Considering Costs of Complications in Bariatric Surgery for the Evaluation of New Technologies based on the Example of Surgical Robotics

  

    
Cost in USD
    
Medical personnel
    
Hotel
    
Laboratory
    
Material
    
Drugs
  
  

    
No complication
    

    

    

    

    

  
  

    
Mean
    
1862
    
541
    
606
    
180
    
154
  
  

    
Stdev.
    
679
    
283
    
519
    
193
    
289
  
  

    
Clavien I
    

    

    

    

    

  
  

    
Mean
    
1894
    
597
    
819
    
201
    
204
  
  

    
Stdev.
    
456
    
222
    
614
    
242
    
325
  
  

    
Clavien II
    

    

    

    

    

  
  

    
Mean
    
2114
    
923
    
1308
    
155
    
106
  
  

    
Stdev.
    
422
    
207
    
774
    
122
    
69
  
  

    
Clavien III
    

    

    

    

    

  
  

    
Mean
    
4292
    
2002
    
2599
    
337
    
3768
  
  

    
Stdev.
    
2511
    
1492
    
1553
    
742
    
6898
  
  

    
One-way ANOVA
    
F(3,191)=28.8, p<0.001
    
F(3,191)=40.2, p<0.001
    
F(3,191)=34.1, p<0.001
    
F(3,191)=1.3, p=0.281
    
F(3,191)=17.5, p<0.001
  
  

    
Tukey HSD post-hoc test
    
Group 1 vs Group 2: Diff=32.0000, 95% CI=-352.1762 to 416.1762, p=0.9964
    
Group 1 vs Group 2: Diff=56.0000, 95% CI=-140.6837 to 252.6837, p=0.8817
    
Group 1 vs Group 2: Diff=213.0000, 95% CI=-81.0808 to 507.0808, p=0.2414
    
Group 1 vs Group 2: Diff=21.0000, 95% CI=-98.3905 to 140.3905, p=0.9684
    
Group 1 vs Group 2: Diff=50.0000, 95% CI=-683.7970 to 783.7970, p=0.9979
  
  

    
Group 1 vs Group 3: Diff=252.0000, 95% CI=-655.8492 to 1159.8492,    p=0.8893
    
Group 1 vs Group 3: Diff=382.0000, 95% CI=-82.7844 to 846.7844, p=0.1474
    
Group 1 vs Group 3: Diff=702.0000, 95% CI=7.0558 to 1396.9442, p=0.0467
    
Group 1 vs Group 3: Diff=-25.0000, 95% CI=-307.1324 to 257.1324,    p=0.9957
    
Group 1 vs Group 3: Diff=-48.0000, 95% CI=-1782.0399 to 1686.0399,    p=1.0000
  
  

    
Group 1 vs Group 4: Diff=2430.0000, 95% CI=1747.8067 to 3112.1933,    p=0.0000
    
Group 1 vs Group 4: Diff=1461.0000, 95% CI=1111.7429 to 1810.2571,    p=0.0000
    
Group 1 vs Group 4: Diff=1993.0000, 95% CI=1470.7918 to 2515.2082,    p=0.0000
    
Group 1 vs Group 4: Diff=157.0000, 95% CI=-55.0053 to 369.0053, p=0.2235
    
Group 1 vs Group 4: Diff=3614.0000, 95% CI=2310.9746 to 4917.0254,    p=0.0000
  
  

    
Group 2 vs Group 3: Diff=220.0000, 95% CI=-729.8061 to 1169.8061,    p=0.9319
    
Group 2 vs Group 3: Diff=326.0000, 95% CI=-160.2647 to 812.2647,    p=0.3073
    
Group 2 vs Group 3: Diff=489.0000, 95% CI=-238.0615 to 1216.0615,    p=0.3045
    
Group 2 vs Group 3: Diff=-46.0000, 95% CI=-341.1714 to 249.1714, p=0.9777
    
Group 2 vs Group 3: Diff=-98.0000, 95% CI=-1912.1799 to 1716.1799,    p=0.9990
  
  

