A multicenter prospective observational study appraising the effectiveness of the Supera stent after subintimal recanalization of femoro-popliteal artery occlusion: The SUPERSUB II study.

BACKGROUND: Complex femoropopliteal artery disease represents a challenge. The Supera stent holds the promise of improving the results of endovascular therapy for complex femoropopliteal disease. AIMS: We aimed at appraising the early and long-term effectiveness of the Supera stent after successful subintimal angioplasty (SuperSUB strategy) for complex femoropopliteal lesions. METHODS: We conducted a multicenter, prospective, single-arm observational study including consecutive patients at participating centers in whom Supera was implanted after successful subintimal angioplasty for complex femoropopliteal lesions. RESULTS: A total of 92 patients were included Femoropopliteal arteries were the most common target, and lesion length was 261 ± 102 mm. Most procedures were technically demanding, with antegrade femoral access in 35 (38%) and retrograde distal access in 55 (60%). Supera stent length was 281 ± 111 mm, with 4, 5, and 6 mm devices being most commonly used: 32 (35%), 35 (38%), and 23 (25%), respectively. Technical success was achieved in 100% of subjects, as was clinical success (per subject), whereas procedural success (per subject) was obtained in 98%. At 24 months, freedom from clinically driven target lesion revascularization was 93%, whereas primary patency was 87%. When compared with a similar historical cohort, Supera stent use appeared to be associated with a reduction in resources. CONCLUSION: Use of Supera stent after successful subintimal recanalization of complex lower limb arterial lesions yields favorable procedural results, which are maintained over follow-up, and are associated also with a favorable resource use profile.

Assessment of Sirolimus- vs. paCLitaxEl-coated balloon angioPlasty In atherosclerotic femoropopliteal lesiOnS (ASCLEPIOS Study): preliminary results.

BACKGROUND: There appears to be an association between paclitaxel-coated devices and increased 5-year all-cause mortality. METHODS: We are conducting a prospective, randomized, controlled, single-center, noninferiority study. All consecutive patients with femoropopliteal arterial disease who fulfilled the inclusion/exclusion criteria are sequentially and consecutively assigned to either paclitaxel (Ranger, Boston Scientific) or sirolimus (MagicTouch, Concept Medical) coated balloon angioplasty treatment. The primary outcome are procedural success and primary vessel patency at index procedure. The secondary outcomes are 30-day and 12-month freedom from MAEs (amputation, death, TLR/TVR, MI, distal embolization that requires a separate intervention or hospitalization), procedural success (≤30% residual diameter stenosis or occlusion after the procedure), Rutherford category improvement (reduction ≤1 category) and ABI improvement (increase ≥0.10 from baseline). RESULTS: A total of six patients have been enrolled in the present study up to now. The mean age was 72.6 years old and five were male. All patients had angiographic evidence of isolated occlusion in the transition segment of the distal femoral superficial artery in the popliteal artery. The mean length was 109 mm. Three patients were treated by sirolimus-coated (group A) and three by paclitaxel coated balloon angioplasty (group B). The primary patency and procedural success was in two of three and three of three patients, for group A and B, respectively. CONCLUSIONS: Preliminary results show safety and feasibility of the Sirolimus-coated balloon angioplasty. Further investigation and increase of sample size will allow for more sustained conclusions regarding patency and procedural success of this type of balloons for the endovascular treatment of peripheral arterial disease.

Technical performance and reproducibility following rotational atherectomy of femoropopliteal artery occlusive lesions: analysis of the multicenter MORPHEAS Registry.

BACKGROUND: The purpose of this study was to define patient and anatomical factors associated with technical results specific to rotational atherectomy. Controversy exists surrounding appropriate utilization of atherectomy to treat femoral-popliteal atherosclerosis. Importantly, the existence of different atherectomy devices and lack of technical reports highlighting variables that impact outcomes obscures the ability to assess perioperative performance. METHODS: The nonindustry sponsored, Multicentric National Registry on the use of rotational atherectomy in femoral-popliteal occlusive atherosclerotic disease (MORPHEAS) database was queried. The MORPHEAS investigators included experienced providers at four centers who previously had not utilized rotational atherectomy. The primary endpoint was flow-limiting dissection and/or >50% recoil resulting in stent-placement while a secondary endpoint included peripheral thromboembolism incidence. RESULTS: One hundred thirteen patients were enrolled. Only femoropopliteal occlusions were included in the analysis and anatomic distribution and calcification severity were depicted separately. The most common adjunctive therapy was drug-coated balloon angioplasty (84%; N.=96). Flow-limiting dissection was identified in 16% (N.=18) and thromboembolism occurred in 4% (N.=4). Diabetes increased risk of thromboembolism (P=0.03) while lesion length ≥8.0 cm (P=0.07) and SFA-popliteal adductor canal location (P=0.01) were associated with flow-limiting dissection. In multivariable analysis, SFA-popliteal adductor canal occlusion had a 4.7-fold risk of perioperative complications (OR=4.7, 95%CI: 1.1-21.0; P=0.04). CONCLUSIONS: Rotational atherectomy was characterized by reproducible performance among four centers; however, diabetic patients, as well as those with long-segment, heavily calcified SFA-popliteal adductor canal occlusion present greatest risk of complications.

Comparison of Prosthetic and Vein Bypass with Nitinol Stents in Long Femoropopliteal Lesions.

BACKGROUND: Guidelines for the treatment of long femoropopliteal lesions are not based on a high level of evidence and recent randomized controlled trials (RCTs) challenge vein bypass (VBP) as the recommended therapy. This study compared prosthetic (PTFE) bypass, VBP and angioplasty with nitinol stents in long femoropopliteal lesions. METHODS: Pooled data from a RCT and a retrospective database with the same inclusion criteria were analyzed with primary and secondary patency as well as freedom from target lesion revascularization (TLR) as primary endpoints. RESULTS: Between 2016 and 2018 a total of 172 lesions were treated in three groups (PTFE: n = 62, VBP: n = 55, stent: n = 55). Clinical and lesion characteristics were similar with mean lesion lengths between 260 and 279mm. Technical success rate in the stent group was 87%. There were no significant differences between the groups in patency rates, freedom from TLR, limb salvage and survival during 2-year follow-up. The primary patency rates for the PTFE, VBP and stent groups were 50%, 56% and 60% at 2 years. The PTFE group had significantly less complications compared to the other groups and a shorter hospital-stay compared to the VBP group. Clinical improvement was significantly better in the PTFE and VBP group compared to the stent group. CONCLUSIONS: The 2-year results indicate that the role of VBP as the recommended therapy for long femoropopliteal lesions may not be unchallenged due to the similar results in all three groups. Further RCTs are needed to determine the best revascularization modality for long femoropopliteal lesions.

Hybrid Deep Venous ARterialisation (DVAR) for No-Option Chronic Limb Threatening Ischemia.

BACKGROUND: Hybrid Deep Venous ARterialisation (DVAR) is offered as a last-ditch attempt for limb salvage in patients with chronic limb threatening ischemia (CLTI). It provides non-selective arterialisation independent of the angiosome, which harnesses the complex venous capillary network bed developed in the leg and foot. METHODS: We present two elderly men who underwent DVAR to salvage limb with CLTI. DVAR was performed by creating an arteriovenous connection by anastomosis of the great saphenous vein (GSV) at the level of the distal popliteal and proximal tibio-peroneal trunk. Fasciotomy was performed over the length of the GSV. Subsequently, proximal in-situ catheter valvotomies of the GSV valves were undergone with the adjuvant on-table balloon maturation. The distal tarsal veins underwent balloon valvotomy under direct vision with subsequent proximal and distal tarsal veins valvuloplasties. Completion angiogram demonstrated restoration of the flow in the foot and both the patients were relieved of rest pain. CONCLUSION: We successfully performed DVAR in 2 elderly patients. Our experience shows that DVAR is a simple and safe option that is easily reproducible without the need for complex endovascular hardware, only if a suitable GSV to the foot is available with no history of deep vein thrombosis.

