Percutaneous intervention versus surgery in the treatment of common femoral artery lesions: study protocol for the prospective, multi-center, randomized PESTO-CFA trial.

BACKGROUND: Endovascular therapy has become established as a first-line therapy in most arterial regions. However, open vascular surgery (endarterectomy) remains the treatment of choice for common femoral artery (CFA) lesions. The aim of this study is to investigate the acute and mid-term results of directional atherectomy plus drug-coated balloon (DCB) in comparison to endarterectomy in treatment of de novo arteriosclerotic CFA lesions. METHODS: This prospective, randomized, multicenter non-inferiority study will enroll 306 participants with symptomatic (Rutherford category 1 to 5) de novo stenosis of the CFA including the bifurcation. Patients eligible for both treatment groups could be included in this 1:1 randomized trial. Primary efficacy endpoint is patency of the target lesion at 12 months defined as restenosis < 50% without the need of clinically driven target lesion revascularization (cdTLR). Primary safety endpoint is a combined endpoint including death, myocardial infarction, major or minor amputation of the target limb, and peri-procedural complications at 30 days. Secondary endpoints include primary patency of the target lesion at 6 and 24 months, secondary patency, cdTLR 6, 12, and 24 months, change in ankle-brachial index, and Rutherford-Becker class at 6, 12, and 24 months. Limb salvage, change in quality of life measured by Walking Impairment Questionnaire, and major adverse events including death, myocardial infarction, and minor or major amputation of the target limb will be determined at 6, 12, 24, and 36 months. DISCUSSION: Endovascular treatment of CFA lesions is still a matter of debate. Few studies compared modern endovascular therapy methods against the so-called gold standard surgical endarterectomy so far. Based on recent positive results, this study aims to confirm non-inferiority of a "leaving nothing behind" endovascular approach combining directional atherectomy and DCB compared to surgical therapy. TRIAL REGISTRATION: ClinicalTrials.gov NCT02517827.

Randomized Trial Comparing a Stent-Avoiding With a Stent-Preferred Strategy in Complex Femoropopliteal Lesions.

BACKGROUND: Limited comparative data exist on different interventional strategies for endovascular revascularization of complex femoropopliteal interventions. OBJECTIVES: In this study, the authors aimed to compare a stent-avoiding (SA) vs a stent-preferred (SP) strategy, promoting optimal lesion preparation and the use of drug-eluting technologies in both arms. METHODS: Within a prospective, multicenter, pilot study, 120 patients with symptomatic complex femoropopliteal lesions (Rutherford classification 2-4, mean lesion length 187.7 ± 78.3 mm, 79.2% total occlusions) were randomly assigned in a 1:1 fashion to endovascular treatment with either paclitaxel-coated balloons or polymer-coated, paclitaxel-eluting stents. Lesion preparation including the use of devices for plaque modification and/or removal was at the operators' discretion in both treatment arms. RESULTS: In the SA group, lesion preparation was more frequently performed (71.7% SA [43/60] vs 51.7% [31/60] SP; P = 0.038) with a high provisional stenting rate (48.3% [29/60]). At the 12-month follow-up, primary patency was 78.2% (43/55) in the SA group and 78.6% (44/56) in the SP group (P = 1.0; relative risk: 0.995; 95% CI: 0.818-1.210). Freedom from major adverse events was determined in 93.1% (54/58) in the SA group and in 94.9% (56/59) in the SP group (P = 0.717; relative risk: 0.981; 95% CI: 0.895-1.075), with all adverse events attributable to clinically driven target lesion revascularization. CONCLUSIONS: Both endovascular strategies promoting lesion preparation before the use of drug-eluting devices suggest promising efficacy and safety results in complex femoropopliteal procedures with a high proportion of total occlusions through 12 months. Ongoing follow-up will show whether different results emerge over time. (Best Endovascular Strategy for Complex Lesions of the Superficial Femoral Artery [BEST-SFA]; NCT03776799).

Vascular Access Team Central Line Dressing Changes to Reduce Infection Risk: A Focused Two-Person Approach in High-Risk Patients.

