The St Jude medical trifecta aortic pericardial valve: Results from a global, multicenter, prospective clinical study

Joseph E. Bavaria, Nimesh D. Desai, Anson Cheung, Michael R. Petracek, Mark A. Groh, Michael A. Borger, Hartzell V Schaff

Research output: Contribution to journalArticle

81 Citations (Scopus)

Abstract

Background: The St Jude Medical Inc (St Paul, Minn) Trifecta valve is a novel aortic biological prosthesis that incorporates several design features, including a true supra-annular sewing cuff, a stent design that maximizes valve hemodynamics while minimizing leaflet stresses, and an ethanol-based anticalcification technology. This study establishes the safety and early clinical and hemodynamic performance of the Trifecta valve. Methods: The Trifecta bioprosthesis was implanted in 1014 eligible patients between 2007 and 2009 at 31 centers. The mean age of the population was 72.5 ± 9.0 years, of whom 650 (64.1%) were male and 364 (35.9%) were female. Eighty-two subjects (8.1%) had undergone previous open surgery. Indications for aortic valve replacement surgery included stenosis in 556 patients (54.8%), regurgitation in 61 patients (6.0%), and mixed pathology in 397 patients (39.2%). Results: The overall follow-up included 844.3 late patient-years. Early (≤30 day) mortality occurred in 18 patients (1.8%), and there were 23 late (≥31 days) deaths yielding a linearized mortality rate of 2.72% per late patient-year. There were 27 early thromboembolic events, including 8 (0.8%) strokes, 17 (1.7%) reversible neurologic events, and 2 (0.2%) systemic embolic events. There were no instances of early valve thrombosis, endocarditis, or clinically significant hemolysis. There were 16 late thromboembolic events (linearized rate of 1.90% per year of follow-up), including 4 strokes and 12 reversible neurologic events. In total, there were 5 late valve explants, including 1 structural deterioration and 4 prosthetic valve endocarditis cases. Overall, freedom from valve explant was 99.4% at 2 years. At the time of discharge, average mean gradients ranged from 9.3 to 4.1 mm Hg and effective orifice area ranged from 1.58 to 2.50 cm2 for valve sizes 19 to 29 mm, respectively. Conclusions: The St Jude Medical Trifecta valve is a unique pericardial bioprosthesis with design elements that provide excellent hemodynamic performance while providing ease of implantation. Long-term follow-up continues to confirm the promising results of this innovative bioprosthesis.

Original languageEnglish (US)
Pages (from-to)590-597
Number of pages8
JournalJournal of Thoracic and Cardiovascular Surgery
Volume147
Issue number2
DOIs
StatePublished - Feb 2014

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Aortic Valve
Prospective Studies
Bioprosthesis
Hemodynamics
Endocarditis
Nervous System
Stroke
Mortality
Hemolysis
Clinical Studies
Prostheses and Implants
Stents
Pathologic Constriction
Thrombosis
Ethanol
Pathology
Technology
Safety
Population

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Surgery
  • Pulmonary and Respiratory Medicine

Cite this

The St Jude medical trifecta aortic pericardial valve : Results from a global, multicenter, prospective clinical study. / Bavaria, Joseph E.; Desai, Nimesh D.; Cheung, Anson; Petracek, Michael R.; Groh, Mark A.; Borger, Michael A.; Schaff, Hartzell V.

In: Journal of Thoracic and Cardiovascular Surgery, Vol. 147, No. 2, 02.2014, p. 590-597.

Research output: Contribution to journalArticle

Bavaria, Joseph E. ; Desai, Nimesh D. ; Cheung, Anson ; Petracek, Michael R. ; Groh, Mark A. ; Borger, Michael A. ; Schaff, Hartzell V. / The St Jude medical trifecta aortic pericardial valve : Results from a global, multicenter, prospective clinical study. In: Journal of Thoracic and Cardiovascular Surgery. 2014 ; Vol. 147, No. 2. pp. 590-597.
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N2 - Background: The St Jude Medical Inc (St Paul, Minn) Trifecta valve is a novel aortic biological prosthesis that incorporates several design features, including a true supra-annular sewing cuff, a stent design that maximizes valve hemodynamics while minimizing leaflet stresses, and an ethanol-based anticalcification technology. This study establishes the safety and early clinical and hemodynamic performance of the Trifecta valve. Methods: The Trifecta bioprosthesis was implanted in 1014 eligible patients between 2007 and 2009 at 31 centers. The mean age of the population was 72.5 ± 9.0 years, of whom 650 (64.1%) were male and 364 (35.9%) were female. Eighty-two subjects (8.1%) had undergone previous open surgery. Indications for aortic valve replacement surgery included stenosis in 556 patients (54.8%), regurgitation in 61 patients (6.0%), and mixed pathology in 397 patients (39.2%). Results: The overall follow-up included 844.3 late patient-years. Early (≤30 day) mortality occurred in 18 patients (1.8%), and there were 23 late (≥31 days) deaths yielding a linearized mortality rate of 2.72% per late patient-year. There were 27 early thromboembolic events, including 8 (0.8%) strokes, 17 (1.7%) reversible neurologic events, and 2 (0.2%) systemic embolic events. There were no instances of early valve thrombosis, endocarditis, or clinically significant hemolysis. There were 16 late thromboembolic events (linearized rate of 1.90% per year of follow-up), including 4 strokes and 12 reversible neurologic events. In total, there were 5 late valve explants, including 1 structural deterioration and 4 prosthetic valve endocarditis cases. Overall, freedom from valve explant was 99.4% at 2 years. At the time of discharge, average mean gradients ranged from 9.3 to 4.1 mm Hg and effective orifice area ranged from 1.58 to 2.50 cm2 for valve sizes 19 to 29 mm, respectively. Conclusions: The St Jude Medical Trifecta valve is a unique pericardial bioprosthesis with design elements that provide excellent hemodynamic performance while providing ease of implantation. Long-term follow-up continues to confirm the promising results of this innovative bioprosthesis.

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