Construct validity of a fibre-optic pressure sensor integrated TAVI guidewire for invasive pressure measurements in transcatheter aortic valve implantation: a prospective registry
G A A Versteeg, M A B Westerhof, N A Stens, J Meuwese, M H van Wely, A C Dimitriu Leen, R J M van Geuns, L A F M van Garsse, G S C Geuzebroek, M W A Verkroost, F J H Nauta, R H Heijmen, D H J Thijssen, L X van Nunen, N van RoyenAbstract
Background
Suboptimal haemodynamic performance following transcatheter aortic valve implantation (TAVI) poses significant risks to valve durability and patient outcomes1,2. Invasive haemodynamic measurements during TAVI help identify patients at risk. Recently, a TAVI guidewire equipped with integrated fibre-optic pressure sensor was developed to guide valve delivery and enable real-time invasive haemodynamic monitoring3. While previous studies have demonstrated its safety profile and pacing efficacy, comprehensive data on the construct validity of its haemodynamic measurements are limited.
Purpose
This study aimed to evaluate the construct validity of haemodynamic measurements obtained with a fibre-optic pressure sensor TAVI guidewire compared to conventional fluid-filled pigtail catheters.
Methods
This investigator-initiated, prospective registry, included patients undergoing TAVI for severe aortic stenosis. Complete haemodynamic assessment was performed pre- and post-TAVI with both the fibre-optic TAVI guidewire and conventional fluid-filled pigtail catheters. Primary endpoint was the construct validity of fibre-optic guidewire-derived post-TAVI mean pressure gradient (PG) compared to fluid-filled pigtail catheter measurements. Secondary endpoints included construct validity of the fibre-optic guidewire for isolated pressure measurements and assessment of paravalvular regurgitation (PVR). Finally, in-depth signal analysis was conducted using previously validated automated algorithm4, which allowed direct comparison of continuous pressure signals by correcting for discrepancies between software packages with different calculation algorithms.
Results
This study included 150 patients (mean age 79.7±5.8 years; 46.7% female). Comparison of invasive pressure measurements yielded moderate to excellent agreement (intraclass correlation coefficient [ICC]-range:0.65-0.95). Bias was observed in left ventricular end-diastolic pressure (LVEDP), with the fibre-optic guidewire measuring higher LVEDPs (+3.5 mmHg). Post-TAVI mean PG showed a mean absolute difference of 2.7±2.1 mmHg (ICC:0.67), minimal bias (-0.45mmHg), and 87% concordance with a discrete cut-off (10 mmHg). Good overall agreement was observed for most indices of PVR [ICC-range:0.81-0.87]. Automated algorithm assessment revealed fewer artefacts and calibration errors for the fibre-optic guidewire (p=0.048). Repeat analysis using algorithm-derived parameters improved agreement between fibre-optic and pigtail catheter measurements of mean PG (ICC:0.85).
Conclusions
The fibre-optic guidewire effectively classifies clinically relevant transvalvular gradients with limited bias post-TAVI. The fibre-optic guidewire produced higher LVEDPs, possibly resulting from wire-induced leaflet interaction. Algorithm-derived assessment revealed the fibre-optic guidewire producing measurements with fewer artefacts and calibration errors, thereby potentially challenging current measurement standards.Figure 1 Central IllustrationFor image description, please refer to the figure legend and surrounding text.Figure 2 Primary EndpointFor image description, please refer to the figure legend and surrounding text.