Editor's Choice - Paclitaxel Coated Balloon Angioplasty vs. Plain Balloon Angioplasty for Haemodialysis Arteriovenous Access Stenosis: A Systematic Review and a Time to Event Meta-Analysis of Randomised Controlled Trials.

OBJECTIVE: A systematic review and meta-analysis of randomised controlled trials (RCTs) was performed to determine the effectiveness and safety of drug coated balloon (DCB) angioplasty compared with uncoated plain balloon (PB) angioplasty in treating arteriovenous access stenosis. METHODS: MEDLINE, Embase, Scopus, and the Cochrane Central Register of Controlled Trials were searched for RCTs comparing paclitaxel coated DCB and PB angioplasty for arteriovenous access stenosis. The last date of the literature search was 31 December 2020. Risk of bias of the retrieved studies was assessed with the Cochrane Collaboration tool for assessing risk of bias (RoB 2.0). The random effects model was used to estimate the risk of loss of target lesion patency (six and 12 months) and circuit patency (six and 12 months). Procedure related adverse events and mortality rate were also compared. Patency results were pooled using the time to event meta-analytical method and the quality of evidence was assessed according to the GRADE approach. RESULTS: Sixteen eligible trials, including 1 682 lesions, were included in the quantitative analysis for the efficacy and safety of paclitaxel coated DCBs. DCBs were associated with a lower risk of loss of target lesion patency at six months (HR 0.53, 95% CI 0.42 - 0.66) and 12 months (HR 0.60, 95% CI 0.47 - 0.76), and were also associated with improved six and 12 month circuit patency. Overall quality of evidence was moderate to low. Procedural complications were rare, and the risk of death up to 12 months was similar between the two groups (OR 1.03, 95% CI 0.68 - 1.56). CONCLUSION: Paclitaxel coated DCBs reduced the risk of loss of target lesion patency and circuit patency in arteriovenous access stenosis compared with PBs. Considering the heterogeneity of the included trials, there is a need to investigate optimal treatment regimens regarding drug dose and agent of the DCB and the treatment procedure.

Outcomes of Carotid Revascularization in the Treatment of Restenosis After Prior Carotid Endarterectomy.

Background and Purpose: Restenosis after carotid endarterectomy (CEA) is associated with an increased risk of ipsilateral stroke. The optimal procedural modality for this indication has yet to be determined. Here, we evaluate the in-hospital outcomes of transcarotid artery revascularization (TCAR), redo-CEA, and transfemoral carotid artery stenting (TFCAS) in a large contemporary cohort of patients who underwent treatment for restenosis after CEA. Methods: We performed a retrospective analysis of all patients in the vascular quality initiative database who underwent TCAR, redo-CEA, or TFCAS after ipsilateral CEA between September 2016 and April 2020. Patients with prior ipsilateral CAS were excluded from this analysis. In-hospital outcomes following TCAR versus CEA and TCAR versus TFCAS were evaluated using multivariate logistic regression analysis. Results: A total of 4425 patients were available for this analysis. There were 963 (21.8%) redo-CEA, 1786 (40.4%) TFCAS, and 1676 (37.9%) TCAR. TCAR was associated with lower odds of in-hospital stroke/death (odds ratio [OR], 0.41 [95% CI, 0.24­0.70], P=0.021), stroke (OR, 0.46 [95% CI, 0.23­0.93], P=0.03), myocardial infarction (MI; OR, 0.32 [95% CI, 0.14­0.73], P=0.007), stroke/transient ischemic attack (OR, 0.42 [95% CI, 0.24­0.74], P=0.002), and stroke/death/MI (OR, 0.41 [95% CI, 0.24­0.70], P=0.001) when compared with redo-CEA. There was no significant difference in the odds of death between the 2 groups (OR, 0.99 [95% CI, 0.28­3.5], P=0.995). TCAR was also associated with lower odds of stroke/transient ischemic attack (OR, 0.37 [95% CI, 0.18­0.74], P=0.005) when compared with TFCAS. There was no significant difference in the odds of stroke, death, MI, stroke/death, or stroke/death/MI between TCAR and TFCAS. Conclusions: TCAR was associated with significantly lower odds of in-hospital stroke, MI, stroke/transient ischemic attack, stroke/death, and stroke/death/MI when compared with redo-CEA and lower odds of in-hospital stroke/transient ischemic attack when compared with TFCAS. Additional long-term studies are warranted to establish the role of TCAR for the treatment of restenosis after CEA.

A Comparison of Outcomes Based on Vessel Type (Native Artery vs. Bypass Graft) and Artery Location (Below-Knee Artery vs. Non-Below-Knee Artery) Using a Combination of Multiple Endovascular Techniques for Acute Lower Limb Ischemia.

