Transcatheter versus surgical aortic valve replacement in patients with severe aortic stenosis at low and intermediate risk: systematic review and meta-analysisBMJ 2016; 354 doi: https://doi.org/10.1136/bmj.i5130 (Published 28 September 2016) Cite this as: BMJ 2016;354:i5130
- Reed A Siemieniuk, PhD student and physician1 2,
- Thomas Agoritsas, assistant professor1 3,
- Veena Manja, PhD student and physician1 4 5,
- Tahira Devji, PhD student1,
- Yaping Chang, PhD student1,
- Malgorzata M Bala, assistant professor6,
- Lehana Thabane, professor1,
- Gordon H Guyatt, distinguished professor1
- 1Department of Clinical Epidemiology and Biostatistics, McMaster University, 1280 Main St West, Hamilton, ON, Canada L8S 4L8
- 2Department of Medicine, University of Toronto, Toronto, ON, Canada
- 3Division General Internal Medicine, and Division of Clinical Epidemiology, University Hospitals of Geneva, Geneva, Switzerland
- 4Department of Internal Medicine, State University of New York at Buffalo, Buffalo, NY,USA
- 5VA WNY Health Care System at Buffalo, Department of Veterans Affairs, Buffalo, NY, USA
- 6Department of Hygiene and Dietetics, Jagiellonian University Medical College, Kraków, Poland
- Correspondence to: R Siemieniuk
- Accepted 19 September 2016
Objective To examine the effect of transcatheter aortic valve implantation (TAVI) versus surgical replacement of an aortic valve (SAVR) in patients with severe aortic stenosis at low and intermediate risk of perioperative death.
Design Systematic review and meta-analysis
Data sources Medline, Embase, and Cochrane CENTRAL.
Study selection Randomized trials of TAVI compared with SAVR in patients with a mean perioperative risk of death <8%.
Review methods Two reviewers independently extracted data and assessed risk of bias for outcomes important to patients that were selected a priori by a parallel guideline committee, including patient advisors. We used the GRADE system was used to quantify absolute effects and quality of evidence.
Results 4 trials with 3179 patients and a median follow-up of two years were included. Compared with SAVR, transfemoral TAVI was associated with reduced mortality (risk difference per 1000 patients: −30, 95% confidence interval −49 to −8, moderate certainty), stroke (−20, −37 to 1, moderate certainty), life threatening bleeding (−252, −293 to −190, high certainty), atrial fibrillation (−178, −150 to −203, moderate certainty), and acute kidney injury (−53, −39 to −62, high certainty) but increased short term aortic valve reintervention (7, 1 to 21, moderate certainty), permanent pacemaker insertion (134, 16 to 382, moderate certainty), and moderate or severe symptoms of heart failure (18, 5 to 34, moderate certainty). Compared with SAVR, transapical TAVI was associated higher mortality (57, −16 to 153, moderate certainty, P=0.015 for interaction between transfemoral versus transapical TAVI) and stroke (45, −2 to 125, moderate certainty, interaction P=0.012). No study reported long term follow-up, which is particularly important for structural valve deterioration.
Conclusions Many patients, particularly those who have a shorter life expectancy or place a lower value on the risk of long term valve degeneration, are likely to perceive net benefit with transfemoral TAVI versus SAVR. SAVR, however, performs better than transapical TAVI, which is of interest to patients who are not candidates for transfemoral TAVI.
Systematic review registration PROSPERO CRD42016042879
We thank members of the Rapid Recommendations panel for critical feedback on outcome selection, GRADE judgments, and manuscript feedback, including Per Vandvik, Frederick Spencer, Rodrigo Bagur, Lyubov Lytvyn, Richard Whitlock, Trond Vartdal, David Brieger, Bert Aertgeerts, Susanna Price, Farid Foroutan, Michael Shapiro, and Ray Mertz.
Contributors: Frederick Spencer, Per Vandvik, RAS, TA, and GHG conceived the study idea. RAS performed the literature search and data analysis. RAS, TA, VM, and GHG interpreted the data analysis. RAS and VM wrote the first draft of the manuscript. TA, VM, TD, YC, and MMB acquired the data and judged risk of bias in the studies. TD extracted patient level survival data from Kaplan-Meier curves. LT provided statistical advice. TA, VM, TD, YC, MMB, and GHG critically revised the manuscript. RAS had full access to all of the data in the study, and takes responsibility for the integrity of the data and the accuracy of the data analysis. RAS is guarantor.
Funding: This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. RAS is supported by a Vanier Canada Graduate Scholarship.
Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: no support from any organization for the submitted work; no financial relationships with any organizations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.
Ethical approval: Not required.
Data sharing: Abstracted trial level and patient level survival data, as well as STATA code will be made publicly available on publication.
Transparency declaration: The lead author (RAS) affirms that the manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned have been explained.
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