12-month Primary Patency Rates Research Articles

Efficacy and Safety of Atherectomy Combined With Balloon Angioplasty vs Balloon Angioplasty Alone in Patients With Femoro-Popliteal Lesions: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Balloon angioplasty (BA), including drug-coated balloons (DCBs) and percutaneous transluminal angioplasty (PTA), has traditionally been used to treat femoral-popliteal lesions. However, in recent years, atherectomy (ATH) has been proposed as a complementary approach. To assess the effectiveness of ATH compared with BA alone in patients with femoral-popliteal artery lesions, we conducted a systematic review and meta-analysis of randomized controlled trials (RCTs). We included RCTs that focused on patients with femoral-popliteal artery lesions and reported data on the use of ATH and BA therapy. Two reviewers conducted a literature search, refined the data, and assessed the risk of bias. We included a total of 6 RCTs involving 399 patients with femoral-popliteal artery lesions. The use of ATH in combination with BA appeared to improve the patency rate at 12 months (odds ratio [OR]=2.04, 95% confidence interval [CI]=1.14-3.62). In addition, ATH with BA was associated with lower major amputation rates (MD=2.01, 95% CI=0.06-0.77, p=0.02) and a decreased likelihood of bailout stenting (OR=0.07, 95% CI=0.02-0.25, p=0.001). However, there were no statistically significant differences between the groups in terms of target lesion revascularization (TLR) at 12 months, major adverse cardiovascular events (MACEs), and distal embolization events. In addition, we performed subgroup analysis for different ATH devices and BA types. Based on this meta-analysis, it can be concluded that the use of ATH in combination with BA is a safe and effective method for treating femoral-popliteal artery lesions. In addition, the patency rate at 1 year is superior to treatment with BA alone. Atherectomy also reduces the likelihood of amputation and bailout stenting. Clinicians should consider these findings when designing future RCTs and developing clinical practice guidelines. This meta-analysis summarises a number of existing studies to advance understanding of the atherectomy devices and to reveal its potential. This new technique, when compared with drug coated balloon, shows the possibility of obtaining better clinical outcomes in femoro-popliteal lesions than drug-coated balloon alone, such as higher 12-month primary patency rates as shown in some studies. Currently, it is important to consider the appropriate technology applicable for individualised treatment. atherectomy devices seem to provide clinicians with additional options in clinical practice and to benefit patients in the future. This requires more high quality studies to explore the role and benefits of atherectomy devices in femoro-popliteal lesions.

Ultrasound-Assessed Lesion Morphology and Drug-Coated Balloon Treatment for de novo Dysfunctional Arteriovenous Fistula in Hemodialysis Patients.

This study aimed to evaluate the effect of ultrasound-assessed lesion morphology on the outcomes of drug-coated balloon (DCB) versus plain old balloon angioplasty (POBA) treatment for de novo dysfunctional arteriovenous fistulas (AVF) lesions. This single-center retrospective study enrolled 114 consecutive patients (mean age, 73 ± 10 years; male, 69%) with de novo dysfunctional AVF lesions who underwent percutaneous transluminal angioplasty (PTA) using DCB (n = 48) and POBA (n = 66). The morphology of the stenotic lesions, evaluated using ultrasonography, was classified into intimal hyperplasia and shrinking types. The outcome measure was 12-month primary patency. Factors associated with loss of primary patency were evaluated using Cox proportional hazards models. The baseline characteristics were not significantly different between the 2 treatment groups. The 12-month primary patency rate was significantly higher in the DCB group than in the POBA group (66.8 ± 7.1% versus 35.9 ± 6.3%, P = .006). The 12-month primary patency rate in the lesions with intimal hyperplasia type was not significantly different (DCB: 70.3 ± 9.5% versus POBA: 45.9 ± 8.0%; P = .310), whereas that in the shrinking type was significantly higher in the DCB group than in the POBA group (61.9 ± 10.6% versus 15.2 ± 8.1%; P < .001). The interaction analysis demonstrated that lesion morphology had a significantly different hazard ratio (HR) for restenosis between the POBA and DCB groups (P for interaction = .031). The multivariate analysis revealed that DCB usage (adjusted hazard ratio [aHR], 0.49; 95% confidence interval [CI]: [0.28, 0.87]; P = .015), ultrasound-assessed lesion morphology (shrinking type: aHR, 1.77; 95% CI: [1.07, 2.93]; P = .026), and location of stenosis (aHR, 2.26; 95% CI: 1.15, 4.46; P = .018) were significantly associated with AVF patency after PTA. This study revealed that lesion morphology evaluated using ultrasonography had a differential impact on DCB and POBA outcomes. The therapeutic effect of DCB was unexpectedly confirmed in the shrinking type. The effectiveness of DCB in inhibiting smooth muscle cell proliferation in intimal hyperplasia lesions was expected based on the known mechanism of action of paclitaxel. However the therapeutic effect of DCB was unexpectedly confirmed in the shrinking type too. We may not need to hesitate usage of DCB for shrinking type.

