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Central venous access devices for the delivery of systemic anticancer therapy (CAVA): a randomised controlled trial
2021
Hickman-type tunnelled catheters (Hickman), peripherally inserted central catheters (PICCs), and totally implanted ports (PORTs) are used to deliver systemic anticancer treatment (SACT) via a central vein. We aimed to compare complication rates and costs of the three devices to establish acceptability, clinical effectiveness, and cost-effectiveness of the devices for patients receiving SACT.
We did an open-label, multicentre, randomised controlled trial (Cancer and Venous Access [CAVA]) of three central venous access devices: PICCs versus Hickman (non-inferiority; 10% margin); PORTs versus Hickman (superiority; 15% margin); and PORTs versus PICCs (superiority; 15% margin). Adults (aged ≥18 years) receiving SACT (≥12 weeks) for solid or haematological malignancy from 18 oncology units in the UK were included. Four randomisation options were available: Hickman versus PICCs versus PORTs (2:2:1), PICCs versus Hickman (1:1), PORTs versus Hickman (1:1), and PORTs versus PICCs (1:1). Randomisation was done using a minimisation algorithm stratifying by centre, body-mass index, type of cancer, device history, and treatment mode. The primary outcome was complication rate (composite of infection, venous thrombosis, pulmonary embolus, inability to aspirate blood, mechanical failure, and other) assessed until device removal, withdrawal from study, or 1-year follow-up. This study is registered with ISRCTN, ISRCTN44504648.
Between Nov 8, 2013, and Feb 28, 2018, of 2714 individuals screened for eligibility, 1061 were enrolled and randomly assigned, contributing to the relevant comparison or comparisons (PICC vs Hickman n=424, 212 [50%] on PICC and 212 [50%] on Hickman; PORT vs Hickman n=556, 253 [46%] on PORT and 303 [54%] on Hickman; and PORT vs PICC n=346, 147 [42%] on PORT and 199 [58%] on PICC). Similar complication rates were observed for PICCs (110 [52%] of 212) and Hickman (103 [49%] of 212). Although the observed difference was less than 10%, non-inferiority of PICCs was not confirmed (odds ratio [OR] 1·15 [95% CI 0·78–1·71]) potentially due to inadequate power. PORTs were superior to Hickman with a complication rate of 29% (73 of 253) versus 43% (131 of 303; OR 0·54 [95% CI 0·37–0·77]). PORTs were superior to PICCs with a complication rate of 32% (47 of 147) versus 47% (93 of 199; OR 0·52 [0·33–0·83]).
For most patients receiving SACT, PORTs are more effective and safer than both Hickman and PICCs. Our findings suggest that most patients receiving SACT for solid tumours should receive a PORT within the UK National Health Service.
UK National Institute for Health Research Health Technology Assessment Programme.
Journal Article
Sustained reduction of catheter-associated bloodstream infections with enhancement of catheter bundle by chlorhexidine dressings over 11 years
by
Ekholm, Bruce
,
Revelly, Jean-Pierre
,
Dupuis-Lozeron, Elise
in
Bundling
,
Catheters
,
Chlorhexidine
2019
BackgroundProspective randomized controlled studies have demonstrated that addition of chlorhexidine (CHG) dressings reduces the rate of catheter (central venous and arterial)-associated bloodstream infections (CABSIs). However, studies confirming their impact in a real-world setting are lacking.MethodsWe conducted a real-world data study evaluating the impact of incrementally introducing chlorhexidine dressings (sponge or gel) in addition to an ongoing catheter bundle on the rates of CABSI, expressed as incidence density rates per 1000 catheter-days measured as part of a surveillance program. Poisson regression models were used to compare infection rates over time. Both dressings were used simultaneously during one of the five study periods.ResultsFrom 2006 to 2014, 18,286 patients were admitted (91,292 ICU-days and 155,242 catheter-days). We recorded 111 CABSIs. We observed a progressive but significant decrease of CABSI rates from 1.48 (95% CI 1.09–2.01) without CHG dressings to 0.69 (95% CI 0.43–1.09) and 0.23 (95% CI 0.11–0.48) episodes per 1000 catheter-days when CHG sponge and CHG gel dressings were used (p = 0.0007; p < 0.001). A non-significant lower rate of infections occurred with CHG gel compared with CHG sponge dressings. An identical low rate of allergic skin reactions (0.3/1000 device-days) was observed with both types of CHX dressings. Post-study data until 2018 confirmed a sustained decrease of infection rates over 11 years.ConclusionsThe addition of chlorhexidine dressings to all CVC and arterial lines to an ongoing catheter bundle was associated with a sustained 11-year reduction of all catheter-associated bloodstream infections. This large real-world data study further supports the current recommendations for the systematic use of CHG dressings on all catheters of ICU patients.
