It was reported that on (b)(6) 2024, a 21mm epic max valve was chosen for implant.The patient was presented with small aortic root, requiring enlargement.The 21mm epic max valve was implanted.However, the patient started bleeding and atrioventricular dissection was noticed.The valve was explanted, and pericardial patch repair was performed.A replacement 19mm epic max valve was implanted.
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It was reported that on (b)(6) 2024, a 21mm epic max valve was chosen for implant in a 64-year-old female patient) with a history of aortic insufficiency, coronary artery disease and hypertension.The patient underwent an aortic valve replacement (avr) with a concomitant coronary artery bypass grafting (cabg) to the left anterior descending coronary artery (lad) using the left internal mammary artery (lima).The patient had a small aortic root with thin aortic tissue and an aortic enlargement was required.The aortic valve was sized for a 21 mm epic max valve using the replica sizer end of the epic max sizer set.The 21 mm sizer fit was good, and a decision was made to implant the 21mm epic max valve.The epic max 21mm was implanted without difficulty with the sutures secured using cor-knots.After coming off cardiopulmonary bypass it was noted that there was bleeding from the base of the aorta in the non-coronary sinus with visible pledgets consistent with an aortic-ventricular separation.The patient was placed back on cardiopulmonary bypass and the epic max 21mm valve was removed to expose the area of bleeding.The aortic bleeding site was repaired with autologous pericardial tissue and the valve was resized.Although an epic max 21mm valve was able to be fitted a decision was made to implant instead an epic max 19mm valve.The patient had difficulty coming off cardiopulmonary bypass due to the prolonged procedure and ultimately an intra-aortic balloon pump (iabp) was placed and the patient successfully came off cardiopulmonary bypass.Over the next few days the myocardial function recovered.However, the patient developed an ischemic lower limb as a complication from the iabp and needed to undergo a lower extremity amputation.However, a decision was made not to amputate the lower extremity and the patient developed sepsis with end-organ failure due to the ischemic lower extremity.The patient subsequently passed away.This issue reportedly caused a clinically significant delay due to having to remove, repair, and replace valve.
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