Medical Devices: Evidence and Research (Sep 2022)
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
Abstract
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 [email protected]: 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.Keywords: radical nephrectomy, hemostasis-related complications, endoscopic surgical staplers, healthcare utilization