Journal Article
O-009 Pump versus syringe: aspiration thrombectomy direct pressure comparisons in a comprehensive benchtop 3D-printed circle of willis model
2025
Background and ObjectivesExperiments have shown 60-cc syringes generate stronger vacuum forces than mechanical pumps. However, few studies have measured catheter tip suction pressure during thrombus engagement. Therefore, this study aimed to compare aspiration forces and pressure drops, generated by mechanical pumps and 60-cc syringes connected to various catheters when aspirating synthetic clots in a 3D-printed model.MethodsThe system included a programmable pulsatile pump, a 3D-printed tissue-matched circle of Willis model, radiopaque synthetic blood clots positioned in the left internal carotid artery terminus, and pressure recordings at 500±10% ml/min and 120/80±10 mmHg. Each catheter underwent three soft and hard clot removal trials using a 60-cc syringe and an aspiration pump. Aspiration source pressure was recorded before, during, and after aspiration. The evaluated variables included engagement pressure change (ΔP engagement), aspiration pressure drops (ΔP aspiration), and pressure efficiency (PE), defined as the percentage of peak pressure (PP) maintained during aspiration.ResultsAspirating soft clots with syringes showed low engagement pressure drops (ΔP engagement) (0–14 mmHg), high PE at 93–99% of Pp, and minimal aspiration pressure drops (ΔP aspiration) (6F catheters: 4–8 mmHg, 8F catheters: 19 mmHg). Conversely, using a pump generated moderate ΔP engagement (6F: 16–51 mmHg, 8F: 122 mmHg), lower PE (69–93% of Pp), and greater ΔP aspiration (6F: 143–151 mmHg, 8F: 270 mmHg). For hard clots, syringes exhibited minimal ΔP engagement and ΔP aspiration (4–13 mmHg and 3–12 mmHg, respectively), while pumps showed moderate ΔP engagement (2–34 mmHg) and large ΔP aspiration (6F: 82–162 mmHg, 8F: 280 mmHg).ConclusionSyringe aspiration generates higher vacuum pressures and smaller pressure drops than aspiration pumps, likely due to vacuum tubing resistance in aspiration pumps. This effect is particularly evident with hard clots and larger ID catheters.Abstract O-009 Figure 1Abstract O-009 Figure 2DisclosuresH. Berns: None. K. Han: None. F. Ramirez-Velandia: None. K. Lewis: None. S. Robertson: None. W. Clark: None. J. Wells: None. M. Alnajrani: None. C. Rapoport: None. K. Hakes: None. J. Granstein: None. C. Ogilvy: None. T. Becker: None. M. Young: None.
