Outcomes of Drug-Coated Balloon Angioplasty for Isolated Chronic Occlusion of the Popliteal Artery: A Retrospective Single-Institution Study

PurposeTo assess the 12-month safety and effectiveness of paclitaxel drug-coated balloon (DCB) for the treatment of patients with isolated chronic occlusions in popliteal arteries and evaluate the risk factors of lesion reocclusion.Materials and MethodsFrom January 2018 to December 2019, DCB angioplasty was performed in 54 limbs with isolated chronic popliteal artery occlusion of 48 patients (32 men) with a mean age of 71.5 ± 12.1 (range, 50–97) years, mean occlusive length of 6.3 ± 3.0 (range, 1–15) cm, and mean preoperative ankle-brachial index (ABI) of 0.42 ± 0.12 (range, 0.19–0.58). A total of 18.5% (10/54) of lesions were long-segment occlusions involving the entire popliteal artery from P1 to P3. Twenty seven of 54 limbs presented with critical limb ischemia (CLI) with a mean ABI of 0.33 ± 0.10 (range, 0.19–0.51). The primary endpoint was primary patency rate at 12 months. The secondary endpoints included technical success rate, 1-year secondary patency rate, limb salvage rate, and improvement in clinical symptoms. Univariate Cox regression analysis was used to determine the predictors of lesion reocclusion.ResultsThe technical success rate was 85.2% (46/54), and bailout stenting was performed in 14.8% (8/54) of lesions. The 12-month primary and secondary patency rates by the Kaplan–Meier estimate were 72.6% and 88.3%, respectively. Two thirds of the reocclusions occurred within 6 months after intervention. No 30-day mortality was observed. The limb salvage rate was 100% during a mean follow-up period of 13 months, and all minor amputations occurred in the limbs presented with CLI. The mean ABI increased from 0.42 before the procedure to 0.73 after the procedure. Patients younger than 60 years and the lesions exhibiting long-segment occlusions present as trending risk factors for lesion reocclusion.ConclusionsPaclitaxel DCB angioplasty is safe and effective in managing isolated chronic occlusion of popliteal arteries. Younger patients and long-segment occlusions of the popliteal artery are associated with a relatively higher reocclusion rate after the procedure.     

Effectiveness and Safety of Atherectomy versus Plain Balloon Angioplasty for Limb Salvage in Tibioperoneal Arterial Disease

PurposeTo evaluate the effectiveness and safety of atherectomy versus plain balloon angioplasty (POBA) for treatment of critical limb ischemia (CLI) due to tibioperoneal arterial disease (TPAD).Materials and MethodsPatients enrolled in the Vascular Quality Initiative registry who had CLI (Rutherford Class 4–6) and underwent atherectomy versus POBA alone for isolated TPAD were retrospectively identified. Of eligible patients, a cohort of 2,908 patients was propensity matched 1:1 by clinical and angiographic characteristics. The atherectomy group comprised 1,454 patients with 2,183 arteries treated, and the POBA group comprised 1,454 patients with 2,141 arteries treated. The primary study endpoint was major ipsilateral limb amputation. Secondary endpoints were minor ipsilateral amputations, any ipsilateral amputation, primary patency, target vessel reintervention (TVR), and wound healing at 12 months.ResultsThe median follow-up period was 507 days, the mean patient age was 69 years ± 11.7, and the mean occluded length was 6.9 cm ± 6.5. There was a trend toward higher technical success rates with atherectomy than with POBA (92.9% vs 91.0%, respectively; P = .06). The rates of major adverse events during the procedure were not significantly different. The 12-month major amputation rate was similar in the atherectomy and POBA groups (4.5% vs 4.6%, respectively; P = .92; odds ratio, 0.97; 95% CI, 0.68–1.37). There was no difference in 12-month TVR (17.9% vs 17.8%; P = .97) or primary patency (56.4% vs 54.5%; P = .64) between the atherectomy and POBA groups.ConclusionsIn a large national registry, treatment of CLI from TPAD using atherectomy versus POBA showed no significant differences in procedural adverse events, major amputations, TVR, or vessel patency at 12 months.     

