Aortic Valve Stenosis
Conditions
Keywords
Bioprosthetic Valve Failure
Brief summary
Transcatheter aortic valve implantation (TAVI) is a key-hole technique to replace an aortic heart valve that is narrowed and/or leaking. Although TAVI is a safe and effective treatment for a faulty aortic heart valve, the new TAVI valve will not last forever. Because it is a 'tissue' valve (made from the lining of a cow or pig heart), the valve will fail after a period of time as the tissue degenerates. When the TAVI valve fails, a viable treatment option is to perform a 'Redo TAVI' procedure, implanting a second TAVI valve inside the first failing valve. The main purpose of this study is to carefully evaluate patients being treated by Redo TAVI in order to document the short-term and long-term outcomes of the procedure. The study will also obtain information about which factors predict those outcomes. The study will also assess outcomes in patients who present with TAVI valve failure but are not suitable for Redo TAVI, and instead are treated either by open-heart surgery and surgical aortic valve replacement, or by medical therapy (medication). The study will provide doctors the information they need to understand the best way to treat patients who present with TAVI valve failure, and in particular how to perform Redo TAVI procedures with the best possible outcomes for patients.
Detailed description
To determine the acute and long-term outcomes of Redo Transcatheter Aortic Valve Implantation (TAVI) for the treatment of Bioprosthetic Valve Failure (BVF) affecting Transcatheter Aortic Heart Valves (THVs) To determine the factors which predict the acute and long-term outcomes of Redo TAVI To determine the proportion of patients presenting with BVF affecting THVs who are deemed unsuitable for Redo TAVI by the Heart Team To determine the acute and long-term outcomes of surgical explantation and aortic valve replacement (AVR) for the treatment of BVF affecting THVs To determine the survival of patients presenting with BVF affecting THVs who are managed conservatively - including optimal medical therapy (OMT) +/- balloon aortic valvuloplasty (BAV)
Interventions
DEVICEAny commercially available Edwards or Medtronic transcatheter aortic valve with the TAV-in-TAV (Redo TAVI) indication
Redo TAVI will be performed using any commercially available Edwards or Medtronic transcatheter aortic valve platforms that have the TAV-in-TAV (Redo TAVI) indication according to the preferences of the local team in keeping with standard clinical care.
PROCEDURESurgical explantation and aortic valve replacement
Surgical explantation of all or part of the index transcatheter aortic valve, with open implantation of a new surgical or transcatheter aortic valve replacement will be performed according to the preferences of the local team in keeping with standard clinical care. Any commercially available approved surgical or transcatheter aortic valve may be used. Additional surgery, such as aortic root replacement, root enlargement, CABG, mitral valve repair/replacement, etc. will be performed at the discretion of the local team.
Conservative treatment, including optimal medical therapy +/- balloon aortic valvuloplasty
Sponsors
The Leeds Teaching Hospitals NHS Trust
Medtronic
NAMSA
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1\. Bio-prosthetic Valve Failure (BVF) of a Transcatheter Aortic Valve requiring possible reintervention
Exclusion criteria
1. Bio-prosthetic Valve Failure due solely to paravalvular aortic regurgitation 2. Active endocarditis 3. Untreated acute valve thrombosis 4. Life-expectancy less than 1 year 5. Subject is less than legal age of consent, legally incompetent, or otherwise vulnerable 6. Pregnant or nursing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| REVALVE success (Redo TAVI) | 30 days | Correct positioning of a single prosthetic heart valve into the proper anatomic location, intended performance of the valve (mean gradient \<20mmHg, peak velocity \<3 m/s, Doppler velocity index ≥0.25. aortic regurgitation \< moderate), Freedom from mortality, coronary obstruction, unplanned coronary revascularisation, surgery or intervention related to the device |
