The research we do today inspires the procedures you will perform tomorrow. That’s why we’re committed to continued scientific advancement, and studies that investigate the safety and performance of new technologies.
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 in the tabs below.
RESILIA tissue is building a track record of study data.
| Year | Description |
|---|---|
| 2010 | Juvenile sheep study |
| 2011 | EU human feasibility study in Poland |
| 2012 | US 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
This study investigated the effect of RESILIA tissue with the absence of any glutaraldehyde-based storage solution and a stable aldehyde capping process on pannus formation.
Methods
- In sheep studies, RESILIA tissue valves were compared to control valves with either the ThermaFix process or XenoLogiX treatment
- In vivo valve performance of RESILIA tissue was studied in two different chronic sheep studies, which were previously published evaluating safety, calcification and hemodynamic performance
- In sheep studies, RESILIA tissue valves were compared to control valves with either the ThermaFix (control group from 5 month study, n=7) or XenoLogiX (control group from 8 month study, n=17)
- The aim of the study is to further evaluate pannus formation of RESILIA tissue valves and the control tissue valves
Results
- RESILIA tissue revealed less pannus formation compared to other commercially available tissue treatments
- The study showed 65% reduction in pannus over the whole valve area in the RESILIA tissue valves vs. the control tissue valves
- RESILIA tissue valves demonstrated better leaflet mobility and more favorable gradients compared to the control tissue valves
Conclusions
- A reduced inflammatory response may lead to pannus formation
- RESILIA tissue valves were associated with reduced pannus formation when compared to control valves. This technology has the potential to improve long term outcomes for patients
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.
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)
Results
- 31 animals (14 controls and 17 test animals) remained in perfect condition during the 8-month follow-up period
- Echocardiography at 1 week showed normal valve function in both groups
- At 8 months, cardiac output increased significantly to the same extent in both groups (vs baseline; P < .01). The mean transvalvular pressure gradient also increased, but significantly more in the control group compared with the test group (P = .03)
- Flow turbulence across the prosthesis was increased in the control valves compared with the test valves. The test valves had significantly less calcium content than the controls (1.9 ± 0.3 vs 6.8 ± 1.6 μg/mg; P = .002). This was confirmed by radiographic analysis and histology (see images below)
No clinical data are available that evaluate the long-term impact of RESILIA tissue in patients.
Conclusions
This study demonstrates that the novel tissue preservation technology, when applied to the PERIMOUNT mitral valve, significantly improves hemodynamic and anti-calcification properties compared with the standard PERIMOUNT valve.
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.
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)
Results
- Safety events
- No cases of SVD 0%/LPY
- Late all-cause mortality 3.2%/LPY
- Late valve thrombosis 0.2%/LPY
- Late endocarditis 0.2%/LPY
- Late major paravalvular leak 0.0%/LPY
- Stable hemodynamic performance observed at 5 years
- Mean gradient was 14.8 ± 7.6 mmHg
- Average EOA was 1.4 ± 0.5 cm2
Conclusions
The RESILIA tissue valve demonstrated excellent hemodynamic performance and safety outcomes over 5 years of follow-up.
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
- 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
- 2898 aggregate patient-years of follow up
- Follow up: 4.3 ± 1.4 yrs (n = 471)
Results
- Safety endpoints, probability event-free at 5 years:
- All-cause mortality, 89.2%
- Major paravalvular leak, 99.5%
- Endocarditis, 97.8%
- Improved hemodynamic performance compared to baseline was observed through 5 years:
- Mean gradient was 10.2 ± 4.6 at 1 year, 10.2 ± 4.5 at 2 years, and 10.8 ± 5.7 at 3 years, 11.1 ± 5.7 mmHg at 4 years, and 11.5 ± 6.0 at 5 years
Conclusions
- Favorable safety profile and stable hemodynamics of RESILIA tissue in a bovine aortic valve
- No SVD through 5 yrs, stable gradients, and freedom from regurgitation all support durability over the observational period.
- Follow-up continues on the long-term safety and effectiveness of this new tissue
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
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.
Results
- Among various variables examined, only patient age at implant and valve size were statistically significantly associated with mean gradient change over 5 years.
- Only valve size was found to be independently associated with a decrease in EOA.
- In the multivariable model, mean gradient over 5 years rose 3.6 mmHg for the typical 55-yr old patient, 2.4 mmHg for the typical 65-yr old patient, and 1.6 mmHg for the typical 75-yr old patient.
- Average 5-year change in EOA was between -0.27 cm2 and -0.29 cm2 for these ages.
- In the multivariable model, mean gradient over 5 years rose between 0.9 mmHg and 2.7 mmHg for valve sizes between 21 mm and 27 mm, respectively.
- Average 5-year change in EOA was between -0.19 cm2 and -0.30 cm2 for these valve sizes
Conclusions
- Only patient age and valve size were found to be independently associated with an increase in mean gradient over 5 years
- The average 65-yr-old patient experienced an increase in mean gradient over 5 years of only 2.4 mmHg, and the average patient with a 23 mm valve size experienced an increase in gradient of only 1.8 mmHg
- These results are encouraging for the potential durability of RESILIA tissue
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
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.
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).
View 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
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.
Figure 1. Study flow chart. CT: computer tomography;
TTE transthoriacic echocardiography
Featured Products
Explore our current RESILIA tissue products
RESILIA Tissue Devices
Indications: INSPIRIS RESILIA Aortic Valve - For use in replacement of native or prosthetic aortic heart valves.
KONECT RESILIA Aortic Valved Conduit - For use in replacement of native or prosthetic aortic heart valves and the associated repair or replacement of a damaged or diseased ascending aorta.
Contraindications: There are no known contraindications with the use of these RESILIA tissue heart valve devices.
Complications and Side Effects: Thromboembolism, valve thrombosis, hemorrhage, hemolysis, regurgitation, endocarditis, structural valve deterioration, nonstructural dysfunction, stenosis, arrhythmia, transient ischemic attack/stroke, congestive heart failure, myocardial infarction, any of which could lead to reoperation, explantation, permanent disability, and death. Additional adverse events potentially associated with the use of polyester vascular grafts in the KONECT RESILIA AVC include hemorrhage, thrombosis, graft infection, embolism, aneurysm, pseudoaneurysm, seroma, occlusion (anastomotic intimal hyperplasia), immunological reaction to collagen (shown to be a weak immunogen; infrequent, mild, localized and self-limiting), intimal peel formation, and conduit dilatation.
Warnings: INSPIRIS RESILIA Aortic Valve - DO NOT ADJUST THE VALVE DIAMETER BY EXPANDING THE BAND PRIOR TO OR DURING IMPLANTATION OF THE SURGICAL VALVE. The expandable band is not designed to allow for compression or expansion during implantation of the surgical valve. This will cause damage to the valve and may result in aortic incompetence. DO NOT PERFORM STAND-ALONE BALLOON AORTIC VALVULOPLASTY PROCEDURES ON THIS VALVE FOR THE SIZES 19 – 25 mm as this may expand the valve causing aortic incompetence, coronary embolism or annular rupture. Valve-in-valve sizing in the INSPIRIS valve has only been tested with specific Edwards transcatheter heart valves. Use of other transcatheter valves may result in embolization of transcatheter devices anchored within or result in annular rupture.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information.
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