Hybrid treatment of multilevel revascularization in patients with                     peripheral arterial disease – a multi-centre study in                     Korea

Abstract. Background: Endovascular treatment is an alternative first-line management for peripheral artery disease (PAD). Hybrid treatment (HT) is defined as a combined treatment for patients with PAD using endovascular and open surgery, simultaneously performed in an operating room. The results of HT are reportedly good for multilevel revascularization (MR) in patients with chronic limb ischaemia, and even in older high-risk patients. The goal of this study was to examine the clinical and haemodynamic outcomes of HT in patients who need MR. Patients and methods: Nine university hospitals in Korea participated in this multicentre study. A total of 134 patients with multilevel PAD underwent HT and MR. Patients were enrolled from July 2014 to June 2015 and were followed for 18 months. Results: The mean age of the patients was 68.8 ± 9.93 years and 88.1 % were men. Patients with Rutherford category 2 to 3 and 4 to 6 comprised 59.0 % and 42.0 % of the group, respectively. The technical success rate was 100 %. The primary patency rates at 12 and 18 months were 77.6 % and 63.9 %, respectively. The primary-assisted patency rates at 12 and 18 months were both 90.0 %. The pre-operative mean ankle brachial index (0.43 ± 0.23) increased to 0.87 ± 0.23 at six months post-operatively (t-test, p < 0.05). The amputation free survival rate was 97.1 %. Conclusions: Although outcomes of multilevel PAD are reportedly poor when endovascular treatment alone is used, we have shown that HT is a feasible alternative modality for patients with multilevel PAD, with satisfactory amputation-free survival and freedom from re-intervention rates.

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Mid-term outcome after endovascular therapy in the superficial femoral and popliteal artery using long stents

VASA ◽

10.1024/0301-1526/a000163 ◽

2012 ◽

Vol 41 (1) ◽

pp. 49-56 ◽

Cited By ~ 10

Author(s):

Schoenefeld ◽

P. Donas ◽

Schönefeld ◽

Osada ◽

Austermann ◽

...

Keyword(s):

Endovascular Treatment ◽

Popliteal Artery ◽

Primary Patency ◽

Stent Fracture ◽

Fracture Rate ◽

Term Outcome ◽

Technical Success Rate ◽

Endovascular Interventions ◽

Artery Disease

Background: Peripheral artery disease (PAD) affecting the femoropopliteal artery is treated by endovascular interventions [2, 5, 13] increasingly. Aim of the study was to evaluate mid-term efficacy and patency of long stents in the superficial femoral and popliteal artery. Patients and methods: Between September 2006 and September 2007 103 patients received 128 stents for endovascular treatment of femoropopliteal vascular stenosis or occlusion. Clinical and hemodynamic parameters were collected. Risk factors, popliteal involvement and TASC classification, were documented and evaluated. Results: Immediate outcome was satisfactory with a technical success rate of 100 %. After a mean follow-up period of 21 months, primary patency was 83.6 %. Potential risk factor analysis for restenosis and fracture demonstrated hypertension to have borderline significance (P = 0.06). In normotensive patients no restenosis occurred. Further pre-conditions, e.g. smoking, metabolic syndrome, age, gender and previous intervention did not show any influence on restenosis or stent fracture. TASC C and D lesion had similar patency rates compared to TASC A and B lesions. Most of the restenoses (13 out of 16) were observed within the first six months of follow-up. Six stent fracture were observed (4.7 %). Conclusions: Long stents had convincing results after endovascular treatment of the femoropopliteal PAD. The used stent was an efficacious endovascular tool for long athersclerotic lesions in the superficial femoral and popliteal artery. Fracture rate was low with an incidence of 4.7 %. Most restenoses occurred within the first six months so that careful follow-up would be necessary.

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One-year outcomes of drug-coated balloon treatment for long femoropopliteal lesions: a multicentre cohort and real-world study

BMC Cardiovascular Disorders ◽

10.1186/s12872-021-02127-x ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Xiaoxi Yu ◽

Xin Zhang ◽

Zhichao Lai ◽

Jiang Shao ◽

Rong Zeng ◽

...

