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October 23, 2017

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This is being provided in a rough-draft format. Communication Access Realtime Translation (CART) is provided in order to facilitate communication accessibility and may not be a totally verbatim record of the proceedings

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>>: Good morning everyone. Welcome to today's webinar. Stroke prevention and early data from the guidelines ablation module. Before we get started, I want to go over a few items so you can participate in today's event. In your interface, you will be able to download the handouts for today's presentation including the release notes and the management report. If, at any time during the presentation, you expressed technical difficulties, they can be resolved by repression or browser.

If that does not work, contact the go to webinar support team found in your confirmation e-mail and or reminder. Today's presentation will be available to download, you will receive a link to the recording following this webinar. You will have opportunity to submit text questions to today's presenter by typing the questions into the questions page of the control panel at the bottom of the right-hand side. You may send in your questions at any time during the webinar.

We will collect the questions during the Q&A session at the end of today's presentation.

I went to introduce Dr. Jonathan and Jeannie, speakers for today. Dr. Jonathan Piccini is a cardiac electrophysiologist and associate professor of medicine at through Duke University and the clinical research Institute. At present, he is the director of the clinical trials program and arrhythmia at Duke University. He also serves as the workgroup member at the American Heart Association for the guidelines a-fib registry program. He is an associate editor for American Heart Journal and is at heart rhythms, European heart Journal. JACC clinical electrophysiology and Journal of cardiac electrophysiology. He has more than 200 publications and hard for the medicine.

Jeannie is a manager who helped quality and at the American Heart Association where she oversees the guidelines a fib patient management tools.

She brings over 25 years’ experience in health information and helps with outcome research.

Today she is preventing on the features now available in the get with the guidelines module. Dr. Piccini I hand it over to you to get started.

>>: Great, good afternoon everyone and thank you for joining us as this is my pleasure to speak to you on behalf of the entire get with the guidelines a-fib clinical working groups from the American Heart Association and Heart Rhythm Society and this is an update on getting with the guidelines including special focus on ablation module.

Fortunately, we have a lot of folks on the call and many good friends and colleagues across the US. We will try to keep things brief and to be very respectful of everyone's time on a busy Monday at your institution. We will try to maintain time for questions at the end of the program.

I will be sharing to analysis or views of the data, if you will, but first is an analysis that we are very proud of. I think it will speak to the great value I will get with the guidelines a fib as a program and improved quality at your hospital across the country.

The second presentation, it is basically a rerun as a very exciting data that we were able to share at the heart rhythm Society meeting. The focus is on the very first data to come out and take it with the guidelines ablation module that is an important part of the get with the guidelines a for program.

As many of you know, improving stroke prevention with atrial fibrillation, it is often regarded as mission impossible. Shown here are data from our colleague, Jonathan works at the University of San Diego where they use the data from the pinnacle registry about cardiology practices and show a very significant number of patients with atrial fibrillation, adequate risk for stroke are not receiving oral anticoagulation, which is the dark teal and dark brown portions of the color bars that you see here.

Even in some high risk populations with Chads Vas scores an excess of five or six, only as many as half of the patients received stroke prevention therapy.

A goal from the beginning of get with the guidelines was to improve the quality for all parents with a-fib that is outlined in the American Cardiology at American Heart Association Joint Performance Measures.

What we did, we wanted to see if we were making any progress in this cold. We collect again with the guidelines of a-fib data at centers who had 90% complete data or better and we examined patients who were admitted with a primary or secondary diagnosis of atrial fibrillation.

We looked at patients who had documented contraindications to oral anticoagulation. Those patients were described and not included in the primary analysis as our question was to see who is getting oral anticoagulation that should be getting it and was eligible to get it and not someone who is not eligible or did not have an indication.

We basically like that adherence to the performance measures.

As you can see here, the average age in the registry or median age was 71 years. Half of the patients were women. The majority of patients had paroxysmal fibrillation and minority had long-standing persistent atrial fibrillation. Comorbidity was relatively common about 30% of them having diabetes and 75% having hypertension and 14% having obstructive sleep apnea.

If we look at contraindications about one in five patients or 19% of patients had a contraindication of oral anticoagulation. These contraindications are fairly similar to what is being described in many cohorts. In some cases, 30% of cases, physician preference decided if a contraindication or if they use their judgment that there was a reason the patient could not be anticoagulated.

Frequent falls or frailty and a quarter with contraindications and high bleeding risks in 23%. It is important to know these are not mutually exclusive categories. If someone thought a patient's need for platelet therapy and the fact they were falling frequently or high bleeding risk where the regions they were not prescribed that the clinician indicated all of those things in the registry.

What we saw, it was very encouraging, despite report after report showing half and 60% of patients get anticoagulation and get with the guidelines in the first few years of the registry this is 90% of patients coming across a wide variety of categories are all receiving oral anticoagulation.

Again, in the educated patients with Chad Vas score of two or greater. That was true whether looking at men or women and was true across race and ethnicity, young or old for those with and without heart failure or coronary disease who did an or did not undergo catheter exploration and those regardless if they were prescribed rate or rhythm control as that strategy.

