Common Femoral Artery Disease Research Articles

Open and Endovascular Treatment of the Common Femoral Artery in a Tertiary Care Center

ObjectivesEndovascular treatment of peripheral arterial disease (PAD) involving the common femoral artery (CFA) remains controversial. This study compares the perioperative and long-term outcomes of open and endovascular lower extremity revascularization (LER) involving the CFA. MethodsA retrospective analysis of all patients undergoing LER for PAD in a tertiary-care center was performed. Patients were divided into the open or endovascular group based on the first LER that involved the CFA. Patient characteristics were compared, and outcomes analysis focused on the ipsilateral CFA reintervention rate. Multivariable regression was used to determine the association between the CFA revascularization strategy and CFA reintervention. Analysis was stratified based on indication. ResultsA total of 1,954 patients underwent 4,879 LER (including all reinterventions) between 2013-2020. The CFA was treated in 22.9% of patients (N=447/1954) and 15.0% of LER procedures involved the CFA (N=734/4,879). Patients treated for CLTI were more likely to undergo open CFA treatment compared to patients with claudication (60.6% vs 42.7%, p<0.001). Patients treated for CLTI with endovascular therapy were more likely to be male compared to patients treated with open surgery (66.7% vs 51.2%, p=0.025). On the other hand, patients treated for claudication with endovascular therapy were more likely to have CAD (64.9% vs 50.5%, p=0.027) and diabetes (49.3% vs 33.0%, p=0.013) compared to open surgery. There was no difference in perioperative amputation or mortality but patients undergoing CFA endarterectomy were more likely to have post-operative bleeding in the claudication group as well as wound infections and longer hospital length of stay in both indication groups. On follow up, patients receiving endovascular LERs were more likely to require an ipsilateral CFA reintervention for both claudication (35.1% vs 21.0%, p=0.019) and CLTI (33.3% vs 20.9%, p=0.043) with no difference in major amputation or survival between the groups. Among claudicants, CFA endarterectomy was significantly more likely in patients initially treated with endovascular therapy (conversion to open endarterectomy) compared to patients initially treated with open surgery (redo endarterectomy) (14.9% vs 5.0%, p=0.015). Multivariable logistic regression revealed an independent association between endovascular therapy and CFA reintervention for claudication (OR= 2.29 [1.16-4.66]) and CLTI (OR=2.38 [1.18-4.90]). Kaplan-Meier analysis showed no difference in MALE-free survival. ConclusionEndovascular treatment of the CFA is associated with higher reintervention of the CFA regardless of indication. CFA endarterectomy is associated with higher perioperative complications and longer hospital stay. Understanding the severity of CFA disease could improve patient selection for optimal therapy.

Popliteal access for iliofemoral occlusive disease in the office-based catheter laboratory

ObjectivePopliteal access as an alternative to conventional femoral access has not been reported in the office-based catheter laboratory setting (OBL) and may be perceived to have higher risks. The purpose of this study was to evaluate the safety and efficacy of popliteal access for the endovascular treatment of iliofemoral arterial occlusive disease in an OBL setting. MethodsFrom October 2018 to October 2023, a total of 1408 interventions for peripheral artery disease were performed in our OBL. A cohort of 27 popliteal access consecutive procedures for femoral and iliac artery occlusions were studied. All interventions were done using a micropuncture needle under ultrasound guidance. All patients were discharged 1 hour after completion of the procedure. Indications for popliteal access were presence of aortoiliac stent grafts, aortobifemoral or aortoiliac bypasses, difficult contralateral or antegrade femoral access, and flush superficial femoral artery occlusions. Procedures were determined to be successful upon complete resolution of the target lesions and safety was measured perioperatively and at 90 days. Patency was determined clinically, by arterial duplex examination, and by need for reintervention for ≤2 years. ResultsWe performed 27 popliteal access procedures in 25 patients (21 complete femoral artery occlusions, 6 severe stenosis). Iliac disease was present in nine. Indications for popliteal access were existing aortoiliac stent graft in 11, aortobifemiliac bypass in 4, noncrossable iliac occlusions in 3, failed antegrade femoral access in 4, flush superficial femoral artery occlusion in 3, and bilateral common femoral artery disease precluding access in 2. Trans-Atlantic Inter-Society Consensus classification preoperatively was B, 4; C, 4; and D, 19. Treatments included atherectomy/balloon angioplasty and stent in 12, balloon angioplasty and stenting in 4, atherectomy/balloon angioplasty in 5, and balloon angioplasty alone in 6. Successful opening of occlusions occurred in 25 of 27 patients (92.5%). No complications or major adverse cardiac events occurred, except one asymptomatic small popliteal arteriovenous fistula. Of the 25 successful procedures, the duplex patency at 3, 6, and 12 months was 19/20 (95%), 11/15 (69.3%), and 11/13 (61%). Rutherford Classification improved from a preoperative value of >4 in 24 of 27 (89%) to a postoperative value of <2 at 1 month in 23 of 23 (100%), at 3 months in 19 of 20 (95%), at 6 months in 11 of 15 (69.3%), and at 12 months in 11 of 13 (61%). Freedom from reintervention at 3 months occurred in 19 of 20 (95%), at 6 months in 13 of 15 (86%), and at 12 months in 12 of 13 (79%). ConclusionsPopliteal artery access for complex iliofemoral disease is safe and effective and should be considered as a valid alternative option in the OBL setting.

