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 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,*

    *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

    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

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

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