Safety and Efficacy of Excimer Laser Atherectomy Combined with a Drug-Coated Balloon in de Novo Femoral Popliteal Artery Disease: A Retrospective Study

ObjectivesThe effectiveness of excimer laser atherectomy (ELA) combined with drug-coated balloon (DCB) for de novo femoropopliteal artery disease (FPAD) is currently unknown. This case series evaluated the clinical outcomes of ELA combined with DCB in de novo FPAD from a real-world clinical perspective. MethodsWe conducted a retrospective study of patients treated with ELA + DCB for de novo FPAD between November 2016 and January 2020. The primary efficacy endpoint was the initial patency rate, secondary endpoints included target lesion revascularization without clinically driven target-lesion revascularization (CD-TLR) and technical success. Primary safety endpoints included all-cause death, unplanned major amputation, and postoperative complications. ResultsThe mean follow-up was 37.8 ± 25.3 months and included 56 consecutive patients (68.23±8.01 years, 41 men). Forty-three patients had lifestyle-restricted claudication and 13 patients had critical limb threatening ischemia. The mean length of the lesion was 178.41 mm in all patients. The total lesion occlusion rate was 48.2 (n=27), and the overall technical success rate was 100%. The 12-month, 24-month, 36-month and 48-month primary patency rates of ELA + DCB group were 75%, 66.1%, 58.9% and 42.8%, respectively. Freedom from CD-TLR at 12, 24, 36 and 48 months was 83.9%, 80.3%, 76.8% and 57.1%, respectively. ConclusionIn real-world clinical practice, ELA + DCB appears to be a safe and effective endovascular treatment for de novo FPAD, with a low rate of freedom from CD-TLR and a good patency rate.

A New Drug-Coated Balloon for the Treatment of Superficial Femoropopliteal Artery Disease: 12-Month Results from the IN-DEPT SFA Trial

PurposeTo report the outcomes of the IN-DEPT trial assessing the feasibility, preliminary safety data, and 12-month outcomes of a new drug-coated balloon (DCB) product for peripheral artery disease (PAD) in Chinese patients. Materials and MethodsThis is a prospective, multicenter, single-arm clinical trial. A total of 160 patients with superficial femoral artery (SFA) and/or proximal popliteal artery lesions were treated with a new paclitaxel-coated DCB. The preliminary effectiveness end point was 12-month primary patency. The primary safety end point was freedom from device- and procedure-related mortality over 30 days and freedom from major target limb amputation and clinically driven target lesion revascularization (CD-TLR) within 12 months after the index procedure. ResultsIn total, 160 patients presented with 162 target lesions. A total of 139 lesions (85.8%) were treated with 1 DCB, whereas the other 23 lesions (14.2%) were treated with 2 devices. The device success rate was 100%. A total of 135 subjects reached the preliminary effectiveness end point, with a 12-month primary patency rate of 84.4%. There was no 30-day device- or procedure-related death or unplanned major target limb amputation at 12 months. Five CD-TLRs (3.1%) occurred during the 12-month follow-up period. ConclusionsResults from the IN-DEPT SFA trial showed satisfactory feasibility and safety of the new DCB over 12 months in Chinese patients with PAD and femoropopliteal de novo lesions, including both stenoses and total occlusions.

Intravascular Ultrasound-Guided Versus Angiography-Guided Endovascular Therapy for Femoropopliteal Artery Disease: A Scoping Review.

The objective of this study was to summarize whether the application of additional intravascular ultrasound (IVUS) can change the outcomes of endovascular treatment in femoropopliteal atherosclerotic lesions compared with conventional angiography alone based on the existing study and evidence. Studies published until September 2022 were searched from PubMed, Embase, and Cochrane databases using the methods of combination of Medical Subject Headings and free text words. The outcomes included in these studies were primary patency rate or restenosis rate and freedom from clinically driven target lesion revascularization (cdTLR) rate, and most studies were concerned about the 12-month results. Two independent authors conducted the process of study selection. And the pooled analysis was attempted. Finally, the inclusion criteria were met by 4 studies (1 randomized controlled trial and 3 retrospective studies) involving 1160 patients. IVUS played its role in measuring lesions and/or guiding wiring passage. Most of the included studies showed that IVUS could achieve a higher 12-month primary patency rate (from 70% to 90%) and higher 12-month freedom from cdTLR rate (from 83.9% to 94.7%) than angiography. The tentative pooled analysis also showed that IVUS significantly improved the 12-month primary patency rate (OR: 2.21, 95%CI: [1.38-3.55], p=0.001) and the 12-month freedom from cdTLR rate (OR: 1.70, 95%CI [1.04-2.78], p=0.03) compared with angiography alone. Intravascular ultrasound-guided endovascular treatment of femoropopliteal artery lesions may have its own advantages such as higher primary patency rate and freedom from cdTLR rate at 12 months. As a novel technology, IVUS is expected to become another beneficial option to guide clinicians performing endovascular therapy in addition to angiography and may achieve better clinical outcomes. More prospective and high-quality studies are needed in the future to investigate the role of IVUS in the process of femoropopliteal artery lesions endovascular treatment. This review summarized a few available studies to promote understanding of IVUS and reveal its potential. This novel technology shows the possibility of achieving better clinical outcomes than angiography in femoropopliteal artery lesions endovascular therapy such as higher 12-month primary patency rate shown in some studies. Currently, it is important to consider suitable technologies applied to individualized treatment. IVUS seems to provide clinicians additional option in clinical practice and benefit patients well in the future. And it needs us to conduct more high-quality studies to explore its roles and advantages in endovascular treatment.

