Lower-Extremity Edema Associated with Gene Transfer of Naked DNA Encoding Vascular Endothelial Growth Factor

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Abstract
Vascular endothelial growth factor (VEGF) promotes angiogenesis and vascular permeability. The extent to which VEGF may cause tissue edema in humans has not been established. To evaluate patients undergoing VEGF gene transfer for evidence of lower-extremity edema. Prospective consecutive case series. Hospital outpatient clinic. 62 patients with critical limb ischemia and 28 patients with claudication. Gene transfer of VEGF DNA. Semiquantitative analysis of lower-extremity edema. Lower-extremity edema was observed in 31 of 90 (34%) patients. Edema was less common in patients with claudication than in those with pain at rest (P = 0.016) or ischemic ulcers (P < 0.001), and it was less common in patients with pain at rest than in those with ischemic ulcers (P = 0.017). Treatment was typically limited to a brief course of oral diuretics. Vascular endothelial growth factor may enhance vascular permeability in humans. At the doses of plasmid DNA used in this study, lower-extremity edema responded to oral diuretic therapy and did not seem to be associated with serious sequelae.

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