The Cost of Cerebral Spinal Fluid Leaks After Spinal Surgery in the USA Presented at the 2009 Annual Meeting of the Congress of Neurological Surgeons (CNS) October 24-29, 2009 • New Orleans, LA Jack Jallo MD, PhD, FACS Introduction Frank R Ernst PharmD, MS The establishment of a watertight closure of the dura mater following spinal surgery is critical as post operative cerebral spinal fluid (CSF) leaks may cause medical complications, increased length of hospital stay, reduced quality of life, and added costs. Neurosurgeries in the infratentorial and spinal regions have a greater risk for CSF leaks than procedures in the supratentorial region likely due to increased hydrostatic pressure associated with gravity when patients are sitting upright.(1) Previous research with fibrin glue, as an adjunct to sutured closure, has found post-operative CSF leak rates in the spinal region as high as 24%.(1) Our study assessed the added cost of CSF leaks following spinal surgery through Premier’s Perspective™ Database (PPD) as little information is available on the direct medical costs associated with CSF leaks after spinal surgery. Michael E Minshall MPH Thomas Jefferson University, Jefferson Medical College, Philadelphia, PA, USA (Jallo) Premier Inc., Charlotte, NC, USA (Ernst) Covidien, North Haven, CT, USA (Minshall). COVIDIEN, COVIDIEN with logo, Covidien logo and positive results for life are U.S. and/or internationally registered trademarks of Covidien AG. © 2009 Covidien. 10.09 P090385 101A First Ave. Waltham, MA 02451 P: 800-722-8772 F: 800-544-8772 www.covidien.com www.durasealinfo.com The Potential Cost Impact of using a PEG Hydrogel Sealant compared with Fibrin Sealant for Cerebral The Potential Cost Impact of using a PEG Hydrogel Sealant compared with Fibrin Sealant Cerebral Spinal for Fluid Leaks after Cranial Surgery Spinal Fluid Leaks after Cranial Surgery Clinton J Baird MD; Frank R Ernst PharmD, MS; Michael E Minshall MPH The Cost of Cerebral Spinal Fluid Leaks After Spinal Surgery in the USA Clinton J Baird MD; Frank R Ernst PharmD, MS; Michael E Minshall MPH Oklahoma Spine & Brain Institute, Tulsa, OK, USA (Baird); Premier Inc., Charlotte, NC, USA (Ernst); Covidien, North Oklahoma Spine & Brain Institute, Tulsa, OK, USA (Baird); Premier Inc., Charlotte, NC, USA (Ernst); Covidien, North Haven, CT, USA (Minshall). Jack Jallo MD, PhD, FACS; Frank R Ernst PharmD, MS; Michael E Minshall Haven, CT, USA (Minshall). MPH Thomas Jefferson University, Jefferson Medical College, Philadelphia, PA, USA (Jallo); Premier Inc., Charlotte, NC, USA (Ernst); Covidien, North Haven, CT, USA (Minshall). Cost Analysis using a PEG Hydrogel Sealant Table 1: Demographic Comparisons: Patients Cost Analysis using a PEG Hydrogel Sealant with CSF Leaks Compared to No CSF Leaks Compared with Fibrin Sealant in Posterior Fossa Compared with Fibrin Sealant in Posterior Fossa with CSF Leaks Compared to No CSF Leaks Cerebrospinal fluid (CSF) leak is a significant causeCerebrospinal Our spinal surgery CSF leaks fluid patient (CSF) cohort leak iswithout a significant cause Table 1 Patients without CSF Patients with CSF p-Value Surgery Surgery of morbidity following cranial surgery. CSF leaks can (n=192,409)following were similar in age surgery. (55.3 years) to our cohort of morbidity cranial CSF leaks can Leaks (n=192,409) Leaks (n=8,837) Demographic We performed a hypothetical analysis for a hospital cause secondary surgical complications We performed a hypothetical analysis for a hospital The establishment of a watertight closure of the duraincluding cause withsecondary CSF leaks (n=8,837, years). However, there was surgical55.4 complications including that performedComparisons: 100 posterior Patients fossa procedures Age using 55.4 55.3 0.422 (Mean, Years) meningitis, encephalitis, pneumocephalus, and mater following spinal surgery is critical as post operative that performed 100 posterior fossa procedures using a statistically significant difference in CSF leak rates meningitis, encephalitis, pneumocephalus, andwith a PEG hydrogel sealant on all 100 patients compared with CSF Leaks chronic hematoma often leading to added cerebral spinal fluidsubdural (CSF) leaks may cause medical a PEG hydrogel 43.2 sealant on all 100 49.1patients compared Male (%) respectsubdural to genderhematoma as females were more likely totohave CSF with fibrin sealant on all 100 patients. The expected chronic often leading added costs.