UPTURE OF ABDOMINAL AORtic aneurysm (AAA) can be prevented by elective surgical repair, but because most AAA never rupture, 1 elective repair is reserved for patients at high risk of rupture. The most commonly used predictor of rupture is the maximum diameter of the AAA. Two randomized trials found no reduction in mortality from repairing AAA smaller than 5.5 cm in patients at low operative risk. 2,3 No randomized trials are available in patients with larger AAA, and decision making in these patients is often complicated by advanced age and serious comorbidities. Surgery is usually deferred in highoperative-risk patients until the AAA attains a diameter at which the risk of rupture is thought to outweigh the operative risk. However, few data are available on the rupture risk of large AAA, resulting in substantial disagreement among experts. 4 We conducted a prospective observational Veterans Affairs Cooperative Study to determine the incidence of rupture in patients with large AAA for whom elective repair was not planned because of medical contraindications or patient refusal.
METHODSEligible patients were those evaluated at 47 Veterans Affairs medical centers who were diagnosed as having AAA of at least 5.5 cm in diameter by ultrasonography or computed tomography (CT) within 3 months prior to enrollment and for
Background—
“Therapeutic angiogenesis” seeks to improve perfusion by the growth of new blood vessels. The Regional Angiogenesis with Vascular Endothelial growth factor (RAVE) trial is the first major randomized study of adenoviral vascular endothelial growth factor (VEGF) gene transfer for the treatment of peripheral artery disease (PAD).
Methods and Results—
This phase 2, double-blind, placebo-controlled study was designed to test the efficacy and safety of intramuscular delivery of AdVEGF121, a replication-deficient adenovirus encoding the 121-amino-acid isoform of vascular endothelial growth factor, to the lower extremities of subjects with unilateral PAD. In all, 105 subjects with unilateral exercise-limiting intermittent claudication during 2 qualifying treadmill tests, with peak walking time (PWT) between 1 to 10 minutes, were stratified on the basis of diabetic status and randomized to low-dose (4×10
9
PU) AdVEGF121, high-dose (4×10
10
PU) AdVEGF121, or placebo, administered as 20 intramuscular injections to the index leg in a single session. The primary efficacy end point, change in PWT (ΔPWT) at 12 weeks, did not differ between the placebo (1.8±3.2 minutes), low-dose (1.6±1.9 minutes), and high-dose (1.5±3.1 minutes) groups. Secondary measures, including ΔPWT, ankle-brachial index, claudication onset time, and quality-of-life measures (SF-36 and Walking Impairment Questionnaire), were also similar among groups at 12 and 26 weeks. AdVEGF121 administration was associated with increased peripheral edema.
Conclusions—
A single unilateral intramuscular administration of AdVEGF121 was not associated with improved exercise performance or quality of life in this study. This study does not support local delivery of single-dose VEGF
121
as a treatment strategy in patients with unilateral PAD.
These results demonstrate for the first time that endogenous opioids modulate in vivo angiogenesis. Opioid growth factor is a tonically active peptide that has a receptor-mediated action in regulating angiogenesis in developing endothelial and mesenchymal vascular cells.
Use of warm water immersion before vein diameter measurement in a sitting position, without a tourniquet, will result in significantly larger diameter findings in normal arm veins. These diameters are likely to more closely resemble the venous diameter after distension with arterial pressure. Further studies are needed to see if warming in patients could result in increased utilization of autogenous arm vein for dialysis access and bypass.
On the basis of substantial improvements over non-contrast MR angiography in efficacy and a minimal and transient side-effect profile, gadofosveset was found to be safe and effective for MR angiography in patients known or suspected to have peripheral vascular disease.
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