Author + information
- Giuseppe Santarpino, MD∗ (, )
- Theodor Fischlein, MD and
- Steffen Pfeiffer, MD
- ↵∗Department of Cardiac Surgery, Paracelsus Medical University, Breslauer Strasse 201, Nuremberg 90471, Germany
The NOTION (Nordic Aortic Valve Intervention) trial compared transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) in predominantly low-risk patients (1). Available evidence is consistent in suggesting that TAVR is associated with a better immediate outcome, given the less invasive nature of the procedure. However, the less favorable immediate outcome reported with SAVR is offset by improved survival, which is the primary therapeutic goal for patients at low- and intermediate-risk.
As partly recognized by Thyregod et al. (1), there are several study limitations to acknowledge:
• Patients with significant concomitant coronary disease were not recruited, so that nearly 90% of patients were excluded at enrollment. In other words, it is not for “all-comers,” as the title says.
• Hospital costs are higher for TAVR than SAVR procedures, and the hypothesis tested in the study would result in an unsustainable healthcare expenditure.
• The “modern TAVR” is compared with the “ancient SAVR.” However, it should be taken into consideration that, at present, SAVR can be performed using different approaches (e.g., minimally invasive surgery, sutureless bioprostheses) that may compete well with current interventional techniques.
• The rate of post-operative cardiogenic shock and major/life-threatening bleeding in this low-risk SAVR population seem unusually high (10.6% and >20%).
• The high rate of post-operative pacemaker implantation in the TAVR group (34.1%) seems to be correlated with the prosthetic device used rather than with TAVR per se. This complication deserves further discussion, given the well-known association between pacemaker stimulation and ventricular deterioration.
• At 1-year follow-up, TAVR patients had more dyspnea compared with SAVR patients, likely due to paraprosthetic regurgitation. This has been frequently described as a complication occurring with current-generation TAVR devices and has been associated with increased mortality. However, the mortality rate after TAVR in the NOTION trial is 1 of the lowest ever reported, and the short follow-up period can account for this positive finding.
Please note: Dr. Fischlein has served as a consultant for Sorin Company. All other 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.