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.     

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.     

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.     

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.     

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.     

Three-Year Efficacy and Safety of the Misago Peripheral Stent for Superficial Femoral Artery Disease: Final Results from the OSPREY Trial

PurposeThis study evaluated the long-term outcomes of the Misago peripheral stent trial (Terumo) for atherosclerotic lesions in the superficial femoral artery (SFA) in patients with claudication.Materials and MethodsThis was a prospective multicenter, single-arm, clinical trial of primary stent placement for de novo cases of SFA disease conducted in the United States and Asia. The primary endpoint was freedom from clinically driven target lesion revascularization (CD-TLR) at 36 months. Secondary outcomes were ankle-brachial index (ABI), Rutherford score, Walking Impairment Questionnaire (WIQ), a quality of life survey, and rate of device fracture.ResultsA total of 276 patients (64.4% male; mean age, 69.3 ± 10.1 years) were enrolled. Freedom from CD-TLR was 78.5% (95% confidence interval [CI], 73.0%–83.0%) at 24 months and 75.4% (95% CI, 69.6%–80.2%) at 36 months. Baseline ABI was 0.7 ± 0.1 and 0.98 ± 0.20 (P < .001) at 30 days after the procedure. Baseline Rutherford score was 3.6 ± 0.6 and 1.6 ± 1.0 30 at 30 days after the procedure (P < .001). Mean (and changed) ABI and Rutherford score at 36 months compared to day 30 after the procedure were, respectively, 0.91 (−0.1 ± 0.2) and 1.5 (−0.2 ± 1.1). WIQ score at baseline was 21.49 ± 26.30 and 50.51 ± 38.49 at 30 days after the procedure ( P < .001). The mean WIQ score at 2 years was 46.65 ± 37.31 (P = .12). Stent fracture rate at 36 months was 2.0% (4 of 202 patients).ConclusionsOSPREY (Occlusive-Stenotic Peripheral Artery Revascularization Study) 36-month data demonstrated persistent freedom from CD-TLR and sustained improvement in ABI and Rutherford score with primary stent placement for SFA lesions.     

Evaluation of the Benefit of Extended Catheter-Directed Thrombolysis with Serial Angiography for Acute Pulmonary Embolism

PurposeTo evaluate whether extended catheter-directed thrombolysis (CDT) with repeat visits to the angiography suite provide added benefit in treatment of acute pulmonary embolism (PE).Materials and MethodsThis was a retrospective review of CDT procedures performed for acute PE in 156 patients (age 56.1 y ± 15.3, 46.2% women) between 2009 and 2019. All patients underwent at least 1 follow-up visit to the angiography suite for evaluation of pulmonary artery pressure (PAP) and thrombus burden (Miller score) before termination (111/156, 71.2%) or continuation of CDT (45/156, 28.8%).ResultsPatients who had CDT extended beyond the first follow-up visit required a higher total dose of tissue plasminogen activator (40.7 mg ± 14.3 vs 22.6 mg ± 9.9, P < .001) to achieve a similar final Miller score (6.4 ± 3.8 vs 7.6 ± 3.9, P = .1) and a similar reduction in systolic PAP (?14.4 mm Hg ± 10.2 vs ?12.6 mm Hg ± 11.9, P = .6). The initial Miller scores were similar in both groups (19.7 ± 5.8 vs 19 ± 4, P = .4) but were significantly higher during the first follow-up visit (after 18 hours ± 5.5 vs 20 hours ± 4.8, P = .06) in patients requiring multiple follow-up visits (12.2 ± 5 vs 7.6 ± 3.9, P < .001). Multiple regression analyses identified heart rate > 100 beats/min and systolic PAP > 55 mm Hg as associated with the need for extended CDT. Extended CDT did not result in a higher hemorrhagic complication rate (1/45 vs 6/111, P = .7).ConclusionsPatients presenting with higher heart rates and systolic PAP may benefit from extended CDT to achieve similar reductions in PAP and thrombus burden, without clear added risk of hemorrhage.     

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.     

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.     

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.     

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.     

Prostatic Artery Embolization Using 100–300-μm Trisacryl Gelatin Microspheres to Treat Lower Urinary Tract Symptoms Attributable to Benign Prostatic Hyperplasia: A Single-Center Outcomes Analysis with Medium-Term Follow-up

