[Assessment of clinical utility of 111In-DTPA-IgG scintigraphy in the detection of inflammation/infection--a report of multicenter phase II clinical trials].

A Phase II clinical study was performed in patients with strongly suspected focal sites of inflammation/infection to investigate clinical utility of 111In-DTPA-IgG. Neither adverse effects nor abnormal laboratory changes were noted in the all cases. Out of 59 patients, the clinical utility was evaluated in 56 patients with a total of 67 suspicious sites (19 in thorax, 13 in abdomen and pelvis, 30 in musculoskeletal system, and 5 in other regions). True positive results were obtained in 100% of lesions in the thorax (13/13) and the musculoskeletal system (26/26). There were three false negative and five false positive results. Overall sensitivity and specificity was 94.0% and 70.6%, respectively. Most of the true positive scintigram with the best image quality was acquired at Day 1 or Day 2 post-injection. A dose of 80 MBq was considered to be a practical dose for imaging. Our study indicates that 111In-DTPA-IgG is a safe and promising imaging agent for the detection of inflammation/infection, and that it is reasonable to proceed with Phase III studies to further evaluate clinical utility of the agent.

Combined assessment with myocardial contractility and an index related to ventricular afterload in patients with isolated severe mitral regurgitation undergoing valve replacement. A retrospective study.

The afterload to the left ventricle increases following valve replacement in chronic mitral regurgitation (MR), yet there has been no study taking into account left ventricular (LV) afterload. In 43 patients with isolated chronic MR undergoing mitral valve replacement (MVR), we calculated LV wall stress using preoperative LV end-diastolic dimensions and diastolic aortic pressure (predictive LV wall stress = pWS). This value would represent LV wall stress at the instant of aortic valve opening immediately after MVR, assuming that LV end-diastolic dimensions and the aortic pressure did not change after operation. We also calculated end-systolic wall stress/volume index (ESS/ESVI) ratio, an index of myocardial function. None of 15 patients with the ESS/ESVI ratio > 1.6 had postoperative mortality or morbidity, whereas among the 26 patients with the ESS/ESVI ratio < 1.6, 12 patients had mortality (3 patients) and/or morbidity requiring intraaortic balloon pumping or prolonged catecholamine support. Three patients who died had pWS > 200 kdynes/cm2. Including these 3, all 5 patients whose pWS > 200 had mortality or severe morbidity immediately after surgery. In contrast, among the 38 patients with lower pWS, none died and only 7 patients (18%) had morbidity. Thus, patients who had a low contractility index and a high predictive afterload value had high mortality and morbidity. We conclude that the prediction of postoperative mortality and morbidity is improved by combined assessment of myocardial function and the hypothetical postoperative LV afterload.