(1) A comparative published reported Compared to No <0.0001 complications, increased length of hospital stay,study reduced with fibrin sealant on all 100 patients. The expected leaks than males (56.8% vs. 43.2%, p<0.0001). costs.(1) A comparative published study reported CSF leak rate for posterior fossa surgery was 2% CSFand leakadded ratescosts. in posterior fossa procedures 56.8 50.9 Female (%) quality of life, Neurosurgeries in the of 2% CSF Leaks CSF leak rate for posterior fossa surgery was 2% CSF leak rates in posterior fossa procedures of 2% using PEG hydrogel sealant (2/100) and 10% for using polyethylene infratentorial anda spinal regions glycol have a (PEG) greaterhydrogel risk for dural 74.8 and 10% for Caucasian (%) using PEG71.5 hydrogel sealant (2/100) fibrin sealant (10/100) based on the comparative sealant in a 100 patient prospective group, and a using a polyethylene glycol (PEG) hydrogel dural CSF leaks than procedures in the supratentorial region Cost of CSF Leaks in Spinal Surgery from the PPD study.(2) We then assumed a cost of $16,495 per fibrin sealant the comparative CSF leak rate of 10% using fibrin sealant in a 100 sealant in a 100 patient prospective group, and a 6.5 (10/100) based on7.4 likely due to increased hydrostatic pressure associated Table 2 describes the costs by major hospital cost category CSF leak, from the PPD analysis, and $620 per African-American (%) patient retrospective, cohort group.(2) Our study CSF leak rate of 10% using fibrin sealant in a 100 study.(2) We then assumed a cost of $16,495 per<0.0001 with gravity when patients are sitting upright.(1) for spinal surgery patients with CSF leaks compared to treatment for a PEG hydrogel sealant comparedHispanic with 2.5 the PPD analysis,2.6 (%) applied the cost of CSF leaks following cranial CSF leak, from and $620 per patient retrospective, cohort group.(2) Our study Previous research with fibrin glue, as an adjunct to those who did not have a CSF leak. $225 per treatment for fibrin sealant applied to all surgery using the Premier Perspective™ Database treatment for a PEG hydrogel sealant 15.2 19.3 compared with Other (%) applied the cost of CSF leaks following cranial sutured closure, has found post-operative CSF leak 100 procedures for each option. These calculations Cost of CSF Leaks in Cranial Surgery (PPD). PPD is the largest clinical and economic $225 per treatment for fibrin sealant applied to all rates in the spinal region as high as 24%.(1) Our study surgery using the Premier Perspective™ are summarized in Table 3. Table 2 describes thecost breakdown costsDatabase by major database developed for quality and utilization • We found the average of spinal in surgeries with 100 procedures for each option. These calculations assessed the added cost of CSF leaks following spinal Cost3.ofTotal CSF Costs Leaksfor in Cranial Surgery (PPD). PPD to is be the largestfor clinical and economic Table 100 Posterior Fossa hospital cost category cranialat surgery patients +$35,977 benchmarking covering one in every five USA CSF leaks significantly higher $25,812 surgery through Premier’s Perspective™ Database (PPD) are summarized in Table 3. Table 2 describes the Hydrogel breakdown in costs by major Procedures using a PEG Sealant database developed for+$22,772 quality and utilization with CSF leaks compared to those who did not have hospital discharges. compared with $19,333 for spinal