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Ann Thorac Surg 1995;59:1063-1067
© 1995 The Society of Thoracic Surgeons

Use of Aprotinin in LVAD Recipients Reduces Blood Loss, Blood Use, and Perioperative Mortality

Divisions of Cardiothoracic Surgery and Circulatory Physiology, College of Physicians & Surgeons, Columbia University, New York, New York

	Abstract

Top Footnotes Abstract Introduction Patients and Methods Results Comment Acknowledgments References

 
Aprotinin, a bovine protease inhibitor, has been used extensively in patients undergoing cardiac surgical procedures in an effort to minimize blood loss and prevent the complications associated with blood replacement. We sought to evaluate the effect of aprotinin on postoperative blood loss, renal function, and the incidence of right ventricular failure in patients undergoing placement of a TCI Heartmate left ventricular assist device as a bridge to cardiac transplantation. Retrospective data analysis in 142 patients (42 receiving aprotinin and 100 untreated) demonstrated that the use of aprotinin was associated with a significant decrease in postoperative blood loss (p = 0.019) and in the intraoperative packed red blood cell transfusion (p = 0.019) and total blood product (p = 0.016) requirements. A transient, yet significant, increase in the postoperative creatinine level in the aprotinin group (p = 0.0006), but not in blood urea nitrogen level (p = 0.22), was noted. Interestingly, we noted an association between blood loss and the subsequent development of right ventricular failure; patients who required a right ventricular assist device bled significantly more than did those who did not suffer right ventricular failure (p = 0.02). Additionally, aprotinin recipients benefited by a reduction of nearly one half in the incidence of the need for a right ventricular assist device. The incidence of perioperative mortality was reduced in those receiving aprotinin compared with that in untreated patients, (p = 0.05). We conclude that aprotinin is safe and effective in decreasing postoperative blood loss and intraoperative blood product requirements, and in reducing perioperative mortality in patients undergoing left ventricular assist device placement as a bridge to cardiac transplantation.

	Introduction

Top Footnotes Abstract Introduction Patients and Methods Results Comment Acknowledgments References

 
See also page 1068.

An increasing number of patients with end-stage heart failure are undergoing insertion of a long-term implantable ventricular assist device as a bridge to cardiac transplantation. Regardless of the device used, bleeding complications have been consistently reported in these patients and limit the success of implantation [1, 2]. Although often multifactorial in nature, bleeding may also result from the excess fibrinolysis and platelet activation that occur in patients with mechanical circulatory support devices [3].

Ongoing blood loss coupled with blood product resuscitation may lead to increased pulmonary vascular resistance [4], a process that may be cytokine mediated [5]. Therefore clinically significant postoperative bleeding may be associated with right ventricular failure, the need for insertion of a right ventricular assist device (RVAD), and increased perioperative mortality.

Aprotinin, a bovine serine protease inhibitor, has been used extensively in patients undergoing cardiac operations in an effort to minimize perioperative blood loss and prevent the potential complications associated with blood transfusions and reoperations for the control of bleeding. A large body of data suggests that aprotinin can be effectively and safely administered in the setting of open heart surgical procedures [6–10].

We retrospectively reviewed the cases of patients who underwent left ventricular assist device (LVAD) placement with and without the perioperative administration of aprotinin. We sought to evaluate its effect on postoperative blood loss, blood product requirement, renal function, the incidence of right-sided circulatory failure (RSCF), and perioperative mortality.

	Patients and Methods

Top Footnotes Abstract Introduction Patients and Methods Results Comment Acknowledgments References

 
Data were gathered by retrospective review of the database from the ThermoCardiosystems Heartmate 1000 IP or 1205 VE (Woburn, MA) LVAD study conducted between January 1, 1986, and June 30, 1993, among 16 North American medical centers (courtesy of Kurt Dasse, PhD, TCI). A total of 121 patients underwent LVAD placement during this period. An additional 21 patients underwent LVAD implantation at Columbia Presbyterian Medical Center between June 30, 1993, and December 31, 1994, and were included in this study. The distribution of the study cases over time is depicted in Figure 1. Consultation with the aprotinin (Miles, West Haven, CT) trial coordinator at each participating institution revealed that 42 patients received aprotinin perioperatively during LVAD placement. Aprotinin was not widely available in the United States during the time of this trial. For those centers where aprotinin was available, the decision to use the drug was made by the participating center; therefore some centers used the drug for most of their patients while others did not use it at all.

View larger version (42K): [in this window] [in a new window]   Fig 1. . Distribution of left ventricular assist device implantations per 3-year period according to aprotinin use. Most of the patients included in the study underwent implantation of the device in the last 3 years. Aprotinin was used mostly during the latter years of the study.

Bleeding was assessed by totaling the chest tube output that was recorded hourly for the first 24 hours postoperatively. The baseline and postoperative day 3 renal function test results were obtained for all patients. The blood product requirement was obtained from the anesthesia and perfusion report sheets.

Data were analyzed with the Statistical Analysis System software (SAS Institute, Cary, NC) on the Columbia Presbyterian Department of Surgery computer system. Fisher's exact test for comparison of proportions and two sample t tests for means were used in the univariate analysis. A p value of 0.05 or less was considered significant.

	Results

Top Footnotes Abstract Introduction Patients and Methods Results Comment Acknowledgments References

 
The findings from the comparison of those patients receiving aprotinin (n = 42) with those not receiving aprotinin (n = 100) are summarized in Table 1. The mean age of patients in both groups was nearly identical. Although the large majority of patients in both groups were male, the sex discrepancy was even more marked in the untreated group. A variety of causes of end-stage cardiac failure were represented in both groups; ischemic and idiopathic cardiomyopathies combined constituted the cause for more than 90% of the patients in both groups. One half of the patients receiving aprotinin had undergone prior sternotomy, whereas one third of the patients in the non–aprotinin-treated group had undergone a prior operation. These figures are consistent with the higher prevalence of ischemic cardiomyopathy (and thus the likelihood of prior coronary bypass grafting) in the aprotinin-treated group. Untreated patients were more likely to have an intraaortic balloon pump in place at the time of implantation, and the mean duration of implant was longer in the aprotinin-treated patients.

