Anatomic Stenosis Severity as a Prognostic Marker in Patients With Low-Flow Low-Gradient Aortic Stenosis Undergoing TAVI (ATLAS TAVI)

Universitätsklinikum Hamburg-Eppendorf

Status: Enrolling

Conditions: Low-Flow, Low-Gradient Aortic Stenosis

Study type: Observational

Funder types: Other

Identifiers

NCT04914481

ATLAS TAVI

Details and patient eligibility

About

The ATLAS TAVI Registry is a retrospective, investigator-initiated, multicenter registry including patients, who underwent Transcatheter Aortic Valve Implantation (TAVI) for classical or paradoxical low-flow, low-gradient aortic stenosis (LFLG AS) with available non-contrast MSCT data on aortic valve calcification (AVC). The main objective of this study is the assessment of outcome after TAVI according to AVC density severity in patients with LFLG AS.

Full description

Aortic valve calcification (AVC) as assessed by MSCT is highly correlated with aortic stenosis (AS) severity and, thus, has become an important tool for diagnosing severe AS, especially in patients with low-flow low-gradient aortic stenosis (LFLG AS). Moreover, in medically treated AS patients AVC is directly associated with poor prognosis. In contrast, the prognostic benefit of eliminating AS by Transcatheter Aortic Valve Implantation (TAVI) in patients with LFLG AS seems to be larger in patients with high AVC density (AVCd) compared to those with low AVCd, at least in "classical" (low EF) LFLG AS. Hence, we hypothesize that AVCd might be a valuable marker for treatment response among TAVI patients with LFLG AS, who are known to suffer from poor outcome even after elimination of AS.

The multicentric ATLAS TAVI Registry of LFLG AS patients, who underwent TAVI, assesses the impact of AVCd on outcome in these patients.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age ≥18 years
• patient gave written informed consent for data acquisition and transfer
• for LFLG AS: -- available non-contrast MSCT data on aortic valve calcification (AVC, Agatston Units)

Exclusion criteria

• LFLG AS without non-contrast MSCT data on AVC

Trial design

1,500 participants in 4 patient groups

Classical Low-Flow, Low-Gradient Aortic Stenosis

Description:

Classical Low-Flow, Low-Gradient Aortic Stenosis is defined as valve area \<1 cm2, mean gradient \<40 mmHg, ejection fraction \<50% and stroke volume index (SVi) ≤35 mL/m2 by resting transthoracic echocardiography. Dobutamine stress echocardiography is not mandatory for the definition of classical LFLG AS. All patients in this subgroup underwent TAVI and have available data on aortic valve calcification.

Paradoxical Low-Flow, Low-Gradient Aortic Stenosis

Description:

Paradoxical Low-Flow, Low-Gradient Aortic Stenosis is defined as valve area \<1 cm2, mean gradient \<40 mmHg, ejection fraction ≥50% and SVi ≤35 mL/m2 by resting transthoracic echocardiography. All patients in this subgroup underwent TAVI and have available data on aortic valve calcification.

High-Gradient Aortic Stenosis (Control group)

Description:

High-Gradient Aortic Stenosis is defined as valve area \<1 cm2 and mean gradient \>40 mmHg by resting transthoracic echocardiography. All patients in this subgroup underwent TAVI. Data on aortic valve calcification is not mandatory for this control group.

Conservative treatment (Control group)

Description:

The subgroup includes all patients with (severe or non-severe) aortic stenosis, who underwent conservative treatment. Data on aortic valve calcification is not mandatory for this control group.