IN.PACT AV Access Randomized Trial: 12-Month Clinical Results Demonstrating the Sustained Treatment Effect of Drug-Coated Balloons

PurposeTo present the 12-month outcomes of the IN.PACT AV Access Study, a prospective, single-blind trial enrolling participants with obstructive de novo or restenotic native upper extremity arteriovenous dialysis fistula lesions treated with a drug-coated balloon (DCB) or percutaneous transluminal angioplasty (PTA).Materials and MethodsAfter successful high-pressure PTA, participants at 29 international sites were randomized 1:1 to treatment with an IN.PACT AV DCB (n = 170) or standard uncoated PTA (n = 160). Outcomes at 12 months include target lesion primary patency (TLPP), defined as freedom from clinically driven target lesion revascularization or access circuit thrombosis; access circuit primary patency; number of reinterventions; and adverse events involving the access circuit.ResultsAt 12 months, TLPP was 63.8% (90/141) in the DCB group compared with 43.6% (61/140) in the PTA group (P < .001). The total number of reinterventions required to maintain TLPP through 360 days was 93 in the DCB group and 144 in the PTA group, with a 35.4% reduction in reinterventions when DCB was used. Access circuit thrombosis occurred in 2.9% (4/138) of the participants in the DCB group and in 6.2% (8/129) of those in the PTA group (P = .19). Time to TLPP was assessed using a multivariable analysis to identify the factors associated with loss of patency. The treatment device was the independent predictor with the largest effect, with a hazard ratio of 0.42 (95% confidence interval, 0.29–0.60; P < .001).ConclusionsTLPP was statistically significantly higher with DCBs than with standard PTA at 12 months, demonstrating the sustained and superior effectiveness of this device for the treatment of dysfunctional arteriovenous dialysis fistulae.     

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.     

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.     

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.     

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

PurposeTo 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 MethodsThis 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.ResultsLLL 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).ConclusionsDespite 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.     

The Lutonix AV Randomized Trial of Paclitaxel-Coated Balloons in Arteriovenous Fistula Stenosis: 2-Year Results and Subgroup Analysis

PurposeTo present final, 2-year results of a randomized trial comparing paclitaxel-coated vs uncoated balloon angioplasty following vessel preparation with ultra–high-pressure percutaneous transluminal angioplasty (PTA) in hemodialysis arteriovenous fistulae (AVFs).Materials and MethodsTwenty-three sites enrolled 285 subjects with dysfunctional AVFs located in the arm. Before 1:1 randomization, successful vessel preparation was achieved (full waist effacement, < 30% residual stenosis). Follow-up was clinically driven except for a 6-month office visit.ResultsNinety-six of 141 subjects in the drug-coated balloon (DCB) arm and 111 of 144 in the control arm completed the study. Target lesion primary patency (TLPP) rates for the DCB and control groups were 58% ± 4 vs 46% ± 4 (P = .02) at 9 months, 44% ± 5 vs 36% ± 4 (P = .04) at 12 months, 34% ± 5 vs 28% ± 4 (P = .06) at 18 months, and 27% ± 4 vs 24% ± 4 (P = .09) at 24 months, respectively. Mean time to TLPP event for subjects with an event was longer for DCBs (322 vs 207 d; P < .0001). Fewer interventions were needed to maintain target lesion patency in the DCB group at 9 months (P = .02) but not at 12 (P = .08), 18 (P = .13), or 24 months (P = .19). The noninferiority safety target was met at all intervals (P < .01). Mortality did not differ between groups (P = .27). Post hoc analyses showed equivalent DCB effect in all subgroups.ConclusionsTwo-year results demonstrate long-term safety and variable efficacy of DCB angioplasty in AVFs.     

Stent Diameter,Not Cephalic Arch Anatomy,Predicts Stent Graft Patency in Cephalic Arch Stenosis

