National Congenital Heart Disease Audit

The National Institute of Cardiovascular Outcomes Research (NICOR) collects data and produces analysis to enable hospitals and healthcare improvement bodies to monitor and improve the quality of care and outcomes of cardiovascular patients.

The Congenital Heart Disease audit collects data on all cardiac surgery and therapeutic cardiac catheterisations procedures used to treat patients with congenital and acquired heart disease.

For acquired heart disease, the audit covers all arrhythmias & cardiomyopathies in patients less than 16 years old only. For congenital heart disease, the audit collects data on both children and adult patients. The audit covers all specialist centers in the UK and Republic of Ireland.

The project aims to improve the quality of care for children and adults with congenital heart disease by providing national comparative analysis of procedure specific activity and outcomes of cardiac surgery and therapeutic cardiac catheterisation procedures. The audit also provides quality indicators for the antenatal detection of major congenital heart disease.

The current dataset is available from here:

http://www.ucl.ac.uk/nicor/audits/congenital/datasets

Study Overview

• Status: Unknown
• Conditions: Congenital Heart Disease (CHD)
• Intervention / Treatment: Procedure: Cardiac Surgery; Procedure: Therapeutic cardiac catheterisations procedures

Detailed Description

The Congenital Heart Disease audit collects data on all cardiac surgery and therapeutic cardiac catheterisations procedures used to treat patients with congenital and acquired heart disease

Data collection:

Hospitals use Patient Administration Systems and manual data entry by cardiac database managers to submit data to NICOR.

Data are either assimilated locally using third party commercial software and imported as a .csv file, or entered directly onto the NICOR database.

Data quality:

NICOR provide tools that communicate possible errors to centres submitting data. A data submitting schedule has been agreed with the centres, data is submitted and a validation report is returned each quarter. Centres are responsible for updating errors in the records.

An import log highlights missing and invalid data as well as records that failed to import due to data quality or compatibility issues.

In addition, data is validated by on site visits with a NICOR representative.

Data linkage:

Data is annually linked with Office fot National Statistics (ONS) life status and Hospital Episodes Statistics (HES) admission data to verify case ascertainment and to track long term outcome measures.

Information governance:

NICOR has Section 251 approval and data protection registration. An organisation-wide standard operating procedure is in place for Information Security Incident Management. University College London has a robust information governance framework, to which NICOR adheres.

• Study Type: Observational
• Enrollment (Anticipated): 120000

Contacts and Locations

Study Locations

• United Kingdom
  • Birmingham, United Kingdom
    • Recruiting
    • Queen Elizabeth Hospital (Edgbaston)
  • London, United Kingdom, SW3 6NP
    • Recruiting
    • Royal Brompton Hospital
  • London, United Kingdom, W1G 8BJ
    • Recruiting
    • The Harley Street Clinic
  • London, United Kingdom
    • Recruiting
    • The Heart Hospital
  • Hampshire
    • Southampton, Hampshire, United Kingdom, SO16 6YD
      • Recruiting
      • Southampton General Hospital
  • Merseyside
    • Liverpool, Merseyside, United Kingdom, L12 2AP
      • Recruiting
      • Alder Hey Hospital
  • Northern Ireland
    • Belfast, Northern Ireland, United Kingdom, BT12 6BA
      • Recruiting
      • Royal Victoria Hospital Belfast
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 9DU
      • Recruiting
      • John Radcliffe Hospital
  • Tyne and Wear
    • Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE7 7DN
      • Recruiting
      • Freeman Hospital
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom, LS1 3EX
      • Recruiting
      • Leeds General Infirmary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All potential patients are assessed through a systematic process of clinical evaluation, diagnostic assessment. Patient selection is effected in each individual unit through a multidisciplinary team process. These teams consist not only of cardiac surgeons and interventional cardiologists but also of many other medical specialties and allied professionals. The decision as to the access route to be used is determined by the multidisciplinary team.

