Wear patterns in the Sorin Bicarbon mechanical heart valve: a clinical explant study.
OBJECTIVE
Mechanical heart valve prostheses are subject to wear due to impact and friction between the occluder(s) and valve housing. Reference data on the extent of wear in vivo is lacking. Therefore, the aim of this study was to describe the wear pattern in Sorin Bicarbon valves explanted from humans for comparison with the findings established in an earlier in vitro study.


METHODS
We investigated eight valves explanted from seven patients, which had been functioning for more than six months and were returned to the Sorin Company for investigation. The protocol comprised: (i) initial visual inspection on receipt; (ii) stereomicroscopy after cleaning and disassembly; (iii) computed planimetry of the worn areas in the housing; (iv) pivot surface profilometry; and (v) scanning electron microscopy.


RESULTS
All wear depths and exposed areas of titanium were less than that predicted from in vitro figures. No valves were explanted due to mechanical failure and none of the patients had reported peripheral embolic events which could be attributed to valve wear. The extent of wear was comparable with that of other valves.


CONCLUSIONS
This descriptive study did not indicate any association between the Bicarbon valve wear characteristics and clinical complications. Clinical studies on valve performance are of paramount importance for elucidating this issue. The establishment of an independent body for studying explanted valves in collaboration with the manufacturers may promote the publication of findings which are of interest for the entire medical community.
Hasenkam
J M
JM
Department of Cardiothoracic and Vascular Surgery, Skejby Sygehus, Aarhus University Hospital, Denmark.
Pasquino
E
E
Stacchino
C
C
Arru
P
P
Vallana
F
F
Paulsen
P K
PK
D000328:Adult; D000368:Aged; D001021:Aortic Valve / Q000601:surgery; D001705:Bioprosthesis; D003936:Diagnosis, Computer-Assisted / Q000295:instrumentation / Q000379:methods; D004869:Equipment Safety; D005260:Female; D006349:Heart Valve Diseases / Q000601:surgery*; D006350:Heart Valve Prosthesis / Q000295:instrumentation* / Q000379:methods; D006801:Humans; D008297:Male; D008855:Microscopy, Electron, Scanning; D008875:Middle Aged; D008943:Mitral Valve / Q000601:surgery; D008991:Monitoring, Physiologic / Q000379:methods; D011474:Prosthesis Design; D011475:Prosthesis Failure; D013997:Time Factors