Keyword(s):

Real World ◽

Cox Regression ◽

Ankle Brachial Index ◽

Primary Patency ◽

Critical Limb Ischaemia ◽

Limb Ischaemia ◽

Cox Regression Analysis ◽

Femoropopliteal Artery ◽

Kaplan Meier ◽

Multicentre Cohort

Abstract Background Drug-coated balloons (DCBs) have shown superiority in the endovascular treatment of short femoropopliteal artery disease. Few studies have focused on outcomes in long lesions. This study aimed to evaluate the safety and effectiveness of Orchid® DCBs in long lesions over 1 year of follow-up. Methods This study is a multicentre cohort and real-world study. The patients had lesions longer than or equal to 150 mm of the femoropopliteal artery and were revascularized with DCBs. The primary endpoints were primary patency, freedom from clinically driven target lesion revascularization (TLR) at 12 months and major adverse events (all-cause death and major target limb amputation). The secondary endpoints were the changes in Rutherford classification and the ankle brachial index (ABI). Results One hundred fifteen lesions in 109 patients (mean age 67 ± 11 years, male proportion 71.6%) were included in this study. The mean lesion length was 252.3 ± 55.4 mm, and 78.3% of the lesions were chronic total occlusion (CTO). Primary patency by Kaplan–Meier estimation was 98.1% at 6 months and 82.1% at 12 months. The rate of freedom from TLR by Kaplan–Meier estimation was 88.4% through 12 months. There were no procedure- or device-related deaths through 12 months. The rate of all-cause death was 2.8%. Cox regression analysis suggested that renal failure and critical limb ischaemia (CLI) were statistically significant predictors of the primary patency endpoint. Conclusion In our real-world study, DCBs were safe and effective when used in long femoropopliteal lesions, and the primary patency rate at 12 months by Kaplan–Meier estimation was 82.1%.

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Efficacy and safety of endovascular treatment for femoropopliteal lesions of TASC II type C and D compared with TASC II type A and B in Korea

Vascular ◽

10.1177/1708538116678539 ◽

2016 ◽

Vol 25 (4) ◽

pp. 351-358 ◽

Cited By ~ 3

Author(s):

Hyung Joon Joo ◽

Duck Hyun Jang ◽

Cheol Woong Yu ◽

Young Jin Choi ◽

Jinsik Park ◽

...

Keyword(s):

Endovascular Treatment ◽

Ankle Brachial Index ◽

Type A ◽

Major Amputation ◽

Lesion Group ◽

Technical Success Rate ◽

Group I ◽

Type C ◽

Group Ii ◽

Symptom Relapse

Objective To compare the long-term safety and clinical efficacy of endovascular treatment for TASC-II type C/D femoropopliteal lesion compared with TASC-II type A/B femoropopliteal lesion in Korea. Methods A total of 179 limbs [TASC-II A/B femoropopliteal lesion (group I, n = 105 limbs) and TASC-II C/D (group II, n = 74 limbs)] were retrospectively analyzed from patients who underwent angioplasty with or without primary stent implantation between February 2008 and November 2012 at two medical centers in South Korea. The major adverse limb event was defined as a composite of target lesion revascularization, symptom relapse with abnormal ankle brachial index, and major amputation. Results Immediate procedural success rates were not significantly different (96.2% vs. 95.7%, p = 0.450). Although major adverse limb event, mainly driven by symptom relapse with abnormal ankle brachial index, were significantly higher in group II ( p = 0.013), the incidence of major amputation was very low and similar in both groups. Conclusion Even though there were higher incidences of overall procedural complication and major adverse limb event, the technical success rate of endovascular treatment for TASC-II C/D femoropopliteal lesion was comparable to endovascular treatment for TASC-II A/B FPL without an increase in major procedural complications or serious clinical events during follow-up.

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Application of relay puncture technique in treating patients with complicated lower extremity arterial diseases

PeerJ ◽

10.7717/peerj.6345 ◽

2019 ◽

Vol 7 ◽

pp. e6345

Author(s):

Chengzhi Li ◽

Huimin You ◽

Hong Zhang ◽

Yulong Liu ◽

Wanghai Li ◽

...

