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Stephen S Johnston,1 Mosadoluwa Afolabi,1 Pranjal Tewari,2 Walter Danker3 1MedTech Epidemiology and Real-World Data Sciences, Johnson and Johnson, New Brunswick, NJ, USA; 2Mu Sigma, Bangalore, India; 3Franchise Health Economics and Market Access, Ethicon, Johnson & Johnson, Raritan, NJ, USACorrespondence: Stephen S Johnston, MedTech Epidemiology and Real-World Data Sciences, Johnson & Johnson, 410 George Street, New Brunswick, NJ, 08901, USA, Tel +1-443-254-2222, Email sjohn147@its.jnj.comBackground: Hemostatic agents are used to control surgical bleeding; however, some patients experience disruptive bleeding despite the use of hemostats. In patients receiving hemostats, we compared clinical and economic outcomes between patients with vs without disruptive bleeding during a variety of surgical procedures.Methods: This was a retrospective analysis of the Premier Healthcare Database. Study patients were age ≥ 18 with a hospital encounter for one of 9 procedures with evidence of hemostatic agent use between 1-Jan-2019 and 31-Dec-2019: cholecystectomy, coronary artery bypass grafting (CABG), cystectomy, hepatectomy, hysterectomy, pancreatectomy, peripheral vascular, thoracic, and valve procedures (first procedure = index). Patients were grouped by presence vs absence of disruptive bleeding. Outcomes evaluated during index included intensive care unit (ICU) admission/duration, ventilator use, operating room time, length of stay (LOS), in-hospital mortality, and total hospital costs; 90-day all-cause inpatient readmission was also evaluated. Multivariable analyses were used to examine the association of disruptive bleeding with outcomes, adjusting for patient, procedure, and hospital/provider characteristics.Results: The study included 51,448 patients; 16% had disruptive bleeding (range 1.5% for cholecystectomy to 44.4% for valve). In procedures for which ICU and ventilator use is not routine, disruptive bleeding was associated with significant increases in the

Barbara H Johnson,1 Stephen S Johnston,1 Pranjal Tewari,2 Mosadoluwa Afolabi,1 Walter Danker III3 1Epidemiology, Johnson & Johnson, New Brunswick, NJ, USA; 2Data Sciences, Mu Sigma, Bengaluru, Karnataka, India; 3Ethicon Franchise Health Economics and Market Access, Johnson & Johnson, Raritan, NJ, USACorrespondence: Barbara H Johnson, Real-World Data Analytics and Research, Epidemiology - MedTech, Johnson & Johnson, 410 George Street, New Brunswick, NJ, 08901, USA, Tel/Fax +1 603 616 6719, Email BJohns23@its.jnj.comPurpose: Prophylactic use of lung sealants among patients undergoing thoracic resection has been reported for the management of intraoperative air leaks and is associated with a lower incidence of prolonged air leak (PAL) and a shorter length of stay (LOS). This study estimated the incremental economic and clinical burden of PAL among patients with lung sealants used during thoracic resection in the United States.Patients and Methods: This retrospective analysis examined hospital data (Premier Healthcare Database) for adults (age ≥ 18 years) with inpatient thoracic resection between October 2015 - March 2021 (first admission=index) and lung sealant used during their procedure. Follow-up extended through 90 days post-discharge. Patients were grouped by presence/absence of PAL (ie, diagnosis of post-procedural air leak or post-procedural pneumothorax with associated LOS exceeding 5 days). Outcomes included intensive care unit (ICU) days, total index hospital costs, all-cause 30-, 60-, and 90-day readmission, discharge status, and in-hospital mortality. Generalized linear models quantified associations between PAL and outcomes, accounting for hospital-level clustering, and patient, procedure, and hospital/provider characteristics.Results: Among the 9727 patients included for study (51.0% female, 83.9% white, mean age 66 years), 12.5% had PAL, which was associated with significant incremental increases in ICU days (0.93 days, p< 0.001) and tot

Stephen S Johnston,1 Barbara H Johnson,1 Divya Chakke,2 Sanjoy Roy,3 Philippe Grange,4 Esther Pollack3 1MedTech Epidemiology and Real-World Data Sciences, Johnson & Johnson, New Brunswick, NJ, USA; 2Analytics, Mu Sigma, Bangalore, India; 3Franchise Health Economics and Market Access, Johnson & Johnson, Raritan, NJ, USA; 4Medical, Johnson & Johnson, Cincinnati, OH, USACorrespondence: Stephen S Johnston, Real-World Data Analytics and Research, MedTech Epidemiology and Real-World Data Sciences, Johnson & Johnson, 410 George Street, New Brunswick, NJ, USA, Tel +1-443-254-2222, Email sjohn147@its.jnj.comPurpose: 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

