Effect of Changing Estimated Glomerular Filtration Rate Formula on Sugammadex Use and Pulmonary Complications for African American and non-African American Patients.

Abstract

Background: Sugammadex is associated with fewer postoperative pulmonary complications than is neostigmine reversal of neuromuscular blockade. However, the Food and Drug Administration-approved package insert states that its use is "not recommended" in severe renal impairment, separately defined as creatinine clearance <30 mL/min. Recently, the formula for estimating glomerular filtration rate (GFR) was updated to remove the race variable. Compared to the prior formula, the new consensus equation lowers the estimated GFR for African American patients and raises it for everyone else. We sought to determine how this change could differently impact the use of sugammadex, and thus the rate of pulmonary complications, for both African American and non-African American patients.

Methods: We used Monte Carlo simulation models to estimate the difference in pulmonary complications that would be suffered by patients when the change in creatine clearance calculated from the estimated GFR (using the old race-based and new race-neutral Chronic Kidney Disease Epidemiology Collaboration formulas) crossed the 30 mL/min threshold, which would require a change in sugammadex or neostigmine use.

Results: We found that 0.22% (95% confidence interval 0.14%-0.36%) of African American patients' creatinine clearance would drop from above to below 30 mL/min making sugammadex not recommended and 0.19% (0.16%-0.22%) of non-African American patients would have creatinine clearance increase to >30 mL/min making sugammadex now recommended. Based on our model, we estimate that African American patients would suffer (count [95% confidence interval]) 3 [0.4-6] more pulmonary complications per 100,000 African American patients who received rocuronium or vecuronium through the change from sugammadex to neostigmine reversal to comply with labeling recommendations. Conversely, the same change in formulas would reduce the number of non-African American patients suffering pulmonary complications by 3 [2-4] per 100,000.

Conclusions: The recent change in GFR formulas may potentially be associated with an increase in postoperative pulmonary complications in African American patients and a decrease in postoperative pulmonary complications in non-African American patients through GFR-driven changes in sugammadex use.