Author + information
- Tomislav Kopjar, MD, PhD∗ (, )
- Bojan Biocina, MD, PhD and
- Hrvoje Gasparovic, MD, PhD
- ↵∗University of Zagreb School of Medicine, Department of Cardiac Surgery, University Hospital Centre Zagreb, Kispaticeva 12, 10000 Zagreb, Croatia
With interest we read the paper by Thyregod et al. (1) on transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) in patients with severe aortic valve stenosis. TAVR has been considered an acceptable treatment option for patients with inoperable severe aortic valve stenosis or at high risk for surgery (2). The NOTION (Nordic Aortic Valve Intervention Trial) study was the first randomized trial comparing TAVR with SAVR in an all-comers patient population with severe symptomatic aortic valve stenosis regardless of their predicted morality score. It was a multicenter, randomized, nonblinded, superiority trial.
No significant differences were found regarding death from any cause, stroke, or myocardial infarction; cardiovascular mortality; or prosthesis re-intervention after 1 year. Power calculations in the trial were far too weak to detect a small (≈3%) absolute difference in primary outcome between groups. Need for permanent pacemaker implantation (38.0% vs. 2.4%; p < 0.001), New York Heart Association functional class II at 1 year (29.5% vs. 15.0%; p = 0.01), and moderate-to-severe regurgitation at 1 year (15.7% vs. 0.9%; p < 0.001) were all better in the SAVR group. Bleeding, acute kidney injury, cardiogenic shock, new-onset atrial fibrillation, and duration of indexed hospitalization were better in the TAVR group, although they did not corroborate to a worse overall 1-year outcome or a difference in the number of hospitalizations or days hospitalized within the first year.
Considering that symptomatic relief is the primary indication for aortic valve replacement (2), we are surprised that the authors did not conclude correctly using the evidence from their own results. A conclusion that one procedure could not be recommended over the other seems misleading when SAVR patients were less symptomatic 1 year after the procedure. If less dyspnea is not enough to recommend SAVR to such patients, what is? Significant residual aortic regurgitation is a known factor responsible for worse outcome in patients after TAVR (3).
Although the nature of the trial as a superiority trial is clearly stated in the Methods section, the conclusions appear to disregard that statement. Concluding simply that TAVR is not superior to SAVR in the lower-risk symptomatic aortic valve stenosis population is far more appropriate than the one stating an inability to recommend or refute one procedure over the other. The authors should be congratulated on their contribution.
Please note: The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- American College of Cardiology Foundation
- Thyregod H.G.,
- Steinbrüchel D.A.,
- Ihlemann N.,
- et al.
- Nishimura R.A.,
- Otto C.M.,
- Bonow R.O.,
- et al.
- Jerez-Valero M.,
- Urena M.,
- Webb J.G.,
- et al.