Transcatheter Aortic Valve Replacement in Severe Low Flow, Low Gradient Aortic Stenosis

LOW-TAVR is a real-world, retrospective and prospective, multicenter Italian registry aimed at evaluating the characteristics and clinical outcomes of patients with severe low flow, low gradient aortic stenosis (LFLG-AS) undergoing transcatheter aortic valve replacement (TAVR).

The register aims to include at least 1350 patients diagnosed with LFLG-AS undergoing TAVR at the participating centres.

The inclusion criteria are:

• LFLG-AS diagnosis according to current European Society of Cardiology guidelines
• Age 18 years or older
• Written informed consent

The exclusion criteria are:

• LFLG-AS pseudo-severe or non-confirmed severe aortic stenosis
• LFLG-AS referred for medical treatment or undergoing surgery

Clinical outcome is evaluated at a 30-day, 1-year, 2-year, and 5-year follow-up.

The primary endpoint of interest of the registry is the assessment of the incidence of the composite of all-cause mortality and hospitalization for heart failure at one year.

The secondary endpoints are the assessment of:

• periprocedural TAVR complications: complete atrioventricular block, stroke, acute myocardial infarction, acute aortic insufficiency, cardiogenic shock, acute pulmonary edema, cardiac tamponade, aortic rupture;
• adverse events during hospitalization: major and minor bleeding, major and minor vascular complications, definitive pacemaker implantation, cardiogenic shock, myocardial infarction, stroke, and death;
• adverse events at 30 days, one year, two years, and five years: all-cause mortality, hospitalizations for heart failure, cardiovascular mortality, myocardial infarction, stroke, major and minor bleedings.

Inclusion criteria

• LFLG-AS diagnosis according to current European Society of Cardiology guidelines
• Age 18 years or older
• Written informed consent

Exclusion criteria

• LFLG-AS pseudo-severe or non-confirmed severe aortic stenosis
• LFLG-AS referred for medical treatment or undergoing surgery