BACKGROUND: To evaluate outcomes of endovascular treatment (EVT) using a combination of multiple endovascular techniques for acute lower limb ischemia (ALLI) and to compare outcomes based on vessel type and artery location. METHODS: A total of 95 consecutive patients with ALLI (mean age, 72.0 years; 65 males; 104 lower limbs) who received emergency EVT using a combination of multiple endovascular techniques including thrombolysis, aspiration thrombectomy, stenting, and balloon angioplasty with or without surgical thromboembolectomy, between January 2005 and December 2017 were included. Vessel type was classified into native artery occlusion (native occlusion) and bypass graft occlusion (graft occlusion), including prosthetic and vein graft. Additionally, native arteries were categorized into below-knee occlusion and non-below-knee occlusion. Technical success, perioperative death (POD), ALLI-related death, amputation, amputation-free survival (AFS), and complications were compared according to vessel type (native occlusion vs. graft occlusion) and artery location (below-knee occlusion vs. non-below-knee occlusion). RESULTS: Of all patients with ALLI, 16.8% underwent a single endovascular technique, whereas 83.2% underwent a combination of multiple endovascular techniques. The technicalsuccess, POD, and ALLI-related death rates in the total number of patients were 94.7%, 11.6%, and 4.2%, respectively. A total of 67 patients (75 limbs) and 28 patients (29 limbs) were classified as having native occlusion and graft occlusion (prosthetic, 24 limbs; vein, 5 limbs), respectively. No significant differences in technical success (native occlusion: 92.5% vs. graft occlusion: 100%), POD (14.9% vs. 3.6%), and ALLI-related death (6.0% vs. 0%) were noted between native occlusion and graft occlusion. However, the 30-day AFS rate of native occlusion was significantly lower than that of graft occlusion (75.2% vs. 96.3%, P=0.01). The amputation rate (P=0.03) and AFS rate (P=0.03) of below-knee occlusion were significantly worse for below-knee occlusion patients than for non-below-knee occlusion patients. CONCLUSIONS: EVT using multiple endovascular techniques for ALLI is effective and safe. A combination of multiple endovascular techniques is crucial for successful treatment. However, native occlusion may have a lower AFS rate than graft occlusion, and below-knee occlusion may have a higher risk of amputation than non-below-knee occlusion.

A Canadian multicenter experience describing outcomes after endovascular abdominal aortic aneurysm repair stent graft explantation.

BACKGROUND: Most studies describing the outcomes after endovascular abdominal aortic aneurysm repair (EVAR) explantation have been from single, high-volume, centers. We performed a multicenter cross-Canadian study of outcomes after EVAR stent graft explantation. Our objectives were to describe the outcomes after late open conversion and EVAR graft explantation at various Canadian centers and the techniques and outcomes stratified by the indication for explant. METHODS: The Canadian Vascular Surgery Research Group performed a retrospective multicenter study of all cases of EVAR graft explantation at participating centers from 2003 to 2018. Data were collected using a standardized, secure, online platform (RedCap [Research Electronic Data Capture]). Univariate statistical analysis was used to compare the techniques and outcomes stratified the indication for graft explantation. RESULTS: Patient data from 111 EVAR explants collected from 13 participating centers were analyzed. The mean age at explantation was 74 years, the average aneurysm size was 7.5 cm, and 28% had had at least one instructions for use violation at EVAR. The average time between EVAR and explantation was 42.5 months. The most common indication for explantation was endoleak (n = 66; type Ia, 46; type Ib, 2; type II, 9; type III, 2; type V, 7), followed by infection in 20 patients; rupture in 18 patients (due to type Ia endoleak in 10 patients, type Ib in 1, type II in 1, type III in 2, and type V in 1), and graft thrombosis in 7 patients. The overall 30-day mortality was 11%, and 45% of the patients had experienced at least one major perioperative complication. Mortality was significantly greater for patients with rupture (33.3%) and those with infection (15%) compared with patients undergoing elective explantation for endoleak (4.5%; P = .003). The average center volume during the previous 15 years was 8 cases with a wide range (2-19 cases). A trend was seen toward greater mortality for patients treated at centers with fewer than eight cases compared with those with eight or more cases (19% vs 9%). However, the difference did not reach statistical significance (P = .23). Overall, 41% of patients had undergone at least one attempt at endovascular salvage before explantation, with the highest proportion among patients who had undergone EVAR explantation for endoleak (51%). Only 22% of patients with rupture had undergone an attempt at endovascular salvage before explantation. CONCLUSIONS: The performance of EVAR graft explantation has increasing in Canada. Patients who had undergone elective explantation for endoleak had lower mortality than those treated for either infection or rupture. Thus, patients with an indication for explanation should be offered surgery before symptoms or rupture has occurred. A trend was seen toward greater mortality for patients treated at centers with lower volumes.

Effect of occult malignancy on femoropopliteal bypass graft thrombosis.

OBJECTIVE: The presence of cancer increases arterial thromboembolic events, specifically myocardial infarction and stroke, before a formal diagnosis of cancer. To the best of our knowledge, this increase in thrombotic risk has not been studied in patients with lower extremity bypass grafts. In the present study, we aimed to determine the effect of occult cancer on femoropopliteal bypass patency. METHODS: A retrospective review of femoropopliteal bypass procedures completed from 2001 to 2018 was performed. International Classification of Diseases, 9th and 10th revision, codes corresponding to breast, lung, prostate, colorectal, skin, brain, and hematologic cancer were used to identify patients who had had occult cancer. Occult cancer was defined as cancer diagnosed within ≤1 year after the bypass procedure. The demographics, comorbidities, bypass configuration and conduit, 1-month, 3-month, 6-month, and 1-year occlusion rates, major adverse limb events, and mortality rates were analyzed. Statistical analysis included t tests, χ2 tests, and Cox regression analysis. RESULTS: A total of 621 procedures in 517 patients met the inclusion criteria. Of the 621 procedures, 36 (5.8%) were classified as procedures in patients with occult cancer. The patients with occult cancer had had higher occlusion rates at 3 months (27.8% vs 8.0%; P < .001), 6 months (30.5% vs 15.1%; P < .01), and 1 year (44.4% vs 19.8%; P < .001). In Cox regression analysis for bypass thrombosis at 1 year, the only significant predictors were occult cancer (hazard ratio [HR], 2.03; P = .01), below-the-knee distal target (HR, 1.88; P < .01), and a compromised conduit (HR, 2.14; P < .001). CONCLUSIONS: We found an increase in bypass graft thrombosis rates in patients who had undergone femoropopliteal bypass who had had occult cancer. Thrombosis of the graft within 1 year postoperatively might be a sign of occult cancer.

