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Ann Thorac Surg 1999;68:2237-2242
© 1999 The Society of Thoracic Surgeons

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Original Articles

Economic outcome of off-pump coronary artery bypass surgery: a prospective randomized study

^a Bristol Heart Institute, Bristol Royal Infirmary, Bristol, United Kingdom

Address reprint requests to Dr Angelini, Bristol Heart Institute, Bristol Royal Infirmary, BS2 8HW, Bristol, UK
e-mail: g.d.angelini{at}bristol.ac.uk

	Abstract

Top Abstract Introduction Material and methods Results Comment References

 
Background. Emphasis on cost containment in coronary artery bypass surgery is becoming increasingly important in modern hospital management. The revival of interest in off-pump (beating heart) coronary artery bypass surgery may influence the economic outcome. This study examines these effects.

Methods. Two hundred patients undergoing first-time coronary artery bypass surgery were prospectively randomized to either conventional cardiopulmonary bypass and cardioplegic arrest or off-pump surgery. Variable and fixed direct costs were obtained for each group during operative and postoperative care. The data were analyzed using parametric methods.

Results. There was no difference between the groups with respect to pre- and intraoperative patient variables. Off-pump surgery was significantly less costly than conventional on-pump surgery with respect to operating materials, bed occupancy, and transfusion requirements (total mean cost per patient: on pump, $3,731.6 ± 1,169.7 vs off-pump, $2,615.13 ± 953.6; p < 0.001). Morbidity was significantly higher in the on-pump group, which was reflected in an increased cost.

Conclusions. Off-pump revascularization offers a safe, cost-effective alternative to conventional coronary revascularization with cardiopulmonary bypass and cardioplegic arrest.

	Introduction

Top Abstract Introduction Material and methods Results Comment References

 
Recent emphasis on cost containment in healthcare has focused attention on the economics of medical procedures. Selection of the appropriate treatment for coronary artery bypass grafting (CABG) is of increasing concern, particularly with regard to the lower initial cost of coronary angioplasty as an alternative procedure [1–3]. Cost containment for conventional coronary artery surgery is reported to be possible through several strategies such as the collaborative efforts from representatives of all the personnel involved in cardiac care, better case-management strategies, and reducing intensive care unit (ICU) length of stay by early extubation [3–5]. Employing these strategies has allowed an overall reduction of ICU and hospital stay, with a median discharge time of 6 to 8 days with consequent decreased costs [6]. However, the major determinant of costs in conventional coronary artery surgery still remain the variable and fixed direct costs in terms of materials used for routine operations, postoperative care, and the management of postoperative complications [3, 7]. Therefore, further savings could be obtained by using a surgical technique able to decrease the fixed direct cost while maintaining clinical quality of care.

Recently, there has been a revival of interest in performing CABG on the beating heart [8–10], with some groups reporting reduced cost with this procedure [11, 12]. However, no data are available from prospective randomized studies on the operative and postoperative economic outcomes of off-pump surgery. We report the results of a cost analysis carried out as part of a prospective randomized study comparing the operative and postoperative costs in terms of bed occupancy, materials, and complication management in patients undergoing first-time coronary artery bypass grafting with conventional cardiopulmonary bypass (CPB) and cardioplegic arrest or off-pump surgery.

	Material and methods

Top Abstract Introduction Material and methods Results Comment References

 
Patient selection
Two hundred patients (161 males, mean age 61.8 ± 9.2 years) undergoing first-time coronary artery bypass grafting were enrolled in the study. Patients were prospectively randomized into two groups by card allocation. Group A (on-pump) underwent conventional myocardial revascularization with normothermic CPB and cardioplegic arrest of the heart, whereas group B (off-pump) underwent beating heart revascularization. Because the preoperative characteristics have important economic and medical implications as determinants of cost [11], exclusion criteria included impaired left ventricular function (ejection fraction of < 30%) as assessed by angiography, recent myocardial infarction (< 1 month), raised serum creatinine (> 130 µmol/L), combined valve surgery, respiratory impairment, previous stroke or transient ischemic attack (TIA), and coagulopathy. Patients with coronary disease involving branches of the circumflex artery distal to the first obtuse marginal branch and posterior branches originating from the left system were also excluded from the study, as these were felt to be technically difficult for adequate revascularization at the beginning of our experiences with off-bypass surgery. The study was approved by the United Bristol Healthcare Trust Ethics Committee.

