Retrospective Comparison of Clinical and Economic Outcomes of Non-Donor Patients Undergoing Radical Nephrectomy Using One of Two Different Linear Stapler Technologies for Transection of the Renal Vessels: Fixed-Height Gripping Surface Reloads vs Variable-Height Reloads.

Purpose: To compare outcomes of non-donor patients undergoing radical nephrectomy using fixed-height gripping surface (FHGS) vs variable-height Tri-Staple™ (VHTS) reloads for transection of the renal vessels. Patients and Methods: Using the Premier Healthcare Database of US hospital discharge records, we selected non-donor patients undergoing inpatient radical nephrectomy with dates of admission between 1 October 2015, and 31 December 2020 (first=index admission). The primary outcome was in-hospital hemostasis-related complications (hemorrhage, acute posthemorrhagic anemia, and/or procedure to control bleeding) during the index admission. Secondary outcomes included index admission intraoperative injury, blood transfusion, conversion from minimally invasive to open surgery, total hospital costs, length of stay (LOS), discharge status, and mortality as well as 30-day all-cause inpatient readmission. We used stable balancing weights to balance the FHGS and VHTS groups on numerous patient, procedure, and hospital/provider characteristics, allowing a maximum post-weighting standardized mean difference ≤0.01 for all covariates; we also exactly matched the groups on laterality (right vs left kidney) and intended surgical approach (open, laparoscopic, robotic). We used bivariate multilevel mixed-effects generalized linear models accounting for hospital-level clustering to compare the study outcomes between the FHGS and VHTS groups. Results: After weighting, the FHGS and VHTS groups comprised 2952 and 795 patients, respectively. The observed incidence proportion of the primary outcome of hemostasis-related complications during the index admission was similar between the groups (8.6% for FHGS vs 9.0% for VHTS, difference 0.4% [95% CI -3.2% to 2.5%], P=0.808). Differences between the FHGS and VHTS groups were not statistically significant for any of the secondary outcomes. Conclusion: Endoscopic surgical staplers have become common for transection of the renal vessels during radical nephrectomy, with FHGS and VHTS being the predominant reload types. In this retrospective study of 3747 non-donor patients undergoing radical nephrectomy, use of FHGS vs VHTS reloads was associated with similar clinical and economic outcomes.

Economic Analysis of Leak Complications in Anastomoses Performed with Powered versus Manual Circular Staplers in Left-Sided Colorectal Resections: A US-Based Cost Analysis.

PURPOSE: To estimate the cost impact of using the ECHELON CIRCULAR™ Powered Stapler (ECP) compared with manual circular staplers (standard of care, SOC) among patients undergoing colectomy procedures that involve left-sided anastomosis. METHODS: A US hospital-based budget impact model was developed to estimate the impact of ECP in reducing the surgical complication of anastomotic leak. The incremental acquisition cost of ECP vs SOC was compared to the net potential savings from reduced complication costs. The model was based on complication rates from a recently published matching-adjusted indirect comparison (MAIC) that compared clinical and healthcare utilization outcomes of patients using ECP with those of a propensity score-matched retrospective SOC control cohort from a real-world clinical practice population. The model assessed total cost, average length of stay (LOS), proportion of patients with a non-home discharge, and all-cause readmission. Deterministic (DSA) and probabilistic sensitivity analyses (PSA) were conducted to evaluate the robustness of the model assumptions and inputs. RESULTS: Despite a higher device cost of $412 for ECP compared with $298 for a manual stapler, annual savings due to avoided complications with ECP was $53,987 for anastomotic leak, assuming 100 procedures per year with each type of circular stapler. ECP also helped to avoid 27 LOS days, 0.38 readmissions and 0.22 non-home discharges. Sensitivity analyses around potential drivers of costs established the robustness of economic savings with the use of ECP - with annual savings being most impacted by the probability of anastomotic leak complication in the DSA. CONCLUSION: This model demonstrates that among patients undergoing left-sided colectomy procedures, the incremental cost of using the ECHELON CIRCULAR™ Powered Stapler instead of a manual circular stapler was offset by the savings from lowered incidence and cost of management of anastomotic leaks in the hospital setting.

Incidence, predictors, and economic burden of circular anastomotic complications in left-sided colorectal reconstructions involving manual circular staplers.

