Comparison of pulsed laser-assisted angioplasty and balloon angioplasty in femoropopliteal artery occlusions.

The authors performed a prospective, comparative study of 96 patients (age, 41-87 years) with femoropopliteal artery occlusions. Laser-assisted angioplasty was performed in 64 patients with 9- and 7-F over-the-wire multifiber catheters. Supplemental balloon dilation was performed after laser angioplasty. Thirty-two patients underwent excimer laser angioplasty (ELA), and 32 underwent pulsed dye laser angioplasty (DLA). The remaining 32 patients underwent conventional balloon angioplasty (BA). The length of occlusions was 3-10 cm (mean, 6.3 cm). Lesion characteristics in the three patient groups were similar. Technical success rates were 84% for ELA, 78% for pulsed DLA, and 81% for conventional BA. The 1-year clinical success rate was 69% (22 of 32 patients) in the ELA group, 63% (20 of 32 patients) in the pulsed DLA group, and 66% (21 of 32 patients) in the BA group (differences were not significant). Laser-assisted angioplasty with multifiber catheters in femoropopliteal artery occlusions did not help improve the technical success rate and 1-year clinical success rate when compared with those of conventional BA.     

Vibrational angioplasty in recanalization of chronic femoropopliteal arterial occlusions: Single center experience

Purpose

This prospective study aims to present the overall success rate, safety and long-term outcome of vibrational angioplasty technique, in the treatment of chronic total femoropopliteal occlusions in our institute.

Methods

Between October 2000 and December 2008, patients with chronic total femoropoliteal arterial occlusions, treated with vibrational angioplasty during the same session after a failed attempt with conventional recanalization technique, were included. Patient's follow up included serial ankle-brachial index measurements and arterial duplex ultrasound examinations at 1, 3, 6, 12, 24, 36 and 48 months.

Results

Twenty-seven patients (16 males and 11 females) and twenty-eight lesions were included in our study. Twenty-five lesions (89.3%) were successfully recanalized. Pain relief was noticed in twenty-one cases. From ten lesions with tissue loss (ulcer or gangrene) in successfully recanalized occlusions, six healed without major, or minor amputation. One non-healing amputation stump was healed after recanalization, without further complications. Four limbs underwent amputation (one minor and three major) despite successful recanalization, however all had an excellent healing of the amputation stump without further complications.The Kaplan–Meier test demonstrated 90%, 85% and 70% amputation-free survival rate at 12, 24 and 36 months, respectively. No major or minor complications were encountered.

Conclusions

Vibrational angioplasty is a safe, effective and durable endovascular technique for the treatment of chronic total occlusions in patients with limb ischemia that would be difficult to recanalize using conventional intraluminal techniques.     

Follow-up of conventional angioplasty versus laser thermal angioplasty for total femoropopliteal artery occlusions: results of a randomized trial.

Sixty-eight patients with 68 femoropopliteal occlusions were entered into a randomized trial of conventional guide-wire and catheter percutaneous angioplasty versus laser thermal angioplasty. Thirty-four occlusions were randomized to conventional angioplasty and 34 to laser thermal angioplasty. After successful recanalization and balloon dilation, the patients were followed up for 1 year. Follow-up consisted of obtaining measurements of the ankle-arm indexes at 1, 3, 6, and 12 months. The increase in the mean resting ankle-arm index 1 year after conventional angioplasty (0.26) was greater than that after laser angioplasty (0.12). At 1-year follow-up, the cumulative success rate was 47% for patients treated with conventional angioplasty versus 39% for those treated with laser angioplasty. Statistical analysis showed no significant difference in clinical success between the two treatment groups.     

