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The Surge

Clinical, training, product and patient outcome resources for cardiac surgeons and their heart team partners

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Medical Professional touching digital screen with a heart
Medical Professional touching digital screen with a heart
October 9, 2023

COMMENCE trial data demonstrate the RESILIA tissue valve difference

Inspiring Results
Inspiring Results
Inspiring Results

For years, the primary challenge with bioprosthetic valve replacement was durability. RESILIA tissue valves are changing what’s possible, as evidenced by data from the ongoing COMMENCE aortic and mitral trials.*

Backed by more than 40 years of tissue technology innovation, RESILIA tissue is designed to solve the calcification and durability challenges of conventional tissue valves.

The COMMENCE aortic and mitral trials are designed to evaluate the safety and effectiveness of bioprosthetic valves made with RESILIA tissue. Years of data, across multiple cohorts, demonstrate the durability and safety of RESILIA tissue.

Here is a brief overview of data released in 2023:

  • COMMENCE aortic trial 7-year
  • COMMENCE aortic trial vs. PARTNER IIA trial contemporary surgical aortic arm
  • COMMENCE mitral trial 5-year

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

Excellent outcomes at 7 years
Excellent outcomes at 7 years
Excellent outcomes at 7 years

Excellent outcomes at 7 years1

In a study of younger AVR patients (mean age of 65.1 years), data on valves with RESILIA tissue from the COMMENCE aortic trial show:

  • 99.3% freedom from SVD through 7 years
  • 97.2% freedom from reoperation through 7 years
COMMENCE aortic trial versus PARTNER IIA trial contemporary surgical aortic arm2
COMMENCE aortic trial versus PARTNER IIA trial contemporary surgical aortic arm2
COMMENCE aortic trial versus PARTNER IIA trial contemporary surgical aortic arm2

COMMENCE aortic trial versus PARTNER IIA trial contemporary surgical aortic arm2

In a study published in January 2023, investigators compared hemodynamic valve deterioration (HVD) related to structural valve deterioration (SVD) of RESILIA tissue valves from the COMMENCE aortic trial (n = 689) to those from the PARTNER IIA trial contemporary surgical aortic valve replacement (AVR) arm (n = 936) based on annual core laboratory echocardiograms through 5 years of follow-up.

Less SVD related HVD with RESILIA tissue valves
Less SVD related HVD with RESILIA tissue valves
Less SVD related HVD with RESILIA tissue valves

Using the randomized PARTNER IIA trial SAVR arm as a comparator, RESILIA tissue valves in the COMMENCE aortic trial demonstrated a lower incidence of SVD-related HVD compared with the PARTNER IIA trial SAVR arm among propensity-matched sub-cohorts. This is impactful since patients in the COMMENCE aortic trial were on average 14 years younger than the PARTNER IIA trial SAVR arm.

5 Year Icon
5 Year Icon
5 Year Icon

Impressive results in the mitral position3

RESILIA tissue is not just for valves in the aortic position. The mitral arm of the COMMENCE trial (n = 82) showed a favorable safety profile and clinically stable hemodynamic performance through 5 years:

  • 98.7% freedom from SVD through 5 years
  • 97.1% freedom from reoperation through 5 years
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More data to come

The library of clinical evidence in support of RESILIA tissue continues to grow. Review the existing data and sign up to make sure you get updates when new data is released.

Promising data. Inspiring results.
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References

  1. Beaver T, Bavaria JE, Griffith B, et al. Seven-year outcomes following aortic valve replacement with a novel tissue bioprosthesis. Presented at the 103rd Annual Meeting of the American Association for Thoracic Surgery, May 2023.
  2. Bartus K, Bavaria JE, Thourani VH, Xu K, Keuffel EL. Structural hemodynamic valve deterioration durability of RESILIA-tissue versus contemporary aortic bioprostheses. J Comp Eff Res. 2023;12(3):e220180.
  3. Heimansohn DA, Baker C, Rodriguez E, et al. Mid-term outcomes of the COMMENCE trial investigating mitral valve replacement using a bioprosthesis with a novel tissue. Ann Thorac Surg. 2023;115(6):1429-1436.
Important Safety Information

Important Safety Information

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. MITRIS RESILIA Mitral Valve - For use in replacement of native or prosthetic mitral heart valves.

Contraindications: There are no known contraindications with the use of these RESILIA tissue heart valve devices.

Complications and Side Effects: INSPIRIS RESILIA Aortic Valve - 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. MITRIS RESILIA Mitral Valve - Thromboembolism, valve thrombosis, hemorrhage, hemolysis, regurgitation, endocarditis, structural valve deterioration, nonstructural dysfunction, stenosis, arrhythmia, transient ischemic attack/stroke, congestive heart failure, myocardial infarction, ventricular perforation by stent posts, any of which could lead to reoperation, explantation, permanent disability, and death.

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 these devices to sale by or on the order of a physician. See instructions for use for full prescribing information.

Edwards, Edwards Lifesciences, the stylized E logo, COMMENCE, INSPIRIS, INSPIRIS RESILIA, KONECT, KONECT RESILIA, MITRIS, MITRIS RESILIA, PARTNER, PARTNER II, and RESILIA are trademarks or service marks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.

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