DIRECT TAVI: Is Predilation Important for Women?

Predilation was used in the early stages of TAVR to facilitate device advancing. However, the increasing operator experience has reduced its use in an attempt to prevent conduction disorders or serious complications, such as annuli rupture, which in turn has simplified the procedure and reduced procedural time. 

50% of women present smaller valves compared to men, and often present smaller diameter access or smaller annuli as well. Even though Predilation might be beneficial in these cases, to this day, results have remained inconclusive. 

This was an analysis of the DIRECTAVI, assessing 91 women. 45 of these women received balloon aortic valvuloplasty prior TAVR (BAV TAVR), while the rest were directly implanted with the device (DIRECT TAVI). SAPIENS 3 was used.  

Primary end point was procedural success, according to the Valve Academic Research Consortium‐2 criteria, which included no mortality within the first 72 hours, correct device positioning, no moderate to severe prosthetic mismatch, mean gradient <20 mmHg, velocity <3m/s and no moderate to severe paravalvular leak.

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The groups had similar baseline characteristics, with mean age 85. There were no differences in comorbidities such as diabetes, hypertension, stroke, PCI, CABG, COPD, peripheral vascular disease, pulmonary hypertension and kidney function deterioration. However, the presence of atrial fibrillation was greater among DIRECT TAVI patients. 

Ejection fraction was 60%, aortic valve area 0.7 cm² and mean gradient 48 mmHg.

There were no significant differences in primary end point (64.4% for BAV TAVI vs. 79.3% for DIRECT TAVI, p=0.3), though there was a numeric difference in mismatch in favor of DIRECT TAVI patients, with no statistical significance.

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At 30 days, there were no differences in terms of mortality, stroke or vascular complications or the need for definite pacemaker implantation, even though the rate was numerically higher in the BAV TAVI group (26.7% vs. 19.6%, p=0.42).

Men in the study were also compared, resulting in women presenting a higher rate of moderate mismatch (27.4% vs. 11%, p<0.001).

Conclusion

Direct implantation of balloon expandable SAPIENS 3 resulted non-inferior to Predilation as regards procedural success in women. Moderate mismatch incidence was higher among women, but this was not related to implantation strategy. 

Original Title: Balloon predilation or direct valve implantation in TAVI for women: Insights from the DIREC TAVI study.

Reference: Pierre Robert, et al. Catheter Cardiovasc Interv. 2024;104:97–104.