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Ann Thorac Surg 2001;71:319-323
© 2001 The Society of Thoracic Surgeons
a Section of General Thoracic Surgery, Emory University, Atlanta, Georgia, USA
b Division of General Thoracic Surgery, Allegheny General Hospital, Pittsburgh, Pennsylvania, USA
Address reprint requests to Dr Miller, Section of General Thoracic Surgery, Emory University, 1365 Clifton Rd, NE/Building A, Atlanta, GA 30322
Presented at the Forty-sixth Annual Meeting of the Southern Thoracic Surgical Association, San Juan, Puerto Rico, Nov 46, 1999.
| Abstract |
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Methods. This was a multicenter trial consisting of 80 patients undergoing pulmonary resection, randomly assigned to the control group (40 patients) or treatment group (40 patients). The treatment group had reinforcement with bovine pericardium.
Results. No statistical differences were noted in the mean intensive care unit length of stay (p = 0.9), number of days with a chest tube (p = 0.6), or total length of stay (p = 0.24). Increased air leak duration was associated with assignment to the control group (r = 0.27, p = 0.02). The mean duration of air leak was 2 days and the mean time to chest tube removal was 5.9 days in patients with a buttressed staple line compared to 3 days and 6.3 days, respectively, for patients with nonbuttressed staple lines.
Conclusions. Within the data of this study, no statistical differences were noted between buttressed and nonbuttressed patients. However, the trend toward shortened air leak time and tube removal time was apparent in the buttressed group. With greater number of patients studied, it is likely that the cost of bovine pericardium would be justified by shorter air leak duration and hospitalization.
| Introduction |
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| Material and methods |
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After it was determined that a patient met inclusion criteria, the study was explained to the patient and informed consent was obtained. The morning of operation, the patient was randomly assigned, using a random numbers table, to either the control group (staples only) or the treatment group (buttressed staple line). Preoperative data were collected on all patients, including institution where the operation was done, gender, age, basic laboratory data (hemoglobin, hematocrit, serum creatinine, and albumin), pulmonary function tests, smoking history, and preoperative radiation or chemotherapy.
All patients underwent appropriate anatomic and physiologic screening with chest roentgenograms, computerized tomography of the chest and abdomen, pulmonary function studies (Including an arterial blood gas), split ventilation/perfusion lung scan when indicated, cardiac evaluation when warranted, and other scans as indicated by individual patient history and physical examination.
Procedure
Each thoracic procedure was completed under the supervision of the two senior participating surgeons with residents or physician assistants for all cases. Each patient was done by median sternotomy, with a double lumen endotracheal tube anesthesia, arterial and central venous pressure lines. For those patients randomized to the treatment group, bovine pericardial strips (Peristrips, Bio-Vascular, Inc, Minneapolis, MN) were applied with a gastrointestinal GIA-75-mm stapler to totally free the fissures. All efforts were made by each surgeon to see that all air leaks were optimally treated before closure of the chest. Postoperative care was standardized at each facility with suction maintained until all air leaks stopped and then the chest tubes were removed sequentially. Every attempt was made to discharge the patient on the day following chest tube removal; however, frequently an extra day in the hospital was required for pain control.
Data collection
Postoperative outcome variables included: postoperative laboratory values, transfusion requirements, duration of air leak, number of days with a chest tube, intensive care unit length of stay, total hospital length of stay, hospital charges, morbidity, and mortality. The frequency, mean, and standard deviation were calculated for the dependent variables. The Students t test was used for two group comparisons with continuous variables.
2 Analysis was used for comparisons between categorical variables. Pearson correlation was used to assess relationships between continuous variables. An
level of 0.05 determined significance.
| Results |
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There were no differences noted in preoperative characteristics, laboratory values, pulmonary function tests, or demographic variables. The mean age for the control group was 62 years (45% women, 55% men) and 66 years for the treatment group (40% women, 60% men). Sixty- five patients underwent lobectomy and 15 had a segmentectomy. The mean forced expiratory volume in 1 second (in liters per minute) for the control group was 1.93 ± 0.79 L and the mean for the treatment group was 1.88 ± 0.612 L. The mean resident volume (RV) for the control group was 2.68 ± 0.85 L and the mean for the treatment group was 2.91 ± 1.38 L. The mean number of bovine pericardial strips used was 4.5 (range, 3 to 6).
The following differences between the two groups were noted (Table 1). Intensive care unit length of stay did not differ between groups (1.5 days in the control group and 1.6 days in the treatment group.) Total length of stay was not statistically different between groups. However, those patients in the control group had a mean total length of stay of 9 days, whereas those who had their staple buttressed stayed an average of 8 days in the hospital. Likewise, air leak duration and the number days with a chest tube did not statistically differ between groups. However, those in the control group had a mean air leak duration of 3 days compared with 2 days for those patients receiving bovine pericardial strips. The mean time to chest tube removal was 5.9 days for those patients receiving pericardial strips compared to 6.3 days for those in the control group.
