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Ross Procedure Vs Mechanical Aortic Valve Replacement in Adults a Systematic Review and Meta-Analysis

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Ross Procedure Vs Mechanical Aortic Valve Replacement in Adults a Systematic Review and Meta-Analysis Research JAMA Cardiology | Original Investigation Ross Procedure vs Mechanical Aortic Valve Replacement in Adults A Systematic Review and Meta-analysis Amine Mazine, MD, MSc; Rodolfo V. Rocha, MD; Ismail El-Hamamsy, MD, PhD; Maral Ouzounian, MD, PhD; Bobby Yanagawa, MD, PhD; Deepak L. Bhatt, MD, MPH; Subodh Verma, MD, PhD; Jan O. Friedrich, MD, DPhil Invited Commentary IMPORTANCE The ideal aortic valve substitute in young and middle-aged adults remains page 988 unknown. Supplemental content OBJECTIVE To compare long-term outcomes between the Ross procedure and mechanical aortic valve replacement in adults. DATA SOURCES The Ovid versions of MEDLINE and EMBASE classic (January 1, 1967, to April 26, 2018; search performed on April 27, 2018) were screened for relevant studies using the following text word search in the title or abstract: (“Ross” OR “autograft”) AND (“aortic” OR “mechanical”). STUDY SELECTION All randomized clinical trials and observational studies comparing the Ross procedure to the use of mechanical prostheses in adults undergoing aortic valve replacement were included. Studies were included if they reported any of the prespecified primary or secondary outcomes. Studies were excluded if no clinical outcomes were reported or if data were published only as an abstract. Citations were screened in duplicate by 2 of the authors, and disagreements regarding inclusion were reconciled via consensus. DATA EXTRACTION AND SYNTHESIS This meta-analysis was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses and Meta-analysis of Observational Studies in Epidemiology guidelines. Data were independently abstracted by 3 reviewers and pooled using a random-effects model. MAIN OUTCOMES AND MEASURES The prespecified primary outcome was all-cause mortality. RESULTS The search identified 2919 reports, of which 18 studies (3516 patients) met inclusion criteria, including 1 randomized clinical trial and 17 observational studies, with a median Author Affiliations: Division of average follow-up of 5.8 (interquartile range, 3.4-9.2) years. Analysis of the primary outcome Cardiac Surgery, Department of showed a 46% lower all-cause mortality in patients undergoing the Ross procedure Surgery, University of Toronto, compared with mechanical aortic valve replacement (incidence rate ratio [IRR], 0.54; 95% CI, Toronto, Ontario, Canada (Mazine, Rocha); Department of Cardiac 2 0.35-0.82; P = .004; I = 28%). The Ross procedure was also associated with lower rates of Surgery, Montreal Heart Institute, stroke (IRR, 0.26; 95% CI, 0.09-0.80; P =.02;I2 = 8%) and major bleeding (IRR, 0.17; 95% Montreal, Quebec, Canada CI, 0.07-0.40; P < .001; I2 = 0%) but higher rates of reintervention (IRR, 1.76; 95% CI, (El-Hamamsy); Department of 2 Cardiac Surgery, Toronto General 1.16-2.65; P =.007;I = 0%). Hospital, Toronto, Ontario, Canada (Ouzounian); Department of Cardiac CONCLUSIONS AND RELEVANCE Data from primarily observational studies suggest that the Surgery, St Michael’s Hospital, Ross procedure is associated with lower all-cause mortality compared with mechanical aortic Toronto, Ontario, Canada (Yanagawa, Verma); Brigham and Women’s valve replacement. These findings highlight the need for a large, prospective randomized Hospital Heart & Vascular Center, clinical trial comparing long-term outcomes between these 2 interventions. Harvard Medical School, Boston, Massachusetts (Bhatt); Department of Critical Care Medicine, St Michael’s Hospital, Toronto, Ontario, Canada (Friedrich). Corresponding Author: Jan O. Friedrich, MD, DPhil, St Michael’s Hospital, 30 Bond St, Toronto, ON JAMA Cardiol. 2018;3(10):978-987. doi:10.1001/jamacardio.2018.2946 M5B 1W8, Canada (j.friedrich Published online August 25, 2018. @utoronto.ca). 978 (Reprinted) jamacardiology.com © 2018 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/29/2021 Ross Procedure vs Mechanical Aortic Valve Replacement in Adults Original Investigation Research ortic valve replacement remains the only therapy that has been shown to improve the natural history in pa- Key Points tients with severe symptomatic aortic valve disease.1,2 A Question What is the optimal aortic valve substitute in young and However, young and middle-aged adults with diseased aortic middle-aged adults undergoing aortic valve replacement? valves constitute a challenging population. Owing to a longer Findings This meta-analysis included 3516 adults who underwent life expectancy, these patients present a higher cumulative life- the Ross procedure and found a 46% lower incidence of all-cause time risk of prosthesis-related complications. Because of