Keyword(s):

Lower Extremity ◽

Femoral Artery ◽

Brachial Artery ◽

Ankle Brachial Index ◽

Transluminal Angioplasty ◽

Primary Patency ◽

Technical Success Rate ◽

Percutaneous Transluminal ◽

Puncture Technique

Objective This study aimed to introduce and evaluate the safety and efficacy of the relay puncture technique in patients with complicated lower extremity arterial diseases. Methods A total of 21 patients (16 male and five female patients; median age: 68.5 years old), who had suffered from lower extremity arterial diseases between December 2014 and July 2017, were retrospectively collected. For all patients, the contralateral femoral artery was not available for puncture access, and the length of the devices was too short for the brachial artery approach. Therefore, the relay puncture technique, in which the first puncture was performed on the brachial artery, followed by an antegrade puncture on the femoral artery, was used to accomplish the endovascular therapy. Percutaneous transluminal angioplasty and/or percutaneous transluminal stenting were/was used to assess the efficacy of the relay puncture technique. The ankle–brachial index (ABI) and Rutherford clinical classification were used to evaluate the improvement of symptoms after treatment. Patients were followed up for 1, 3, 6, and 12 months, and annually (mean: 16.6 months) after discharge. Results The relay puncture treatment had a 100% technical success rate, and immediately decreased the ischemic symptoms of patients after the procedure. The ABI significantly increased from 0.33 ± 0.18 to 0.75 ± 0.21 at the 1-year follow-up time point (P < 0.05). No serious complications occurred during the follow-up period. The 1-year primary patency rate was 71.43%. Conclusion The relay puncture technique is a feasible technique in the hands of experienced and skilled equipment operators for the treatment of lower extremity arterial diseases, when the contralateral femoral artery is not available for puncture, and the length of the device is too short to treat the distal lesion of the femoral artery and popliteal artery through the brachial artery approach.

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Clinical outcomes of extended endovascular recanalization of 16 consecutive Buerger’s disease patients

Vascular ◽

10.1177/1708538118805623 ◽

2018 ◽

Vol 27 (3) ◽

pp. 233-241 ◽

Cited By ~ 2

Author(s):

Fehmi Kacmaz ◽

Adnan Kaya ◽

Muhammed Keskin ◽

Serdar Keceoglu ◽

Ibrahim Halil Algin ◽

...

Keyword(s):

Blood Flow ◽

Endovascular Treatment ◽

Clinical Outcomes ◽

Ankle Brachial Index ◽

Buerger’S Disease ◽

Technical Success ◽

Buerger's Disease ◽

Technical Success Rate ◽

Endovascular Recanalization ◽

Significant Difference

Objective Buerger’s disease is one of the worst diseases causing peripheral artery occlusions (especially lower extremity) with increased morbidity and mortality. Endovascular treatment of the diseased arteries gains preference over bypass surgery nowadays. Here, we aimed to present the clinical outcomes of 16 consecutive Buerger’s disease patients underwent extended endovascular recanalization which is a new technique to restore direct blood flow to at least one foot artery, with the performance of angioplasty for each tibial and foot artery obstructions. Methods A total of 16 consecutive patients with confirmed diagnosis of Buerger’s disease that percutaneously treated in our center between February 2014 and March 2018 were included in the study. The mean age of the patients was 44.25 ± 4.28 ranging from 36 to 50 years. After physical examination and complementary diagnostic tests, performance of extended angioplasty for occluded arteries was intended to restore direct blood flow to at least one of the blow-the-knee arteries. Results A successful extended endovascular treatment was performed in 20 of 22 limbs, achieving a technical success of 91%. All patients were successfully discharged without any complication. Mean follow-up duration was 21.43 ± 7.08 months. Reintervention was performed in one patient and minor amputation was needed in one of the failed limbs. Limb salvage rate was 100%. A significant difference was observed based on Rutherford classification, ankle brachial index, direct blood flow to foot, presence of ulcer and rest pain when compared before and after the intervention. Conclusion We showed successful extended endovascular recanalization of Buerger’s disease patients with a high technical success rate and sustained clinical improvement. Extended endovascular recanalization could be a therapeutic option in Buerger’s disease patients, since they are not good candidates for surgery.

