Trifecta GT Aortic Valve | Aortic Valve Replacement
CARDIOVASCULAR
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TRIFECTA GT VALVE:
BECAUSE HEMODYNAMICS MATTER

The Trifecta valve with Glide Technology (GT) and Linx anticalcification (AC) is designed for supra-annular placement in the aortic position.

Although some recent transcatheter aortic valve replacement (TAVR) trials have set a new standard for single-digit gradients 1-4, Trifecta GT remains an excellent choice with its best-in-class pressure gradients and effective orifice areas (EOAs). 5-10,*

*For References 5-10, information is taken from pericardial valve IFUs, not from a head-to-head clinical trial. Information provided for educational purposes only.

PERFORMANCE ENHANCING TECHOLOGIES

Trifecta GT provides excellent performance during both minimally invasive and conventional surgical aortic valve replacement procedures by improving ease of implantability and enhancing ease of placement.11

Linx AC technology is designed to improve long-term performance and valve durability. The Linx AC technology has demonstrated resistance to valve calcification by:

  • Extracting lipids12
  • Reducing free aldehydes13,14
  • Minimizing cholesterol uptake15
  • Stabilizing leaflet collagen15

DESIGNED FOR OPTIMAL FLOW

Trifecta Valves

*Across all valve sizes >= 21mm.


Trifecta Valves

THE CRUCIAL IMPACT OF TRIFECTA VALVE’S HEMODYNAMICS

The Trifecta valve exhibits best-in-class hemodynamic performance with its unmatched pressure gradients and superior EOAs.5-10,* Accordingly, consider how improved hemodynamics are associated with:

  • Improved left ventricular (LV) mass regression3,16
  • Faster recovery during exercise17
  • Lower risk of congestive heart failure18

*For References 5-10, information is taken from pericardial valve IFUs, not from a head-to-head clinical trial. Information provided for educational purposes only.

Learn more about the Trifecta valves’ clinical data.


References

1. Hahn RT, Pibarot P, Stewart WJ, et al. Comparison of transcatheter and surgical aortic valve replacement in severe aortic stenosis: a longitudinal study of echocardiography parameters in cohort A of the PARTNER trial (Placement of Aortic Transcatheter Valves. J Am Coll Cardiol. 2013;61(25):2514-2521.
2. Reardon MJ, Adams DH, Kleiman NS, et al. 2-year outcomes in patients undergoing surgical or self-expanding transcatheter aortic valve replacement. J Am Coll Cardiol. 2015;66(2):113-121.
3. Pibarot P, Weissman NJ, Stewart WJ, et al. Incidence and sequelae of prosthesis-patient mismatch in transcatheter versus surgical valve replacement in high-risk patients with severe aortic stenosis: a PARTNER trial cohort-A analysis. J Am Coll Cardiol. 2014;64(13):1323-1334.
4. Zorn GL III, Little SH, Tadros P, et al. Prosthesis-patient mismatch in high-risk patients with severe aortic stenosis: a randomized trial of a self-expanding prosthesis. J Thorac Cardiovasc Surg. 2016;151(4):1014-1023.e.3.
5. Trifecta valve [package insert]. Chicago, IL: Abbott; table 9.
6. Carpentier-Edwards Perimount Magna Ease aortic heart valve [package insert]. Irvine, CA: Edwards Lifesciences; table 7.
7. Edwards pericardial aortic bioprosthesis [package insert for Resilia valve]. Irvine, CA: Edwards Lifesciences; table 9.
8. Avalus bioprosthesis [package insert]. Minneapolis, MN: Medtronic; table 8.
9. Intuity Elite valve system [package insert]. Irvine, CA: Edwards Lifesciences; table 13.6.
10. Perceval sutureless heart valve [package insert]. London, UK: LivaNova; table 12.
11. 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;147:590-597.
12. Vyavahare, N, Hirsch, D, Lerner, E, et al. Prevention of bioprosthetic heart valve calcification by ethanol preincubation. Circulation. 1997:95;479-488. doi.org/10.1161/01.CIR.95.2.479.
13. Kelly SJ, Ogle MF, Carlyle WC, et al. Biocompatibility and calcification of bioprosthetic heart valves. Presented at: Society for Biomaterials, Sixth World Biomaterials Congress Transaction. May 2000:1353.
14. Frater RWM, Seifter E, Liao K, et al. Chapter 8. In: Gabbay, S, Wheatley DJ, eds. Advances in Anticalcific and Antidegenerative Treatment of Heart Valve Bioprostheses. 1st ed. Austin: Silent Partners, Inc; 1997:105-113.
15. Vyavahare NR, Hirsch D, Lerner E, et al. Prevention of calcification of glutaraldehyde-crosslinked porcine aortic cusps by ethanol preincubation: mechanistic studies of protein structure and water-biomaterial relationships. J Biomed Mater Res. 1998;40:577-585.
16. Rubens FD, Gee YY, Ngu JM, et al. Effect of aortic pericardial valve choice on outcomes and left ventricular mass regression in patients with left ventricular hypertrophy. J Thorac Cardiovasc Surg. 2016;152(5):1291-1298.
17. 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-e301.
18. Ruel M, Rubens FD, Masters RG, et al. Late incidence and predictors of persistent or recurrent heart failure in patients with aortic prosthetic valves. J Thorac Cardiovasc Surg. 2004;127:149-159. doi:10.1016/j.jtcvs.2003.07.043

