Radiographic Detection of Strut Separations in Björk–Shiley Convexo-Concave Mitral Valves
William W. O'Neill, M.D., James G. Chandler, M.D., Richard E. Gordon, D.O., Donovan M. Bakalyar, Ph.D., Amir H. Abolfathi, M.S., Mark D. Castellani, M.D., Jamie Lee Hirsch, M.S., David W. Wieting, Ph.D., Joseph S. Bassett, M.D., Karen C. Beatty, R.N., Mary Ann Soltis, B.S., Gerald C. Timmis, M.D., and Cindy L. Grines, M.D.
Background The outlet struts of Björk–Shiley convexo-concaveheart valves can occasionally fracture. By December 31, 1994,564 complete strut fractures had been reported to the manufacturer,approximately two thirds of which were fatal. There are no reliablediagnostic methods to detect valves that may be at risk forstrut fracture. The outlet strut has two legs, and one leg oftenappears to break before the other, potentially permitting detectionof the single-leg separation while the valve is still functionallyintact.
Methods We used high-resolution cineradiography and definedvalve profiles to evaluate 315 patients selected on the basisof their having mitral convexo-concave valves with an estimatedfracture rate of 0.46 percent or higher per year. Two examinationswere scheduled six months apart, with early reimaging performedwhen initial ratings were indeterminate.
Results Three patients had unsatisfactory studies, the mostrecent examinations in 277 patients were rated as apparentlynormal, 23 had findings considered minimally suspicious, and1 had findings termed suspicious. The number of false negativeresults in this study group is unknown. Eleven cineradiogramswere rated as showing probable or definite single-leg separations.All five "definite" ratings and five of the six "probable" ratingswere confirmed by removal of the valves. One valve with a "probable"rating was intact. Two complete outlet-strut fractures occurredthree and seven months after apparently normal radiographicexaminations. Unsuspected new positive findings were not foundat six months among 288 patients who completed the examinationcycle.
Conclusions Cineradiographic imaging can detect some single-legseparations in mitral convexo-concave valves and may help theestimated 47,000 patients with these valves worldwide and theirphysicians decide about elective valve removal.
Source Information
From the Division of Cardiology, Department of Internal Medicine, William Beaumont Hospital, Royal Oak, Mich. (W.W.O., R.E.G., D.M.B., M.D.C., J.S.B., K.C.B., G.C.T., C.L.G.); and the Shiley Heart Valve Research Center, Irvine, Calif. (J.G.C., A.H.A., J.L.H., D.W.W., M.A.S.).
Address reprint requests to Dr. O'Neill at the Division of Cardiology, William Beaumont Hospital, 3601 W. 13 Mile Rd., Royal Oak, MI 48073.
Konen, E., Goitein, O., Feinberg, M. S., Eshet, Y., Raanani, E., Rimon, U., Di-Segni, E.
(2008). The Role of ECG-Gated MDCT in the Evaluation of Aortic and Mitral Mechanical Valves: Initial Experience. Am. J. Roentgenol.
191: 26-31
[Abstract][Full Text]
Padera, R. F. Jr., Schoen, F. J.
(2008). Pathology of Cardiac Surgery. Card Surg Adult
3: 111-178
[Full Text]
Matheny, M. E., Ohno-Machado, L., Resnic, F. S.
(2006). Monitoring Device Safety in Interventional Cardiology. J. Am. Med. Inform. Assoc.
13: 180-187
[Abstract][Full Text]
Maisel, W. H.
(2005). Safety Issues Involving Medical Devices: Implications of Recent Implantable Cardioverter-Defibrillator Malfunctions. JAMA
294: 955-958
[Full Text]
Blot, W. J., Ibrahim, M. A., Ivey, T. D., Acheson, D. E., Brookmeyer, R., Weyman, A., Defauw, J., Smith, J. K., Harrison, D.
(2005). Twenty-Five-Year Experience With the Bjork-Shiley Convexoconcave Heart Valve: A Continuing Clinical Concern. Circulation
111: 2850-2857
[Abstract][Full Text]
van Gorp, M. J., van der Graaf, Y., de Mol, B. A. J. M., Bakker, C. J. G., Witkamp, T. D., Ramos, L. M. P., Mali, W. P. T. M.
(2004). Bjork-Shiley Convexoconcave Valves: Susceptibility Artifacts at Brain MR Imaging and Mechanical Valve Fractures. Radiology
230: 709-714
[Abstract][Full Text]
Maisel, W. H.
(2004). Medical Device Regulation: An Introduction for the Practicing Physician. ANN INTERN MED
140: 296-302
[Abstract][Full Text]
Schoen, F. J., Padera, R. F. Jr.
(2003). Cardiac Surgical Pathology. Card Surg Adult
2: 119-185
[Full Text]
Omar, R Z, Morton, L S, Halliday, D A, Danns, E M, Beirne, M T, Blot, W J, Taylor, K M
(2001). Outlet strut fracture of Bjork-Shiley convexo concave heart valves: the UK cohort study. Heart
86: 57-62
[Abstract][Full Text]
Hopper, K. D., Gilchrist, I. C., Landis, J. R., Abolfathi, A. H., Russell Localio, A., Wilson, R. P., Pae, W. E. Jr., Kunselman, A. R., Wieting, D. W., Griffith, J. W., Pierce, W. S., Potok, P. S., TenHave, T. R., Chandler, J. G.
(1998). In Vivo Accuracy Of Two Radiographic Systems In The Detection Of Bjork-Shiley Convexo-Concave Heart Valve Outlet Strut Single Leg Separations. J. Thorac. Cardiovasc. Surg.
115: 582-586
[Abstract][Full Text]
Dow, J.J., Plemons, T. D., Scarbrough, K., Reeder, H., Hovenga, M., Wieting, D. W., Chandler, J. G.
(1997). Acoustic Assessment of the Physical Integrity of Bjork-Shiley Convexo-Concave Heart Valves. Circulation
95: 905-909
[Abstract][Full Text]
Powell, K. A., Obuchowski, N. A., Mueller, K. D., LaPresto, E., Hwang, C. G., Hirsch, J. L., Nissen, S. E., Cornhill, J. F.
(1996). Quantitative Detection of Outlet Strut Separations in Bjork-Shiley Convexo-concave Mitral Valves. Circulation
94: 3251-3256
[Abstract][Full Text]
Vongpatanasin, W., Hillis, L. D., Lange, R. A.
(1996). Prosthetic Heart Valves. NEJM
335: 407-416
[Full Text]
Steyerberg, E. W., Eijkemans, M. J.C., O'Neill, W. W.
(1995). Strut Separations in Bjork-Shiley Mitral Valves. NEJM
333: 1714-1715
[Full Text]
Walker, A. M., Funch, D. P., Sulsky, S. I., Dreyer, N. A.
(1995). Patient Factors Associated With Strut Fracture in Bjork-Shiley 60° Convexo-Concave Heart Valves. Circulation
92: 3235-3239
[Abstract][Full Text]
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