Advice

Summary

Summary

TactiCath Quartz 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 delivering radiofrequency energy during ablation procedures. It may also be used to map the electrical activity of the heart, pace or confirm electrical isolation. TactiCath Quartz 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. The evidence from 3 comparative studies is of limited quantity and quality. In the TOCCASTAR randomised controlled trial, TactiCath achieved non‑inferior efficacy and safety outcomes compared with pulmonary vein isolation using a non‑contact force‑sensing catheter. The list price of TactiCath Quartz is £3,565 (excluding VAT), but additional components are needed for the ablation procedure.

NICE has also published a medtech innovation briefing on the ThermoCool SmartTouch catheter.

Product summary and likely place in therapy

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

  • It delivers radiofrequency ablation as well as providing real‑time contact force measurements during cardiac ablation procedures. TactiCath Quartz may also be used to map the electrical activity of the heart, pace or confirm electrical isolation.

  • It would be used in people with cardiac arrhythmias requiring ablation, including people diagnosed 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 ThermoCool SmartTouch catheter.

Effectiveness and safety

  • The published evidence summarised in this briefing used the TactiCath catheter (the predecessor to TactiCath Quartz) and is limited in quantity and quality. The main evidence comes from 510 patients across 1 randomised controlled trial, 1 non‑randomised prospective comparative study and 1 non‑randomised retrospective comparative study.

  • The TOCCASTAR randomised controlled trial compared TactiCath (n=152) with a non‑contact force‑sensing catheter (n=146). This study showed non‑inferiority of TactiCath in device and procedural safety and effectiveness at 12 months.

  • A non‑randomised study which compared TactiCath (n=32) with a non‑contact force‑sensing catheter (n=35) showed a statistically significant reduction in total procedural time (78 minutes compared with 96 minutes) for the TactiCath catheter, but no statistically significant difference in recurrence of atrial fibrillation at 6 or 12 months.

  • A non‑randomised study involved a retrospective analysis of local registry data, comparing TactiCath (n=31) with a non‑contact force‑sensing catheter (n=112). The analysis showed a statistically significant reduction in total procedural time (128 minutes compared with 158 minutes) and a statistically significant reduction in the recurrence of atrial fibrillation at 12 months (16.1% compared with 36.6%) using the TactiCath catheter.

Technical and patient factors

  • TactiCath Quartz 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 TactiCath Quartz catheter must be used with the TactiSys Quartz system to visualise the contact force applied. The manufacturer recommends a contact force between 10 g and 30 g during a cardiac ablation procedure.

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

Cost and resource use

  • The list price of a single‑use TactiCath Quartz catheter is £3,565. A steerable introducer sheath may also be needed which costs from £1,178 to £1,364. A TactiSys Quartz system is also necessary and costs £25,730 (excluding VAT).

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

  • Conventional radiofrequency ablation catheters without contact force‑sensing technology are available from St. Jude Medical, ranging in cost from £1,147 to £3,255. Separate circular mapping catheters (to confirm electrical pulmonary vein isolation) are also available from St. Jude Medical, ranging in cost from £1,550 to £2,170.

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