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.
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.
Authors: Tesfaldet T Michael; Dimitri Karmpaliotis; Emmanouil S Brilakis; Mohammed Alomar; Shuaib M Abdullah; Ben L Kirkland; Katrina L Mishoe; Nicholas Lembo; Anna Kalynych; Harold Carlson; Subhash Banerjee; Michael Luna; William Lombardi; David E Kandzari Journal: Catheter Cardiovasc Interv Date: 2014-01-31 Impact factor: 2.692
Authors: Georgios Christopoulos; Dimitri Karmpaliotis; Khaldoon Alaswad; Robert W Yeh; Farouc A Jaffer; R Michael Wyman; William L Lombardi; Rohan V Menon; J Aaron Grantham; David E Kandzari; Nicholas Lembo; Jeffrey W Moses; Ajay J Kirtane; Manish Parikh; Philip Green; Matthew Finn; Santiago Garcia; Anthony Doing; Mitul Patel; John Bahadorani; Muhammad Nauman J Tarar; Georgios E Christakopoulos; Craig A Thompson; Subhash Banerjee; Emmanouil S Brilakis Journal: Int J Cardiol Date: 2015-06-27 Impact factor: 4.164
Authors: Loes P Hoebers; Bimmer E Claessen; George D Dangas; Truls Råmunddal; Roxana Mehran; José P S Henriques Journal: Nat Rev Cardiol Date: 2014-05-27 Impact factor: 32.419
Authors: Barbara Anna Danek; Aris Karatasakis; Dimitri Karmpaliotis; Khaldoon Alaswad; Robert W Yeh; Farouc A Jaffer; Mitul Patel; John Bahadorani; William L Lombardi; Michael R Wyman; J Aaron Grantham; Anthony Doing; Jeffrey W Moses; Ajay Kirtane; Manish Parikh; Ziad A Ali; Sanjog Kalra; David E Kandzari; Nicholas Lembo; Santiago Garcia; Bavana V Rangan; Craig A Thompson; Subhash Banerjee; Emmanouil S Brilakis Journal: Int J Cardiol Date: 2016-04-06 Impact factor: 4.164
Authors: Lei Song; Akiko Maehara; Matthew T Finn; Sanjog Kalra; Jeffrey W Moses; Manish A Parikh; Ajay J Kirtane; Michael B Collins; Tamim M Nazif; Khady N Fall; Raja Hatem; Ming Liao; Tiffany Kim; Philip Green; Ziad A Ali; Candido Batres; Martin B Leon; Gary S Mintz; Dimitri Karmpaliotis Journal: JACC Cardiovasc Interv Date: 2017-05-22 Impact factor: 11.195