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CLINICAL TRIAL
JOURNAL ARTICLE
The CarboMedics "top hat" supraannular prosthesis in the small aortic root.
Journal of Cardiac Surgery 1995 May
Twenty-three patients, 11 men and 12 women, with a mean age of 64 (range, 34 to 78) underwent aortic valve replacement (AVR) with a CarboMedics "Top Hat" supraannular prosthesis between March 1993 and August 1994. The top hat supraannular prosthesis, a standard bileaflet valve with the cuff transferred to the valve inflow level, allowed implantation of 21-mm, 23-mm, and 25-mm valves, where a standard 19-mm or 21-mm valve would have usually been placed. One patient who had been in preoperative cardiogenic shock died in the perioperative period. Another had an intraoperative cerebral embolism with permanent impairment. Follow-up on 22 of 23 patients over a mean period of 9 months revealed mean Doppler gradients of 18 +/- 6 mmHg, 15 +/- 2.8 mmHg, and 11 mmHg, for the 21-mm, 23-mm, and 25-mm valves, respectively. Functional improvement was noted, with 17 patients in New York Heart Association (NYHA) Class I and 6 in NYHA Class II, postoperatively, compared with 0 in Class I, 9 in Class II, 10 in Class III, and 4 in Class IV, preoperatively. One patient showed reduced postoperative ventricular function with fractional shortening below 25%. Pandiastolic regurgitation intrinsic to the valve graded as slight was noted in all patients. Other postoperative complications included one patient with anticoagulant-related gastrointestinal bleeding and one other with prosthetic valve endocarditis successfully treated with antibiotics. The CarboMedics top hat valve allows a gain in prosthesis size of 2 mm to 4 mm in the aortic position over standard prostheses, resulting in favorable postoperative hemodynamics.
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