Long-term mortality and patency after drug-coated balloon angioplasty in the hemodialysis circuit: A systematic review and meta-analysis of randomized controlled trials

Purpose: To compare all-cause mortality and primary patency with drug-coated balloon angioplasty (DCBA) compared with plain balloon angioplasty (PBA) in people with hemodialysis-related stenosis. Materials and methods: PubMed, Embase, and Cochrane Library databases were searched from November 1966 to February 2021 to identify randomized controlled trials (RCTs) that assessed the use of DCBA versus PBA for stenosis in hemodialysis circuits. Data extracted from the articles were integrated to determine all-cause mortality, target lesion primary patency (TLPP), circuit access primary patency (CAPP), 30-day adverse events, and technical success for the two approaches. We performed meta-analysis on these results using a fixed-effects model to evaluate odds ratios (ORs) and 95% confidence intervals (CIs) where I2 < 50% in a test for heterogeneity, or a random-effect model if otherwise. Sensitivity and subgroup analyses were also performed. Results: Sixteen RCTs of 1672 individuals were included in our meta-analysis, of which 839 individuals received DCBA and 833 received PBA. The pooled outcome showed no statistical difference between DCBA and PBA in all-cause mortality at 6 months (OR = 1.29, 95% CI = 0.72–2.32, p = 0.39, I2 = 4%), 12 months (OR = 1.02, 95% CI = 0.68–1.53, p = 0.91, I2 = 0%), and 24 months (OR = 1.50, 95% CI = 0.87–2.57, p = 0.15, I2 = 0%), 30-day adverse events (OR = 1.09, 95% CI = 0.30–3.98, p = 0.90, I2 = 66%), and technical success (OR = 0.18, 95% CI = 0.02–1.92, p = 0.16, I2 = 65%). The DCBA had significantly better outcomes versus PBA in TLPP at 6 months (OR = 2.37, 95% CI = 1.84–3.04, p < 0.001, I2 = 44%) and 12 months (OR = 1.77, 95% CI = 1.22–2.56, p = 0.002, I2 = 56%), and CAPP at 6 months (OR = 2.07, 95% CI = 1.21–3.54, p = 0.008, I2 = 67%) and 12 months (OR = 1.66, 95% CI = 1.29–2.15, p < 0.001, I2 = 0%). Conclusion: In hemodialysis circuit stenosis, DCBA appears to have similar safety but greater efficacy than PBA.

No Mortality Signal With Stellarex Low-Dose Paclitaxel DCB: ILLUMENATE Pivotal 4-Year Outcomes

Background: Paclitaxel-coated balloons have shown safety and efficacy in the short- to intermediate-term; however, long-term data remain limited. Objectives: To report late safety and efficacy outcomes for a low-dose paclitaxel drug-coated balloon (DCB) compared with percutaneous transluminal angioplasty (PTA) in femoropopliteal lesions from a large randomized controlled trial (RCT). Methods: ILLUMENATE Pivotal is a multicenter, single-blind RCT conducted across 43 US and EU centers to examine the safety and efficacy of the Stellarex DCB for the treatment of femoropopliteal disease. Assessments were recorded for all active patients at 36 and 48 months. Vital status of patients formally exited from the study was also collected. Results: Primary patency through 36 months for patients treated with DCB was significantly higher compared with PTA (p=0.016). The primary safety endpoint through 36 months was 77.4% and 72.4%, respectively (p=0.377). Kaplan-Meier analysis indicated that a higher proportion of DCB subjects were event-free compared with PTA at all study visits. The rate of major adverse event (MAE) through 48 months was 32.9% in the DCB group and 37.9% in the PTA group (p=0.428). No differences in the rate of mortality were evident through 48 months of follow-up with 15.6% in the DCB group and 15.2% in the PTA group (p=0.929). Conclusions: Stellarex DCB was associated with significantly higher patency compared with PTA through 3 years with no mortality difference detected through 4 years. The data from the ILLUMENATE Pivotal RCT support the long-term safety and efficacy of the low-dose Stellarex DCB.

