Methods of ultrasonic angiography and spectrum analysis of the Doppler signal in the diagnosis of the degree of occlusive lesions of the brachiocephalic arteries

Results of an examination of 39 patients are described and critically assessed. An analysis of the resolving power of the method of ultrasonic angiography in pathological formations of major vessels of the neck is given.     

Clinical Evaluation of Automatic Tachycardia Diagnosis by an Implanted Device

Reliable discrimination between sinus tachycardia (ST) and pathologic tachycardia has been a major problem for automatic implantable antitachycardia devices. In patients whose sinus response to activity is as rapid or faster than their pathologic tachycardia (rate crossover), these unsophisticated devices deliver the programmed tachycardia response to either the pathologic or sinus tachycardia. Over a one-year period, 50 Intermedics Intertach Model 262–12 antitachycardia pulse generators were implanted to evaluate the specificity of a new group of tachycardia recognition algorithms. Patients were subjected to exercise testing and noninvasive programmed stimulation to demonstrate the efficacy of this new approach. The five recognition algorithms tested were various combinations of the following criteria: high rate HR), sudden onset (SO), rate stability (RS), and sustained high rate (SHR). False positive rates (tachycardia response inappropriately triggered by ST) were as follows: HR (93%); HR + SO (3%); HR + RS (63%); HR + (RS or SHR) (87%); HR + HS + SO (8%). Pair-wise significance testing between HR only and HR + SO (p < 0.001), HR + RS (p = 0.01) and HR + SO + RS (p < 0.001), demonstrated a significant reduction in the rate of false positives through the use of the sudden onset and rate stability criteria in concert with the standard high rate criterion.     

On the natural course of oral lichen lesions in a Swedish population-based sample

OBJECTIVES: The aim was to assess the natural course of oral lichen lesions (OLL) among unselected, non-consulting individuals. SUBJECTS AND METHODS: A cohort of 327 subjects with OLL, confirmed in 1973-1974 during a population-based survey in two Swedish municipalities, was followed through January 2002 via record linkages with nationwide and essentially complete registers. A sample of 80 drawn from the 194 surviving subjects who still resided in the area in 1993-1995 was invited for interview and oral re-examination. RESULTS: At the end of follow-up, one case of oral cancer was detected, while 0.4 were expected. The overall mortality among subjects with OLL was not significantly different from that in the 15,817 OLL-free subjects who participated in the initial population based survey in 1973-1974. The lesion had disappeared in 14 (39%) of 36 re-examined subjects with white OLLs in 1973-1974, and four (11%) had transformed into red types. In the corresponding group of 19 with red forms initially, five (26%) had become lesion free and four (21%) had switched to white types. Although the cohort size does not permit firm conclusions regarding oral cancer risk, the natural course over up to 30 years appears to be benign in the great majority.     

FDA’S Perspectives on Cardiovascular Devices

The Food and Drug Administration (FDA) decision process for approving or clearing medical devices is often determined by a review of robust clinical data and extensive preclinical testing of the device. The mission statement for the Center for Devices and Radiological Health (CDRH) is to review the information provided by manufacturers so that it can promote and protect the health of the public by ensuring the safety and effectiveness of medical devices deemed appropriate for human use (Food, Drug & Cosmetic Act, §903(b)(1, 2(C)), December 31, 2004; accessed December 17, 2008 ). For high-risk devices, such as ventricular assist devices (VADs), mechanical heart valves, stents, cardiac resynchronization therapy (CRT) devices, pacemakers, and defibrillators, the determination is based on FDA’s review of extensive preclinical bench and animal testing followed by use of the device in a clinical trial in humans. These clinical trials allow the manufacturer to evaluate a device in the intended use population. FDA reviews the data from the clinical trial to determine if the device performed as predicted and the clinical benefits outweigh the risks. This article reviews the regulatory framework for different marketing applications related to cardiovascular devices and describes the process of obtaining approval to study a cardiovascular device in a U.S. clinical trial.