STUDY AIM: Manual circular staplers are widely used in colorectal surgery; however, limited literature exists examining complications related to circular anastomoses when such devices are used. The present study evaluated the incidence, predictors, and economic burden of circular anastomotic complications in left-sided colorectal reconstructions involving manual circular staplers. MATERIALS AND METHODS: Patients aged ≥18 years who underwent hemicolectomy, low anterior resection, or sigmoidectomy between 1 October 2016 and 31 December 2018 were identified from the Premier Healthcare Database. Manual circular stapler use was identified from hospital administrative billing records. Circular anastomotic complications were defined as a composite endpoint of multiple circular stapler use (proxy for stapler failure) or other circular anastomotic complications (anastomotic leak, bleeding, device/surgical complications, infection, and transfusion). Multivariable analyses were used to model the associations between circular anastomotic complications and total hospital costs, length of stay, operating room time, and 30-, 60-, and 90-day readmission rates. RESULTS: A total of 13,167 patients met the study criteria, of whom 2,984 (22.7%) had circular anastomotic complications. Predictors of circular anastomotic complications included age, procedure type, provider region, and select patient comorbidities. As compared with those who did not, patients who suffered circular anastomotic complications had significantly higher adjusted total hospital costs ($26,924 vs. $18,748; p < .0001), length of stay (7.79 vs. 4.99 days; p < .0001), operating room time (280 vs. 239 min; p < .0001), non-home discharge status (9.63% vs. 4.61%; p < .0001), and all-cause readmission at 30 days (12.2% vs. 8.7%; p < .0001), 60 days (16.0% vs. 11.6%; p < .0001), and 90 days (18.5% vs. 13.4%; p < .0001). LIMITATIONS: The present study is limited by the observational nature and potential for measurement error that is inherent to administrative healthcare databases. CONCLUSIONS: In this analysis of patients undergoing left-sided colorectal reconstructions involving a manual circular stapler, circular anastomotic complications were associated with adverse economic consequences.

Surgical Outcomes, Health Care Utilization, and Costs Associated with Staple Line Buttressing Among Primary Sleeve Gastrectomy Patients.

PURPOSE: Staple line buttressing is a method of reinforcing surgical staple lines using buttress materials. This study evaluated surgical outcomes, hospital utilization, and hospital costs associated with staple line buttressing among patients who underwent primary laparoscopic sleeve gastrectomy (PLSG) in the United States. METHODS: This was a retrospective cohort study using Premier Healthcare Database data from January 1, 2012 to December 31, 2017. Patients aged ≥ 18 years who underwent PLSG were selected and assigned to buttress or non-buttress cohorts based on the use of buttress material during their hospitalization for PLSG (index). Propensity score matching (PSM) was conducted to balance patient demographic and clinical characteristics between the cohorts. Generalized estimating equation models were used to compare the clinical and economic outcomes of the matched buttress and non-buttress users during the index hospitalization. RESULTS: A total of 38,231 buttress and 27,349 non-buttress patients were included in the study. After PSM, 24,049 patients were retained in each cohort. Compared with non-buttress cohort, the buttress cohort patients had a similar rate of in-hospital leaks (0.28% vs 0.39%; p = 0.160) and a lower rate of bleeding (1.37% vs 1.80%, p = 0.015), transfusion (0.56% vs 0.77%, p = 0.050), and composite bleeding/transfusion (1.57% vs 2.04%, p = 0.019). Total costs ($12,201 vs $10,986, p < 0.001) and supply costs ($5366 vs $4320, p < 0.001) were higher in the buttress cohort compared with the non-buttress cohort. CONCLUSIONS: Staple line buttressing was associated with an improvement in complication rates for bleeding and transfusion. Total and supply costs were higher in the buttress cohort, necessitating further research into cost-effective buttressing materials.

Comparative Effectiveness Assessment of Two Powered Surgical Stapling Platforms in Laparoscopic Sleeve Gastrectomy: A Retrospective Matched Study.

