Primary Patency Rates Research Articles

Sex-Specific Analysis of Mid-Term Outcomes of Atherectomy-Assisted Endovascular Treatment in Severe Peripheral Arterial Disease.

Background: Endovascular treatment of lower-extremity peripheral disease (PAD) is associated with higher complication rates and suboptimal outcomes in women. Atherectomy has shown favourable outcomes in calcified lesions, minimising the incidence of stent placement caused by recoil or flow-limiting dissection. To date, there are no published mid-term outcomes evaluating the performance of atherectomy differentiated by sex. This study aims to evaluate sex-specific outcomes and prognostic factors affecting the results of atherectomy-assisted endovascular treatment in severe PAD. Methods: A retrospective analysis was conducted at a single centre in Germany, initiated by physicians and not sponsored by industry, on patients presenting with Rutherford categories ranging from III to V and featuring de novo occlusive or stenotic lesions of the superficial femoral (SFA) and/or popliteal arteries. The intervention involved rotational atherectomy-assisted angioplasty utilising the Jetstream (Boston, US®) device. The point of interest of this study was postinterventional clinical improvement as well as mid-term outcomes, including primary patency, over a targeted 2-year follow-up period. Statistical analysis utilised Cox regression (survival analysis) to calculate hazard ratios according to sex category. Comparative survival analysis was performed using the log-rank test and visually represented through Kaplan-Meier curves. Risk factors associated with absence of clinical improvement were examined across both sex groups utilising the chi-square or Fisher exact test, as appropriate. Results: A total of 98 patients (103 limbs) were initially included, with >75% having moderate-to-severe lesion calcification (>50%). A total of 84 patients (97 limbs, 62 male and 35 female) proceeded to a 2-year follow-up (mean 16.4 months for males and 16.1 for females) after a successful index procedure. Age distribution, Rutherford class, diabetes, chronic kidney disease (CKD), target vessel, lesion type, and length were balanced among both groups. Similar primary patency rates, of 89% among female and 91% among male limbs, were observed (p = 0.471). Female patients exhibited a lower rate of clinical improvement based on the Rutherford scale in comparison to males (80.6% vs. 94.5%, p = 0.048). CDK was the only significant prognostic factor across pooled data (odds ratio for CKD: 15.15, p < 0.001). Conclusions: Rotational atherectomy showed comparably high rates of mid-term primary patency, with low rates of bailout stent placement. These findings highlight the beneficial use of atherectomy in female patients who are per se at risk for higher rates of complications during and after endovascular interventions.

Twenty-Four-Month Safety and Effectiveness of TCD-17187 Drug-Coated Balloon for Treatment of Atherosclerotic Lesions in Superficial Femoral and Proximal Popliteal Artery

PurposeIn the present trial, the 24-month safety and effectiveness of the TCD-17187 drug-coated balloon (DCB) for the treatment of atherosclerotic lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PA) were evaluated in Japanese patients.MethodsThis was a prospective, multicenter, core laboratory-adjudicated, single-arm trial. From 2019 to 2020, 121 patients with symptomatic peripheral artery disease were enrolled. The primary effectiveness outcome measure was primary patency. The safety outcome measure was the major adverse event (MAE) rate.ResultsAge was 74.5 ± 7.3 years, and diabetes mellitus was present in 67.5%. Lesion length and reference vessel diameter (RVD) were 106.0 ± 52.6 mm and 5.2 ± 0.8 mm, respectively. Chronic total occlusion (CTO) and bilateral calcification rate (Grade 3 and 4 by peripheral arterial calcium scoring system (PACSS)) were 17.5% and 50.8%, respectively. The 24-month primary patency rate by duplex ultrasound was 71.3%, while freedom from clinically driven target lesion revascularization (CD-TLR) was 87.0%. The MAE rate was 13.2% and all events consisted of CD-TLR. There were no instances of device- or procedure-related deaths major amputations throughout the 24 months. Multivariate Cox proportional hazards regression analysis revealed significant differences associated with loss of primary patency in the following characteristics: CTO, restenotic lesion and RVD.ConclusionThis trial confirmed the safety and effectiveness of TCD-17187 DCB for atherosclerotic lesions of the SFA and/or proximal PA for up to 24 months.Level of EvidenceLevel 3, Cohort study.Clinical Trial Registration: URL: https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000038612&type=summary&language=J:Registration ID: UMIN000034122. Registration Date: September 13, 2018.

#2515 Optimizing brachial-basilic arteriovenous fistula outcomes: insights from a mapping and pre-transposition review