Long-Term Outcomes of Endovascular Interventions in More than 500 patients with Budd–Chiari Syndrome

PurposeTo assess and compare the long-term outcomes of various endovascular interventions in patients with Budd-Chiari syndrome (BCS).Materials and MethodsIn this single-center retrospective study, 510 consecutive patients with BCS who had undergone a total of 618 endovascular procedures from January 2001 to December 2019 were included. Details of the type of endovascular intervention, technical success, clinical success, patency rate, complications, and survival outcomes were analyzed.ResultsThe overall technical success rate was 96% (593 of 618 procedures; 500 in treatment-naïve patients and 93 repeat interventions for recurrent disease). Endovascular procedures included recanalization procedures (angioplasty and stent placement) in 355 patients (71%) and transjugular intrahepatic portosystemic shunt (TIPS) creation in 145 (29%). Major postprocedure complications occurred in 14 patients (2.8%). Vascular/stent restenosis occurred in 95 patients (19%), and successful repeat intervention was performed in 82 of those 95 (86.3%). An additional 11 of these 82 (13.4%) underwent a third intervention for restenosis. In the recanalization and TIPS groups, the 1- and 5-y cumulative patency rates were 87% and 74% and 95% and 68%, respectively. The 1- and 5-y survival rates were 96% and 89% and 90% and 76%, respectively.ConclusionsEndovascular interventions for BCS are feasible and safe in the majority of patients, with excellent short- and long-term patency and survival rates.     

Assessment of 3-Year Patency after Endoluminal versus Surgical Bypass Therapy for Complex Femoropopliteal Artery Disease

PurposeTo compare the 3-year clinical outcomes of endoluminal bypass with those of surgical bypass for complex femoropopliteal (FP) arterial lesions.Materials and MethodsIn this retrospective multicenter study, 530 patients with symptomatic peripheral artery disease (Rutherford classification 1–3, 66.0%; 4–6, 34.0%) who underwent either endoluminal bypass with Viabahn stent grafts (n = 276) or surgical bypass (n = 254) (with saphenous vein grafts, 74.4%; prosthetic grafts, 25.6%) for FP arterial lesions between 2010 and 2018 were analyzed. The propensity score-matched analysis was performed to compare the 3-year clinical outcomes of endoluminal bypass with those of surgical bypass. The primary end point was primary patency (freedom from restenosis). The secondary end points were secondary patency, freedom from target lesion revascularization (TLR), limb salvage, and overall survival. The interaction effect of baseline characteristics on the association of the revascularization strategy with the risk of restenosis was analyzed using the Poisson mixed-effect model.ResultsThe propensity score-matched analysis extracted 107 pairs. After propensity score matching, the primary patency rate at 1, 2, and 3 years was 84.5%, 75.1%, and 70.9%, respectively, for the endoluminal bypass group versus 78.6%, 73.3%, and 72.0%, respectively, for the surgical bypass group (P = .65). There was no significant difference in secondary patency, freedom from TLR, limb salvage, and overall survival (all P > .05). The subsequent interaction analysis revealed that the involvement of popliteal lesions, small distal reference vessel diameters, and long lesions favored surgical bypass over endoluminal bypass because of improved primary patency (all P for interaction < .05).ConclusionsThe 3-year clinical outcomes after endoluminal bypass or surgical bypass for FP arterial lesions were similar.     

