Advice

Summary

Summary

ThermoCool SmartTouch is a single‑use cardiac ablation catheter with a deflectable distal section and a contact force sensor at the tip. It is used to treat cardiac arrhythmias, such as atrial fibrillation, by mapping the electrical activity of the heart, delivering radiofrequency energy during ablation procedures, and confirming electrical isolation. ThermoCool SmartTouch differs from standard ablation catheters by providing a real‑time measurement of the contact force applied by the catheter tip to the heart wall during the ablation procedure. This briefing includes 10 studies of mixed quality, including 2 randomised controlled trials and 2 large comparative studies. The studies reported a higher mean contact force, fewer pulmonary reconnections and shorter procedural, ablation and fluoroscopy times with ThermoCool SmartTouch compared with radiofrequency ablation with contact force measurements blinded or with conventional catheters. The list prices for the ThermoCool SmartTouch uni- and bi‑directional catheters are £1,675 and £1,750 (excluding VAT) respectively, but additional components are needed for the ablation procedure.

NICE has also published a medtech innovation briefing on the TactiCath Quartz catheter.

Product summary and likely place in therapy

  • ThermoCool SmartTouch is a single‑use radiofrequency ablation catheter with a deflectable distal section and a contact force sensor at the tip.

  • It conducts cardiac mapping, delivers radiofrequency ablation and provides real‑time contact force guidance during cardiac ablation procedures.

  • It would be used in people with symptomatic atrial fibrillation and would replace conventional radiofrequency ablation catheters without contact force‑sensing technology.

  • NICE has also published a medtech innovation briefing on the TactiCath Quartz catheter.

Effectiveness and safety

  • The relevant evidence summarised in this briefing includes 2 randomised controlled trials and 2 observational studies including 2,273 patients and is of mixed quality. Six non‑randomised comparative studies have also been considered. There are several further studies in progress.

  • Two randomised controlled trials compared pulmonary vein isolation using ThermoCool SmartTouch with and without the contact force measurements being visible to the user. The first study (n=120) reported fewer acute and persistent pulmonary vein reconnections and a shorter procedural time in the contact force‑guided group. The second trial (n=38) reported a higher mean contact force, a shorter procedural time and fewer residual connection gaps in the contact force‑guided group.

  • A retrospective observational cohort study (n=1,515) compared the use of ThermoCool SmartTouch with a non‑contact force‑sensing catheter. The study reported lower fluoroscopy times, radiation doses and shorter procedural times with ThermoCool SmartTouch.

  • A retrospective observational study (n=600) compared the use of ThermoCool SmartTouch with non‑contact force catheters. The study found that using ThermoCool SmartTouch independently predicted clinical success in ablation of paroxysmal atrial fibrillation but not non‑paroxysmal atrial fibrillation.

Technical and patient factors

  • ThermoCool SmartTouch would be used in the cardiac catheterisation laboratory of a secondary or tertiary care hospital. It would be used by cardiac electrophysiologists who have appropriate training.

  • The ThermoCool SmartTouch catheter must be used with the CARTO 3 navigation system to visualise the contact force applied. The manufacturer does not recommend a particular optimal contact force to be used during ablation procedures.

  • NICE has published interventional procedures guidance on percutaneous radiofrequency ablation procedures for atrial fibrillation.

Cost and resource use

  • The list prices for single‑use ThermoCool SmartTouch uni- and bi‑directional catheters are £1,675 and £1,750 (excluding VAT) respectively. The CARTO 3 navigation system is also necessary and costs £129,999 (excluding VAT).

  • A Biosense Webster radiofrequency generator and irrigation system are also needed for the ablation procedure, although they may be readily available in cardiac catheterisation laboratories.

  • A conventional radiofrequency ablation catheter without contact force‑sensing technology – ThermoCool Nav – is available from Biosense Webster, and has a list price of £1,250. Separate circular mapping catheters (to confirm electrical pulmonary vein isolation) are also available from Biosense Webster, with list prices ranging from £1,000 to £1,200.

  • No evidence on cost effectiveness or resource consequences was identified from the literature review.