Promising data. Inspiring results.

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 Year	Description
2010	Juvenile sheep study
2011	EU human feasibility study in Poland
2012	Aortic/mitral COMMENCE IDE study
2017	INSPIRIS RESILIA valve approved by FDA
2018	RESILIENCE study begins

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

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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.

Pannus Formation Study Clinical Summary

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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

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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.

Juvenile Sheep Study Clinical Paper Details

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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

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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.

EU Feasibility Study Clinical Summary

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COMMENCE Trial

Five-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

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Prospective, multinational, multicenter (n = 27), single-arm, FDA Investigational Device Exemption trial
689 patients underwent surgical AVR with the Edwards Pericardial Aortic Bioprosthesis with RESILIA tissue (model 11000A)
- Mean age 66.9 ± 11.6 years, with 140 patients (21%) under 60 years
- 71.8% male
- 26% NYHA Class III/IV
- Mean STS PROM 2.0 ± 1.8%
- 59% isolated AVR
2989 aggregate patient-years of follow up
- Follow up: 4.3 ± 1.4 years (n=471)

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

COMMENCE Trial Clinical Summary

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Five-year outcomes of the COMMENCE Trial investigating Aortic Valve Replacement with a Novel Tissue Bioprosthesis

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Hear the results of the COMMENCE trial conducted to evaluate the safety and effectiveness of aortic valve replacement (AVR) using a bioprosthesis with novel RESILIA tissue. Presenting Author: Joseph Bavaria, MD

COMMENCE Trial Hemodynamics Sub-Analysis

Sub-analysis of the five-year outcomes of the COMMENCE aortic trial investigating patient and valve factors associated with longitudinal hemodynamic change and the study valve’s hemodynamic performance.⁵

COMMENCE Trial Hemodynamics Sub-Analysis Clinical Summary

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Methods

Patients underwent echocardiograms annually through 5 years of follow up; these were evaluated by a core laboratory.
Only patients with evaluable echo data (N=663) at any of the post-op visits were eligible for inclusion in this sub-analysis.
Longitudinal models were constructed to estimate the change in mean gradient and change in effective orifice area (EOA) separately over 5 years post-operatively.

For a more detailed overview of the COMMENCE trial hemodynamics sub-analysis methodology and results, download the clinical summary.

COMMENCE Trial Hemodynamics Sub-Analysis Clinical Summary

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COMMENCE Trial Bicuspid Aortic Valve Sub-Analysis

Sub-analysis of the five-year outcomes of the COMMENCE aortic trial investigating safety outcomes and mean gradients in patients with bicuspid aortic valves.⁶

COMMENCE Trial Bicuspid Aortic Valve Sub-Analysis Clinical Summary

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Methods

Patients underwent echocardiograms annually through 5 years of follow up; these were evaluated by a core laboratory.
Evaluations included safety outcomes, paravalvular and transvalvular regurgitation, and summary hemodynamics.
Longitudinal models were constructed to estimate the change in mean gradient and change in effective orifice area (EOA) separately over 5 years post-operatively.

For a more detailed overview of the COMMENCE trial bicuspid aortic valve sub-analysis methodology and results, download the clinical summary.

COMMENCE Trial Bicuspid Aortic Valve Sub-Analysis Clinical Summary

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COMMENCE Mitral Trial

Four-year outcomes of the COMMENCE trial investigating mitral valve replacement (MVR) with a novel tissue bioprosthesis showed clinically stable hemodynamics and one incident of SVD in 82 patients. In the one instance of SVD reported, the patient, a 77-year-old female, had multiple comorbidities including: renal cell carcinoma, coronary artery disease, hypertension, atrial fibrillation, non-Hodgkin’s lymphoma after bone marrow transplant and ongoing tobacco use.

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)⁷

RESILIENCE Study Design Clinical Summary

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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

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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

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.

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References

Tod reference is: TJ Tod et al. Cardiovasc Eng Technol 2021;12:418-25.
Flameng W, et al. J Thorac Cardiovasc Surg. 2015;149:340–5.
Bartus K et al. Eur J Cardiothorac Surg 2021;59:434-41.
Bavaria JE et al. Ann Thorac Surg 2022 doi: https://doi.org/10.1016/j.athoracsur.2021.12.058
Mumtaz MA, Bavaria JE, Griffith B, et al. Presented at the Society of Thoracic Surgeons Annual Meeting, January 2022.
Bavaria JE, et al. Presented at the American Association for Thoracic Surgery Annual Meeting, May 2022.
Pibarot P, et al. Structural Heart. 2020;4(1):46-52.

Promising data. Inspiring results.

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

RESILIA tissue is building a track record of study data.

Pannus Formation Study

Pannus Formation Study Clinical Summary

Methods

Pannus Formation Study Clinical Summary

Juvenile Sheep Study

Juvenile Sheep Study Clinical Paper Details

Methods

Juvenile Sheep Study Clinical Paper Details

EU Feasibility Study

EU Feasibility Study Clinical Summary

Methods

EU Feasibility Study Clinical Summary

COMMENCE Trial

Methods

COMMENCE Trial Clinical Summary

COMMENCE Trial Clinical Summary

COMMENCE Trial Hemodynamics Sub-Analysis

Sub-analysis of the five-year outcomes of the COMMENCE aortic trial investigating patient and valve factors associated with longitudinal hemodynamic change and the study valve’s hemodynamic performance.5

COMMENCE Trial Hemodynamics Sub-Analysis Clinical Summary

Methods

COMMENCE Trial Hemodynamics Sub-Analysis Clinical Summary

COMMENCE Trial Bicuspid Aortic Valve Sub-Analysis

Sub-analysis of the five-year outcomes of the COMMENCE aortic trial investigating safety outcomes and mean gradients in patients with bicuspid aortic valves.6

COMMENCE Trial Bicuspid Aortic Valve Sub-Analysis Clinical Summary

Methods

COMMENCE Trial Bicuspid Aortic Valve Sub-Analysis Clinical Summary

COMMENCE Mitral Trial

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)7

RESILIENCE Study Design Clinical Summary

RESILIENCE Study Design Clinical Summary

Methods

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References

Sub-analysis of the five-year outcomes of the COMMENCE aortic trial investigating patient and valve factors associated with longitudinal hemodynamic change and the study valve’s hemodynamic performance.⁵

Sub-analysis of the five-year outcomes of the COMMENCE aortic trial investigating safety outcomes and mean gradients in patients with bicuspid aortic valves.⁶

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)⁷