Evaluation of the Efficacy of Early Implantation of a Percutaneous Left Ventricular Assist Devices in Acute Coronary Syndrome Complicated by Cardiogenic Shock Compared to Conventional Therapy: a Prospective, Multicenter, Randomized, Controlled and Open-label Clinical Trial

Korábbi kezelés

• Contra-indication to antiplatelet or anticoagulant therapy

Más betegség

• Patient with prolonged cardiac arrest (\>5 mins)
• Contra-indications to Impella CP implantations:
  • Isolated right ventricular failure
  • LV thrombus
  • Mechanical aortic valve or heart constrictive device
  • Aortic valve stenosis or calcification (equivalent to an orifice area of 0.6cm2 or less)
  • Moderate to severe aortic insufficiency (echocardiographic assessment graded as ≥ 2)
  • Severe peripheral arterial disease precluding placement of the Impella system
  • Combined cardiorespiratory failure
  • Presence of an Atrial or Ventricular Septal Defect (including post infarctus VSD)
  • Left ventricular rupture Cardiac tamponade
• Mechanical complication of myocardial infarction
• Active bleeding

Egyéb

• Persons referred in articles L.1121-5 to L.1121-8 and L.1122-2 of the Public Health Code:
  • Pregnant, parturient or breastfeeding woman
  • Person deprived of liberty for judicial or administrative decision
  • Adult person under legal protection (any form of public guardianship)
• Onset of shock \>24 hours
• CS not related to ACS
• Cerebral deficit with fixed dilated pupils or irreversible neurological pathology
• Anoxic brain injury
• Life expectancy \< 1 year

• Age between 18 and 80 years old;
• ACS ≤ 24 hours;
• Cardiogenic shock defined by:
• At least one criteria of low cardiac output defined by
• SBP ≤ 90 mmHg or the need to use inotropes/vasopressors in order to obtain SBP\> 90 mmHg
• CI ≤ 2.2L/min/m2
• At least one criteria of left overload defined by
• clinical (killip class ≥ 2),
• biological (NtproBNP \> 900pg/ml or BNP \> 400pg/ml),
• radiological
• non invasive or invasive hemodynamic evaluation
• At least one criteria of malperfusion defined by
• clinical (marbles, oliguria ≤ 0.5ml/min/kg, cold/clammy skin and extremities,..)
• biological approach (arterial lactate ≥ 2mmol/L, ScVO2 \< 60%)
• Stage C or D of the ACC classification of CS
• Revascularization by PCI intended after coronary angiography;
• Lack of significant femoral artery stenosis or other local contra-indication to a 14 Fr sheath;
• Signed informed consent (patient and/or family/relative) or emergency procedure
• Subject affiliated to or beneficiary of a social security system.