James Sapontis1, Steven P Marso, David J Cohen, William Lombardi, Dimitri Karmpaliotis, Jeffrey Moses, William J Nicholson, Ashish Pershad, R Michael Wyman, Anthony Spaedy, Stephen Cook, Parag Doshi, Robert Federici, Craig R Thompson, Karen Nugent, Kensey Gosch, John A Spertus, J Aaron Grantham. 1. aMonashHeart, Melbourne, Victoria, Australia bResearch Medical Center cSaint Luke's Mid America Heart Institute dDepartment of Medicine, University of Missouri - Kansas City, Kansas City eBoone County Hospital, Columbia, Missouri fDepartment of Medicine, University of Washington, Seattle, Washington gDepartment of Medicine, Columbia University, New York Presbyterian Hospital, New York, New York hWellSpan York Hospital, York, Pennsylvania iDepartment of Medicine, Banner Good Samaritan Medical Center, Phoenix jBanner Heart Hospital, Mesa, Arizona kTorrance Medical Center, Torrance, California lPeacehealth Sacred Heart Medical Center, Springfield, Oregon mAlexian Brothers Medical Center, Chicago, Illinois nPresbyterian Heart Center, Albuquerque, New Mexico oBoston Scientific Inc., Maple Grove, Minnesota, USA.
Abstract
BACKGROUND: Patients with chronic total occlusions of a coronary artery represent a complex, yet common, clinical conundrum among patients with ischemic heart disease. Chronic total occlusion angioplasty is increasingly being used as a treatment for these complex lesions. There is a compelling need to better quantify the safety, efficacy, benefits, and costs of the procedure. METHODS: To address these gaps in knowledge, we designed the Outcomes, Patient Health Status, and Efficiency IN Chronic Total Occlusion Hybrid Procedures (OPEN CTO) study, an investigator-initiated multicenter, single-arm registry including 12 centers with a planned enrollment of 1000 patients. To ensure the accuracy of our observations, we used a unique auditing process through the National Cardiovascular Disease Registries' Cath/PCI Registry, angiographic core lab analysis, clinical events adjudication, and a systematic collection of patient-reported outcomes and costs. RESULTS: Between 21 January 2014 and 22 July 2015, 1000 patients were enrolled in OPEN CTO. A total of 28 patients either refused (N=26) or were missed by the screening process (N=2). In the National Cardiovascular Disease Registry Cath/PCI registry audit, there were 1096 chronic total occlusion-percutaneous coronary intervention procedures that were performed by participating operators during the time they enrolled in OPEN CTO. Overall, 987 of those patients could be definitively matched to an OPEN CTO enrolled patient (enrolled group). The remaining 109 were considered to be not enrolled in OPEN CTO (not enrolled group). Compared with the enrolled group, the patients in the nonenrolled group were less frequently of White race and more frequently of Hispanic origin. Procedural outcomes including National Cardiovascular Disease Registry-defined technical success, procedural success, and major adverse coronary events rates were similar. CONCLUSION: OPEN CTO is the most comprehensive and rigorously collected dataset to date that will provide unique insights into the success, safety, benefits, and the costs of chronic total occlusion-percutaneous coronary intervention using a reproducible technical approach to patients with these complex lesions.
