[187709454]
(b)(6) study. It was reported that complete heart block(chb), bradycardia, and atrial fibrillation occurred. Procedure summary: prior to the index procedure, heparin or other anticoagulant was given. The patient received loading doses of 300 mg of aspirin and clopidogrel each. A lotus introducer sheath was placed and then the native aortic valve was treated with balloon valvuloplasty (bav) according to the directions for use. New left bundle branch block (lbbb) was noted post bav. The aortic valve was treated with deployment of a 25 mm lotus edge valve. Successful repositioning of the lotus edge valve involved complete and partial re-sheathing of the lotus edge valve in the delivery system catheter and deployment into a more accurate position within the aortic annulus. Post procedure event summary: three days post index procedure, the patient developed multiple episodes of complete heart block with heart rate at 35-45 beats per minute. Mild symptoms of lightheadedness was noted in the morning. The hospitalization was prolonged due to the event. At this time the block was asymptomatic, however the patient was recommended to start isoprenaline if heart rate was continuously lower than 30. The patient initiated isoprenaline due to symptoms of complete heart block. The following day, the patient was reported to be mildly dizzy with a postural drop at 15 mmhg. Platelets trended low to 96 from 160-200 (standard reference range: 150000- 450000 per microliter of blood) which was diagnosed as thrombocytopenia. Antihypertensive medication was withheld and, on electrophysiology consultation, a permanent pacemaker was recommended to be implanted for new left bundle branch block with intermittent complete heart block. Five days post index procedure, a new permanent pacemaker was successfully implanted and on the same day, the event was considered to be recovered. The electrocardiogram (ecg) report post pacemaker implant showed sinus rhythm with left bundle branch block.
Patient Sequence No: 1, Text Type: D, B5