Due to low compliance by bedside nursing with a central line-associated bloodstream infection (CLABSI) prevention bundle and increased CLABSI rates, a mandatory re-education initiative at a 1200-bed university-affiliated hospital was undertaken. Despite this, 2 units, housing high-risk immunocompromised patients, continued to experience increased CLABSI rates. A quality improvement before-after project design in these units replaced bedside nursing staff with 2 nurses from the vascular access team (VAT) to perform central vascular access device (CVAD) dressing changes routinely every 7 days or earlier if needed. The VAT consistently followed the bundled components, including use of chlorhexidine gluconate (CHG)-impregnated dressings on all patients unless an allergy was identified. In this case, a non-CHG transparent semipermeable membrane dressing was used. There were 884 patients with 14 211 CVAD days in the preimplementation period and 1136 patients with 14 225 CVAD days during the postimplementation period. The VAT saw 602 (53.0%) of the 1136 patients, performing at least 1 dressing change in 98% of the patients (n = 589). The combined CLABSI rate for the 2 units decreased from 2.53 per 1000 CVAD days preintervention to 1.62 per 1000 CVAD days postintervention. The estimated incidence rate ratio (IRR) for the intervention was 0.639, a 36.1% reduction in monthly CLABSI rates during the postimplementation period.

Global variations in funding and use of hemodialysis accesses: an international report using the ISN Global Kidney Health Atlas.

BACKGROUND: There is a lack of contemporary data describing global variations in vascular access for hemodialysis (HD). We used the third iteration of the International Society of Nephrology Global Kidney Health Atlas (ISN-GKHA) to highlight differences in funding and availability of hemodialysis accesses used for initiating HD across world regions. METHODS: Survey questions were directed at understanding the funding modules for obtaining vascular access and types of accesses used to initiate dialysis. An electronic survey was sent to national and regional key stakeholders affiliated with the ISN between June and September 2022. Countries that participated in the survey were categorized based on World Bank Income Classification (low-, lower-middle, upper-middle, and high-income) and by their regional affiliation with the ISN. RESULTS: Data on types of vascular access were available from 160 countries. Respondents from 35 countries (22% of surveyed countries) reported that > 50% of patients started HD with an arteriovenous fistula or graft (AVF or AVG). These rates were higher in Western Europe (n = 14; 64%), North & East Asia (n = 4; 67%), and among high-income countries (n = 24; 38%). The rates of > 50% of patients starting HD with a tunneled dialysis catheter were highest in North America & Caribbean region (n = 7; 58%) and lowest in South Asia and Newly Independent States and Russia (n = 0 in both regions). Respondents from 50% (n = 9) of low-income countries reported that > 75% of patients started HD using a temporary catheter, with the highest rates in Africa (n = 30; 75%) and Latin America (n = 14; 67%). Funding for the creation of vascular access was often through public funding and free at the point of delivery in high-income countries (n = 42; 67% for AVF/AVG, n = 44; 70% for central venous catheters). In low-income countries, private and out of pocket funding was reported as being more common (n = 8; 40% for AVF/AVG, n = 5; 25% for central venous catheters). CONCLUSIONS: High income countries exhibit variation in the use of AVF/AVG and tunneled catheters. In low-income countries, there is a higher use of temporary dialysis catheters and private funding models for access creation.

[Implementing vascular access protection indicators (VAPI) in dialysis: an innovation in quality of care]. / Mise en place d'indicateurs de protection des abords vasculaires (IPAV) en dialyse : une innovation dans la qualité des soins.

Between 2013 and 2021, indicators of vascular access protection (IPAV) integrating a census of haematomas and multiple punctures were set up on the active file of chronic kidney failure patients with a vascular access dialyzed in Monaco's private haemodialysis center. They could help reduce the occurrence of complications and improve the quality of care offered to patients. This article reports on the results obtained before and after the introduction of this quality approach.

Retrospective analysis on diameters of drug-coated balloons and predilatation balloons in infra-inguinal endovascular treatment (RABBIT study).

