Eur Spine J DOI 10.1007/s00586-014-3504-7

ORIGINAL ARTICLE

Health care costs of incidental durotomies and postoperative cerebrospinal fluid leaks after elective spinal surgery Clemens Weber • Ju¨rgen Piek • David Gunawan

Received: 19 May 2014 / Revised: 29 July 2014 / Accepted: 30 July 2014 Ó Springer-Verlag Berlin Heidelberg 2014

Abstract Purpose To explore the additional health care costs of incidental durotomies and cerebrospinal fluid (CSF) leaks after elective surgery for degenerative spinal disorders. Methods Prospective, observational single-center study including all patients operated for a degenerative condition of the spine over a 13-month period. Incidental durotomies and cerebrospinal fluid leaks were registered prospectively and a detailed analysis of health care costs of each case was performed. Results In total 239 patients were included; an incidental durotomy occured in ten patients and a postoperative cerebrospinal fluid leak occured in one patient causing significantly higher hospital costs, as well as significantly longer hospital stay and operation time. While the hospital costs increased by nearly 50 % the hospitals reimbursement increased only by 21 % and this resulted in an average financial loss of 730 € per case. Conclusion Incidental durotomy or postoperative cerebrospinal fluid leak after elective surgery for degenerative spinal disorders causes significantly higher health care costs. Keywords Spinal surgery  Complication  Durotomy  Cerebrospinal fluid leak  Health care costs

Introduction Incidental durotomies and subsequent cerebrospinal fluid (CSF) leaks are well-known complications after spinal surgery [1]. The incidence rate of incidental durotomies described in the literature varies between 1 and 17 % and several studies have focused on the management and clinical outcome of CSF leaks after spinal procedures [2– 4], but there is little knowledge about the additional health care costs of these frequent complications. There are two studies reporting about the additional costs and the economical consequences of postoperative CSF leaks after intracranial intradural surgery and both studies report a roughly doubling of health care costs if a CSF leak occurs after intracranial surgery [5, 6]. There are, to our knowledge, no reports or studies describing the additional health care costs of incidental durotomies and CSF leaks after surgery for degenerative spinal disorders. In this study, designed as a prospective, observational single-center study, we explored the additional health care costs of incidental durotomies and CSF leaks after elective surgery for degenerative spinal disorders.

Materials and methods Patients and treatment

C. Weber  J. Piek  D. Gunawan Department of Neurosurgery, University of Rostock, Rostock, Germany C. Weber (&) Department of Neurosurgery, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway e-mail: [email protected]

This study was designed as a prospective, observational single-center study over a 13-month period (January 2009– March 2010) and all patients from the age of 14 years and above, scheduled for elective spinal surgery at the Department of Neurosurgery at the University of Rostock, Germany, were registered consecutively. If an unintended durotomy occured the patient was followed for at least

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30 days after discharge from hospital. The following variables were registered for all patients: type of pathology, risk factors, type of surgery, surgical site and approach, unintended durotomy, primary suture repair, closeness of the primary repair, use of dural patch or sealant, use of wound drainage and type of wound closure. If an incidental durotomy occured intraoperatively the surgeon tried to suture the dural defect primarily, the suture or the defect was secured with additional materials (dural graft, sealant, glue) and the patient was confined to bed for 3 days. If a postoperative CSF leak occured the following variables were registered: occurrence and localisation of the CSF leak, further complications caused by the CSF leak (e.g., neurological deficit, radicular pain, meningitis, local infection), surgical treatment of the CSF leak, duration of hospital stay and clinical outcome. The German diagnosis related groups (G-DRG) system and cost calculation A detailed calculation of health care costs was performed in each registered patient. The hospital income for each individual patient was calculated according to the German diagnosis related group (G-DRG) rate representing the hospital’s revenues received from the patient’s health insurance company via the federal health care system. The hospital’s expenses for each individual patient were calculated taking into account all costs for the individual hospital stay, such as operative and diagnostic procedures, personnel costs, surgical implants, medical devices and other additional materials (Table 1). Statistics Data were stored and analyzed using IBM SPSS Statistics for Windows, Version 20.0 (IBM Corp., Armonk, NY, USA). Statistical significance level was defined as Table 1 G-DRG rates and health care costs Amount (€) G-DRG rates G-DRG base rate 2009

2,744.93

G-DRG base rate 2010

2,855.00

Procedure/material Hospital ward (per day) Operating room costs (per minute) Spinal MRI scan Spinal CT scan

340.00 7.28 171.53 77.60

Routine blood samples

27.50

Microbiological samples Lumbar puncture

11.83 33.21

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p B 0.05. All tests were two-sided. Normal distribution was assessed with Q-Q plots. Binominal data were analyzed with Pearson’s Chi-square test. Ethics The study was approved by the local committee for medical research ethics at the University of Rostock.

