TrifectaTM GT

Why HemodynamiCS
Matter

Because Patients’ Lives Matter

The TrifectaTM 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 TrifectaTM 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 CoreValveTM 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 TrifectaTM 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 TrifectaTM 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 TrifectaTM 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 CoreValveTM 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 TrifectaTM 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 TrifectaTM data compared to other SAVR valves.

AP2947046-WBU Rev. A

References
  1. Avalus bioprosthesis [package insert]. Minneapolis, MN: Medtronic; table 8.
  2. Intuity EliteTM valve system [package insert]. Irvine, CA: Edwards Lifesciences; table 13.6.
  3. Carpentier-Edwards PERIMOUNT Manga EaseTM 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. TrifectaTM 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.
     
Important safety information

TRIFECTATM VALVE WITH GLIDETM TECHNOLOGY (GT)
INDICATION FOR USE


The TrifectaTM Valve with GlideTM Technology is intended as a replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic heart valve.

CONTRAINDICATIONS

None known.

WARNINGS

  • For single use only. Do not reuse or resterilize. Attempts to resterilize the valve may result in valve malfunction, inadequate sterilization, or patient harm.
  • Do not oversize. Valve size selection is based on the size of the recipient annulus and the anatomy of the sinotubular junction. If the native annulus measurement falls between the two valve sizes, use the smaller size valve. Use only the Model TF2000 TrifectTM Sizers for sizing the valve. Implantation of an oversized valve may result in stent deformation, valvular incompetence, valve damage, diminished tissue durability, and/or damage to the surrounding tissues.
  • Passage of a diagnostic catheter or transvenous pacing lead through any bioprosthesis may damage the valve and is therefore not recommended.
  • Accelerated deterioration of the valve may occur in:
    • Children, adolescents, or young adults
    • Patients with altered calcium metabolism (e.g., patients with hyperparathyroidism or chronic renal failure)
    • Individuals requiring hemodialysis
  • Do not use if:
    • The valve has been dropped, damaged, or mishandled in any way, or if there is any sign of deterioration.
    • The expiration date has elapsed.
    • The tamper-evident jar seal is damaged, broken, or missing or if fluid is leaking from the packaging.
    • The storage solution does not completely cover the valve.
  • Use only the TrifectaTM Model TF2000 sizers1 for sizing the valve.
  • The titanium valve stent is not designed as a flexible stent. Do not bend the titanium valve stent. Deformation of the stent may impair valve function.

PRECAUTIONS

  • Safety and effectiveness of the valve has not been established for the following specific populations:
    • Patients who are pregnant
    • Nursing mothers
    • Patients with chronic renal failure
    • Patients with aneurysmal aortic degenerative conditions (e.g., cystic medial necrosis, Marfan’s syndrome)
    • Patients with chronic endocarditis
    • Patients requiring pulmonic or tricuspid valve replacement
    • Children, adolescents, or young adults
  • Sizer sets are supplied non-sterile, and must be cleaned and sterilized prior to each use. Do not use cracked, crazed, or deformed sizer set components.
  • Do not place the non-sterile exterior of the valve jar in the ssterile field.
  • Do not use the valve if shipping temperature indicators on the product carton have turned red, or if the valve has been improperly stored in temperature conditions outside of the 5°C–25°C (41°F–77°F) range.
  • Do not expose the valve to solutions other than the formaldehyde solution in which it was shipped,  the sterile isotonic saline solution used during the rinsing procedure, or the sterile isotonic saline  used to irrigate the valve.
  • Do not add antibiotics to either the valve storage solution or the rinse solution.
  • Do not apply antibiotics to the valve.
  • Do not allow the valve tissue to dry. Place the valve in isotonic sterile saline rinse solution immediately upon removal from the valve storage solution. Once removed from this solution, the valve should be periodically irrigated during implantation.
  • Do not implant the valve without thoroughly rinsing as directed.
  • Position the valve so that the stent posts do not obstruct the coronary ostia or come in direct contact with the aortic wall.
  • Never handle the leaflet tissue.
  • Avoid prolonged contact with the formaldehyde storage solution. Immediately after contact,  thoroughly flush any skin exposed to the solution with water. In case of contact with eyes with water and seek appropriate medical care.
  • Use caution when placing sutures through the  sewing cuff to void lacerating the valve tissue.  If a valve is damaged, the valve must be replaced.
  • Do not use cutting edge needles, unprotected forceps, or sharp instruments, as they may cause structural damage to the valve.
  • Do not attempt to repair a valve. Damaged valves must not be used.
  • Do not pass the replica end of the TF2000 sizer through the annulus when sizing the valve.
  • Use caution when tying knots to avoid bending  the stent posts.

ADVERSE EVENTS

The TrifectaTM Valve with GlideTM Technology is based upon the TrifectaTM Valve design. Therefore, a previous clinical investigation of the TrifectaTM Valve supports the safety of the TrifectaTM Valve with GlideTM Technology. Between June 2007 and November 2009, one thousand and twenty-two (1022) subjects were implanted with the Trifecta valve in the aortic position at 31 investigational sites in the United States (18), Canada (7), and Europe (6). Data are presented on the one thousand and fourteen (1014) subjects who met eligibility criteria. The cumulative follow-up for all subjects was 924.18 patient-years with a mean follow-up of 0.91 years (SD = 0.49 years, range 0 - 2.38 years).

Adverse events potentially associated with the use of bioprosthetic heart valves include:

  • angina
  • cardiac arrhythmias
  • endocarditis
  • heart failure
  • hemolysis
  • hemolytic anemia 
  • hemorrhage
  • leak, transvalvular or paravalvular
  • myocardial infarction
  • nonstructural dysfunction (entrapment by pannus or suture, inappropriate sizing or positioning, or other)
  • prosthesis regurgitation
  • stroke
  • structural deterioration (calcification, leaflet tear, or other)
  • thromboembolism
  • valve thrombosis

It is possible that these complications could lead to:

  • reoperation
  • explantation
  • permanent disability
  • death

See the Clinical Study section of these instructions for adverse event data collected in the TrifectaTM Valve clinical investigation.

1. TF2000 sizers are included in sizer set models TF2000 and TF2000-2.

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