Safety and effectiveness of Phoenix atherectomy for endovascular treatment in calcified common femoral artery lesions

VASA ◽  
2021 ◽  
pp. 1-9
Author(s):  
Mariya Kronlage ◽  
Christian Erbel ◽  
Michael Lichtenberg ◽  
Ulrike Heinrich ◽  
Hugo A. Katus ◽  
...  
Keyword(s):  
Endovascular Treatment ◽  
Femoral Artery ◽  
Clinical Success Rate ◽  
Common Femoral Artery ◽  
Target Lesion ◽  
Target Lesion Revascularization ◽  
Type I ◽  
Complication Rates ◽  
Peripheral Embolization

Summary: Background: Traditionally endarterectomy has been considered as the gold standard technique for the treatment of common femoral artery (CFA) lesions. The aim of this study is to investigate the procedural safety and mid-term outcomes of minimal invasive Phoenix atherectomy for the treatment of CFA lesions. Patients and methods: Phoenix atherectomy was used for treatment of 61 consecutive, moderately to heavily calcified CFA lesions in 56 patients. Lesions were classified based on the CFA occlusive disease classification (Type I, II&III lesions). Primary endpoints were technical, procedural, and clinical success rate. Safety endpoints (vessel perforation, peripheral embolization) and clinically driven target lesion revascularization (TLR) were also assessed. Results: Of 61 CFA lesions, 58 (95%) exhibited at least moderate/severe calcification (PACSS3 in 38 (62%) and PACSS4 in 20 (33%) cases). Type III lesions were present in 30 (49%), type I/II lesions in 31 (51%) cases. Technical and procedural success was achieved in 30 (49%) and all 61 (100%) lesions, respectively with low complication rates (0% perforation, 2% embolization). Adjunctive treatment after atherectomy was performed using drug-coated balloon (DCB) in 35 (57%) and bail-out stenting in 6 (10%) cases. Target lesion revascularization (TLR) occurred in 4 (7%) cases during a mean follow-up duration of 11±7months. All patients exhibited clinical improvement at follow-up, showing mean Rutherford category reduction from 3.7±1.1 to 1.5±1.1 (p<0.001). Conclusions: The Phoenix device can be used for the effective endovascular treatment of CFA lesions, due to its reasonable safety profile and mid-term results.

scholarly journals Systematic Review and Proportional Meta-Analysis of Endarterectomy and Endovascular Therapy with Routine or Selective Stenting for Common Femoral Artery Atherosclerotic Disease

2019 ◽  
Vol 2019 ◽  
pp. 1-12 ◽  
Author(s):  
Khalid Hamid Changal ◽  
Mubbasher Ameer Syed ◽  
Tawseef Dar ◽  
Muhammad Asif Mangi ◽  
Mujeeb Abdul Sheikh
Keyword(s):  
Endovascular Treatment ◽  
Femoral Artery ◽  
Meta Analysis ◽  
Common Femoral Artery ◽  
Target Lesion ◽  
Target Lesion Revascularization ◽  
Inclusion Criteria ◽  
One Year ◽  
New Evidence

