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Page 2 of 31 1 1 2 3 1 Trends in Elective and Ruptured Abdominal Aortic Aneurysm Repair by Practice Setting 4 2 in Ontario, Canada from 2003 to 2016: a population-based cross-sectional study 5 3 6 1 1 1 7 4 Konrad Salata , MD; Mohamad A. Hussain , MD, PhD; Charles de Mestral , MD, PhD; Elisa 1 1,2 1 3,4 8 5 Greco , MD, MEd; Badr A. Aljabri, MD ; Sandra Sabongui ; Muhammad Mamdani , 9 6 PharmD, MPH, MA; Thomas L. Forbes5, MD; Deepak L. Bhatt, MD, MPH6,7; Subodh Verma8, 10 7 MD, PhD; Mohammed Al-Omran1,2, MD, MSc. 11 8 12 9 1Division of Vascular Surgery, Li Ka Shing Knowledge Institute of St. Michael’s Hospital, and 13 10 University of Toronto, Toronto, ON, Canada; 2Department of Surgery, King Saud University, 14 3 15 11 Riyadh, Kingdom of Saudi Arabia; Li Ka Shing Centre for Healthcare Analytics Research and 16 12 Training (CHART), Li Ka Shing Knowledge Institute, St. Michael’s Hospital Toronto, ON, 17 13 Canada; 4Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, ON, Canada; 18 14 5Division of Vascular Surgery, Peter Munk Cardiac Centre & University Health Network, and 19 15 University of Toronto, Toronto, ON, Canada; 6Brigham and Women's Hospital Heart and 20 7 8 21 16 Vascular Center, Boston, MA, USA; Harvard Medical School, Boston, MA, USA; Division of 22 17 Cardiac Surgery, Li Ka Shing ConfidentialKnowledge Institute of St. Michael’s Hospital, and University of 23 18 Toronto, Toronto, ON, Canada. 24 19 25 20 Address for Correspondence: Dr. Mohammed Al-Omran, Division of Vascular Surgery, St. 26 21 Michael’s Hospital, 30 Bond Street, Suite 7-074, Bond Wing, Toronto, Ontario, M5B 1W8, 27 22 Canada. Tel: 001-416-864-6047, E-mail: [email protected]. 28 29 23 30 24 Funding: This work was jointly funded by the Physicians’ Service Incorporated Resident 31 25 Research Grant, the Division of Vascular Surgery at St. Michael’s Hospital, Toronto, Ontario, 32 26 and funds from the Department of Surgery, King Saud University, Riyadh, Kingdom of Saudi 33 27 Arabia. Dr. Salata is supported in part by the Canadian Institutes of Health Research Canada 34 28 Graduate Scholarship Master’s salary support award, and the Goerc and Toronto Academic 35 29 Vascular Specialists Surgeon Scientist Training Program Scholarship. 36 37 30 38 31 Disclosures: Dr. Deepak L. Bhatt discloses the following relationships - Advisory Board: 39 32 Cardax, Elsevier Practice Update Cardiology, Medscape Cardiology, Regado Biosciences; Board 40 33 of Directors: Boston VA Research Institute, Society of Cardiovascular Patient Care; Chair: 41 34 American Heart Association Quality Oversight Committee; Data Monitoring Committees: 42 35 Cleveland Clinic, Duke Clinical Research Institute, Harvard Clinical Research Institute, Mayo 43 44 36 Clinic, Mount Sinai School of Medicine, Population Health Research Institute; Honoraria: 45 37 American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org; 46 38 Vice-Chair, ACC Accreditation Committee), Belvoir Publications (Editor in Chief, Harvard 47 39 Heart Letter), Duke Clinical Research Institute (clinical trial steering committees), Harvard 48 40 Clinical Research Institute (clinical trial steering committee), HMP Communications (Editor in 49 41 Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest 50 42 Editor; Associate Editor), Population Health Research Institute (clinical trial steering 51 52 43 committee), Slack Publications (Chief Medical Editor, Cardiology Today’s Intervention), 53 44 Society of Cardiovascular Patient Care (Secretary/Treasurer), WebMD (CME steering 54 45 committees); Other: Clinical Cardiology (Deputy Editor), NCDR-ACTION Registry Steering 55 46 Committee (Chair), VA CART Research and Publications Committee (Chair); Research 56 57 58 59 60 For Peer Review Only Page 3 of 31 2 1 2 3 1 Funding: Abbott, Amarin, Amgen, AstraZeneca, Bristol-Myers Squibb, Chiesi, Eisai, Ethicon, 4 2 Forest Laboratories, Ironwood, Ischemix, Lilly, Medtronic, Pfizer, Regeneron, Roche, Sanofi 5 6 3 Aventis, The Medicines Company; Royalties: Elsevier (Editor, Cardiovascular Intervention: A 7 4 Companion to Braunwald’s Heart Disease); Site Co-Investigator: Biotronik, Boston Scientific, 8 5 St. Jude Medical (now Abbott); Trustee: American College of Cardiology; Unfunded Research: 9 6 FlowCo, Merck, PLx Pharma, Takeda. The remaining authors of this manuscript declare no 10 7 competing interests. 