Percutaneous Transluminal Balloon Angioplasty Research Articles

Allergic Acute Coronary Artery Stent Thrombosis After the Administration of Sugammadex in a Patient Undergoing General Anesthesia: A Case Report

In addition to cutaneous, gastrointestinal, hemodynamic, and respiratory symptoms, allergic reactions can induce an acute coronary syndrome in normal or atheromatous coronary arteries and can cause coronary stent thrombosis. Here, we report a case of coronary stent thrombosis due to allergic acute coronary syndrome during anaphylaxis induced by sugammadex in a female patient undergoing general anesthesia. She was emergently treated with percutaneous transluminal coronary balloon angioplasty with catecholamine, vasodilator, and intraaortic balloon support. Knowledge of perioperative allergy-triggered acute coronary syndrome is crucial for prompt and appropriate treatment.

Surgical Treatment of Cephalic Arch Stenosis through Rotation of the External Jugular Vein

The percutaneous transluminal balloon angioplasty or cephalic vein transposition is the treatment for cephalic arch stenosis. In some cases, rotation of the external jugular vein may be a good option for the cephalic arch problems. We describe a new technique to treat cephalic arch stenosis. The technique enables the cephalic arch and subclavian vein to be bypassed altogether through the rotation of the external jugular vein. It consists of 3 small incisions, thus causing minimal surgical damage.

Inferior Vena Cava Rupture Caused by Balloon Angioplasty During the Treatment of Budd-Chiari Syndrome.

Percutaneous transluminal balloon angioplasty (PTA) is the main treatment option for Budd-Chiari syndrome (BCS) with inferior vena cava (IVC) obstruction. However, IVC rupture caused by PTA has never been reported. Between August 2004 and December 2016, a consecutive cohort of 617 BCS patients with obstructed IVC who underwent PTA with or without stent placement were reviewed retrospectively to identify IVC rupture. Pre- and post-procedural imaging data, clinical and procedural technical data were analyzed. Of the 617 BCS patients, five patients had IVC rupture caused by PTA (0.81%). Four of these patients had retroperitoneal, intra-hepatic IVC rupture without extravasation into abdominal cavity which was successfully managed conservatively. One patient had supra-hepatic IVC rupture into the pericardial cavity which was surgically treated. IVC rupture is a rare complication of PTA treatment of BCS and most commonly located at the intra-hepatic IVC caused by oversized balloons which does not require additional treatment.

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.

CLINICAL OUTCOMES OF ENDOVASCULAR INTERVENTIONS IN DIABETIC PATIENTS WITH CRITICAL LOWER LIMB ISCHEMIA

The article describes the features of lower limb vessel lesions in patients with diabetes, modern methods for diagnosing critical lower limb ischemia (CLLI), indications for endovascular interventions, and reviews the clinical outcomes of percutaneous transluminal balloon angioplasty in patients with diabetes. The authors emphasized high efficacy of endovascular operations in CLI in patients with diabetes. The issues of the prevention of CLLI and the treatment of the lower limb vascular diseases in diabetes are discussed.

Effectiveness and Postoperative Prognosis of Using Preopening and Staged Percutaneous Transluminal Angioplasty of the Inferior Vena Cava in Treating Budd-Chiari Syndrome Accompanied with Inferior Vena Cava Thrombosis

Budd-Chiari syndrome (BCS) is a rare disorder that has relatively high prevalence in the Huang-Huai area of China. Effective treatment of BCS accompanied with inferior vena cava thrombosis is challenging. This study retrospectively analyzed the clinical effectiveness and safety of traditional open operations versus preopening and staged percutaneous transluminal angioplasty (PTA) of the inferior vena cava in treating BCS accompanied with inferior vena cava thrombosis. Data from patients hospitalized and treated for BCS accompanied with inferior vena cava thrombosis between January 1997 and December 2017 were retrospectively analyzed. Thirty-two patients received traditional open operation (open group). Fifty-six patients received preopening and staged PTA of the inferior vena cava (PTA group). Baseline and clinical data were compared between groups. The patients were followed for up to 60months. Postoperative recurrence rates and restenosis degree were recorded. Eighty-eight patients were included (47 males and 41 females), aged 41.82±10.12years (range 29-65). In the open group, no pulmonary arterial embolism was found during and after the operation, and the technique success rate was 100%. One patient died of intrathoracic bleeding. In the PTA group, 2 patients had shifting of thrombus in the inferior vena cava that blocked the blood flow restored by the preopening, one resulted in treatment failure, while the other had blood flow restored by dilation with a 12-mm balloon; the success rate was 55/56 (98.21%). The median follow-up time was 32months (range 3-60). Two patients in the open group developed restenosis 2years after operation (recurrence rate: 6.25%), and were successfully treated by balloon PTA. Seven patients in the PTA group had severe restenosis 18-42months after operation (recurrence rate: 12.96%). No thrombosis was found in these 7 patients, and normal blood flow was restored in the inferior vena cava after balloon PTA. Preopening and staged PTA of the inferior vena cava is a safe and simple method for the treatment of BCS accompanied with inferior vena cava thrombosis, with satisfactory treatment effectiveness that could be applied in clinical practice.

