TY - JOUR
T1 - Safety and efficacy of dedicated guidewire, microcatheter, and guide catheter extension technologies for chronic total coronary occlusion revascularization
T2 - Primary results of the Teleflex Chronic Total Occlusion Study
AU - Kandzari, David E.
AU - Alaswad, Khaldoon
AU - Jaffer, Farouc A.
AU - Brilakis, Emmanouil
AU - Croce, Kevin
AU - Kearney, Kathleen
AU - Spaedy, Anthony
AU - Yeh, Robert
AU - Thompson, Craig
AU - Nicholson, William
AU - Wyman, R. Michael
AU - Riley, Robert
AU - Lansky, Alexandra
AU - Buller, Christopher
AU - Karmpaliotis, Dimitrios
N1 - Funding Information:
Dr. Kandzari reports institutional research and educational grant support from Abbott Vascular, Biotronik, Boston Scientific, Cardiovascular Systems, Inc., Medtronic CardioVascular, Orbus Neich, and Teleflex; personal consulting honoraria from Cardiovascular Systems and Medtronic; and equity, Traverse Vascular. Dr. Alaswad reports institutional research and educational grant support from Boston Scientific, and Abiomed, and personal consulting honoraria from Cardiovascular Systems, Inc., Boston Scientific, Livanova, and Teleflex; Dr. Jaffer reports sponsored research from Canon, Siemens, Teleflex, Shockwave, and Boston Scientific; consultant for Boston Scientific, Abbott Vascular, Siemens, Magenta Medical, Asahi Intecc and IMDS; equity in Intravascular Imaging, Inc. and DurVena.; Dr. Brilakis reports consulting/speaker honoraria from Abbott Vascular, American Heart Association (associate editor Circulation), Amgen, Asahi Intecc, Biotronik, Boston Scientific, Cardiovascular Innovations Foundation (Board of Directors), ControlRad, CSI, Elsevier, GE Healthcare, IMDS, InfraRedx, Medicure, Medtronic, Opsens, Siemens, and Teleflex; owner, Hippocrates LLC; equity, MHI Ventures, Cleerly Health; Dr. Croce reports grant/research support from Abbott, Takeda, Teleflex, CSI; consulting honoraria from Abbott, BSCI, Biotronic, Philips, Abiomed, CSI, Takada, Cordis; equity, Dyad Medical; Dr. Kearney reports Consulting/Advisory board/honoraria from Abbott, Abiomed, Boston Scientific, CSI, Medtronicand Teleflex; Dr. Spaedy reports clinical research support from Teleflex and Abbott Vascular; consulting honoraria from Abbott Vascular, Boston Scientific, and Medtonic; Dr. Yeh reports institutional research grant support from Abbott Vascular, AstraZeneca, BD Bard, Boston Scientific, Cook Medical, Medtronic and Philips Medical, and personal consulting honoraria from Abbott Vascular, AstraZeneca, Boston Scientific, Elixir Medical, Medtronic, Shockwave Medical and Zoll; Dr. Thompson reports no related conflicts of interest; Dr. Nicholson reports consulting and proctoring honoraria from Boston Scientific, Medtronic, Abbott Vascular, Rampart; intellectual property/founder, Traverse Vascular; Dr. Wyman reports consulting honoraria from Boston Scientific, Abbott Vascular, Asahi. Dr. Riley reports honoraria from Boston Scientific, Shockwave Medical, Medtronic, and Asahi Intecc.; Dr. Lansky reports no related conflicts of interest; Dr. Buller is an employee of Teleflex, Inc.; Dr. Karmpaliotis reports honoraria from Boston Scientific, Abbot Vascular; equity, Saranas, Soundbite and Traverse Vascular.
Funding Information:
Study support provided by Vascular Solutions LLC, a subsidiary of Teleflex, Inc., Minneapolis, MN.
Publisher Copyright:
© 2021 Wiley Periodicals LLC.
