Heart Failure, Interventional Cardiology, Structural Heart Disease, Tricuspid Regurgitation
Conditions
Brief summary
TTVR-AHI is a multicenter, retrospective registry including heart failure patients displaying a severe and symptomatic tricuspid regurgitation (TR), deemed non-eligible to cardiac surgery and therefore treated with transcatheter tricuspid valve replacement (TTVR) devices. This substudy of the main registry will focus on those with post-procedural acute hemodynamic instability (AHI).
Detailed description
TTVR-AHI is an international, multicenter, retrospective registry collecting routine clinical and echocardiographic data, on top of a dedicated analysis of the preprocedural CT-scan using Laralab® software. Patients with AHI will be compared to a control group without AHI, composed of individuals implanted with TTVR at Columbia University Irving Medical Center. In this substudy at Columbia, the investigators aim to describe AHI incidence, its clinical presentation, its impact on prognosis, and the predictors of its occurrence.
Interventions
None listed
Sponsors
Columbia University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients implanted with TTVR: Evoque valve system (Edwards Lifesciences), and all other device in the setting of compassionate use And * Patients presenting an AHI, defined by the need for inotrope and/or vasopressor support within 24 hours after the procedure due to hemodynamic instability (according to local investigator's judgement).
Exclusion criteria
* Major procedural complication explaining hemodynamic situation (bleeding, tamponade, etc. ) * Patients started on inotrope/vasopressor either as part of a routine post-interventional protocol or preventively for "right ventricular (RV) support" without sign of hypoperfusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality Rate | 1 Year | The prognosis of AHI after TTVR will be measured as the rate of all cause mortality in comparison to the control group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Coronary Artery Disease (CAD) | Baseline (Day 0) | Provide a multimodality description of the AHI population in comparison to the control group by defining the specificities of the AHI population. The number of participants with CAD will be reported. |
| Number of Participants with Right Ventricular (RV) Dysfunction | Baseline (Day 0) | Provide a multimodality description of the AHI population in comparison to the control group by defining the specificities of the AHI population. The number of participants with RV dysfunction will be reported. |
| Number of Participants with Pulmonary Hypertension | Baseline (Day 0) | Provide a multimodality description of the AHI population in comparison to the control group by defining the specificities of the AHI population. The number of participants with pulmonary hypertension will be reported. |
| Number of Participants with Primary Left Ventricular Cardiomyopathy | Baseline (Day 0) | Provide a multimodality description of the AHI population in comparison to the control group by defining the specificities of the AHI population. The number of participants with primary left ventricular cardiomyopathy will be reported. |
| Number of Participants with Post-Procedural Fever | Within 48 hours after the procedure | The number of participants with post-procedural fever will be reported and used to define the factors associated with the occurrence of AHI after TTVR in multivariable analysis. |
| Number of Participants with Post-procedural Inflammatory Response | Within 48 hours after the procedure | The number of participants with post-procedural inflammatory response will be reported and used to define the factors associated with the occurrence of AHI after TTVR in multivariable analysis. |
| Number of Participants with AHI | Within 24 hours after the procedure | Number of Participants with AHI among all the population screened |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTamim Nazif, MD
Columbia University
Outcome results
None listed