    
Group 2 vs Group 4: Diff=2398.0000, 95% CI=1660.8913 to 3135.1087,    p=0.0000
    
Group 2 vs Group 4: Diff=1405.0000, 95% CI=1027.6283 to 1782.3717,    p=0.0000
    
Group 2 vs Group 4: Diff=1780.0000, 95% CI=1215.7549 to 2344.2451,    p=0.0000
    
Group 2 vs Group 4: Diff=136.0000, 95% CI=-93.0714 to 365.0714, p=0.4166
    
Group 2 vs Group 4: Diff=3564.0000, 95% CI=2156.0833 to 4971.9167,    p=0.0000
  
  

    
Group 3 vs Group 4: Diff=2178.0000, 95% CI=1073.4965 to 3282.5035,    p=0.0000
    
Group 3 vs Group 4: Diff=1079.0000, 95% CI=513.5361 to 1644.4639,    p=0.0000
    
Group 3 vs Group 4: Diff=1291.0000, 95% CI=445.5200 to 2136.4800,    p=0.0006
    
Group 3 vs Group 4: Diff=182.0000, 95% CI=-161.2468 to 525.2468,    p=0.5172
    
Group 3 vs Group 4: Diff=3662.0000, 95% CI=1552.3399 to 5771.6601,    p=0.0001
  

Table 4: Itemized costs stratified by Clavien-Dindo classification: Medical Personnel, Hotel, Laboratory, Material, Drugs.

Discussion

To our knowledge, this is the first attempt to systematically evaluate the specific cost of complications in bariatric surgery. While it appears logical that more significant complications generate higher perioperative treatment costs, more detailed insights are essential to allow more precise economic modeling when evaluating the financial impact of postoperative complications. A detailed cost data of complications may also offer insights into the source of expenses when perioperative complications occur. In addition, if the structure of the cost data is well understood in the clinical context, it may be used as a tool to minimize the financial impact of complications.

Our data show the baseline cost outcomes of patients without complications, which are in line with previous publications from our group [5,8]. Interesting observations can be found when closely evaluating the itemized costs as outlined in Table 3: operating room and anesthesia costs are similar for patients with and without a Clavien I complication, but this post is slightly higher for patients with a Clavien II and significantly higher for Clavien III complication. It appears logical that a Clavien III complication incurs higher costs for the operating room on average because, as per its definition, this class of complication requires a re-intervention. However, this should not be the case for patients suffering from a Clavien II complication. While not statistically significant – also due to the relatively small cohort of patients with a Clavien II complication - we found higher OR costs for patients with a Clavien II complication when compared to patients with or without a Clavien I complication. In this cohort, the cost increases most likely stem from the initial surgery as no reintervention was conducted. This can be caused either by a prolonged procedure or by higher usage of instruments during the initial surgery. It seems reasonable to assume that a deviation from the standard surgical path (standard length case and/or standard set of instruments) might put the patients at a higher risk of perioperative complications. Still, this dataset does not allow the exact identification of cost drivers in each itemized segment and this comparison is not adequately powered. As such, there might also be a bias since longer procedures can be more complex in patients with high BMIs and other conditions that may lead to longer OR times or higher risk of postoperative complications. It would be interesting to explore further if cost-driving events in the OR can be used as predictors for perioperative complications and as such, if warning systems could be developed depending on the course of the surgical procedures. However, this dataset is not sufficiently deep for such analyses.

A closer look at the itemized costs of the patients with a Clavien I complication show comparable costs to the cohort without complications. However, we found an increase - although not statistically significant - in imaging and laboratory costs. This observation seems reasonable in the clinical context as a Clavien I complication is a deviation from the standard clinical path not requiring specific treatment. As a matter of fact, most of these patients did not have a real medical problem, bur received additional imaging or laboratory work prescribed by an inexperienced resident. As a teaching institution, residents are primarily responsible for the postoperative patients at night and over weekends and have the freedom to order these tests. Under these circumstances, we often observe a rather generous use sometimes without clear medical indication. However, as per definition these patients need to be classified as a Clavien I and it easily explains increased costs for imaging and laboratory. Another logical observation is the absence of intensive care unit costs for patients with or without a Clavien I and Clavien II complication, but the presence of intensive care unit costs when a re-intervention is needed. All the above mentioned clinically relevant consistencies suggest that this set of cost data is robust and can be used as a solid baseline for economic modeling.

