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

Area of Science:

• Cardiology
• Medical Imaging
• Interventional Cardiology

Background:

• Transcatheter mitral valve implantation (TMVI) offers a new treatment for symptomatic mitral valve disease.
• Accurate patient anatomical assessment is crucial for TMVI success but currently relies on complex software.
• Standardized multislice computed tomography (MSCT) measurements may simplify this evaluation.

Purpose of the Study:

• To evaluate the effectiveness of simple, standardized MSCT measurements in predicting anatomical suitability for Tendyne™ TMVI.
• To identify specific MSCT-derived measurements that best discriminate between patients who pass or fail anatomical screening.

Main Methods:

• Analysis of 496 patients screened for the Tendyne Expanded Clinical Study (Jan 2016-Sep 2019).
• Core measurements included mitral annular dimensions, simulated device implantation, and neo-LVOT area.
• Nine standard patient anatomy measurements were assessed for predictive value.

Main Results:

• CT-derived left ventricular end-systole diameter (LVESD) showed the highest discriminatory power (AUC 0.908) for TMVI anatomical suitability.
• Mitral inter-commissural (IC) dimension best predicted annular dimensions within range, with <30mm or >50mm having 94.4% negative predictive value.
• Of 257 eligible patients, 153 underwent TMVI, while 104 were excluded, primarily due to LVOT obstruction risk.

Conclusions:

• Standardized MSCT-derived mitral IC dimension and LVESD are effective and easily performed predictors of anatomical suitability for tether-based TMVI.
• These measurements can aid in efficient patient screening, potentially reducing reliance on specialized software.