Aortic Valve Stenosis, Aortic Valve Surgery
Conditions
Keywords
Aortic valve, Stenosis, Surgery
Brief summary
Many cardiologists are convinced that early surgery in asymptomatic aortic stenosis (AS) saves lives. However there is currently no direct evidence for this and most recommendations from the ESC/ EACTS or ACC/ AHA in this field are supported by Level-B or C evidence. Therefore, the investigators designed a randomized controlled trial to demonstrate whether early surgery improves mortality and morbidity of patients with asymptomatic severe AS and low operative risk.
Interventions
OTHEREarly surgical aortic valve replacement
OTHERDelayed Surgical aortic valve replacement
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adult patient, aged between 18 and 80 years (18 ≤ age ≤80) * Low operative risk, defined as EuroSCORE II ≤ 5% * No symptom potentially attributable to AS: no dyspnea, angina or syncope during exercise * No class I indication for surgery * No symptom/ fall in blood pressure during exercise test * Severe AS according to current echocardiography criteria: Vmax \> 4.0 m/s and/ or MPG \> 40 mm Hg); AVA \< 1.0 cm2 (not mandatory) * Preserved LV systolic function: LVEF \>50% according to echocardiography ; no LV wall motion abnormality * Signed informed consent
Exclusion criteria
* Moderate/ high operative risk for aortic valve replacement, defined as EuroSCORE II \> 5% * Class-I indication for AVR (ESC-EACTS 2012, ACC/ AHA 2014) or fall in blood pressure during exercise testing (Class-IIa) * Other indication for cardiac surgery (CABG, thoracic aorta) * Positive exercise test including A/ unmasking of symptoms (angina, dyspnea at low workload, dizziness or syncope) during exercise or B/ Fall in systolic blood pressure during exercise below the baseline value. * Patients unable to perform the exercise ECG * More than mild AR (\>grade 2/4)/ other significant valve disease LVEF ≤ 50% * Serum creatinine \>160 μmol/L * Serious extra cardiac comorbidity/ life expectancy \<2 years * Patient included in another trial with signed informed consent * Patient not affiliated to social insurance * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Combination of overall mortality and cardiac morbidity | 1 year after randomization. | Any adverse cardiac event requiring hospitalization. Adverse cardiac events include: 1/ development of any symptom clearly related to AS (dyspnea, angina, pre-syncope or syncope during exercise); 2/ major adverse cardiac events defined as congestive heart failure or acute coronary syndrome; 3/ death of any cause, including cardiac death. |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative Exercise test (Exercise Electrocardiogram) | assessed at 3 months after surgery |
| Each items of the composite criteria, overall and cardiovascular mortality and cardiac morbidity | 1 year after randomization |
| Performance capacities assessed by speckle-tracking imaging (longitudinal function) in each group | assessed at 3 months after surgery |
| Number of patients with preserved LV systolic function ( LVEF >50% according to echocardiography ) in each group | assessed at 3 months after surgery |
Countries
France
Contacts
Primary ContactJean-Luc MONIN, MD PhD.
Outcome results
None listed