麻豆传媒

Balloon post-dilatation did not eliminate the occurrence of paravalvular regurgitation after transcatheter aortic valve replacement (TAVR) with the Sapien 3 valve, but it didn't hurt outcomes either, an observational registry in PARTNER II showed.

The 12.5% of patients who got balloon post-dilatation were no worse off in permanent pacemaker, annular rupture, or valve embolization rates.

But 18.8% of the post-dilatation group had no regurgitation versus 30.7% among patients who didn't get that step, Rebecca Hahn, MD, of Columbia University Medical Center/New York-Presbyterian Hospital in New York City, and colleagues reported online in .

Thirty-day death and stroke rates were similar between groups. There were more minor strokes at 1 year with balloon post-dilatation, but that association dissipated upon statistical adjustment for calcium burden and other baseline differences.

"The current study of the PARTNER II, SAPIEN 3 Registry shows that although BPD [balloon post-dilatation] patients continue to have more PVR [paravalvular regurgitation], this maneuver is not associated with other procedural complications," Hahn's group concluded, noting that this step in TAVR has been previously tied to valve embolization, stroke, annular or septal rupture, heart block, and acute kidney injury.

Even though the Sapien 3 device was designed for less oversizing, it might be worthwhile to avoid too-little oversizing in the quest for less regurgitation, the authors suggested.

"Although we assume that BPD decreased the immediate post-implant severity of regurgitation, this maneuver may not eliminate regurgitation from malapposition of the transcatheter stent with native tissue in regions of non-compressible calcium," they wrote, "particularly in the setting of significant undersizing of the valve or elliptical annuli."

Notably, more in the post-dilatation group got a second valve during the initial procedure. And post-dilatation was associated with risk for aortic re-intervention at 1 year, independent of baseline characteristics and annular anatomy, Hahn and colleagues noted.

"The Sapien S3 valve has been previously demonstrated to have an effective profile in term of balancing between the degree of oversizing from one hand and the need for BPD from the other," according to Reda Ibrahim, MD, and Jeremy Ben-Shoshan, MD, PhD, both of the Montreal Heart Institute.

The new findings highlight the key trade-off between these two techniques, they wrote in an accompanying editorial.

"These findings reflect that less oversizing is still a 'short blanket', even with the latest generation of transcatheter heart valves, and BPD provides a limited backup for patients with residual PVR following valve deployment," although a safe way to minimize PVR, they wrote.

Of the intermediate- and high-risk patients with aortic stenosis included in the SAPIEN 3 observational study under the PARTNER II umbrella (n=1661), balloon post-dilatation was more likely in those with higher Society of Thoracic Surgeons score, less oversizing, more severe subannular calcification, and a high degree of ellipticity.

Patients in the study were followed for a median of 427 days. During BPD, 14.2% of patients had no additional volume added to the balloon, 71.6% up to 1 cc, and 11.6% 1-2 cc.

The study authors acknowledged that selection bias was possible in their observational study.