TAVI without predilation is feasible and safe

Courtesy of Dr. Carlos Fava.

Transcatheter aortic valve implantation has already proven to be beneficial for high-risk and inoperable patients. In that sense, it is also an increasingly frequent solid option for lower-risk patients. However, due to the presence of valve calcifications, it may occasionally be necessary to assess the benefits and risks of valve dilation before the procedure.

This study analyzed 678 patients: 400 (60%) received aortic valve predilation before TAVI and 278 (40%) did not.

The characteristics of both groups were similar. However, patients who underwent TAVI without predilation were more commonly male, had a slightly lower fraction ejection, and presented a lower prevalence of hypertension. Among patients who did not receive predilation, 31% presented severe valve calcification.

In this group, the SAPIENS XT was the valve most used, and the SAPIENS 3 valve was the one most used in patients from the other group.

Implantation success was 98% for both groups. Procedural times were lower in the group without predilation (85.6 ± 42.9 vs. 56.7 ± 26.1 minutes p = <0.001), as were the rates of fluoroscopy time (9.5 ± 5.7 vs. 6.2 ± 3.9 minutes, p = <0.001), and contrast volume (131.9 ± 60.8 vs. 85.4 ± 37.4 mL; p = <0.001).

There were no differences neither in the final gradient nor in the presence of ≥2 leaks. The need for cardiovascular resuscitation was higher among patients who underwent predilation (5.3% vs. 1.4%; p = 0.01).

The implantation success endpoint (VARC-2) was 88.3% vs. 92.4% (p = 0.07) and the clinical efficacy endpoint was 88.7% vs. 92.4% (p = 0.11). It is clear that outcomes with and without predilation were similar. However, the safety endpoint was less frequent in the group that underwent predilation (85.2% vs. 90.2%, p=0.004), while there were no differences as regards stroke (1.5%).

At 30 days, patients in the group that did not undergo predilation presented lower all-cause mortality rates (6.8% vs. 2.9%; p = 0.04) and lower cardiac mortality rates (5.3% vs. 1.4%).

Conclusion

TAVI without prior valvuloplasty is feasible without apparent adverse impact on patients receiving a balloon-expandable TAVI prosthesis. The omission of prior valvuloplasty is associated with shorter procedural time, less radiation exposure, lower rates of cardiovascular resuscitation, and a better safety profile.

Editorial Comment

Not carrying out a valvuloplasty favors lower procedural times and lower contrast volumes. It also allows for the reduction of costs without diminishing procedural quality.

This study must have been affected not only by the learning curve, but also by technological valve development, since, in the early days of TAVI, valvuloplasties before implantation were performed more frequently.

Surely, there are many patients with severe valve calcification (particularly in the bicuspid valves) that require prior dilation.

Courtesy of Dr. Carlos Fava.

Original title: Omission of Predilation in Balloon-Expandable Transcatheter Aortic Valve Implantation: Retrospective Analysis in a Large-Volume Centre.

Reference: Karsten Hamm et al. EuroIntervention 2017;13:e161-e167.

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