Femoropopliteal Artery Research Articles

Microcrystalline paclitaxel-coated balloon for revascularization of femoropopliteal artery disease: Three-year outcomes of the randomized BIOPAC trial.

The aim of the BIOPAC trial was to determine long-term safety and efficacy of a novel microcrystalline paclitaxel-coated balloon (mcPCB) with a biocompatible polymer as an excipient in the treatment of occlusive femoropopliteal lesions. In this first-in-human prospective controlled randomized trial, 66 patients with femoropopliteal, symptomatic (Rutherford stages 2B to 5) occlusive arterial disease were randomized to either mcPCB (study group) or POBA (plain old balloon angioplasty) (control group) on a 1:1 basis. Late lumen loss (LLL) at 6 months was the primary endpoint of the study and serious adverse events (SAE: death, amputation, repeated revascularization) were considered a composite secondary endpoint. Routine angiography was scheduled for all study subjects at 6-month follow-up; outpatient appointments were scheduled at 12 and 36 months after intervention. At 6 months, the LLL was 63% lower in the mcPCB group compared to the POBA group (0.52 ± 1.2 vs 1.39 ± 1.1 mm; psup < 0.01). Binary restenosis occurred in 23% vs 52% of patients (p = 0.02). At 3 years, the prevalence of SAE was significantly lower in the mcPCB group (33.3 vs 63.3%; p = 0.02), which mainly resulted from a twofold reduction in target vessel revascularization rate (28.6 vs 59.3%; p = 0.02). The difference in mortality was nonsignificant (7.4 vs 14.3%; p = 0.42). Patients with mcPCB were less symptomatic and less likely to adhere to secondary prevention measures. In this pivotal trial, a novel mcPCB proved superior to POBA concerning LLL at 6-month follow-up, and SAE at 12 months. This result was sustained up to 3 years. There was no difference between groups regarding mortality. ClinicalTrials.gov Identifier: NCT02145065.

Mechanical rotational thrombectomy in long femoropopliteal artery and bypass occlusions: risk factors for periprocedural peripheral embolization.

We aimed to examine lesion characteristics influencing technical outcome and periprocedural peripheral embolization (PPE) during percutaneous mechanical rotational thrombectomy (PMT) of long femoropopliteal artery and bypass occlusions. Retrospectively, 65 consecutive patients (43 male patients, mean age 70±12 years; Rutherford category I-III), undergoing PMT (Rotarex®, Straub Medical AG) with acutely/subacutely occluded femoropopliteal arteries/bypasses were included. Occlusions (mean length, 217±98 mm) were treated by PMT followed by percutaneous transluminal angioplasty (PTA) plus drug-coated balloon or PTA plus stenting/stentgrafting. Technical success was defined as residual stenosis <30%. Follow-up included duplex ultrasound and ankle-brachial index (ABI) after 12 months. Endpoints were technical success, complications, improvement of Rutherford category, ABI, and patency (re-stenosis <50%). The influence of lesion length, duration, and thrombus density (measured in preinterventional computed tomography angiography) on technical success and PPE was analyzed. Technical success was 18% (12/65) after PMT alone, 92% (60/65) after additional means. Four patients (6%) underwent bypass surgery and one patient (2%) amputation. PPE occurred in 11% (7/65). During the 12-month follow-up, three patients (5%) were lost to follow-up. ABI increased from baseline 0.5±0.12 to 0.81±0.14 (p = 0.001) and Rutherford category increased by at least one level in 57 patients at 12-month follow-up (clinical success, 88%). At 12 months, primary patency was 57.4% (95% CI, 45.8%-68.9%) and secondary patency was 75.0% (95% CI, 59.8%-72.3%). As risk factors for PPE, we identified lesion length >200 mm (15%; 6/39; OR 4.5; 95% CI, 0.5-40; p = 0.014) and thrombus density ≤45 HU (20%; 2/10; OR 3.0; 95% CI, 0.2-38.9; p = 0.05). No significant relation between risk factors and technical success was found. PMT followed by PTA or implantation of stent (grafts) appears to be effective and safe for revascularization of acute/subacute long occlusions. Thrombus density <45 HU and lesion length above 20 cm represent risk factors for PPE during PMT.

Early and midterm results of the retrograde transpopliteal approach as the first-line treatment for total occlusions of iliofemoral arteries.

This study aims to present our early and midterm results regarding the use of the retrograde popliteal artery approach as the first-line treatment for patients with total occlusions of the iliac or femoropopliteal arteries. Between July 2017 and July 2019, 84 patients underwent transpopliteal retrograde subintimal recanalization for iliac and femoral artery occlusive disease. The procedure was technically successful in 92.9% of the patients and had a complication rate of 5.95%. Complications, including stent thrombosis, dissection, and rupture, were treated successfully. No hematomas were observed at the puncture site. The primary patency rates at 6, 12, and 18 months were 86.9%, 82.1%, and 77%, respectively. With respectable early and midterm results, the retrograde popliteal artery approach can be considered a primary treatment option for iliac or femoropopliteal arteries' recanalization in selected patients.

Use of Atherectomy During Index Peripheral Vascular Interventions.

The aim of this study was to describe physician practice patterns and examine physician-level factors associated with the use of atherectomy during index revascularization for patients with femoropopliteal peripheral artery disease. There are minimal data to support the routine use of atherectomy over angioplasty and/or stenting for the endovascular treatment of peripheral artery disease. Medicare fee-for-service claims (January 1 to December 31, 2019) were used to identify all beneficiaries undergoing elective first-time femoropopliteal peripheral vascular intervention (PVI) for claudication or chronic limb-threatening ischemia. Hierarchical logistic regression was used to evaluate patient- and physician-level characteristics associated with atherectomy. A total of 58,552 patients underwent index femoropopliteal PVI by 1,627 physicians. There was a wide distribution of physician practice patterns in the use of atherectomy, ranging from 0% to 100% (median 55.1%). Independent characteristics associated with atherectomy included treatment for claudication (vs. chronic limb-threatening ischemia; odds ratio [OR]: 1.51), patient diabetes (OR: 1.09), physician male sex (OR: 2.08), less time in practice (OR: 1.41 to 2.72), nonvascular surgery specialties (OR: 2.78 to 5.71), physicians with high volumes of femoropopliteal PVI (OR: 1.67 to 3.51), and physicians working primarily at ambulatory surgery centers or office-based laboratories (OR: 2.19 to 7.97) (p≤ 0.03 for all). Overall, $266.8 million was reimbursed by Medicare for index femoropopliteal PVI in 2019. Of this, $240.6 million (90.2%) was reimbursed for atherectomy, which constituted 53.8% of cases. There is a wide distribution of physician practice patterns for the use of atherectomy during index PVI. There is a critical need for professional guidelines outlining the appropriate use of atherectomy in order to prevent overutilization of this technology, particularly in high-reimbursement settings.

Long-term safety and efficacy of angioplasty of femoropopliteal artery disease with drug-coated balloons from the AcoArt I trial

ObjectiveWe evaluated the long-term safety and efficacy of treatment using drug-coated balloons (DCBs) in Chinese patients with severe femoropopliteal artery (FPA) disease (FPAD). MethodsIn this prospective, multicenter, randomized controlled trial, 200 Chinese patients with FPAD were prospectively randomized to undergo percutaneous transluminal angioplasty with a DCB or an uncoated balloon (UCB). The clinical endpoints were all-cause mortality, clinically driven target lesion revascularization, and major amputation of the treated leg within 5 years after treatment. ResultsDuring the 5-year follow-up period, freedom from all-cause mortality was 82.7% in the DCB group compared with 73.2% in the UCB group (log-rank P = .262). Freedom from clinically driven target lesion revascularization was 77.5% in the DCB group vs 59.1% in the UCB group (log-rank P < .001). No device- or procedure-related deaths occurred in either group. Cox regression analysis revealed that coronary heart disease and provisional FPA lesion stenting were associated with an increased mortality risk and the nominal paclitaxel dose was not associated with mortality during the 5-year follow-up period. ConclusionsWe found no significant differences in 5-year mortality between patients with FPAD treated with DCBs vs UCBs. The clinical benefit of DCBs vs UCBs in terms of clinically driven target lesion revascularization persisted for the 5-year period.

Survival and Causes of Death Among Veterans With Lower Extremity Revascularization With Paclitaxel-Coated Devices: Insights From the Veterans Health Administration.

