BECAUSE YOUR PATIENTS’ LIVES MATTER.
SAVR ON TRIAL
Two pivotal trials.1,2
PARTNER TRIAL (COHORT 1A) 2013, n=699 and COREVALVE HIGH RISK TRIAL 2015, n=790 characterized SAVR valves as having inferior hemodynamics.
Three consistent findings as compared to TAVR.1-4
- Significantly Higher Gradients with SAVR
- Significantly more Prosthesis-Patient Mismatch (PPM) with SAVR
- Increased Mortality with Severe PPM
One undisputed conclusion.
THE EVIDENCE IS CLEAR:
MULTIPLE STUDIES LINK HEMODYNAMICS TO PATIENT OUTCOMES
BEST-IN-CLASS, SINGLE-DIGIT GRADIENTS ACROSS ALL VALVE SIZES ≥ 21MM5‑10
“THE NEARLY CYLINDRIC OPENING… PROVIDES GRADIENTS AND EOAs THAT SURPASS ANY OTHER AVAILABLE STENTED AORTIC PROSTHESIS”
Bavaria et al.6
The Trifecta™ Valve with Glide™ Technology is intended as a replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic heart valve.
Average Mean Gradient by Valve Size at One Year5‑10, 12*
*Data from IFU; not from a head-to-head comparison. Information provided for educational purposes only.
TAKE THE GRADIENT CHALLENGE
Compared with the latest pericardial valves, only Trifecta™ GT valves consistently demonstrate favorable gradients, with most valve sizes achieving single-digit gradients—similar to TAVR valves.5‑10
For each increase on 1mmHg in mean gradient, the probability of heart failure (HF) recurrence or HF-related death is increased by 6%13
TRIFECTA™ VALVE: CLINICAL DATA
Left Ventricular (LV) Mass Index After Aortic Valve Replacement14
SIGNIFICANTLY GREATER LV MASS REGRESSION COMPARED WITH MAGNA EASE™ VALVE14
An independent, propensity-matched, head-to-head study following 258 patients receiving either a Magna Ease™ Valve (n=141) or Trifecta™ Valve (n=117) demonstrates higher LV mass regression.
- Greater total LV mass regression
- Greater mass regression over time
SIGNIFICANTLY REDUCED RISK COMPARED TO MAGNA EASE™ VALVE14
The same comparative study of 258 patients cited above found:
OF HF REQUIRING URGENT
Retrospective Review: 351 Patients with
Small Aortic Annulus (≤ 21mm) (p=0.001)12
Consistently Low Rate of Severe PPM12,15‑16
- Meta-analysis across 13 studies with over 2,500 patients finds extremely low 2.7% severe PPM with Trifecta™ Valve15
- Restrospective review of 351 patients with small aortic annulus (21mm; chart shown at left) finds now no severe PPM with Trifecta™ Valve12
Excellent Mid-Term Durability
Trifecta™ Valves show consistently excellent clinical durability in multiple mid-term studies.
Published Freedom from Reop. SVD
Cleveland Clinic Study:
Hemodynamics Determine Valve Durability20
- Increased PPM and higher gradients at implantation linked to valve deterioration and explant, especially in younger patients
- To maximize durability, optimize hemodynamics
Choose Trifecta™ GT.
- Hahn, R. T., Pibarot, P., Stewart, W. J., Weissman, N. J., Gopalakrishnan, D., Keane, M. G., … & Herrmann, H. C. (2013). Comparison of transcatheter and surgical aortic valve replacement in severeaortic stenosis. Journal of the American College of Cardiology, 61(25), 2514-2521.
- Reardon, M. J., Adams, D. H., Kleiman, N. S., Yakubov, S. J., Coselli, J. S., Deeb, G. M., … & Heiser, J. (2015). 2-year outcomes in patients undergoing surgical or self-expanding transcatheter aortic valve replacement. Journal of the American College of Cardiology, 66(2), 113-121.
- Pibarot P, Weissman NJ, Stewart WJ, 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):1323-34.
- Zorn GL III, Little SH, Tadros P, 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):1014-22,1023.e1-3.
- Avalus Bioprosthesis: Instructions for Use. Table 8.
- Edwards Intuity Elite Valve System: Summary of Safety and Effectiveness Data. Table 13.6.
- Carpentier-Edwards PERIMOUNT Manga Ease Aortic Heart Valve: Instructions for Use. Table 7.
- Perceval Sutureless Heart Valve: Summary of Safety and Effectiveness Data. Table 12.
- Edwards Pericardial Aortic Bioprosthesis: Summary of Safety and Effectiveness Data. Table 9.
- Trifecta Valve Summary of Safety and Effectiveness Data: P100029. Table 9.
- Bavaria JE, Desai ND, Cheung A, et al. The St Jude Medical Trifecta aortic pericardial valve: Results from a global, multicenter, prospective clinical study. J Thorac Cardiovasc Surg. 2014;147(2):590-7.
- Ghoneim A, Bouhout I, Demers P, 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):1019-28.
- Ruel M, Rubens FD, Masters RG, et al. Late incidence and predictors of persistent or recurrent heart failure in patients with aortic prosthetic valves. J Thorac Cardiovasc Surg. 2004;127(1):149-59.
- Rubens FD, Gee Y, Ngu JM, Chen L, Burwash I. 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.e2.
- Stock S, Lohmann I, Hanke T, et al. Rest and exercise haemodynamics in patients with one of two stented bioprostheses and in healthy controls with small aortic annuli. Interact CardioVasc Thorac Surg. 2017; doi:10.1093/icvts/ivx356.
- Colli A, Marchetto G, Salizzoni S, Rinaldi M, Di Marco L, Pacini D 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;49:478–85.
- Goldman S, Cheung A, Bavaria JE, et al. Midterm, multicenter clinical and hemodynamic results for the Trifecta aortic pericardial valve. J Thorac Cardiovasc Surg. 2017;153(3):561-569.e2.
- Lehmann S, Meyer A, Schroeter T, 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):1933-1939.
- Anselmi A, Ruggieri VG, Lelong B, et al. Mid-term durability of the Trifecta bioprosthesis for aortic valve replacement. J Thorac Cardiovasc Surg. 2017;153(1):21-28.
- Johnston DR, Soltesz EG, Vakil N, et al. Long-term durability of bioprosthetic aortic valves: implications from 12,569 implants. Ann Thorac Surg. 2015 Apr;99(4):1239-47.
IMPORTANT SAFETY INFORMATION
INDICATIONS FOR USE Indications for Use The Trifecta™ Valve with Glide™ 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. Valve size selection is based on the size of the recipient annulus and the anatomy of the sinotubular junction. Implantation of an inappropriately large valve may result in stent deformation, valvular incompetence, and/or damage to the surrounding tissues. Do not oversize the valve. If the native annulus measurement falls between two valve sizes, use the smaller valve size. Passage of a diagnostic catheter or transvenous pacing lead through any bioprosthesis may damage the valve and is therefore not recommended. Accelerated deterioration due to calcific degeneration 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 Trifecta™ 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 sterile 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. 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, flush with water and seek appropriate medical care. Use caution when placing sutures through the sewing cuff to avoid 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 Trifecta™ Valve with Glide™ Technology is based upon the Trifecta™ Valve design. Therefore, a previous clinical investigation of the Trifecta Valve supports the safety of the Trifecta Valve with Glide 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 Trifecta™ Valve clinical investigation.
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Perimount, Magna Ease, Resilia, Intuity Elite are trademarks of Edwards LifeScience. CoreValve and Avalus are trademarks of Medtronic. Mitroflow and Perceval are trademarks of LivaNova.