Introduction. Common femoral endarterectomy (CFE) has been the therapy of choice for common femoral artery atherosclerotic disease (CFA-ASD). In the past, there was inhibition to treat CFA-ASD endovascularly with stents due to fear of stent fracture and compromise of future vascular access site. However, recent advances and new evidence suggest that CFA may no longer be a ‘stent-forbidden zone’. In the light of new evidence, we conducted a meta-analysis to determine the use of endovascular treatment for CFA-ASD and compare it with common femoral endarterectomy in the present era.Methods. Using certain MeSH terms we searched multiple databases for studies done on endovascular and surgical treatment of CFA-ASD in the last two decades. Inclusion criteria were randomized control trials, observational, prospective, or retrospective studies evaluating an endovascular treatment or CFE for CFA-ASD. For comparison, studies were grouped based on the treatment strategy used for CFA-ASD: endovascular treatment with selective stenting (EVT-SS), endovascular treatment with routine stenting (EVT-RS), or common femoral endarterectomy (CFE). Primary patency (PP), target lesion revascularization (TLR), and complications were the outcomes studied. We did proportional meta-analysis using a random-effect model due to heterogeneity among the included studies. If confidence intervals of two results do not overlap, then statistical significance is determined.Results. Twenty-eight studies met inclusion criteria (7 for EVT-RS, 8 for EVT-SS, and 13 for CFE). Total limbs involved were 2914 (306 in EVT-RS, 678 in EVT-SS, and 1930 in CFE). The pooled PP at 1 year was 84% (95% CI 75-92%) for EVT-RS, 78% (95% CI 69-85%) for EVT-SS, and 93% (95% CI 90-96%) for CFE. PP at maximum follow-up in EVT-RS was 83.7% (95% CI 74-91%) and in CFE group was 88.3% (95% CI 81-94%). The pooled target lesion revascularization (TLR) rate at one year was 8% (95% CI 4-13%) for EVT-RS, 19% (95% CI 14-23%) for EVT-SS, and 4.5% (95% CI 1-9%) for CFE. The pooled rate of local complications for EVT-RS was 5% (95% CI 2-10%), for EVT-SS was 7% (95% CI 3 to 12%), and CFE was 22% (95% CI 14-32%). Mortality at maximum follow-up in CFE group was 23.1% (95% CI 14-33%) and EVT-RS was 5.3% (95% CI 1-11%).Conclusion. EVT-RS has comparable one-year PP and TLR as CFE. CFE showed an advantage over EVT-SS for one-year PP. The complication rate is lower in EVT RS and EVT SS compared to CFE. At maximum follow-up, CFE and EVT-RS have similar PP but CFE has a higher mortality. These findings support EVT-RS as a management alternative for CFA-ASD.

scholarly journals Treatment of de novo coronary artery lesions with paclitaxel drug coated balloons (DCB) in diabetic and non-diabetic patients

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
K.M.Z Mohd Saad Jalaluddin
Keyword(s):  
Myocardial Infarction ◽  
Coronary Artery ◽  
De Novo ◽  
Target Lesion ◽  
Diabetic Group ◽  
Target Lesion Revascularization ◽  
Diabetic Patients ◽  
Coronary Artery Lesions ◽  
Artery Disease

Abstract Background Drug-coated balloon has been widely used to treat In-Stent Restenosis as recommended by ESC/EACT coronary intervention guideline. However, trials of effectiveness of DCB in treating de novo lesions in diabetic patients are limited. This study will highlight the impact of DCB in diabetic patients with only de novo lesions against non-diabetic patients. Aim To compare the outcomes of Paclitaxel Drug Coated Balloon (DCB) in Diabetic and non-diabetic patients with only de novo coronary artery disease. Methods A retrospective, single center study was conducted from January 2016 till December 2018. All diabetic and non-diabetic patients underwent angioplasty to only de novo coronary artery lesions were included in the study. Patients' baseline characteristic, angiographic data, post procedural and 12 months follow-up outcomes including major adverse coronary artery event (MACE), target lesion revascularization (TLR) and myocardial infarction (MI) are compared. Results A total of 1257 patients (726 diabetic and 531 non-diabetic patients) with total 1385 de novo coronary artery lesions (791 lesions in diabetic group and 594 lesions in non-diabetic group) were included in this study. Mean age for non-diabetic group was 57.6±10.6 years and diabetic group was 59.6±9.6 years with male predominance (91.1% in non-diabetic group, n=484 and 79.2% in diabetic group, n=575). Majority of diabetic group has hypertension (83.7%, n=608 vs 58.6%, n+311), chronic renal failure (10.3%, n=75 vs 1.9%, n=10), documented coronary artery disease (55.6%, n=404 vs 47.5%, n=252) and previous coronary angioplasty 39.5%, n=287 vs 28.8%, n=153). Adequate pre-dilatation was done in both groups (98.5%, n=585 in non-diabetic group and 99.4%, n=786 in diabetic group; p=0.000). Mean DCB diameter and length were almost similar in both groups. Mean residual stenosis after DCB was 11.15±16.9% in non-diabetic group and 13.13±13.4% in the diabetic group (p=0.008). 74.6% of non-diabetic group (n=396) and 77.1% of diabetic group (n=560) were on double antiplatelet therapy for 12 months. 86.8% (n=461) of non-diabetic and 88.4% (n=642) of diabetic patients were available for follow up. MACE events were significantly higher (p=0.000) in diabetic group (4.3%, n=31) as compare to non-diabetic group (0.6%, n=3). Target lesion revascularization (TLR) and myocardial infarction (MI) was also significantly higher in diabetic group (TLR 1.4%, N=10 vs 0.6%, n=3, p=0.049; MI 2.6%, n=19 vs 0.4%, n=2, p=0.002). Conclusion Treating de novo coronary lesions in diabetic patients with DCB associated with significantly higher MACE events, target lesion revascularization and myocardial infarction. Diabetic patients appear to have a greater volume of atherosclerotic plaque and increased propensity for atherosclerotic plaque rupture. Funding Acknowledgement Type of funding source: None

