Long-term outcomes of staged iliofemoral endoconduits prior to complex endovascular aortic aneurysm repair.

OBJECTIVE: Adverse iliofemoral anatomy may preclude complex endovascular aortic aneurysm repair (EVAR). In our practice, staged iliofemoral endoconduits (ECs) are planned prior to complex EVAR to improve vascular access and decrease operative time while allowing the stented vessel to heal. This study describes the long-term results of iliofemoral ECs prior to complex EVAR. METHODS: Between 2012 and 2023, 59 patients (44% male; median age, 75 ± 6 years) underwent ECs before complex EVAR using self-expanding covered stents (Viabahn). For common femoral artery (CFA) disease, ECs were delivered percutaneously from contralateral femoral access and extended into the CFA to preserve the future access site for stent graft delivery. Internal iliac artery patency was maintained when feasible. During complex EVAR, the EC extended into the CFA was directly accessed and sequentially dilated until it could accommodate the endograft. Technical success was defined as successful access, closure, and delivery of the endograft during complex EVAR. Endpoints were vascular injury or EC disruption, secondary interventions, and EC patency. RESULTS: Unilateral EC was performed in 45 patients (76%). ECs were extended into the CFA in 21 patients (35%). Median diameters of the native common iliac, external iliac, and CFA were 7 mm (interquartile range [IQR], 6-8 mm), 6 mm (IQR, 5-7 mm), and 6 mm (IQR, 6-7 mm), respectively. Internal iliac artery was inadvertently excluded in 10 patients (17%). Six patients (10%) had an intraoperative vascular injury during the EC procedure, and six patients (10%) had EC disruption during complex EVAR, including five EC collapses requiring re-stenting and one EC fracture requiring open cut-down and reconstruction with patch angioplasty. In 23 patients (39%), 22 Fr OD devices were used; 20 Fr were used in 22 patients (37%), and 18 Fr in 14 patients (24%). Technical success for accessing EC was 89%. There was no difference in major adverse events at 30 days between the iliac ECs and iliofemoral ECs. Primary patency by Kaplan-Meier estimates at 1, 3, and 5 years were 97.5%, 89%, and 82%, respectively. There was no difference in primary patency between iliac and iliofemoral ECs. Six secondary interventions (10%) were required. The mean follow-up was 34 ± 27 months; no limb loss or amputations occurred during the follow-up. CONCLUSIONS: ECs improve vascular access, and their use prior to complex EVAR is associated with low rates of vascular injury, high technical success, and optimal long-term patency. Complex EVAR procedures can be performed percutaneously by accessing the EC directly under ultrasound guidance and using sequential dilation to avoid EC disruption.

Intravascular Lithotripsy for Treatment of Severely Calcified Common Femoral Artery Disease: Results From the Disrupt PAD III Observational Study.

BACKGROUND: Surgical endarterectomy is currently considered the front-line therapy for the treatment of calcified lesions in the common femoral artery (CFA). Endovascular interventions have evolved, and their use is increasing in frequency. Intravascular lithotripsy (IVL) has shown promising safety and effectiveness in calcified CFA lesions in a small pilot study, but "real-world" evidence from a larger cohort is lacking. METHODS: The Disrupt PAD III Observational Study (NCT02923193) was a prospective, multicenter registry designed to assess the acute safety and effectiveness of IVL treatment for calcified peripheral arterial disease. Any concomitant treatment with other calcium-modifying technologies as well as definitive treatment strategies was at the discretion of the operators. Patients with CFA lesions were evaluated for acute angiographic safety and effectiveness outcomes following IVL treatment as determined by an independent angiographic core lab. RESULTS: Common femoral artery treatment was indicated in 177 patients (n=163 could be analyzed based on core-laboratory data) enrolled at 23 sites. Characteristics for 164 treated lesions included moderate-severe calcification 95.1%, diameter stenosis 74.8±17.7%, and lesion length 53.6±53.1 mm. Concomitant calcium-modifying therapy was used in 32.3% of lesions. Final therapy included drug-coated balloons in 68.9% and stenting in 16.5% of lesions. Post-IVL and final residual stenoses were 29.2±16.5%and 23.6±11.5%, respectively. No vascular complications (flow-limiting dissections, perforations, embolization, slow or no reflow, or abrupt closure) were present at the end of the procedure by core-laboratory assessment, with 1 (0.8%) flow-limiting dissection initially occurring immediately following IVL treatment. CONCLUSION: This study represents the largest real-world experience of IVL treatment in heavily calcified CFA lesions. Intravascular lithotripsy treatment showed significant stenosis reduction and favorable periprocedural safety in this challenging patient population. CLINICAL IMPACT: In this study we show that calcified common femoral artery disease can be safely and effectively treated with shockwave balloon angioplasty with high procedural success and low complication rates and in clinical practice can now be offered as an alternative to surgical treatment in those patients reluctant to or high risk for vascular surgery. This opens another option for clinicians to treat calcified common femoral artery disease without the risk of dissection, perforation or distal embolization that are associated with atherectomy. This study shows that shockwave lithoplasty offers an innovative plaque modification technology to tackle calcified disease in the common femoral artery.

