Restoring arteriovenous access: Pilot study using a scoring balloon in 50 patients

2020 ◽  
pp. 112972982094940
Author(s):  
JR Ross

Background: Arteriovenous access failure is most often due to the development of neointimal hyperplastic stenoses. Balloon angioplasty remains standard of care for endovascular treatment of stenoses obstructing blood flow in hemodialysis fistulas and grafts. Scoring balloon technologies have been developed to disrupt the atheromatous plaque and have shown to be safe and effective for treating stenosis in the hemodialysis access circuit. However, improvement in patency has yet to be established. Methods: This prospective, single-arm study included 50 patients with stenosed hemodialysis fistula/grafts treated with the AngioSculpt® scoring balloon (Philips) and followed for 6 months. The primary endpoint was target lesion primary patency at 2 and 6 months defined as freedom from re-intervention. Results: Treatment with the scoring balloon resulted in a reduction in stenosis from 78% ± 13.36% to 7.2% ± 7.57% (mean ± standard deviation). Scoring balloon inflation pressures averaged 11.4 atm; no slippage/dissections occurred. After 2 months, 10% of patients required re-intervention. At 6 months, 19% of patients required re-intervention. The 6-month freedom from re-intervention rate was higher for patients with stenosed fistulas (83.3%) compared to patients with stenosed grafts (71.4%). Six-month patency rates were highest for patients with no or one previous intervention (91.6% and 90.0%, respectively); patients with two to five preceding interventions had a 6-month patency rate of 80%, and those with more than five previous interventions had a 50% 6-month patency rate. Conclusion: Results from this pilot study suggest that the AngioSculpt scoring balloon may be a viable treatment option for stenosed arteriovenous fistula/graft access.

2021 ◽  
pp. 152660282110570
Author(s):  
Hirokazu Konishi ◽  
Ryoji Koshida ◽  
Maoto Habara ◽  
Kenya Nasu ◽  
Keisuke Hirano ◽  
...  

Purpose: The endovascular approach for eccentric calcified lesions of the no-stenting zone is challenging. This study aimed to investigate the effect of a novel technique for these lesions. Methods: We performed EVT for severe and eccentric calcified lesions using the technique, which is presented previously and named aggressive wire recanalization in calcified atheroma and dilatation (ARCADIA). In brief, a guidewire is passed to the residual lumen firstly. Next, another guidewire is advanced into and cross through the calcified plaque and returned to the distal original lumen with intravascular ultrasound (IVUS) guided. The calcified plaque is dilated by using a scoring-balloon or non-compliant balloon. Results: Consecutive 14 peripheral artery disease patients with isolated and eccentric calcification in a no-stenting zone were treated using ARCADIA technique between January 2018 and March 2020. In IVUS data, lumen cross-section area was significantly increased from 5.2 ± 2.0 mm2 to 18.1 ± 6.9 mm2 (p < 0.01), lumen area was expanded roundly evaluating as symmetry index from 0.45 ± 0.09 to 0.81 ± 0.12 (p < 0.01). There were no distal embolization and perforation after ARCADIA technique. One-year target lesion revascularization occurred in only 2 cases. The primary patency of 1 year was 85.7%. Conclusion: ARCADIA technique is safe and appropriate, and can be 1 option to treat for eccentric calcified lesions of the no-stenting zone as an optimal wire crossing method.


2021 ◽  
pp. 112972982110501
Author(s):  
Shih-Ming Huang ◽  
Honda Hsu ◽  
Ing-Heng Hii ◽  
Chien-Hwa Chang

