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Ann Thorac Surg 2000;70:510-515
© 2000 The Society of Thoracic Surgeons

Original articles: cardiovascular

Economic impact of preoperative intraaortic balloon pump therapy in high-risk coronary patients

Jan T. Christenson, MD, PhDa, François Simonet, MDa, Martin Schmuziger, MDa

a Department of Cardiovascular Surgery, Hôpital de la Tour, Meyrin-Geneva, Switzerland

Address reprint requests to Dr Christenson, Department of Cardiovascular Surgery, Hôpital Cantonal Universitaires de Genève, Rue Micheli-du-Crest 24, CH-1211 Geneva, Switzerland;
e-mail: jtchristenson{at}hotmail.com


   Abstract
Top
 Abstract
Introduction
 Patients and methods
 Results
 Comment
 References
 
Background. The efficacy of preoperative intraaortic balloon pump therapy in high-risk coronary patients has been demonstrated earlier.

Methods. This study investigates the economic aspect by a detailed cost analysis of pooled information from two previously published randomized studies and 144 consecutive low-risk coronary artery bypass graft operations. Costs for patients receiving preoperative intraaortic balloon pump therapy before aortic cross-clamping (n = 62) were compared to those in a control group (n = 50). Detailed cost analysis was based on data provided by the hospital finance department.

Results. The total hospital costs were as follows: low-risk coronary artery bypass graft operations cost 35,335 ± 1,694 Swiss francs ($23,400 ± $1,121); high-risk coronary artery bypass graft without preoperative intraaortic balloon pump therapy cost 65,892 ± 31,719 Swiss francs ($43,637 ± $21,006); and high risk coronary artery bypass graft with preoperative intraaortic balloon pump therapy cost 41,948 ± 10,379 Swiss francs ($27,780 ± $6,874) (p = 0.0015). There were no significant differences in average cost among the preoperative intraaortic balloon pump therapy subgroups.

Conclusions. Preoperative intraaortic balloon pump therapy in high risk coronary patients is significantly cost-beneficial, With an average saving of 24,000 Swiss francs ($16,000) on the total hospital cost, a 36% cost reduction.


   Introduction
Top
 Abstract
 Introduction
Patients and methods
 Results
 Comment
 References
 
T he technique of intraaortic balloon pump (IABP) counter pulsation has provided essential circulatory support for numerous patients experiencing hemodynamic instability. It has been shown effective in reducing mortality and morbidity when used directly after acute myocardial infarction [1], in those with cardiogenic shock [2], and in those with severe left ventricular dysfunction [3]; it is also effective in stabilizing patients who are undergoing angioplasty [4] and who have undergone myocardial revascularization [5, 6]. Recently several studies have expanded the potential clinical applications of IABP to include its use as preoperative therapy for high-risk patients undergoing coronary artery bypass grafting (CABG) [7–9]. Numerous studies have provided considerable evidence for the efficacy of this therapeutic approach [8–11].

The rapid development of invasive cardiology techniques and approaches has led to a changing pattern in the characteristics of coronary patients undergoing CABG. A larger proportion of patients coming for surgical intervention are repeat or re-repeat operations; these more often present with unstable angina, poor left ventricular function (ejection fraction <= 0.30), severe left main coronary artery stenosis, or a combination of those disorders. Preoperative IABP therapy has a proven efficacy in this group of patients, significantly lowering hospital mortality and morbidity as well as significantly shortening both intensive care unit stay and total length of hospital stay [8, 9].

However, in the health care profession’s increasingly restrained economic situation, the introduction of any new therapeutic modality should have not only a proven efficacy but also a demonstrable impact on the total procedural cost. Preoperative IABP therapy has been suggested to be cost beneficial in previous reports [9, 10]. In the present study, we perform a detailed cost analysis using patients included in two previously published randomized prospective studies [9, 12].