HEMODIALYSIS;

Objective: To evaluate the treatment success rate of percutaneous transluminal angioplasty (balloon angioplasty) for peripheral and central venous stenosis in hemodialysis patients. Study Design: Retrospective/observational study. Place and Duration of Study: Department of Cardiology, Shaikh Zayed Hospital Lahore from 1st January 2018 to 30th June 2018. Methods: Thirteen patients of both genders presenting during from two years of hemodialysis failure and ipsilateral arm and neck swelling followed by peripheral and central venous stenosis were included in this study. Patients ages were ranging from 25 to 70 years. Patient’s detailed history including hemodialysis treatment, age, sex, socio-economic status was examined after taking informed consent from the patients. Percutaneous transluminal angioplasty (PTA) was performed at all the patients. Procedural success rate was examined. Results: There were 9 (69.23%) patients were men and rest (13.77%) were women. 5 (38.46%) patients were ages between 25 to 45 years, 6 (46.15%) patients had an ages 46 to 65 years and 2 (15.38%) patients were ages greater than 65 years. 10 (76.92%) had rural residency. 40 % patients had income >30000 PKR. Location and severity of lesions was examined as brachiocephalic vein, subclavian vein, Axillary vein, basilica, cephalic and median cubtal vein in 1,3,2,3,3 and 1 patients respectively. We determine priority patency rate in central lesion PTA was 82.7%, 62% and 38% at 3, 6 and 12 months and priority patency rate in peripheral lesions PTA was 87%, 79.5% and 67.8% at 3, 6 and 12 months. Conclusion: It is concluded that percutaneous transluminal angioplasty (balloon angioplasty) procedure for treatment of central and peripheral venous stenosis in hemodialysis patients was safe and effective with no procedural complications.

Treatment of restenosis in radiocephalic arteriovenous hemodialysis fistulas: percutaneous transluminal angioplasty or drug-coated balloon.

Background Percutaneous transluminal angioplasty (PTA) is an established treatment of arteriovenous fistula (AVF) stenosis. Drug-coated balloons (DCB) are coated with an antiproliferative drug intended to decrease neointimal hyperplasia and restenosis. Purpose To investigate the patency after treatment of restenosis in radiocephalic AVFs with PTA versus DCB. Material and Methods A retrospective study comprising 26 patients, recruited from treatment registers, receiving at least one previous PTA and a re-intervention (13 PTAs and 13 DCBs) at the same anatomic location, were observed for 24 months. Patency after re-intervention was compared between the two cohorts. Furthermore, an intra-subject analysis, comparing patency before and after DCB, was performed in the DCB cohort. The Kaplan–Meier method was used to estimate the proportion of stenosis-free patients at different time points after treatment. Results After 12 and 24 months, the estimated proportions of stenosis-free patients were 61% and 31%, respectively, in the DCB cohort, compared to 40% and 15% in the PTA cohort. In the intra-subject analysis, 15% and 8% of the patients treated with PTA remained stenosis-free after 12 and 24 months, respectively. Patients treated with DCB had significantly longer patency than patients in the PTA cohort (median 16 vs. 5 months, respectively; P = 0.05). Additionally, in the intra-subject analysis, patency after DCB treatment exceeded PTA (median 16 vs. 5 months, respectively; P = 0.01). Conclusion Our results indicate that DCB angioplasty is associated with significantly improved patency in the treatment of restenosis in radiocephalic AVFs. A longer follow-up or randomized controlled trial is warranted.