Abstract Background and Aims Brachial- Basilic arteriovenous fistulas (BBAVF) are an option for our patients when superficial vascular patrimony is lacking, but they pose technical and time challenges due to the necessity of a second-stage surgical transposition. The literature reports a 47% primary patency rate within the first year. BBAVFs are associated with higher incidences of steal syndrome and increased stenosis rates, commonly requiring interventions. This study aims to provide insights about optimizing BBAVF outcomes through a comprehensive mapping and pre-transposition evaluation. Method We developed a retrospective single-centre study from 2016 to 2022 that included 101 patients with BBAVFs mapped and constructed at Centro Hospitalar Universitário de Santo António. Mapping and pre-transposition evaluations data were collected from our digital records and the dialysis centre's provided insights about the BBAVFs outcomes through telephonic contact. A comparative analysis between patients achieving one-year primary patency (1Y-P) and those who did not (No 1Y-P) was performed, considering mapping variables (brachial artery and basilic vein diameters) and pre-transposition variables (brachial artery flow and basilic vein diameter). Results At 12 months our primary patency rate was 72.27%. The 1Y-P and No 1Y-P groups showed no significant differences concerning to baseline characteristics such as sex (p = 0.536), age (p = 0.489), and major comorbidities like diabetes (p = 0.929), ischemic heart disease (p = 0.741), peripheral arterial disease (p = 0.174), kidney transplantation (p = 0.384), and previous haemodialysis (p = 0.384). When the BBAVFs were constructed as the first access, they were significantly associated with less primary patency at 12 months (1Y-P n = 32 (43.84%) vs No 1Y-P n = 23 (82.14%); p &amp;lt; 0.001). In the vascular mapping the brachial artery (1Y-P 4.32 ± 0.86 mm vs No 1Y-P 4.11 ± 0.78 mm; p = 0.454) and basilic vein (1Y-P 3.90 ± 1.11 mm vs No 1Y-P 3.59 ± 0.88 mm; p = 0.249) diameters were larger in the 1Y-P group, although without statistically significance. It is important to emphasise that only 12 BBAVFs were constructed with less than 3 mm basilic veins and we only had 50% 12-month primary patency in those patients. Pre-transposition flow was significantly higher in patients with primary patency at 12 months (1Y-P 1069,77 ± 311,89 ml/min vs No 1Y-P 985,00 ± 500,83 ml/min; p = 0.018) and basilic vein diameter was higher in the same group, but without statistical significance (1Y-P 6.50 ± 1.19 mm vs No 1Y-P 6.14 ± 1.53 mm; p = 0.123). Conclusion Our primary patency rate was higher than the described in the literature, which could be a reflection of the organized mapping process in our centre that excludes limit size veins from the BBAVF construction. Patients with BBAVF as their initial access face worse outcomes with decreased primary patency time, probably due to lack of intrinsic vascular patrimony. Stringent construction criteria are warranted in those cases. Contrary to expectations, vessel diameters did not show significant relevance, prompting consideration of factors like distensibility or vessels calcifications as potentially influential. However, we have to underline that the average mapping basilic vein diameter was greater than 3 mm in both groups, which suggests a pre-selection is already carried out in our centre, and, even though there was not statistical significance, the 1Y-P group had bigger basilic veins in the vascular mapping. Our results were worst in the 12 BBAVFs constructed with less than 3 mm basilic veins. BBAVFs pre-transposition evaluation importance is emphasized by the association of higher pre-transposition brachial artery flow rates with improved outcomes. This research highlights the importance of mapping and pre transposition evaluation for optimal BBAVF outcomes, but further studies need to be done with longer follow up times and including more vascular access mapping criteria.

#2559 “Remote software technology to assist clinical decision in vascular access surveillance: single UK centre experience”

Abstract Background and Aims Optimal arteriovenous access monitoring and surveillance aims for early detection of dysfunctional access, enabling pre-emptive referral for angioplasty or surgery to prevent access loss or thrombosis. Here we compared the addition of remote software surveillance to standard clinical care in our units. Method From January–December 2023 we conducted a 12-month prospective study of maintenance hemodialysis (HD) patients. We used Vasc-Alert software technology to assist clinical decision making for vascular access (VA) surveillance in 2 out of 5 HD units. In these units, vascular access risk score was calculated using Vasc-Alert software platform from routinely collected data from the dialysis procedure as previously described [1]. Patients with high Vasc-Alert access risk score (≥7) underwent clinical assessment and were referred for fistulogram if they met the relevant KDOQI criteria [2]. The following variables were collected from all 5 HD units: baseline permanent VA prevalence, subsequent VA events (stenosis or thrombosis), access abandonment (i.e. unsalvageable access loss), complication free days (CFD)-extended over one year (defined as days without serious vascular access events, radiological or surgical intervention, VA infection, hospitalisation or use of central venous catheter). Data was collected on patients who were pre-emptively referred for diagnostic fistulogram ± angioplasty but thrombosed while awaiting intervention. Median time interval from the date of fistulogram request till the date of confirmed thrombosed access was calculated. Comparison between HD units with Vasc-Alert use (Group 1) or without (Group 2) was performed using appropriate statistical tests depending on the type and distribution of the data. Survival analysis of post-intervention primary patency rate was conducted at 3 and 6 months defined as the time from the index procedure until the next access thrombosis or reintervention [3]. Results There were 81 (53.6%) patients with permanent VA in group 1and 201 (59.3%) patients in group 2at the start of the study. We recorded 23 (28.4%) episodes of stenosis and 6 (7.4%) episodes of thrombosis in Group 1 and 40 (19.9%) episodes of stenosis and 21 (10.4%) episodes of thrombosis in Group 2 (p value 0.121 and 0.432, respectively). In Group 2, 11 patients (5.5%) developed repeated stenosis and 2 patients (1%) repeated thrombosis. In Group 1, 5 /6 (83%) cases preemptively referred for diagnostic fistulogram ± angioplasty developed thrombosis whilst awaiting elective intervention, compared with 4/21 (19%) in group 2 (p value = 0.008) (Fig. 1). The median time interval from the date of fistulogram request till date of thrombosed VA was 26 days with Interquartile range (IQR 25-75%) of 21-34 days. Group 1 had better post-intervention primary patency rate of VA (Fig. 2) and longer CFD-extended compared to group 2 (p values &amp;lt; 0.001 and 0.002 respectively) (Table 1). Conclusion Our study shows that integrating Vasc-Alert technology into the VA surveillance program was associated with improved early detection of high-risk access, higher primary patency rates and CFD-extended. Additionally, our data emphasizes the need to enhance interventional radiology capacity for timely access intervention, to realise the true potential of Vasc-Alert technology in prevent access thrombosis.

