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Reasons from anatomy, pathophysiology, and the IDEAL stage of surgical innovation through IDE/IND pathways, NSQIP/STS registry risk-adjustment, CUSUM learning-curve analysis, and ischemia-timed biobank SOPs while treating unrisk-adjusted case series, indication-confounded surgeon-preference comparisons, cold-ischemia biomarker artifact, and conflated learning-curve and surgeon-volume effects as first-class failure modes.