Application of penetration device (Tornus) for percutaneous coronary intervention in balloon uncrossable chronic total occlusion—procedure outcomes, complications, and predictors of device success

OBJECTIVE: To evaluate procedure outcomes, complications, and the predictors of device success while using the Tornus in CTO revascularization. BACKGROUND: The success of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) may be limited by the presence of severe calcified CTO lesions, especially in the smallest balloon uncrossable arteries. A penetrating device (Tornus) could improve the success rate. METHODS: Device and angiographic success rates as well as procedural complications were assessed in 56 patients, who were consecutively and retrospectively enrolled into this study. Device success was defined as successful passage of the Tornus catheter through a CTO lesion. Procedure success was defined by a final TIMI 3 flow and <30% residual stenosis. RESULTS: The device success rate was 71.4% in 40 patients and failure rate was 28.6% in 16 patients. The final procedure success was significantly higher in the Tornus success group compared with the Tornus failure group (87.5% vs. 37.5%, P < 0.001). One patient in the Tornus success group (1.8%) had wire perforation resulting in cardiac tamponade and cardiac death. Another patient (1.8%) in the Tornus success group had acute in-stent thrombosis and non-Q MI in 24 hr and was resuscitated by emergent PCI. The only independent predictor of device success was a calcium score < 2 (odds ratio (OR): 3.86 (95% CI: 1.14-13.1, P = 0.03). CONCLUSION: The Tornus catheter can be used in severe calcified CTO PCI when the calcium score <2 and not be used in patients with a calcium score ≥2.