Mitral Regurgitation (MR), Pediatric Cardiac Surgery
Conditions
Keywords
Mitral Regurgitation, Pediatric Cardiac Surgery, Mitral Valve Repair, Surgical Outcomes
Brief summary
This prospective, multicenter cohort study aims to evaluate the outcomes of surgical repair for pediatric mitral regurgitation (MR) in China. From March 2020 to December 2024, consecutive patients younger than 14 years who underwent mitral valve repair at eight representative congenital heart disease centers were enrolled. Eligible patients were those with at least moderate MR on preoperative echocardiography and no prior mitral valve surgery. Patients with uncorrectable concomitant cardiac anomalies, moderate or greater mitral stenosis, ischemic MR, severe leaflet dysplasia, connective tissue disorders (e.g., Barlow, Marfan), cardiomyopathies, or single-ventricle physiology were excluded. The primary endpoint is a composite of all-cause mortality, reoperation for cardiovascular causes, or recurrence of moderate-or-severe MR during follow-up. Secondary endpoints include perioperative outcomes such as postoperative hospital stay, intensive care unit stay, mechanical ventilation time, and hospitalization cost. This study is designed to provide high-quality prospective evidence on the safety, durability, and predictors of surgical repair for pediatric MR in a contemporary, real-world, multicenter setting. The findings may inform surgical decision-making and postoperative management strategies for this rare but challenging population.
Interventions
PROCEDUREconventional mitral valve repair
Patients undergoing conventional mitral valve repair, including annuloplasty, leaflet cleft closure, chordal transfer, and chordal resection, et al.
PROCEDUREstandardized mitral valve repair
Patients undergoing the standardized mitral valve repair strategy proposed by Professor Li at Fuwai Hospital in 2016, which involves comprehensive exploration and correction of abnormalities at the subvalvular, leaflet, and annular levels.
Sponsors
China National Center for Cardiovascular Diseases
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 14 Years
Healthy volunteers
No
Inclusion criteria
* Age \< 14 years * No prior mitral valve surgery * Preoperative echocardiography demonstrating moderate or severe mitral regurgitation
Exclusion criteria
* Concomitant cardiac malformations unable to be corrected simultaneously * Moderate or severe mitral stenosis * Ischemic mitral regurgitation * Severe leaflet dysplasia precluding adequate coaptation * Connective tissue disorders(e.g., Barlow's disease, Marfan syndrome) * Any type of cardiomyopathy * Single ventricle physiology or common atrioventricular valve
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Primary Endpoint | From date of index surgery until last follow-up (up to 5 years) | Time-to-first event of any of the following: (a) all-cause mortality; (b) mitral valve reoperation; or (c) recurrence of ≥ moderate mitral regurgitation on transthoracic echocardiography. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Hospital Length of Stay | perioperatively | Total postoperative days from surgery to hospital discharge. |
| ICU Length of Stay | perioperatively | Consecutive time in intensive care unit. |
| Duration of Invasive Mechanical Ventilation | perioperatively | Cumulative duration of invasive mechanical ventilation during the index hospitalization, including all episodes of intubation and re-intubation. |
| Hospitalization Cost | perioperatively | Total in-hospital medical cost for the index surgical admission (local currency), extracted from billing records. |
Countries
China
Outcome results
None listed