Epidemiology of Congenital Heart Disease in France (EPIDEMIO-CHD)

Epidemiology of Congenital Heart Disease in France : EPIDEMIO-CHD

Congenital heart disease (CHD) is the leading cause of birth defects, with an incidence of 0.8%. Since the 1980s, France has been a pioneer in neonatal CHD surgery (Pr. Fontan, Pr. Lecomte, Pr. Serraf, etc.), in prenatal diagnosis, and in interventional cardiac catheterization.

Actually, first children operated for complex CHD have reached adulthood and a new epidemiology of CHD is emerging. Currently, one of the public health challenges is the need to maintain appropriate follow-up and to avoid disruption of care during the transition from adolescence to adulthood. Thus, the national health authorities (DGOS) recently certified a national network of expert centers for complex CHD (M3C).

In addition, under the leadership of the French Society of Cardiology, the sub-specialty of Pediatric and Congenital Cardiology has been recognized.

However, while North American and North European countries have published their updated data on the main indicators of CHD morbidity and mortality, no study has reported epidemiology of CHD in France.

Currently, available data are approximate, estimating that 200,000 children and 250,000 adults would be living in France with a CHD. Nevertheless, no information is available on hospitalizations, type of CHD, their follow-up, possible disruption in care, and morbidity and mortality in patients with CHD in France. This epidemiological study will use the national health insurance hospital database to answer these questions.

Study Overview

• Status: Completed
• Conditions: Congenital Heart Disease

Detailed Description

Retrospective epidemiological study based on the national health insurance hospital database from 2010 to 2020 (10 years):

Main objective:

• To assess the prevalence of patients with CHD hospitalized in France over 10 years.

Secondary objectives: asess over the same period:

• Overall mortality rate according to the CHD classification and the geographic area
• Overall morbidity rate, according to the CHD classification and the geographic area
• Overall cardiac surgery-related mortality rate (cardiac surgery and other surgery), according to the CHD classification (adjusted for the severity of the CHD and the surgical procedure) and to geographic area
• Overall cardiac catheter-related mortality rate, according to the CHD classification (adjusted for the severity of the CHD and the catheterization procedure) and to geographic area
• CHD follow-up within and outside the national M3C network
• Periods of loss of cardiological follow-up (within or outside the M3C network, in hospital or in town)
• Obstetrical data for women (parity, pregnancy)
• The existence of a prenatal diagnosis (yes / no and the term of pregnancy at the time of diagnosis of CHD)

• Study Type: Observational
• Enrollment (Actual): 450000

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • UH Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient with congenital heart disease (CHD)

Description

Inclusion criteria:

- Patient (of any age) with a CHD as defined by the international ACC-CHD classification and listed in the ICD10 classification, hospitalized from 01/01/2010 to 12/31/2019 in a French tertiary care hospital from the M3C network.

Exclusion criteria:

- Patient with non-malformative genetic heart disease (cardiomyopathy, hereditary rhythmic disease).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of patients with CHD hospitalized in France	Rate of patients with CHD hospitalized in France	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of mortality in patients with CHD	Rate of mortality in patients with CHD	10 years
Rate of cardiac surgery-related mortality in patients with CHD	Rate of cardiac surgery-related mortality in patients with CHD	10 years
Rate of cardiac catheter-related mortality in patients with CHD	Rate of cardiac catheter-related mortality in patients with CHD	10 years
Rate of CHD patient's loss to follow-up within and outside the national M3C network	Rate of CHD patient's loss to follow-up within and outside the national M3C network	10 years
Rate of CHD prenatal diagnosis	Rate of CHD prenatal diagnosis	10 years

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: National Reference Center for Complex Congenital Heart Disease, Marie-Lannelongue Medical and Surgical Center, Le Plessis Robinson; National Reference Center for Complex Congenital Heart Disease, University Hospital of Bordeaux
• Investigators: Principal Investigator: Sarah Cohen, • Centre Médico-Chirurgical Marie-Lannelongue, Le Plessis Robinson; Principal Investigator: Jean-Benoit Thambo, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: February 1, 2021
• First Submitted That Met QC Criteria: February 1, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Actual): March 16, 2021
• Last Update Submitted That Met QC Criteria: March 15, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Epidemiology; Congenital heart disease; Paediatric cardiology; M3C network
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: RECHMPL20_0119

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: NC

Drug and device information, study documents

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