Long-term results of stent graft in the treatment of TASC C, D femoropopliteal artery occlusive disease / 中华普通外科杂志

Objective:To evaluate the long-term outcome of Viabahn stent graft in the treatment of complex femoropopliteal occlusive lesions.Methods:From Sep 2013 to Mar 2020, clinical data of TASC C and D femoropopliteal lesions treated with Viabahn were retrospectively analyzed. Patency rates, the freedom rate from clinically-driven target lesion revascularization (F-TLR), limb salvage and survival after five years were calculated.Results:A total of 65 patients (67 lower limbs) were included. 20 limbs were TASC C lesions, 47 limbs were TASC D lesions. The mean lesion length was (29.1±9.4) cm, including 48 chronic total occlusion (CTO) lesions (71.6%) with mean lesion length of (26.1±10.4) cm. Technique success rate was 98.6%. Mean length of stent graft was (31.3±10.1) cm.Major amputation was performed in 4.2% cases within 5 years. All-cause mortality in 5 years was 23.1%. Primary patency rates at 1,3,and 5 years were 76.8%,59.4%,50.9%, Assisted primary patency rates were 88.4%, 83.4%, 83.4% and secondary patency rates were 88.4%, 85.8%, and 85.8% . F-TLR at 1, 3 and 5 year was 88.2%,76.9%,73.1% .Conclusion:Viabahn for complex and long femoropopliteal artery occlusions is an acceptable treatment with fair long-term outcome.

Application of Rotarex catheter system in femoropopliteal artery stenosis accompanied with thrombosis / 北京大学学报(医学版)

OBJECTIVE@#To evaluate the effectiveness and safety of Rotarex catheter system in treating femoropopliteal artery stenosis accompanied with thrombosis.@*METHODS@#From Jun. 2017 to Dec. 2019, the clinical data of 32 femoropopliteal artery stenosis accompanied with thrombosis cases treated with Rotarex catheter system were retrospectively analyzed. There were 23 males and 9 females aged from 50 to 89 years and the mean age was (70.7±10.3) years. Six cases had acute course of disease (≤2 weeks), 17 cases had subacute course of disease (>2 weeks, ≤3 months), and 9 cases had chronic course of disease (>3 months). Mean lesion length was (23.4±13.7) cm, mean occlusion length was (19.9±13.3) cm, and in-stent occlusion 7 cases. The superficial femoral artery (SFA) was involved in 13 cases, the popliteal artery (PA) was involved in 8 cases, and both SFA and PA were involved in the other 11 cases. All the cases were treated with Rotarex catheter system. When necessary, suction with large lumen catheter was enabled. Residual stenosis was treated with percutaneous transluminal angioplasty (PTA). Drug-coated balloon (DCB) was only used in patients with financial status, and stent was used only when it was necessary. Heparin was used for 24 h after procedures, and after that, antiplatelet agents were used. Doppler ultrasonography was taken during the followed-up.@*RESULTS@#Technical success was 100%, and mean procedure time was (107.4±21.5) min. 8F (1F≈0.33 mm) and 6F Rotarex catheter were used in 27 and 5 cases respectively. In 27 cases, forward flow was obtained immediately after debulking with Rotarex catheter, and in the other 5 cases, suction with large lumen catheters were used. PTA was used in all 32 cases. DCB were used in 8 cases, of which 4 were used in in-stent stenosis. Twelve cases were implanted stents. There were no perioperative deaths. The only one procedure related complication was distal embolism. We took out the thrombus with guiding catheter. In all cases, mean hospital stay were (4.6±1.5) d. The ankle brachial index increased from 0.32±0.15 to 0.86±0.10 after treatment (t=-16.847, P < 0.001). The Rutherford stages decreased significantly (Z=-4.518, P < 0.001). All the patients were followed up for 6.0-36.0 months, and the median time was 16.0 months. 2 cases stopped antiplatelet agents, which resulted in acute thrombosis. Another percutaneous mechanical thrombectomy and PTA were taken in one of them. Two cases died of cardiovascular disease during the follow-up, and no amputation was observed. Target lesion restenosis occurred in 7 cases during the follow-up, and target lesion revascularization (TLR) was taken in two of them.@*CONCLUSION@#In treating femoropopliteal artery stenosis accompanied with thrombosis, Rotarex catheter can remove thrombus effectively, and that can expose underlying lesions and reduce stent use and complications rates. It is a safe and effective method.

Paclitaxel coated balloon in the treatment of femoral popliteal artery disease / 中华普通外科杂志

Objective:To summarize the clinical efficiency of paclitaxel drug coated balloon (DCB) in femoral popliteal artery disease.Methods:Retrospective analysis was made on 125 patients (141 limbs) admitted from Jun 2016 to Jul 2019 for femoral popliteal disease treated with DCB.Results:Median follow-up time was 19 months. The average lesion length was (138±78) mm, with an overall cumulative primary patency rate of 81.4% and 60.8% at 12 and 24 months postoperatively and f-TLR rates of 90.1% and 83.0%, respectively. In a total of 109 primary lesions, subgroup analysis showed that among the TASC C/D primary lesions, the primary patency rate was significantly lower in those with combined severe calcification and the f-TLR rate in those with popliteal involved lesions. TASC grade C/D lesions, severe calcified lesions were independent risk factors for patency, while hypertension was an independent protective factor.In-stent restenosis (ISR) target lesions involving the popliteal segment had a significantly worse prognosis than ISR of the superficial femoral artery.Conclusion:DCB in the treatment of lower femoral popliteal artery lesions can achieve a satisfactory medium-term patency outcome, while the efficacy for complex lesions still needs further improvement.

Comparing plain old balloon and drug-coated balloon supported bare metal stents in the treatment of femoral-popliteal TASC D lesions / 中华普通外科杂志

Objective:To compare the efficacy between drug-coated balloon (DCB) combined with bare metal stenting (BMS) and plain old balloon angioplasty (POBA) with BMS placement in the treatment of femoral-popliteal TASC D lesions.Methods:According to the Trans-Atlantic Inter-Society Consensus (TASC) D grade femoral-popliteal lesions as the standard, we enrolled 115 cases (120 limbs) receiving DCB combined with BMS (group DCB, 37 limbs in 36 cases) and POBA combined with BMS (group POBA, 83 limbs in 79 cases) from Jan 2017 to Mar 2020 to observe patency rate, freedom from clinical-drived target lesion reintervention rate (FCD-TLR) and complications.Results:The mean follow-up time was 18.1 months and the average occlusion length was (29.1±6.5)mm. In group DCB vs group POBA, the primary patency rates at 3-month, 9-month, 1-year and 2-year were 89.2% vs. 86.7%, 86.4% vs. 76.9%, 66.8% vs. 70.9% and 63.1% vs. 56.9%, respectively ( P=0.73); FCD-TLRs were 100.0% vs. 95.1%, 94.3% vs. 82.3% , 78.5% vs. 80.6% and 74.1% vs. 68.9% ( P=0.69), respectively. Conclusion:The benefit of DCB combined with BMS over POBA combined with BMS in improving the early primary patency rate and reducing FCD-TLR was not definite.

Efficacy of drug-coated balloons in treatment of TASC Ⅱ C/D femoro-popliteal artery de novo stenosis and in-stent restenosis / 中华全科医师杂志

Objective:To evaluate the mid-term clinical efficacy of drug-coated balloons (DCB)in the treatment of femoro-popliteal artery TASC Ⅱ C/D de novo stenosis and in-stent restenosis.Methods:A total of 126 patients with TASC Ⅱ C/D femoro-popliteal artery stenosis treated with DCB in Renji Hospital and Pudong New Area People's Hospital from December 2016 to August 2020 were retrospectively enrolled, including 74 cases of de novo stenosis (de novo group) and 52 cases of in-stent restenosis (ISR group). The clinical data and lesion characteristics were analyzed; the primary patency rate, primary-assisted patency rate, secondary patency rate, and the freedom from target lesion revascularization (f-TLR)rate were evaluated; the perioperative complications, mortality and amputation rate were compared between two groups. Kaplan-Meier method was used to evaluate the patency rate of target vessel lesions, and Cox regression analysis was used to evaluate the relative risk factors.Results:There were 6 patients died in each group during the followup period. The lesion length of the de novo and ISR groups were (21.25±12.64) cm and (34.71±12.02) cm, respectively( t=33.74, P<0.001). The popliteal artery involvement was 33.8% (25/74) in the de novo group and 15.4% (8/52) in the ISR group (χ 2=5.35, P=0.021). The operational success rate was 100.0% in both groups, and the perioperative complication rate was 6.8% (5/74) in the de novo group and 1.9% (1/52) in ISR group. The median follow-up time was 22 month and 17 months; the mean follow-up time were(19.78 ± 11.02) months and (20.02 ± 11.32) months in the de novo group and ISR group, respectively. The primary patency rates at 6, 12 and 24 months after intervention were 89.1%, 73.4%, 50.8% in the Denovo group, and 87.8%, 68.8%, 42.0% in the ISR group, respectively; the primary assisted patency rate was 90.7%, 78.4%, 62.8% in the de novo group, and 89.3%,77.1%, 62.8% in the ISR group, respectively; the secondary patency rate was 95.1%,95.1%, 88.7% in de novo group, and 94.9%, 88.9%, 84.3% in ISR group, respectively; the f-TLR rate was 97.3%, 88.6%, 79.2% in de novo group, and 90.0%, 77.7%, 74.7% in ISR group, respectively (all P>0.05). Cox regression analysis showed that P2 and P3 segment involvement of the popliteal artery were independent factors affecting the patency rate of target lesion. Conclusions:The mid-term clinical efficacy of DCB in the treatment of TASC Ⅱ C/D femoro-popliteal artery de novo stenosis and in-stent restenosis is satisfactory.