This multicenter retrospective study assessed the clinical outcomes of endovascular therapy (EVT) using a drug-coated balloon (DCB) that was larger than the predilatation balloons for femoropopliteal artery lesions. We analyzed 1140 cases with symptomatic peripheral artery disease that underwent EVT with DCB for femoropopliteal lesions between 2017 and 2021. The primary endpoint was procedural failure, defined as a composite of deteriorated dissection and bailout stenting. The secondary endpoints included deteriorated dissection, bailout stenting, restenosis, and target lesion revascularization. We performed propensity score matching to compare the clinical outcomes between EVT with a DCB which was larger than the predilatation balloon (larger DCB) and EVT with a DCB which was not (nonlarger DCB). We assigned 276 cases to the larger DCB group and 864 cases to the nonlarger DCB group. Procedural failure was observed in 75 cases, whereas restenosis occurred in 282 cases during a mean follow-up period of 12.7 ± 9.7 months. Propensity score matching extracted 273 pairs with no intergroup difference in baseline characteristics, except the predilatation balloon size. Procedural failure (9.2% versus 6.1%, P = 0.11), deteriorated dissection and bailout stenting proportion (both P > 0.05), and 1-year rates of freedom from restenosis (82.4% versus 84.1%, P = 0.59) and target lesion revascularization (89.7% versus 90.4%, P = 0.83) showed no significant difference between the larger and nonlarger DCB groups. Irrespective of whether the DCB size was larger than the predilatation balloon, no difference was observed in either procedural or clinical outcomes.

Effect of EDTA with porous balloon on calcified lesion: An atherosclerotic cadaver study.

BACKGROUND: Ethylene diamine tetra-acetic acid (EDTA) is a chelating agent used to dissolve calcium deposits but evidence in decalcifying atherosclerotic lesions is limited. AIMS: We assessed the feasibility and efficacy of EDTA delivered via porous balloon to target calcified lesions in cadaveric below-the-knee (BTK) arteries. METHODS: Using porcine carotid arteries, EDTA concentration was measured in the arterial wall and outside the artery at the 0-, 0.5-, 4-, and 24-h circulation after the injection through a porous balloon. In cadaver BTK samples, the proximal and distal anterior tibial artery (ATA) and distal posterior tibial artery (PTA) were studied. EDTA-2Na/H2O or EDTA-3Na/H2O were administrated using a porous balloon, then circulated for 6 h for EDTA-3Na/H2O and 24 h for EDTA-2Na/H2O and EDTA-3Na/H2O. Micro-CT imaging of the artery segments before and after the circulation and cross-sectional analyses were performed to evaluate calcium burden. RESULTS: In the porcine carotid study, EDTA was delivered through a porous balloon present in the arterial wall and was retained there for 24 h. In BTK arteries, cross-sectional analyses of micro-CT revealed a significant decrease in the calcium area in the distal ATA segment under 24-h circulation with EDTA-2Na/H2O and in the distal ATA segment under 24-h circulation with EDTA-3Na/H2O. The proximal ATA segment under 6-h circulation with EDTA-3Na/H2O showed no significant change in any parameters of calcium CONCLUSION: EDTA-3Na/H2O or EDTA-2Na/H2O with longer circulation times resulted in greater calcium reduction in atherosclerotic lesion. EDTA may have a potential therapeutic option for the treatment of atherosclerotic calcified lesions.

Extravasation and infiltration: under-recognised complications of intravenous therapy.

Occasionally, the administration of intravenous (IV) therapies can go wrong. Infiltration or extravasation is a complication when a drug or IV therapy leaks into the tissues surrounding the vascular access device. Extravasation can cause serious and often life-changing injuries. Extravasation is often associated with systemic anti-cancer therapy but non-chemotherapy drugs have been reported as having a greater risk of serious complications. This study outlines the first UK Infusion unit evaluation of the ivWatch infusion monitoring device which was undertaken from August 2023 to January 2024. Out of 2254 infusions monitored with ivWatch, the device prevented 122 cases of infiltration and extravasation from causing any harm to the patient, corresponding to a 5.4% 'check IV' notification rate.

The influence of needleless connectors and inserted catheters on flow rates through vascular introducer sheaths.

