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Adverse Effects Associated With Transcatheter Aortic Valve Implantation: A Meta-Analysis of Contemporary Studies
Study Questions:
What are the adverse effects associated with transcatheter aortic valve implantation (TAVI), and is there an association between the type of transcatheter valve and the route of valve implantation with differences in adverse outcomes?
Methods:
All studies that included at least 100 patients who had TAVI and reported at least one outcome of interest were included. Two reviewers abstracted the data independently. A random-effects model was used to combine data on adverse outcomes and conduct stratified analyses.
Results:
A total of 49 studies enrolling 16,063 patients met the inclusion criteria. Overall 30-day and 1-year survival after TAVI were 91.9% (95% confidence interval [CI], 91.1%-92.8%) and 79.2% (CI, 76.9%-81.4%), respectively. Heart block requiring permanent pacemaker implantation was the most common adverse outcome (13.1%), and was 5 times more common with the CoreValve (Medtronic, Minneapolis, MN) than the Sapien valve (Edwards Lifesciences, Irving, CA) implanted using the transarterial route (25.2% vs. 5.0%, respectively). The overall rate of vascular complications was 10.4% and was highest with transarterial implantation of the Sapien valve (22.3%). Acute renal failure requiring renal replacement therapy was the third most common complication, occurring in 4.9% of patients.
Conclusions:
The authors concluded that the most common adverse effects associated with TAVI are heart block, vascular complications, and renal failure.
Perspective:
This systematic review reported that heart block requiring permanent pacemaker insertion, vascular complications, and acute renal failure requiring renal replacement therapy were the most common side effects associated with TAVI. Implantation with the CoreValve was associated with a fivefold increased rate of permanent pacemaker insertion, but one half the rate of vascular complications compared with the Sapien valve. Furthermore, transapical replacement was associated with significantly lower 30-day survival rates compared with transarterial replacement. Findings from this study may assist/guide clinicians in the multidisciplinary team in assessing the risks and benefits of this therapy for appropriate candidates with severe aortic stenosis.
Keywords: Renal Insufficiency, Coronary Angiography, Survival Rate, Heart Block, Pacemaker, Artificial, Heart Valve Prosthesis Implantation
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