Evaluation of Long-Term Outcomes of Femoropopliteal Bypass Surgery in Patients With Chronic Limb-Threatening Ischemia in an Endovascular Era.

BACKGROUND: To investigate the long-term outcomes of femoropopliteal bypass surgery in patients with chronic limb-threatening ischemia (CLTI) and TransAtlantic Inter-Society Consensus II (TASC II), type D (TASC D) femoropopliteal disease. METHODS: A retrospective analysis was performed for all consecutive patients undergoing above-knee (AK) femoropopliteal bypass surgery at an academic vascular centre between January 2007 and March 2019. Patients with claudication (IC) and patients with CLTI were included. Patency rates and freedom from major adverse limb events (MALE) after 5 years were analysed. RESULTS: In total, 432 femoropopliteal grafts were performed. Indications for surgery were claudication and CLTI in 232 (53.7%) and 200 (46.3%) patients, respectively. Graft material was autologous vein in 186 patients (43.1%), polytetrafluoroethylene (PTFE) in 128 patients (29.6%), and heparin-bonded expanded polytetrafluoroethylene (HePTFE) in 118 patients (27.3%). At the 5-year follow-up, the primary patency rate was 58.1% and 58.3% in patients with CLTI and claudication, respectively. Secondary patency rates were 74.1% and 68.6%, respectively. Freedom from MALE was 64.5% and 61.9%, respectively. Analyses of graft material in the CLTI group showed that, at 5 years, autologous vein grafts had better long-term patency rates than PTFE and HePTFE grafts. At 5 years, the primary and secondary patency rate for autologous vein grafts were 63.2% (P= 0.324) and 83.2% (P = 0.020), respectively. Freedom from MALE was 72.0% with the use of autologous vein grafts, 47.9% using PTFE and, 52.9% using HePTFE, respectively (P= 0.021). CONCLUSIONS: Our study shows that femoropopliteal bypass surgery in patients with TASC D lesions is safe and effective in the long term. Autologous vein grafts remain the first choice for patients with CLTI, also for bypasses in AK position. However, prosthetic grafts in AK the position are an acceptable alternative for revascularisation when the saphenous vein is not available.

Nonatheromatous Popliteal Artery Disease.

OBJECTIVE: Peripheral artery disease (PAD) is often caused by atherosclerosis. However, causes other than atherosclerosis is often overlooked. Popliteal artery entrapment syndrome (PAES) and popliteal artery adventitial cystic disease (PACD) are two common nonatheromatous causes of claudication and critical limb ischemia. The purpose of this study is to present early results of treatment of PAES and PACD involving the lower limbs. METHODS: From December 2019 to February 2021, 10 patients with PAES underwent surgeries, and 1 patient with PAES received conservative treatment. 2 patients with PACD underwent surgery. Patient data including age, gender, etiology of vascular pathology, diseased vessel, surgical method, and hemodynamic status were collected retrospectively. RESULTS: The mean follow-up duration was 5.64 ± 3.72 months (range, 1-12 months). All patients had their symptoms improved or resolved. The success rate of surgery was 100%, the rate of freedom from reintervention for any reason was 100%. There were no death, bleeding, embolism, or skin ulcers during late follow-up. CONCLUSIONS: PAES and PACD require early diagnosis and intervention, and early surgery may lead to good early- and mid-term results.

Viabahn-Assisted Extra-Arterial Bypass Combined With Surgical Arterial Endarterectomy as a Salvage Technique to Treat Critical Limb Ischemia.