SummaryA vascular introducer sheath is often used for rapid volume replacement. However, common manipulations such as the addition of needleless connectors to infusion ports and the insertion of catheters or other devices through the introducer sheath may impede flow. In this study we utilised a rapid infuser to deliver room-temperature normal saline through two introducer sheath configurations with and without the addition of needleless connectors and the placement of catheters through the introducer sheaths. The maximal flow rate delivered by the rapid infuser was 1000 mL/min, which was observed with both introducer sheath sizes tested without additional resistive elements. However, with the addition of a needleless connector, flow rates through the introducer sheaths were substantially lower (64 (standard deviation (SD) 6) mL/min and 61 (SD 7) mL/min for the 8.5 Fr and 9 Fr introducers, respectively). Flow rates were also reduced when catheters were placed within the sheaths (298 (SD 9) mL/min with the 7 Fr catheter and 74 (SD 9) mL/min with the 8 Fr catheter placed in an 8.5 Fr sheath; 649 (SD 6) mL/min with the 7 Fr catheter and 356 (SD 14) mL/min with the 8 Fr catheter placed in the 9 Fr sheath). These findings indicated that both needleless connectors and the placement of catheters through vascular introducer sheaths substantially reduced potential flow rates. Even 'large' vascular introducer sheaths capable of delivering high flow rates could be rendered minimally effective for rapid fluid administration when used in this way. Clinicians should consider these impediments to flow when rapid fluid administration is required, and obtain alternative vascular access if necessary.

Assessment of the safety and efficacy of the Zoom 45 and 55 reperfusion catheters for medium and distal mechanical thrombectomies: A multi-institutional study.

INTRODUCTION: The Zoom aspiration catheters harbor novel dimensions and construction to enhance trackability and deliverability. In addition, a beveled tip may improve thrombus interaction and aspiration force for a set inner diameter. This study evaluates their utility in medium and distal vessel occlusions. OBJECTIVE: To evaluate the safety and efficacy of Zoom 45 and 55 aspiration catheters in medium and distal vessel thrombectomy. METHODS: Patients treated for distal vessel occlusions via mechanical thrombectomy utilizing either the Zoom 45/55 catheter or a historical control catheter between 2021-2022 at two institutions were included in this study. Medium and distal occlusions were defined as any anterior or posterior cerebral artery branch as well as the M2-4 segment of the middle cerebral artery (MCA). Preprocedural, procedural, and postprocedural variables were obtained. RESULTS: Thirty-eight patients underwent thrombectomy with Zoom 45 or 55 catheters; four had multiple occluded vessels. Occlusion location included the M2 in 32 cases, M3-4 in 7 cases, A2 in 2 cases and P2 in 1 case. The mean number of passes per occlusion was 1.6 and overall successful reperfusion (TICI 2b or greater) was achieved in 84 % of cases. There were no symptomatic procedure-related complications such as perforation or post-procedural symptomatic ICH. Modified Rankin scores rates of 0-2, 3-5, and 6 at three months post-procedure were 35.7 %, 21.4 %, and 42.9 %, respectively. CONCLUSIONS: The Zoom beveled tip aspiration catheters are safe and effective for more challenging medium and distal vessel occlusions.

Outcomes of Excimer Laser Ablation Combined with Drug-coated Balloon in Atherosclerotic Lesions of the Popliteal Artery.

BACKGROUND: The treatment of atherosclerotic lesions in the popliteal artery is challenging. This study aims to investigate the efficacy and safety of excimer laser ablation (ELA) combined with drug-coated balloon (DCB) for these lesions. METHODS: From June 2019 to December 2021, data of patients who underwent ELA combined with DCB in the popliteal artery were retrospectively reviewed. Demographics, lesion characteristics, periprocedural complications, and follow-up information were analyzed. The primary endpoint was primary patency. Secondary endpoints included major amputation-free survival rate, technical success, bailout stenting, clinically-driven target lesion reintervention, improvement of ankle-brachial index (ABI), and Rutherford class. RESULTS: A total of 61 patients were enrolled. The mean age was 73.4 ± 11.7 years. 20 (32.8%) patients had stenotic lesions, while 41 (67.2%) patients had chronic total occlusions. The mean length of these lesions was 7.3 ± 2.8 cm. Procedure technical success rate was 95.1%. Bailout stent was performed in 3 (4.9%) patients. Intraprocedural distal embolization occurred in 3 (4.9%) patients, while flow limiting dissections occurred in 3 (4.9%) patients. The mean ABI was significantly improved from 0.45 ± 0.13 at baseline to 0.90 ± 0.12 after ELA, 0.88 ± 0.11 at 6 months and 0.85 ± 0.12 at 12 months during the follow-up period. The median follow-up time was 28.2 ± 6.1 months. Reintervention was performed in 5 (8.2%) patients. The 2-year primary patency was 83.5%. CONCLUSIONS: ELA combined with DCB is a safe and effective strategy in the treatment of popliteal artery atherosclerotic lesions with low rates of bail-out stenting and high primary patency.

