Evaluation of the IITC tail cuff blood pressure recorder in the rat against intraarterial pressure according to criteria for human devices.

National standards govern the manufacture and marketing of medical devices in the United States, including those for indirect blood pressure measurement in man. There are no comparable standards for devices for recording in laboratory animals. Noninvasive tail cuff blood pressure (BP) recording in the rat is widely accepted, but beset by methodologic difficulties. Intraarterial recording is regarded as the "gold standard" but is invasive and also susceptible to methodologic error. We compared the IITC Mark 12 photoelectric/oscillometric tail cuff system (IITC Life Sciences, Woodland Hills, CA) versus simultaneous femoral intraarterial recordings in spontaneously hypertensive rats, during anesthesia and 1 to 2 days after recover (150 recordings under each condition), according to the guidelines for human data collection and analysis suggested the American National Standard for automated sphygmomanometers. Within- and between-observer disagreements in estimates made by two observers from 40 anesthetized recordings were less for intraarterial measurements than for the tail cuff method. Within-observer differences (mean +/- SD of differences [SDD]) for systolic, diastolic, and mean pressure were 0 +/- 1, 0 +/- 1, and 0 +/- 1 mm Hg for intraarterial versus -1 +/- 3, 0 +/- 8, and 0 +/- 5 mm Hg for tail cuff. Between-observer differences were 0 +/- 2, 0 +/- 1, and 6 +/- 2 mm Hg versus 5 +/- 4, 13 +/- 7, and 0 +/- 5 mm Hg, respectively. Differences between tail cuff and intraarterial methods were 16 +/- 13, -5 +/- 11, and 2 +/- 8 mm Hg in anesthetized animals and 8 +/- 14, -5 +/- 9, and 0 +/- 9 mm Hg in conscious animals (39% to 82% of differences exceeded 5 mm Hg). The upper limits of clinically acceptable disagreement in the American National Standard are: mean of 5 mm Hg, SDD of 8 mm Hg. The disagreement between tail cuff and intraarterial recordings cannot be ascribed to either method with certainty. These findings do not support the manufacturer's guarantee of tail-cuff readings within "5 mm Hg of intraarterial." Inaccuracy and unreliability of devices intended for laboratory animal use have considerable scientific, fiscal, and ethical implications. Marketing of these devices should also be governed by rigorous standards.

Midline "nonhealing" granuloma.

Destructive processes of the midface can occur in a wide variety of diseases. Intrinsic in consideration of these is a cluster of lesions, including Wegener's granulomatosis (WG), idiopathic midline granuloma (IMG), polymorphic reticulosis (PR), and lymphoma. Although there is still confusion as to whether the latter three represent a spectrum of the same malignant process, there is general agreement that WG is a separate entity on the basis of clinical presentation and therapeutic response. It is probable that PR is an emergent lymphoma, with the same prognostic and therapeutic features. Idiopathic midline granuloma is clinically similar to PR and lymphoma, but histologically it appears to be inflammatory in nature with no clearly definable malignant cell type present. At this point in time three diseases are best collectively referred to as midline "nonhealing" granuloma. The cases presented represent the spectrum of this enigmatic process.