Clinical Research
Heart Valve Disease
The Impact of Integration of a Multidetector Computed Tomography Annulus Area Sizing Algorithm on Outcomes of Transcatheter Aortic Valve Replacement: A Prospective, Multicenter, Controlled Trial

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Objectives

This study prospectively investigated the impact of integration of a multidetector computed tomography (MDCT) annular area sizing algorithm on transcatheter aortic valve replacement (TAVR) outcomes.

Background

Appreciation of the 3-dimensional, noncircular geometry of the aortic annulus is important for transcatheter heart valve (THV) sizing.

Methods

Patients being evaluated for TAVR in 4 centers underwent pre-procedural MDCT. Recommendations for balloon-expandable THV size selection were based on an MDCT sizing algorithm with an optimal goal of modest annulus area oversizing (5% to 10%). Consecutive patients who underwent TAVR with the algorithm (MDCT group) were compared with consecutive patients without the algorithm (control group). The primary endpoint was the incidence of more than mild paravalvular regurgitation (PAR), and the secondary endpoint was the composite of in-hospital death, aortic annulus rupture, and severe PAR.

Results

Of 266 patients, 133 consecutive patients underwent TAVR (SAPIEN XT THV) in the MDCT group and 133 consecutive patients were in the control group. More than mild PAR was present in 5.3% (7 of 133) of the MDCT group and in 12.8% (17 of 133) in the control group (p = 0.032). The combined secondary endpoint occurred in 3.8% (5 of 133) of the MDCT group and in 11.3% (15 of 133) of the control group (p = 0.02), driven by the difference of severe PAR.

Conclusions

The implementation of an MDCT annulus area sizing algorithm for TAVR reduces PAR. Three-dimensional aortic annular assessment and annular area sizing should be considered for TAVR.

Key Words

annulus area
multidetector computed tomography
transcatheter aortic valve replacement
transcatheter heart valve sizing

Abbreviations and Acronyms

MDCT
multidetector computed tomography
PAR
paravalvular regurgitation
TAVR
transcatheter aortic valve replacement
TEE
transesophageal echocardiography
THV
transcatheter heart valve
TTE
transthoracic echocardiography

Cited by (0)

Edwards Lifesciences funded the image transfer but had no involvement in data collection, data analysis, or manuscript writing. Drs. Binder, Webb, Norgaard, Dumont, Wood, Rodés-Cabau, and Leipsic are consultants to Edwards Lifesciences. Drs. Binder and Toggweiler received unrestricted research grants from the Swiss National Foundation. Drs. Hansson and Pibarot received research grants from Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.