Multicenter Registry of Common Femoral Artery Disease Treated With Endovascular Revascularization Using Interwoven Nitinol Stents: An Observational Retrospective Study.

PURPOSE: Surgical thromboendarterectomy has been the gold standard treatment for common femoral artery (CFA) disease. However, endovascular therapy (EVT) is conducted in certain patients with CFA lesions because of multiple comorbidities. The interwoven nitinol stent (IWS) has been developed to prevent stent fracture. Thus, this study aimed to evaluate the feasibility of EVT using IWS for CFA lesions in clinical practice. MATERIALS AND METHODS: This retrospective multicenter registry analyzed patients who had symptomatic lower-extremity artery disease due to CFA lesions and underwent EVT using IWS between 2019 and 2021. The primary endpoint was restenosis 2 years after EVT. RESULTS: This study enrolled a total of 177 patients with 196 CFA lesions. The 2-year estimate of freedom from restenosis was 88.0%. The 2-year freedom rates from the target-lesion revascularization, major amputation, and all-cause death were 92.9%, 99.0%, and 75.2%, respectively. The clinical features significantly associated with restenosis risk were the reference vessel diameter (RVD, per 1.0 mm, hazard ratio [HR], 0.24 [0.08-0.70]; p=0.009), external iliac artery (EIA) involvement (HR=4.03 [1.56-10.4]; p=0.004), superficial femoral artery (SFA) involvement (HR=3.05 [1.00-9.25]; p=0.049), body mass index (BMI; per 1.0, HR=0.85 [0.73-0.99]; p=0.032), occlusion of deep femoral arteries (DFAs) at baseline (HR=7.89 [2.04-30.5]; p=0.003), and chronic limb-threatening ischemia (CLTI, HR=2.63 [1.02-6.78]; p=0.045). Their significant association was also confirmed by the random survival forest analysis. During a median follow-up of 12.0 months, guiding sheaths were inserted via CFAs implanted IWSs in 73 cases (37.2%), and no patients had cannulation-related complications, such as failed hemostasis, fracture of IWS, and stent occlusion. CONCLUSIONS: Endovascular therapy using IWS in CFA lesions showed acceptable 2-year patency rates at 88.0% and might preserve the arterial access via the ipsilateral CFAs. Small RVD, involving EIA and SFA lesions, emaciation, occluded DFA, and CLTI are associated with poor 2-year patency rates following EVT, thus, IWS implantation in CFA lesions may be an option for patients unsuitable for surgical revascularization. CLINICAL IMPACT: This retrospective multicenter registry enrolled 177 patients with 199 CFA lesions treated with EVT using interwoven nitinol stents, because surgical thromboendarterectomy was difficult due to their multiple comorbidities. The 2-year estimate of freedom from restenosis was acceptable at 88.0%. The 2-year freedom rate from major amputation was also high at 99.0%. Moreover, during a median follow-up of 12.0 months, guiding sheaths were inserted via CFAs implanted IWSs in 73 cases, and no patients had cannulation-related complications such as failed hemostasis, fracture of IWS, and stent occlusion.

Safety and effectiveness of the Phoenix atherectomy device for endovascular treatment of common femoral and popliteal arteries: Results of the EN-MOBILE trial.

Background: This study aimed to assess the peri- and postprocedural outcomes of atherectomy-assisted endovascular treatment of the common femoral (CFA) and popliteal arteries. Methods: Phoenix atherectomy was used for the treatment of 73 and 53 de novo CFA and popliteal artery lesions, respectively, in 122 consecutive patients. Safety endpoints encompassed perforation and peripheral embolization. Postprocedural endpoints included freedom from clinically driven target lesion revascularization (CD-TLR) and clinical success (an improvement of ⩾ 2 Rutherford category [RC]). In addition, 531 patients treated for popliteal artery stenosis or occlusion without atherectomy were used as a comparator group. Results: Procedural success (residual stenosis < 30% after treatment) was 99.2%. The need for bail-out stenting was 2 (2.7%) and 3 (5.7%) in CFA and popliteal artery lesions, respectively. Only one (1.4%) embolization occurred in the CFA, which was treated by catheter aspiration. No perforations occurred. After 1.50 (IQR = 1.17-2.20) years, CD-TLR occurred in seven (9.2%) and six (14.6%) patients with CFA and popliteal artery lesions, respectively, whereas clinical success was achieved in 62 (91.2%) and 31 (75.6%), respectively. Patients treated with atherectomy and DCB in the popliteal artery after matching for baseline RC, lesion calcification, length, and the presence of chronic total occlusion, exhibited higher freedom from CD-TLR compared to the nondebulking group (HR = 3.1; 95% CI = 1.1-8.5, p = 0.03). Conclusion: Atherectomy can be used safely and is associated with low rates of bail-out stenting in CFA and popliteal arteries. CD-TLR and clinical success rates are clinically acceptable. In addition, for the popliteal artery, atherectomy combined with DCB demonstrates lower CD-TLR rates compared to a DCB alone strategy. (German Clinical Trials Register: DRKS00016708).

