Influence of Original Native Tricuspid Valve Lesion (Stenosis or Steno-insufficiency or Insufficiency) on Post-implant Structural Bioprosthetic Degeneration After Tricuspid Valve Replacement.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Valve replacement.
- Who it may be relevant to
- Registry conditions: Degeneration of Tricuspid Surgical Bioprosthesis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
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.
Interventions
- 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 pr
Primary outcome measures
- Long term durability [Time frame: 20 years]
Secondary outcome measures (1)
- Long term survival [Time frame: 20 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- Cardio-Thoracic Surgery Department - Heart & Vascular Centre - Maastricht University Medic — Maastricht
Identifiers
NCT: NCT06875154 · 2023-0324