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Comparison of drug-eluting balloon angioplasty with self-expanding interwoven nitinol stent deployment in patients with complex femoropopliteal lesions

Vascular ◽

10.1177/1708538117719580 ◽

2017 ◽

Vol 26 (1) ◽

pp. 54-61 ◽

Cited By ~ 6

Author(s):

Burak Teymen ◽

Suleyman Akturk ◽

Ulku Akturk ◽

Muhammed Tdjani

Keyword(s):

Ankle Brachial Index ◽

Primary Patency ◽

Stent Deployment ◽

Nitinol Stent ◽

Technical Success Rate ◽

Before And After ◽

Drug Eluting ◽

Drug Eluting Balloon ◽

One Year

Objective The aim of this study was to compare the drug-eluting balloon with self-expanding interwoven nitinol stent deployment in patients with complex femoropopliteal lesions. Methods We retrospectively identified patients at our clinic with complex femoropopliteal artery lesions treated either with self-expanding interwoven nitinol stent or drug-eluting balloon. All patients had ankle-brachial index measured before and after the intervention, and regular clinical follow-up with Doppler ultrasonography was performed at six months and one year. Patients underwent peripheral angiography if needed. Results From April 2012 to July 2015, 107 patients with complex femoropopliteal lesions treated with using self-expanding interwoven nitinol stent ( N = 49, mean length 143.5 mm, mean follow-up of 14.1 ± 3.7 months) or drug-eluting balloon ( N = 58, mean length 140.6 mm, mean follow-up of 13.8 ± 4.1 months). The technical success rate was 100% in Supera® and 96.6% in drug-eluting balloon group. There were seven restenosis in self-expanding interwoven nitinol stent (SUS) group (84.8% patency) and 11 restenosis in drug-eluting balloon group (79.2% patency). A significant increase in the ankle-brachial index in both groups after intervention demonstrated a hemodynamic success (SUS group 0.45 ± 0.06, drug-eluting balloon group 0.43 ± 0.07). The mean Rutherford Becker Class significantly decreased in both groups after a follow-up of 12 months (SUS group 0.70 ± 0.73, drug-eluting balloon group 0.74 ± 0.75). Conclusion Deploying drug-eluting balloon or self-expanding interwoven nitinol stent in patients with complex femoropopliteal lesions are both safe and effective with high patency rates with no statistical difference for one-year primary patency rates between them.

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Infrared Thermography as a Diagnostic Tool for the Assessment of Patients with Symptomatic Peripheral Arterial Disease Undergoing Infrafemoral Endovascular Revascularisations

Diagnostics ◽

10.3390/diagnostics11091701 ◽

2021 ◽

Vol 11 (9) ◽

pp. 1701

Author(s):

Gladiol Zenunaj ◽

Nicola Lamberti ◽

Fabio Manfredini ◽

Luca Traina ◽

Pierfilippo Acciarri ◽

...

Keyword(s):

Peripheral Arterial Disease ◽

Infrared Thermography ◽

Ankle Brachial Index ◽

Blood Perfusion ◽

Arterial Disease ◽

Critical Limb Ischaemia ◽

Limb Ischaemia ◽

Technical Success ◽

Technical Success Rate ◽

Peripheral Arterial

Aim: The aim of this study was to evaluate the utility and reliability of temperature foot changes measured by infrared thermography (IRT) for the evaluation of patients with atherosclerotic peripheral arterial disease (PAD) before and after endovascular revascularisation. Methods: This is an observational prospective study carried out on symptomatic PAD patients. Evaluations consisted of a clinical examination, duplex scan with ankle–brachial index calculation (ABI) and IRT measurements with infrared camera FLIR-ONE connected to a smartphone with android technology. Locations on the foot sampled with IRT were the anterior tibial, pedal, posterior and arcuate arteries. Results obtained with IRT on the symptomatic foot were compared to the contralateral foot and with the ABI values obtained bilaterally before and 24 h after revascularisation. Results: Within one year, 40 patients were enrolled, among whom 87,5% suffered from critical limb ischaemia. In three patients, it was impossible to obtain ABI measurements because of ulcerations on the limb. Skin temperature changes obtained by IRT between the symptomatic limb and the contralateral limb had a mean difference of 1.7 °C (range: 1.1–2.2 °C), p < 0.001. There was a positive correlation between ABI and temperature values of the limb needed for treatment before revascularisation (p = 0.025; r = 0.36) and after revascularisation (p = 0.024, r = 0.31). The technical success rate was 100% in all cases, achieving a significant increase in temperature at all points of the foot analysed, with a median change of 2 °C (p < 0.001). Conclusion: IRT is a safe, reliable and simple application. It could be a valuable tool for the assessment of the clinical presentation and severity of foot blood perfusion in symptomatic PAD patients and the evaluation of the technical success of endovascular revascularisation. IRT might have a role in follow-up of revascularisation procedures.