Outcome and Distal Access Patency in Subintimal Arterial Flossing with Antegrade-Retrograde Intervention for Chronic Total Occlusions in Lower Extremity Critical Limb Ischemia

PurposeTo report the outcome and distal access patency of the Subintimal Arterial Flossing with Antegrade-Retrograde Intervention (SAFARI) technique for chronic total occlusion (CTO) in critical limb ischemia (CLI).Materials and MethodsFrom January 2009 to June 2015, 220 SAFARI procedures were performed for 200 limbs in 191 patients (108 males [56.5%]; median age, 70 years old; range, 36 to 97 years old) with CLI (9.4% were Fontaine classification 3; and 90.6% were Fontaine classification 4). Distal access was obtained from the distal superficial femoral artery (n = 6), popliteal artery (n = 49), anterior tibial artery (n = 56), dorsalis pedis (n = 51), peroneal artery (n = 12), posterior tibial artery (n = 45), and lateral plantar artery (n = 1). Distal access hemostasis was obtained with internal balloon tamponade in 71.4% (n = 157). Outcome measurements were technical success, freedom from major amputation and complications. Preprocedural angiograms of clinically driven repeat interventions were reviewed in 73 cases for distal access patency.ResultsTechnical success was achieved in 80.5% (n = 177). Reasons for technical failure include inability to obtain distal access (n = 3), cross the occlusion retrogradely (n = 16), re-enter the true lumen (n = 9), and achieve antegrade blood flow after the procedure (n = 15). Freedom from major amputation for technically successful procedures was 84.7%, 82.9%, and 81.9% at 6, 12, and 24 months, respectively. There were 3 cases of distal access bleeding with 1case that required coil embolization. The distal access remained patent in 80.8% of observable cases with repeated endovascular intervention.ConclusionsDistal retrograde arterial access (SAFARI) technique is safe and effective in the treatment of CTOs in the context of CLI, after failure of antegrade revascularization.     

Evaluation of Technical Success,Efficacy, and Safety of Portomesenteric Venous Intervention following Nontransplant Hepatobiliary or Pancreatic Surgery

PurposeTo evaluate technical success, efficacy and safety of portomesenteric venous (PMV) intervention for PMV stenosis or occlusion following nontransplant hepatobiliary or pancreatic (HPB) surgery.Materials and MethodsA retrospective review identified 42 patients (mean age 60 y) with PMV stenosis (n = 33; 79%) or occlusion (n = 9; 21%) who underwent attempted PMV intervention following HPB surgery between June 1, 2011, and April 1, 2018. Main outcomes were technical success, primary patency rates, and complications. Technical success was compared by venous pathology and primary PMV patency based on anticoagulation status after the procedure using Fisher exact test. Rates of primary patency by stent group were estimated using Kaplan-Meier method.ResultsTechnical success was 91% (n = 38/42) and significantly higher in patients with stenosis (n = 33/33; 100%) vs occlusion (n = 5/9; 56%) (P = .001). Primary presenting symptom resolved in 28 (87%) patients, including 6 (100%) patients with gastrointestinal bleeding. At mean imaging follow-up of 8.6 months ± 8.8, primary stent patency was 76%. There was no significant difference in primary stent patency based on anticoagulation status after the procedure (P = .48). There were 2 (4.8%) periprocedural complications.ConclusionsPortomesenteric venoplasty and stent placement following nontransplant HPB surgery is safe with a high rate of technical success if performed before chronic occlusion.     

Prospective,Multicenter Clinical Study of the Covera Vascular Covered Stent in the Treatment of Stenosis at the Graft-Vein Anastomosis of Dysfunctional Hemodialysis Access Grafts

PurposeTo study the use of the self-expanding Covera covered stent for the treatment of stenotic lesions at the venous anastomosis of hemodialysis arteriovenous grafts (AVGs).Materials and MethodsA total of 110 patients with AVG venous anastomotic stenosis of ≥50% and access dysfunction were treated at 14 centers in the United States using percutaneous transluminal angioplasty followed by covered stent placement. The primary end points were 30-day safety and 6-month target lesion primary patency (TLPP). The secondary measures included access circuit primary patency, circuit cumulative patency, and the number of reinterventions through 24 months.ResultsFreedom from a primary safety event at 30 days was 96.4% while the 6-month TLPP rate was 70.3%. Seventy-five patients completed 24-month follow-up (68.2%). The TLPP rates were 54.2% at 365 days and 36.9% at 730 days while the access circuit primary patency rates were 16.7% at 365 days and 7.8% at 730 days (Kaplan-Meier analysis). The access circuit cumulative patency rates were 85.4% at 12 months and 73.6% at 24 months. The number of reinterventions to maintain the patency of the access circuit was 3.6 ± 3.1 at 24 months (1.6 ± 1.9 at the target lesion).ConclusionsUse of the Covera covered stent for hemodialysis graft-vein anastomotic stenosis provided a safe treatment option with a TLPP rate of 70.3% at 6 months and TLPP and cumulative access circuit patency rates of 36.9% and 73.6% at 2 years.     

