Standardized Invasive Hemodynamics for Elevated Gradients Post TAVR (DISCORDANCE TAVR)

Standardized Invasive Hemodynamics for Monitoring Acute and Long Term Valve Performance in Patients With Elevated Gradients Post Transcatheter Aortic Valve Replacement

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 Overview

• Status: Recruiting
• Conditions: Aortic Stenosis; Aortic Valve Stenosis
• Intervention / Treatment: Diagnostic test: Standardized Invasive Hemodynamics

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
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Denise Spacek; Phone Number: 6048381081; Email: dspacek@cci-cic.org

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • Recruiting
      • St. Paul'S Hospital
      • Contact: Elizabeth Grieve; Phone Number: 64980 604-682-2344
    • Vancouver, British Columbia, Canada, V5Z1M9
      • Recruiting
      • Vancouver General Hospital
      • Contact: Celine Yan; Phone Number: 604 875 5120; Email: celine.yan@vch.ca
      • Principal Investigator: David A Wood, MD
  • Ontario
    • Hamilton, Ontario, Canada, L8S 4L8
      • Recruiting
      • McMaster University
      • Contact: Tej Sheth, MD
• United States
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Recruiting
      • PIMA Heart Centre
      • Contact: Tom Waggoner, DO
  • Florida
    • Boca Raton, Florida, United States, 33484
      • Recruiting
      • Tenet Health
      • Contact: Ranjith Shetty, MD
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Recruiting
      • eCommunity
      • Contact: Sandeep Dube, MD
    • Munster, Indiana, United States, 46321
      • Recruiting
      • Community Hospital
      • Contact: Samer Abbas, MD
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Sammy Elmmaria, MD
  • Michigan
    • Southfield, Michigan, United States, 48076
      • Recruiting
      • William Beaumont Hospital
      • Contact: Amr Abbas, MD
  • Texas
    • Dallas, Texas, United States, 75246
      • Withdrawn
      • Baylor Scott & White

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients > 1 month post-transcatheter aortic valve replacement

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transaortic valve gradients	Transaortic valve gradients measured by echocardiography and direct invasive methods	30 days
Transaortic mean gradient reclassification	Proportion of patients reclassified to a transaortic mean gradient < 20mmHg using direct invasive methods	30 days
VARC-3 hemodynamic valve deterioration reclassification	Proportion of patients reclassified to ≤ moderate VARC-3 hemodynamic valve deterioration using direct invasive methods, including mean gradient and valve area, compared to echocardiography	30 days
Patient-Prosthesis Mismatch (PPM) reclassification	Proportion of patients with echocardiographic severe PPM reclassified as non-severe PPM using direct invasive methods	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total procedure time	Total procedure time (mins) to complete standardized invasive hemodynamics	30 days
Risks of procedural complications	Evaluate risks of procedural complications associated with direct-invasive hemodynamics	30 days

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Edwards Lifesciences
• Investigators: Principal Investigator: David Wood, MD, University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2021
• Primary Completion (Estimated): November 15, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: March 29, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: June 6, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: H21-00824

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No