OBJECTIVE: To compare outcomes between the two latest innovations in powered stapling technology, the ECHELON FLEX™ GST system (GST) and the Signia™ Stapling System (SIG), among patients undergoing sleeve gastrectomy for obesity. PATIENTS AND METHODS: Using the Premier Healthcare Database of US hospital discharge records, we selected patients undergoing inpatient sleeve gastrectomy with dates of surgical admission between March 1, 2017 (SIG launch), and December 31, 2018. Outcomes measured during the surgical admission included in-hospital hemostasis-related complications (bleeding/transfusion; primary outcome), leak, total hospital costs, length of stay (LOS), and operating room time; 30-, 60-, and 90-day all-cause inpatient readmissions were also examined. We used 1:1 cardinality matching to balance the GST and SIG groups on numerous patient and hospital/provider characteristics, allowing a maximum standardized mean difference (SMD) ≤0.05 for all matching covariates. Generalized estimating equations (GEE) accounting for hospital-level clustering were used to compare the study outcomes between the GST and SIG groups. RESULTS: Of the 5573 identified cases, there were 491 patients in each group (982 total) after matching. The observed incidence proportion of hemostasis-related complications during the surgical admission was lower in the GST group as compared with the SIG group (3 events/491 [0.61%] vs 11 events/491 [2.24%]; odds ratio [SIG=reference] = 0.28, 95% CI=0.13-0.60, P=0.0012). Differences between the GST and SIG groups were not statistically significant for leak, total hospital costs, LOS, OR time, and all-cause inpatient readmission at 30, 60, and 90 days. CONCLUSION: In this retrospective study of 982 matched patients undergoing sleeve gastrectomy, the ECHELON FLEX™ GST system was associated with a lower rate of hemostasis-related complications as compared with the Signia™ Stapling System. Further controlled prospective studies are needed to confirm the validity of this finding.

Tropical cyclone risk assessment using geospatial techniques for the eastern coastal region of Bangladesh.

Tropical cyclones frequently affect millions of people, damaging properties, livelihoods and environments in the coastal region of Bangladesh. The intensity and extent of tropical cyclones and their impacts are likely to increase in the future due to climate change. The eastern coastal region of Bangladesh is one of the most cyclone-affected coastal regions. A comprehensive spatial assessment is therefore essential to produce a risk map by identifying the areas under high cyclone risks to support mitigation strategies. This study aims to develop a comprehensive tropical cyclone risk map using geospatial techniques and to quantify the degree of risk in the eastern coastal region of Bangladesh. In total, 14 spatial criteria under three risk components, namely, vulnerability and exposure, hazard, and mitigation capacity, were assessed. A spatial layer was created for each criterion, and weighting was conducted following the Analytical Hierarchy Process. The individual risk component maps were generated from their indices, and subsequently, the overall risk map was produced by integrating the indices through a weighted overlay approach. Results demonstrate that the very-high risk zone covered 9% of the study area, whereas the high-risk zone covered 27%. Specifically, the south-western (Sandwip and Sonagazi), western (Patiya, Kutubdia, Maheshkhali, Chakaria, Cox's Bazar and Chittagong Sadar) and south-western (Teknaf) regions of the study site are likely to be under a high risk of tropical cyclone impacts. Low and very-low hazard zones constitute 11% and 28% of the study area, respectively, and most of these areas are located inland. The results of this study can be used by the concerned authorities to develop and apply effective cyclone impact mitigation plans and strategies.

Impact of Powered and Tissue-Specific Endoscopic Stapling Technology on Clinical and Economic Outcomes of Video-Assisted Thoracic Surgery Lobectomy Procedures: A Retrospective, Observational Study.

INTRODUCTION: Video-assisted thoracic surgery (VATS) lung resections are complex procedures with a critical role played by endoscopic staplers in the transection of vessels, bronchi, and lung tissue. This retrospective, observational study compared hospital resource use, costs, and complications of VATS lobectomy procedures for whom powered versus manual endoscopic surgical staplers were used. METHODS: Patients ≥ 18 years of age undergoing elective VATS lobectomy during an inpatient admission from January 1, 2012 to September 30, 2016 were identified from the Premier Healthcare Database (first admission = index admission). Use of either powered or manual endoscopic staplers during the index admission was identified from hospital administrative records. Multivariable regression analyses adjusting for patient, hospital, and provider characteristics and hospital-level clustering were carried out to compare the following outcomes between the powered and manual stapler groups: hospital length of stay (LOS), operating room time (ORT), hospital costs, complications (bleeding and/or transfusions, air leak complications, pneumonia, and infection), discharge status, and 30-, 60-, and 90-day all-cause readmissions. RESULTS: The powered and manual stapler groups comprised 659 patients (mean age 66.1 years; 53.6% female) and 3100 patients (mean age 66.7 years; 54.8% female), respectively. In the multivariable analyses, the powered stapler group had shorter LOS (4.9 vs. 5.9 days, P < 0.001), lower total hospital costs ($23,841 vs. $26,052, P = 0.009), and lower rates of combined hemostasis complications (bleeding and/or transfusions; 8.5% vs. 16.0%, P < 0.001) and transfusions (5.4% vs. 10.9%, P = 0.002), compared with the manual stapler group. Other outcomes did not differ significantly between the study groups. Similar trends were observed in subanalyses comparing devices across predominant manufacturers in each group, and in subanalyses of patients with comorbid chronic obstructive pulmonary disease. CONCLUSION: In this analysis of VATS lobectomy procedures, powered staplers were associated with significant benefits with respect to selected types of hospital resource use, costs, and clinical outcomes when compared with manual staplers. FUNDING: Johnson & Johnson.

