Lowest Mean Gradients in Comparative Data

  • Interpreting SAVR vs TAVR Data

    The PARTNER trial and CoreValve High-Risk trial characterized surgical aortic valve replacement (SAVR) valves as having inferior emodynamics to transcatheter aortic valve replacement (TAVR), as shown.

    Significantly higher gradients with savr1,2

    Average Mean Gradient at One Year*

    Significantly more ppm with savr3,4

    Severe Prosthesis-Patient Mismatch(PPM) Incidence at One Year*

    Given these findings, it is particularly important to consider the hemodynamic performance of various SAVR valves—in particular the Trifecta valve with Glide Technology (GT).

  • Single-Digit Gradients with the Trifecta Valve

    The following visual illustrates that compared with the latest pericardial valves, the Trifecta valve consistently demonstrates the lowest (most favorable) gradients. Most Trifecta valve sizes achieved single-digit gradients, similar to TAVR valves.
     

    Average Mean Pressure Gradient by Valve Size at One Year 5-10,*

  • Consistently Low Rates of PPM

    Retrospective Review: 351 Patients with Small Aortic Annulus 14
    ≤ 21 mm valves (p = 0.01)

    Retrospective Review: 351 Patients with Small Aortic Annulus14 Ghoneim

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

    Retrospective Review: 791 Patients15 Colli

  • Greater Left Ventricular (LV) Mass Regression with Trifecta

    LV Mass Index After Aortic Valve Replacement 18

    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
  • Lower Relative Risk Reduction with Trifecta Valve

    The same comparative study described above reported these risk reduction benefits with the Trifecta valve (compared to the Magna Ease™ valve):18 Rubens

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. 11

Exceptional Effective Orifice Areas, Consistently Low Rates of PPM

The Trifecta valve also offers exceptional EOAs, 5-10,* and positive performance was sustained during exercise.

  • EOA Index Increased with Exercise
    Thorsten Hanke, et al.12

    “During exercise, the EOAI in the [TrifectaTM] 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 PPM

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”. 16 Phan

Prosthesis-Patient Mismatch (PPM) as a Factor

“[In the CoreValve High-Risk Trial] 5 of the 27 SAVR deaths in the 1 to 4–month time frame were related
to [PPM]. . . . If we eliminate these 5 cases . . . the mortalities are comparable between TAVR and SAVR.”
— Arman Kilic, et al. 17

Consistently Low Rates of PPM

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”. 16 Phan

Trifecta Valve’s High Mid-Term Durability

A number of trials established mid-term durability of the Trifecta valve.19-21

 

 

Lower Relative Risk Reduction with Trifecta Valve

Hemodynamics Determine Valve Durability The data presented above are not unexpected given the findings of a Cleveland Clinic study that revealed the following: 13

  • To maximize durability, it’s important to optimize hemodynamics
  • Increased PPM and higher gradients at implantation are linked to valve deterioration and  explantation, especially in younger patients

AP2947046-WBU Rev. A

References
  1. Hahn RT, et al. Comparison of transcatheter and surgical aortic valve replacement in severe aortic stenosis: a longitudinalstudy 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, 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, 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, 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. Avalus bioprosthesis [package insert]. Minneapolis, MN: Medtronic; table 8.
  6. Intuity Elite valve system [package insert]. Irvine, CA: Edwards Lifesciences; table 13.6.
  7. Carpentier-Edwards PERIMOUNT Manga Ease aortic heart valve [package insert]. Irvine, CA: Edwards Lifesciences; table 7.
  8. Perceval sutureless heart valve [package insert]. London, UK: LivaNova; table 12.
  9. Edwards pericardial aortic bioprosthesis [package insert for Resilia valve]. Irvine, CA: Edwards Lifesciences; table 9.
  10. Trifecta valve [package insert]. Chicago, IL: Abbott; table 9.
  11. 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.
  12. 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
  13. Johnston DR, et al. Long-term durability of bioprosthetic aortic valves: implications from 12,569 implants. Ann Thorac Surg. 2015;99:1239–1247. doi.org/10.1016/j.athoracsur.2014.10.070.
  14. 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.
  15. 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.
  16. 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.
  17. Kilic A, et al. Gone fishing: looking to catch some answers for differing mortality in the CoreValve High-Risk Trial. J Thorac Cardiovasc Surg. 2017;153(6):1302.
  18. 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.
  19. Goldman S, et al. Midterm, multicenter clinical and hemodynamic results for the Trifecta aortic pericardial valve. J Thorac Cardiovasc Surg. 2017;153(3):561-569.e2.
  20. Lehmann S, et al. Midterm durability and hemodynamic performance of a third-generation bovine pericardial prosthetic aortic valve: the Leipzig experience. Ann Thorac Surg. 2017;103(6):1933-1940.
  21. Anselmi A, et al. Mid-term durability of the Trifecta bioprosthesis for aortic valve replacement. J Thorac Cardiovasc Surg. 2017;153(1):21-28.

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