Shaffer K M, Mullins C E, Grifka R G, O'Laughlin M P, McMahon W, Ing F F, Nihill M R
Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital, Houston 77030, USA.
J Am Coll Cardiol. 1998 Mar 1;31(3):661-7. doi: 10.1016/s0735-1097(97)00535-4.
This report describes the results of the Food and Drug Administration's phase 1 and 2 clinical trials of intravascular stents at Texas Children's Hospital.
Since the late 1980s, intravascular stent implantation for the treatment of arterial and venous stenoses in congenital heart disease has been highly successful.
Stents were placed in postoperative pulmonary artery (PA) stenoses, congenital PA stenoses or stenoses of systemic veins/venous anastomoses. Prospective collection of data according to protocol was done before intervention, after stent implantation and at follow-up catheterization.
At stent implantation, pressure gradients decreased significantly in all three groups (mean +/- SD): from 46 +/- 25 to 10 +/- 13 mm Hg in postoperative PA stenoses (p < 0.001); from 71 +/- 45 to 15 +/- 21 mm Hg in congenital PA stenoses (p < 0.001); and from 7 +/- 6 to 1 +/- 2 mm Hg in stenoses of systemic veins/venous anastomoses stenoses (p < 0.001). Vessel diameters markedly increased: from 6 +/- 3 to 12 +/- 3 mm in postoperative PA stenoses (p < 0.001); from 3 + 1 to 9 + 1 mm in congenital PA stenoses (p < 0.001); and from 3 +/- 4 to 12 +/- 4 mm in stenoses of systemic veins/venous anastomoses (p < 0.001). In the postoperative and congenital PA stenoses groups, right ventricular pressure decreased (right ventricular pressure indexed to femoral artery pressure ratio): from 0.63 +/- 0.2 to 0.41 +/- 0.02 (p < 0.001) and from 0.71 +/- 0.3 to 0.55 +/- 0.35 (p = 0.04), respectively. Perfusion to a single affected lung increased from 31 +/- 17% to 46 +/- 14% (p < 0.001). On recatheterization (mean 14 months), results varied minimally. Repeat angioplasty of residual stent stenoses was safe and effective. Complications included four early patients with stent migration, three with stent thrombosis and two deaths. There were no late complications. Significant restenosis occurred in only three patients.
Intravascular stents for the treatment of vascular stenoses in congenital heart disease provide excellent immediate and long-term results.
本报告描述了美国食品药品监督管理局在德克萨斯儿童医院进行的血管内支架1期和2期临床试验结果。
自20世纪80年代末以来，血管内支架植入术治疗先天性心脏病的动脉和静脉狭窄取得了巨大成功。
将支架置入术后肺动脉（PA）狭窄、先天性PA狭窄或体静脉/静脉吻合口狭窄处。按照方案在干预前、支架植入后和随访导管插入术时前瞻性收集数据。
在支架植入时，所有三组的压力梯度均显著降低（均值±标准差）：术后PA狭窄组从46±25降至10±13 mmHg（p<0.001）；先天性PA狭窄组从71±45降至15±21 mmHg（p<0.001）；体静脉/静脉吻合口狭窄组从7±6降至1±2 mmHg（p<0.001）。血管直径显著增加：术后PA狭窄组从6±3增至12±3 mm（p<0.001）；先天性PA狭窄组从3+1增至9+1 mm（p<0.001）；体静脉/静脉吻合口狭窄组从3±4增至12±4 mm（p<0.001）。在术后和先天性PA狭窄组中，右心室压力降低（右心室压力与股动脉压力比值）：分别从0.63±0.2降至0.41±0.02（p<0.001）和从0.71±0.3降至0.55±0.35（p=0.04）。单叶患肺的灌注从31±17%增至46±14%（p<0.001）。再次导管插入术时（平均14个月），结果变化极小。残余支架狭窄的重复血管成形术安全有效。并发症包括4例早期支架移位患者、3例支架血栓形成患者和2例死亡。无晚期并发症。仅3例患者发生显著再狭窄。
血管内支架治疗先天性心脏病的血管狭窄可提供优异的近期和长期效果。
