Author + information
- Raja Hatem1,
- Dimitri Karmpaliotis2,
- Louis-Philippe Riel3,
- Philippe Généreux4,
- Juan Granada5,
- Martin Brouillette3 and
- Stéphane Rinfret6
- 1Hôpital du Sacré-Coeur de Montréal, Montréal, Quebec, Canada
- 2NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York, United States
- 3SoundBite Medical Solutions Inc., Montreal, Quebec, Canada
- 4Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, New Jersey, United States
- 5CRF Skirball Center for Innovation, Orangeburg, New York, United States
- 6McGill University Health Centre (MUHC), Montreal, Quebec, Canada
The lack of a simple and effective wire for crossing chronic total occlusions (CTO) has led to the development of the SoundBite Crossing System. The SoundBite Crossing System is a recanalization tool, and is designed to assist placement of a conventional guidewire in the intraluminal space beyond CTOs. It consists of a steerable Active Wire energized by shockwaves generated by a bedside console. In-vitro and exvivo evidence indicates the shockwaves enhance the wire’s transit through calcific and fibrotic tissue typical of CTOs. We sought to validate these concepts in an in-vivo porcine model of human CTOs.
Three animals, each with one artificial mid left anterior descending artery CTO, were used in this study. A ≥30-second ‘tap test’, to confirm the proximal cap could not be readily crossed with an enhanced tip-load polymer-jacketed wire (Pilot 200 - Abbott Vascular, NY) was performed before escalating to the Active Wire. The Active Wire was energized upon initial contact with the presumed proximal cap and remained energized whenever manipulated. The operators endeavoured to cross the entire occlusion using the Active Wire, in conjunction with a microcatheter, but were permitted to use commercially available coronary guidewires, as required, for non-progression or redirection. Technical performance and acute safety of the Active Wire was evaluated.
All CTOs had ambiguous proximal caps. J-CTO score was 2 (difficult) for all CTOs. Average CTO length was 25 mm ± 6 mm (N=3). Tap tests failed to engage the proximal cap in all three animals. After switching to the Active Wire, proximal cap engagement was achieved rapidly in all three cases. All CTOs were successfully crossed with angiographic confirmation of microcatheter placement in the distal lumen. All animals survived the procedure without angiographic, or other cardiovascular complications. Average total CTO crossing time was 55 min ± 25 min (N=3) average wire activation time was 13 min ± 9 min (N=3).
In this first in-vivo coronary study, the energized Active Wire system enabled crossing in all 3 JCTO-2 occlusions that were resistant to a conventional wire. A promising safety profile was also demonstrated.
CORONARY: Complex and Higher Risk Procedures for Indicated Patients (CHIP).