Possibility of stent folding due to Perceval valve oversizing

LivaNova Singapore Pte Ltd would like to inform healthcare professionals of more than anticipated cases of valve insufficiency, primarily caused by oversizing leading to “stent folding”. Although this issue has been observed with all prosthesis sizes, it has been more frequently reported with sizes S and M. The main root cause identified for stent folding is valve oversizing, associated with other factors such as extremely eccentric aortic annulus, highly calcified portion of the annulus, or uneven decalcification. Patients with an implanted Perceval valve may also experience valve folding when emergency cardiovascular procedures, such as cardiopulmonary resuscitation are administered post-implant. Healthcare professionals are advised on the key steps in prevention and early detection of stent folding. Please refer to the letter for details.

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.