Mechanochemical Endovenous Ablation of Varicose Veins in Pediatric Patients with Klippel-Trénaunay Syndrome: Feasibility,Safety, and Initial Results

PurposeTo evaluate feasibility, safety, and results of endovenous mechanochemical ablation (MOCA) for treatment of persistent embryonic and dysplastic veins in pediatric patients with Klippel-Trénaunay syndrome (KTS).Materials and MethodsThirteen MOCA procedures were performed in 11 patients (age range, 4–16 years) with KTS and symptomatic persistent embryonic or dysplastic veins during a 24-month period. All patients were evaluated with color Doppler (CD) ultrasound (US), contrast-enhanced MR imaging, and venography to assess the anatomy of the target vessels and patency of the deep venous system. All procedures were performed under general anesthesia with a ClariVein catheter and liquid sodium tetradecyl sulfate as the sclerosing agent. US and fluoroscopic guidance were used in all cases. Technical success rate, primary occlusion rate, adverse effects, and recanalization rates were evaluated. Clinical and radiological (CD US) controls were performed 1 day, 7 days, 1 month, and 6 months after the procedure and once a year thereafter, with a mean follow-up of 16 months (range, 6–25 months).ResultsTechnical success and primary occlusion were achieved in all patients with no adverse events. During the follow-up period, CD US demonstrated partial recanalization and symptom recurrence in 2 patients (18%), 14 and 18 months after the initial procedure. These 2 patients had a second ablation procedure with no recanalization or symptom recurrence during the subsequent follow-up period.ConclusionsMOCA is feasible and appears to be a safe and effective technique for treatment of varicose veins in pediatric patients with KTS.     

Below-the-Ankle Angioplasty in Patients with Critical Limb Ischemia: A Systematic Review and Meta-Analysis

PurposeTo evaluate the safety and effectiveness of below-the-ankle (BTA) angioplasty and to assess whether additional BTA angioplasty after below-the-knee (BTK) angioplasty would improve clinical outcomes in patients with critical limb ischemia.Materials and MethodsTwo authors independently performed the search, study selection, assessment of methodological quality, and data extraction for this systematic review and meta-analysis. MEDLINE, Embase, and the Cochrane Database of Systematic Reviews were searched. Articles were eligible if it was reported that BTA angioplasty was performed and if the articles were published in English and had the full text available. Methodological quality was assessed using the Methodological Index for Non-Randomized Studies (MINORS) score. The primary outcome was 12-month limb salvage rate. Secondary outcomes were 12-month amputation-free survival, technical success, complications, survival, and freedom from reintervention.ResultsTen articles met the inclusion criteria, reporting a total of 478 patients with BTA angioplasty performed in 524 legs. Three of the 10 included studies compared BTK angioplasty only to BTK angioplasty and additional BTA angioplasty. The pooled 12-month limb salvage rate was 92% (95% confidence interval [CI], 0.88–0.96). No statistically significant difference was found in limb salvage when additional BTA angioplasty was compared to BTK angioplasty only (odds ratio [OR], 1.23; 95% CI, 0.61–2.49). The pooled 12-month amputation-free survival was 78% (95% CI, 0.69–0.87). No statistically significant difference was found in amputation-free survival rate when additional BTA angioplasty was compared to BTK angioplasty only (OR, 1.58; 95% CI, 0.95–2.64). The methodological quality of the studies included was moderate, according to the MINORS score.ConclusionsThis systematic review and meta-analysis showed that additional BTA angioplasty is a safe and feasible procedure, with a 92% pooled proportion of limb salvage at 12 months.     