   Patients and methods
Top
 Abstract
 Introduction
 Patients and methods
Results
 Comment
 References
 
The present study used pooled patient information from two recently published randomized trials addressing the efficacy of preoperative IABP therapy in a high-risk cohort of patients undergoing myocardial revascularization [9, 12]. Between June 1994 and June 1998, 62 patients (group 1) were randomized to receive preoperative IABP therapy. The IABP therapy in those patients was started either 2 hours (group 1a, n = 29 patients), 12 hours (group 1b, n = 10 patients), or 24 hours (group 1c, n = 23 patients) before cross-clamping. Another 50 high-risk coronary patients (group 2) were randomized to the control group, which did not receive preoperative IABP therapy. On admission to the hospital all coronary patients defined as high-risk were randomly assigned to group by lottery principle, drawing prepared sealed envelopes containing their group assignment.

We defined a high-risk coronary patient as one presenting with at least two of the following inclusion criteria: (1) left ventricular dysfunction calculated from the preoperative ventriculography (preoperative left ventricular ejection fraction <= 0.30); (2) unstable angina at the time of surgery (angina severity fluctuating between Canadian Cardiovascular Society angina classes or angina at rest despite nitroglycerine infusion and calcium-channel inhibitors); or (3) left main stem stenosis greater than or equal to 70%, repeat or re-repeat coronary artery bypass grafting (CABG), or various combinations thereof. All preoperative clinical and catheterization data plus operation data, hemodynamic data, and reports of postoperative complications were entered into a computer database at the time of hospitalization. The definition of high risk was made before the start of the first study [9] and not altered during the duration of the two studies. Anesthesia, cardiopulmonary bypass time, and surgical techniques were standardized and did not change during the entire study period. Further details about definitions and anticoagulation and IABP techniques may be found in our previous reports [9, 12].

Preoperative patient characteristics did not differ between group 1 and 2 except that significantly more group 1 patients had unstable angina at the time of operation (51 versus 27 patients, p = 0.0021); group 1 patients also had significantly worse New York Heart Association classifications than did group 2 patients (3.5 ± 0.5 versus 3.2 ± 0.5, respectively; p = 0.0303). Left main coronary artery stenosis was present in 44.6 of all 112 patients (42.9%), 48 were undergoing repeat operations ( 42.9%), and 81 patients (73.3%) had diffuse coronary artery disease. The average preoperative left ventricular ejection fraction in group 1 was 0.26 ± 0.09 compared with 0.35 ± 0.11 in group 2 (p = 0.0303), a purely coincidental phenomenon related to the preset requirement of two or more of the defined inclusion criteria. Other preoperative and operative findings did not differ between the groups, except that cardiopulmonary bypass time was significantly longer in group 2 than in group 1 (mean minutes, 123 ± 43.1 versus 85.7 ± 22.4, respectively). The ischemia time was the same in the two groups, thus indicating a better immediate postoperative cardiac performance with no difficulties weaning from cardiopulmonary bypass among group 1 patients.

Economic data regarding costs for all patients were obtained from the hospital’s finance department’s database and expressed as total hospital cost as well as distribution of costs into categories of standard hospital commodities. Adjusting hospital charges to defined profit margins for each commodity category generated the hospital cost. In calculations of the total hospital cost the costs for preoperative coronary angiography, echocardiography, stress exercise tests, or any combination of those tests were excluded, since the inclusion of cost of these procedures varied according to whether patients were admitted locally or as referrals from another hospital and whether or not they had undergone full preoperative investigations elsewhere. Doctors’ fees (for surgeon, anesthesiologist, and others) were also not included in the total hospital cost, since the fees varied according to the patient’s insurance, even though all physicians’ fees were known. Basic surgeon’s and anesthesiologist’s fees did not differ between the groups. On the other hand, when analyzing the distribution of cost in various commodity categories, we did calculate an average doctor’s fee for each study group.

For comparison, similar cost data were collected from 144 consecutive low-risk coronary patients who underwent operations at our institution during the latter part of the study period. The cost calculations excluded only patients who died within 24 hours postoperatively in order to eliminate the impact of early mortality on the average cost in an entire group.

Statistics
We employed the {chi}2 test (Fisher’s exact test) for nominal measurements, the median and Mann-Whitney tests for ordinal measurements, and an independent group Student t test for metric measurements to assess the differences among groups and subgroups and determine the presence of statistical significance where appropriate. A probability level (p) of less than 0.05 was required to consider a result as statistically significant. All data whenever possible were presented as mean plus or minus standard deviation.