#1387 Comprehensive evaluation of clinical consequences in diverse forms of fistula elevation procedure

Abstract Background and Aims Arteriovenous fistula (AVF) superficialization is a recommended alternative autologous vascular access (VA) in patients for whom conventional AVF creation is not possible because of insufficient forearm vessels. This procedure utilizes a deeply located vein as an outflow conduit in AVF creation and makes the vein accessible for cannulation. Tunnel transposition (TT) is employed in a standard manner as a venous superficialization technique. This is accomplished by tunneling the transected vein through a subcutaneous tunnel. However, TT is frequently associated with stenosis at the area of transposition because the transposed vein is torsed, kinked, or compressed by external tissue. Thus, TT tends to be exclusively applied to the basilic vein in the upper arm considering both the anatomic positional relation and the inherent limitations of this procedure. We recently reported that elevation transposition (ET) can serve as a practical substitute for TT (Contrib Nephrol. 2019:198:1-11). ET is a simplified minimally invasive superficialization approach in which the vein is elevated and positioned in a subcutaneous pocket immediately beneath the incision. In AVF superficialization employing ET (i.e., fistula elevation procedure [FEP]), three potential outflow veins are available in the upper arm: the cephalic, basilic, and brachial veins. This study was performed to comprehensively evaluate the clinical consequences of three valid FEP techniques to ascertain whether they are reasonable alternatives to autologous VA and which, if any, have superior performance. Method The demographic and outcome data of 111 patients who underwent the FEP from April 2016 to June 2023 were retrospectively collected and analyzed. The outcomes of the three fistula techniques were assessed and compared in terms of patency rates, requirements for VA intervention therapy (VAIVT), and complication rates. Results The mean follow-up period was 36.2 ± 20.1 (range, 1.3-80.8) months. The basilic, cephalic, and brachial vein-based FEP was performed in 63.1%, 23.4%, and 13.5% of cases, respectively. The overall cumulative primary and secondary patency rates were 76.2% and 98.2% at 1 year and 70.7% and 97.0% at 2 years, respectively. VAIVT was required in 32.4% of cases, and the patency rates at 1 and 2 years after VAIVT were 65.3% and 62.0%, respectively. There were no significant differences in these patency rates among the three FEP types. Minor complications such as lymphorrhea or epidermolysis occurred in only 4.5% of cases. Conclusion Our results suggest that the FEP provides three equivalently reliable options to accommodate the deeply located venous anatomy of the upper arm on individual-patient basis. The diversity of the FEP may contribute to avoiding prosthetic VA and central venous catheter-based dialysis, at least in part, by expanding the applicability of the autologous VA.

#1664 Assessing vascular access thrombectomy service adherence to GIRFT recommendations: single centre experience

Abstract Background and Aims Studies showed that early thrombectomy of dialysis vascular access (VA) is associated with better outcomes [1], especially for native VA [2]. Timely treatment of VA thrombosis within 24-48 hours is recommended by GIRFT to minimize access loss and requirement for dialysis line insertion [3]. Our centre has approximately 430 HD patients but has no on-site vascular surgery or vascular access interventional radiology (IR) service. Wait time for elective VA surgery or fistuloplasty is &amp;gt;8 weeks and VA surveillance is based on routine clinical monitoring. VA prevalence is 62% AV fistula (AVF), 2% AV graft (AVG), 36% central venous catheter (CVC). Fistula thrombectomy is provided at another centre, with increasing waiting times over recent years due to shortage of interventional radiologists. This study evaluates adherence to GIRFT recommendations for patients at our centre requiring thrombectomy and will identify potential local strategies to reduce fistula thrombosis and CVC use. Method In a 24-months’ retrospective cohort analysis of maintenance HD patients with permanent VA, we obtained data on: Results 44 patients with permanent VA developed VA thrombosis. The median waiting time for thrombectomy was 8 days (Fig. 1). Post-intervention primary patency rate was 71% at 3-months and 60% at 6-months (Fig. 2). 61% of patients required hospital admission with a 12-day median length of stay, with total inpatient admission days of 403 days over 2 years (2022-2023), and total cost of £246,065 (Figs. 3 and 4). The median CFD-extended was 356 days, i.e. 9 days/patient/year with VA-related complications (Fig. 5). Conclusion This study shows that our centre's VA thrombectomy service falls far outside the GIRFT recommendation of intervention within 24-48 hours. The high associated rates of CVC use, inpatient bed days and avoidable costs place a heavy burden on patient outcomes and NHS resources. The ideal solution of an on-site thrombectomy service is difficult to achieve due to lack of vascular IR support. In response to this study, we now aim to reduce thrombosis rates by training additional interventional nephrologists in elective fistuloplasty, implementing a robust VA surveillance to improve early detection of malfunctioning VA suitable for elective intervention and improving staff education on fistula care.

#2431 Vascular access outcomes among patients on maintenance hemodialysis in Perpetual Succour Hospital: a 3-year cross-sectional analysis

