12-month Patency Research Articles

Contemporary outcomes of infrapopliteal atherectomy with angioplasty versus balloon angioplasty alone for critical limb ischemia

ObjectiveLimited data exist comparing atherectomy (At) with balloon angioplasty for infrapopliteal peripheral arterial disease. The objective of this study was to compare the outcomes of infrapopliteal At with angioplasty vs angioplasty alone in patients with critical limb ischemia. MethodsThis is a retrospective, single-center, longitudinal study comparing patients undergoing either infrapopliteal At with angioplasty or angioplasty alone for critical limb ischemia, between January 2014 and October 2017. The primary outcome was primary patency rates. Secondary outcomes were reintervention rates, assisted primary patency, secondary patency, major adverse cardiac events, major adverse limb events, amputation-free survival, overall survival, and wound healing rates. Data were analyzed in multivariate generalized linear models with log rank tests to determine survival in Kaplan-Meier curves. ResultsThere were 342 infrapopliteal interventions, 183 percutaneous balloon angioplasty (PTA; 54%), and 159 atherectomies (At) with PTA (46%) performed on 290 patients, with a mean age of 67 ± 12 years; 61% of the patients were male. The PTA and At/PTA groups had similar demographics, tissue loss (79% vs 84%; P = .26), ischemic rest pain (21% vs 16%; P = .51), mean follow-up (19 ± 9 vs 20 ± 9 months; P = .32), mean number of vessels treated (1.7 ± 0.8 vs 1.9 ± 0.8; P = .08) and the mean lesion length treated (6.55 ± 5.00 cm vs 6.02 ± 4.00 cm; P = .08), respectively. Similar 3-month (96 ± 1% vs 94 ± 1%), 6-month (85 ± 2% vs 86 ± 3%), 12-month (68 ± 3% vs 69 ± 4%), and 18-month (57 ± 4% vs 62 ± 4%) primary patency rates were seen in the two groups (P = .87). At/PTA patients had significantly higher reintervention rates as compared with the PTA patients (28% vs 16%; P = .02). Similar assisted primary patency rates (67 ± 4% vs 69 ± 4%; P = .78) and secondary patency rates (61 ± 4% vs 66 ± 4%; P = .98) were seen in the PTA and At/PTA groups at 18 months. The 30-days major adverse cardiac event rates (3% vs 2%; P = .13) and 30-day major adverse limb event rates (5% vs 4%; P = .2) were similar in both groups. Wound healing rates (72 ± 3% vs 75 ± 2%; P = .12), 1-year amputation-free survival (68 ± 4.1% vs 70 ± 2%; P = .5), and 1-year overall survival (76 ± 4% vs 78 ± 4%; P = .39) rates did not differ in the PTA and At/PTA groups. THE At/PTA group had higher local complication rates (7 [4%] vs 1 [0.5%]; P = .03) ConclusionsAt with angioplasty provides similar patency rates compared with angioplasty alone for infrapopliteal peripheral arterial disease, but associated with higher reintervention and local complication rates. Further appropriately designed studies are required to determine the exact role of At in this subset of patients.

Single arm retrospective study of bioresorbable vascular scaffolds to treat patients with severe infrapopliteal arterial disease.

To assess the safety and efficacy of the Absorb bioresorbable vascular scaffold (BVS) in complex, infrapopliteal lesions for the management of chronic limb ischemia. The interventional management of infrapopliteal PAD remains challenging due to high restenosis rates with metallic drug-eluting stents and balloon angioplasty. Metallic stents are associated with impaired vessel vasomotor tone, remodeling, autoregulation, and long-term inflammation. BVSs are biodegradable scaffolds that provide short-term vascular support before degrading to allow restoration of vasomotor tone and endothelial function. A recent trial reported excellent 12-month vessel patency rates in simple infrapopliteal arterial lesions treated with Absorb BVS. This single-center, retrospective study evaluated the use of the Absorb BVS (everolimus impregnated poly-L-lactic scaffold) in patients with infrapopliteal PAD with respect to safety (thrombosis and TIMI bleeding), technical success, and clinically driven target vessel failure (CD-TVF) at 12 months. Thirty-one patients (51.6% male) with a median age of 67 years with advanced infrapopliteal disease were treated with 49 BVS in 41 vessels. The mean stenosis was 94% (80-100), with 49% of lesions being CTOs. No scaffold thrombosis or periprocedural bleeding was observed. Procedural success was achieved in all patients. Freedom from CD-TVF was 95.1% at 12 months driven by one revascularization and one amputation. Primary patency was 96.7% at 12 months. All patients were alive at 12 months, and 96.8% of patients improved their Rutherford-Becker classification. At 12 months, our study found that patients with advanced infrapopliteal PAD who were treated with Absorb BVS reported improved clinical status and a low rate of CD-TVF.

Outcomes of endovascular salvage of clotted arteriovenous access and predictors of patency after thrombectomy

ObjectiveThis study aimed to report the outcomes of endovascular salvage of clotted arteriovenous (AV) accesses and to determine potential predictors of poor patency rates after thrombectomy. MethodsRecords of hemodialysis patients who underwent endovascular salvage of clotted AV access were reviewed retrospectively. Technical and clinical success rates, complication rates, and 3- and 6-month patency rates were determined. Multivariate analysis was performed to determine the predictors of patency after thrombectomy. ResultsA total of 294 patients underwent endovascular salvage of clotted AV access during the study period; 156 patients had arteriovenous fistula, whereas the remaining 138 were arteriovenous grafts (AVGs). The technical and clinical success rates were 96.3% and 93.2%; the major and minor complication rates were 0.7% and 9.9%. Post-thrombectomy primary, assisted primary, and secondary patency rates were 62.9%, 76.2%, and 77.6% at 3 months and 43.9%, 59.5%, and 61.6% at 6 months. The patency rates were significantly better for arteriovenous fistula than for AVG except for 6-month assisted primary and secondary patency. Multivariate Cox regression analysis showed that prior thrombosis within 90 days was significantly associated with loss of primary patency (hazard ratio [HR], 1.90; 95% confidence interval [CI], 1.21-2.98; P < .01), assisted primary patency (HR, 2.42; 95% CI, 1.42-4.13; P < .01), and secondary patency (HR, 2.52; 95% CI, 1.40-4.53; P < .01). Having an AVG was also negatively associated with primary patency. ConclusionsMost clotted AV accesses can be salvaged by endovascular technique. Recurrent thrombosis within 90 days is associated with poor short- and long-term patency even after successful endovascular reinterventions.

Midterm Outcome of Directional Atherectomy Combined with Drug-Coated Balloon Angioplasty Versus Drug-Coated Balloon Angioplasty Alone for Femoropopliteal Arteriosclerosis Obliterans

The "leave nothing behind" strategies have been becoming a popular treatment for femoropopliteal arteriosclerosis obliterans. Atherectomy before drug-coated balloon (DCB) angioplasty may have an advantage in improving the efficiency of drug delivery into the blood vessel wall. This study aimed to compare the therapeutic effects of directional atherectomy combined with DCB angioplasty with DCB angioplasty alone in the treatment of femoropopliteal arteriosclerosis obliterans. Patients with femoropopliteal arteriosclerosis obliterans who received endovascular therapy from June 2016 to June 2018 in our hospital and presented with life-limiting claudication or severe chronic limb ischemia comprised the study cohort. The patients were randomized to receive directional atherectomy combined with DCB angioplasty (n=45) or DCB alone (n=49). Ninety-four patients were enrolled in our study with 72 males, and the mean age was 67±10years. The mean lesion length was 112±64mm. There were no significant differences in the baseline characteristics of patients and lesions between the 2 randomized groups (P>0.05). Flow-limiting dissections occurred more frequently in the DCB group (n=12; 24.5%) than in the DA-DCB group (n=2; 4.4%; P=0.006). The technical success rate in the DA-DCB group was superior to that in the DCB group (95.6% vs. 75.5%, P=0.006). The mean follow-up duration was 16.7±6.1months in the DCB group and 15.3±5.8months in the DA-DCB group. No amputations were performed. The overall mortality in the DCB group was 4.1% (2/49), while all patients survived in the DA-DCB group. The 12-month and 24-month primary patencies in the DA-DCB group were greater than those in the DCB group (80.5% vs. 75.7% and 67.1% vs. 55.1%, respectively); however, using all available patency data, no significant differences over time were observed (P=0.377). In this study, directional atherectomy combined with DCB angioplasty can decrease the flow-limiting dissection rate in the treatment of femoropopliteal arteriosclerosis obliterans compared with DCB angioplasty alone. There was no significant difference between the 2 groups in terms of primary patency rate which was needed to be further clarified.

