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Published on: March 26, 2018
Transcatheter aortic valve implantation for high-risk patients with severe aortic stenosis: A systematic review
Tristan D Yan1, Christopher Cao, Julie Martens-Nielsen
1Department of Cardiothoracic Surgery, The University of Sydney, Royal Prince Alfred Hospital, Sydney 2050, Australia. Tristan.Yan@unsw.edu.au
Insights
Transcatheter aortic valve implantation shows short-term efficacy for severe aortic stenosis but carries risks. Long-term outcomes remain uncertain, necessitating cautious use within clinical trials.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Technology Assessment
Background:
- Severe aortic stenosis poses significant risks for patients unsuitable for traditional surgery.
- Transcatheter aortic valve implantation (TAVI) has emerged as an alternative treatment option.
Purpose of the Study:
- To systematically review the safety and clinical effectiveness of TAVI in high-risk patients with severe aortic stenosis.
- To assess the feasibility, safety, efficacy, and durability of TAVI based on available evidence.
Main Methods:
- Conducted systematic electronic searches across 6 databases from January 2000 to March 2009.
- Synthesized clinical effectiveness through narrative review and tabulation of results from observational studies.
- Focused on short-term outcomes due to evidence limitations.
Main Results:
- Procedural success rates for TAVI ranged from 74% to 100%.
- Significant short-term adverse events were noted, including mortality (0%-25%) and major cardiovascular events (3%-35%).
- Echocardiographic improvements in valve area and pressure gradients were observed, with no significant deterioration during follow-up.
Conclusions:
- TAVI demonstrates short-term efficacy for severe aortic stenosis, evidenced by improved hemodynamic parameters.
- The procedure carries a potential for serious complications, and long-term outcome data is limited.
- Current evidence suggests TAVI should be primarily considered within the context of clinical trials.
Objectives:
The present systematic review objectively assessed the safety and clinical effectiveness of transcatheter aortic valve implantation for patients at high surgical risk with severe aortic stenosis.
Methods:
Electronic searches were performed in 6 databases from January 2000 to March 2009. The end points included feasibility, safety, efficacy, and durability. Clinical effectiveness was synthesized through a narrative review with full tabulation of results of all included studies.
Results:
The current evidence on transcatheter aortic valve implantation for aortic stenosis is limited to short-term observational studies. The overall procedural success rates ranged from 74% to 100%. The incidence of major adverse events included 30-day mortality (0%-25%), major ventricular tachyarrhythmia (0%-4%), myocardial infarction (0%-15%), cardiac tamponade (2%-10%), stroke (0%-10%), conversion to surgery (0%-8%), moderate to major paravalvular leak (4%-35%), vascular complication (8%-17%), valve-in-valve procedure (2%-12%), and aortic dissection/perforation (0%-4%). The overall 30-day major adverse cardiovascular and cerebral events ranged from 3% to 35%. The mean aortic valve area ranged from 0.5 to 0.8 cm(2) before and 1.3 to 2.0 cm(2) after transcatheter aortic valve implantation. The mean pressure gradient ranged from 34 to 58 mm Hg before and 3 to 12 mm Hg after transcatheter aortic valve implantation. There was no significant deterioration in echocardiography measurements during the assessment period. Death rate at 6 months postprocedure ranged from 18% to 48%. No studies had adequate follow-up to reliably evaluate long-term outcomes.
Conclusions:
The procedure has a potential for serious complications. Although short-term efficacy based on echocardiography measurements is good, there is little evidence on long-term outcomes. The use of transcatheter aortic valve implantation should be considered only within the boundaries of clinical trials.
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