TY - JOUR AU - Smolle-Jüttner, Freyja AB - Abstract Objective: To compare the cost of materials and hospitalization for standard techniques (suturing, stapling and electrocautery) for sealing the lung after pulmonary resection with those for a fleece-bound sealing procedure. Methods: This cost comparison analysis uses as its basis a prospective randomised clinical trial involving 152 patients with pulmonary lobectomy/segmentectomy (standard technique group: 77 patients; fleece-bound sealing group: 75 patients). The cost comparison was performed from the economic perspective of Austrian and German hospitals, taking into consideration the cost of materials for the two alternatives as well as the mean time to hospital discharge. Results: The clinical study found significantly smaller postoperative air leaks in the fleece-bound sealing group. The mean times to chest drain removal and to hospital discharge were also significantly reduced after application of fleece-bound sealing [5.1 vs. 6.3 days (P=0.022) and 6.2 vs. 7.7 days (P=0.01), respectively]. The cost of materials for sealing air leaks amounted to €47 per patient in the standard technique group and €410 per patient in the fleece-bound sealing group. The 1.5-day reduction in the length of hospital stay associated with fleece-bound sealing represents a saving of €462 per patient. Conclusions: There was an overall saving of €99 for the fleece-bound sealing procedure compared to standard techniques for sealing the lung following pulmonary resection. Air leakage, Lung, Fleece-bound sealing, Suture, Staples 1. Introduction Persistent air leakage following lung surgery occurs in 15–25% of patients and may last more than seven days. This is a major limiting factor preventing discharge from hospital due to the need for prolonged chest tube drainage [1,2]. The surgeon may choose from various alternatives – classical suturing, stapling and electrocautery techniques as well as fibrin glue [3–5], synthetic polyethylene glycol-based materials [1,6,7] and collagen patches coated with fibrinogen and thrombin [8] – to seal the leak. Fleece-bound sealing (TachoSil® and its precursor products TachoComb®, TachoComb® H) has been available in Austria and Germany since the early 1990s. TachoSil® consists of a collagen matrix coated with lyophilised fibrinogen and thrombin. When the matrix comes into contact with physiological fluids, a solid, mechanically stable, fibrin clot forms causing adhesion between the collagen patch and the wound surface. Its structure means that the collagen matrix is both air-tight and fluid-tight (Fig. 1 ). Fig. 1. View largeDownload slide Schematic diagram of the composition of TachoSil®. Fig. 1. View largeDownload slide Schematic diagram of the composition of TachoSil®. A recent systematic review article summarised the available evidence for fleece-bound sealing. It analysed 49 publications covering diverse surgical sectors and concluded that, in addition to clinical benefits, fleece-bound sealing also resulted in economic benefits, such as reductions both in the time to hospital discharge and complication rates [9]. Diagnosis-related group (DRG)-based reimbursement of inpatient medical services were introduced in Austria in 1997 and in Germany in 2005. These types of systems provide strong incentives for efficient treatment, since the financial risk of the medical treatment and its outcome lie exclusively with the care provider. From the hospital's perspective, the highest priority today must be to treat patients with minimum resource utilisation while providing optimal therapeutic outcome. The operating room is one of the most cost-intensive facilities in a hospital, but, at the same time, it is also where added value for surgical disciplines must be generated. As a result, surgical departments play a significant role in the cost-effectiveness of a hospital. This implies that those performing surgery bear great responsibility in terms of practicing sparing and sensible use of resources. In this analysis, the extent to which the additional cost of tissue gluing is compensated for by shorter hospitalisation times is considered, using data from a clinical trial that was carried out in 2005 and 2006 at the University Teaching Hospital, Graz, Austria [10]. 