Transcatheter versus surgical aortic valve replacement in patients with severe aortic stenosis at low and intermediate risk: systematic review and meta-analysis.
- Siemieniuk RA Department of Clinical Epidemiology and Biostatistics, McMaster University, 1280 Main St West, Hamilton, ON, Canada L8S 4L8 Department of Medicine, University of Toronto, Toronto, ON, Canada reed.siemieniuk@medportal.ca.
- Agoritsas T Department of Clinical Epidemiology and Biostatistics, McMaster University, 1280 Main St West, Hamilton, ON, Canada L8S 4L8 Division General Internal Medicine, and Division of Clinical Epidemiology, University Hospitals of Geneva, Geneva, Switzerland.
- Manja V Department of Clinical Epidemiology and Biostatistics, McMaster University, 1280 Main St West, Hamilton, ON, Canada L8S 4L8 Department of Internal Medicine, State University of New York at Buffalo, Buffalo, NY,USA VA WNY Health Care System at Buffalo, Department of Veterans Affairs, Buffalo, NY, USA.
- Devji T Department of Clinical Epidemiology and Biostatistics, McMaster University, 1280 Main St West, Hamilton, ON, Canada L8S 4L8.
- Chang Y Department of Clinical Epidemiology and Biostatistics, McMaster University, 1280 Main St West, Hamilton, ON, Canada L8S 4L8.
- Bala MM Department of Hygiene and Dietetics, Jagiellonian University Medical College, Kraków, Poland.
- Thabane L Department of Clinical Epidemiology and Biostatistics, McMaster University, 1280 Main St West, Hamilton, ON, Canada L8S 4L8.
- Guyatt GH Department of Clinical Epidemiology and Biostatistics, McMaster University, 1280 Main St West, Hamilton, ON, Canada L8S 4L8.
- 2016-09-30
Published in:
- BMJ (Clinical research ed.). - 2016
English
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.
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.
- Language
-
- English
- Open access status
- hybrid
- Identifiers
-
- DOI 10.1136/bmj.i5130
- PMID 27683246
- Persistent URL
- https://folia.unifr.ch/global/documents/103553
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