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

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. 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. 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. 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. 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.

Treatment of common femoral artery steno-occlusive disease: a comprehensive review of anatomical and hemodynamic considerations.

Open surgical repair, often in the form of endarterectomy, is still the gold standard for steno-occlusive disease in the common femoral artery, despite the success of lower-risk endovascular alternatives in other peripheral arterial regions. Stenting in the common femoral artery is not widely adopted due to the proximity of the artery to the mobile hip joint, and the perceived risk this has on the stent structure due to kinking. The purpose of this review was to assess how hip movement contributes to the anatomical and biomechanical challenges proposed in the common femoral artery, and how these challenges impact the hemodynamics with both open surgical and endovascular stent treatments. The findings demonstrated that the common femoral artery is a fixed arterial segment which does not bend or twist as previously perceived. However, high degrees of bending and twisting are evident in the vessels directly proximal and distal to the common femoral artery. Mechanical testing suggests that the latest generation braided Nitinol stents could be well-suited to these challenges. Both endarterectomy and stenting provide good hemodynamic results regarding limb perfusion. However, other hemodynamic parameters, such as wall shear stress, may not be optimized with either modality, increasing the risk of chronic restenosis. As a high proportion of common femoral artery disease extends into the adjacent arterial segments, further research is warranted to ascertain the optimum hemodynamic stent configuration, as a lower-risk alternative to open surgery.

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

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. 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. 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. 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. 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.

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

ObjectiveAdverse 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. MethodsBetween 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. ResultsUnilateral 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. ConclusionsECs 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.

Anatomic patterns in claudicants who fail supervised exercise therapy

ObjectivePatients with intermittent claudication (IC) from peripheral arterial disease (PAD) have significant improvement with supervised exercise therapy (SET). However, many patients have progressive disease that will ultimately require revascularization. We sought to determine whether the anatomic patterns of PAD were associated with response to SET. MethodsWe prospectively enrolled patients with IC at the West Haven, Connecticut Veterans Health Administration between June 2019 and June 2022. Patients were classified based on the level of their arterial disease with >50% obstruction. SET failure was defined as progressive symptoms or development of critical limb-threatening ischemia (CLTI) requiring revascularization. ResultsThirty-eight patients with PAD were included. Thirteen patients (34.2%) had significant common femoral artery (CFA) disease, and 25 (65.8%) had non-CFA disease. Over a median follow-up of 1407 days, 11 patients (84.6%) with CFA disease failed SET as compared with three patients (12.0%) with non-CFA disease (P < .001). Patients with CFA disease were more likely to develop CLTI (46.2% vs 4.0%; P = .001) and have persistent symptoms (38.5% vs 8.0%; P = .02). Patients with CFA disease had significantly lower post-SET ankle-brachial index (0.58 ± 0.14 vs 0.77 ± 0.19; P = .03). In multivariate analysis, the only variable associated with SET failure was CFA disease location (odds ratio, 68.75; 95% confidence interval, 5.05-936.44; P = .001). ConclusionsPatients with IC from high-grade CFA atherosclerosis are overwhelmingly likely to fail SET, potentially identifying a subset of patients who benefit from upfront revascularization.

