Treatment Of Superficial Femoral Artery Research Articles

Pedal medial arterial calcification influences the outcomes of isolated infra-malleolar interventions for chronic limb-threatening ischemia

ObjectiveInframalleolar disease is present in most diabetic patients presenting with tissue loss. Inframalleolar (pedal) artery disease and pedal medial arterial calcification (pMAC) are associated with major amputation in patients with chronic limb-threatening ischemia (CLTI). This study aimed to examine the impact of pMAC on the outcomes after isolated inframalleolar (pedal artery) interventions. MethodsA database of lower extremity endovascular intervention for patients with tissue loss between 2007 and 2022 was retrospectively queried. Patients with CLTI were selected, and those undergoing isolated inframalleolar intervention on the dorsalis pedis and medial and lateral tarsal arteries and who had foot x-rays were identified. X-rays were assessed blindly for pMAC and scored on a scale of 0 to 5. Patients with concomitant superficial femoral artery and tibial interventions were excluded. Intention to treat analysis by the patient was performed. Amputation-free survival (survival without major amputation) was evaluated. ResultsA total of 223 patients (51% female; 87% Hispanic; average age, 66 years; 323 vessels) underwent isolated infra-malleolar intervention for tissue loss. All patients had diabetes, 96% had hypertension, 79% had hyperlipidemia, and 63% had chronic renal insufficiency (55% of these were on hemodialysis). Most of the patients had Wound, Ischemia, and foot Infection (WIfI) stage 3 disease and had various stages of pMAC: severe (score = 5) in 48%, moderate (score = 2-4) in 31%, and mild (score = 0-1) in 21% of the patients. Technical success was 94%, with a median of one vessel treated per patient. All failures were in severe pMAC. Overall, major adverse cardiovascular events was 0.9% at 90 days after the procedure. Following the intervention, most patients underwent a planned forefoot amputation (single digit, multiple digits, ray amputation, or trans-metatarsal amputation). WIfI ischemic grade was improved by 51%. Wound healing at 3 months was 69%. Those not healing underwent below-knee amputations. The overall 5-year amputation-free survival rate was 35% ± 9%. The severity of pMAC was associated with decreased AFS. ConclusionsIncreasing severity of pMAC influences the technical and long-term outcomes of infra-malleolar intervention in diabetes. Severe pMAC is associated with amputation and should be considered as a variable in the shared decision-making of diabetic patients with CLTI.

A registry-based study of paclitaxel drug-coated balloon angioplasty for the treatment of in-stent restenosis of the femoral-popliteal artery

ObjectiveThe aim of this study was to report the results of a prospective, single-arm, registry-based study assessing the safety and performance of a paclitaxel drug-coated balloon (DCB) for the treatment of superficial femoral artery (SFA) or popliteal artery in-stent restenosis (ISR) in a United States population. MethodsWe conducted a prospective, non-randomized, multi-center, single-arm, post-market registry of the IN.PACT Admiral DCB for the treatment of ISR lesions in the SFA or popliteal artery at 43 sites within the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) Registry from December 2016 to January 2020. Clinical outcomes were assessed at 12, 24, and 36 months. The primary endpoint was target lesion revascularization at 12 months. Secondary endpoints included technical success, target vessel revascularization, major limb amputation, and all-cause mortality. Results are presented as survival probabilities based on Kaplan-Meier survival estimates. ResultsPatients (N = 300) were 58% male, with a mean age of 68 ± 10 years. Diabetes was present in 56%, 80% presented with claudication, and 20% with rest pain. Lesions included ISR of the SFA in 68%, SFA-popliteal in 26%, and popliteal arteries in 7%. The mean lesion length was 17.8 ± 11.8 cm. Lesions were categorized as occlusions in 43% (mean occluded length, 16 ± 10 cm). TASC type was A (17%), B (29%), C (38%), and D (15%). Technical success was 99%. Re-stenting was performed in 5% and thrombolysis in 0.6% of patients. Kaplan-Meier estimates for freedom from target lesion revascularization were 90%, 72%, and 62% at 12, 24, and 36 months. Freedom from target vessel revascularization was 88%, 68%, and 59% and freedom from major target limb amputation was 99.6%, 98.9%, and 98.9%, respectively, at 12, 24, and 36 months. Survival was 95%, 89%, and 85% at 12, 24, and 36 months. ConclusionsThis post-market registry-based study shows promising results in treating femoral-popliteal ISR with paclitaxel DCB in comparison to the results of plain balloon angioplasty reported in the literature. These results demonstrate the ability of the SVS VQI to conduct post-market evaluation of peripheral devices in partnership with industry and federal regulators.