TRIFECTA GT VALVE FOR HEMODYNAMICS, DURABILITY, AND IMPLANTABILITY

The Trifecta valve with Glide Technology (GT) system is particularly designed for a minimally invasive procedure with its small streamlined valve holder, smooth delivery, screw-in handle, and single-cut release.

features of the Trifecta GT valve

The Trifecta GT valve was designed to offer excellent performance in 3 key areas—hemodynamics, durability, and implantability—all of which are essential for optimal outcomes.

EFFECTIVENESS OF TRIFECTA VALVES: ECHO IMAGES

These images document how the Trifecta aortic valve works to mimic the function of a natural, healthy heart valve.  All of these transthoracic echocardiogram images, taken at 6-month follow-up, reveal the Trifecta valve in the aortic position.

Parasternal Long Axis During Systole

echo of Trifecta heart valve during diastole, long axis

  • Note the large area of leaflet coaptation

Parasternal Long Axis During Systole

echo of Trifecta tissue valve during systole, long axis

  • Note the wide leaflet opening

 

Parasternal Short Axis During Diastole

echo of Trifecta aortic valve during diastole, short axis

 

Parasternal Long Axis, Color Flow Doppler During Diastole 

color flow Doppler of Trifecta prosthetic valve during diastole

  • Note the large area of leaflet coaptation—and no regurgitation is visible

 

Pasternal Long Axis, Color Flow Doppler During Systole

color flow Doppler of Trifecta tissue valve during systole

  • Note the laminar flow through wide leaflet opening

 

Low Pressure Gradient for the Trifecta Valve in the Aortic Position

low pressure gradients for Trifecta aortic valve

  •  The 23-mm Trifecta aortic valve achieves a mean gradient of 7.6 mmHg

 

References

1. Hahn RT, Pibarot P, Stewart WJ, et al. Comparison of transcatheter and surgical aortic valve replacement in severe aortic stenosis: a longitudinal study of echocardiography parameters in cohort A of the PARTNER trial (Placement of Aortic Transcatheter Valves. J Am Coll Cardiol. 2013;61(25):2514-2521.
2. Reardon MJ, Adams DH, Kleiman NS, et al. 2-year outcomes in patients undergoing surgical or self-expanding transcatheter aortic valve replacement. J Am Coll Cardiol. 2015;66(2):113-121.
3. Pibarot P, Weissman NJ, Stewart WJ, et al. Incidence and sequelae of prosthesis-patient mismatch in transcatheter versus surgical valve replacement in high-risk patients with severe aortic stenosis: a PARTNER trial cohort-A analysis. J Am Coll Cardiol. 2014;64(13):1323-1334.
4. Zorn GL III, Little SH, Tadros P, et al. Prosthesis-patient mismatch in high-risk patients with severe aortic stenosis: a randomized trial of a self-expanding prosthesis. J Thorac Cardiovasc Surg. 2016;151(4):1014-1023.e.3.
5. Trifecta valve [package insert]. Chicago, IL: Abbott; table 9.
6. Carpentier-Edwards Perimount Magna Ease aortic heart valve [package insert]. Irvine, CA: Edwards Lifesciences; table 7.
7. Edwards pericardial aortic bioprosthesis [package insert for Resilia valve]. Irvine, CA: Edwards Lifesciences; table 9.
8. Avalus bioprosthesis [package insert]. Minneapolis, MN: Medtronic; table 8.
9. Intuity Elite valve system [package insert]. Irvine, CA: Edwards Lifesciences; table 13.6.
10. Perceval sutureless heart valve [package insert]. London, UK: LivaNova; table 12.