Results Over the 13-month study period, a total of 239 patients with a mean age of 54.9 years underwent a surgical procedure for a degenerative disorder of the cervical, thoracic or lumbar spine at the Department of Neurosurgery of the University of Rostock, Germany, and were registered and included in the study; in 10 cases (4.1 %) an incidental durotomy occured intraoperatively. No certain risk factors that can be associated with an incidental durotomy could be identified, there were no significant differences in age, pathology, type of surgery and revision surgery. The patient characteristics are presented in Table 2. If an incidental durotomy occured the duration of surgery increased significantly from 116 to 153 min (p \ 0.0001), also the hospital stay was significantly prolonged from 8.8 to 12.4 days (p \ 0.0001). If an incidental durotomy occured the mean hospital costs per case increased by 50.4 %, while the reimbursement increased by only 20.8 %. This resulted in an average loss of 730 € per patient when an incidental durotomy occurred perioperatively. The additional health care costs are presented in Table 3. Only one of 10 patients with an intraoperative dural tear developed a postoperative CSF leak, this patient was a 49-year-old lady operated with microsurgical decompression and implantation of an interspinous device for lumbar spinal stenosis. A primary suture of the dural defect was initially not performed because of the lateral localisation of the durotomy, but the defect was covered with an artificial dural graft implant (DuraformTM, Codman & Shurtleff Inc., Raynham, MA, USA) and sealed with a synthetic polymer glue (DuraSealTM, Covidien PLC, Dublin, Ireland). The patient developed spinal headache 8 days after surgery; in addition, a subcutaneous fluid collection occured in relation to the site of surgery. MR imaging verified a fluid collection located to the surgical approach consistent with a postoperative CSF leak. Revision surgery was performed, the approach to the spinal canal was enlarged, the dural defect was exposed and sutured and the defect was covered with DuraformTM (Codman & Shurtleff Inc., Raynham, MA, USA) and TachoSilÒ (Takeda, Osaka, Japan). The patient was confined to bed for 3 days and stayed in

Eur Spine J Table 2 Patient characteristics Patient characteristics

All patients, N (%)

Patients with incidental durotomy, N (%)

All patients

239 (100)

10 (4.2)

Female

120 (50.2)

5 (2.1)

Male

119 (49.8)

5 (2.1)

\65 years

171 (71.5)

7 (2.9)

68 (28.5)

3 (1.3)

Cervical spine Thoracic spine

66 (27.6) 4 (1.7)

1 (0.4) 1 (0.4)

Lumbar spine

169 (70.7)

8 (3.3)

Disc herniation

97 (40.6)

1 (0.4)

Stenosis/other degenerative

142 (59.4)

9 (3.8)

93 (38.9)

2 (0.8)

146 (61.1)

8 (3.4)

65 years and older Location

Pathology

Type of surgery Decompression only Decompression and fusion

hospital for in total 22 days after primary surgery. No recurrence of the CSF leak occurred and the final clinical outcome was favorable. Discussion In this prospective, observational single-center study we explored the institutional incidence rate and the additional health care costs of incidental durotomies and CSF leaks in 239 patients operated for a degenerative spinal disorder. An

