Saud Khawaja; Lydia Hanna; Abhinav Singh; Carla Lucarelli; Prerna Garg; Iqbal Malik; Nearchos Hadjiloizou; Neil Ruparelia; Adam Hartley; Ramzi Khamis; Matthew Shin; Richard Gibbs; Ghada Mikhail

doi:10.4244/EIJ-D-26-00425

A randomised trial of carbon-dioxide flushing to reduce vascular brain injury in patients undergoing TAVI

Saud Ahmed Khawaja¹^,², MD; Lydia Hanna¹^,², MD; Abhinav Singh¹, MD; Carla Lucarelli¹^,², MD; Prerna Garg¹, MD; Iqbal Malik¹, MD; Nearchos Hadjiloizou¹, MD; Neil Ruparelia¹, MD; Adam Hartley¹, MD; Ramzi Khamis¹^,², MD; Matthew Shun Shin¹, MD; Richard Gibbs¹^,², MD; Ghada W. Mikhail¹^,², MD

Abstract

Background: Stroke remains a significant concern in patients undergoing Transcatheter Aortic Valve Implantation (TAVI). Despite advances in TAVI technology and techniques, rates have remained unchanged, with trials of Cerebral embolic protection devices (CEPD) failing to reduce rates. The concept of air emboli has never been previously investigated in TAVI procedures. We hypothesize that gaseous emboli could play a significant role in TAVI and that carbon dioxide (CO₂) flushing of the TAVI valves could reduce the incidence of new neurological lesions post-TAVI.

Aims: To demonstrate the neuroprotective benefits of CO₂ flushing in TAVI.

Methods:INTERCEPTavi is a pilot single centre, blinded, randomized controlled trial that studied the effects of flushing TAVI valves with CO₂ versus conventional saline on neurological outcomes post TAVI assessed using MRI and transcranial doppler(TCD). Patients with aortic stenosis were randomised after access was obtained. Peri-procedure TCD assessed solid and gas emboli to the brain. Post-procedure, patients underwent brain MRI to detect lesions. Here we report the primary outcome of feasibility, as well as the secondary MRI and mechanistic TCD data.

Results: 60 patients were recruited and randomised 1:1 to CO₂ and saline flushing (TAVI-CO₂) versus saline flushing only (TAVI-S). CO₂ flushing significantly reduced the average number of lesions per patient (TAVI-CO₂ 4 lesions/patient vs TAVI-S 8.5 lesions/patient; P=0.031). The total infarct area was numerically lower in the CO₂ group (40.32 mm² vs 93.20 mm²), although this did not reach statistical significance (p=0.111). Similarly, Transcranial Doppler (TCD) showed fewer micro-embolic signals in the CO₂ arm, primarily due to a reduction in gaseous emboli, but this difference was not statistically significant (p=0.5).

Conclusions: INTERCEPTavi is a pioneering first-in-man randomised trial that demonstrated that CO₂ flushing of the TAVI reduces the number of cerebral lesions measured on MRI. CO₂ is an accessible, cost-effective method that can be easily implemented in any catheter laboratory to provide neurological advantages.

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