Conventional Balloon Angioplasty Research Articles

Ablation of atrial flutter in a patient after Fontan procedure: a case report of challenging access to the common atrium

Abstract Background In patients with a total cavopulmonary connection in Fontan circulation, the access to the common atrium (CA) during a catheter ablation can be challenging, even in the presence of fenestration in an intra-atrial lateral tunnel (IALT). In our department, the fenestration is typically marked with metal clips (MCs). To the best of our knowledge, there is no previous report of balloonoplasty of clipped fenestration. Case summary A 19-year-old male with hypoplastic left heart syndrome (HLHS) was scheduled for catheter ablation of recurrent atrial tachycardia. He was diagnosed with HLHS prenatally and underwent a stepwise surgical palliation. Fontan circulation was completed with the creation of a fenestrated IALT. The fenestration was marked by four MCs. During the ablation procedure, the passage of the steerable sheath with mapping catheter to the CA was prevented by a small fenestration size and rigidness of the edges of the fenestration caused by the MCs. Multiple attempts to dilate the fenestration using a peripheric angioplasty balloon failed. Only angioplasty with the ‘balloon-against-dilator’ technique was finally successful. Activation map showed a counterclockwise atrial flutter in the CA; successful ablation was performed. Discussion We present a case of challenging access to the CA through a clipped fenestration in a polytetrafluoroethylene baffle for atrial tachycardia ablation. Even though a tunnel fenestration in Fontan patients facilitates access to the CA, the passage of a steerable introducer with a mapping catheter may be challenging due to diameter mismatch and the rigidity of its edges caused by MCs. The balloon-against-dilator technique might be helpful when conventional balloon angioplasty fails.

Patency of Drug-Coated versus Conventional Balloon Angioplasty for Hemodialysis Access Stenosis.

This study aimed to evaluate the post-intervention target primary patency of drug-coated balloon angioplasty (DCBA) compared with conventional balloon angioplasty (CBA) in the treatment of the dysfunctional autogenous arteriovenous fistula (AVF) in a real-world clinical setting. This retrospective study included 24 patients with end-stage renal disease, who developed dysfunctional AVF during hemodialysis, and underwent endovascular treatment using CBA and DCBA from January 1, 2014, to June 30, 2021. The demographic data of patients and details regarding their fistula were recorded. Post-intervention target primary patency was analyzed. Sixteen men and 8 women with an average age of 63.9 ± 14.2 years, who underwent 333 endovascular treatments in 57 target lesions of access were enrolled. DCBA was a protective factor for the treatment of a target lesion of dysfunctional access with an adjusted hazard ratio of 0.725 (95% confidence interval [CI]: 0.528-0.996; P = 0.047). According to the Weibull proportional hazards regression model, DCBA showed a longer post-intervention target primary patency than CBA. DCBA has better outcomes in terms of post-intervention target primary patency in the real-world treatment of dysfunctional autogenous AVF.

Angioplasty for dysfunctional arteriovenous fistulas: A meta-analysis of recent randomized controlled trials compared paclitaxel-coated balloon versus conventional balloon angioplasty.

Stenosis in arteriovenous fistulas (AVF) due to neointimal hyperplasia is one of the most common causes of hemodialysis vascular access dysfunction. Treating patients with dysfunctional AVF with drug-coated balloon (DCB) angioplasty may potentially improve outcomes. This systematic review aimed to compare the effectiveness and safety of DCB angioplasty versus conventional balloon angioplasty by pooling evidence from the most recent randomized controlled trials. We conducted a comprehensive literature search in the Web of Science, Embase, and Cochrane central databases. Two independent researchers screened the article, extracted interest, and evaluated included studies for risk of bias. Pooled estimation was conducted in terms of 6-month target-lesion primary patency (TLPP) and target-lesion reintervention (TLR), as well as other outcomes. Results were expressed with odds ratio (OR) and 95% confidence interval (CI). A total of five RCTs were identified and included in the meta-analyses, with 1107 participants. DCB has a trend of a higher rate of TLPP (OR 1.79, 95% CI 0.66-4.90, p = 0.181) and a significantly lower rate of TLR (0.52, 95% CI 0.29-0.92, p = 0.034), as compared to conventional balloon angioplasty. No difference in the 6-month access circuit primary patency and reinvention was observed between the two groups. DCB may be an alternative treatment of dysfunctional AVF given a trend of a higher rate of TLPP and a significantly lower rate of TLR than conventional balloon angioplasty within 6 months after the indexed procedure. Moreover, DCB was non-inferior to conventional balloon angioplasty in terms of safety. Considering variations in the DCB technique, further studies are warranted for a standardized process.