The observation of below-the-knee artery by optical frequency domain image and angioscopy: a case series

Abstract Background Endovascular treatment (EVT) is a well-established treatment for patients with chronic limb-threatening ischaemia, and below-the-knee (BTK) artery is its main target, although the re-intervention rate is still high. Understanding of the characteristics of BTK artery atherosclerosis would be required to overcome this issue. In this case series, we elucidated the characteristics of non-stenotic BTK artery atherosclerosis in the patients who received EVT of the superficial femoral artery (SFA) using optical frequency domain imaging (OFDI) and angioscopy. Case summary We presented five patients who underwent EVT of SFA and subsequent observation of ipsilateral BTK artery using OFDI and angioscopy. Patients one and two had advanced atherosclerosis; however, patients three, four, and five had only mild atherosclerosis. Discussion All patients had multiple risk factors for atherosclerosis and stenosis/occlusion of the SFA and ipsilateral BTK arteries. Furthermore, some patients had several other atherosclerotic vascular diseases suggesting the presence of advanced systemic atherosclerosis. On the other hand, some patients with multiple BTK artery stenosis/occlusion did not have advanced atherosclerosis in the examined BTK artery. The absence of significant atherosclerosis in a BTK artery in patients with multiple stenoses or occlusion in other ipsilateral BTK arteries may suggest some mechanism of vessel occlusion other than atherosclerosis. Further investigations are needed to clarify the mechanism.

Determinants of Drug-Coated Balloon Failure in Patients Undergoing Femoropopliteal Arterial Intervention

BackgroundDrug-coated balloons (DCB) are frequently used to treat femoropopliteal artery disease. However, patency loss occurs in ≥10% of patients within 12 months posttreatment with poor understanding of the underlying mechanisms. ObjectivesThe authors sought to investigate the determinants of DCB failure in femoropopliteal disease. MethodsData from randomized clinical trials (IN.PACT SFA, MDT-2113 SFA Japan) and 2 prespecified imaging cohorts of the IN.PACT Global Clinical Study were included. Influential procedural characteristics were evaluated by an independent angiographic core laboratory. The primary endpoint was DCB failure (patency loss during follow-up). Additional endpoints were binary restenosis and clinically driven target lesion revascularization. Multivariable analyses evaluated the clinical, anatomical, and procedural predictors of DCB failure. ResultsIncluded were 557 participants with single lesions and 12-month core laboratory–adjudicated duplex ultrasonography. Key clinical characteristics were as follows: mean age 68.8 years, 67.5% male, 87.6% with hypertension, 76.9% with hyperlipidemia, 40.5% with diabetes mellitus, 90.5% in Rutherford Classification Category (RCC) 2 to 3, and 9.5% in RCC 4 to 5. Average length and reference vessel diameter (RVD) were 16.37 cm and 4.66 mm, respectively; 49.7% of lesions were totally occluded. In multivariable analysis, only residual stenosis >30% was associated with patency loss, whereas residual stenosis >30% and smaller preprocedure RVD were associated with increased binary restenosis risk. RCC >3 and residual stenosis >30% were associated with increased 12-month clinically driven target lesion revascularization risk. ConclusionsPatency loss after DCB treatment was influenced by procedural and clinical factors. Residual stenosis >30%, smaller preprocedure RVD, and higher RCC may be considered predictors of increased risk of DCB failure and its components in femoropopliteal artery disease. (Randomized Trial of IN.PACT Admiral® Drug Coated Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease [INPACT SFA I]; NCT01175850; IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery [SFA] and Proximal Popliteal Artery [PPA] [INPACT SFA II]; NCT01566461; MDT-2113 Drug-Eluting Balloon vs. Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery [MDT-2113 SFA]; NCT01947478; IN.PACT Global Clinical Study; NCT01609296)