Assessing relative cost of complications following orthotopic liver transplant.

INTRODUCTION: Perioperative complications impose both a clinical and financial burden on patients and the healthcare system. This study sought to identify the frequency and economic impact of complications following orthotopic liver transplantation (OLT). METHODS: The Premier Perspective® Hospital Database was queried for patients undergoing OLT between 2008 and 2015. Complications were identified by ICD-9 code and grouped by complication type. Complication frequency as well as impact on clinical and economic outcomes was calculated. Complication frequency and effect on cost were combined to determine the annual impact of each complication type on perioperative OLT cost. RESULTS: Among 2747 OLT patients, the most common groups of complications following OLT were pulmonary, bleeding, and infectious. The complications with the greatest average effect on treatment-related costs were infectious, neurologic, deep vein thrombosis/pulmonary embolus, and hepatic arterial thrombosis. Infectious, pulmonary, and bleeding complications had the greatest annual effect on perioperative OLT cost. CONCLUSIONS: Efforts focused on preventing coagulopathic bleeding, improving post-operative pulmonary toilet, and minimizing sources of infection can help improve the cost-effectiveness of OLT. Additionally, the combination of these cost data and systematized protocols can help insurers construct bundled payments for OLT that more accurately reflect the cost of perioperative transplant care.

Economic Impact of Laparoscopic Conversion to Open in Left Colon Resections.

BACKGROUND AND OBJECTIVES: Studies have shown economic and clinical advantages of laparoscopic left-colon resections. Laparoscopic conversion to open is an important surgical outcome. We estimated conversion incidence, identified risk factors, and measured the clinical and economic impact. METHODS: In this retrospective study, we used the Premier Perspective database to analyze left-sided colectomies from 2009 to 2014. Operating room time (ORT), length of stay (LOS), total hospital cost (2014 U.S. dollars); along with incidence of in-hospital clinical outcomes (anastomotic leak surrogate [Leak], transfusion, and mortality) were evaluated. Multivariable models accounting for hospital clustering were used to identify conversion risk factors and analyze the effect of conversion on economic and clinical outcomes. RESULTS: A total of 41,417 patients: 8,468 left hemicolectomy and 32,949 sigmoidectomy were identified. Lap-Conversion incidence was 13.3% (95% CI, 12.9-13.7). Adjusted mean LOS (±SE) days was significantly lower for the Lap-Successful group (4.9 compared with Lap-Conversion 6.8 and Open-Planned 7.0), but Lap-Conversion and Open-Planned had similar LOS. Adjusted mean cost was higher for Lap-Conversion $20,165 compared to Open-Planned $18,797; but this difference was smaller than the cost savings for Lap-Successful $16,206 ± $219. Open-Planned had lower odds of Leak compared to Lap-Conversion. Open-Planned and Lap-Conversion had similar odds of transfusion and mortality. Conversion risk factors included inflammatory bowel disease and left-hemicolectomy. Colorectal specialists were associated with 38% decreased odds of conversion. CONCLUSIONS: Successful laparoscopic surgery was the most cost effective, with decreased LOS and odds of blood transfusion, leak surrogate, and mortality. Conversion was the most expensive and had increased odds of leak surrogate, but similar LOS compared to Open-Planned. The beneficial effect size of successful laparoscopic surgery was larger than the negative effect of conversion compared to Open-Planned.

Laparoscopic Suturing as a Barrier to Broader Adoption of Laparoscopic Surgery.

BACKGROUND: Laparoscopic surgery is increasingly replacing the open procedure because of its many patient-related benefits that are well aligned with policies and programs that seek to optimize health system performance. However, widespread adoption of laparoscopic surgery has been slow, in part, because of the complexity of laparoscopic suturing. The objective of this study was to review the clinical and economic impacts of laparoscopic suturing in key procedures and to assess its role as a barrier to the broader adoption of laparoscopic surgery. DATABASE: A medical literature search of MEDLINE, EMBASE, and BIOSIS from January 2010 through June 2016 identified 47 relevant articles. CONCLUSION: Laparoscopic suturing and intracorporeal knot tying may result in extended surgical time, complications, and surgeon errors, while improving patient quality of life through improved cosmesis, diet toleration, and better bowel movements. Despite advancement in surgical techniques and the availability of newer surgical tools, the complexity of laparoscopic suturing continues to be a barrier to greater adoption of MIS. The results of the study underscore the need for development of proficiency in laparoscopic suturing, which may help improve patient outcomes and reduce healthcare costs.