BACKGROUNDThe long‐term safety of paclitaxel‐coated devices (PCDs; drug‐coated balloon or drug‐eluting stent) for peripheral endovascular intervention is uncertain. We used data from the Veterans Health Administration to evaluate the association between PCDs, long‐term mortality, and cause of death.METHODS AND RESULTSUsing the Veterans Administration Corporate Data Warehouse in conjunction with International Classification of Diseases, Tenth Revision (ICD‐10) Procedure Coding System, Current Procedural Terminology, and Healthcare Common Procedure Coding System codes, we identified patients with peripheral artery disease treated within the Veterans Administration for femoropopliteal artery revascularization between October 1, 2015, and June 30, 2019. An adjusted Cox regression, using stabilized inverse probability–weighted estimates, was used to evaluate the association between PCDs and long‐term survival. Cause of death data were obtained using the National Death Index. In total, 10 505 patients underwent femoropopliteal peripheral endovascular intervention; 2265 (21.6%) with a PCD and 8240 (78.4%) with a non‐PCD (percutaneous angioplasty balloon and/or bare metal stent). Survival rates at 2 years (77.4% versus 79.7%) and 3 years (70.7% versus 71.8%) were similar between PCD and non‐PCD groups, respectively. The adjusted hazard for all‐cause mortality for patients treated with a PCD versus non‐PCD was 1.06 (95% CI, 0.95–1.18, P=0.3013). Among patients who died between October 1, 2015, and December 31, 2017, the cause of death according to treatment group, PCD versus non‐PCD, was similar.CONCLUSIONSAmong patients undergoing femoropopliteal peripheral endovascular intervention within the Veterans Administration Health Administration, there was no increased risk of long‐term, all‐cause mortality associated with PCD use. Cause‐specific mortality rates were similar between treatment groups.

Drug-Coated Balloon versus Bare Nitinol Stent in Femoropopliteal Artery: 12 Months Outcome from a Single Center in China

The study sought to compare the safety and effectiveness of drug-coated balloon (DCB) with bare nitinol stent in patients with complex femoropopliteal(FP) lesions in real-world practice. Patients with symptomatic (Rutherford stage 2 to 5) femoropopliteal lesions who underwent DCB or bare nitinol stent implantation at the Department of Cardiovascular Surgery of China-Japan Friendship Hospital from June 2016 to September 2017 were included. Demographics, angiographic and procedural variables were included. Freedom from target lesion revascularization (TLR), primary patency and major adverse events were obtained from follow-up results at 3,6 and12 months. Descriptive analysis was performed on all variables. A total of 90 eligible patients were enrolled, which included 51 DCB subjects (mean age, 63.1 ± 13.2 years; 76.5% male) with 55 lesions and 39 nitinol stent subjects (mean age, 66.5 ± 10.5 years; 61.5% male) with 42 lesions. Significant higher primary patency was observed in the DCB group compared with the stent group (74.5% vs. 52.4%; log-rank test P = 0.018; HR 0.335, 95%CI 0.124-0.903, P = 0.031). The rates of freedom from TLR (f-TLR) were 78.2% and 59.5% (log-rank test P = 0.032) for the DCB group and the stent group, respectively, at 12 months. CD-TLR rates were 18.2% vs. 38.1% with a P-value of 0.023. Female sex (HR 6.122, 95%CI 1.880-19.934, P = 0.003), lesion length over 20 cm (HR 5.514, 95%CI 2.312-13.148, P < 0.001) and renal insufficiency (HR 2.609, 95%CI 1.087-6.260, P = 0.032) were suggested as independent risk factors of reducing primary patency. There were no significant differences in major adverse events between the 2 groups. The result above demonstrates that DCB treatment has higher primary patency and lower TLR at 12 months than nitinol stent. These data confirm the safety and effectiveness of the DCB for patients with complex femoropopliteal lesions.

A computational study of fatigue resistance of nitinol stents subjected to walk‐induced femoropopliteal artery motion

Fatigue resistance of nitinol stents implanted in femoropopliteal arteries is a critical issue because of their harsh biomechanical environment. Limb flexions due to daily walk expose the femoropopliteal arteries and, subsequently, the implanted stents to large cyclic deformations, which may lead to fatigue failure of the smart self-expandable stents. For the first time, this paper utilised the up-to-date measurements of walk-induced motion of a human femoropopliteal artery to investigate the fatigue behaviour of nitinol stent after implantation. The study was carried out by modelling the processes of angioplasty, stent crimping, self-expansion and deformation under diastolic-systolic blood pressure, repetitive bending, torsion and axial compression as well as their combination. The highest risk of fatigue failure of the nitinol stent occurs under a combined loading condition, with the bending contributing the most, followed by compression and torsion. The pulsatile blood pressure alone hardly causes any fatigue failure of the stent. The work is significant for understanding and improving the fatigue performance of nitinol stents through innovative design and procedural optimisation.