PurposeTo report medium-term outcomes of prostatic artery embolization (PAE) using 100–300-μm trisacryl gelatin microspheres to treat lower urinary tract symptoms (LUTS) from benign prostatic hyperplasia (BPH) and to evaluate how cone-beam computed tomography-measured prostate gland volume (PGV), median lobe enlargement (MLE), age, and Charlson Comorbidity Index (CCI) affect these results.Materials and MethodsSeventy-four consecutive patients who underwent PAE from April 2014 through August 2018 were retrospectively reviewed. Patients had International Prostate Symptom Score (IPSS) >12, Quality of Life (QoL) score >2, prostate gland volume (PGV) >40 mL, age older than 45 years, and medical therapy failure. Twelve patients were excluded for bladder pathology or prostate cancer. Patients (n = 62, age = 71.8 ± 9.3 years, CCI = 3.5 ± 1.7, PGV = 174 ± 110 mL) had pre-procedure IPSS = 22.4 ± 5.6, QoL score = 4.4 ± 0.9, and post-void residual (PVR) = 172 ± 144 mL. Post-procedure values were compared to baseline at 1, 3, 6, 12, and 24 months. Associations between outcomes and PGV, MLE, age, and CCI were evaluated. Adverse event recording used Clavien-Dindo classification.ResultsOne month after PAE (n = 37), IPSS improved to 7.6 ± 5.2 (P < .0001) and QoL score improved to 1.7 ± 1.4 (P < .0001). At 3 months (n = 32), improvements continued, with IPSS = 6.4 ± 5.1 (P < .0001), QoL score = 1.2 ± 1.2 (P < .0001), PVR = 53 ± 41 mL (P < .001), and PGV = 73 ± 38 mL (P < .0001). Results were sustained at 6 months (n = 35): IPSS = 6.4 ± 4.1 (P < .0001), QoL score = 1.2 ± 1.2 (P < .0001), PVR = 68 ± 80 mL (P < .0001), PGV = 60 ± 19 mL (P < .001). At 12 months, patients (n = 26) had IPSS = 7.3 ± 5.5 (P < .0001), QoL score = 1.2 ± 0.8 (P <.0001), PVR = 89 ± 117 mL (P < .0001), PGV = 60 ± 48 mL (P < .01). At 24 months, patients (n = 8) had IPSS = 8.0 ± 5.4 (P < .0001), QoL score = 0.7 ± 0.5 (P < .0001), PVR = 91 ± 99mL (P = 0.17), and PGV = 30 ± 5mL (P = .11). Improvements were independent of PGV, MLE, age, and CCI. Two grade II urinary infections occurred.ConclusionsPAE with 100–300-μm microspheres produced sustained substantial improvements in LUTS, PGV, and PVR, which were independent of baseline PGV, MLE, age, or CCI.     

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.     

A Comparative Study of Cavitary and Noncavitary Non–small Cell Lung Cancer Patients Treated with CT-Guided Microwave Ablation

PurposeTo explore the outcomes of computed tomography‒guided microwave (MW) ablation in patients with cavitary non–small cell lung cancer (NSCLC) and to compare the outcomes of cavitary and noncavitary NSCLC treated with MW ablation.Materials and MethodsA total of 317 patients with NSCLC (194 men and 123 women) treated with MW ablation were include: 19 patients with cavitary NSCLC and 298 patients with noncavitary NSCLC. Complications, progression-free survival (PFS), and overall survival (OS) were evaluated and compared between the 2 groups. The Kaplan-Meier method was used to investigate the correlation of cavity and OS in patients with NSCLC.ResultsA total of 364 MW ablation procedures were performed. Adenocarcinoma was the predominant histopathological subtype in patients with cavitary NSCLC (73.7%). Cavitary NSCLC had an incidence rate of 57.9% in overall complications, which was significantly higher than that of 34.6% for noncavitary NSCLC (P = .040). In a mean follow-up of 27.2 months ± 11.9, the median PFS and OS for cavitary NSCLC were 9.0 months ± 8.5 and 14.0 months ± 10.8, respectively, and those for noncavitary NSCLC were 13.0 months ± 10.7 and 17.0 months ± 10.9, respectively. There was no significant difference in PFS (P = .180) or OS (P = .133) between cavitary and noncavitary NSCLC. In addition, the local recurrence rates for cavitary and noncavitary NSCLC were 15.8% and 21.5%, respectively, and no significant difference was found (P = .765). The Kaplan-Meier method revealed no association between the cavity and OS in patients with NSCLC treated with MW ablation.ConclusionsMW ablation was an effective and safe approach for cavitary NSCLC treatment. Compared with noncavitary NSCLC, cavitary NSCLC manifested with more complications but a comparable outcome after MW ablation.     

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.     

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.     

