Pentaray contraindicated for use with mechanical valves

We recently reviewed the EP Case Express article ‘How to release PentaRay catheter entrapped in the hinge point of mechanical mitral valve?’ by Kawajiet al.1 Per the Instructions For Use (IFU)2 of the PENTARAY® Catheter, the catheter is contraindicated for use in patients with prosthetic valves as the splines of the catheter may become entangled in the valves. If this happens, the physician could have difficulty withdrawing the catheter from the patient and may apply excessive force against the resistance, which may cause part of the catheter spline to detach and potentially embolize inside the patient ’s body. Surgical intervention may be required in order to retrieve the detached part. Biosense Webster, the manufacturer of the catheter, has received such complaints in routine clinical use of the PENTARAY® Catheter in patients with prosthetic valves. The authors of the case report suggested a manoeuvre to remove the entrapped catheter. However, Biosense Webster has not validated any such manoeuvre in product testing. The practice of medicine is centred around the balancing of risks and benefits for the patient. We wish to provide your readers with a clear understanding of the risks and encourage review of the IFU prior to device utilization. At Biosense Webster, we have a strong commitment to patient care and we continuously monitor the performance of our products to ensure the safety of our patients and meet the expectations of our customers.

Source: Europace - July 13, 2020 Category: Cardiology Source Type: research