Seventeen-year clinical results of 1,037 Mitroflow pericardial heart valve prostheses in the aortic position.
OBJECTIVE
It is generally believed that the pericardial tissue valve is associated with a greater propensity to early structural failure and subsequent valve-related complications. However, a modified valve design during recent years has considerably improved the clinical durability of this bioprosthesis.


METHODS
Between April 1986 and December 2003, single Mitroflow pericardial valve prostheses were inserted in the aortic position in 1,037 patients (mean age 72.4 +/- 8.4 years). Coronary artery bypass grafting (CABG) was performed in 373 patients (36%). Preoperative echocardiographic findings of structural valve deterioration (SVD) were confirmed at reoperation. Total follow up was 5,022 patient-years (pt-yr) (mean 4.85 +/- 4.7 years) and was 99.7% complete (three patients lost).


RESULTS
Early (30-day) mortality was 2.9% for elective surgery; 434 patients (41.9%) died during the follow up period. Actuarial survival at 17 years was 23.2 +/- 2%. Actuarial freedom from valve-related mortality at 17 years was 92.0 +/- 2.2%, whereas the linearized mortality rate was 0.4%/pt-yr. Linearized valve-related complications occurred at a rate of 3.6%/pt-yr (n = 122). SVD of Mitroflow bioprostheses occurred at a rate of 1.0%/pt-yr, and caused stenosis (36.7%), insufficiency (20.4%) and combined stenosis and insufficiency (42.9%). Actual freedom from SVD at 17 years was 95.3 +/- 0.7% for all patients, 96.2 +/- 0.6% for those aged > 60 years, and 99.0 +/- 0.4% for those aged > 70 years.


CONCLUSIONS
The Mitroflow pericardial bioprosthesis, in the aortic position, provides an excellent clinical performance and a low rate of valve-related morbidity, mortality and reoperation for up to 17 years. The prosthesis also demonstrates satisfactory hemodynamic performance, and is therefore recommended for patients aged > or = 70 years and for those aged 60-69 years with comorbidities.
Yankah
Charles A
CA
Deutsches Herzzentrum Berlin, Berlin, Germany. yankah@dhzb.de
Schubel
Jens
J
Buz
Semih
S
Siniawski
Henryk
H
Hetzer
Roland
R
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D001705:Bioprosthesis; D019544:Equipment Failure Analysis; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis; D006801:Humans; D008297:Male; D008875:Middle Aged; D010496:Pericardium; D011183:Postoperative Complications / Q000453:epidemiology; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012086:Reoperation; D015996:Survival Rate; D013997:Time Factors