Drug-Coated Balloon Angioplasty Compared with Uncoated Balloons in the Treatment of Infrapopliteal Artery Lesions: 6-Month Results of a Randomized, Multi-Centers, Single-Blind, and Superiority Trial

Background: Drug-coated balloons (DCBs) have shown promising results in treating femoropopliteal artery lesions while data on infrapopliteal lesions are controversial. We undertook this clinical trial to compare the safety and efficacy of DCBs versus uncoated balloon percutaneous transluminal angioplasty (control) of de novo or recurrent steno-occlusive lesions of the infrapopliteal arteries in patients with critical limb ischemia. Methods: In this prospective multicenter single-blind randomized study, 120 patients were randomized to the DCB group (Litos/Tulip, Acotec Scientific; n=61) or control group treated with uncoated balloons (n=59) in 11 centers in China from May 22, 2014, to June 13, 2018. Follow-up was scheduled at one and six months and included angiographic assessment at six months. Adverse events were assessed by an independent clinical events committee, angiographic parameters by an independent core laboratory. The study is registered at ClinicalTrials.gov, number NCT02137577. Findings: Regarding the primary safety endpoint (composite of all-cause mortality, target extremity major amputation, and target lesion revascularization at 30 days), there was one event (1·6%) in the DCB group and none in the control group (p=0·33). The primary efficacy endpoint-primary patency (defined as absence of target vessel occlusion, major amputation, or target lesion revascularization) at six months was accomplished in 77·1% [95% Cl 65·2%-89%] of the DCB group and 28·3% [95% Cl 15·3%-41·3%] of control group (p<0·001). Freedom from clinically driven target lesion revascularization was 95·1% [95% Cl 89·5%-100%] versus 79·7% [95% Cl 69·7%-90·1%] (p < 0·01) and late lumen loss 0·35±0·74mm [95% Cl 0·14-0·56mm] versus 1·08±0·62mm [95% Cl 0·90-1·26mm] (p<0·001). Interpretation: The Litos/Tulip DCBs are safe and effective in treating infrapopliteal artery lesions, resulting in improved angiographic and clinical outcomes compared with uncoated balloon PTA. Trial Registration Number: The study is registered at ClinicalTrials.gov, number NCT02137577. Funding: Acotec. Declaration of Interest: We declare no competing interests. Ethical Approval: The trial was conducted in conformity with the Declaration of Helsinki and the provisions for the conduct of clinical trials of medical devices issued by the China Food and Drug Administration. It was approved by the Chinese PLA General Hospital Ethics Committee and other ten local ethics committees of participating hospitals in China. All patients gave written informed consent prior to any study procedure.

Association of Survival With Femoropopliteal Artery Revascularization With Drug-Coated Devices

In a recent meta-analysis of randomized clinical trials, femoropopliteal artery revascularization with paclitaxel drug-coated devices was associated with increased long-term all-cause mortality compared with non-drug-coated devices. However, to our knowledge, these findings have not been replicated in other data sources and may be subject to confounding from missing data associated with patient withdrawal and loss to follow-up. To evaluate differences in all-cause mortality between patients who were treated with drug-coated devices vs non-drug-coated devices for femoropopliteal artery revascularization. This nationwide, multicenter retrospective cohort study included 16 560 Centers for Medicare and Medicaid Services beneficiaries who were admitted for femoropopliteal artery revascularization from January 1, 2016, to December 31, 2016. All-cause mortality was analyzed through September 30, 2017. Drug-coated devices (drug-eluting stent [DES] or drug-coated balloon [DCB]) compared with non-drug-coated devices (bare metal stent or uncoated percutaneous transluminal angioplasty balloon). The primary outcome was all-cause mortality analyzed through the end of follow-up. Among 16 560 patients treated at 1883 hospitals, the mean (SD) age was 72.9 (11) years, 7734 (46.7%) were men, 12 232 (73.9%) were white, 8222 (49.7%) currently or had previously used tobacco, 9817 (59.3%) had diabetes, and 8450 (51.0%) had critical limb ischemia (CLI). Drug-coated devices were used in 5989 participants (36.2%). The median follow-up was 389 days (interquartile range, 277-508 days). Among all patients, treatment with drug-coated devices was associated with a lower cumulative incidence of all-cause mortality compared with treatment with non-drug-coated devices through 600 days postprocedure (32.5% vs 34.3%, respectively; log-rank P = .007). Similar survival trends were observed when treatment was stratified by using a DCB alone or DES with or without DCB. After multivariable adjustment, drug-coated devices were not associated with a difference in all-cause mortality compared with non-drug-coated devices (hazard ratio [HR], 0.97; 95% CI, 0.91-1.04; P = .43). These findings were consistent among those with CLI (HR, 0.93; 95% CI, 0.85-1.01; P = .09) or without CLI (HR, 0.94; 95% CI, 0.85-1.03; P = .20), and for those treated with DCB alone (HR, 0.94; 95% CI, 0.86-1.03; P = .17) or DES with or without DCB (HR, 0.97; 95% CI, 0.89-1.06; P = .48). In this large nationwide analysis of Centers for Medicare and Medicaid Services beneficiaries, there was no evidence of increased all-cause mortality following femoropopliteal artery revascularization with drug-coated devices compared with non-drug-coated devices.

