Microcirculatory investigations to determine the effect of spinal cord stimulation for critical leg ischemia: The Dutch Multicenter Randomized Controlled Trial,☆☆,,★★

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Abstract

Purpose: Patients with non-reconstructable critical limb ischemia generally undergo medical treatment only to prevent or postpone amputation. There is some evidence that spinal cord stimulation (SCS) stimulates ischemic wound healing. Thus, this could benefit limb survival through improved skin perfusion. We investigated the effect of SCS versus conservative treatment on skin microcirculation in relation to treatment outcome in patients with non-reconstructable critical limb ischemia. Methods : Standard medical treatment plus SCS was compared with only standard medical treatment in a multicenter randomized controlled trial comprised of 120 patients with surgically non-reconstructable chronic rest pain or ulceration. We investigated skin microcirculation by means of capillary microscopy, laser Doppler perfusion, and transcutaneous oxygen measurements in the foot. The microcirculatory status just before treatment was classified in three categories (poor, intermediate, and good) and was related to limb survival after a minimum follow-up period of 18 months. Results : Clinical parameters, peripheral blood pressures, and limb survival rates showed no significant differences between the SCS and standard groups during the follow-up period. In both treatment groups, amputation frequency after 18 months was high in patients with an initially poor microcirculatory skin perfusion (SCS 80% vs standard treatment 71%; NS) and low in those with a good skin perfusion (29% vs 11 %, respectively; NS). In patients with an intermediate skin microcirculation amputation, frequency was twice as low in patients additionally treated with SCS as in the standard treatment group (48% vs 24%; P = .08). In these patients, microcirculatory reactive hyperemia during the follow-up period reduced in the standard group but not in the SCS group (P < .01). Conclusion: Selection on the basis of the initial microcirculatory skin perfusion identifies patients in whom SCS can improve local skin perfusion and limb survival. (J Vasc Surg 1999;30:236-44.)

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Please see related commentary by Turnipseed on pages 370-1.

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From the Department of Vascular Surgery (Drs Ubbink and Jacobs), Academic Medical Center; the Department of Neurosurgery (Dr Spincemaille), De Wever Hospital; the Department of Clinical Epidemiology (Dr Prins), Academic Medical Center; and the Department of Physiology (Dr Reneman), Cardiovascular Research Institute Maastricht.

Reprint requests: D. Th. Ubbink, MD, PhD, Academic Medical Center, Department of Vascular Surgery, G4-105, PO Box 22700, 1100 DE Amsterdam, The Netherlands.

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