Impact of Runoff Quality on Superficial Femoral Artery Endovascular Interventions: The Good, the Bad, and the Ugly

Endovascular therapy is the first choice for femoropopliteal occlusive disease treatment in most cases. Multiple factors are known to affect the outcomes of endovascular therapy, including lesion anatomy and distal runoff status. Information regarding the influence of runoff status on the outcomes of superficial femoral artery (SFA) interventions is still scarce and has not been well studied in the current literature. The aim of the present study was to investigate the effect of the runoff score on the outcomes of endovascular SFA interventions.

Antegrade Access for Peripheral Vascular Interventions of the Lower Limb: Our Experience at a Tertiary Centre

Purpose: Antegrade superficial femoral artery (SFA) access for peripheral artery disease reduces the time, radiation, and contrast required versus contralateral common femoral access (CFA). Yet, this technique remains underutilised in the treatment of SFA, popliteal, and tibial disease, and there remains limited data on the safety and efficacy of antegrade SFA access.

Periprocedural Outcomes of Popliteal vs Upper Extremity Access in the Treatment of Superficial Femoral Artery Occlusive Disease

Purpose: Percutaneous lower extremity revascularization is being performed via upper extremity, pedal, or popliteal access with increasing frequency. This study aimed to compare periprocedural outcomes of popliteal (POA) and upper extremity (UEA) access for the treatment of isolated superficial femoral artery (SFA) occlusive disease. Materials and Methods: A retrospective cohort study compared the outcomes of patients undergoing primary percutaneous intervention of SFA occlusive disease with POA or UEA using the Vascular Quality Initiative database from December 2010 to June 2019. Our primary endpoint was technical success. Secondary endpoints included factors associated with perioperative complications. Results: A total of 349 patients underwent isolated SFA intervention through the popliteal, radial, or brachial artery. UEA was performed in 188 (53.9%) patients and POA in 161 (46.1%). Technical success with TASC A lesions was 95.8% and with TASC D lesions, 65.0%. POA had a higher proportion of TASC D lesions (24.8% vs 10.6%, p<0.001), and larger (≥7 Fr) sheath size (14.3% vs 2.7%, p<0.001). UEA had a higher proportion of no calcification (27.1% vs 11.2%, p<0.001), and smaller (4–5 Fr) sheath size (46.8% vs 34.8%, p=0.023). There was no difference in technical success between UEA and POA (88.8% vs 84.5%, p=0.230), which was also seen on multivariable analysis (p=0.985). Univariate analysis revealed technical failure was associated with TASC D lesions (45.7% vs 12.9%, p<0.001) and the presence of severe calcifications (39.1% vs 17.5%, p=0.002). Multivariable analysis confirmed technical failure was associated with degree of calcification (OR, 2.4; 95% CI, 1.18 to 4.89; p=0.016) and TASC D lesions (OR, 5.01; 95% CI, 2.45 to 10.24; p<0.001). Postoperative complications were associated with UEA on univariate (p=0.041) and multivariate analysis (OR, 2.08; 95% CI, 0.80 to 5.37; p=0.016). Access site complications were also associated with UEA compared to POA (4.3% vs 0.0%, p=0.027). Conclusions: There is no difference in technical success between UEA and POA when treating isolated SFA occlusive disease, and UEA is associated with a higher complication rate. Technical success is dependent on calcification and TASC II classification. Based on similar technical success rates and low complication rates, POA should be considered as a viable alternative to UEA when planning endovascular interventions.