scholarly journals Percutaneous Treatment of Superficial Femoral Artery Total Occlusions: Single Center Experience

Acta Medica ◽  
2019 ◽  
Vol 50 (4) ◽  
pp. 30-35
Author(s):  
AHMET HAKAN ATEŞ ◽  
AYSU BAŞAK ÖZBALCI ◽  
SELİM KUL ◽  
MUSTAFA YENERÇAĞ ◽  
Metin Okşul ◽  
...  
Keyword(s):  
Femoral Artery ◽  
Superficial Femoral Artery ◽  
Treatment Strategy ◽  
Percutaneous Treatment ◽  
Arterial Disease ◽  
Complication Rates ◽  
Total Occlusion ◽  
First Choice ◽  
Stenting Procedure

Objectives Superficial femoral artery (SFA) is the most commonly effected vessel in peripheral arterial disease (PAD) and SFA total occlusions constitute the 50% of PAD patients presenting with symptoms. In this study, we investigated our patients with SFA total occlusions who were treated with percutaneous treatment strategy.   Methods In this study, we included ambulatory patients who were admitted to our clinics due to symptomatic severe SFA total occlusion and underwent PTA or PTA + stenting procedure.The demographic findings of the patients, procedure details, complications and follow-up results were noted. Results Out of 67 patients, 62 (92.5%) underwent PTA or PTA + stenting procedure successfully for SFA total occlusions. Only one serious complication, acute renal failure resulting in death developed during hospitalization. The mean follow-up time after the procedure was 11.1±7.2 months. During this follow-up time 36 (58.1%) were asymptomatic.  Out of 26 patients who were symptomatic, only 6 of them underwent reintervention and 3 were recommended surgical intervention.   Conclusion Peripheral interventions for SFA total occlusions are being performed successfully in experienced centers with low complication rates as the first treatment strategy in PAD. Herein,we have presented our patients who underwent successful PTA and/or stenting procedure with   high success and low complication rates. Peripheral interventions should be the first choice for SFA total occlusions in experienced centers.  

scholarly journals Outcomes of Deferred Revascularization Following Physiological Coronary Assessment Using Fractional Flow Reserve

2019 ◽  
Vol 04 (04) ◽  
pp. 190-194
Author(s):  
Shabbir Ali Shaik ◽  
Aramalla Sunitha ◽  
Indrani Garre ◽  
VS Bharathi Lakshmi
Keyword(s):  
Fractional Flow Reserve ◽  
Event Rate ◽  
Coronary Event ◽  
Target Lesion ◽  
Target Lesion Revascularization ◽  
Fractional Flow ◽  
Noninvasive Test ◽  
Flow Reserve ◽  
One Year

