., Schonberger J.P., Everts P.A., et al. Postcardiotomy shock. Ann Thorac Surg 1993;56:346-356.[Abstract]
13. Castells E., Calbet J.M., Fontanillas C., et al. Ventricular circulatory assistance with the ABIOMED system as a bridge to heart transplantation. Transplant Proc 1995;27:2343-2345.[Medline]
14. Holman W.L., Bourge R.C., Spruell R.D., Murrah C.P., McGiffin D.C., Kirklin J.K. Ventricular assist devices as a bridge to cardiac transplantation. A prelude to destination therapy. Ann Surg 1997;225:695-706.[Medline]
15. Pennington D.G., McBride L.R., Peigh P.S., Miller L.W., Swartz M.T. Eight years’ experience with bridging to cardiac transplantation. J Thorac Cardiovasc Surg 1994;107:472-481.[Abstract/Free Full Text]
16. Farrar D.J., Hill J.D. Univentricular and biventricular Thoratec VAD support as a bridge to transplantation. Ann Thorac Surg 1993;55:276-282.[Abstract]
17. Champsaur G., Ninet J., Vigneron M., et al. Use of the ABIOMED BVS System 5000 as a bridge to cardiac transplantation. J Thorac Cardiovasc Surg 1990;100:122-128.[Abstract]
18. El-Banayosy A., Posival H., Minami K., et al. Seven years of experience with the centrifugal pump in patients with cardiogenic shock. Thorac Cardiovasc Surg 1995;43:347-351.[Medline]
19. El-Banayosy A., Minami K., Arusoglu K., et al. Long-term mechanical circulatory support. Thorac Cardiovasc Surg 1997;45:127-130.[Medline]

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