11 8 12 9 13 14 10 15 11 16 12 17 13 18 14 19 15 20 21 16 22 17 Confidential 23 18 24 19 25 20 26 21 27 22 28 29 23 30 24 31 25 32 26 33 27 34 28 35 29 36 37 30 38 31 39 32 40 33 41 34 42 35 43 44 36 45 37 46 38 47 39 48 40 49 41 50 42 51 52 43 53 44 54 45 55 46 56 57 58 59 60 For Peer Review Only Page 4 of 31 3 1 2 3 1 ABSTRACT 4 5 6 2 Background: Recent years have seen centralization of vascular surgery services in Ontario. We 7 8 3 sought to examine the trends in overall and approach specific elective (eAAA) and ruptured 9 10 4 abdominal aortic aneurysm (rAAA) repair by hospital type (teaching vs. community). 11 12 5 Methods: We conducted a population-based time-series analysis of eAAA and rAAA repairs in 13 14 15 6 Ontario, Canada from 2003 to 2016. Quarterly rates of repairs per 100,000 Ontarians > 40 years 16 17 7 old were calculated. We fit exponential smoothing models to the approach and hospital type 18 19 8 stratified data to examine repair trends. 20 21 22 9 Results: We identified 19,219Confidential eAAA and 2,722 rAAA repairs from 2003 to 2016. The rates of 23 24 10 eAAA repair and elective open surgical repair (OSR) in teaching and community hospitals 25 26 11 decreased by 1.15% (p=0.0077), 67% (p<0.0001), 23% (p<0.0001), and 60% (p=0.0002), 27 28 29 12 respectively. The rate of elective endovascular repair (EVAR) increased 667% in teaching 30 31 13 hospitals, (p<0.0001). Elective EVAR began in community centres after 2010 and increased to 32 33 14 0.98/100,000 (p<0.0001), resulting in a rebound in overall eAAA repair rates in the community. 34 35 15 Overall rAAA repairs and ruptured OSR decreased by 84% (p=0.0007) and 88% (p=0.0017) at 36 37 38 16 community centres. Ruptured EVAR at community centres increased from no procedures prior 39 40 17 to 2006, to 0.03/100,000 in 2016 (p=0.0048). 41 42 18 Interpretation: Endovascular aortic repair has seen substantial uptake in teaching and 43 44 45 19 community hospitals in Ontario. Furthermore, community hospital uptake of EVAR has begun 46 47 20 decentralization of AAA repair. Increased experience and training in EVAR, and reduced 48 49 21 specialized care requirements will likely lead to continued decentralization. 50 51 52 22 53 54 23 55 56 57 58 59 60 For Peer Review Only Page 5 of 31 4 1 2 3 1 INTRODUCTION 4 5 6 2 It is well known that open surgical repair (OSR) of abdominal aortic aneurysm (AAA) is 7 8 3 associated with 30-day mortality as high as 7%(1). However, studies have shown that outcomes 9 10 4 can be improved when OSR is conducted at experienced centres. Landon et al. demonstrated a 11 12 5 greater than 3% peri-operative mortality reduction at centres conducting more than 50 OSRs per 13 14 15 6 annum when compared to those that conducted fewer than 10 OSRs(1). Elsewhere, larger 16 17 7 hospital size, academic hospital type and greater annual surgeon volume have been associated 18 19 8 with significantly lower 30-day complication and re-operation rates (2, 3). Consequently, many 20 21 22 9 jurisdictions have moved towardConfidential centralization of AAA care to improve patient outcomes. 23 24 10 The advent of endovascular aortic repair (EVAR), a minimally invasive alternative to 25 26 11 OSR for AAA repair, may have removed the need for centralization. Studies comparing EVAR 27 28 29 12 to OSR for AAA repair have demonstrated superior short term mortality and morbidity for 30 31 13 EVAR, as well as shorter procedure times, transfusion requirements, ventilation times, and 32 33 14 intensive care unit (ICU) and hospital lengths of stay(4-7). In contrast, early work has also 34 35 15 shown the importance of individual volume requirements for EVAR competence and significant 36 37 38 16 shortening of the EVAR learning curve for surgeons learning at experienced centres(8, 9). These 39 40 17 factors would suggest that despite better outcomes and fewer requirements for specialized care, 41 42 18 AAA repair should remain centralized at large academic hospitals. The approach specific trends 43 44 45 19 in elective (eAAA) and ruptured abdominal aortic aneurysm (rAAA) repair by practice setting 46 47 20 are not well-studied, and the results of efforts to centralize AAA care in the endovascular era are 48 49 21 not known. The purpose of the present study is to determine the trends in OSR and EVAR of 50 51 52 22 eAAA and rAAA stratified by practice setting in Ontario, Canada from 2003 to 2016. 53 54 23 55 56 57 58 59 60 For Peer Review Only Page 6 of 31 5 1 2 3 1 METHODS 4 5 6 2 Study Design and Setting 7 8 3 We conducted a population-based, cross-sectional, time-series analysis of open surgical 9 10 4 (OSR) and endovascular repair (EVAR) of elective (eAAA) and ruptured (rAAA) abdominal 11 12 5 aortic aneurysms in Ontario.