   Results
Top
 Abstract
 Introduction
 Patients and methods
 Results
Comment
 References
 
Hospital mortality and the incidence of postoperative low cardiac output (cardiac index <= 2.0 L · min-1 · m-2 established by 3 repeated measurements over a period of at least 15 minutes) was significantly lower in group 1 (those receiving preoperative IABP therapy) than in group 2 (controls) (p = 0.007) but without statistically significant differences among subgroups 1a, 1b, and 1c (Table 1). Three patients (5%) died in group 1; the fatalities occurred at 3, 7, and 17 days postoperatively, whereas the 11 fatalities (22%) in group 2 occurred between 26 hours and 7 days postoperatively. The postoperative cardiac performance was significantly better in group 1 than in group 2 patients [9, 12]. In all patients in group 1 who had low postoperative cardiac index (n = 15), IABP therapy was immediately continued and successfully terminated an average of 19 ± 12 hours postoperatively (range, 4 to 42 hours). On the other hand, 34 out of 37 group 2 patients who experienced postoperative low cardiac output required postoperative insertion of an intraaortic balloon catheter and IABP support, in addition to extensive pharmacological inotrope therapy; the average duration of IABP therapy in group 2 was 55 ± 32 hours (range, 23 to 123 hours).


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  		Table 1. Comparison of In-Hospital Mortality and Postoperative Low Cardiac Output Among Groups and Subgroups

 
Also as previously reported, intubation time, time required in the intensive care unit, and the lengths of total hospital stay were significantly shorter in group 1, who received preoperative IABP therapy before CABG, than they were in group 2, who did not receive IABP therapy. But low-risk coronary patients undergoing CABG had both a significantly shorter intensive care unit stay and a significantly shorter total length of hospital stay than did either of those two high-risk groups. Interestingly, though, was the finding of shorter intubation time in group 2 patients than in the low-risk patients (Table 2). postoperative low cardiac output, more patients with postoperative low cardiac output experienced renal failure and gastrointestinal complications and required prolonged ventilation support, compared with those with cardiac indices above 2.0 L · min-1 · m-2 (Table 3) ; low cardiac output thus certainly contributed to increased total hospital costs.


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  		Table 2. Clinical Data

 

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  		Table 3. Postoperative Complications According to Postoperative Cardiac Index

 
Economic impact
The total average hospital cost of myocardial revascularization (CABG) was 41,948 ± 10,379 Swiss francs (SF) ($27,780 ± $6,874, based on the exchange rate of June 15,1999) in group 1, comprising high-risk coronary patients receiving preoperative IABP therapy, and 65,892 ± 31,719 SF ($43,637 ± $21,006) in the control group (group 2)—a statistically significant difference (p = 0.0015). As expected the hospital cost in high-risk patients was significantly higher than in low-risk patients (Table 4). The cost difference was even more pronounced when we separated group 2 patient into two subgroups: those who had postoperative low cardiac output, defined as acardiac index of 2.0 L · min-1 · m-2 or greater (n = 37), and those with a postoperative cardiac index of less than 2.0 L · min-1· m-2 (n = 13) (Table 4).


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  		Table 4. Comparison of Total Average Hospital Costs Minus Doctors Fees for CABG in Low-Risk Coronary Patients With High-risk Coronary Patients With and Without Preoperative IABP Therapy

 
Comparing costs within various categories of standard hospital commodities revealed other striking differences: the cost of pharmaceuticals was markedly significantly higher in group 2 than in group 1. Additionally, intensive care costs were much lower in group 1 than in group 2. In fact, costs in all categories were significantly higher in group 2 than in group 1, with only three exceptions: the categories of laboratory costs, supplies, and fees (Table 5).


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  		Table 5. Comparison of Various Commodity Cost Categories in Low-Risk and High-Risk Coronary Patients Undergoing CABG

 
When comparing low-risk CABG patients with high-risk CABG patients treated preoperatively with IABP (group 1), the only statistically significant differences were found among the commodity categories of intensive care unit, radiology, and physicians’ fee; costs for low-risk patients were significantly lower in those categories (Table 5). The distribution of the total procedural cost among each of the commodity groups in high- and low-risk coronary patients is shown in Figure 1. The three commodity cost categories of pharmacy, intensive care unit, and radiology were each found to consume a larger proportion of the total expenditure in high-risk patients than they did in low-risk patients receiving CABG.