Anesthetic technique
Anesthetic technique was standardized for all patients. This consisted of intravenous anesthesia with propofol infusion at 3 mg/kg/h combined with remifentanil infusion at 0.5 to 1 µg/kg/min. Neuromuscular blockade was achieved by 0.1 to 0.15 mg/kg pancuronium bromide or vecuronium, and the lungs ventilated to normocapnia with air and oxygen (45% to 50%) without positive end expiratory pressure (PEEP). In the on-pump group, metaraminol or phentolamine were used to maintain the systemic perfusion pressure at a mean of 60 mm Hg. In the off-pump group, mean arterial pressure of 60 mm Hg or above was maintained with increments of metaraminol 0.5 to 1.0 mg or volume as dictated by the hemodynamic condition, in combination with esmolol to maintain a heart rate below 70 beats per minute.

Heparin and protamine management
In the on-pump group, heparin was given at a dose of 300 international units (IU/kg) to achieve a target activated clotting time (ACT) of 480 seconds or above before commencement of CPB. The ACT was monitored during the bypass period (every 15 minutes) and an additional 3,000 IU of heparin was administered if required. In the off-pump group, heparin (100 IU/kg) was administered before the start of the first anastomosis to achieve an ACT of 250 to 350 seconds. On completion of all anastomoses, protamine was given to reverse the effect of heparin and return the ACT to preoperative levels.

Surgical technique
Group A: on-pump
Cardiopulmonary bypass was instituted using ascending aortic cannulation and two-stage venous cannulation of the right atrium. A standard circuit was used: a Bard tubing set, which included a 40-µm filter, a Stockert roller pump, and a hollow-fiber membrane oxygenator (Sorin Biomedica, Midhurst, UK). The extracorporeal circuit was primed with 1,000 mL of Hartmann’s solution, 500 mL of Gelofusine, 0.5 g/kg mannitol, 7 mL of 10% calcium gluconate, and 6,000 IU of heparin. Nonpulsatile flow was used and flow rates throughout bypass were 2.4 L/m²/min. Systemic temperature was kept between 34°C and 36°C. Myocardial protection was achieved by using intermittent anterograde hyperkalemic warm blood cardioplegia [13, 14].

On completion of all distal anastomoses, the aortic cross-clamp was removed and the proximal anastomosis performed with partial clamping.

Group B: off-pump
The method of exposure and stabilization to perform the anastomosis consisted of the technique previously described by our group [15], with or without the use of the CTS retractor and stabilizer (Cupertino, CA) [16]. The target vessel was then exposed and snared above the anastomotic site using a 4-0 Prolene suture with a soft plastic snugger to prevent coronary injury. The coronary artery was then opened and the anastomosis performed. Visualization was enhanced by using a surgical blower-humidifier (model SSVW-002, Surgical Site Visualization Wand; Research Medical Inc, Midvale, UT) with 0.25-inch PVC gas line and fluid administration set connected to a regulated gas source of compressed air. An intracoronary shunt (Anastoflo Intravascular Shunt; Research Medical Inc, Midvale, UT) was used only in case of relative electrocardiographic or hemodynamic instability or excessive bleeding during the anastomosis. As a safety measure, the CPB machine was kept with circuit mounted, but not primed (dry), for emergency standby should it be required.