Significance of Distal Runoff Score as a Key Influencer on Clinical Outcomes after Endovascular Interventions for Superficial Femoral Artery Disease

Endovascular therapy (EVT) is being adopted by many surgeons as a suitable first choice in the treatment of most femoropopliteal disease when clinically indicated. However, there are multiple factors affecting the outcome of EVT including the anatomy of lesions and distal runoff status. The evidence of runoff effect on the outcome of superficial femoral artery (SFA) interventions is still scarce and not well studied in the current literature. The aim of this study was to investigate the effect of runoff score on the outcomes of SFA endovascular interventions. Retrospective analysis was carried out on prospectively collected data on patients who underwent SFA endovascular intervention for critical limb ischemia (CLI) in a single tertiary center. Patients with Rutherford categories 4, 5, and 6 who did not have any previous vascular interventions were included in the study. The modified SVS runoff score was used after calculating scores from popliteal and all tibial vessels. Runoff was stratified into good (score <5), compromised (score 5-10), and poor (score >10). Amputation-free survival, patency rates, and overall survival were compared between all groups at 5 years. Between 2011 and 2018, 254 procedures were performed in 220 patients. Technical success was >92%; 66 patients required SFA stents, and 55 had concomitant tibial angioplasty. There was no significant difference between good, compromised, or poor runoff groups regarding complication rates, with 3.5% overall perioperative mortality (5 cases in the compromised group and 4 in the poor runoff group). A runoff score of <5 was associated with significantly marked clinical improvement (P<0.001). Patency rates were significantly worse in the compromised and poor runoff groups, with 5-year cumulative primary patency rates of 80%, 50%, and 22% in the good, compromised, and poor runoff groups, respectively (P<0.001). Amputation-free survival worsened as the runoff got poorer with 98%, 91%, and 78% in the good, compromised, and poor runoff groups, respectively, at 5 years (P<0.001). SFA stenting and concomitant tibial angioplasty led to slight improvement in patency rates in the poor runoff group. Poor runoff with a score of >10 was associated with significantly reduced amputation-free survival and patency rates at 5 years in patients undergoing SFA endovascular intervention for CLI. Patients with a runoff score of <5 showed marked clinical improvement postoperatively when compared with patients with a runoff score of ≥5.

Antegrade Superficial Femoral Artery Access for Lower Extremity Arterial Disease Is Safe and Effective in the Outpatient Setting

Antegrade superficial femoral artery (SFA) access for peripheral artery disease reduces the time, radiation, and contrast required with contralateral common femoral access (CFA). Yet, this technique remains underutilized in the treatment of SFA, popliteal and tibial disease, and there remains limited data on the safety and effectiveness of antegrade SFA access in the outpatient setting. A retrospective review of lower extremity peripheral arterial interventions in our office-based endovascular suite was conducted from 2013 to 2018. Interventions necessitating CFA access such as iliac, common femoral, or deep femoral artery revascularization were excluded (n=206). In addition, interventions potentially requiring large sheaths not amenable to SFA access (e.g., popliteal aneurysm) were excluded. Relevant demographic and treatment variables including postoperative complications were abstracted. We identified 718 patients, who underwent revascularization of the SFA, popliteal and tibial arteries. Antegrade SFA access was chosen in 448 patients (62.4%) with the remaining 270 patients having retrograde CFA access. Antegrade SFA access was achieved primarily with a 4-French sheath, while a majority of retrograde CFA interventions utilized a 6-French sheath for access (87.7% vs 69.5%, P<0.001). Significantly less fluoroscopy (9.5 vs 16.4min, P<0.001) and contrast (25.4 vs 38.5mL, P<0.001) were used during SFA access compared with retrograde access. Technical success was achieved in 93.2% with antegrade SFA vs 94.8% retrograde CFA access (P = 0.42). The overall rate of complications was low for both cohorts (2.7% vs 3.7%, P = 0.78) and there were no statistical differences in access site complications (1.1% vs 1.5%, P = 0.94), hematoma (0.7% vs 1.1%, P = 0.84), and pseudoaneurysm (0.4% vs 0%, P = 0.98) between techniques. Percutaneous antegrade SFA access can be performed safely in the outpatient setting and remains an effective alternative to retrograde CFA access with significantly less utilization of fluoroscopy and contrast.

