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Trifecta™ Valve

This device is commercially available for use in select international markets.

When the Goal Is Exceptional Hemodynamics
the Valve Is Trifecta1

The Trifecta™ valve from St. Jude Medical is a pericardial aortic, supra-annular stented tissue valve with a tri-leaflet design.

Results from the global, multicenter, prospective clinical study:

“This study establishes the safety and early clinical and hemodynamic performance of the Trifecta valve in one of the largest prospective evaluations ever performed…” 1

View Global, Multicenter, Prospective Study

 

1 Bavaria JE, Desai ND, Cheung A, et al. The St. Jude Medical Trifecta aortic pericardial valve: Results from the global, multicenter, prospective clinical study. J Thorac Cardiovasc Surg. 2014;147(2):590-7.

Proven Exceptional Hemodynamics1

This three-minute video highlights the clinical and hemodynamic performances of the Trifecta valve. (Video does not contain sound.)

Overview

Designed for outstanding performance in all three areas of hemodynamics, durability and implantability, the Trifecta valve demonstrates our passion for putting more control into the hands of physicians.

Learn more about the Trifecta manufacturing process and quality measures. See Materials & Links

When the Goal Is Hemodynamics

Created exclusively for the aortic position, the Trifecta valve delivers larger EOAs, resulting in single-digit pressure gradients.1 The Trifecta valve is designed to mimic the flow of a natural, healthy heart valve and offers excellent hemodynamic performance, which may provide patients with an improved quality of life.

 

Trifecta Valve Mean Gradient 01 
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In vivo single-digit mean gradients averaged across all valve sizes at one year.1

 

Trifecta Valve effective orifice area 
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Large EOAs across all valve sizes result in decreased risk of prosthesis-patient mismatch at one year.1

Featuring Dr. Marc Sakwa, Chief, Division of Cardiovascular Surgery, William Beaumont Hospital, Royal Oak, Michigan, USA. Documentary video contains information on how the valve was developed and testimonials on its performance.


When the Goal Is Durability

With more than 30 years of market experience, the Trifecta valve was designed for long-term durability and performance. The result is a design that has demonstrated excellent in vitro wear testing.2

Trifecta Valve Mean Gradient 02 1. Pericardial-covered stent for tissue-to-tissue contact reducing the risk of abrasion and structural valve deterioration.2
2. Elimination of tacking suture at top of commissure reduces risk of tearing.
3. Proper leaflet shaping and coaptation are achieved through proprietary tissue leaflet fixation.2
4. Leaflets from a single pericardial sheet, externally mounted, designed to optimize coaptation and maximize flow.
Trifecta Valve stent Fatigue-resistant, high-strength titanium stent designed to reduce stress on leaflets during cardiac cycle.2

When the Goal Is Implantability

The Trifecta valve offers exceptional hemodynamic performance1 with the implantability of a stented valve, accommodating a surgeon's existing implantation technique.

  • Contoured silicone insert within a unique polyester cuff is designed to conform to the shape of the native annulus for proper seating and to reduce the risk of PV leak.1
  • Trifecta valve sizers are optimized for true-to-size selection.
  • Efficient 2 x 10-second rinse.
  • Aortic valve holder provides visibility and cuff access for suturing.
  • Both the flexible and rigid valve holder handles provide quick, click-in handle attachment and removal to stabilize the valve, minimizing the risk of unseating.

References

1. Bavaria JE, Desai ND, Cheung A, et al. The St. Jude Medical Trifecta aortic pericardial valve: Results from the global, multicenter, prospective clinical study. J Thorac Cardiovasc Surg. 2014;147(2):590-7.
2. St. Jude Medical. Data on File.

For Cardiologists

When the Goal Is In Vivo
Hemodynamic Performance

Documented in these echocardiographic images, the Trifecta™ valve is designed to mimic the flow of a natural, healthy heart valve.

Parasternal Long Axis – Diastole

Parasternal long axis — diastole
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  • Transthoracic echocardiogram — 6-month follow-up
  • Normal Trifecta valve in the aortic position
  • Large area of leaflet coaptation

 

Parasternal Long Axis, Color Flow Doppler – Diastole

Parasternal long axis, color flow Doppler — diastole
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  • Transthoracic echocardiogram — 6-month follow-up
  • Normal Trifecta valve in the aortic position
  • Large area of leaflet coaptation
  • No regurgitation seen

Parasternal Long Axis – Systole

Parasternal long axis — systole
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  • Transthoracic echocardiogram — 6-month follow-up
  • Normal Trifecta valve in the aortic position
  • Wide leaflet opening

 