Identification of micro-channels within chronic total occlusions using contrast-enhanced ultrasound

BackgroundVascular micro-channels within chronic total occlusions (CTO) have been identified in histopathology and animal studies. They have been proposed as a potential path for achieving endovascular crossing via the lumen. There are currently no noninvasive means of imaging these structures. The aim of this study was to investigate whether contrast-enhanced ultrasound (CEUS) examination can identify micro-channels within CTO in humans. MethodsCTO within the femoropopliteal arteries were imaged with CEUS examination in 38 patients. Segments containing micro-channels were identified and their length measured. The proportion of occlusion length containing micro-channels was assessed for each case. Micro-channel appearances including linear or tortuous configuration, crossing of occlusion caps, and connections to vasa vasorum were recorded. ResultsThe median CTO length was 17.0 cm (interquartile range [IQR], 6.9-27.9 cm) and median age of CTO was 12 months (IQR, 6-16 months). Micro-channels were identified in 92.1% of cases (35/38). The median length within a lesion containing micro-channels was 6.4 cm (IQR, 2.4-14.3 cm) and median proportion of CTO containing micro-channels was 47.9% (IQR, 1.7%-28.5%). A linear micro-channel configuration was seen in 84.2% of cases and a tortuous configuration was seen in 57.9% of cases. Micro-channel connections through the cap were seen in 50% (19/38 cases) and connections to the vasa vasorum in 71.1% (27/38 cases). No association was found between the proportion of each lesion containing micro-channels and CTO age, lesion length or calcification severity. There were no adverse effects related to contrast use. ConclusionsCEUS can be used to detect micro-channels in CTO in human femoropopliteal arteries. This imaging technique is safe and minimally invasive and may represent a practical method for selection of occlusion crossing method. Further work is required to determine whether identification of micro-channels can be used to improve treatment decision-making and provide a better understanding of the natural history of femoropopliteal CTO.

Impact of leg bending in the patient-specific computational fluid dynamics of popliteal stenting

Endovascular treatment of the femoro-popliteal artery has recently become a valuable therapeutic option for popliteal arterial aneurysms. However, its efficacy remains controversial due to the relatively high rate of complications, such as stent occlusion as result of intra-stent thrombosis. The elucidation of the interplay among vessel geometrical features, local hemodynamics, and leg bending seems crucial to understand onset and progression of popliteal intra-stent thrombosis. To this aim, patient-specific computational fluid dynamic simulations were performed in order to assess the intra-stent hemodynamics of two patients endovascularly treated for popliteal arterial aneurysm by stent-grafts and experiencing intra-stent thrombosis. Both Newtonian and non-Newtonian blood rheological models were considered. Results were presented in terms of tortuosity, luminal area exposed to low (< 0.4 Pa) and high (> 1.5 Pa) time-averaged wall shear stress (TAWSS), area exposed to high (> 0.3) oscillatory shear index (OSI), and flow helicity. Study outcomes demonstrated that leg bending induced significant hemodynamic differences (> 50% increase) in both patients for all the considered variables, except for OSI in one of the two considered patients. In both leg configurations, stent-graft overlapping induced a severe discontinuity of the lumen diameter where the proximal stented zone is characterized by low tortuosity, low velocity, low helicity, low TAWSS, and high OSI; while the distal part has higher tortuosity, velocity, helicity, TAWSS, and lower OSI. Sensitivity study on applied boundary conditions showed that the different inlet velocity profiles for a given inlet waveform affect slightly the numerical solution; conversely, the shape and magnitude of the prescribed inlet waveform is determinant. Focusing on the comparison between the Newtonian and non-Newtonian blood models, the area with low TAWSS is greater in the Newtonian model for both patients, while no significant difference occurs between the surfaces with high TAWSS.GraphicPatient-specific computational fluid dynamic simulations were performed in order to assess the intra-stent hemodynamics of two patients endovascularly treated for popliteal arterial aneurysm and experiencing intra-stent thrombosis. Both Newtonian and non-Newtonian blood rheological models were considered. In both straight and bent leg configurations, stent-graft overlapping induced a severe discontinuity of the lumen diameter where the proximal stented zone is characterized by low tortuosity, low velocity, low helicity, low time-averaged wall shear stress (TAWSS), and high oscillatory index (OSI); while the distal part has higher tortuosity, velocity, helicity, TAWSS, and lower OSI.

