World's First Experience Treating TASC II C and D Tibial Occlusive Disease Using the Selution SLR Sirolimus-Eluting Balloon: Six-Month Results From the PRESTIGE Study.

PURPOSE: The performance of sirolimus-coated devices has not been studied in patients with chronic limb-threatening ischemia patients. PRESTIGE aims to investigate the 6-month efficacy and safety profile of the Selution Sustained Limus Release (SLR) sirolimus-eluting balloon for treatment of TASC II C and D tibial occlusive lesions in patients with CLTI. MATERIALS AND METHODS: PRESTIGE is a pilot prospective, nonrandomized, single-arm, multi-investigator, single-center clinical study. Endpoints were adverse event-free survival at 1 month, technical success rate, primary tibial patency at 6 months, limb salvage success, target lesion revascularization (TLR), and amputation free survival (AFS). RESULTS: A total of 25 patients were included. There were 17 (68.0%) males; mean age, 63.7±9.73 years. CLTI severity was based on the Rutherford scale (R5=25/25; 100.0%). Significant comorbidities included diabetes mellitus (n=22; 88.0%) and end-stage renal failure (n=11; 44.0%). A total of 33 atherosclerotic lesions were treated (TASC II D=15 (45.5%)). Mean lesion length treated was 191±111 mm. Technical success was 100%. Primary tibial patency at 6 months was 22/27 (81.5%) and freedom from clinically driven TLR was 25/30 (83.3%). AFS was 21/25 (84.0%; 3 deaths and 1 major lower extremity amputation). Mean Rutherford score improved from 5.00 at baseline to 1.14±2.10 (p<0.05) at 6 months. There was a wound healing rate of 13/22 (59.1%) and 17/21 (81.0%) at 3 and 6 months respectively. CONCLUSIONS: Selution SLR drug-eluting balloon is a safe and efficacious modality in treating complex tibial arterial occlusive lesions in what is an otherwise frail cohort of CLTI patients, with a high prevalence of diabetes and end-stage renal failure. Technical and clinical success rates are high and 6-month target lesion patency and AFS are more than satisfactory.

A systematic review and meta-analysis of drug-coated balloon versus conventional balloon angioplasty for dialysis access stenosis.

BACKGROUND: Arteriovenous fistulas for patients undergoing hemodialysis (HD) are at high risk of stenosis. Despite conventional balloon angioplasty (CBA), restenosis rates are high. The use of a drug-coated balloon (DCB) may offer an alternative to reduce restenosis. METHODS: This study has been performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. An electronic search on MEDLINE, Embase, and the Cochrane Library was performed to identify articles evaluating DCB angioplasty for patients with HD access stenosis. Risk ratios (RRs) of primary patency were pooled, and relevant subgroup and sensitivity analyses were conducted. RESULTS: There were 17 studies (8 randomized controlled trials [RCTs], 9 cohort studies) included, comprising a total of 1113 stenotic dialysis accesses, of which 54.7% underwent DCB angioplasty and 45.3% underwent CBA. There was a significantly superior 6-month (RR, 0.57; 95% confidence interval [CI], 0.44-0.74; P < .00001; I2 = 62%) and 12-month (RR, 0.73; 95% CI, 0.63-0.84; P < .0001; I2 = 53%) primary patency in the DCB angioplasty group in comparison to the CBA group (71.0% vs 49.2% at 6 months; 44.2% vs 20.6% at 12 months). Subgroup analyses of study design (RCTs, cohort studies) showed similar trends. Sensitivity analyses by excluding one poor-quality RCT and those employing the crossover analysis design also showed similar results. Studies investigating central venous stenosis showed significantly better 6-month (RR, 0.57; 95% CI, 0.41-0.79; P = .0009; I2 = 67%) and 12-month (RR, 0.69; 95% CI, 0.56-0.85; P = .0004; I2 = 64%) primary patency in the DCB angioplasty group in comparison to the CBA group. The pooled rate of minor complications was low in both the DCB (1.1%) and CBA (0.9%) groups. CONCLUSIONS: DCB angioplasty appears to be a better and safe alternative to CBA in treating patients with HD stenosis in terms of 6- and 12-month primary patency. However, a larger trial is warranted to establish these findings.

Fenestrated Endovascular Repair of Zones 1 and 2 Aortic Arch Pathologies.

BACKGROUND: Surgical management of aortic arch pathologies is complex, and endovascular developments have now enabled total or hybrid endovascular aortic arch repair. We present our early experience with fenestrated aortic arch repairs in Ishimaru zones 1 and 2 pathologies. METHODS: In a single tertiary institution, all consecutive endovascular aortic arch repairs were reviewed. A preoperative computed tomography aortogram was performed to assess anatomic suitability, which we defined as having a proximal sealing zone with a maximum diameter of 38 mm and minimum length of 20 mm, absence of significant aortic tortuosity, and suitable sealing zones in target vessels. RESULTS: From September 2015 to February 2018, 5 cases of fenestrated aortic arch endovascular repairs were performed. There were 3 male patients. The patients were between 57 and 83 years old, all of whom were American Society of Anesthesiologists (ASA) class II or III. Indications for surgery included aortic arch aneurysms (n = 3), a symptomatic aortic dissection, and a left subclavian artery aneurysm. Three patients had a scallop to the innominate artery, and one patient had a scallop to the left common carotid artery. Fenestrations were made to 3 left common carotid arteries and 3 left subclavian arteries. In 2 patients, a left carotid-subclavian bypass was performed, and the left subclavian artery origin occluded with a vascular plug. Technical success was 100%. One patient developed a right occipital infarct and acute myocardial infarction. The mean duration of surgery was 164 min, and the mean length of stay was 4.2 days. The mean follow-up period was 14.4 months. CONCLUSIONS: The use of fenestrated grafts in the aortic arch is a feasible treatment option. However, certain limitations still exist, and preoperative planning is important in ensuring clinical success. Although this procedure appears feasible in the short term, long-term results and durability remain to be seen.

Use of Paclitaxel Coated Drug Eluting Technology to Improve Central Vein Patency for Haemodialysis Access Circuits: Any Benefit?

PURPOSE: Central venous stenosis is a recurring problem affecting dialysis access patency. Increasing evidence suggests that the use of drug-coated balloons (DCBs) improves target lesion primary patency (TLPP) in dialysis access. However, few studies have investigated the use of DCBs specifically in central venous stenosis. Thus, this study presents our initial experience with DCBs in the central vein of a dialysis access circuit. MATERIALS AND METHODS: This is a retrospective cohort study of all hemodialysis patients who underwent central vein angioplasty with DCB between February 2017 and March 2018 at Singapore General Hospital. We compared the primary patency post DCB angioplasty to the primary patency of the patient's previous plain old balloon angioplasty (POBA). RESULTS: We observed a 100% anatomic and procedural success rate with no complications. The median follow-up period was 151 days (interquartile range, 85.5-234 days) and no patients were lost to follow-up. The 30- and 90-day TLPPs after DCB were 93.3% and 75.7%, respectively. The mean primary patency in our study group post-DCB during the follow-up period was 164 days (vs. 140 days in the POBA group). However, no statistically significant difference was detected. CONCLUSION: DCB showed a similar TLPP to that for POBA in treating central venous stenosis with a trend toward a longer re-intervention-free period for DCB. However, there were numerous confounding factors and a well-designed randomized controlled trial is warranted to assess the true utility of DCB in treating central venous stenosis.