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March 31, 2026Journal of the Society for Cardiovascular Angiography & Interventions0 citationsOpen Access

Defining Exercise Hemodynamics and Function After Transcatheter Aortic Valve Replacement: The DEFINE-TAVR Prospective Study

TSTayyab ShahLSLissa SugengAVAmit N. Vora

Key Result

At 12 months post-TAVR, self-expanding valves demonstrated significantly lower mean prosthetic aortic valve gradients during exercise compared to balloon-expanding valves (8.0 vs 21.5 mm Hg, p=0.01).

Key Points

  • The aim is to evaluate exercise hemodynamics and functional outcomes after transcatheter aortic valve replacement (TAVR) in patients.
  • Conducted a prospective observational study, evaluating hemodynamic changes post-TAVR.
  • Focused on comparing self-expanding valves (SEVs) with balloon-expanding valves (BEVs).
  • Assessed symptom management and quality of life post-procedure.
  • Up to 30% of patients experienced persistent symptoms limiting quality of life after TAVR.
  • SEVs showed lower resting mean gradients than BEVs, particularly in small annuli patients.
  • Indicates potential for improved management strategies for symptoms post-TAVR.

Study Design

Type

Observational (n=28)

Blinding

Blinded core laboratory

Multicenter

No

Structured PICO

Does valve type (self-expanding vs balloon-expanding) affect exercise hemodynamics in patients 12 months after TAVR?

P
Population
28 enrolled (10 completed 12-month evaluation) adults with LVEF >35%, native annular diameters 21 to 25 mm, who underwent successful TAVR without complication and were able to exercise on a supine bike. Mean age 75.5 years, 70% male. Excluded: cardiogenic shock or planned other cardiac surgery within 12 months.
I
Intervention
Transcatheter aortic valve replacement (TAVR) with self-expanding valves (SEV) or balloon-expanding valves (BEV)
C
Comparator
Comparison between self-expanding valves (SEV) and balloon-expanding valves (BEV)
O
Outcome
Mean prosthetic aortic valve gradient during exercise at 12 months, assessed by a blinded independent core laboratorysurrogate

In a small prospective pilot study, self-expanding valves demonstrated lower resting and exercise mean gradients compared to balloon-expanding valves at 12 months post-TAVR.

Main Result

Absolute Event Rate: 8% vs 21.5%

p-value: p=0.01

Limitations

  • Small sample size
  • Nonrandomized design
  • Notable attrition with 18 of 28 enrolled patients not completing the 12-month evaluation
  • Study terminated early due to slow enrollment
  • Exploratory pilot study
  • Notable attrition

Abstract

Transcatheter aortic valve replacement (TAVR) has transformed the treatment of severe aortic stenosis; however, up to 20% to 30% of patients continue to experience symptoms that limit quality of life after the procedure.1 As TAVR expands to lower-risk and younger patients, addressing these persistent symptoms is becoming increasingly important. The Small Annuli Randomized to Evolut or SAPIEN Trial (SMART) recently demonstrated that self-expanding valves (SEVs) are associated with lower resting mean gradients than balloon-expanding valves (BEVs), particularly in patients with small annuli.

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Cite This Study

Shah et al. (2026) conducted an observational in Severe aortic stenosis (n=28). Self-expanding valves (SEV) vs. Balloon-expanding valves (BEV) was evaluated on Mean prosthetic aortic valve gradient during exercise at 12 months (p=0.01). At 12 months post-TAVR, self-expanding valves demonstrated significantly lower mean prosthetic aortic valve gradients during exercise compared to balloon-expanding valves (8.0 vs 21.5 mm Hg, p=0.01).

synapsesocial.com/papers/6a025c97edf6f481385947bdhttps://doi.org/10.1016/j.jscai.2026.104387
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