Complicated Evolution of Superior Vena Cava Syndrome Post Cardiac Surgery

Introduction: Superior vena cava syndrome (SVCS) is the clinical manifestation of superior vena cava (SVC) obstruction, with a severe reduction in venous backflow to the right atrium. Symptoms classically include neck, facial and upper limb swelling, development of swollen collateral veins on the front of the chest wall, shortness of breath, coughing, headache, stridor and other neurological complaints, which may all be exacerbated by different postures. CASE REPORT: A 31-year-old man, with a sinus venosus atrial septal defect (SVASD) and partial anomalous pulmonary venous return (PAPVC), was undergone to surgery, in the postoperative course showed a superior vena cava syndrome (SVCS). A second surgery to solve this complication was performed nevertheless, some days after this intervention, the patient developed SVCS symptom’s once again. A new strategy with a large stent implantation in the superior vena cava had acceptable results. The patient kept asymptomatic during four months. Discussion: This syndrome is a rare complication after cardiac surgery; it is associated mostly with bicaval cannulation; various causes such as localized hematoma, swollen absorbable hemostat, and narrowing of the SVC by surgical sutures have been reported. There are no exact guidelines for the clinical management of SVCS. The treatments include long-term anticoagulation, thrombolysis, percutaneous transluminal balloon angioplasty, stent implantation, and open surgical reconstruction. CONCLUSION: This article highlights the importance of bear in mind the potential risk of SVCS during cardiac surgery with bicaval cannulation, whereby the proper precautions must be taken into account. Another outstanding fact of this case report shows the value of working with interventional cardiology department as a team to reach successful results in the benefit of the patients.

Central Venous Stenosis in a Patient on Maintenance Hemodialysis: A Case Report

A 57-year-old male patient of chronic kidney disease on maintenance hemodialysis via right radio-cephalic fistula presented with swelling of his right arm and right half of face and headache. With the clinical suspicion of central venous obstruction he underwent venogram of right upper limb. A stenosis was found in right brachiocephalic vein. He underwent a percutaneous transluminal balloon angioplasty and his symptoms improved substantially.&#x0D; Birdem Med J 2019; 9(1): 82-84

Antiplatelet therapy for tibial balloon angioplasty: A clinical perspective.

Percutaneous transluminal tibial balloon angioplasty has an important role in the therapeutic approach of critical limb ischaemia. Despite a growing number of patients with critical limb ischaemia, there are no trials to guide the pharmacologic approach post intervention. Guidelines pertaining to the antiplatelet therapy post percutaneous transluminal tibial balloon angioplasty have not been developed. In addition, critical limb ischaemia patients have multiple comorbidities and a higher risk of bleeding. To examine the shortest duration of antiplatelet therapy post percutaneous transluminal tibial balloon angioplasty, we reviewed the preclinical data used to develop the standards for the current angioplasty technique.