Parasternal Long Axis, Color Flow Doppler – Systole

Parasternal long axis, color flow Doppler — systole
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  • Transthoracic echocardiogram — 6-month follow-up
  • Normal Trifecta valve in the aortic position
  • Laminar flow seen through wide leaflet opening

Parasternal Short Axis – Diastole

Parasternal short axis — diastole
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  • Transthoracic echocardiogram — 6-month follow-up
  • Normal Trifecta valve in the aortic position

 

Low Pressure Gradient for Trifecta Valve in the Aortic Position

Low pressure gradient for Trifecta valve in the aortic position
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  • Transthoracic echocardiogram — 6-month follow-up
  • 23 mm Trifecta valve
  • Mean gradient of 7.6 mmHg
Evidence

Evidence


pdf The St. Jude Medical Trifecta Aortic Pericardial Valve: Results from a Global, Multicenter, Prospective Clinical Study1 [PDF 122KB] 
Joseph E. Bavaria, MDa; Nimesh D. Desai, MD, PhDa; Anson Cheung, MDb; Michael R. Petracek, MDc; Mark A. Groh, MDd; Michael Borger, MDe; Hartzell V. Schaff, MDf
Hospital of the University of Pennsylvania, Philadelphia, PA; bSt. Paul’s Hospital, Vancouver, BC, Canada; cVanderbilt Medical Center, Nashville, TN;
dMission Health & Hospitals, Asheville, NC; eHerzzentrum Leipzig GmbH, Leipzig, Germany; fMayo Clinic, Rochester, MN

1. Bavaria JE, Desai ND, Cheung A, et al. The St. Jude Medical Trifecta aortic pericardial valve: Results from a global, multicenter, prospective clinical study.
J Thorac Cardiovasc Surg. 2014;147(2):590-7.


pdf Single Center Midterm Results from the FDA Pivotal Trial of the St. Jude Medical Trifecta Pericardial Aortic Valve Bioprosthesis1 [PDF 237KB]
Joseph E. Bavaria, Scott McClure, Rohan S. Menon, Wilson Szeto, Sofiane Lazar, Melanie Freas, Virginia Buckley-Blaskovich, Nimesh D. Desai
University of Pennsylvania, Philadelphia, PA, USA
Abstract Presentation, The Society for Heart Valve Disease, Italy 2013

1. Bavaria JE, McClure S, Menon RS et al. Single Center Midterm Results from the FDA Pivotal Trial of the St. Jude Medical Trifecta Pericardial Aortic Valve Bioprosthesis. 7th Biennial Scientific Meeting of the Society for Heart Valve Disease and the Heart Valve Society of America; Venice, Italy. June 22-25, 2013.


pdf Hemodynamic Performance of Bioprosthetic Aortic Valves: A Real-World Experience1 [PDF 67KB]
Karla Campos-Arce, MD; Mayralexandra Barreda, MD; Roberto Cervera, MD; Ross Reul, MD; Joseph Coselli, MD; Ourania Preventza, MD; Nishant Shah, MD; Suwei Wang, MD; Raymond Stainback, MD; Stephanie Coulter, MD
Texas Heart Institute at St. Luke’s Episcopal Hospital, Houston, TX, USA, Baylor College of Medicine, Houston, TX, USA

1. Campos-Arce, K, Barreda M, Cervera R, et al. Hemodynamic performance of bioprosthetic aortic valves: A real-world experience [ACC Poster 1241-83]. J Am Coll Cardiol. 2013;61(10S):E1992.


pdf Early Hemodynamic Performance of Three Contemporary Aortic Valve Bioprostheses [PDF 88KB]
Murat Ugur, Rakesh M. Suri, Richard Daly, Joseph Dearani, Soon J. Park, Lyle D. Joyce, Harold Burkhart, Kevin L. Greason, Hartzell V. Schaff
Mayo Clinic, Rochester, MN, USA
Abstract Presentation, The Society for Heart Valve Disease, Italy 2013

1. Ugur M, Suri RM, Daly R, et al. Early hemodynamic performance of three contemporary aortic valve bioprostheses [poster]. 7th Biennial Scientific Meeting of the Society for Heart Valve Disease and the Heart Valve Society of America; Venice, Italy. June 22-25, 2013.


pdf One-year Clinical and Echocardiographic Outcomes for the 19 mm Trifecta Aortic Bioprosthesis in a Selected Female Patient Sample with Small Body Surface1 [PDF 68KB] 
Marisa De Feo1, Alessandro Della Corte1, Eduardo Vitagliano1, Veronica D’Oria1, Paolo Pepino2, Raffaela Provenzano2, Ciro Bancone1, Gianantonio Nappi1
1Second University of Naples, Naples, Italy,2 Pineta Grande Hospital, Castelvolturno, Italy
Abstract Presentation, The Society for Heart Valve Disease, Italy 2013