Stent grafts improved patency of ruptured hemodialysis vascular accesses

This study aimed to compare stent graft with balloon tamponade for ruptured dialysis access during percutaneous transluminal angioplasty. Patients over an 8-year period (2010–2018) were identified from a database of 11,609 procedures. The primary endpoint was target lesion primary patency at 12 months. A total of 143 patients who had rupture dialysis access were enrolled, of whom 52 were salvaged by stent grafts and 91 were salvaged by balloon tamponade. The 6-month target lesion primary patency was greater in the stent graft group than in the balloon tamponade group (66.7% vs. 29.5%, P < 0.001). The benefit of stent grafts was sustained for 12 months (52.5% vs. 9.0%, P < 0.001). The stent grafts increased the median time from the index procedure to the next intervention in the ruptured area by 171 days (260 vs. 89 days) at 12 months. There was no significant difference in the access circuit patency rates at 6 months (25.5% vs. 19.8%, P = 0.203) and 12 months (12.0% vs. 5.8%, P = 0.052). The patency results of the stent grafts remained after the multivariable adjustment analysis. Compared to balloon tamponade alone, stent grafts provided superior target lesion primary patency at 6 and 12 months. The access circuit patency rates were similar.

The use of AVF.SIM system for the surgical planning of arteriovenous fistulae in routine clinical practice

Background: The number of patients treated with hemodialysis (HD) in Europe is more than half a million and this number increases annually. The arteriovenous fistula (AVF) is the vascular access (VA) of first choice, but the clinical outcome is still poor. A consistent number of AVFs fails to reach the desired blood flow rate for HD treatment, while some have too high flow and risk for cardiac complications. Despite the skill of the surgeons and the possibility to use Ultrasound investigation for mapping arm vasculature, it is still not possible to predict the blood flow volume that will be obtained after AVF maturation. Methods: We evaluated the potential of using a computational model (AVF.SIM) to predict the blood flow volume that will be achieved after AVF maturation, within a multicenter international clinical investigation aimed at assessing AVF.SIM predictive power. The study population included 231 patients, with data on AVF maturation in 124 patients, and on long-term primary patency in 180 patients. Results: At 1 year of follow-up, about 60% of AVFs were still patent, with comparable primary patency in proximal and distal anastomosis. The correlation between predicted and measured blood flow volume in the brachial artery at 40 days after surgery was statistically significant, with an overall correlation coefficient of 0.58 ( p < 0.001). The percent difference between measured and predicted brachial blood flow 40 days after surgery was less than 30% in 72% of patients investigated. Conclusions: The results indicate that the use of the AVF.SIM system allowed to predict with a good accuracy the blood flow volume achievable after VA maturation, for a given location and type of anastomosis. This information may help in AVF surgical planning, reducing the AVFs with too low or too high blood flow, thus improving AVF patency rate and clinical outcome of renal replacement therapy.

Endovascular salvage of failing arterio-venous fistulas utilising sirolimus eluting balloons: Six months results from the ISABELLA trial