Low Posterior Internal Jugular Vein Approach for Tunnelled Haemodialysis Catheter Insertion: A Report on Outcomes at a Single Centre.

The impact of technical differences in cannulation technique for tunnelled haemodialysis catheter insertion is undetermined. We aimed to assess clinical outcomes of the low posterior approach for internal jugular vein tunnelled catheter placement. A retrospective audit was undertaken on consecutive tunnelled catheter procedures performed at a single centre between January 2016 and June 2022. Only catheters specifically placed with a low posterior internal jugular approach were included. The study's primary outcome was 12-month catheter survival, evaluated using the Kaplan-Meier survival curve and log-rank test. Secondary outcomes included catheter performance and procedure-related complications. During the study period, 391 tunnelled internal jugular haemodialysis catheters were inserted in 272 patients using the low posterior technique. The 12-month primary patency rate was 68%. Catheter insertion was successful in 96% of cases. Peri-procedural complications occurred in 4% of cases, most frequently bleeding. The most common reasons for catheter loss were dysfunction (10%) and bacteraemia (6%). The best predictors of catheter failure were advanced age (HR 1.02, 95% CI 1.00-1.04) and in-centre dialysis treatment locality (HR 2.04, 95% CI 1.19-3.45). The low posterior approach for internal jugular vein tunnelled catheter insertion is effective and safe. We demonstrated a 12-month catheter survival rate of 68%. Further research comparing the low posterior approach with other internal jugular vein cannulation techniques is warranted.

Five-Year Outcomes of the Bioresorbable Peripheral Remedy Stent in the Treatment of Iliac Artery Disease

PurposeTo evaluate the 5-year performance of a bioresorbable vascular scaffold, the Remedy stent, for the treatment of iliac artery atherosclerotic disease. Materials and MethodsThis prospective, multicenter, single-arm clinical study evaluated 97 patients (97 lesions) with symptomatic TransAtlantic Inter-Society Consensus II A/B iliac artery lesions for 5 years after stent placement. The primary efficacy end point was 12-month primary patency compared with the prespecified standard derived from historical data with metallic stents, and the primary safety end point was the occurrence of major adverse clinical events within 5 years. All angiographic and computed tomography angiographic findings were evaluated by an independent core laboratory for quantitative vessel analysis. ResultsThe 12-month primary patency rate was 88.6% (95% CI, 80.1%–94.4%), which was lower than the prespecified standard. No significant difference was noted between the diameter stenosis at 9 and 12 months. There were no device- or procedure-related deaths, major amputation, or distal embolization during the follow-up period. The ankle-brachial index maintained significant improvement through the 5-year period compared with that at baseline. The Kaplan–Meier estimates of freedom from target lesion revascularization (TLR), major adverse cardiovascular events, and major adverse cardiovascular and limb events were 95.8%, 91.7%, and 87.5% at 12 months and 85.4%, 72.1%, and 62.5% at 5 years, respectively. ConclusionsThe 5-year follow-up outcomes, including freedom from TLR, of the Remedy stent in iliac artery lesions were satisfactory, with a good safety profile. Nevertheless, the 12-month primary patency did not meet the expected standard compared with that of contemporary metallic stents.

