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Promising data. Inspiring results.

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Edwards Lifesciences is committed to continued scientific advancement, and studies that investigate the safety and performance of new technologies.

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Our trials aim to build upon one another by adding new variables which further challenge valve safety and efficacy. Our COMMENCE trial increased the patient population from the EU Feasibility trial, and the RESILIENCE trial is designed to look at different outcome measures to help further establish long-term valve durability.

Learn more about the current methodologies, promising results and conclusions of the various RESILIA tissue studies below.

RESILIA tissue is building a track record of study data.

Start YearDescription
2010Juvenile sheep study
2011EU human feasibility study in Poland
2012Aortic/mitral COMMENCE IDE study
2018RESILIENCE study begins

Juvenile Sheep Study

A randomized assessment of an advanced tissue preservation technology in the juvenile sheep model2

The aim of the study was to assess the effects of RESILIA tissue technology on valve function and durability in a chronic sheep model. The model was designed to mirror the accelerated calcification seen in younger humans.

Juvenile Sheep Study Clinical Paper Details

Juvenile Sheep Study Clinical Paper
Juvenile Sheep Study Clinical Paper
Juvenile Sheep Study Clinical Paper
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Methods

  • 45 juvenile sheep were randomized and either a PERIMOUNT mitral valve (6900P, control group) or the same valve design incorporating the RESILIA tissue preservation technology (test group) was implanted in the mitral position
  • All valves were 25 mm
  • A transthoracic echocardiography was performed at 1 week and at 8 months postoperatively
  • Necropsy was performed at 8 months, and the valves were examined radiographically (soft tissue radiograph), histologically (hematoxylin and eosin and Von Kossa staining), and chemically (calcium content)

For a more detailed overview of the Juvenile Sheep Study methodology and results, please see link to clinical paper details.

Flameng W, et al. J Thorac Cardiovasc Surg. 2015;149:340–5.

Juvenile Sheep Study Clinical Paper Details

Juvenile Sheep Study Clinical Paper
Juvenile Sheep Study Clinical Paper
Juvenile Sheep Study Clinical Paper
View Details

Pannus Formation Study

Influence of tissue technology on pannus formation on bioprosthetic heart valves1

The objective of this publication is to study the effect of RESILIA tissue on pannus formation.

Pannus Formation Study Clinical Summary

pannus thumbnail
pannus thumbnail
pannus thumbnail
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Methods

  • This publication reports the outcomes of two independent studies using a juvenile sheep model of mitral valve replacement with bovine pericardial tissue
    • In an 8-month study, valves with RESILIA tissue were compared to control valves with XenoLogiX treatment (XLX)
    • In a 5-month study, valves with RESILIA tissue were compared to control valves treated with the ThermaFix process (TFX)
  • Control valves were commercially available Carpentier-Edwards PERIMOUNT mitral valves, models 6900P, and 7000TFX*. Test articles were the same models configured with RESILIA tissue
  • Explanted valves were examined macroscopically and histologically. Histological observations were made by an independent pathologist, blinded to group identity
  • Independent means of pannus quantification were employed in the two studies

For a more detailed overview of the Pannus Formation Study methodology and results please download the clinical summary.

TJ Tod et al. Cardiovasc Eng Technol 2021;12:418-25.
* The 7000TFX valve model is no longer CE marked

Pannus Formation Study Clinical Summary

pannus thumbnail
pannus thumbnail
pannus thumbnail
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EU Feasibility Study

5-year outcomes after aortic valve replacement with a novel RESILIA tissue bioprosthesis3

The EU Feasibility study investigated the safety and performance in AVR patients of a bioprosthesis with RESILIA tissue. Absence of structural valve deterioration (SVD) and stable transvalvular gradients were observed through 5 years.

EU Feasibility Study Clinical Summary

EU Feasibility Study
EU Feasibility Study
EU Feasibility Study
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Methods

  • Prospective, multicenter, single-arm, trial conducted at two sites
  • 133 patients underwent surgical AVR with an Edwards Pericardial Aortic Bioprosthesis with RESILIA tissue
    • Mean age 65.3 ± 13.5 years, with (26%) ≤ 60 years
    • 19 or 21 mm valve implanted in 43.6% of patients
  • Median follow up = 5 years; Total late follow-up time of 565.2 patient years (LPY)

For a more detailed overview of the EU Feasibility Study methodology and results please download the clinical summary.

Bartus K et al. Eur J Cardiothorac Surg 2021;59:434-41.

EU Feasibility Study Clinical Summary

EU Feasibility Study
EU Feasibility Study
EU Feasibility Study
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COMMENCE Aortic Trial

Seven-year outcomes of the COMMENCE trial investigating aortic valve replacement with a novel tissue bioprosthesis4

The COMMENCE trial is an FDA pivotal trial designed to evaluate the safety and effectiveness of a bioprosthetic valve with the novel RESILIA tissue.

Methods

COMMENCE Trial Clinical Summary

COMMENCE Trial Thumbnnail
COMMENCE Trial Thumbnnail
COMMENCE Trial Thumbnnail
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  • Prospective, multinational, multicenter (n = 27), single-arm, FDA Investigational Device Exemption trial

Full Cohort

  • Between January 2013 and March 2016, 689 patients underwent AVR with the Edwards Pericardial Aortic Bioprosthesis with RESILIA tissue (model 11000A)
    • Mean age 66.9 ± 11.6 years 
    • STS risk score 2.0 ± 1.8%
    • NYHA Class II and III were 50% and 24%, respectively 
  • A total of 512 patients completed 5-year follow up

Re-Consented Cohort

  •  A total of 225 patients were re-consented for extended follow up
    • Mean age 65.1 ± 10.9 years
    • STS risk score 2.1 ± 2.1%
    • NYHA Class II and III were 43% and 19%, respectively 
  • A total of 195 patients completed 7-year follow up

For a more detailed overview of the COMMENCE trial methodology and results please download the clinical summary.

