Rotational atherectomy with adjunctive balloon angioplasty in calcified chronic total occlusions of superficial femoral artery

Vascular ◽  
2020 ◽  
pp. 170853812097081
Author(s):  
Aysen Y Engin ◽  
Onur Saydam
Keyword(s):  
Balloon Angioplasty ◽  
Critical Limb Ischemia ◽  
Limb Ischemia ◽  
Primary Patency ◽  
Rotational Atherectomy ◽  
Secondary Patency ◽  
Technical Success ◽  
Technical Success Rate ◽  
The Mean ◽  
Drug Coated Balloon

Objectives The aim was to report the mid-term outcomes of Jetstream™ rotational atherectomy device in complex femoropopliteal lesions. Methods Between November 2016 and April 2018, 55 patients who were treated with rotational atherectomy and adjunctive balloon angioplasty due to complex femoropopliteal lesions were retrospectively scanned. Results Fifty-five patients who underwent endovascular treatment with rotational atherectomy for chronic total occlusive femoropopliteal lesions were included in the study. Technical success rate was 100%. The mean age was 63 (±10.5) years. The cohort included 25 (45.4%) diabetics and 45 (81.8%) current smokers. The mean length of the lesions was 20.8 ± 11.2 cm. Chronic total occlusive lesions were detected in 35 (63.6%) patients, and mixed-type steno-occlusive lesions were detected in 20 patients (36.4%). Thirty-three (60%) lesions were moderate or severely calcified. Adjunctive balloon angioplasty was performed with plain old balloon angioplasty (POBA) on 31 (56.4%) patients and with drug-coated balloon angioplasty on 24 (43.6%) patients. After adjunctive balloon angioplasty, flow limiting dissection was observed in 20 (36.3%) patients, and 17 (30.9%) patients needed stent implantation. The Kaplan–Meier analysis method estimated that the overall primary patency rates at 12 and 24 months were 81.8% and 70.9%, respectively. Overall, secondary patency rates at 12 and 24 months were 94.5% and 80%. No statistically significant differences of 24-month primary patency and secondary patency rates were found between patients treated with drug-coated balloon angioplasty and POBA as an adjunctive therapy, even though primary patency (83.3% vs. 61.3%, p = .06) and secondary patency (91.7% vs. 71%, p = .56) rates of drug-coated balloon angioplasty were slightly higher than POBA. Patients with claudication had better primary patency (90.5% vs. 58.8%, p = .001) and secondary patency (100% vs. 67.6%, p = .004) rates than patients with critical limb ischemia at 24 months. Significant differences between patients who did and did not stop smoking were found in 24-month primary patency (57% vs. 88%, p = .007) and secondary patency (67% vs. 96%, p = .007). Six patients underwent unplanned amputation. There were eight (14.5%) mortalities during follow-up. Conclusions Rotational atherectomy with adjunctive balloon angioplasty has satisfactory technical success rates and mid-term outcomes. As an adjunctive method, there was no difference between drug-coated balloon angioplasty s and POBAs. Smoking cessation is always the first-step treatment to improve mid-term patency results. Patients with critical limb ischemia have worse patency results compared to the patients with claudication.

Early outcomes of novel Temren atherectomy device combined with drug-coated balloon angioplasty for treatment of femoropopliteal lesions

Vascular ◽  
2021 ◽  
pp. 170853812110298
Author(s):  
Görkem Yiğit
Keyword(s):  
Critical Limb Ischemia ◽  
Bypass Graft ◽  
Ankle Brachial Index ◽  
Limb Ischemia ◽  
Rotational Atherectomy ◽  
Total Occlusion ◽  
The Mean ◽  
Knee Pathology ◽  
Drug Coated Balloon