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Hospital charges were calculated for both groups: Number 20: 10 patients in the treatment group and 10 patients in the control group. These patients were randomly selected. Financial data were available from only one institution (Emory University). There was no statistical difference in the control group versus the treatment group. Both groups are statistically similar. It was difficult to obtain financial data from the respective institutions and only a breakdown of charges and total patient bill charges were available. Patient charges for treatment and control groups were obtained as the institution would allow. Although there was no statistical difference noted between groups (p = 0.18), there was a 17% reduction in total hospital charges for those patients with a buttressed staple line compared with the control group. In looking at lobectomy versus segmentectomy, however, duration of air leaks, number of intensive car unit days, and total length of stay was greater in the lobectomy group (Tables 2 and 3).
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| Comment |
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The definition of a prolonged air leak (PAL) has been arbitrarily defined as the presence of an air leak for 5 to 14 days. However, the majority of reports in the past 5 years have defined a persistent PAL as a complication when persisting for more than 7 days. For the purpose of this study, a PAL is defined as a leak that persists postoperatively following a pulmonary resection for more than 7 days. PAL has been reported in 1% to 15% of patients undergoing resection of pulmonary parenchymal disease and in up to 50% of those undergoing lung volume reduction. Fossberg [1] stated that the significance of PAL is not in its duration but its impact on outcomes and resource utilization. When an air leak affects these factors, it is morbid irrespective of its definition. Thus, control of a PAL is important in hospital cost containment and length of stay.
A number of investigators have reported the incidence of a PAL after pulmonary resections (Table 4). Rice and Kirby [2] reported that 30 to 197 patients (15.2%) had a PAL for more than 7 days, but it persisted for more than 14 days in only 3 patients (1.5%). Deslauriers and colleagues [3] documented that in a series of 674 lobectomies or lesser resections, the incidence of PAL was 4%. Nagasaki and associates [4] reported a PAL (7 to 20 days) occurring in 10 of 971 pulmonary resections (<1%). Keagy and colleagues [5] in a review of 369 lobectomies reported 16 (4.3%) PAL. Venuta and associates [6] described a PAL in 3% to 4% of patients undergoing lobectomy.
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In preoperative assessment, the lung volume reduction era has helped to define the patient at increased risk for a PAL. Patients with reduced forced expiratory volume in 1 second (<50% of predicted), decreased diffusion capacity (<50% of predicted), and computerized tomography scans showing bleb disease or diffuse generalized emphysema all have a significant potential for a PAL.
The prevention of air leak control is the responsibility of the surgeon in charge and depends on his or her knowledge and experience. Intraoperative prevention of air leaks requires meticulous surgical technique, complete reexpansion of the remaining lung, and if a remaining space exists, knowledge of ways to reduce that space. Most important is to be aware of the potential problem and the potential solutions. Intraoperative techniques that can be used to decrease postoperative air leaks include: simple clamp and tie, utilization of buttressed Teflon felt, mechanical staplers, synthetic buttressing with bovine pericardium or Gore-Tex (W. L. Gore & Associates, Flagstaff, AZ), biological glues, and synthetic sealers. Intraoperative technical maneuvers that can be used to decrease residual postoperative spaces and consequently decrease postoperative air leaks include pleural tent, pneumoperitoneum, phrenic nerve crush (only with optimum pulmonary function tests), Lyman Brewer maneuver, muscle flap transfer, modified thoracoplasty, diaphragm repositioning and correct position, and number of chest tubes.
The main prevention of PAL is intraoperative recognition and management. However, despite all attempts of the surgeon to maximize control of air leaks, some will persist postoperatively. When air leaks persist postoperatively, the surgeon should be aware of a number of factors. These include patience, consideration of suction or no suction, the need for additional chest tubes, knowledge of "intricacies of chest tube management," Heimlich valve, and the possible need for reoperation.
We have noted three historical advancements that have essentially eliminated all PALs more than 4 days. First, Dr Jean Deslauriers pointed out the utilization of pleural tents and pneumoperitoneum in reduction of the postoperative pleural space. Second, Dr Joel Cooper brought to the forefront the need for "no suction on chest tubes" in patients with severe lung disease. In the era of John Alexander, chest tube suction was seldom used. Doctor Osler Abbott of Emory University stressed no suction. It was not until the 1960s and 1970s that suction was considered mandatory. Doctor Cooper brought us back to the realization that suction was not mandatory. In an institutional experience (Emory University Medical Center) with more than 100 patients with pneumothoraces, secondary to human immunodeficiency virus disease (mainly 1984 to 1994), has shown the effectiveness of Heimlich valves in the management and control of PALs. When no space exist, there is essentially no PAL that a Heimlich valve cannot control.