Drug-coated balloon angioplasty superior to conventional balloon angioplasty for stenotic arteriovenous fistula lesions: With caution

The key finding of this study is that stenotic peripheral arteriovenous fistulas (AVF) lesions treated with drug-coated balloon angioplasty (DCB) had a significant improvement in the 6-month and 12-month primary patency rates when compared with those lesions treated with conventional balloon angioplasty.1 Treatment of central venous stenosis was also significantly improved with DCB, although this is more controversial because there are no large diameter drug-coated balloons (10-14 mm) that are approved in the United States.

Low-Dose Paclitaxel-Coated Balloon Angioplasty versus Uncoated Percutaneous Transluminal Balloon Angioplasty for Femoropopliteal Peripheral Artery Disease: 6-Month Results in a Tertiary Care Hospital of Central India

Abstract Introduction Superficial femoral and popliteal arteries are the most common locations of peripheral vascular disease (PVD). Endovascular interventional therapy including drug-coated balloon (DEB) angioplasty or percutaneous transluminal angioplasty (PTA) and stenting are important options for treatment of PVD. Aims and Objectives The main objective is to compare the efficacy of DEB over PTA with optional stenting in management of obstructive femoropopliteal lesions in terms of 6-month patency rate. Materials and Methods The clinical experimental study was carried out in a tertiary care center over duration of 2 years. All symptomatic patients having lower limb PVD in femoropopliteal segment were included. Total 37 patients were included in this study in which 16 underwent plain balloon angioplasty (with 3 patients undergoing bare metal stenting [BMS]) and 21 additional underwent DEB angioplasty. Patients with previously intervened lesions, primary lesion failure, major ischemic tissue loss, poor aortoiliac or common femoral inflow, or end-stage kidney disorders were excluded. Result At 1-month follow-up, patency rates in DEB and conventional PTA ± BMS were 85.71% and 87.5%, respectively. On 6-month follow-up, patency rates were found to be 71.4% versus 37.5%, respectively (p = 0.039; significant). In case of occluded lesions, on 6-month follow-up, patency rate in DEB group was higher than that in plain balloon group (66.7% vs. 25%). In both the cohorts, success rate, i.e., patency rates were more in short and intermediate length lesions than long segment lesions. DEB was found to be superior to plain angioplasty with optional stenting in terms of 6-month patency rate.

IF03. Prospective Randomized Controlled Trial Comparing Drug-Eluting Versus Conventional Balloon Angioplasty Below the Knee in Critical Limb Ischemia: The 6-Month Results

To report the 6-month Results of a prospective randomized, controlled trial comparing drug-eluting balloon (DEB) angioplasty versus conventional balloon (CB) angioplasty for below the knee arteries in patients with critical limb ischemia (CLI). In this investigator-initiated, prospective, multicenter, randomized controlled trial (NCT02129634), 138 CLI patients (93 males and 45 females) with a mean age of 62.6 years (standard deviation [SD], 9.9), were randomized 1:1 to either DEB group (n = 70) or CB group (n = 68). Of these patients, 94.2% were diabetics and 52.9% had end-stage renal failure. The primary end point was angiographic primary patency rate of target lesions at 6 months. Efficacy analysis was analyzed by generalized linear model adjusted for end-stage renal failure status in an intention-to-treat population. Missing data for primary end point was imputed by multiple imputation. Patient demographics were similar between the two groups. The mean lesion length treated was 90.3 mm (SD, 73.9) for the DEB group and 81.8 mm (SD, 71.8) for the CB group (difference, 8.5 mm; 95% confidence interval [CI], -16.2 to 33.2; P = .498). There was no statistical difference in the 6-month angiographic patency rates (DEB 41.9% vs CB 37.8%; risk difference, 6.2%; 95% CI, -11.0% to 23.4%; P = .479) and 6-month limb salvage rates (DEB 77.9% vs CB 84.8%; risk difference, 8.8%; 95% CI, -21.7% to 4.7%; P = .188). The 6-month amputation-free survival was worse in the DEB group and the difference was statistically significant (DEB 69.6% vs CB 80.3%; P = .030). The serious adverse event rate at 6 months was similar between the two groups. Our data showed no statistically significant differences in 6-month target lesion angiographic patency and limb salvage rate between DEB and CB groups in below the knee angioplasty for CLI. However, the 6-month amputation-free survival is significantly worse in the DEB group.