Cost calculation
The outcome variable was the total cost for both operative and postoperative services. Professional fees, preoperative costs, theater and perfusionist staff, as well as drug costs were excluded. Variable and fixed direct costs were obtained for each care area and included the cost of theater materials, bed occupancy (which included nursing costs), transfusion products, and postoperative complication management. Indirect costs such as hospital administration, building, and maintenance costs were excluded. In the only two deaths (days 6 and 8), these patients were censored at the time of death, and costs to this time were included as this reflected neither early curtailment nor prolonged management [11].

Combined operating material costs
The combined operation costs were calculated from data obtained from the theater manager and principal perfusionist. The operative costs included the procedure tray, operative bag, and sutures. Perfusion costs included CPB and cardioplegia materials in the on-pump group, and CTS retractor, blower system, and intracoronary shunt in the off-pump group when used. Theater staff and perfusionist fees were excluded from the study, as they represented a constant, being required throughout the procedure whether on- or off-pump. Operative times were similar between the groups and time in theater did not affect initial operative costs.

Bed occupancy and nursing costs
Bed occupancy was calculated according to nursing shifts at each dependency level, which included three 8-hour shift periods per day. The cost was therefore calculated from respective shift rates and length of stay at each dependency level and included both the costs of maintaining the bed and nursing costs. The shift rate ranged from $230.40 for an ICU bed, $115.20 for a high dependency unit (HDU) bed, to $57.60 for a ward bed. Suitability for discharge from ICU and HDU followed unit protocol and was based on the judgment of an independent anesthetist, cardiac surgeon, and the ICU nursing staff.

Transfusion costs
The total number of units of red blood cells (RBC), fresh-frozen plasma (FFP), and platelets were recorded for each patient, and costs were calculated from number of units transfused only.

Postoperative complication management costs
All complications, occurring from entry into the ICU until discharge from the hospital, were listed, and materials costs for their management per patient were recorded. This included intraaortic balloon pumps (IABP), Swan-Ganz catheters, chest aspiration or drains, hemofiltration circuits, and wound infection dressings. Reopening of chests incurred the materials costs and theater staff overtime costs.

Statistical analysis
Data are presented as mean ± standard error of the mean (SEM) unless otherwise stated. Comparison between the groups were performed using the unpaired t test and Fisher’s exact test where appropriate, assuming equal variance. Two-tailed tests were used and differences were considered significant where p was less than 0.05.

	Results

Top Abstract Introduction Material and methods Results Comment References

 
Preoperative and operative characteristics are shown in Table 1. The two groups were balanced preoperatively with respect to age, gender, severity of coronary disease, diabetes mellitus, New York Heart Association (NYHA) class, and stable or unstable angina. Operative characteristics were similar, such as number of distal anastomoses, conduit usage, and operative times.

Material costs per patient needed to perform a routine operation were significantly higher in the on-pump than in the off-pump group ($1,252.62 vs $854.98 ± 27.36, p < 0.001) (Table 2).

View larger version (14K): [in this window] [in a new window]   Fig 1. Bed occupancy costs per patient at each dependency level. Data are presented as mean ± standard error of mean. p Values: ICU < 0.05, HDU < 0.05, ward = 0.09, total < 0.01.

View larger version (15K): [in this window] [in a new window]   Fig 2. Costs for each determinant factor. Data are presented as mean ± standard error of mean. p Values: operation cost < 0.001, bed occupancy cost = 0.01, transfusion cost < 0.01, complications cost < 0.05, total < 0.001.

Finally, the total cost for each patient was determined by adding the operation materials, bed occupancy, transfusion, and complication management costs (Fig 2). Using these data, the mean total cost for an on-pump patient was $3,731.6 ± 1,169.7, significantly higher than for an off-pump patient ($2,615.3 ± 953.6; p < 0.001).