Abstract Background and Aims Hemodialysis (HD) is the most widely used treatment modality worldwide in the care of patients with end stage renal disease (ESRD). The success of the therapy depends largely on the quality of the VA and its proper functioning, which has a bearing on the patient's quality of life. Vascular access dysfunction remains one of the leading causes of excessive morbidity, mortality, and healthcare costs in this group. A functional vascular access is mandatory to achieve good levels of dialytic efficiency, and it is considered the lifeline of patients on maintenance HD. The ideal vascular access should have specific characteristics among which the most important are the following: ease of placement; delivery of adequate blood flow for effective dialysis; good primary patency rates; low rates of complications and side effects; long-lasting life; and low economic costs. There are 3 types of vascular accesses (VAs): the internal arteriovenous fistula (IAVF); the central venous catheter, which can be tunneled (CVC-T) or not (CVC-nT); and the synthetic vascular graft. Internal arteriovenous fistula is considered the best option because it is safer, more durable, and less expensive. The catheter is essential for emergency onset in HD but is associated with a higher number of infections, higher mortality, and greater costs. Arteriovenous fistulae (AVF) have advantages over arteriovenous grafts (AVG) and central venous catheters (CVC), but whether AVF are associated independently with better survival is unclear. The aim of this study is to determine the vascular access outcomes of ESRD patients on maintenance hemodialysis. Specifically, this study (1) described the clinicodemographic profile of the patients in terms of age, sex, primary etiology of ESRD, employment status, comorbidities, hepatitis status and family history of the disease; (2) determined the vascular access used on the HD patients (AVF/AVG, CVC or IJ; (3) identified interventions performed to maintain vascular access for hemodialysis; (4) determined the categories of the vascular access site; (5) assessed the vascular access outcome; (6) determined the reason and number for vascular access change and the (7) clinical outcome of the HD patients. Method This is a single center, cross-sectional study of ESRD patients on maintenance hemodialysis enrolled in Perpetual Succour Hospital Hemodialysis Unit from April 1, 2021, to November 30, 2023. Results There were 260 hemodialysis patients included, with successful vascular access outcome (73.13%) and were younger (57.2 ± 14.1). Those who had failed vascular access were females (54.2%), unemployed (61.4%) and had diabetes mellitus (50.6%) as the primary etiology of their ESRD. Those with failed vascular access were hypertensive (86.7%), with history of CAD and MI (57.8%) and were having diabetes mellitus (56.6%). Proportion of those with failed and successful vascular access significantly differ among hypertensives $(p = .012)$, diabetics $(p = .039)$, with chronic glomerulonephritis $(p = .011)$, and among those with malignancy $(p = .003)$. Most of those who were alive had successful vascular access (76.8%), however, among those who had failed vascular access died (57.6%). And the association of clinical outcomes (death or not) and failure or success of vascular access is statistically significant, $(p = .001)$. Conclusion Our study showed that failed vascular access were more associated with female gender, diabetes mellitus as the primary etiology of ESRD and with other co-morbid conditions such as hypertension and CAD or MI. Successful vascular outcome were among those of younger age group compared to those whose vascular access failed, probably due to better vascular condition and fewer co-morbidities. As shown in Table 2, type of access, interventions performed, and vascular access site significantly differ among HD patients with failed vascular access outcome and with those who were successful $(p = .001)$Those with failure on the vascular access were changed to CVC (44.6%) while others had changed to IJ (22.9%). Eighty of those with failed vascular (96.4%) access has changed site due to no bruit (65.0%) and thrombosis (33.8%).

Outcomes of brachial artery transposition in hemodialysis patients

ObjectiveIn hemodialysis patients with a difficult access extremity who are not suitable for an arteriovenous fistula or arteriovenous graft creation, the concept of cannulating a superficialized artery for arterial outflow in dialysis sessions has been adopted as a tertiary alternative. However, its long-term patency and complications have not been recognized widely. We report our 16-year experience with hemodialysis access creation using the brachial artery transposition (BAT) technique. MethodsThis single-center retrospective study included consecutive patients who underwent BAT for hemodialysis vascular access between June 1, 2006, and December 31, 2022. The patency of the whole access circuit and the transposed brachial artery itself was evaluated independently. ResultsIn total, 193 surgical procedures were included. The success rate was 93.2%. The mean operative time was 128 minutes. The median interval from access placement to first cannulation was 21 days. The primary patency rates for BAT were 92.3%, 91.3%, 90.3%, 86.1%, and 71.9% at 1, 2, 3, 5, and 10 years, respectively. The secondary patency rates for BAT were 96.3%, 96.3%, 95.0%, 90.1%, and 74.9% at 1, 2, 3, 5, and 10 years, respectively. The primary patency rates for the whole access circuit were 61.4%, 49.2%, 45.8%, and 26.9% at 1, 2, 3, and 5 years, respectively. The secondary patency rates for the whole access circuit were 85.1%, 83.3%, 82.0%, and 68.6% at 1, 2, 3, and 5 years, respectively. The overall patient survival rates were 79.6%, 69.6%, 54.6%, 36.5%, and 13.4% at 1, 2, 3, 5 and 10 years, respectively. The abandonments of BAT were brachial artery thrombosis (n = 6), pseudoaneurysm (n = 2), aneurysmal change (n = 1), and other reasons (n = 1). The abandonments of the whole access circuit were exhaustion of venous return (n = 26), abandonment of BAT (n = 7), and other reasons (n = 2). Complications were exhaustion of venous return (n = 26), aneurysmal change (n = 12), pseudoaneurysm (n = 6), brachial artery thrombosis (n = 7), impaired wound healing (n = 19), lymphorrhea (n = 9), skin infection (n = 5), hematoma on cannulation (n = 3), and reduced peripheral blood flow (n = 2). ConclusionsThe patency of BAT was excellent, and that of the whole access circuit was adequate, with a few complications. BAT is an effective alternative from a long-term perspective for patients who are unsuitable for conventional hemodialysis access creation.