PC042. Performance of Gore Viabahn VBX Compared With Atrium iCast as Bridging Stents During Fenestrated Endovascular Aortic Repairs

Fenestrated endovascular aneurysm repair (FEVAR) is a well-established, effective technique for complex abdominal and thoracoabdominal aneurysm repair. Among various bridging stents, Atrium iCast (Maquet, Rastatt, Germany) covered stents have been adopted by many as the device of choice, with excellent outcomes. Recently, Gore Viabahn VBX stents (W. L. Gore & Associates, Flagstaff, Ariz) became commercially available in the United States. The aim of our study was to compare our experience with VBX and iCast as bridging stents during FEVAR. A retrospective review was performed of FEVARs for complex abdominal and thoracoabdominal aneurysms at a single institution from 2015 to 2018. All patients were at high risk for open repairs. Custom-manufactured or physician-modified devices were implanted. Bridging stents across reinforced fenestrations were included in the study. VBX and iCast stents were compared for technical success, branch patency, branch-related endoleak, and reinterventions. There were 75 patients who underwent FEVAR during the study period; 10 patients had juxtarenal, 23 had pararenal, and 41 had thoracoabdominal aortic aneurysms, and 1 had a pseudoaneurysm. Twenty-four patients were symptomatic, and three patients presented with rupture. A total of 197 branch vessels were targeted with fenestrations. Of 197 targeted branch vessels, 193 (34 celiac, 55 superior mesenteric artery [SMA], 104 renals) were bridged successfully (98%). Four target vessels (three renals and one dominant intercostal) could not be bridged because of severe aortic tortuosity causing fenestration misalignment. A total of 87 vessels were incorporated with iCast and 106 vessels with VBX. The mean follow-up was 5.5 months (6.7 months for iCast and 3.8 months for VBX). Secondary relining stents were used in 14 (16.1%) iCast branches (1 celiac, 3 SMA, and 10 renals) and 8 (7.5%) VBX stents (4 SMA, and 4 renals; P = .072). The 6-month branch patency for iCast was 96.2%, with one celiac and one renal in-stent stenosis; the 6-month patency for VBX was 97.4%, with one celiac branch occlusion (P = .661). At 6 months, there were no branch-related endoleaks for iCast, whereas six VBX branch (5.7%) vessels had type IC endoleak due to branch stent undersizing (P = .033). There were no type III endoleaks across the fenestration seal in either group. Overall short-term branch-related reintervention rate was 0% for iCast and 2.8% (3/106) for VBX (P = .253). One celiac and two SMA endoleaks were intervened on in the VBX group. Gore Viabahn VBX and Atrium iCast show high short-term patency and low endoleak rates as bridging stents during fenestrated endovascular repair of complex abdominal and thoracoabdominal aneurysms. Longer follow-up is needed to assess late device-related complications.

Paclitaxel-coated balloon in the treatment of recurrent dysfunctional arteriovenous access, real-world experience and longitudinal follow up.

Dysfunctional arteriovenous (AV) access remains a significant cause of morbidity and hospital admission for patients with end stage renal failure on haemodialysis. This study was performed to evaluate the impact of paclitaxel-coated Balloon (PCB) on the patency of AV access with recurrent stenoses. We retrospectively studied haemodialysis patients who presented to our centre with recurrent AV access dysfunction and compared intervention-free patency using plain balloon versus PCB. A total of 147 patients were followed up longitudinally. Intervention-free patency was better following PCB compared to previous intervention using plain balloons (6.4 ± 5.8 versus 4.0 ± 3.7, P < 0.01). The 3- and 6-month patency rates after PCB were significantly better compared to standard plain angioplasty balloon: 69.4% versus 52.4%, P < 0.01 and 42.9% versus 15.6%, P < 0.01 respectively. Kaplan-Meier survival analysis of circuit patency demonstrated the superiority of PCB over plain balloon angioplasty in both arteriovenous fistula and arteriovenous graft (P < 0.01 and P = 0.01 respectively) although the patency of arteriovenous fistula remained significantly better than arteriovenous graft following interventions with PCB (P < 0.01). Age of AV access and the number of previous interventions were found to be significant predictors of patency following PCB intervention. Arteriovenous access intervention with PCB was shown to be superior compared to plain balloon in the treatment of both non-thrombosed and thrombosed AV accesses in our multi-ethnic population.

Lower extremity endovenous reconstruction for symptomatic occlusive disease in pediatric patients: techniques, clinical outcomes, and long-term stent patencies.

