My name is Joan Michaels, I'm the Director of the Impact Registry at the American College of Cardiology. In my presentation today, I will be reviewing both procedural volume as well as the use of radiation and contrast within all of the procedures that are collected within the registry. Currently there are 106 participating sites in the Impact Registry within the United States. The registry started in 2010 with a version upgrade in 2016, which included transcatheter pulmonary procedures as well as EP ablation. As of 2021, there were well over 400,000 records collected in the registry. I'd like to present some current volumes for the procedures that we are collecting. As of 2021, there were 27,471 diagnostic cath procedures, 1,842 ASD procedures, 728 co-op procedures, 351 aortic valvuloplasty procedures were collected in 2021, 1,035 pulmonary valvuloplasty procedures, 2,657 PDA closures, 816 proximal PA stenting procedures were done in 2021, 4,595 ablation procedures, and 1,058 transcatheter pulmonary valve replacement procedures were completed in 2021. Recently, the FDA recommended thyroid monitoring in babies and young children who receive injections of iodine-containing contrast media for medical imaging. This is something we have collected since the beginning of the registry, and I'd now like to show you some data that we have collected. The FDA also approved a new warning to the prescribing information for the entire class of iodine contrast media injections and monitoring recommendations for children three years of age or younger. The warning describes the risk of underactive thyroid or a temporary decrease in thyroid hormone levels. I'd just like to point out here that we do collect contrast volume in milliliters under our fluoroscopy section of the impact registry. So this is collected for all procedures that are completed. The registry collects procedures by age, and during the time period of 2016 quarter 2 to 2022 quarter 3, I wanted to show the breakdown of cases from zero to one month, 3,191, one month to one year, 10,763, one year to three years, 6,410, and greater than four years included 50,428 patients. This slide shows the mean contrast volume in milliliters for that same time period of 2016 quarter 2 to 2022 quarter 3. Within the age brackets, we previously discussed zero to one month, one month to one year, one year to three years, and four years and greater. Looking at the age breakdown of impact cases between 2021 quarter 2 and 2022 quarter 3, there are 28.8% of the cases were three years and under versus 71.2% were four years and over. I just want to point here again, the fluoro time under our fluoroscopy section of the impact registry data collection form, we have from the beginning and currently also collect dose area product for all cases done. For aortic valvuloplasty procedures, the average dose area product used for patients less than one month was 7.54, for less than a year, 45.63, and for less than 18 years, 43.09. For ASD patients, the average dose area product for less than one month, 2.69, for less than a year, 3.8, for less than 18 years, 21.56. And since the impact registry, remember, includes improving pediatric and adult procedures, over 18 years, the dose and area product use was a mean of 32.21. The mean dose area product used in co-op procedures was again, 6.66 for less than one month of age, up to a year, 36.13, less than 18 years, 52.26, and greater than 18, 133.82 was the average dose area product use. For our diagnostic health population, for less than a month, 59, close to 60, was the average dose area product use, less than one year, 48.26, less than 18 years, 28.1, and greater than 18 years of age, 94.86. The average dose area product used in our EP ablation cases, as you can see for less than one month, was 0.91, for less than a year, 10.83, for less than 18 years, 4.55, and for patients over the age of 18, 6.12. The average dose area product use in PDA cases ranged from 10, for patients less than one month, to 18, for less than a year, 20.73, for less than 18 years, and patients greater than 18 years of age, 185.30. For proximal stenting, the average dose area product, again, broken out by age, 9.81, for less than one month, 97.4, for less than one year, 60.9, for under 18 years, and for patients over 18 years, the average dose area product use was 175. Pulmonary valvuloplasty average dose area product use, less than one month, 98.83, less than a year, 39.8, less than 18 years, 22.7, and greater than 18 years, 131.4. And the average dose area product for our transcatheter pulmonary valve replacement patients ranged from 15.9, for those less than one month of age, less than a year, 2.24, less than 18 years, 84.5, and greater than 18 years of age, 176.2. What I'd like to conclude from sharing some data is that it's extremely important to communicate with your cath lab team, your data collectors, and abstractors to make sure that they're accurately and completely documenting the use of fluorotime and contrast use within all the cases. As you well know, some of these patients come back for repeated procedures, even within the month, the week, the year, and it's very important for the cumulative effects and data collection to be reflected in the patient's chart so that everyone is aware of the amount of exposure that the patient has had through their life of care. I'd like to thank you so much for listening to this brief presentation, and I look forward to sharing the very exciting news coming up soon about the new version upgrade that the impact registry will be launching. Thank you so much for taking the time to listen to the presentation. Again, I would like to thank you for listening to the presentation, and I hope you enjoy the rest of the program. Thank you.

Joan Michaels

Impact Registry

procedural volume

contrast use

registry