Demierre Adeline, Pedrazzoli Kaliska, Hayoz Daniel, Engelberger Rolf P, Périard Daniel
Angiology, HFR Fribourg, Hôpital Universitaire et Cantonal, Fribourg, Switzerland.
J Endovasc Ther. 2025 Jan 18:15266028241312346. doi: 10.1177/15266028241312346.
Angioplasty of lower extremity arteries with calcification may result in flow-limiting dissection requiring bail-out stenting with unfavorable long-term outcomes. Vessel preparation prior to angioplasty may improve immediate results of the angioplasty and long-term patency. This prospective study assessed the 12-month outcomes of patients who underwent novel vessel preparation catheter, the FLEX Vessel Prep™ System (FLEX VP), prior to drug-coated balloon angioplasty (DCB-PTA).
This investigator-initiated single-arm prospective trial enrolled patients with symptomatic lower extremity peripheral artery disease with de novo, restenotic, or in-stent stenosis of the superficial femoral or popliteal arteries. Target lesions were prepared using FLEX VP that created 12 longitudinal micro-incisions before drug-coated balloon angioplasty.
Forty-three lesions in 41 patients were treated in this study with an average lesion length of 118 mm (10-291 mm), average stenosis of 82% (40-100%), and an occlusion rate of 27.9% with an average occlusion length of 89 mm (10-272 mm). Calcification was observed in 85.7% of the lesions, with 66.7% of lesions demonstrating grade 3 or 4 of the Peripheral Arterial Calcification Scoring System. After FLEX VP and DCB-PTA, 92.7% of patients were absent of flow-limiting dissections. Stenting occurred in 39% (16/41) patients (median stent length 40 mm) for residual stenosis (15 patients) and flow-limiting dissection (1 patient). There was one death prior to the 12-month follow-up, not related to the index procedure. Freedom from clinically driven target lesion revascularization at 12 months was 97.5% (39/40). Rutherford classification shifted from 41.5% Class ≥3 at baseline to 95% Class ≤1 at 12 months. There were no amputations at 12 months.
Vessel preparation with longitudinal micro-incisions of complex and calcified lesions prior to angioplasty was associated with few flow-limiting dissections. The majority of stents were placed to treat focal residual stenosis, using the shortest available stent length at the time of the study (40 mm) for the majority. Only one stent was needed to treat a flow-limiting dissection. The 97.5% freedom from clinically driven target lesion revascularization (CDTLR) and symptom relief at 12 months suggest that vessel preparation via FLEX VP provides value in maintaining long-term outcomes in patients with highly calcified superficial femoral artery (SFA) or popliteal lesions.
Vessel preparation with longitudinal micro-incisions is a short and efficient intervention associated with promising clinical outcomes and patency rate 12 months after treatment of long and calcified occlusions or stenosis of the femoral and popliteal arteries. This innovative vessel preparation provides post-procedure less residual stenosis and more favorable dissection morphology, decreasing the placement of stent and especially their length. Vessel preparation by longitudinal incisions also favors optimal distribution of anti-restenotic drug in the lesion and thus prevents further intervention due to restenosis.
对伴有钙化的下肢动脉进行血管成形术可能会导致限流性夹层形成，需要置入补救支架，但其长期预后不佳。血管成形术前的血管预处理可能会改善血管成形术的即刻效果和长期通畅率。本前瞻性研究评估了在药物涂层球囊血管成形术（DCB-PTA）之前使用新型血管预处理导管FLEX Vessel Prep™系统（FLEX VP）的患者的12个月预后。
本研究者发起的单臂前瞻性试验纳入了患有症状性下肢外周动脉疾病、股浅动脉或腘动脉出现初发、再狭窄或支架内狭窄的患者。在药物涂层球囊血管成形术之前，使用FLEX VP对靶病变进行预处理，该系统会形成12条纵向微切口。
本研究共治疗了41例患者的43处病变，平均病变长度为118 mm（10 - 291 mm），平均狭窄率为82%（40 - 100%），闭塞率为27.9%，平均闭塞长度为89 mm（10 - 272 mm）。85.7%的病变观察到钙化，66.7%的病变显示外周动脉钙化评分系统为3级或4级。在FLEX VP和DCB-PTA术后，92.7%的患者没有出现限流性夹层。39%（16/41）的患者因残余狭窄（15例）和限流性夹层（1例）而置入支架（中位支架长度40 mm）。在12个月随访前有1例死亡，与索引手术无关。12个月时免于临床驱动的靶病变血运重建的比例为97.5%（39/40）。卢瑟福分级从基线时41.5%的≥3级转变为12个月时95%的≤1级。12个月时没有截肢病例。
血管成形术前对复杂钙化病变进行纵向微切口血管预处理与较少的限流性夹层相关。大多数支架是为治疗局灶性残余狭窄而置入的，在研究期间大多数使用了当时最短的可用支架长度（40 mm）。仅需1枚支架来治疗限流性夹层。12个月时97.5%免于临床驱动的靶病变血运重建（CDTLR）以及症状缓解表明，通过FLEX VP进行血管预处理在维持高度钙化的股浅动脉（SFA）或腘动脉病变患者的长期预后方面具有价值。
纵向微切口血管预处理是一种简短而有效的干预措施，在治疗股动脉和腘动脉的长段钙化闭塞或狭窄后12个月具有良好的临床预后和通畅率。这种创新性的血管预处理在术后减少了残余狭窄，并使夹层形态更有利，减少了支架的置入，尤其是其长度。通过纵向切口进行血管预处理还有利于抗再狭窄药物在病变中的最佳分布，从而防止因再狭窄而进行进一步干预。
