A review of the available information was performed.The purpose of the study is to assess the rate of occurrence of permanent pacemaker implantation within 14 days of surgery with on-x prosthetic heart valve with anatomic sewing ring when used to replace diseased aortic valves in human subjects through the use of a retrospective registry.The protocol for this study is as follows: this study is multicenter and retrospective.All centers will follow a common protocol in which eligible patients will be entered into the registry after the 14th postoperative day.No procedures will be done and only retrospective data covering the preoperative, operative and the first 2 weeks postop will be collected.The valve safety primary endpoint is "occurrence of permanent pacemaker implantation within 14 days of surgery as a valve-related adverse event per the definitions of the aats (american association for thoracic surgery)/sts (society of thoracic surgeons) guidelines." the valve safety secondary endpoint is "occurrence of other valve-related adverse events within 14 days of surgery per the definitions of the aats/sts guidelines." per the information available to us, this study began in 2013.The study was closed out 04/30/2018 and we are now becoming aware of the primary and secondary endpoints reported by all of the centers.For each event, the date of implant, date of event, and valve-identifying information is unknown.Patient 194, by protocol, is the recipient of an onxan or onxane model on-x valve in the aortic position.The patient was a 59 year old female.Preoperatively, she was in atrial fibrillation and nyha (new york heart association) ii.She had no prior cardiac surgery.Sometime after the on-x valve surgery, she was the recipient of a permanent pacemaker (ppm), and since the observational window is 14 days postoperatively, it would be classified as a major adverse valve-related event per the aats /sts criteria.No other information is available after this observation and so we have no further indications supporting the decision to implant the ppm.In any case, the instructions for use recognize arrhythmia and the possibility of subsequent reoperation as potential adverse events following aortic valve replacement.This event does not identify any additional hazards or modify the probability and severity of existing hazard.
|