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  		Fig 1. Distribution of the total procedural cost of each commodity group in low-risk coronary patients (n = 144) undergoing CABG compared with high-risk coronary patients receiving preoperative IABP therapy (group 1, n = 62) and high risk patients without preoperative IABP, controls (group 2, n = 50). (CABG = coronary artery bypass grafting; IABP = intraaortic balloon pump.)

 
There was a nominal tendency among group 1 patients for cost to increase as preoperative IABP therapy time increased; the differences did not reach statistical significance, however (Table 6). The commodity category distribution analysis did not reveal any differences among the subgroups 1a, 1b, and 1c, with one exception: intensive care unit cost was significantly greater in group 1c (patients who had IABP 24 hours preoperatively) than in group 1a (those who had IABP 2 hours preoperatively) (8122 ± 2914 SF versus 6313 ± 3224 SF, respectively, p = 0.0112).


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  		Table 6. Total Average Hospital Cost Minus Doctors Fees for 62 High Risk Coronary Patients Undergoing CABG Operation and Receiving IABP Therapy

 

   Comment
Top
 Abstract
 Introduction
 Patients and methods
 Results
 Comment
References
 
At a time when patients with end-stage coronary artery disease are facing a grim future because of insufficiently effective medical therapy [13, 14], limited access to donor organs for heart transplantation [15], and lack of an easily accessible and functional artificial device, other therapeutic solutions need to be explored. Cardiomyoplasty has been tried but has not been entirely successful [16, 17], and the efficacy of transmyocardial laser treatment is still controversial [17, 18]. In the presence of viable myocardium, extensive myocardial revascularization has been performed successfully [19, 20], but the procedure has been associated with an unacceptably high postoperative mortality and morbidity. Preoperative IABP therapy in this cohort of high-risk patients has proved to improve the outcome dramatically following coronary artery bypass grafting in several studies, both retrospective and prospective [3, 7–12]. Preoperative IABP therapy significantly improves the cardiac function before a procedure, thus allowing CABG to be performed on a less-ischemic myocardium, which may be the main explanation for improved postoperative cardiac function [7, 9, 12]. The efficacy of the preoperative treatment has been documented by significantly reduced hospital mortality and morbidity; patients have a significant shortening of both time required in the intensive care unit and length of total hospital stay [8–12]. Of course, one important issue is to define the selection criteria for patients most likely to benefit from this preoperative therapy. This question has been addressed in previous publications [7, 12, 21]. One indicator that the chosen selection criteria for preoperative IABP are fairly accurate can be seen in our control group, in which 74% (37 of 50 patients) had poor cardiac performance postoperatively (cardiac index lower than 2.0 L · min-1 · m-2) and required postoperative IABP support in addition to large doses of inotrope pharmacological treatment [9, 12]. In the latest series, where the majority of the patients fulfilled 3 selection criteria, 83% (25 of 30 patients) of the control group had low cardiac output and 92% of those patients (23 of 25) required IABP support postoperatively [12].

The preoperative patient characteristics were the same in the two study groups, with only the exception of left ventricular ejection fraction. This difference, however, was coincidental and related to the requirement of fulfilling at least two of the defined inclusion criteria to be enrolled into the study. Since our preoperative IABP group (group 1) had a lower mean left ventricular ejection fraction, the risk of overestimating the impact of preoperative IABP therapy on outcome is minimal.

The reason for the superior postoperative pulmonary function in group 1 patients is not fully understood. Shorter cardiopulmonary bypass-time and immediate improved cardiac function may be important contributing factors, but further studies would be required to evaluate the exact mechanisms. The longer cardiopulmonary bypass time that was observed in group 2 seems to be linked directly to the worse outcome in that group than in group 1, but the present study does not allow further elaboration of this notable relationship.

