Primary Assisted Patency Research Articles

USE of IMplanting the Biotronik PassEo-18 Lux drug coated balloon to treat failing haemodialysis arteRiovenous FIstulas and grafts (SEMPER FI Study)

Background: Plain old balloon angioplasty has been the mainstay of treatment for arteriovenous fistula (AVF) stenoses. Recent studies suggest that drug coated balloons (DCB) may significantly reduce re-intervention rates on native and recurrent lesions. The Passeo-18 Lux DCB (Biotronik AG, Buelach, Switzerland) is packaged with a 3.0 µg/mm2 dose of paclitaxel. The hypothesis is that its use provides better target lesion primary patency (TLPP), primary assisted patency (PP), secondary patency (SP) rates and reduces the number of visits for re-intervention in a cohort of patients with stenotic AVF and arteriovenous grafts (AVGs). Methods: The USE of IMplanting the Biotronik PassEo-18 Lux DCB to treat failing haemodialysis arteRiovenous FIstulas and grafts trial (SEMPER FI) was a prospective double-centre, multi-investigator, non-consecutive, non-blinded single-arm study investigating the efficacy and safety of the Passeo-18 Lux DCB in patients with stenotic AVF/AVG lesions between January 2021 and January 2022. Patient demographics, clinical characteristics, vascular access history, operative indications, details and outcomes were collected prospectively. TLPP, circuit access primary patency (CAP), PP, SP and deaths 6- and 12-months post-intervention were studied. Results: Ninety-one patients with 110 lesions were recruited across the two centres. 62.6% ( n = 57) were male with a median age of 63.5 years (SD = 10.5). 62.6% ( n = 57) were taking anti-platelets. Eighty-five AVFs and six AVGs were treated. 60% ( n = 54) of AVFs intervened were radiocephalic. 52.7% ( n = 58) of targeted lesions were juxta-anastomotic stenosis (JAS) and one-third ( n = 33) at the AVF/AVG outflow. 70.9% ( n = 78) of lesions were recurrent. Median time from last intervention was 219 days. 78% of target lesions ( n = 85) and circuits ( n = 70) were patent at 6-months, of which 96.7% ( n = 87) of those requiring assisted intervention were patent. Conclusion: This study shows that the Passeo-18 Lux DCB can be an effective and safe tool in the treatment of failing haemodialysis AVFs/AVGs.

Small Arteriovenous Anastomosis in Fistula Creation: Establishing a Functional Vascular Access while Minimizing Steal Syndrome

ObjectivesThe size selection of the arteriovenous (AV) anastomosis in dialysis access creation requires a careful balance: the diameter must be large enough to accommodate sufficient flow for hemodialysis, but small enough to minimize the complication of steal syndrome. Steal syndrome affects up to 10% of patients after creation of dialysis access with sometimes devastating consequences. Conventional teaching recommends an 7-10 mm anastomosis. We sought to assess the efficacy of using a smaller (5-6 mm) anastomosis in new arteriovenous fistula (AVF) creation. MethodsWe conducted a comparative retrospective analysis of patients who underwent fistula creation with a small versus regular size anastomosis at any upper extremity anatomic site between March 2019 and October 2020 at our institution. Anatomic sites included radiocephalic, brachiocephalic and brachiobasilic. All arteriovenous anastomoses were measured intra-operatively to be 5-6 mm in diameter for the small size groups and 8-10mm for the regular size group. Endpoints included steal syndrome, functional patency, primary patency and secondary patency. ResultsOut of 110 patients who underwent an AVF creation, 59.1% received a 5-6 mm anastomosis with a median follow-up time of 10±6 months. Patients’ demographics and comorbidities were relatively similar between the two groups except for a higher rate of hyperlipidemia (55.4% vs. 28.9%, P=0.008) in the small size group. Patients in the small size group were more likely to undergo a radiocephalic fistula (40% vs. 4.5%, P<0.001) and to have a smaller mean vein diameter on preoperative duplex ultrasound (3.2±1mm vs. 3.9±1mm, P=0.0016) when compared to their regular size counterparts. During follow-up, none of the patients in the small group developed steal syndrome (0% vs. 9%, P=0.015). At 1 year, patients in the regular size group achieved higher rates of primary patency (67.9% vs. 46.9%, P=0.02); however, no difference was seen in 1-year primary-assisted patency (84.9% vs. 73.6%, P=0.3), secondary patency (89.6% vs. 79.5%, P=0.3) nor in functional patency (87.7% vs. 82.2%, P=0.64) between the small and regular size groups, respectively. ConclusionsThe use of a 5-6 mm anastomosis in the creation of new arteriovenous fistulas of the upper extremities appears to be a technically safe option for dialysis access. Our experience suggests that smaller anastomosis still creates enough flow to maintain a functional AV access while minimizing the incidence of steal syndrome. Additionally, even with smaller vein sizes pre-operative, adequate dialysis access can be created via a small sized anastomosis, including distal arm access. Larger studies with longer follow-up are needed to evaluate long-term outcomes of small anastomosis fistulas.

Twelve-Month Outcomes of Intravascular Lithotripsy for Treatment of Calcified Popliteal and Infrapopliteal Lesions in Patients With Chronic Limb-Threatening Ischemia.

