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Trifecta™ performs well in its first 5-year multi-centre study

Details have recently emerged from the first 5-year multi-centre study of St Jude Medical’s tri-leaflet stented pericardial valve, Trifecta™. The study set out to further evaluate the long-term clinical safety and effectiveness of the Trifecta™ valve.
The study was conducted exclusively in the United States in six of the country’s leading hospitals, including the Mayo Clinic, Rochester, MN; the Hospital of the University of Pennsylvania, Philadelphia, PA; and the Abbott Northwestern Hospital, Minneapolis, MN and featured a sample of 444 subjects.
The valve was found to perform exceptionally well. Freedom from structural valve deterioration at five years was 99.7% (95% confidence limits). The valve was also found to have very low complication rates, such as TE, Bleeding, leakage, etc.
Patient outcomes were similarly very positive. The average mean gradient by valve size was ≤ 14.6 mmHg at four years. Subjects had average EOAIs ≥ 0.84 cm2/m2 at four years. Preoperatively 51.4% of subjects were in NYHA Class III or IV. At five years postoperatively 98.0% were NYHA Class I or II. More than 85% of subjects had no or trivial regurgitation at four years.
The results of the clinical study demonstrate that the St. Jude Medical Trifecta™ valve is a safe and effective replacement for a malfunctioning native or prosthetic aortic heart valve. The clinical safety and effectiveness of the Trifecta™ valve was confirmed by establishing adverse event rates, New York Heart Association functional classification and hemodynamic performance.
If you would like to know more about the study please click here or opposite to download a copy.
If you would like to know more about the Trifecta™ valve please contact you local PEI hospital representative or call +353 1 419 6900.

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