Treatment of femoropopliteal lesions with the low-dose Lutonix DCB reduced late lumen loss with safety comparable to that of control angioplasty. (LEVANT I, The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis; NCT00930813)
Background—
Critical limb ischemia due to peripheral arterial occlusive disease is associated with a severely increased morbidity and mortality. There is no effective pharmacological therapy available. Injection of autologous bone marrow-derived mononuclear cells (BM-MNC) is a promising therapeutic option in patients with critical limb ischemia, but double-blind, randomized trials are lacking.
Methods and Results—
Forty patients with critical limb ischemia were included in a multicenter, phase II, double-blind, randomized-start trial to receive either intraarterial administration of BM-MNC or placebo followed by active treatment with BM-MNC (open label) after 3 months. Intraarterial administration of BM-MNC did not significantly increase ankle-brachial index and, thus, the trial missed its primary end point. However, cell therapy was associated with significantly improved ulcer healing (ulcer area, 3.2±4.7 cm
2
to 1.89±3.5 cm
2
[
P
=0.014] versus placebo, 2.92±3.5 cm
2
to 2.89±4.1 cm
2
[
P
=0.5]) and reduced rest pain (5.2±1.8 to 2.2±1.3 [
P
=0.009] versus placebo, 4.5±2.4 to 3.9±2.6 [
P
=0.3]) within 3 months. Limb salvage and amputation-free survival rates did not differ between the groups.
Repeated BM-MNC administration and higher BM-MNC numbers and functionality were the only independent predictors of improved ulcer healing. Ulcer healing induced by repeated BM-MNC administration significantly correlated with limb salvage (
r
=0.8;
P
<0.001).
Conclusions—
Intraarterial administration of BM-MNC is safe and feasible and accelerates wound healing in patients without extensive gangrene and impending amputation. These exploratory findings of this pilot trial need to be confirmed in a larger randomized trial in patients with critical limb ischemia and stable ulcers.
Clinical Trial Registration—
URL:
http://www.clinicaltrials.gov
. Unique identifier: NCT00282646.
Long-term event-free survival, amputation rates, and changes in Rutherford-Becker class after treatment of focal infrapopliteal lesions are significantly improved with SES in comparison with BMS. (YUKON-Drug-Eluting Stent Below the Knee-Randomised Double-Blind Study [YUKON-BTX]; NCT00664963).
CJ, Engstrom BI, et al. J Vasc Interv Radiol 2012;23: 69-74 Conclusion: Covered stent exclusion of intragraft dialysis access graft pseudoaneurysms is correlated with a high rate of eventual graft infection.Summary: Prosthetic arteriovenous (AV) grafts are prone to develop pseudoaneurysms that are thought related to graft material degeneration secondary to repeated cannulation at specific sites. Such pseudoaneurysms may be particularly prone to develop infection in the face of outflow obstruction. Endovascular treatment can be used to treat prosthetic AV graft pseudoaneurysms with reports of high technical success and acceptable patency rates (Vesely TM, J Vasc Interv Radiol 2005;16:1301-7; Najibi S et al, J Surg Res 2002;106:15-19). However, the authors of this report indicated an anecdotal impression that incorporating this technique into their practice resulted in a higher incidence of prosthetic AV graft infection. They therefore sought to study whether stent graft treatment of prosthetic AV graft pseudoaneurysms influenced the incidence of AV graft infection. The authors reviewed their interventional radiology database for prosthetic AV graft interventions involving stent deployment anywhere within the AV graft and found 235 interventions in 174 patients between November 2004 and December 2008. The incidence of AV graft infection was analyzed by stent type (bare metal vs covered), location, and indication for stent deployment on a per-stent, per-procedure, and per-graft basis. Eventually, 16.3% of AV grafts with stents implanted required surgical excision for graft infection. When covered stents were used to treat intragraft pseudoaneurysms, the subsequent rate of graft infection increased compared with bare-metal stents or covered stents deployed within the graft for other reasons (42.1% vs 18.2%, P ϭ .011). When stents were deployed at an intragraft location, there was a higher incidence of graft infection compared with those deployed at a venous anastomosis or in an outflow vein (26.9% vs 6.9%, P Ͻ .001).Comment: Pseudoaneurysms of prosthetic dialysis grafts are usually associated with a history of repeated punctures at the site where the pseudoaneurysm developed. More punctures in a specific site will likely increase the risk of contamination, and the more the risk of contamination the more the risk of infection. It follows, as shown here, that placing an additional prosthetic under such circumstances is not likely to have favorable outcomes.
Cognition After Carotid Endarterectomy or Stenting: A Randomized ComparisonAltinbas A, van Zandvoort MJ, van den Berg E, et al. Neurology 2011;77: 1084-90.
The use of the Pathway PV System in atherosclerotic lesions appears to be safe and effective in improving stenosis severity, even in the presence of challenging lesion conditions. Vessel patency following intervention appears to be good up to 12 months, and these results translate into clinical benefit.
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