Literature DB >> 20621499

The Italian study on the Mitroflow postoperative results (ISTHMUS): a 20-year, multicentre evaluation of Mitroflow pericardial bioprosthesis.

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Abstract

OBJECTIVE: A multicentre experience with the Mitroflow pericardial bioprosthesis has been evaluated longitudinally over a 20-year period.
METHODS: From 1988 through 2008, 1591 patients (mean age, 75.3±6.8 years, and 60.1% female) from 12 centres had a Mitroflow in the aortic position. Concomitant coronary artery bypass was performed in 41.9% (n=666) of patients, urgency/emergency surgery in 9.5% (n=152) and replacement of degenerated prosthesis in 2.3% (n=36). Follow-up (7.447 patient-years) was 99.2% complete. Median follow-up was 61.9 months (interquartile range (IQR) 30.8-90.9 months). The study was carried out following American Association for Thoracic Surgery/Society for Thoracic Surgeons/European Association for Cardio-Thoracic Surgery (AATS/STS/EACTS) Guidelines for reporting valve morbidity and mortality.
RESULTS: The early (30-day) mortality was 6.5% (n=104). Actuarial survival rates at 10, 15 and 18 years were 53%, 34% and 27%, respectively (2.2 patient/year). Re-operation was required in 96 patients (5.9%), of whom 59 patients (3.7%) for structural valve degeneration. Actuarial freedom from prosthetic valve degeneration at 18 years was 65.5% (78% in patients>70 years) with a linearised rate of 1.4 patient/year (0.8 patient/year in patients>70 years). At 18 years, freedom from embolism was 82% (0.9 patient/year), freedom from valve endocarditis was 89% (0.6 patient/year) and freedom from bleeding episodes was 95% (0.2 patient/year), respectively.
CONCLUSIONS: This independent multicentre study indicates that the Mitroflow pericardial bioprosthesis provides favourable long-term postoperative results with a low rate of valve-related events and need of re-intervention, particularly in patients older than 70 years. Copyright Â
© 2010 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.

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Year:  2010        PMID: 20621499     DOI: 10.1016/j.ejcts.2010.03.069

Source DB:  PubMed          Journal:  Eur J Cardiothorac Surg        ISSN: 1010-7940            Impact factor:   4.191


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