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SURGICAL VALVE SOLUTIONS

TRIFECTA™ GT CLINICAL DATA

The Trifecta™ valve with Glide™ Technology (GT) and Linx™ anticalcification (AC) technology offers exceptional hemodynamic performance1-7—whether implanted via a minimally invasive procedure or conventional surgical aortic valve replacement (SAVR).

SINGLE-DIGIT GRADIENTS WITH THE TRIFECTA™ VALVE

Compared with the latest pericardial valves, the Trifecta™ valve consistently demonstrates the lowest (most favorable) gradients, as demonstrated in the chart below. Most Trifecta valve sizes achieved single-digit gradients, similar to TAVI valves.

Average mean pressure gradient by valve size at one year1-6,*
 

Average mean pressure gradient by valve size at one year

*Note: For References 1-6, data not from head to head studies. Data differences depicted between these trials may not be directly comparable, statistically significant, or clinically meaningful due to differences in trial protocols, endpoints, and/or patient populations. Data provided for informational purposes only.

Why gradients are critical: Higher gradients increase heart failure risk


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.7

EFFECTIVE ORIFICE AREAS (EOA)

The Trifecta valve also offers exceptional EOAs,1,* and positive performance was sustained during exercise.

  • Average EOA at one year1-6,*
    Average EOA at one year

    *Note: For References 1-6, data not from head to head studies. Data differences depicted between these trials may not be directly comparable, statistically significant, or clinically meaningful due to differences in trial protocols, endpoints, and/or patient populations. Data provided for informational purposes only.


    EOA INDEX INCREASED WITH EXERCISE

    Thorsten Hanke, et al.8
     

    “During exercise, the EOAI in the [Trifecta] group increased significantly until maximum exercise [p = 0.02]. . . . In contrast, there was no change in EOAI in the [Medtronic Freestyle aortic bioprosthesis] group.”

CONSISTENTLY LOW RATES OF PROSTHESIS-PATIENT MISMATCH (PPM)

A retrospective review found no severe PPM with the Trifecta valve (p = 0.01).9 

  • Retrospective review: 351 patients with small aortic annulus9
    Retrospective review: 351 patients with small aortic annulus

    Other studies have also revealed very low rates of severe PPM with the Trifecta valve.

  • Retrospective review: 791 patients10
    Retrospective review: 791 patients



    In addition, a large meta-analysis of 13 studies, with more than 2,500 patients, revealed an extremely low 2.7% rate of severe PPM with the Trifecta valve. As noted by Phan et al., this rate “is considerably lower than the 9.8% incidence in the general population undergoing aortic valve replacement.”11
     

    Percent

GREATER LEFT VENTRICULAR (LV) MASS REGRESSION WITH TRIFECTA

LV Mass Index after Aortic Valve Replacement12

An independent, propensity-matched study examined patients receiving either a Magna Ease‡ valve (n = 141) or a Trifecta valve (n = 117). The Trifecta valve demonstrated:

  • Greater total LV mass regression
  • Greater mass regression over time
LV Mass Index after Aortic Valve Replacement

MAT-2115463 v1.0 | Item approved for U.S. use only.

References

Perimount, Magna Ease, Resilia, Intuity Elite are trademarks of Edwards Lifesciences. CoreValve and Avalus are trademarks of Medtronic. Mitroflow and Perceval are trademarks of LivaNova.

  1. TrifectaTM valve [package insert]. Chicago, IL: Abbott; table 9.
  2. Avalus bioprosthesis [package insert]. Minneapolis, MN: Medtronic; table 8.
  3. Intuity EliteTM valve system [package insert]. Irvine, CA: Edwards Lifesciences; table 13.6.
  4. Carpentier-Edwards PERIMOUNT Manga EaseTM aortic heart valve [package insert]. Irvine, CA: Edwards Lifesciences; table 7.
  5. Perceval sutureless heart valve [package insert]. London, UK: LivaNova; table 12.
  6. Edwards pericardial aortic bioprosthesis [package insert for Resilia valve]. Irvine, CA: Edwards Lifesciences; table 9.
  7. Ruel M, 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.
  8. Hanke T, 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.
  9. Ghoneim A, 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.
  10. Colli A, 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.
  11. Phan K, 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.
  12. Rubens FD, 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.
Important Safety Information

TRIFECTATM VALVE WITH GLIDETM TECHNOLOGY (GT)
INDICATION FOR USE


The TrifectaTM Valve with GlideTM 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 the 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 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 TrifectaTM Model TF2000 sizers1 for 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 TrifectaTM Valve with GlideTM Technology is based upon the TrifectaTM Valve design. Therefore, a previous clinical investigation of the TrifectaTM Valve supports the safety of the TrifectaTM Valve with GlideTM 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 TrifectaTM Valve clinical investigation.

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

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