In addition to the efficacy of the treatment, a substantial cost benefit of this treatment has been suggested earlier [9–10]. However, the present study is the first to report a detailed cost analysis of preoperative IABP treatment in high-risk coronary patients undergoing CABG using data from a prospective randomized trial.

As expected from the previously reported outcome data on the same patient populations, [9, 12] it was found that preoperative IABP therapy in the cohort of high-risk coronary patients had a significant cost benefit, with an average cost reduction of 24,000 SF ($16,000), or 36%. In all commodity categories, control patients had higher costs than patients receiving preoperative IABP therapy, except in the two cost categories of laboratory and supplies, likely due to large standard deviations, and fees, which are total procedural fees at our institution. Notably, the most significant cost differences were to be found in the commodity categories of pharmacy and intensive care. High-risk coronary patients receiving preoperative IABP had significantly higher costs in the commodity categories of intensive care and radiology than did low-risk CABG patients. Other commodity category costs were fairly similar in these two groups. There were no statistically significant differences in costs among the preoperative IABP subgroups except that increase in intensive care cost directly correlated with increase in the length of time of preoperative IABP therapy.

The relatively high mortality rate in the control group (group 2) is a reflection of the fact that the patient population we studied contained numerous patients who underwent salvage operations. However, there were no differences between the groups in either patient demographics or incidence of emergent or urgent operations. Several of the patients had been refused for myocardial revascularization elsewhere. The studied patient population is a subgroup of our normal patient population, since we do not perform cardiac transplantation at our institution.

Intraaortic balloon pump counterpulsation is, like any other therapy, associated with certain complications, most often vascular in nature and affecting the lower extremity. The IABP complication rate has been reported in the literature as 4% to 11% [8, 22]. In the present two series the combined IABP complication rate was 4.5% (5 of 112 patients), including 2 patients in group 1 and 3 patients in group 2; all complications were related to leg ischemia. In 2 patients, the intraaortic balloon was removed, and 2 patients required catheter removal and arterial thrombectomy. One patient needed a short interposition graft due to an intimal dissection. However, these complications did not have any significant impact on the total procedural cost and were without sequelae. The complication rate seems to be related to the length of treatment as well as to catheter size [22]. Because using preoperative IABP therapy significantly shortens the treatment time [8, 9, 12], fewer complications have been observed when it is employed. The necessity for close surveillance of peripheral circulation in patients with IABP is emphasized in order to allow early detection of compromised peripheral circulation and early intervention.

In conclusion, this analysis of hospital cost data from high-risk coronary patients undergoing CABG and participating in two randomized prospective trials of preoperative IABP has disclosed a highly significant cost-beneficial effect in addition to increased treatment efficacy. The use of preoperative IABP treatment resulted in a 36% overall cost reduction—a significant gain—with very few and economically unimportant complications reported.


   Acknowledgments
 
We are thankful to Mr Nicholas Froelicher, Chief Financial Officer (CFO) of the Hôpital de la Tour, for his help in preparing and sharing the hospital cost data.


   Footnotes
 
This study was supported by a research grant from Datascope Corp, Fairfield, NJ.


   References
Top
 Abstract
 Introduction
 Patients and methods
 Results
 Comment
 References
 

