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. 2023 Aug;102(2):318-327.
doi: 10.1002/ccd.30752. Epub 2023 Jun 24.

Anatomic suitability for transapical transcatheter mitral valve implantation using a tether-based device

Philipp Blanke  1 , Thomas Modine  2 , Alison Duncan  3 , Maurizio Taramasso  4 , Nicolas Dumonteil  5 , Michael L Chuang  6 , Lenard Conradi  7
Affiliations

Anatomic suitability for transapical transcatheter mitral valve implantation using a tether-based device

Philipp Blanke et al. Catheter Cardiovasc Interv. 2023 Aug.

Abstract

Background: Transcatheter mitral valve implantation (TMVI) is a novel therapeutic option for treating symptomatic mitral valve disease. Evaluating patient anatomical suitability is a critical step in the TMVI screening process, but currently requires specialized software and computerized device models.

Aims: This analysis sought to assess the effectiveness of simple and standardized multislice computed tomography (MSCT) anatomic measurements for their ability to discriminate between patients who passed anatomical screening for Tendyne™ TMVI.

Methods: Subjects screened for the Tendyne Expanded Clinical Study from January 2016 through September 2019 were included. Core laboratory screening measurements included mitral annular (MA) dimensions at end-systole and end-diastole, simulated device implantation, and neo-left ventricular outflow tract (LVOT) area. Additionally, nine standard measurements of patient anatomy were assessed for their predictive value of patients passing the anatomic screening process.

Results: Out of 496 subjects screened for eligibility, 257 subjects met clinical eligibility criteria with MA dimensions within the manufacturer's suggested range: 153 (59.5%) underwent TMVI while 104 (40.5%) were excluded from the study for other anatomic reasons (76% due to risk of LVOT obstruction). CT-derived left ventricular end-systole diameter (LVESD) had the highest discriminatory power for predicting TMVI anatomical suitability (area under the curve of 0.908, p < 0.0001). The mitral inter-commissural (IC) dimension was best predictive of annular dimensions being within range, with dimensions <30 or >50 mm resulting in a negative predictive value of 94.4%.

Conclusions: MSCT-derived mitral IC dimension and LVESD easily performed measures that are effective predictors of anatomical suitability or screen failure for this tether-based TMVI device.

Keywords: LVOT obstruction; mitral regurgitation; multislice computed tomography; transapical transcatheter mitral valve implantation.

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References

REFERENCES

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