1. De Feo M, Della Corte A, Vitagliano E, et al. One-year Clinical and Echocardiographic Outcomes for the 19 mm Trifecta Aortic Bioprosthesis in a Selected Female Patient Sample with Small Body Surface. 7th Biennial Scientific Meeting of the Society for Heart Valve Disease and the Heart Valve Society of America; Venice, Italy. June 22-25, 2013.


pdfClinical and Echocardiographic Outcomes after Implantation of the Trifecta Aortic Bioprosthesis: An Initial Single-Centre Experience1 [PDF 60KB]
Angelo M. Dell’Aquilaa, Dominik Schlarba, Stefan R.B. Schneidera, Jürgen R. Sindermannaa, Andreas Hoffmeiera, Gerrit Kaleschkeb, Sven Martensa, Andreas Rukosujew a
a Department of Cardiac Surgery, Universitätsklinikum Münster, Münster, Germany
b Department of Cardiology and Angiology, Universitätsklinikum Münster, Münster, Germany

1. Dell’Aquila AM, Schlarb D, Schneider SR, et al. Clinical and echocardiographic outcomes after implantation of the Trifecta aortic bioprosthesis: An initial single-centre experience. Interact Cardiovasc Thorac Surg. 2013;16(2):112-5.


pdf Haemodynamic Performance of a New Pericardial Aortic Bioprosthesis [Trifecta] during Exercise and Recovery: Comparison with Pulmonary Autograft, Stentless Aortic Bioprosthesis and Healthy Control Groups[PDF 87KB]
Thorsten Hanke, Efstratios I. Charitos, Hauke Paarmann, Ulrich Stierle, Hans-H. Sievers
Clinic for Cardiac and Thoracic Vascular Surgery and Clinic for Anaesthesiology, University Clinic of Schleswig-Holstein, Lübeck, Germany

1. Hanke T, Charitos EI, Paarmann H, et al. Haemodynamic performance of a new pericardial aortic bioprosthesis during exercise and recovery: Comparison with pulmonary autograft, stentless aortic bioprosthesis and healthy control groups. Eur J Cardiothorac Surg. 2013;44(4):e295-301..


pdf Single Center Four Year Results from the FDA Pivotal Trial of the St. Jude Medical Trifecta Pericardial Aortic Valve Bioprosthesis1 [PDF 101KB]  
Joseph E. Bavaria, Wilson Szeto, Christian Covington, Kristen Burtch, Virginia Blaskovich, Martine StClair, Caroline Komlo,
Nimesh Desai
Department of Cardiothoracic Surgery, University of Pennsylvania, Philadelphia, PA, USA

1. Bavaria JE, Szeto W, Covington C, et al. Single Center Four Year Results from the FDA Pivotal Trial of the St. Jude Medical Trifecta Pericardial Aortic Valve Bioprosthesis.
Presented at the 50th Annual Eastern Cardiothoracic Surgical Society Meeting, Naples, Florida, October 4-6, 2012.


pdf Comparison of Hemodynamic Performance of the Trifecta and Mitroflow Aortic Valve Prostheses1 [PDF 68KB] 
Rakesh M. Suri, Murat Ugur, Richard Daly, Joseph Dearani, Soon J. Park, Lyle D. Joyce, Harold Burkhart,
Kevin L. Greason, Hartzell V
Schaff Mayo Clinic, Rochester, MN, USA
Abstract Presentation, The Society for Heart Valve Disease, Italy 2013

1. Suri RM, Ugur M, Daly R, et al. Comparison of Hemodynamic Performance of the Trifecta and Mitroflow Aortic Valve Prostheses. 7th Biennial Scientific Meeting of the Society for Heart Valve Disease and the Heart Valve Society of America; Venice, Italy. June 22-25, 2013.

Tech Specs

Trifecta™ Valve

Ordering Information   View Catalog   

Contents: Aortic Supra-Annular Stented Tissue Valve (1 unit per box)

Reorder Number Valve Size (mm) Tissue Annulus Diameter (mm) Cuff Outer Diameter (mm) Aortic Protrusion (mm) Total Height (mm)
TF-19A 19 19 24 12 15
TF-21A 21 21 26 13 16
TF-23A 23 23 28 13 17
TF-25A 25 25 31 14 18
TF-27A 27 27 33 15 19
TF-29A 29 29 35 16 20

Indications, Safety & Warnings
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Please review the Instructions for Use prior to using these devices for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

Product referenced is approved for CE Mark.

Last Updated: 26 February 2014