Dataset Information

Safety and Effectiveness of a Novel Microcatheter in Coronary Chronic Total Occlusions-The BIOMICS Study.

ABSTRACT:

Background

Chronic total occlusion (CTO) remains the most complex anatomical subset of lesions in percutaneous coronary intervention (PCI), often requiring advanced techniques and technologies, including the use of microcatheters.

Methods

The BIOMICS study is a premarket first-in-human prospective, multicenter, open-label, single-arm trial investigating the safety and efficacy of a novel coronary microcatheter (BioMC, Biosensors International) in 100 patients with symptoms of ischemia undergoing elective CTO-PCI. The primary efficacy end point of the study was device success defined according to the CTO-ARC (Chronic Total Occlusion Academic Research Consortium) criteria namely the ability of the microcatheter to successfully facilitate placement of a guide wire beyond the occluded coronary segment. The primary safety end point was the incidence of in-hospital cardiac death or myocardial infarction at hospital discharge.

Results

Hundred patients were recruited between March 2022 and January 2023. The primary efficacy end point was achieved in 75% of patients (95% CI, 65.3%-83.1%; P < .0001 for superiority compared to the prespecified performance goal of 54%). The primary safety end point of in-hospital cardiac death or myocardial infarction was observed in 2% of the patients. There were no study device-related coronary perforations or device failures.

Conclusions

The use of a novel coronary microcatheter during CTO-PCI was associated with a high device success and an excellent safety profile.

SUBMITTER: Sidik N

PROVIDER: S-EPMC11308310 | biostudies-literature | 2024 Jul

REPOSITORIES: biostudies-literature

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Publications

Safety and Effectiveness of a Novel Microcatheter in Coronary Chronic Total Occlusions-The BIOMICS Study.

Sidik Novalia N McEntegart Margaret M Joshi Francis F Owens Colum C Shaukat Aadil A Gallagher Sean S Strange Julian J Tang Kare K Elghamaz Ahmed A Mozid Abdul A Ladwiniec Andrew A Oldroyd Keith K Schuette Diana D Copt Samuel S Spratt James C JC

Journal of the Society for Cardiovascular Angiography & Interventions 20240518 7

<h4>Background</h4>Chronic total occlusion (CTO) remains the most complex anatomical subset of lesions in percutaneous coronary intervention (PCI), often requiring advanced techniques and technologies, including the use of microcatheters.<h4>Methods</h4>The BIOMICS study is a premarket first-in-human prospective, multicenter, open-label, single-arm trial investigating the safety and efficacy of a novel coronary microcatheter (BioMC, Biosensors International) in 100 patients with symptoms of isch ...[more]

PMID: 39132006

Similar Datasets

Project description:ObjectiveTo assess the spatial distribution of chronic total occlusions (CTOs) within the coronary arteries and describe procedural strategies and outcomes during CTO percutaneous coronary intervention (PCI).BackgroundAcute occlusions due to plaque rupture tend to cluster within the proximal third of the coronary artery.MethodsWe examined the clinical and procedural characteristics of 1,348 patients according to lesion location within the coronary tree.ResultsA total of 1,369 lesions in 1,348 patients (mean age 66 ± 10 years, 85% male) were included. CTO PCI of proximal segments (n = 633, 46%) was more common than of mid (n = 557, 41%) and distal segments (n = 179, 13%). Patients undergoing CTO PCI of proximal segments were more likely to be smokers (P < 0.01), have prior coronary artery bypass graft surgery (P = 0.03) and lower ejection fraction (P = 0.04). CTOs occurring in proximal segments had longer length (P <0.01), proximal cap ambiguity (P < 0.01), and moderate/severe calcification (P < 0.01) compared to mid or distally located CTOs. Interventional collaterals were more often present in CTO PCI of proximal segments (64%, 53%, 56%, P < 0.01) consistent with the higher use of retrograde approach (47%, 33%, 37%, P < 0.01) relative to antegrade wire escalation (67%, 82%, 82%, P < 0.01). Procedural complexity was higher in CTO PCI of proximal segments (vs. mid and distal): contrast volume= 275 ml (200-375), 260 ml (200-350), 250 ml (175-350), P = 0.01; fluoroscopy time 53 minutes (32-83), 39 minutes (24-65), 40 minutes (22-72), P < 0.01. However, procedural success (87%, 90%, 85%, P = 0.1), technical success (89%, 91%, 88%, P = 0.24), and complications rates (2.8%, 2.5%, 2.2%, P = 0.88) were not different.ConclusionsThe most common target vessel location for CTO PCI is the proximal coronary segment. PCI of proximal occlusions is associated with adverse clinical and angiographic characteristics and often requires use of the retrograde approach, but can be accomplished with high procedural and technical success and low complication rates. © 2016 Wiley Periodicals, Inc.

Project description:It has been demonstrated that gender differences are related to different procedural and long-term clinical outcomes among a general patient population treated using percutaneous coronary interventions (PCI). The objective of our analysis was to conduct assessment regarding the relationship between gender and procedural outcomes in patients treated for PCI regarding chronic total occlusions (CTO), based on a large, real-life registry. Data used to conduct the following analysis was derived from the national registry of percutaneous coronary interventions (ORPKI), upheld in co-operation with the Association of Cardiovascular Interventions (AISN) of the Polish Cardiac Society. The study involved data procured from the registry within the period from January 2014 to December 2020. All subsequent CTO procedures recorded in the registry during that period were included in the analysis. We assessed the correlation between gender and the overall rate of periprocedural complications, procedure-related mortality, and success evaluated as TIMI flow grade 3 after the procedure by univariate and multivariable modeling. At the time of conducting our investigation, there were 162 existing and active CathLabs, at which 747,033 PCI procedures were carried out during the observational period. Of those, 14,903 (1.99%) were CTO-PCI procedures, and 3726 were women (25%). The percentage share between genders did not experience any significant changes during the consecutive years observed in the current analysis. Overall periprocedural complication rate was greater among women than men (3.45% vs. 2.31%, p = 0.02). A comparable relationship was noted for procedural mortality (0.7% vs. 0.2%, p = 0.006), while procedural success occurred more often in the case of women (69.3% vs. 65.2%, p < 0.001). Women were found to be more frequently affected by periprocedural complications (OR = 1.553; 95%CI: 1.212-1.99, p < 0.001) as well as procedural success (OR = 1.294; 95%CI: 1.151-1.454, p < 0.001), evaluated using multivariable models. Based on the current analysis performed on all-comer patients treated using PCI in CTO, women are affected by more frequent procedural complication occurrence as well as greater procedural success compared to men.

Dataset Information

Safety and Effectiveness of a Novel Microcatheter in Coronary Chronic Total Occlusions-The BIOMICS Study.

Background

Methods

Results

Conclusions

Publications

Safety and Effectiveness of a Novel Microcatheter in Coronary Chronic Total Occlusions-The BIOMICS Study.

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