A latent bleeding complication in ipsilateral common femoral puncture involving delayed diagnosis: a case report.

BACKGROUND: The trans femoral ipsilateral approach is often adopted for endovascular treatment (EVT) for better steerability of guidewires or better device deliverability. However, contrary to the trans femoral contralateral approach, ipsilateral antegrade puncture sometimes causes peculiar bleeding complications. CASE PRESENTATION: A 76-year-old female underwent EVT for chronic occlusion of the left superficial femoral artery (SFA) via the ipsilateral antegrade approach. After guidewire passage, we inflated the drug-coated balloons, but angiography showed blood flow stasis at the mid segment of the SFA. We also ensured prolonged balloon inflation, which resulted in favorable blood flow. While trying to ensure hemostasis, the blood pressure remained decreased, but neither bleeding nor superficial hematoma were observed at the puncture site. After hemostasis was achieved, we removed the surgical drape and noticed a swelling in the mid-portion of the thigh, distant from the puncture point. We then approached the left common femoral artery (CFA) contralaterally. Angiography showed continuous bleeding from a little bit distally to the sheath insertion point that was spreading through an intramuscular space. We stopped the bleeding with balloon tamponade inside the CFA. Angiography after hemostasis demonstrated blood flow stasis at the mid-segment of the SFA, similarly as that seen before. We confirmed compression of the SFA by a large hematoma using both intra- and extra- vascular ultrasound. Therefore, we deployed a self-expandable stent at the compressed SFA position. Finally, we achieved favorable blood flow on angiography. CONCLUSION: We encountered a case that latent bleeding unrecognized in the surgical field persisted while prolonged inflation of DCB was conducted at just proximal SFA. We could have avoided bailout stenting by noticing the bleeding incident in a timely manner. Prediction and prevention are essential for all kinds of procedural complications in EVT.

Endovascular treatment with interwoven nitinol stent for common femoral artery lesions: 2-year outcomes of a single center experience.

OBJECTIVE: The study aimed was to report 2-year outcomes of endovascular treatment with interwoven nitinol (Supera™) stent for common femoral artery (CFA) lesions. METHODS: We reviewed the clinical data of 20 patients who presented with CFA stenosis or occlusion and underwent balloon angioplasty followed by Supera™ stenting in CFA between February 2016 and January 2022. The outcomes were evaluated in these patients in terms of technical success, post-intervention complications, reintervention, and cumulative patency (1 year, and 2 years). RESULTS: The study included 20 patients (22 lesions) who presented with isolated CFA lesions (3), iliac lesions involving CFA (6), superficial femoral artery (SFA) lesions involving CFA (8), and extensive lesions from the iliac artery to SFA (5). There were 16 men (80%) with a mean age of 69.7 years (range, 34-83). Hypertension, smoking, and diabetes were found in 15 (75%), 7 (35%), and 7 patients (35%), respectively. Clinical presentations were Rutherford stage 5 (9, 45%), Rutherford stage 4 (5, 25%), Rutherford stage 6 (4, 20%), and Rutherford stage 3 (2, 10%). Technical success was achieved in all patients (100%). The procedures for treatment were isolated CFA Supera™ stenting (1, 4.5%), CFA plus DFA Supera™ stenting (jailed SFA) (2, 9.1%), CFA plus SFA Supera™ stenting (jailed DFA) (8, 36.4%), CFA Supera™ stenting plus bare iliac stenting (Astron) (6, 27.3%), CFA plus SFA Supera™ stenting (jailed DFA) plus bare iliac stenting (Astron) (5, 22.7%), and additional DFA angioplasty (7, 31.8%). The rate of in-hospital mortality and morbidity were 0% and 10%, respectively. Distal embolization after pre-dilatation occurred in 1 patient, and cerebral infarction occurred 12 h after the procedure in 1 patient. The mean follow-up time was 23 months (range, 2-64). During the follow-up period, in-stent occlusion occurred in 2 patients at 9 and 46 months. Re-intervention was performed in 1 patient due to recurrent symptom of claudication. The cumulative primary patency at 1 year and 2 years were 93.3% and 93.3%, respectively. CONCLUSION: Endovascular treatment with interwoven nitinol (Supera™) stent for CFA lesions was associated with acceptable outcomes at 2 years.

Aortobifemoral reconstruction in open abdominal aortic aneurysm repair is associated with increased morbidity and mortality.