Prospective, Multicenter Study of Rotational Atherectomy with Antirestenotic Therapy for Infrainguinal Arterial Disease

Thrombi are common in steno-occlusive lesions of infrainguinal atherosclerotic diseases. Despite the easy passage of guidewires through these lesions, conventional ballooning or stenting cannot effectively treat them, and patients are at risk of distal embolization. This study aimed to investigate the clinical outcomes of using a rotational aspiration atherectomy system to treat infrainguinal atherosclerotic disease. Patients underwent revascularization of target lesions using the Jetstream™ Atherectomy System. The primary endpoint was the freedom from clinically driven target lesion revascularization (CD-TLR) 12-month after the procedure. Outcomes were evaluated according to the clinical severity, lesion type, use of drug-coated balloons (DCBs), and lesion length, characteristics, and sites. Survival analysis for CD-TLR over time was plotted. All statistical analyses were performed using SPSS version 22 (IBM; Armonk, NY, USA). P-values <0.05 were considered statistically significant. In total, 150 patients (91.2% male; mean age, 69.8years; 66.2% with diabetes) with de novo or restenotic infrainguinal lesions were enrolled. The mean lesion length was 17.2cm, 75.0% were occlusive, and 38.2% had severe calcification. The lesion types were sclerotic (64.7%), thrombosclerotic (20.6%), thrombotic (8.8%), and in-stent (5.9%). Adjunctive DCB was used in 86.8% of patients. The 12-month primary patency rate (PPR) and CD-TLR rates were 81.6% and 90.1%, respectively. The 12-month CD-TLR rate was significantly better in the sclerotic and thrombosclerotic groups than in the thrombotic group (100% and 100% vs. 66.7%; P=0.001). The 12-month PPR was significant better in TransAtlantic Inter-Society Consensus (TASC) A and B groups than TASC C and D groups (P=0.02). The 12-month PPR is significantly better after using a DCB or stent placement than after using a simple balloon (P=0.01). There were no major adverse events, including procedure-related death, myocardial infarction, or major amputation. The results of this study demonstrated the safety and effectiveness of the Jetstream atherectomy device for complex infrainguinal lesions. This system functions optimally with TASC A/B lesions and sclerotic or thrombosclerotic lesions.

Twelve-month end point results from the evaluation of the Zilver Vena venous stent in the treatment of symptomatic iliofemoral venous outflow obstruction (VIVO clinical study)

BackgroundIn the present study, we evaluated the safety and effectiveness of the Zilver Vena venous stent in the treatment of patients with symptomatic iliofemoral outflow obstruction. MethodsThe VIVO clinical study was a prospective, nonrandomized, multicenter study that enrolled patients with symptomatic obstruction of one iliofemoral venous segment. Included were patients with Clinical, Etiological, Anatomical, Pathophysiological (CEAP) clinical classification of ≥3 or a Venous Clinical Severity Score (VCSS) pain score of ≥2. All patients received a self-expanding venous stent (Zilver Vena venous stent; Cook Ireland Ltd, Limerick, Ireland). The primary safety end point was 30-day freedom from major adverse events. The primary effectiveness end point was the 12-month rate of primary quantitative patency by venography as determined by the core laboratory. The secondary end point was the change in the VCSS from baseline to 1 and 12 months. Additional measures included freedom from clinically driven reintervention; change in the CEAP C classification, Venous Disability Score (VDS), and Chronic Venous Disease Quality of Life Questionnaire (CIVIQ) scores from baseline to 12 months; and stent durability measures. ResultsBetween December 2013 and October 2016, 243 patients (70% female; mean age, 53 ± 15 years; 67.5% with current or previous deep vein thrombosis) were enrolled at 30 institutions. Iliac vein compression by the iliac artery (n = 191; 78.6%) was the primary indication for stent placement. The mean lesion length was 98.6 ± 69.8 mm. The 30-day freedom from major adverse events rate was 96.7%, greater than the literature-defined performance goal of 87% (95% confidence interval [CI], 93.5%-98.6%; P < .0001). The 12-month primary quantitative patency rate was 89.9%, greater than the literature-defined performance goal of 76% (95% CI, 85.1%-93.4%; P < .0001). The change in the VCSS from baseline was −3.0 (95% CI, −3.5 to −2.6; P < .0001) at 1 month and −4.2 (95% CI, −4.7 to −3.7; P < .0001) at 12 months, demonstrating clinical improvement. Similarly, significantly (P < .0001) fewer symptoms over time (from preprocedure through 12 months) were measured using the clinical measures of VDS, CEAP C classification, and CIVIQ. The 12-month rate of freedom from clinically driven reintervention was 95.8% ± 1.3%. Through 12 months, no stent fractures and one clinical migration (Clinical Events Committee adjudicated the latter as technique-related due to device undersizing at placement) had occurred. ConclusionsThe 12-month results of the VIVO study have demonstrated the safety and effectiveness of the Zilver Vena venous stent for the treatment of symptomatic iliofemoral venous outflow obstruction, including clinical symptom improvement compared with baseline.