Background: Endovascular therapy, such as percutaneous transluminal angioplasty (PTA), stenting, or embolization, is a well-established form of treatment to prolong the lifespan of arteriovenous access. These procedures, especially PTA, can be accompanied with severe pain. We reviewed and analyzed the efficacy, safety, and outcome of sedoanalgesia using intravenous midazolam and fentanyl, for pain relief during these procedures. Methods: Two hundred and two consecutive patients with dysfunctional dialysis access that had undergone endovascular procedure in our institute between July and November 2017 were included in this study. The dialysis access profile, procedure complication, and 10-point Visual Analog Scale (VAS) were collected. One-year clinical follow-up record was also collected to evaluate arteriovenous access patency and long-term complications. Results: Among the 202 patients, the mean age was (mean ± SD) 67.0 ± 12.08 years. Dialysis access profile of these patients were 119 (58.9%) native arteriovenous fistula and 162 (74.2%) forearm access. The number of lesions treated were 1.63 ± 0.802. Immediate complications included 11 (5.44%) nausea/vomiting, 24 (11.88%) desaturation (SpO2 < 90%, resolved after pillow removal or jaw trust), 16 (7.9%) hypotension (SBP < 90 mmHg, resolved without inotropic agents). There was a low average pain score (1.16 ± 1.594) during the procedure with 136 (67.3%) no pain (VAS 0–1) and 56 (27.7%) mild pain (VAS 2–4). Higher VAS score correlated with overweight patients, longer PTA time and pain after procedure. Six-month primary patency rate was 49.17% and primary assisted patency rate was 93.04%. Conclusions: Sedoanalgesia with intravenous midazolam and fentanyl is an easy, safe, and effective method for surgeons.


Vascular ◽  
2018 ◽  
Vol 26 (5) ◽  
pp. 457-463 ◽  
Author(s):  
Berkan Ozpak ◽  
Sahin Bozok ◽  
Mustafa Cagdas Cayir

Objectives To evaluate 36-month outcomes of drug-eluting balloons in infrapopliteal (=below-the-knee) arterial segments, we made a prospective registry enrolling patients (Rutherford class 2 to 5, ankle–brachial index 0.4–0.7) who were revascularized with drug-eluting balloon from August 2011 to December 2014. Methods Three hundred and seven infrapopliteal arteries were revascularized only with drug-eluting balloon. Endpoints included target lesion revascularization, primary patency rate, and changes in ankle–brachial index and Rutherford class. Results Both ankle–brachial index improvement and Rutherford reduction were statistically significant (p < 0.001). At 36 months control, ankle–brachial index improvement was 59.3% (p = 0.032). The clinically driven target lesion revascularization rate was 28% at 36 months. Limb salvage was accomplished in 73.6% of the critical limb ischemia cases, and complete wound healing was detected in 67.8% of cases with Rutherford category 5. Overall, the 1-year primary patency rate was 32.5%. Conclusions Drug-eluting balloons have shown successful performance in infrapopliteal arteries in mid-term, and evidence regarding clinical effectiveness and safety supports drug-eluting balloon angioplasty as the first line therapy in this segment.


2014 ◽  
Vol 8s2 ◽  
pp. CMC.S15224
Author(s):  
Michael Lichtenberg ◽  
Birgit Hailer ◽  
Matthias Kaeunicke ◽  
Wilhelm-Friedrich Stahlhoff ◽  
Dirk Boese ◽  
...  

Purpose To evaluate the patency and the freedom of target lesion revascularization of the 4-French Pulsar-18 self-expandable (SE) nitinol stent for the treatment of long femoropopliteal occlusive disease in a two-center, prospective, all-comers registry with a follow-up period of 12 months. Methods This registry enrolled 36 patients with symptomatic femoropopliteal long lesions for recanalization and implantation of the 4-French Pulsar-18 SE nitinol stent. Routine follow-up examination including duplex ultrasound was performed after 6 and 12 months. Primary patency was defined as no binary restenosis on duplex ultrasound (Peak systolic velocitiy ration (PSVR) <2.5) and no target lesion revascularization was performed within 12 months' follow-up. No drug-eluting devices were allowed in this registry. Results Average lesion length of the femoropopliteal segment was 182.3 ± 51.8 mm. Mean stent implantation length was 181.5 ± 35.4 mm. Total occlusion was present in 46 of the 48 (95.8%) treated lesions. Involvement of popliteal segment I–III was present in 3 (6.3%) lesions. The primary patency after 6 and 12 months was 87.5% and 85.4%, respectively. The clinically driven overall freedom from target lesion revascularization (fTLR) was 89.6% after 6 months and 87.5% after 12 months. ABI, pain-free walking distance and Rutherford category, all improved significantly ( P < 0.001) after 6 and 12 months. The primary patency rate in patients with diabetes ( P = 0.18) and renal insufficiency ( P = 0.3) was not significantly lower as compared to the overall primary patency. Conclusions In this two-center, all-comers registry, the use of the Pulsar-18 SE nitinol stent for endovascular intervention of femoropopliteal disease with a mean lesion length of 182.3 ± 51.8 mm showed promising primary patency and fTLR rates after 6 and 12 months. Diabetes and renal insufficiency had no negative impact on the patency rate.


