Aortic Stenosis, Aortic Stenosis, Severe
Conditions
Keywords
Transcatheter Aortic Valve Implantation (TAVI), TAVI, TAVR, Same-Day Discharge, Early Discharge, Self-Expanding Valve, Evolut FX, Evolut FX+, Evolut PRO+
Brief summary
Transcatheter aortic valve implantation (TAVI) has become the standard treatment for patients with severe aortic stenosis across a broad range of surgical risk. Advances in device technology and procedural techniques have enabled minimalist approaches and shorter hospital stays. Preliminary observational studies suggest that same-day discharge after TAVI may be feasible and safe in carefully selected patients, but randomized evidence remains limited, particularly in patients treated with self-expanding valves. The HOME-TAVI trial is a prospective, multicenter, international, randomized controlled trial designed to evaluate whether a same-day discharge strategy is non-inferior to standard hospital discharge after successful transfemoral TAVI with the Medtronic Evolut PRO+/FX/FX+ system. Eligible patients who remain clinically stable 6 hours after the procedure will be randomized in a 1:1 ratio to same-day discharge or standard-of-care discharge. The primary endpoint is a composite of all-cause mortality, type 2-4 bleeding, stroke, and hospital readmission within 30 days after TAVI. Secondary objectives include assessment of quality of life, patient-reported experience measures, healthcare resource utilization, and cost-effectiveness.
Detailed description
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.
Interventions
OTHERSame-Day Discharge Strategy
Participants are discharged on the same day following successful transfemoral TAVI after confirmation of clinical stability 6 hours after the procedure. The discharge pathway includes standardized clinical assessment, patient and caregiver education, pre-discharge transthoracic echocardiography and blood testing, and a follow-up telephone assessment on the day after discharge.
OTHERStandard-of-Care Discharge Strategy
Participants receive routine post-procedural inpatient care following successful transfemoral TAVI and are discharged according to standard clinical practice (next-day or later discharge), with follow-up assessments performed according to the study protocol.
Sponsors
Hospital Clinic of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
This study is open-label with respect to patients and treating providers. However, to minimize bias, statistical analyses will be conducted by a statistician blinded to group allocation whenever feasible.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of all-cause mortality, type 2-4 bleeding, stroke, and hospital readmission | from randomization (6 hours after TAVI) through 30 days after TAVI | Composite of all-cause mortality, type 2-4 bleeding, stroke, and hospital readmission, defined according to Valve Academic Research Consortium-3 (VARC-3) criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in health-related quality of life assessed using the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) | Baseline and 30 days | Change in health-related quality of life measured using the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12). The KCCQ-12 is a disease-specific questionnaire assessing symptoms, physical limitations, social limitations, and quality of life in patients with heart disease. Scores range from 0 to 100, with higher scores indicating better health status and quality of life. |
| Change in health-related quality of life assessed using the EuroQol-5 Dimensions 5 Levels (EQ-5D-5L) | Baseline and 30 days | Change in health-related quality of life measured using the EuroQol-5 Dimensions 5 Levels (EQ-5D-5L) questionnaire. The EQ-5D-5L descriptive system assesses five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with five response levels. Responses are converted into an EQ-5D-5L index value, with higher values indicating better health status. (If you are reporting the EQ Visual Analogue Scale instead of the index score, the description should instead state that the EQ VAS ranges from 0 to 100, with higher scores indicating better perceived health.) |
| Readiness for Hospital Discharge | Pre-discharge | Patient-reported readiness for hospital discharge assessed using the Readiness for Hospital Discharge Scale (RHDS) before discharge. The RHDS score ranges from 0 to 10, with higher scores indicating greater readiness for hospital discharge. |
| Post-discharge care delivery satisfaction | 7 days | Patient-reported satisfaction with post-discharge care assessed using the Post-Discharge Care Delivery Satisfaction (PDCDS) questionnaire at 7 days after discharge. The PDCDS score ranges from \[minimum\] to \[maximum\], with higher scores indicating greater satisfaction with post-discharge care. |
| Quality-adjusted life years (QALYs) | 1 year | Quality-adjusted life years (QALYs) calculated by combining survival duration and health utility values derived from the EuroQol-5 Dimensions 5 Levels (EQ-5D-5L) questionnaire into a single outcome measure. |
| All-cause mortality | 7 days and 30 days | Incidence of all-cause mortality defined according to Valve Academic Research Consortium 3 (VARC-3) criteria. |
| Type 2-4 bleeding | 7 days and 30 days | Incidence of Type 2-4 bleeding events, as defined according to Valve Academic Research Consortium 3 (VARC-3) criteria. |
| Major vascular complications | 7 days and 30 days | Incidence of major vascular complications according to Valve Academic Research Consortium-3 (VARC-3) criteria. |
| Stroke | 7 days and 30 days | Incidence of stroke according to Valve Academic Research Consortium-3 (VARC-3) criteria. |
| Cardiovascular hospital readmission | 7 days and 30 days | Incidence of cardiovascular hospital readmission during follow-up. |
| Non-cardiovascular hospital readmission | 7 days and 30 days | Incidence of non-cardiovascular hospital readmission during follow-up. |
| Permanent pacemaker implantation | 7 days and 30 days | Incidence of permanent pacemaker implantation. |
| Acute kidney injury (stage 2-4) | 7 days and 30 days | Incidence of acute kidney injury (stage 2-4) according to Valve Academic Research Consortium-3 (VARC-3) criteria. |
| New-onset heart failure | 7 days and 30 days | Incidence of new-onset heart failure according to Valve Academic Research Consortium-3 (VARC-3) criteria. |
| Hospital length of stay | 30 days | Total hospital length of stay following the index procedure, measured in days. |
| Total intensive care unit (ICU) days | 30 days | Total number of intensive care unit days during the 30-day follow-up period. |
| Total number of hospital bed-days | 30 days | Total number of hospital bed-days during the 30-day follow-up period. |
| Cost-utility analysis | 1 year | Cost-utility analysis comparing the two treatment strategies, including healthcare costs and health outcomes, over 1 year in the Hospital Clínic de Barcelona cohort |
| Incremental cost-effectiveness ratio (ICER) | 1 year | Incremental cost-effectiveness ratio (ICER) comparing the two treatment strategies, expressed as the incremental cost associated with the additional health benefit over 1 year in the Hospital Clínic de Barcelona cohort over 1 year. |
| Budget impact analysis | 1 year | Budget impact analysis evaluating the financial consequences of implementing the intervention in the Hospital Clínic de Barcelona cohort over 1 year. |
Countries
Canada, Spain
Contacts
CONTACTAnder Regueiro, MD
CONTACTEmilie Pelletier Beaumont, Msc
STUDY_DIRECTORJosep Rodes-Cabau, Md, PhD
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Outcome results
None listed