David F. Vener, M.D. Database Coordinator Congenital Cardiac Anesthesia Society Assoc. Professor of Pediatrics and Anesthesiology Baylor College of Medicine/Texas Childrens Hospital Houston, TX

Disclaimer Slide I am not associated with any commercial vendors, ventures or products associated with the creation or maintenance of the STS Congenital Heart Database or the CCAS and do not receive funds from any commercial vendors, the STS or the CCAS for my work. I have no known conflicts of interest to disclose in relationship to this talk.

CCAS Database Committee Nina Guzzetta, MD – Emory University/CHCA Jumbo Williams, MB - Stanford Lena Sun, MD – Columbia University, NYC Mark Twite, MD – Denver Children’s Anshuman Sharma, MD – Washington Univ St Louis Courtney Hardy, MD – Children’s Memorial, Chicago David Jobes, MD – CHOP Roxann Barnes, MD – Mayo Clinic Scott Schulman, MD – Duke

Background Anesthesia-related complications are relatively rare events and congenital cardiac surgery is a relatively rare procedure so the only way to contemporaneously and accurately capture anesthesia-related data is through a multi-site model. Patients with congenital heart disease have up to 85x greater likelihood of having an adverse event intraoperatively than non-cardiac patients, regardless of the procedure being performed.

Participation Data start date of January 1, 2010 Current fee schedule: $3500 per year, regardless of number of anesthesia providers or cases. This does not include any expenses associated with vendor fees and is in addition to any fees paid by the congenital heart surgeons. Cases input into database may include not only cardiac surgical cases, but any procedures in which congenital cardiac anesthesiologists are involved: Cath Lab, Diagnostic and Interventional Radiology, General OR, ICU, etc.

Results On August 1, 2011 we received back the first report from the STS-CCAS data collection efforts 20 Programs paid the $3500 fee, of which 18 submitted at least some minimal data to DCRI during the Spring 2011 harvest for calendar year 2010 The results represent both full and partial calendar year submissions and many centers chose to enter only CV surgical cases at this time.

Who submitted? 2010 Annual Volume Categories, CPB Cases (Provided Groupings) VolumeNumber of Participants Small (< 125)6 Medium (125 – 250)7 Large (251 – 500)3 Very Large (> 500)2

Who submitted? Number of Participants by the 4 US Census Regions RegionNumber of Participants Midwest 2 Northeast 4 South 8 West 4

Case Types Total of 5,757 anesthesia cases submitted Surgical CPB – 3,386 (58.8%) No CPB – 1,084 (18.8%) Cardiology – 772 (13.4%) Diagnostic – 44 (0.8%) Interventional – 474 (8.2%) Electrophysiology Studies/Tx – 254 (4.4%) Support Devices (VAD, ECMO) – 146 (2.5%) Other (Thoracic, Minor, etc.) – 369 (6.4%)

Age of Patients Submitted 2010

STS – EACTS Mortality/Complexity Categories *Not Assigned includes all non-CV surgical cases.

Overall Adverse/Unexpected Events None/Missing – 5,589 (97.1%) Airway Dental - 3 (0.1%) Respiratory Arrest – 2 (0.0%) Unexpected Difficult Intubation – 23 (0.4%) Stridor – 18 (0.3%) Unexpected Extubation – 3 (0.1%) Airway injury – 1 (0.0%)

Overall Adverse/Unexpected Events Vascular Injury/Line Related Arrhythmia requiring Tx with CVL – 1 (0.0%) Myocardial Injury with CVL – 1 (0.0%) Vascular Injury w CVL (Bleeding) – 15 (0.3%) Vascular Access Issues (unable to obtain desired access within one hour of induction) – 46 (0.8%) Hematoma – 3 (0.1%) Inadvertent Arterial Puncture – 32 (0.6%) Regional Anesthesia-Related – 1 (0.0%) site

Overall Adverse/Unexpected Events Drug-Related Events Anaphylaxis/Anaphylactoid Reaction - 6 (0.1%) Medication Administration (Wrong Drug) – 1 (0.0%) Medication Dosage – 2 (0.0%) Suspected Malignant Hyperthermia – 1 (0.0%) Protamine Reaction req Tx – 3 (0.1%) Cardiac Arrest Unrelated to Surgery – 10 (0.2%) (compared to Odegard et al: 11/5213 (0.2%))

Overall Adverse/Unexpected Events TEE – Related Esophageal Bleeding/Rupture – 3 (0.1%) Extubation – 1 (0.0%) Airway Compromise w TEE – 11 (0.2%) Patient Transfer Events – 2 (0.0%) Neurologic Injury – 4 (0.1%)

Pre-Operative Medications (Surgical Cases Only) Anticoagulants – 382 (8.5%) Antiarrhythmics – 108 (2.4%) Prostaglandin – 383 (8.6%) Cardiac Medications IV Inotropes – 368 (8.2%) IV Systemic Vasodilators – 30 (0.7%) IV Systemic Vasoconstrictors – 30 (0.4%) IV Pulmonary Vasodilators – 1 (0.0%)

Neurologic Monitoring (Surgical Cases Only) Yes (60.7%) Of those monitored there is an analysis problem with this in that it allowed single-choice only, where multi- modal monitoring is used frequently: NIRS 2449 (90.3%) TCD 5 (0.2%) BIS 233 (8.6%) Other 4 (0.1%) – other forms of EEG?

Areas for Improvement Report Writing There were multiple areas where the report produced did not really match up what we were trying to ascertain. This is largely a formatting issue that can be easily addressed. New Items Updated drug listings Updated complications Better information about airway issues (preoperative FiO2, in- situ airways, airway intubation mechanism (DL, FOB, etc.)

Areas for Improvement Ultrasound Guidance for CVL placement New Dispositions Discharge Home as planned Admit to Floor as planned Admit to ICU as planned Unexpected admission to hospital or ICU Perioperative Demise (within 24 hours of last anesthetic), regardless of cause

Contact Information The collection of anesthesia fields will be associated with a number of questions. I am always available by to answer any questions. Please do not hesitate to contact me: David Vener, MD Departments of Pediatrics and Anesthesiology Baylor College of Medicine Houston, TX