Distal Radial Artery Access for Superficial Femoral Artery Interventions

Purpose: To compare the acute success and complication rates of distal radial (DR) vs proximal radial (PR) artery access for superficial femoral artery (SFA) interventions. Materials and Methods: Between 2016 and 2019, 195 consecutive patients with symptomatic SFA stenosis were treated via DR (n=38) or PR (n=157) access using a sheathless guide. Secondary access was achieved through the pedal artery when necessary. The main outcomes were technical success, major adverse events (MAEs), and access site complications. Secondary outcomes were treatment success, fluoroscopy time, radiation dose, procedure time, and crossover rate to another puncture site. Results: Overall technical success was achieved in 188 patients (96.4%): 37 of 38 patients (97.3%) in the DR group and 151 of 157 patients (96.2%) in the PR group (p=0.9). Dual (transradial and transpedal) access was used in 14 patients (36.8%) in the DR group and 28 patients (18.9%) in the PR group (p<0.01). Chronic total occlusions were recanalized in 25 of 26 DR patients (96.1%) and in 79 of 81 PR patients (92.6%) (p=0.57). The crossover rate to femoral access was 0% in the DR group vs 3.2% in the PR group (p=0.59). Stents were implanted in the SFA in 15 DR patients (39.4%) and in 39 patients (24.8%) in the PR group (p=0.1). The contrast volume, fluoroscopy time, radiation dose, and procedure time were not statistically different between the DR and PR groups, nor were the rates of access site complications (2.6% and 7.0%, respectively). The cumulative incidences of MAE at 6 months in the DR and PR groups were 15.7% vs 14.6%, respectively (p=0.8). Conclusion: SFA interventions can be safely and effectively performed using PR or DR access with acceptable morbidity and a high technical success rate. DR access is associated with few access site complications.

Influence of Self-Expanding Paclitaxel-Eluting Stent Sizing on Neointimal Hyperplasia in Superficial Femoral Artery Lesions.

Although self-expanding drug-eluting stents (DES) have recently shown superior outcomes for superficial femoral artery (SFA) lesions, optimal sizing of DES diameter in SFA intervention is unclear.Methods and Results:A total of 40 de novo SFA lesions were randomized 1:1 to receive self-expanding DES with either a 1-mm or 2-mm larger diameter than the reference vessel diameter. Follow-up optical coherence tomography (OCT) was scheduled 6 months after DES implantation to evaluate the vascular response to the stents. Volume index (VI) was defined as volume divided by stent length. The primary endpoint was neointimal VI at 6 months. Baseline reference vessel diameter was similar between the 1-mm larger diameter group and the 2-mm larger diameter group (5.0±0.8 mm vs. 4.7±0.9 mm, P=0.35). Stent diameter was 6.3±0.6 mm in the 1-mm larger group and 7.1±0.6 mm in the 2-mm larger group (P<0.0001), and stent to reference vessel diameter ratio (SV ratio) was 1.3±0.2 and 1.5±0.2 (P<0.0001), respectively. At 6-month, neointimal VI was greater in the 2-mm larger diameter group (5.5±1.5 mm2vs. 9.6±3.4 mm2, P<0.001). The correlation analysis revealed that degree of neointimal VI was positively correlated with SV ratio (r=0.43, P<0.01). Implantation of self-expanding DES with a considerably high SV ratio resulted in neointimal hyperplasia in SFA lesions.

Drug-coated balloon angioplasty for the treatment of edge stenosis after self-expanding covered stent placement for superficial femoral artery occlusive disease.

Edge stenoses are the predominant limitation of self-expanding covered stent treatment of superficial femoral artery (SFA) occlusive disease, necessitating reinterventions. Angioplasty of an edge stenosis is associated with a high recurrence rate. Drug-coated balloon (DCB) treatment of edge stenoses might improve outcomes by decreasing the incidence of restenosis. The aim of this study was to evaluate the outcomes of using a DCB for the treatment of edge stenoses after self-expanding covered stent placement for SFA occlusive disease. We performed a retrospective analysis of patients treated with a DCB for edge stenoses after self-expanding covered stent placement. The primary endpoint was primary patency at one year. The secondary endpoints included procedure-related complications, secondary patency, and freedom from target lesion revascularization (TLR). A total of 21 patients with 28 edge stenoses were included. The time from primary treatment to treatment of the edge stenosis was 19 months (interquartile range (IQR) 8; 52 months). Primary patency and assisted primary patency at one year were 66.7% with a secondary patency of 90.9%. Freedom from TLR was 86.1%, and freedom from clinically driven TLR was 89.4%. Four patients presented with a hemodynamically significant restenosis, and three of those patients had an occlusion. Median time to failure was six months (IQR 3.5; 7.0 months), and median time to occlusion was four months (IQR 3.0; 6.0 months). The treatment of edge stenoses using a DCB is associated with a safe one-year outcome; however, this has to be confirmed in larger prospective studies. The continuous surveillance of patients is indicated.