BACKGROUND: Revascularization of patients with critical limb ischemia (CLI) is always challenging because of long occlusive arterial lesions with severe calcification and poor general condition. Here we describe a novel hybrid technique to treat a CLI patient. METHODS: The patient was a 60-year-old male with left foot ulcer. Preoperative scan showed long calcific and occlusive lesions running from the left proximal common femoral artery to P1 of the popliteal artery (PA). Surgical endarterectomy was performed on the proximal femoral artery. Then, retrograde PA access was achieved to protect the vital collateral artery at the proximal PA. When the retrograde V18 guidewire failed to advance because of severe occlusion in the middle one-third of the SFA, we punctured the artery with the V18 guidewire, and manually introduced it into the lumen of the proximal SFA. Three Viabahn stent grafts were successively implanted, parts of which were situated outside the SFA. RESULTS: Computed tomography 1 week after surgery showed patent blood flow to the left toes. Good recovery was observed during a 1-year follow up, the toe wound healed after amputation, and no rest pain recurred. Ultrasound showed 60% stenosis in the PA stent, while the other stents were patent. The anklebrachial index of the left limb was 0.48. CONCLUSIONS: This case illustrates successful use of Viabahn-assisted extra-arterial bypass combined with surgical arterial endarterectomy to salvage the limb after CLI. This novel technique might be an alternative in carefully selected patients.

United States Investigational Device Exemption study of the Revolution Peripheral Atherectomy System.

OBJECTIVE: Atherectomy has become commonplace as an adjunct to interventional treatments for peripheral arterial disease, but the procedures have been complicated by risks including distal embolization and arterial perforation. This study aimed to examine the safety and effectiveness of a novel atherectomy system to treat femoropopliteal and below-knee peripheral arterial disease. METHODS: The Revolution Peripheral Atherectomy System (Rex Medical LP, Conshohocken, Pa) was studied in 121 patients with 148 femoropopliteal and below-knee lesions, enrolled at 17 United States institutions. Technical success was defined when the post-atherectomy angiographic stenosis was ≤50%, as assessed by an independent core laboratory. Major adverse events were adjudicated by an independent Clinical Events Committee. RESULTS: Among 148 site-identified target lesions in 121 patients, 21.4% were in the superficial femoral artery, 13.7% involved the popliteal artery, and 67.9% were in tibial arteries; 3.1% involved more than one segment. Technical success was 90.2%, with stenoses decreasing from 73% ± 19% at baseline to 42% ± 14% after atherectomy. Adjunctive treatment after atherectomy included angioplasty with uncoated balloons in 91%, drug-coated balloons in 11%, bare stent deployment in 8%, and drug-eluting stent placement in 3%. Procedural success (<30% residual stenosis) was achieved in 93.7% of target lesions. Complications during the procedure included one target vessel perforation and two distal embolizations; each of which were adjudicated by the Clinical Events Committee as unrelated to the device and were not visualized angiographically by the core laboratory. Freedom from major adverse events was 97.3% through 30 days. The Kaplan-Meier estimates of primary, assisted primary, and secondary patency were 81.6%, 87.7%, and 91.6% at 6 months, respectively. CONCLUSIONS: The use of the Revolution Peripheral Atherectomy System was associated with few procedural complications and a high rate of success at the index procedure and through 6 months.

Does aerobic fitness impact prolonged sitting-induced popliteal artery endothelial dysfunction?

PURPOSE: Acute prolonged bouts of sitting reduce popliteal artery blood flow and flow-mediated dilation (FMD). Individuals with higher aerobic fitness have enhanced popliteal FMD. Conflicting evidence regarding whether more aerobically fit individuals are protected from the negative impacts of sitting on popliteal endothelial function in male-dominated studies have been reported. We further explored the relationship between aerobic fitness and sitting-induced impairments in popliteal blood flow and FMD in a more sex-balanced cohort. METHODS: Relative peak oxygen consumption (V̇O2peak) was assessed using a cycling-based incremental test in 21 healthy adults (eight males; 23 ± 2 years; 23.9 ± 2.9 kg/m2). Popliteal blood flow and relative FMD (%) were measured via duplex ultrasonography before and after 3 h of uninterrupted sitting. Pearson correlations were performed separately between V̇O2peak versus pre-sitting and sitting-induced reductions in popliteal outcomes. RESULTS: Aerobic fitness (41.0 ± 9.7 ml/kg/min) was positively correlated with pre-sitting popliteal blood flow (65 ± 23 mL/min; R = 0.59, P = 0.005) and relative FMD (4.2 ± 1.5%; R = 0.49, P = 0.03). As expected, sitting reduced resting blood flow (19 ± 11 mL/min) and FMD (1.9 ± 0.7%) (both, P < 0.001). V̇O2peak was inversely related to sitting-induced declines in blood flow (Δ-46 ± 23 mL/min; R = - 0.71, P < 0.001) and FMD (Δ-2.4 ± 1.5%; R = - 0.51, P = 0.02). CONCLUSIONS: Although higher aerobic fitness was associated with more favorable popliteal endothelial-dependent vasodilator responses, it also corresponded with larger sitting-induced impairments in FMD. This suggests that being more aerobically fit does not protect against sitting-induced vascular endothelial dysfunction. As such, all young adults should minimize habitual prolonged sedentary bouts, regardless of their aerobic fitness level.