Vessel calcification is estimated to be present in 30% to 50% of patients with peripheral arterial disease (PAD) and is one of the main challenges in endovascular treatment. The popliteal artery is unique compared with other arteries due to its exposure to significant deformation and biomechanical stress during knee motion. Intravascular lithotripsy (IVL) is a novel technique that uses acoustic pressure waves to cause microfractures within the intimal and medial wall calcification. Intravascular lithotripsy is safe in femoropopliteal and infrapopliteal lesions, but follow-up studies are lacking. Therefore, the purpose of this study was to describe the first follow-up outcomes of IVL in popliteal and infrapopliteal arterial disease. This prospective, multicenter cohort study included all patients treated with IVL in the popliteal and infrapopliteal arteries at 4 sites. Standardized follow-up with duplex ultrasonography was scheduled at 6 to 8 weeks and 12 months. The primary safety endpoint was a composite of major adverse events (MAEs) at 30 days. Primary efficacy endpoints were primary patency, limb salvage, and amputation-free survival (AFS) at 12 months. Secondary endpoints were primary-assisted patency and freedom from target lesion revascularization (TLR). Endpoints were distributed for patients with chronic limb-threatening ischemia (CLTI) and intermittent claudication (IC) and estimated using the Kaplan-Meier method. Between April 2021 and March 2023, 29 patients with 30 limbs were treated. Diabetes mellitus (DM) and CLTI were present in 62.1% and 80.0% of patients, respectively. Within the 32 treated lesions, severe calcification was present in 84.4% and bailout stenting was necessary in 12.5% of the lesions. Four MAEs occurred within 30 days: 1 closure device failure, 1 major amputation, and 2 deaths, neither of which was related to the study device. The primary patency, primary-assisted patency, freedom from TLR, limb salvage, and AFS at 12 months were 68.8%, 90.0%, 93.3%, 83.9%, and 57.1% for CLTI patients, respectively. No events occurred in restenosis, re-occlusion, TLR, major amputation, or mortality in patients with IC. This first-ever analysis on follow-up outcomes of IVL in the popliteal and infrapopliteal arteries demonstrated promising safety and efficacy outcomes with a low rate of bailout stenting. Vessel calcification is a common feature in peripheral arterial disease (PAD) and is one of the main challenges in endovascular treatment. The popliteal artery is subjected to biomechanical stress during knee motion, which makes stenting unappealing and often leads to worse clinical outcomes. This study aimed to describe the first follow-up outcomes of IVL in popliteal and infrapopliteal arterial disease. As in line with previous studies, no relevant procedural complications were found and the rate of bail-out stenting was only 12.5%. Moreover, in a complex patient population, this study demonstrated promising safety and efficacy outcomes. The comparison of IVL with angioplasty alone or other vessel preparation devices for popliteal and infrapopliteal arterial disease is warranted.

Patency and Durability of Stent Grafts Placed in the Dialysis Circuit Cannulation Zone

PurposeTo investigate the safety, durability, and patency rates of stent grafts (SGs) placed in the cannulation zone of hemodialysis access circuits. Materials and MethodsFrom April 2020 to April 2023, all procedures with SGs placed in the cannulation zone were retrospectively analyzed. A total of 40 patients (25 men and 15 women) with SGs placed in the cannulation zone were included in the study. Mean age of the patients was 70 years. The Covera covered stent (BD, Franklin Lakes, New Jersey) was used in all cases. Of these, 26 were arteriovenous (AV) fistulae and 14 were AV grafts. SGs were placed for residual stenosis, perforation, aneurysm, and thrombosis. Follow-up outcomes were determined using follow-up angiographic images and included primary patency, primary-assisted patency, and secondary patency. ResultsThe primary patency of the target lesion was 89% (SD ± 5) and 74% (SD ± 8.4) at 6 and 12 months, respectively. The primary-assisted patency was 89% (SD ± 5.2) and 78% (SD ± 7.6) at 6 and 12 months, respectively. Secondary patency of the access circuit was 97% (SD ± 2.5) at both 6 and 12 months. Mean follow-up was 332 days (range, 28–661 days). All SGs were successfully cannulated for hemodialysis. No cases of stent fracture or stent infection were observed during follow-up. ConclusionsSGs placed for cannulation zone pathologies can be safely cannulated for dialysis and have adequate short- and mid-term patency rates.

Directional Atherectomy With Antirestenotic Therapy Versus PTA/Supera Stenting for Popliteal Artery Lesions: A Propensity-Matched Analysis.