PROVEN HEMODYNAMICS WITH TRIFECTA AORTIC VALVES:
BEST-IN-CLASS PRESSURE GRADIENTS

In comparison with the latest pericardial valves, the Trifecta valves consistently reveal the lowest mean pressure gradients. The 1-year single-digit mean pressure gradient information taken from pericardial valve IFUs indicate that the results for most Trifecta valve sizes are similar to transcatheter aortic valve replacement.5-10,* The Trifecta valve hemodynamics are comparable to stentless valves and new sutureless valves as well.11,12


Trifecta aortic valve with 0% PPM vs other valves


These low pressure gradients are important because for each 1 mmHg increase in mean pressure gradient after aortic valve replacement, there is a 6% increased risk of congestive heart failure (CHF) or CHF-related death.13

*For References 5-10, information is taken from pericardial valve IFUs, not from a head-to-head clinical trial. Information provided for educational purposes only.

LOW RATE OF SEVERE PPM AFTER AORTIC VALVE REPLACEMENT WITH TRIFECTA

The incidence of prosthesis-patient mismatch (PPM) is associated with worse clinical outcomes and decreased survival rates.14  The study data illustrated below show 0% severe PPM with the Trifecta aortic valve in comparison to other valves.


Trifecta aortic valve with 0% PPM vs 3 other valvesRetrospective Review: 351 Patients with Small Aortic Annulus14
≤ 21 mm valves (p = 0.01)

Other studies have also demonstrated very low rates of severe PPM with Trifecta valves.15,16  

EXCELLENT LONG TERM DATA

Outcomes from the Trifecta valve prospective, multicenter study (n = 710)17 demonstrate that the valve has excellent durability and survival rates when examining 7- year data (n = 215 at follow-up) and 8-year data (n = 134 at follow-up):

  • 99.0% freedom from valve-related mortality at 8 years 
  • 98.6% freedom from paravalvular leak at 8 years
  • 94.1%. freedom from surgical explant due to structural valve deterioration at 8 years 
  • 97.7% in NYHA Class I or II at 7 years 

SIGNIFICANT RELATIVE RISK REDUCTION WITH TRIFECTA VALVES

In addition, researchers have reported these risk reduction benefits with the Trifecta valve (compared to the Magna Ease valve):18

  • 76.5% relative risk reduction of readmission (cardiac related, p = 0.011)
  • 82.3% relative risk reduction of heart failure requiring urgent intervention (p = 0.016)

 