Towards a better understanding of the posttreatment hemodynamic behaviors in femoropopliteal arteries through personalized computational models based on OCT images.

The hemodynamic behavior following endovascular treatment of patients with peripheral arterial disease plays a significant role on the occurrence of restenosis in femoro-popliteal (FP) arteries. The atheroprone flow conditions that are generally accepted to promote restenosis can be calculated by computational fluid dynamics (CFD) analyses, and these results can be used to assess individualized treatment outcomes. However, the impact of endovascular therapy on the flow behaviors of FP arteries are still poorly understood, as the imaging modalities used in existing numerical works (X-ray angiography, computed tomography angiography) are unable to accurately represent the post-treatment arterial geometry due to their low resolutions. Therefore, this study proposes a new algorithm that combines intra-arterial lumen geometry obtained from high-resolution optical coherence tomography (OCT) images with centerlines generated from X-ray images to reconstruct the FP artery with an in-plane resolution of 10 µm. This superior accuracy allows modeling characteristic geometrical structures, such as angioplasty-induced arterial dissections, that are too small to be reconstructed with other imaging modalities. The framework is applied on the clinical data of patients treated either with only-percutaneous transluminal angioplasty (PTA) (n = 4) or PTA followed by stenting (n = 4). Based on the generated models, PTA was found to cause numerous arterial dissections, covering approximately 10% of the total surface area of the lumen, whereas no dissections were identified in the stented arteries. CFD simulations were performed to investigate the hemodynamic conditions before and after treatment. Regardless of the treatment method, the areas affected by low time-averaged wall shear stress (< 0.5 Pa) were significantly higher (p < 0.05) following endovascular therapy (pre-PTA: 0.95 ± 0.59 cm2; post-PTA: 2.10 ± 1.09cm2; post-stent: 3.10 ± 0.98 cm2). There were no statistical differences between the PTA and the stent groups. However, within the PTA group, adverse hemodynamics were mainly concentrated at regions created by arterial dissections, which may negatively impact the outcomes of a leave-nothing-behind strategy. These observations show that OCT-based numerical models have great potential to guide clinicians regarding the optimal treatment approach.

One-year outcomes of drug-coated balloon treatment for long femoropopliteal lesions: a multicentre cohort and real-world study.

BACKGROUND: Drug-coated balloons (DCBs) have shown superiority in the endovascular treatment of short femoropopliteal artery disease. Few studies have focused on outcomes in long lesions. This study aimed to evaluate the safety and effectiveness of Orchid® DCBs in long lesions over 1 year of follow-up. METHODS: This study is a multicentre cohort and real-world study. The patients had lesions longer than or equal to 150 mm of the femoropopliteal artery and were revascularized with DCBs. The primary endpoints were primary patency, freedom from clinically driven target lesion revascularization (TLR) at 12 months and major adverse events (all-cause death and major target limb amputation). The secondary endpoints were the changes in Rutherford classification and the ankle brachial index (ABI). RESULTS: One hundred fifteen lesions in 109 patients (mean age 67 ± 11 years, male proportion 71.6%) were included in this study. The mean lesion length was 252.3 ± 55.4 mm, and 78.3% of the lesions were chronic total occlusion (CTO). Primary patency by Kaplan-Meier estimation was 98.1% at 6 months and 82.1% at 12 months. The rate of freedom from TLR by Kaplan-Meier estimation was 88.4% through 12 months. There were no procedure- or device-related deaths through 12 months. The rate of all-cause death was 2.8%. Cox regression analysis suggested that renal failure and critical limb ischaemia (CLI) were statistically significant predictors of the primary patency endpoint. CONCLUSION: In our real-world study, DCBs were safe and effective when used in long femoropopliteal lesions, and the primary patency rate at 12 months by Kaplan-Meier estimation was 82.1%.

