Faculty of Medicine, University Medical Center Groningen and University of Groningen, Groningen, The Netherlands.
Neuromodulation. 2011 May-Jun;14(3):258-65; discussion 265. doi: 10.1111/j.1525-1403.2011.00355.x. Epub 2011 Apr 19.
Patients suffering from chronic angina pectoris, insufficiently controllable with medication and revascularization, are an increasing medical and psychosocial problem. Although spinal cord stimulation (SCS) is proven to employ, safe, long-term anti-angina, and anti-ischemic effects for these patients, the use of SCS in this group remains limited. The reason for this restricted use is largely unknown. However, among other reasons, it may be related to the difficulties in positioning an electrode in the epidural space. We studied the feasibility and efficacy of subcutaneous implantation of an entire system.
Seven male patients, mean age 67 ± 3.6 years, received complete subcutaneously implanted electrical nerve stimulation (SENS) systems, with one or more leads fixed in parallel with the sternum, covering the angina area. At baseline and 2 months follow-up patients performed exercise and quality of life tests (Seattle Angina Questionnaire and diaries number angina attacks and glyceryl trinitrate use).
All patients showed clinical relevant improvement (baseline vs. follow-up), in exercise (63%) and quality of life (Seattle Angina Questionnaire 59%). The number of angina attacks dropped 82% and the number of glyceryl trinitrate use decreased by 90%. No major adverse events were observed.
This small feasibility study demonstrates SENS to be an effective and safe method to treat patients suffering from refractory angina. Furthermore, SENS is less invasive and appears to have less lead migrations compared with SCS.
患有慢性稳定性心绞痛的患者，经药物和血运重建治疗后仍控制不佳，这是一个日益严重的医学和心理社会问题。尽管脊髓刺激（SCS）已被证明对这些患者具有长期的抗心绞痛和抗缺血作用，且安全有效，但 SCS 在这一人群中的应用仍然有限。其原因尚不清楚。然而，除其他原因外，这可能与在硬膜外腔中定位电极的困难有关。我们研究了皮下植入整个系统的可行性和疗效。
7 名男性患者，平均年龄 67 ± 3.6 岁，接受了完整的皮下植入式电神经刺激（SENS）系统治疗，一根或多根电极与胸骨平行固定，覆盖心绞痛区域。在基线和 2 个月的随访时，患者进行了运动和生活质量测试（西雅图心绞痛问卷和心绞痛发作次数和硝化甘油使用日记）。
所有患者均表现出临床相关的改善（基线与随访相比），在运动（63%）和生活质量（西雅图心绞痛问卷 59%）方面。心绞痛发作次数减少了 82%，硝化甘油使用次数减少了 90%。未观察到重大不良事件。
这项小型可行性研究表明，SENS 是治疗难治性心绞痛患者的一种有效且安全的方法。此外，与 SCS 相比，SENS 具有侵入性更小，且电极移位的可能性更小。
