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J Thorac Cardiovasc Surg 2005;130:759-764
© 2005 The American Association for Thoracic Surgery

Surgery for Acquired Cardiovascular Disease

A randomized comparison of the MCRI On-X and CarboMedics Top Hat bileaflet mechanical replacement aortic valves: Early postoperative hemodynamic function and clinical events

Valve Study Group, Guy's and St Thomas Hospitals, London, United Kingdom

Some of the data in this article were presented at the Second Biennial Meeting of the Society of Heart Valve Disease (2003) and the Annual Meeting of the Society of CardioThoracic Surgeons of Great Britain (2004).

Received for publication November 6, 2004; revisions received February 10, 2005; accepted for publication February 25, 2005.

^_* Address for reprints: John Chambers, MD, FACC, Cardiothoracic Centre, St Thomas Hospital, London SE1 7EH, UK (Email: jboydchambers{at}aol.com).

OBJECTIVE: This study compared hemodynamic function and clinical events in consecutive patients randomly assigned to receive a wholly supra-annular replacement valve or a valve with an intra-annular component.

METHODS: Fifty-two patients with an average age of 62 years (range 40–74 years) were sized for both a CarboMedics Top Hat valve (CarboMedics Inc, Austin, Tex) and an MCRI On-X valve (Medical Carbon Research Institute, LLC, Austin, Tex) before random assignment to receive either valve type. Echocardiographic and clinical assessments were performed in the immediate postoperative period and at 1 year.

RESULTS: The mean effective orifice areas were 1.41 ± 0.42 cm² for the Top Hat and 2.17 ± 0.78 cm² for the On-X (P < .0001). The mean pressure differences were 12.2 ± 4.4 mm Hg and 6.9 ± 3.6 mm Hg, respectively (P < .0001). New York Heart Association functional class was better with the On-X than the Top Hat valves, but there were no differences in clinical events, regression of left ventricular mass, or measures of hemolysis.

CONCLUSION: The partially intra-annular MCRI On-X valve was hemodynamically superior to the wholly supra-annular CarboMedics Top Hat valve. However, there were no differences in early clinical outcomes between the two valve types.

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