Doctor Joel Cooper first reported the utilization of bovine pericardium in air leak control [7]. Subsequently, a number of researchers have shown the effectiveness of bovine pericardium in air leak control and subsequently, the decrease and duration of air leak and length of stay [68].
The present study was undertaken in an attempt to show that appropriate use of bovine pericardium in patients undergoing lobectomy or segmentectomy could reduce duration of air leak, length of stay, and, subsequently, cost. The clinical results indicate the duration of air leak and length of stay can be decreased with appropriate use of bovine pericardium in the stapling of fissures in patients that can be expected to have increase PALs. The present study shows that not only is the duration of air leak and, consequently, length of stay decreased, but the total hospital charges are decreased. Institutional data at one medical center showed that the cost of a single firing of bovine pericardium was $135 with the average number of firings per case being three. The cost of bovine pericardium for five firings was $400. The length of stay was 1.4 days less in the buttressed group. Hence, it is easily shown that the cost of bovine pericardium is justified in duration of air leak, length of stay, and, subsequently, cost reduction. This is in contrast of the study of Hazelrig and colleagues [9] who reported that duration of air leak was decreased but difference in charges between buttressed and nonbuttressed patients was not significant.
In 1997, Wright and associates presented an article "Pulmonary Lobectomy Patient Care Pathway" [10]. They compared data between 1995 and 1996 for total cost of lobectomy at the Massachusetts General Hospital. Mean cost in 1995 was $16,063 versus 1996 mean cost was $14,792. The mean length of stay was 7 days in 1996 and 6 days in 1996. They attributed this decreased cost savings to three factors. First, same-day admissions policy effective in 1996; second, early discontinuation of epidural analgesia, 1 day before chest tube removal; and, third, availability by 7 AM of all morning chest roentgenograms reviewed so that appropriate decisions regarding chest tube management could be made.
In our study, it was shown that duration of air leak and total length of stay were decreased each by 1 day in the treatment group. Total charges (n = 20) in the control group versus treatment group was $28,678 to $23,910.
The increase in charges in the control group compared with the treatment group can be explained by four factors: (1) slight increase in the operating room time of the control group; (2) increased total length of stay; (3) increased air leak duration; and (4) number of days with a chest tube. These four factors help to explain the discrepancies between the two groups.
It is apparent to the senior authors (J.I.M., R.J.L.) that the second most common cause of prolonged hospitalization is pain management. In the past, it was our practice to leave the epidural catheter in until all chest tubes were removed. In general, this required 1 extra day of hospitalization for the patient to adjust to the shock of coming off epidural analgesia and converting to oral pain medication. We have now started to discontinue epidural catheters 1 day before chest tube removal to alleviate that extra day in the hospital and, subsequently, decrease hospital cost.
It is our conclusion that within the parameters of this study, no statistical differences were noted between buttressed and nonbuttressed patients. However, the trend between shortened air leak time and tube removal time was apparent in the buttressed group. With a greater number of patients studied, it is likely that cost of bovine pericardium would be justified by shorter air leak duration and hospitalization.
| Footnotes |
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| Discussion |
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DR MILLER: The difference is in the length of stay in the hospital of about 1.4 days. The room cost is about $820. It is about $2,000 a day, $2,000 plus, to be in the hospital at Emory on the floor, I mean, considering medication charges and everything else, and this was all charges taken directly from the patients bill and from which all data were gathered. It was about 1.4 days longer, and I know that actually it would be $4,000 if you take all costs, and this included medication and all parameters.
DR KEVIN D. ACCOLA (Orlando, FL): Doctor Miller, I enjoyed your paper and as always well thought out conclusions. I would like to ask about the utilization of biologic sealants in addition to the pericardial strips. We have been using the biologic sealants with a clinically significant decrease in leaks. It would be interesting to determine whether you have used it on those individuals with both techniques, the biologic glue and the pericardial strips, versus just the biologic strips, and whether there was any significant difference in your results.
DR MILLER: In this study, no, we did not use any sealants. We have used sealants in lung volume reduction, but we did not in this particular study.
DR ALVAN W. ATKINSON (Raleigh, NC): One factor that you did not look at in this study that has just impressed me in the past couple of years of making rounds on a lot of my partners patients is whether the patient is eating or not. Obviously these things stop because the lung heals and fibrous tissue forms over the leak, but as soon as the patients start to eat, within a day or two, the air leaks, in my experience, generally stop if they are relatively small, and I wonder if we started looking at the nutritional status of some of these patients before they came into the hospital. Also if control of postop hyperalimentary would improve nutrition.
DR MILLER: I do not know. They were all pain patients; none of them were emaciated. The other thing that I did not mention is the second major factor is pain control, and we standardized this. We did not remove the epidural until the chest tubes were out. That is a mistake. We need to remove the epidural before that, because we can save a day in the hospital by getting the epidural out.
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