VASA ◽  
2015 ◽  
Vol 44 (6) ◽  
pp. 466-472 ◽  
Author(s):  
Chia-Hsun Lin ◽  
Yen-Yang Chen ◽  
Chai-Hock Chua ◽  
Ming-Jen Lu

Abstract. Background: In this study, we investigated the patency of endovascular stent grafts in haemodialysis patients with arteriovenous grafts, the modes of patency loss, and the risk factors for re-intervention. Patients and methods: Haemodialysis patients with graft-vein anastomotic stenosis of their arteriovenous grafts who were treated with endovascular stent-grafts between 2008 and 2013 were entered into this retrospective study. Primary and secondary patency, modes of patency loss, and risk factors for intervention were recorded. Results: Cumulative circuit primary patency rates decreased from 40.0 % at 6 months to 7.3 % at 24 months. Cumulative target lesion primary patency rates decreased from 72.1 % at 6 months to 22.0 % at 24 months. Cumulative secondary patency rates decreased from 81.3 % at 12 months to 31.6 % at 36 months. Patients with a history of cerebrovascular accident had a significantly higher risk of secondary patency loss, and graft puncture site stenosis jeopardised the results of stent-graft treatment. Conclusions: Our data can help to improve outcomes in haemodialysis patients treated with stent-grafts for venous anastomosis of an arteriovenous graft.


2021 ◽  
pp. 028418512110051
Author(s):  
Surasit Akkakrisee ◽  
Keerati Hongsakul

Background Endovascular treatment is a first-line treatment for upper thoracic central vein obstruction (CVO). Few studies using bare venous stents (BVS) in CVO have been conducted. Purpose To evaluate the treatment performance of upper thoracic central vein stenosis between BVS and conventional bare stent (CBS) in hemodialysis patients. Methods Hemodialysis patients with upper thoracic central vein obstruction who underwent endovascular treatment at the interventional unit of our institution from 1 January 2008 to 31 December 2018 were enrolled in the present study. CBS was used to treat central vein obstruction in 43 patients and BVS in 34 patients. We compared the primary patency rates and complications between the two stent types. P values < 0.05 were considered statistically significant. Results The patient demographic data between the CBS and BVS groups were similar. The characteristics of the lesions, procedures, and complications were not significantly different between the two groups ( P > 0.05). There were no statistically significant differences of primary patency rates at three and six months between the BVS and CBS groups (94.1% vs. 86.0% and 73.5% vs. 58.1%, respectively; P > 0.05). The primary patency rate at 12 months in the BVS group was significantly higher than that in the CBS group (61.8% vs. 32.6%; P = 0.008). Conclusion Endovascular treatment of central vein obstruction with BVS provided a higher primary patency rate at 12 months than CBS.


Perfusion ◽  
2021 ◽  
pp. 026765912199576
Author(s):  
Pasha Normahani ◽  
Ismail Yusuf Anwar ◽  
Alona Courtney ◽  
Amish Acharya ◽  
Viknesh Sounderajah ◽  
...  

Introduction: The aim of this study was to identify factors associated with primary graft patency 1 year following open lower limb revascularisation (LLR) at a tertiary referral vascular service. Methods: A retrospective analysis of patients undergoing infra-inguinal bypass surgery between January 2016 and May 2017 at a tertiary vascular centre (St Mary’s Hospital, London) was performed. Data regarding patient demographics, comorbidities, type of operation and post-operative anti-thrombotic strategy were collected. Quality of run-off score was assessed from pre-operative imaging. Results: Seventy-seven cases were included in the analysis. Overall, the primary patency rate at 1-year was 63.6% ( n = 49/77) and the secondary patency rate was 67.5% ( n = 52/77). Independent variables with statistically significant inferior patency rates at 1-year were (1) bypasses with below knee targets (p = 0.0096), (2) chronic limb threatening ischaemia indication (p = 0.038), (3) previous ipsilateral revascularisation (p < 0.001) and (4) absence of hypertension history (p = 0.041). There was also a trend towards significance for American Society of Anesthesiologists (ASA) grade (p = 0.06). Independent variables with log-rank test p values of <0.1 were included in a Cox proportional hazards model. The only variable with a statistically significant impact on primary patency rates was previous open or endovascular ipsilateral revascularisation (HR 2.44 (1.04–5.7), p = 0.04). Conclusion: At 1-year follow-up, previous ipsilateral revascularisation was the most significant factor in affecting patency rates. Patients in this subgroup should therefore be deemed high-risk, which should be reflected in the informed consent and peri-operative management.