Short Term Outcome of Bare Metal Stent vs Covered Stent in Treatment of Symptomatic Central Venous Occlusion in Association with Functioning upper Limb Arterio-Venous Access

Aim: To assess the primary patency of the central veins of the upper limb after percutaneous transluminal balloonangioplasty (PTA) with bare metal stent Vs covered stent. Patients and methods: 26 patients having venous hypertension of the upper limb on regular hemodialysis at Ain Shams University Hospitals dialysis units and Menia University were included in the study from June 2016 till June 2017. Collected data were followed up till December 2018. Patients were divided randomly into two groups, Group A: 13 Patients who underwent balloon dilatation of completely occluded or more than 50% stenosed central veins with bare metal stent and Group B: 13 Patients who underwent balloon dilatation of completely occluded or more than 50% stenosed central veins with covered stent . The primary patency, assisted primary patency and secondary patency of these procedures were assessed in a period of 18 months. Results: The technical success rate was 100% (n=26), 1ry stenting was done in 100% (n=26) of cases. The patency rate at 18 months after intervention was 69.2% primary assisted patency and 92.3% secondary patency in bare metal stent group while it was 100% both primary assisted and secondary patency at 18 months in covered stent group. Conclusion: Percutaneous transluminal angioplasty with covered stent carries a higher patency rate in short termfollow up. But more cases should have longer follow up time in multi centers.

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.

Sustainable Antirestenosis Effect With a Low-Dose Drug-Coated Balloon: The ILLUMENATE European Randomized Clinical Trial 2-Year Results

ObjectivesThe aim of this study was to assess the safety and effectiveness of a next-generation low-dose drug-coated balloon (DCB) designed to optimize the amount of drug transferred into the vessel wall and to maximize the amount of time the drug resides in the vessel wall. BackgroundSeveral randomized controlled studies evaluating various DCBs have demonstrated a significantly higher patency rate compared with noncoated percutaneous transluminal angioplasty balloons at 1 year. However, the data are limited and vary by DCB at longer follow-up time points. An earlier generation low-dose DCB failed to demonstrate significant treatment effect at 2 years, raising questions regarding the durability of low-dose DCBs. MethodsIn this prospective, multicenter trial, 294 patients were randomized (3:1) to treatment with a DCB or an uncoated percutaneous transluminal angioplasty balloon. Assessments at 2 years included primary patency with duplex ultrasonography, clinically driven target lesion revascularization, and functional outcomes. ResultsPrimary patency at 2 years was significantly higher in the DCB cohort (75.9% vs. 61.0%; p = 0.025), and the rate of clinically driven target lesion revascularization was significantly lower (12.1% vs. 30.5%; p < 0.001). There were no major limb amputations in either group. The rates of all-cause (6.5% vs. 5.1%; p = 1.00) and cardiovascular-related (1.6% vs. 1.7%; p = 1.00) mortality were similar between groups. Functional improvements over baseline were sustained in both groups, with 60% fewer reinterventions in the DCB group. ConclusionsA sustained treatment effect is achievable with a low-dose DCB with an optimized coating formulation. This trial demonstrated for the first time a statistically significantly higher primary patency rate for a low-dose DCB versus PTA at 2 years. (CVI Drug Coated Balloon European Randomized Clinical Trial; NCT01858363)

Drug-Coated Balloon Angioplasty Compared With Uncoated Balloons in the Treatment of 200 Chinese Patients With Severe Femoropopliteal Lesions: 24-Month Results of AcoArt I

ObjectivesThe authors sought to investigate the midterm efficacy and safety of drug-coated balloon (DCB) in the treatment of severe femoropopliteal artery disease (FPAD). BackgroundThe midterm outcome of DCB versus uncoated balloon percutaneous transluminal angioplasty (PTA) for FPAD are still debated. MethodsA total of 200 Chinese patients with FPAD were prospectively randomized into treatment with DCB or with PTA. The primary efficacy endpoints were primary patency of the target lesion, freedom from clinically driven target lesion revascularization, improved ankle-brachial index, and improved Rutherford class at 24 months. The primary safety endpoint was the rate of major adverse events. ResultsThe DCB group and PTA group were comparable in demographic characteristics and clinical severity at baseline. At 24-month follow-up, primary patency was better in the DCB group versus PTA group (64.6% vs. 31.4%; p < 0.001). The DCB group had a higher rate of freedom from clinically driven target lesion revascularization than the PTA group (86.5% vs. 58.9%; p < 0.001). Rutherford class and ankle-brachial index also confirmed more improvements in the DCB group (p < 0.01 and p < 0.05, respectively). There was no significant difference in major adverse events. ConclusionsThe superiority of DCB versus PTA in the efficacy of FPAD treatment persists at 24-month follow-up and the safety of DCB is equivalent to that of PTA.

