Zeller T, Krankenberg H, Reimers B, Frank U, Bürgelin K, Schwarzwälder U, Neumann F-J
Abteilung Angiologie, Herz-Zentrum Bad Krozingen.
Rofo. 2004 Jan;176(1):70-5. doi: 10.1055/s-2004-814661.
Evaluation of the efficacy and safety of a new 7F-atherectomy device (30-day endpoint) for the treatment of short and mid-length arterial lesions with a reference diameter of 2.5-7 mm.
Fifty-eight femoto-popliteal stenoses in 46 patients (67% male, mean age 66 +/- 9 years) with chronic peripheral occlusive disease of the lower limbs [Rutherford stage 2: n = 13 (28%); stage 3: n = 29 (63%), stage 4: 2 (4%), stage 5: n = 2 (4%)], were treated with directional atherectomy. Target lesion characteristics: Common femoral artery: n = 1 (2%), superficial femoral artery: n = 47 (81%); popliteal artery, n = 10 (17%); in stent n = 3 (5 %). Thirty (65 %) of the interventions were performed using an antegrade approach, 16 (35%) interventions in cross-over technique. Mean degree of stenosis was 83 +/- 11 mm, mean length of lesion was 37 +/- 37 mm.
6.5 +/- 2 (4-10) passes of the lesion were performed with the catheter. Three lesions were treated after predilatation, 55 (95%) interventions as primary atherectomy. In 31/58 lesions (53%) additional balloon angioplasty was performed, in 1 lesion (2%) additional stent placement was needed. The mean degree of stenosis after atherectomy was reduced to 29 +/- 20% (0-60%) after additional balloon angioplasty, it was 11 +/- 10% (0-30 %). A residual stenosis of < 50% after plain atherectomy was achieved in 55 (95%) lesions, of < 30% in 49 (84%).
3 (6.5%) cases of embolism of debris were detected and treated successfully by aspiration. The mean ankle-brachial index increased from 0.62 +/- 0.12 to 0.92 +/- 0.36 before discharge, and to 0.86 +/- 0.17 after 30 days. Rutherford stage after 30 days: stage 0: n = 038 (83%); Stage 1: n = 4 (8%); Stage 2: n = 3 (6%); Stage 5: n = 1 (2%).
Lesions up to 8 cm in length of the femoropopliteal arteries can be treated successfully in most cases with the new atherectomy catheter. Embolism, the only complication that occurred, can be avoided by cleaning the nose cone after at least 4 passes of the lesion.
评估一种新型7F旋切装置（30天终点指标）治疗参考直径为2.5 - 7mm的短、中长度动脉病变的疗效和安全性。
46例慢性下肢周围闭塞性疾病患者（男性占67%，平均年龄66±9岁）的58处股腘动脉狭窄[卢瑟福分级2级：n = 13（28%）；3级：n = 29（63%），4级：2例（4%），5级：n = 2（4%）]接受了定向旋切术治疗。靶病变特征：股总动脉：n = 1（2%），股浅动脉：n = 47（81%）；腘动脉，n = 10（17%）；支架内病变n = 3（5%）。30例（65%）干预采用顺行入路，16例（35%）干预采用交叉技术。平均狭窄程度为83±11mm，平均病变长度为37±37mm。
用导管对病变进行了6.5±2（4 - 10）次通过。3处病变在预扩张后进行治疗，55例（95%）干预为初次旋切术。在31/58处病变（53%）中进行了额外的球囊血管成形术，1处病变（2%）需要额外放置支架。旋切术后平均狭窄程度在额外球囊血管成形术后降至29±20%（0 - 60%），为11±10%（0 - 30%）。单纯旋切术后残余狭窄<50%在55处病变（95%）中实现，<30%在49处病变（84%）中实现。
检测到3例（6.5%）碎片栓塞病例，并通过抽吸成功治疗。出院前平均踝肱指数从0.62±0.12增加到0.92±0.36，30天后增加到0.86±0.17。30天后卢瑟福分级：0级：n = 38（83%）；1级：n = 4（8%）；2级：n = 3（6%）；5级：n = 1（2%）。
大多数情况下，新型旋切导管可成功治疗长度达8cm的股腘动脉病变。栓塞是唯一发生的并发症，在病变至少通过4次后清洁鼻锥可避免。