Description

Inclusion Criteria:

Patient, judged by multidisciplinary team meeting as unsuitable for the procedure

Exclusion Criteria:

Patient, judged by multidisciplinary team meeting, as unsuitable for the procedure

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Congenital; All patients with congential and acquired heart disease treated by cardiac surgery and therapeutic cardiac catheterisations procedures . For acquired heart disease, the audit covers all arrhythmias & cardiomyopathies in patients less than 16 years old only. For congenital heart disease, the audit collects data on both children and adult patients.

Procedure: Cardiac Surgery; All patients with congential and acquired heart disease treated by cardiac surgery procedures.; Other Names: Norwood procedure (Stage 1); Heart Transplant; TAPVD Repair + Arterial Shunt; Fontan procedure; Bidirectional cavopulmonary shunt; Senning or Mustard procedure; Truncus and interruption repair; Truncus arteriosus repair; Tricuspid valve replacement; Interrupted aortic arch repair; Multiple VSD Closure; Mitral valve replacement; Repair of total anomalous pulmonary venous drainage; Atrioventricular septal defect and tetralogy repair; Atrioventricular septal defect (complete) repair; Atrioventricular septal defect (partial) repair; Aortic valvotomy; Aortic valvoplasty; Anomalous coronary artery repair; Cor triatriatum repair; Arterial switch + VSD closure; Arterial switch (for isolated transposition); Pulmonary atresia VSD repair; Pulmonary valve replacement; Tetralogy with absent pulmonary valve repair; Tetralogy repair; Isolated coarctation repair; Aortic Valve Replacement - non Ross; Supravalvar aortic stenosis repair; Rastelli procedure; Aortic valve replacement - Ross; Aortic root replacement (not Ross); Subvalvar aortic stenosis repair; Aortopulmonary window repair; ASD repair; VSD Repair; Arterial shunt; Isolated Pulmonary artery band; PDA ligation (surgical); Procedure: Therapeutic cardiac catheterisations procedures; All patients with congential and acquired heart disease treated by therapeutic cardiac catheterisations procedures .; Other Names: Implantable Cardioverter Defibrillator; Transcatheter PVR; VSD closure (catheter); Aortic balloon valvotomy; Coarctation angioplasty; Pulmonary artery stenting; ASD closure (catheter); PDA closure (catheter); Recoarctation angioplasty; Pulmonary balloon valvoplasty; Blade atrial septostomy; Coarctation stenting; PFO closure (catheter); Pulmonary valvotomy (radiofrequency); Duct Stenting; RVOT Stenting; Radiofrequency ablation for supraventricular tachycardia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30 day survival rates	The analysis shows the national survival rates at 30 days for each procedure and the national survival rates for individual procedures by age.	30 day survival from operation date

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1 year survival rates	Analysis include 1-year outcome but a death would not appear in the table until a full year has passed for the whole cohort of patients within that year. For example, the audit collection period is based on financial year of April 1st to March 31st. A patient that died in April would be reported within the same period as one that died 11 months later in March.	1 year survival rates after the date of the procedure

Collaborators and Investigators

• Sponsor: University College, London
• Collaborators: Society for Cardiothoracic Surgery in Great Britain & Ireland; British Congenital Cardiac Association
• Investigators: Study Chair: Rodney Franklin, MD, Royal Brompton & Harefield NHS Foundation Trust

Publications and helpful links

General Publications

• Pagel C, Utley M, Crowe S, Witter T, Anderson D, Samson R, McLean A, Banks V, Tsang V, Brown K. Real time monitoring of risk-adjusted paediatric cardiac surgery outcomes using variable life-adjusted display: implementation in three UK centres. Heart. 2013 Oct;99(19):1445-50. doi: 10.1136/heartjnl-2013-303671. Epub 2013 Apr 5.

Study record dates

Study Major Dates

• Study Start: April 1, 2000
• Primary Completion (ANTICIPATED): March 1, 2017
• Study Completion (ANTICIPATED): March 1, 2017

Study Registration Dates

• First Submitted: November 25, 2014
• First Submitted That Met QC Criteria: November 25, 2014
• First Posted (ESTIMATE): December 1, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): November 4, 2016
• Last Update Submitted That Met QC Criteria: November 3, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: pediatric; Congenital heart disease; paediatric; European Paediatric Cardiac Code Short List; Specific Procedure Definitions; OPCS
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: NICOR-CONGENITAL