Comparison of peripheral cutting balloon angioplasty with conventional balloon angioplasty for recurrent hemodialysis vascular access stenosis: A prospective randomized controlled trial.

This study aimed to compare the efficacy and safety of cutting balloon angioplasty (CBA) and conventional balloon angioplasty (control group) for recurrent vascular access stenosis in arteriovenous fistulas. This prospective, randomized single-center clinical trial included patients with hemodynamically significant recurrent vascular access stenosis of an arteriovenous fistula. The Kaplan-Meier method was used to assess primary patency, whereas the log-rank test was used to evaluate differences in patency between groups. Functional evaluations were performed using Doppler ultrasonography. Patients (n = 122) were randomly assigned to undergo CBA or conventional balloon angioplasty between December 2012 and November 2017. The clinical success rate was 100% in both groups. The anatomical success rates were 65% and 56% in the CBA and control groups, respectively. The primary patency of the target lesion was significantly better in the CBA group (33.3%) than in the control group (16.1%) at 6 months (hazard ratio, 0.50; 95% confidence interval, 0.33-0.77; p = 0.00171). The stenosis percentage decreased significantly after angioplasty in the CBA group (Δ-50.7%) compared with the control group (Δ-41.9%) (p = 0.0008). Access flow, measured using duplex Doppler ultrasonography, improved after angioplasty in both groups (300-526 ml/min in the control group and, 268-546 ml/min in the CBA group). Change in access flow (Δ + 278 ± 162) in the CBA group tended to be greater than that in the control group (Δ + 226 ± 151) (p = 0.07). However, the difference was not statistically significant. In patients with recurrent vascular access stenosis of the arteriovenous fistula CBA is effective and superior to conventional angioplasty.

A Bayesian network meta-analysis for acute thrombosis after lower extremity artery endovascular treatment.

Various endovascular treatment devices have been widely used in the lower extremity arterial disease (LEAD). Their patency efficiency for target lesions has been well studied and reported. Comparison of the risk of acute thrombosis events between the different endovascular treatment devices is unclear. To rank the risk of acute thrombosis events when bare metal stents (BMSs), covered stents (CSs), drug-eluting stents (DESs), drug-coated balloons (DCBs), and conventional percutaneous transluminal balloon angioplasty (PTA) are used to treat LEAD through Bayesian network meta-analysis. We performed a network meta-analysis of randomized controlled trials comparing the risk of 1-year postoperative acute thrombosis between BMSs, CSs, DESs, DCBs, and PTA for treating LEAD. Bayesian random models were used for pooled endovascular treatment modality comparisons. We ranked these treatment modalities via the Bayesian method according to their surface under the cumulative ranking curve (SUCRA) and estimated probabilities. Nineteen studies (38 study arms; 2758 patients) were included. The Bayesian network ranking of treatments indicated that DCB had the lowest risk of acute thrombosis, PTA had the second-lowest risk of thrombosis, and CS, BMS, and DES had the highest risk of thrombosis. Regarding the treatment efficacy, the OR values of the loss of primary patency were significantly lower for DCB (OR = 0.44, 95% CI: 0.30-0.62), DES (OR = 0.36, 95% CI: 0.14-0.94), and CS (OR = 0.31, 95% CI: 0.18,0.56) than for PTA. When BMS was used as a reference, only the OR for CS was significantly lower (OR = 0.41, 95% CI = 0.21-0.82). Correspondingly, the Bayesian ranking of treatments from better to worse target lesion primary patency was CS, DES, DCB, BMS, and PTA. With the available research evidence and according to the network analysis ranking, DES appears to have the highest risk of acute thrombosis and DCB appears to have the lowest risk.

