Biventricular Remodeling in Transcatheter Tricuspid Valve Replacement - Acute Hemodynamic Instability Study

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.

Primary outcomes

• 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 outcomes

• 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

Sex: All, ages: 18 Years to any

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.

• Tamim Nazif, MD, Principal investigator, Columbia University