A prospective controlled trial of St. Jude versus Starr Edwards aortic and mitral valve prostheses.
BACKGROUND
There is a paucity of controlled trials comparing the merits of different heart valve prostheses. In this prospective randomized trial we compared Starr Edwards and St. Jude prostheses in the aortic and mitral positions.


METHODS
Two hundred sixty-seven patients and 122 patients undergoing aortic and mitral valve replacement, respectively, were allocated by minimization to receive either St. Jude or Starr Edwards prostheses. Patients (2 patients were lost to follow-up) were followed up in a special clinic. Event definition, recording, and reporting were in accordance with published guidelines.


RESULTS
There were no demographic differences between patients receiving the two different valve models. With the exception of infective endocarditis, we found no differences in the rates of death or complication between patients receiving a Starr Edwards prosthesis or a St. Jude prosthesis in either position. Neither were there any differences between the two valve models in either position, in terms of symptomatic relief 5 years after surgery.


CONCLUSIONS
We found no differences in rates of complication or of symptomatic improvement between the Starr Edwards and St. Jude valve prostheses in either aortic or mitral position. Left ventricular function had such a marked effect on long-term survival that it overwhelmed any differences that might exist between different prosthetic designs. This confirms that historical comparisons are of limited value in deciding the respective merits of heart valve prostheses. The most reliable method of assessing surgical procedures is through prospective controlled trials.
Murday
Andrew J
AJ
Department of Cardiothoracic Surgery, St. George's Hospital, London, United Kingdom. andrew.murday@btinternet.com
Hochstitzky
Andreas
A
Mansfield
Judith
J
Miles
Julie
J
Taylor
Beverley
B
Whitley
Eileen
E
Treasure
Tom
T
D000368:Aged; D001021:Aortic Valve / Q000503:physiopathology / Q000601:surgery; D002423:Cause of Death; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006349:Heart Valve Diseases / Q000175:diagnosis / Q000401:mortality* / Q000601:surgery*; D006350:Heart Valve Prosthesis; D006801:Humans; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve / Q000503:physiopathology / Q000601:surgery; D011183:Postoperative Complications; D011336:Probability; D011446:Prospective Studies; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012086:Reoperation; D018570:Risk Assessment; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome