Hi, and thanks for listening to this presentation. My name is Joan Michaels. I am the program manager for the STS ACC TVT registry. I work alongside Carol Crone at STS on this registry. This presentation will focus on the TVT metrics that will be used in version 3.0. I would like to review the new metrics that have been added, as well as review some modifications and review the metrics that will be retired in version 3.0. I will also review how metrics are used. The objectives for this presentation are to recognize metrics that are used in appropriate use criteria and in the risk model, and to identify two new metrics. Metrics are measurements that demonstrate how your program is doing and also allow you to compare how you are doing in comparison to other facilities. Benchmarking is important and can help you guide in areas of quality improvement for your site. Before we discuss changes in the TVT metrics, I would like to step back and give some background on the data we have collected through all your hard work. There are currently 718 active participating sites in the TVT registry. There are well over 200,000 records in the TVT registry. That is significant because you need a large number of records in order to develop meaningful metrics for reporting. Up to this point, we have had three risk models. The in-hospital risk-adjusted mortality, 30-day risk-adjusted mortality, and in-hospital risk-adjusted stroke. These three risk models may be found in the current outcomes report. As of January, they will be retired to make way for a more comprehensive risk model. The morbidity-mortality composite risk model will take place of the previously mentioned risk models and is viewed as the gold standard to measure a quality TAVR program. Composite risk model will include approximately 50 covariance, as you can see here. I would like to emphasize two in particular, the baseline KCCQ and the baseline 5-meter walk test will be especially important to take note of. In order to be included in the composite risk model, you will have to obtain a 90% or greater of the baseline KCCQ and 5-meter walk test for a rolling three-year period to be included in the composite risk model. This may sound like a daunting achievement or high mountain to climb, however, many sites are achieving KCCQ completeness as seen in this graph. Since the beginning of the TBT registry, we have been monitoring and collecting both baseline 30-day and one-year KCCQ on TAVR sites. You can complete the KCCQ via email or over the phone with your patients. The amount of missing or not performed 5-meter walk test is declining. During COVID, it might be helpful to know that you can complete the 5-meter walk test the morning of the procedure if that is helpful. And 5-meter walk test for TAVR patients is only required at baseline. The composite risk model is a hierarchical model and consists of six categories based on the worst possible outcome, which is death, to the best possible outcome, alive and free of any complications, during hospitalization, and at the 30-day follow-up period. Here is a sample of the public reporting report your hospital will soon receive. You will receive the draft report in October and have a few months to decide if you would like to voluntarily participate in the TBT registry public reporting. Now I would like to review some of the new, some of the retired, and some of the modified metrics that you will be seeing in version 3.0, the next generation, in both TAVR, MITRA, and tricuspid modules, starting out with the new TAVR metrics that you will see in 3.0. The in-hospital pacemaker rate is currently 8% for 2020 Quarter 1, and the 30-day pacemaker rate is 11%. This is an important quality metric. Pacemaker-rated discharge, as well as 30-day, has now been added to the 3.0 registry metrics. This graph shows the slight decrease in pacemaker use, both at the in-hospital and at the 30-day rate. As with many other of our NCDR registries, cardiac rehabilitation will be a new metric for 3.0. Cardiac rehabilitation patient referral from an inpatient setting for all procedures is based on the 2018 cardiac rehabilitation performance measures. Adding this as a metric will harness an existing ACC measure, which includes referrals for patients who have had a cardiac valve repair or valve replacement. Now I'd like to review some of the metrics for the 3.0 transcatheter mitral valve repair module. Once again, cardiac rehabilitation patient referral will also be added as a metric to the TMVR repair module. The purpose for adding this is the same as we discussed in the TAVR module. The new transcatheter mitral valve replacement module will also have new metrics. Cardiac rehabilitation will also be added as a metric to the TMVR metrics. We're very excited in version 3.0 to be adding a tricuspid module, and along with that, we will be adding the following tricuspid metrics. The tricuspid module is the new module added, and at baseline, the following will be collected. Observed mortality, observed stroke, which will also include any ischemic, hemorrhagic, or undetermined stroke, acute kidney injury stage three, disabling bleed, any vascular access site complication, length of stay will be measured as a median post-procedure in days, KCCQ performed pre-procedurally, and of course, cardiac rehab referral as mentioned in the previous modules will also be added to the tricuspid module. The metrics that will be collected at 30 days will include observed mortality, any stroke including ischemic, hemorrhagic, or undetermined, acute kidney injury stage three, readmission for heart failure, tricuspid regurgitation, moderately severe to severe, patients with an acceptable quality of life outcome at 30 days based on their KCCQ score, patients with a 30-day follow-up, and ECHO not performed at discharge, and at 30 days will be measured. Now I'd like to review some of the modified metrics that you'll be seeing in version 3.0. In the TAVR metrics, significant cardiac event, procedure-related, after TAVR currently includes patients who experience coronary obstruction, annular rupture, cardiac perforation after TAVR. In 2019, the TVT registry rate was 1.1%. The following will be added to the numerator of the significant cardiac event metric, conversion to open heart during the procedure, emergent use of cardiopulmonary bypass during the procedure, mechanical support use of ECMO during the procedure. We've also retired a few metrics in the new version of 3.0. Valve regurgitation at TAVR discharge will be retired. ECHO data is captured at discharge and at 30 days. Some sites may not perform a discharge ECHO, but will in fact complete the 30-day ECHO. We will continue to capture and report ECHO data at discharge, but the valve regurgitation metric will be reported at 30 days as the quality metric, and no longer at discharge. Valve regurgitation and mitral repair discharge will also be retired. The rationale is the same as TAVR. Some sites may no longer perform a discharge ECHO, but will complete the 30-day ECHO. We will continue to capture and report ECHO data at discharge, but the valve regurgitation will be reported at 30 days as the quality metric. Valve regurgitation at TMVR discharge will also be retired, transcatheter mitral valve replacement. Sites may not perform a discharge ECHO, but again may complete the 30-day ECHO. We will continue to capture the ECHO at discharge, but the metric will be of the regurgitation reported at 30 days. Median fluorotime for TAVR will be retired in 3.0. This metric will be updated to a radiation safety metric in the future. It will remain on the data collection form, but it will no longer be reported as a metric. Median fluorotime for TMVR, met mitral valve replacement, will also be updated to a radiation safety metric in the future. And finally, the median fluorotime for TMVR patients will also be updated. We will continue to refine the risk models and the data collected in the TBT registry. Currently, we are working on a 30-day mitral clip risk-adjusted mortality and a live and well at one year after TAVR risk model as well. Thank you for your time, and I hope the review of both the new, modified, and retired metrics and risk models will be helpful as you continue to collect data for TAVR.

Joan Michaels

STS ACC TVT registry

metrics

version 3.0

benchmarking