The efficacy and safety of different endovascular modalities for infrapopliteal arteries lesions: A network meta-analysis of randomized controlled trials

Endovascular treatment has become the first-line therapy for infrapopliteal artery occlusive disease (IPOD), while the optimal endovascular method remains to be determined. We performed a network meta-analysis (NWM) of randomized controlled trials (RCTs) to simultaneously compare the outcomes of different endovascular modalities for IPOD. The Pubmed, Embase, and Cochrane databases were used as data sources. The NWM approach used random-effects models based on the frequentist framework. In total, 22 eligible RCTs (44 study arms; 1,348 patients) involving nine endovascular modalities or combinations [balloon angioplasty (BA), drug-coated balloon (DCB), drug-eluting stent (DES), atherectomy device + BA (AD + BA), AD + DCB, balloon-expandable bare metal stent (BMS), self-expanding stent (SES), absorbable metal stents (AMS), and inorganics-coated stent (ICS)] were included. BA had a lower 12-month primary patency rate than DCB (RR 0.50, CI 0.27, 0.93) and AD + DCB (RR 0.34, CI 0.12, 0.93). AD + DCB decreased 6-month TLR compared with AMS (RR 0.15, CI 0.03, 0.90), and DES decreased it compared with BMS (RR 0.25, CI 0.09, 0.71). DCB had a lower 6-month TLR rate than AMS (RR 0.26, CI 0.08, 0.86) and BA (RR 0.51, CI 0.30, 0.89). BA had a higher 12-month TLR rate than DCB (RR 1.76, CI 1.07, 2.90). According to the value of the surface under the cumulative ranking curve (SUCRA), AD + DCB was considered the best treatment in terms of primary patency at 6 months (SUCRA = 87.5) and 12 months (SURCA = 91). AD + BA was considered the best treatment in terms of 6-month TLR (SUCRA = 83.1), 12-month TLR (SURCA = 75.8), and 12-month all-cause mortality (SUCRA = 92.5). In terms of 12-month major amputation, DES was considered the best treatment (SUCRA = 78.6), while AD + DCB was considered the worst treatment (SUCRA = 28.8). Moreover, AD + BA always ranks higher than AD + DCB in the comparison including these two combinations. Subgroup analyses of modalities without stenting did not significantly change the primary outcomes. ADs showed noteworthy advantages in multiple terms for IPOD except for 12-month major amputation. AD + BA may be a better method for IPOD than AD + DCB. The efficacy and safety of ADs are worthy of further investigation. [https://www.crd.york.ac.uk/prospero/], identifier [CRD42022331626].

A method of assessing peripheral stent abrasiveness under cyclic deformations experienced during limb movement

Poor outcomes of peripheral arterial disease stenting are often attributed to the inability of stents to accommodate the complex biomechanics of the flexed lower limb. Abrasion damage caused by rubbing of the stent against the artery wall during limb movement plays a significant role in reconstruction failure but has not been characterized. Our goals were to develop a method of assessing the abrasiveness of peripheral nitinol stents and apply it to several commercial devices. Misago, AbsolutePro, Innova, Zilver, SmartControl, SmartFlex, and Supera stents were deployed inside electrospun nanofibrillar tubes with femoropopliteal artery-mimicking mechanical properties and subjected to cyclic axial compression (25%), bending (90°), and torsion (26°/cm) equivalent to five life-years of severe limb flexions. Abrasion was assessed using an abrasion damage score (ADS, range 1–7) for each deformation mode. Misago produced the least abrasion and no stent fractures (ADS 3). Innova caused small abrasion under compression and torsion but large damage under bending (ADS 7). Supera performed well under bending and compression but caused damage under torsion (ADS 8). AbsolutePro produced significant abrasion under bending and compression but less damage under torsion (ADS 12). Zilver fractured under all three deformations and severely abraded the tube under bending and compression (ADS 15). SmartControl and SmartFlex fractured under all three deformations and produced significant abrasion due to strut penetration (ADS 20 and 21). ADS strongly correlated with clinical 12-month primary patency and target lesion revascularization rates, and the described method of assessing peripheral stent abrasiveness can guide device selection and development. Statement of significancePoor outcomes of peripheral arterial disease stenting are related to the inability of stents to accommodate the complex biomechanics of the flexed lower limb. Abrasion damage caused by rubbing of the stent against the artery wall during limb movement plays a significant role in reconstruction failure but has not been characterized. Our study presents the first attempt at assessing peripheral stent abrasiveness, and the proposed method is applied to compare the abrasion damage caused by Misago, AbsolutePro, Innova, Zilver, SmartControl, SmartFlex, and Supera peripheral stents using artery-mimicking synthetic tubes and cyclic deformations equivalent to five life-years of severe limb flexions. The abrasion damage caused by stents strongly correlates with their clinical 12-month primary patency and target lesion revascularization rates, and the described methodology can be used as a cost-effective and controlled way of assessing stent performance, which can guide device selection and development.

