Bariatric Surgery Evaluation and Assessment of Treatment Efficacy - Intervention Trial

The primary objective is to study the effect of a bariatric surgery strategy on the hierarchical occurrence of: 1) all-cause mortality within 2 years, 2) emergency room visit or hospitalization for HF within 2 years, 3) recurrent ECG-documented AF within 2 years, 4) decrease of ≥30gr of left ventricular (LV) mass on transthoracic echocardiography, and 5) improvement of ≥5 points on the Kansas City Cardiomyopathy Questionnaire (KCCQ).

Inclusion criteria

• Signs and symptoms of HF according to the Europeans Society of Cardiology guideline;
• Left ventricular ejection fraction ≥40%;
• HFA-PEFF score ≥5 or HFA-PEFF score 2-4 in combination with positive stress test;
• Between 45 and 70 years of age;
• BMI 32-40 kg/m2;
• Paroxysmal or persistent AF with a rhythm control strategy;
• Willing to undergo both treatment strategies;
• Written informed consent.

Exclusion criteria

• BMI ≥40 kg/m2;
• BMI <32 kg/m2;
• Patients unwilling or unable to sign informed consent;
• More than moderate mitral valve regurgitation/aortic valve regurgitation;
• More than mild mitral valve stenosis/aortic valve stenosis;
• Inadequate echocardiographic window for the assessment of LV mass index and/or the echocardiographic criteria needed for the HFA-PEFF score;
• History of myocardial infarction, myocarditis, any invasive cardiac intervention (e.g. surgery, percutaneous coronary intervention, ablation) or stroke, <3 months before inclusion;
• Scheduled for AF ablation;
• Complex congenital heart disease;
• Negative treatment advise from a specialized psychiatrist due to non-stabilized psychotic disorders, severe depression and/or personality disorders;
• Patients unable to care for themselves or who are unable adapt to inherent lifestyle changes following bariatric surgery;
• Any medical condition that limits life span <2 years;
• Diseases requiring long term use of anti-inflammatory treatments;
• The use of medication associated with substantial effects (>5 kg) on body weight.