Single-Center Prospective Pilot Study of Sirolimus Drug-Coated Balloon Angioplasty in Maintaining the Patency of Thrombosed Arteriovenous Graft

PurposeTo investigate the use of a sirolimus drug-coated balloon (DCB) in the management of a thrombosed arteriovenous graft (AVG).Materials and MethodsA single-center prospective pilot study was conducted between October 2018 and October 2019. Twenty patients (age = 67.0 years ± 10; male = 35%; mean time on dialysis = 31 months) with thrombosed upper limb AVG were enrolled. After successful pharmacomechanical thrombectomy and adequate treatment of the graft vein junction, sirolimus DCB angioplasty was performed at the graft vein junction. The patients were followed-up for 6 months, and all adverse events occurring during the study period were recorded.ResultsThe primary circuit patency rates at 3 and 6 months were 76% and 65%, respectively, while the assisted-primary circuit patency rates at 3 and 6 months were 82% and 65%, respectively. The 3- and 6-month secondary circuit patency rates were 88% and 76%, respectively. Using Kaplan-Meier analyses, the estimated mean primary, assisted-primary, and secondary patencies were 285 days (95% confidence interval (CI) = 194–376 days), 319 days (95% CI = 221–416 days), and 409 days (95% CI = 333–485 days). No adverse event directly related to sirolimus DCB use was observed.ConclusionsThe results of this pilot study suggest that the application of sirolimus DCB at the graft vein junction after the successful thrombectomy of AVG may be a feasible option to improve patency outcomes.     

A Multinational,Single-Arm Pivotal Study Assessing the Performance of the SoundBite Crossing System for Peripheral Chronic Total Occlusions (The PROSPECTOR Study)

PurposeThis study aimed to demonstrate the efficacy and safety of the SoundBite Crossing System?Peripheral (SCS-P) to facilitate crossing chronic total occlusions (CTOs) of infrainguinal arteries.Materials and MethodsThis clinical trial was approved by the Ethics Committees of all 4 participating centers and enrolled 52 patients with symptomatic de novo infrainguinal CTOs. Technical device success, the primary efficacy endpoint, was defined as the ability to facilitate the treatment of the target lesion by crossing a portion or the whole length of the CTO. Freedom from SCS-P–related major adverse events (MAEs) at 30 days after the procedure was the primary safety endpoint.ResultsThe SCS-P met the primary efficacy and safety endpoints in 92.3% (48/52) and 100% (52/52) of subjects, respectively. Technical device success with postprocedural patency and freedom from SCS-P–related MAEs was achieved in 88.5% (46/52) of subjects. The mean CTO crossing time was 20.0 minutes ± 30.8, and the SCS-P was able to traverse the whole CTO and enter the distal true lumen without the need of any other device in 59.6% (31/52) of subjects. The mean Rutherford category and ankle-brachial index improvement at the 30-day follow-up was 2.4 ± 1.17 and 0.23 ± 0.22, respectively.ConclusionsThe SCS-P demonstrated a satisfactory safety and performance profile to cross peripheral CTOs and enter the distal true lumen of infrainguinal CTOs.     

The Effect of Smoking Cessation on the Technical Success of Endovascular Treatment for Thromboangiitis Obliterans

