A review of the available information of the on-x prosthetic heart valve anatomic suture ring post-market study 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 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 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.As reported in the post-market study, the patient is a (b)(6) year old male.By protocol, he is the recipient of an onxan or onxane model on-x valve in the aortic position.He was in sinus rhythm preoperatively with no prior history of cardiac surgery reported.Postoperatively, he was diagnosed with congestive heart failure (chf), not valve related.According to the postoperative case report form, he did not receive a pacemaker following this surgery.No other information is available after this observation, including an outcome, as the protocol limits adverse event reporting to 14 days postop.Non valve related chf is generally associated with either myocardial or conduction failure, but no other information is available to draw any physiological association.Consequently, there is no indication that the on-x valve contributed to the event.The ifu [instructions for use] recognizes heart failure as a potential adverse event following aortic valve replacement.No further action is required at this time.The root cause of the event cannot be determined with available information.No indication the on-x valve contributed to the event.The ifu provides instruction about the potential adverse events associated with the use of prosthetic heart valves which may lead to explantation, reoperation, permanent disability, or death.No action necessary.
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