Evaluating the Clinical Outcomes of Drug-Coated Balloon and Conventional Balloon Angioplasty in the Management of Stent Edge Restenosis

Background Coronary stenting is frequently complicated by stent edge restenosis (SER), which causes the artery to re-narrow. Drug-eluting stents (DES), plain balloon angioplasty (POBA), conventional balloon angioplasty (CBA), and drug-coated balloons (DCBs) are possible treatments for SER. Methods This study compared the effectiveness of DCB angioplasty with CBA to treat SER. Eighty patients were randomly assigned to receive either DCB or CBA. At 8th week and 6 months, the primary patency of the target lesion and access circuits were assessed as clinical outcomes. Furthermore, levels of perceived stress were measured by perceived stress scores. Results At 8th week, the perceived stress levels of the DCB group were statistically significantly (<0.05) lower than those of the CBA group. Compared to the CBA group, the DCB group experienced improved outcomes at 6 months in all clinical outcomes. Conclusion DCB angioplasty may be superior to CBA in treating SER. In addition to enhancing vascular access, DCB angioplasty may also enhance mental and general well-being. Keywords Anxiety, Depression, Drug-Coated Balloon Vascular Access, Perceived Stress.

Comparative Outcomes of Interventions for Femoropopliteal Chronic Total Occlusion Versus Non-Chronic Total Occlusion Lesions From the Multicenter XLPAD Registry.

Background Endovascular intervention of femoropopliteal chronic total occlusions (CTOs) is technically more complex. However, there is lack of comparative analysis between CTO and non-CTO femoropopliteal interventions. Methods and Results We report procedural details and outcomes of patients treated for femoropopliteal CTO and non-CTO lesions in the XLPAD (Excellence in Peripheral Artery Disease) registry (NCT01904851) between 2006 and 2019. Primary outcomes were procedural success and 1-year major adverse limb events, a composite of all-cause death, target limb revascularization, or major amputation. Analysis included 2895 patients (CTO: n=1516 patients; non-CTO: n=1379 patients) with 3658 lesions (CTO: n=1998 lesions; non-CTO: n=1660 lesions). Conventional balloon angioplasty (20.86% versus 33.48%, P<0.001) or drug-coated balloon angioplasty (1.26% versus 2.93%, P<0.001) were more frequent in the non-CTO group, whereas bare-metal stents (28.09% versus 20.22%, P<0.001) or covered stents (4.08% versus 1.83%, P<0.001) were more frequent in the CTO group. Debulking procedures were more commonly performed in the non-CTO group (41.44% versus 53.13%, P<0.001), despite a similar degree of calcification between the 2 groups. Procedural success was higher in the non-CTO group (90.12% versus 96.79%, P<0.001). Procedural complications were higher in the CTO group (7.21% versus 4.66%, P=0.002), mainly due to excess distal embolization (1.5% versus 0.6%, P=0.015). Adjusted 1-year major adverse limb events were higher in the CTO group (22.47% versus 18.77%, P=0.019), driven mainly by target limb revascularization (19.00% versus 15.34%, P=0.013). Conclusions Procedural success is lower for endovascular treatment of femoropopliteal CTO compared with non-CTO lesions. CTO lesions are associated with higher rates of periprocedural complications and reinterventions after 1 year.

A Randomised Trial Comparing Drug Coated Balloons and Conventional Balloons for the Treatment of Stent Graft Stenosis in Dialysis Vascular Access

