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 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.     

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.     

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.     

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.     

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.     

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.     

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.     

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.     

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.     

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.     

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.     

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.     

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.     

Prostatic Artery Embolization for Benign Prostatic Hyperplasia: Bleomycin-Eluting versus Bland Microspheres in a Canine Model

PurposeTo prospectively assess safety and efficacy of prostatic artery embolization (PAE) with bleomycin-eluting microspheres for benign prostatic hyperplasia (BPH) in a canine model.Materials and MethodsTwelve adult male beagles (mean age, 1.6 y ± 0.2; range, 1.2–2.0 y) were randomly assigned to group A (n = 6; PAE with bleomycin-eluting 30–60-μm HepaSphere microspheres) and group B (n = 6; PAE with bland 30–60-μm HepaSphere microspheres) between April 2017 and November 2018. Plasma bleomycin concentration in group A was measured within 7 days. Prostate volume (PV) and ischemic volume after PAE were measured by magnetic resonance imaging. Prostates and adjacent organs were harvested after the last magnetic resonance study and histopathologically examined.ResultsPlasma bleomycin concentration peaked at 10 minutes at 2,055.0 ng/mL ± 606.1 and lasted for 1,440 min at low levels after PAE. PV reduction percentage was greater in group A than in group B at 1 month (74.1% ± 4.3 vs 63.7% ± 3.5; P = .006) and 3 months (61.5% ± 6.7 vs 46.1% ± 3.8; P = .001) after PAE. Proportion of prostate ischemic volume was greater in group A than in group B (75.3% ± 3.0 vs 62.0% ± 7.1; P = .006) at 1 month after PAE. Proportion of prostate ischemic volume at 1 month positively correlated with PV percentage reduction at 3 months in group A (r = 0.840, P = .036) and group B (r = 0.844, P = .035). There were no complications or nontarget embolization to surrounding organs after the procedures.ConclusionsIn a canine model, PAE with bleomycin-eluting microspheres was feasible and well tolerated and caused ischemic necrosis and reduction in PV.     

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.     

Comparison of Clinical Performance of VectorFlow and Palindrome Symmetric-Tip Dialysis Catheters: A Multicenter,Randomized Trial

PurposeTo compare clinical performance of 2 widely used symmetric-tip hemodialysis catheters.Materials and MethodsPatients with end-stage renal disease initiating or resuming hemodialysis were randomized to receive an Arrow–Clark VectorFlow (n = 50) or Palindrome catheter (n = 50). Primary outcome was 90-d primary unassisted catheter patency. Secondary outcomes were Kt/V ([dialyzer urea clearance × total treatment time]/total volume of urea distribution), urea reduction ratio (URR), and effective blood flow (Q_B).ResultsPrimary unassisted patency rates with the VectorFlow catheter at 30, 60, and 90 d were 95.5% ± 3.3, 87.2% ± 7.3, and 80.6% ± 9.8, respectively, compared with 89.1% ± 6.2, 79.4% ± 10.0, and 71.5% ± 12.6 with the Palindrome catheter (P = .20). Patients with VectorFlow catheters had a mean Kt/V of 1.5 at 30-, 60-, and 90-day time points, significantly higher than the mean Kt/V of 1.3 among those with Palindrome catheters (P = .0003). URRs were not significantly different between catheters. Catheter Q_B rates exceeded National Kidney Foundation–recommended thresholds of 300 mL/min at all time points for both catheters and were similar for both catheters (median, 373 mL/min). Catheter failure, ie, poor flow rate requiring guide-wire exchange or removal, within the 90-day primary outcome occurred in 3 VectorFlow subjects and 5 Palindrome subjects (P = .72). Infection rates were similar, with 0.98 infections per 1,000 catheter days for VectorFlow catheters compared with 2.62 per 1,000 catheter days for Palindrome catheters (P = .44).ConclusionsThe 90-day primary patency rates of Palindrome and VectorFlow catheters were not significantly different, and both achieved sustained high Q_B through 90 day follow-up. However, dialysis adequacy based on Kt/V was consistently better with the VectorFlow catheter versus the Palindrome.     

