Influence of Original Native Tricuspid Valve Lesion (Stenosis or Steno-insufficiency or Insufficiency) on Post-implant Structural Bioprosthetic Degeneration After Tricuspid Valve Replacement. (DURABLE-TRIC)

The structural deterioration process of the implanted bioprosthesis in tricuspid position for tricuspid valve pathology is gradual and irreversible and includes many changes, such as pannus growth, leaflet fibrosis and calcification, delamination of the connective tissue, ruptures and perforations of leaflets. In the great majority of cases SVD consists of leaflet calcium deposits and can be clinically associated with young age, hypercholesterolemia, hypertension, diabetes mellitus, renal failure. The long term durability of these bioprosthesis is still missing.

Study Overview

• Status: Enrolling by invitation
• Conditions: Degeneration of Tricuspid Surgical Bioprosthesis
• Intervention / Treatment: Procedure: Valve replacement

Detailed Description

It is not clear if the same biochemical, hemodynamic and immunological mechanisms leading to native valve calcification can cause bioprosthetic SVD. We hypothesize that the mechanisms protecting the native valve from calcification in the insufficiency disease may subsequently protect also the bioprosthetic valve from calcific SVD. In such a case, considering also the reduced incidence in insufficiency patients of prosthesis-patient mismatch, supposedly associated with increased risk of SVD, indication for bioprosthetic valve use could be expanded in patients with insufficiency. Because of the rising demand of bioprosthetic valve implantation, even a few years increase in the expected durability of the BHV, although limited to a defined population of patients, will have a very relevant clinical impact.

We aim to perform a retrospective, multi-center, observational study. All patients undergoing elective tricuspid valve replacement from 2000 to 2020 who met the inclusion criteria for the study (described in the dedicated section) will be enrolled in the study. These patients will be followed-up as part of routine care, and information about the clinical status, NYHA functional class, possible rehospitalization, possible cardiovascular events and postoperative echocardiography will be available for analysis. Once consent is given, and if required by local governance, pre-, intra- and post-operative data will be collected in a dedicated, structured, database.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands
    • Cardio-Thoracic Surgery Department - Heart & Vascular Centre - Maastricht University Medical Centre (MUMC+)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing elective tricuspid valve replacement from 2000 to 2020 who met the inclusion criteria for the study (described in the dedicated section) will be enrolled in the study

Description

Inclusion Criteria:

- Age ≥ 18 years; 6

- Patients who underwent isolated tricuspid valve replacement for stenosis, regurgitation or steno-regurgitation

- Signed informed consent, inclusive of release of medical information where required by local governance.

Exclusion Criteria:

• Tricuspid valve replacement associated with other surgical procedures (CABG or other)

Previous cardiac surgery of any kind;

- Surgery for acute endocarditis

- Participation in another clinical trial that could interfere with the endpoints of this study.

- Pregnant or breastfeeding at time of screening.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Surgical Tricuspid bioprosthesis; All patients undergoing elective tricuspid valve replacement from 2000 to 2020. All operations were performed through median longitudinal sternotomy, mini-sternotomy or mini- thoracotomy.Intraoperative transesophageal echocardiography (TOE) was used in all patients. Arterial cannulation was central and venous cannulation was achieved with a common two-stage cannula in the right atrium. Left ventricle was vented through the right superior pulmonary vein.In minimally invasive procedures, venous cannulation was achieved percutaneously. Myocardial protection was achieved by administration of cold crystalloid or blood cardioplegia at the surgeon's discretion in an antegrade (indirect or selective) or retrograde fashion. Beating heart procedure can be performed without the use of aortic clamp. The prosthesis were be implanted with 2-0 U-shaped sutures.

Procedure: Valve replacement; All operations were performed through median longitudinal sternotomy or mini-sternotomy or minitoracothomy Intraoperative transesophageal echocardiography (TOE) was used in all patients. Arterial cannulation was central and venous cannulation was achieved with a common two-stage cannula in the right atrium or from peripheral access. Left ventricle was vented through the right superior pulmonary vein. In minimally invasive procedures, venous cannulation was achieved percutaneously. Myocardial protection was achieved by administration of cold crystalloid or blood cardioplegia at the surgeon's discretion in an antegrade (indirect or selective) or retrograde fashion.. All the prosthesis were be implanted with supranular technique and 2-0 U-shaped pledgeted sutures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long term durability	Long term durability of the tricuspid bioprosthesis in terms of structural valve deterioration or /and associated complications. Echocardiographic parameters will be used. Continous variables will be implied.	20 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long term survival	Long term survival, event free survival, freedom from reoperations and hospitalization.	20 years

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Actual): January 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: March 7, 2025
• First Submitted That Met QC Criteria: March 7, 2025
• First Posted (Actual): March 13, 2025

Study Record Updates

• Last Update Posted (Actual): May 4, 2025
• Last Update Submitted That Met QC Criteria: April 30, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: tricuspid valve; Durability; Tricuspid bioprosthesis
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: 2023-0324

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
• product manufactured in and exported from the U.S.: No