Unverdorben Martin, Degenhardt Ralf, Erny Dominique, Scholz Manfred, Wagner Eberhard, Köhler Henning, Berthold Heiner K, Vallbracht Christian
Institute for Clinical Research, Center for Cardiovascular Diseases, Rotenburg an der Fulda, Germany.
Indian Heart J. 2005 Mar-Apr;57(2):114-20.
To reduce procedural cost, cardiac centers increasingly use resterilized balloon catheters for percutaneous coronary interventions. Data addressing the procedural and mid-term outcome in a prospective randomized trial comparing new and resterilized balloons are not available.
Percutaneous coronary interventions were performed at random in 238 consecutive patients with either new or 1-3 times reused balloon catheters. Crossing of the stenosis decreased from 96% with new balloon catheters to 93.2% (p=0.46), with 1 time reused balloon catheters to 81.8% (p=0.0056) with 2 times reused balloon catheters and to 80.8% (p=0.01) with 3 times reused balloon catheters. In all primary failures using resterilized balloon catheters, new ones of the same nominal diameter were successful. The 4.1 +/- 1.9 month angiographic follow-up rates were 96/124 (77.4%) for new balloon catheter, 35/44 (79.5%) for 1 time reused balloon catheters, 33/44 (75.0%) for 2 times reused balloon catheters, and 21/26 (80.8%) for 3 times reused balloon catheters (p for all >0.05). The late losses for new versus reused balloon catheters were 0.48 +/- 0.75 mm versus 0.73 +/- 0.79 mm (p=0.03). The percent stenosis was higher in reused versus new balloon catheters (51.9 +/- 23.2% v. 42.3 +/- 22.3%; p=0.0042) as was the restenosis rate [39/89 (43.8%] v. 31/96 (32.3%), p=0.13]. There was one death in reused balloon catheter category but no event of myocardial infarction. Rates of target lesion revascularizations were similar in stent recipients and more frequent after stand-alone balloon angioplasty with reused versus new balloon catheters [15/55 (27.3%) versus [5/59 (8.5%), p=0.01].
The use of two or three times resterilized balloon catheters of the type tested does not seem to be justified in stand-alone balloon angioplasty of de novo coronary stenoses and should be limited to stent procedures until data is available for other indications.
为降低手术成本，心脏中心越来越多地将再次消毒的球囊导管用于经皮冠状动脉介入治疗。目前尚无关于比较新球囊导管和再次消毒球囊导管的前瞻性随机试验中的手术及中期结果的数据。
对238例连续患者随机进行经皮冠状动脉介入治疗，分别使用新的或重复使用1至3次的球囊导管。使用新球囊导管时狭窄病变的通过成功率为96%，使用1次重复使用的球囊导管时降至93.2%（p = 0.46），使用2次重复使用的球囊导管时为81.8%（p = 0.0056），使用3次重复使用的球囊导管时为80.8%（p = 0.01）。在所有使用再次消毒球囊导管出现的原发性失败病例中，更换相同标称直径的新球囊导管后手术成功。新球囊导管的4.1±1.9个月血管造影随访率为96/124（77.4%），1次重复使用球囊导管为35/44（79.5%），2次重复使用球囊导管为33/44（75.0%），3次重复使用球囊导管为21/26（80.8%）（所有p>0.05）。新球囊导管与重复使用球囊导管的晚期管腔丢失分别为0.48±0.75mm和0.73±0.79mm（p = 0.03）。重复使用球囊导管组的狭窄百分比高于新球囊导管组（51.9±23.2%对42.3±22.3%；p = 0.0042），再狭窄率也是如此[39/89（43.8%）对31/96（32.3%），p = 0.13]。重复使用球囊导管组有1例死亡，但无心肌梗死事件。支架置入患者的靶病变血运重建率相似，在单纯球囊血管成形术中，使用重复使用球囊导管后的靶病变血运重建率高于新球囊导管[15/55（27.3%）对5/59（8.5%），p = 0.01]。
在对初发冠状动脉狭窄进行单纯球囊血管成形术时，使用本文所测试类型的经过两次或三次再次消毒的球囊导管似乎不合理，在有其他适应证的数据可用之前，应仅限于支架手术。