Early Outcomes of Interwoven Nitinol Wire Stent Placement versus Endarterectomy for the Treatment of Atherosclerotic Disease of the Common Femoral Artery

PurposeTo compare the clinical outcomes of common femoral artery (CFA) atherosclerotic disease treated with either surgical endarterectomy or an interwoven nitinol wire stent system. Materials and MethodsA retrospective review was conducted of all patients with chronic, de novo atherosclerotic CFA disease treated with surgical endarterectomy (CFAE) or stent placement between July 2019 and March 2022. Outcome measures assessed up to 12 months after procedure included clinical improvement, primary restenosis, target vessel revascularization (TVR), major adverse limb events (MALEs), and all-cause mortality. ResultsThirty-nine stents were deployed in 33 patients, and 56 CFAEs were performed in 55 patients. No differences were noted in the rate of primary patency (95.5% vs 94.4%, P = .618), TVR (2.9% vs 1.8%, P = .777), MALE (5.1% vs 5.4%, P = .949), and all-cause mortality (14.1% vs 3.6%, P = .076) between the stent and CFAE groups up to 12 months after procedure. There was greater improvement in median clinical severity in the stent group than in the CFAE group (Rutherford score change of 3.0 vs 1.5, P = .013). The median length of stay was less for the stent group (3 vs 7 days, P = .002), and there was a lower likelihood of severe or disabling adverse events in the stent group (0 vs 9 cases, P = .010). ConclusionsPatients treated with an interwoven nitinol wire stent had patency rates comparable to those treated with CFAE while having a lower incidence of severe adverse events and a shorter length of hospital stay than those who underwent CFAE.

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

To compare the outcomes of thromboendarterectomy (TEA) and endovascular therapy (EVT) with stenting for patients with atherosclerotic common femoral artery (CFA) occlusive disease. 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. 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. 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. 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.

Surgical, Endovascular, and Multimodal Approaches to the Management of Atherosclerotic Common Femoral Artery Disease.

Common femoral artery disease is at the heart of nearly all treatment algorithms and decisions for patients with symptomatic peripheral arterial disease. Surgical endarterectomy has been the mainstay of common femoral treatment with a wealth of data supporting its safety, efficacy, and durability. Advances in endovascular technology and techniques for the management of iliac and superficial femoral artery disease has resulted in a paradigm shift in management. The common femoral artery has been aptly named a "no stent zone" due to anatomic and disease-specific challenges that have limited the role for endovascular techniques. New technology and techniques in the endovascular management of common femoral disease seek to change our treatment strategies. A multimodal approach utilizing a combination of angioplasty, atherectomy, and stenting has been shown most beneficial, although limited long-term data leave durability an unanswered question. While surgical treatment remains the gold standard, advances in the endovascular approach will certainly continue to improve outcomes. As truly isolated common femoral disease is a rarity, a collaborative approach combining all benefits of open and endovascular techniques in the treatment of peripheral arterial disease is essential.

Feasibility of patchless proximal profundoplasty and common femoral endarterectomy.

Typical repair of common femoral artery (CFA) occlusive disease involves surgical endarterectomy followed by patch closure; however, prosthetic materials may become infected. In addition, in our institution, we have experienced an increased incidence of severe patch-related restenosis. We describe a technique for CFA endarterectomy and patchless proximal profundoplasty, and evaluate its feasibility. We performed a single-centre retrospective cohort study of patients who, between July 1, 2020, and June 30, 2021, underwent a procedure that consisted of transection of the superficial femoral artery (SFA) off the femoral bifurcation in a bevelled manner, eversion endarterectomy of the SFA, remote-type endarterectomy of the CFA, direct visualization of the end point in the profunda femoris artery (PFA) with a longitudinal arteriotomy extension if needed and reimplantation of the SFA "hood" as a patch. We collected clinical information and outcomes from the patients' charts. Ten patients who underwent a patchless profundoplasty procedure during the study period were identified. Indications for repair included tissue loss (3 patients), rest pain (2 patients), claudication (3 patients) and establishing access for other procedures (2 patients). Profunda femoris artery arteriotomy extensions were used in 5 cases. Six cases included simultaneous iliac or infrainguinal revascularization. All cases were technically successful. There was 1 intraoperative complication of remote tibial balloon angioplasty tear. The mean follow-up time was 199 (range 29-381) days. There were no surgical site infections. All patients were asymptomatic, with patent CFAs, at last follow-up. There was 1 case of surgical site restenosis and 1 reintervention for remote stenosis. The average increase in ankle and toe brachial indices was 44% and 75%, respectively. One patient was readmitted for gastrointestinal bleeding. One patient died from an acute myocardial infarction, on postoperative day 34. The patchless profundoplasty technique is feasible and results in autologous anatomic repair of CFA disease without the need for vein, and allows direct visualization and tacking sutures of the proximal PFA. This technique may replace the ubiquitous vascular procedure of patch arterioplasty of the CFA, depending on the anatomic configuration.

Strategies for treatment approach of steno-occlusive common femoral artery disease. The rol of scientific evidence

Strategies for treatment approach of steno-occlusive common femoral artery disease. The rol of scientific evidence

Perception and acceptability of open versus endovascular treatment of common femoral artery disease: barriers and facilitators for randomised controlled trials

Introduction: The common femoral artery (CFA) is often affected by atherosclerosis in patients with peripheral arterial disease, requiring revascularisation. Open surgical CFA endarterectomy (CFAE) remains the standard of care in this context; however, there have been multiple recent advances in endovascular CFA therapies. However, randomised controlled trials (RCTs) comparing CFA treatments have suffered from multiple pitfalls. This research aimed to assess opinions regarding potential barriers and enablers of delivering a high-quality RCT of open surgical CFAE versus endovascular CFA therapy. Methods: A mixed-methods qualitative study was performed, including a structured online survey and face-to-face semi-structured interviews with healthcare professionals. Survey content and interview topic guides were developed following a literature review to identify ongoing and completed RCTs comparing CFA treatments. The data were analysed using thematic analysis. Results: The online survey was completed by 121 participants, including vascular surgeons (n=75, 62%) and interventional radiologists (n=22, 18%), mostly from the UK (n=92, 76%). A total of 61 participants (51%) would be willing to take part in an RCT comparing open versus endovascular CFA revascularisation. The majority (n=89, 74%) believed that such an RCT is urgently needed. Fifteen participants were interviewed face-to-face. Five main themes emerged regarding barriers and facilitators for a high-quality RCT in this context: factors directly limiting patient recruitment; clinicians’ attitudes towards equipoise between treatments; clinicians’ attitudes towards endovascular therapies; attitudes towards outcomes examined in a potential RCT; and factors facilitating patient recruitment. From these, 10 sub-themes were identified. Conclusion: The majority of survey respondents believed an RCT comparing open and endovascular CFA revascularisation is necessary and would participate in such a trial. Important barriers and enablers, grouped in five overarching themes, have been identified, which would require serious consideration when designing and delivering such an RCT.

P05] Perception and Acceptability of Open vs. Endovascular Treatment of Common Femoral Artery Disease: Barriers and Facilitators for Randomised Controlled Trials

P05] Perception and Acceptability of Open vs. Endovascular Treatment of Common Femoral Artery Disease: Barriers and Facilitators for Randomised Controlled Trials

VASCADE closure device use in severe common femoral artery disease.

VASCADE closure device use in severe common femoral artery disease.

Pure Endovascular versus Hybrid Approach for Management of Iliofemoral Arterial Disease: A Randomized Controlled Trial.

Common femoral artery (CFA) atherosclerotic lesions currently remain one of the last limitations for adoption of endovascular repair as the first-line treatment, easy surgical accessibility, and, last but not least, favorable long-term outcomes, still making CFA disease treatment part of the surgical domain. In the last 5 years, improvement of the endovascular equipment and technical skills of the operators have led to an increase in percutaneous CFA procedures. A single-center randomized prospective study of 36 symptomatic (Rutherford 2-4) CFA stenotic or occlusive lesions were included, and patients were randomized over two groups based on the management approach SUPERA versus hybrid technique. Patients had a mean age 60.8 ± 8.2 years. Thirty-two (88.9%) patients reported improvement of the clinical symptoms, 28 (87.5%) patients had intact pulse postoperatively, and 28 (87.5%) had patent vessels. Follow-up showed that none developed reocclusion or restenosis during the period of follow-up. Comparison of difference in peak systolic velocity ratio (PSVR) among study groups showed that the hybrid technique had more reduction of PSVR postintervention compared to the SUPERA group with a p -value of < 0.0001. Safety and feasibility of endovascular approach with the SUPERA stent to the CFA (no stent zone) has low incidence of postoperative morbidity and mortality in well experienced surgical hands.

Real-world VASCADE closure device versus manual compression use and outcomes in patients with severe common femoral artery disease.