Diagnostic Performance of CT-Guided Bone Biopsies in Patients with Suspected Osteomyelitis of the Appendicular and Axial Skeleton with a Focus on Clinical and Technical Factors Associated with Positive Microbiology Culture Results

PurposeTo assess diagnostic performance of CT-guided percutaneous needle bone biopsy (CTNBB) in patients with suspected osteomyelitis and analyze whether certain clinical or technical factors were associated with positive microbiology results.Materials and MethodsAll CTNBBs performed in a single center for suspected osteomyelitis of the appendicular and axial skeleton during 2003–2018 were retrospectively reviewed. Specific inclusion criteria were clinical and radiologic suspicion of osteomyelitis. Standard of reference was defined using outcome of surgical histopathology and microbiology culture and clinical and imaging follow-up. Technical and clinical data (needle size, comorbidities, clinical factors, laboratory values, blood cultures) were collected. Logistic regression was performed to assess associations between technical and clinical data and microbiology biopsy outcome.ResultsA total of 142 CTNBBs were included (46.5% female patients; age ± SD 46.10 y ± 22.8), 72 (50.7%) from the appendicular skeleton and 70 (49.3%) from the axial skeleton. CTNBB showed a sensitivity of 42.5% (95% confidence interval [CI], 32.0%–53.6%) in isolating the causative pathogen. A higher rate of positive microbiology results was found in patients with intravenous drug use (odds ratio [OR] = 5.15; 95% CI, 1.2–21.0; P = .022) and elevated white blood cell count ≥ 10 × 10⁹/L (OR = 3.9; 95% CI, 1.62–9.53; P = .002). Fever (≥ 38°C) was another clinical factor associated with positive microbiology results (OR = 3.6; 95% CI, 1.3–9.6; P = .011).ConclusionsCTNBB had a low sensitivity of 42.5% for isolating the causative pathogen. Rate of positive microbiology samples was significantly higher in patients with IV drug use, elevated white blood cell count, and fever.     

γ-Glutamyltranspeptidase as a Prognostic Biomarker in Advanced Hepatocellular Carcinoma Treated with Transarterial Chemoembolization

PurposeTo evaluate the prognostic value of pretreatment serum γ-glutamyltransferase (GGT) level in patients with advanced hepatocellular carcinoma (HCC) receiving transarterial chemoembolization.Materials and MethodsThis retrospective study included 140 patients (123 male, 17 female; mean age, 56.9 y ± 12.0; range, 22.0–82.0 y) with Barcelona Clinic Liver Cancer class C HCC who received first-line conventional chemoembolization between December 2013 and March 2018. Patients were divided into low and high GGT groups based on a cutoff value calculated with a receiver operating characteristic curve. Overall survival (OS) was compared between groups by log-rank test. Univariate and multivariate survival analyses were performed.ResultsThe optimal cutoff values of GGT were 119.5 U/L in men and 175.0 U/L in women. The 6-, 9-, and 12-mo OS rates were 81.7%, 72.4%, and 62.9%, respectively, for patients in the low GGT group (n = 44) and 58.8%, 35.7%, and 28.8%, respectively, for patients in the high GGT group (n = 96; P < .001). Multivariable Cox regression analysis identified high pretreatment serum GGT level (hazard ratio [HR], 2.71; 95% confidence interval [CI], 1.67–4.40; P < .001), multiple tumors (HR, 3.05; 95% CI, 1.23–7.53; P = .02), and performance of target treatment (ie, sorafenib; HR, 0.41; 95% CI, 0.24–0.72; P = .002) or ablation (HR, 0.35; 95% CI, 0.18–0.66; P = .001) as independent prognostic factors for OS.ConclusionsPretreatment serum GGT level was an independent prognostic factor for OS in patients with advanced HCC treated with chemoembolization, suggesting that GGT is a useful prognostic biomarker for advanced HCC.     

“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.     

Transcatheter Arterial Embolization in the Management of Postpartum Hemorrhage due to Genital Tract Injury after Vaginal Delivery

PurposeTo evaluate efficacy and safety of transcatheter arterial embolization (TAE) in managing postpartum hemorrhage (PPH) due to genital tract injury after vaginal delivery and to investigate factors associated with outcome of TAE.Materials and MethodsA retrospective review of 43 women (mean age, 32.6 years) who underwent TAE to manage PPH secondary to genital tract injury after vaginal delivery was performed at a single institution between January 2007 and December 2018. Clinical data and outcomes were obtained. Patients were classified into clinical success (n = 39) and failure (n = 4) groups, and comparisons between the groups were performed.ResultsThe clinical success rate of TAE for PPH due to genital tract injury was 90.7%. In the clinical failure group, transfusion volumes were higher (failure vs success: packed red blood cells, 14 pt ± 3.37 vs 6.26 pt ± 4.52, P = .003; platelets, 10.33 pt ± 4.04 vs 2.92 pt ± 6.15, P = .036); hemoglobin levels before the procedure were lower (failure vs success: 7.3 g/dL vs 10.7, P = .016). Periprocedural complications included pulmonary edema (25.6%), fever (23.3%), and pain (9.3%). Twenty-four patients were either followed for > 6 months or answered a telephone survey; 23 (95.8%) recovered regular menstruation, and pregnancy was confirmed in 11 (45.8%). Regarding fertility desires, 7 women attempted to conceive, 6 of whom (85.7%) became pregnant.ConclusionsTAE is an effective and safe method for managing PPH due to genital tract injury after vaginal delivery. Lower hemoglobin levels before the procedure and higher transfusion volumes were associated with clinical failure of TAE.