Blandine Mondésert1, Jamil Bashir2, François Philippon3, Marc Dubuc1, Guy Amit4, Derek Exner5, Jacqueline Joza6, David H Birnie7, Chris Lane8, Bernice Tsang9, Victoria Korley10, Danna Spears11, Andrea Ling4, Angie Djuric4, Eugene Crystal12, Tom Hruczkowski13, Jean-François Roux14, Sandra Carroll4, Vidal Essebag6, Andrew D Krahn2, Jeff S Healey15. 1. Department of Medicine, Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada. 2. University of British Columbia, Vancouver, British Columbia, Canada. 3. Institut Universitaire de cardiologie et de pneumologie de Québec, Laval University, Quebec City, Quebec, Canada. 4. Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada. 5. Libin Cardiovascular Institute of Alberta, Calgary, Alberta, Canada. 6. McGill University Health Centre, Montreal, Quebec, Canada. 7. University of Ottawa Heart Institute, Ottawa, Ontario, Canada. 8. Royal Jubilee Hospital, Victoria, British Columbia, Canada. 9. Southlake Regional Health Centre, Newmarket, Ontario, Canada. 10. Division of Cardiology, Department of Medicine, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada. 11. Peter Munk Cardiac Center Toronto General Hospital, University Health Network, Toronto, Canada. 12. Arrhythmia Services, Schulich Heart Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada. 13. Department of Medicine, Division of Cardiology, University of Alberta, Edmonton, Canada. 14. Cardiology Service, Medicine department, Medicine and Health sciences university, Sherbrooke university, Sherbrooke, Quebec, Canada. 15. Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada. Electronic address: Jeff.Healey@phri.ca.
Abstract
BACKGROUND: The defibrillator lead is the weakest part of the transvenous (TV) implantable cardioverter defibrillation (ICD) system and a frequent cause of morbidity. Lead dislodgement, cardiac perforation, insertion-related trauma including pneumothorax and vascular injury, are common early complications of TV-ICD implantation. Venous occlusion, tricuspid valve dysfunction, lead fracture and lead insulation failure are additional, later complications. The introduction of a totally sub-cutaneous ICD (S-ICD) may reduce these lead-related issues, patient morbidity, hospitalizations and costs. However, such benefits compared to the TV-ICD have not been demonstrated in a randomized trial. DESIGN:ATLAS (Avoid Transvenous Leads in Appropriate Subjects) is a multi-centered, randomized, open-label, parallel group trial. Patients younger than 60 years are eligible. If older than 60 years, patients are eligible if they have an inherited heart rhythm disease, or risk factors for ICD-related complication, such as hemodialysis, a history of ICD or pacemaker infection, heart valve replacement, or severe pulmonary disease. This study will determine if using an S-ICD compared to a TV-ICD reduces a primary composite outcome of perioperative complications including pulmonary or pericardial perforation, lead dislodgement or dysfunction, tricuspid regurgitation and ipsilateral venous thrombosis. Five hundred patients will be enrolled from 14 Canadian hospitals, and data collected to both early- (at 6 months) and mid-term complications (at 24 months) as well as mortality and ICD shock efficacy. SUMMARY: The ATLAS randomized trial is comparing early- and mid-term vascular and lead-related complications among S-ICD versus TV-ICD recipients who are younger or at higher risk of ICD-related complications.
RCT Entities:
BACKGROUND: The defibrillator lead is the weakest part of the transvenous (TV) implantable cardioverter defibrillation (ICD) system and a frequent cause of morbidity. Lead dislodgement, cardiac perforation, insertion-related trauma including pneumothorax and vascular injury, are common early complications of TV-ICD implantation. Venous occlusion, tricuspid valve dysfunction, lead fracture and lead insulation failure are additional, later complications. The introduction of a totally sub-cutaneous ICD (S-ICD) may reduce these lead-related issues, patient morbidity, hospitalizations and costs. However, such benefits compared to the TV-ICD have not been demonstrated in a randomized trial. DESIGN: ATLAS (Avoid Transvenous Leads in Appropriate Subjects) is a multi-centered, randomized, open-label, parallel group trial. Patients younger than 60 years are eligible. If older than 60 years, patients are eligible if they have an inherited heart rhythm disease, or risk factors for ICD-related complication, such as hemodialysis, a history of ICD or pacemaker infection, heart valve replacement, or severe pulmonary disease. This study will determine if using an S-ICD compared to a TV-ICD reduces a primary composite outcome of perioperative complications including pulmonary or pericardial perforation, lead dislodgement or dysfunction, tricuspid regurgitation and ipsilateral venous thrombosis. Five hundred patients will be enrolled from 14 Canadian hospitals, and data collected to both early- (at 6 months) and mid-term complications (at 24 months) as well as mortality and ICD shock efficacy. SUMMARY: The ATLAS randomized trial is comparing early- and mid-term vascular and lead-related complications among S-ICD versus TV-ICD recipients who are younger or at higher risk of ICD-related complications.
Authors: Mafalda Carrington; Rui Providência; C Anwar A Chahal; Flavio D'Ascenzi; Alberto Cipriani; Fabrizio Ricci; Mohammed Y Khanji Journal: Front Cardiovasc Med Date: 2022-02-15
Authors: Larry M Baddour; Raul Weiss; George E Mark; Mikhael F El-Chami; Mauro Biffi; Vincent Probst; Pier D Lambiase; Marc A Miller; Timothy McClernon; Linda K Hansen; Bradley P Knight Journal: Pacing Clin Electrophysiol Date: 2020-04-23 Impact factor: 1.976