Vascular access device type for systemic anti-cancer therapies in cancer patients: A scoping review.

BACKGROUND: Patients with cancer can expect to receive numerous invasive vascular access procedures for intravenous therapy and clinical diagnostics. Due to the increased incidence and prevalence of cancer globally there will be significantly more people who require first-line intravenous chemotherapy over the next ten years. METHODS: Our objective was to determine the types of evidence that exist for the vascular access device (VAD) type for the delivery of systemic anti-cancer therapy (SACT) in cancer patients. We used JBI scoping review methodology to identify the types of VADs used for SACT and with a specific search strategy included articles from 2012-2022 published in the English language. We identify (i) type of VADs used for SACT delivery (ii) the type of insertion and post-insertion complications (iii) the geographical location and clinical environment (iv) and whether VAD choice impacts on quality of life (QOL). Findings were presented using the PAGER framework. MAIN FINDINGS: Our search strategy identified 10,390 titles, of these, 5318 duplicates were removed. The remaining 5072 sources were screened for eligibility, 240 articles met the inclusion criteria. The most common design include retrospective study designs (n = 91) followed by prospective study designs (n = 31). We found 28 interventional studies with 21 registered in a clinical trial registry and identified no core outcome sets papers specific to VAD for SACT. The most prevalent publications were those that featured two or more VAD types (n = 70), followed by tunnelled intravenous VADs (n = 67). Of 38 unique complications identified, the most frequent catheter related complication was catheter related thrombosis (n = 178, 74%), followed by infection (n = 170, 71%). The county where the most publications originated from was China (n = 62) with one randomized controlled multicenter study from a comprehensive cancer centre. Of the thirty three studies that included QOL we found 4 which reported on body image. No QOL measurement tools specific to the process of SACT administration via VAD are available INTERPRETATION: Our findings suggest a systematic review and meta-analysis of VAD use for intravenous SACT can be considered. However, the development of a core outcome set for SACT should be prioritised. Funding for high quality programs of research for VAD in cancer are needed. Comprehensive cancer centres should lead this research agenda.

Hemodynamic Monitoring In The Cardiac Surgical Patient: Comparison of Three Arterial Catheters.

OBJECTIVE: Systemic systolic (SAP) and mean (MAP) arterial pressure monitoring is the cornerstone in hemodynamic management of the cardiac surgical patient, and the radial artery is the most common site of catheter placement. The present study compared 3 different arterial line procedures. It is hypothesized that a 20-G 12.7- cm catheter inserted into the radial artery will be equal to a 20-G 12.7- cm angiocath placed in the brachial artery, and superior to a 20-G 5.00 cm angiocath placed in the radial artery. DESIGN: A prospective randomized control study was performed. SETTING: Single academic university hospital. PARTICIPANTS: Adult patients ≥18 years old undergoing nonemergent cardiac surgery using cardiopulmonary bypass (CPB). INTERVENTIONS: After approval by the Rhode Island Hospital institutional review board, a randomized prospective control study to evaluate 3 different peripheral intraarterial catheter systems was performed: (1) Radial Short (RS): 20-G 5- cm catheter; (2) Radial Long (RL): 20-G 12- cm catheter; and (3) Brachial Long (BL): 20-G 12- cm catheter. MEASUREMENTS AND RESULTS: Gradients between central aortic and peripheral catheters (CA-P) were compared and analyzed before CPB and 2 and 10 minutes after separation from CPB. The placement of femoral arterial lines and administration of vasoactive medications were recorded. After exclusions, 67 BL, 61 RL, and 66 RS patients were compared. Before CPB, CA-P SAP and MAP gradients were not significant among the 3 groups. Two minutes after CPB, the CA-P SAP gradient was significant for the RS group (p = 0.005) and insignificant for BL (p = 0.47) and RL (p = 0.39). Two-group analysis revealed that CA-P SAP gradients are similar between BL and RL (p = 0.84), both of which were superior to RS (p = 0.02 and p = 0.04, respectively). At 10 minutes after CPB, the CA-P SAP gradient for RS remained significant (p = 0.004) and similar to the gradient at 2 minutes. The CA-P SAP gradients increased from 2 to 10 minutes for BL (p = 0.13) and RL (p = 0.06). Two minutes after CPB, the CA-P MAP gradients were significant for the BL (p = 0.003), RL (p < 0.0001), and RS (p < 0.0001) groups. Two-group analysis revealed that the CA-P MAP gradients were lower for the BL group compared with the RL (p = 0.054) and RS (p< 0.05) groups. Ten minutes after CPB, the CA-P MAP gradients in the RL and RS groups remained significant (p < 0.0001) and both greater than the BL group (p = 0.002). A femoral arterial line was placed more frequently in the RS group (8/66 = 12.1%) than in the RL group (3/61 = 4.9%) and the BL group (2/67 = 3.0%). Vasopressin was administered significantly more frequently in the RS group. CONCLUSION: Regarding CA-P SAP gradients, the RL group performed equally to the BL group, both being superior to RS. Regarding CA-P MAP gradients, BL was superior to RL and RS. Clinically, femoral line placement and vasopressin administration were fewer for the BL and RL groups when compared with the RS group. This study demonstrated the benefits of a long (12.7 cm) 20- G angiocath placed in the radial artery.