surgeries as little information is available on the direct medical Table 3. Total Costs for 100 Posterior Fossa Compared Fibrin Sealant a CSF leak. covering one in every five USA hospital with cost category for cranial surgery patients benchmarking Introduction Introduction costs associated with CSF leaks after spinal surgery. Methods Table 1: Demographic Comparisons: Patients Introduction without CSF leaks (p<0.0001). Table 2. Cost of CSF Leaks by Major Cost hospital discharges. Category The cost differences were largely driven by the following The PPD was used to establish the costs of CSF factors: leaks following cranial surgery using ICD-9 and CPT Methods codes for cranial procedures discharged between Q4 • Increased length of hospital stay (6.2 days compared The PPD was used to establish the costs of CSF The PPD was used toQ3 establish costs of CSF 2006 and 2008. the Specifically, ICD-9 procedure with 3.5 days, p<0.0001) for spinal surgery patients with leaks following cranial surgery using ICD-9 and CPT codesspinal used surgery were forusing CSF ICD-9 repairsand while ICD-9 leaks following CPT CSF leaks; for cranial procedures discharged between Q4 diagnosis codes were used for dural tears codes for spinal procedures discharged between Q4 and CSFcodes • Intensive care unit stay (1.2 days compared with 0.4 leaks. CPT codes for ICD-9 cranialprocedure procedures were also 2006 and Q3 2008. Specifically, ICD-9 procedure 2006 and Q3 2008. Specifically, days, p<0.0001) for spinal surgery patients with CSF leaks; included. We then compared potential hospital costcodes used were for CSF repairs while ICD-9 codes used were for CSF repairs while ICD-9 • Pharmacy costs ($1511+$3,792 compared with offsets using a PEG hydrogel diagnosis codes were used for dural tearssealant and CSF($620 per diagnosis codes were used for dural tears and CSF $853+$4,186, p<0.0001) for spinal surgery patients treatment, 5 ml size, Company List Price, Covidien, leaks. CPT codes for spinal procedures were also leaks. CPT codes for cranial procedures were also with CSF leaks. Waltham, MA) with fibrinand sealant ($225 per Note: Summing the cost categories may not add up to the total included. PPD is the largest clinical economic included. We then compared potential hospital cost cost since each subgroup may have smaller population sizes. treatment, ml size, Company List Price, Baxter, Other Hospital Information database developed for4quality and utilization offsets a PEG hydrogel sealant per We using found the average cost of cranial ($620 surgeries with Deerfield, IL) assuming CSF leak rates of 2% and benchmarking including one in every five USA The PPD analysis also Company provided other useful information treatment, 5 ml size, List Price, Covidien, CSF leaks (n=1,192) to be $49,132+$51,169 10% for posterior fossa procedures only.(2) hospital discharges. The major direct medical costs regarding characteristics of spinal surgery patients in the Waltham, MA)with with fibrin sealant ($225 per for compared $32,637+$38,677 (p<0.0001) assessed included length of hospital stay, laboratory USA: cranial surgeries without CSF leaks The treatment, 4 ml size, Company List (n=16,587). Price, Baxter, costs, pharmacy costs, and central hospital supply. • Spinal surgery patients with CSF leaks were more likely cost difference was largely driven by increased Deerfield, IL) assuming CSF leak rates of 2% and Results tolength be seenofinhospital a teaching compared withcare non(3.4hospital days) and intensive 10% for posterior fossa procedures only.