Effect of Direct Oral Anticoagulants Versus Warfarin on Patency in High-Risk Bypass Patients

The use of warfarin for anticoagulation in thromboembolic disease has been the mainstay of treatment. Direct oral anticoagulants (DOACs) have demonstrated equivalent anticoagulant effects, without increased bleeding risks or need for frequent monitoring. However, the role of DOACs remains unclear in the setting of replacing warfarin for high-risk peripheral artery disease (PAD) interventions. The purpose of this study is to evaluate the efficacy of DOACs compared to warfarin during the postoperative period in patients that underwent a lower extremity high-risk bypass (HRB). The study is a single institution, retrospective review of all lower extremity HRBs between January 2012 and June 2021, who were previously placed on or started on anticoagulation with a DOAC or warfarin. The HRB group included all patients undergoing femoral to above or below knee bypass with an adjunct procedure, or below knee bypass with synthetic or composite vein conduit. All demographics, preoperative factors, and complications were evaluated with respect to DOAC versus warfarin. A total of 44 patients (28 males; average age 68.8±10.9) underwent an HRB during the study period. There were no significant differences in demographics and preoperative characteristics between the 2 groups. Among patient comorbidities, coronary artery disease was found to be significantly higher in patients on DOACs (P=0.03). The 12-month primary patency rate was 83.3% versus 57.1%, for DOAC versus warfarin respectively (P=0.03). Multivariate analyses revealed that <30-day reinterventions contribute to 12-month patency (P=0.02). Patients who underwent lower extremity HRB with postoperative DOAC appeared to exhibit higher graft patency rates than those who were placed on warfarin. Due to their low incidence of undesirable side effects and the lack of frequent monitoring, DOACs could be considered a safe alternative to warfarin in the postoperative period for patients with HRB.

The role of vacuum-assisted mechanical thrombectomy in the management of acutely thrombosed arteriovenous fistulas and grafts.

The purpose of this study is to evaluate the safety and efficacy of the mechanical thrombectomy with the Indigo System in the treatment of thrombosed arteriovenous fistulas and grafts. A retrospective search of endovascular procedures performed from November 2018 to June 2020 was conducted. Inclusion criteria were: acute arteriovenous fistula or graft thrombosis that underwent endovascular mechanical thrombectomy with Indigo System. The following information was collected from each case: sex, age, fistula modality, fistula location, treatment modality, and outcomes. Endpoints evaluated were: technical and clinical success rates; primary, assisted primary, and secondary patency rates; complication rates. Twenty-six mechanical thrombectomy procedures for declotting of arteriovenous fistula thrombosis, using the Indigo System, were performed in 22 patients. Technical and clinical success was achieved in 23/26 cases (88%). Mean follow-up was 9 months (range 11-539 days). The 6-month primary, primary assisted, and secondary patency rates were 71%, 86%, 93% and the 12-month primary, primary assisted, and secondary patency rates were 71%, 72%, 80%, respectively. No technical or device-related complications were observed during thrombectomy, however two venous ruptures occurred on the angioplasty of the underlying stenosis. In conclusion, vacuum-assisted thrombectomy of acutely thrombosed arteriovenous fistulas and grafts with Indigo System is safe and effective, providing good short term patency rates.

A-40 | 12-Month Primary Patency Rates of Contemporary Endovascular Device Therapy for SFA Occlusive Disease

Superficial femoral artery (SFA) disease is the most common cause of symptomatic PAD which may progress to lifestyle-limiting claudication, critical limb ischemia or limb amputation. In this study, we attempted to investigate the 12—month primary patency rates of various endovascular therapies in patients with SFA PAD using published registries, case reports, and trials.

Safety and efficacy of percutaneous mechanical thrombectomy through ipsilateral calf venous access in the treatment of entire-limb acute deep venous thrombosis

Objective: To evaluate the safety and clinical efficacy of percutaneous mechanical thrombectomy (PMT) through ipsilateral calf venous access in the treatment of entire-limb acute deep vein thrombosis (DVT). Methods: From July 2017 to August 2020, the clinical data of patients with entire-limb acute DVT at Renji Hospital, School of Medicine, Shanghai Jiaotong University treated by AngioJet through ipsilateral calf venous access were analyzed retrospectively. All patients received rivaroxaban or warfarin anticoagulant therapy for at least 6 months after operation. Pressure gradient socks were given routinely after operation. All patients were followed up at 3, 6, 12 months and every year after operation. The primary end points were the 12-month primary patency rate and the incidence of post thrombotic syndrome (PTS). The secondary end points included the thrombus clearance rate, total complication rate, bleeding complication rate and the 12-month incidence of moderate to severe PTS. Results: A total of 31 patients were included in the study. The age ranged from 31 to 80 (63±14) years, including 16 males and 15 females, 23 left lower limb DVT and 8 right lower limb DVT. There were 15 cases treated through peroneal venous access, 6 cases through anterior tibial venous access and 10 cases through posterior tibial venous access. Moreover, 9 cases underwent combined catheter-directed thrombolysis, 25 cases underwent iliac vein percutaneous transluminal angioplasty (PTA), and 10 cases underwent iliac vein stenting. The thrombus clearance rate was grade Ⅱ in 19 cases (61.3%) and grade Ⅲ in 12 cases (38.7%). One patient (3.2%) with anterior tibial venous access developed hematoma at the puncture site, which was improved after pressure bandage, and there were no other bleeding and serious complications. All the 31 patients were followed up for at least 12 months, with an average follow-up period of (22±9) months. The 12-month primary patency rate was 77.4% (24/31). The 12-month incidence of PTS was 16.1% (5/31) and the incidence of moderate to severe PTS was 3.2% (1/31). Conclusions: PMT through ipsilateral calf venous access is safe and effective in the treatment of entire-limb acute DVT. Thrombus in the distal popliteal vein can be one-stage removed and the incidence of PTS is low. It is considered as the first choice of access for the endovascular treatment of entire-limb acute DVT.

