PracticeUpdate Cardiology Best of 2018

ACC 2018 21

TAVR for LowRisk PatientsWith Severe Aortic Stenosis Interview with James E. Udelson MD by Jennifer N. Caudle DO Dr. Udelson is Chief of the Division of Cardiology, Director of Nuclear Cardiology Laboratory, and Professor of Medicine and Radiology at Tufts University School of Medicine in Boston, Massachusetts. Dr. Caudle: The NOTION trial looked at 5-year outcomes in low-risk patients with severe aortic stenosis. Could you discuss the design and results of the trial? Dr. Udelson: It might be best to start with a little bit of background to really under-

If cardioversion was indicated, both tests were repeated after the procedure. Dr. Bumgarner and his team compared the automated smartwatch band interpretations with the physician-re- viewed standard ECG. Apple Watch-derived recordings were stripped of identifying infor- mation, shuffled, and reviewed by two blinded electrophysiologists. When the automated algorithm was able to pro- vide a diagnosis (sinus rhythm or atrial fibrillation), it detected atrial fibrillation with 93% sensitivity and 84% specificity vs clinical-grade ECG. When an electrophysiologist also interpreted this data, accuracy improved to 99% sensitivity and 83% specificity. A total of 34.9% of recordings from the watch were classified as an undeter- mined rhythm (59 of 169). When these noninterpretable watch recordings were reviewed, interpreting electrophysiologists were able to diagnose atrial fibrillation with 100% sensitivity and 80% specificity. According to Dr. Bumgarner, Kardia Band was very good at identifying atrial fibrillation on its own, and became more clinically informative when combined with a physician’s interpreta- tion of the recording. His team was not involved in developing the algorithm nor the technology. Dr. Bumgarner noted that the accuracy was comparable with a standard 12-lead electrocardiogram that is used daily in the clinic. He also noted that a device like this may poten- tially save money. According to Dr. Bumgarner, a normal heart rhythm was determined by Kardia Band and val- idated by ECG in approximately 8% of patients. This technology may be used in the future to screen patients and help avoid scheduling unnecessary procedures. The electrophysiology lab at the Cleveland Clinic performs as many as 10 to 15 cardioversions daily. While this study involved only patients with atrial fibrillation who had been scheduled for elective cardioversion, Dr. Bumgarner noted that it would not be unreasonable to apply this technology to outpatients as well. Because atrial fibrillation prevalence is rising and many patients choose to undergo cardioversion for normal heart rhythm restoration, this technol- ogy may be more widely applicable in the future, he continued. Kardia Band, paired with an app that provides an algorithm for detecting atrial fibrillation, attaches to the Apple Watch as an add-on accessory. The device was cleared by the FDA in November 2017 and is now available. AliveCor, which manufactures company Kardia Band, provided Apple Watches for the study but was not involved in study design, implementa- tion, analysis, or interpretation. www.practiceupdate.com/c/64980

stand why this was important. About 6 years ago in the United States, a little longer in Europe, TAVR, transcath- eter aortic valve replacement, replacing valves with catheters began to be done, and the initial trials looked at the sickest of the sick elderly people, people who were absolutely not surgical candidates, and that initial trial showed a dramatic reduction in mortality. Then, the next step was TAVR as an alter- native to very high risk surgical people,

" …you can now approach a patient, who is a low risk aortic stenosis patient, and offer them a choice either transcatheter or open heart surgery. "

and then, TAVR was shown to be an alternative to what’s called intermediate risk. And when we say risk, it’s developed by a scoring system involving age, comorbidities, etc from the Society of Thoracic Surgeons, so that’s really in the United States, at least, the landscape for TAVR. And there is an ongoing ques- tion about whether TAVR is a good alternative to surgery in lower risk people, which is actually a really large number. It’s never really been shown, and it’s not approved for that purpose. So the NOR- DIC trial was a trial looking at sort of all comers, who presented with severe aortic stenosis for intervention, who were randomized to either surgical inter- vention or TAVR intervention. It just so happened that of all of these people, about a little more than 80%, were in this low-risk category by the STS score. So in that sense, it’s really the first long-term study of low-risk people looking at TAVR versus surgical aortic valve replacement. So the design, as you asked, they were randomized, everyone followed for 4–5 years, which is a long time. Echo was done to look at the valve function, and you know, it was a very well designed and executed trial. Dr. Caudle: What impact do you feel that these data may have on how you approach low risk patients with severe aortic stenosis? Dr. Udelson: Well, the results showed that for the primary endpoint, which was all- cause mortality, stroke or myocardial infarction, there was really no difference over the 5-year period. There was no difference in any of those components, and in fact, the transcatheter valves had a little bit of a lower gradient, a little bit of a larger orifice area, so that’s all good. On the downside, the TAVR procedure was associated with a higher need for permanent pacemaker use just by nature of the valve implantation technique. But overall, the big picture, they were pretty equivalent outcomes in these elderly patients. And so the impact really is that ultimately it suggests that you can now approach a patient, who is a low risk aortic stenosis patient, and offer them a choice either transcatheter or open heart surgery. Here in the United States, we have to wait until there’s an approval for that, but this suggests that ultimately there will be, and there are trials going on here to look at that specif- ically. They’re just not done yet.

Go to www.practiceupdate.com/c/65305 to watch this interview with Dr. Udelson.

VOL. 3 • NO. 4 • 2018