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Percutaneous Mechanical Atherectomy Plus Thrombectomy Using the Rotarex®S Device Followed by a Drug-Coated Balloon for the Treatment of Femoropopliteal Artery In-stent Restenosis: A Prospective Single-Center, Single-Arm Efficacy Trial (PERMIT-ISR Trial)

Frontiers in Surgery ◽

10.3389/fsurg.2021.671849 ◽

2021 ◽

Vol 8 ◽

Author(s):

Ming-Yuan Liu ◽

Wenrui Li ◽

Xiaobo Guo ◽

Zhiwen Zhang ◽

Bin Liu ◽

...

Keyword(s):

De Novo ◽

Ankle Brachial Index ◽

Primary Patency ◽

Secondary Patency ◽

Single Center ◽

Technical Success ◽

Clinical Trial Registration ◽

Technical Success Rate ◽

Stent Restenosis ◽

In Stent Restenosis

Background: Studies investigating debulking devices with drug-coated balloons (DCBs) in the treatment of femoropopliteal (FP) artery in-stent restenosis (ISR) are limited. We aimed to evaluate the safety and midterm outcome of percutaneous mechanical atherectomy plus thrombectomy (MATH) using the Rotarex®S (Straub Medical, Wangs, Switzerland) catheter followed by a DCB in the treatment of FP-ISR.Methods: This study was a single-center single-arm trial. Patients with symptomatic (Rutherford category 2–5) de novo restenosis lesions of FP-ISR were treated with MATH and subsequent DCB. From June 2016 to May 2018, 59 patients with FP-ISR were enrolled. The primary endpoint was target lesion revascularization (TLR) and changes in the Rutherford category of the target limb at 12 months. Secondary endpoints included primary and secondary patency at 12 months, technical success rate, major adverse events, and ankle-brachial index (ABI). Risk factors for TLR were analyzed using Cox proportional hazard model.Results: The average follow-up time was 33 ± 8 months. The rate of technical success was 88.1% (52/59). Nine patients received bailout stenting. The rate of freedom from TLR was 84.7% (50/59) at 1 year, the Rutherford category changed at 12 months were significantly improved from baseline (p < 0.01). The primary patency rates and the secondary patency at the 12-month follow-ups were 82.5 and 92.5%, respectively. The ABI changed at 12 months were significantly improved from baseline (p < 0.01). Global limb anatomic staging system (GLASS) classification III [hazard ratio (HR) 18.44, 95% CI (1.57–215.99), p = 0.020] and postoperative Rutherford classification ≥4 [HR 8.28, 95% CI (1.85–37.06), p = 0.006] were identified as independent predictors of TLR.Conclusion: Our preliminary data suggested that MATH using a Rotarex®S catheter combined with DCB angioplasty is a safe, minimally invasive, and effective treatment for FP-ISR with favorable, immediate, and midterm outcomes.Clinical Trial Registration:http://www.chictr.org.cn, identifier [ChiCTR2000041380].

