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THE JOURNAL OF CARDIOVASCULAR SURGERY

Rivista di Chirurgia Cardiaca, Vascolare e Toracica


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The Journal of Cardiovascular Surgery 2003 February;44(1):25-30

Copyright © 2009 EDIZIONI MINERVA MEDICA

lingua: Inglese

Initial clinical and hemodynamic experience with Edwards MIRATM Mechanical Bileaflet Valve

De Feo M., Renzulli A., Onorati F., Della Corte A., Dialetto G., Covino F. E., Cotrufo M.

Depart­ment of ­Cardio-Tho­racic Sci­ences, 2nd ­Uni­ver­sity of ­Naples, ­Naples, ­Italy


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Aim. An ­enhanced ­bileaflet ­valve, the ­Edwards ­MIRA™ Mechan­ical ­Valve ­became avail­able in 1998. Favor­able hydro­dy­namic fea­tures and a rede­signed ­sewing ­ring encour­aged us to ­implant ­this ­device in indi­cated ­patients. Hemo­dy­namics and clin­ical per­for­mance param­e­ters ­were eval­u­ated.
­Methods. ­Between Feb­ruary 1998 and ­October 1999, 338 ­patients (171 ­males, 167 ­females) under­went ­native ­valve replace­ment ­with a ­MIRA™ pros­thesis. ­Mean age 56.6±13.6 ­years, 320 ­patients ­were in ­NYHA ­class III/IV. Sixty-seven ­patients had echoc­ar­di­o­graphic exam­ina­tions. Stan­dard car­di­o­pul­mo­nary ­bypass was ­employed uti­lizing insti­tu­tion­ally ­accepted implan­ta­tion tech­niques. ­Aortic ­valve replace­ment was per­formed in 163 ­patients, ­mitral ­valve replace­ment in 134 ­patients, 35* ­double ­valve replace­ments and 1 ­triple ­valve replace­ment.
­Results. ­Follow-up is 98% com­plete. ­Mean ­follow-up is 6.9±3.3 ­months (178.2 ­patient ­years). ­There ­were no oper­a­tive ­deaths. ­Four ­early ­deaths ­were ­seen (1.18%). ­Late ­deaths ­reported in 12 ­patients. Lin­e­ar­ized ­rate of ­late mor­tality was 6.7% per ­patient ­year (ppy). ­Overall actu­arial sur­vival at 13 ­months is 92.2%. ­Mean gra­dients and Effec­tive Ori­fice ­Areas (­EOA’s) are com­par­able to ­other ­bileaflet ­valves. Lin­e­ar­ized ­rates for ­valve-­related com­pli­ca­tions was 4.49% ppy. ­Only 5 tran­sient throm­boem­bolic ­events (TE = 2.81% ppy) and 3 non-struc­tural ­valve dys­func­tion ­events (­NSVD = 1.68%) ­were ­seen. No ­reports of ­bleeding ­events, pros­thetic endo­car­ditis, ­valve throm­bosis or struc­tural ­valve dete­ri­ora­tion. One ­patient ­required ­mitral ­valve reop­er­a­tion for per­i­val­vular ­leak.
Con­clu­sion. ­Short-­term hemo­dy­namic and clin­ical ­results are com­par­able to ­other ­bileaflet ­valves. The ­sewing ­ring is non-obstruc­tive, com­pliant ­with ­smoother ­needle pen­e­tra­tion. ­Early clin­ical ­results are encour­aging, ­follow-up ­should be con­tinued.

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