Four-factor prothrombin complex concentrate is not inferior to andexanet alfa for the reversal or oral factor Xa inhibitors: An Eastern Association for the Surgery of Trauma multicenter study.

BACKGROUND: Andexanet alfa (AA) is the only FDA-approved reversal agent for apixaban and rivaroxaban (DOAC). There are no studies comparing its efficacy with four-factor prothrombin complex concentrate (PCC). This study aimed to compare PCC to AA for DOAC reversal, hypothesizing noninferiority of PCC. METHODS: We performed a retrospective, noninferiority multicenter study of adult patients admitted from July 1, 2018, to December 31, 2019, who had taken a DOAC within 12 hours of injury, were transfused red blood cells (RBCs) or had traumatic brain injury, and received AA or PCC. Primary outcome was PRBC unit transfusion. Secondary outcome with intensive care unit length of stay. MICE imputation was used to account for missing data and zero-inflated Poisson regression was used to account for an excess of zero units of RBC transfused. Two units difference in RBC transfusion was selected as noninferior. RESULTS: Results: From 263 patients at 10 centers, 77 (29%) received PCC and 186 (71%) AA. Patients had similar transfusion rates across reversal treatment groups (23.7% AA vs. 19.5% PCC) with median transfusion in both groups of 0 RBC. According to the Poisson component, PCC increases the amount of RBC transfusion by 1.02 times (95% confidence interval, 0.79-1.33) compared with AA after adjusting for other covariates. The average amount of RBC transfusion (nonzero group) is 6.13. Multiplying this number by the estimated rate ratio, PCC is estimated to have an increase RBC transfusion by 0.123 (95% confidence interval, 0.53-2.02) units compared with AA. CONCLUSION: PCC appears noninferior to AA for reversal of DOACs for RBC transfusion in traumatically injured patients. Additional prospective, randomized trials are necessary to compare PCC and AA for the treatment of hemorrhage in injured patients on DOACs. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level III.

Laparoscopic gastric bypass to robotic gastric bypass: time and cost commitment involved in training and transitioning an academic surgical practice.

The Roux-en-Y gastric bypass is the gold standard procedure for weight loss. This relatively complex procedure has excellent outcomes when performed via laparoscopy. The advent of the DaVinci robotic platform has been a technological advancement. Our goal is to provide information regarding the cost, time commitment, and advantages of transitioning an LRYGB program to an RRYGB program in an academic setting. We retrospectively reviewed the last 25 laparoscopic gastric bypass procedures and the first 25 robotic gastric bypass procedures performed by a single surgeon. We compared clinical outcomes and focused on time and hospital cost during this transition phase. There was no significant demographic difference between the groups. The mean age was 41.7 (RRYGB) years vs 43.4 (LRYGM) years. The mean BMI were similar between groups, 45.3 vs 46.5 kg/m(2) for RRYGB and LRYGB. No anastomotic leaks or mortalities were noted. There was one anastomotic stricture in both groups. Excess weight loss was similar in both groups at 1 year. There was a significant increase in operative time with RRYGB, mean 241 min vs mean 174 min (p = 0.0005). Operative time fell by 25 min after the first 10 cases. The hospital cost was also increased with RRYGB mean $5922 vs $4395 (p = 0.03). Transitioning from a laparoscopic to a robotic practice can be done safely, however, the initial operative times were longer and the hospital cost was higher for robotic gastric bypass. We hope in the future that these will decrease after overcoming the learning and as the technology becomes widespread.