Objectives In this study, perioperative properties and early outcomes of patients who underwent combined Temren rotational atherectomy (RA) and drug-coated balloon (DCB) angioplasty treatment for complex femoropopliteal lesions in a single center were reported. Methods Between June 2019 and February 2020, 40 patients who underwent combined Temren RA and DCB treatment due to critical lower limb ischemia or claudication-limiting daily living activities were retrospectively evaluated. Results The mean age of patients was 73.2 ± 7.8 years and the majority of the patients were male (65%). Of the patients, 17 had critical limb ischemia and 23 had lifestyle-limiting claudication. Pathologies were total occlusion in 33 limbs and critical stenosis in seven limbs. Nine patients previously underwent endovascular intervention or surgery. The mean total occlusion length was 140.9 ± 100.9 (range, 20–360) mm in patients with chronic total occlusion. There was an additional iliac artery pathology in 5 and below the knee pathology in 8 patients. Rotational atherectomy was possible in all cases. Flow-limiting dissection was seen in six patients (15%). Provisional stent was performed to these patients. Following Temren RA, all patients underwent DCB. Adequate vascular lumen (less than 30% stenosis) was provided in all patients and the symptoms regressed. No distal embolization was encountered. Access site complications (17.5%) were small hematoma in four patients, ecchymosis in two patients, and pseudoaneurysm of the femoral artery in one patient. The mean follow-up was 13.55 ± 4.2 (range, 1–18) months. Re-occlusion was seen in three patients (7.5%) ( n = 2 at 2 months and n = 1 at 4 months). Of these patients, two had required open revascularization via femoropopliteal bypass graft with common, superficial femoral, and popliteal artery endarterectomy and one had required femoro-posterior tibial artery bypass. Four minor toe amputations (10%) were performed to reach complete wound healing in the critical limb ischemia patients. A below-knee amputation was performed in a 94-year-old patient with long segment stenosis at the end of a 1-month follow-up period. There was no mortality after follow-ups. The Kaplan–Meier estimator estimated the rate of freedom from target lesion revascularization (TLR) which was 92.3%. The decrease in the Rutherford levels after the procedure was found to be statistically significant in 36 patients ( p < 0.001). The increase in the ankle–brachial index after the procedure was found to be statistically significant in 36 patients ( p < 0.001). Conclusions Combined use of Temren RA with adjunctive DCB is safe and effective method with high rates of primary patency and freedom from TLR and low rates of complication in the treatment of femoropopliteal lesions.

Preliminary six-month outcomes of LIMBSAVE (treatment of critical Limb IscheMia with infragenicular Bypass adopting in situ SAphenous VEin technique) registry

Vascular ◽  
2020 ◽  
pp. 170853812096612 ◽  
Author(s):  
Nicola Troisi ◽  
Giovanni De Blasis ◽  
Mauro Salvini ◽  
Stefano Michelagnoli ◽  
Carlo Setacci ◽  
...  
Keyword(s):  
Limb Salvage ◽  
Critical Limb Ischemia ◽  
Saphenous Vein ◽  
Limb Ischemia ◽  
Primary Patency ◽  
Secondary Patency ◽  
Bypass Patency ◽  
The Mean

Objectives Guidelines recommend open bypass surgery for long occlusions of infrainguinal arteries. In situ saphenous vein bypass is a standardized technique. The aim of this study was to report preliminary six-month outcomes of a national, multicenter, observational, prospective registry based on the examination of treatment of critical Limb IscheMia with infragenicular Bypass adopting the in situ SAphenous VEin technique (LIMBSAVE). Methods From January 2018 until October 2019, 428 patients from 41 centers were enrolled in the LIMBSAVE registry. Data were prospectively collected in a dedicated database, including demographics, preoperative risk factors, clinical and diagnostic preoperative assessments, intraoperative measures (including safety and effectiveness of the valvulotome during the surgical procedures), and 30-day follow-up data. Furthermore, estimated six-month outcomes according to Kaplan–Meier curves in terms of primary patency, primary assisted patency, secondary patency, and limb salvage were evaluated. Results Patients were predominantly male ( n = 332, 77.6%) with a mean age of 73.3 years (range 39–95). Technical success, defined as bypass pulse after use of the valvulotome, was obtained in all cases. The proximal anastomosis could be reached by the valvulotome in all cases. The mean number of valvulotome uses was 2.5 (range 1–5). No vein perforation was reported. In nine cases (2.1%), a vein lesion with intramural hemorrhage occurred. The mean length of hospital stay was 11.1 days (range 1–60). At 30-day follow-up, the overall bypass patency rate was 97.4%, and the rate of open or endo reinterventions for failing bypass was 5.4%. At six-month follow-up, the estimated primary patency, primary assisted patency, secondary patency, and limb salvage were 78.1%, 86.2%, 92.1%, and 94.7%, respectively. Conclusions Preliminary intraprocedural outcomes of the LIMBSAVE registry show that the in situ technique with the valvulotome is safe and effective in disrupting valves and obtaining pulsatility in the saphenous vein. The complication rate related to the use of the valvulotome is low. The six-month preliminary outcomes in terms of overall patency and limb salvage are promising. Further examinations and continuous follow-up are needed to evaluate long-term outcomes.