This study examines the use and impact of directional atherectomy with antirestenotic therapy (DAART) versus angioplasty plus Supera stent implantation on the outcomes during endovascular treatment of popliteal lesions in clinical practice. Overall 143 consecutive patients (mean age 75.0±12.2 years, 72% male), with isolated atherosclerotic disease of the popliteal artery who underwent endovascular treatment using DAART therapy or percutaneous transluminal angioplasty (PTA)/Supera stenting of the popliteal artery between January 2016 and December 2021 were identified from a retrospectively database. Patient and plaque characteristics were collected. A propensity-score matched, case-control analysis was conducted to balance covariates between the group of patients who underwent DAART and the one treated by PTA/Supera stenting. A total of 51 patients (35.7%) showed severe claudication and 92 (64.3%) critical limb ischemia. There was a trend toward longer treated lesions (90.4±81 vs 72.5±5.3 mm, p=0.089) and more chronic total occlusions (60.5% vs 46.8%, p=0.058) in the PTA/Supera stenting group, although not reaching statistically significance. Moderate-to-severe calcification was present in most lesions treated (75.8% of DAART group, 80.2% of PTA/Supera stenting group, and 78.3% of total cohort). Among the 53 case-matched pairs of patients treated with DAART or PTA/Supera stenting, there were no significant differences in short-term outcomes, including rate of technical success (96.2% vs 98.1%, p=0.232), procedural success (88.7% vs 90.1%, p=0.251), distal embolization (1.9% vs 1.9%, p=0.178), dissection (5.7% vs 1.9%, p=0.268), perforation (3.8% vs 5.6%, p=0.163), hospital discharge (1.2±0.1 vs 1.0±0.1, p=0.325), 30 day minor (28.3% vs 32.1%, p=0.264) or major amputation rates (7.5% vs 3.8%, p=0.107), and 30 day mortality (1.9% vs 1.9%, p=0.173). At 1 year, there was no difference in primary patency (73.6% vs 77.4%, p=0.233), primary assisted patency (81.3% vs 84.9%, p=0.167), secondary patency (86.8% vs 92.5%, p=0.094), ipsilateral minor (35.8% vs 39.6%, p=0.472) or major amputation (9.4% vs 7.5%, p=0.186), ankle brachial index improvement (0.32±0.12 vs 0.37±0.37, p=0.401), or mortality (5.7% vs 5.7%, p=0.121) rate between patients who underwent DAART or PTA/Supera stenting for popliteal lesions. Twelve-month results following DAART technique or PTA/Supera stenting of atherosclerotic lesions of the popliteal artery are not different, regardless of patient and plaque characteristics. The DAART technique for the treatment of popliteal artery atherosclerotic disease is presented as a "leave nothing behind" strategy with on-year clinical outcomes similar to ATP/Supera stenting.

Investigation of center-specific saphenous vein utilization rates in femoral popliteal artery bypass and associated impact of conduit on outcomes

ObjectiveThe purpose of this study is to investigate variation in great saphenous vein (GSV) use among the various centers participating in the Vascular Quality Initiative infrainguinal bypass modules. Further, differences in outcomes in femoral-popliteal artery bypass with single segment GSV conduit vs prosthetic conduit will be documented. Center GSV use rate impact on outcomes will be investigated. MethodsPrimary exclusions were patients undergoing redo bypass, urgent or emergent bypass, and those in whom prosthetic graft was used while having undergone prior coronary artery bypass grafting. The distribution of GSV use across the 260 centers participating in Vascular Quality Initiative infrainguinal bypass module was placed into histogram and variance in mean GSV use evaluated with analysis of variance analysis. Centers that used GSV in >50% of bypasses were categorized as high use centers and centers that used the GSV in <30% of cases were categorized as low use centers. Baseline differences in patient characteristics and comorbidities in those undergoing bypass with GSV vs prosthetic conduit were analyzed with χ2 testing and the Student t test, as were those undergoing treatment in high vs low use centers. Multivariable time-dependent Cox regression analyses were then performed for the primary outcomes of major amputation ipsilateral to the operative side and mortality in long-term follow-up. High vs low use center was a dichotomous variable in these regressions. Secondary outcomes of freedom from graft infection and freedom from loss of primary patency were performed with Kaplan-Meier analysis. ResultsAmong centers with >50 patients meeting inclusion criteria for this study, GSV use ranged from 15% to 93% (analysis of variance P < .001). When considering all centers irrespective of number of patients, the range was 0% to 100%. On Kaplan-Meier analysis, GSV conduit use was associated with improved freedom from loss of primary or primary assisted patency, improved freedom from major amputation after index hospitalization, improved freedom from graft infection after the index hospitalization, and improved freedom from mortality in long-term follow-up (log-rank P < .001 for all four outcomes). Both low use center (hazard ratio, 1.35; P < .001) and prosthetic graft use (hazard ratio, 1.24; P < .001) achieved multivariable significance as risks for mortality in long-term follow-up. Other variables with a multivariable mortality association are presented in the manuscript. Low use center and prosthetic bypass were significant univariable but not multivariable risks for major amputation after index hospitalization. ConclusionsThere is remarkably wide variation in GSV use for femoral popliteal artery bypass among various medical centers. GSV use is associated with enhanced long-term survival as well as freedom from loss of bypass patency and graft infection. The data herein indicate institutional patterns of prosthetic conduit choice, which has the potential to be altered to enhance outcomes.

The Vascular Quality Initiative assessment of the Bard Lifestent for the treatment of popliteal artery occlusive disease

ObjectiveThe Bard LifeStent self-expanding stent is approved for the treatment of occlusive disease involving the superficial femoral artery and proximal popliteal artery. We conducted a post-market trial of treatment of the popliteal artery above and below the knee (P1, P2, and P3 segments) within the Society for Vascular Surgery Vascular Quality Initiative (VQI) Peripheral Vascular Intervention registry. MethodsA single-arm, prospective trial was conducted at 29 VQI sites in the United States, enrolling 74 patients from November 2016 to May 2019. The primary safety outcome was freedom from major adverse events including device-/procedure-related mortality and major amputation at 1 year. The primary efficacy outcomes were freedom from target vessel revascularization and freedom from target lesion revascularization at 1 year. Secondary outcomes included lesion success; procedural success; primary, primary-assisted, and secondary patency; and sustained clinical (improvement in Rutherford class) and hemodynamic success (increase in ankle brachial index >0.10). Outcomes were assessed by Kaplan-Meier analysis. Arteriogram of patients undergoing target lesion revascularization were assessed for stent fracture by a core laboratory. ResultsThe mean age was 71 years, with 63.5% male and 55% with diabetes. The indication was claudication 28% and chronic limb-threatening ischemia in 72%. The superficial femoral artery-popliteal artery was stented in 38% and the popliteal artery alone in 62%. The majority of stents were placed in the P1 + P2 (39%) or P1 + P2 + P3 (37%) segments of the popliteal artery. The composite primary endpoint of freedom from major adverse events was 82% and 74% at 1 and 2 years, respectively. Freedom from mortality was 100% and 97%, and freedom from major amputation was 100% and 90% at 1 and 12 months, with all deaths and major amputations occurring in patients with chronic limb-threatening ischemia. freedom from target lesion revascularization was 86%, and freedom from target vessel revascularization was 84% at 12 months. At discharge, lesion treatment success was 99%, and procedural success was 82%. Primary patency was 80% and 72%, primary-assisted patency was 80% and 72%, and secondary patency was 89% and 82% at 12 and 24 months. Sustained clinical success was 98% and 95%, and sustained hemodynamic success was 100% and 79% at 12 and 24 months. ConclusionsIn this multi-center, registry-based, single-arm prospective study the Bard LifeStent self-expanding stent demonstrated favorable performance in the challenging anatomy of the P2 and P3 popliteal segment. Post-market studies for label expansion of peripheral vascular intervention devices can be successfully conducted within the Society for Vascular Surgery VQI registry.