  1. Waksman R., Weiss A.T., Gotsman M.S., Hassin Y. Intra-aortic balloon counterpulsation improves survival in cardiogenic shock complicating acute myocardial infarction. Eur Heart J 1993;14:71-74.[Abstract/Free Full Text]
  2. Kantrowitz A., Tjonneland S., Freed P.S., Phillips S.J., Butner A.N., Sherman J.L., Jr Initial experience with intraaortic balloon pumping in cardiogenic shock. JAMA 1968;203:135-140.
  3. Christakis G.T., Weisel R.D., Fremes S.E., et al. Coronary artery bypass grafting in patients with poor ventricular function. J Thorac Cardiovasc Surg 1992;103:1083-1092.[Abstract]
  4. Ohman E.M., George B.S., White C.J., et al. randomized IABP study group. Use of aortic counterpulsation to sustained coronary artery patency during acute myocardial infarction. Results of a randomized trial. Circulation 1994;90(2):792-799.[Abstract/Free Full Text]
  5. Naunheim K.S., Schwartz M.T., Pennington D.G., et al. Intraaortic balloon pumping in patients requiring cardiac operations. Risk analysis and long-term follow-up. J Thorac Cardiovasc Surg 1992;104:1654-1660.[Abstract]
  6. Christenson J.T., Buswell L., Velebit V., Maurice J., Simonet F., Schmuziger M. The intraaortic balloon pump for postcardiotomy heart failure. Experience with 169 intraaortic balloon pumps. Thoracic Cardiovasc Surg 1995;43:129-133.[Medline]
  7. Creswell L.L., Rosenbloom M., Cox J.L., et al. Intraaortic balloon counterpulsation. Patterns of usage and outcome in cardiac surgery patients. Ann Thorac Surg 1992;54:11-20.[Abstract]
  8. Christenson J.T., Badel P., Simonet F., Schmuziger M. Preoperative intraaortic balloon pump enhances cardiac performance and improves the outcome of redo CABG. Ann Thorac Surg 1997;64:1237-1244.[Abstract/Free Full Text]
  9. Christenson J.T., Simonet F., Badel P., Schmuziger M. Evaluation of preoperative intra-aortic balloon pump support in high risk coronary patients. Eur J Cardiothorac Surg 1997;11:1097-1103.[Abstract]
  10. Dietl C.A., Berkheimer M.D., Woods E.L., et al. Efficacy and cost-effectiveness of preoperative IABP in patients with ejection fractions of 0.25 or less. Ann Thorac Surg 1997;62:401-409.[Abstract/Free Full Text]
  11. Gutfinger D.E., Ott R.A., Miller M., et al. Aggressive preoperative use of intraaortic balloon pump in elderly patients undergoing coronary artery bypass grafting. Ann Thorac Surg 1999;67:610-613.[Abstract/Free Full Text]
  12. Christenson J.T., Simonet F., Badel P., Schmuziger M. Optimal timing of preoperative intraaortic balloon pump support in high risk coronary patients. Ann Thorac Surg 1999;68:934-939.[Abstract/Free Full Text]
  13. Leier C.V., Unverferth D.V. Medical therapy of end-stage congestive and ischemic cardiomyopathy. Cardiovasc Clin 1988;19:243-251.[Medline]
  14. Dzau V., Brunswald E. Resolved and unresolved issues in the prevention and treatment of coronary artery disease. Am Heart J 1991;121:1244-1263.[Medline]
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  16. Furuta H., Watanabe G., Misaki T., Ueyama K. A new method of double cardiomyoplasty. " Ann Thorac Surg 1999;67:1339-1344.[Abstract/Free Full Text]
  17. Haverich A., Watanabe G. Heart transplantation, assist devices, and cardiomyoplasty. Curr Opin Cardiol 1992;7:259-266.[Medline]
  18. Nagele H., Stubbe H.M., Nienaber C., Rodiger W. Results of transmyocardial laser revascularization in non-revascularizable coronary artery disease after 3 years follow-up. Eur Heart J 1998;19:1525-1530.[Abstract/Free Full Text]
  19. Christenson J.T., Maurice J., Simonet F., et al. Effect of low left ventricular ejection fractions on outcome of primary coronary bypass grafting in end-stage coronary artery disease. J Cardiovasc Surg (Torino) 1995;36:45-51.[Medline]
  20. Dreyfus G., Duboc C., Blasco A., et al. Coronary surgery can be an alternative to heart transplantation in selected patients with end-stage ischemic heart disease. Eur J Cardiothorac Surg 1993;7:482-488.[Abstract]
  21. Christenson J.T., Simonet F., Schmuziger M. The effect of preoperative intra-aortic balloon pump support in high risk patients requiring myocardial revascularization. J Cardiovasc Surg 1997;38:397-402.[Medline]
  22. Arafa O.E., Pedersen T.H., Svennevig J.L., Fosse E., Geiran O.R. Vascular complications of the intraaortic balloon pump in patients undergoing open heart operations. Ann Thorac Surg 1999;67:645-651.[Abstract/Free Full Text]
Accepted for publication March 27, 2000.




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