Key result
Intra-operative balloon pressure-volume sizing accurately determines annular diameter with high repeatability in preclinical models.
Why the study?
Preoperative image-based sizing for TAVI has inherent limitations leading to suboptimal prosthesis sizing and complications such as aortic regurgitation or conduction disturbance.
Does an intra-operative sizing method using balloon pressure-volume data accurately determine the dimension of compliant aortic annuli in idealized phantoms?
Does an intra-operative sizing method using balloon pressure-volume data accurately determine the dimension of compliant aortic annuli in idealized phantoms?
An intra-operative sizing algorithm using balloon pressure-volume data can accurately determine the dimensions of compliant and elliptical aortic annuli in vitro, representing progress toward improving TAVI device selection.
May aid TAVI sizing if validated in vivo; leaves open translation from phantoms to patients.
OBJECTIVE: Aortic stenos (AS) is a heart valve disease that commonly affects the elderly. Transcatheter aortic valve implantation is a minimally invasive treatment that allows to replace the function of the diseased native valve with a prosthetic device, relying on catheters for device implantation. According to the current clinical guidelines, the choice of the implanted device is based on preoperative sizing determined by image-based technology. However, this assessment faces inherent limitations that can lead to sub-optimal sizing of the prosthesis; in turn, this can cause major post-operative complications like aortic regurgitation or cardiac electrical signal disruption. METHOD: By utilizing balloon pressure and volume data, this article proposes an intra-operative method for determining the dimension of the aortic annulus which takes into account its compliance and geometric irregularity. The intra-balloon pressure-volume curves were obtained using an Automated Balloon Inflation Device operating a commercially available valvuloplasty balloon catheter. A sizing algorithm to estimate the dimensions of the annulus was integrated via a validated analytical model and a numerical model for balloon free-inflation. Tests were performed on circular and elliptical idealised aortic phantoms. RESULTS: Experimental results confirm that the pressure-volume data processed with the sizing algorithm can be used to determine the circular annular diameter for all tissue rigidities. CONCLUSION: The measurement of stiffer elliptical annulus phantoms shows good accuracy and high repeatability. SIGNIFICANCE: This work represents substantial progress toward improving the selection of TAVI devices by using balloon catheters to improve the sizing of compliant aortic annuli with complex geometry.
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Yao et al. (2023) studied Aortic Stenosis (in vitro model) (n=32). Automated Balloon Inflation Device (ABID) sizing algorithm vs. Known phantom dimensions was evaluated on Estimated annular diameter. The intra-operative sizing algorithm using balloon pressure-volume data accurately determined the circular annular diameter across all tissue rigidities and demonstrated high repeatability in stiffer elliptical phantoms.
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