Same-Day Versus Standard Hospital Discharge After TAVI (HOME-TAVI)

Transcatheter aortic valve implantation (TAVI) has undergone substantial technological and procedural advances, leading to improved procedural safety, widespread adoption of minimalist approaches, and progressive reductions in hospital length of stay. As TAVI expands to lower-risk populations and procedure volumes continue to increase, optimizing post-procedural care pathways has become increasingly important to improve healthcare efficiency while maintaining patient safety.

Same-day discharge has emerged as a potential strategy to reduce healthcare resource utilization, improve patient satisfaction, and lower healthcare costs. Although observational studies have demonstrated the feasibility of same-day discharge in selected patients, robust randomized evidence remains scarce, especially for patients treated with self-expanding transcatheter heart valves.

The HOME-TAVI trial is a prospective, multicenter, international, randomized, controlled, open-label study evaluating a same-day discharge strategy compared with standard hospital discharge in patients undergoing elective transfemoral TAVI with the Medtronic Evolut PRO+/FX/FX+ transcatheter heart valve system.

Following a successful TAVI procedure and confirmation of clinical stability 6 hours after the intervention, eligible patients will be randomized in a 1:1 ratio to same-day discharge or standard-of-care discharge. Participants will undergo follow-up assessments at 7 days, 30 days, and 1 year.

The primary objective is to demonstrate that same-day discharge is non-inferior to standard discharge with respect to a composite of all-cause mortality, type 2-4 bleeding, stroke, and hospital readmission within 30 days after TAVI. Secondary objectives include evaluation of quality of life, patient-reported experience measures, healthcare resource utilization, quality-adjusted life years, and health economic outcomes.

Inclusion criteria

• Adults (≥18 years of age)
• Severe symptomatic aortic stenosis scheduled for elective transfemoral TAVI
• Treatment with the Medtronic Evolut PRO+, Evolut FX, Evolut FX+, or subsequent iterations
• Successful TAVI procedure according to VARC-3 technical success criteria
• Clinical stability 6 hours after TAVI
• Written informed consent obtained before study participation

Exclusion criteria

• Inability to ambulate independently at baseline
• Hemodynamic or clinical instability before TAVI
• Urgent or emergent TAVI procedure
• Non-transfemoral access
• Inadequate social support for discharge home
• Inability to understand or comply with post-discharge instructions
• Baseline right bundle branch block or high-grade atrioventricular block
• Baseline left ventricular ejection fraction <20%
• Severe chronic kidney disease (estimated glomerular filtration rate : eGFR <30 mL/min/1.73 m² or dialysis).
• Type 2-4 bleeding within 6 hours after TAVI
• New-onset left bundle branch block or high-grade atrioventricular block within 6 hours after TAVI, unless a permanent pacemaker has already been implanted
• New-onset atrial fibrillation within 6 hours after TAVI
• Persistent hemodynamic instability within 6 hours after TAVI