A Quantitative Method for Prediction of True Lumen Recanalization in Chronic Total Occlusion of the Superficial Femoral Artery

This study aimed to examine a quantitative method for evaluating calcification in failure in recanalization (FR) in endovascular treatment of superficial femoral artery (SFA) chronic total occlusion, and to investigate the possibility of using a formula to predict the incidence of true lumen recanalization (TR) in such cases. Patients who met the inclusion criteria were retrospectively analyzed in our center from January 2012 to September 2017. A Calcification Lesion Analyzing and Scoring System (CLASS) was established to quantify the characteristics of calcification in SFA computed tomography slices, which were ranked as grade 1-4 and class A-E. Corresponding scores were obtained, and the Cumulative Calcification Score (CCSO) of occlusive SFA was calculated on the basis of CLASS. The factors correlating to FR and the formula for predicting TR were evaluated. A total of 215 patients were included in this study. There were 150 cases of TR and 65 cases of subintimal recanalization; 12 (5.6%) cases had FR. The maximum CLASS of occlusion was correlated with FR. Not only the formula including Trans-Atlantic Inter-Society Consensus II grade and CCSO but also the formula including occlusion length and CCSO predicted the incidence of TR well. The degree of the most severe calcification in occlusive lesions clearly affects success in recanalization. Two quantitative formulas that combine occlusion length or Trans-Atlantic Inter-Society Consensus II grade with CCSO can predict TR in endovascular treatment of SFA lesions with chronic total occlusion.

Outcomes of isolated inframalleolar interventions for chronic limb-threatening ischemia in diabetic patients

BackgroundInframalleolar disease is present in many diabetic patients presenting with tissue loss. The aim of this study was to examine the patient-centered outcomes after isolated inframalleolar interventions. MethodsA database of patients undergoing lower extremity endovascular interventions for tissue loss (critical limb-threatening ischemia, Wound, Ischemia, and foot Infection [WIfI] stage 1-3) and a de novo intervention on the index limb between 2007 and 2017 was retrospectively queried. Those patients with isolated inframalleolar interventions on the dorsalis pedis and medial and lateral tarsal arteries were identified. Patients with concomitant superficial femoral artery and tibial interventions were excluded. Intention-to-treat analysis by patient was performed. Patient-oriented outcomes of clinical efficacy (absence of recurrent symptoms, maintenance of ambulation, and absence of major amputation), amputation-free survival (AFS; survival without major amputation), and freedom from major adverse limb events (above-ankle amputation of the index limb or major reintervention [new bypass graft, jump or interposition graft revision]) were evaluated. ResultsThere were 109 patients (48% male; average age, 65 years; 153 vessels) who underwent isolated inframalleolar interventions for tissue loss. All patients had diabetes, and 53% had chronic renal insufficiency (47% of these were on hemodialysis). The majority of the patients had WIfI stage 3 disease. Technical success was 81%, with a median of one vessel treated per patient. Thirty-four percent of interventions were a direct revascularization of the intended angiosome in the foot. The 30-day major adverse cardiovascular event rate was 0%. The majority of patients underwent some form of planned forefoot surgery (single digit, multiple digits, ray or transmetatarsal amputation). Wound healing at 3 months in those not requiring amputation was 76%. Predictors for wound healing were improved pedal runoff score (<7), absence of infection, direct angiosome revascularization, and absence of end-stage renal disease. Those in whom the primary wounds or the initial amputation site failed to heal ultimately underwent below-knee amputations. The clinical efficacy was 25% ± 7% (mean ± standard error of the mean) at 5 years. The 5-year AFS rate was 33% ± 8%, and the 5-year freedom from major adverse limb events was 27% ± 9%. On Cox proportional multivariate analysis, predictors for AFS were absence of significant coronary disease, postprocedure pedal runoff score <7 (good runoff), WIfI stage <3, and absence of end-stage renal disease. ConclusionsInframalleolar intervention can be successfully performed in high-risk limbs with acceptable short-term results. However, long-term AFS remains poor because of the underlying disease process.