PurposeTo investigate the relationship between anatomic factors and primary patency of brachiocephalic arteriovenous fistulae (AVFs) after stent graft (SG) placement for cephalic arch stenosis (CAS).Materials and MethodsThis retrospective study reviewed all cephalic arch SGs placed in brachiocephalic AVFs in a tertiary academic medical center between 2014 and 2017. Sixty-three patients were included in the study. The mean patient age at the time of SG placement was 62.6 years ± 19, and the mean patient follow-up was 1,994 days ± 353. A cohort of patients (n = 31) who underwent brachiocephalic fistulograms for CAS but only received percutaneous transluminal angioplasty (PTA) was the control group. Patient demographic characteristics, AVF anatomy, SG type, and clinical outcomes were reviewed. The duration of primary cephalic arch patency after SG placement was compared with that after previous PTA.ResultsThe median AVF age at the time of data retrieval was 345 days. The primary patency of CAS after SG placement at 6 months, 12 months, and 3 years was 64%, 49.9%, and 23.5%, respectively. Primary cephalic arch patency was significantly associated with the SG diameter (P = .007) but not with cephalic vein–axillary vein junction anatomy, size of feeding artery, or SG length (P > .05). The primary patency of CAS in patients treated with PTA only (n = 31) at 6 months, 12 months, and 3 years was 61%, 35%, and 0%, respectively, which was significantly lower than that in patients treated with SG placement (P = .01).ConclusionsThis study showed that the primary patency of CAS after SG placement was significantly higher than that of PTA-only treatment. Moreover, primary cephalic arch patency after SG placement was significantly associated with the SG diameter.     

The Effects of Protrusion into the Outflow Vein on Outcomes of Stent Grafts Used to Treat Cephalic Arch Stenoses in Dysfunctional Brachiocephalic Fistulae

PurposeTo assess long-term patency rates of cephalic arch stent grafts in brachiocephalic fistulae and the importance of device position.Materials and MethodsThis retrospective study reviewed 152 patients with dysfunctional brachiocephalic fistulae and cephalic arch stenosis treated with stent grafts (Viabahn; W. L. Gore) at a single tertiary center between 2012 and 2021. The median age was 67.5 years (range, 25–91 years), and the median follow-up period was 637 days (range, 3–3,368 days). A grading system of protrusion was applied: (a) Grade 0, no protrusion; (b) Grade 1, perpendicular; and (c) Grade 2, in-line protrusion. Subsequent fistulograms were available in 133 (88%) of the 152 patients and were assessed for central vein stenosis within 10 mm of the stent graft. Clinical records were assessed for sequelae of stent graft protrusion. Stent graft primary and cumulative circuit patencies were calculated using the Kaplan-Meier method.ResultsProtrusion was documented in 106 (70%) stent grafts—56 Grade 1 and 50 Grade 2. Central vein stenosis was seen in 1 (2%) case of no protrusion (Grade 0) and 38 (40%) cases of protrusion (P < .0001). There was no significant difference in stenosis between Grade 1 and 2 protrusion (P = .15). No adverse clinical sequelae occurred in 147 (97%) patients. Eight patients had a new access subsequently formed in the same arm, and 3 of these 8 patients developed symptoms due to the previous stent graft protrusion (all Grade 2). The primary patency rates of the stent-grafts at 6 and 12 months were 73% and 50%, respectively. The cumulative access circuit patency rates at 1, 2, and 5 years were 84%, 72%, and 54%, respectively.ConclusionsThis study demonstrated that protrusion of a cephalic arch stent graft into the central vein is safe and only clinically relevant when a subsequent ipsilateral access is created.     

Sex-Related Differences in the Long-Term Outcomes of Patients with Femoropopliteal Arterial Disease Treated with the IN.PACT Drug-Coated Balloon in the IN.PACT SFA Randomized Controlled Trial: A Post Hoc Analysis

PurposeTo evaluate sex-related disparities in long-term outcomes of patients with peripheral artery disease (PAD) treated with IN.PACT drug-coated balloon (DCB) or percutaneous transluminal angioplasty (PTA).Materials and MethodsA post hoc analysis of the IN.PACT SFA trial was performed. Participants with Rutherford Clinical Classification 2–4 PAD and femoropopliteal artery lesions up to 18 cm long were randomly assigned to treatment with DCB (n = 220) or PTA (n = 111). Effectiveness outcomes were evaluated, including 36-month primary patency (freedom from binary restenosis and freedom from clinically driven [CD] target lesion revascularization [TLR]).ResultsIn the DCB group, women were significantly older (69.4 y ± 9.9) than men (66.4 y ± 9.1; P = .025). Mean reference vessel diameter (RVD) was significantly smaller in women (4.4 mm ± 0.68) compared with men (4.8 mm ± 0.89, P < .001). Primary patency was 65.4% in women and 71.8% in men (P = .302). Freedom from CD-TLR was 81.1% in women and 86.4% in men (P = .285). Women treated with PTA were older (70.4 y ± 8.3) than men (66.9 y ± 9.5; P = .063). Mean RVD was significantly smaller in women (4.2 mm ± 0.77) compared with men (4.9 mm ± 0.77, P < .001). Primary patency was 42.3% in women and 46.7% in men (P = .551). Freedom from CD-TLR was 59.4% in women and 75.5% in men (P = .109). No significant differences were noted in safety and mortality outcomes.ConclusionsIn both groups, women were older and had smaller vessels. Particularly in the PTA group, women had worse clinical outcomes, though not reaching statistical significance. Further evaluation is necessary to understand the disparate nature of disease progression and outcomes following endovascular treatment in women compared with men.     