A decade's experience with retrograde open mesenteric stenting for acute mesenteric ischemia

ObjectiveRetrograde open mesenteric stenting (ROMS) is an alternative to mesenteric bypass in patients with acute mesenteric ischemia (AMI) with variable reported 30-day mortality rates. Large studies evaluating patient outcomes following ROMS are scarce. Our study aims to assess the results of this approach among patients presenting with AMI. MethodsWe reviewed all the patients with AMI who were treated with ROMS (2011-2022). Patient demographics, presentation, operative details, and outcomes were analyzed. Primary end points were in-hospital, 30-day, and 1-year mortality. Kaplan-Meier estimate for 1-year mortality and primary patency loss were generated. Secondary end points included postoperative 30-day complications. ResultsBetween 2011 and 2022, ROMS was attempted on a total of 42 patients. The median age was 70 ± 15 years and the majority of patients were female. Pain out of proportion to the physical examination was the most common presenting symptom (n = 18, 42.9%) followed by peritonitis (n = 14, 33.4%). All patients underwent preoperative intravenous contrast computed tomography imaging. In situ thrombosis was identified as the etiology of AMI in 36 patients (85.7%). Technical success was achieved in 40 patients (95.2%). Conventional, non-hybrid operating rooms were used for the majority of cases. Revascularization of all 40 patients involved angioplasty and stenting of superior mesenteric artery. A single stent was placed in 35 patients (87.5%) and the reminder had more than one stent. Eighty percent of patients required bowel resection. A second-look laparotomy was required in 34 patients (85.0%). The mean operative time, including both the general surgery and vascular surgery portions of the index procedure, was 192 ± 57 minutes. Sepsis was the most common complication observed within 30 days, occurring in 8 patients (20.0%). In terms of mortality, 13 patients (32.5%) died during their index hospitalization, and 9 died (22.5%) within 30 days. On Kaplan-Meier analysis, the 1-year overall patient survival rate was 58.6%, and the primary patency rate for stents was 51.4%. ConclusionsROMS has an excellent technical success rate in management of AMI with lower than traditionally reported mortality rates for AMI. The dual benefits of rapid revascularization and bowel evaluation should make this surgical modality an alternative approach for treatment of AMI.

Contemporary Therapy of Femoropopliteal In-Stent Restenosis / Occlusion, 36-month Follow up Study.

Drug-eluting devices improved outcomes of endovascular therapy (EVT) for femoropopliteal lesions, but mainly for de novo lesions. Endovascular therapy for in-stent restenosis/occlusion (ISR/O) is challenging, and large trials and long-term data are not well reported. This study is a physician initiated, multicenter, and retrospective design. From 7 Japanese institutes, 3635 femoropopliteal cases were enrolled in the study. Among these, 346 cases of first ISR/O were studied. We defined drug-coated-balloon, drug-eluting stent, and covered stent as New devices. Balloon angioplasty and bare nitinol stent were included in the control group. The propensity score matching extracted 112 pairs. At 12months, the primary patency rate was 80.3% in the new device group and 52.7% in the control group, and there was a significant intergroup difference (P = .004). However, at 36months, the rate was 43.3% vs 39.2%, with no significant difference (P = .090). No baseline characteristics had any significant interaction effect (all P > .05). The New devices were more effective than the control group for ISR/O at 1year, but caught up at 3years.

Role of Retrograde Tibiopedal Access in Limb Salvage in Patients with Critical Lower Limb Ischemia

AbstractThe aim of this study was to assess the efficacy and safety of retrograde tibiopedal access as an alternative approach in cases of critical limb ischemia (CLI) when antegrade access has failed. A prospective study was conducted that included patients with CLI who underwent tibiopedal access after failed antegrade recanalization from January 2018 to June 2022. Follow-up was conducted at 6, 12, and 24 months. The primary outcomes evaluated were technical success rate and primary patency. Secondary outcomes included complication rate, mortality rate, and limb salvage rate (LSR). Forty-eight patients had CLI and Trans Atlantic Inter-Society Consensus infrainguinal lesions. The retrograde approach was used through the anterior tibial artery in 28 patients (58%), the posterior tibial artery in 18 patients (37.5%), and the peroneal artery in 2 patients (4.5%). Technical success was achieved in 90% of patients (43 patients). There was a significant increase in the anklebrachial index after the procedure with a mean follow-up of 22 months. Twenty-two months primary patency rate was 85.2%, while secondary patency rate was 100% and LSR was 96%, respectively. There was no mortality in the series. Retrograde tibiopedal approach is an alternative option for managing peripheral arterial disease and CLI. This method offers another means of crossing lesions when antegrade access failed, and the intervention can be completed either in an antegrade or retrograde approach. As the retrograde approach does not impact access site, considered a feasible safe treatment alternative which increase the success rate of endovascular treatment.

Bypass Patency and Amputation-Free Survival after Popliteal Aneurysm Exclusion Significantly Depends on Patient Age and Medical Complications: A Detailed Dual-Center Analysis of 395 Consecutive Elective and Emergency Procedures.

