Sanborn T A, Gibbs H H, Brinker J A, Knopf W D, Kosinski E J, Roubin G S
Department of Medicine, New York Hospital-Cornell Medical Center, New York 10021.
J Am Coll Cardiol. 1993 Nov 1;22(5):1273-9. doi: 10.1016/0735-1097(93)90529-a.
A new percutaneous collagen hemostasis device was compared with conventional compression techniques after diagnostic catheterization and angioplasty.
Peripheral vascular complications after diagnostic catheterization or more complex interventional procedures, as well as the discomfort of manual compression and prolonged bed rest, represent significant morbidity for invasive cardiac procedures.
A prospective, multicenter, randomized trial was designed to compare the hemostasis time in minutes and the incidence of vascular complications in patients receiving a vascular hemostasis device with those undergoing conventional compression techniques.
After diagnostic catheterization, hemostasis time was significantly less with the vascular hemostasis device than with conventional manual compression (4.1 +/- 2.8 min [n = 90 patients] vs. 17.6 +/- 9.2 min [n = 75], p < 0.0001). This difference was greater in patients undergoing angioplasty and was unrelated to the anticoagulation status (4.3 +/- 3.7 min [n = 71 not receiving heparin], 7.6 +/- 11.6 min [n = 85 receiving heparin], 33.6 +/- 24.2 min [n = 134 control patients not receiving heparin], p < 0.0001 vs. control patients). The time from the start of the procedure to ambulation was slightly less after diagnostic catheterization in patients treated with the device (13.3 +/- 12.1 h vs. 19.2 +/- 17.8 h, p < 0.05). It was also less in patients who underwent angioplasty when the device was used after discontinuation of anticoagulation (23.0 +/- 11.1 h, without heparin), as compared with control compression techniques (32.7 +/- 18.8 h, p < 0.0001). Time to ambulation was even shorter (16.1 +/- 11.1 h, p < 0.0001) in patients in whom the device was placed immediately after angioplasty while they were still fully anticoagulated with a prolonged activated clotting time (336 +/- 85 s). There were no major complications (surgery or transfusion) after diagnostic catheterization and a low incidence of major complications in patients who underwent angioplasty (0.7% in control patients, 1.4% with the device without heparin, 1.2% with the device and heparin, p = NS). After angioplasty, there was a trend toward fewer hematomas when the device was used in the absence of heparin (4.2% vs. 9.7% in control patients, p = 0.14).
A new vascular hemostasis device can significantly reduce the puncture site hemostasis time and the time to ambulation without significantly increasing the risk of peripheral vascular complications. The role of this technology in reducing complications, length of hospital stay and cost remains to be determined.
将一种新型经皮胶原蛋白止血装置与诊断性导管插入术和血管成形术后的传统压迫技术进行比较。
诊断性导管插入术或更复杂的介入手术后的外周血管并发症，以及手动压迫的不适和长时间卧床休息，是侵入性心脏手术的重大发病原因。
设计一项前瞻性、多中心、随机试验，比较接受血管止血装置的患者与采用传统压迫技术的患者的止血时间（以分钟计）和血管并发症发生率。
诊断性导管插入术后，血管止血装置的止血时间明显短于传统手动压迫（4.1±2.8分钟[n = 90例患者]对17.6±9.2分钟[n = 75例]，p < 0.0001）。这种差异在接受血管成形术的患者中更大，且与抗凝状态无关（4.3±3.7分钟[n = 71例未接受肝素]，7.6±11.6分钟[n = 85例接受肝素]，33.6±24.2分钟[n = 134例未接受肝素的对照患者]，与对照患者相比p < 0.0001）。使用该装置治疗的患者在诊断性导管插入术后从手术开始到下床活动的时间略短（13.3±12.1小时对19.2±17.8小时，p < 0.05）。在血管成形术后停用抗凝剂后使用该装置的患者中，与对照压迫技术相比，下床活动时间也更短（23.0±11.1小时，未使用肝素）（32.7±18.8小时，p < 0.0001）。在血管成形术后立即完全抗凝且活化凝血时间延长（336±85秒）时放置该装置的患者中，下床活动时间甚至更短（16.1±11.1小时，p < 0.0001）。诊断性导管插入术后无重大并发症（手术或输血），血管成形术患者的重大并发症发生率较低（对照患者为0.7%，未使用肝素的装置组为1.4%，使用装置且使用肝素组为1.2%，p =无统计学意义）。血管成形术后，在未使用肝素的情况下使用该装置时血肿有减少的趋势（4.2%对对照患者的9.7%，p = 0.14）。
一种新型血管止血装置可显著缩短穿刺部位止血时间和下床活动时间，而不会显著增加外周血管并发症的风险。该技术在减少并发症、住院时间和成本方面的作用仍有待确定。