Previous studies on arteriovenous fistulas have demonstrated the potential benefit of drug coated balloons (DCBs) in maintaining the patency of dialysis access. However, stenoses involving stent grafts were excluded from these studies. Therefore, the aim was to evaluate the effectiveness of DCBs in treating stent graft stenosis. This was a prospective, single blinded, randomised controlled study. From March 2017 to April 2021, 40 patients with dysfunctional vascular access owing to stent graft stenosis were randomised to treatment with a DCB or conventional balloon. Clinical follow up was scheduled at one, three, and six months, and angiographic follow up was performed six months after the intervention. The primary outcome was angiographic late luminal loss at six months, and secondary outcomes included target lesion and access circuit primary patency at six months. Thirty-six participants completed follow up angiography. The DCB group had a superior mean late luminal loss at six months compared with the control group (1.82 mm ± 1.83 mm vs. 3.63 mm ± 1.08 mm, respectively, p= .001). All 40 patients completed clinical follow up. The DCB group had a superior six month target lesion primary patency compared with the control group [hazard ratio (HR) 0.23, 95% confidence interval (CI) 0.07 - 0.71; p= .005). Additionally, the DCB group had a numerically higher six month access circuit primary patency rate than the control group, although the difference was not statistically significant (HR 0.54, 95% CI 0.26 - 1.11, p= .095). Conventional balloon angioplasty is not durable in stent graft stenosis treatment. Treatment with DCBs provides less angiographic late luminal loss and potentially superior primary patency of the target lesion than treatment with conventional balloons. [ClinicalTrials ID: NCT03360279.].

Fracking compared to conventional balloon angioplasty alone for calcified common femoral artery lesions using intravascular ultrasound analysis: 12-month results

BackgroundFracking is a novel technique to crack calcified lesions by hydraulic pressure. This study aimed to compare the performance of fracking and conventional balloon angioplasty without stenting for calcified common femoral artery (CFA) lesions using intravascular ultrasound (IVUS) analysis.MethodsThis retrospective, single-center, comparative observational study included 59 patients (67 limbs) with calcified CFA lesions treated with either fracking (n = 30) or balloon angioplasty (n = 29) between January 2018 and December 2020. The primary endpoint was 1-year primary patency. The secondary endpoints included procedure success, freedom from target lesion revascularization (TLR), procedure-related complications, and freedom from major adverse limb events (MALE). Predictors of restenosis were identified using multivariate Cox proportional hazards analysis.ResultsThe mean follow-up duration was 403 ± 236 days. The fracking group had significantly higher incidence of 1-year primary patency (89.8% versus 49.2%, P < 0.001), procedure success (96.9% versus 74.3%, P = 0.009), and freedom from TLR (93.5% versus 74.2%, P = 0.038) than the balloon group. The rate of freedom from MALE was significantly higher in the fracking group than in the balloon group (76.9% versus 48.6%, P = 0.033). The groups had no significant difference in procedure-related complications (6.2% versus 5.7%, P = 0.928). A larger postprocedural IVUS-estimated minimum lumen area (MLA) was associated with a lower risk of restenosis (hazard ratio, 0.78; 95% confidence interval, 0.67–0.91; P < 0.001), with a cut-off value of 16.0 mm2 determined using receiver operating characteristics curve analysis. The incidence of 1-year primary patency in patients with a postprocedural MLA ≥16.0 mm2 (n = 37) was significantly higher than that in those with a postprocedural MLA < 16.0 mm2 (n = 30) (87.8% versus 44.6%, P < 0.001).ConclusionThis study demonstrated the superior procedural efficacy of fracking compared to balloon angioplasty in treating calcified CFA lesions. The safety outcomes after fracking were comparable to those after balloon angioplasty. Large postprocedural MLA was an independent positive predictor of patency.

Comparative efficacy and safety of four common balloon angioplasty techniques for an arteriovenous fistula or graft stenosis: a systematic review and network meta-analysis of randomized controlled trials.

Balloon angioplasty could decrease restenosis of hemodialysis vascular access. The present study investigated the comparative effects and safety of commonly available balloon angioplasty techniques for treating patients with failing autogenous arteriovenous fistulas (AVFs) and grafts (AVGs) stenosis. A comprehensive literature search, including an updated search of PubMed and Embase (via Ovid) and screening of published meta-analyses, was conducted. Primary patency at 6 and 12 months was the primary outcome, and the incidence of complications was the secondary outcome. The random-effects model was used to conduct all statistical analyses, which were performed using RevMan 5.3 and ADDIS 1.16.8. A total of 20 eligible studies involving four balloon angioplasty techniques were entered into the final analysis. Although the direct meta-analysis indicated that cutting balloon angioplasty (CtBA) significantly improved primary patency at 6 [odds ratio (OR), 1.91; 95% confidence interval (CI): 1.27 to 2.86] and 12 (OR, 1.56; 95% CI: 1.13 to 2.15) months compared with conventional balloon angioplasty (CBA), this was not supported by network meta-analysis, which suggested that CtBA was associated with a higher risk of complications compared with drug-coated balloon angioplasty (DcBA) [OR, 0.05; 95% credible interval (CrI): 0.00 to 0.83], high-pressure balloon angioplasty (HBA) (OR, 0.04; 95% CrI: 0.00 to 0.69), and CBA (OR, 0.11; 95% CrI: 0.02 to 0.59). Subgroup analysis of AVFs did not detect any significant differences. In failing AVF and AVG stenosis, HBA might be a preferential option as it is related to a lower risk of complications and has numerically higher primary patency than DcBA and CBA. Further studies are needed to confirm these findings.