2. Materials and methods 2.1. Design of the underlying clinical trial The efficacy of fleece-bound tissue gluing for sealing air leaks after pulmonary resection and primary leakage closure was evaluated in a recent randomised, prospective, open-label, parallel group, single-centre study of 173 patients undergoing lobectomy (n=148) or segmentectomy (n=25) for non-small cell lung cancer with complete mediastinal lymph node dissection. The aim of the study was to compare fleece-bound sealing (Tachosil®, TS) and standard techniques (ST – defined as suture with or without staples) for closure of alveolar air leaks following parenchymal resection. The trial evaluated whether the time to chest drain removal and duration of hospitalisation were influenced by type of treatment in patients with proven intraoperative air leakage. Air leakage was quantified by means of air-flowmetry. Full details of the conduct and outcome of the trial can be found in the paper by Anegg et al. [10]. In the TS group, 9.5×4.8 cm fleeces were applied to close the leakages. If several fleeces were required, they were overlapped by at least 1 cm. In the ST group, pledget-reinforced PDS 4.0 sutures with absorbable patches or staples were used depending on the degree of air leakage. When leakage occurred adjacent to the lobar margin, stapling devices provided satisfactory tissue closure. Additionally, electrocautery was applied at the outer edges of the site of the leak in order to thermally shrink the treated area. All patients received two drainage tubes connected to a Buelau drainage system. The first chest drain tube was removed when there was no clinical evidence of air leakage and a routine chest X-ray showed no major pneumothorax. Removal of the second chest tube was scheduled when the leakage volume was <20 ml/min and the drainage quantity <200 ml/24 h. The primary efficacy endpoints of the study were postoperative quantification of air leakage on days 1 and 2 after surgery. Secondary efficacy parameters were mean time to chest drain removal and mean time to hospital discharge. 2.2. Unit cost calculation The costs of applying each technique were calculated based on the prices quoted by the University Teaching Hospital, Graz, which was the trial centre (prices as of November 2006). All price data included VAT at the Austrian rate (20%). Disposable linear staplers are used at the Graz University Teaching Hospital; hence the costs for these instruments were included in the calculation if appropriate. Table 1 shows all the prices used in the calculations. Table 1 Unit costs Resource  Costs/unit    (€ incl. 20% VAT)  Prolene® 4.0 fixation suture    6.00  Linear cutter/stapler with one magazine  194.00  Additional magazine stapler (reloadable)   14.50  TachoSil® patch (9.5×4.8 cm)  270.00  Hospital stay (per night)  300.00  Resource  Costs/unit    (€ incl. 20% VAT)  Prolene® 4.0 fixation suture    6.00  Linear cutter/stapler with one magazine  194.00  Additional magazine stapler (reloadable)   14.50  TachoSil® patch (9.5×4.8 cm)  270.00  Hospital stay (per night)  300.00  View Large The cost allocation for the hospital stay, expressed as a mean value for one average day in hospital, can only be an approximation, since, from the perspective of the hospital, the actual cost depends on many factors. These include hospital-specific factors (e.g. personnel costs, energy costs) and indication-related factors (e.g. nursing care required, mobility, etc.). According to the Austrian Federal Ministry for Health and Women, the average cost per day in hospital in 2003 was €439 [11,12]. The German Statistical Federal Agency reports that the cost for one average day in hospital in 2004 was €384 [13]. Since these average costs include the cost of interventions, they represent an overestimation of the actual cost of occupying a hospital bed for one day. However, the patients in this clinical study required Buelau drainage during their stay, which is resource-intensive. A value of €300 per day was assumed to be a reasonable estimate for the present calculation. The costs of a single day in hospital were calculated in a sensitivity analysis in which the two alternatives involved identical resource consumptions. The reimbursement for lung surgery provided by statutory health insurance for cancer patients in Germany varies between approx. €5800 (smaller segmentectomy, e.g. DRG code E06B, relative weight 2.01, base rate €2900) and €12,200 (extended bilateral lobectomy, e.g. DRG code E01A, relative weight 4.21, base rate €2900), depending on the extent of resection and the severity of disease. 