TY - JOUR
T1 - Use of a novel crossing and re-entry system in coronary chronic total occlusions that have failed standard crossing techniques
T2 - Results of the FAST-CTOs (facilitated antegrade steering technique in chronic total occlusions) trial
AU - Whitlow, Patrick L.
AU - Burke, M. Nicholas
AU - Lombardi, William L.
AU - Wyman, R. Michael
AU - Moses, Jeffrey W.
AU - Brilakis, Emmanouil S.
AU - Heuser, Richard R.
AU - Rihal, Charanjit S.
AU - Lansky, Alexandra J.
AU - Thompson, Craig A.
N1 - Copyright:
Copyright 2019 Elsevier B.V., All rights reserved.
PY - 2012/4
Y1 - 2012/4
N2 - Objectives: This study sought to examine the efficacy and safety of 3 novel devices to recanalize coronary chronic total occlusions (CTOs). Background: Successful percutaneous coronary intervention (PCI) of CTOs improves clinical outcome in appropriately selected patients. CTO PCI success, however, remains suboptimal. Methods: A new crossing catheter and re-entry system was evaluated in a prospective, multicenter, single-arm trial of CTO lesions refractory to standard PCI techniques. The primary efficacy endpoint was the frequency of true lumen guidewire placement distal to the CTO (technical success). Results: Enrollment included 147 patients with 150 CTOs. The mean lesion length was 41 ± 17 mm. A crossing catheter crossed 56 lesions into the distal true lumen, and a re-entry catheter facilitated tapered-wire cannulation of the distal lumen in 59 CTOs initially crossed subintimally (77% technical success). Success in the first 75 CTOs was 67%, rising to 87% in the last 75 CTOs. Mean fluoroscopy and procedure times were 45 ± 16 min and 90 ± 12 min, respectively, each significantly shorter than in historical controls (p < 0.0001 for both). Coronary perforation occurred in 14 cases (9.3%), requiring treatment in 3 cases (prolonged balloon inflation, with additional coil embolization in 1 case). No tamponade or hemodynamic instability occurred. Six patients had periprocedural non-ST-segment elevation myocardial infarction. No emergency surgery, ST-segment elevation myocardial infarction, or cardiac reintervention occurred. Two deaths occurred within 30 days, neither as a direct result of the procedure. The 30-day major adverse cardiac event rate was 4.8%. Conclusions: In CTOs failing standard techniques, use of a new crossing and re-entry system results in a high success rate without increasing complications.
AB - Objectives: This study sought to examine the efficacy and safety of 3 novel devices to recanalize coronary chronic total occlusions (CTOs). Background: Successful percutaneous coronary intervention (PCI) of CTOs improves clinical outcome in appropriately selected patients. CTO PCI success, however, remains suboptimal. Methods: A new crossing catheter and re-entry system was evaluated in a prospective, multicenter, single-arm trial of CTO lesions refractory to standard PCI techniques. The primary efficacy endpoint was the frequency of true lumen guidewire placement distal to the CTO (technical success). Results: Enrollment included 147 patients with 150 CTOs. The mean lesion length was 41 ± 17 mm. A crossing catheter crossed 56 lesions into the distal true lumen, and a re-entry catheter facilitated tapered-wire cannulation of the distal lumen in 59 CTOs initially crossed subintimally (77% technical success). Success in the first 75 CTOs was 67%, rising to 87% in the last 75 CTOs. Mean fluoroscopy and procedure times were 45 ± 16 min and 90 ± 12 min, respectively, each significantly shorter than in historical controls (p < 0.0001 for both). Coronary perforation occurred in 14 cases (9.3%), requiring treatment in 3 cases (prolonged balloon inflation, with additional coil embolization in 1 case). No tamponade or hemodynamic instability occurred. Six patients had periprocedural non-ST-segment elevation myocardial infarction. No emergency surgery, ST-segment elevation myocardial infarction, or cardiac reintervention occurred. Two deaths occurred within 30 days, neither as a direct result of the procedure. The 30-day major adverse cardiac event rate was 4.8%. Conclusions: In CTOs failing standard techniques, use of a new crossing and re-entry system results in a high success rate without increasing complications.
KW - chronic stable angina
KW - chronic total occlusion
KW - coronary artery disease
KW - percutaneous coronary intervention
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U2 - 10.1016/j.jcin.2012.01.014
DO - 10.1016/j.jcin.2012.01.014
M3 - Article
C2 - 22516395
AN - SCOPUS:84859801630
VL - 5
SP - 393
EP - 401
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
SN - 1936-8798
IS - 4
ER -