Intraarterial Administration of Bone Marrow Mononuclear Cells in Patients With Critical Limb Ischemia

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. A Randomized-Start, Placebo-Controlled Pilot Trial (PROVASA) was published in Circulation - cardiovascular interventions.In this study Limb salvage and amputation-free survival rates did not differ between the control and study groups. However, cell therapy was associated with significantly improved ulcer healing (ulcer area, 3.2±4.7 cm² to 1.89±3.5 cm²P=0.014] versus placebo, 2.92±3.5 cm²² [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. 

We in India, need to be careful in jumping to conclusions without adequate  supportive evidence in favor of the cell therapies to treat the critical limb ischaemia for the present. If the strong evidence becomes available certainly and eagerly we are waiting to bring that in to our clinical practice.

What is optimum anticoagulation with Heparin in peripheral vascular treatments?

             Beyond the heparin dose ( initially up to 60 U/kg) and the ACT level (250 seconds) , in the multivariate analysis it was found that female sex, creatinine clearance <60 mL/min per 1.73m² age >70 years, preprocedural anemia, history of heart failure, hybrid vascular surgery, rest pain, and below-knee interventions were independent predictors of higher postprocedural bleeding risk. These findings are consistent with those from 2 large retrospective databases of patients undergoing PCI and a registry of 24 045 patients with acute coronary syndromes from the Global Registry of Acute Coronary Events (GRACE).Less aggressive anticoagulation, or use of an alternative anticoagulant strategy such as a direct thrombin inhibitor, may decrease the incidence of bleeding complications in these subgroups of high-risk patients.
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References

1. Moscucci M, Fox KA, Cannon CP et al. Predictors of major bleeding in acute coronary syndromes: the Global Registry of Acute Coronary Events (GRACE). Eur Heart J. 2003; 24: 1815– 1823
2. Shammas NW,Allie D,Hall P: Predictors of in-hospital and 30-day complications of peripheral vascular interventions using bivalirudin as the primary anticoagulant: results from the APPROVE Registry. J Invasive Cardiol. 2005; 17: 356– 359