Predilation in TAVR: Definitive Data for Easier Decision-Making?

Direct implantation (without predilation) resulted non-inferior vs. the conventional strategy with prior balloon aortic valvuloplasty using the S3 prosthesis (even though this did not translate into a simplified procedure). In a few patients, the prosthesis was not able to cross the native valve, which resulted in device retrieval and subsequent valvuloplasty. According to these data, direct implantation is possible if patients are selected correctly and providing you did not expect any benefits out of it. 

The DIRECTAVI (Direct Transcatheter Aortic Valve Implantation) was an open non-inferiority study which included patients with severe aortic stenosis receiving the Edwards SAPIEN 3 randomized to direct implantation vs. prior predilation with balloon aortic valvuloplasty. 

Procedural success rate with direct implantation was 80.2% and resulted non-inferior to the group with predilation (75.7%; p=0.02). There was no prosthetic mismatch or paravalvular aortic regurgitation in these groups. 

5.8% of patients randomized to direct implantation requiring predilation given the impossibility of crossing the native valve with the prosthesis. 

Complications were basically conduction problems requiring pacemaker implantation and resulted almost identical in both groups (20.9% vs 19%; p=0.7).

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There were no differences between strategies in terms of procedural duration, contrast volume, radiation exposure and post dilation rate. 

Conclusion

TAVR with direct implantation was similar in terms of outcomes to TAVR with pre- dilation with no difference in procedural duration. It might be impossible to cross the stenotic valve with the prosthesis and therefore we must select patients accordingly. 

Original Title: Prior Balloon Valvuloplasty Versus Direct Transcatheter Aortic Valve Replacement Results From the DIRECTAVI Trial.

Reference: Florence Leclercq et al. J Am Coll Cardiol Intv 2020;13:594–602.

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