Endovascular stent reconstruction is the standard of care for chronic venous occlusive disease in adults, but it has not been reported in pediatric patients. This study reports the technical success, complications, clinical outcomes, and stent patency of iliocaval stent reconstruction for chronic iliocaval thrombosis in pediatric patients. Fourteen patients, 13 (93%) male with a mean age of 16.4years (range: 8-20years), underwent iliocaval stent reconstruction for chronic iliocaval thrombosis. The mean number of prothrombotic risk factors was 2.5 (range: 0-4), including 7 (50%) patients with inferior vena cava atresia. At initial presentation, the Clinical, Etiology, Anatomy, and Pathophysiology classification (CEAP) score was C3 in 2 (14%) patients, C4 in 11 (79%) patients, and C6 in 1 (7.1%) patient. Time course of presenting symptoms included chronic (>4weeks) (n=7; 50%) and acute worsening of chronic symptoms (2-4weeks) (n=7; 50%). Aspects of recanalization and reconstruction, stenting technical success, complications, clinical outcomes and stent patency were recorded. Clinical success was defined as a 1-point decrease in the CEAP. Primary, primary-assisted, and secondary patency were defined by Cardiovascular and Interventional Radiological Society of Europe guidelines. Most procedures employed three access sites (range: 2-4). Intravascular ultrasound was employed in 11 (79%) procedures. Blunt and sharp recanalization techniques were used in 12 (86%) and 2 (14%) patients, respectively. Stenting technical success was 100%. Two (14%) minor adverse events occurred and mean post-procedure hospitalization was 2.8days (range: 1-8days). Clinical success rates at 2weeks, 6months and 12months were 85%, 82%, and 83%, respectively. At a mean final clinical follow-up of 88months (range: 16-231months), clinical success was 93%. Estimated 6- and 12-month primary stent patencies were 86% and 64%, respectively. Six- and 12-month primary-assisted and secondary stent patency rates were both 100%. Iliocaval stent reconstruction is an effective treatment for symptomatic chronic iliocaval thrombosis in pediatric patients with high rates of technical success, 6- and 12-month clinical success, and 6- and 12-month primary-assisted and secondary patency rates.

03:09 PM Abstract No. 354 Treatment of non-maturing fistula for hemodialysis access via transradial approach: a case-control study

Percutaneous salvage of nonmaturing hemodialysis fistulas remains challenging. We retrospectively compared a strategy of single transradial access for both diagnosis and intervention with our current protocol of brachial artery access for angiography followed by uni/bidirectional fistula access for intervention. IRB-approved review of immature fistulas intervened between 2015-2018. Multiple interventionalists performed 27 transradial access procedures in 26 patients compared to a contemporaneous control group of 30 procedures in 29 patients. Records were analyzed for procedure time, no. of punctures, treatment success, time to cannulation, primary unassisted/assisted patency and complications. Treated fistula types are shown in Table 1. 96%(26/27) and 83%(25/30) of interventions in the transradial and control groups were initially successful, respectively (P=0.11). Fewer direct punctures to the access were required in the transradial group compared to the control group (mean punctures per procedure 0.26 vs 1.2, P<0.001). A significant reduction in procedure time was seen in the transradial group (67 vs. 97 min, P<0.001). Time from intervention to cannulation trended toward a shorter interval in the transradial group (49 vs. 73 days, P=0.15). Post-intervention primary unassisted and assisted 6-month patency were similar in both groups (62 vs 49% and 88 vs 81% transradial vs control, respectively, P=0.12 and 0.18). Both groups had only minor complications which occurred in similar incidences. Treatment of non-maturing fistulas via transradial approach was associated with similar rates of an immediate successful outcome and decreased procedure time with fewer direct fistula accesses compared to a conventional access strategy. This study suggests that transradial access may be utilized as an alternative approach and further studies are warranted to determine the best percutaneous approach.Table 1TypeTransradial (pct)Contemporary (pct)Radiocephalic18(67)16(53)Single stage basilic1(4)2(7)Basilic vein transposition5(19)5(17)Brachiocephalic3(11)7(23) Open table in a new tab

Effectiveness of the PowerWire Radiofrequency Guidewire in Recanalizing Chronically Occluded Iliac Venous Stents