A Multicenter Global Registry of Paclitaxel Drug-Coated Balloon in Dysfunctional Arteriovenous Fistulae and Grafts: 6-Month Results.

PURPOSE: To assess the safety and clinical benefit of the Lutonix drug-coated balloon (DCB) catheter for the treatment of dysfunctional arteriovenous fistulae (AVF) and grafts (AVG) in a heterogenous real-world population. MATERIALS AND METHODS: This multicenter, prospective study enrolled 320 subjects from 12 countries in 25 sites across Europe and Asia. A total of 392 lesions were treated with the Lutonix 035 DCB catheter. Lesions were de novo and restenotic, located in every part of the circuit from the cannulation zone to central venous outflow. In-stent restenotic lesions also were treated. The primary safety endpoint was freedom from serious adverse events involving the access circuit through 30 days. The primary effectiveness endpoint was target lesion primary patency (TLPP) through 6 months. Secondary endpoints included access circuit primary patency (ACPP) at 6 months and the investigation of factors that would independently influence the primary endpoints. RESULTS: The primary safety endpoint was 95.5%, while TLPP was 73.9% at 6 months, per Kaplan-Meier survival analysis. ACPP was 71% at 6 months. TLPP for stenosis of AVFs was 78.1%. Subgroup analysis showed significantly improved TLPP when DCB was dilated for ≥120 seconds (P = .007). TLPP was significantly better when predilation occurred compared with cases where only DCB angioplasty was performed (77% vs 48.6%, P = .0005). CONCLUSIONS: The Lutonix AV Global Registry confirms that the Lutonix DCB is a safe and effective treatment option in real-world patients with dysfunctional AVF or AVG. Procedural details had a significant role in TLPP. No significant difference in TLPP was observed among different treatment areas.

Safety and Efficacy of Paclitaxel-Eluting Balloon Angioplasty for Dysfunctional Hemodialysis Access: A randomized trial Comparing with Angioplasty Alone.

PURPOSE: To assess whether angioplasty of hemodialysis access (HA) stenosis with a drug-coated balloon (DCB) would prevent restenosis in comparison with plain-balloon percutaneous transluminal angioplasty (PTA). MATERIALS AND METHODS: This prospective randomized clinical trial enrolled 120 patients with dysfunctional arteriovenous fistulae (n = 109) and grafts (n = 11), due to a ≥50% stenosis between March 2014 and April 2018. All patients underwent high-pressure balloon angioplasty and were then randomized to either DCB (n = 60) or PTA (n = 60). Patients were followed-up for 1 year, and angiography was performed 6 months after angioplasty. The primary endpoint was the late lumen loss (LLL) at 6 months. Secondary endpoints included other angiographic parameters at 6 months and HA failures, adverse event, and mortality at 12 months. Continuous variables were compared with a Student t-test, and Kaplan-Meier curves were used for freedom from HA failure and for mortality. RESULTS: LLL in the DCB and in the PTA group were 0.64 mm ± 1.20 and 1.13 mm ± 1.51, respectively (P = .082, adjusted P = .0498). DCB was associated with lower percentage stenosis (54.2% ± 19.3 vs 61.7% ± 18.2; P = .047) and binary restenosis ≥50% (56.5% vs 81.1%; P = .009) than PTA. The number of HA failures after 12 months was lower for DCB than for PTA (45% vs 66.7%; P = .017). Mortality at 12 months was 10% and 8.3% in the DCB and PTA groups, respectively (P = .75). CONCLUSIONS: Despite LLL improvement that failed to reach statistical significance, this study demonstrated decreased incidence and severity of restenosis with DCB compared with PTA to treat dysfunctional HA.

Risk Factors for Early and Late Iliac Limb Occlusions of Stent Grafts Extending to the External Iliac Artery after Endovascular Abdominal Aneurysm Repair.

BACKGROUND: Iliac limb stent grafting to the external iliac artery (EIA) is a commonly performed procedure in various situation during endovascular abdominal aneurysm repair (EVAR). However, this procedure is associated with a risk of graft occlusion. We evaluated risk factors affecting occlusion among patients who underwent iliac limb stent-graft extension to the EIA. MATERIALS AND METHODS: We compared occluded limbs with patent limbs during the follow-up period using variables, including anatomical values, demographics, and other factors. Thereafter, we divided the occluded limbs into early and late occlusion subgroups. The main and subgroup analyses used the same variables. Survival analysis was performed to evaluate time-dependent risk factors for late limb occlusion. RESULTS: From 2007 to 2016, 766 iliac limbs from 383 patients who underwent EVAR were initially included in our analysis. Among them, 134 iliac limbs underwent limb extension to the EIA. The limb extension was a significant risk factor for occlusion (hazard ratio = 6.34, P < 0.001). Occlusion occurred in 10 patients who underwent iliac limb extension. The size of common iliac artery (CIA) was associated with occlusion. The most significant factor was iliac bifurcation diameter (patent vs. occluded limbs, 21.6 ± 7.6 vs. 27.5 ± 9.5 mm, P = 0.005). Subgroup analysis revealed that the CIAs of the early occlusion subgroup were generally more tortuous (1.16 ± 0.33 vs. 1.47 ± 0.25, P = 0.091) and longer (53 ± 24 vs. 74 ± 9, P = 0.01) than those of the patent limb group. In addition, the EIA diameters of the late occlusion subgroup were narrower than those of the patent limb group (10.9 ± 1.6 mm vs. 9.1 ± 0.8 mm, P = 0.011). Using the log-rank test, those patients with an EIA diameter narrower than 10.1 mm had a higher risk for late limb occlusion (log-rank χ2 = 5.73, P = 0.017) and the patients who did not take at least a single antiplatelet agent had a significantly higher chance of limb occlusion (log-rank χ2 = 11.029, P = 0.001). In addition, the patients who did not take a statin had a higher risk for late limb occlusion (log-rank χ2 = 7.41, P = 0.007). CONCLUSIONS: Among patients who underwent EVAR with iliac limb extension, the CIA length affected early limb occlusion and predisposed patients to vessel injury or stent-graft kinking, and there was the possibility that CIA tortuosity was associated with a higher risk. The late occlusion subgroup had narrower EIAs than the patent limb group. Appropriate antiplatelet and statin therapy is expected to play a key role in the prevention of late limb occlusion after EVAR.

