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J Thorac Cardiovasc Surg 1996;112:1669-1671
© 1996 Mosby, Inc.

BRIEF COMMUNICATIONS

COMPLETE INTRAOPERATIVE DISLODGMENT OF A ST. JUDE MEDICAL MECHANICAL HEART VALVE HEMODYNAMIC PLUS* VALVE SEWING CUFF

Bari, Italy

Received for publication April 2, 1996 Accepted for publication April 9, 1996. Mechanical disruption of bileaflet heart valves has previously been described. ^1-4 The St. Jude Medical Mechanical Heart Valve Hemodynamic Plus (HP) valve (St. Jude Medical, Inc., St. Paul, Minn.) is a prosthesis designed to reduce transvalvular gradients by increasing valvular area. In 1995, a randomized Italian multicenter study on the hemodynamic performance in the aortic position of the St. Jude Medical HP valve versus the St. Jude Medical standard valve (St. Jude Medical, Inc.) was started. We describe a case of complete intraoperative dislodgment of a St. Jude Medical HP sewing cuff that occurred during the course of that study. We believe this event to be the first reported case of sewing cuff slip-off of a St. Jude Medical valve in the literature.

A 61-year-old man with coronary artery disease and severe aortic regurgitation was referred to our department for aortic valve replacement and coronary artery bypass grafting. After admission to our unit, he gave informed consent for his enrollment in the multicenter study on the hemodynamic performance in the aortic position of the St. Jude Medical HP valve versus the St. Jude Medical standard valve.

At operation, once standard cardiopulmonary bypass had been instituted with two-stage venous cannululation, the aorta was crossclamped and opened. Surgical inspection revealed severe aortic regurgitation with advanced thinning of the valve cusps and no calcification. After valvular excision, the aortic anulus was measured with both St. Jude Medical standard and HP sizers; a 23 mm diameter was found to be adequate and a 23 mm St. Jude Medical HP valve was randomly selected.

The valve implantation was performed in our usual manner. Interrupted U-shaped 2-0 Tevdek sutures (Deknatel Division, Fall River, Mass.) with no pledgets were passed at supraannular level and then through the sewing cuff. The prosthesis was oriented with the axis perpendicular to the ventricular septum. During these stages, the prosthesis was always encased in its holder and held by the assistant surgeon, so no stress was applied to the sewing cuff while the stitches were being placed through the cuff, nor was any rotational force exerted on the valve.

When the prosthesis was inserted while it was being slid down to its supraannular position, the entire sewing cuff was dislodged, causing the sewing cuff to slip completely off of the pyrolitic carbon ring (Figs. 1 and 2). The insertion maneuver was carried out by the first surgeon, who always held the prosthesis in its holder so that no stress was applied to the cuff.

View larger version (121K): [in this window] [in a new window]   Fig. 1. Sewing cuff dislodgment of 23 mm St. Jude Medical HP aortic valve prosthesis.

View larger version (120K): [in this window] [in a new window]   Fig. 2. Complete slip-off of sewing cuff of 23 mm St. Jude Medical HP aortic valve prosthesis.

The postoperative course was uneventful. At the time of this writing, the patient is well and free of complications. The broken St. Jude Medical HP valve has been returned to the manufacturer for examination.

Structural dysfunction of bileaflet valve prosthesis generally concerns leaflet rupture with subsequent embolization. ^1-4 To the best of our knowledge, this is the first reported case of intraoperative dislodgment of the sewing cuff.

The problem occurred during implantation of a 23 aortic St. Jude Medical HP valve in a patient with severe aortic regurgitation. The sewing cuff on the St. Jude Medical HP series of valves is a small horizontal flange designed to be sutured above the anulus. Only the carbon orifice ring is placed into the anulus. The sewing cuff is held in place by six suture windings running tightly around the inner ring. To increase the orifice area, the sewing cuff was thinned by eliminating all cuff material from the anulus, enabling the use of a larger pyrolitic carbon orifice.

The likely explanations for this structural malfunction may be the sudden disruption of the suture windings. This event may be caused either by the windings being cut by the suture needles or may result from a spontaneous breakdown of the winding material caused by a manufacturing defect.

With respect to the first hypothesis, it is recommended by the manufacturer that U-shaped stitches not be used for the implantation of St. Jude Medical HP valves because of the reduced flange thickness, which makes the St. Jude Medical HP valve potentially more susceptible to disruption of the cuff windings. Nevertheless, before this event, several St. Jude Medical HP aortic valves had been implanted at our institution with the same suture technique, and no such complications had been observed, either during operation or at follow-up. Moreover, care was taken during valve implantation not to pass stitches too close to the carbon ring, and no stress or rotation of any sort was exerted on the valve at any time. In addition to these technical precautions, the Tevdek 2-0 sutures used do not have sharp needles. In case of a manufacturing defect, further examination of the manufacturing process may explain its causes.

In conclusion, the complication we observed may highlight a design drawback of the St. Jude Medical HP valve, which otherwise is characterized, at least in our experience, by decreased aortic transvalvular gradient and better prosthetic performance.

Acknowledgments

We thank Ms. Rossella Mercuri and all the staff of St. Jude Medical Italia, Valve Division, for their assistance during the study on the St. Jude Medical HP aortic prosthesis.

Footnotes

From the Departments of Cardiac Surgery^a and Anesthesiology,^b Medical School, University of Bari, Bari, Italy.

J THORAC CARDIOVASC SURG 1996;112:1669-71

*St. Jude Medical Mechanical Heart Valve Hemodynamic Plus is a trade name of St. Jude Medical, Inc., St. Paul, Minn.

References

1. Odell JA, Durandt J, Shama DM, Vythilingum S. Spontaneous embolization of a St. Jude prosthetic mitral valve leaflet. Ann Thorac Surg 1985;39:569-72.[Medline]
   
2. Hasse J. Escaped leaflet in a St. Jude Medical mitral prosthesis. In: DeBakey ME, editor. Advances in cardiac valves: clinical perspectives. New York: Yorke Medical Books, 1983:115-23.
   
3. Hjelms E. Escape of a leaflet from St. Jude Medical prosthesis in the mitral position. Thorac Cardiovasc Surg 1983;31:310-2.[Medline]
   
4. Klepetko W, Moritz A, Mlczoch J, Schurawitzki H, Domanig E, Wolner E. Leaflet fracture in Edwards-Duromedics bileaflet valves. J Thorac Cardiovasc Surg 1989;97:90-4.[Abstract]
   

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