Time-related risk of the St. Jude Silzone heart valve

European Journal of Cardio-thoracic Surgery

Volumn 30, Issue 1, 2006, Pages 20-27

  Grunkemeier, Gary L ^a   Jin, Ruyun ^a   Im, KyungAh ^b   Holubkov, Richard ^c   Kennard, Elizabeth D ^b   Schaff, Hartzell V ^d  

^a EARLE A CHILES RESEARCH INSTITUTE   (United States)

^b UNIVERSITY OF PITTSBURGH   (United States)

^c UNIVERSITY OF UTAH SCHOOL OF MEDICINE   (United States)

^d MAYO CLINIC   (United States)

Author keywords

Additive regression; Hazard function; Paravalvular leak; Silzone heart valve; Thrombo embolism and bleeding

Indexed keywords

ADULT; AORTA VALVE; ARTICLE; BLEEDING; CARDIAC PATIENT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; ENDOCARDITIS; FEMALE; FOLLOW UP; HAZARD ASSESSMENT; HEART VALVE PROSTHESIS; HEART VALVE REPLACEMENT; HUMAN; MAJOR CLINICAL STUDY; MALE; MEASUREMENT; MITRAL VALVE; MORTALITY; POSTOPERATIVE PERIOD; PRIORITY JOURNAL; PROPORTIONAL HAZARDS MODEL; RANDOMIZED CONTROLLED TRIAL; REGRESSION ANALYSIS; RISK ASSESSMENT; STATISTICAL SIGNIFICANCE; SURGICAL PATIENT; THROMBOEMBOLISM;

AGED; AORTIC VALVE; ENDOCARDITIS; EPIDEMIOLOGIC METHODS; FEMALE; HEART VALVE DISEASES; HEART VALVE PROSTHESIS; HEART VALVE PROSTHESIS IMPLANTATION; HEMORRHAGE; HUMANS; MALE; MIDDLE AGED; MITRAL VALVE; PROSTHESIS DESIGN; PROSTHESIS FAILURE; REOPERATION; THROMBOEMBOLISM; TIME FACTORS;

EID: 33744916065     PISSN: 10107940     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejcts.2006.04.012     Document Type: Article

References (16)

1. Schaff H., Carrel T., Steckelberg J.M., Grunkemeier G.L., and Holubkov R. Artificial Valve Endocarditis Reduction Trial (AVERT): protocol of a multicenter randomized trial. J Heart Valve Dis 8 (1999) 131-139
2. Schaff H.V., Carrel T.P., Jamieson W.R., Jones K.W., Rufilanchas J.J., Cooley D.A., Hetzer R., Stumpe F., Duveau D., Moseley P., van Boven W.J., Grunkemeier G.L., Kennard E.D., and Holubkov R. Paravalvular leak and other events in silzone-coated mechanical heart valves: a report from AVERT. Ann Thorac Surg 73 (2002) 785-792
3. Davila-Roman V.G., Waggoner A.D., Kennard E.D., Holubkov R., Jamieson W.R., Englberger L., Carrel T.P., and Schaff H.V. Prevalence and severity of paravalvular regurgitation in the Artificial Valve Endocarditis Reduction Trial (AVERT) echocardiography study. J Am Coll Cardiol 44 (2004) 1467-1472
4. Edmunds Jr. L.H., Clark R.E., Cohn L.H., Grunkemeier G.L., Miller D.C., and Weisel R.D. Guidelines for reporting morbidity and mortality after cardiac valvular operations. Eur J Cardiothorac Surg 10 (1996) 812-816
5. Kaplan E.L., and Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 53 (1958) 457-481
6. Cox D.R. Regression methods and life table. J R Stat Soc, Series B 34 (1972) 187-220
7. Aalen O.O. A linear regression model for the analysis of life times. Stat Med 8 (1989) 907-925
8. Aalen O.O. Further results on the non-parametric linear regression model in survival analysis. Stat Med 12 (1993) 1569-1588
9. Hosmer D.W., and Lemeshow S. Applied survival analysis: regression modeling of time to event data. Wiley series in probability and statistics (1999), John Wiley & Sons, New York p. 1-386
10. Ionescu A.A., Fraser A.G., and Butchart E.G. Unexpectedly high incidence of embolic events with the St Jude Silzone valve. Eur Heart J 20 Abstract Suppl. (1999) 558
11. Ionescu A.A., Fraser A.G., and Butchart E.G. High incidence of embolism after St Jude Silzone prosthetic valve implantation. Circulation 100 (1999) I-524
12. Ionescu A.A., Payne N., Fraser A.G., Giddings J., Grunkemeier G.L., and Butchart E.G. Incidence of embolism and paravalvar leak after St Jude Silzone valve implantation: experience from the Cardiff Embolic Risk Factor Study. Heart 89 (2003) 1055-1061
13. Akins C.W. Results with mechanical cardiac valvular prostheses. Ann Thorac Surg 60 (1995) 1836-1844
14. Bodnar E. A critical assessment of thrombosis and embolism reporting methods. In: Butchart E.G., and Bodnar E. (Eds). Thrombosis embolism and bleeding (1992), ICR publishers, London 476-484
15. Cannegieter S.C., Rosendaal F.R., Wintzen A.R., van der Meer F.J., Vandenbroucke J.P., and Briet E. Optimal oral anticoagulant therapy in patients with mechanical heart valves. N Engl J Med 333 (1995) 11-17
16. Hosmer D.W., and Royston P. Using Aalen's linear hazards model to investigate time-varying effects in the proportional hazards regression model. Stata J 2 (2002) 331-350