Background: Aim of this pilot clinical study was to evaluate the safety and efficacy of the Selution Sustained Limus Release (SLR)™ sirolimus-eluting balloon (SEB) for improving failing arterio-venous fistulas (AVF) patency in Asian haemodialysis patients. Methods: Prospective single-centre, multi-investigator, non-consecutive, non-blinded single arm trial. Forty end-stage renal failure Asian patients with a dysfunctional AVF underwent SEB angioplasty between May and November 2020. All stenotic lesions were prepared with high pressure non-compliant balloon angioplasty prior to SEB angioplasty. Endpoints of interest included target lesion primary patency and circuit access patency and safety through 30 days. All patients received dual antiplatelet therapy for 1 month and were followed up with Duplex ultrasound at 6 months. Results: There was one subject dropout so final n = 39 patients (mean age 65.0 ± 11.9; males = 26 (66.7%)) and n = 43 target lesions treated. Main indication for intervention was dropping access flow (24/39; 61.5%) and most common target lesion was in the juxta-anastomosis (24/43; 54.5%). There was 100% technical and procedural success. There were no adverse events related to the SEB. Target lesion primary patency rates at 3 and 6 months were 39/41 (95.1%) and 28/39 (71.8%) respectively. Access circuit patency rates at 3 and 6 months were 35/37 (94.6%) and 22/35 (62.9%) respectively. There were 3 (7.7%) deaths all attributable to patients’ underlying co-morbidities. Conclusions: Fistuloplasty using the novel Selution SLR™ SEB for dysfunctional AVF circuits seems a safe and effective modality in Asian haemodialysis patients at 6 months but larger randomised controlled studies are required now to determine its true efficacy against plain balloon angioplasty.

Study of endovascular treatment in obstructive aortoiliac lesions: Immediate and short-term results

Objective: Aorto-iliac occlusive disease (AIOD) is a common atherosclerotic disease causing significant morbidity. Transatlantic intersociety consensus for the management of peripheral arterial disease (TASC II) recommends endovascular therapy (ET) for better management of patients with lesions type A and B. With the advent of endovascular therapy, type C and D lesions management is becoming more feasible with endovascular therapy than open surgery for aorto-iliac occlusive disease. We aimed to evaluate patients with AOID and to describe short-term outcome of endovascular treatment for such lesions. Methods: Patients with aorto-iliac occlusive diseases who underwent endovascular therapy were enrolled in the study. Their demographic data and risk factors were recorded. Patients were followed at 3 and 6 months and their primary patency rate and symptom status were recorded. Results: We enrolled 100 patients with a mean age of 59.77 (8.75) years with the majority of patients being male. The most common presentation was claudication (59%) followed by rest pain (31%) and gangrene (20%). The majority of patients had Transatlantic inter-society consensus (TASC) II type A (44%) and type B (31%) lesions; 15% of patients had types C lesions and the remaining 10% patients had type D lesions. Access site hematoma and contrast-induced nephropathy were present in 7% and 5% of patients respectively. Stent patency rate was 97% and 95% at 3 and 6 months follow up respectively. Conclusion: Endovascular therapy in aorto-iliac occlusive disease is a safe, effective, and low-cost treatment option with a high patency rate and symptomatic improvement in the short-term.

Comparison of Therapeutic Efficacy of Debulking Plus Drug-coated Balloon Angioplasty Versus Drug-coated Balloon Angioplasty Alone for Femoropopliteal Tosaka Class Iii in-stent Restenosis Lesions

Background: Femoropopliteal (FP) Tosaka Class III in-stent restenosis (ISR) Lesions remain a significant clinical problem and optimal revascularization management including the use of drug-coated balloon (DCB) and debulking devices have the potential to improve the outcomes for these patients. However, few studies have been published comparing the debulking plus DCB with DCB alone in Tosaka III FP-ISR treatment. This study was to compare debulking plus DCB versus DCB alone for the treatment of Tosaka III FP-ISR lesions in patients.Methods: This was a single-center retrospective study of patients Tosaka III FP-ISR who underwent endovascular interventions of debulking plus DCB or DCB alone for Tosaka III FP-ISR lesions. One-year primary patency was the main outcome. Other outcome measures are 12-month freedom from clinical-driven target lesion revascularization (f-CD-TLR), technical success rate, and periprocedural complications.Results: A total of 70 patients with Tosaka III FP-ISR were included; 29 were treated with debulking plus DCB, in which 13 were treated with laser atherectomy (LA) plus DCB and 16 were treated with rotational atherectomy (RA) plus DCB. 41 were treated with DCB alone. Lesions in the debulking plus DCB group were significantly longer (16.45±4.40mm vs. 14.04±3.67mm, p=0.015). the 12-month primary patency was not significant different in the comparison of debulking+DCB with DCB group (75.9% vs. 73.2%, p=0.798). in the subgroup comparison, no significant difference was found in the LA+DCB and RA+DCB group (69.2% vs. 81.3%, p=0.544). There were also no significant differences in the group and subgroup comparison of 12-month f-CD-TLR, technical success rate, and periprocedural complications.Conclusions: Debulking plus DCB or DCB alone are both safe and effective for Tosaka III FP-ISR lesions. Although no significant difference was seen, lesions in the debulking+DCB group were significantly longer, suggesting that debulking plus DCB treatment has possible superiority for longer lesions than DCB alone management.