Abstract Objective Outcomes of patients with deferred revascularization for intermediate stenosis coronary lesion based upon physiological assessment using fractional flow reserve ([FFR] >0.80). Methods Patients with chest pain with angiographic intermediate stenosis, (40–70% stenosis) without noninvasive test evidence of ischemia were selected and underwent an FFR assessment between January 1, 2015, and August 31, 2018. Patients with intermediate lesions of FFR > 0.80 were followed, and those patients with lesion with FFR < 0.8 were excluded from the study. The primary outcomes of the study were to know the composite of target lesion revascularization (TLR), myocardial infarction (MI), and other vascular complications (major adverse cardiovascular events [MACE]). Results In 102 patients who underwent deferred revascularization (FFR > 0.80), 104 FFR studies were done and followed over one year. Four patients needed target lesion revascularization (3.92%). Three patients underwent percutaneous coronary intervention (2.94%) within nine months of follow-up, and one patient underwent coronary artery bypass graft (CABG) (0.98%) at one year of follow-up. Two patients died with acute MI with sudden cardiac arrest (1.96%). Two patients developed right hemiparesis (2.94%) on one year of follow-up due to acute ischemic stroke of a middle cerebral artery, and one patient underwent permanent pacemaker implantation for complete heart block (CHB). The incidence of the total events was 8.82%, TLR was 3.92%, Coronary event rate was 5.88%, and MACE was 7.84%. Conclusions Our study shows that there was a significant increase in the incidence of coronary event rate (5.88%) and the MACE rate (7.84%) in patients of deferred coronary revascularization based on higher FFR values (>0.8).

Endovascular Treatment of the Common Femoral Artery for Limb Ischemia

2013 ◽  
Vol 47 (8) ◽  
pp. 639-644 ◽  
Author(s):  
Robert S. M. Davies ◽  
William Adair ◽  
Amman Bolia ◽  
Guy Fishwick ◽  
Robert D. Sayers ◽  
...  
Keyword(s):  
Endovascular Treatment ◽  
Femoral Artery ◽  
Limb Ischemia ◽  
Common Femoral Artery ◽  
The Common

scholarly journals Late open conversion after endovascular repair of abdominal aneurysm failure: Better and easier option than complex endovascular treatment

2018 ◽  
Vol 7 ◽  
pp. 204800401775283 ◽  
Author(s):  
Stefano Bonardelli ◽  
Franco Nodari ◽  
Maurizio De Lucia ◽  
Emanuele Botteri ◽  
Alice Benenati ◽  
...  
Keyword(s):  
Endovascular Treatment ◽  
Endovascular Repair ◽  
Open Repair ◽  
Multiple Organ ◽  
Type I ◽  
Abdominal Aneurysm ◽  
Open Conversion ◽  
Technical Errors ◽  
Report Data

Aim Conversion to open repair becomes the last option in case of endovascular repair of abdominal aneurysm failure, when radiological interventional procedures are unfeasible. While early conversion to open repair generally derives from technical errors, aetiopathogenesis and results of late conversion to open repair often remain unclear. Methods We report data from our Institute’s experience on late conversion to open repair. Twenty-two late conversion to open repairs out of 435 consecutive patients treated during a 18 years period, plus two endovascular repair of abdominal aneurysms performed in other centres, are analysed. The indication for conversion to open repair was aneurysm enlargement because of type I, type III, type II endoleak and endotension. Even if seven cases (23%) had shown an initial aneurysmal shrinkage, in a later phase, the sac began to enlarge again. In 12 patients, conversion to open repair was the last chance after unsuccessful secondary endovascular procedures. Results Three cases (12.5%) were treated in emergency. Aortic cross-clamping was only infrarenal in 10 cases, only or temporarily suprarenal in 14 and temporarily supraceliac in 9 cases, for 19 total and 5 partial endograft excisions. Two patients died for Multiple Organ Failure (MOF), on 42nd (endovascular repair of abdominal aneurysm infection) and 66th postoperative day. No other conversion to open repair-related deaths or major complications were revealed by follow-up post-conversion to open repair (mean: 68 months ranging from 24 to 180 months). Conclusion Late conversion to open repair is often an unpredictable event. It represents a technical challenge: specifically, the most critical point is the proximal aortic clamping that often temporarily excludes the renal circulation. In our series, conversion to open repair can be performed with a low rate of complications. In response to an endovascular repair of abdominal aneurysm failure, before applying complex procedures of endovascular treatment, conversion to open repair should be taken into account.

scholarly journals Endovascular treatment of the common femoral artery in the Vascular Quality Initiative