Journal Article
E-069 The ‘clot ingestion’ protocol: new frontiers in mechanical thrombectomy with a combination of novel atraumatic self-centering delivery catheters and super large-bore aspiration (SLBA) catheters
by
Massari, F
in
Catheters
2025
IntroductionLarge, and even more Super Large Bore Aspiration (SLBA), have shown high rates of First-Pass Efficacy (FPE) during mechanical thrombectomy. The utilization of the novel atraumatic delivery catheters has provided the adequate support to safely and efficiently reach the clot with large and super-large bore catheters, without need for crossing the occlusion.Aim of StudyWe performed a comparison of the novel atraumatic delivery catheters actually on the market (SENDit, Penumbra Inc; Tenzing 7 and 8, Route 92 Medical; Cheetah, Q’apel; Zipline, Perfuze; Innerglide, J&J MedTech; Carrier SM, MD and LG, Balt) or in advanced testing phase (FastPass, Stryker) analyzing the different features, especially in combination with the paring aspiration catheters on the market (RED 72, Penumbra Inc; FreeClimb 70 & 88 and HiPoint 88, Route 92 Medical; Hippo 072, Q’apel; Millipede 088, Perfuze; Cereglide 71 & 92, J&J MedTech; Ballast 088, Balt) or in advanced testing phase (Broadway 84, Stryker).MethodsThese platforms entail the utilization of a triaxial assembly: guide/long sheath catheter with/without balloon, a 0.070’/72’ or 0.084’/92’ reperfusion catheter and an insert catheter that completely consumes the inner diameter of the large-bore (LBA) or super large-bore (SLBA) aspiration catheters.ResultsThese novel atraumatic delivery catheters have proven their superior capability in navigating the matching reperfusion catheters to the proximal aspect of the occlusion. The virtually atraumatic self-centering soft tapered tip is capable to cruise the tortuous cervical-cranial vasculature. The extremely large shaft almost zeroes the step-off with the aspiration catheters and reduces the risk to get stuck at vascular ledges/bifurcations, making unnecessary to cross the embolus, which significantly reduces the risk of downstream clot embolization.ConclusionBuilding scientific evidences has demonstrated the elevated safety and efficacy of this new generation of triaxial stroke-dedicated platforms combining a large-bore (LBA) or super large-bore (SLBA) aspiration catheters to novel atraumatic and self-centering delivery catheters.DisclosuresF. Massari: None.
Journal Article
E-238 Steam shaping of angled-tip aspiration catheter to improve deliverability in treating acute ischemic stroke
2025
BackgroundVarious techniques have been developed to optimize the treatment of large vessel occlusion (LVO) strokes. Further innovation is critical to maximizing the speed and success in clot retrieval. Application of steam shaping to angled-tip aspiration catheters utilizing a non-wire advancement technique has yet to be explored.ObjectiveTo explore the outcomes and efficacy of steam-shaped angled-tip aspiration catheters in conjunction with non-wire advancement.MethodsOur case series included patients with anterior circulation LVO using a non-wire advancement technique with a steam shaped angled-tip aspiration catheter, Zoom 71. Outcomes were aspiration passes, time to first pass and recanalization, degree of final reperfusion (TICI), and adverse outcomes.ResultsOf the 10 cases analyzes, 60% were male with median age of 70 (IQR 62.3 – 75.5) and median NIHSS score of 22.5 (IQR 19.3 – 25.0). 70% had singular occlusions, while tandem occlusions included 1 ICA-M1 and 2 ICA-M2 cases. Most (60%) had a cavernous carotid siphon angle type II. First pass took 11.5 minutes (IQR 10.0 – 15.0) and recanalization took 20.0 minutes (IQR 15.8 – 25.8) with an average of 2.2 passes. For singular occlusions, 57.1% of cases required 2 or fewer passes. The tandem ICA-M1 occlusion needed only one pass at each location, while both ICA-M2 occlusions required one ICA pass with Zoom 71 with a pass at M2 with Zoom 45. 80% of cases achieved a final TICI score of 2C or greater. There were no intra-operative complications, though 4 cases presented with post-operative complications with 1 death unrelated to the procedure. In all cases the aspiration catheter was able to be delivered without the use of another device.ConclusionSteam-shaping of angled-tip catheters appears to perform superiorly when utilizing a non-wire advancement technique without compromising patient safety.DisclosuresC. Badger: None. A. Trang: None. S. Singha: None. M. Arnold: None. S. Majmundar: None. T. Miller: None. D. Gandhi: None. J. Cherian: None.