Secondary Interventions and Long-term Follow-up after Endovascular Abdominal Aortic Aneurysm Repair.

BACKGROUND: Early morbidity and mortality are low after endovascular abdominal aneurysm repair (EVAR), but secondary interventions and late complications are common. The aim of the present multicenter cohort study is to detail the frequency and indication for interventions after EVAR and the impact on long-term survival. METHODS: A retrospective multicenter cohort study of secondary interventions after elective EVAR for an infrarenal abdominal aortic aneurysm was conducted. Consecutive patients (n = 349) undergoing EVAR between January 2007 and January 2012 were analyzed, with long-term follow-up until December 2018. Those requiring intervention were classified in accordance with the indications and specific nature of the intervention and treatment. The primary study end point was overall survival classified for patients with and without intervention. Kaplan-Meier analysis was used to estimate overall survival for those who did and who did not undergo secondary interventions. Univariable and multivariable Cox regression were performed to identify independent variables associated with mortality. RESULTS: Some 56 patients (16%) underwent 72 secondary interventions after EVAR during a median (interquartile range) follow-up period of 53.2 months (60.1). Some 45 patients (80.4%) underwent one intervention. Indications for intervention included mainly endograft kinking/outflow obstruction and type II endoleak. An endovascular technique was used in 40.3% of interventions. Median time to secondary intervention was 24.1 months. In 93 patients with abnormalities on imaging, no intervention was performed mainly because the abnormality had disappeared on follow-up imaging (43%). Kaplan-Meier curves showed no difference in survival for patients with and without secondary interventions (P = 0.153). Age (hazard ratio [HR]: 1.089, 95% confidence interval [CI]: 1.063-1.116), ASA classification (ASA III, IV HR: 1.517, 95% CI: 1.056-2.178) were significantly related to mortality. CONCLUSIONS: Secondary intervention rates are still considerable after EVAR. Endograft kinking/outflow obstruction and endoleak type II are the most common indications for a secondary intervention. Secondary interventions did not adversely affect long-term overall survival after EVAR.

Revascularization of occluded renal artery stent grafts after complex endovascular aortic repair and its impact on renal function.

BACKGROUND: Acute occlusion of renal bridging stent grafts after fenestrated/branched endovascular aortic repair (F/B-EVAR) is an acknowledged complication with high morbidity that often results in chronic dialysis dependence. The feasibility and effect of timely or late (≥6 hours of ischemia) renal artery revascularization has not been adequately reported. METHODS: We performed a retrospective, multicenter study across 11 tertiary institutions of all consecutive patients who had undergone revascularization of renal artery stent graft occlusions after complex EVAR. The end points were technical success, association between ischemia time and renal function salvage, interventional complications, mortality, and mid-term outcomes. RESULTS: From 2009 to 2019, 38 patients with 46 target vessels (TVs; eight bilateral occlusions) were treated for renal artery occlusions after complex EVAR (mean age, 63.5 ± 10 years; 63.2% male). Six patients had a solitary kidney (15.8%). Of the 38 patients, 16 (42.1%) had undergone FEVAR and 22 (57.9%) had undergone BEVAR. The technical success rate was 95.7% (44 of 46 TVs). The recanalization technique used was sole aspiration thrombectomy in 5.3%, aspiration thrombectomy and stent graft relining in 52.6%, and sole stent graft relining in 36.8%. The median renal ischemia time was 27.5 hours (range, 4-720 hours; interquartile range, 4-36 hours). Most patients (94.4%) had been treated after ≥6 hours of renal ischemia time, and 55.6% had been treated after 24 hours. In 14 patients (36.8%), renal function had improved after intervention (mean glomerular filtration rate improvement, 14.2 ± 9 mL/min/1.73 m2). However, 24 patients (63.2%) showed no improvement. Improvement of renal function did not correlate with the length of renal ischemia time. Of the 14 patients with bilateral renal artery occlusion or a solitary kidney, 9 experienced partial recovery of renal function and no longer required hemodialysis. In-hospital mortality was 2.6%. The cause of renal stent graft occlusion could not be identified in 50% of the TVs (23 of 46). However, in 19 (41.3%), significant stenosis or a kink of the renal stent graft was found. The median follow-up was 11 months (interquartile range, 0-28 months). The estimated 1-year patient survival and patency rate of the renal stent grafts was 97.4% and 83.8%, respectively. CONCLUSIONS: Revascularization of occluded renal bridging stent grafts after F/B-EVAR is a safe and feasible technique and can lead to significant improvement of renal function, even after long ischemia times (>24 hours) of the renal parenchyma or bilateral occlusion, as long as residual perfusion of the renal parenchyma has been preserved. Also, the long-term patency rates justify aggressive management of renal artery occlusion after F/B-EVAR.

