Heart Failure, Mitral Regurgitation, Mitral Repair, Tricuspid Regurgitation
Conditions
Keywords
transcatheter edge-to-edge repair, mitral TEER, mitral regurgitation, tricuspid regurgitation
Brief summary
Mitral regurgitation (MR) and tricuspid regurgitation (TR) are common causes of breathlessness, fluid retention and other heart failure symptoms, which lead to reduced quality of life and frequent hospitalisation. These conditions are particularly prevalent in older adults with many of these patients being at high risk for surgical intervention due to frailty and comorbidities, leaving them with few treatment alternatives. Transcatheter edge-to-edge repair (TEER) procedures have increasingly been used to improve the severity of both MR and TR, offering patients symptomatic relief and reductions in heart failure hospitalisation at low procedural risk. There is considerable geographic variation in protocols to assess these patients prior to the procedure and also in length of hospital stay. The standard of care in the UK, and particularly in Oxford, emphasises fewer investigations before the TEER procedure and shorter length of hospital stay. This prospective, observational cohort study will examine the safety and feasibility of this practice.
Interventions
BEHAVIORALEarly discharge protocol
Patients admitted for transcatheter edge-to-edge repair to either mitral or tricuspid valve and then discharged within 36 hours
Sponsors
Edwards Lifesciences
Oxford University Hospitals NHS Trust
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged ≥18 years * Accepted by Heart Team for TEER (mitral and/or tricuspid) * Willing and able to give informed consent for participation in the study. * Regurgitation (mitral and/or tricuspid) grade ≥2+ as assessed by echocardiography * Patient is willing and able to attend all follow-up visits
Exclusion criteria
* Patients in whom safety or clinical concerns preclude participation * Patient declines to be involved in the study (unwilling to consent to enrolment or deemed by the patient advocate to be unwilling to consent) * Patient in whom a TOE is contraindicated, or screening TOE is unsuccessful * Pregnant or planning pregnancy within next 12 months * Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator * Patients requiring emergency TEER
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients discharged 'early' after edge -to-edge repair | up to 30 days | defined as \< 36 hours after completion of procedure |
| All - cause rehospitalisation after completion of procedure | 30 days, 1 year | Any hospital admission after discharge from the index procedure |
| All cause death after completion of procedure | 30 days, 1 year | All patient death following discharge after the index procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptomatic improvement | 3 months, 1 year | Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score from pre-procedure to post-procedure (validated score for assessing symptoms, physical and social limitations, and quality of life in patients with heart failure, score 0-100, where 100 = no symptoms). |
| Hospital length of stay | Up to 3 months | Length of hospital stay from admission to discharge for outpatient procedures, or from procedure to discharge for inpatient procedures |
| Heart failure hospitalisation | 30 days, 1 year | Any heart failure related hospitalisations after the index procedure |
| Proportion of patients requiring intensive care unit care | Up to 3 months | The proportion of patients admitted to intensive care unit after their procedure |
| Safety outcomes a. Major adverse events at the time of the procedure b. Major adverse events (procedure/device related) up to 30 days | During index admission up to 30 days post procedure. | Evaluating safety a. Major adverse events (procedure/device related) at the time of procedure b. Major adverse events (procedure/device related) up to 30 days (including unplanned surgery relating to a device/procedural complication) |
Countries
United Kingdom
Outcome results
None listed