Stimulation Characteristics, Complications, and Efficacy of Spinal Cord Stimulation Systems in Patients with Refractory Angina: A Prospective Feasibility Study

Abstract

In a prospective study with a 1-year follow-up we evaluated: (1) the feasibility of a method for the adjustment of spinal cord stimulator (SCS) parameters, (2) complications of SCS, and (3) efficacy of SCS. In patients receiving an SCS for severe angina unresponsive to standard therapies, SCS characteristics were evaluated within 1 week and at 4, 14, 26, and 52 weeks after SCS treatment. Step-by-step adjustment of pulse output parameters was performed at the electrode configuration at which paresthesias occurred ("sensory threshold"), covered the anginal area ("adjusted setting"), or provoked pain ("motor threshold"). In addition, the number of anginal attacks and intake of glyceryl trinitrate (GTN) tablets were recorded at regular intervals. Twenty-two patients with either a bipolar (14) or a unipolar (8) system were evaluated. In the 14 patients with bipolar systems, alteration in paresthesias required 26 reprogrammings of the configuration. In the eight patients with bipolar systems who completed the follow-up without lead dislocation, the mean "sensory threshold" was 3.3 V (1.7-5.6), the mean "adjusted stimulation" output was 4.5 V (2.8-7.6), and the mean "motor threshold" was 4.9 V (2.8-7.7) after 4 weeks SCS. The mean stimulation duration per 24 hours was 14.1% (5%-24%), and the mean standardized impedance was 821 omega (748-893) after 4 weeks SCS. The unipolar group demonstrated comparable results. After 1-year follow-up the parameters had not changed significantly. During the 1-year follow-up, 6 of 22 patients experienced lead dislocation that required surgery. In all patients, anginal attacks (P < 0.003) and GTN intake (P < 0.005) were reduced significantly with SCS. The effect lasted during the 1 year. During a 1-year follow-up, the stimulation parameters did not change significantly in the 16 patients without lead dislocations. Our standardized method appears to be feasible for follow-up of SCS. Moreover, SCS seems to be an effective adjuvant therapy for intractable angina, despite a relatively frequent dislocation of the electrode.