Ultrasound-guided versus fluoroscopy-guided large-bore femoral access in PCI of complex coronary lesions: the international, multicentre, randomised ULTRACOLOR Trial.

BACKGROUND: Transfemoral access is often used when large-bore guide catheters are required for percutaneous coronary intervention (PCI) of complex coronary lesions, especially when large-bore transradial access is contraindicated. Whether the risk of access site complications for these procedures may be reduced by ultrasound-guided puncture is unclear. AIMS: We aimed to show the superiority of ultrasound-guided femoral puncture compared to fluoroscopy-guided access in large-bore complex PCI with regard to access site-related Bleeding Academic Research Consortium 2, 3 or 5 bleeding and/or vascular complications requiring intervention during hospitalisation. METHODS: The ULTRACOLOR Trial is an international, multicentre, randomised controlled trial investigating whether ultrasound-guided large-bore femoral access reduces clinically relevant access site complications compared to fluoroscopy-guided large-bore femoral access in PCI of complex coronary lesions. RESULTS: A total of 544 patients undergoing complex PCI mandating large-bore (≥7 Fr) transfemoral access were randomised at 10 European centres (median age 71; 76% male). Of these patients, 68% required PCI of a chronic total occlusion. The primary endpoint was met in 18.9% of PCI with fluoroscopy-guided access and 15.7% of PCI with ultrasound-guided access (p=0.32). First-pass puncture success was 92% for ultrasound-guided access versus 85% for fluoroscopy-guided access (p=0.02). The median time in the catheterisation laboratory was 102 minutes versus 105 minutes (p=0.43), and the major adverse cardiovascular event rate at 1 month was 4.1% for fluoroscopy-guided access and 2.6% for ultrasound-guided access (p=0.32). CONCLUSIONS: As compared to fluoroscopy-guided access, the routine use of ultrasound-guided access for large-bore transfemoral complex PCI did not significantly reduce clinically relevant bleeding or vascular access site complications. A significantly higher first-pass puncture success rate was demonstrated for ultrasound-guided access. CLINICALTRIALS: gov identifier: NCT04837404.

Comparison of Radifocus versus Silverway Guidewires for Percutaneous Radial Angiography Following Failed Use of a J-Tip Guidewire.

BACKGROUND During transradial coronary angiography, when conventional J-tip wires fail to deliver catheters to the aortic root due to anatomical obstacles, additional hydrophilic wires, such as Radifocus (Terumo) or Silverway (Asahi), are used. We recently showed that the Silverway guidewire was effective at delivering the catheter to the aortic root. In this study, we aimed to compare the efficacy and safety of Radifocus and Silverway guidewires in 100 patients after failed use of the J-tip guidewire. MATERIAL AND METHODS After patients had a failure of a conventional J-tip wire to reach the aortic root, 100 patients were 1:1 randomized to either the Silverway or Radifocus wire. All patients with failure of the J-tip wire were eligible. The primary endpoint was the time between wire entry in the catheter and successful delivery of the catheter to the aortic root. Secondary endpoints included change of access site, number of complications, and questionnaires on subjective wire assessments by the performing interventional cardiologist. RESULTS The primary endpoint was significantly shorter in patients randomized to the Silverway arm (median 30 s [21-39] vs 48 s [36-66]; P<0.001)). The percentage of patients with change of access site was not different between the groups (2 vs 2, not significant). Only 1 minor complication (2%) occurred, in the Radifocus group. Questionnaires revealed that torque control, crossing, and support were all significantly better with the Silverway wire (P<0.001). CONCLUSIONS Silverway showed superior torque control, resulting in faster catheter delivery to the aortic root when compared with the Radifocus guidewire.

Prophylactic Impella CP versus VA-ECMO in Patients Undergoing Complex High-Risk Indicated PCI.

Objectives: To compare two different forms of mechanical circulatory support (MCS) in patients with complex high-risk indicated PCI (CHIP): the Impella CP system and veno-arterial extracorporeal membrane oxygenation (VA-ECMO). Background: To prevent hemodynamic instability in CHIP, various MCS systems are available. However, comparable data on different forms of MCS are not at hand. Methods: In this multicenter observational study, we retrospectively evaluated all CHIP procedures with the support of an Impella CP or VA-ECMO, who were declined surgery by the heart team. Major adverse cardiac events (MACE), mortality at discharge, and 30-day mortality were evaluated. Results: A total of 41 patients were included, of which 27 patients were supported with Impella CP and 14 patients with VA-ECMO. Baseline characteristics were well-balanced in both groups. No significant difference in periprocedural hemodynamic instability was observed between both groups (3.7% vs. 14.3%; p = 0.22). The composite outcome of MACE showed no significant difference (30.7% vs. 21.4%; p = 0.59). Bleeding complications were higher in the Impella CP group, but showed no significant difference (22.2% vs. 7.1%; p = 0.22) and occurred more at the non-Impella access site. In-hospital mortality was 7.4% in the Impella CP group versus 14.3% in the VA-ECMO group and showed no significant difference (p = 0.48). 30-Day mortality showed no significant difference (7.4% vs. 21.4%; p = 0.09). Conclusions: In patients with CHIP, there were no significant differences in hemodynamic instability and overall MACE between VA-ECMO or Impella CP device as mechanical circulatory support. Based on this study, the choice of either VA-ECMO or Impella CP does not alter the outcome.

Complex High-Risk Indicated Percutaneous Coronary Intervention With Prophylactic Use of the Impella CP Ventricular Assist Device.

OBJECTIVES: Patients with complex coronary artery disease, concomitant cardiac disease, and multiple comorbidities are addressed as complex higher-risk indicated patients (CHIPs). Selecting a revascularization strategy in this population remains challenging. If coronary artery bypass grafting is deemed high risk or patients are considered inoperable, high-risk percutaneous coronary intervention (PCI) with the support of the Impella CP ventricular assist device (Abiomed) may be an attractive alternative. METHODS: In this retrospective, multicenter study, we included consecutive patients undergoing Impella CP-facilitated complex high-risk PCI. All patients were discussed by the heart team and were declined for surgery. Additionally, periprocedural mechanical circulatory support was deemed necessary. We collected demographic, clinical, and procedural characteristics. Major adverse cardiac event (MACE) and mortality rates up to 30 days were evaluated. RESULTS: A total of 27 patients (median age, 73 ± 9.7 years; 74.1% men) were included in our study. The median SYNTAX score was 32 (range, 8-57) and EuroSCORE was 7.25% (range, 1.33-49.66; ± 12.76%). Periprocedural hemodynamic instability was observed in 1 patient (3.7%). In-hospital combined with 30-day mortality was 7.4% (2/27). No repeat revascularization was necessary. MACE was observed in 10 patients (37.0%). Six patients (22.2%) had a major bleeding complication, of which 2 were related to Impella access site. Median Impella run time was 1.22 hours and there was no significant decrease in kidney function. Median admission time after PCI was 3 days (range, 1-23; ± 4.76). CONCLUSIONS: The Impella CP system showed good feasibility and provided adequate hemodynamic support during high-risk PCI in this CHIP population.