Advice

Summary

Summary

  • The technology described in this briefing is Cor‑Knot. It is used for securing sutures in open and minimally invasive valve surgery.

  • The innovative aspects according to the company are that the device provides a quicker, more consistent and secure knot than hand-tied knots.

  • The intended place in therapy would be as an alternative to hand-tied knots in people having open and minimally invasive valve surgery, or an alternative to endoscopic knot pushers, which are used in minimally invasive valve surgery.

  • The main points from the evidence summarised in this briefing are from 5 studies, including a systematic review of 2 randomised controlled trials and 6 retrospective cohort studies, and 4 observational studies. The studies involve a total of 1,715 adult patients in secondary care. They show that Cor‑Knot may reduce aortic cross-clamp time and cardiopulmonary bypass time when used in valve surgery compared with standard care.

  • Key uncertainties around the evidence or technology are that there is limited high-quality evidence, with only 2 randomised controlled trials and limited evidence of follow up of patients to assess the long-term efficacy of Cor‑Knot.

  • Safety issues raised for the technology include that some patients develop post-operative valve regurgitation after Cor-Knot damaged the valve leaflets. The company acknowledges a very low rate of leaflet perforation (0.0021%) and that appropriate fastener orientation prevents leaflet damage. The company states reported adverse events are low (0.00015%) and claims events are primarily related to surgical technique. There is limited evidence of follow up of patients to assess the long-term safety of Cor‑Knot.

  • The cost of Cor‑Knot is £650 to £750 per patient (not including VAT), depending on the number of knots tied. The resource impact would be greater than standard care. However, this could be offset if there are greater benefits, such as reduced adverse events, reduced length of stay or time saving during procedures. Evidence to support these claims is limited.