Percutaneous Coronary Intervention for Bifurcation Lesions: Bench Testing and the Real World

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This is a consensus document from the European Bifurcation Club concerning bench testing in coronary artery bifurcations. It is intended to provide guidelines for bench assessment of stents and other strategies in coronary bifurcation treatment where the United States Food and Drug Administration (FDA) or International Organization for Standardization (ISO) guidelines are limited or absent. These recommendations provide guidelines rather than a step-by-step manual. We provide data on the anatomy of bifurcations and elastic response of coronary arteries to aid model construction. We discuss testing apparatus, bench testing endpoints and bifurcation nomenclature.

“…Ideally, testing should be performed by an independent party to avoid selective testing, data interpretation or reporting 4 .…”

Section: Applications Of Bench Testing Of Devices In Coronary Artery mentioning

confidence: 99%

Section: Device Deliverabilitymentioning

confidence: 99%

Bench testing and coronary artery bifurcations: a consensus document from the European Bifurcation Club

Ormiston¹,

Kassab²,

Finet³

et al. 2018

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Lessons from the real bench: non-BRS

Ormiston

Darremont

Iwasaki³

et al. 2015

Bench testing of stents used in bifurcations can provide information on the general properties that influence performance including crossing profile, radial strength, recoil, flexibility and radiopacity. Problems with device delivery can be clarified. Bench testing identified that side branch dilatation caused stent distortion and elucidated correction strategies. Bench testing led to a stent design change adding connectors between hoops to help overcome the clinical problem of longitudinal distortion. Testing on the bench can determine best deployment strategies and showed that a two-step post-dilatation strategy produced the best deployment with "crush" stenting. Scanning electron microscopy showed that withdrawal of a coronary guidewire trapped between a stent (or scaffold) and a mock arterial wall during a provisional side branch stenting strategy caused only mild linear polymer coating damage. Stent fracture can cause adverse clinical events and our repetitive bend test identified the stents most resistant to fracture. Causes of obstruction of the passage of a balloon over a wire through the side of a stent include damage to the catheter tip, complex cell geometry and inadvertent passage of a wire behind a strut. Bench testing plays a major role in validation of computer modelling of bifurcation treatments and flow alterations.

Absorb everolimus-eluting bioresorbable scaffolds in coronary bifurcations: a bench study of deployment, side branch dilatation and post-dilatation strategies

Ormiston

Webber²,

Ubod³

et al. 2015