Outcomes of endovascular treatment for stenosis occurring after cephalic vein transposition and graft interposition

ObjectiveTo evaluate the outcome of endovascular treatment after surgical treatment for cephalic arch stenosis (CAS) in the brachiocephalic fistula (BCF) and to analyze the factors influencing patency. MethodsWe conducted a retrospective review of patients undergoing cephalic vein transposition (CVT) or graft interposition (GIP) for CAS from January 1, 2017, to December 31, 2019. A total of 73 patients with restenosis were included in this study. Patients were classified into cephalic transposition (BCF-CVT) (n = 49) and graft interposition (BCF-GIP) (n = 24) groups. We calculated the postintervention primary and secondary patency of endovascular treatment by using the Kaplan-Meier analysis and analyzed variables associated with loss of postintervention patency. ResultsSix-month and 12-month postintervention primary patency rates of endovascular treatment for restenosis were 56.7% and 15.6% and secondary patency rates were 89.7% and 72.1%, respectively. In the BCF-CVT group, 6-month and 12-month postintervention primary patency was 56.8% and 17.6% and secondary patency was 93.3% and 79.4%, respectively. In the BCF-GIP group, 6-month and 12-month postintervention primary patency was 56.5% and 8.7% and secondary patency was 85.7% and 56.3%, respectively. There was no significant difference in postintervention primary patency between the two groups (P = .79). However, the BCF-CVT group demonstrated higher postintervention secondary patency (P = .034). The BCF-GIP group had a higher number of stenosis sites (P < .01). There was no significant predictor of reduced postintervention primary patency. The only adverse variable of postintervention secondary patency was BCF-GIP (hazard ratio, 3.14; 95% CI, 1.06-9.34; P < .05). ConclusionsEndovascular treatment is still the acceptable option for stenosis occurring after surgical treatment for CAS. CVT provides higher postintervention secondary patency than GIP.

Combination of RotarexⓇS Rotational Atherothrombectomy and Drug-Coated Balloonangioplasty for Femoropopliteal Total In-Stent Occlusion

Currently, there is little information on the optimal treatment for patients with femoropopliteal total in-stent occlusion.The aim of this study was to evaluate the benefit of drug-coated balloon(DCB) angioplasty after RotarexⓇS rotational atherectomy plus thrombectomy for femoropopliteal total in-stent occlusion at 12 months. From June 2016 to April 2019, 36 patients (21 male, mean age 71.1 ± 8.2 years) with femoropopliteal total in-stent occlusion were treated using Rotarex S rotational atherectomy plus thrombectomy in combination with DCB angioplasty and 29 (18 male, meanage68.8 ± 7.2 years) underwent DCB angioplasty alone. Primary patency and freedom from target lesion revascularization (TLR) rates during12 months of follow-up were retrospectively compared between the 2 groups. Procedural success was achieved in all patients. There were no procedure-related adverse events. The mean lesion length was 26.1 ± 6.5 cm in the combination therapy group and 25.5 ± 6.1 cm in the DCB only group (P=0.703). The 6-month and 12-month primary patency rates were significantly higher in the combination therapy group (94.4% [standard error, 0.038] and 77.8% [0.069], respectively) than in the DCB only group (72.4% [0.083] and 48.3% [0.093]; P=0.010). The freedom from TLR rate at 12 months was 86.1% (standard error, 0.060) in the combination therapy group and 62.1% (0.096) in the DCB only group (P=0.016). Three patients (combination therapy, n=2; DCB only, n=1) developed distal embolization and were treated successfully by additional 6-F guiding catheter aspiration. No deaths or amputations occurred in either group during 12 months of follow-up. Rotarex S rotational atherectomy plus thrombectomyin combination with DCB was safe and effective in patients with femoropopliteal total in-stent occlusion during12 months of follow-up.

