Presented at ASA, October 24, 2015

Lisa M. Einhorn, M.D., Jonathan C. Routh, M.D.,M.P.H., Nathaniel H. Greene, M.D.
Duke University Medical Center, Durham, North Carolina, United States


Background: In 2007, the United States Food and Drug Administration Anesthetic and Life Support Drugs Advisory Committee released a recommendation that all elective procedures in infants be delayed until six months of age for concerns of neurotoxicity. Since then, a substantial number of medical procedures requiring general anesthesia have been postponed. However, there have been no reports in the medical literature examining how often elective procedures are still being performed in this population. This study uses publicly available data to estimate the number of elective procedures occurring in infants less than six months of age in the United States.

Methods: The State Ambulatory Surgery Database (SASD) of the Healthcare Cost and Utilization Project (HCUP), sponsored by the Agency for Healthcare Research and Quality (AHRQ), provides data for a given state on all ambulatory procedures performed within a state for a given year. All patients less than six months of age who had a primary surgical Current Procedural Terminology (CPT) code associated with an ambulatory encounter were identified in the states of California, North Carolina, and Utah from 2007 to 2010. CPT codes that represented elective procedures that could reasonably be postponed until six months of age (hernia repairs, skin cosmetic procedures, and hypospadias procedures) were identified. Using population estimates from the Centers for Disease Control and Prevention (CDC) Wide-ranging Online Data for Epidemiologic Research (WONDER) database for the states represented and the rest of the United States, epidemiologic estimates of unnecessarily early procedures were produced for each state, and extrapolated for the entire United States. Analysis of variance (ANOVA) was used to detect a significant difference between reported rates. A multivariable logistic regression model was additionally developed to estimate the impact of insurance status and state of procedure on the probability that the procedure was unnecessarily early.

Results: The rates of elective procedures performed before six months of age in California, North Carolina, and Utah were 6.6, 25.1, and 15.2 per 10,000 person years (p<0.001), respectively, using population estimates as a denominator population. Using all medical procedures in infants less than six months of age as denominator populations, the proportions in California, North Carolina, and Utah were 27%, 29%, and 29%, respectively (p=0.02). Using a multivariable model, having private insurance was a risk factor for an unnecessarily early procedure (OR 1.29, 95% CI [1.21, 1.37], p<0.001) and having no insurance (self-pay status) trended towards significance (OR 1.23, 95% CI [0.98, 1.56], p=0.08) when compared to government-based insurance. Having a procedure in North Carolina was associated with an increased probability of a procedure being unnecessarily early (OR 1.11, 95% CI [1.04, 1.18], p = 0.002). Based on this data, the estimated number of unnecessarily early surgical procedures in the United States is 8,602.

Discussion: For unclear reasons, a substantial number of likely unnecessarily early surgical procedures are still performed in infants less than six months of age. Furthermore, there is significant variation in timing of these procedures among states. Insurance status and geography may be independent predictors of unnecessarily early surgery being performed.