Iliac venous stenting is a commonly performed procedure in treating post-thrombotic and nonthrombotic iliac venous disease. Whereas overall stent patency rates are high, stent occlusion does occur. Recanalizing chronically occluded stents is technically challenging and often impossible with conventional guidewires and catheters. The PowerWire (Baylis Medical, Burlington, Mass) radiofrequency guidewire is a 0.035-inch guidewire that delivers radiofrequency energy at the end of the guidewire. A retrospective chart review was conducted of patients with chronically occluded iliac venous stents who underwent an iliac venous recanalization attempt using the PowerWire from March 2015 to June 2018. A total of 15 patients underwent a recanalization attempt with the PowerWire. All patients had initial unsuccessful attempts at recanalizing the occluded iliac vein stents with conventional guidewires. Successful recanalization was defined as restoration of antegrade iliac venous flow after angioplasty alone or angioplasty and placement of additional stents. Percutaneous recanalization of chronically occluded iliac venous stents using the PowerWire was successful in 10 patients. Cumulative 6-month patency rate was 62%. Cumulative 12-month patency rate was 43%. There were two complications that occurred with use of the PowerWire. One patient had transient footdrop of the ipsilateral limb that was successfully recanalized. One patient had self-limited perforation of the left common iliac artery during unsuccessful recanalization. The PowerWire is an effective and relatively safe device for recanalizing chronically occluded iliac venous stents.

Endovascular arteriovenous fistula for hemodialysis access

Hemodialysis arteriovenous fistulas (AVFs) are inconstantly used primarily due to problems with maturation, early thrombosis and patient nonacceptance. An endovascular approach to fistula creation without open surgery offers another hemodialysis vascular access option. Published studies as well as our own clinical experience and remarkable single center cases are analyzed. Basic literature is reported and expert opinions are discussed. AVFs with fused anastomoses (Avenu Medical, Ellipsys) were created in 95.0% (102/107) of patients. Primary flow and diameter endpoints were achieved in 86.0% (92/107) of patients. In the NEAT study (Novel Endovascular Access Trial, using the everlinQ 6 Fr system), 80 patients were enrolled. In the EASE study and in all of our patients (access from the wrist) using the novel 4 Fr everlinQ system, an endoAVF was successfully created. Due to the unique anatomy and vessels used to create endoAVFs, those studies were single-arm studies without a surgical comparator. An endoAVF can be reliably created using different catheter-based systems, without open surgery and with minimal complications. EndoAVFs can be successfully used for hemodialysis and demonstrated a high 12-months cumulative patency in several studies. In the future, it may be an alternative for achieving AVFs for hemodialysis patients in need of a vascular access.

Drug-coated balloons versus 1ry stenting for TASC C and D femoropopliteal lesions

Background: To compare the effectiveness and outcome of Drug-Coated Balloon (DCB) versus primary nitinol stenting for the treatment of long femoropopliteal lesions (TASC II C and D).Methods: This was retrospective study along 3 years included all the cases of femeropopliteal disease TASC C and D that was treated with DEB or primary stenting. The safety endpoint was 30-day free from major limb amputation and mortality. The primary end point was primary patency and freedom from clinically driven target lesion revascularization at 6 and 12 months, patient genders, demographics, co-morbidities, smoking history, indications for intervention were recorded.Results: PTA and post-dilation with paclitaxel-eluting balloons was done in 32 patients (group I) and 1ry stenting was done in 30 patients (group II) with either stenosis or occlusion. The mean lesion length was 18.43±2cm in group 1 and 18.8±2.32cm in group. The technical success rate was 100% in group II and 93.7% in group I. 6 months and 12-month patency rate for group I and II were 93.3% vs. 93.3% and 83.3% vs. 86.6%, respectively. There were no 30 days related major amputations or mortalities in either group.Conclusions: DCB for long femoropopliteal lesions showed a comparable result to primary stenting and provide durable results and lower incidence of target revascularization in patients with TASC C and D lesions.

A randomized trial of vonapanitase (PATENCY-1) to promote radiocephalic fistula patency and use for hemodialysis

ObjectiveArteriovenous fistulas created in patients with chronic kidney disease often lose patency and fail to become usable. This prospective trial evaluated the efficacy of vonapanitase, a recombinant human elastase, in promoting radiocephalic fistula patency and use for hemodialysis. MethodsPATENCY-1 was a double-blind, placebo-controlled trial that enrolled 349 patients on or approaching hemodialysis and being evaluated for radiocephalic arteriovenous fistula creation. Of these, 313 were randomized and 311 treated. Patients were assigned to vonapanitase (n = 210) or placebo (n = 103). The study drug solution was applied topically to the artery and vein for 10 minutes immediately after fistula creation. The primary and secondary end points were primary patency (time to first thrombosis or corrective procedure) and secondary patency (time to abandonment). Tertiary end points included use of the fistula for hemodialysis, fistula maturation by ultrasound, and procedure rates. ResultsThe Kaplan-Meier estimates of 12-month primary patency were 42% (95% confidence interval [CI], 35-49) and 31% (95% CI, 21-42) for vonapanitase and placebo (P = .25). The Kaplan-Meier estimates of 12-month secondary patency were 74% (95% CI, 68-80) and 61% (95% CI, 51-71) for vonapanitase and placebo (P = .048). The proportions of vonapanitase and placebo patients were 39% and 25% (P = .035) with unassisted use for hemodialysis and 64% and 44% (P = .006) with unassisted plus assisted use. ConclusionsVonapanitase treatment did not significantly improve primary patency but was associated with increased secondary patency and use for hemodialysis. Further research is needed to evaluate these end points.