Early experience with the Abre venous stent for central venous stenoses and occlusions in hemodialysis patients.

Hemodialysis patients are prone to stenoses and occlusions throughout the access circuit. Central venous stenoses or occlusions (CVO) can be particularly challenging. There are many different types of balloons and stents available for treatment, including a new generation of dedicated venous stents (VS). In this study, we report our experience and patency rates with the Abre VS in central venous lesions in hemodialysis patients. From April 2020 to May 2023, all procedures with Abre VSs placed for central venous lesions in hemodialysis patients were retrospectively analyzed from a prospectively collected database of 980 hemodialysis access interventions. Follow up outcomes were obtained from angiographic images on follow up angiography and included primary patency and primary assisted patency. Effective hemodialysis was considered a surrogate for access patency if no angiographic follow-up was available. A total of 15 patients with CVO were treated with the Abre VS. Technical success was 100%. All patients were able to achieve adequate hemodialysis after VS placement. Stents were placed across the thoracic inlet in 73% of patients. Post procedure primary patency at the target lesion site was 85% at 6 months and 70% at 12 months. Primary assisted patency of the circuit was 93% at 6 and 12 months. No stent fractures were observed. Treatment of CVO remains extremely challenging, especially when the lesion is located at the thoracic inlet. In these patients, VSs provide acceptable primary patency rates and allow patients to continue to receive effective hemodialysis. However, routine follow-up and re-interventions will likely be necessary to maintain patency in the long term.

One-year results of a balloon expandable endoprosthesis as a bridging stent for branched endovascular aortic repair

ObjectiveThis post-market multicenter registry aimed to evaluate the safety and performance of the GORE VIABAHN VBX balloon expandable endoprosthesis (VBX stent) implanted in peripheral vessels. In this subgroup analysis, we assessed the outcomes of the VBX stent as a bridging stent graft for visceral vessels during branched endovascular aortic repair at 1 year. MethodsA single cohort from a prospective, multicenter, observational, 16-site European registry. Patients were enrolled from November 2018 to March 2022. Endpoints included 1-year primary patency (PP), primary assisted patency (PAP), and secondary patency (SP), stent graft-related death and serious adverse events through 30 days. ResultsSeventy-three patients were enrolled in this registry sub-cohort, 57 (78.1%) were male, and the mean age was 73 ± 8.1 years. Thoracoabdominal aneurysms predominated the cohort with 68 patients (93.2%), followed by five patients (6.8%) with pararenal and infrarenal aneurysms. Overall, 233 target vessels were treated with the index bridging graft. The overall per stent graft analysis demonstrated a PP of 95.8% at 1 year; PAP was 95.8%, and SP reached 97.9%. The per-target vessel analysis demonstrated a PP, PAP, and SP in the celiac trunk of 100%, 100%, and 100%; in the superior mesenteric artery of 96.0%, 96.0%, and 100%, and in the renal arteries of 94.2%, 94.2%, and 95.1%, respectively. Four patients (5%) died at 1 year; none of the deaths were device-related. The composite endpoint of target vessel technical success and freedom from VBX stent-related serious adverse events through 30 days was achieved in 98.6% of patients. ConclusionsIn this prospective post-market multicenter registry, the VBX stent demonstrated excellent results at 1 year, with almost 96% primary patency and 98% secondary patency. Patency in the renal arteries seems to be lower. Nevertheless, the VBX stent appears to be a reliable bridging stent for branched endovascular aortic repair.

Recanalization of portal vein thrombosis after pediatric liver transplantation: Efficacy and safety of the transsplenic access.

Endovascular management of portal vein thrombosis (PVT) is challenging. Transsplenic access (TSA) is growing as an access option to the portal system but with higher rates of bleeding complications. The aim of this article is to evaluate the efficacy and safety of transsplenic portal vein recanalization (PVR) using a metallic stent after pediatric liver transplantation. This is a retrospective review of 15 patients with chronic PVT who underwent PVR via TSA between February 2016 and December 2020. Two children who had undergone catheterization of a mesenteric vein tributary by minilaparotomy were excluded from the patency analysis but included in the splenic access analysis. The technical and clinical success of PVR and complications related to the procedure via TSA were evaluated. Thirteen children with PVT were treated primarily using the TSA. The mean age was 4.1 years (range, 1.5-13.7 years), and the most common clinical presentation was hypersplenism (60%). Technically successful PVR was performed in 11/13 (84.6%) children, and clinical success was achieved in 9/11 (81.8%) children. No major complications were observed, and one child presented moderate pain in the TSA (from a total of 17 TSA). The median follow-up was 48.2 months. The median primary patency was 9.9 months. Primary patency in the first 4 years was 75%, and primary assisted patency was 100% in the follow-up period. Transsplenic PVR is a safe and effective method for the treatment of PVT after pediatric liver transplantation.

