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

Official title

HOspitalized Versus saME Day Discharge Transcatheter Aortic Valve Implantation (TAVI) With Self-expanding Valves. A Randomized Clinical Trial: The HOME-TAVI Trial

Overview

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

• Other Same-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.
• Other Standard-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.

Primary outcome measures

• Composite of all-cause mortality, type 2-4 bleeding, stroke, and hospital readmission [Time frame: from randomization (6 hours after TAVI) through 30 days after TAVI]

Secondary outcome measures (12)

• Change in health-related quality of life assessed using the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) [Time frame: Baseline and 30 days]
• Change in health-related quality of life assessed using the EuroQol-5 Dimensions 5 Levels (EQ-5D-5L) [Time frame: Baseline and 30 days]
• Readiness for Hospital Discharge [Time frame: Pre-discharge]
• Post-discharge care delivery satisfaction [Time frame: 7 days]
• Quality-adjusted life years (QALYs) [Time frame: 1 year]
• All-cause mortality [Time frame: 7 days and 30 days]
• Type 2-4 bleeding [Time frame: 7 days and 30 days]
• Major vascular complications [Time frame: 7 days and 30 days]
• Stroke [Time frame: 7 days and 30 days]
• Cardiovascular hospital readmission [Time frame: 7 days and 30 days]
• Non-cardiovascular hospital readmission [Time frame: 7 days and 30 days]
• Permanent pacemaker implantation [Time frame: 7 days and 30 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

Spain · 2 centers

• Hospital Clínic de Barcelona — Barcelona
• Hospital Universitario 12 de Octubre — Madrid

Canada · 1 center

• Institut Universitaire de cardiologie et de pneumologie de Quebec — Québec

Publications

• Russo MJ, Okoh AK, Stump K, Smith M, Erinne I, Johannesen J, Chaudhary A, Chiricolo A, Hakeem A, Lemaire A, Lee LY, Chen C. Safety and Feasibility of Same Day Discharge after Transcatheter Aortic Valve Replacement Post COVID-19. Struct Heart. 2021 Mar-Apr;5(2):182-185. doi: 10.1080/24748706.2020.1853861. Epub 2022 Mar 21. No abstract available. PMID 35378799
• Goel A, Malik AH, Bandyopadhyay D, Chakraborty S, Gupta R, Abbott JD, Ahmad H. The 30-Day Readmission Rate of Same-Day Discharge Following Transcatheter Aortic Valve Implantation (from National Readmission Database 2015 to 2019). Am J Cardiol. 2022 Aug 1;176:112-117. doi: 10.1016/j.amjcard.2022.04.033. Epub 2022 May 27. PMID 35644697
• Zahid S, Rai D, Tanveer Ud Din M, Khan MZ, Ullah W, Usman Khan M, Thakkar S, Hussein A, Baibhav B, Rao M, Abtahian F, Bhatt DL, Depta JP. Same-Day Discharge After Transcatheter Aortic Valve Implantation: Insights from the Nationwide Readmission Database 2015 to 2019. J Am Heart Assoc. 2022 Jun 7;11(11):e024746. doi: 10.1161/JAHA.121.024746. Epub 2022 May 27. PMID 35621233
• Cepas-Guillen P, Vidal-Cales P, Gabani R, Espinosa T, Trilla M, Regueiro A. Initial experience of same-day discharge after transcatheter aortic valve implantation. Rev Esp Cardiol (Engl Ed). 2023 Sep;76(9):743-745. doi: 10.1016/j.rec.2023.03.020. Epub 2023 May 16. No abstract available. English, Spanish. PMID 37201715
• Grubb KJ, Gada H, Mittal S, Nazif T, Rodes-Cabau J, Fraser DGW, Lin L, Rovin JD, Khalil R, Sultan I, Gardner B, Lorenz D, Chetcuti SJ, Patel NC, Harvey JE, Mahoney P, Schwartz B, Jafar Z, Wang J, Potluri S, Vora AN, Sanchez C, Corrigan A, Li S, Yakubov SJ. Clinical Impact of Standardized TAVR Technique and Care Pathway: Insights From the Optimize PRO Study. JACC Cardiovasc Interv. 2023 Mar 13;16(5 PMID 36922042
• Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Pibarot P, Leipsic J, Hahn RT, Blanke P, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Szeto WY, Genereux P, Pershad A, Pocock SJ, Alu MC, Webb JG, Smith CR; PARTNER 3 Investigators. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. PMID 30883058
• Popma JJ, Deeb GM, Yakubov SJ, Mumtaz M, Gada H, O'Hair D, Bajwa T, Heiser JC, Merhi W, Kleiman NS, Askew J, Sorajja P, Rovin J, Chetcuti SJ, Adams DH, Teirstein PS, Zorn GL 3rd, Forrest JK, Tchetche D, Resar J, Walton A, Piazza N, Ramlawi B, Robinson N, Petrossian G, Gleason TG, Oh JK, Boulware MJ, Qiao H, Mugglin AS, Reardon MJ; Evolut Low Risk Trial Investigators. Transcatheter Aortic-Valve Rep PMID 30883053
• Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, Capodanno D, Conradi L, De Bonis M, De Paulis R, Delgado V, Freemantle N, Gilard M, Haugaa KH, Jeppsson A, Juni P, Pierard L, Prendergast BD, Sadaba JR, Tribouilloy C, Wojakowski W; ESC/EACTS Scientific Document Group. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2022 Feb 12;43(7):561-632 PMID 34453165

Identifiers

NCT: NCT07738575 · HOME-TAVI 2026-4460

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