OBJECTIVE: Much attention has been given to the influence of anatomic and technical factors, such as maximum abdominal aortic aneurysm diameter and proximal clamp position, in open abdominal aortic aneurysm repair (OSR). However, no studies have rigorously examined the correlation between site of distal anastomosis and OSR outcomes despite conventional wisdom that more proximal sites of anastomosis are preferrable when technically feasible. This study aimed to test the association between sites of distal anastomosis and clinical outcomes for patients undergoing primary elective OSR. METHODS: Our study included 5683 patients undergoing primary elective OSR at 233 centers from 2014 to 2020. Using a variety of statistical methods to account for potential confounders, including multivariable logistic regression and Cox proportional hazards modeling, as well as subgroup analysis, we examined the association between site of distal anastomosis and clinical outcomes in elective OSR. Primary outcomes were major in-hospital complication rate, 30-day mortality, and long-term survival. RESULTS: Patients undergoing elective aortobifemoral reconstruction (n = 672) exhibited significantly increased rates of smoking, chronic obstructive pulmonary disease, and peripheral artery disease in comparison to patients undergoing elective OSR with distal anastomosis to the aorta (n = 2298), common iliac artery (n = 2163), or external iliac artery (n = 550). Patients undergoing aorto-aortic tube grafting were significantly less likely to exhibit iliac aneurysmal disease and significantly more likely to be undergoing elective OSR with a suprarenal or supraceliac proximal clamp position. Using multivariable logistic regression and Cox proportional hazards analysis to control for important confounders, such as age, smoking status, and medical history, we found that distal anastomosis to the common femoral artery was associated with increased odds of major in-hospital complications (adjusted odds ratio, 1.79; 95% confidence interval, 1.46-2.18; P < .001) and reduced long-term survival (adjusted hazard ratio, 1.44; 95% confidence interval, 1.09-1.89; P = .010). We observed no significant differences in 30-day mortality across sites of distal anastomosis in our study population. CONCLUSIONS: It is generally accepted that more proximal sites of distal anastomosis should be selected in OSR when technically feasible. Our findings support this hypothesis by demonstrating that distal anastomosis to the common femoral artery is associated with increased perioperative morbidity and reduced long-term survival. Careful diligence regarding optimization of preoperative health status, perioperative care, and long-term follow-up should be applied to mitigate major complications in this patient population.

Stent Implantation and Thromboendarterectomy for the Common Femoral Artery in Real-World Practice.

PURPOSE: To compare the outcomes of thromboendarterectomy (TEA) and endovascular therapy (EVT) with stenting for patients with atherosclerotic common femoral artery (CFA) occlusive disease. MATERIALS AND METHODS: From a retrospective registry of 1193 consecutive patients with CFA treatment performed between 2018 and 2020 at 66 institutions in Japan, we identified patients who underwent TEA (n=432) or stent implantation (n=157). The primary outcome measures were the 1-year primary patency of TEA versus stenting with propensity score matching. The secondary outcome measures were perioperative complications, length of hospital stay, any reintervention, limb salvage, and overall survival. Interaction analysis for primary patency was performed with propensity score stratification to determine the appropriate target population for CFA stenting. RESULTS: Propensity score matching extracted 101 pairs (101 patients in the EVT group and 253 patients in the TEA group). The 1-year primary patency rate was significantly higher in the TEA cohort (92.8% vs 84.6%, p=0.006). The freedom from reintervention rate was also significantly higher in the TEA cohort (94.0% vs 89.9%, p=0.030). However, the 1-year limb salvage (98.7% vs 100.0%, p=0.32), 1-year overall survival (90.8% vs 85.0%, p=0.14), and frequency of perioperative complications were not significantly different between the cohorts (6.9% vs 14.2%, p=0.10). Based on interaction analysis, the superiority of TEA over EVT in terms of patency was less apparent in patients with advanced age and chronic heart failure. CONCLUSIONS: Thromboendarterectomy was superior to stenting in terms of primary patency and freedom from revascularization at 1 year. There was no significant difference in the incidence of perioperative complications between both groups. Thromboendarterectomy may be recommended as the standard treatment strategy for patients with atherosclerotic CFA disease, whereas stenting may be considered for patients with advanced age and chronic heart failure. CLINICAL IMPACT: Thromboendarterectomy compared to stenting was the preferred revascularization strategy for patients with CFA disease in terms of primary patency and freedom from target lesion revascularization during the 1st year. The difference was attenuated in subgroups with advanced age (85 years or older) or chronic heart failure, thus stenting may be considered in patients with these backgrounds.

Midterm Results of Intravascular Lithotripsy for Severely Calcified Common Femoral Artery Occlusive Disease: A Single-Center Experience.