Long-term results of proximal and distal reconstructions in patients with lower limb arteries diffuse lesions and diabetes mellitus

Relevance . Treatment of diffuse lesions of the arteries of the lower extremities is often reduced to primary amputation at the hip level, since the healing of trophic ulcers is not guaranteed during arterial reconstruction. Profundoplasty without distal bypass surgery can be considered an alternative method. The aim of this study is to compare the long-term results of distal shunting and isolated profundoplasty in patients with diffuse lesions of the lower limb arteries and trophic ischemic ulcers. Materials and Methods . The study included 86 patients with diffuse lesions of the lower limb arteries. There were 52 (60.4%) men and 34 (39.6%) women. The average age was 67.3 16.8 years. All patients had diffuse lesions of the arteries below the pupar ligament, the state of the lower leg arteries was 5-8.5 points on the Rutherford scale, in all cases there were trophic ulcers. Group 1 included 48 patients who underwent reconstruction of the leg arteries. Group 2 consisted of 38 individuals who had limited intervention with endarcteriotomy from common femoral and deep femoral arteries. Results and Discussion . Amputations at the hip level were performed within a year in 11 (23.4%) patients of group 1 and in 3 (6.3%) patients within 30 days after surgery. Thus, 14 (29.7%) patients lost their limbs. A comparative analysis revealed that the group of patients with amputations had a more severe form of diabetes (p = 0.003), an outflow score on the Rutherford scale (p 0.001), and lower transcutaneous oxygen tension values before and after surgery. Within 12 months after the bypass surgery, the primary patency of the shunts was 65.9% (thrombosis occurred in 16 patients). Conclusion . The preservation of the limb in patients in our study by the end of 1 year after reconstruction is similar regardless of the reconstruction method. Given the minimal invasion during profundoplasty, this operation may be the method of choice for diffuse lesions of the arteries of the lower extremities.

One-Year Outcomes of Two Different Paclitaxel-Eluting Stents (Zilver PTX and Eluvia) for Trans-Atlantic Inter-Society Consensus Document (TASC) C/D Obstructive Femoropopliteal Lesions

