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A Journal on Phlebology
Acta Phlebologica 2014 April;15(1):19-23
Transvascular autonomic modulation, initial assessment of safety
Arata M., Debarge P.
Synergy Health Concepts, Newport Beach, CA, USA
AIM: This study assesses the safety of transvascular autonomic modulation (TVAM), a novel treatment for improving cardiovascular autonomic nervous system (ANS) dysfunction.
METHODS: One hundred forty-four patients who exhibited symptoms of cardiovascular ANS dysfunction underwent TVAM. Treatment deviated from balloon angioplasty by treating veins (internal jugular, azygos and renal veins) regardless of the presence of vascular abnormalities. The improvement in ANS function was indicated by determining the changes in R-R interval during deep breathing, valsalva maneuver, and postural change.
RESULTS: One hundred forty patients (97%) reported subjective improvement in at least one symptom. Warming of the extremities was seen in 64% of patients with improvements in fatigue, 62%, and cognition, 64%, also reported. Post treatment HRV analysis demonstrated MCR and postural response in 71% and 57%, respectively. The MCR parameter change reached statistical significance 0.75±2.1, P<0.01. Acute adverse events did not occur during any of the procedures. Two access site infections requiring oral antibiotic therapy and one jugular thrombosis were identified within 30 days of procedure, corresponding to an overall 30 day adverse event rate of 2.3%.
DISCUSSION: TVAM appears safe to perform in the outpatient setting. Subjective symptomatic and HRV improvements are encouraging. TVAM should be investigated further.