Femoropopliteal artery recanalization: Factors affecting clinical outcome of conventional and laser-assisted balloon angioplasty

Purpose The clinical efficacy of 44 successful conventional and laser-assisted recanalizations of the femoropopliteal artery was assessed in a noncomparative study by the life-table method.Methods Laser-assisted angioplasty using continuous laser and a sapphire probe was performed to achieve primary recanalization in femoral artery occlusions when conventional guidewire recanalization had already failed. Nineteen of the patients underwent a conventional recanalization (PTA; mean length of occlusion 4.4 ± 4.1 cm), and 25 underwent percutaneous laser-assisted angioplasty (PLA; mean length of occlusion 10.1 ± 6.7 cm).Results There was no statistical relation between the preprocedure Fontaine classification and the success rate in the PTA cases (p = 0.25), whereas there was a statistical relation in the PLA cases: The success rate in patients preprocedurally classified as Fontaine II was better than in those classified as Fontaine III/IV (p = 0.05). After a 3-year follow-up the patency rate in the patients with the PTA recanalizations was 37% and that in those with the PLA procedure was 53%. This difference was not statistically significant (p = 0.47).Conclusion It is concluded that the laser should remain an investigational device.     

Laser-assisted balloon angioplasty in complete femoropopliteal occlusions: Preliminary results

Laser-assisted balloon angioplasty (LA) using a Nd-YAG laser with a sapphire tip probe was performed in 40 selected patients with complete chronic femoropopliteal occlusions (SFA n=30, PA n=10), in whom the lesion was resistent to conventional guidewire/catheter traversal. Overall technical success rate was 77.5% (31/40). Technical failure occurred in nine cases due to calcifications (n=2), imminent perforation (n=5), or complete perforation (n=4). In I case a Simpson atherectomy was done following LA. In addition, 3 cases of peripheral embolizations were managed successfully by selective fibrinolysis and thrombus aspiration. Follow-up studies up to 14 months demonstrated a clinical improvement in 87% (27/31). Early reocclusion rate was 4/31; after 2–14 months, reocclusion rate was 7/31. Our results demonstrate that LA may be recommended for chronic occlusions resistent to conventional guidewire or catheter traversal in spite of a relatively high rate of technical failure and complications, and recurrence.     

Total peripheral artery occlusions: conventional versus laser thermal recanalization with a hybrid probe in percutaneous angioplasty--results of a randomized trial.

Increasing the primary success rate in recanalization of peripheral vascular occlusions is one aim of using laser techniques in the treatment of peripheral vascular disease. Although reports of lasers enabling recanalization after failure of guide wires have been numerous, direct comparisons of the success of the two techniques in a randomized trial have been few. The results of a randomized trial showed no statistical difference in recanalization of femoropopliteal occlusions between the conventional guide wire and hybrid laser probe. The number of patients with iliac occlusions was small and comparisons are difficult to make, but the findings suggest that the hybrid laser probe has little to offer. Immediate crossover to the alternative method allowed investigation of the relationship between the two methods in practice. Combining the two methods improved the primary success rate from 82% to 91% for femoropopliteal occlusions randomized to laser thermal recanalization and from 74% to 91% for those randomized to conventional recanalization.     

内膜下再通术在股腘动脉腔内成形术中的应用

目的 探讨内膜下再通技术(SIR)治疗股腘动脉粥样硬化闭塞病变的技术要点和疗效.方法 使用内膜下再通技术治疗患者股腘动脉完全闭塞病变42例.使用超滑导丝穿通闭塞段动脉内膜下腔,通过闭塞段后重新进入流出道真腔.建立闭塞段动脉内膜下通道后,用球囊腔内成形及支架置入以保证管腔通畅.结果 39例患者内膜下再通治疗获得成功,临床...     

