Standardized Invasive Hemodynamics for Elevated Gradients Post TAVR (DISCORDANCE TAVR)
Study Details
Study Description
Brief Summary
The DISCORDANCE TAVR study will determine the discordance between echocardiography-derived and invasive transaortic gradients, as determined by a consistent and reproducible technique (Standardized Invasive Hemodynamics) post-TAVR.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Since the introduction of Doppler echocardiography, non-invasive estimation of aortic valve gradients through modification and simplification of the Bernoulli equation and derivation of the AVA, via the continuity equation, have become the primary method to assess the severity of AS.
The utility of echocardiography to successfully determine aortic valve gradients and AVA has been established in the presence of AS, and such observations have been extrapolated to prosthetic valves. However, several reports following SAVR and TAVR for both native and valve-in-valve have demonstrated significant discordance between echocardiography-derived and direct invasive measurements of aortic valve mean gradients.
The indexed AVA (iAVA) is derived from the stroke volume indexed to the BSA. The stroke volume index (SVI) divided by the Doppler velocity time integral of the continuous wave aortic valve spectral profile, is used to determine the presence of severe PPM. As such, a low iAVA may occur due to a low flow state defined by a reduced SVI (<35 ml/m2) or a reduced stroke flow rate (< 200 ml/second) and calculated by dividing the SV by the ejection time spuriously increasing the incidence of severe PPM. A low indexed effective orifice area due to a low SVI, in the absence of intrinsic PPM, has been referred to as "pseudo-severe PPM", but the impact of flow state on PPM has not been described.
Nonetheless, echocardiographic thresholds for the evaluation of prosthetic valve performance after TAVR have been widely adopted: mean-gradient > 20mmHg, severe PPM as defined by an iAVA < 0.65 cm2/m2, and AR, including paravalvular and transvalvular AR of moderate or greater severity. These criteria are suggested to indicate procedural success and predict long-term clinical outcomes (12). Practically many centers utilize an echocardiography-derived mean gradient for the follow-up of transcatheter heart valves. While the association of at least moderate paravalvular AR with mortality has been consistently demonstrated, there remains uncertainty regarding the clinical impact of severe PPM as determined by index echocardiography. Furthermore, the magnitude of discordance between echocardiography-derived and invasive aortic valve mean-gradients post TAVR is unknown and it remains unclear how to reconcile measurement discordances in clinical practice. These potential differences may have an important impact on patient management post TAVR.
The DISCORDANCE TAVR study will determine the discordance between echocardiography-derived and invasive transaortic gradients, as determined by a consistent and reproducible technique (Standardized Invasive Hemodynamics) post-TAVR.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with Elevated Gradients Post Transcatheter Aortic Valve Replacement Patients who have an echocardiographic transaortic mean gradient ≥ 20mmHg OR VARC-3 criteria for ≥ moderate hemodynamic valve deterioration post TAVR on any TTE > 1 month post-TAVR |
Diagnostic Test: Standardized Invasive Hemodynamics
The SIH technique is a standardized, reproducible and efficient way of obtaining hemodynamic measurements.
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Outcome Measures
Primary Outcome Measures
- Transaortic valve gradients [30 days]
Transaortic valve gradients measured by echocardiography and direct invasive methods
- Transaortic mean gradient reclassification [30 days]
Proportion of patients reclassified to a transaortic mean gradient < 20mmHg using direct invasive methods
- VARC-3 hemodynamic valve deterioration reclassification [30 days]
Proportion of patients reclassified to ≤ moderate VARC-3 hemodynamic valve deterioration using direct invasive methods, including mean gradient and valve area, compared to echocardiography
- Patient-Prosthesis Mismatch (PPM) reclassification [30 days]
Proportion of patients with echocardiographic severe PPM reclassified as non-severe PPM using direct invasive methods
Secondary Outcome Measures
- Total procedure time [30 days]
Total procedure time (mins) to complete standardized invasive hemodynamics
- Risks of procedural complications [30 days]
Evaluate risks of procedural complications associated with direct-invasive hemodynamics
Eligibility Criteria
Criteria
Inclusion Criteria:
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Echocardiographic transaortic mean gradient ≥ 20mmHg OR VARC-3 criteria for ≥ moderate hemodynamic valve deterioration post TAVR on any TTE > 1 month post-TAVR
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Consensus by the Heart Team that the patient is suitable for Standardized Invasive Hemodynamics (SIH).
Exclusion Criteria:
- CT demonstrating leaflet thrombosis or hypoattenuated leaflet thickening (HALT)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | PIMA Heart Centre | Tucson | Arizona | United States | 85712 |
| 2 | Tenet Health | Boca Raton | Florida | United States | 33484 |
| 3 | Emory University Hospital | Atlanta | Georgia | United States | 30322 |
| 4 | eCommunity | Indianapolis | Indiana | United States | 46256 |
| 5 | Community Hospital | Munster | Indiana | United States | 46321 |
| 6 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 7 | William Beaumont Hospital | Southfield | Michigan | United States | 48076 |
| 8 | Baylor Scott & White | Dallas | Texas | United States | 75246 |
| 9 | Vancouver General Hospital | Vancouver | British Columbia | Canada | V5Z1M9 |
| 10 | St. Paul's Hospital | Vancouver | British Columbia | Canada | V6Z 1Y6 |
| 11 | McMaster University | Hamilton | Ontario | Canada | L8S 4L8 |
Sponsors and Collaborators
- University of British Columbia
- Edwards Lifesciences
Investigators
- Principal Investigator: David Wood, MD, University of British Columbia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H21-00824