Background: Endovascular therapy is one of the standard treatment options for patients with peripheral arterial disease. Paclitaxel-eluting stents (PES) have shown promising results in the treatment of obstructive femoropopliteal lesions. Two types of PES, namely, Zilver PTX (Cook Medical, USA) and Eluvia (Boston Scientific, USA), are available worldwide. However, no study has yet compared the outcomes of applying both PES types in the real world. Objectives: This study aimed to assess the one-year outcomes of two different types of PES for Trans-Atlantic Inter-Society Consensus Document (TASC) C/D obstructive femoropopliteal lesions following suboptimal angioplasty. Patients and Methods: This single-center, retrospective, observational study examined 37 limbs of 34 patients (30 males and four females) with the mean age of 71.9 ± 9.1 years (range, 53-90 years), who were included consecutively from February 2017 to May 2018. In all patients, either a Zilver PTX (Cook Medical) or an Eluvia (Boston Scientific) PES was used for TASC C/D obstructive femoropopliteal lesions following suboptimal angioplasty. Moreover, the patients’ one-year primary patency rate, freedom from clinically driven target lesion revascularization (TLR), and event-free survival rates were determined. Results: The mean lesion length was measured to be 24.6 ± 6.6 cm (range, 9 - 46 cm). Based on the results, 78% of the lesions (29 limbs) showed occlusion, and 46% (17 limbs) showed more than moderate calcification. According to the TASC classification, type D lesions were detected in 25 (68%) limbs, while type C lesions were detected in 12 (32%) limbs. The mean number of stents used was 2.5 ± 0.7 per limb (range, 1 - 3) to cover a mean length of 24.3 ± 7.9 cm (range, 6-35 cm). Overall, 56 Zilver PTX stents for 23 limbs and 36 Eluvia stents for 14 limbs were used. The Kaplan-Meier estimates of one-year primary patency and freedom from TLR were 78% and 88%, respectively (Zilver PTX stent, 76.3% and 81.2%, respectively; Eluvia stent, 91.7% and 100%, respectively). Major adverse events were reported in two patients (2/37, 5.4%), including acute thrombotic occlusion of the treated lesions. Conclusion: Both types of PES showed promising one-year outcomes for TASC C/D lesions regarding safety and efficacy, without any significant differences; therefore, they can be considered as an alternative therapeutic approach for surgery.

MagicTouch PTA Sirolimus Coated Balloon for Femoropopliteal and Below the Knee Disease: Results From XTOSI Pilot Study Up To 12 Months

Introduction: Sirolimus coated balloon (SCB) is a promising treatment option to prevent restenosis for peripheral arterial occlusive disease (PAOD). This is a pilot first-in-human study of MagicTouch percutaneous transluminal angioplasty (PTA) SCB for treatment of PAOD for both femoropopliteal and below the knee arteries (BTK). Material and Methods: Xtreme Touch-Neo [MagicTouch PTA] Sirolimus Coated Balloon (XTOSI) pilot study is a prospective, single-arm, open-label, single-center trial evaluating MagicTouch PTA SCB for symptomatic PAOD. Primary endpoint was defined as primary patency at 6 months (duplex ultrasound peak systolic velocity ratio ≤2.4). Secondary endpoints included clinically driven target lesion revascularization (CD-TLR), amputation free survival (AFS), all-cause mortality, and limb salvage success. Results: Fifty patients were recruited. The mean age was 67 (n=31 [62%] males). SCB was applied to femoropopliteal in 20 patients (40%) and BTK in 30 patients (60%). Majority of treatments (94%) were performed for limb salvage indications (Rutherford scores 5 or 6). This was a high risk cohort, in which 90% had diabetes, 36% had coronary artery disease, 20% had end stage renal failure, and American Society of Anaesthesiologists (ASA) score was 3 or more in 80%. Mean lesion length treated was 227±81 mm, of which 36% were total occlusions. Technical and device success were both 100%. At 30 days, mortality was 2% and major limb amputation was also 2%. Six-month primary patency was 80% (88.2% for femoropopliteal; 74% for BTK). At 12 months, freedom from CD-TLR was 89.7% (94.1% for femoropopliteal; 86.3% for BTK), AFS was 81.6% (90.0% for femoropopliteal; 75.9% for BTK), all-cause mortality was 14.3% (10.0% for femoropopliteal; 17.2% for BTK), and limb salvage success was 92.9% (94.4% for femoropopliteal; 91.7% for BTK). There was a statistically significant increase between baseline and 6-month toe pressures for both femoropopliteal (57.3±23.3 mm Hg vs 82.5±37.8 mm Hg; p<.001) and BTK lesions (52.8±19.2 mm Hg vs 70.7±37 mm Hg; p<.037). At 12 months, wound healing rate was 33/39 (84.6%). Conclusions: MagicTouch PTA SCB in the XTOSI study showed promising 6-month primary patency and encouraging 12-month freedom from CD-TLR, AFS, and limb salvage rates. No early safety concerns were raised. Randomized trials are needed to investigate the safety and efficacy of SCB for treatment of PAOD.