scholarly journals Directional Atherectomy With Antirestenotic Therapy vs Drug-Coated Balloon Angioplasty Alone for Isolated Popliteal Artery Lesions

2016 ◽  
Vol 24 (2) ◽  
pp. 181-188 ◽  
Author(s):  
Konstantinos Stavroulakis ◽  
Arne Schwindt ◽  
Giovanni Torsello ◽  
Arne Stachmann ◽  
Christiane Hericks ◽  
...  
Keyword(s):  
Popliteal Artery ◽  
Patency Rate ◽  
Primary Patency ◽  
Lesion Length ◽  
Secondary Patency ◽  
Technical Success ◽  
Primary Patency Rate ◽  
Technical Success Rate ◽  
Directional Atherectomy ◽  
Drug Coated Balloon

Purpose: To report a single-center study comparing drug-coated balloon (DCB) angioplasty vs directional atherectomy with antirestenotic therapy (DAART) for isolated lesions of the popliteal artery. Methods: Seventy-two patients were treated with either DCB angioplasty alone (n=31) or with DAART (n=41) for isolated popliteal artery stenotic disease between October 2009 and December 2015. The majority of patients presented with lifestyle-limiting claudication (74% vs 86%, respectively). Vessel calcification (29% vs 29%, respectively), mean lesion length (47 vs 42 mm, respectively), and number of runoff vessels were comparable between the groups. The primary outcome measure was primary patency; secondary outcomes were technical success (<30% residual stenosis or bailout stenting), secondary patency, and freedom from clinically driven target lesion revascularization (TLR). Results: The technical success rate following DCB was 84% vs 93% (p=0.24) after DAART. The 12-month primary patency rate was significantly higher in the DAART group (65% vs 82%; hazard ratio 2.64, 95% confidence interval 1.09 to 6.37, p=0.021), while freedom from TLR did not differ between the 2 treatment strategies (82% vs 94%, p=0.072). Secondary patency at 12 months was identical for both groups (96% vs 96%). Although not statistically significant, bailout stenting was more common after DCB angioplasty (16% vs 5% for DAART, p=0.13) and aneurysmal degeneration of the popliteal artery was seen more often after DAART (7% vs 0% for DCB alone, p=0.25). Popliteal artery injury was observed in 2 patients treated using DAART (5% vs 0% for DCB alone, p=0.5), whereas distal embolization rates were comparable between the groups (3% for DCB alone vs 5% for DAART, p=0.99). Conclusion: In this study, the use of DAART was associated with a higher primary patency rate compared with DCB angioplasty for isolated popliteal lesions. Nonetheless, both treatment options were associated with excellent 12-month secondary patency. Aneurysmal degeneration of the popliteal artery and increased bailout stenting could compromise the outcomes of DAART and DCB, respectively.

scholarly journals Comparison of Therapeutic Efficacy of Debulking Plus Drug-coated Balloon Angioplasty Versus Drug-coated Balloon Angioplasty Alone for Femoropopliteal Tosaka Class Iii in-stent Restenosis Lesions