Background/Objectives: A popliteal artery aneurysm (PAA) is traditionally treated by an open PAA repair (OPAR) with a popliteo-popliteal venous graft interposition. Although excellent outcomes have been reported in elective cases, the results are much worse in cases of emergency presentation or with the necessity of adjunct procedures. This study aimed to identify the risk factors that might decrease amputation-free survival (efficacy endpoint) and lower graft patency (technical endpoint). Patients and Methods: A dual-center retrospective analysis was performed from 2000 to 2021 covering all consecutive PAA repairs stratified for elective vs. emergency repair, considering the patient (i.e., age and comorbidities), PAA (i.e., diameter and tibial runoff vessels), and procedural characteristics (i.e., procedure time, material, and bypass configuration). Descriptive, univariate, and multivariate statistics were used. Results: In 316 patients (69.8 ± 10.5 years), 395 PAAs (mean diameter 31.9 ± 12.9 mm) were operated, 67 as an emergency procedure (6× rupture; 93.8% severe acute limb ischemia). The majority had OPAR (366 procedures). Emergency patients had worse pre- and postoperative tibial runoff, longer procedure times, and more complex reconstructions harboring a variety of adjunct procedures as well as more medical and surgical complications (all p < 0.001). Overall, the in-hospital major amputation rate and mortality rate were 3.6% and 0.8%, respectively. The median follow-up was 49 months. Five-year primary and secondary patency rates were 80% and 94.7%. Patency for venous grafts outperformed alloplastic and composite reconstructions (p < 0.001), but prolonged the average procedure time by 51.4 (24.3-78.6) min (p < 0.001). Amputation-free survival was significantly better after elective procedures (p < 0.001), but only during the early (in-hospital) phase. An increase in patient age and any medical complications were significant negative predictors, regardless of the aneurysm size. Conclusions: A popliteo-popliteal vein interposition remains the gold standard for treatment despite a probably longer procedure time for both elective and emergency PAA repairs. To determine the most effective treatment strategies for older and probably frailer patients, factors such as the aneurysm size and the patient's overall condition should be considered.

Recanalization of superficial femoral artery chronic total occlusion through retrograde popliteal approach recanalization of superficial femoral artery chronic total occlusion

PurposeThis retrospective study aims to evaluate the safety, practicality, and efficacy of the independent retrograde popliteal approach for recanalization superficial femoral artery (SFA) occlusions when the bilateral common femoral artery approach is unavailable, such as after endovascular aneurysm repair or common iliac artery stenting. MethodsThis treatment was considered for patients with contralateral iliac artery occlusion, severe iliac tortuosity, or those who had previously undergone endovascular aneurysm repair or common iliac stenting. Patients with SFA lesions extending into the P1–P2 segment of the popliteal artery or with calcification in the P3 segment were excluded. Angioplasty and stenting were conducted via the popliteal artery approach, with hemostasis at the puncture site achieved using an EXOSEAL vascular closure device. Patients were routinely followed up at 3, 6, and 12 months, and annually thereafter. ResultsForty-eight consecutive patients with SFA occlusion who underwent endovascular treatment via the retrograde popliteal artery approach were included in this study. Retrograde puncture of the popliteal artery was successful in all cases. Six-French sheaths were utilized in all procedures. The EXOSEAL vascular closure device was successfully applied in all 48 cases. No instances of pseudoaneurysms, arteriovenous fistulas, major bleeding, or embolic complications were observed. The technical success rate for SFA recanalization was 100 %. All patients experienced clinical improvement. The ankle-brachial index significantly increased from an initial 0.33 ± 0.11 at admission to 0.81 ± 0.19 at discharge (P < 0.001). The mean follow-up period was 25.1 ± 11.7 months. Kaplan-Meier analysis revealed primary patency rates of 82.5 % at 12 months and 71.8 % at 24 months. No patients required major amputation during the follow-up period. ConclusionThe endovascular treatment of SFA occlusions via the independent retrograde popliteal approach is a viable alternative, demonstrating a low incidence of puncture-related complications and a high success rate of recanalization.

The efficacy of atherectomy combined with percutaneous transluminal angioplasty (PTA)/drug-coated balloon (DCB) compared with PTA/DCB for infrapopliteal arterial diseases: A systematic review and meta-analysis.

With the development of endovascular therapies, some studies have indicated a therapeutic potential for infrapopliteal arterial revascularization with atherectomy (AT). This study was designed to perform a meta-analysis to investigate the efficacy of AT combined with percutaneous transluminal angioplasty (PTA) or drug-coated balloon (DCB) compared with PTA or DCB for infrapopliteal arterial diseases. This is a systematic review and meta-analysis. The Pubmed, Web of Science, and Cochrane Library were systematically searched for articles published up to November 2022, reporting using atherectomy devices for infrapopliteal arterial patients. Randomized controlled trials and retrospective studies were included, and clinical characteristic outcomes were extracted and pooled. Then, we analyzed the efficacies of the AT (AT + PTA or DCB) group and the non-AT (DCB or PTA) group for infrapopliteal arterial patients. We identified 6 studies with 1269 patients included in this meta-analysis. The risk ratios (RRs) of primary patency for patients treated with atherectomy group compared to non-atherectomy group at 6months was 1.03 (95% confidence intervals (CIs) 0.86-1.23, p = .74), at 12months was 1.05 (95% CIs 0.84-1.30, p = .66), in the subgroup analysis between AT combined with DCB and DCB alone, the RRs of primary patency was 1.56 (95% CIs 1.02-2.39, p = .04). The RRs of freedom from target lesion revascularization (TLR) at 6 months was 1.04 (95% CIs 0.93-1.17, p = .45), at 12 months was 1.20 (95% CIs 0.83-1.75, p = .33). The RRs of mortality at 6 months was 0.57 (95% CIs 0.29-1.11, p = .10), and at 12 months was 0.79 (95% CI 0.50-1.25, p = .31). The RRs of limb salvage at 12 months was 0.99 (95% CIs 0.92-1.07, p = .87). The standardized mean difference (SMD) of (Ankle-brachial index) ABI at 12months was 0.16 (95% CIs 0.06-0.26, p = .001). According to this systematic review and meta-analysis, no significant advantages were found with the addition of atherectomy to balloon angioplasty in the below-the-knee segment. Only in the analysis of a small subgroup of atherectomy + DCB versus DCB alone was the primary patency rate at six months significantly higher when adding atherectomy. No further significant differences were found related to 12months of primary patency, TLR, limb salvage, and mortality among groups.