Efficacy and Safety of Ultrasound-Guided Supraclavicular Brachial Plexus Block during Angioplasty of Dysfunctional Arteriovenous Access: A Prospective,Randomized Single-Center Clinical Trial

PurposeTo evaluate the efficacy and safety of the ultrasound-guided supraclavicular brachial plexus block (BPB) during angioplasty of dysfunctional arteriovenous access.Materials and MethodsEighty study participants with dysfunctional arteriovenous access were enrolled in this prospective, randomized clinical trial between November 2016 and February 2018. Eighty patients were randomized to either the ultrasound-guided supraclavicular BPB group (mean age ± standard deviation [SD], 65.1 ± 12.4; male:female = 17:23) or the no regional anesthesia group (mean age ± SD, 64.0 ± 11.7; male:female = 25:15). Pain was assessed on the 10-point Visual Analogue Scale. Participant satisfaction was examined. Six-month clinical follow-up was done to evaluate arteriovenous access patency and long-term complications.ResultsThe BPB group showed a lower average pain score than the control group (mean ± SD, 0.9 ± 1.9 vs 6.4 ± 2.5; P < .001). Participant satisfaction (mean ± SD, 2.8 ± 0.5 vs 2.1±0.8; P < .001) was also higher in the BPB group. Six-month patency was 65% (26/40) in the BPB group and 59% (23/39) in the control group, with no significant difference between the 2 groups (P = .59). No major immediate or delayed complications were observed.ConclusionsUltrasound-guided BPB is highly effective in reducing pain during angioplasty of dysfunctional arteriovenous access with an acceptable safety profile.     

Percutaneous Arteriovenous Fistula Creation with Intended Brachial Vein Outflow and Secondary Brachial Vein Transposition Using the WavelinQ EndoAVF System

PurposeTo assess percutaneous arteriovenous fistula (pAVF) creation with subsequent brachial vein transposition (BVT) using the WavelinQ endoAVF system.Materials and MethodsA pre-existing database was retrospectively reviewed. Nine patients underwent attempted pAVF-BVT creation between December 2017 and November 2021. Study outcomes included technical success, time to maturation, patency rates, adverse events, and secondary interventions. Maturation was defined as a pAVF flow of ≥500 mL/min, outflow vein diameter ≥5 mm, and successful 2-needle cannulations in patients on active hemodialysis (HD).ResultspAVF-BVT creation was technically successful in 8 of 9 patients (89%). Six of 8 created pAVFs remained patent and matured at 4 weeks, subsequently undergoing secondary BVT. Primary patency rates at 6, 12, and 24 months were 37.5%, 12.5%, and 12.5%, respectively. Secondary patency rates at 6, 12, and 24 months were 75%, 37.5%, and 37.5%, respectively. One patient had postprocedural access site bleeding, and 4 required secondary interventions to maintain patency. Two patients with failed pAVFs with BVT were successfully converted to surgical AVFs, probably facilitated by sufficient enlargement of superficial veins following pAVF creation.ConclusionsOff-label use of the WavelinQ system to create brachial vein outflow pAVF with BVT may be an alternative procedure for HD access creation in select patients with exhausted superficial veins.     

Combination of Percutaneous Rotational Thrombectomy and Drug-Coated Balloon for Treatment of Femoropopliteal Artery Nonembolic Occlusion: 12-Month Follow-up