Abstract No. 94 Extended 5-Year Amputation and Survival Outcomes from SINGAPACLI: A Randomized Clinical Trial Comparing Drug-Coated Balloon to Conventional Balloon Angioplasty for Below-the-Knee Arteries in Critical Limb Ischemia

Abstract No. 94 Extended 5-Year Amputation and Survival Outcomes from SINGAPACLI: A Randomized Clinical Trial Comparing Drug-Coated Balloon to Conventional Balloon Angioplasty for Below-the-Knee Arteries in Critical Limb Ischemia

Angioplasty for Supra-Aortic Arterial Lesions from Takayasu Arteritis: Efficacy of Cutting Balloon Angioplasty Versus Conventional Balloon Angioplasty

This retrospective study aimed to evaluate the safety and efficacy of cutting balloon angioplasty and conventional balloon angioplasty in supra-aortic arterial lesions caused by Takayasu arteritis. A total of 46 patients with supra-aortic arterial lesions between January 2011 and December 2018 were included. Cutting balloon angioplasty was applied for 17 patients with 24 supra-aortic arterial lesions (group A), while 29 patients with 36 supra-aortic arterial lesions received conventional balloon angioplasty (group B). The preoperative clinical manifestation, operation result, and postoperative outcomes were recorded and compared in the 2 groups. Dizziness, visual disturbance, and unequal/absent pulses were the most common manifestations. The technical success of revascularization was 93.5% (43/46) in patients and 93.3% (56/60) in lesions. The stent implantation rate in group A was significantly lower than that in group B (4.2% vs. 50% in lesions, P<0.05). Restenosis was the most common complication in both groups. Although the early (≤30days) and late (>30days) complications in group A were less than those in group B, there was no significant difference between the 2 groups (P>0.05). Moreover, the primary-assisted patency of cutting balloon angioplasty and conventional balloon angioplasty at 1, 2, and 5years were 66.7%, 62.5%, and 62.5% and 61.1%, 58.2%, and 49.8%, there was no significant difference between the 2 groups (P>0.05), respectively. Compared with conventional balloon angioplasty, cutting balloon angioplasty could be considered a safe and effective alternative for supra-aortic arterial lesions caused by Takayasu arteritis, demonstrating better patency and clinical benefit.

Specialty Balloons for Vessel Preparation During Infrainguinal Endovascular Revascularization Procedures: A Review of Literature.

Balloon angioplasty with/without utilizing drug eluting technology or stenting constitutes the treatment of choice for a significant percentage of patients with peripheral artery disease requiring an intervention. However, in cases of diffuse disease and plaque complexity, angioplasty may lead to dissection, recoil, and/or early restenosis, making vessel preparation a key component for successful and durable endovascular revascularization outcome. This review of literature aims to present contemporary data for several commercially available specialty balloons that have been designed to minimize the arterial wall stress of conventional balloon angioplasty and facilitate technical success, as well as long-term patency.

