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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,*
 

Abbott Trifecta GT valve demonstrates the most favorable gradients compared to the latest pericardial valves
Abbott Trifecta GT valve demonstrates the most favorable gradients compared to the latest pericardial valves

*Note: For References 1-6, data not from head to head studies. Data provided for informational purposes only.

Why gradients are critical: Higher gradients increase heart failure risk


For each increase of 1 mmHg in mean gradient, the relative risk of heart failure (HF) recurrence or HF-related death is increased by 6%.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,*
    Abbott Trifecta GT valve also offers exceptional Effective Orifice Areas (EOAs)

    *Note: For References 1-6, data not from head to head studies. 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
    Consistently low rates of prosthesis-patient mismatch (PPM) for Trifecta GT valve

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

  • Retrospective review: 791 patients10
    Retrospective review with 791 patients found very low rates of severe PPM with the Trifecta GT valve



    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
     

    Meta-analysis of 13 studies revealed extremely low rate of severe Prosthesis-Patient Mismatch with the Trifecta GT valve

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
Greater left ventricular (LV) mass regression with Trifecta GT

MAT-2201632 v1.0 | Item approved for Global OUS 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.
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