Prediction, pattern recognition and modelling of complications post-endovascular infra renal aneurysm repair by artificial intelligence.

OBJECTIVES: The study evaluates the plausibility and applicability of prediction, pattern recognition and modelling of complications post-endovascular aneurysm repair (EVAR) by artificial intelligence for more accurate surveillance in practice. METHODS: A single-centre prospective data collection on (n = 250) EVAR cases with n = 26 preoperative attributes (factors) on endpoint of endoleak (types I-VI), occlusion, migration and mortality over a 13-year period was conducted. In addition to the traditional statistical analysis, data was subjected to machine learning algorithm through artificial neural network. The predictive accuracy (specificity and -1 sensitivity) on each endpoint is presented with percentage and receiver operative curve. The pattern recognition and model classification were conducted using discriminate analysis, decision tree, logistic regression, naive Bayes and support vector machines, and the best fit model was deployed for pattern recognition and modelling. RESULTS: The accuracy of the training, validation and predictive ability of artificial neural network in detection of endoleak type I was 95, 96 and 94%, type II (94, 83, 90 and 82%) and type III was 96, 94 and 96%, respectively. Endpoints are associated with increase in weights through predictive modeling that were not detected through statistical analytics. The overall accuracy of the model was >86%. CONCLUSION: The study highlights the applicability, accuracy and reliability of artificial intelligence in the detection of adverse outcomes post-EVAR for an accurate surveillance stratification.

Mid-Term Outcomes of Thrombolysis for Acute Lower Extremity Ischemia at a Tertiary Care Center.

BACKGROUND: Acute limb ischemia (ALI) is challenging to treat because of high morbidity and mortality. Endovascular-first options beginning with thrombolysis are technically feasible with similar results to open surgery. We examined our experience with thrombolysis to identify patients and target conduits that are predictive of improved outcomes. METHODS: We performed a retrospective review of our institutional database of thrombolysis cases for arterial lower extremity disease. Thrombolysis was the index procedure, and any subsequent treatment was a reintervention. Conversion to open surgery perioperatively such as thromboembolectomy or bypass was considered a technical failure. Primary outcomes included primary patency, secondary patency, amputation-free survival (AFS), and survival. Secondary outcomes included conversion to open, reintervention <30 days, and amputation <30 days. Descriptive statistics and analysis of variance were performed for preoperative and intraoperative risk factors. Kaplan-Meier estimation and Cox proportional hazard models were used for primary and secondary outcomes. RESULTS: Ninety-nine patients with ALI were treated with thrombolysis from 2007 to 2017. Thrombolysis was attempted on native artery (40%), vein bypass (7%), prosthetic bypass (33%), and stent (19%). Rutherford class distribution was 50% class 1, 41% class 2a, 5% class 2b, and 3% class 3. Technical success was 70%, characterized by an all-endovascular approach, patency at 30 days, and AFS for 30 days. Primary patency at 1- and 2-years was 31% and 22%, respectively. Secondary patency at 1- and 2-years was 39% and 27%, respectively. Overall, 30% required conversion to open surgery at the time of the index procedure, 7% reintervention <30 days, 5% mortality <30 days, and 5% major amputation <30 days. Prosthetic grafts and vein bypasses had the worst primary and secondary patency (P < 0.05). Five out of 7 vein bypasses required open conversion. Thrombolysis of native arteries was most successful maintaining primary patency (P < 0.05), secondary patency (P < 0.05), and AFS (P < 0.05). Patients who had adjunctive procedures at the time of thrombolysis had a significantly greater primary patency (P < 0.05) and secondary patency (P < 0.05) but not greater AFS. CONCLUSION: Outcomes in thrombolysis for ALI have not significantly improved 20 years after the STILE trial. Technical success and mid-term patency rates are modest at best. Thrombolysis of vein bypasses and prosthetic grafts have poor technical success and primary patency compared with native arteries. However, aggressive adjunctive interventions during thrombolysis appear to improve primary and secondary patency.

A systematic review and meta-analysis of the risk of death and patency after application of paclitaxel-coated balloons in the hemodialysis access.