Novel Scaffolds for the Treatment of Below-the-Knee Peripheral Arterial Disease With Chronic Limb Threatening Ischemia: A Review

Below-the-knee (BTK) peripheral arterial disease (PAD) is a significant source of cardiovascular morbidity and mortality. Patients with chronic limb-threatening ischaemia in BTK PAD represent one of the highest-risk cohorts of PAD patients, with little progress having been made regarding long-term patency and mortality over the past four decades. Although conventional balloon angioplasty has long been the standard of care, several novel scaffolds have been introduced over the past decade with promising 1-year patency rates and freedom from clinically driven target limb revascularisation, which may herald a new age of endovascular intervention for BTK PAD. In this review, we present a critical appraisal of the literature surrounding novel scaffolds and drug-eluting technology in the treatment of BTK PAD.

Comparison of drug-coated balloon with conventional balloon for angioplasty in symptomatic intracranial atherosclerotic stenosis

BackgroundDrug-coated balloon (DCB) angioplasty has been studied for reducing the occurrence of restenosis after treatment for intracranial atherosclerotic stenosis (ICAS), but no comparison has been published of the use of...

Abstract 13394: Primary Perfusion Balloon Angioplasty in Primary Percutaneous Coronary Intervention for St-Segment Elevation Myocardial Infarction - The Novel Cardioprotective Revascularization Strategy

Background: In patients with STEMI, primary PCI reduces the risk of cardiovascular death, whereases following myocardial reperfusion injury indicating poor prognosis. Post-conditioning is expected to limit reperfusion infarction but the long-term outcome is unclear. We investigated whether primary perfusion balloon angioplasty (PPBA) strategy might reduce reperfusion injury and improve prognosis. Methods: PPBA is maneuver treating as primary revascularization procedure with perfusion balloon angioplasty undergoing long-inflation (5-minutes or more) as post-conditioning. This study is a retrospective analysis from an observational registry which enrolled all consecutive 49 patients with STEMI undergoing PCI in PPBA strategy or conventional balloon angioplasty (CBA) strategy at a single center from February 2021 to January 2022. The primary outcome of the study was MACE as a composite of all-cause death, cardiac death, MI, CI-TVR, hospitalization because of heart failure, and cerebrovascular disease followed at 6 months. The secondary outcome was the composite of no-reflow or slow flow phenomenon, ST elevation, and VT or VF occurrence immediately after primary revascularization procedure. Results: 24 patients were treated with PPBA strategy and 25 patients were treated with CBA strategy. At the 6-months, primary composite outcome occurred in 25% treated with PPBA strategy and in 52% treated with CBA strategy (HR, 0.38; P=0.04); the difference was driven by a lower incidence of cardiac death, MI, CI-TVR in PPBA arm. Immediately after primary revascularization, secondary composite outcome occurred in 4.2% treated with PPBA and in 56% treated with CBA (RR, 0.03; P=0.0001); the difference was driven by a lower incidence of no-reflow/slow flow and ST elevation in PPBA arm. Conclusions: PPBA strategy as primary cardioprotective revascularization expected post-conditioning reduces lethal reperfusion injury, resulting in a better prognosis in STEMI.

Drug-Coated Balloon Angioplasty for Carotid Artery In-Stent Restenosis: Case Series

Objectives: Few case reports have demonstrated promising results of drug-coated balloons (DCBs) as an emerging management for carotid artery in-stent restenosis (CAISR). Herein, we report 6 cases of CAISR which were treated with a DCB with or without new stent deployment. Background: Carotid artery in-stent restenosis is a high-risk condition with an estimated incidence rate that varies widely from 6% to 40%. Several strategies are available now for the management of the CAISR including conventional balloon angioplasty, plaque modification balloon angioplasty, and new stent placement. Methods: A retrospective review of consecutive patients with a diagnosis of severe CAISR at Baylor Scott & White The Heart Hospital Plano from 2011 to 2021 was performed. This study was approved by the Baylor Scott & White Research Institute institutional review board. Results: Six patients underwent DCB angioplasty with or without stent placement under an embolic protection device. Resolution of CAISR was achieved in all cases with 0% to 10% residual stenosis in all cases. Following the procedure, 1 patient had a brief episode of syncope with balloon inflation with immediate recovery on deflation of the balloon. There were otherwise no significant neurological or cardiac events prior to discharge. All patients were asymptomatic at their follow-up visit with no neurological or cardiac events reported at 12, 24, and 36 months following the procedure. Conclusion: While CAISR treatment remains a challenging condition, our study shows that the use of DCB with or without stent placement is a feasible and promising treatment option when compared with other conventional treatment options. Clinical Impact Carotid artery in-stent restenosis treatment remains a challenging condition. Our study shows that the use of drug coated balloon with or without stent placement is a feasible and promising treatment option when compared with current conventional treatment options.