Stephen S Johnston,1 Brian Po-Han Chen,2 Pragya Rai,1 Philippe Grange,3 Harikumaran R Dwarakanathan,4 Tony Amos,5 Barbara H Johnson,1 Sudip K Ghosh,2 Noor Buchholz6 1MedTech Epidemiology and Real-World Data Sciences, Johnson & Johnson, New Brunswick, NJ, USA; 2Health Economics and Market Access, Ethicon, Raritan, NJ, USA; 3Medical Affairs, Johnson & Johnson, Cincinnati, OH, USA; 4MuSigma, Bengaluru, Karnataka, India; 5Real World and Integrated Evidence Strategy, LCI, Johnson & Johnson, New Brunswick, NJ, USA; 6U-Merge Ltd. (Urology for Emerging Countries), London, UKCorrespondence: Stephen S Johnston, Real-World Data Analytics and Research, Epidemiology - MedTech Epidemiology and Real-World Data Sciences, Johnson & Johnson, 410 George Street, New Brunswick, NJ, 08901, USA, Tel +1-443-254-2222, Email sjohn147@its.jnj.comPurpose: This study describes the incremental healthcare costs associated with retreatment among adults undergoing ureteroscopy (URS) or percutaneous nephrolithotomy (PCNL) for upper urinary tract stones (UUTS).Patients and Methods: The IBM® MarketScan® Commercial Database was used to identify adults aged 18– 64 years with UUTS treated with URS or PCNL between January 2010 and December 2019. Patients had 12 months of continuous insurance coverage before (baseline) and after (follow-up) the first (index) procedure. The primary outcome was total all-cause healthcare costs measured over the 365-day follow-up period, not inclusive of index costs. Generalized linear models were used to estimate the incremental costs associated with retreatment within 90 (early) or 91– 365 days post-index (later) relative no retreatment. The models adjusted for demographics, comorbidities, stone(s) location, treatment setting, procedural characteristics (eg, 1-step vs 2-step PCNL) and index year.Results: Approximately 23% (27,402/119,800) of URS patients were retreated (82% had early retreatments). The adjusted mean total cost was &dollar;10,478 (9

Walter Danker III,1 Jyoti Aggarwal,2 Sneha S Kelkar,2 Xiaocong L Marston,2 Xin Gao,2 Stephen S Johnston3 1Ethicon Inc., Somerville, NJ, USA; 2OPEN Health, Bethesda, MD, USA; 3Johnson & Johnson Co., New Brunswick, NJ, USACorrespondence: Jyoti Aggarwal, OPEN Health, 4350 East West Hwy #1100, Bethesda, MD, 20814, USA, Tel +1-240-821-1265, Email jyotiaggarwal@OpenHealthgroup.comBackground: Topical hemostatic agents are an option for controlling bleeding during cardiovascular surgery. Previous studies comparing topical hemostatic agents in cardiovascular surgery predate the 2012 reformulation of Surgiflo®, which had been re-engineered to increase paste viscosity and thus be more adherent to the bleeding surface.Objective: To compare clinical and economic outcomes in patients receiving the current formulation of Surgiflo vs Floseal during cardiovascular surgeries.Methodology: A retrospective analysis was conducted using the Premier Healthcare Database. Eligible patients had an inpatient cardiovascular surgery between 1/1/2013 and 6/1/2018, were ≥ 18 years old and received the current formulation of Surgiflo or Floseal during surgery. Propensity score matching was performed, with exact matching on the surgery year and surgery type (aortic, coronary artery bypass grafting, valve, or other). Descriptive analysis and generalized estimating equations models compared outcomes between the Surgiflo and Floseal groups.Results: The matched sample included 5768 patients in each group (mean age: 66.5 years; 66.3% male). In the matched sample, rates of any documented bleeding event were similar in Surgiflo and Floseal groups (6.9% vs 7.2%; P = 0.576). Differences in transfusion rates between patients receiving Surgiflo vs Floseal varied by operational definition and timing of measurement but did not differ by > 2 percentage points. Compared to Floseal, patients who received Surgiflo experienced longer surgery duration (306.0 vs 299.4 minutes), lower hospitalization cost ($44