Comparison of femoropopliteal plain balloon angioplasty for chronic limb-threatening ischemia in the BASIL trial and in a UK contemporary series.

BACKGROUND: Since the turn of the millennium, there has been a worldwide trend towards an endovascular-first strategy where possible revascularization strategy for chronic limb-threatening ischemia. There is concern that this may be inappropriate and can result in net patient harm. The aim of this study, therefore, is to compare important clinical outcomes following femoropopliteal plain balloon angioplasty (FP-PBA), with selective use of bare metal stents (BMSs), in a contemporary series (CS) of patients treated in our unit between 2009 and 2014 with those observed following FP-PBA ± BMS in the United Kingdom National Institute of Health Research Health Technology Assessment-funded Bypass vs Angioplasty in Severe Ischaemia of the Leg (BASIL-1 [B1]) trial (treated 1999-2004). METHODS: Baseline and clinical outcome data (amputation-free survival [AFS], overall survival [OS], limb salvage, freedom from reintervention, and freedom from major adverse limb events) were obtained from prospectively gathered hospital data and B1 trial case record forms. RESULTS: There were 237 CS and 218 B1 patients. CS patients were older (77 vs 73 years; P = .0002). B1 patients were more likely to be current smokers, less likely to be on best medical therapy, and underwent more extensive endovascular interventions. CS had more hospital admissions (4 vs 2; P < .0001) before they reached their primary endpoint (AFS). Immediate technical success was nonsignificantly higher in the CS patients (87% vs 83%; P = .2). BMS were used in 20 CS (8%) and 2 B1 (1%) patients (P = .0002). AFS (hazard ratio, 0.64; 95% confidence interval, 0.49-0.82; P = .0005) and OS (hazard ratio, 0.58; 95% confidence interval, 0.44-0.76; P = .0001) were significantly worse in the CS cohort. There was no significant difference in limb salvage, freedom from reintervention, or freedom from major adverse limb events. CONCLUSIONS: Patients with chronic limb-threatening ischemia managed in our unit (2009-2014) by means of a FP-PBA ± BMS first (where possible) revascularization strategy experienced significantly worse AFS and OS than patients treated with FP-PBA ± BMS in the B1 trial 10 years earlier (1999-2004).

Endovascular Treatment of Long Femoropopliteal Lesions with Contiguous Bare Metal Stents.

OBJECTIVES: Recent controversies on the use of drug coated/eluting devices in the arteries of the lower extremities renewed the focus on the evaluation of more conventional techniques. The results of the stenting of short and/or intermediate femoro-popliteal lesions are well known, but little data relate to the endovascular treatment of long femoro-popliteal lesions with contiguous bare metal stents (ETLFBS). The objective of this study was to report our results of ETLFBS. MATERIAL AND METHODS: Between January 2014 and December 2017, 1233 patients had an infrainguinal angioplasty in our center. The files of patients treated for femoropopliteal lesions longer than 250 mm using extensive stenting with contiguous bare metal stents were reviewed and analyzed. The primary outcome was the 12-month primary patency, defined by the absence of restenosis (≥50%) and/or reintervention on the target lesion. Continuous data were expressed as mean and standard deviation. Survival analysis was carried out according to Kaplan-Meier. RESULTS: Overall, 64 patients aged 80 ± 11 years were included, with 49 (76.6%) presenting with critical limb ischemia. Lesions were classified as TASC D in 54.7% of the cases. The length of the lesions was 295 ± 64 mm and 3 ± 1 stents were implanted. The 30-day mortality was null but two patients (3.1%) presented nonvascular major complications. With a follow-up of 27 ± 17 months, 22 patients (34.3%) died including three of vascular causes. The healing of the trophic disorder was obtained in 77.5% of the cases. The rate of amputation was 10.9%. The 6-, 12-, and 24-month primary patency rates were 79.7%, 66.6%, and 60.9%, respectively. The 6-, 12-, and 24-month rates of freedom from target lesion revascularization were 96.3%, 73.9%, and 71.9%, respectively. The 6-, 12-, and 24-month survival rates were 90.3%, 83.6%, and 65.6%, respectively. CONCLUSIONS: The 12-month primary patency rate of ETLFBS is acceptable. This strategy constitutes an acceptable alternative in patients presenting with critical limb ischemia and a limited life expectancy.