their mortality compared with patients undergoing mechanical aortic proven durability and ease of implantation, mechanical pros- valve replacement, indicating a significant difference. theses are the most frequently used option in this patient Meaning In carefully selected young and middle-aged adults, the group.3 Recent evidence suggests better long-term survival in Ross procedure is associated with lower all-cause mortality young and middle-aged adults who undergo aortic valve re- compared with mechanical aortic valve replacement. placement with mechanical prostheses compared with bio- logic prostheses.4,5 However, mechanical valves are throm- bogenic and require lifelong anticoagulation, exposing prostheses in adults undergoing aortic valve replacement. Stud- the patient to a continuous hazard of bleeding and thrombo- ies were included if they reported the primary outcome embolic events. Recent studies have reported excess mortal- (ie, all-cause mortality) or any of the prespecified secondary ity in young adults undergoing mechanical aortic valve re- clinical outcomes: operative mortality, perioperative compli- placement compared with the age- and sex-matched general cations, late complications (reoperation, stroke, major bleed- population.6 ing, endocarditis), echocardiographic outcomes at follow-up Replacement of the aortic valve with a pulmonary auto- (mean aortic valve gradient, left ventricular ejection frac- graft and placement of a homograft in the pulmonary posi- tion), or quality of life. Studies were excluded if no clinical out- tion (Ross procedure) was first described by Donald Ross in comes were reported or if data were published only as an ab- 1967.7 In addition to alleviating the need for anticoagulation, stract. Citations were screened in duplicate by 2 of the authors this procedure remains the only aortic valve replacement op- (A.M. and R.V.R.), and full text review, also in duplicate, was eration that provides continued long-term viability of the aor- performed to determine eligibility when either screening re- tic valve substitute, thus allowing adaptive remodeling and viewer felt a citation potentially met inclusion criteria. Dis- conferring a hemodynamic profile similar to that of the na- agreements regarding inclusion were reconciled via consen- tive aortic valve.8 After an initial wave of enthusiasm in the sus. When there was overlap between 2 or more studies, we early 1990s, use of the Ross procedure has declined markedly included only the report with the larger sample size, the lon- over the last 2 decades owing to concerns over the perceived ger duration of follow-up, and/or the most complete descrip- complexity of this operation, which is felt by many to in- tion of the data. crease surgical risk and lead to high rates of reintervention due to autograft failure.9,10 In addition, patients who undergo the Data Analysis Ross procedure are also at risk of late homograft failure, al- Three reviewers (A.M., R.V.R., and J.O.F.) independently ab- though this problem is increasingly managed using percuta- stracted data including details of the publication (ie, study au- neous approaches in the current era.11-13 Thus, there is equi- thors, enrollment period, year of publication, study design), poise regarding the ideal aortic valve substitute in young and inclusion/exclusion criteria, demographics of the enrolled pa- middle-aged adults. Our aim was to compare early and late out- tients, description of the interventions used, and outcome defi- comes in adult patients who undergo the Ross procedure vs nitions and events. Risk of bias in randomized clinical trials mechanical aortic valve replacement. (including blinding of participants, method of sequence gen- eration and allocation concealment, intention-to-treat analy- sis, early trial stoppage for efficacy before planned enroll- Methods ment completion, and loss to follow-up) and cohort studies (including retrospective vs prospective data collection, con- Search Strategy and Selection Criteria current vs historical controls, and comparable baseline char- We conducted a systematic review and meta-analysis in ac- acteristics of cases and controls) were formally assessed using cordance with the Preferred Reporting Items for Systematic re- the Cochrane Collaboration’s Risk of Bias tool for randomized views and Meta-Analyses and Meta-analysis of Observa- clinical trials and the Newcastle-Ottawa Scale for nonrandom- tional Studies in Epidemiology guidelines (eTable 1 in ized studies,16,17 respectively, with disagreements resolved by Supplement 1).14,15 We systematically searched Ovid versions consensus. of MEDLINE (January 1, 1967, to April 26, 2018) and EMBASE All analyses were performed using Review Manager classic (January 1, 1967, to April 26, 2018; search performed on (RevMan version 5.2; Cochrane Collaboration) and the April
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