Pharmacist-Integrated Early Screening for Postoperative Complications in Pediatric Cardiac Surgery: Evidence Synthesis and Derivation of the Pediatric Early Complication Score

Abstract

Background: Early postoperative complications remain a major determinant of morbidity and mortality in pediatric cardiac surgery despite improved survival. Conventional risk systems such as RACHS and RASCH focus on procedural complexity and mortality rather than real-time complication prediction Objectives: This systematic review and meta-analysis aimed to quantify the pooled incidence and predictors of early postoperative complications and to derive a concise, evidence-based Pediatric Early Complication Score (PECS) to support early screening and pharmacist-integrated care. Methods: Eligible studies enrolled patients <18 years undergoing congenital heart surgery and reported extractable complication incidences or predictor-adjusted effects. Data were pooled using random-effects meta-analysis with prespecified thresholds (e.g., cardiopulmonary bypass [CPB] ≥120 minutes, C-reactive protein [CRP] >118 mg/L). Internal validity was reinforced by preregistration, standardized definitions, duplicate assessment, adjusted-effect preference, and ROBINS-I/RoB2 risk-of-bias tools. Results: Across 13 observational studies (n≈25,000) and two randomized trials, higher operative complexity (RACHS 3–6 or RASCH-2 ≥4), prolonged CPB exposure, neonatal age (≤60 days), and elevated CRP/D-dimer were consistently associated with approximately threefold higher early-complication risk (pooled adjusted effect ≈2.8, 95% CI 2.03–3.88, I²≈23%). These reproducible predictors were transformed into integer points (4, 2, 2, 2, 1 respectively) to form the PECS, which stratifies patients into low (0–3), moderate (4–6), and high (≥7) risk tiers via a logistic probability link. Conclusions: The PECS offers a transparent, internally valid, and clinically tractable bedside tool integrating surgical complexity, CPB duration, age, and inflammatory response to predict early postoperative complications. Its pragmatic design supports pharmacist-led, prevention-focused care and warrants multicenter calibration and external validation.