Femoral vein translocation for complex hemodialysis access

ObjectiveVascular access is difficult in patients without suitable arm veins and prior graft infections. The use of femoral vein translocation (FVT) to the upper extremity or contralateral lower extremity for hemodialysis access may be associated with low infection rates and high patency rates. FVT is used for patients without central venous occlusion who have failed prior access either owing to graft infection or repetitive graft thrombosis. The largest case series consists of 30 cases. The objective of this study is to determine the infection incidence, primary patency, primary-assisted patency, and secondary patency rates among FVTs. MethodsA retrospective chart review was performed on all patients who underwent FVT by a single vascular practice over a 10-year period (2013-2023). Study variables included length to last follow-up (months), prior access, prior graft infection, comorbid conditions, primary patency, primary-assisted patency, secondary patency, postoperative steal syndrome, postoperative graft infection, postoperative harvest site complication, and postoperative lower extremity compartment syndrome. ResultsA total of 131 FVTs were performed from 2013 to 2023; 126 patients (47% male, 53% female; 76% Black, 24% White) with a mean age of 52 ± 14 years and a mean body mass index of 29 ± 8 had at least 1 month of follow-up and were included for analysis. The median follow-up was 46 months (interqurtile range, 19-72 months). The mean number of prior permanent accesses was 2.5 ± 1.4. Forty-eight percent of patients had prior graft infections. The primary, primary-assisted, and secondary patency rates were 66%, 93%, and 98%, respectively, at 6 months; 43%, 85%, and 96% at 12 months; 25%, 70%, and 92% at 24 months; 16%, 61%, and 88% at 36 months; and 14%, 56%, and 82% at 48 months. Postoperative steal syndrome and postoperative access infection requiring excision was observed 16% and 5% of patients, respectively. Harvest site complications requiring an additional procedure occurred in 19% of cases. Three patients developed lower extremity compartment syndrome postoperatively, requiring fasciotomy. Six patients developed chronic lower extremity edema after femoral vein harvest. The mean procedure time and hospital length of stay were 197 ± 40 minutes and 3.5 ± 2.8 days, respectively. ConclusionsFVT is associated with low infection rates and high long-term patency rates. Significant postoperative complications include steal syndrome and harvest site complications. FVT remains a viable option for patients who have failed prior access owing to graft infection or repetitive graft thrombosis.

Outcomes of Surgical and Endovascular Treatment for Cephalic Arch Stenosis in Proximal Arteriovenous Fistula.

The cephalic arch is a significant site of stenosis in proximal arteriovenous fistulas (AVFs) that contributes to access dysfunction and thrombosis. This study aimed to evaluate the outcomes of surgical treatment (ST) and endovascular treatment (ET) for cephalic arch stenosis (CAS). A total of 62 patients with proximal AVF who underwent CAS revision using either ST or ET were enrolled between January 2018 and March 2023. In the ET group, only the initial ET following AVF formation was considered, to mitigate bias. In the ST group, central transposition of the native AVF (transposition group) or interposition of the prosthetic graft into the proximal basilic or axillary vein (interposition group) was performed. We evaluated primary and functional patency based on these groups and calculated the number of patency loss events after CAS treatment. Of the 62 patients, 38 (61%) were male, with a mean age of 66.4 years. ST was performed in 26 (42%) patients, including transposition in 16 and interposition in 10, whereas ET was administered to 36 patients during the study period. Among the ST recipients, 42% had a history of ET for CAS. The incidence of AVF thrombosis was marginally higher in the ST group than in the ET group (39% vs. 19%, P=0.098). The primary patency rates at 6 months, 1 year, and 3 years were 87%, 87%, and 66% in the transposition group; 45%, 23%, and 11% in the interposition group; and 66%, 49%, and 17% in the ET group, respectively. Notably, the primary patency of the transposition group was significantly higher than that of the interposition (P=0.001) and ET groups (P=0.016). The frequency of patency loss events per person-year after the initial revision was 0.40, 0.52, and 1.42 in the transposition, interposition, and ET groups, respectively. Transposition exhibited the most favorable primary patency rate and the lowest number of subsequent patency loss events during follow-up despite the higher rates of AVF thrombosis and previous ET at presentation. Consequently, transposition should be actively considered in eligible patients with CAS.

The influence of near-infrared therapy on arteriovenous fistula patency in haemodialysis patients: A multicentre, randomised, controlled clinical trial.

Arteriovenous fistula (AVF) is the preferred vascular access for patients undergoing haemodialysis (HD). AVF malfunction remains a major clinical problem and is a significant independent risk factor for death. Although far-infrared (FIR) therapy has been shown to reduce complications and improve the patency rate of AVFs in various studies, it has been cautiously recommended by the Kidney Disease Outcome Quality Initiative (KDOQI) guidelines for AVF care due to insufficient evidence. Therefore, it is necessary to identify more effective methods for preventing AVF dysfunction. Many in vitro studies and few clinical studies have examined the effects of near-infrared (NIR) therapy on the vasculature. This study will examine the effects of NIR therapy on AVF. A randomised, controlled, open-label, multicentre trial will compare the effect of NIR on AVF patency after 1 year of therapy with that of a control group of patients with existing AVF. One group of patients received NIR treatment above their AVFs, whereas the control group received regular care. The primary outcome is the primary fistula patency rate within 12 months. In addition, acute changes in inflammatory, vasodilatory and haemodynamic parameters after a single treatment in the first 40 participants will be examined. This study was registered in the Clinical Trials Registry (ChiCTR2300071305) at https://register.clinicaltrials.gov/. This study will explore the long-term and acute effects of NIR on AVFs. The study findings will provide information that can be used to develop new technical support for the prevention of AVF dysfunction in patients undergoing haemodialysis.