OBJECTIVE: The comparison between paclitaxel-coated balloon (PCB) angioplasty and plain balloon angioplasty (PBA) for hemodialysis (HD) access stenosis or occlusion has not been well investigated. The objectives of this systematic review and meta-analysis were to compare all-cause mortality, HD access primary patency, and circuit primary patency after endovascular maintenance procedures using PCB angioplasty vs PBA. METHODS: MEDLINE, Embase, and Cochrane Databases were systematically searched to identify all the relevant studies on paclitaxel-coated devices for stenosis or thrombosis of HD access. A random effects model was applied to pool the effect measures. Dichotomous data were presented using an odds ratio (OR). Effect data were presented using pooled hazard ratio (HR) with 95% confidence interval (CI). RESULTS: A total of 16 studies were included in this meta-analysis, 12 randomized controlled trials and 4 cohort studies involving 1086 patients who underwent endovascular treatment for HD access stenosis or occlusion. All-cause mortality rates at 6, 12, and 24 months after intervention were similar between the PCB and PBA groups (6 months: OR, 1.06 [95% CI, 0.38-2.96; P = .907; I2 = 19.2%]; 12 months: OR, 1.20 [95% CI, 0.66-2.16; P = .554; I2 = 0%]; 24 months: OR, 1.43 [95% CI, 0.83-2.45; P = .195; I2 = 0%]). There was a significant improvement of primary patency in the PCB group compared with the PBA group (HR, 0.47; 95% CI, 0.33-0.69; P < .001; I2 = 67.3%). This benefit was consistent with the analysis of randomized controlled trials, whereas cohort studies were excluded. Further subgroup analysis of target lesions demonstrated that primary patency was significantly higher in the PCB group than in the PBA group, not only for arteriovenous fistula (HR, 0.54; 95% CI, 0.30-0.98; P = .041; I2 = 76.8%) but also for central venous stenosis (HR, 0.39; 95% CI, 0.22-0.71; P = .002; I2 = 0%). The PCB group was associated with higher 6-month (OR, 0.40; 95% CI, 0.27-0.59; P < .001) and 24-month lesion primary patency (OR, 0.28; 95% CI, 0.11-0.72; P = .009) than PBA and was marginally associated with 12-month lesion primary patency (OR, 0.52; 95% CI, 0.26-1.03; P = .06). Circuit primary patency analysis showed a marginal trend toward better outcome in the PCB group (HR, 0.63; 95% CI, 0.40-1.00) but no statistical significance (P = .052). CONCLUSIONS: This systematic review and meta-analysis demonstrated that PCB angioplasty is associated with significantly improved primary patency of arteriovenous fistula and central venous stenosis for HD access maintenance, with no evidence of increasing all-cause mortality based on short-term and midterm follow-up. Further large cohort study is needed to investigate long-term mortality.

The Role of Routine Ultrasound Surveillance after In Situ Infrainguinal Peripheral Vein Bypass for Critical Limb-Threatening Ischemia.

BACKGROUND: To evaluate systematic duplex ultrasound (DUS) surveillance of patients treated with in situ great saphenous vein bypass (ISSVB) due to critical limb-threatening ischemia (CLTI) we performed a retrospective analysis of prospectively entered registry data. METHODS: Single-center study including consecutive patients undergoing elective ISSVB surgery due to CLTI between 2011 and 2015. Postoperative graft surveillance program included clinical examination, ankle-brachial indices (ABIs), and DUS at 6 weeks and 3 and 12 months. All DUS scans were performed by trained nurse sonographers. Patient data were extracted from the Danish Vascular Registry, electronic medical records and Picture Archiving and Communication System (PACS). Primary outcomes were reintervention rate, patency, and survival. RESULTS: In total, 363 consecutive and treatment-naive CLTI patients were revascularized with ISSVB and included in the study. Of those, 310 patients had minimum one follow-up visit and in total 1,199 DUS examinations. During the study period, 84 (23%) patients received 125 graft preserving reinterventions of which 20 were indicated solely on routine DUS without concurrent ischemic symptoms and/or significant (>15%) decrease in ABI. Hence, to find one asymptomatic graft stenosis requiring reintervention, we needed to scan 60 patients. After 1, 2, and 3 years, assisted primary patency was (Kaplan-Meier estimate) 79.4% (95% CI: 74.4, 83.5), 76.3% (95% CI: 70.7, 81.0), and 73.6% (95% CI: 66.9, 79.2), respectively. Survival rates were 82.6% (95% CI: 78.1, 86.3), 64.2% (95% CI: 57.8, 69.9) and 47.7% (95% CI: 40.6, 54.4) at 1, 2, and 3 years, respectively. CONCLUSIONS: In this study, one in four patients received a graft preserving intervention, but very few were driven by routine DUS and most graft lesions were detected on clinical findings. These findings suggest that development of a more individualized surveillance program differentiating between high- and low-risk infrainguinal bypass patients may increase cost-effectiveness.

Stent-Only Versus Adjunctive Balloon Angioplasty Approach for Saphenous Vein Graft Percutaneous Coronary Intervention: Insights From DIVA Trial.

BACKGROUND: Direct stenting without pre-dilation or post-dilation has been advocated for saphenous vein graft percutaneous coronary intervention to decrease the incidence of distal embolization, periprocedural myocardial infarction, and target lesion revascularization. METHODS: We performed a post hoc analysis of patients enrolled in the DIVA (Drug-Eluting Stents Versus Bare Metal Stents in Saphenous Vein Graft Angioplasty; NCT01121224) prospective, double-blind, randomized controlled trial. Patients were stratified into stent-only and balloon-stent groups. Primary end point was 12-month incidence of target vessel failure (defined as the composite of cardiac death, target vessel myocardial infarction, or target vessel revascularization). Secondary end points included all-cause death, stent thrombosis, myocardial infarction, and target lesion revascularization during follow-up. RESULTS: Of the 575 patients included in this substudy, 185 (32%) patients underwent stent-only percutaneous coronary intervention. Patients in the stent-only versus balloon-stent group had similar baseline characteristics and similar incidence of target vessel failure at 12-months (15% versus 19%; hazard ratio, 1.34 [95% CI, 0.86-2.08]; P=0.19). During long-term follow-up (median of 2.7 years), the incidence of definite stent thrombosis (1% versus 5%; hazard ratio, 9.20 [95% CI, 1.23-68.92]; P=0.0085), the composite of definite or probable stent thrombosis (5% versus 11%; hazard ratio, 2.52 [95% CI, 1.23-5.18]; P=0.009), and target vessel myocardial infarction (8% versus 14%; hazard ratio, 1.92 [95% CI, 1.08-3.40]; P=0.023) was lower in the stent-only group. Multivariable analysis showed that a higher number of years since coronary artery bypass grafting and >1 target saphenous vein graft lesions were associated with increased target vessel failure during entire follow-up, while preintervention Thrombolysis in Myocardial Infarction-3 flow was protective. CONCLUSIONS: In patients undergoing percutaneous coronary intervention of de novo saphenous vein graft lesions, there was no difference in target vessel failure at 12 months and long-term follow-up in the stent-only versus the balloon-stent group; however, the incidence of stent thrombosis was lower in the stent-only group, as was target vessel myocardial infarction. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01121224.