Percutaneous transluminal angioplasty and enclosed thrombolysis versus percutaneous transluminal angioplasty in the treatment of femoropopliteal occlusions: Results of a prospective randomized trial

Purpose: To determine whether percutaneous transluminal angioplasty (PTA) and enclosed thrombolysis (ET) is superior to PTA alone in the treatment of femoropopliteal occlusions. Methods: Twenty-five patients with 5–15-cm-long occlusions in the femoropopliteal segments, with otherwise normal run-in arteries and at least one normal tibioperoneal artery to the foot, were randomized to ET/PTA or PTA alone. Ankle brachial systolic index (ABI) was measured before the procedure and at 24 hr and 12 months after the procedure, when a duplex scan was also carried out. End points in the study were patency at, or repeat intervention before, 12 months. Results: Procedures were successful in 23 of 25 patients. There was one immediate occlusion of tibioperoneal arteries, and one early reocclusion of a reopened segment in the ET/PTA group. There was one early reocclusion in the PTA group. At 12 months patency was 70% and 69.2% in the ET/PTA and PTA groups respectively. Covariant analysis showed no significant difference in ABI between the two groups at any of the three measurement times. Conclusion: This trial demonstrated no difference between ET/PTA and PTA alone in femoropopliteal occlusions associated with normal proximal arteries and at least one normal tibioperoneal artery.     

Dye laser-assisted angioplasty with multifiber catheters: short-term results in the treatment of 29 peripheral arterial occlusions

The use of pulsed dye laser energy for angioplasty offers the possibility of ablating atherosclerotic plaques without thermal damage to the adjacent arterial wall. However, to be of value, systems that deliver the energy safely and effectively are required. We tested multifiber catheters in 504-nm pulsed dye laser angioplasty for treatment of peripheral arterial occlusions. Flexible multifiber catheters consist of 12 (7-French) and 19 (9-French) concentrically arranged 200-microns quartz fibers allowing guidewire-directed use. Laser-assisted angioplasty was performed in 2- to 13-cm- (mean, 7.5-cm) long occlusions of iliac (six) and femoropopliteal (23) arteries in patients with symptomatic occlusive vascular disease. Angiograms were obtained before and after laser ablation, after subsequent balloon dilatation, and if signs or symptoms indicated restenosis, during follow-up. The laser procedure was impossible to perform in three (10%) of 29 patients; this was related to unsuccessful passage of the wire in one patient and to inability to advance the laser catheter across the lesion in two patients. In one other patient, reocclusion occurred 1 day after angioplasty. Stand-alone laser angioplasty relieved residual stenosis of less than 30% in six (26%) of 23 femoropopliteal arteries, making balloon dilatation dispensable. Immediate clinical improvement was achieved in 26 (90%) of 29 patients. Laser treatment caused no perforation and no embolization, but minor dissections occurred in 36% of the patients. Our experience suggests that pulsed dye laser angioplasty via multifiber catheters converts arterial occlusions into stenoses. With the exception of angioplasty in distal femoropopliteal arteries, additional balloon dilatation is necessary to complete recanalization.     

Angioplasty using a Nd:YAG laser with a sapphire probe

Laser angioplasty with Sapphire Contact Probes coupled to a Nd:YAG laser followed by balloon angioplasty was performed in 30 patients with 26 femoropopliteal and 4 iliac artery occlusions. Mean length of the occlusions was 4.5 +/- 1.6 cm with a mean duration of occlusion of 7.06 +/- 6.18 months. Initial angiographic success was obtained in 25/30 (83%) procedures, including 3/4 successes in the iliac artery (75%) and 22/26 successes in the femoropopliteal artery (84%). Reason for failure was perforation in 2 patients, and subintimal passage of the probe in 2, and heavy calcification of the lesion in 1 patient. Early rethrombosis in 3 patients reduced the primary success rate to 73%. Peripheral emboli necessitating surgical intervention occurred in 2 patients. Of the 22 recanalized arteries 21 remained patent with a mean follow-up of 8.4 +/- 3.3 months. It remains to be determined whether the angiographic and clinical short and long term success rate of "laser assisted balloon angioplasty" will be greater than after thrombolysis or conventional balloon angioplasty.     