	Comment

Top Abstract Introduction Material and methods Results Comment References

 
The present era of healthcare places major emphasis on reducing costs and resources while maintaining quality of care and patient satisfaction. Clinicians are being challenged to achieve this within the framework of a patient subset that is increasing in severity of disease and risk-adjusted mortality. As CABG surgery with CPB is a common and expensive procedure, there are now a number of alternative therapies claiming lower cost, such as coronary angioplasty and stenting [17, 18], minimally invasive direct coronary artery bypass (MIDCAB) grafting [12], and off-pump surgery through a midline sternotomy [19]. However, we should not lose sight of the fact that first and foremost remains the comprehensive management of the patient, which runs the risk of being jeopardized if only cost is used as a determinant of procedure.

Off-pump surgery is reported to provide better myocardial protection, lower perioperative morbidity, conserve blood constituents, and avoid neurological deficits caused through under-perfusion during CPB and embolic events from the CPB pump and cross-clamping of the aorta [20]. Performing off-pump surgery through a median sternotomy allows complete revascularization in multivessel disease, which is a limiting factor with MIDCAB surgery. Recently, Buffolo and coworkers showed in a retrospective study that CABG without CPB is a safe and cost-effective procedure, with a mortality rate of 2.5% and perioperative myocardial infarction rate of 4.8% [9]. However, to date, there are no data as part of a prospective randomized trial addressing the issue of whether costs can be reduced using an alternative surgical strategy such as off-pump coronary revascularization.

The principal findings of our study follow.

(1) Operative costs are significantly lower in the off-pump group. The stabilizing devices available account for the only source of significant cost, which is offset by the savings from not using the CPB materials. More recently, we have developed a reusable stabilizer autoclavable device, which will allow further significant savings in the off-pump patients.

(2) Bed occupancy and nursing costs account for the largest saving in the off-pump group, predominantly through the reduced ICU and HDU length of stay. Generally, the limitation in the transferral of patients from ICU is time to extubation [21] and inotrope dependency [22], both significantly lower in the off-pump group. Given this fact, a further potential benefit in costs would be the better utilization of ICU bed occupancy with scope for increasing throughout of patients per day.

(3) Blood loss and transfusion requirements were significantly less in the off-pump group, in line with previous reports in the literature. Given that nearly 10% of the 3.2 million annual recipients of red blood cell transfusions in the U.S. are patients undergoing CABG [23], the routine implementation of this surgical technique has significant implications for the reduction in blood product transfusion complications. This includes the reduced risk of transmitting diseases such as acquired immunodeficiency syndrome, and hepatitis B and C [24]. The blood loss in this study, while slightly high, may be attributable to the large proportion of unstable, in-hospital referrals who were still receiving low molecular weight heparin and aspirin at the time of surgery. We do not routinely use an adjunctive therapy, such as tranexamic acid or aprotonin, or routinely use a cell saver system postsurgery. In addition, this on-pump blood loss is in line with other recent reports in the literature [25, 26].

(4) The costs for the management of postoperative complications accounted for directly by the materials used and indirectly by the prolonged bed occupancy were significantly higher in the on-pump group. This is largely borne by the increased use of Swan-Ganz catheters and IABPs in patients where hemodynamic instability or low cardiac output were a concern. While complication rate was not the principal aim of this study, it is both of interest to note and influences cost analysis.

Limitations of this study concern the relatively small number of patients with complications to infer definite benefits of one or the other technique. While complications may also be lower in the off-pump group in the early postoperative period, these would also need to be translated into long-term outcome (ie, the need for reintervention: angiography or reoperation) for the cost reduction to be truly effective. While every attempt has been made to keep this study as accurate as possible, in practice, costs in the operative and postoperative management of patients are generally absorbed across the department, and segregation of costs is occasionally difficult to specify.

In conclusion, this study shows that off-pump coronary revascularization is a safe and effective surgical technique that offers significant overall savings when compared with conventional on pump coronary surgery. Furthermore, these cost reductions are distributed from the operative theater to postoperative management.

	Acknowledgments

 
We thank nurse manager Fiona Thomas, theater manager Susan Hepburn, and principal perfusionist Richard Downes for their contribution to the access of accounting data. This work was supported by the British Heart Foundation and Sir Siegmund Warburg’s Voluntary Settlement.

	References

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