Journal Article
E-236 Medium vessel thrombectomy with the vecta-46 catheter: a safety and outcome analysis
2025
IntroductionMechanical thrombectomy is the standard of care for acute ischemic stroke due to proximal large vessel occlusion (LVO). Ongoing studies have expanded the indications for endovascular thrombectomy (EVT) to include larger core infarcts and smaller vessel occlusions, including medium vessel occlusions (MeVOs). Newer aspiration catheters designed for MeVOs have been introduced, yet there remains a paucity of clinical data regarding their safety and efficacy. This study evaluates the performance of the Vecta-46 intermediate catheter in MeVO thrombectomy compared to larger-bore aspiration catheters.MethodsWe conducted a retrospective cohort study analyzing thrombectomy cases at the University of Florida Health from July 2022 to June 2024. A total of 179 thrombectomy procedures were reviewed, including 32 cases utilizing the Vecta-46 catheter for MeVOs and 147 cases employing other catheters primarily for LVOs. The primary outcome measure was the rate of successful revascularization (>=TICI 2b). Secondary outcomes included NIH Stroke Scale (NIHSS) score, modified Rankin Scale (mRS) while in-patient, mortality rate, intracranial hemorrhage (ICH) incidence, and procedural duration.ResultsBaseline characteristics were comparable between the groups. The Vecta-46 catheter demonstrated a similar safety profile and revascularization success rate compared to larger-bore aspiration catheters. As expected, Vecta-46 was used for more distal vessel occlusions and was associated with an increased number of aspiration attempts. Discharge mRS scores did not differ significantly between groups, indicating comparable functional outcomes.ConclusionsThe Vecta-46 intermediate catheter is a safe and effective tool for thrombectomy in medium vessel occlusions, an expanding indication for endovascular mechanical thrombectomy. Its safety metrics and revascularization rates align with those of currently utilized larger-bore catheters. Future studies with larger sample sizes will further reveal its role in MeVO thrombectomy.Abstract E-236 Table 1Vecta-46 usage characteristicsNon-Vecta46Vecta46Totalp-valueMortality No100231230.671Yes47956 Revascularization Yes145311760.48No213 Hemorrhage Rate19 (12.9%)5 (15.6%)24/1480.675Abstract E-236 Figure 1mRS distribution at discharge[Figure omitted. See PDF]Abstract E-236 Figure 2NIHSS on admission & 7 days[Figure omitted. See PDF]DisclosuresD. Sarathy: None. C. DeYoung: None. H. Hutchinson: None. G. Hey: None. W. Gillem: None. Z. Sorrentino: None. B. Chowdhury: None. M. Koch: None.
Journal Article
E-005 Vessel size and segmental variations in the COMPLETE registry
2025
Introduction/PurposeAspiration catheters are widely used alone or in combination with stent retrievers to treat intracranial large and medium vessel occlusions in acute ischemic stroke. Matching catheter size to the vessel diameter is recognized as a key factor influencing reperfusion success and has increased in importance with the inclusion of large-bore catheters in practice. However, detailed data on the distribution of vessel diameters and the relationship to occlusion sites remain limited. Moreover, the association between occlusion sites/diameter and clinical severity is not well understood. We aimed to describe the distribution of vessel diameters in occlusion segments, and explore baseline clinical factors in the COMPLETE Registry.Materials and MethodsCOMPLETE was a prospective, global, multicenter registry. We retrospectively analyzed 643 patients enrolled in the COMPLETE Registry. Cerebral angiograms during mechanical thrombectomy were reviewed to measure vessel diameters at the clot face for each occlusion site. Baseline characteristics, age, sex, National Institutes of Health Stroke Scale (NIHSS), and comorbidities were collected prospectively. Frequencies and percentages were used to characterize occlusion sites, and descriptive statistics (mean, median, standard deviation, range) were computed for vessel diameters in each segment.ResultsAmong the 643 participants (mean age 68.4±14.2 years; 54.3% female), hypertension (72.0%), cardiovascular disease (50.9%), and hyperlipidemia (42.5%) were the most prevalent comorbidities. The median baseline NIHSS was 15 (IQR 9–20). Most occlusions (92.5%) involved the anterior circulation, primarily distal ICA (18.4%), proximal M1 (15.9%), distal M1 (36.9%), and M2 segments (8.6% proximal, 9.3% distal). In the posterior circulation (7.5%), basilar artery lesions predominated (distal, mid, or proximal).Vessel diameters varied substantially by segment. Proximal M1 arteries averaged 2.34 mm (median 2.32, range 1.54–3.54), whereas distal M1 measured 2.26 mm (median 2.19, range 1.53–3.43). M2 diameters decreased from approximately 2.09 mm (proximal) to 1.75 mm (distal). In the posterior circulation, proximal basilar segments were slightly larger (~2.45 mm) than distal basilar (~2.37 mm). Notably, patients with proximal M1 occlusions had a higher median NIHSS (~16) than those with distal M1 (~14). A similar trend was observed between proximal and distal M2 subgroups.ConclusionThis independent radiographic analysis of the COMPLETE Registry demonstrates considerable variation in intracranial vessel diameters across different occlusion segments and suggests corresponding differences in clinical severity. By establishing segment-specific diameter profiles, our study provides essential baseline data to inform ongoing inquiries regarding device choice, procedural safety, and long-term efficacy.Abstract E-005 Figure 1a: Vessel diameter at site of occlusion[Figure omitted. See PDF]DisclosuresN. Kaneko: None. H. Saber: None. A. Hassan: None. J. Fifi: None. O. Zaidat: None. A. Yoo: None. S. Sheth: None. D. Liebeskind: None.
