Longterm Outcome After Ventricular Septal Defect Closure
Condition: Ventricular Septal Defect
MeSH terms: Heart Septal Defects; Heart Septal Defects, Ventricular
Study type: Observational

Summary: 
      Isolated ventricular septal defect (VSD) is a well know congenital heart anomaly. If
      discovered in infancy or early childhood surgical intervention can be of necessity depending
      on the size of the defect, to assure a healthy adulthood. The long-term results of surgical
      closure of VSD in childhood are good and after surgery the children are considered as equally
      healthy and physically fit as their peers. However, there is inconsistency in data regarding
      follow-up on this group of patients, in relation to exercise capacity as a measure of the
      cardiopulmonary function. To further approach this matter the post-operative cardiac factors
      of these patients have to be investigated.

      With this study the investigators intend to examine the long-term outcome on cardiac output
      after heart surgery in VSD-patients. It presents an opportunity to also evaluate the
      correlation between cardiac output determined by gas-exchange and by MRI. The overall
      objectives of this study are to 1) examine whether VSD-operated patients have reduced cardiac
      output during exercise in comparison with matched controls, and furthermore 2) to evaluate a
      correlation between cardiac output measured by MRI and cardiac output determined by
      gas-exchange.

      The project is designed as a long-term follow-up and method study. A cohort of 20 children
      who in the 1990's underwent surgical closure of a congenital VSD will be asked to participate
      in this study. An equal amount of healthy young adults, will function as control group. Each
      participant will complete two different exercise tests, a MRI of the heart during lower body
      exercise on a supine ergometer bicycle, and a Supine ergometer bicycle exercise test. This
      data can be used for comparing cardiac output between the test groups, and furthermore it
      allows an evaluation of the correlation between the two methods.

      VSD is as described, the most common congenital heart anomaly. If not intervened with in
      childhood, it can cause severe heart complications later in life. It is unclear whether this
      intervention can cause long-term impact on patients exercise capacity, and for that reason it
      is of great importance that we strive for improving our knowledge of the long-term
      postsurgical outcome after VSD-closure.
    


Intervention name(s): MRI exercise test; Gas-exchange exercise test
Intervention type(s): Other; Other
Intervention description(s): Measuring cardiac output with MRI during exercise on an ergometer bicycle.; Measuring cardiac output by gas-exchange, while during exercise on an ergometer bicycle.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Of 182 children who in the years 1990 to 1995 underwent surgical closure of a congenital
        VSD at Aarhus University Hospital (AUH), Denmark, a small group of 20 is randomly selected
        to participate. These children form a homogenous group of patients comparing surgeons,
        anesthetists, surgical procedures and post-surgical period. An equal amount of healthy
        controls, matched on age and gender, form the control group.