Impact of cilostazol on prevention of late failure of autologous vein grafts.

The effectiveness of postoperative medication for the prevention of late graft failure is controversial. We conducted the present study to investigate whether cilostazol improved the mid-term outcomes after infrainguinal autologous vein bypass for chronic limb-threatening ischemia (CLTI). From April 1994 to March 2022, we performed 590 de novo infrainguinal bypass procedures using autologous vein grafts (AVGs) in three hospitals. The bypass grafts were classified according to the postoperative prescription of cilostazol. The loss of graft patency and major adverse limb events (MALEs) were set as endpoints. Patients who died within 30days and grafts that lost primary patency within 30days after surgery were excluded. Data up to 3years were analyzed. The cumulative primary patency (PP), assisted primary patency (AP), secondary patency (SP), and freedom from MALE (ffMALE) rates were calculated by the Kaplan-Meier method and compared between the cilostazol group and the non-cilostazol group. After a propensity score matching, same statistical analyses were performed. In addition, a Cox proportional hazards regression analysis that included preoperative factors, intraoperative factors, and postoperative medications was performed to identify whether cilostazol is an independent predictor for the outcomes. A total of 523 AVGs met inclusion criteria. Kaplan-Meier curves showed that the cilostazol group was superior to the non-cilostazol group in all outcomes, while the cilostazol group was superior to the non-cilostazol group in AP and SP after a propensity score matching. A multivariable analysis showed that non-use of cilostazol was identified as an independent predictor for loss of AP, SP, and ffMALE. Cilostazol improved the mid-term outcomes after infrainguinal autologous vein bypass.

AFX unibody stent graft: Effective and safe for the treatment of severe aorto-iliac occlusive disease.

The primary objective of this study was to determine the primary, assisted primary and secondary patency rates of the Endologix AFX stent-graft in patients considered high risk for open surgery with complex aorto-iliac occlusive disease. The secondary objective was to determine 30-day major adverse cardiovascular and cerebrovascular events. A retrospective review was undertaken of clinical records of 38 patients who underwent AFX stent-graft placement for aorto-iliac occlusive disease from 2016 to 2019. Patient data was de-identified and entered into a REDcap secure database. Descriptive statistical analysis (means and standard deviations) and Kaplan-Meier survival curves were created to determine the duration of patency of the AFX stent-graft system. Primary patency rates at 6, 12 and 24months were 92%, 92% and 84%, respectively. Assisted primary patency rates at these times were 100%, 100% and 93% with secondary patency of 100% maintained throughout. The incidence of 30-day major adverse cardiovascular and cerebrovascular events was 8% and major adverse limb events was 3%. One death unrelated to the AFX device occurred during the study period though outside of the 30-day peri-operative period. Primary, assisted primary and secondary patency rates of AFX stent-grafts, when used to treat aorto-iliac occlusive disease, are high. This study supports the use of the AFX stent-graft for the endovascular treatment of complex aorto-iliac occlusive disease as an alternative to other endovascular options as well as a safe alternative to open aorto-iliac or aorto-femoral bypass in patients who are at high risk for open procedures.

Duplex ultrasound-guided angioplasty of hemodialysis vascular access

ObjectiveDuplex ultrasound-guided angioplasty (DA) for hemodialysis vascular accesses remains questionable regarding its feasibility and safety. Minor complications (requiring no more treatment than nominal therapy) might be over-reported. Our hypothesis is that this procedure has no significant differences between observed rates and the recommended threshold of main outcomes of the procedure defined by the standards of arteriovenous fistulas (AVF) angioplasty. MethodsIn a single-center retrospective study, 298 DA performed on 141 patients from 2015 to 2019 were analyzed. Occluded AVF or concomitant use of radiographic guidance were excluded. Duplex ultrasound parameters were collected up to 1 month before, at the end of angioplasty, and on day 30 after the procedure. Complications were registered, and patency rates were studied at 24 months of follow-up. ResultsAnatomical success was achieved in 142 procedures (47.7%), clinical success in 284 (95.3%), and hemodynamic success in 283 (95.0%). Major complications—requiring at least a specific therapy—were reported in 8 procedures (2.7%) and minor complications—requiring no adjunctive therapy—in 157 (52.7%). At 24 months, overall postintervention primary patency was 34.0%, primary-assisted patency 87.4%, and secondary patency 92.5%. There were no significant differences of patency rates between groups with or without minor complications (P value for primary patency, 0.08; primary-assisted patency, 0.08; secondary patency, 0.23) or 30% residual stenosis (P value for primary patency, 0.82; primary-assisted patency, 0.46; secondary patency: 0.63). Duplex parameters further improved at postoperative day 30 after angioplasty. ConclusionsDA of AVF is feasible, safe—despite over-reported minor complications having no impact on postintervention patency rates—and efficient. A minor complication can be seen as an event without bad or good consequences. Anatomical definition of success does not fit on DA for hemodialysis vascular access. Further studies are required to define the duplex parameter threshold for efficacy.