Targeted tibio-peroneal re-entry during subintimal revascularization using the Outback\xae catheter

BackgroundRe-entry devices are used regularly in subintimal recanalization of chronic occlusions of the iliac and femoro-popliteal arteries and significantly contribute to the high success rate of these interventions. However, the use in tibio-peroneal arteries has only been described in few cases so far. The present work is a retrospective evaluation of the Outback® re-entry device for gaining targeted true lumen access at the level of the tibio-peroneal arteries.MethodsFrom 9/2017 until 10/2020 the Outback® catheter was used in case of failed spontaneous re-entry at the level of the tibio-peroneal arteries in 14 patients either instead of the usual retrograde approach via a pedal/distal-crural access (n = 11) or in combination with it (n = 3). Baseline demographic and clinical data, morphologic characteristics of the occlusions, procedural succedss, as well as the Society of Vascular Surgery (SVS) runoff score before and after revascularization were documented.ResultsAll patients (median age: 78 years; range: 66–93) suffered from peripheral artery occlusive disease Rutherford stage 4 to 6 with a median lesion length of 12 cm (range: 7–35). Technical and procedural success was achieved in all 14 patients. The mean re-entry accuracy was 0.25 cm (range: 0–0.8). The SVS runoff score improved from a median of 14.5 (interquartile range IQR: 10.8–16.4) to 7 (IQR: 6.3–7) (p < 0.01).ConclusionsThe use of the Outback® catheter for targeted tibio-peroneal re-entry is associated with a high technical and procedural success rate and should be considered in case of otherwise failed ante- and retrograde recanalization.

Endovascular balloon angioplasty for infrainguinal arterial occlusive disease: Efficacy analysis.

Background We present early and mid-term clinical outcomes of endovascular revascularization for femoropopliteal involvement of peripheral arterial disease. Methods A total of 128 patients (113 males, 15 females; mean age: 63.4±9.9 years; range, 32 to 87 years) who underwent percutaneous transluminal angioplasty for femoropopliteal lesions between August 2016 and April 2018 were analyzed retrospectively. Treatment with Luminor® paclitaxel-coated drug-eluting balloon catheter or bailout therapy with iVolution® self-expanding nitinol stent were performed. Overall patency rates and freedom from reintervention rates were analyzed using the Kaplan-Meier analysis. The primary patency and freedom from reintervention to target lesion rates at 12 and 24 months were evaluated. Results Technical success was achieved in 133 (93%) of the interventions with a median follow-up of 11 (range, 1 to 35) months. At 12 and 24 months, the mean overall patency rates were 85.6±3.7% and 66.8±6.7%, respectively and the mean freedom from reintervention to target lesion rates were 91.6±2.9% and 78.1±6.3%, respectively. The primary patency and freedom from reintervention to target lesion rates were significantly higher in the bailout stenting group than the drug-eluting balloon group at 12 months (97.3±2.7% vs. 94.8±6.1%, respectively, p=0.025 and 97.1±2.9% vs. 84.2±5.5%, respectively, p=0.005) and at 24 months (76.9±7.9% vs. 55.8±13.4%, respectively, p=0.025 and 85.2±7.0% vs. 70.2±13.6%, respectively, p=0.005). Conclusion Endovascular procedures including drug-eluting balloon and bailout stenting seem to be effective alternative treatment modalities for treatment of infrainguinal peripheral arterial disease and can be also used in patients with long lesions and/or total occlusion of femoropopliteal arteries.

Long-term clinical outcome and mortality risks after paclitaxel-coated balloon angioplasty in patients with peripheral artery disease: An observational clinical study.

Background and aimsDrug‐eluting devices (DEDs) are usually used as a standard therapy for revascularization in femoropopliteal artery disease. Randomized controlled trails have found that DEDs with paclitaxel result in superior patency rates and decreased target lesion revascularization. A meta‐analysis by Katsanos et al indicated an increased long‐term mortality in patients treated with paclitaxel‐coated devices. The aim of this observational clinical study was to assess the long‐term clinical outcomes and mortality risk after paclitaxel‐coated balloon angioplasty in patients with symptomatic peripheral artery disease.MethodsWe retrospectively evaluated 287 patients with peripheral interventions, including 173 drug‐coated balloon (DCB) angioplasties and 114 plain old balloon angioplasties (POBA), performed at our center between 2015 and 2018.ResultsThere were no significant differences in mortality rates between patients who received DCB angioplasty and those who received POBA. In the first year, the hazard ratio (HR) for DCB angioplasty was 0.59 (95% confidence interval [CI] 0.31 to 1.12, P = .104). After 2 years, this HR was 0.64 (95% CI 0.36‐1.17, P = .145), while the 3‐year and 4‐year HR increased to 0.71 and 1.30 (3‐year: 95% CI 0.37‐1.33, P = ,283; 4‐year: 95% CI 0.55‐3.08, P = .546). No paclitaxel dose‐response relationship with mortality rate was identified when adjusted for key predictors of mortality.ConclusionsAnalyses of patient level data identified no significant mortality differences between DCB angioplasty and POBA after 4 years of follow‐up. Furthermore, there was no dose‐response relationship between paclitaxel and mortality. These findings demonstrate that paclitaxel DCB is safe. Further long‐term multicenter studies are needed to determine the risk of late mortality.

