Brief Title
Standardized Invasive Hemodynamics for Elevated Gradients Post TAVR (DISCORDANCE TAVR)
Official Title
Standardized Invasive Hemodynamics for Monitoring Acute and Long Term Valve Performance in Patients With Elevated Gradients Post Transcatheter Aortic Valve Replacement
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.
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 Type
Observational
Primary Outcome
Transaortic valve gradients
Secondary Outcome
Total procedure time
Condition
Aortic Stenosis
Intervention
Standardized Invasive Hemodynamics
Study Arms / Comparison Groups
Patients with Elevated Gradients Post Transcatheter Aortic Valve Replacement
Description: 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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
50
Start Date
August 30, 2021
Completion Date
September 2022
Primary Completion Date
July 14, 2022
Eligibility Criteria
Inclusion Criteria:
- Echocardiographic transaortic mean gradient ≥ 20mmHg OR VARC-3 criteria for ≥ moderate
hemodynamic valve deterioration post TAVR on any TTE > 1 month post-TAVR
- 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)
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
David Wood, MD, 604-838-1081, [email protected]cic.org
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT04827238
Organization ID
H21-00824
Responsible Party
Principal Investigator
Study Sponsor
University of British Columbia
Collaborators
Edwards Lifesciences
Study Sponsor
David Wood, MD, Principal Investigator, University of British Columbia
Verification Date
April 2022