Comparison of Lower and Upper Extremity Arteriovenous Graft: A Retrospective Clinical Analysis with 5-Year Follow-Up

For patients in whom an upper extremity (UE) vascular access cannot be established, the lower extremity (LE) arteriovenous graft (AVG) could be selected. However, the application of LE AVG is limited owing to its high infection rate, uncertain patency time, and technical difficulties. This study aimed to compare the long-term patency rates and the incidence of vascular access complications of AVG in the LE and UE to provide a reference for the applications of AVG, especially in the LEs. This was a retrospective analysis of patients who successfully underwent LE or UE AVG placement from March 2016 to October 2021. Patient characteristics were collected and compared using parameter or nonparameter tests according to data type. Postoperative patency was evaluated using Kaplan-Meier test. Postoperative complication incidence density and intergroup comparison were estimated using the Poisson distribution. Twenty-two patients with LE AVG and 120 patients with UE AVG were included. The 1-year primary patency rate was 67.4% (±11.0% standard error [SE]) in the LE group and 30.1% (±4.5% SE) in the UE group (P=0.031). The assisted primary patency rate at postoperative months 12, 24, and 36 was respectively 78.6% (±9.6% SE), 65.5% (±14.4% SE), and 49.1% (±17.8% SE) in the LE group and 63.3% (±4.6% SE), 47.5% (±5.4% SE), and 30.4% (±6.1% SE) in the UE group (P=0.137). The secondary patency rate at postoperative months 12, 24, and 36 remains 95.5% (±4.4% SE) in the LE group and 89.3% (±2.9% SE), 83.7% (±3.9% SE), and 73.0% (±6.2% SE), respectively, in the UE group (P=0.200). Postoperative complications included stenosis, occlusion/thrombosis, infection, steal syndrome, pseudoaneurysm, severe postoperative serum swelling, and AVG exposure. The total incidence rates of postoperative complications were 0.87 (95% confidence interval [CI] 0.59-1.23) versus 1.61 (95% CI 1.45-1.79) (P=0.001) cases/person-year, the incidence rates of stenosis were 0.45 (95% CI 0.26-0.73) versus 0.92 (95% CI 0.80-1.06) (P=0.005) cases/person-year and the incidence rates of occlusion/thrombosis were 0.34 (95% CI 0.17-0.59) versus 0.62 (95% CI 0.52-0.74) cases/person-year in the LE group compared to those in the UE group (P=0.041). LE AVG had higher primary patency rate and lower postoperative complication incidence than UE AVG. With the development of interventional technology, both LE AVG and UE AVG exhibited high secondary patency rates. LE AVG can be a reliable and long-term alternative for appropriately selected patients with unusable UE vessels.

Preoperative mapping and multidisciplinary team are the key to success of arteriovenous access for hemodialysis

Introduction and objectivesFunctional and durable vascular access is needed for adequate hemodialysis. Arteriovenous fistula is preferred over prosthetic grafts or central venous catheters, but it is associated with high rates of primary failure and maturation failure.Preoperative mapping of arm vessels with color Doppler ultrasound (CDU) has been shown to be helpful in achieving better short and long-term outcomes. Unfortunately, is more time-consuming than a physical examination and requires an experienced examiner and special equipment; some authors defend that CDU should not be part of the routine preoperative assessment.We reported our experience in preoperative vessel mapping using color Doppler ultrasound to purpose a vascular access to the surgical team, surveillance of vascular access, and evaluation of main outcomes (primary failure, maturation failure, and patency). MethodsThis is a single-center retrospective study that includes patients who attended a specific appointment for vascular access planning consultation between January 2019 and December 2021. A nephrologist performed the physical exam and vascular mapping and proposed to the vascular surgeon team a specific type and location of vascular access. Patients were followed until one month after the first hemodialysis through functioning vascular access. ResultsIn this study, 167 patients were evaluated (114 incident patients – chronic kidney disease stage 4 or 5 – and 53 prevalent patients – under hemodialysis through central venous catheter). The vascular accesses proposed by nephrologist were radial-cephalic arteriovenous fistula in 70 patients (41.9%), brachio-cephalic arteriovenous fistula in 50 patients (29.9%), brachio-basilic arteriovenous fistula in 34 patients (20.4%), arteriovenous graft in 8 patients (4.8%) and central venous catheter in 2 patients (1.2%).Vascular access was constructed in 141 patients: distal arteriovenous fistula in 57 patients (40.4%), brachio-cephalic arteriovenous fistula in 54 patients (38.3%), brachio-basilic AVF in 27 patients (19.1%), and arteriovenous graft in 3 patients (2.1%). The created access corresponds to the proposed access in 129 patients (91.5%).Twenty-two (15.6%) primary failures were registered. Distal arteriovenous fistulas and diabetes mellitus were associated with a higher risk of primary failure (OR=3.929 (1.485–10.392), p=0.004; OR=3.867 (1.235–12.113), p=0.014, respectively).The incidence of maturation failure at eight weeks was 4.8%.The primary patency at 6, 12 and 24 months was 76.3%, 70.4% and 49.2%. Primary assisted patency was 84.8% at 6 and 12 months and 81.3% at 24 months. ConclusionsThis study demonstrates that the study of the entire vascular territory performed with color Doppler ultrasound, within a multidisciplinary team of nephrologists and vascular surgeons, is associated with high rates of autologous access and very low rates of primary failure and maturation failure (almost unprecedented in the literature).

Is the Mid-Term Patency Rate of Small-Diameter Viabahn Stent-Grafts in Peripheral Artery Disease Related to Their Length? A Systematic Review.

