Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in patients with ADvanced heart failure - TAVR UNLOAD

Oct 28, 2024
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Kim A. Eagle, MD, MACC
Trial Sponsor:
Edwards Lifesciences
Date Presented:
10/28/2024
Date Published:
10/28/2024
Original Posted Date:
10/28/2024
References

Contribution To Literature:

The TAVR UNLOAD trial failed to show that early TAVR improved clinical events and quality of life among patients with chronic systolic heart failure and moderate aortic stenosis.

Description:

The goal of the trial was to evaluate transcatheter aortic valve replacement (TAVR) compared with clinical surveillance among patients with chronic systolic heart failure and moderate aortic stenosis (stage B aortic stenosis).

Study Design

  • Randomized
  • Parallel

Patients with chronic systolic heart failure and moderate aortic stenosis (stage B aortic stenosis) were randomized to TAVR (n = 89) vs. clinical surveillance (n = 89).

  • Total number of enrollees: 178
  • Duration of follow-up: 23 months
  • Mean patient age: 77 years
  • Percentage female: 21%

Inclusion criteria:

  • Chronic systolic heart failure (left ventricular ejection fraction [LVEF] 20-50%) on appropriate guideline-directed medical therapy
  • New York Heart Association (NYHA) class II-IV symptoms
  • Moderate aortic stenosis

Exclusion criteria:

  • Hospitalization for acute decompensated heart failure within the last 2 weeks
  • Cardiac resynchronization therapy within the last month
  • Coronary artery revascularization within the last month
  • Severe aortic and/or mitral regurgitation
  • Bicuspid aortic valve
  • Concomitant non-aortic valve disease warranting primary correction
  • Previous aortic valve replacement
  • Severe right ventricular dysfunction
  • Previous stroke with permanent disability
  • Severe lung disease
  • Severe chronic kidney disease
  • Gastrointestinal bleeding within the last 3 months
  • Cirrhosis
  • Active systemic infection
  • Unwilling to accept blood transfusion
  • Dementia
  • Life expectancy <2 years

Other salient features/characteristics:

  • Change in LVEF in the TAVR group: 39.3 mm Hg at baseline to 44.2 mm Hg at 1 year (0.002)
  • Change in LVEF in the clinical surveillance group: 38.3 mm Hg at baseline to 43.5 mm Hg at 1 year (0.0008)
  • Mean aortic valve area (baseline or dobutamine stress): 1.2 cm2 in the TAVR group vs. 1.3 cm2 in the clinical surveillance group
  • Mean aortic valve gradient (baseline or dobutamine stress): 21.9 mm Hg in the TAVR group vs. 21.9 mm Hg in the clinical surveillance group
  • In the clinical surveillance group, 43% underwent TAVR at a median of 12 months

Principal Findings:

The primary outcome was all-cause mortality, stroke, disease-related hospitalization and heart failure equivalents, and change from baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ). At the longest follow-up, TAVR resulted in 47.6% win pairs vs. 36.6% in the clinical surveillance group (p = 0.14). At 1-year follow-up, TAVR resulted in 48.0% win pairs vs. 30.9% in the clinical surveillance group (p = 0.032).

Secondary outcomes:

  • At the longest follow-up, mean change in KCCQ: 10.9 in the TAVR group vs. 6.1 in the clinical surveillance group (p = 0.20)
  • Mean change in KCCQ at 1 year: 12.8 in the TAVR group vs. 3.2 in the clinical surveillance group (p = 0.018)

Interpretation:

Among patients with chronic systolic heart failure and stage B aortic stenosis, TAVR failed to improve a composite of clinical events and quality of life at the longest follow-up period. When analysis was restricted to 1 year of follow-up, TAVR was associated with an improvement in the composite of clinical events and quality of life. At 1-year follow-up, TAVR was also associated with an improvement in KCCQ compared with clinical surveillance.

There are multiple potential reasons why TAVR versus clinical surveillance was not convincingly associated with benefit in this population. The LVEF increased in the clinical surveillance group. The trial was relatively small and underpowered to detect a difference in treatment groups. This likely attenuated the ability to detect any treatment difference. The PROGRESS trial is also exploring the utility of TAVR versus clinical surveillance among stage B aortic stenosis and signs of cardiac damage.

References:

Van Mieghem NM, Elmariah S, Spitzer E, et al. Transcatheter Aortic Valve Replacement in Patients With Systolic Heart Failure and Moderate Aortic Stenosis: TAVR UNLOAD. J Am Coll Cardiol 2024;Oct 28:[Epub ahead of print].

Editorial Comment: Généreux P, Gupta A, Makkar RR, et al, TAVR in Patients With Moderate Aortic Stenosis and Heart Failure. J Am Coll Cardiol 2024;Oct 28:[Epub ahead of print].

Presented by Dr. Nicolas M. Van Mieghem at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2024), Washington, DC, October 28, 2024.

Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Acute Heart Failure, Interventions and Structural Heart Disease

Keywords: Aortic Valve Stenosis, Heart Failure, TCT24, Transcatheter Aortic Valve Replacement, Transcatheter Cardiovascular Therapeutics


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