Bavaria JE et al. Ann Thorac Surg 2022 doi: https://doi.org/10.1016/j.athoracsur.2021.12.058

COMMENCE Trial Clinical Summary

COMMENCE Trial Thumbnnail
COMMENCE Trial Thumbnnail
COMMENCE Trial Thumbnnail
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COMMENCE Mitral Trial

Mid-term outcomes of the COMMENCE trial investigating mitral valve replacement using a bioprosthesis with a novel tissue6

The COMMENCE trial is an ongoing prospective study to evaluate mitral valve replacement (MVR) using valves with RESILIA tissue.

COMMENCE Mitral Trial 5-Year Clinical Summary

commence mitral trial 5-year summary
commence mitral trial 5-year summary
commence mitral trial 5-year summary
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Methods

  • Prospective, multi-center (17 sites), single-arm, Investigational Device Exemption trial
  • 82 patients underwent MVR with the Edwards Pericardial Mitral Bioprosthesis with RESILIA tissue (model 11000M)
    • Median patient age was 70 years with 52.4% of patients aged 70 years or above
    • Median follow-up for the study cohort was 5.1 (1.4) years, with a total of 374.2 patient-years in aggregate
    • A total of 54 patients completed 5-year follow up

COMMENCE Mitral Trial 5-Year Clinical Summary

commence mitral trial 5-year summary
commence mitral trial 5-year summary
commence mitral trial 5-year summary
Download

RESILIENCE Study Design

Study Design of the Prospective Non-Randomized Single Arm Multicenter Evaluation of the Durability of Aortic Bioprosthetic Valves with RESILIA Tissue in Subjects under 65 Years old (RESILIENCE Trial)5

RESILIENCE Study Design Clinical Summary

RESILIENCE thumbnail
RESILIENCE thumbnail
RESILIENCE thumbnail
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The objective of the RESILIENCE trial is to determine the time to valve failure due to valve deterioration requiring re-intervention, as well as to collect/investigate early potential predictors of valve durability (e.g. calcification and hemodynamic deterioration) in RESILIA tissue. The RESILIENCE trial is the first prospective study to associate both clinical and imaging definitions of SVD with long-term (11 years) bioprosthetic valve durability.

RESILIENCE Study Design Clinical Summary

RESILIENCE thumbnail
RESILIENCE thumbnail
RESILIENCE thumbnail
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Methods

  • Multicenter, prospective, non-randomized, single-arm, observational trial
  • Up to 250 patients who previously underwent SAVR with a RESILIA tissue valve will be enrolled at up to 15 investigational centers across the United States and Europe
    • Includes patients <65 years old; at time of implant this is a population that is at high risk to develop SVD
    • First patient enrolled on November 21, 2018
    • Anticipated 3 year enrollment period
  • Patients undergo a TTE and non-contrast CT at 5, 7, 9, and 11 years post-valve implant (Figure 1).
  • The definition proposed by Dvir et al. includes four stages: Stage 0: no SVD; Stage 1: Morphological SVD; Stage 2: Moderate hemodynamic SVD; and Stage 3: Severe hemodynamic SVD
study flow chart
study flow chart
study flow chart
Figure 1. Study flow chart. CT: computer tomography; TTE transthoriacic echocardiography
study flow chart
study flow chart
study flow chart
Figure 1. Study flow chart. CT: computer tomography; TTE transthoriacic echocardiography

Echocardiography and CT Core Laboratories will be responsible for independently evaluating TTEs and CTs submitted by trial sites and will report upon the primary and secondary outcomes of the trial.

  • The morphology and mobility of the bioprosthetic valve leaflets will be visually assessed in multiple views by 2D echocardiography
  • Non-contrast CT images will be acquired using a 64 slice or dual-source scanner
    • Valve leaflet calcification will be measured by the volumetric method that identifies calcium within the valve leaflets
    • The total volume of calcification over the 3 valve leaflets will be calculated and expressed in mm3

The RESILIENCE trial will be the first prospective study that uses both clinical and imaging definitions of SVD to provide a comprehensive description of all stages of SVD and determine the long-term (11 years) durability of the RESILIA tissue in a aortic valve.

For a more detailed overview of the RESILIENCE study methodology, please download the clinical summary.

Pibarot P, et al. Structural Heart. 2020;4(1):46-52.

Featured Products

Explore our current RESILIA tissue products

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INSPIRIS RESILIA aortic valve

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MITRIS RESILIA mitral valve

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References

  1. Tod reference is: TJ Tod et al. Cardiovasc Eng Technol 2021;12:418-25.
  2. Flameng W, et al. J Thorac Cardiovasc Surg. 2015;149:340–5.
  3. Bartus K et al. Eur J Cardiothorac Surg 2021;59:434-41.
  4. Beaver T, Bavaria JE, Griffith B, et al. Seven-year outcomes following aortic valve replacement with a novel tissue bioprosthesis. J Thorac Cardiovasc Surg. 2023 Sep 29:S0022-5223(23)00873-5.Epub ahead of print. PMID: 37778503.
  5. Pibarot P, et al. Structural Heart. 2020;4(1):46-52.
Medical device for professional use

Medical device for professional use

No clinical data are available that evaluate the long-term impact of RESILIA tissue in patients

Medical device for professional use. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use (consult eifu.edwards.com  where applicable).