PurposeTo show that smoking cessation improves the technical success of lower extremity endovascular treatment in patients with thromboangiitis obliterans (TAO), or Buerger disease.Materials and MethodsOne hundred two patients with TAO who underwent endovascular treatment for chronic limb-threatening ischemia or severe claudication of lower extremities in a tertiary hospital between 2015 and 2022 were included in this retrospective study. Data on serum cotinine levels were available for the last 45 patients, and 38 patients constituted the study population. Per the institution’s protocol, patients were instructed to quit smoking 15 days before the intervention. However, cotinine levels showed that some of the patients continued smoking. Technical and recanalization successes were assessed as the primary end points. The secondary end point was the improvement in Rutherford scores at the 1-month follow-up. The McNemar test was used to compare the proportion of recanalized arteries after the intervention.ResultsThirty-seven men and 1 woman (mean age, 42.9 years ± 10.1) were evaluated. The overall technical success rate was 86.8% in the study group. The technical success rate was significantly higher in the nonsmoker group (n = 24 [96%]) than in the smoker group (n = 8 [61.5%]; P = .006). One-month clinical data were available for 100% of the patients. The Rutherford category of the nonsmoker group was significantly lower at the 1-month follow-up. In addition, the Wilcoxon signed-rank test revealed lower Rutherford scores after the intervention in the nonsmoker group. The adverse event rate was 8%. One (2.7%) patient in the smoker group underwent a minor amputation.ConclusionsCessation of smoking before endovascular therapy improved technical success and recanalization rates in patients with TAO.     

Management of Port Occlusions in Adults: Different-Site Replacement versus Same-Site Salvage

PurposeTo compare the safety and effectiveness of different-site port placement versus same-site port salvage in adult patients with occluded ports.Materials and MethodsNinety-five occluded subcutaneous infusion ports (ports) in 95 patients presenting between July 1, 2002, and June 30, 2017, were retrospectively reviewed: 48 (51%) different-site placements (replacements; same-day indwelling port removal and different-site new port placement) and 47 (49%) same-site salvages (salvages; 35 fibrin sheath strippings, 12 over-the-wire exchanges). Demographic information, indication for initial placement and replacement or salvage, procedural details, post-intervention primary catheter patency, and post-intervention port sequelae were recorded. Post-intervention primary catheter patency, and malfunction and infection rates were compared with Kaplan-Meier estimation and the log-rank test, and Fisher exact test, respectively. The association of patient risk factors and port patency was assessed with Cox regression.ResultsMedian primary catheter patency after replacement was 254 days (interquartile range [IQR], 297) and after salvage was 391 days (IQR, 906) (P = .25). Within the salvage group, median primary catheter patency after stripping was 391 days (IQR, 658) and after exchange was 666 days (IQR, 1412) (P = .08). There was no statistical difference in malfunction (P = .12) and infection (P = .74) rates between the replaced and salvaged groups or in malfunction (P = .09) and infection (P = .1) rates between the exchanged and stripped subgroups. None of the patient or catheter characteristics assessed were significantly associated with primary catheter patency.ConclusionsThere was no statistical difference between patency, malfunctions, or infections after replacement and salvage, or after stripping and exchange, so technique selection should be based on the patient’s estimated lifetime venous access requirements, cost, and physician preference.     

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.     

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

PurposeTo 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 MethodsThis 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.ResultsThe 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).ConclusionsThe 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.     

“Angioplasty-First” Approach for Limb Salvage in Asian Patients with Critical Limb Ischemia: Outcomes from 3,303 Angioplasties on 2,402 Limbs in a Single Tertiary Hospital

PurposeTo review outcomes of patients with critical limb ischemia (CLI) who underwent conventional percutaneous transluminal angioplasty (PTA) as first-line treatment for revascularization.Materials and MethodsRetrospective review of 3,303 angioplasty procedures on 2,402 limbs in 1,968 patients with CLI was conducted. Mean patient age was 68 years ± 11, and 1,057 patients (54%) were male. Diabetes mellitus (DM) was present in 1,736 patients (88%), and end-stage renal disease (ESRD) in 579 (29%). A majority of patients (90%) had tissue loss. Limb salvage rates were generated by Kaplan–Meier plot. Univariate and multivariate Cox regression analysis was conducted to investigate associations between clinical predictors and time-to-event outcome.ResultsLimb salvage rates at 1, 3, 5, and 10 years were 75%, 73%, 72%, and 62%, respectively, and overall survival rates were 79%, 64%, 56%, and 34%, respectively. In multivariable Cox regression analysis with the outcome of major amputation, significant predictors included age < 69 years (P = .032), Malay race (P = .029), DM (P < .001), history of cerebral vascular disease (P = .003), ESRD (P < .001), Rutherford classification (P = .042), repeat intervention (P = .034), and number of straight-line flows (P < .001) and plantar arch integrity (P < .001) on completion angiography. Significant associations with mortality were age < 69 years (P < .001), male sex (P = .030), Malay race (P = .027), history of ischemic heart disease (P < .001), ESRD (P < .001), and repeat intervention (P < .001).ConclusionsPTA as first-line revascularization for patients with CLI is safe and effective. Further studies are suggested to validate the outcome predictive model.     