Peripheral arterial occlusions: initial results from percutaneous angioplasty with a hybrid laser probe

Percutaneous laser-assisted angioplasty performed with a laser-heated metal-capped fiber has been shown to be safe and effective. A hybrid probe was developed that allows a small percentage of laser light to emerge, converting the rest to heat. The probe was used to recanalize 37 peripheral arterial occlusions (10 in the iliac segment, 2-7 cm long, and 27 in the femoropopliteal segment, 1-35 cm long) in 37 patients. Primary success was defined as successful recanalization and continued patency during the first 24 hours, as assessed at physical examination. Primary success in the iliac segments was 70% and in the femoropopliteal segments was 85% (overall, 81%). The only complication was an arterial wall perforation, which had no sequelae. The probe is safe for use in peripheral arterial occlusions. There was no increase in the rate of perforation compared with the rate with the "hot-tip" laser probe, and the technique may have advantages over use of the original "hot-tip" laser probe.     

Comparison of efficacy in crossing femoropopliteal artery occlusions with movable core and hydrophilic guidewires

Purpose Compare the recanalization rate of femoropopliteal occlusions between movable core wire guide (MG) and hydrophilic guidewire (HG).Methods Conventional PTA technique was used, followed by enclosed thrombolysis. The MG was used for all patients in the first 2 years, the HG in the following 2 years. Baseline characteristics were similar for the two groups of patients.Results Recanalization of 124 femoropopliteal occlusions was attempted. Technical success was achieved with the MG in 45 of 59 procedures; 42 procedures were clinically successful. Using the HG, technical success was achieved in 35 of 65 procedures; clinical success was achieved in 29 cases (p < 0.0048). At 1-year follow-up, 32 extremities improved after treatment with MG and 22 extremities after treatment with HG (p < 0.035).Conclusion The results suggest that the MG should be the first choice in recanalization of femoropopliteal occlusions.     

Vascular inflammation and percutaneous transluminal angioplasty of the femoropopliteal artery: association with restenosis

PURPOSE: To determine the association of pre- and postprocedural serum levels of C-reactive protein (CRP), serum amyloid A (SAA), and fibrinogen at 6-month evaluation of restenosis after percutaneous transluminal angioplasty (PTA) of the femoropopliteal artery. MATERIALS AND METHODS: In a prospective cohort study, 172 consecutive patients with peripheral artery disease of Fontaine stage IIa, IIb, or III who underwent successful PTA of the superficial femoral and popliteal arteries were included. Patency at 6 months was evaluated by using oscillography, ankle-brachial index, and color-coded duplex ultrasonography. The association of restenosis and CRP, SAA, and fibrinogen levels at baseline, 24 hours, and 48 hours after intervention was assessed by means of multivariate analysis with adjustment for known risk factors for restenosis. RESULTS: Restenosis was found in 56 patients (33%) within 6 months. CRP values at baseline (adjusted odds ratio, 2.2; 95% CI: 1.1, 4.2) and 48 hours after intervention (adjusted odds ratio, 2.3; 95% CI: 1.6, 3.1) were independently associated with 6-month restenosis. SAA and fibrinogen values at any time interval were not significantly associated with patency in the multivariate models. CONCLUSION: The extent of vascular inflammation as measured by means of acute-phase reactants before and after PTA of the femoropopliteal artery is associated with 6-month restenosis. Baseline and 48-hour CRP levels were independent predictors of postangioplasty outcome.     

Segmentally enclosed thrombolysis in percutaneous transluminal angioplasty for femoropopliteal occlusions: A report from a pilot study

Segmentally enclosed thrombolysis (SET) was performed immediately following 34 percutaneous transluminal angioplasties (PTAs) for femoropopliteal occlusions. The dilated segment was sealed off with a double balloon catheter, and recombinant tissue plasminogen activator (rt-PA) I mg/ml and heparin 200 IU/ml were injected between the balloons. The catheter was removed after 30 min and heparin treatment was continued for 24 h. Alpha-2-antiplasmin was initially reduced by 13% and normalized 2 h after SET, indicating that only small amounts of free palsmin were liberated during thrombolysis. No clinically relevant changes in plasma fibrinogen occurred. Two puncture site hemorrhages did not coincide with the coagulopathy induced by SET. One-year patency was 80%. Early rethrombosis occurred in 9% versus 41% in our previous series on standard PTA for femoropopliteal occlusions (p<0.001). Therefore, SET is considered beneficial in reducing the incidence of early rethrombosis.     