| Freedom from death/stroke/re-hospitalisation for valve or procedure-related causes (Redo TAVI) | 12 months | Composite outcome of freedom from death/stroke/re-hospitalisation for valve or procedure-related causes |
| Valve Academic Research Consortium 3 (VARC3) Early Safety (EXPLANT) | 30 days | Composite outcome of freedom from: death/stroke/VARC 3-4 bleeding/major vascular, access-related, or cardiac structural complication/AKI 3 or 4/moderate or severe AR/new permanent pacemaker/device-related surgery or intervention |
| Freedom from death/stroke/re-hospitalisation for valve or procedure-related causes (EXPLANT) | 12 months | Composite outcome of freedom from death/stroke/re-hospitalisation for valve or procedure-related causes |
| Freedom from death/stroke/re-hospitalisation for valve or procedure-related causes (OMT) | 12 months | Composite outcome of freedom from death/stroke/re-hospitalisation for valve or procedure-related causes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Valve Academic Research Consortium 3 (VARC3) Technical Success (Redo TAVI and EXPLANT) | End of procedure | Freedom from mortality, successful access, delivery of the device, and retrieval of the delivery system, correct positioning of a single prosthetic heart valve into the proper anatomical location, freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication |
| Valve Academic Research Consortium 3 (VARC3) Device Success (Redo TAVI and EXPLANT) | 30 days | Technical success, Freedom from mortality, Freedom from surgery or intervention related to the device, or to a major vascular or access-related or cardiac structural complication, Intended performance of the valve (mean gradient \<20 mmHg, peak velocity \<3 m/s, Doppler velocity index ≥0.25, aortic regurgitation \< moderate) |
| Valve Academic Research Consortium 3 (VARC3) Early Safety (Redo TAVI) | 30 days | Freedom from: death/stroke/VARC 2-4 bleeding (only VARC 3-4 for EXPLANT) /major vascular, access-related, or cardiac structural complication/Acute kidney injury (AKI) 3 or 4/moderate or severe Aortic Regurgitation/new permanent pacemaker/device-related surgery or intervention |
| Peak and mean invasive gradient post-procedure (Redo TAVI) | End of procedure | Invasive pressure measurements |
| In-hospital Clinical Outcomes | Immediately after the procedure/surgery | All-cause mortality; All stroke; Myocardial infarction; Coronary artery obstruction; Unplanned coronary revascularisation (PCI or CABG); Bleeding (VARC 1-4); Major or minor Vascular and access-related complications; Cardiac structural complications; Permanent pacemaker implantation; Acute kidney injury (AKI) stage 1-4; Endocarditis; Clinically significant valve thrombosis |
| Echocardiographic Assessment: Peak velocity | Pre-discharge or at 30 days, 1, 3, 5 years | Peak velocity |
| Echocardiographic Assessment: Mean gradient | Pre-discharge or at 30 days, 1, 3, 5 years | Mean gradient |
| Echocardiographic Assessment: Aortic valve area | Pre-discharge or at 30 days, 1, 3, 5 years | Aortic valve area |
| Echocardiographic Assessment: Patient-prosthesis mismatch | Pre-discharge or at 30 days | Patient-prosthesis mismatch |
| Echocardiographic Assessment: Aortic Regurgitation - paravalvular, transvalvular or total | Pre-discharge or at 30 days, 1, 3, 5 years | Aortic Regurgitation - paravalvular, transvalvular or total |
| Echocardiographic Assessment: Left ventricular systolic function | Pre-discharge or at 30 days, 1, 3, 5 years | Left ventricular systolic function |
| Clinical Outcomes | 1, 3 and 5 years | All-cause mortality; Cardiovascular mortality; Valve-related mortality; Hospitalisation; Cardiovascular hospitalisation; Hospitalisation for valve or procedure-related causes; All stroke; Myocardial infarction; Coronary angiography; Coronary revascularization; Bioprosthetic valve dysfunction: i. Structural valve deterioration; ii. Non-structural valve deterioration (Prosthesis-patient mismatch, Paravalvular aortic regurgitation, Other) iii. Thrombosis iv. Endocarditis; Bioprosthetic valve failure; Aortic valve re-intervention |
Countries
Denmark, Finland, France, Germany, Israel, Italy, Netherlands, Norway, Sweden, Switzerland, United Kingdom
Contacts
CONTACTDave Pickles
CONTACTBenaka Karanth
PRINCIPAL_INVESTIGATORDaniel Blackman, MD
Leeds Teaching Hospitals NHS Trust
Outcome results
None listed