A review was performed of the available information of the on-x prosthetic heart valve anatomic suture ring post-market study.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 american association for thoracic surgery/society of thoracic surgeons (aats/sts) 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 (b)(6) 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.As reported in the post-market study, the patient, a (b)(6) male, is the recipient of an onxan or onxane model on-x valve in the aortic position.He was nyha 1 in sinus rhythm preoperatively, but diagnosed with paroxysmal supraventricular tachycardia (psvt) and atrial fibrillation (af) within 14 days of surgery.A pacemaker was not implanted at this time.No other information is available following this diagnosis as the protocol limits adverse event reporting to 14 days postop.The aats/sts guidelines for reporting mortality and morbidity after cardiac interventions define the implantation of a permanent pacemaker or defibrillator within 14 days after surgery as a major valve related event.So, although this patient suffered arrhythmia postoperatively, he received neither a pacemaker nor defibrillator and so the event is not classified as a major valve related adverse event per the guidelines.Nevertheless, the instructions for use (ifu) lists cardiac arrhythmia as a potential complication following aortic valve replacement [ifu]; but as no pacer was implanted and we have no subsequent information, we do not know what, if any, relationship the arrhythmia has to the valve.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.
|