2017 ◽  
Vol 65 (4) ◽  
pp. 1039-1046 ◽  
Author(s):  
Jeffrey J. Siracuse ◽  
Kathryn Van Orden ◽  
Jeffrey A. Kalish ◽  
Mohammad H. Eslami ◽  
Marc L. Schermerhorn ◽  
...  
Keyword(s):  
Endovascular Treatment ◽  
Femoral Artery ◽  
Common Femoral Artery ◽  
The Common

scholarly journals Endovascular Treatment of Common Femoral Artery Atherosclerotic Disease

2018 ◽  
Vol 1 (1) ◽  
pp. 12-16 ◽  
Author(s):  
Omar Jawaid ◽  
Ehrin Armstrong
Keyword(s):  
Endovascular Treatment ◽  
Femoral Artery ◽  
Common Femoral Artery ◽  
Critical Limb Ischaemia ◽  
Limb Ischaemia ◽  
Long Term Outcomes ◽  
Patch Angioplasty ◽  
The Common ◽  
Artery Disease

Common femoral artery atherosclerosis is a common cause of claudication and critical limb ischaemia. Surgical endarterectomy with or without patch angioplasty has been considered the gold standard for the treatment of common femoral peripheral artery disease. Endovascular intervention to the common femoral artery has gained popularity in recent years as devices and technical skills have advanced. A systematic review of the literature from 1987 to 2018 for endovascular treatment of common femoral artery disease was conducted. This article summarises the data on acute and long-term outcomes for endovascular treatment of common femoral artery disease.

scholarly journals Paclitaxel-Coated Balloon for the Treatment of Infrainguinal Disease: 12-Month Outcomes in the All-Comers Cohort of BIOLUX P-III Global Registry

2020 ◽  
Vol 27 (2) ◽  
pp. 304-315 ◽  
Author(s):  
Gunnar Tepe ◽  
Thomas Zeller ◽  
Matej Moscovic ◽  
Jean-Marc Corpataux ◽  
Johnny Kent Christensen ◽  
...  
Keyword(s):  
Real World ◽  
Target Lesion ◽  
Performance Outcomes ◽  
Limb Amputation ◽  
Lesion Length ◽  
Complication Rates ◽  
Stent Restenosis ◽  
And Performance ◽  
Global Registry

Purpose: To further investigate the safety and performance of the Passeo-18 Lux drug-coated balloon (DCB) for the treatment of atherosclerotic infrainguinal disease under real-world conditions. Materials and Methods: BIOLUX P-III is an international, prospective, observational registry ( ClinicalTrials.gov identifier NCT02276313) conducted at 41 centers in Europe, Asia, and Australia with follow-up visits at 6, 12, and 24 months. Of 700 patients (mean age 70.0±10.2 years; 439 men) with 863 lesions in the all-comers cohort, 330 (47.1%) patients had diabetes and 234 (37.7%) had chronic limb-threatening ischemia. The majority (79.3%) of lesions were in the femoropopliteal segment; of all lesions, 645 (74.9%) were calcified and 99 (11.5%) had in-stent restenosis (ISR). The mean lesion length was 84.7±73.3 mm. The primary clinical endpoint was major adverse events (MAEs) within 6 months, a composite of device- and procedure-related mortality through 30 days, major target limb amputation, and clinically-driven target lesion revascularization (TLR). The primary performance endpoint was clinically-driven TLR within 12 months. Results: At 6 and 12 months, freedom from MAEs was 94.0% and 89.5% in the all-comers cohort: 95.0% and 91.2% in the femoropopliteal group and 95.3% and 88.0% in the ISR subgroup, respectively. Freedom from clinically-driven TLR at 12 months was 93.1% in the all-comers cohort, 93.9% in the femoropopliteal lesions, and 89.4% for ISR lesions. All-cause mortality was 6.1% in the all-comers cohort: 5.9% in both the femoropopliteal and ISR subgroups. There were no device- or procedure-related deaths at up to 12 months. The Rutherford category improved in >80% of all subgroups at 12 months. Conclusion: In a real-world patient population, the safety and performance of the Passeo-18 Lux DCB for the treatment of atherosclerotic infrainguinal lesions are maintained, with good performance outcomes and low complication rates at 12 months.

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