Di Pede Francesco, Lanza Gaetano Antonio, Zuin Guerrino, Alfieri Ottavio, Rapati Massimo, Romanò Massimo, Circo Antonio, Cardano Paola, Bellocci Fulvio, Santini Massimo, Maseri Attilio
Ospedale Umberto I, Mestre, Italy.
Am J Cardiol. 2003 Apr 15;91(8):951-5. doi: 10.1016/s0002-9149(03)00110-3.
The treatment of patients with angina pectoris refractory to medical therapy and unsuitable for revascularization procedures has yet not been well standardized. Previous retrospective studies and small prospective studies have suggested beneficial effects of spinal cord stimulation (SCS) in these patients. We created a Prospective Italian Registry of SCS to evaluate the short- and long-term clinical outcome of patients who underwent SCS device implantation because of severe refractory angina pectoris. Overall, 104 patients were enrolled in the registry (70 men, aged 68 +/- 17 years), most of whom (83%) had severe coronary artery disease. Average follow-up was 13.2 +/- 8 months. Overall, 17 patients (16%) died, 8 (8%) due to cardiac death. Among clinical variables, only age was found to be significantly associated both with total mortality (p = 0.04) and cardiac mortality (p = 0.02) on Cox regression analysis. A significant improvement of anginal symptoms (> or =50% reduction of weekly anginal episodes, compared with baseline) occurred in 73% of patients, and Canadian Cardiovascular Society angina class improved by > or =1 class in 80% and by > or =2 classes in 42% of patients, with a relevant reduction in the rate of hospital admission and days spent in the hospital because of angina (p <0.0001 for both). No life-threatening or clinically serious complications were observed. The most frequent side effect consisted of superficial infections, either at the site of puncture of electrode insertion or of the abdominal pocket, which occurred in 6 patients. In conclusion, our prospective data point out that SCS can be performed safely and is associated with a sustained improvement of anginal symptoms in a relevant number of patients with refractory stable angina pectoris.
对于药物治疗无效且不适合进行血运重建手术的心绞痛患者，其治疗方法尚未得到很好的标准化。既往的回顾性研究和小型前瞻性研究表明，脊髓刺激（SCS）对这些患者有有益作用。我们创建了一个意大利SCS前瞻性注册研究，以评估因严重难治性心绞痛而接受SCS装置植入的患者的短期和长期临床结局。总体而言，104例患者被纳入该注册研究（70例男性，年龄68±17岁），其中大多数（83%）患有严重冠状动脉疾病。平均随访时间为13.2±8个月。总体上，17例患者（16%）死亡，8例（8%）死于心源性死亡。在临床变量中，经Cox回归分析发现，只有年龄与总死亡率（p = 0.04）和心源性死亡率（p = 0.02）显著相关。73%的患者心绞痛症状有显著改善（与基线相比，每周心绞痛发作次数减少≥50%），80%的患者加拿大心血管学会心绞痛分级改善≥1级，42%的患者改善≥2级，因心绞痛住院率和住院天数有显著降低（两者p均<0.0001）。未观察到危及生命或临床严重的并发症。最常见的副作用是浅表感染，发生在电极插入穿刺部位或腹部囊袋处，有6例患者出现。总之，我们的前瞻性数据表明，SCS可以安全进行，并且在相当数量的难治性稳定型心绞痛患者中与心绞痛症状的持续改善相关。