Feasibility of aorta after endarterectomy as middle hepatic vein reconstruction in living donor liver transplantation

Introduction: Cryopreserved iliac vein, Polytetrafluoroethylene (PTFE) grafts, and cryopreserved aorta without endarterectomy have been used as middle hepatic vein (MHV) conduits for right liver graft in living donor liver transplantation, but each has advantages and disadvantages. In this study, we started to use aorta after endarterectomy (AoE) without any additional patches and checked patency after engraftment. Method: From January 2015 to June 2018, 111 cases of adult LDLT with modified right lobe grafts using aorta after endarterectomy were performed at Asan Medical Center. Retrospective analysis of patency in these recipients were carried out and compared with control group who received iliac vein (n=436) during the same study period. All vessels were stored and prepared as cryopreservation. Patency of reconstructed MHV was assessed by computed tomography (CT) which was routinely followed at every week during in-hospital stay and at 1, 3, 6, and 12 months after LDLT. Result: Clinically significant stenosis of MHV requiring interventional stenting was occurred in three patients (2.7%) in AoE group, not significantly different from seventeen patients (3.9%) in iliac vein group (p=0.778). Aorta after endarterectomy showed 3-month patency rate of 91.6% and 1-year patency rate of 63.5%. Mean patency time of MHV with AoE 21.4±1.9 months. When compared to iliac vein group, which demonstrated 3-month and 1-year patency rate as 90.0% and 37.3%, respectively, AoE proved superior patency outcome (p=0.001). Mean patency time of iliac vein was 19.6±2.2 months. Conclusion: In this study, AoE showed an acceptable outcome and even better patency compared to iliac vein. Clinically significant complication of stenosis or obstruction of MHV was fairly low. Larger diameter with well-matched thickness to MHV branches, not requiring iliac artery patch, is of great advantage in AoE as interposition graft.

Atherectomy-assisted versus percutaneous angioplasty interventions for treatment of symptomatic infra-inguinal peripheral arterial disease.

IntroductionThe role of atherectomy (ATHERO) for the treatment of symptomatic infra-inguinal arterial lesions remains controversial. We evaluated the effectiveness and safety of atherectomy-assisted endovascular interventions in comparison with percutaneous angioplasty (PTA).Material and methodsA systematic search utilizing MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials was conducted for studies comparing ATHERO with PTA from February 1995 to May 2018. Only studies comparing ATHERO to PTA for symptomatic infra-inguinal disease were included. Random-effects meta-analysis was used to pool the data and endpoints across studies. Study endpoints included vessel dissection, distal embolization, residual stenosis (> 30%), vessel patency at 6 months, target lesion revascularization (TLR) at 12 months and major amputation rates at 1, 6, and 12 months.ResultsA total of 2923 patients were included from 8 studies. PTA was associated with higher vessel dissection (OR = 4.00, 95% CI: 1.15–13.86) and lower 12-month major amputation rates (OR = 0.73, 95% CI: 0.59–0.90). There was no significant difference between ATHERO and PTA groups in terms of distal embolization (OR = 0.45, 95% CI: 0.04–4.63), residual stenosis (OR = 1.28, 95% CI: 0.58–2.80), vessel patency at 6 months (OR = 1.27, 95% CI: 0.50–3.22), TLR at 12 months (OR = 1.07, 95% CI: 0.46–2.51), or limb amputation at 1 month (OR = 0.69, 95% CI: 0.44–1.07) or 6 months (OR = 1.54, 95% CI: 0.38–6.15).ConclusionsIn patients undergoing infra-inguinal endovascular interventions, PTA was associated with higher peri-procedural vessel dissection and lower 12-month major amputation rates. Both modalities were associated with similar distal embolization, residual stenosis, and 6-month vessel patency and amputation rates.