Mortality risk after use of a paclitaxel-coated stent in femoropopliteal peripheral artery disease.

Although paclitaxel-based devices which demonstrated improved outcomes in the treatment of lower-extremity peripheral artery disease (PAD) have been used worldwide, Katsanos et al. reported a systematic review and summary-level meta-analysis of RCTs in which application of paclitaxel-based devices in the femoropopliteal artery was associated with an increased mortality risk. The purpose of this study was to describe the safety of endovascular therapy (EVT) using paclitaxel-coated stents for femoropopliteal disease by evaluating the mortality risk compared with patients treated with paclitaxel-free devices. A retrospective, multicenter, non-randomized study examined 481 de-novo symptomatic PAD patients treated in 13 Japanese medical centers from January 2011 to December 2015. The risk of all-cause mortality was analyzed between the 65 patients treated with a paclitaxel-coated stent (PTX-coated group) and 416 patients treated with an uncoated balloon or bare nitinol stent (PTX-free group). Overall survival of the PTX-coated group and the PTX-free group were compared after propensity score matching. The 2-year overall survival estimates were 87.7% in the PTX-coated group vs 88.7% in the PTX-free group. There were no significant differences in the mortality risk between the groups through a full follow-up of 2years (p = 0.80). The multivariate cox proportional hazards model identified three significant predictors of mortality; age (HR, 1.08; 95% CI, 1.03-1.13; p = 0.002), hemodialysis (HR, 3.16; 95% CI, 1.34-7.42; p = 0.008), and albumin (g/dl) (HR, 0.46; 95% CI, 0.25-0.85; p = 0.01).

Sensitivity and Specificity of Ankle Brachial Index (ABI) and Pulse Wave Handheld Doppler (PWHD) Compared with Angiography as Diagnostic Test for Patients with Peripheral Artery Disease (PAD)

Background: Peripheral artery disease (PAD) is a clinical condition that occurs due to atherosclerosis and narrowing of the arteries involving the aorta, branches of the visceral arteries such as the iliac arteries, and the arteries of the distal extremities. The femoropopliteal artery is the most commonly involved site in patients with atherosclerotic PAD. Ankle Brachial Index (ABI) determination may have limited value in some patients with diabetes, because calcification of the tibial artery can render it uncompressible, resulting in a very high ABI value (&gt;1.40). Handheld vascular Doppler with pulse volume waveform interpretation (PVW) is an easily available and non-invasive modality for evaluation of the inferior extremity arteries and can detect the severity of blood flow disturbances or ongoing PAD. The best diagnostic method for PAD is angiography using digital substraction angiography (DSA) to assess existing atherosclerotic lesions. The advantages of ABI and PWHD examinations are in terms of simplicity, ease of use, and non-invasiveness instead of angiography in PAD diagnosis led the investigators to compare the sensitivity and specificity values between ABI and PWHD with angiography as a diagnostic test for PAD patients. Methods: This study used a cross-sectional diagnostic test design with the subjects were patients diagnosed with PAD, both outpatients and inpatients at Prof. DR. R.D Kandou Manado. ABI, PWHD and angiography examination were performed on all study subjects. Results: The data show that ABI has a sensitivity of 95.2% and a specificity of 80% in diagnosing PAD patients when compared to angiography as the standard of diagnosis of PAD. PWHD compared to angiography has a sensitivity of 100% and a specificity of 100%. When ABI and PWHD are combined, it has a sensitivity of 100% with a specificity of 80%. The sensitivity and specificity of PWHD compared to angiography based on angiographic location in popliteal artery has a sensitivity of 91.7% and a specificity of 92.6%. PWHD compared with angiography on posterior tibial artery (PTA) has a sensitivity of 81% and a specificity of 88.9%. ABI compared with angiography on dorsalis pedis artery has a sensitivity of 100% and a specificity of 71.4%, with p &lt;0.0001. Conclusion: The high sensitivity and specificity of ABI and PWHD can be used as a diagnostic test tool for PAD patients by general practitioners in first level health facilities.

Atherectomy plus drug-coated balloon versus drug-coated balloon only for treatment of femoropopliteal artery lesions: A systematic review and meta-analysis.