PURPOSE: Common femoral artery (CFA)-occlusive disease has traditionally been treated with open surgery, yet nowadays the frailty of patients has induced to find new techniques of revascularisation by endovascular means. So far, intravascular lithotripsy (IVL) has shown promising results in several lower limbs arterial districts. The purpose of this article is to report our experience with IVL for severely calcified peripheral arterial disease (PAD) of the CFA. METHODS: From November 2018 and October 2020, 10 consecutive patients (12 limbs) treated with IVL were prospectively enrolled in a dedicated database. Inclusion criteria were CFA localization of PAD, with a severe degree of calcification, a lesion length ≥10 mm, and a degree of stenosis ≥70% (severe). The only admitted adjunctive treatment was drug-coated balloon (DCB) angioplasty. Primary outcomes were technical and procedural success, clinical success, and target lesion revascularisation (TLR). Secondary outcomes were target extremity revascularisation (TER) and major adverse events (MAEs). RESULTS: All patients underwent IVL with associated DCB angioplasty. The median percentage of achieved stenosis reduction was 55.5% (interquartile range [IQR] 50-60.75), with a technical and procedural success of 100%. Over the study period, TLR only occurred in one limb (8.3%), with a mean upgrade in Rutherford class of 2.7 ± 0.77. No target vessel and access site complications were reported, as well as no distal embolization. One death and one major amputation occurred over the follow-up period, both in the same patient. CONCLUSIONS: Based on our experience, IVL for selected cases of severely calcified CFA disease, associated with DCB angioplasty, may be considered a safe and effective technique. Of course, a long-term follow-up and a larger series of patients are needed to validate our results.

Intravascular Lithotripsy and Drug-Coated Balloon Angioplasty for Severely Calcified Common Femoral Artery Atherosclerotic Disease.

OBJECTIVES: Intravascular lithotripsy (IVL) followed by drug-coated balloon (DCB) angioplasty might be a valuable alternative to surgery for calcified common femoral artery (CFA) atherosclerotic disease. Nonetheless, the 12 months performance of this treatment strategy remains unknown. This study reports on the 12 months outcomes of IVL with adjunctive DCB angioplasty for calcified CFA lesions. METHODS: This is a retrospective single-center, single-arm study. Consecutive patients treated by IVL and DCB for calcified CFA disease between February 2017 and September 2020 were evaluated. The primary measure outcome of this analysis was primary patency. Procedural technical success (<30% stenosis), freedom from target lesion revascularization (TLR), secondary patency, and overall mortality were additionally analyzed. RESULTS: Thirty-three (n=33) patients were included in this study. The majority presented with lifestyle limiting claudication (n=20, 61%), 52% (n=17) of the patients had chronic kidney disease (CKD) and 33% (n=11) had diabetes. The procedural technical success was 97% (n=32). A flow-limiting dissection post IVL was observed in 2 patients (6%) and a peripheral embolization in a single patient (3%), while the bail-out stenting rate amounted to 12% (n=4). No perforation was observed. The median length of hospital stay was 2 days (interquartile range 2-3). At 12 months, the primary patency was 72%. The freedom from TLR and the secondary patency rates were 94% and 88%, respectively. The 12-month survival amounted to 100% and 75% (n=25) of the patients were asymptomatic or presented with mild claudication. The presence of chronic limb-threatening ischemia (CLTI) (hazard ratio [HR], 0.92; confidence interval (CI); 0.18-4.8, p=0.7) or CKD (HR, 1.30; 95% CI, 0.29-5.8; p=0.72), as well as the use of a 7 mm IVL catheter (HR, 0.59; 95% CI, 0.13-2.63; p=0.49) or of high-dose DCB (HR, 0.68; 95% CI, 0.13-3.53; p=0.65) did not influence the primary patency. CONCLUSIONS: In this study, the combination of IVL and DCB angioplasty for calcified CFA disease was associated with low risk for periprocedural complications, acceptable 12 months clinical outcomes, and low rates of reinterventions. CLINICAL IMPACT: Intravascular lithotripsy in combination with DCB angioplasty can be an alternative to surgery in highly selected patients with CFA atherosclerotic disease. In this Cohort the combination therapy lead to acceptable clinical results and low reintervention rates at 12 months.

ABS-SMART (Aortic Balloon Supporting for Superior Mesenteric Artery Recanalization Technique): A New Technical Option for Recanalization of Complete Superior Mesenteric Artery Occlusion in Chronic Mesenteric Ischemia.

OBJECTIVE: To report our experience with a new technique for recanalization of the superior mesenteric artery (SMA)/celiac trunk (CT) with complete occlusion at the origin. TECHNIQUE: We describe our ABS-SMART (Aortic Balloon Supporting for Superior Mesenteric Artery Recanalization Technique) for recanalization of the CT and SMA in cases of complete occlusion of these arteries with a short or inexistent stump, which usually corresponds to chronic lesions with important calcification of the ostium. CONCLUSION: The ABS-SMART is an alternative for the recanalization of visceral arteries in cases where other conventional techniques have failed. It is particularly useful in scenarios characterized by a short occlusion at the origin of the target vessel, with no entry stump or severe calcification at the origin. CLINICAL IMPACT: Catheterization and recanalization of visceral stenoses may pose a challenge in some cases, as for example in the presence of a very narrow angle between the root or origin of the vessel and the aorta, as well as in the case of long and calcified stenoses, or when arteriography is unable to visualize the origin of the vessel. The present study describes our experience with the endovascular revascularization of visceral vessels using an aortic balloon-supported recanalization technique not previously described in the literature, that may be an effective alternative for the treatment of lesions of difficult access, such as total occlusion at the origin of the target vessel, with no entry stump or severe calcification at the origin of the SMA and CT, by improving the chances for technical success.