HDA 3. A Prospective Randomized Study Comparing the Use of Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheters With Plain Balloon Angioplasty Catheters to Treat Stenotic Segments at the Venous Anastomotic Site After Thrombectomy for Thrombosed Prosthetic Vascular Grafts for Dialysis

HDA 3. A Prospective Randomized Study Comparing the Use of Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheters With Plain Balloon Angioplasty Catheters to Treat Stenotic Segments at the Venous Anastomotic Site After Thrombectomy for Thrombosed Prosthetic Vascular Grafts for Dialysis

NF-κB Decoy Oligodeoxynucleotide-Coated Balloon Catheter for Arteriovenous Fistula in Hemodialysis

IntroductionNew treatments to inhibit neointimal formation after percutaneous transluminal angioplasty (PTA) are needed for patients undergoing chronic hemodialysis (HD). We compared the efficacy and safety of AMG0102, a balloon catheter containing nuclear factor κB (NF-κB) decoy oligodeoxynucleotide (ODN) with the PTA balloon catheter (control group) for arteriovenous fistula (AVF) stenosis.MethodsIn total, 175 patients (age ≥20 years, undergoing HD, with venous stenosis at the anastomotic region) were registered in this prospective open-label, randomized study. Patients were followed postoperatively for 36 weeks. The duration of primary patency on the targeted venous stenosis site (primary endpoint) was estimated by the Kaplan–Meier method.ResultsA lower restenosis risk was observed for the AMG0102 group, but it was not statistically significant (stratified log-rank test P = 0.250, hazard ratio [HR] 0.774; 95% confidence interval [CI]: 0.500–1.198). The median duration of primary patency was 245 days and 172 days in the AMG0102 and control groups, respectively. After stratification based on the status of diabetes complications, the HR was 0.666 (95% CI: 0.366–1.212; P = 0.183) and the median duration of primary patency was prolonged by 108 days in the AMG0102 group with diabetes complications (245 days) compared with the control group (137 days). Adverse event (AE) incidence up to 36 postoperative weeks did not differ between groups. Four device failures occurred in 3 patients (AMG0102 group), but none resulted in AEs.ConclusionFurther modifications to enhance NF-κB decoy ODN uptake and efficacy are necessary to show its clinical utility for AVF stenosis in chronic HD.

Acquired Pulmonary Vein Stenosis After Radiofrequency Ablation for Atrial Fibrillation: Single-Center Experience in Catheter Interventional Treatment

ObjectivesThe aim of the present study was to analyze and report a single-center experience with catheter interventional treatment of radiofrequency-induced pulmonary vein stenosis (PVS) following atrial fibrillation (AF) ablation. BackgroundCatheter interventional treatment of radiofrequency-induced PVS following AF ablation remains a challenging field because of a lack of randomized data and treatment guidelines. MethodsAll patients at a single center who underwent catheter interventional treatment for radiofrequency-induced PVS were retrospectively assessed. ResultsFrom January 2004 to September 2017, the total rate of PVS following interventional AF ablation was 0.78% (87 of 11,103). Thirty-nine patients with PVS were treated with 84 catheter interventions: 68 (81%) with percutaneous transluminal balloon angioplasty (PTA) and 16 (19%) with stent implantation. The distribution of stent type was 3 drug-eluting stents (19%) and 13 bare-metal stents (81%). The overall restenosis rate was 53% after PTA versus 19% after stent implantation (p = 0.007) after a median follow-up period of 6 months (interquartile range: 3 to 55 months). The total complication rate for PTA was 10% versus 13% for stenting (p = NS). ConclusionsThis study demonstrates significantly better outcomes in terms of restenosis after stent implantation versus PTA only, with comparable complication rates for these 2 options of interventional treatment of radiofrequency-induced PVS. In summary, despite the lack of randomized studies, the present data and currently available published studies seem to favor stent implantation as a first-line therapy in patients with radiofrequency-induced severe PVS.