Influence of Preprocedural Statin Usage on Primary Patency and Amputation in Patients Undergoing Lower Limb Peripheral Angioplasty

Peripheral arterial disease can progress to critical limb ischemia, which is associated with high amputation rates and requires revascularization. The endovascular approach has lower long-term patency because of restenosis due to neointimal hyperplasia. Statins are significantly advantageous for patients undergoing percutaneous interventions; however, only few studies have reported surgical improvements with statin therapy after endovascular treatment in such patients. This retrospective cohort study assessed the effects of preprocedural statins on lower limb arterial angioplasty outcomes by evaluating patency and amputation rates and comparing with those without statins. Patients who underwent percutaneous transluminal angioplasty of the lower limbs for critical ischemia of the lower limbs or for limiting claudication were included in this retrospective cohort study. Patients were categorized according to statin use prior to and during hospitalization. Patient demographics, lesion morphology, primary patency, and limb salvage rates were compared between these groups. Statistical analyses were performed using Kaplan-Meier and multivariate regression analysis. A total of 178 patients undergoing endovascular intervention by critical ischemia or limiting claudication were included. Approximately 80% of the procedures were ballon angioplasty. Primary patency was 73% in 1year and preprocedural statin usage was not associated with improved primary patency rates (P=0.2798). After adjusting the amputation outcomes for pre-established variables, such as prehospitalization statin use, diabetes, procedure indication, disease location, Trans-Atlantic Inter-Society Consensus classification, and current smoking, there was no statistically significant difference associated with preprocedural statin use in primary patency (hazard ratio: 0.87 [0.33-2.29], P=0.79) or amputation (hazard ratio: 0.70 [0.40-1.23], P=0.22). The use of preprocedural statin did not improve primary patency or amputation rates in patients undergoing peripheral angioplasty.

Long-term clinical outcomes of arterial bypass and the factors independently associated with the primary patency in patients with suprainguinal arterial occlusion

IntroductionAortoiliac occlusive disease and iliofemoral occlusion are impact patient quality of life, cause limb loss and mortality. The aim of this study was to investigate the long-term clinical outcomes of arterial bypass, and the factors associated with the outcomes. MethodThis retrospective chart/image review included all types of arterial bypass procedures performed for suprainguinal arterial occlusion during January 2004 to December 2017. The primary outcome was the primary patency. The secondary outcomes were the secondary patency, amputation-free survival, overall survival and the factors associated with the outcomes. ResultA total of 135 patients (107 males) were included. The median age was 65 years. The 1-year, 5-year, and 10-year primary patency rates were 74.3%, 65.7%, and 55.6%, respectively, with independent predictors of poor outcomes being underlying cerebrovascular disease (p = 0.003) and postoperative graft infection (p = 0.016). Secondary patency rates at 1-year, 5-year, and 10-year intervals were 90.1%, 87.1%, and 77.8%, respectively, with independent predictors of poor outcomes being underlying cardiovascular disease (p = 0.013) and postoperative acute kidney injury (p = 0.010). Amputation-free survival rates at 1-year, 5-year, and 10-year intervals were 77.1%, 71.6%, and 66.0%, respectively, with the independent predictor of poor outcome being preoperative foot infection (p = 0.013). Overall survival rates at 1-year, 5-year, and 10-year intervals were 84.4%, 58.6%, and 35.3%, respectively, with independent predictors of poor outcomes being chronic kidney disease (p = 0.030) and postoperative myocardial infarction (p = 0.018). However, antiplatelet therapy emerged as an independent predictor of favorable overall survival outcomes (p = 0.034). ConclusionOur results showed the primary patency rates of arterial bypass to be relatively low at our center; however, most grafts could be saved with high secondary patency. Both disease-associated factors and patient condition-associated factors were found to influence the outcomes of this fragile patient population.

Results of Palliative Stenting in Malignant Superior Vena Cava Syndrome Analyzing Self-Expanding Stainless Steel and Nitinol Venous Bare Metal Stents.

The purpose was to analyze the technical, clinical, and survival outcomes of our patients with malignant superior cava vein syndrome (SVCS) treated with endovascular approach and analyze the efficacy of different stent types used. It is an observational, retrospective, single-center study. From 2006 to 2023, 42 patients (32 male, 10 female, mean age 62 years, age range, 41-87 years) underwent percutaneous stent placement for malignant SVCS. One stainless steel stent (Wallstent) and 2 venous nitinol stent type (Sinus-XL, Venovo) were used. Follow-up mean was 276 days. A total of 53 stents were deployed. Clinical success was 97.6% in less 24 hours. Technical success was achieved in 97.6%. No complications were found except 1 patient died during the procedure due to stent migration and atrial dissociation (2.3%). Overall intraprocedural stent migration rate was 11.9% (18.8% stainless steel stent, 9.6% nitinol stent, p>0.05). Overall survival rates were 87.8%, 41.99%, and 34.12%, and overall primary patency rates were 100%, 93.3%, 91.6% at 1, 6, and 12 months, respectively. Endovascular treatment is a safe and effective therapeutic option for SVCS with high technical and clinical success rates and low complication and recurrence rates. The malignant superior cava vein syndrome is a rare clinical entity treated classically with radiation and chemotherapy with a slower response, or surgical bypass, which is an aggressive surgical technique. Endovascular treatment offers a low-invasive technique with quick clinical resolution and good permeability results. However, further studies are lacking to deal with procedure technical characteristics, stent type used, technical complications, and medium- and long-term patency studies. This study aims to evaluate all these items, analysing self-expanding stainless steel and nitinol venous bare metal stents, and add value to endovascular treatment, confirming the good results of this technique.