To compare the safety and efficiency of atherectomy plus drug-coated balloon with drug-coated balloon only for the treatment of femoropopliteal artery lesions. This systematic review and meta-analysis was performed and reported following the requirement of the PRISMA. EMBASE, MEDLINE, and Cochrane library were queried from January 2000 to June 2020 to identify eligible literature. The modified Downs and Black checklist was used to assess the quality of included studies. Outcome measures included bail-out stenting, distal embolization, perforation, hematoma, primary patency at 12 months, target lesion revascularization at 12 months, leg amputation at 12 months, and mortality at 12 months. We used DerSimonian and Laird random-effects model to pool the dichotomous data on risk ratio (RR) with 95% confidence intervals (CIs) from each study to obtain an overall estimate for major outcomes. Subgroup analysis and sensitivity analyses were conducted. Six studies (two randomized controlled trials and four retrospective cohort studies) with 470 patients were included. Atherectomy plus drug-coated balloon group was associated with lower rates of bail-out stenting (RR: 0.49, 95%CI: 0.34-0.71, P < 0.001). There was no significant difference between two groups in terms of distal embolization (RR: 2.06, 95%CI: 0.51-8.38, P = 0.31), perforation (RR: 2.04, 95%CI: 0.43-9.71, P = 0.37), hematoma (RR: 1.75, 95%CI: 0.43-7.09, P = 0.43), primary patency at 12 months (1.09, 95%CI: 0.98-1.21, P = 0.12), target lesion revascularization at 12 months (RR: 0.68, 95%CI: 0.41-1.14, P = 0.15), leg amputations at 12 months (RR: 0.54, 95%CI: 0.13-2.23, P = 0.39), mortality at 12 months (RR: 2.18, 95%CI: 0.71-6.64, P = 0.17). Sensitivity analysis had no effect on our findings. The combination of atherectomy and drug-coated balloon was safe and effective in the treatment of femoropopliteal artery lesions, with lower incidence of bail-out stenting compared with drug-coated balloon only.

Wound outcomes and factors associated with wound healing after first-time femoropopliteal artery intervention in patients with ischemic tissue loss

Background/objectiveThis study’s goal is to describe wound outcomes at 2 years following intervention for atherosclerotic femoropopliteal lesions in patients with ischemic tissue loss. MethodsA retrospective review of 135 first-time endovascular procedures for chronic femoropopliteal atherosclerotic lesions related to ischemic tissue loss was performed. The final wound outcomes were categorized according to the initial wound healing, recurrence and the need of major/minor amputation. ResultsAt 2-years of follow up, 76 limbs (56.3%) showed complete wound healing without recurrence, however, wound development occurred at other sites on the same foot following complete primary healing in 11 limbs (8.1%). Tolerable wounds persisted or wounds recurred at the same site in 30 limbs (22.2%), and 18 limbs (13.3%) needed major amputations. Independent factors that prevented wound healing without recurrence at 2 years were renal insufficiency (HR = 0.225, 95% C.I. = 0.091–0.556, p = 0.001), ankle pressure < 50 mmHg or flat forefoot PVR (HR = 0.328, 95% C.I. = 0.124–0.867, p = 0.025) and functional performance < 4 metabolic equivalents (MET) (HR = 0.150, 95% C.I. = 0.063–0.360, p < 0.001). ConclusionWound outcome classifications showed detailed information regarding clinical outcomes in patients with ischemic tissue loss. Renal insufficiency, ischemia grade 3 and poor functional performance were independent risk factors that prevented wound healing.

Primary Patency Rate of Superficial Femoral Artery Angioplasty in Patients with Stenosis/Occlusion of Femoropopliteal Artery

Background: The primary patency rate (PPR) is still controversial in angioplasty and heart bypass surgery for blood vessel repair and reconstruction in patients with femoropopliteal disease. Objectives: This study aimed to investigate the prolonged PPR rate in patients with stenosis/occlusion of the femoropopliteal artery undergoing superficial femoral artery (SFA) and popliteal angioplasty. Methods: A case series study population consisted of patients demonstrating femoropopliteal artery occlusion referred to Sina Hospital, Tehran, Iran for angiography during 2016-2018. After angiography, patients underwent either stent placement or balloon angioplasty in the case of stenosis/occlusion of femoropopliteal arteries. After angioplasty, patients were followed up in the 3rd, 12th, and 24th months for re-examination, and color Doppler ultrasonography of femoropopliteal arteries was also performed to measure the patency rate. The SPSS Statistics version 21.0 was used to analyze the data. The Kaplan–Meier method and a log-rank test were utilized to evaluate this rate. Results: Sixty patients were included in the study, from which 44 were women (73.3%) and 16 were men (26.6%) with a mean age of 69.9 years. Fifty-two, 41, and 29 patients were examined at intervals of 3, 12, 24 months, with PPRs of 86%, 79%, and 68%, respectively. There was a significant relationship between claudication degree and procedure success (P = 0.02). Conclusion: The prolonged PPR rate of patients after femoropopliteal artery angioplasty was acceptable and was a safe and effective treatment. For future studies, an increase in the number of study variables, a more comprehensive classification, and PPR-related variables are suggested.

Deep learning-based classification of lower extremity arterial stenosis in computed tomography angiography

PurposeThe purpose of this study is to develop and evaluate a deep learning model to assist radiologists in classifying lower extremity arteries based on the degree of arterial stenosis caused by plaque in lower extremity computed tomography angiography (CTA) of patients with peripheral artery disease. MethodsIn this retrospective study, 265 patients who underwent lower-extremity CTA between January 1, 2016 and October 31, 2019 were selected. A total of 17050 axial images of iliac, femoropopliteal and infrapopliteal artery from these patients were used for the training and validation of the parallel efficient network (p-EffNet), a kind of supervised convolutional neural network, to classify the lower-extremity artery segments according to the degree of stenosis with digital subtraction angiography as reference standard. The classification results of the p-EffNet were then compared with those obtained from radiologists. Receiver operating characteristic curve (ROC) was used to evaluate the performance of the p-EffNet and accuracy, specificity, sensitivity and area under the curve (AUC) were used as measure metrics to compare the performance of the p-EffNet and that of radiologists. ResultsThe p-EffNet exhibited a good performance of 91.5 % accuracy, 0.987 AUC and 90.2 % sensitivity and 97.7 % specificity in classifying above-knee artery and 90.9 % accuracy, 0.981 AUC, 91.3 % sensitivity and 95.2 % specificity in classifying below-knee artery. When compared with human readers, for both above-knee and below-knee artery, the p-EffNet had comparable accuracy (p = 0.266 and p = 0.808, respectively) and specificity (p = 0.118 and p = 0.971, respectively) but lower sensitivity (p < 0.001 and p = 0.022, respectively). ConclusionsThe p-EffNet demonstrates promising diagnostic performance and has the potential to reduce the workload of radiologists and help to find the plaques that might otherwise have been missed or misjudged.

Clinical outcomes of polymer-free, paclitaxel-coated stents vs stent grafts in peripheral arterial disease patients with femoropopliteal artery lesions

ObjectiveZilver PTX polymer-free, paclitaxel-coated stents and Viabahn stent grafts are effective for the treatment of femoropopliteal lesions. The aim of this study was to compare clinical outcomes between the two devices in patients with symptomatic peripheral arterial disease in real-world settings. MethodsThis multicenter, retrospective study concerned a clinical database of 445 patients with symptomatic peripheral arterial disease (Rutherford categories 1-6) who underwent either Zilver PTX or Viabahn implantation for a femoropopliteal lesion of 10 cm or longer with reference vessel diameters of 4.0 to 7.5 mm between 2012 and 2018 at five hospitals in Japan. Outcome measures were primary patency, freedom from stent thrombosis, freedom from any target lesion reintervention, limb salvage, and overall survival. After propensity score matching, these clinical outcomes were compared between patients treated with the Zilver PTX and those treated with the Viabahn. Also assessed were the interaction effects of baseline characteristics on the association of the Zilver PTX and Viabahn with restenosis and stent thrombosis. ResultsIn total, 271 patients were treated with the Zilver PTX, and 174 patients were treated with the Viabahn. Propensity score matching extracted 133 patient pairs with no major intergroup differences in baseline characteristics. The Zilver PTX group had a lower rate of 3-year primary patency (59.5%; [95% confidence interval (CI), 53.0%-66.2%] vs 69.6% [95% CI, 59.3%-79.4%]; P = .005), but a higher rate of 3-year freedom from stent thrombosis (93.6% [95% CI, 90.0%-96.3%] vs 82.4% [95% CI, 74.5%-89.0%], P = .038). There was no significant difference in overall survival, limb salvage, or freedom from reintervention (all P > .05). An interaction analysis showed that the restenosis risk of the Zilver PTX was significantly higher vs the Viabahn in patients with no or one below-the-knee runoff vessel and in those with intravascular ultrasound use than in patients with two or three below-the-knee runoff vessels and in those without intravascular ultrasound use, respectively (P for interaction = .046 and .010, respectively), whereas the stent thrombosis risk of the Zilver PTX was significantly smaller vs the Viabahn in patients not on dialysis than in those on dialysis (P for interaction = .034). ConclusionsCompared with Viabahn stent grafts, Zilver PTX stents have a lower rate of primary patency but a higher rate of freedom from stent thrombosis.