Does simplifying TAVR involve a cost? At least for low-risk patients included in the PARTNER 3, the question appears somewhat abstract. Predilation and direct TAVR resulted equally safe, though the latter shortened procedural time and did not require further post dilation.
Both strategies resulted virtually identical in terms of clinical events.
The use of predilation during transcatheter aortic valve replacement (TAVR) largely depends on operator, center, device, and even country. Part of this great variability is owed to the lack of information for or against direct implantation which leaves strategy to operator criterion. In addition, we should take into account the different populations being treated.
The PARTNER 3 included 495 patients with severe aortic stenosis and low surgical risk undergoing TAVR with the Sapien 3 valve.
Predilation or direct implantation was left to operator criterion.
Primary end point was a combination of all cause death, stroke or rehospitalization. Among the secondary end points were device hemodynamic profile and need of post dilation. To compare populations, they used propensity score matching.
286 patients received predilation (57.8%) and 209 (42.2%) received direct valve implantation.
Read also: Bifurcations: A Long Return Journey.
Primary end point at 30 days was 3.8 vs 4.8% (p=0.604) and at one year, 8.7% vs 8.1% (p=0.831) for predilation and direct implantation, respectively.
Avoiding predilation saved around 10 minutes or procedural time (63.2 vs 51.4 minutes; p=0.001) with no impact on post dilation rate (24.8% vs 18.8%; p=0.15).
These study outcomes were replicated in many other studies.
Conclusion
Both predilation and direct TAVR implantation resulted safe in surgical low-risk patients. Direct implantation saves procedural time and does not predispose to post dilation.
Original Title: Impact of Predilation During Transcatheter Aortic Valve Replacement: Insights From the PARTNER 3 Trial.
Reference: Julien Ternacle et al. Circ Cardiovasc Interv. 2021 Jun 18, Online ahead of print. doi: 10.1161/CIRCINTERVENTIONS.120.010336.
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