Small-diameter endografts can be used for the treatment of the peripheral vascular disease, but the patency rate during the follow-up is still under debate. With this review, we aimed at analyzing the mid-term patency of small-diameter Viabahn stent-grafts and investigating the relationship between patency and the length of the graft. We performed a review of articles published until September 2020 and reporting use of ≤7-mm-diameter Viabahn stent-grafts in diseased peripheral arteries. Data on study type, demographic, lesion length, stent-graft diameter, length, and patency (1-year, 3-year, 5-year primary patency, primary-assisted patency, and secondary patency), follow-up, endoleak, and re-intervention rates were extracted and analyzed. A statistical test was applied to identify a correlation between stent-graft length and patency. 16 retrospective and 7 prospective studies reported the outcome of 1613 patients (mean age: 69.6±33.7 years). There was considerable heterogeneity in reporting standards among studies. The diameter of Viabahn stent-grafts ranged 5 to 7mm and the average length was 23.6±12.4cm. Heparin-bonded grafts were used in 46.4% of cases. Mean follow-up time was 26.4±17.6 months. The 1- and 5-year primary patency rate was 75.7% (95% CI, 73.6%-77.8%) and 46.8% (95% CI, 41.0%-52.6%), respectively. The 1- and 5-year primary-assisted patency rate was 80.9% (95% CI, 73.9%-87.8%) and 60.9% (95% CI, 46.4-75.5%), respectively. The 1- and 5-year second-assisted patency was 90.4% (95% CI, 87.4%-93.3%) and 73.7% (95% CI, 64.7%-82.8%), respectively. No correlation between the stent-graft length and patency was found. Small-diameter Viabahn stent-graft implantation represents a safe treatment for patients with peripheral artery disease, and the mid-term patency rate seems not be affected by the length of the graft. The use of small diameter stent-grafts for peripheral vascular disease is an established technique but the patency rate is still under debate. With this review we have investigated the relationship between the mid-term patency and the diameter of the stent-grafts. Afterv having analysed data from 23 published studies including 1613 patients we can conclude that the treatment of the peripheral artery disease with small diameter stent-grafts is safe and the mid-term patency rate seems not be affected by the lenght of the grafts.

Outcomes of Omniflow® II prosthesis used for revascularization in the femoral tract both in infected and non-infected setting.

Evidence regarding the outcomes of Omniflow® II prosthesis in peripheral arterial revascularization at different anatomical sites and for different indications is scarce. Therefore, the aim of this study was to evaluate the outcomes of the Omniflow® II used at various positions within the femoral tract both in infected and non-infected setting. Patients who underwent reconstructive lower leg vascular surgery with implantation of an Omniflow® II from 2014 until 2021 at five medical centers were retrospectively included (N.=142). Patients were subdivided into the following categories: femoro-femoral crossover (N.=19), femoral interposition (N.=18), femoro-popliteal (above-the-knee [N.=25; AK] or below-the-knee [N.=47; BK]), and femoro-crural bypass grafts (N.=33). Primary outcome was primary patency and secondary outcomes included primary assisted patency, secondary patency, major amputation, vascular graft infection, and mortality. Outcomes were compared according to different subgroups and the surgical setting (infected versus non-infected). The median follow-up was 35.0 (17.5-54.3) months. Three years primary patency of 58% was observed for femoro-femoral crossover bypass, 75% for femoral interposition graft, 44% for femoro-popliteal above-the-knee bypass, 42% for femoro-popliteal below-the-knee bypass, and 27% in the femoro-crural position (P=0.006). Freedom from major amputation at three years were 84% for femoro-femoral crossover bypass, 88% for femoral interposition bypass, 90% for femoro-popliteal AK bypass, 83% for femoro-popliteal BK bypass, and 50% for femoro-crural bypass (P<0.001). This study demonstrates the safety and feasibility of the use of Omniflow® II for femoro-femoral crossover-, femoral interposition-, and femoro-popliteal (AK and BK) bypass. Omniflow® II seems to be less suitable for femoro-crural bypass with a significantly lower patency compared to other positions.

Use of Omniflow® II Biosynthetic Graft for the Treatment of Vascular Graft and Endograft Infections

Vascular graft/endograft infection is a rare but life-threatening complication of cardiovascular surgery and remains a surgical challenge. Several different graft materials are available for the treatment of vascular graft/endograft infection, each having its own advantages and disadvantages. Biosynthetic vascular grafts have shown low reinfection rates and could be a potential second best after autologous veins in the treatment of vascular graft/endograft infection. Therefore, the aim of our study was to evaluate the efficacy and morbidity of Omniflow® II for the treatment of vascular graft/endograft infection. A multicenter retrospective cohort study was performed to evaluate the use of Omniflow® II in the abdominal and peripheral region to treat vascular graft/endograft infection between January 2014 and December 2021. Primary outcome was recurrent vascular graft infection. Secondary outcomes included primary patency, primary assisted patency, secondary patency, all-cause mortality, and major amputation. Fifty-two patients were included with a median follow-up duration of 26.5 (10.8-54.8) months. Nine (17%) grafts were implanted in intracavitary position and 43 (83%) in peripheral position. Most grafts were used as femoral interposition (n=12, 23%), femoro-femoral crossover (n=10, 19%), femoro-popliteal (n=8, 15%), and aorto-bifemoral (n=8, 15%) graft. Fifteen (29%) grafts were implanted extra-anatomically and 37 (71%) in situ. Eight patients (15%) presented with reinfection during follow-up, most of these patients received an aorto-bifemoral graft (n=3, 38%). Intracavitary vascular grafting had a 33% (n=3) reinfection rate and peripheral grafting 12% (n=5; p=0.025). The estimated primary patencies at 1, 2, and 3 years were 75%, 72%, and 72% for peripherally located grafts and 58% (at all timepoints) for intracavitary grafts (p=0.815). Secondary patencies at 1, 2, and 3 years were 77% (at all timepoints) for peripherally located prostheses and 75% (at all timepoints) for intracavitary prostheses (p=0.731). A significantly higher mortality during follow-up was observed in patients who received a intracavitary graft compared to patients with a peripheral graft (p=0.003). This study highlights the efficacy and safety of the Omniflow® II biosynthetic prosthesis for the treatment of vascular graft/endograft infection, in absence of suitable venous material, with acceptable reinfection, patency, and freedom of amputation prevalences, especially in replacing peripheral vascular graft/endograft infection. However, a control group with either venous reconstruction or another alternative graft is needed to make firmer conclusions.

