Safety and efficacy of endovascular sonolysis using the EkoSonic endovascular system in patients with acute stroke.

BACKGROUND AND PURPOSE: Sonolysis is a new therapeutic procedure for arterial recanalization. The aim of this study was to confirm the safety and efficacy of endovascular sonolysis by using the EkoSonic Endovascular System in subjects with acute ischemic stroke. MATERIALS AND METHODS: Patients with acute ischemic stroke with occlusion of the middle cerebral artery or basilar artery were enrolled consecutively in this prospective study. The control group (44 MCA and 12 BA occlusions) was selected from historical controls. EkoSonic Endovascular System was started within 8 hours after stroke onset. The NIHSS score at hospital admission, after 24 hours, and at 7 days; arterial recanalization; early neurologic improvement; symptomatic intracerebral hemorrhage; and favorable 3-month clinical outcome defined as a modified Rankin Scale score of 0-2 were evaluated by statistical means. RESULTS: Fourteen patients (10 men; mean age, 65.1 ± 11.2 years; median NIHSS score, 16.5) underwent EkoSonic endovascular sonolysis. Arterial recanalization after endovascular treatment was achieved in 6 of 7 (85.7%) patients with MCA occlusion (4 complete recanalizations) and in all 7 (100%) patients with BA occlusion (6 complete recanalizations). No (0%) symptomatic intracerebral hemorrhage or periprocedural complications occurred. Seven (50%) patients were independent at 3 months (median mRS score, 2). Early neurologic improvement and favorable clinical outcome were significantly more frequent in patients with MCA occlusion undergoing EkoSonic endovascular sonolysis than in controls (100% and 71.4% versus 4.6% and 13.6% of patients; P = .0001 and P = .003, respectively). Three-month mortality was significantly lower in patients with BA occlusion undergoing EkoSonic endovascular sonolysis than in controls (0% versus 66.7% patients, P = .013). CONCLUSIONS: In this small study, EkoSonic endovascular sonolysis allowed safe and potentially effective revascularization in patients experiencing acute ischemic stroke.

Cell therapy, a new standard in management of chronic critical limb ischemia and foot ulcer.

Fifty percent of diabetics (7% of general population) suffer from peripheral arterial occlusive disease, which may lead to amputation due to critical limb ischemia (CLI). The aim of our study was to prevent major limb amputation (MLA) in this group of patients using a local application of autologous bone marrow stem cells (ABMSC) concentrate. A total of 96 patients with CLI and foot ulcer (FU) were randomized into groups I and II. Patients in group I (n = 42, 36 males, 6 females, 66.2 ± 10.6 years) underwent local treatment with ABMSC while those in group II (n = 54, control, 42 males, 12 females, 64.1 ± 8.6 years) received standard medical care. The frequency of major limb amputation in groups I and II was 21% and 44% within the 120 days of follow up, respectively (p < 0.05). Only in salvaged limbs of group I both toe pressure and toe brachial index increased (from 22.66 ± 5.32 to 25.63 ± 4.75 mmHg and from 0.14 ± 0.03 to 0.17 ± 0.03, respectively, mean ± SEM). The CD34(+) cell counts in bone marrow concentrate (BMC) decreased (correlation, p = 0.024) with age, even though there was no correlation between age and healing. An unexpected finding was made of relative, bone marrow lymphopenia in the initial bone marrow concentrates in patients who failed ABMSC therapy (21% of MLA). This difference was statistically significant (p < 0.040). We conclude ABMSC therapy results in 79% limb salvage in patients suffering from CLI and FU. In the remaining 21% lymphopenia and thrombocytopenia were identified as potential causative factors, suggesting that at least a partial correction with platelet supplementation may be beneficial.

Autologous bone marrow stem cell transplantation in patients with end-stage chronical critical limb ischemia and diabetic foot.

A total 37 patients suffering from end stage-IV Fontaine (CLI and diabetic foot) with an ulcerated limb in whom all previous therapeutic strategies failed (e.g. surgical revascularization and endovascular repair) were selected and underwent local transplantation of Autologous Bone Marrow Stem Cells (ABMSCs). The efficacy/safety ofthis therapy was assessed by using several endpoints such as (a) prevention of amputation, (b) wound healing and (c) degree of angiogenesis. In order to assess the limb ischemia and hypoxia the several tests and measurements were performed pre- and post transplantation at a variety of time intervals. The measurements include: TP-toe pressure measurements (by Periflux 5000 Laser Doppler and Oxymetry system), SPP-skin perfusion pressure, ABI-ankle brachial index, LDP-Laser Doppler baseline and heat perfusion assessment, TcpO2 without and with O2 provocation inhalation test. In addition, a battery of biochemical and hematological tests of peripheral venous blood samples and bone marrow analysis were performed. Limb salvage was 81% in 30 patients, 7 patients (19%) were amputated for terminal severe ischemia and gangrene progression. In the group of limb salvage patients initial Toe pressure 23.119 (std. error 5.358) increased in 90 days follow-up into 29.888 (std. error 5.99), Toe brachial index increased from 0.1469 (std. 0.0326) to 0.1991(std. 0.401). In LASER doppler and TcpO2, TcpCO2 tissue perfusion examination TcpO2% Increase after O2 provocation inhalation test was elevated from 162.95 (%) to 229.86% which confirmed a very good tissue vasoreactivity after BMSC transplantation.