2021 ◽  
Author(s):  
Liqiang Li ◽  
Zhu Tong ◽  
Shijun Cui ◽  
Lianrui Guo ◽  
Yongquan Gu
Keyword(s):  
Success Rate ◽  
Balloon Angioplasty ◽  
Primary Patency ◽  
Class Iii ◽  
Technical Success ◽  
Technical Success Rate ◽  
Stent Restenosis ◽  
Significant Difference ◽  
Drug Coated Balloon ◽  
In Stent Restenosis

Abstract Background: Femoropopliteal (FP) Tosaka Class III in-stent restenosis (ISR) Lesions remain a significant clinical problem and optimal revascularization management including the use of drug-coated balloon (DCB) and debulking devices have the potential to improve the outcomes for these patients. However, few studies have been published comparing the debulking plus DCB with DCB alone in Tosaka III FP-ISR treatment. This study was to compare debulking plus DCB versus DCB alone for the treatment of Tosaka III FP-ISR lesions in patients.Methods: This was a single-center retrospective study of patients Tosaka III FP-ISR who underwent endovascular interventions of debulking plus DCB or DCB alone for Tosaka III FP-ISR lesions. One-year primary patency was the main outcome. Other outcome measures are 12-month freedom from clinical-driven target lesion revascularization (f-CD-TLR), technical success rate, and periprocedural complications.Results: A total of 70 patients with Tosaka III FP-ISR were included; 29 were treated with debulking plus DCB, in which 13 were treated with laser atherectomy (LA) plus DCB and 16 were treated with rotational atherectomy (RA) plus DCB. 41 were treated with DCB alone. Lesions in the debulking plus DCB group were significantly longer (16.45±4.40mm vs. 14.04±3.67mm, p=0.015). the 12-month primary patency was not significant different in the comparison of debulking+DCB with DCB group (75.9% vs. 73.2%, p=0.798). in the subgroup comparison, no significant difference was found in the LA+DCB and RA+DCB group (69.2% vs. 81.3%, p=0.544). There were also no significant differences in the group and subgroup comparison of 12-month f-CD-TLR, technical success rate, and periprocedural complications.Conclusions: Debulking plus DCB or DCB alone are both safe and effective for Tosaka III FP-ISR lesions. Although no significant difference was seen, lesions in the debulking+DCB group were significantly longer, suggesting that debulking plus DCB treatment has possible superiority for longer lesions than DCB alone management.

Long-term mortality and patency after drug-coated balloon angioplasty in the hemodialysis circuit: A systematic review and meta-analysis of randomized controlled trials

2022 ◽  
pp. 112972982110701
Author(s):  
Yunfeng Li ◽  
Zhenwei Shi ◽  
Yunyun Zhao ◽  
Zhanjiang Cao ◽  
Zhengli Tan
Keyword(s):  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Balloon Angioplasty ◽  
Meta Analysis ◽  
Primary Patency ◽  
Controlled Trials ◽  
Technical Success ◽  
Randomized Controlled ◽  
All Cause Mortality ◽  
Drug Coated Balloon

Purpose: To compare all-cause mortality and primary patency with drug-coated balloon angioplasty (DCBA) compared with plain balloon angioplasty (PBA) in people with hemodialysis-related stenosis. Materials and methods: PubMed, Embase, and Cochrane Library databases were searched from November 1966 to February 2021 to identify randomized controlled trials (RCTs) that assessed the use of DCBA versus PBA for stenosis in hemodialysis circuits. Data extracted from the articles were integrated to determine all-cause mortality, target lesion primary patency (TLPP), circuit access primary patency (CAPP), 30-day adverse events, and technical success for the two approaches. We performed meta-analysis on these results using a fixed-effects model to evaluate odds ratios (ORs) and 95% confidence intervals (CIs) where I2 < 50% in a test for heterogeneity, or a random-effect model if otherwise. Sensitivity and subgroup analyses were also performed. Results: Sixteen RCTs of 1672 individuals were included in our meta-analysis, of which 839 individuals received DCBA and 833 received PBA. The pooled outcome showed no statistical difference between DCBA and PBA in all-cause mortality at 6 months (OR = 1.29, 95% CI = 0.72–2.32, p = 0.39, I2 = 4%), 12 months (OR = 1.02, 95% CI = 0.68–1.53, p = 0.91, I2 = 0%), and 24 months (OR = 1.50, 95% CI = 0.87–2.57, p = 0.15, I2 = 0%), 30-day adverse events (OR = 1.09, 95% CI = 0.30–3.98, p = 0.90, I2 = 66%), and technical success (OR = 0.18, 95% CI = 0.02–1.92, p = 0.16, I2 = 65%). The DCBA had significantly better outcomes versus PBA in TLPP at 6 months (OR = 2.37, 95% CI = 1.84–3.04, p < 0.001, I2 = 44%) and 12 months (OR = 1.77, 95% CI = 1.22–2.56, p = 0.002, I2 = 56%), and CAPP at 6 months (OR = 2.07, 95% CI = 1.21–3.54, p = 0.008, I2 = 67%) and 12 months (OR = 1.66, 95% CI = 1.29–2.15, p < 0.001, I2 = 0%). Conclusion: In hemodialysis circuit stenosis, DCBA appears to have similar safety but greater efficacy than PBA.

Antegrade vs Crossover Femoral Artery Access in the Endovascular Treatment of Isolated Below-the-Knee Lesions in Patients With Critical Limb Ischemia

2017 ◽  
Vol 24 (3) ◽  
pp. 331-336 ◽  
Author(s):  
Yukun Li ◽  
Ali Esmail ◽  
Konstantinos P. Donas ◽  
Georgios Pitoulias ◽  
Giovanni Torsello ◽  
...  
Keyword(s):  
Endovascular Treatment ◽  
Success Rate ◽  
Femoral Artery ◽  
Critical Limb Ischemia ◽  
Limb Ischemia ◽  
Technical Success ◽  
Femoral Access ◽  
Technical Success Rate ◽  
Below The Knee ◽  
Antegrade Approach

Purpose: To evaluate the safety and effectiveness of antegrade vs crossover femoral artery access in the endovascular treatment of isolated below-the-knee (BTK) lesions in patients with critical limb ischemia (CLI). Methods: Between January 2014 and December 2015, 224 high-risk patients (mean age 75.8±9.8 years; 151 men) with CLI underwent infragenicular interventions on 292 crural vessels in 3 European vascular centers. All patients had isolated TransAtlantic Inter-Society Consensus (TASC) C (n=26) or D (n=198) BTK lesions. Primary endpoints were freedom from access-related complications and technical success comparing the antegrade vs crossover access groups. Results: Balloon angioplasty was the most used treatment modality (169 vessels, 75.4%). The technical success rate was 88.4% in the entire cohort and 88.0% in the antegrade group vs 90.4% in the crossover group (p>0.99). In all patients, the technical success rate was higher for stenotic lesions (100%) vs occlusions (85.5%, p=0.002) and in patients with TASC C BTK lesions (100%) vs TASC D (86.9%, p=0.033). The overall freedom from access-related complications was 97.8%: 99% in the antegrade group and 90.6% in the crossover group (p=0.022). Larger sheath size (5/6-F vs 4-F) was associated with a significantly higher risk for access-related complications (7.1% vs 1.1%, respectively; p=0.047). Conclusion: The present multicenter study showed high technical success and a low incidence of access-related complications in the treatment of isolated BTK lesions using either antegrade or crossover femoral access. The antegrade approach with the use of a 4-F system seems to have a significantly lower rate of access-related complications.

Results of isolated infrapopliteal percutaneous transluminal angioplasty for critical limb ischemia in high-risk diabetic patients

Vascular ◽  
2016 ◽  
Vol 24 (5) ◽  
pp. 515-522 ◽  
Author(s):  
E Tartaglia ◽  
A Lejay ◽  
Y Georg ◽  
M Roussin ◽  
F Thaveau ◽  
...  
Keyword(s):  
High Risk ◽  
Limb Salvage ◽  
Critical Limb Ischemia ◽  
Limb Ischemia ◽  
Primary Patency ◽  
Diabetic Patients ◽  
Secondary Patency ◽  
Cerebrovascular Event ◽  
Arterial Lesions ◽  
Infrapopliteal Angioplasty

Aim Infrapopliteal occlusive arterial lesions mostly characterize diabetic patients arteriopathy. Diabetic patients are prone to multiple comorbidities that make them candidates for low-invasive therapeutic options. The aim of this study was to evaluate the safety of infrapopliteal angioplasty in high-risk diabetic patients. Methods We undertook a study (retrospective study of a prospectively collected database) of all infrapopliteal endovascular revascularizations performed for critical limb ischemia in high-risk (≥3 major comorbidities) diabetic patients in our institution between 2008 and 2010. Study end points were safety, technical success rate, healing rate, overall 1-year survival, primary patency, secondary patency and limb salvage rates. Results A total of 101 high-risk diabetic patients (160 arterial lesions: 94 stenosis and 66 occlusions) underwent infrapopliteal endovascular surgery. No major adverse cardiovascular or cerebrovascular event was recorded within 30 days. Two major adverse limb events (two thromboses requiring major amputation) and seven minor adverse events were recorded. Technical and healing rates were, respectively, 83% and 78%. The 1-year survival, primary patency, secondary patency and limb salvage rates were, respectively, 86%, 67%, 83% and 84%. Conclusion Infrapopliteal angioplasty can be considered as a safe and feasible option for high-risk diabetic patients with critical limb ischemia.

scholarly journals Endovascular Recanalization of Chronic Total Occlusions of the Native Superficial Femoral Artery After Failed Femoropopliteal Bypass in Patients with Critical Limb Ischemia.

2021 ◽  
Author(s):  
Roberto Minici ◽  
Michele Ammendola ◽  
Marisa Talarico ◽  
Maria Luposella ◽  
Marco Minici ◽  
...  
Keyword(s):  
Femoral Artery ◽  
Critical Limb Ischemia ◽  
Superficial Femoral Artery ◽  
Limb Ischemia ◽  
Secondary Patency ◽  
Femoropopliteal Bypass ◽  
Technical Success ◽  
Clinical Prognosis ◽  
Chronic Total Occlusions ◽  
Endovascular Recanalization

Abstract Background: The femoropopliteal bypass occlusion in patients with critical limb ischemia and chronic total occlusion of the native superficial femoral artery remains a significant problem, that hardly challenges vascular surgeons and interventional radiologists. Performing a secondary femoropopliteal bypass is still considered the standard of care, although it is associated with a higher complication rate and lower patency rate in comparison with primary bypass. Advanced age, lack of a good great saphenous vein, anastomosis’ pseudoaneurysms and high surgical risks make surgical approach not always suitable. Over the past few years, angioplasty has been commonly used, with the development in endovascular technologies, to treat chronic total occlusions of the native SFA, with a good technical success rate and clinical prognosis. Hence, the idea to recanalize the native SFA chronic total occlusions, in patients with critical limb ischemia (CLI) and femoro-popliteal bypass failure, has been born, limited to those patients unfit for surgery or refusing surgical reconstruction. Data regarding long-term outcomes of this approach in femoro-popliteal bypass failure are limited to few case-series studies.Results: Technical success was achieved in 51 (94.4%) of 54 limbs. Angiographically, 77.8% of the lesions were TASC II category D, while 22.2% TASC II category C. The average length of the native SFA lesions was 26.8 cm. Clinical success, with improved Rutherford classification staging, followed each case of technical success. The median follow-up value was 5.75 years (IQR, 1.5 – 7). By Kaplan-Meier survival analysis, primary patency rates were 61% (±0.07 SE) at 1 year and 46% (±0.07 SE) at 5 years. Secondary patency rates were 93% (±0.04 SE) at 1 year and 61% (±0.07 SE) at 5 years. Limb salvage rates were 94% (±0.03 SE) at 1 year and 88% (±0.05 SE) at 5 years.Conclusions: The endovascular recanalization of chronic total occlusions (CTO) of the native superficial femoral artery (SFA) after failed femoropopliteal bypass is a safe and effective therapeutic option in patients unfit for surgery with critical limb ischemia.

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