2.3. Comparing costs Cost savings were calculated from the perspective of the hospital. All the cost and benefit components were assessed in monetary units [14,15]. A formal calculation was made of the average cost of materials minus the estimated average cost of the hospital stay to arrive at an estimation of the overall cost differences for the alternative treatments [16]. The raw data from the underlying clinical study were utilised in the cost-benefit analysis. Only those cost factors that distinguished the two alternatives after randomisation (i.e. those exclusively reserved for the treatment of air leakage) were considered. This refers to the consumption of TachoSil® fleeces in the TS group and to the consumption of sutures and staplers in the ST group. The cost of electrodes for electrocautery were not included in the analysis, as it was assumed that this was part of the usual surgical procedure and thus did not represent any additional resource consumption for the closure of pulmonary leakages. Costs related to the need to establish access to the target site or to the closure of the thorax were not considered in the calculations, since these are not directly connected with the leakage closure technique itself and can be considered to be identical for the two alternatives. 2.4. Statistics Only descriptive statistical methods were employed to analyse the data included in the cost analysis. The statistical method used for the underlying clinical trial was the t-test for independent samples. A P-value of <0.05 was considered significant. 3. Results 3.1. Clinical results Continuous measurements of the volume of air leaking from the lung were carried out intraoperatively and on days 1 and 2 following surgery for all 152 patients. The baseline characteristics and surgical variables of the patients in both the groups were comparable [10]. The findings of the clinical study are summarised in Table 2 . At all measurement times, the fleece-bound sealing technique was found to be superior to the standard technique. The rate of complications, such as postoperative pneumonia, postoperative haemorrhage and infection, was similar in the two groups [10]. No significant differences were found between the two groups. Table 2 Mean values for air leakage and hospital stay in patients after lung surgery according to Anegg et al. [10] Parameter  TachoSil®  Standard  P-value    (TS) (n=75)  (ST) (n=77)    Intraoperative air leakage (ml/min)  153.3  251.0  0.009  Air leakage after day 1 (ml/min)   43.6   86.1  0.004  Air leakage after day 2 (ml/min)   20.1   42.5  0.023  Time to chest drain removal (d)    5.1    6.3  0.022  Length of stay in-hospital (d)    6.2    7.7  0.010  Parameter  TachoSil®  Standard  P-value    (TS) (n=75)  (ST) (n=77)    Intraoperative air leakage (ml/min)  153.3  251.0  0.009  Air leakage after day 1 (ml/min)   43.6   86.1  0.004  Air leakage after day 2 (ml/min)   20.1   42.5  0.023  Time to chest drain removal (d)    5.1    6.3  0.022  Length of stay in-hospital (d)    6.2    7.7  0.010  View Large 3.2. Resource consumption A comparison of the cost of materials for costs of the two alternative surgical techniques shows that fleece-bound sealing with TachoSil® is more costly than the conventional standard techniques (suturing, stapling). On average, 1.52 fleeces were required in the TS group, representing an average cost of €410.40 per patient. In the ST group, 2.6 units of suture material were used on average. In addition, stapling was used in 12 of the 77 patients. One magazine of staples sufficed in nine cases, while the stapler had to be reloaded in three cases. The mean cost of the suture material was €15.82, with additional average costs of €30.80 per patient for stapling. The average total cost of materials for the ST group was €46.62. The difference in average cost of materials between the TS and ST groups is therefore €363.78. The results are presented in Table 3 . Table 3 Resource consumption for leakage closure Parameter  Tachosil® (TS)   Standard (ST)     Units  Costs (€)  Units  Costs (€)  Mean  1.520  410.40  Suture: 2.64   46.62        Stapler: 0.20    S.D.  0.601  162.24  Suture: 1.11   72.58        Stapler: 0.49    Median  1  270.00  Suture: 3   18.00        Stapler: 0    Min  1  270.00  Suture: 1    6.00        Stapler: 0    Max  3  810.00  Suture: 5  226.50        Stapler: 2    Parameter  Tachosil® (TS)   Standard (ST)     Units  Costs (€)  Units  Costs (€)  Mean  1.520  410.40  Suture: 2.64   46.62        Stapler: 0.20    S.D.  0.601  162.24  Suture: 1.11   72.58        Stapler: 0.49    Median  1  270.00  Suture: 3   18.00        Stapler: 0    Min  1  270.00  Suture: 1    6.00        Stapler: 0    Max  3  810.00  Suture: 5  226.50        Stapler: 2    View Large 3.3. Cost of hospitalization The mean times to chest drain removal and hospital discharge are shown in Table 2. The duration of hospitalisation served as the benefit parameter for the calculations. The mean difference in the duration of hospitalization between the TS and ST groups was 1.54 days (95% CI: 0.37–2.71 days). Assuming that the cost of one day in hospital is €300, this represents a monetary equivalent of €462 (95% CI: €112–812) in favour of fleece-bound sealing with TachoSil®. 