TAVR in large annulus
The indications and contraindications for transcatheter aortic valve intervention became common in the medical literature. Individuals at high surgical risk and those considered inoperable have a clear indication for correction by TAVR. Low surgical risk patients can also be treated by the same technique, with good results in the medium term.
However, some situations are considered contraindications to the percutaneous procedure, such as a very wide aortic valve annulus. The expandable balloon prostheses available on the market work with some prosthetic measures, the largest being 29mm, more precisely for an aortic annulus area of 683mm2. The Evolut R prosthesis has a piece for larger annulus, but it is a self-expanding prosthesis and brings its own characteristics.
A retrospective analysis that observed patients classified with large valve annuli, that is, above the recommended area for the implantation of a size 29 sapiens 3, showed some interesting data.
Even though it is an off-label procedure and not recommended by the manufacturer’s package insert, these prostheses were implanted in these patients, showing at the 1-year follow-up, acceptable results in terms of mortality. Vascular complications and strokes also proved to be similar to patients who fit the manufacturer’s package insert.
There was a higher prevalence of paraprosthetic leak, but what influenced this statistic was the discrete Leak. Moderate regurgitation did not have a greater incidence in the large annulus group.
One of the reasons to explain this finding related to leak was that interventionists using Sapiens tend to under-size the prosthesis routinely, due to the risk of annulus rupture, since it is an expandable balloon prosthesis and ballooning could cause serious injury. In other words, the interventionist chooses to make mistakes less in these cases. Thus, the incidence of leaks with hemodynamic repercussions ends up being equal.
What drew attention in this group was the high incidence of central regurgitation in the prosthesis. Mild intensity reflux occurred at around 12% after one year, although the clinical impact of this was not apparent. One explanation for this is the recurrent use of an expander balloon after the prosthesis is released, seeking to reduce current leaks. In addition to leading to over-expansion, the risk of traumatic injury to the leaflets is not ruled out, which in the long run may be responsible for early deterioration.
What we have taken from this analysis is that it is possible to treat patients with an enlarged aortic annulus, even if it is above the recommended by the prosthesis, but we must keep in mind the possible complications expected. Talking to the family and the patient is the best way, as this is often the only treatment available and acceptable.
1 – Sengupta A, Zaid S, Kamioka N, et al. Mid-Term Outcomes of Transcatheter Aortic Valve Replacement in Extremely Large Annuli With Edwards SAPIEN 3 Valve. JACC Cardiovasc Interv. 2020; 13 (2): 210-216.