Background: The 1.5mm 'Baby J' hydrophilic narrow J tipped wire is a development of the standard 0.035" 3mm J tipped peripheral guidewire, designed to improve efficiency of transradial coronary procedures by safely navigating small caliber radial arteries to the aorta. There is currently a lack of evidence comparing the procedural success and safety of different peripheral guidewires used in transradial cardiac procedures. We compared the efficacy and safety of a narrow J tipped hydrophilic 0.035" wire (intervention - Radifocus™ 'Baby J' guidewire, TERUMO Co., Tokyo, Japan). versus standard fixed core (FC) 0.035" J wire (control). Methods: Investigator initiated, blinded, Australian, multicenter randomized trial in patients undergoing clinically indicated coronary angiography and/or PCI. Randomized 1:1 via sealed envelope method to use either the control or the intervention guidewire. The primary endpoint (technical success) was defined as gaining aortic root access with the randomized guidewire. Results: 330 patients were randomized between October 2022 - June 2023 (median age 69 years, 36% female, BMI 29 kg/m²). The primary endpoint was achieved more frequently in the intervention group [96% v 84%; mean difference 12% (95% CI 5.7-18.3); p<0.001]. Women assigned to the control wire experienced a higher failure rate compared to men (31% v 8% in men; p<0.001). Fluoroscopy time was significantly shorter in the baby J group (median 344 versus 491 seconds; p=0.024). The main mechanisms of failure using the control wire were radial artery spasm (15/26; 57%) and subclavian tortuosity (5/26; 19.2%). There were no differences in overall procedure times, MACE, or vascular complications between guidewires. Conclusions: A narrow 1.5mm J tipped hydrophilic guidewire resulted in greater technical success and reduced fluoroscopy time compared to the standard 3mm J tip non-hydrophilic guidewire. The guidewire is safe and demonstrated key incremental benefits for the trans-radial approach particularly in women.
Transfemoral access is nowadays required for an increasing number of percutaneous procedures, such as structural heart interventions, mechanical circulatory support, and interventional electrophysiology/pacing. Despite technological advancements and improved techniques, these devices necessitate large-bore (≥12 French) arterial/venous sheaths, posing a significant risk of bleeding and vascular complications, whose occurrence has been related to an increase in morbidity and mortality. Therefore, optimizing large-bore vascular access management is crucial in endovascular interventions. Technical options, including optimized preprocedural planning and proper selection and utilization of vascular closure devices, have been developed to increase safety. This review explores the comprehensive management of large-bore accesses, from optimal vascular puncture to sheath removal. It also discusses strategies for managing closure device failure, with the goal of minimizing vascular complications.
Background: The ASTRAL trial (Angioplasty and Stenting for Renal Artery Lesions) recruited 806 patients between 2000 and 2007. Patients with atherosclerotic renal artery stenosis (RAS) and clinician uncertainty about the benefit of revascularization were randomized 1:1 to medical therapy with or without renal artery stenting. The initial results were presented in 2009 at a median 33.6-month follow-up, with no benefit of revascularization on renal or cardiovascular outcomes. Surviving patients remained under follow-up until the end of 2013, and the long-term results are presented in this study.
Methods: Data were analyzed to assess whether there was a later impact of revascularization on renal function, cardiovascular events, and survival, including a composite outcome of renal and cardiovascular outcomes and death (as in the CORAL trial [Cardiovascular Outcomes in Renal Atherosclerotic Lesions]). Prespecified subgroup analyses included different categories of renal function, rapid deterioration in kidney function, and degree of RAS. Post hoc analyses of patients with severe RAS (bilateral 70% or >70% in a solitary kidney), those with or without proteinuria, and a per-protocol analysis were performed.
Results: The mean age of the entry population was 70.5 years, the mean estimated glomerular filtration rate was 40 mL/min/1.73 m2, the mean RAS was 76%, and the mean blood pressure was 150/76 mm Hg; 83% of the revascularization group underwent attempted stenting. The median follow-up was 56.4 months, with 108 patients lost to follow-up. By the end of follow-up, 50% of the evaluable population had died, 18% had suffered a first renal event, and 40% had suffered a first cardiovascular event. No statistical difference was observed for any outcome in the intention-to-treat and per-protocol analyses.
Conclusions: The long-term follow-up of the ASTRAL trial showed no overall benefit of renal revascularization to renal and cardiovascular outcomes. It has been highlighted that a proportion of the population had lower-risk RAS, and there is likely to be merit in further study in a higher-risk population.
Registration: URL: https://www.isrctn.com; Unique identifier: ISRCTN59586944.
Background: Clot-in-transit is associated with high mortality, but optimal management strategies remain uncertain. The aim of this study was to compare the outcomes of different treatment strategies in patients with clot-in-transit.
Methods: This is a retrospective study of patients with documented clot-in-transit in the right heart on echocardiography across 2 institutions between January 2020 and October 2023. The primary outcome was a composite of in-hospital mortality, resuscitated cardiac arrest, or hemodynamic decompensation.
Results: Among 35 patients included in the study, 10 patients (28.6%) received anticoagulation alone and 2 patients (5.7%) received systemic thrombolysis, while 23 patients (65.7%) underwent catheter-based therapy (CBT; 22 mechanical thrombectomy and 1 catheter-directed thrombolysis). Over a median follow-up of 30 days, 9 patients (25.7%) experienced the primary composite outcome. Compared with anticoagulation alone, patients who received CBT or systemic thrombolysis had significantly lower rates of the primary composite outcome (12% versus 60%; log-rank P<0.001; hazard ratio, 0.13 [95% CI, 0.03-0.54]; P=0.005) including a lower rate of death (8% versus 50%; hazard ratio, 0.10 [95% CI, 0.02-0.55]; P=0.008), resuscitated cardiac arrest (4% versus 30%; hazard ratio, 0.12 [95% CI, 0.01-1.15]; P=0.067), or hemodynamic deterioration (4% versus 30%; hazard ratio, 0.12 [95% CI, 0.01-1.15]; P=0.067).
Conclusions: In this study of CBT in patients with clot-in-transit, CBT or systemic thrombolysis was associated with a significantly lower rate of adverse clinical outcomes, including a lower rate of death compared with anticoagulation alone driven by the CBT group. CBT has the potential to improve outcomes. Further large-scale studies are needed to test these associations.
Background: The prognostic impact of functionally significant coronary artery disease, as assessed with quantitative flow ratio (QFR), in patients with severe aortic stenosis treated with transcatheter aortic valve replacement is unknown.
Methods: This is a retrospective study with blind analysis of angiographic data, enrolling consecutive patients with severe aortic stenosis treated with transcatheter aortic valve replacement at 4 Italian centers. None of the patients enrolled received pre-transcatheter aortic valve replacement or concomitant coronary revascularization, either for the absence of significant coronary stenoses or by clinical decision. Visual estimation of diameter stenosis and QFR analysis were performed in all coronary arteries. The end point was all-cause mortality at a 3-year follow-up.
Results: A total of 318 patients were enrolled. At visual estimation, 140 patients (44%) presented a diameter stenosis ≥50% in at least 1 coronary artery, whereas 78 patients (24.5%) had at least 1 vessel with QFR <0.80 and, therefore, included in the positive QFR group. Overall, 69 (21.7%) patients died during the follow-up. In the Kaplan-Meier analysis, patients with positive QFR experienced significantly higher rates of death during follow-up compared with those without (51.1% versus 12.1%; P<0.001), whereas no significant difference was evident in terms of death between patients with or without significant coronary artery disease according to angiographic evaluation (24.3% versus 19.7%; P=0.244). In a multivariate regression model, positive QFR was an independent predictor of all-cause death during follow-up (hazard ratio, 5.31 [95% CI, 3.21-8.76]).
Conclusions: Coronary QFR can predict mortality in patients with severe aortic stenosis treated with transcatheter aortic valve replacement without revascularization.