The Conformal left atrial appendage seal (CLAAS)

The Conformal device (Conformal Medical, USA) is designed to adapt to each patient’s left atrial appendage anatomy and reduce the need for transesophageal echocardiography and general anesthetic during implantation.

It has a nitinol skeleton with tw––o rows of 20 anchors that attach to the wall of the left atrial appendage, with a plug-shaped foam matrix coating. The upper portion of this, the part which is exposed to blood, is coated with an expanded polytetrafluoroethylene (ePTFE) layer to prevent device thrombosis1.

The foam matrix allows more effective sealing of potential leaks that occur with other devices, and the two available sizes can adapt to most anatomical variations of the left atrial appendage. The great advantage of the ePTFE coating is that it substantially reduces clot formation on the device, particularly when anticoagulation or anti-platelet agents are contraindicated.

A prospective, multicenter, single-arm clinical trial (ClinicalTrials.gov identifier NCT03616028) is currently underway to assess the device’s safety (mortality, ischemic stroke, systemic thromboembolism, or any device or procedural complication requiring cardiac surgery) and efficacy (complete closure on transesophageal echocardiography at 45 days).

REFERENCES

Palabras clave: cierre de orejuela izquierda, fibrilación auricular, hemorragia. Keywords: left atrial appendage closure, atrial fibrilation, anticoagulation, bleeding.