Role of percutaneous transluminal angioplasty for radiocephalic fistulae with junctional stenosis

Background Morbidity from end-stage renal disease is primarily from vascular access. Access thrombosis is the main cause of arterio venous (AV) access failure. Decreased fistula blood flow leads to access thrombosis in arteriovenous fistulae, which occurs secondary to venous stenosis. Junctional stenosis is a complication of arteriovenous fistulas. Surgical correction and percutaneous transluminal angioplasty may correct it. Our study aimed to clarify factors for primary success of percutaneous transluminal angioplasty of radiocephalic fistulae with stenosis at the arteriovenous junction with long-term patency on follow-up. Radiocephalic junctional stenosis of fistulae involves both the radial artery and cephalic vein and site of bifurcation. Usually, radiocephalic fistula stenosis is located in the venous limb near the arteriovenous junction. Patients and methods This prospective study included 50 percutaneous transluminal angioplasty cases with stenosis at the arteriovenous junction of radiocephalic fistulae. Demographic data including age, sex, site of fistula (right or left arm), and approach (radial artery or cephalic vein) were recorded. Analysis included primary percutaneous transluminal angioplasty success and long-term patency rates. Results The total primary success rate was 88%. The existence of total occlusion was recognized as the only factor significantly associated with a high procedural failure rate (83.3 vs. 16.6%, P=0.03). For long-term patency rate, the only significant factor was the involvement of proximal radial artery dilatation (P=0.023). The 6, 12, and 18-month patency rates were 66.4, 46.8, and 23.1%, respectively, for all procedures. Conclusion Percutaneous transluminal angioplasty for junctional stenosis at radiocephalic fistula involving both the radial artery and cephalic vein at the site of anastomosis without dilating the radial artery side of the arteriovenous junction reduces the long-term patency rate; however, the initial success rate will not be affected. Initial procedural failure depends on presence of occlusive lesion mainly.

Circular incision and cutting, a novel treatment for patients with esophageal cancer with anastomotic stricture after esophagectomy.

Endoscopic balloon dilation (EBD) is still considered the standard treatment for patients with anastomotic strictures after esophagectomy. However, repeated dilation sessions are often required to maintain the lumen patency. We therefore developed a novel method called circular incision and cutting (CIC) and compared the efficacy of CIC and EBD among patients with anastomotic strictures after esophagectomy or gastrectomy. In this retrospective study, 71 consecutive patients with esophageal cancer with anastomotic strictures after esophagectomy or gastrectomy between January 2011 and December 2016 were included. Among them, 22 patients received CIC therapy and 49 were treated with EBD. The dysphagia in all patients immediately ameliorated and no serious adverse events requiring further intervention were observed after CIC therapy. Compared with EBD, CIC exhibited a greater score in the difference of dysphagia before and after treatment (1.73 vs 1.16, P = 0.03). Moreover, the interval of restenosis and 6-month lumen patency in CIC had a better effect than that in EBD (88.07 days vs 62.76 days, P = 0.001; dysphagia score 0.63 vs 1.44, P = 0.007). The CIC method may be an effective and safe option for patients with esophageal cancer with anastomotic strictures after esophagectomy.

Clinical Evaluation of the Cook Advance Enforcer 35 Focal-Force PTA Balloon Catheter for Treatment of Hemodialysis Fistula Stenoses: A Feasibility Study

PurposeA prospective, single-center, single-arm feasibility study evaluated procedural and short-term performance of the Advance Enforcer 35 focal-force percutaneous transluminal angioplasty (PTA) balloon catheter in treating stenoses of mature native arteriovenous (AV) hemodialysis access circuits. Materials and MethodsTwenty-eight patients undergoing treatment for stenosis of a mature native AV hemodialysis access circuit were enrolled at a single institution. Angiographic assessments of the study lesion were required at baseline and after the procedure. Adjunctive procedures for significant residual stenosis were permitted, and patients had clinical and imaging follow-up for as long as 6 months. ResultsTreatment with the study balloon was effective in reducing the average percent diameter stenosis of the treated lesion from 66.3% (range, 43.8%–93.3%) before the procedure to 23.7% (range, −6.7% to 51.4%) after the procedure. The average inflation pressure required was 12.3 atm. Only 1 patient required an adjunctive procedure, and all patients could resume normal dialysis following the study procedure. At 3 months, 62.0% of study lesions remained patent, and the 6-month patency rate was 25.1%. Two adverse events associated with the study procedure were reported: access-site hematoma and forearm pain (3.6% each). ConclusionsThe results demonstrate safety of the study balloon in treating AV access stenosis. Nominal-diameter angioplasty was achieved at relatively low pressure in most study patients without the use of adjunctive procedures, and resumption of normal dialysis was achieved for all patients.