Microvascular Function in Patients Undergoing Transcatheter Aortic Valve Implant (TAVI) for Severe Symptomatic Aortic Stenosis: Association With Myocardial Fibrosis
- Conditions
- Severe Symptomatic Aortic Stenosis
- Interventions
- Device: coronary physiology
- Registration Number
- NCT05326126
- Lead Sponsor
- Matteo Montorfano
- Brief Summary
Microvascular function in patients undergoing Transcatheter Aortic Valve Implant (TAVI) for severe symptomatic aortic stenosis: association with myocardial fibrosis
- Detailed Description
Severe symptomatic aortic stenosis is commonly encountered in clinical practice, affecting close to 5% of individuals older than 65 years of age, and carries a dismal prognosis if left untreated.(1,2) Chronically increased left ventricular afterload triggers a compensatory myocardial response, ultimately leading to ventricular hypertrophy, aimed at reducing chronically increased wall tension an restore cardiac performance.(3) Hypertrophy ultimately results in maladaptive changes and ultimately leads to heart failure and eventually increased risk of cardiac mortality. Myocardial fibrosis and altered myocardial perfusion appear to play a role in progressive cardiac decompensation.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 75
• All patients referred to IRCCS Ospedale San Raffaele who are candidates to receive a TAVI implant for severe, symptomatic aortic stenosis under current appropriateness criteria and clinical practice guidelines will be considered eligible to take part in the study
- Age <18 years
- Inability to express informed consent to take part in the present study.
- Pregnancy or lactation
- Pre-existing known disease determining a prognosis quo ad vitam shorter than the follow up of the present study
- Significant chronic kidney disease (estimated glomerular filtration rate <30 ml/min)
- Known significant epicardial coronary artery stenosis
- Known contraindication to adenosine administration:
- Known allergic reactions
- Second or third degree atrioventricular block before the procedure (in absence of a functional permanent pacemaker)
- Long QT syndrome
- Unstable angina
- Severe hypotension
- Acutely decompensated heart failure
- Chronic obstructive pulmonary disease with bronchospasm
- Concomitant use of dypiridamole
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Coronary physiology evaluation coronary physiology Patient will undergo TAVI and then Myocardial fibrosis will be evaluated on images acquired at the time of the cardiac CT obtained for TAVI planning. Briefly, an extra late post-contrast acquisition image will be acquired. The delayed post-contrast scan will be reconstructed with a soft convolution kernel and will be reformatted in the short- and long-axis planes (slice thickness 8 mm; gap 0 mm) in average mode.
- Primary Outcome Measures
Name Time Method The burden of myocardial fibrosis 1 year Myocardial fibrosis measured as the percentage of delay-enhanced myocardium over total myocardial volume
Index of microcirculatory resistance (IMR) 1 year IMR a validated estimate of resistance in the coronary capillary, computed as the ratio between transit time of a 3 cc bolus of room temperature saline and distal coronary artery pressure.
- Secondary Outcome Measures
Name Time Method Cardiovascular rehospitalization 1 year Admission to an inpatients' service for cardiovascular conditions lasting \>24h
Acute change in coronary flow reserve (CRF) 1 year Ratio of maximal coronary blood flow obtained by hyperemia to baseline coronary blood flow
Computed tomography derived extracellular volume 1 year The extracellular volume fraction (ECV) is the relative value of the volume of the extracellular space in the myocardium, therefore express as a percentage. It could be measured from computed tomography (CT) and Index of microcirculatory resistance (MRI) images, and was validated with histology. ECV-CT is calculated as follows:
ECVCT = (1-haematocrit) × (ΔHUmyo/ΔHUblood) where ΔHU is the change in Hounsfield unit attenuation pre- and post-contrast (i.e. HUpost-contrast - HUpre-contrast)Cardiovascular death 1 year Death from any cardiac condition (e.g. myocardial infarction, acute pulmonary edema, low-output state, etc..) or vascular condition (including aortic dissection, stroke, etc...)
All-cause death 1 year Death from any cause
Acute change in index of microcirculatory resistance (IMR) 1 year Estimate of microvascular resistance derived by pressure and an indirect estimate of flow
Any rehospitalization 1 year Admission to an inpatients' service for any cause lasting \>24h
Trial Locations
- Locations (1)
IRCCS San Raffaele
🇮🇹Milan, Italy