Combined Transcatheter Aortic Valve Implantation and Percutaneous Closure of the Left Atrial Appendage

Combined Transcatheter Aortic Valve Implantation and Percutaneous Closure of the Left Atrial Appendage

Atrial fibrillation (AF) is a common comorbidity of patients candidates to transcatheter aortic valve implantation (TAVI). The management of chronic oral anticoagulation (OAC) for the prevention of ischemic stroke is very challenging in this population of complex and frail subjects. Since the percutaneous left atrial appendage (LAA) closure with the WATCHMAN device proved promising safety and efficacy results in randomized comparisons with OAC (current standard of care), the aim of the current study is to assess the feasibility and the early safety of performing TAVI with the Lotus System and percutaneous LAA closure with the WATCHMAN device at the same session.

Inclusion Criteria:

• TAVI candidates
• Elderly patients with symptomatic, severe, calcific, native aortic valve stenosis, assessed by echocardiography AVA up to 1.0 cm2 or AVAi up to 0.6 cm2m2 and mean pressure gradient 40 mmHg or jet velocity 4 ms
• Inoperable or at increased surgical risk (according to multidisciplinary heart team decision)
• Non-valvular AF (paroxysmal, persistent or permanent)
• CHA2DS2-VASc ≥ score
• HAS-BLED score ≥ 2
• Written informed consent
• Aortic annulus size ≥ 20 mm and ≤ 27 mm
• Adequate LAA ostium diameter (17 31mm)

Exclusion Criteria:

• Previous TAVI
• Previous LAA closure (surgical or percutaneous)
• Previous RF ablation of AF
• Need for long-term OAC (history of pulmonary embolism, mechanical heart valve)
• Contraindication to aspirin
• Relevant CAD requiring revascularization
• Infective endocarditis
• LV ejection fraction < 20 percent
• Cardiogenic shock or hemodynamic instability
• Symptomatic carotid disease
• Life expectancy < 1 year
• Severe renal failure (dialysis or serum creatinine level > 3.0 mg/dl or 265 μmol/L)
• CVE within the past 3 months
• Acute complications occurring during TAVI procedure
• Congenital unicuspid aortic valve
• Femoral artery lumen diameter <6.0 mm or <6.5 mm (for the 23-mm valve or the 25-mm and 27-mm valves, respectively)
• Documented LAA and/or LV thrombi
• Severe MR
• Atrial septal defect