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Venous stent versus conventional stent for the treatment of central vein obstruction in hemodialysis patients: a retrospective study

Acta Radiologica ◽

10.1177/02841851211005163 ◽

2021 ◽

pp. 028418512110051

Author(s):

Surasit Akkakrisee ◽

Keerati Hongsakul

Keyword(s):

Endovascular Treatment ◽

Patency Rate ◽

Demographic Data ◽

Hemodialysis Patients ◽

Primary Patency ◽

Central Vein ◽

Primary Patency Rate ◽

Patient Demographic Data ◽

Upper Thoracic ◽

Vein Stenosis

Background Endovascular treatment is a first-line treatment for upper thoracic central vein obstruction (CVO). Few studies using bare venous stents (BVS) in CVO have been conducted. Purpose To evaluate the treatment performance of upper thoracic central vein stenosis between BVS and conventional bare stent (CBS) in hemodialysis patients. Methods Hemodialysis patients with upper thoracic central vein obstruction who underwent endovascular treatment at the interventional unit of our institution from 1 January 2008 to 31 December 2018 were enrolled in the present study. CBS was used to treat central vein obstruction in 43 patients and BVS in 34 patients. We compared the primary patency rates and complications between the two stent types. P values < 0.05 were considered statistically significant. Results The patient demographic data between the CBS and BVS groups were similar. The characteristics of the lesions, procedures, and complications were not significantly different between the two groups ( P > 0.05). There were no statistically significant differences of primary patency rates at three and six months between the BVS and CBS groups (94.1% vs. 86.0% and 73.5% vs. 58.1%, respectively; P > 0.05). The primary patency rate at 12 months in the BVS group was significantly higher than that in the CBS group (61.8% vs. 32.6%; P = 0.008). Conclusion Endovascular treatment of central vein obstruction with BVS provided a higher primary patency rate at 12 months than CBS.

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Bifurcated bypass in severe chronic limb threatening ischaemia

Vascular ◽

10.1177/1708538121999856 ◽

2021 ◽

pp. 170853812199985

Author(s):

Daniele Adami ◽

Michele Marconi ◽

Alberto Piaggesi ◽

Davide M Mocellin ◽

Raffaella N Berchiolli ◽

...

Keyword(s):

Survival Rates ◽

Primary Patency ◽

Free Survival ◽

Mortality And Morbidity ◽

Bypass Patency ◽

Stage 4 ◽

Endovascular Approach ◽

The Mean ◽

Clinical Records

Objectives Revascularization according to the angiosome concept is of proven importance for limb salvage in chronic limb threatening ischaemia but it is not always practicable. Bifurcated bypasses could be considered as an option when an endovascular approach is not feasible or has already failed and a single bypass would not allow direct revascularization of the ischaemic area. Bifurcated bypasses are characterized by landing on two different arteries, the main artery (in direct continuity with the foot vessels) and the secondary one (perfusing the angiosome district). The aim of this study is to evaluate the safety and effectiveness of bifurcated bypass in chronic limb threatening ischaemia. Methods Thirty-five patients were consecutively treated with a bifurcated bypass for chronic limb threatening ischaemia from January 2014 to December 2019 in a single vascular surgery centre. Data from clinical records and operative registers were collected prospectively in an electronic database and retrospectively analysed. Primary and primary assisted bypass patency, amputation-free survival, morbidity and mortality rates at 12 and 24 months were analysed. Results Mean follow-up period was 25.1 months (range 2–72 months). Thirty-six bifurcated bypasses were performed on 35 patients (age 75.3 ± 7.2 years; 69.4% were male). According to Wound, Ischemia, foot Infection classification 22.2% belonged to stage 3 and 77.8% to stage 4 and the mean Rutherford’s class was 5.1 ± 0.7. Immediate technical success was 100%. Early mortality and morbidity rates were respectively 5.5%, and 33.3%; foot surgery was performed in 50% of cases with wound healing in all patients. Primary patency and primary assisted bypass patency were 96.7% and 100% at 6 months; 85.2% and 92% at 12 months, 59.9% and 73.4% at 24 months, respectively. Amputation-free survival at 12 and 24 months was, respectively, 95.6% and 78.8%. Overall survival rates at 12 and 24 months were respectively 94.4% and 91.6%. Conclusions Bifurcates bypass can provide good results in patients with chronic limb threatening ischaemia without endovascular option, especially in diabetic ones. Bifurcated bypass is a complex surgical solution, both to be planned and performed, and it is quite invasive for frail patients that should be accurately selected.

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