Computed Tomography, Tricuspid Regurgitation
Conditions
Keywords
transcatheter tricuspid valve intervention, TTVI, TR, MSCT, Tricuspid regurgitation
Brief summary
The aim of this study is to enhance the predictability of therapeutic success in transcatheter tricuspid valve intervention (TTVI) for patients with severe tricuspid regurgitation (TR). This will be achieved through automated analyses of pre-interventional computed tomography (CT) scans. Severe tricuspid regurgitation is associated with poor patient outcomes. In advanced stages, pharmacological therapy becomes ineffective, and surgical intervention carries a high mortality risk. Given this clinical challenge, catheter-based treatment of the tricuspid valve has become a focal point of research. One well-established treatment strategy is percutaneous tricuspid valve intervention, which aims to reduce regurgitation either through annuloplasty, leaflet-based edge-to-edge repair or valve replacement. This approach has been shown to significantly decrease the severity of regurgitation, leading to a dramatic reduction in symptom burden and a marked improvement in quality of life. However, predicting which patients will benefit most from TTVI and determining the optimal technique for each individual remain largely unresolved challenges. Artificial intelligence (AI)-powered software, such as heart.ai by LARALAB (Munich), enables automated measurement of anatomical structures captured via CT imaging. This technology already allows for rapid and precise assessment of cardiac chambers and the tricuspid annulus throughout the entire cardiac cycle, facilitating a comprehensive three-dimensional evaluation of right heart anatomy. To refine patient selection and optimize procedural strategies for TR treatment, the researcher work a multi-center collaboration to analyze treatment outcomes and patient response to specific therapeutic approaches.
Interventions
None listed
Sponsors
Ludwig-Maximilians - University of Munich
University Hospital Schleswig-Holstein
University of Cologne
Heart Center Leipzig - University Hospital
Charite University, Berlin, Germany
University of Bern
University Medical Center Mainz
Heart and Diabetes Center North-Rhine Westfalia
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* the patient underwent full cycle cardiac computed tomography for analysis of valvular heart disease * a transcatheter tricuspid valve intervention is performed * the patient is 18 years or older
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 1 year | Detection of mortality after transcatheter tricuspid intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Residual Tricuspid Regurgitation | At discharge, 30 days and 1 year | Grade of residual tricuspid regurgitation after transcatheter tricuspid valve intervention |
| rehospitalization rate | 1 year | Detection of rehospitalization rate after transcatheter tricuspid intervention |
| reintervention rate | 1 year | Detection of reintervention rate on the tricuspid valve after transcatheter tricuspid intervention |
| NYHA Class | 30 days and 1 year | Changes on New York Heart Association functional class after transceather tricuspid valve intervention |
| Intraprocedural success | 30 days | All of the following must be present: 1. Absence of intraprocedural mortality or stroke; and 2. Successful access, delivery, and retrieval of the device delivery system; and 3. Successful deployment and correct positioning of the intended device(s) without requiring implantation of unplanned additional devices; and 4. Adequate performance of the transcatheter device. Performance of devices whose purpose is a reduction in TR, should include the absence of tricuspid stenosis, reduction of total tricuspid regurgitation to optimal 5. Absence of device-related obstruction of forward flow 6. Absence of device-related pulmonary embolism 7. Freedom from emergency surgery or reintervention during the first 24 h related to the device or access procedure |
Countries
Germany
Contacts
Primary ContactJohannes Kirchner, Dr. med.
Outcome results
None listed