Short-term efficacy of paclitaxel -coated balloon in the treatment of femoropopliteal artery disease / 中华普通外科杂志

Objective:To evaluate the efficacy and safety of drug-coated balloon (DCB) with paclitaxel in the treatment of femoropopliteal arteriosclerosis obliterans (ASO).Methods:From Dec 2016 to Dec 2018, clinical data of femoropopliteal artery disease patients treated with paclitaxel DCB in Renji Hospital, School of Medicine, Shanghai Jiaotong University were retrospectively analyzed.Results:A total of 83 patients (95 lower limbs) underwent DCB therapy. Including 50 chronic total occlusion (CTO) lesions (52.6%) with mean lesion length of (18.35±10.61) cm. Twenty-four lesions (25.3%) were moderately or severely calcified. Bail-out stent implantation was performed in 29.5% cases. The mean follow-up time was 17.5 months. Twelve months after intervention, the all-cause mortality rate was 6.0%, the major amputation rate was 4.3%, the primary patency rate was 60.6%, the primary assisted patency rate was 72.4%, the secondary patency rate was 83.4%, and the freedom rate from clinically-driven target lesion revascularization(F-TLR) was 77.0%. Moderate to severe calcification was an independent risk factor for the primary patency of DCB therapy.Conclusion:DCB is a safe and effective endovascular therapy for femoropopliteal artery disease.

Application of drug-coated balloon in femoropopliteal artery occlusive disease / 中华普通外科杂志

Objective To investigate the efficacy of drug-coated balloon in treatment of femoropopliteal artery occlusive disease.Methods The clinical data of 49 patients with femoropopliteal artery occlusive disease from Feb 2016 to Oct 2017 were retrospectively analyzed.25 cases underwent drugcoated balloon treatment (DCB group),and 24 cases received plain balloon angioplasty (POBA group).Results The procedures were successful in all cases.There were no amputation or death occurred.In DCB group compared to POBA group,the patency rate at postoperative 3 months were not significantly different (96.0％ vs.87.5％,P ＞ 0.05),while it was significantly different at postoperative 6 and 12 months (88.0％ vs.66.7％;80.0％ vs.50.0％,both P ＜0.05).Minimal lumen diameter (MLD) changes and late lumen loss(LLL):The MLD in preoperative,immediate postoperative was not statistically significant between the three group(P ＞ 0.05).At 6 months and 12 months after operation,MLD of DCB group was higher than POBA group (P ＜ 0.05).At 12 months after surgery,LLL in DCB group was significantly lower than the POBA group (P ＜ 0.05).Conclusion DCB is the effective method to treat femoropopliteal artery occlusive disease,which has better short and mid-term efficacy than POBA.

Drug-coated balloon versus uncoated balloon angioplasty for femoropopliteal artery ischemic disease:a meta-analysis of curative effect and safety / 介入放射学杂志

Objective To conduct a meta-analysis of the curative effect and safety of the drug-coated balloon (DCB) and uncoated balloon (UCB) in treating femoropopliteal artery ischemic disease in order to provide more credible conclusion to guide clinical practice.Methods By retrieving relevant documents contained in Medline,EMbase,Cochrane library,EBSCO,Springer Link,Scopus,Web and other data pools,the research articles of clinical trials that met the inclusion and exclusion criteria were collected.According to the risk assessment standard of Cochrane collaboration network,the academic qualities of included articles were evaluated,the relevant data were extracted,then,the meta-analysis was conducted with RevMan5.3 software.Results A total of 8 papers were collected,which were originated from 6 clinical trials (from 2008 to 2015) and included 1188 patients in total.DCB group had 722 patients,and UCB group had 466 patients.Meta analysis showed that the target lesion revascularization (TLR) rates at 6,12 and 24 months after angioplasty in DCB group were significantly lower than those in UCB group.The late lumen loss (LLL) amount and re-stenosis rate at 6 month after angioplasty in DCB group were lower than those in UCB group.No statistically significant differences in amputation rate and mortality at 6,12 and 24 months after angioplasty existed between the two groups.Conclusion In treating femoropopliteal artery ischemic disease,the use of DCB is superior to the use of UCB in aspects of TLR rate,LLL amount and re-stenosis rate,besides,no significant difference in safety exists between DCB and UCB.Therefore,priority should be given to the use of DCB when the patient's economic conditions permit.

Application progresses of drug-coated balloon for femoropopliteal disease / 中国介入影像与治疗学

Percutaneous transluminal angioplasty is the preferred treatment of femoropopliteal arterial disease at present.But the high rate of restenosis needs to be solved rapidly.As a new treatment strategy,drug-coated balloon (DCB) can reduce the late lumen lose and the revascularization of target lesion by inhibiting intimal proliferation and inflammatory response,also it can treat femoropopliteal in-stent restenosis effectively.In addition,combining DCB and atherectomy or stenting can improve the outcomes for severe stenosis of femoropopliteal artery.The recent application progresses of DCB for femoropopliteal disease were reviewed in this article.