Comparison of economic and clinical outcomes between patients undergoing laparoscopic bariatric surgery with powered versus manual endoscopic surgical staplers.

AIMS: To compare economic and clinical outcomes between patients undergoing laparoscopic Roux-en-Y gastric bypass (LRY) or laparoscopic sleeve gastrectomy (LSG) with use of powered vs manual endoscopic surgical staplers. MATERIALS AND METHODS: Patients (aged ≥21 years) who underwent LRY or LSG during a hospital admission (January 1, 2012-September 30, 2015) were identified from the Premier Perspective Hospital Database. Use of powered vs manual staplers was identified from hospital administrative billing records. Multivariable analyses were used to compare the following outcomes between the powered and manual stapler groups, adjusting for patient and hospital characteristics and hospital-level clustering: hospital length of stay (LOS), total hospital costs, medical/surgical supply costs, room and board costs, operating room costs, operating room time, discharge status, bleeding/transfusion during the hospital admission, and 30, 60, and 90-day all-cause readmissions. RESULTS: The powered and manual stapler groups comprised 9,851 patients (mean age = 44.6 years; 79.3% female) and 21,558 patients (mean age = 45.0 years; 78.0% female), respectively. In the multivariable analyses, adjusted mean hospital LOS was 2.1 days for both the powered and manual stapler groups (p = .981). Adjusted mean total hospital costs ($12,415 vs $13,547, p = .003), adjusted mean supply costs ($4,629 vs $5,217, p = .011), and adjusted mean operating room costs ($4,126 vs $4,413, p = .009) were significantly lower in the powered vs manual stapler group. The adjusted rate of bleeding and/or transfusion during the hospital admission (2.46% vs 3.22%, p = .025) was significantly lower in the powered vs manual stapler group. The adjusted rates of 30, 60, and 90-day all-cause readmissions were similar between the groups (all p > .05). Sub-analysis by manufacturer showed similar results. LIMITATIONS: This observational study cannot establish causal linkages. CONCLUSIONS: In this analysis of patients who underwent LRY or LSG, the use of powered staplers was associated with better economic outcomes, and a lower rate of bleeding/transfusion vs manual staplers in the real-world setting.

The clinical and economic burden of significant bleeding during lung resection surgery: A retrospective matched cohort analysis of real-world data.

OBJECTIVES: The objective of this retrospective study was to quantify the clinical and economic burden of significant bleeding in lung resection surgery in the US. METHODS: This study utilized 2009-2012 data from the Premier Perspective DatabaseTM. Adult patients with primary pulmonary lobectomy or segmentectomy procedures were categorized by the surgical approach (VATS vs open) and primary diagnosis (primary or metastatic lung cancer vs non-lung cancer). Patients requiring ≥3 units of blood products with at least 1 unit of PRBCs: "significant bleeding" cohort; those requiring <3 units: "non-significant bleeding" cohort; and those not requiring blood products: "no bleeding" cohort. A matched cohort analysis was performed between the "significant bleeding" and the "no bleeding cohort" using matching variables: hospital, lung cancer diagnosis, year of surgery, APR-DRG severity score, procedure type and approach, age, and gender. RESULTS: The "All-patient" cohort comprised 21,429 patients: 213 "significant bleeding"; 2,780 "non-significant bleeding"; and 18,436 "no bleeding". Overall incidence of significant chest bleeding was 0.99%. Patients from "significant bleeding" cohort and "non-significant bleeding" cohort had 2.5 days and 2 days (p < 0.0001) longer length of stay in the hospital compared to those in the "no bleeding" cohort, respectively. Overall, hospital costs for "significant bleeding" cohort were higher than "no bleeding" cohort for those who were covered under Medicare ($59,871 vs $23,641), were ≥76 years of age ($64,010 vs $24,243), had greater severity of illness ($97,813 vs $51,871) and underwent open segmentectomy ($74,220 vs $21,903). Hospital costs for "significant bleeding" cohort and "non-significant bleeding" were significantly higher ($11,589 and $5,280, respectively, p < 0.0001) than no bleeding cohort. CONCLUSIONS: Although significant bleeding during lung resection surgery is rare, patients with such complication could stay longer at the hospital and cost an average of $13,103 more than those without.