To patch, or not to patch a common femoral artery, that is the question.

OBJECTIVES: There is no strong evidence to support or reject the use of patch angioplasty (PA) after femoral endarterectomy (FE). The current study aimed to assess early postoperative complications and compare primary patency (PP) rates after FE in patients treated with PA versus direct closure (DC). METHODS: This is a retrospective study of patients admitted during 06/2002-07/2017 with signs and symptoms of chronic lower limb ischemia (Rutherford categories 2-6). Patients with angiographically confirmed stenoses or occlusions of the common femoral arteries (CFAs) and managed with FE with or without PA were included in the study. Early postoperative wound complications were assessed. The PP analysis was based on imaging-confirmed data. The impact of PA on the patency was evaluated in a confounder-adjusted Cox regression model. PP rates were compared with log-rank between the PA and DC groups using Kaplan-Meier survival analysis in the propensity score-matched (PSM) cohorts. RESULTS: A total of 295 primary FEs were identified. The patients' median age was 75 years. A total of 210 patients were managed with PA and 85 with DC. Altogether, 38 (12.9%) local wound complications were registered, 15 (5.1%) of which required re-interventions. There were 9 (3.2%) cases of deep wound infection, 20 (7.0%) seromas, and 11 (3.9%) cases of major bleeding, with no significant difference between the PA and DC groups. All of the infected patches were made of synthetic material, and 83% of them were removed. The PP analysis was performed on 50 PSM patient pairs with a median age of 74 years. The median imaging-confirmed follow-up lengths were 77 months (IQR = 47 months) for the PA patients and 27 months (IQR = 64 months) for the DC patients. The preoperative median diameter of the CFA was 8.8 mm (IQR = 3.4). The 5 year primary patency rates of CFAs with a minimum diameter of 5.5 mm managed with PA or DC exceeded 91%, p > 0.05. Female sex was associated with the loss of PP, odds ratio 4.17, p = 0.046. CONCLUSIONS: Wound complications after FE with or without patching are not uncommon and often lead to reoperations. The PP rates of CFAs with a minimum diameter of 5.5 mm and accomplished with or without patching are comparable. Female sex is associated with the loss of patency.

A novel endovascular method of atherectomy for calcified common femoral and popliteal disease using the crosser system: Crossbow and Rambow techniques.

OBJECTIVES: This study aims to report the efficacy and safety of new atherectomy methods using the Crosser system for calcified lesions in the common femoral and popliteal artery: the Crosser system supported by bended 0.014 wire (Crossbow) technique and retrograde approach of sheathless Crosser system supported by bended 0.014 wire (Rambow) technique. MATERIALS AND METHODS: This report describes a single-center, retrospective study. A total of 23 patients (mean ± SD age, 73 ± 10 years; 19 men) with symptomatic peripheral artery disease received the Crossbow technique and Rambow technique for treatment of calcified common femoral and popliteal disease; these patients were enrolled between October 2013 and October 2015. The primary efficacy outcome was acute technical success, defined as achievement of residual stenosis < 30% for stenting and < 50% for angioplasty or atherectomy. The primary safety outcome was assessed on the basis of angiographic complications. RESULTS: The Crossbow and Rambow techniques were undertaken in 100% and 17% of the patients, respectively. Acute technical success was achieved in 96% of the patients. There were two embolic events. CONCLUSION: Crossbow and Rambow techniques could be effective atherectomy methods of calcified common femoral and popliteal disease. Regarding safety, embolic protection devices may be needed for our atherectomy methods.

Vascular handlebar syndrome with blunt injury of common femoral artery.

Vascular handlebar syndrome with blunt injury of the common femoral artery is a rare vascular trauma mechanism, with high possibility of being missed or delayed. We present two cases of vascular handlebar syndrome treated in our hospital and a systematic review of the literature using MEDLINE and SCOPUS databases. Literature review identified 20 similar cases. The median age of patients was 18 years, and in vast majority males in gender. In most cases, the common femoral artery injury was an intimal flap and lumen occlusion with intramural thrombosis followed by transection and intimal injury without occlusion or thrombosis. The median time between injury and diagnosis/treatment was half an hour. Clinical presentation ranged from asymptomatic to acute limb ischemia. The grade of acute ischemia was mostly Rutherford class I (n=14), while acute IIa (n=4), chronic ischemia (n=3), and no ischemia (n=1) were also noticed. The correct diagnosis was revealed by clinical examination only (n=1), or by the combination of clinical and imaging techniques including computed tomography angiography (n=7) and duplex ultrasonography (n=4) or both (n=10). Management of the handlebar trauma syndrome injuries was surgical in most cases. Outcome was favorable in all patients. Vascular handlebar syndrome is extremely rare and high suspicion is required for early diagnosis and definitive treatment, as the early management is effective and crucial for averting the devastating consequences. An individualized approach to the vascular trauma patient is to be applied with considerations taken to the age of the patient, the mechanism of the injury, the anatomy of the lesion, and symptomatology of the case.

Factors related to high bifurcation level of common femoral artery.

BACKGROUND: Common femoral artery (CFA) puncture is performed for endovascular treatment. However, we sometimes experience branch punctures when the CFA bifurcation level is high. In this study, we examined the frequency of high CFA bifurcation level and related factors. METHODS: The CFA bifurcation level was identified in 100 patients, who underwent cerebral angiography or endovascular treatment by femoral artery (FA) puncture, on 191 sides. The height of the CFA bifurcation level was classified into three groups: normal, high, and very high. Age, gender, left-right difference, height, weight, body mass index, and comorbidities, including hypertension, dyslipidemia, and diabetes, were examined to determine the factors associated with high CFA bifurcation level. RESULTS: The normal, high, and very high groups were on 142, 35, and 14 sides, respectively. The high and very high groups, which were defined as high CFA bifurcation levels, accounted for 25% of all patients. Multivariate analysis revealed that the proportion of patients with high CFA bifurcation levels was higher in the elderly (p = 0.009) and those with a history of diabetes (p = 0.042). CONCLUSIONS: Approximately one-fourth of all patients undergoing cerebral angiography or endovascular treatment by FA puncture had high CFA bifurcation levels, which had a significant association with old age and history of diabetes. For urgent treatment, FA puncture might be performed at a higher level below the inguinal ligament if patients are elderly of those with a history of diabetes.

Three-year outcome of directional atherectomy and drug coated balloon for the treatment of common femoral artery steno-occlusive lesions.

BACKGROUND: Endarterectomy is considered the gold standard therapy for common femoral artery (CFA) steno-occlusive lesions, but a significant risk of perioperative mortality and complications has been reported. OBJECTIVE: Aim of this study is to evaluate the efficacy at a long-term follow-up of patients with CFA steno-occlusive lesions treated with directional atherectomy and drug coated balloon (DCB). MATERIAL AND METHODS: In this single-center registry, 78 patients (male: 80.7%; age: 71 ± 15 years; occlusions: 25%) with 80 CFA lesions were included, with 39.7% of them undergoing directional atherectomy and drug coated balloon due to critical limb ischemia and 60.3% due to lower-limb intermittent claudication. The long-term follow-up was completed by 75 patients (3 years). The 31 patients with critical ischemia (39.7%) were further subdivided into 20 (25.6%) patients with pain at rest and 11 (14.1%) with trophic changes, ulcers and/or tissue loss. We considered the primary and the secondary outcome, referring, respectively to peak systolic velocity ratio (PSVR) ≥ 2.4 on duplex or > 50% stenosis on digital subtraction angiography at 36 months and to clinically driven target lesion revascularization at 36 months. RESULTS: The primary and secondary outcome was obtained in 84% and 86.7% of patients, at 36 months of follow up. Bailout stenting was necessary in 6/80 cases (7.5%) for suboptimal result. Freedom from MALE was obtained in 98.6% of patients. CONCLUSIONS: These results confirm that directional atherectomy and drug coated balloon strategy for the treatment of CFA lesions is effective at a long-term follow-up and could be considered as a good alternative to surgery.

Editor's Choice - Eligibility of Common Femoral Artery Atherosclerotic Disease for Endovascular Treatment - the CONFESS Study.

OBJECTIVE: Advances in endovascular technologies have allowed the treatment of common femoral artery (CFA) steno-occlusive disease by minimally invasive means; however, the proportion of lesions treated with common femoral artery endarterectomy (CFAE) which would be amenable to endovascular treatment is unknown. This observational study aimed to describe the morphology and composition of CFA lesions treated with CFAE and report the proportion that would be amenable to endovascular treatment with modern technologies. METHODS: Patients presenting with symptomatic peripheral artery disease who underwent CFAE from January 2014 to December 2018 in two tertiary NHS hospitals were included. Extensive data relating to patient demographics, risk factors, clinical outcomes, as well as anatomical and morphological characteristics of the CFA atherosclerotic lesions, were collected which included detailed plaque analysis using 3D reconstruction of pre-operative computed tomography angiograms. CFA lesions were considered suitable for endovascular treatment if presented with patent iliac inflow, at least one patent outflow vessel (superficial femoral artery [SFA] or profunda femoral artery [PFA]), and stenotic rather than occluded CFA. RESULTS: A total of 829 CFAs in 737 consecutive patients who underwent CFAE were included (mean age 71 ± 10 years; 526 males, 71%); 451 (62%) presented with chronic limb threatening ischaemia. Overall, 35% of CFAs had a localised lesion (no bifurcation disease) that could possibly be treated endovascularly. In total, 376 (45%) target vessels did not feature severe calcium load, with a patent CFA, PFA, and proximal SFA and therefore would have been amenable to endovascular treatment; while 271 CFAs (33%) featured a significant calcium load which would have potentially required stenting. CONCLUSION: A significant proportion of patients with atherosclerotic CFA lesions who undergo surgery could potentially be candidates for endovascular treatment. A randomised trial comparing CFAE and new endovascular techniques in this clinical context is required.

