Intravascular Lithotripsy for Treatment of Calcified, Stenotic Iliac Arteries: A Cohort Analysis From the Disrupt PAD III Study.

PURPOSE: The presence of calcification in the iliac arteries is associated with decreased procedural success and increased complication risk during endovascular intervention. The objective of this study was to evaluate the safety and efficacy of peripheral intravascular lithotripsy (IVL) during endovascular treatment of iliac arterial peripheral artery disease (PAD). METHODS: The Disrupt PAD III Observational Study is a prospective, non-randomized, multi-center single-arm study to assess the 'real-world' safety and effectiveness of the Shockwave Peripheral IVL System for the treatment of de novo calcified lesions in the peripheral arteries, with a goal of treating 1500 patients. This is an analysis of consecutive patients enrolled for treatment of an iliac artery, a specified sub-group, with at least moderate calcification and a minimum length of 20 mm. RESULTS: Between December 2017 and July 2019, 118 patients with a total of 200 lesions were enrolled across 20 sites. 101 patients were treated primarily for claudication or critical limb ischemia, while 17 patients were treated to optimize the iliac vasculature for large-bore access. All 118 patients had successful IVL catheter delivery. The average reference vessel diameter was 7.3 mm ± 1.9 mm, with an average diameter stenosis of 83.1% ± 13.4% and an average lesion length of 58.3 mm ± 57.6 mm. Severe calcification was present in 82.0% of overall cases. Stent placement was performed in 72.9% of the overall cases. As expected, the access group received less adjunctive therapies including stents (41.2%, p < 0.001). Angiographic complications were minimal with no flow-limiting dissections and a final mean residual stenosis of 12.0% ± 12.1% with no differences between the groups. CONCLUSIONS: Acute results with IVL in calcified iliac lesions suggest that it is a safe and effective option for calcified, stenotic iliac disease. IVL can be used successfully both for treatment of PAD symptoms and to optimize access for large-bore procedures.

Autoradiographic evaluation of electromagnetic field effects on serotonin (5HT1A) receptors in rat brain.

Serotonin (5HT1A) is a chemical mediator of inflammation and the largest single neurotransmitter system of the brain. Its secretion and physiological actions mediate stress and pain, affecting both immune and nervous system functions through the hypothalamic-pituitary-adrenal axis. Serotonin receptor dysfunction is well-characterized in mental disturbances like depression and anxiety. Transcranial magnetic stimulation has been used therapeutically to treat refractory disorders like non-responsive depression and may act in part through its effect on 5HT1A receptors. Previously we have shown that in vitro, 5HT1A receptor binding to a radioactive agonist can be modulated by specific intensity and frequency electromagnetic fields (EMFs). In the present report we have used quantitative receptor autoradiography to evaluate 5HT1A receptor density in rat brain and the impact of pulsed EMF exposure on receptor binding in key brain regions. Rats used in this study had whole body exposures to either a geofield control or to pulsed EMFs to evaluate the treatment for chemically-induced tendinitis. Since the brains were exposed coincidentally as a consequence of the main experiment, we investigated the potential for EMF-induced changes in areas such as the hippocampus. This pilot study should provide a detailed understanding of magnetic field effects on stress-responsive brain regions and will lead to a more coordinated approach to the use of such modalities for therapeutic intervention in humans.

Effect of short duration electromagnetic field exposures on rat mass.

Daily preexposure and postexposure mass measurements of 65 rats (young males and females, old males) a proprietary pulsed wound healing field, pulsed electromagnetic field, (PEMF), or their control fields for 4 h/day for 21 days. Statistical analysis of mass changes over time showed that young rats exposed to PEMF lost more mass and recovered it more slowly compared to controls (2-4% more loss) than did older PEMF exposed rats or any 60 Hz exposed rats. We conclude that daily preexposure and postexposure mass measurements are needed to adequately assess the effects of electromagnetic fields on body mass.