Use of drug-eluting stents in patients with critical limb ischemia and infrapopliteal arterial disease: a real-world single-center experience.

BACKGROUND: Although no drug-eluting stent (DES) has been approved by the Food and Drug Administration to treat infrapopliteal arterial disease, several industry-sponsored trials have reported the outcomes with the use of paclitaxel or sirolimus DESs. To the best of our knowledge, only one study to date has reported on the use of everolimus DESs for infrapopliteal arterial disease. In the present study, we analyzed the clinical outcomes with everolimus DESs in our real-world, single-center experience. METHODS: A total of 107 limbs with critical limb threatening ischemia (98 patients; 118 lesions) treated with DESs (Xience; Abbott Vascular, Santa Clara, Calif) were analyzed. The postoperative early outcomes, major adverse limb events (above the ankle limb amputation or major intervention at 1 year), and major adverse events (death, amputation, target lesion thrombosis or reintervention) were analyzed. Kaplan-Meier analysis was used to estimate the primary patency rates (using duplex ultrasound), amputation-free rates, and amputation-free survival rates. RESULTS: Of the 118 lesions treated, 33% were in the anterior tibial artery, 28% were in the tibioperoneal (TP) artery, 21% were in the posterior tibial artery, 8% were in the peroneal artery, 5% were in the TP/posterior tibial artery, 4% were in the TP artery/PA, and 1% were in the TP/anterior tibial artery. The mean lesion length was 41 mm, and 59% were totally occluded (41% stenotic). The mean follow-up was 18.5 months (range, 1-70 months). The overall postoperative complication rate was 11% (2% major amputations), with 2% mortality. Late symptom improvement of one or more Rutherford category was obtained in 71%. The major adverse events rate at 30 days and 1 year was 12% and 45%, respectively. The major adverse limb events rate at 1 year was 15%. The overall primary patency rate was 42%. The primary patency rate at 1, 2, and 3 years was 57%, 45%, and 33%, respectively. The major amputation-free and overall amputation-free survival rates were 87%, 80%, and 77% and 76%, 65%, and 61% at 1, 2, and 3 years, respectively. CONCLUSIONS: The clinical outcomes after DES (Xience; Abbott Vascular) for infrapopliteal lesions were somewhat satisfactory at 1 year but inferior to the previously reported outcomes, especially at 3 years. Further data with long-term follow-up are needed.

Outcomes of bypass and endovascular interventions for advanced femoropopliteal disease in patients with premature peripheral artery disease.