Lower Extremity Venous Stent Placement: A Large Retrospective Single-Center Analysis

PurposeTo study short-term and long-term outcomes of lower extremity venous stents placed at a single center and to characterize changes in vein diameter achieved by stent placement.Materials and MethodsA database of all patients who received lower extremity venous stents between 1996 and 2018 revealed 1,094 stents were placed in 406 patients (172 men, 234 women; median age, 49 y) in 513 limbs, including patients with iliocaval stents (9.4% acute thrombosis, 65.3% chronic thrombosis, 25.3% nonthrombotic lesions). Primary, primary assisted, and secondary patency rates were assessed for lower extremity venous stents at 1, 3, and 5 years using Kaplan-Meier analyses and summary statistics. Subset analyses and Cox regression were performed to identify risk factors for patency loss. Vein diameters and Villalta scores before and up to 12 months after stent placement were compared. Complication and mortality rates were calculated.ResultsPrimary, primary assisted, and secondary patency rates at 5 years were 57.3%, 77.2%, and 80.9% by Kaplan-Meier methods and 78.6%, 90.3%, and 92.8% by summary statistics. Median follow-up was 199 days (interquartile range, 35.2–712.0 d). Patency rates for the subset of patients (n = 46) with ≥ 5 years of follow-up (mean ± SD 9.1 y ± 3.4) were nearly identical to cohort patency rates at 5 years. Patients with inferior vena cava stent placement (hazard ratio 2.11, P < .0001) or acute thrombosis (hazard ratio 3.65, P < .0001) during the index procedure had significantly increased risk of losing primary patency status. Vein diameters were significantly greater after stent placement. There were no instances of stent fracture, migration, or structural deformities. In patients with chronic deep vein thrombosis, Villalta scores significantly decreased after stent placement (from 15.7 to 7.4, P < .0001). Perioperative mortality was < 1%, and major perioperative complication rate was 3.7%.ConclusionsCavo-ilio-femoral stent placement for venous occlusive disease achieves improvement of vein disease severity scores, increase in treated vein diameters, and satisfactory long-term patency rates.     

Midterm and Long-Term Outcomes following Dedicated Endovenous Nitinol Stent Placement for Symptomatic Iliofemoral Venous Obstruction: Three- to 5-Year Results of the VIRTUS Study

PurposeTo assess the midterm patency and long-term safety of placement of a dedicated venous stent (Vici Venous Stent System) for the treatment of venous lesions of the iliofemoral outflow tract.Materials and MethodsPatients with unilateral obstructive disease of the iliofemoral veins and a Clinical, Etiological, Anatomical, Pathophysiological class of 3 or higher or a Venous Clinical Severity Score of 2 or greater were enrolled in this prospective, multicenter, single-arm study at 23 sites in the United States and Europe. The patients were followed up for 36 months after the index procedure for the assessment of patency and up to 60 months for the assessment of safety. The clinical outcomes in 11 patients with a stent fracture were assessed.ResultsA total of 200 patients enrolled in 2 cohorts (ie, feasibility cohort, n = 30; pivotal cohort, n = 170) were combined for this analysis. The overall 36-month primary patency rate was 71.7% (86/120), and the 36-month primary patency rate was 96.4% (27/28) for the nonthrombotic group and 64.1% (59/92) for the postthrombotic group. The freedom from major adverse events was 81.2% (53/65) through 60 months. The 60-month Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) was 84.3%. In 9 of the 11 patients who had a stent fracture (1 patient with nonthrombotic etiology and 10 patients with postthrombotic etiology) identified at 12 months, the stents extended into the common femoral vein. The TVR rates and clinical outcomes were similar between patients with and without a stent fracture.ConclusionsThe results of the VIRTUS study demonstrated good midterm patency and long-term safety following the placement of a dedicated venous stent for iliofemoral obstruction.     