Contemporary Minimally Invasive Surgery for TASC-D Aorto-Iliac Lesions: Analysis of Outcomes and Risk Factors for Primary and Secondary Patency

For complex extensive TASC-II D lesions, the standard of care remains conventional surgery. Nevertheless, guidelines tend to broaden endovascular surgery indications in expert centers for patients at high surgical risk with TASC-II D lesions. Due to the increasing use of endovascular surgery in this setting, we planned to evaluate the patency rate of this approach. We conducted a retrospective study in a tertiray center. All patients treated for symptomatic peripheral arterial disease (PAD) with classified D lesions according to the TASC-II classification and requiring management of the aortoiliac bifurcation were retrospectively included between January 1, 2007 and December 31, 2017. The type of surgical approach was classified as a pure percutaneous approach or hybrid surgery. The main objective was to describe long-term patency results. The secondary objectives were to identify risk factors for loss of patency and long-term complications. The primary outcomes were primary patency, primary assisted patency and secondary patency at 5 years of follow-up. 136 patients were included. For the overall population, the primary, primary assisted and secondary patency proportions at 5 years were: 71.6% (95% CI 63.2% -81%), 82.1% (95% CI 74.9% - 89.3%), 96.3% (95% CI 92-100%), respectively. For primary patency, there was a significant difference in favor of the covered stent group at 36 months (p <0.01) and 60 months (p = 0.037). In a multivariate model, only CS and age were associated with a better primary patency (HR 0.36, CI95% [0.15 - 0.83], p=0.0193 and a HR 0.07, 95%CI [0.05-0.09], p=0.005, respectively). The overall rate of perioperative complications was 11%. We report that endovascular and hydrid surgery are safe and effective in the management of TASC-D complex aortoiliac lesions in mid to long-term follow-up. Short- and long-term complications were all considered as minor.

8mm Conduit Outperforms 6mm Conduit in Extra-anatomic Bypass

Extra-anatomic bypass is an important tool in relieving supra-inguinal occlusive disease. These bypasses are frequently conducted with prosthetic material, commonly available in 6-mm and 8-mm sizes. Previous studies have demonstrated infra-inguinal bypass has improved patency when graft size is 6 mm or greater. This study aimed to examine outcomes of 6-mm vs 8-mm prosthetic graft use in extra-anatomic bypasses. A retrospective analysis of the Vascular Quality Initiative supra-inguinal database (2010-2022) was conducted. Patients undergoing either axillary-femoral or femoral-femoral prosthetic bypass with available conduit size data were included. Primary endpoints included graft patency and major adverse limb events (MALE). A logistic regression analysis was performed of demographic and operative variables to determine if any factors contributed to the selection of graft size. Then, multivariable Cox regression analysis was conducted in groups based on prosthetic diameter (6 mm vs 8 mm), controlling for these factors. Seven mm was excluded from formal regression analysis due to small sample size but included in survival curves to demonstrate the stepwise impact of graft size. A total of 6463 patients were included for analysis; 2355 axillary-femoral bypasses and 4128 femoral-femoral bypasses. Of these, 1071 patients underwent bypass with 6-mm graft, and 5392 patients underwent bypass with 8-mm graft. Significant predictors (P < .05) of 8-mm graft use in both types of extra-anatomic bypass included male gender, body mass index (BMI) of 25-35 kg/m2, and common femoral as distal target when compared to profunda, superficial femoral artery, and other distal vessels. The most significant predictor (P < .001) of improved primary patency in both types of extra-anatomic bypass examined was larger conduit diameter (8 mm vs 6 mm axillary-femoral hazard ratio [HR], 0.5; femoral-femoral HR, 0.66). Cox regression curves by graft size were generated for both axillary-femoral and femoral-femoral bypasses (Figs 1 and 2), which demonstrated significantly higher primary patency in patients with 8-mm bypasses over time. Improved performance in 8-mm graft compared with 6-mm graft was additionally demonstrated in primary-assisted patency, secondary patency, and MALE regression curves with P < .001 for both axillary-femoral and femoral-femoral bypasses. In this retrospective analysis of extra-anatomic bypasses, 8-mm grafts had significantly improved patency rates and fewer MALE when compared with 6-mm grafts over time. Male sex and body mass index were associated with larger diameter bypass use; after controlling for these preoperative factors, 8-mm grafts still outperformed 6-mm grafts. Vascular surgeons should be cognizant of the potential implications in limb salvage when selecting prosthetic graft for extra-anatomic bypass.Fig 2Primary patency of axillary-femoral bypass over time by graft size.View Large Image Figure ViewerDownload Hi-res image Download (PPT)