2021 ◽  
Vol 49 (4) ◽  
pp. 030006052110065
Author(s):  
Hao Ren ◽  
Jie Liu ◽  
Jiwei Zhang ◽  
Baixi Zhuang ◽  
Weiguo Fu ◽  
...  

Objective To assess the association between post-balloon angioplasty dissection and the mid-term results of the AcoArt I trial evaluating complex femoropopliteal artery disease. Methods The outcome data for 144 patients from the AcoArt 1 trial were reanalysed. These patients were randomly divided into percutaneous transluminal angioplasty (PTA) and drug-coated balloons (DCB) groups. The primary endpoint was the primary patency (PP) rate and clinically-driven target lesion revascularisation at 24 months. Results After 24 months of follow-up, the PP rate of dissection cases in the PTA group was lower vs non-dissection cases. In patients receiving a bailout stent for dissection, the PP rate in the PTA group was lower vs the DCB group. Cox regression analysis showed that dissection decreased the PP rate; mild dissection reduced the PP rate as follows: 52%, PTA group and 19%, DCB group. With severe dissection, the PP rate reduction was as follows: 75%, PTA group and 73%, DCB group. Conclusions The mid-term follow-up showed that post-balloon angioplasty dissection reduced the PP rate in the PTA group but not in the DCB group. Additionally, in patients receiving a bailout stent for dissection, the DCB group had a better PP rate than the PTA group.


2020 ◽  
pp. 153857442096897
Author(s):  
Hanbee Hong ◽  
Ui Jun Park ◽  
Young Nam Roh ◽  
Hyoung Tae Kim

Purpose: The knowledge regarding the benefits of the scoring balloon (SB) in comparison to the plain balloon (PB) is limited. This study aims to elucidate the difference in efficacy between SB and PB as pre-balloon in superficial femoral artery angioplasty. Methods: We retrospectively analyzed angiographic images of 113 lesions in 98 patients treated with endovascular surgery. 37 lesions were prepared by SB and 76 lesions by PB. Lesions without significant residual stenosis nor a flow-limiting dissection were treated by drug-coated balloon and the others by drug-eluting stent. Severity of dissection was evaluated by Kobayashi dissection grade and NHLBI classification. The rate of stent implantation was compared between the 2 groups. Kaplan-Meier analysis estimated freedom from target lesion revascularization (TLR) rate at 12 months. Results: Severe dissections (>1/3 of lumen) occurred less frequently in the SB group (SB 40.5% vs. PB 75.0%, P = 0.001). Overall stent implantation rate was lower in the SB group (SB 27.0% vs. PB 55.3%, P = 0.005). In subgroup analysis for the complex lesions, the SB group had lower rate of severe dissection(>1/3 of lumen) in patients with long lesions(>15 cm) (SB 51.7% vs. PB 76.9%, P = 0.020) and lesions of calcium grade ≥2 (SB 43.8% vs. PB 72.5%, P = 0.009). SB group had lower stent implantation rate in patients with long lesions (SB 34.5% vs. PB 59.6%, P = 0.030), lesions of calcium grade ≥2 (SB 31.3% vs. PB 56.9%, P = 0.023), and total occlusion (SB 30.8% vs. PB 80.0%, P = 0.002). There were no procedure-related complications in either group except 1 case of puncture-site hematoma. There was no significant difference in TLR rate between both groups at 12 months (P = 0.509). Conclusion: SB reduces the incidence of severe dissection (>1/3 of lumen) and rate of overall stent implantation in comparison with PB. The use of SB is a safe and effective method of lesion preparation in SFA angioplasty.


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