	Comment

Top Footnotes Abstract Introduction Patients and Methods Results Comment Acknowledgments References

 
Aprotinin, a serine protease inhibitor derived from bovine lung tissue, has been used in Europe and the United States [6–9, 13] in an effort to minimize bleeding and prevent the potential complications associated with blood product transfusion in patients undergoing cardiac operations. Aprotinin inhibits the activity of kallikrein and plasmin, thereby effectively serving as an antifibrinolytic agent [14]. Although the precise mechanism responsible remains to be determined, aprotinin may additionally inhibit the turnover of coagulation factors and may enhance platelet adhesiveness, rendering them less prone to damage during cardiopulmonary bypass [15, 16].

Controlled trials have demonstrated that the perioperative use of aprotinin significantly reduces perioperative blood loss and exogenous blood product requirements [6–9]. We evaluated the effect of aprotinin in patients undergoing a cardiac procedure that is associated with a high risk of bleeding and bleeding-related morbidity and mortality. As seen in patients undergoing coronary artery bypass procedures, the bleeding that occurred in patients undergoing LVAD placement was notably reduced. As has been previously reported [17], the blood product requirement was also reduced significantly. Indeed, transfusion was avoided in 7% of the aprotinin-treated LVAD recipients versus 2% of the untreated cohort. The reduced exposure to blood antigens should in turn reduce the chance of immunologic abnormalities that can complicate cardiac transplantation.

Different aspects of renal function have been reported to be affected by aprotinin use [18, 19]. Its use in this series was associated with a significant elevation in the postoperative day 3 serum creatinine level, although this change was transient and there was eventual recovery of baseline function in all surviving patients.

Despite the theoretic possibility of a procoagulant effect of aprotinin, only one adverse thromboembolic event occurred in the treated group. In fact, the aprotinin-treated group had a lower incidence of thromboembolic events than did the untreated group, although statistical significance was not achieved.

The most common cause of death in the early postoperative period in patients undergoing LVAD placement is right heart failure or RSCF. Although the frequency of RVAD placement represents a gauge of RSCF, it likely underestimates its true incidence. For this reason, we believe the 7-day mortality is a more accurate estimate of RSCF. It is likely that the additional mortality observed in the non–aprotinin-treated cohort was largely due to right ventricular failure that was not treated with an RVAD. The statistically significant difference in perioperative mortality in the aprotinin recipients may therefore indeed reflect the inability of the frequency of RVAD placement to measure the true incidence of RSCF.

An important finding in this study is the association of postoperative bleeding with the development of RSCF. Hemorrhage and resuscitation induce the transcription of multiple cytokines (including interleukins 1-beta, 6, and 10, as well as tumor necrosis factor-alpha), which may contribute to the development of the acute lung injury often seen in this setting [5]. Moreover, the rapid administration of blood products has been shown to result in pulmonary hypertension and acute heart failure in animals [20]. Furthermore, evidence is accumulating that proinflammatory cytokines play a role in the pathophysiologic mechanism of heart failure [21–23]. There is also some evidence that aprotinin, as a protease inhibitor, affects the synthesis and release of thromboxane A₂ [24], which has been implicated in the development of pulmonary hypertension [25].

A reduction in blood loss with the use of aprotinin and other agents may be critical in reducing hemorrhage and transfusion-mediated cytokine effects on the heart, including the development of right ventricular failure in LVAD recipients. Despite the lack of statistical significance indicating that the incidence of right ventricular failure requiring RVAD support was reduced in those patients receiving aprotinin, a clinically meaningful effect may be present.

The use of aprotinin was associated with a significant decrease in perioperative mortality, which may be attributed at least in part to the decrease in bleeding complications. By the time of transplantation, however, the survival in both groups was identical.

We conclude that aprotinin is safe and effective in decreasing postoperative blood loss and intraoperative blood product requirements, and in reducing the perioperative mortality in patients undergoing LVAD placement as a bridge to cardiac transplantation. Demonstration of the potential beneficial effect of aprotinin in significantly reducing perioperative right ventricular failure requires further clinical experience.

The retrospective nature of this study, which was based mostly on database collection, imposes certain limitations on the interpretation of our findings. In particular, the large number of participating centers with differing intraoperative criteria for transfusion, different thresholds for RVAD placement, and varied clinical experience translates into a nonuniform population of patients for comparison. In addition, the results may be biased by the fact that aprotinin was mostly used in the latter part of the LVAD study, at which time clinical experience with LVAD placement was greater. Because of the benefits conferred by aprotinin therapy during LVAD implantation, a randomized prospective study may prove ethically difficult to undertake.

	Acknowledgments

Top Footnotes Abstract Introduction Patients and Methods Results Comment Acknowledgments References

 
Doctor Oz is an Irving Scholar of Columbia University.

	Footnotes

Top Footnotes Abstract Introduction Patients and Methods Results Comment Acknowledgments References

 
Presented at the Thirty-first Annual Meeting of The Society of Thoracic Surgeons, Palm Springs, CA, Jan 31–Feb 2, 1995.

Address reprint requests to Dr Oz, Division of Cardiothoracic Surgery, Columbia Presbyterian Medical Center, Milstein Hospital 7GN-435, New York, NY 10032.

	References

Top Footnotes Abstract Introduction Patients and Methods Results Comment Acknowledgments References

 

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