Medtronic's MOSAIC Bioprosthesis Versus Baxter Carpentier-Edwards SAV Porcine Valve

Medtronic's MOSAIC Bioprosthesis Versus Baxter Carpentier-Edwards SAV Porcine Valve: A Longterm Prospective Randomized Clinical Evaluation

The study compares the clinical performance of the Mosaic valve with that of the Baxter valve (Carpentier-Edwards) which is widely used throughout the UK and is considered to be the "bench mark".

Specific objectives will be to determine structural failure and valve explantation rates, thromboembolic events and mortality rates for each valve.

Haemodynamic assessments will also be made using echocardiography to measure gradients across the valves and changes in left ventricular function and wall thickness.

Study Overview

• Status: Completed
• Conditions: Cardiac Valve Replacement
• Intervention / Treatment: Device: Carpentier-Edwards SAV bioprostheses; Device: Medtronic Mosaic bioprostheses

Detailed Description

The bioprostheses (xenografts) to be used in this study are third generation valves derived from porcine aortic valves. The chief advantage over mechanical prostheses is that they do not require lifelong anticoagulation with warfarin with its attendant risks of haemorrhage if the patient becomes over anticoagulated, or thromboembolism if anticoagulation is inadequate. However their disadvantage is that they are prone to calcification and mechanical failure over time. Because of this, bioprosthetic valves are usually reserved for older patients in whom the chance of repeat surgery is reduced.

The Medtronic Mosaic stented bioprosthesis has been recently introduced. The Mosaic bioprosthesis utilizes Physiological Fixation (root fixation with zero pressure differential across the valve leaflets). This allows valves to maintain their natural leaflet structure and root geometry. The Mosaic bioprosthesis uses the AOA anti-mineralisation treatment. Developed in collaboration with Biomedical Design, Inc., AOA has been shown in multiple animal studies to be an effective treatment in preventing leaflet calcification.

Baxter currently produces the Carpentier Edwards SAV porcine bioprosthesis that has abundant long-term follow-up data and is widely used. Low pressure fixation (less than 1.5mmHg) and anti-mineralisation treatment with FET 80TM are used in its preparation. The stent (which supports the cusps) has been designed to allow for the wider opening angle of the softer leaflets.

These features aim to improve on the haemodynamic performance of earlier generation valves and offer the potential for increased durability. Early results look promising with excellent haemodynamic parameters and remarkably low rates of structural failure.

If zero pressure fixation and anti-mineralisation treatment can be shown to increase the longevity of the bioprosthetic valve, the age criteria for implantation will undoubtedly be lowered allowing a younger cohort of patients to benefit from anticoagulation-free therapy and freedom from associated morbidities.

• Study Type: Interventional
• Enrollment (Actual): 428
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Devon
    • Plymouth, Devon, United Kingdom, PL6 8BX
      • Plymouth Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who require isolated or combined aortic or mitral valve replacement with or without coronary artery bypass grafting
• Patients requesting anticoagulation-free therapy
• Patients who are able to provide informed consent

Exclusion Criteria:

• Concomitant procedures other than coronary artery bypass grafting
• Presence of illness other than valve disease that would substantially increase the likelihood of death within one year
• Patients unlikely to be available for long term follow-up activities
• Patients indicated for receiving a mechanical prosthesis
• Patients refusing or not able to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Carpentier-Edwards SAV bioprostheses	Device: Carpentier-Edwards SAV bioprostheses; Performance of these bioprostheses
Active Comparator: Medtronic Mosaic bioprostheses	Device: Medtronic Mosaic bioprostheses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Early mortality was defined as death occurring within 30 days of implantation if the patient was discharged from hospital or at any time after implantation if the patient was not discharged from hospital. Hospital-to-hospital transfer was not considered as discharge. Late mortality was defined as all deaths that occurred after 30 days of implant, if the patient was discharged from hospital. The reporting of mortality and morbidity follows the guidelines of the Society of Thoracic Surgeons (STS), the American Association of Thoracic Surgeons (AATS) and the European Association for Cardiothoracic Surgery (EACTS). () Edmunds LH, Clark R, Cohn L, et al. Guidelines for Reporting Morbidity and MortalityAfter Cardiac Valvular Operations. Ann Thorac Surg 1996;62:932-5)	10 years
Freedom from structural valve deterioration (SVD)	Defined as re-operation and thromboembolic events. Valve-related complications were defined as thromboembolism, structural valve dysfunction, non-structural valve dysfunction and prosthetic valve endocarditis.	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Haemodynamic performance (mmHg)	Transvalvular gradients measured in mmHg	10 years
Left ventricular (LV) mass regression (grams)	Evidence of left ventricular mass regression measured in grams	10 years

Collaborators and Investigators

• Sponsor: University Hospital Plymouth NHS Trust
• Investigators: Principal Investigator: Jonathan Unsworth-White, BSc FRCS, University Hospital Plymouth NHS Trust

Publications and helpful links

General Publications

• Zibdeh O, Bugg I, Patel S, Twine G, Unsworth-White J. Randomized trial of the Carpentier-Edwards supra-annular prosthesis versus the Medtronic Mosaic aortic prosthesis: 10-year results. Eur J Cardiothorac Surg. 2018 Aug 1;54(2):281-287. doi: 10.1093/ejcts/ezx512. Erratum In: Eur J Cardiothorac Surg. 2018 Aug 1;54(2):406.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2001
• Primary Completion (Actual): February 2, 2006
• Study Completion (Actual): January 12, 2016

Study Registration Dates

• First Submitted: September 8, 2017
• First Submitted That Met QC Criteria: November 14, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): November 17, 2017
• Last Update Submitted That Met QC Criteria: November 14, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 1301 (Tesch-Övermo Stiftelsen)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No