PurposeTo evaluate safety and efficacy of percutaneous mechanical thrombectomy using the Rotarex catheter combined with drug-coated balloon (DCB) in treatment of femoropopliteal artery occlusive disease.Materials and MethodsBetween January 2016 and February 2018, 81 patients with acute or subacute femoropopliteal artery occlusions were treated with the Rotarex catheter combined with DCB. Lesions were classified according to the onset of symptoms as acutely (< 14 d) or subacutely (14 d to 3 mo) occluded. The mean lesion length was 12.1 cm ± 6.7. The primary endpoint was target lesion patency at 1 year as evaluated by duplex ultrasound (peak systolic velocity ratio < 2.4) and freedom from clinically indicated target lesion revascularization. Amputation rate, major adverse events, and ankle-brachial index at 12 months were evaluated.ResultsTechnical success rate was 100% (n = 81). Bailout stents were necessary in 14 patients owing to residual stenosis or flow-limiting dissection. Additional thrombolysis was applied in 10 interventions. No major adverse events occurred during hospital stay. There were 9 restenosis cases during the 12-month follow-up period. Primary patency rate was 87.3% (62/71), and freedom from target lesion revascularization rate was 90.1% (64/71). Ankle-brachial index significantly increased from 0.46 ± 0.15 to 0.77 ± 0.14 during follow-up. The amputation rate was 1.4% at 12 months.ConclusionsThese initial data from 2 centers suggest that the combination of the Rotarex catheter and DCB may be safe and effective for treatment of acute or subacute thrombotic femoropopliteal occlusion with superior immediate and midterm results achieved.     

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.     

Treatment of Arm Swelling in Hemodialysis Patients with Ipsilateral Arteriovenous Access and Central Vein Stenosis: Conversion to the Hemodialysis Reliable Outflow Graft versus Stent Deployment

PurposeTo compare outcomes after conversion of arteriovenous (AV) access to Hemodialysis Reliable Outflow (HeRO) graft vs stent deployment in patients with arm swelling owing to ipsilateral central vein stenosis.Materials and MethodsThis single-center retrospective study comprised 48 patients (19 men, mean age 58 y) with arm swelling ipsilateral to AV access and central vein stenosis over a 13-year period who had clinical follow-up and without prior central stents. Twenty-one patients underwent placement of a HeRO graft with anastomosis of the HeRO graft to the existing graft or fistula, and 27 patients underwent central venous stent deployment. Symptomatic improvement in arm swelling and access patency rates after intervention were ascertained from medical records.ResultsImprovement in swelling within 1 month after HeRO conversion and stent deployment was found in 95% and 89%, respectively (P = .62). Swelling eventually recurred in 16 patients (59%) treated with stents compared with 1 patient (5%) who underwent HeRO conversion (P < .001). Primary access patency was statistically significantly longer after HeRO conversions than stent deployments, with 6- and 12-month primary patency rates of 89% and 72% vs 47% and 11% (P < .001). HeRO conversions also resulted in longer 6- and 12-month secondary access patency rates (95% and 95% vs 79% and 58%, P = .006). Mean number of interventions per 1,000 access days to maintain secondary patency was 2.7 for the HeRO group vs 6.3 for the stent group.ConclusionsAlthough stent deployment and HeRO graft conversion are effective for alleviating arm swelling in the short term in patients receiving hemodialysis with clinically significant arm swelling and functioning AV access, the HeRO graft has more durable results.     

The Retrograde Basilic Approach for Balloon-Assisted Maturation of Brachiocephalic Arteriovenous Fistulas

PurposeTo assess the feasibility and outcomes of an approach utilizing transbasilic access for balloon-assisted maturation (BAM) of brachiocephalic arteriovenous fistulas (BCAVFs).Materials and MethodsThis retrospective analysis comprised 28 patients (mean age, 63 years ± 10.8) who underwent endovascular treatment of their immature BCAVFs via a basilic approach from December 2016 to December 2018. The mean age of the BCAVFs was 3.3 months ± 1.4 at the time of BAM. Other demographic data, vascular access characteristics, procedural data, technical and clinical success rates, and adverse events were also evaluated.ResultsAll patients had inflow juxta-anastomotic stenoses, with 4 patients (14%) having concomitant outflow tract stenoses and 1 patient (4%) having a short-segment occlusion at the stenotic juxta-anastomotic segment. Technical success was achieved in 27 patients (96%). The mean diameter of the largest balloon used was 5.7 mm ± 0.6. Clinical success was achieved in 22 patients (79%), with 6 patients (21%) requiring a subsequent additional intervention before successful cannulation. No perioperative adverse events were observed.ConclusionsThe retrograde basilic approach is feasible, safe, and effective for BAM of BCAVFs.     