The Market Reacts Quickly: Changes in Paclitaxel Vascular Device Purchasing Within the Ascension Healthcare System.

BACKGROUND: A meta-analysis of trials in endovascular therapy suggested an increased mortality associated with treatment exposure to paclitaxel. Multiple publications and corrections of prior data were performed, and the United States Food and Drug Administration has issued multiple advisories regarding paclitaxel use. We analyzed how this controversy impacted device purchasing and related utilization patterns in the period immediately following publication of the meta-analysis. METHODS AND RESULTS: Ascension Healthcare System purchase data over a 14-month period were synthesized across centers for both paclitaxel and non-paclitaxel devices. A fixed-effects regression model and a binary regression model with facility-level controls were used to compare purchasing patterns before and after the meta-analysis. Purchase volumes of each paclitaxel device fell. Pooled purchase volumes of all paclitaxel devices decreased from a 14-month peak of 631 devices in October 2018 to a 14-month nadir of 359 devices in February 2019. An F-test comparing the pooled-month specific fixed effects for the months before vs after the publication of the meta-analysis has an F-statistic of 11.64, suggesting that average purchasing levels in the two periods are statistically different (P<.001). Utilization of non-paclitaxel devices did not decline. CONCLUSIONS: Purchase volumes of paclitaxel devices decreased immediately during the months following publication of the related meta-analysis. Total Ascension-wide paclitaxel device purchase volume in February 2019 demonstrated a 43.1% reduction from peak monthly purchase volume during the assessed period and a 32.5% reduction compared with November 2019, the last month preceding publication of the meta-analysis.

Outcomes of primary percutaneous cardiac intervention for ST elevation myocardial infarction with a saphenous vein graft culprit.

BACKGROUND: Patients treated with primary percutaneous coronary intervention (pPCI) for ST elevation myocardial infarction (STEMI) who have a history of coronary artery bypass grafting (CABG) are at high risk of adverse cardiovascular outcomes. Data on the risk of a saphenous vein graft (SVG)-infarct-related artery (IRA) compared to other culprit vessels are sparse. METHODS: The study was based on a prospectively collected registry of 2,405 consecutive patients with STEMI attending a tertiary medical center in 2001-2017. Patients with an SVG-IRA (n = 172) were compared with patients with native vessel disease (n = 2,333) for mortality and major adverse cardiac events (MACE), which included death, myocardial infarction (MI), target vessel revascularization (TVR), and coronary artery bypass surgery (CABG) at 1 month and 3 years. RESULTS: The SVG-IRA group was significantly older than the native vessel group (p = .05), with no between-group differences in rates of male patients (76 vs. 82%, p = .59), diabetes (24.2 vs. 26.2%, p = .73), and renal failure (18.8 vs. 9.2%, p = .25). Mortality was higher in the SVG-IRA group at 1 month (13.9 vs. 2.5%, p < .01) and 3 years (23.9 vs. 7.4%, p < .01). At 3 years, SVG-IRA was associated with the highest rates of MACE (55.6%), compared with native vessel disease. After correction for confounders, SVG-IRA remained an independent risk factor for MACE both at 1 month (HR-2.08, 95%CI 1.72-3.11, p < .01) and 3 years (HR-2.01, 95%CI 1.28-3.09, p < .01). CONCLUSION: Among patients treated with pPCI for STEMI, outcomes are worse when the culprit is an SVG.

Evolving Management of Distal Anastomotic Technical Issues During Open Aortic Aneurysm Repair.

BACKGROUND: Thrombosis of the iliac anastomosis is an important complication of open aortic aneurysm repair. We evaluated our evolving management of this complication to an endovascular approach and compared it with open revision to the common femoral artery. METHODS: Consecutive patients undergoing open aortic aneurysm repair from January 2009 through November 2016 at our institution were reviewed. Patients who developed iliac limb flow issues or thrombosis intraoperatively or within 48 hrs postoperatively were identified. Patients were grouped by management strategies of either 1) an endovascular approach including iliac angiography, thrombectomy if needed, and stenting or 2) open surgical revision of the iliac anastomosis with or without bypass to the common femoral artery. Demographics, comorbidities, operative variables, and outcomes were retrospectively analyzed between groups. Primary patency and mortality were assessed by Kaplan-Meier estimates. RESULTS: There were 711 patients who underwent aortoiliac aneurysm repair during the study period. 43/711 patients (6.0%) developed early perioperative iliac limb flow issues including thrombosis. Twenty-nine patients (31 limbs) were managed by an endovascular approach, and 14 patients (15 limbs) were managed by open surgical revision. The mean age of the cohort was 69 years, and 27 patients (62.8%) were male. Preoperative creatinine and diabetes frequency were higher in patients managed by an endovascular approach, although no other differences existed between preoperative comorbidities. Thrombosis or limb flow issues presented intraoperatively more commonly in the open surgical group and in the first 24 hrs postoperatively in the endovascular group. All patients had complete restoration of outflow as a result of the rescue procedure. Transfusion requirements and crystalloid replacement were significantly higher in the open surgical group. Length of stay, perioperative complications, and mortality were similar between groups. Overall, 21/31 limbs in the endovascular group and 9/15 limbs in the open surgical group had postoperative imaging, with mean follow-up of 35.0 and 55.6 months, respectively. Only one patient in the cohort lost patency: an iliofemoral jump graft that presented with late infection after postoperative wound infection, requiring staged extra-anatomic bypass and explant at 12 months. Three-year primary patency was 100% for the endovascular group and 85.7% for the surgical group by Kaplan-Meier method (P = 0.32). Endovascular management became our institution's primary salvage approach during the study. Whereas 8/15 limbs (53.3%) were managed by an endovascular approach from 2009-2011, 23/31 (74%) were managed by iliac stenting from 2012-2016. CONCLUSIONS: Endovascular management of iliac limb flow issues or thrombosis after open aneurysm repair is potentially a viable alternative to open surgical revision in the early postoperative period.