OBJECTIVE: Patients with premature peripheral artery disease (PAD), defined as age ≤50 years at presentation, have had poor outcomes with open and endovascular lower extremity revascularization. It is unclear whether either strategy is associated with better outcomes because comparative studies have been limited to case series in this patient population. The aim of the present study was to compare the outcomes of patients with premature PAD who had undergone bypass or endovascular revascularization for advanced femoropopliteal disease. Our hypothesis was that open bypass would provide superior long-term outcomes compared with endovascular intervention for patients with premature advanced femoropopliteal PAD. METHODS: All the patients with premature PAD who had undergone isolated femoropopliteal lower extremity revascularization and included in the Vascular Quality Initiative infrainguinal bypass and peripheral vascular intervention files were reviewed from 2003 through 2019. Propensity score matching (1:1) was performed between patients who had undergone femoropopliteal bypass and endovascular interventions for isolated femoropopliteal Trans-Atlantic Classification System C or D lesions. The 1-year outcomes, including reintervention, patency, major amputation, and mortality, were analyzed. RESULTS: Of the 2538 included patients, 902 had undergone isolated femoropopliteal endovascular intervention and 1636 had undergone femoropopliteal bypass. The endovascular intervention group were more likely to have diabetes (68.9% vs 54.0%; P < .001), coronary artery disease (31.0% vs 23.0%; P < .001), renal failure requiring dialysis (14.2% vs 7.2%; P < .001), and claudication (45.1% vs 36.6%; P < .001) compared with the bypass group. After propensity score matching, 466 patients were in each group with no significant differences in the baseline characteristics. Perioperative morbidity was higher with femoropopliteal bypass compared with endovascular intervention (12.0% vs 7.9%; P = .038); however, the rates of major amputation and mortality were not different. At 1 year, patients who had undergone femoropopliteal bypass were less likely to require reintervention (17.0% vs 25.2%; P = .012). However, no differences were found in major amputation (7.7% vs 7.9%; P = .928) or mortality (5.2% vs 5.2%; P = 1.00). Propensity score matching was also performed between femoropopliteal bypass with the great saphenous vein and isolated femoropopliteal endovascular interventions, and the outcomes were similar. CONCLUSIONS: For patients with premature PAD and advanced femoropopliteal disease, bypass surgery decreased the reintervention rate at 1 year but was associated with increased perioperative morbidity and hospital length of stay compared with endovascular therapy. No differences were found in major amputation or mortality between the two strategies.

Predictive Factors for Restenosis Following Stent-Supported Endovascular Therapy with Intravascular Ultrasound Evaluation for Femoropopliteal Chronic Total Occlusion.

PURPOSE: To determine the predictive factors for in-stent restenosis (ISR) following stent-supported endovascular therapy (EVT) with intravascular ultrasound (US) evaluation for femoropopliteal chronic total occlusion. MATERIALS AND METHODS: This was a single-center, retrospective, observational study. The study included 276 lesions in 251 patients who underwent stent-supported EVT with intravascular ultrasound evaluation for femoropopliteal chronic total occlusion from July 2012 to June 2019. The wire passage route was assessed using intravascular US, and lesions were classified accordingly into 2 groups: intraluminal and subintimal passage. In this study, the intraluminal group was further divided into 3 subgroups by severity of calcification: none, <180°, and ≥180° circumferential. The subintimal group was further divided into 2 subgroups: subintimal passage without or with calcification. The primary outcome measure was ISR. Cox proportional hazards regression was used to determine the association of clinical characteristics with ISR rates. RESULTS: The mean follow-up period was 19 months ±16, during which time ISR was observed in 31% of lesions. After multivariate analysis, an increased degree of plaque burden (hazard ratio [HR] = 1.101) and subintimal passage with calcification (HR = 3.408) were associated with an increased risk of ISR; a larger distal external elastic membrane area (HR = 0.898) and use of a stent graft (HR = 0.130) were significantly associated with a reduced risk of ISR. CONCLUSIONS: This study revealed that factors associated with ISR after stent-supported EVT with intravascular US evaluation were distal external elastic membrane area, plaque burden, subintimal passage with calcification, and use of a stent graft.

Popliteal Artery Thrombosis in a Young Patient Secondary to Proximal Tibial Osteochondroma.

Popliteal artery occlusion is mainly seen in elderly patients with late stage atherosclerotic occlusive disease. In young, nonsmoking patients, popliteal artery occlusion can be caused by a variety of other etiologies. The diagnosis is suspected clinically and confirmed with ultrasound, computed tomography angiogram (CTA) or angiography, which can also aid in understanding the underlying cause. We present a 40-year-old very active male, who developed progressive symptoms of claudication over a 4 months interval and was found to have a thrombosed popliteal artery secondary to external compression from a tibial osteochondroma. The patient was treated with in-situ saphenous vein bypass from the above knee popliteal artery to the anterior tibial artery. The bypass was widely patent at 24 months.