Interventional Radiologists Achieve Equivalent Outcomes and Lower Costs for Totally Implantable Venous Access Device Placement Compared to Operating Room Placement

PurposeTo compare the cost and outcomes of surgical and interventional radiology (IR) placement of totally implantable venous access devices (TIVADs) within a large regional health system to determine the service line with better outcomes and lower costs to the health system.Materials and MethodsA retrospective review of all chest port placements performed in the operating room (OR) and IR suite over 12 months was conducted at a large, integrated health system with 6 major hospitals. Secondary electronic health record and cost data were used to identify TIVAD placements, follow-up procedures indicating port malfunction, early adverse events (within 1 month after the surgery), late adverse events (2–12 months after the procedure), and health system cost of TIVAD placement and management.ResultsFor 799 total port placements included in this analysis, the rate of major adverse events was 1.3% and 1.9% for the IR and OR groups, respectively, during the early follow-up (P = .5655) and 4.9% and 2.8% for the IR and OR groups, respectively, during the late follow-up (P = .5437). Malfunction-related follow-up procedure rates were 1.8% and 2.6% for the IR and OR groups, respectively, during the early follow-up (P = .4787) and 12.4% and 10.5% for the IR and OR groups, respectively, during the late follow-up (P = .4354). The mean cost of port placement per patient was $4,509 and $5,247 for the IR and OR groups, respectively. The difference in per-patient cost of port placement was $1,170 greater for the OR group (P = .0074).ConclusionsThe similar rates of adverse events and follow-up procedures and significant differences in insertion cost suggest that IR TIVAD placement may be more cost effective than surgical placement without affecting the quality.     

Percutaneous Arteriovenous Fistula Creation with the WavelinQ 4-French EndoAVF System: A Single-Center Retrospective Analysis of 30 Patients

PurposeTo retrospectively assess the safety and efficacy of percutaneous arteriovenous fistula (pAVF) creation with the WavelinQ 4-F EndoAVF System.Materials and MethodsFrom February 2018 to June 2020, 30 pAVFs were created in 30 consecutive patients (men; age, 55.3 years ± 13.6). Of the 30 patients, 21 (70%) were already on hemodialysis using a central venous catheter. The primary outcome measures were technical success, complications, and cannulation rate. The secondary outcome measures included the number of secondary procedures needed for cannulation, maintenance time to cannulation, and pAVF survival.ResultsTechnical success was 100%. The adverse event rate was 6.7% (2/30), including a pseudoaneurysm of the brachial artery that developed immediately after sheath removal and an aneurysm of the anastomosis 17 days after the procedure, which was treated with a covered stent placed in the arterial side. The mean follow-up was 547 days ± 315.7 (range, 14–1,071 days). The cannulation rate was 86.7% (26/30). The mean time to cannulation was 61.3 days ± 32.5 (range, 15–135 days). The mean follow-up after cannulation was 566.2 days ± 252.7 (range, 35–1,041 days). Four pAVFs were thrombosed after cannulation, with 2 of them successfully declotted. Sixteen interventions were needed to achieve cannulation after the index procedure in 15 patients (overall, 0.53 procedures/patient). Seven maintenance endovascular interventions (following cannulation) were performed during the follow-up period in 6 patients (overall, 0.27 procedures/patient, 0.17 procedures/patient-years). For the pAVFs that were cannulated, patency was 96% at 1 year, and 82% at 2 and 3 years, according to the Kaplan-Meier survival analysis.ConclusionsThis initial experience suggests that pAVF creation is safe and can be successfully performed with high maturation and long-term patency rates. Larger-scale prospective studies are needed to validate the results.     

Diagnosis and Treatment of Nonmaturing Fistulae for Hemodialysis Access via Transradial Approach: A Case-Control Study