Impact of Switching From an Initial Tumor Necrosis Factor Inhibitor on Health Care Resource Utilization and Costs Among Patients With Rheumatoid Arthritis.

PURPOSE: Despite improved clinical outcomes for the majority of patients, nearly 30% of patients with rheumatoid arthritis (RA) who initiate tumor necrosis factor antagonist (anti-TNF) biologic agents fail to respond to their first-line anti-TNF and switch to another anti-TNF or a non-TNF biologic. How this change affects health care costs and resource utilization is unknown. We therefore compared RA patients taking first-line anti-TNFs who switched to a second anti-TNF versus those patients who switched to an alternate biologic. METHODS: Health care claims data were obtained from a large US database for eligible adults with confirmed RA diagnoses who initiated anti-TNF treatment and switched to another biologic. Health care costs and utilization during the first 12 months' postswitch were compared. Generalized linear models were used to adjust for differences in demographic and clinical characteristics before switching. FINDINGS: Patients who switched to a second anti-TNF rather than a non-TNF biologic were generally younger (53.0 vs. 55.3 years; P < 0.0001) and less likely to be female (79.7% vs. 82.7%; P = 0.0490). Of the 3497 eligible patients who switched from first-line anti-TNFs, 2563 (73.3%) switched to another anti-TNF and 934 (26.7%) switched to a non-TNF. Adalimumab was the most frequently prescribed (43.4%) second-line anti-TNF, and abatacept was the most common non-anti-TNF (71.4%). Patients who switched to a second anti-TNF remained on their first medication for a significantly shorter period (342.5 vs 420.6 days; P < 0.0001) and had lower comorbidity indices and higher disease severity at baseline than those who switched to a non-anti-TNF. After adjusting for baseline differences, patients who switched to second anti-TNFs versus a non-TNF incurred lower RA-related costs ($20,938.9 vs $22,645.2; P = 0.0010) and total health care costs ($34,894.6 vs $38,437.2; P = 0.0010) 1 year postswitch. These differences were driven by increased physician office visit costs among the non-TNF group. IMPLICATIONS: Among the anti-TNF initiators who switched therapy, more patients switched to a second anti-TNF than to a non-TNF. Switching to a second anti-TNF treatment was associated with lower all-cause and RA-related health care costs and resource utilization than switching to a non-TNF. Because switching therapy may be unavoidable, finding a treatment algorithm mitigating this increase to any extent should be considered. These data are limited by their retrospective design. Additional confounding variables that could not be controlled for may affect results.

Similar patient outcomes yet different hospital costs between flowable hemostatic agents.

INTRODUCTION: SURGIFLO and FLOSEAL are absorbable gelatin-based products that form hemostatic matrices. These products are indicated as adjuncts to hemostasis when control of bleeding by conventional surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. This study analyzed the effect of surgery time and the choice of product on cost to the hospital and patient outcomes. METHODS: The data source was the Premier Hospital database from January 1, 2010-June 30, 2012. Eligible patients were ≥18 years of age with a spinal fusion or refusion surgery with either SURGIFLO (Ethicon Inc.) or FLOSEAL (Baxter International Inc.). The hospital Charge Master was used to identify the amount of flowable product, whether it included Thrombin, and the cost. Multivariable models were performed on overall cost and likelihood of surgical complications. All models were adjusted for patient demographics and severity as well as hospital, and surgical characteristics. RESULTS: A total of 24,882 patient records from 121 hospitals were analysed, which included 15,088 FLOSEAL records and 9794 SURGIFLO records, with 1498 SURGIFLO with Thrombin patients. Little or no differences in surgical complications were found between surgeries with SURGIFLO vs. surgery with FLOSEAL. Regression models showed a reduction in cost of $65 associated with use of SURGIFLO with Thrombin and an additional $21 reduction in hospital cost for each additional hour of surgery. Modeling which accounts for hospital fixed effects suggest that, in addition to a gap of ∼$300 favoring SURGIFLO with Thrombin, every additional hour of surgery was associated with an additional reduction in hospital costs of ∼$26. CONCLUSIONS: While the choice of flowable product had no effect on clinical outcomes, use of SURGIFLO was associated with hospital cost savings for flowable product. These savings increased with the length of surgery, even when controlling for the amount of flowable product (mL) used.