Ultrasound-Guided Deployment of a Plug-Based Vascular Closure Device in Femoral Arteries with Calcified Plaque or Stenosis

From January 2019 to January 2020, 106 patients (age, 64.8 ± 14.1 years; male, 63.2%) were included to retrospectively investigate the feasibility and safety of ultrasound-guided deployment of ExoSeal after femoral artery access. Baseline characteristics were not different except for age (P = .022), body mass index (P = .009), and diameter (P < .001) between the calcified plaque or stenosis (CS) group (n = 49) and non-CS group (n = 57). The overall technical and clinical success rates were 96.2% and 100%, respectively. The technical (CS group, 48/49; non-CS group, 54/57) and clinical success rates (100%), time to hemostasis (CS group, 3.21 ± 0.54 min; non-CS group, 3.39 ± 0.71 min), and complication rates (CS group, 1/49; non-CS group, 0/57) were not different between the 2 groups. ExoSeal seems to be safe to use under ultrasound guidance in the femoral arteries with CS.     

Portal Vein Recanalization for Noncirrhotic Portal Vein Cavernous Transformation: Transjugular Intrahepatic Portosystemic Shunt Creation versus Portal Vein Stent Placement

PurposeTo compare the clinical outcomes of transjugular intrahepatic portosystemic shunt (TIPS) creation versus portal vein stent placement (PVS) in patients with noncirrhotic cavernous transformation of the portal vein (CTPV).Materials and MethodsIn this retrospective study, clinical data from patients with noncirrhotic CTPV who underwent TIPS creation or PVS were compared. A total of 54 patients (mean age, 43.8 years ± 15.8; 31 men and 23 women) were included from January 2013 to January 2021; 29 patients underwent TIPS creation, and 25 patients underwent PVS. Stent occlusion, variceal rebleeding, survival, and postprocedural complications were compared between the 2 groups.ResultsThe mean follow-up time was 40.2 months ± 26.2 in the TIPS group and 35.3 months ± 21.1 in the PVS group. The stent occlusion rate in the PVS group (16%, 4 of 25) was significantly lower than that in the TIPS group (41.4%, 12 of 29) during the follow-up (P = .042). The cumulative variceal rebleeding rates in the TIPS group were significantly higher than those in the PVS group (28% vs 4%; P = .027). The procedural success rate was 69% in the TIPS group and 86% in the PVS group (P = .156). There was a higher number of severe adverse events after TIPS than after PVS (0% vs 24%; P = .012).ConclusionsPortal vein recanalization with PVS may be a preferable alternative to TIPS creation in the treatment of noncirrhotic CTPV because of higher stent patency rates, lower risk of variceal rebleeding, and fewer adverse events.     

Evaluation of Fibrinogen Levels during Catheter-Directed Thrombolysis for Acute Pulmonary Embolism

PurposeTo evaluate the effect of catheter-directed thrombolysis (CDT) with tissue plasminogen activator (tPA) on plasma fibrinogen levels (PFLs) in the setting of acute pulmonary embolism (PE) and the relationship between PFL and hemorrhagic complications.Materials and MethodsA retrospective review of CDT procedures between 2009 and 2019 identified 147 CDT procedures for massive or submassive PE (55.8% males; age, 56.5 ± 14.8 years; 90.5% submassive). All patients received therapeutic anticoagulation during CDT with unfractionated heparin (UFH) (69.4%) or low-molecular-weight heparin (LMWH, 30.6%) infusion. CDT was performed with ultrasound-accelerated thrombolysis (USAT) catheters (n = 98), conventional catheter-directed thrombolysis (CCDT) catheters (n = 34), or a combination of both (n = 15).ResultsThere was a decrease (P = .007) of 15.1 ± 69.4 mg/dl from the initial PFL (376.1 ± 122.7 mg/dl) to the final PFL (361 ± 118.7 mg/dl), which was measured after a mean of 24.1 ± 11.7 hours with a mean tPA dose of 28.3 ± 14.2 mg. The fibrinogen nadir was 327.6 ± 107.1 mg/dl measured 13.4 ± 10.3 hours after initiation of thrombolysis. Of patients with hemorrhagic complications (n = 6), initial, final, and nadir PFL were not significantly lower (P = .053, P = .081, and P = .086, respectively) than the remainder of the cohort. No significant difference was noted in initial and final PFL between the LMWH and UFH groups (P = .2 and P = .1, respectively) or between the CCDT and USAT groups (P = .5 and P = .9, respectively). The UFH group had a lower nadir PFL than the LMWH group (P = .03).ConclusionsDespite a significant drop in PFL during CDT for acute PE, this was not associated with hemorrhagic complications. These findings were not affected by the choice of anticoagulant or catheter delivery system.