3.4. Costs vs. benefits When the excess cost of materials (€368.72) for the TS group is set against the economic benefit of a shorter hospital stay (€462), an overall cost reduction of €98 in favour of fleece-bound sealing is found. Fig. 2 presents the relationship between the results of the cost–benefit calculation and the assumed cost per day in hospital. It also presents the data for the cost reduction arising through the reduction in hospital stay based on 95% confidence limits (lower limit 0.37 days, upper limit 2.71 days). Fig. 2. View largeDownload slide Sensitivity analysis of hospital day unit costs. Fig. 2. View largeDownload slide Sensitivity analysis of hospital day unit costs. Note that if it is assumed that a day in hospital costs €236, the present model shows parity for the two alternatives (intersection to x-axis). Also, if the cost per day in hospital is assumed to be €300 but the reduction in the length of hospitalisation is 1.21 days, the cost of the two alternatives is again equal. The trend is, therefore, in favour of fleece-bound sealing; however, because the range of confidence limits is wide, it cannot be concluded that fleece-bound sealing is economically superior over the whole confidence interval. 4. Discussion Postoperative air leakage is a common problem following lung resection. Standard techniques do not result in adequate sealing in the majority of patients. As a result, these patients require prolonged chest tube drainage time, increasing the risk of contracting pleural infections, pulmonary embolism, respiratory distress and associated pain. Persistent air leakage is the most common reason for prolonged hospital stays. Significant reductions in the volume of air leakage in the early postoperative period with concomitant early chest drain removal and reduced time to hospital discharge after using the fleece-bound sealing technique were demonstrated for this selected population of patients with established intraoperative air leakage. This analysis compares the costs and benefits of fleece-bound sealing from the perspective of a hospital operating within a DRG-based reimbursement system. The additional costs of €364 associated with fleece-bound sealing compared with suturing and stapling are more than compensated for by the shortened (by 1.54 days) hospital stay. Assuming that the average cost of treating and caring for a patient for a day in hospital is €300, fleece-bound sealing offers a potential cost saving of €98. However, the study was not powered to detect differences in economic terms, and the wide confidence limits for the economic analysis do not allow for the conclusion that fleece-bound sealing is economically superior to standard care over the whole confidence interval. Lang and colleagues conducted a similar study [8]. They also found that fleece-bound sealing reduced the number and frequency of persistent leakages. Prophylactic application of fleece-bound sealing in patients in whom a sufficient closure had already been achieved intraoperatively with standard techniques did not offer any advantages. The duration of hospitalisation was not examined for these patients, nor was an economic evaluation conducted. In 1996, Carbon and co-workers demonstrated the possibility of reducing the length of stay in hospital by applying fleece-bound sealing to close pulmonary air leaks. These authors reported a reduction in the drain dwell time from several weeks to a few days in the minimally invasive treatment of pneumothorax in children with cystic fibrosis or Marfan's syndrome [17]. Fleece-bound sealing also shortened the drain dwell time in pneumothorax, chylothorax and splenic rupture in children [18], and for sealing mediastinal lymph node dissection in patients with non-small cell lung carcinoma (stage I and II). Reductions in both drain dwell time and drainage volume associated with fleece-bound sealing after lobectomy have also been reported [19]. To our knowledge, a reduction in the length of hospital stay after fleece-bound sealing has not so far been demonstrated in a clinical trial setting. 