Cost-Effectiveness of Drug-Coated Balloon Angioplasty Compared With Conventional Balloon Angioplasty for Arteriovenous Access Flow Dysfunction

ObjectivesThis study aimed to determine the cost-effectiveness of drug-coated balloon (DCB) angioplasty compared with conventional balloon angioplasty (cPTA) in patients with arteriovenous fistulas (AVFs) and arteriovenous grafts (AVGs) dysfunction from a Singapore healthcare perspective. MethodsExisting cost-effectiveness studies comparing DCB and cPTA have not incorporated AVF/AVG abandonment costs. This Markov model-based economic evaluation incorporated AVF/AVG creation and maturation costs on top of routine intervention costs to model a hypothetical cohort of 60-year-old AVF/AVG flow dysfunction patients. Effectiveness was measured in quality-adjusted life-years. Cost-effectiveness was assessed using incremental net monetary benefit (NMB) at a Singapore willingness-to-pay threshold of Singapore dollar (S$)87 000. Deterministic and probabilistic sensitivity analyses were performed to examine parameter uncertainty. To test hypotheses regarding cost-effectiveness, intervention counts per patient, cumulative incidence functions of AVF/AVG abandonment, and survival curves of death were compared between DCB and cPTA. ResultsDCB was not cost-effective at 3-year horizon (NMB = −S$1424), but was cost-effective at 1- and 6-year horizons (NMB = S$356 and S$3738, respectively). At 3 years, there was a 34.5% probability of DCB being cost-effective, but at 1- and 6-year horizons there was, respectively, 58.6% and 59.9% probability of DCB being cost-effective. DCB had graphically less AVF/AVG-abandonments, but this was not statistically significant (P = .21). Differences in other parameters were neither graphically nor statistically significant. ConclusionsWith AVF/AVG abandonment considered, DCB may be weakly cost-effective compared with cPTA in treating AVF/AVG flow dysfunction. AV access creation and maturation costs could have important explanatory value in assessing DCB cost-effectiveness.

Abstract No. 203 Drug-coated balloon angioplasty versus conventional balloon angioplasty for arteriovenous fistula stenosis: a cost effectiveness study

Abstract No. 203 Drug-coated balloon angioplasty versus conventional balloon angioplasty for arteriovenous fistula stenosis: a cost effectiveness study

Randomized evaluation of vessel preparation with orbital atherectomy prior to drug-eluting stent implantation in severely calcified coronary artery lesions: Design and rationale of the ECLIPSE trial

Severe coronary artery calcification has been associated with stent underexpansion, procedural complications, and increased rates of early and late adverse clinical events in patients undergoing percutaneous coronary intervention. To date, no lesion preparation strategy has been shown to definitively improve outcomes of percutaneous coronary intervention for calcified coronary artery lesions. ECLIPSE (NCT03108456) is a prospective, randomized, multicenter trial designed to evaluate two different vessel preparation strategies in severely calcified coronary artery lesions. The routine use of the Diamondback 360 Coronary Orbital Atherectomy System is compared with conventional balloon angioplasty prior to drug-eluting stent implantation. The trial aims to enroll approximately 2000 subjects with a primary clinical endpoint of target vessel failure, defined as the composite of cardiac death, target vessel-related myocardial infarction, or ischemia-driven target vessel revascularization assessed at 1 year. The co-primary endpoint is the acute post-procedural in-stent minimal cross-sectional area as assessed by optical coherence tomography in a 500-subject cohort. Enrollment is anticipated to complete in 2022 with total clinical follow-up planned for 2 years. ECLIPSE is a large-scale, prospective randomized trial powered to demonstrate whether a vessel preparation strategy of routine orbital atherectomy system is superior to conventional balloon angioplasty prior to implantation of drug-eluting stents in severely calcified coronary artery lesions.