药物涂层球囊和无涂层球囊治疗股腘动脉缺血性疾病疗效及安全性meta分析

目的 对药物涂层球囊(DCB)和无涂层球囊(UCB)治疗股腘动脉病变所致缺血性疾病的效果及安全性进行meta分析,以得出更为可信的结论指导临床工作.方法 通过检索Medline、EMbase、Cochrane Library、EBSCO、Springer Link、Scopus、Web等数据库中相关文献,筛选出符合预定纳入和排除标准的临床试验研究文献,并依据Cochrane协作网偏倚风险评价标准评价纳入文献质量后提取其中数据,采用RevMan5.3软件作meta分析.结果 最终纳入8篇文献,源于6项临床试验研究(2008年至2015年),总计1 188例患者(DCB组722例,UCB组466例).Meta分析结果显示,术后6、12、24个月内DCB组靶病变血运重建(TLR)率均明显低于UCB组,术后6个月时DCB组晚期管腔丢失(LLL)数、再狭窄率均低于UCB组,术后6、12、24个月内两组截肢率、死亡率差异无统计学意义.结论 与UCB相比,DCB治疗股腘动脉病变所致缺血性疾病在术后TLR率、LLL数、再狭窄率方面均表现出明显优势,在安全性方面无明显差异,因此在患者经济条件允许情况下可优先考虑DCB治疗.     

Long-term results of ePTFE stent-graft versus angioplasty in the femoropopliteal artery: single center experience from a prospective,randomized trial

PURPOSE: To describe a single-center experience as part of a U.S. multicenter prospective randomized trial of PTA versus percutaneous transluminal angioplasty (PTA)- and ePTFE (expanded polytetrafluoroethylene)-covered endoprosthesis placement for the treatment of superficial femoral artery (SFA) and proximal popliteal artery stenoses and occlusions. MATERIALS AND METHODS: Twenty-eight patients with claudication or ischemia were treated by PTA alone (n = 13) or PTA and endoprosthesis placement (n = 15). Baseline characteristics, including exercise ankle/brachial index (ABI), number of patent runoff vessels, Rutherford-Becker ischemia score, and lesion length, were equivalent. Follow-up included postprocedure, objective, noninvasive vascular evaluation and a clinical status scale for a minimum of 24 months. RESULTS: Technical success was achieved in 15 of 15 patients (100%) in the endoprosthesis group and 12 of 13 patients (92%) in the PTA group. Complications in the endoprosthesis group included clinically significant embolization (n = 1, successfully treated by thrombolysis) and transient thigh pain that required medication in three patients (20%). Clinical improvement was achieved initially in all patients with a significant increase in exercise ABI in both groups (mean increase from baseline was 0.51 with 95% CI: 0.37-0.64 in endoprosthesis patients and 0.39 with 95% CI: 0.31-0.47 in PTA patients; P =.13). At 6-month follow-up with duplex US, 93% of patients (14 of 15) treated with the Hemobahn endoprosthesis (W.L. Gore & Associates, Flagstaff, AZ) remained primarily patent versus 42% of patients (five of 12) treated with PTA alone. At 2 years follow-up, primary patency remained 87% (13 of 15 patients) in the endoprosthesis group versus only 25% (three of 12 patients) in the PTA group (P =.002). Exercise ABI was >0.15 higher than baseline in 93% of patients (14 of 15) treated with endoprosthesis placement versus 54% of patients (seven of 13) treated by PTA alone. Clinical success was maintained in 87% of patients (13 of 15) in the endoprosthesis group versus 46% of patients (six of 13) in the PTA group. CONCLUSION: This single-center experience with placement of the Hemobahn endoprosthesis (W.L. Gore & Associates) in the SFA demonstrated a statistically significant improvement in both patency and clinical outcome compared with PTA alone.