Phase IV postmarketing surveillance study shows continued efficacy and safety of Stempeucel in patients with critical limb ischemia due to Buerger's disease.

Buerger's disease or thromboangiitis obliterans is a type of obstructive vascular diseases categorized as vasculitis and usually present in 95% of young smoker men. The main pathogenetic mechanism is interplay between immune system and inflammation. Earlier our phase II study has shown that Stempeucel is safe when injected at 2 million cells/kg body weight by virtue of its anti-inflammatory, immunomodulatory, and angiogenetic properties. The present study was conducted to further assess the safety and efficacy of Stempeucel in critical limb ischemia due to Buerger's disease after obtaining approval from Indian FDA based on the data generated in the phase II study. This is an open label, multicenteric phase IV PMS study conducted across India with experienced vascular surgeons. Fifty patients of critical limb ischemia due to Buerger's disease with Rutherford III-5 or III-6 were included in the study and each individual received a dose of 2 million cells/kg body weight of Stempeucel in the calf muscles and around the ulcer. These patients were evaluated over 12 months from drug administration. The present study showed the continued long term efficacy over a period of 12 months follow up in these patients corroborating the result obtained in the previous phase II studies. There was significant improvement in rest pain, ankle systolic pressure, and ankle brachial pressure index with accelerated ulcer healing. In conclusion, the present study shows that the intramuscular administration of Stempeucel continues to be safe, tolerable, and effective alternative treatment in patients with Buerger's disease.

An Endovascular Approach to Spontaneous Isolated Acute Iliac Dissecting Aneurysm with Contained Rupture.

Acute spontaneous isolated common and external iliac dissection with aneurysm is a very rare entity involving high morbidity and mortality, with only few reports in literature. If not treated promptly, they have high morbidity or mortality in case they rupture. We report a case of similar dissection with aneurysmal formation managed with percutaneous stent-graft placement. This is a unique case where aorta was not involved and patient presented to us in stable hemodynamic status in spite of a contained rupture at the dissected site.

Outcomes of angiosome and non-angiosome targeted revascularization in critical lower limb ischemia.

OBJECTIVE: Blood supply to the foot is from the posterior tibial, anterior tibial, and the peroneal arteries. Ischemic ulceration of the foot is the most common cause for major amputations in vascular surgical patients. It can be presumed that revascularization of the artery directly supplying the ischemic angiosome may be superior to indirect revascularization of the concerned ischemic angiosome. METHODS: This was a prospective study of 64 patients with continuous single crural vessel runoff to the foot presenting with critical limb ischemia from January 2007 to September 2008. Direct revascularization (DR) of the ischemic angiosome was performed in 61% (n=39), indirect revascularization (IR) in 39% (n=25). Open surgery was performed in 60.9% and endovascular interventions in 39.1%. All patients were evaluated for the status of the wound and limb salvage at 1, 3, and 6 months. The study end points were major amputation or death, limb salvage, and wound epithelialization at 6 months. RESULTS: In the study, 81.2% of patients had forefoot ischemia, 17.2% had ischemic heel, whereas 1.6% had midfoot nonhealing ischemic ulceration. The runoff involved the anterior tibial artery in 42.2% (27/64), posterior tibial artery in 34.4% (22/64), and the peroneal artery in 23.4% (15/64). All patients were followed at 1, 3, and 6 months postoperatively for ulcer healing, major amputation, or death. At the end of 6 months, nine patients expired, and six were lost to follow-up. Of 49 patients who completed 6 months, nine underwent major amputation, and 40 had limb salvage. Ulcer healing at 1, 3, and 6 months for DR vs IR were 7.9% vs 5%, 57.6% vs 12.5%, and 96.4% vs 83.3%, respectively. This difference in the rates of ulcer healing between the DR and IR groups was statistically significant (P=.021). The limb salvage in the DR group (84%) and IR group (75%) was not statistically significant (P=.06). The mortality was 10.2% for DR and 20% for IR at 6 months. CONCLUSIONS: To attain better ulcer healing rates combined with higher limb salvage, direct revascularization of the ischemic angiosome should be considered whenever possible. Revascularization should not be denied to patients with indirect perfusion of the ischemic angiosome as acceptable rates of limb salvage are obtained.