Preoperative Risk Factors for Access Site Failure in Ultrasound-Guided Percutaneous Treatment of TASC C and D Aorto-Iliac Occlusive Disease.

BACKGROUND: At our institution, we adopted routinely ultrasound guided approach for all percutaneous procedures. The objective of this study was to describe the predictors of access site failures (ASFs) in patients undergoing percutaneous aorto iliac revascularization and to also evaluate whether other factors such as time period or different vascular devices may influence outcomes in terms of ASFs. METHODS: We reviewed all consecutive percutaneous revascularizations performed for aortoiliac occlusion or stenosis at our institution from 2011 to 2020. All procedure were performed using an ultrasound (US) guided common femoral access. The primary outcome was ASFs, defined as bleeding or groin hematomas that required transfusions; pseduoaneurysm (diagnosed by US); retroperitoneal hematoma; artery laceration or ruptured (diagnosed intraoperatively); and thrombosis. Multivariable logistic regression was used to determine predictors of ASFs. RESULTS: A total of 502 femoral arteries were accessed under DUS guidance with no failure in sheath placement. Technical success was achieved in 498 of 502 procedures (99.2%). ASFs occurred in 21 patients (7%); but year of procedure appear to be associated with an excess of ASFs as rates were different between the first and second period of the study (10.9% vs. 4.8%, P = 0.04). Results of multivariable logistic regression model indicated that independent predictors of ASFs were common femoral artery (CFA) calcification peripheral artery calcium scoring system (PACCS) grade (odds ratio [OR], 8.7; 95% confidence interval [CI], 5.5-13.7), and CFA diameter (OR, 0.46; 95% CI, 0.25-0.85). Compared to patients with successful percutaneous access, ASFs resulted in longer post-op lengths of stay (P = < 0.001). CONCLUSION: Percutaneous US guided access can be safely performed in patients undergoing endovascular procedures for aorto iliac revascularization with TASC C and D lesions. CFA calcification PACCS grade greater than 3 and smaller femoral vessel diameter are independent risk factors for ASFs.

Optimal bail-out and complication management strategies in protected high-risk percutaneous coronary intervention with the Impella.

Despite the routine use of percutaneous mechanical circulatory support (pMCS) with the Impella heart pump, vascular and bleeding complications may occur during removal with or without pre-closure. To safely close the large-bore access (LBA), post-hoc selection of the appropriate treatment of vascular complications is critical to patient recovery and survival. Femoral artery access is typically utilized for LBA, and percutaneous axillary artery access is a common alternative, especially in the instance of severe peripheral artery disease. Optimization of patient outcomes and efficiency of pMCS can be achieved with adequate arterial access using state-of-the-art techniques. Impella removal techniques with or without pre-closure will be addressed as well as the management of large-bore femoral access complications. In addition, treatment strategies to manage patient deterioration during a protected high-risk percutaneous coronary intervention will be provided.

Endovascular treatment of calcific lesions of the common femoral artery using atherectomy device associated with scoring balloon angioplasty in diabetic patients with high "major amputation" risk.

OBJECTIVES: To investigate the outcomes of patients with calcific lesions in the common femoral artery undergoing endovascular procedures with atherectomy device and scoring balloon angioplasty combined with treatment of steno-occlusive disease of the remaining arterial districts of the lower limb. METHODS: Between January 2015 and December 2018, 11 diabetic patients at high risk for "major amputation", with calcific lesions of the common femoral artery and ischemic ulcers requiring endovascular treatment were retrospectively evaluated. Technical success was defined as revascularization of the common femoral artery with a residual stenosis lower than 30%. Primary endpoints were an immediate increase of perilesional transcutaneous oxygen pressure (TCPO2) > 40 mmHg, ulcerative lesions improvement up to healing or skin flaps re-epithelialization after minor amputation, limb rescue with rejected major amputation, and resolution of rest pain if present. RESULTS: The success rate of the revascularization procedures was 100%. No patient underwent surgical conversion. One case of peri-operative bleeding at the brachial access site was observed. There were no cases of arterial dissection or undesired distal embolization. The average baseline value of perilesional TCPO2 was 21.8 ± 9.2 mmHg. The mean TCPO2 value was 57.4 ± 7.2 mmHg three days after the procedure (P < 0.05), and 51.2 ± 9.8 mmHg 15 days after (P < 0.05). Minor amputations were performed in five patients with advanced ulcerative lesions. No major amputations were performed in the follow-up period. At 14 months follow-up, one patient developed new occlusion of the CFA for extension from the external iliac artery and underwent a new endovascular procedure. We observed an overall primary patency rate of 91% and a primary assisted patency rate of 100% in our 18-month follow-up. CONCLUSIONS: Endovascular approach for severely calcified atherosclerotic lesions of the common femoral artery seems to represent a valid therapeutic option associated with promising results in terms of clinical outcome and low complication rates.