References

1. Hahn RT, Pibarot P, Stewart WJ, et al. Comparison of transcatheter and surgical aortic valve replacement in severe aortic stenosis: a longitudinal study of echocardiography parameters in cohort A of the PARTNER trial (Placement of Aortic Transcatheter Valves. J Am Coll Cardiol. 2013;61(25):2514-2521.
2. Reardon MJ, Adams DH, Kleiman NS, et al. 2-year outcomes in patients undergoing surgical or self-expanding transcatheter aortic valve replacement. J Am Coll Cardiol. 2015;66(2):113-121.
3. Pibarot P, Weissman NJ, Stewart WJ, et al. Incidence and sequelae of prosthesis-patient mismatch in transcatheter versus surgical valve replacement in high-risk patients with severe aortic stenosis: a PARTNER trial cohort-A analysis. J Am Coll Cardiol. 2014;64(13):1323-1334.
4. Zorn GL III, Little SH, Tadros P, et al. Prosthesis-patient mismatch in high-risk patients with severe aortic stenosis: a randomized trial of a self-expanding prosthesis. J Thorac Cardiovasc Surg. 2016;151(4):1014-1023.e.3.
5. Trifecta valve [package insert]. Chicago, IL: Abbott; table 9.
6. Carpentier-Edwards Perimount Magna Ease aortic heart valve [package insert]. Irvine, CA: Edwards Lifesciences; table 7.
7. Edwards pericardial aortic bioprosthesis [package insert for Resilia valve]. Irvine, CA: Edwards Lifesciences; table 9.
8. Avalus bioprosthesis [package insert]. Minneapolis, MN: Medtronic; table 8.
9. Intuity Elite valve system [package insert]. Irvine, CA: Edwards Lifesciences; table 13.6.
10. Perceval sutureless heart valve [package insert]. London, UK: LivaNova; table 12.
11. Perceval sutureless aortic heart valve [package insert]. Burnaby, BC, Canada: Sorin Group; table 10.
12. Freestyle™ subcoronary bioprosthesis [package insert]. Minneapolis, MN: Medtronic; tables 21, 26, 27.
13. Ruel M, Rubens FD, Masters RG, et al. Late incidence and predictors of persistent or recurrent heart failure in patients with aortic prosthetic valves. J Thorac Cardiovasc Surg. 2004;127:149-159. doi:10.1016/j.jtcvs.2003.07.043.
14. Ghoneim A, Bouhout I, Demers P, et al. Management of small aortic annulus in the era of sutureless valves: a comparative study among different biological options. J Thorac Cardiovasc Surg. 2016;152(4):1019-1028.
15. Colli A, Marchetto G, Salizzoni S, et al. The TRIBECA study: (TRI)fecta (B)ioprosthesis (E)valuation versus (C)arpentier Magna-Ease in (A)ortic position. Eur J Cardiothorac Surg. 2016;49:478–485.
16. Phan K, Ha H, Phan S, et al. Early hemodynamic performance of the third generation St Jude Trifecta aortic prosthesis: a systematic review and meta-analysis. J Thorac Cardiovasc Surg. 2015;149(6):1567-1575.
17. Trifecta long-term follow-up study: 8-year clinical compendium. Data on file at Abbott. 2018.
18. Rubens FD, Gee YY, Ngu JM, et al. Effect of aortic pericardial valve choice on outcomes and left ventricular mass regression in patients with left ventricular hypertrophy. J Thorac Cardiovasc Surg. 2016;152(5):1291-1298.

TRIFECTA GT VALVE ORDERING INFORMATION

Reorder Number

Tissue Annulus Diameter (mm)

Cuff Outer Diameter (mm)

Total Height (mm)

Aortic Protrusion (mm)

Mean Implanted Height* (mm)

TFGT-19A

19

24

15

12

14

TFGT-21A

21

26

16

13

15

TFGT-23A

23

28

17

13

16

TFGT-25A

25

31

18

14

17

TFGT-27A

27

33

19

15

18

TFGT-29A

29

35

20

16

19

  • Implanted height differs from total height since the Trifecta GT cuff is compressed when it is sutured into place.

References

1. Hahn RT, Pibarot P, Stewart WJ, et al. Comparison of transcatheter and surgical aortic valve replacement in severe aortic stenosis: a longitudinal study of echocardiography parameters in cohort A of the PARTNER trial (Placement of Aortic Transcatheter Valves. J Am Coll Cardiol. 2013;61(25):2514-2521.
2. Reardon MJ, Adams DH, Kleiman NS, et al. 2-year outcomes in patients undergoing surgical or self-expanding transcatheter aortic valve replacement. J Am Coll Cardiol. 2015;66(2):113-121.
3. Pibarot P, Weissman NJ, Stewart WJ, et al. Incidence and sequelae of prosthesis-patient mismatch in transcatheter versus surgical valve replacement in high-risk patients with severe aortic stenosis: a PARTNER trial cohort-A analysis. J Am Coll Cardiol. 2014;64(13):1323-1334.
4. Zorn GL III, Little SH, Tadros P, et al. Prosthesis-patient mismatch in high-risk patients with severe aortic stenosis: a randomized trial of a self-expanding prosthesis. J Thorac Cardiovasc Surg. 2016;151(4):1014-1023.e.3.
5. Trifecta valve [package insert]. Chicago, IL: Abbott; table 9.
6. Carpentier-Edwards Perimount Magna Ease aortic heart valve [package insert]. Irvine, CA: Edwards Lifesciences; table 7.
7. Edwards pericardial aortic bioprosthesis [package insert for Resilia valve]. Irvine, CA: Edwards Lifesciences; table 9.
8. Avalus bioprosthesis [package insert]. Minneapolis, MN: Medtronic; table 8.
9. Intuity Elite valve system [package insert]. Irvine, CA: Edwards Lifesciences; table 13.6.
10. Perceval sutureless heart valve [package insert]. London, UK: LivaNova; table 12.

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