Economic Impact of the Use of an Absorbable Adhesion Barrier in Preventing Adhesions Following Open Gynecologic Surgeries.

We used an economic model to assess the impact of using the GYNECARE INTERCEED absorbable adhesion barrier for reducing the incidence of postoperative adhesions in open surgical gynecologic procedures. Caesarean section surgery, hysterectomy, myomectomy, ovarian surgery, tubal surgery, and endometriosis surgery were modeled with and without the use of GYNECARE INTERCEED absorbable adhesion barrier. Incremental GYNECARE INTERCEED absorbable adhesion barrier material costs, medical costs arising from complications, and adhesion-related readmissions were considered. GYNECARE INTERCEED absorbable adhesion barrier use was assumed in 75% of all procedures. The economic impact was reported during a 3-year period from a United States hospital perspective. Assuming 100 gynecologic surgeries of each type and an average of one GYNECARE INTERCEED absorbable adhesion barrier sheet per surgery, a net savings of $540,823 with GYNECARE INTERCEED absorbable adhesion barrier during 3 years is estimated. In addition, GYNECARE INTERCEED absorbable adhesion barrier use resulted in 62 fewer cases of patients developing adhesions. Although the use of GYNECARE INTERCEED absorbable adhesion barrier added $137,250 in material costs, this was completely offset by the reduction in length of stay ($178,766 savings), fewer adhesion-related readmissions ($458,220 savings), and operating room cost ($41,078 savings). Adoption of the GYNECARE INTERCEED absorbable adhesion barrier for appropriate gynecologic surgeries would likely result in significant savings for hospitals, driven primarily by clinical patient benefits in terms of decreased length of stay and adhesion-related readmissions.

Clinical and economic burden of surgical site infection in hysterectomy.

BACKGROUND: Owing to a lack of current understanding of outcomes and costs by type of hysterectomy procedure, we attempt to quantify the incidence and impact of surgical site infection (SSI) in laparoscopic and non-laparoscopic approaches to abdominal and vaginal hysterectomy. METHODS: Patients whose data were contained in the Premier Perspectives Database of 600 hospitals in the United States were selected on the basis of a post-operative diagnosis of SSI and treatment with antibiotics. The incidence of SSI and associated hospital length of stay (LOS) and costs were estimated. The effect of SSI on readmission was also analyzed. RESULTS: Of 210,916 hysterectomies included in the study, 55% were open abdominal procedures. Although the overall incidence of SSI in hysterectomy was low, its incidence was greater in open abdominal hysterectomy than in other approaches to hysterectomy. Patients with an SSI experienced a three- to five-fold greater LOS, two-fold greater cost, and three-fold greater risk of hospital readmission than those without an SSI. CONCLUSIONS: This study provides clinical evidence in support of less invasive approaches to hysterectomy. In addition to other documented benefits of such less invasive procedures, the lower incidence of SSIs and lower rates of associated complications and costs with these procedures than with open abdominal hysterectomy should be taken into account when weighing the risks and benefits of a surgical approach for patients whose condition warrants hysterectomy.

Economic considerations for mid-urethral sling procedures among patients with stress urinary incontinence.

OVERVIEW: Stress urinary incontinence (SUI) is associated with a hefty economic burden. Retropubic and transobturator vaginal slings have become common surgical options for women with SUI. This study examines the costs of transobturator slings for SUI surgeries. METHODS: A model was created to estimate the budget impact to hospitals of transobturator sling surgery in women with SUI. Current practice using transobturator slings including the MonarcTM Subfascial Hammock, Obtryx® Transobturator Mid-Urethral Sling System, Aris® Transobturator Sling System, Align® TO Trans-Obturator Urethral Support System, GYNECARE TVTTM Obturator System Tension-free Support for Incontinence and GYNECARE TVT ABBREVOTM Continence System were modeled. Four surgical complications were considered: re-operation due to failure, revision or removal of sling, urologic complications including urinary obstruction and urinary tract infection, and pelvic complications. This model calculates the average 1-year cost per patient with the use of each sling product and estimates the total budget for sling urinary incontinence surgery associated with each product based on these calculations. RESULTS: Average incremental cost over 1 year ranged from $2,601 (GYNECARE TVTTM Obturator) to $3,132 (Desara®) per patient. In a hypothetical population of 100 patients, a 10% shift from the most to the least expensive option was associated with a 2% decrease in hospital expenditures. With the current market share for transobturator sling products, the expected expenditure is around $285,533 for a surgical population of 100 patients. Sling costs account for approximately $105,526 (37%) of this cost, with complications comprising the remaining majority. CONCLUSION: This study represents the first comparative assessment of the costs of different sling options for stress urinary incontinence surgeries. GYNECARE TVT ABBREVOTM and GYNECARE TVTTM Obturator products represent a sound clinical and economic choice for hospitals. Moreover, the reduction in expenditures is obtained at the benefit of patients, who experience fewer complications and avoid complication-related procedures.