Table 3 Health care costs

incidental durotomy occured in 10 patients and caused significantly higher hospital costs, as well as significantly longer hospital stay and operation time. While the hospital costs increased by nearly 50 %, the hospitals reimbursement increased by only 21 % and this resulted in a financial loss of 730 € per patient with incidental durotomy. The rate of incidental durotomies in our study was 4.2 % which is similar to the rates reported in the current literature, a recent, large registry study with 3,764 patients reported a rate of 4.3 % [7]. Our study population included cervical, thoracic and lumbar surgeries with and without instrumentation and is representative for a non-specialized neurosurgery unit. We could not identify certain significant risk factors for incidental durotomies, age, pathology, type of surgery or revision surgery did not increase the risk of an incidental durotomy. Also, the long-term clinical outcome was not affected if an incidental durotomy occured which is in agreement with the current literature [8]. Health care costs have been the subject of ongoing debate among health care providers and the increasing number and costs of spinal surgery are frequently discussed, though patients are usually not aware of the high costs of spinal surgery [9]. Complications of spinal surgery do not only affect the clinical outcome, but increase the health care costs considerably. Our study shows that if an incidental durotomy occured during elective spinal surgery, the duration of surgery is significantly prolonged increasing operating room costs by 40 %. Also, the hospital stay was extended significantly from 8.8 to 12.4 days and this averagely increased the hospital ward costs by 46 %. Another important factor causing additional costs is the use of artificial sealing materials to cover and secure the dural

Patients without incidental durotomy (n = 229) Mean (SD) (€)

Patients with incidental durotomy (n = 10) Mean (SD) (€)

Patient with CSF leak (n = 1)

Hospital costs

5,282 (2,720)

7,945 (3,717)

13,820

\0.0001

DRG reimbursement Hospital earnings

5,972 (2,370) 690 (2,110)

7,215 (2,509) -730 (1,966)

10,350 -3,470

\0.0001 \0.0001

Operating theater

875

1,227

2,657

\0.0001

Dura closure

8

342

1,330

\0.0001

Hospital stay

2,894

4,216

7,480

\0.0001

Roentgen and ultrasound

17

26

38

\0.0001

CT imaging

18

47

0

\0.0001

MR imaging

38

34

0

\0.0001

Antibiotics

15

33

321

\0.0001

Implants

1,275

1,946

1,926

\0.0001

Lab

32

40

40

\0.0001

p value

(€)

Economical aspects

Hospital costs

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defect. In this study different grafts and glues were used and this that resulted in additional costs of averagely 334 € per surgery with an incidental durotomy. Although securing an incidental durotomy with artificial materials causes increasing costs, it may help to avoid the development of postoperative CSF leak and additional surgery. In total, the overall hospital treatment costs increased by nearly 50 % if an incidental durotomy occurred perioperatively. At the same time, the hospital’s reimbursement increased by only 21 % and the hospital made a loss of approximately 730 € per patient. If the patient developed a postoperative CSF leak after an incidental durotomy the hospital made a deficit of 3,470 €. Indirect costs and legal aspects of incidental durotomies and postoperative CSF leaks after spinal surgery were not analyzed in this study, but a former US study reports that unintended or incidental durotomy was the second most frequent cause of medical malpractice cases involving surgery of the lumbar spine [10] and this implicates the this type of complication can even further increase the hospital costs in particular and health care costs in general. Another important aspect is that a prolonged hospital stay increases the overall treatment duration, which leads to a longer nonproductive time of the individual patient causing additional costs for the society. For intracranial surgery it was shown earlier that a postoperative CSF leak increases the health care costs extensively [5, 6]. To our knowledge, the present study is the first study evaluating the additional health care costs of incidental durotomies and CSF leaks after spinal surgery. As a spinal surgeon it is important to know that an incidental durotomy or a postoperative CSF leak can not only affect the clinical outcome, but furthermore result in a fulminant increase in health care costs. Study strengths and limitations The completeness of data and the detailed analyses of health care costs of each individual patient certainly strengthens the study results. The interpretation of the study results may be limited by the low number of patients with incidental durotomies and CSF leaks.

Conclusion An incidental durotomy or a postoperative CSF leak after spinal surgery causes significantly longer operation time and hospital stay resulting in significantly higher health

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care costs. While the hospital costs increases by nearly 50 %, the hospitals reimbursement increases by only 21 % resulting in an average financial loss of 730 € per patient. Therefore, all efforts should be made to avoid this complication not only from a clinical, but also from a health care cost perspective.

Conflict of interest Costs for organizing the study and for statistical analysis were paid by Nycomed (now Takeda Inc., Osaka, Japan). Ju¨rgen Piek held different paid lectures for Nycomed.

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Health care costs of incidental durotomies and postoperative cerebrospinal fluid leaks after elective spinal surgery.

To explore the additional health care costs of incidental durotomies and cerebrospinal fluid (CSF) leaks after elective surgery for degenerative spina...
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