Overall, Clavien I complications within the 18 days of robotic bariatric surgery seem to incur a moderate cost increase of about 3.6%, but the further increase of about 36% and 164% for Clavien II and III complications are rather exponential. It appears evident that any complication requiring treatment is not only devastating for the patient, but also an economic challenge to the healthcare system. As such, there is room for investments to avoid complications and from an economic perspective. As this is a first dataset quantifying the economic impact of complications in bariatric surgery, it can be used as a guide to show the extent of upfront investments that can be afforded to improve outcomes. While these investments might include a wide range of measures including surgeon training, patient preparation, and others, we want to focus on the investment in new surgical technologies. Albeit the absence of high quality and high level of evidence supporting robotics for a widespread application in bariatric surgery, this technology finds an increasing adoption, also driven by the desire to reduce perioperative complications of bariatric surgery. As an example, a few groups have published the positive impact of surgical robotics for gastric bypass surgery regarding procedure times per BMI and a reduction in severe complications such as intestinal leaks [8,14-16]. One study showed a cost reduction with a robotic approach versus laparoscopy for gastric bypass surgery due to a reduction in complications and the use of fewer surgical staplers [8]. This dataset shows that a Clavien III complication costs about USD 33,000. Therefore, a 1% reduction in a postoperative reintervention rate would save USD 33,000 in 100 patients, and this money can be spent on new surgical technologies such as robotics.

Currently, the da Vinci Surgical System is the most widely used robot and its published costs have been listed above [7]. While these costs may fluctuate depending on the exact surgical approach and the instruments required, this post has been calculated to be USD 1,582.91 in a previous academic publication for gastric bypass surgery in 2011 [8]. Applying this cost structure, it becomes obvious, that a 1% reduction in re-interventions (saving about USD 33,000) would not be sufficient to counterbalance this upfront investment, but a significantly greater reduction of Clavien III complications would be required to financially justify the use of the da Vinci Surgical System. While this is a very simplified model, it outlines the practical applicability of this dataset and the extent of financial considerations that have to be made before widespread clinical adoption.

Still, several shortcomings of this analysis have to be mentioned: first, this dataset is mostly based on economic data and many conclusions require more data breadth and depth. In addition, this analysis includes a limited number of subjects in the healthcare environment of Switzerland. As such, the data might not be applicable in other geographic regions or might not be the same when looking at larger cohorts. Also, this is a retrospective analysis with all commonly known sources of bias. Lastly, the cost of robotic surgery is currently under development: Intuitive Surgical as well as new competitors address the cost issue with alternative models including flat-fee payments and lease options [17,18]. Still, this is a unique approach for analyzing the bariatric cohort and might be a decent source of reflection for both clinicians and economists.

Conclusion

Complications are important cost drivers and correlate to the Clavien-Dindo classification with an exponential increase for more significant complications. While this is a good rationale to justify higher procedural costs if complications can be avoided, major investments including current surgical robotics might not be offset by a clinically realistic reduction of complications. More systematic research, including the analyses of broader and deeper datasets, is needed to generate more detailed insights into the correlation of perioperative complications and costs.

Compliance with Ethical Standards

Conflict of interest

Dr. Hagen reports grants from Intuitive Surgical Inc., personal fees and non-financial support from Quantgene Inc., personal fees and non-financial support from Verb Surgical, personal fees and nonfinancial support from Johnson & Johnson, outside the submitted work.

Dr. Jung reports personal fees and non-financial support from Intuitive Surgical Inc., personal fees and non-financial support from Ethicon Endosurgery, outside the submitted work.