PurposeTo compare outcomes of transradial access for endovascular treatment of nonmaturing hemodialysis fistulae compared to brachial arteriography followed by unidirectional or bidirectional fistula access for intervention.Materials and MethodsIn this institutional review board-approved, retrospective, case-control study, 56 consecutive patients with nonmaturing arteriovenous fistulae underwent percutaneous intervention between 2015 and 2018. The transradial group (n = 28) underwent radial artery access for diagnostic fistulography and intervention. The control group (n = 28) underwent retrograde brachial artery access for fistulography followed by unidirectional/bidirectional fistula access for intervention. Both groups had similar demographics, fistula characteristics, and stenosis locations.ResultsFewer punctures were required in the transradial group compared to controls (1.2 vs 2.4, P < .0001), and procedure time was shorter (64.9 vs 91.3 minutes, P = .0016). Anatomic, technical, and clinical success rates trended higher in the transradial group compared to controls (93% vs 86%, 96% vs 89%, and 82% vs 64%, respectively). Nonmaturation resulting in fistula abandonment was lower in the transradial group (3.7% vs 25%, P = .025). Primary unassisted patency at 3, 6, and 12 months was 77.1% ± 8.2%, 73.1% ± 8.7%, and 53.3% ± 10.6% in the transradial group, respectively, and 63.0% ± 9.3%, 55.6% ± 9.6%, and 48.1% ± 9.6% in the control group, respectively (P = .76). Primary assisted patency at 12 months was 92.3% ± 5.3% in the transradial group compared to 61.8% ± 9.6% at 12 months in the control group (P = .021). No major complications occurred. Minor complications were lower in the transradial group than in the control group (14% vs 39%, P = .068).ConclusionsTreatment of nonmaturing fistulae via a transradial approach was safe, improved midterm patency, and was associated with lower rates of fistula abandonment.     

The Use of an Inflatable Adhesive External Compression Device for Maintenance of Hemostasis following Angiography in Children

PurposeTo assess the safety and efficacy of the posthemostasis use of an inflatable adhesive external compression device (SafeGuard) following angiography in children performed under general anesthesia.Materials and MethodsMedical records of 74 children (43 females) with a mean age of 8.9 years (range, 0.4–18.0 years) and mean weight of 44.0 kg (range, 7.3–115.7 kg) in whom an inflatable adhesive external compression device was used for maintaining hemostasis following angiography under general anesthesia were retrospectively reviewed. After establishing hemostasis with manual compression, the device was applied and inflated over the arteriotomy. The patients were assessed for access-related adverse events in the recovery unit and during postprocedural follow-up.ResultsThe inflatable adhesive external compression device was utilized to maintain hemostasis following 181 angiography procedures. The mean length of the procedure was 396 minutes. The common femoral artery (n = 170, 93.9%) was the most common access, using 4–5-F vascular sheath (n = 118, 65.2%) or 3–5-F sheathless (n = 8, 12.7%) catheters. The mean time to deflation was 93 minutes. There were no adverse events other than minor bleeding from the arteriotomy after deflation (n = 2, 1.1%) and early deflation of the device because of pain (n = 1, <1%). Follow-up ultrasonography (n = 109 procedures, 60.2% at a mean follow-up of 2.2 years) demonstrated patency of the access artery.ConclusionsThe use of an inflatable adhesive external compression device following angiography in children to maintain hemostasis during the emergence phase of anesthesia and recovery period is safe and effective. The use of this simple device may reduce the need for postprocedural sedation and facilitate early discharge.     

Prostatic Artery Embolization Versus Transurethral Resection of the Prostate for Benign Prostatic Hyperplasia: A Cost-Effectiveness Analysis

PurposeTo compare the cost effectiveness of prostatic artery embolization (PAE) with that of transurethral resection of the prostate (TURP) for the treatment of medically refractory benign prostatic hyperplasia (BPH).Materials and MethodsA cost-effectiveness analysis with Markov modeling was performed, comparing the clinical course after PAE with that after TURP for 3 years. Probabilities were obtained from the available literature, and costs were based on Medicare reimbursements and published cost analyses. Outcomes were measured using quality-adjusted life-year (QALY). Statistical analyses included base case calculation, probabilistic sensitivity analysis, and deterministic sensitivity analysis to assess the robustness of the conclusion under different clinical scenarios.ResultsBase case calculation showed comparable outcomes (PAE, 2.845 QALY; TURP, 2.854 QALY), with a cost difference of $3,104 (PAE, $2,934; TURP, $6,038). The incremental cost-effectiveness ratio was $360,249/QALY. PAE was dominant in 23.2% and more cost effective in 48.4% of the probabilistic sensitivity analysis simulations. PAE was better if its recurrence risk was <20.4% per year and even when the TURP recurrence risk was assumed to be 0%. TURP would be more cost effective when its procedural cost was <$3,367 or the PAE procedural cost >$4,409. PAE remained cost effective when varying the risks and costs of the minor and major short-term or long-term adverse events of both procedures. TURP would be the better strategy if the utility of BPH recurrence was <0.85 QALY.ConclusionsPAE is a cost-effective strategy to treat medically refractory BPH, resulting in comparable health benefits at a lower cost than that of TURP even when accounting for extreme alterations in adverse events, costs, and recurrence rates.