IN.PACT AV Access Trial: Economic Evaluation of Drug-Coated Balloon Treatment for Dysfunctional Arteriovenous Fistulae Based on 12-Month Clinical Outcomes

PurposeTo study, from a U.S. payer’s perspective, the economic consequences of drug-coated balloon (DCB) versus standard percutaneous transluminal angioplasty (PTA) use for the treatment of stenotic lesions in dysfunctional hemodialysis arteriovenous fistulae.Materials and MethodsCost differences between DCBs and PTA at year 1 and beyond were calculated via 2 methods. The first approach used the mean absolute number of trial-observed access circuit reinterventions through 12 months (0.65 ± 1.05 vs 1.05 ± 1.18 events per patient for DCBs and PTA, respectively) and projected treatment outcomes to 3 years. The second approach was based on the trial-observed access circuit primary patency rates at 12 months (53.8% vs 32.4%) and calculated the cost difference on the basis of previously published Medicare cost for patients who maintained or did not maintain primary patency. Assumptions regarding DCB device prices were tested in sensitivity analyses, and the numbers needed to treat were calculated.ResultsUsing the absolute number of access circuit reinterventions approach, the DCB strategy resulted in an estimated per-patient savings of $1,632 at 1 year and $4,263 at 3 years before considering the DCB device cost. The access circuit primary patency approach was associated with a per-patient cost savings of $2,152 at 1 year and $3,894 at 2.5 years of follow-up. At the theoretical DCB device reimbursement of $1,800, savings were $1,680 and $2,049 at 2.5 and 3 years, respectively. The one-year NNT of DCB compared to PTA was 2.48.ConclusionsEndovascular therapy for arteriovenous access stenosis with the IN.PACT AV DCB can be expected to be cost-saving if longer follow-up data confirm its clinical effectiveness.     

Iliocaval Skip Stent Reconstruction Technique for Chronic Bilateral Iliocaval Venous Occlusion

PurposeTo report safety and efficacy of a skip stent technique using nitinol stents in patients with chronic bilateral iliocaval venous occlusions.Materials and MethodsA retrospective analysis of 48 consecutive patients (32 men; mean age, 40.7 years; age range, 18–68 years) with chronic bilateral iliocaval obstructions treated using a nonoverlapping stent technique was conducted at a single center. None of the patients had May-Thurner syndrome. Iliocaval confluence was treated by deploying a nitinol stent in inferior vena cava (IVC) and a nitinol stent in each common iliac vein close to the caval stent. Patency of stents was assessed by duplex US at 2 weeks, 3 months, and 6 months and yearly thereafter.ResultsRecanalization and stent reconstruction was technically successful in 47 (98%) patients. The sinus-XL venous stent was used to treat IVC (95 [100%]). Common iliac and external iliac veins were treated with sinus-Venous and VENOVO stents (80 [83%] and 16 [17%] limbs, respectively). External iliac and common femoral veins were treated with sinus-Venous and VENOVO stents (83 [92%] and 7 [18%] limbs, respectively). Early thrombosis (< 30 days) of the iliac vein with stent occurred in 2 limbs. Cumulative primary, assisted primary, and secondary patency rates at 30 months were 74%, 83%, and 97%.ConclusionsFindings of this study suggest that leaving a skipped lesion at the level of iliocaval confluence may not adversely affect stent patency. Patency rates were comparable with other reported techniques of stent reconstruction at the level of iliocaval confluence.