Trifecta GT

Why HemodynamiCS
Matter

Because Patients’ Lives Matter

The Trifecta valve with Glide Technology (GT) and Linx anticalcification (AC) technology offers exceptional hemodynamics1-6,* and excellent performance7—whether implanted via a minimally invasive procedure or conventional surgical aortic valve replacement (SAVR).

The Trifecta GT valve is particularly designed for a minimally invasive approach.

Evaluating TAVR vs SAVR Hemodynamic Performance

It’s essential for implanting physicians to examine the critical role of hemodynamics when choosing valves, given that the findings of recent pivotal trials, i.e. the PARTNER trial and the CoreValve High-Risk trial,8,9 and related studies found that compared to transcatheter aortic valve replacement (TAVR), SAVR exhibited:

  • Higher gradients8-11
  • More prosthesis-patient mismatch (PPM)8,10,11
  • Increased mortality with severe PPM8,10,11

Despite the current debate about SAVR vs TAVR, it’s important to realize that the performance of the surgical valves used in these trials8-11 may not be replicated by all SAVR devices. When compared to competing SAVR valves, data show that the hemodynamic performance of the Trifecta valve demonstrates:

  • Exceptional single-digit pressure gradients apply across all valve sizes ≥ 21 mm1-6,*
  • Lower rates of PPM than competitors12-14


*For References 1-6, information is taken from pericardial valve IFUs, not from a head-to-head clinical trial. Information provided for educational purposes only.

 

  • Unsurpassed Gradients and EOAs, Uniquely Low PPM
    Joseph Bavaria, et al.7

    “The nearly cylindric opening [of the Trifecta valve] . . .  provides gradients and EOAs that surpass any other available stented aortic prosthesis. . . . The favorable hemodynamics led to an incidence of severe PPM that was uniquely low for the Trifecta valve.”

     

Putting the Findings into Perspective

Consider this finding from the PARTNER trial:

Severe PPM was an independent predictor of 2-year mortality in the SAVR-RCT cohort. In fact the authors noted, “It is important to emphasize that the protocol of the PARTNER I trial cohort A strongly discouraged the use of valves other than the Edwards bioprostheses . . . therefore, the incidence of PPM in the SAVR arm of this randomized study may be higher than if other prosthetic valves with higher effective orifice areas [EOAs] had been used.”10

In light of that finding, consider also the Kilic et al. editorial regarding the CoreValve trial:
Five 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.”15

Furthermore, interventional cardiologists have noted that the long-term comparative durability (> 10 years) of TAVR versus SAVR remains unknown.16

A Look at the Impact of Hemodynamics

Consider how the Trifecta valve’s excellent hemodynamics17 affect overall cardiac function:

  • Left ventricular mass regression: Better hemodynamics are associated with improved left ventricular (LV) mass regression among patients with LV hypertrophy.10,18
  • Quicker recovery during exercise: Valve designs with lower gradients offer quicker recovery during exercise, which may be important for active patients.19
  • Lower risk of congestive heart failure (CHF): There’s a 6% increased risk of CHF or CHF-related death for every 1 mmHg increase in mean pressure gradient after aortic valve replacement (AVR).20

The Trifecta Valve’s Consistently Low PPM Rates

One more factor related to hemodynamics is prosthesis-patient mismatch (PPM), which impacts quality of life21,22 and is significantly associated with all-cause and cardiac mortality after AVR.21

See the in-depth Trifecta data compared to other SAVR valves.

AP2947045-WBO Rev. A

References
  1. Avalus bioprosthesis [package insert]. Minneapolis, MN: Medtronic; table 8.
  2. Intuity Elite valve system [package insert]. Irvine, CA: Edwards Lifesciences; table 13.6.
  3. Carpentier-Edwards PERIMOUNT Manga Ease aortic heart valve [package insert]. Irvine, CA: Edwards Lifesciences; table 7.
  4. Perceval sutureless heart valve [package insert]. London, UK: LivaNova; table 12.
  5. Edwards pericardial aortic bioprosthesis [package insert for Resilia valve]. Irvine, CA: Edwards Lifesciences; table 9.
  6. Trifecta valve [package insert]. Chicago, IL: Abbott; table 9.
  7. Bavaria JE, et al. The St Jude Medical Trifecta aortic pericardial valve: results from a global, multicenter, prospective clinical study. J Thorac Cardiovasc Surg. 2014;147:590-597.
  8. Hahn RT, et al. Comparison of transcatheter and surgical aortic valve replacement in severe aortic stenosis: a longitudinal study of echocardiography parameters in cohort A of the PARTNER trial (Placement of Aortic Transcatheter Valves). J Am Coll Cardiol. 2013;61(25):2514-2521.
  9. 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.
  10. 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.
  11. 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.
  12. 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.
  13. 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.
  14. 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.
  15. 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.
  16. Rutkin B. SAVR versus TAVR: treating intermediate-risk patients. Card Interv Today.2018; March-April issue.
  17. Levy F, et al. Hemodynamic performance during exercise of the new St. Jude Trifecta aortic bioprosthesis: results from a French multicenter study. J Am Soc Echocardiogr. 2014;27(6):590-597.
  18. 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.
  19. 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.
  20. 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.
  21. Head SJ, et al. The impact of prosthesis-patient mismatch on long-term survival after aortic valve replacement: a systematic review and meta-analysis of 34 observational studies comprising 27 186 patients with 133 141 patient-years. Eur Heart J. 2012;33(12):1518-1529.
  22. Pibarot P, et al. Prosthesis‐patient mismatch: definition, clinical impact, and prevention. Heart. 2006;92(8):1022–1029. doi: 10.1136/hrt.2005.067363.
     

This site uses cookies to improve your experience.

To find out more please read our Privacy and Cookies policy.

Ok

Sign up

Receive updates from Abbott Structural Heart

YOU ARE ABOUT TO ENTER AN ABBOTT COUNTRY OR REGION SPECIFIC WEBSITE.

Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of the product that are not approved in other countries or regions.