PY - 2022/2/1
Y1 - 2022/2/1
N2 - Background: Description of procedural outcomes using contemporary techniques that apply specialized coronary guidewires, microcatheters, and guide catheter extensions designed for chronic total occlusion (CTO) percutaneous revascularization is limited. Methods: A prospective, multicenter, single-arm study was conducted to evaluate procedural and in-hospital outcomes among 150 patients undergoing attempted CTO revascularization utilizing specialized guidewires, microcatheters and guide extensions. The primary endpoint was defined as successful guidewire recanalization and absence of in-hospital cardiac death, myocardial infarction (MI), or repeat target lesion revascularization (major adverse cardiac events, MACE). Results: The prevalence of diabetes was 32.7%; prior MI, 48.0%; and previous bypass surgery, 32.7%. Average (mean ± standard deviation) CTO length was 46.9 ± 20.5 mm, and mean J-CTO score was 1.9 ± 0.9. Combined radial and femoral arterial access was performed in 50.0% of cases. Device utilization included: support microcatheter, 100%; guide catheter extension, 64.0%; and mean number of study guidewires/procedure was 4.8 ± 2.6. Overall, procedural success was achieved in 75.3% of patients. The rate of successful guidewire recanalization was 94.7%, and in-hospital MACE was 19.3%. Achievement of TIMI grade 2 or 3 flow was observed in 93.3% of patients. Crossing strategies included antegrade (54.0%), retrograde (1.3%) and combined antegrade/retrograde techniques (44.7%). Clinically significant perforation resulting in hemodynamic instability and/or requiring intervention occurred in 16 (10.7%) patients. Conclusions: In a multicenter, prospective registration study, favorable procedural success was achieved despite high lesion complexity using antegrade and retrograde guidewire maneuvers and with acceptable safety, yet with comparably higher risk than conventional non-CTO PCI.
AB - Background: Description of procedural outcomes using contemporary techniques that apply specialized coronary guidewires, microcatheters, and guide catheter extensions designed for chronic total occlusion (CTO) percutaneous revascularization is limited. Methods: A prospective, multicenter, single-arm study was conducted to evaluate procedural and in-hospital outcomes among 150 patients undergoing attempted CTO revascularization utilizing specialized guidewires, microcatheters and guide extensions. The primary endpoint was defined as successful guidewire recanalization and absence of in-hospital cardiac death, myocardial infarction (MI), or repeat target lesion revascularization (major adverse cardiac events, MACE). Results: The prevalence of diabetes was 32.7%; prior MI, 48.0%; and previous bypass surgery, 32.7%. Average (mean ± standard deviation) CTO length was 46.9 ± 20.5 mm, and mean J-CTO score was 1.9 ± 0.9. Combined radial and femoral arterial access was performed in 50.0% of cases. Device utilization included: support microcatheter, 100%; guide catheter extension, 64.0%; and mean number of study guidewires/procedure was 4.8 ± 2.6. Overall, procedural success was achieved in 75.3% of patients. The rate of successful guidewire recanalization was 94.7%, and in-hospital MACE was 19.3%. Achievement of TIMI grade 2 or 3 flow was observed in 93.3% of patients. Crossing strategies included antegrade (54.0%), retrograde (1.3%) and combined antegrade/retrograde techniques (44.7%). Clinically significant perforation resulting in hemodynamic instability and/or requiring intervention occurred in 16 (10.7%) patients. Conclusions: In a multicenter, prospective registration study, favorable procedural success was achieved despite high lesion complexity using antegrade and retrograde guidewire maneuvers and with acceptable safety, yet with comparably higher risk than conventional non-CTO PCI.
KW - chronic total occlusion
KW - guide catheter extensions
KW - guidewires
KW - microcatheters
KW - percutaneous coronary intervention
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U2 - 10.1002/ccd.29962
DO - 10.1002/ccd.29962
M3 - Article
C2 - 34582080
AN - SCOPUS:85115833903
SN - 1522-1946
VL - 99
SP - 263
EP - 270
JO - Catheterization and Cardiovascular Interventions
JF - Catheterization and Cardiovascular Interventions
IS - 2
ER -