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.

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

• Note the large area of leaflet coaptation

Parasternal Long Axis During Systole

• Note the wide leaflet opening

Parasternal Short Axis During Diastole

Parasternal Long Axis, Color Flow Doppler During Diastole 

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

Pasternal Long Axis, Color Flow Doppler During Systole

• Note the laminar flow through wide leaflet opening

Low Pressure Gradient for the Trifecta Valve in the Aortic Position

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

REFERENCES

<sup>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.</sup>

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

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.

Retrospective 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

<sup>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.</sup>

TRIFECTA GT VALVE ORDERING INFORMATION

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

REFERENCES

<sup>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.</sup>