Complex Fracture of an Up and Over Peripheral Guiding Sheath in the Right Femoral Artery During Antegrade Left Superficial Femoral Artery Intervention Endovascular Retrieval and a Review of Options

Complex Fracture of an Up and Over Peripheral Guiding Sheath in the Right Femoral Artery During Antegrade Left Superficial Femoral Artery Intervention Endovascular Retrieval and a Review of Options

Assessment of Vascular Patency and Inflammation with Intravascular Optical Coherence Tomography in Patients with Superficial Femoral Artery Disease Treated with Zilver PTX Stents

Zilver PTX nitinol self-expanding drug-eluting stent with paclitaxel coating is effective for treatment of superficial femoral artery (SFA) disease. However, as with any stent, it induces a measure of vascular inflammatory response. The current clinical trial (NCT02734836) aimed to assess vascular patency, remodeling, and inflammatory markers with intravascular optical coherence tomography (OCT) in patients with SFA disease treated with Zilver PTX stents. Serial OCT examinations were performed in 13 patients at baseline and 12-month follow-up. Variables evaluated included neointimal area, luminal narrowing, thrombus area, stent expansion as well as measures of inflammation including, peri-strut low-intensity area (PLIA), macrophage arc, neovascularization, stent strut apposition and coverage. Percentage of malapposed struts decreased from 10.3 ± 7.9% post-intervention to 1.1 ± 2.2% at 12-month follow-up, but one patient showed late-acquired stent malapposition (LASM). The percent of uncovered struts at follow-up was 3.0 ± 4.5%. Average expansion of stent cross-sectional area from baseline to follow-up was 35 ± 19%. The average neointimal area was 7.8 ± 3.8 mm2. Maximal luminal narrowing was 61.1 ± 25.0%, and average luminal narrowing was 35.4 ± 18.2%. Average peri-strut low-intensity area (PLIA) per strut was 0.017 ± 0.018 mm2. Average number of neovessels per mm of stent was 0.138 ± 0.181. Average macrophage angle per frame at follow-up was 7 ± 11°. Average thrombus area at follow-up was 0.0093 ± 0.0184 mm2. At 12-month follow-up, OCT analysis of Zilver PTX stent shows outward remodeling and minimal neointimal growth, but evidence of inflammation including PLIA, neovessels, thrombus and macrophages. Thirteen patients with PAD had paclitaxel-coated stents implanted in their SFAs and were then imaged with OCT at baseline and 12-month follow-up. OCT proxy metrics of inflammation were quantified.

How to deal with calcium in the superficial femoral artery.

Despite the continuous evolution of endovascular therapy, severe calcification remains a major issue for the minimally invasive treatment of superficial femoral artery (SFA) disease. The presence of calcium might negatively affect both the crossing of peripheral lesions and outcomes of all available treatment modalities and is therefore associated with unfavorable acute and long-term results. This manuscript summarizes the challenges raised from severe calcified atherosclerotic lesions and presents the outcomes of the various endovascular modalities in the treatment of calcified SFA disease.

IP213. Comparison of Men and Women Presenting for Peripheral Vascular Intervention of Superficial Femoral Artery and Popliteal Artery in the National Vascular Quality Initiative Database

IP213. Comparison of Men and Women Presenting for Peripheral Vascular Intervention of Superficial Femoral Artery and Popliteal Artery in the National Vascular Quality Initiative Database

