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,*
 

*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,*

    *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

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

  • Retrospective review: 791 patients10



    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
     

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

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