Early Discharge After Mitral and Tricuspid Edge-to-edge Repair: an Assessment of Feasibility and Safety

Oxford University Hospitals NHS Trust127 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

127

Conditions

Mitral Regurgitation Tricuspid Regurgitation Mitral Repair Heart Failure

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Proportion of patients discharged 'early' after edge -to-edge repair

defined as \< 36 hours after completion of procedure

Time frame: up to 30 days

All - cause rehospitalisation after completion of procedure

Any hospital admission after discharge from the index procedure

Time frame: 30 days, 1 year

All cause death after completion of procedure

All patient death following discharge after the index procedure

Time frame: 30 days, 1 year

Secondary Outcomes

Hospital length of stay

Length of hospital stay from admission to discharge for outpatient procedures, or from procedure to discharge for inpatient procedures

Time frame: Up to 3 months

Proportion of patients requiring intensive care unit care

The proportion of patients admitted to intensive care unit after their procedure

Time frame: Up to 3 months

Safety outcomes a. Major adverse events at the time of the procedure b. Major adverse events (procedure/device related) up to 30 days

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)

Time frame: During index admission up to 30 days post procedure.

Symptomatic improvement

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).

Time frame: 3 months, 1 year

Heart failure hospitalisation

Any heart failure related hospitalisations after the index procedure

Time frame: 30 days, 1 year

Early Discharge After Mitral and Tricuspid Edge-to-edge Repair: an Assessment of Feasibility and Safety

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes