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.

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.

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.

Retrograde Popliteal Access to Percutaneous Peripheral Intervention for Chronic Total Occlusion of Superficial Femoral Arteries

2017 ◽  
Vol 51 (5) ◽  
pp. 240-246 ◽  
Author(s):  
Mert Dumantepe
Keyword(s):  
Popliteal Artery ◽  
Ankle Brachial Index ◽  
Limb Ischemia ◽  
Stent Fracture ◽  
Secondary Patency ◽  
Total Occlusion ◽  
Chronic Total Occlusions ◽  
Type D ◽  
Secondary Patency Rate

Objective: The aim of this study is to present our initial experience with the use of the retrograde popliteal artery access in patients with chronic total occlusions of superficial femoral artery (SFA). Method: From July 2012 to May 2014, a total of 28 patients (20 men, mean age 61.2 ± 11.5 years) with total occlusion of the SFA and good distal runoff were treated with percutaneous atherectomy, balloon angioplasty, and stenting (mean length 165.3 ± 57.5 mm, range 72-336 mm). All patients had severe claudication or critical limb ischemia, and most of the lesions were TransAtlantic Inter-Society Consensus classification type D (n = 21). Results: Technical success was achieved in all cases. In majority (26, 92.8%) of the patients, endoluminal recanalization was possible from the popliteal access; SFA recanalization in the other 2 cases was obtained through the subintimal space. During a mean follow-up of 12.9 ± 2.5 months, claudication, severity, rest pain, and toe ulcers improved significantly. Ankle–brachial index changed from 0.54 ± 0.11 to 0.91 ± 0.2 at 1 year after intervention ( P < .001), and patency rates at 1, 6, and 12 months after interventions were 100%, 92.8%, and 85.7%, respectively. One pseudoaneurysm and 1 arteriovenous fistula were found in the popliteal region on duplex examinations. There were 2 in-stent restenosis and 3 occlusions during the 12-month follow-up. These occlusions were treated with reendovascular procedures. Our secondary patency rate was 96.4%. No stent fracture was observed. Conclusion: The retrograde popliteal artery approach under duplex guidance can be considered as safe, efficient, and the primary SFA recanalization strategy in carefully selected patients, with competitive immediate and mid-term results.

Below Knee Angioplasty Results in Diabetic aAnd Non-Diabetic Patients

2021 ◽  
Vol 15 (6) ◽  
pp. 2063-2066
Author(s):  
Afghani Reza ◽  
Cheraghali Roozbeh
Keyword(s):  
Critical Limb Ischemia ◽  
Ankle Brachial Index ◽  
Limb Ischemia ◽  
Tissue Loss ◽  
Diabetic Patients ◽  
Test Analysis ◽  
Significant Difference ◽  
Before And After ◽  
The Mean ◽  
Toe Pressure

Ten to 25 % of all diabetic patients will develop a lower limb ulcer in their lifetime. Ankle-brachial index is not accurate in diabetic patients .The resting systolic toe pressure (TP) may be a measure of small arterial function within the periphery. Objective: The purpose of this article is to consider the effect of below-knee angioplasty on systolic toe pressure changes in diabetic patients with critical limb ischemia. Methods/Materials: In this prospective study 114 patients, were included who satisfied the inclusion criteria: patients with critical limb ischemia in the form of tissue loss(ulcer or gangrene) or rest pain, presence of below-knee vessel lesion, and absence of proximal vessels lesion or stenosis. We evaluated the effect of angioplasty on toe pressure of diabetic patients and compared them to non-diabetics. Results: Among 114 patients, 78(68/4%) were men and 36(31/6%) were women. Diabetic patients were 96(84/2%) and non-diabetics were 18 (15.8%). In Paired T-Test analysis we compared toe pressure values of each patient before and after angioplasty and it was a significant difference in both Diabetic and non-diabetic groups.(0.00 and 0.008 respectively). The mean of systolic toe pressure before angioplasty had no difference between the 2 groups (PValue: 0.13). The mean of toe pressure in non-diabetic patients was 42±31.9 and in diabetics was 25.6 and after angioplasty, the mean of toe pressure raised 44.3 in non-diabetics and 19.4 in diabetics. Conclusions: Systolic toe pressure is a valuable tool to evaluate and predict angioplasty effect on below-knee ulcers especially in diabetic patients. Keywords: Below knee Angioplasty, Systolic toe pressure, Diabetes

Endothelial function indicators in patients with critical limb ischemia compared to patients with limb claudication – one-year follow-up period after endovascular revascularisation

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
P Kaczmarczyk ◽  
P Maga ◽  
R Januszek ◽  
M Frolow ◽  
A Belowski ◽  
...  
Keyword(s):  
Endothelial Function ◽  
Critical Limb Ischemia ◽  
Limb Ischemia ◽  
Public Institution ◽  
Waveform Analysis ◽  
Funding Source ◽  
Survival Curves ◽  
Kaplan Meier ◽  
The Mean

Abstract Background Critical limb ischemia (CLI) is the most advanced stage of peripheral arterial disease. Limb revascularization is considered the first line of treatment. Purpose The aim of the study was to compare endothelial function and clinical outcomes in CLI and non-CLI patients during a 12-month follow-up period after endovascular treatment (PTA). Methods The study was conducted as a prospective, single-centre, follow-up evaluation. The authors recruited 30 CLI and 40 non-CLI patients. The following markers of endothelial dysfunction were evaluated: flow-mediated dilatation (FMD), reactive-hyperaemia index (RHI), arterial pulse-waveform analysis (aPWA) indices and clinical markers such as ankle-brachial index, toe-brachial index and Rutherford scale. Results Better clinical improvement may be observed in patients with CLI - the mean Rutherford grade significantly decreased in the CLI group (p&lt;0.001). These patients also have better endothelial response to revascularization – CLI patients continue to have improved RHI up to 6 months after PTA, where in non-CLI patients, improvement was only noted during the first month. The mean FMD value did not change significantly during the follow-up in either of the groups. When comparing selected intervals, the FMD values in the CLI and non-CLI groups improved during the first month of observation and then decreased between the 1st and 6th month of follow-up. Finally, in CLI patients, baseline intima-media thickness predicts the number of reinterventions and major adverse events. Conclusions Patients with CLI differ significantly from patients with claudication based on clinical response and endothelial changes after revascularization. Figure 1. A) Kaplan-Meier survival curves according to CLI and non-CLI status for all study endpoints. B) Kaplan-Meier survival curves according to CLI and non-CLI status for reinterventions. Funding Acknowledgement Type of funding source: Public Institution(s). Main funding source(s): Collegium Medicum of Jagiellonian University - internal grant

scholarly journals Autologous Peripheral Blood Mononuclear Cells for Limb Salvage in Diabetic Foot Patients with No-Option Critical Limb Ischemia

2021 ◽  
Vol 10 (10) ◽  
pp. 2213
Author(s):  
Alessia Scatena ◽  
Pasquale Petruzzi ◽  
Filippo Maioli ◽  
Francesca Lucaroni ◽  
Cristina Ambrosone ◽  
...  
Keyword(s):  
Peripheral Blood Mononuclear Cells ◽  
Critical Limb Ischemia ◽  
Diabetic Foot ◽  
Peripheral Blood ◽  
Mononuclear Cells ◽  
Limb Ischemia ◽  
Control Group ◽  
Peripheral Blood Mononuclear ◽  
Blood Mononuclear Cells

Peripheral blood mononuclear cells (PBMNCs) are reported to prevent major amputation and healing in no-option critical limb ischemia (NO-CLI). The aim of this study is to evaluate PBMNC treatment in comparison to standard treatment in NO-CLI patients with diabetic foot ulcers (DFUs). The study included 76 NO-CLI patients admitted to our centers because of CLI with DFUs. All patients were treated with the same standard care (control group), but 38 patients were also treated with autologous PBMNC implants. Major amputations, overall mortality, and number of healed patients were evaluated as the primary endpoint. Only 4 out 38 amputations (10.5%) were observed in the PBMNC group, while 15 out of 38 amputations (39.5%) were recorded in the control group (p = 0.0037). The Kaplan–Meier curves and the log-rank test results showed a significantly lower amputation rate in the PBMNCs group vs. the control group (p = 0.000). At two years follow-up, nearly 80% of the PBMNCs group was still alive vs. only 20% of the control group (p = 0.000). In the PBMNC group, 33 patients healed (86.6%) while only one patient healed in the control group (p = 0.000). PBMNCs showed a positive clinical outcome at two years follow-up in patients with DFUs and NO-CLI, significantly reducing the amputation rate and improving survival and wound healing. According to our study results, intramuscular and peri-lesional injection of autologous PBMNCs could prevent amputations in NO-CLI diabetic patients.

scholarly journals Successful Off-Label Use of an Iliac Branch Device to Rescue an Occluded Aortofemoral Bypass Graft

2018 ◽  
Vol 26 (1) ◽  
pp. 128-132 ◽  
Author(s):  
Mario D’Oria ◽  
Marco Pipitone ◽  
Francesco Riccitelli ◽  
Davide Mastrorilli ◽  
Cristiano Calvagna ◽  
...  
Keyword(s):  
Bypass Graft ◽  
Limb Ischemia ◽  
Aortofemoral Bypass ◽  
Off Label ◽  
Alternative Approach ◽  
Aortic Thrombus ◽  
Endovascular Device ◽  
Completion Angiography ◽  
Antegrade Catheterization

Purpose: To report an alternative approach for rescue of an occluded aortofemoral bypass using the Gore Excluder Iliac Branch Endoprosthesis (IBE). Case Report: A 52-year-old man presented with acute right limb ischemia because of displaced and occluded iliac stents and was treated with aortofemoral bypass. On the third postoperative day, there was early bypass failure due to distal embolization from aortic thrombus. After fluoroscopy-guided balloon thrombectomy of the bypass, an endovascular bailout strategy was used. The Gore Excluder IBE was deployed below the renal arteries (with the external iliac limb opening in the surgical prosthesis and the gate opening within the aortic lumen). After antegrade catheterization of the gate, a Gore Viabahn endoprosthesis was inserted as the bridging endograft and deployed so that it landed just above the preimplanted aortoiliac kissing stents without overlapping them. Completion angiography showed technical success without complications; results were sustained at 1-year follow-up. Conclusion: The Gore Excluder IBE may represent a versatile solution for the rescue of complex cases when open surgery would be associated with a considerable risk. This off-label application of a well-recognized endovascular device is safe and feasible and may prove useful as a valuable alternative in properly selected patients.

Magnetresonanzphasenkontrastgeschwindigkeitsmessungen als noninvasive Nachbeobachtungsmaßnahme nach perkutaner transluminaler Angioplastie

VASA ◽  
2002 ◽  
Vol 31 (4) ◽  
pp. 235-240 ◽  
Author(s):  
Heverhagen ◽  
Wagner ◽  
Bandorski ◽  
Hoppe ◽  
Alfke
Keyword(s):  
Phase Contrast ◽  
Ankle Brachial Index ◽  
Transluminal Angioplasty ◽  
Walking Distance ◽  
Slice Thickness ◽  
Non Invasive ◽  
The Mean ◽  
Percutaneous Transluminal ◽  
Phase Contrast Sequence

Background: The aim of this study was to evaluate magnetic resonance phase contrast velocimetry (MRVL) as a non-invasive follow up tool to assess restenosis after percutaneous transluminal angioplasty (PTA). Patients and methods: We prospectively investigated 51 consecutive patients who underwent PTA of the femoropopliteal region. MRVL was conducted prior, one day, six weeks, twelve weeks and 24 weeks after PTA using a circular polarized extremity coil and a gradient echo sequence (TR/TE 600/6 ms, flip angle 30°, slice thickness 10 mm). Hemodynamic data, derived from the MR phase contrast sequence, allowed to calculate the degree of area stenosis of the lesion treated with PTA. These data were correlated with clinical hemodynamic parameters (ankle-brachial index and walking distance). Results: The mean grade of area stenosis was 69% ± 27% before PTA, 30% ± 20% one day, 29% ± 23% six weeks, 39% ± 17% twelve weeks and 42% ± 18% 24 weeks after PTA and correlated well with clinical data and the post angioplasty clinical course of the patients. Conclusions: Follow up measurements using MRVL are suitable to assess restenosis after PTA and allow quantifying the grade of recurrent stenosis as well as the hemodynamic consequences.

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