EACVI Research projects

The aim of this registry will be to examine gender differences in VHD from the time point of admission to the hospital (either elective or urgent admission) up to the first follow-up in an outpatient clinic. We will recruit both men and women in order to analyse the gender disparities. The primary objective is to compare gender in terms of management plan (intervention vs surgery). Secondary objectives are: to compare the time from diagnosis to care between two genders, to measure the time from symptom onset to presentation to the tertiary center and to compare gender in terms of procedural complications.

This is an observational, prospective, multicentric, international, non-commercial (non-profit) registry of patients with VHD. From 1^st March 2024 to 31^st March 2025, all involved centres will collect demographic, clinical, laboratory and imaging data of patients with any VHD who present to the tertiary centre. In each Centre, a young physician and/or a valve CNS and/or a research assistant will recruit patients under the supervision of a senior. Patients will be followed up from baseline admission to the tertiary centre up to 6 months follow up.

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EURECA Imaging Registry – Prolonged F-up 
The prospective, multicentre EURECA registry assessed the use of imaging and adoption of the 2019 European Society of Cardiology (ESC) Guidelines (GL) in patients with chronic coronary syndromes (CCS). 
Between May 2019 and March 2020, 5156 patients were recruited in 73 centres from 24 ESC member countries. The adoption of GL recommendations was evaluated according to clinical presentation and pre-test probability (PTP) of obstructive coronary artery disease (CAD). 
In the main paper titled “Use of cardiac imaging in chronic coronary syndromes: the EURECA Imaging registry” (Eur Heart J 2023;44:142-158) it was demonstrated that In patients with CCS, current clinical practice does not adopt GL recommendations on the use of diagnostic tests in a significant proportion of patients. When the diagnostic approach adopts GL recommendations, invasive procedures are less frequently used and the diagnostic yield and therapeutic utility are superior. 
Due to the short follow-up duration of 6 months, the possible impact on outcome of the adoption of GLs, as well as of the management choices based on the imaging defined disease phenotypes, could not be fully evaluated. To this purpose a prolonged Follo-up of at least 3 years will be performed in the EURECA population ending in December 2023. 
Keywords: Chronic coronary syndromes; Coronary artery disease; Imaging.

BACKGROUND: Multiple and mixed valvular heart disease (MMVD), ie, the combination of stenotic or regurgitant lesions occurring on ≥2 cardiac valves (multiple valvular heart disease (VHD)) or the combination of stenotic and regurgitant lesions on the same valve (mixed VHD), are frequent in clinical routine. Nevertheless, their clinical, biological, cardiovascular imaging, and management is not well established.

AIMS: This study will assess the proportion of MMVD including each combination of multiple and mixed VHD in a multicentre registry of all consecutive patients assessed on a cardiovascular imaging department for VHD. Furthermore, as secondary objectives, baseline characteristics, decision-making and therapeutic strategy at baseline and their impact in terms of prognostic and change in quality of life.

METHODS: This is a prospective multicentre observational (“real-life”) study will be conducted as a cohort study with a 1-year follow-up. Consecutive patients with a diagnosis of MMVD by echocardiography who meet the inclusion criteria will be included during the 6 months period of recruitment. In the context of a “real-life” cohort, baseline evaluation will be left to the discretion of the attending physician (and could encompass clinical evaluations, biomarkers, electrocardiograms, transthoracic and transesophageal echocardiography, cardiac catheterization, invasive angiography, cardiac CT, and CMR). Final diagnosis of the physician will be given, and the physician will manage the patient in accordance with their local guidelines. One year follow-up will be performed during a patient visit or by contact with the treating physician or the patient: vital status, hospitalizations for cardiac reasons (including HF), QoL questionnaire, history of stroke and the performance of a new valvular intervention

RESULTS: The primary endpoint will be the proportion of MMVD among all patients admitted for VHD evaluation in the imaging department. Secondary endpoints encompass; (i) epidemiologic distribution of clinical, biological and cardiovascular imaging characteristics at baseline. (ii) proportion of MMVD treated by surgery, percutaneous or medical as well as the detail for management and how complication are managed and (iii) Prognostic evaluation at one year of follow-up in terms of clinical composite outcome, all-cause mortality, hospitalisation for heart failure and change in quality of life.

CONCLUSIONS: This is the first prospective multicentre study assessing the proportion of MMVD and their characteristics in terms of diagnosis, management, and prognostic.

AMEND-CRT
Mechanical dyssynchrony as a selection criterion for cardiac resynchronisation therapy: a multicentre, randomised, double-blind, sham-controlled, non-inferiority trial
Each year in Europe, approximately 80.000 patients diagnosed with severe heart failure and a QRS duration of ≥130ms receive a new cardiac resynchronisation therapy (CRT) device. Unfortunately, a third of these patients do not seem to benefit from it. In Europe alone, this represents an annual cost of 50 to 117 million euros on devices that may not improve patient outcome. In addition, one in ten recipients require re-intervention during the first six months after implantation. To avoid excessive costs and complications a better approach to selecting patients without affecting the treatment efficacy is necessary.
In retrospective and observational studies we were able to distinguish patients who benefitted most from CRT using two echocardiographic criteria of left ventricular mechanical dyssynchrony: (1) septal flash, a rapid inward motion of the septum during pre-ejection systole, and (2) apical rocking, a septal-to-lateral motion of the apex during systole. Patients who exhibited these motion patterns on echocardiography before CRT implantation improved more and lived longer compared to patients who did not express these patterns. However, none of those studies included a control group and could therefore not be used to determine whether patients should have septal flash or apical rocking to be eligible for CRT.  
Therefore, we designed the AMEND-CRT trial as an international, randomised, double-blind, sham-controlled, non-inferiority trial to determine if septal flash or apical rocking should be present in addition to the current ECG criteria to be considered for CRT. To participate in the trial, patients must be eligible for CRT according to the latest ESC guidelines. Patients are randomised 1:1 to an active control arm (“Guideline Arm”) or an experimental arm (“Echo Arm”). All patients receive a CRT device, however, in the Echo Arm, CRT is activated only if the patient has either septal flash or apical rocking. The results of both arms will be compared after one year.
The AMEND-CRT trial will determine if septal flash and apical rocking are to be the cornerstone for CRT patient selection. If the trial results are positive, we will have demonstrated that a more stringent selection procedure can achieve at least similar results to the current ECG-based guidelines. This will lead to less device implantations, reducing excessive costs and complications. 

The trial is registered at ClinicTrials.gov with identifier NCT04225520
For more information go to AMEND-CRT.info