(2) Characteristics of Cranial Surgery Patients with and stays (2.7 days)(53.0% for cranial surgery patients with teaching hospitals vs. 46.3%; p<0.0001); without CSF Leaks CSF leaks (both p<0.0001). The PPD • Spinal surgery patients were more likelyanalysis to be seen Table 1 provides basic demographic comparisons of that allwith cost300 categories increased in a of Patient Characteristics of Spinal Surgery Patients inshowed large hospitals beds or more regardless cranial surgery patients who had CSF leaks statistically significant manner when comparing with and without CSF Leaks whether they had CSF leaks or not (79.6% vs. 81.1%). compared to those who did not have a CSF leak. Results cranial surgery patients with a CSF leak to those Table 1 provides basic demographic comparisons of Characteristics of Cranial Surgery Patients with and without a CSF leak. spinal surgery patients who had CSF leaks compared to Methods Results those who did not have a CSF leak. without CSF Leaks Table 1 provides basic demographic comparisons of cranial surgery patients who had CSF leaks Table 2 Costnot Category with CSF leaks compared to those who did have per Patient a CSF leak.Cost of CSF Leaks by Table 2. Cost ofCost CSFCategory Leaks by Major Central Cost Supply Major Category Laboratory *CSF leak rates reported in posterior fossa procedures.(2) Conclusions Procedures using Hydrogel Sealant Patients without CSF Patients with CSF a PEG (n=192,409) Leaks (n=8,837) Compared with Fibrin Leaks Sealant p-Value $9,351 + $16,063 $9,201 + $15,170 0.392 $351 + $892 $205 + 540 <0.0001 Pharmacy $1,511 + $3,792 $853 + $4,186 <0.0001 Room and Board $5,857 + $12,983 $2,935 + $6,554 <0.0001 Surgery/OR, Nursing, Radiology, etc. $9,384 + $13,086 $6,907 + $7,777 <0.0001 *CSF leak rates reported in posterior fossa procedures.(2) Use of a PEG hydrogel sealant compared with fibrin sealant could potentially save $92,460 for a hospital $25,812 + $35,977 $19,333 + $22,772 <0.0001 TOTALS that performed 100 posterior fossa procedures using Note: Summing the cost categories may not add up to the total cost since each subgroup may have smaller population sizes. Conclusions a PEG hydrogel sealant compared with using fibrin Use of a PEG hydrogel sealant compared with fibrin sealant on all 100 procedures. This study sealant could potentially save $92,460 for a hospital demonstrates thethe economic advantages of add using Note: Summing cost categories may not upato the total that performed 100 posterior fossa procedures using PEG hydrogel sealant in posterior fossa procedures. cost since each subgroup may have smaller population sizes. Future studiesthe would be beneficial confirmsurgeries these a PEG hydrogel sealant compared with using fibrin We found average cost oftocranial with findings and understand the possible economic sealant on all 100 procedures. This study CSF leaks (n=1,192) to be $49,132+$51,169 advantages for other types of cranial surgeries. Conclusions demonstrates economic advantages using compared with $32,637+$38,677 for system by the increased hospital (2.7 days) andofICU staysa (0.8 days). CSF leaks after spinal surgery(p<0.0001) cost our healthcare an PEG hydrogel sealant intargeted posterior fossa procedures. cranial surgeries leaks (n=16,587). The Interventions towards reducing the incidence of averagewithout of $6,479 CSF incremental additional dollars compared References Future studies would be beneficial to confirm these difference wasNeurosurgery largely driven increased CSF leaks after spinal surgery could lower hospital costs who do not have by a CSF leak. Increased costs (1)cost Sawamura Y etto al,patients 1999. 44(2):332-337. findings and understand possible (2)length Than KD of et al, 2008. Neurosurgery 63(ONS Suppl 1):ONS184hospital (3.4 after days) andsurgery intensive care and potentially the improve patienteconomic quality of life. for CSF leaks spinal were primarily driven ONS189. advantages for other types of cranial surgeries. stays (2.7 days) for cranial surgery patients with CSF leaks (both p<0.0001). The analysis References: (1) Sugawara T et PPD al, 2005. Neurosurgery 57 (ONS Suppl 3):ONS290-ONS294. showed that all cost categories increased in a References (1) Sawamura Y et al, 1999. Neurosurgery 44(2):332-337. statistically significant manner when comparing