An mHealth application for chronic vascular access: Consumer led co-creation.

PURPOSE: Children with chronic and complex health conditions frequently need intravenous devices. The current approach to intravenous device selection, insertion, and monitoring is inconsistent, and healthcare consumers are often negatively affected by siloed health information, and poor future planning. Despite child- and family-centred care being recognised as a pillar of paediatric nursing care, limited implementation for vascular access device planning and management is evident. DESIGN AND METHODS: To address this, we conducted a multi-phased approach to co-create, then evaluate, a mobile health (mHealth) application: IV Passport. Co-creation involved a prioritisation survey, followed by a Passport advisory panel consensus meeting. Following confirmation of the required content and features of the Passport, the mHealth application was designed and content validation achieved via survey. RESULTS: The prioritisation survey yielded recommendations for seven features (e.g., graphical presentations of current/past devices). Content for nine device types (e.g., totally implanted ports) was suggested, each with 10 related items (e.g., insertion site). Content items for device-associated complications, future vascular access plans, and educational resources were also suggested. Following design, the application was released through Apple and Android platforms; and adapted to a paper version. Content validation was established; 100% strongly agreed the application was easy to use; 80% agreed/strongly agreed that they would recommend the Passport to others. CONCLUSION: IV Passport embodies effective child- and family-centred care through consumer co-creation to empower patients and families manage vascular access devices. PRACTICE IMPLICATIONS: IV Passport remains active; and can be utilised across many healthcare settings and patient populations.

Five-Year Safety and Effectiveness of Paclitaxel Drug-Coated Balloons Alone or With Provisional Bare Metal Stenting for Real-World Femoropopliteal Lesions: IN.PACT Global Study Subgroup Analysis.

BACKGROUND: The treatment of complex infra-inguinal disease with drug-coated balloons (DCBs) is associated with a significant number of patients undergoing provisional stenting to treat a suboptimal result. To determine the potential long-term impact of DCB treatment with provisional bare metal stenting in complex lesions in real-world patients, a post hoc analysis was performed on data from the IN.PACT Global Study (The IN.PACT Global Clinical Study for the Treatment of Comprehensive Superficial Femoral and/or Popliteal Artery Lesions Using the IN.PACT Admiral Drug-Eluting Balloon). Five-year outcomes were compared between participants who were stented after DCB treatment versus those treated with DCB alone. METHODS: The IN.PACT Global Study enrolled 1535 participants with intermittent claudication and/or ischemic rest pain caused by femoropopliteal lesions; 1397 patients were included in this subgroup analysis (353 stented and 1044 nonstented). Effectiveness was assessed as freedom from clinically driven target lesion revascularization through 60 months. The primary safety composite end point was defined as freedom from device- and procedure-related death through 30 days, and freedom from major target limb amputation and clinically driven target vessel revascularization through 60 months. RESULTS: Lesions in the stented group were longer (15.37 versus 10.98 cm; P<0.001) and had more total occlusions (54.7% versus 28.6%; P<0.001) compared with the nonstented group. The 5-year Kaplan-Meier estimated freedom from clinically driven target lesion revascularization was similar between groups (66.8% stented versus 70.0% nonstented group, log-rank P=0.22). The safety composite end point was achieved in 64.5% stented versus 68.2% nonstented participants (log-rank P=0.19) as estimated by the Kaplan-Meier method. No significant difference was observed in the cumulative incidence of major adverse events (49.1% stented versus 45.0% nonstented; log-rank P=0.17), including all-cause death (19.6% stented versus 19.3% nonstented, log-rank P=0.99). CONCLUSIONS: In this real-world study, revascularization of complex femoropopliteal artery lesions with DCB angioplasty alone or DCB followed by provisional bare metal stenting in certain lesions achieved comparable long-term safety and clinical effectiveness. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01609296.