Outcomes Following Percutaneous Coronary Intervention in Saphenous Vein Grafts With and Without Embolic Protection Devices.

OBJECTIVES: The aim of this study was to describe the early (inpatient and 30-day) and late (1-year) outcomes of percutaneous coronary intervention (PCI) in saphenous vein grafts (SVGs), with and without the use of embolic protection devices (EPD), in a large, contemporary, unselected national cohort from the database of the British Cardiovascular Intervention Society. BACKGROUND: There are limited, and discrepant, data on the clinical benefits of the adjunctive use of EPDs during PCI to SVGs in the contemporary era. METHODS: A longitudinal cohort of patients (2007 to 2014, n = 20,642) who underwent PCI to SVGs in the British Cardiovascular Intervention Society database was formed. Clinical, demographic, procedural, and outcome data were analyzed by dividing into 2 groups: no EPD (PCI to SVGs without EPDs, n = 17,730) and EPD (PCI to SVGs with EPDs, n = 2,912). RESULTS: Patients in the EPD group were older, had more comorbidities, and had a higher prevalence of moderate to severe left ventricular systolic dysfunction. Mortality was lower in the EPD group during hospital admission (0.70% vs. 1.29%; p = 0.008) and at 30 days (1.44% vs. 2.01%; p = 0.04) but similar at 1 year (6.22% vs. 6.01%; p = 0.67). Following multivariate analyses, no significant difference in mortality was observed during index admission (odds ratio [OR]: 0.71; 95% confidence interval [CI]: 0.42 to 1.19; p = 0.19), at 30 days (OR: 0.87; 95% CI: 0.60 to 1.25; p = 0.45), and at 1 year (OR: 0.92; 95% CI: 0.77 to 1.11; p = 0.41), along with similar rates of in-hospital major adverse cardiovascular events (OR: 1.16; 95% CI: 0.83 to 1.62; p = 0.39) and stroke (OR: 0.68; 95% CI: 0.20 to 2.35; p = 0.54). In propensity score-matched analyses, lower inpatient mortality was observed in the EPD group (OR: 0.46; 95% CI: 0.13 to 0.80; p = 0.002), although the adjusted risk for the periprocedural no-reflow or slow-flow phenomenon was higher in patients in whom EPDs were used (OR: 2.16; 95% CI: 1.71 to 2.73; p < 0.001). CONCLUSIONS: In this contemporary cohort, EPDs were used more commonly in higher risk patients but were associated with similar clinical outcomes in multivariate analyses. Lower inpatient mortality was observed in the EPD group in univariate and propensity score-matched analyses.

Temporal Trends and Management of Acute Aortic Occlusion: A 21 Year Experience.

OBJECTIVES: The aim was to study patients with acute aortic occlusion (AAO), a rare and life threatening event, in a population based cohort and the outcome of surgical treatment. METHODS: The Swedish nationwide vascular database (Swedvasc) was used to identify cases, and the population registry to study long term survival. Variables associated with outcome were tested with the chi-square test and analysis of variance. RESULTS: During the 21 year study period (1994-2014), 693 cases of surgical treatment for AAO were included, with a yearly incidence of 3.6 per million inhabitants. Mean ± SD age was 69.9 ± 11.2 years, 352 patients (50.8%) were women, and mean ± SD length of follow up was 5.2 ± 5.5 years. Most patients presented with bilateral acute limb ischaemia (596 patients, 86.0%). The aetiology of AAO was native artery thrombosis in 458 patients (66.1%), saddle embolus in 152 (21.9%), and occluded graft/stent/stent grafts in 83 (12.0%). The proportion of occluded grafts/stent/stent grafts increased during the study period (n = 14 [6.7%] in 1994-2000 vs. n = 45 [17.4%] in 2008-2014; p < .001) with a simultaneous reduction of arterial thrombosis (n = 149 [71.6%] in 1994-2000 vs. n = 158 [61.2%] in 2008-2014; p <. 001). Major amputation above the ankle was performed in 39 patients (8.5%), and 140 patients died within 30 days of surgery (20.2%). Thirty day mortality rate was lower after occluded grafts/stents/stent grafts (eight patients [9.6%]) and higher after saddle embolus (47 patients [30.9%]); p < .001). There was a reduction in overall 30 day mortality over time (n = 53 [25.5%] in 1994-2000 vs. n = 40 [15.5%] in 2008-2014; p = .007). Long term survival revealed significant differences between the subgroups, although the difference occurred early after the event (p < .001). CONCLUSIONS: Mortality after surgical treatment of AAO is improving over time, yet a significant mortality rate was observed throughout the study period. The proportion of AAO secondary to occluded grafts/stents/stent grafts increased over time.