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A comprehensive clinical validation of the nuclear stethoscope.

Five studies were conducted to examine the degree of variability to be expected during the use of the non-imaging nuclear probe (BIOS Inc.) under a variety of clinical conditions. Comparison of the ejection fraction (EF) readings between the nuclear probe and a gamma camera showed good agreement, with the nuclear probe tending to underestimate lower, and overestimate higher camera EF values [mean (S.D.) difference, 0.84% (6.06)]. A comparison of two nuclear probes showed a small mean (S.D.) difference of EF readings of 0.063% (2.26). EF readings obtained in normal subjects 6 weeks apart were reproducible and differed by a mean (S.D.) of 0.23% (4.42). The administration of placebo to 10 normal subjects followed by sequential measurements for 4 h produced EF changes large enough to mimic a clinical effect, the largest hourly change observed being 5.4%, indicating the need for strict placebo control in interventional experiments. Data on four patients with heart failure showed small non-significant EF changes in the 1 h after placebo administration but a wide intra-subject range of ejection time and time to peak filling measurements. This highlights the problem of accurate, reproducible cursor placement in such patients. The nuclear probe is a portable, low cost instrument which produces accurate EF measurements when compared with the gamma camera.

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