Treatment of Hemodialysis Vascular Access Repeated Stenosis with Paclitaxel-Coated Balloon Angioplasty: A Retrospective Study.

INTRODUCTION: The objective of this study was to report our experience of angioplasty with paclitaxel-coated balloon (PCB) versus common balloon (CB) for the treatment of repeated failing vascular access. METHODS: Retrospective, single-center analysis consisting of 88 patients treated with percutaneous transluminal angioplasty in the period from October 2020 through December 2021. Patients were divided into two groups according to the type of treatment as PCB (n = 41) and CB (n = 47). We analyzed target lesion primary patency and vascular access primary patency for 6 months and the rate of complications. RESULTS: There was no significant difference in the target lesion primary patency which was similar for 6 months between the two groups (PCB group vs. CB group at 1, 3, and 6 months; 95.12 vs. 89.36% (p = 0.55), 75.61 versus 74.47% (p = 0.90), 53.66% versus 63.83% (p = 0.33), respectively). Similarly, vascular access primary patency in the PCB group and CB group was 90.24 and 89.36% (p = 0.83), respectively, at 1 month, 65.85 and 68.09% (p = 0.82), respectively, at 3 months, 39.02 and 53.19% (p = 0.18), respectively, at 6 months. There were no major complications after endovascular treatment. CONCLUSION: Compared to CB angioplasty, PCB angioplasty has no short-term patency benefit in the treatment of vascular access repeated stenosis.

A comparative analysis of infection and complication rates between single- and double-lumen ports.

OBJECTIVE: Port-a-caths are implanted intravascular chest ports that enable venous access. With more port placements performed by interventional radiologists, it is important to discern differences in infection and complication rates between double- and single-lumen ports. METHODS: We retrospectively reviewed 1,385 port placements over 2 years at the University of Miami. Patients were grouped by single- or double-lumen ports. Data on duration of catheter stay, bloodstream infections, malfunctions, and other complications (fibrin sheath, thrombosis, catheter malposition) were collected. Multivariate Cox regression was performed to identify variables predicting port infection. RESULTS: The mean patient age was 58.8 years; the mean BMI was 26.9 kg/m2; and 61.5% of these patients were female. Our search revealed 791 double-lumen ports (57.1%) and 594 single-lumen ports (42.9%). The median follow-up was 668 days (range, 2-1,297). Double-lumen ports were associated with significantly higher rates of bacteremia (2.78% vs 0.84%; P = .02), port malfunction (8.3% vs 2.0%; P < .001), fibrin sheath formation (2.2% vs 0.5%; P < .02), catheter tip malposition (1.0% vs 0; P = .01), and catheter-associated thrombosis (1.4% vs 0; P = .003). Multivariate Cox regression analysis, after adjusting for other variables, showed that double-lumen chest ports had 2.98 times (95% confidence interval, 1.12-7.94) the hazard rate of single-lumen ports for developing bloodstream infection (P = .029). CONCLUSIONS: Double-lumen chest ports are associated with increased risk for bloodstream infection, malfunction, fibrin sheath formation, catheter tip malposition, and catheter-associated thrombosis. Interventional radiologists may consider placing single-lumen ports if clinically feasible; however, future studies are needed to determine clinical significance. The study limitations included the retrospective study design and the potential loss of patient follow-up.