Valvular & structural heart diseaseCohort study
Construct Validity of a Novel Fiberoptic Transcatheter Aortic Valve Replacement (TAVR) Guidewire for Invasive Pressure Measurements
- prospective registry study
- hemodynamic assessment performed in-duplo
Authors' conclusion
The fiberoptic guidewire effectively classified clinically relevant transvalvular gradients with limited bias post-TAVR, although it produced higher LVEDPs, possibly reflecting wire-induced leaflet interaction. Algorithm-derived assessment revealed the fiberoptic guidewire producing measurements with fewer artefacts and calibration errors, supporting its proof-of-concept potential to complement current invasive assessment standards.
Study context
- Population
- Patients undergoing TAVRpatients (mean age 79.7 ± 5.8 years, 46.7% female)
- Participants
- 150 patients
- Exposure
- hemodynamic measurements obtained with the fiberoptic TAVR guidewire compared to conventional fluid-filled pigtail catheters
- Outcome
- Agreement between modalities for post-TAVR mean pressure gradient (PG)
- Follow-up
- Post-TAVR
Main finding
As reported in the abstract
Mean absolute difference
2.7 ± 2.1 mm Hg
ICC
0.67
Bias
−0.45 mm Hg
Concordance with a discrete cutoff (10 mm Hg)
87%
Observational data: associations, not effects.
Secondary outcomes
Agreement of invasive pressure measurements
- Moderate to excellent agreement, ICC-range
- 0.65 to 0.95
Bias in left ventricular end-diastolic pressure (LVEDP)
- Fiberoptic guidewire measuring higher LVEDPs
- +3.5 mm Hg
Agreement for indices of paravalvular regurgitation
- Good overall agreement for most indices, ICC-range
- 0.81-0.87
Automated algorithm assessment: artefacts and calibration errors
- Fewer artefacts and calibration errors for the fiberoptic guidewire
- P = 0.048
- Repeat analysis improved mean pressure gradient (PG) agreement, ICC-range
- 0.80-0.85
Original publication
Summarised from the published abstract; every number is checked against it