Description of Event or Problem · 1
THE PATIENT, WHO WAS RECENTLY DIAGNOSED WITH AN ATRIAL SEPTAL DEFECT, WAS TAKEN TO THE CARDIAC CATHETERIZATION LAB AND UNDERWENT TEE, RIGHT AND LEFT CARDIAC CATHETERIZATION AND PLACEMENT OF AN ASD OCCLUDER DEVICE. IN THE MORNING FOLLOWING HER PROCEDURE, SHE WAS NOTED TO HAVE SIGNIFICANT HEMODYNAMIC INSTABILITY WITH TACHYCARDIA AND DECREASED PERFUSION AND WAS EMERGENTLY TRANSFERRED TO THE CARDIAC INTENSIVE CARE UNIT BECAUSE OF A CONCERN FOR CARDIAC TAMPONADE. SHE WAS EMERGENTLY TAKEN TO THE OPERATING ROOM. THERE WAS AN INJURY TO THE RIGHT ATRIAL FREE WALL NEAR THE JUNCTION OF THE AORTA AND THE LEFT ATRIUM. THE BLOOD WAS EVACUATED AND THE INJURY REPAIRED. THE ASD (ATRIAL SEPTAL DEFECT) OCCLUDER DEVICE WAS REMOVED AND THE ASD WAS CLOSED WITH AUTOLOGOUS PERICARDIAL PATCH. POSTOPERATIVELY, PT DID QUITE WELL. PT WAS DISCHARGED TO HOME FOUR DAYS AFTER THE INITIAL PROCEDURE.BALLOON SIZING WAS PERFORMED IN THE CATH LAB UNDER TRANSESOPHAGEAL GUIDANCE. A 25 MM SIZING BALLOON WAS USED. WITH THE 25 MM BALLOON, THERE WAS MINIMAL RESIDUAL LEAK. THE BALLOON, INFLATED DURING THE SIZING, MEASURED 25 MM BY BOTH ANGIOGRAPHY AND BY ECHOCARDIOGRAM. GIVEN THE SLIGHT RESIDUAL LEAK, A 26 MM DEVICE WAS SELECTED. WE TYPICALLY LIKE TO CHOOSE A DEVICE 1 TO 2 MM LARGER THAN THE DEFECT SIZE OBTAINED BY BALLOON SIZING. A LARGER DEVICE (28 MM) WAS NOT CHOSEN DUE TO CONCERNS THAT THE TOTAL SEPTAL LENGTH WOULD NOT ACCOMMODATE A LARGER SIZE.PER SURGEON: NO, THIS IS THE FIRST TIME I HAVE EXPERIENCED A DEVICE EROSION, AND THIS IS THE FIRST TIME AN EVENT OF THIS KIND HAS TAKEN PLACE AT THIS FACILITY. DEVICE EROSION IS A KNOWN, THOUGH RARE, COMPLICATION THAT HAS BEEN REPORTED BY OTHER CENTERS. THE ESTIMATED RATE OF OCCURRENCE IS APPROXIMATELY 1 PER 1000 DEVICES IMPLANTED. CONTRIBUTING ASSOCIATED RISK FACTORS INCLUDE AN INSUFFICIENT RETRO-AORTIC RIM, AND THE USE OF LARGE DEVICES IN RELATIVELY SMALL PATIENTS. THIS PATIENT HAD THE ABOVE RISK FACTORS AND THE POSSIBILITY OF DEVICE EROSION, INCLUDING THE FDA WARNING ISSUED IN USING THESE DEVICES IN PATIENTS WITH INSUFFICIENT RETRO-AORTIC RIM, WAS DISCUSSED EXTENSIVELY WITH THE FAMILY BOTH IN PRE-CATHETERIZATION CONSULTATION AND THE MORNING OF THE PROCEDURE AFTER THE TRANSESOPHAGEAL ECHOCARDIOGRAM CONFIRMED THE FINDING (OF THE RETRO-AORTIC RIM). THE FAMILY PREFERENCE WAS TO AVOID SURGERY IF AT ALL POSSIBLE. THEREFORE, THEY PREFERRED TO ATTEMPT DEVICE CLOSURE WITH THE KNOWN RISK OF DEVICE EROSION.