Giuseppe Gargiulo, MD (*); Anna Sannino, MD (*); Davide Capodanno, MD, PhD; Marco Barbanti, MD; Sergio Buccheri, MD; Cinzia Perrino, MD, PhD; Piera Capranzano, MD; Ciro Indolfi, MD, PhD; Bruno Trimarco, MD; Corrado Tamburino, MD, PhD; Giovanni Esposito, MD, PhD
Grant Support: The authors are funded by their academic institutions.
Disclosures: Dr. Gargiulo reports grants from the CardioPath PhD Program, Federico II University of Naples, and from the European Association of Percutaneous Coronary Interventions, outside the submitted work. Dr. Barbanti is a consultant for Edwards Lifesciences. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M16-0060.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer.
Reproducible Research Statement:Study protocol: See Supplement 1. Statistical code and data set: Available from Dr. Gargiulo (e-mail, firstname.lastname@example.org or email@example.com).
Requests for Single Reprints: Giovanni Esposito, MD, PhD, Division of Cardiology, Department of Advanced Biomedical Sciences, Federico II University of Naples, Via Pansini 5, 80131 Naples, Italy; e-mail, firstname.lastname@example.org.
Current Author Addresses: Dr. Gargiulo, Dr. Perrino, Prof. Trimarco, and Prof. Esposito: Division of Cardiology, Department of Advanced Biomedical Sciences, Federico II University of Naples, Via Pansini 5, 80131 Naples, Italy.
Dr. Sannino: Baylor Research Institute, Baylor Heart and Vascular Hospital, 621 North Hall Street, Dallas, TX 75226.
Prof. Capodanno; Drs. Barbanti, Buccheri, and Capranzano; and Prof. Tamburino: Department of General Surgery and Medical–Surgical Specialties, University of Catania, c/o Ospedale Ferrarotto, Via Salvatore Citelli 31, 95124 Catania, Italy.
Prof. Indolfi: Department of Medical and Surgical Sciences and URT Consiglio Nazionale delle Ricerche, Magna Graecia University, Viale Europa, Catanzaro 88100, Italy.
Author Contributions: Conception and design: G. Gargiulo, A. Sannino, D. Capodanno, G. Esposito.
Analysis and interpretation of the data: G. Gargiulo, A. Sannino, D. Capodanno, S. Buccheri, C. Perrino, P. Capranzano, B. Trimarco, C. Tamburino, G. Esposito.
Drafting of the article: G. Gargiulo, A. Sannino.
Critical revision for important intellectual content: G. Gargiulo, D. Capodanno, S. Buccheri, P. Capranzano, C. Indolfi, B. Trimarco, C. Tamburino.
Final approval of the article: G. Gargiulo, A. Sannino, D. Capodanno, M. Barbanti, S. Buccheri, C. Perrino, P. Capranzano, C. Indolfi, B. Trimarco, C. Tamburino, G. Esposito.
Statistical expertise: G. Gargiulo, D. Capodanno.
Collection and assembly of data: G. Gargiulo, A. Sannino.
The comparative benefits and harms of transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) for patients with aortic stenosis are unclear.
To compare clinical outcomes, including early (≤30-day) and midterm (≤1-year) mortality, in adults with severe aortic stenosis undergoing either TAVI or SAVR.
MEDLINE, Cochrane, and Scopus databases (without language restrictions) from April 2002 to 5 April 2016; multiple registries and Web sites; scientific meeting presentations.
Five randomized trials and 31 observational matched studies comparing mortality outcomes after TAVI or SAVR.
Two investigators independently extracted study data and rated risk of bias.
16 638 patients were analyzed. Overall, there was no statistically significant difference between TAVI and SAVR in early (odds ratio [OR], 1.01 [95% CI, 0.81 to 1.26]) or midterm (OR, 0.96 [CI, 0.81 to 1.14]) all-cause mortality. Analyses restricted to trials (early: OR, 0.80 [CI, 0.51 to 1.25]; midterm: OR, 0.90 [CI, 0.64 to 1.26]) were inconclusive, with wide CIs, whereas analyses of matched studies were similar to the overall results. Transfemoral TAVI provided mortality benefits over SAVR in trials. Analyses restricted to studies of patients at low to intermediate risk showed statistically nonsignificant reductions in early (OR, 0.67 [CI, 0.42 to 1.07]) and midterm (OR, 0.91 [CI, 0.67 to 1.23]) mortality with TAVI. Incidence of periprocedural myocardial infarction, major bleeding, acute kidney injury, and new-onset atrial fibrillation was lower with TAVI, but risk for pacemaker implantation, vascular complications, and paravalvular leak increased. Overall, there was a statistically nonsignificant increased risk in long-term (2- to 5-year) all-cause mortality with TAVI (OR, 1.28 [CI, 0.97 to 1.69]), whereas long-term mortality outcomes in patients at low to intermediate risk were inconclusive, with wide CIs (OR, 1.06 [CI, 0.59 to 1.91]).
The number of trials was limited, and study designs and patient characteristics were heterogeneous.
Compared with SAVR, TAVI may have similar or better early and midterm outcomes for adults with aortic stenosis, including those at low to intermediate risk.
Giuseppe Gargiulo, Anna Sannino, Davide Capodanno, Marco Barbanti, Sergio Buccheri, Cinzia Perrino, et al. Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement: A Systematic Review and Meta-analysis. Ann Intern Med. 2016;165:334–344. doi: 10.7326/M16-0060
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Published: Ann Intern Med. 2016;165(5):334-344.
Published at www.annals.org on 7 June 2016
Cardiology, Valvular Heart Disease.
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