Clinical trial NCT00446160: Adult Congenital Heart Disease Surgery
Official title: Proposal for Retrospective Review of an Adult Congenital Heart Surgery Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Disorders
Keywords: Congenital Heart Disease
Surgery
Adult
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2007-03-12
Enrollment: 700
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a retrospective chart review examining patients over the age of 18 years who have undergone operations for congenital heart disease. The primary interest of the study is to look at the breakdown of our adult congenital program in regards to location, personnel, and case type. All charts reviewed will be of patients who had their surgery at Children's Healthcare of Atlanta or Emory University between January 1, 2000 and December 31, 2007. We will review approximately 350 charts for this study.

Some of the patients have been cared for in the system for many years, first at Egleston and then at Emory. We are only interested in the congenital operations performed on patients after the age of 18 years old up until approximately 65 years of age. Initially these were done at Egleston, although more recently they are being done at Emory.

Brief summary: It is now estimated that the number of adults with congenital heart disease in the U.S is over 800,000. Unfortunately, these patients, in some way, have become a lost population. They have congenital abnormalities familiar to a children's hospital, yet have surpassed the age cutoff for admission.

Recently, we have developed a specialized program to care for this unique patient population. Dedicated programs such as ours hope to optimize patient care, consolidate specialized resources, provide sufficient patient numbers for training and maintain expertise and facilitate research in this unique population.

Detailed description: In the United States, approximately 30,000 children are born with congenital heart disease every year. As technology, operative technique, and critical care medicine have improved significantly over the years, more of these children are surviving into adulthood.

Care of the congenital cardiac surgical patient requires a concerted effort on the part of the surgeons, perfusionists, anesthesiologists, intensivists, nurses, respiratory therapists, rehabilitation services and social workers. It is hoped that the same excellent care received in a children's congenital heart surgery program can be continued as these patients graduate into an adult program.

This is a retrospective chart review examining patients over the age of 18 years who have undergone operations for congenital heart disease. The primary interest of the study is to look at the breakdown of our adult congenital program in regards to location, personnel, and case type. All charts reviewed will be of patients who had their surgery at Children's Healthcare of Atlanta or Emory University between January 1, 2000 and December 31, 2006. We will review approximately 225 charts for this study.

The first aim of the study would be to examine the demographics of the adult congenital heart surgery program itself. The following information will be collected:

* Location of the surgery - children's hospital vs adult hospital
* Surgeon - adult cardiac surgeon vs congenital cardiac surgeon

The second aim of the study would be to analyze the types of surgeries being performed. The following information will be collected:

* Pathologic diagnosis
* Number of re-operative sternotomies
* Number of open-heart surgeries

The third aim of the study would be to analyze our outcomes. The following information will be collected:

- Number of surgical mortalities

Eligibility criteria: Inclusion Criteria:

* surgery at Children's Healthcare of Atlanta or Emory University between 1.1.2000 and 12.31.2007
* surgery on patients after 18 years to approximately 65 years of age

Exclusion Criteria:

* Those who do not meet inclusion criteria

Primary outcomes:
measure: The primary interest of the study is to look at the breakdown of our adult congenital program in regards to location, personnel, and case type.
timeFrame: Retrospective chart review
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Subhadra E Shashidharan, MD
role: PRINCIPAL_INVESTIGATOR
References: