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 - Funding Information:
Funding for the study was provided by BridgePoint Medical, Plymouth, Minnesota. All the authors' institutions received support for the clinical trial from BridgePoint Medical. In addition, Drs. Burke, Wyman, Lombardi, and Thompson all received consulting fees and have an equity interest in BridgePoint Medical. Dr. Whitlow received institutional grant support for patients enrolled in this study. Dr. Wyman also received honoraria/consulting fees from Boston Scientific, Terumo, and Abbott Vascular. Dr. Moses is a consultant for Abbott and Boston Scientific Corporation (minor). Dr. Brilakis received speaker honoraria from St. Jude Medical and Terumo and research support from Abbott Vascular. His spouse is also an employee of Medtronic. Dr. Thompson is also a consultant for Abbott Vascular, Terumo, and Volcano. Dr. Lombardi is also a speaker consultant advisory board member for Abbott Vascular and Boston Scientific. All other authors have stated that they have no relationships relevant to the contents of this paper to disclose.
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 -