An explanatory model for state Medicaid per capita prescription drug expenditures.

Rising prescription drug expenditure is a growing concern for publicly funded drug benefit programs like Medicaid. To be able to contain drug expenditures in Medicaid, it is important that cause(s) for such increases are identified. This study attempts to establish an explanatory model for Medicaid prescription drugs expenditure based on the impacts of key influencers/predictors identified using a comprehensive framework of drug utilization. A modified Andersen's behavior model of health services utilization is employed to identify potential determinants of pharmaceutical expenditures in state Medicaid programs. Level of federal matching funds, access to primary care, severity of diseases, unemployment, and education levels were found to be key influencers of Medicaid prescription drug expenditure. Increases in all, except education levels, were found to result in increases in drug expenditures. Findings from this study could better inform intervention policies and cost-containment strategies for state Medicaid drug benefit programs.

Assessment of the psychometric properties of the Short-Form Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) following surgical placement of Prolift+M: a transvaginal partially absorbable mesh system for the treatment of pelvic organ prolapse.

INTRODUCTION: Impairment of sexual function is a significant problem among women suffering from pelvic organ prolapse (POP). Because anatomical measures of POP do not always correspond with patients' subjective reports of their condition, patient-reported outcome measures may provide additional valuable information regarding the experiences of women who have undergone surgery. The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) is a validated, widely used condition-specific questionnaire focused on sexual function among patients with POP or urinary incontinence. AIM: This study aims to report sexual function outcomes as measured by PISQ-12 and to evaluate the psychometric characteristics of the questionnaire following surgical mesh implant for the treatment of POP. MAIN OUTCOME MEASURES: The PISQ-12 was used to measure sexual function, while a set of other measures, namely, Pelvic Organ Prolapse Quantification, Patient Global Impression of Change, Pelvic Floor Distress Inventory, Pelvic Floor Impact Questionnaire, and Surgical Satisfaction Questionnaire, was used for validation. METHODS: Data for the study were collected from a prospective multicenter, single-arm study of surgical POP repair via the transvaginal placement of a partially absorbable mesh system. For baseline, month 3, and month 12 following POP surgery, several psychometric properties of the PISQ-12 were evaluated, including internal consistency (Cronbach's alpha), concurrent validity, discriminant validity, and responsiveness. RESULTS: As measured by the PISQ-12 questionnaire, statistically significant improvements were observed in the composite summary score as well as all three subscale scores at 1 year. The PISQ-12 generally demonstrated good psychometric properties including internal consistency reliability, validity, and responsiveness. The PISQ-12 items had good distributional properties at baseline, with substantial ceiling effects at follow-up visits reflecting improvements experienced by the patients. CONCLUSION: The PISQ-12 is a valid measure of sexual function in studies involving patients with POP.

A real-world comparative assessment of complications following various mid-urethral sling procedures for the treatment of stress urinary incontinence.

Stress urinary incontinence affects a significant proportion of the adult female population in the United States with prevalence increasing with growing age. Mid-urethral slings are among surgical options offering important improvement in the condition. The aim of this study was to evaluate clinical outcomes of different mid-urethral sling products with respect to postsurgery complications. This retrospective study utilized data from the Premier Perspective Database for mid-urethral sling procedures between 2005 and 2009. Patients were grouped into retropubic or transobturator cohorts, and these cohorts were further divided by the sling utilized during the procedure. Surgical outcomes and 12-month complication rates were assessed. In general, there were fewer complications noted for transobturator procedures than for retropubic procedures. In the retropubic category, Gynecare TVT had significantly lower rates of urinary obstruction/retention than other retropubic procedures. In the transobturator category, lower rates of overall pelvic complications as well as urologic complications, including urgency incontinence and urinary tract infections, were observed in the Gynecare TVTO subgroup than other transobturator procedures. Results of this study confirm the low overall rate of complications for midurethral sling procedures while at the same time suggesting that product choice may also have an impact on complication rates.