Dr. Douissard reports grants from Intuitive Surgical Inc., personal fees and non-financial support from Verb Surgical, outside the submitted work.

Dr. Cohen has nothing to disclose.

Dr. Buchs has nothing to disclose.

Dr. Toso reports grants from Intuitive Surgical Inc., personal fees and non-financial support from Ethicon Endosurgery Inc., outside the submitted work.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Acknowledgement

We thank Francoise Bernardi (University Hospital Geneva) for data collection.

References

1. Fuchs KH. Minimally invasive surgery. Endoscopy. 2002; 34: 154-159.
2. Abdelmoaty WF, Dunst CM, Neighorn C, Swanstrom LL, Hammill CW. Robotic-assisted versus laparoscopic unilateral inguinal hernia repair: a comprehensive cost analysis. Surg Endosc. 2018.
3. Hagen ME, Balaphas A, Podetta M, Rohner P, Jung MK, Buchs NC, et al. Robotic single-site versus multiport laparoscopic cholecystectomy: a casematched analysis of short- and long-term costs. Surg Endosc. 2018; 32: 1550-1555.
4. Trehan A, Dunn. TJ. The robotic surgery monopoly is a poor deal. BMJ. 2013; 347: f7470.
5. Hagen ME, Rohner P, Jung MK, Amirghasemi N, Buchs NC, Fakhro J, et al. Robotic Gastric Bypass Surgery in the Swiss Health Care System: Analysis of Hospital Costs and Reimbursement. Obes Surg. 2017: 27: 2099-2105.
6. Niklas C, Saar M, Berg B, Steiner K, Janssen M, Seiemer S,et al. da Vinci and Open Radical Prostatectomy: Comparison of Clinical Outcomes and Analysis of Insurance Costs. Urol Int. 2016; 96: 287-294.
7. Inc., IS. Investor Presentation Q4 2019. Accessed. 11-19-2019.
8. Hagen ME, Pugin F, Chassot G, Huber O. Reducing cost of surgery by avoiding complications: the model of robotic Roux-en-Y gastric bypass. Obes Surg. 2012; 22: 52-61.
9. Buchs NC, Hagen ME, Pugin F, Volonte F, Bucher P, Schiffer E, et al. Intraoperative fluorescent cholangiography using indocyanin green during robotic single site cholecystectomy. Int J Med Robot. 2012; 8: 436-440.
10. Buchs NC, Pugin F, Chassot G, Volonte F, Koutny-Fong P, Hagen ME, et al. Robot-assisted Roux-en-Y gastric bypass for super obese patients: a comparative study. Obes Surg. 2013; 23: 353-357.
11. Hagen ME, Jung MK, Fakhro J, Buchs NC, Buehler L, Mendoza JM, et al. Robotic versus laparoscopic stapling during robotic Roux-en-Y gastric bypass surgery: a case-matched analysis of costs and clinical outcomes. Surg Endosc. 2018; 32: 472-477.
12. Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004; 240: 205-213.
13. Besson P. REKOLE^® - Betriebliches Rechnungswesen im Spital, (Comptabilité analytique à l’hôpital) 2013: Die Spitäler der Schweiz H+, Bern.
14. Sanchez BR, Mohr CJ, Morton JM, Safadi BY, Alami RS, Curet MJ. Comparison of totally robotic laparoscopic Roux-en-Y gastric bypass and traditional laparoscopic Roux-en-Y gastric bypass. Surg Obes Relat Dis. 2005; 1: 549-554.
15. Mohr CJ, Nadzam GS, Alami RS, Sanchez BR, Curet MJ. Totally robotic laparoscopic Roux-en-Y Gastric bypass: results from 75 patients. Obes Surg. 2006; 16: 690-696.
16. Tieu K, Allison N, Snyder B, Wilson T, et al. Robotic-assisted Roux-en-Y gastric bypass: update from 2 high-volume centers. Surg Obes Relat Dis. 2013; 9: 284-288.
17. Guthard G, Morgan JP. Health care Conference. 2020; 2020.
18. CMR. Accessed 02-16-2020.