4.1. Limitations One limitation of this analysis is that although the reduction in length of hospital stay in the underlying study is significant, the results exhibit a relatively wide range for the confidence limits. Fig. 2 demonstrates that the reduction in the time in hospital cannot lead to a savings potential with TachoSil® over the entire 95% confidence limit range. Moreover, the estimation of the average cost for one day in hospital has a large margin of fluctuation depending on various factors that are specific to the hospital and therapeutic indication. It appears to be an unquestionable fact that the present results demonstrate a reduction of one day of Buelau drainage, thus saving one day of above-average costs for care and monitoring. Only a portion of the relevant economic aspects pertaining to the fleece-bound sealing procedure can be highlighted here. Of particular note, however, is the avoidance of postoperative complications associated with fleece-bound sealing, for which evidence is also provided in the literature [20,21]. Furthermore, reduced duration of surgery when fleece-bound sealing is used has also been confirmed in clinical trials [22,23]. Kallinowski et al. evaluated the benefit of fleece-bound sealing with TachoSil® in an open observational study. In terms of avoiding hospital resource consumption, the cost analysis showed a distinct potential for savings in favour of TachoSil® application. The greatest contributing factor was the saving in time spent in the operating room [24]. Similar conclusions were drawn in a recent study with a similar design [25]. These factors cannot be analysed in the present study, but an even greater savings potential is ultimately indicated. 4.2. Summary and conclusions In summary, the present evaluation demonstrates that using TachoSil® to close air leakages after lobectomy is worthwhile not only from a clinical viewpoint, but also from the hospital's economic perspective. In most cases, a reduction in the length of hospital stay will in itself justify the additional cost associated with fleece-bound sealing in this indication. This is particularly interesting when hospital medical services are reimbursed through DRG systems, as is the case in Austria and Germany. More rapid mobilisation and reduction in postoperative morbidity due to infection, pulmonary embolism, respiratory distress and pain associated with thoracic drainage enhance the economic benefits, although these factors could not be evaluated in this analysis. ☆ Presented at the 15th European Conference on General Thoracic Surgery, Leuven, Belgium, June 3–6, 2007. 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Molins (Barcelona, Spain): Thank you very much for your presentation. We have also used this product and it really works. But were the indications you announced in every single case, or just in those where the bubbles are great. Because there are other factors that can prolong the lung and the patient can go home with… What would be the real indication for you to use this product? Dr. U.C. Anegg: As I showed, the indication was grade I and grade II air leakage which we treated conventionally and on the other hand using Tachosil. Grade III was operated by conventional methods. Grade I and II were the target population for it. Dr. P. Goldstraw (London, UK): The grade III that you treated and thereby down-staged the air leak might have a different natural history to the grade I and II. Did you stratify for those? Dr. U.C. Anegg: Yes, these were bronchials, more than 1 mm mostly. Dr. P. Goldstraw: When you down-staged them and put them into another category of air leak prior to randomisation did you stratify separately for them, because they may have a different outcome. Do you know how many fell into this group? Dr. U.C. Anegg: We just treated them by suturing, re-measured them by lung submersion test and operated them to I or II and moved them into randomisation. Dr. P. Goldstraw: Did you see any long-term morbidity either for persistent air leak in the control group or in the use of the Tachosil in your treatment group? Dr. U.C. Anegg: Although this was no endpoint target parameter I don't remember any significant difference of both groups in terms of post-morbidity. Published by European Association for Cardio-Thoracic Surgery. All rights reserved. TI - Do the benefits of shorter hospital stay associated with the use of fleece-bound sealing outweigh the cost of the materials? JF - Interactive CardioVascular and Thoracic Surgery DO - 10.1510/icvts.2007.162677 DA - 2008-04-01 UR - https://www.deepdyve.com/lp/oxford-university-press/do-the-benefits-of-shorter-hospital-stay-associated-with-the-use-of-rToGeKw9tL SP - 292 EP - 296 VL - 7 IS - 2 DP - DeepDyve ER -