BACKGROUND:Patients with chronic total occlusions of a coronary artery represent a complex, yet common, clinical conundrum among patients with ischemic heart disease. Chronic total occlusion angioplasty is increasingly being used as a treatment for these complex lesions. There is a compelling need to better quantify the safety, efficacy, benefits, and costs of the procedure. METHODS: To address these gaps in knowledge, we designed the Outcomes, Patient Health Status, and Efficiency IN Chronic Total Occlusion Hybrid Procedures (OPEN CTO) study, an investigator-initiated multicenter, single-arm registry including 12 centers with a planned enrollment of 1000 patients. To ensure the accuracy of our observations, we used a unique auditing process through the National Cardiovascular Disease Registries' Cath/PCI Registry, angiographic core lab analysis, clinical events adjudication, and a systematic collection of patient-reported outcomes and costs. RESULTS: Between 21 January 2014 and 22 July 2015, 1000 patients were enrolled in OPEN CTO. A total of 28 patients either refused (N=26) or were missed by the screening process (N=2). In the National Cardiovascular Disease Registry Cath/PCI registry audit, there were 1096 chronic total occlusion-percutaneous coronary intervention procedures that were performed by participating operators during the time they enrolled in OPEN CTO. Overall, 987 of those patients could be definitively matched to an OPEN CTO enrolled patient (enrolled group). The remaining 109 were considered to be not enrolled in OPEN CTO (not enrolled group). Compared with the enrolled group, the patients in the nonenrolled group were less frequently of White race and more frequently of Hispanic origin. Procedural outcomes including National Cardiovascular Disease Registry-defined technical success, procedural success, and major adverse coronary events rates were similar. CONCLUSION: OPEN CTO is the most comprehensive and rigorously collected dataset to date that will provide unique insights into the success, safety, benefits, and the costs of chronic total occlusion-percutaneous coronary intervention using a reproducible technical approach to patients with these complex lesions.
Authors: Mohammed Qintar; Taishi Hirai; Suzanne V Arnold; Justin Sheehy; James Sapontis; Phil Jones; Yuanyuan Tang; William Lombardi; Dimitri Karmpaliotis; Jeffery Moses; Christian Patterson; William J Nicholson; David J Cohen; John A Spertus; J Aaron Grantham; Adam C Salisbury Journal: Am Heart J Date: 2019-04-26 Impact factor: 4.749
Authors: Mohammed Qintar; J Aaron Grantham; James Sapontis; Kensey L Gosch; William Lombardi; Dimitri Karmpaliotis; Jeffery Moses; Adam C Salisbury; David J Cohen; John A Spertus; Suzanne V Arnold Journal: Circ Cardiovasc Qual Outcomes Date: 2017-12
Authors: Yevgeniy Khariton; Sophia Airhart; Adam C Salisbury; John A Spertus; Kensey L Gosch; J Aaron Grantham; Dimitrios Karmpaliotis; Jeffrey W Moses; William J Nicholson; David J Cohen; William Lombardi; James Sapontis; James M McCabe Journal: JACC Cardiovasc Interv Date: 2018-11-26 Impact factor: 11.195
Authors: Marcelo Harada Ribeiro; Carlos M Campos; Lucio Padilla; Antonio Carlos B da Silva; João Eduardo T de Paula; Marco Alcantara; Ricardo Santiago; Franklin Hanna; Franciele R da Silva; Karlyse C Belli; Lorenzo Azzalini; Pedro P de Oliveira; Gustavo N Araujo; Vincenzo Sucato; Kambis Mashayekhi; Alfredo R Galassi; Alexandre Abizaid; Alexandre Quadros Journal: J Am Heart Assoc Date: 2022-06-03 Impact factor: 6.106
Authors: Neel M Butala; Hector Tamez; Eric A Secemsky; J Aaron Grantham; John A Spertus; David J Cohen; Philip Jones; Adam C Salisbury; Suzanne V Arnold; Frank Harrell; William Lombardi; Dimitrios Karmpaliotis; Jeffrey Moses; James Sapontis; Robert W Yeh Journal: J Am Heart Assoc Date: 2022-05-16 Impact factor: 6.106
Authors: Ali O Malik; John A Spertus; James A Grantham; Poghni Peri-Okonny; Kensey Gosch; James Sapontis; Jeffrey Moses; William Lombardi; Dimitri Karmpaliotis; William J Nicholson; Firas Al Badarin; Adam C Salisbury Journal: Am J Cardiol Date: 2020-01-08 Impact factor: 2.778
Authors: Poghni A Peri-Okonny; John A Spertus; J Aaron Grantham; Kensey Gosch; Ajay Kirtane; James Sapontis; William Lombardi; Dimitri Karmpaliotis; Jeffrey Moses; William Nicholson; Adam C Salisbury Journal: J Am Heart Assoc Date: 2019-04-02 Impact factor: 5.501