Residual or Recurrent Obstruction After Septal Myectomy

Residual or Recurrent Obstruction After Septal Myectomy in Young Children and Infants With Hypertrophic Cardiomyopathy

The goal of this observational study is to report the outcomes after septal myectomy in young children and infants and identify the mechanisms of residual or recurrent obstruction after surgery. in The main question[s] it aims to answer are:

• What is the early and mid-term results of septal myectomy in young children and infants with severe and extensive obstructive hypertrophic cardiomyopathy (HCM)?
• What are the mechanisms of residual or recurrent obstruction?

Echocardiography and clinical course of children and infants under the age of 14 who underwent septal myectomy for hypertrophic obstructive cardiomyopathy from January 2013 to December 2020 will be followed up.

Study Overview

• Status: Completed
• Conditions: Hypertrophic Obstructive Cardiomyopathy

• Study Type: Observational
• Enrollment (Actual): 56

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children with HOCM who remain severely symptomatic despite medical therapy or have a particularly high resting LVOT gradients (>100mmHg) underwent septal myectomy by the same surgeon Y from January 2013 to December 2020. A total of 56 consecutive children younger than 14 were included. All patients were on Beta blockers therapy and symptomatic.

Description

Inclusion Criteria:

• Clinical diagnosis of hypertrophic obstructive cardiomyopathy (HOCM)
• Age young than 14 years
• Patients who have undergone septal myectomy

Exclusion Criteria:

• older than 14 years old;
• secondary left ventricular hypertrophy (LVH) related to subaortic stenosis or aortic stenosis.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
death	postoperative death during follow-up	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
recurrent obstruction	postoperative recurrent obstruction during follow-up	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: January 6, 2023
• First Submitted That Met QC Criteria: January 13, 2023
• First Posted (Actual): January 18, 2023

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 13, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Septal myectomy; Residual or recurrent obstruction; children and infants; hypertrophic obstructive cardiomyopathy
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Hypertrophy; Cardiomyopathies; Cardiomyopathy, Hypertrophic
• Other Study ID Numbers: 2020-I2M-C&T-B-060

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No