Author + information
- Hans Gustav Hørsted Thyregod, MD∗ (, )
- Daniel Andreas Steinbrüchel, MD, DMSc and
- Lars Søndergaard, MD, DMSc
- ↵∗Department of Cardiothoracic Surgery, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9 DK-2100, Copenhagen, Denmark
To our knowledge, no randomized trials comparing transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) in an all-comers population including intermediate- and low-risk patients had been conducted before the NOTION (Nordic Aortic Valve Intervention) trial. Therefore, improved survival after SAVR compared with TAVR has not been proven as suggested by Dr. Santarpino and colleagues.
Our trial aimed to compare TAVR versus SAVR and therefore excluded patients with significant coronary artery disease. We screened all patients 70 years of age or older referred to intervention and offered all eligible patients trial inclusion. About one-third of patients were not offered surgery, some were not technical suitable for TAVR, and others were not willing to participate. However, the majority of eligible patients were enrolled. The purpose of our trial was not to examine health economics. The cost of TAVR is currently higher than surgery but will most likely change over time. Also, the length of hospital stay was at an average 4 days shorter for TAVR patients but more received a pacemaker. We agree that newer surgical prostheses and minimally invasive aortic valve surgery should also be compared with TAVR in future trials. Our trial was conducted at 3 large cardiac surgical centers and the Valve Academic Research Consortium 2 definitions were used for event adjudication (1). We believe the outcomes represent daily practice well. The pacemaker implantation rate was higher in the TAVR group and well known to be related to the specific TAVR system used (2), but no studies have demonstrated an association between pacemaker implantation and mortality (3).
The rate of moderate-to-severe paravalvular leakage (PVL) was about 15% for TAVR in our trial, and PVL has previously been associated with increased mortality (4). The issue of PVL should be resolved before the routine use of TAVR in lower-risk patients. In current clinical practice, the introduction of 3-dimensional aortic annular measurements using cardiac computed tomography scans and newer TAVR systems designed to minimize PVL have decreased the rate of moderate-to-severe PVL to 3% to 4% (S.Kodali et al., 2015 ACC meeting, San Diego, CA).
Intervention for severe aortic valve stenosis is indicated for both symptomatic as well as asymptomatic patients with compromised cardiac function, rapid disease progression, or positive exercise test (5). The primary outcome of the NOTION trial was the composite rate of death from any cause, stroke, or myocardial infarction 1 year after intervention. With superiority testing, we could not demonstrate a significant difference between TAVR versus SAVR. As mentioned by Dr. Kopjar and colleagues, other procedural complications were significantly different between groups. More surgical patients had no dyspnea compared with transcatheter patients 1 year after intervention. We can only speculate on the reasons for this difference. As mentioned previously, the high rate of moderate-to-severe PVL after TAVR could be a reason. While we could not prove the alternative hypothesis, that TAVR was superior to SAVR, we found fewer events for all individual components of the primary outcome in the TAVR group and differences in important secondary safety and functional outcomes. On the basis of our results and other available clinical evidence, we cannot recommend or refute one procedure over the other for low-risk patients at present.
Please note: Dr. Søndergaard is a proctor for, has received speakers fee from, and has been involved in research contracts with Medtronic, Inc. Drs. Steinbrüchel has been involved in research contracts with Medtronic, Inc. Dr. Thyregod has reported that he has no relationships relevant to the contents of this paper to disclose.
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