The working group is developing the following two new AAMI Standards (Contact: Mike Miskell): 

• AAMI PC85; Requirements for Fatigue Performance of Cardiac Rhythm Management Leads. This standard outlines requirements for characterizing the fatigue performance of cardiac leads based on benchtop fatigue testing and bending stiffness measurements, focusing on conductor integrity. It excludes polymer and elastomeric components, bonds, biodegradation, and corrosion. Methods are provided for measuring lead bending stiffness and fatigue strength in different regions, for preconditioning leads, and for accepting fatigue performance through comparison with proven designs or using a Bayesian model to predict survival rates based on lead stiffness.  

• AAMI PC125; Implantable leads—Perforation propensity—Requirements and test methods. This standard establishes a method to assess the perforation propensity of permanently implantable cardiac pacing and defibrillation leads for transvenous use in the right atrium or ventricle, excluding preformed “J”-shaped and left bundle branch area pacing leads. It focuses on the acute phase post-implantation, prior to fibrotic encapsulation, and does not address all aspects of perforation propensity, such as implant technique or patient-specific factors. The methods and criteria are based on conventional leads and may not apply to novel designs or unique clinical applications.