To Close, Observe, or Reconstruct: The Third Way of Managing Dialysis Fistula Aneurysms in Kidney Transplant Recipients.

Background: The management of patent dialysis fistulas in patients after kidney transplantation (KTx) is controversial—the options that are usually considered are the fistula’s closure or observation. Many complications of dialysis fistulas occur in patients after KTx, and immunosuppression increases the risk of fistula aneurysms and hyperkinetic flow. This study aimed to evaluate the results of dialysis fistula aneurysm treatment in patients after KTx and to compare them to procedures performed in an end-stage renal disease (ESRD) dialyzed population. Methods: We enrolled 83 renal transplant recipients and 123 ESRD patients with dialysis fistula aneurysms qualified for surgical revision to this single-center, prospective study. The results of the surgical treatment of dialysis fistula aneurysms were analyzed, and the primary, assisted primary and secondary patency rate, percentage and type of complications were also assessed. Results: For the treatment of dialysis fistula aneurysms in transplant patients, we performed dialysis fistula excisions with fistula closure in 50 patients (60.2%), excision with primary fistula reconstruction (n = 10, 12.0%) or excision with PTFE bypasses (n = 23, 27.7%). Postoperative complications occurred in 11 patients (13.3%) during a follow-up (median follow-up, 36 months), mostly in distant periods (median time after correction procedure, 11.7 months). The most common complication was outflow stenosis, followed by hematoma, dialysis fistula thrombosis and the formation of a new aneurysm and postoperative bleeding, infection and lymphocele. The 12-month primary, primary assisted and secondary patency rates of fistulas corrected by aneurysm excision and primary reconstruction in the KTx group were all 100%; in the control ESRD group, the 12-month primary rate was 70%, and the primary assisted and secondary patency rates were 100%. The 12-month primary, primarily assisted and secondary patency rates after dialysis fistula aneurysm excision combined with PTFE bypass were better in the KTx group than in the control ESRD group (85% vs. 71.8%, 90% vs. 84.5% and 95% vs. 91.7%, respectively). Kaplan–Meier analysis showed a significant difference in primary patency (p = 0.018) and assisted primary (p = 0.018) rates and a strong tendency in secondary patency rates (p = 0.053) between the KTx and ESRD groups after dialysis fistula excisions combined with PTFE bypass. No statistically significant differences in patency rates between fistulas treated by primary reconstruction and reconstructed with PTFE bypass were observed in KTx patients. Conclusions: Reconstructions of dialysis fistula aneurysms give good long-term results, with a low risk of complications. The reconstruction of dialysis fistulas can be an effective treatment method. Thus, this is an attractive option in addition to fistula ligation or observation in patients after KTx. Reconstructions of dialysis fistula aneurysms enable the preservation of the dialysis fistula while reducing various complications.

First Clinical Results of the Merit WRAPSODY\u2122 Cell-Impermeable Endoprosthesis for Treatment of Access Circuit Stenosis in Haemodialysis Patients

PurposeThis prospective, observational first in human study evaluated the safety and effectiveness of WRAPSODYTM Cell-impermeable Endoprosthesis (Merit Medical Systems, Inc.) in the treatment of arteriovenous fistula and arteriovenous graft access circuit stenosis.Materials and MethodsInvestigators conducted a prospective analysis of 46 patients with access circuit stenosis from three centres. Treatment sites included the peripheral outflow veins (e.g. cephalic arch, basilic vein swing point; 16 fistula and 10 graft patients); the graft-vein anastomosis (9 patients); and the central veins (up to, but not including the SVC; 11 patients). Primary outcome measures included 30-day freedom from access circuit-related safety events and 30-day target lesion primary patency. Secondary outcome measures included procedural success; device- and procedure-related adverse events; target lesion primary patency; access circuit primary patency; and secondary patency. In-person follow-up was scheduled at 1, 3, 6, and 12 months. An independent data monitoring/clinical event committee adjudicated all reinterventions and device/procedure-relatedness for adverse events.ResultsAll initial procedures were successful. All but one patient was free from safety events through the first 30 days (97.8% (45/46)). This event was not device-related. Over the remainder of the study, one adverse event was adjudicated as possibly device-related. Six- and 12-month target lesion primary patency rates were 97.7% (42/43) and 84.6.% (33/39), respectively. Six- and 12-month access circuit primary patency rates were 84.4% (38/45) and 65.9% (29/44), respectively.ConclusionResults suggest that the study device is safe and effective for treatment of stenoses in the peripheral and central veins of arteriovenous access circuits.Level of EvidenceLevel 2b, cohort study.

Endovascular Treatment of Long Femoropopliteal Lesions with Contiguous Bare Metal Stents

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. 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. 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. 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.