Valve-in-valve TAVI, an essential alternative to open heart surgery

MedTech & Diagnostics News: Transcatheter aortic valve implantation (TAVI) has firmly established itself as the treatment of choice for patients with native aortic valve stenosis who are at high or intermediate risk for surgical aortic valve replacement.

The valve-in-valve transcatheter aortic valve implantation (ViV TAVI) offers a vital alternative for patients with severe symptomatic aortic stenosis who have undergone surgical aortic valve replacement (SAVR) or TAVI and now face symptomatic structural valve deterioration (SVD), especially when open-heart surgery poses higher risks.

Edwards Lifesciences initially pursued public funding for its SAPIEN 3 Ultra Transcatheter Heart Valve (THV) system, with the application reviewed by the PICO Advisory Committee (PASC) in April. The next step would have been submitting an ADAR (Applicant Developed Assessment Report) for evaluation, after which the application would be scheduled to an Medical Services Advisory Committee (MSAC) meeting agenda. However, the company has informed Health Industry Hub that it is currently not proceeding with this application.*

Input from hearts4heart, Medtronic Australasia and Abbott Medical Australia was generally supportive for ViV TAVI. However, the feedback was mixed regarding the proposed population. Some feedback advocated not to restrict the intervention to “high risk patients” as all patients with bioprosthetic aortic valve SVD could benefit, and limiting to high-risk patients is inconsistent with current Australian or International practice.

A recent meta-analysis highlighted ViV TAVI’s superiority over redo SAVR in patient outcomes. The study found that ViV TAVI was linked to significantly lower procedural mortality (p=0.04) and 30-day mortality (p<0.00001). While long-term mortality rates between the two procedures were comparable (p=0.42), ViV TAVI showed clear advantages in reducing the likelihood of stroke (p<0.0001), major bleeding (p<0.000001), acute kidney injury (p<0.0001), and new permanent pacemaker insertion (PPI) (p<0.002).

On the flip side, ViV TAVI did come with a higher risk of vascular complications (p<0.0003), though rates of hospital readmission (p=0.18) and acute myocardial infarction (MI) (p=0.38) were similar to those seen with redo SAVR. Moreover, patients undergoing ViV TAVI enjoyed a significantly shorter hospital stay (p<0.004).

Intriguingly, a more recent meta-analysis of twelve studies concluded that “Although the long-term outcomes seem similar between Redo-SAVR and ViV-TAVI at a five-year follow-up, ViV-TAVI shows significantly lower mortality within 30 days. This advantage disappeared between 30 days and 1 year and reversed in favour of redo-SAVR 1 year after the intervention.”

*This article has been revised to reflect new information provided by Edwards Lifesciences.

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