Combined Transradial and Transpedal Approach for Femoral Artery Interventions

ObjectivesThe purpose of this prospective study was to evaluate the acute success and complication rates of combined transradial and transpedal access for femoral artery intervention. BackgroundImproved equipment and techniques have resulted in transition from transfemoral to transradial access for intervention of superficial femoral artery. MethodsBetween 2014 and 2016, clinical and angiographic data from 145 consecutive patients with symptomatic superficial femoral stenosis, treated via primary radial access using the 6-F SheathLess Eaucath PV guiding catheter were evaluated in a pilot study. Secondary access was achieved through the pedal or popliteal artery. The primary endpoints were major adverse events, target lesion revascularization, and rates of major and minor access-site complications. Secondary endpoints included angiographic outcome, procedural factors, crossover rate to femoral access site, and duration of hospitalization. ResultsTechnical success was achieved in 138 patients (95.2%). Combined radial and pedal access was obtained in 22 patients (15.1%). The crossover rate to a femoral access site was 2%. Stent implantation was necessary in 23.4% of patients. Chronic total occlusion recanalization was performed in 63 patients, with a 90.4% technical success rate. The mean contrast consumption, radiation dose, and procedure time were 112.9 ml (101.8 to 123.9 ml), 21.84 Gy/cm2 (9.95 to 33.72 Gy/cm2), and 34.9 min (31.02 to 38.77 min), respectively. The cumulative rate of access-site complications was 4.8% (0% major, 4.8% minor). The cumulative incidence rates of major adverse events at 3 and 12 months follow-up was 8.3% and 19.2%. The cumulative incidence rates of death at 3- and 12-month follow-up were 2.8% and 5.6%. ConclusionsFemoral artery intervention can be safely and effectively performed using radial and pedal access with acceptable morbidity and a high technical success rate.

VESS03. Outcomes of Isolated Inframalleolar (Pedal Artery) Interventions for Limb-Threatening Critical Ischemia

Inframalleolar (pedal) artery disease has been demonstrated to be a predictor of limb salvage and wound healing in this cohort of patients. The aim of this study was to examine the patient-centered outcomes after isolated inframalleolar (pedal artery) interventions. A database of patients undergoing lower extremity endovascular interventions for tissue loss between 2007 and 2017 was retrospectively queried. Patients with tissue loss (Rutherford 5 and 6) were selected, and those undergoing isolated inframalleolar intervention on the dorsalis pedis and medial and lateral tarsal arteries were identified. Patients with concomitant superficial femoral artery and tibial interventions were excluded. Intention-to-treat analysis by patient was performed. Patient-oriented outcomes of clinical efficacy (absence of recurrent symptoms, maintenance of ambulation, and absence of major amputation), amputation-free survival (survival without major amputation), and freedom from major adverse limb events (above-ankle amputation of the index limb or major reintervention [new bypass graft, jump/interposition graft revision]) were evaluated. There were 109 patients (48% male; average age, 65 years; 153 vessels) who underwent isolated inframalleolar intervention for tissue loss. All patients had diabetes, 94% had hypertension, 63% had hyperlipidemia, and 53% had chronic renal insufficiency (47% of these were on hemodialysis). The majority of the patients had Wound, Ischemia, and foot Infection (WIfI) stage 3 disease. Technical success was 81%, with a median of one vessel treated per patient and a mean preoperative pedal runoff score of 12 that improved to a mean of 6 after intervention (<7 is considered good pedal runoff); 34% of interventions were a direct revascularization of the intended angiosome. Overall major adverse cardiovascular event rate was <1% at 90 days after the procedure. The majority of patients underwent some form of planned forefoot amputations (single digit, multiple digits, ray amputation, or transmetatarsal amputation). Wound healing at 3 months was 76%. Those who failed to heal underwent below-knee amputations. The clinical efficacy was 25% ± 7% (mean ± standard error of the mean) at 5 years. The 5-year amputation-free survival rate was 33% ± 8%, and the 5-year major adverse limb event rate was 27% ± 9%. On Cox proportional multivariate analysis, predictors for amputation-free survival were absence of significant coronary disease, a pedal runoff <7, WIfI stage 3 disease, and absence of end-stage renal disease. Predictors for wound healing were improved pedal runoff score (<7), absence of infection, direct angiosome revascularization, and absence of end-stage renal disease. Inframalleolar intervention can be successfully performed in high-risk limbs with high expectation of good short-term results. Long-term patient-centered results remain poor because of the underlying disease process.