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

Glide Technology 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, to promote anticalcification, is designed to improve long-term performance and valve durability. The Linx AC treatment has demonstrated resistance to calcification by:

Extracting lipids¹²
Reducing free aldehydes^13,14
Minimizing cholesterol uptake¹⁵
Stabilizing leaflet collagen¹⁵

DESIGNED FOR OPTIMAL FLOW

Trifecta Valves

^{*Across all valve sizes >= 21mm. See Important Safety Information referenced within.}

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 regression^3,16
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

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

^{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

IMPORTANT SAFETY INFORMATION

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TRIFECTA™ VALVE WITH GLIDE™ TECHNOLOGY (GT)

INDICATION FOR USE

The Trifecta™ Valve with Glide™ Technology is intended as a replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic heart valve.

CONTRAINDICATIONS

None known.

WARNINGS

For single use only. Do not reuse or resterilize. Attempts to resterilize the valve may result in valve malfunction, inadequate sterilization, or patient harm.
Do not oversize. Valve size selection is based on the size of the recipient annulus and the anatomy of the sinotubular junction. If the native annulus measurement falls between two valve sizes, use the smaller size valve. Use only the Model TF2000 Trifecta Sizers for sizing the valve. Implantation of an oversized valve may result in stent deformation, valvular incompetence, valve damage, diminished tissue durability, and/or damage to the surrounding tissues.
Passage of a diagnostic catheter or transvenous pacing lead through any bioprosthesis may damage the valve and is therefore not recommended.
Accelerated deterioration due to calcific degeneration of the valve may occur in:
- Children, adolescents, or young adults
- Patients with altered calcium metabolism (e.g., patients with hyperparathyroidism or chronic renal failure)
- Individuals requiring hemodialysis
Do not use if:
- The valve has been dropped, damaged, or mishandled in any way, or if there is any sign of deterioration.
- The expiration date has elapsed.
- The tamper-evident jar seal is damaged, broken, or missing, or if fluid is leaking from the packaging.
- The storage solution does not completely cover the valve.
Use only the Trifecta™ Model TF2000 sizers¹for sizing the valve.
The titanium valve stent is not designed as a flexible stent. Do not bend the titanium valve stent. Deformation of the stent may impair valve function.

PRECAUTIONS

Safety and effectiveness of the valve has not been established for the following specific populations:
- Patients who are pregnant
- Nursing mothers
- Patients with chronic renal failure
- Patients with aneurysmal aortic degenerative conditions (e.g., cystic medial necrosis, Marfan’s syndrome)
- Patients with chronic endocarditis
- Patients requiring pulmonic or tricuspid valve replacement
- Children, adolescents, or young adults
Sizer sets are supplied non-sterile, and must be cleaned and sterilized prior to each use. Do not use cracked, crazed, or deformed sizer set components.
Do not place the non-sterile exterior of the valve jar in the sterile field.
Do not use the valve if shipping temperature indicators on the product carton have turned red, or if the valve has been improperly stored in temperature conditions outside of the 5°C–25°C (41°F–77°F) range.
Do not expose the valve to solutions other than the formaldehyde solution in which it was shipped, the sterile isotonic saline solution used during the rinsing procedure, or the sterile isotonic saline used to irrigate the valve.
Do not add antibiotics to either the valve storage solution or the rinse solution.
Do not apply antibiotics to the valve.
Do not allow the valve tissue to dry. Place the valve in isotonic sterile saline rinse solution immediately upon removal from the valve storage solution. Once removed from this solution, the valve should be periodically irrigated during implantation.
Do not implant the valve without thoroughly rinsing as directed.
Position the valve so that the stent posts do not obstruct the coronary ostia or come in direct contact with the aortic wall.
Never handle the leaflet tissue.
Avoid prolonged contact with the formaldehyde storage solution. Immediately after contact, thoroughly flush any skin exposed to the solution with water. In case of contact with eyes, flush with water and seek appropriate medical care.
Use caution when placing sutures through the sewing cuff to avoid lacerating the valve tissue. If a valve is damaged, the valve must be replaced.
Do not use cutting edge needles, unprotected forceps, or sharp instruments, as they may cause structural damage to the valve.
Do not attempt to repair a valve. Damaged valves must not be used.
Do not pass the replica end of the TF2000 sizer through the annulus when sizing the valve.
Use caution when tying knots to avoid bending the stent posts.

ADVERSE EVENTS

The Trifecta™ Valve with Glide™ Technology is based upon the Trifecta™ Valve design. Therefore, a previous clinical investigation of the Trifecta Valve supports the safety of the Trifecta Valve with Glide Technology. Between June 2007 and November 2009, one thousand and twenty-two (1022) subjects were implanted with the Trifecta valve in the aortic position at 31 investigational sites in the United States (18), Canada (7), and Europe (6). Data are presented on the one thousand and fourteen (1014) subjects who met eligibility criteria. The cumulative follow-up for all subjects was 924.18 patient-years with a mean follow-up of 0.91 years (SD = 0.49 years, range 0 - 2.38 years).

Adverse events potentially associated with the use of bioprosthetic heart valves include:

angina
cardiac arrhythmias
endocarditis
heart failure
hemolysis
hemolytic anemia
hemorrhage
leak, transvalvular or paravalvular
myocardial infarction
nonstructural dysfunction (entrapment by pannus or suture, inappropriate sizing or positioning, or other)
prosthesis regurgitation
stroke
structural deterioration (calcification, leaflet tear, or other)
thromboembolism
valve thrombosis

It is possible that these complications could lead to:

reoperation
explantation
permanent disability
death

See the Clinical Study section of these instructions for adverse event data collected in the Trifecta™ Valve clinical investigation.

1.TF2000 sizers are included in sizer set models TF2000 and TF2000-2.

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TRIFECTA™ GT AORTIC VALVE