Journal Article
E-109 Comparison of pressure and corking force in commercial aspiration catheters
2025
IntroductionMechanical thrombectomy (MT) has become the standard approach for ~800,000 acute ischemic strokes that occur each year in the U.S. However, up to 20% of MT procedures fail altogether. Recent studies have begun to investigate the influence of aspiration catheter (AC) designs on clot removal during MT. Therefore, this study focuses on determining how AC design effects clot ingestion and engagement.Methods0% hematocrit clots were fabricated using a Chandler loop, and their dimensions were measured. To mimic MT, clots were lodged in PVC tubing, ACs were passed through a hemostatic valve to the clot’s proximal face, and manual aspiration with a 60ml VacLock was performed. The clot length outside of the AC was measured and normalized by its initial length to determine ingestion (%). The system (occluded AC and hemostatic valve) was transferred to an Instron (figure 1A). The clots were pulled until they dislodged from the AC, and the corking force (force to remove the clot from the AC) was recorded. Aspiration and corking tests were performed with React 71 (Medtronic), SOFIA Flow Plus (Terumo), Large Bore (Cerenovus), and Red 72 (Penumbra) ACs.ResultsThe average % ingestion (n=5 for each AC) for the SOFIA, React 71, Large Bore, and Red 72 were 9.7±4.5%, 10.9±4.2%, 12.3±7.5%, and 13.5±6.5%. Although a slight increase in % ingestion is seen as AC diameter increases (0.07’–0.072’), no correlation was determined between % ingestion and AC diameter or % ingestion and corking force. However, statistical differences in corking force were found between the React 71 and Large Bore, React 71 and Red 72, and SOFIA and Red 72 (figure 1B).ConclusionA greater corking force suggests it’s more difficult for a clot to dislodge from the AC tip during retrieval. Our results support previous studies indicating clot ingestion is proportional to AC diameter. However, the suggestion that force to remove a clot from the catheter tip is proportional to its cross-sectional area (due to F=PA) does not necessarily hold for all ACs. In this study, only the SOFIA and React 71 corking forces are similar to their theoretical values, suggesting that catheter design may influence clot retrieval. Prior studies comparing commercial AC trackability forces found similar trends inferring Medtronic and Terumo AC tips are more deformable, which could explain the differences in corking forces.Abstract E-109 Figure 1A)Custom testing apparatus with occluded react 71. B)Average corking force across ACs (* = p<0.05, ** =p<0.01)[Figure omitted. See PDF]DisclosuresD. Poulos: None. M. Froehler: 1; C; Siemens, Genetech, Medtronic. 2; C; Balt, Cerenovus, TG Medical, Jacobs Institute, Sonorous, Imperative Care. B. Good: None.
Journal Article
SUPPORTING THE 3RS BY INCREASING CATHETER PATENCY DURATION
by
Lapierre, A
in
Catheters
2023
Journal Article