The VASCADE closure device deploys an extravascular collagen plug. Its use in those with access site disease undergoing peripheral vascular intervention (PVI) is unknown. We aimed to evaluate the efficacy and safety of the VASCADE closure device compared to manual compression (MC) in patients with moderate femoral access site disease. We performed a single-center, retrospective review of patients undergoing PVI with at least moderate access site disease. Our institutional database was linked to the Vascular Quality Initiative database, and 200 patients were selected from a 1:1 propensity-matched cohort. Data on procedural metrics and outcomes up to 30-days were abstracted. There were 103 procedures that used VASCADE and 97 used MC. Baseline variables were similar between groups. The mean age was 68.2 ± 11.2 years and 37.6% were women. Closing mean activated clotting time (ACT) was shorter in VASCADE (198 s VASCADE vs. 213 s MC; p = 0.018). There was a nonsignificant decrease in external compression device use with VASCADE (VASCADE 19.0% vs. MC 28.1%; p = 0.15). At 30-days, there was a nonsignificant reduction in hematoma with VASCADE (3.8% vs. 7.8% MC; p = 0.25) and no difference in retroperitoneal bleeding (0.5%). Pseudoaneurysm rate was similar (1.3% VASCADE vs. 1.7% MC; p = 0.79). The 30-day mortality rate was similar between the two groups and not related to the procedure (1.3% VASCADE vs. 0.9% MC; p = 0.79). In patients undergoing PVI with at least moderate access site disease, safety and efficacy after using VASCADE was comparable withMC.

Intravascular Lithotripsy vs Atherectomy in the Treatment of Calcified Common Femoral Artery Disease.

Common femoral artery (CFA) disease is often heavily calcified and prone to low patency rates with endovascular treatment compared with surgical endarterectomy. Recent data suggest promising short-term outcomes with the adjunct use of intravascular lithotripsy; however, data on its midterm effectiveness are lacking. We compared clinically driven target lesion revascularization (CD-TLR) between patients receiving drug-coated balloon angioplasty with adjunct intravascular lithotripsy (IVL-DCB) vs adjunct atherectomy (Ath-DCB) for treatment of CFA disease. In a single-center retrospective cohort study, patients receiving IVL-DCB vs Ath-DCB for symptomatic CFA disease from January 2015 to March 2020 were included. The primary outcome was cumulative CD-TLR with angiographic restenosis ≥50%, estimated by Kaplan-Meier analysis during 18-month follow-up and compared by log-rank test. Total of 68 CFA lesions (Ath-DCB, 35; IVL-DCB, 33) were included. Patients had a mean age (standard deviation) of 72 (8) years and were predominantly male (63.3%) and White (92%). Mean baseline angiographic stenosis was 78% (11) in the Ath-DCB group and 70% (10) in the IVL-DCB group (P = .002). Technical success was 100% in both groups. One flow-limiting dissection occurred in IVL-DCB requiring stent placement, whereas 2 bailout stentings were performed in the Ath-DCB group. Cumulative Kaplan-Meier freedom from CD-TLR was 91.2% (95% CI, 81.6%-100%) in the Ath-DCB group vs 79.4% (95% CI, 64.6%-94.2%) in the IVL-DCB group (Log-rank P = .167). The safety and effectiveness of IVL-DCB were comparable to those of Ath-DCB in the treatment of calcified CFA disease during the 18-month follow-up. Further studies are required to verify these findings.

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

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. 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). 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. 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.

Endovascular Intravascular Lithotripsy in the Treatment of Calcific Common Femoral Artery Disease: A Case Series With an 18-Month Follow-Up

BackgroundIntravascular lithotripsy (IVL) is a novel endovascular treatment for calcified common femoral artery disease (CFA). Data on midterm effectiveness for clinically driven target lesions revascularization (CD-TLR) is lacking. This study investigated CD-TLR during 18-month follow-up in patients requiring IVL for CFA disease treatment. MethodsIn a single-center retrospective cohort study, electronic medical record of patients undergoing IVL for CFA disease from January 2018 to March 2020 were reviewed. Primary outcome was CD-TLR estimated by Kaplan-Meier method during 18-month follow-up. Univariate logistic regression was used to compare differences in CD-TLR by the type of adjunct therapy used. ResultsAmong 54 CFA lesions in 50 patients, mean age (SD) was 75(8) years, gender and race were predominantly male (74%, n = 37) and white (94%, n = 47), respectively. Rutherford class III claudication was most common (70%, n = 35) with mean ABI of 0.66 (0.26) and mean angiographic stenosis of 77% (13%). Adjunct use of drug-coated balloon (DCB) angioplasty was 83% (n = 45) and atherectomy was 39% (n = 21). Residual angiographic stenosis was <30% in all cases. Complications included dissection requiring stent placement (2%, n = 1). After 18-months, 18% (n = 9) died unrelated to procedural complications and 6% (n = 3) were lost to follow-up. 18-month cumulative freedom from CD-TLR was 80.6% (95% CI: 69.1%, 92%). Univariate logistic regression did not reveal a statistically significant difference in CD-TLR with type of adjunct therapy used (p > 0.05). ConclusionIVL with adjunct use of DCB and/or atherectomy is safe and effective in treatment of calcified CFA disease. Randomized studies are required to confirm these findings.