There was variation across the sites and, for those who are figure with these types of plots where you look at the use of some therapy across all sites in a program or registry. You will notice that, while there is variation present, it is reassuring to see that even the sites with relatively low oral and I quite relation were still using coagulation 6 percent or more of the time.

It is suggested the program is making an impact.

This slide really is the most important one. You can see in this 13th quarter of the program there is a discharge anticoagulation of patients eligible with a Chad Vas score of two and greater was over 95% and that is a trend that has continued to get with the guidelines.

To those experts who get up and say this is mission impossible and 50 or 60% it is awful. You see the data proves they say there's proves them wrong. These are hospitals and these are hospitals, large hospitals, small hospitals, those all of the United States and we have visited many of them and these are real institutions where we have been able to make an impact and get life-saving stroke prevention therapy used more than 95% of the time.

Hopefully, with your help, we can continue on with this upward trajectory.

To review patients a minute with a five hat contraindication, anticoagulation and among hospitals participating in the program, stroke prevention therapy and discharge and eligible guideline indication, those with high and improved over time. The program shows a high degree of inheritance as stroke prevention and quality measures are achievable and sustainable.

That is some of the early success. What things have we been doing in the registry to make it even more valuable to healthcare systems, providers and patients alike? I would say one of the things we are very proud of, that was not present in the very beginning stages of the guidelines registry and is present now and a strong program, it is the presence of a-fib ablation sub registry or model.

Obviously, our collaboration with heart rhythm Society is a very integral part to this initiative.

The first question someone may ask is why would we even need and a-fib ablation registry. Do we have too many with data collection forms already?

I think the answer to that is we do need it and, many of you know that when it comes to the care of patients with a trophy relation, we are trying to prevent the development of heart failure by controlling the rate, controlling the rhythm and we are also trying to improve quality of life.

This is an important slide in the entire history of a-fib science. This is the data from Dr. Dorian, in Canada, they show that the quality of life present in individuals with atrial fibrillation is similar to patients who have just myocardial infarction or are suffering from congestive heart failure.

Could just a part of your data is not on the site, but the data is comparable. And many patients, atrial fibrillation has a significant impact on the quality of life and, patients with symptomatic arrhythmia or catheter ablation is an important way that we can improve the maintenance of sinus rhythm and quality of life.

Obviously, we have practice guidelines regarding atrial fibrillation ablation and the 2014 guidelines, this is from the American Heart Association and cardiology and heart rhythm Society, the catheter ablation is a class one recommended therapy with a level of A. Those with proximate small interest ablation that is problematic and felt one or more antiarrhythmic drugs.

A class to indication, it is persistent patients who failed one or more drugs and is reasonable as a class to recommendation with a first-line therapy in patients with paroxysmal atrial fibrillation before medical therapy when appropriate shared decision-making has been pursued and patients express that preference to avoid drug therapy.

Not a therapy where we have a small evidence-based, we have a very robust evidence space bar catheter ablation and the clinical trials like the clinical trials of ATAC and AF was prevented presented with cardiology are increasing the depth of that evidence based and improvements and help with catheter ablation.

There is a need because the procedure is becoming increasingly use the clinical practice and this flight, importantly, ends with data from a little after 2005. As many of you know from other studies, there catheter ablation can use to increase across the United States and across the world.

There is also a need because the proposed performance measure from heart rhythm Society include matrix on the safety of catheter ablation for atrial fibrillation including rate of cardiac tamponade or pericardiocentesis is following atrial fibrillation ablation. I would emphasize that the module does not have direct reporting for performance measure at this time and it allows sites to track the data and keep an eye on this and in the future the registry will allow the reporting of this performance measure and this is what we are continuing to work on with this.

To get a patient in to go with the guidelines, as you know, it really acquires a principal diagnosis of atrial ablation or atrial flutter and hospitals are encouraged to enroll that with a second diagnosis of atrial flutter.

Hospitals can choose patients in an observation and not admitted as inpatient and that is important because as many know over half of ablations performed are performed on an outpatient basis where they are spending one night in the hospital an observation or outpatient status.

The module for the atrial fibrillation, it is not a spring chicken at this time, it was lodged at the end of 2015. We are coming up on the two-year anniversary of the module. This is, as of the summer, we had 17 sites actively entering data. It is more than that now.

Here are some screenshots of the module, obviously, this is an indication for ablation and that is important because that information is important when considering whether the ablation is consistent with a guideline as outlined by the American Heart Association.

There are questions regarding the patient's level of symptoms. There are questions regarding whether or not the patients have prior ablation.

Let me go back. This is just one of several questions and it was very important to the members of the clinical working group, but membership at the Society for American Heart Association that this is not going to be a module with seven pages worth of data. We wanted to get the information necessary to help improve outcomes and to help hospitals and providers track the information that they need to improve characters with ablation.

Again, these were data that were hot off the press in the early spring time and continue to be so. These are not published and have never been formally presented and these are a sneak peek that we are pleased to share with you today. The median age and the ablation model is a little lower than overall registry as one would expect the median age is 65.

A third of the ablative patients were women. Consistent with current guideline recommendations where the level of evidence and recommendation is highest with those with paroxysmal age of ablation, most patients have proximate small atrial fibrillation. The diameter was 4.1 centimeters indicating that clinicians are choosing optimal patients for ablation and not targeting patients with end-stage myopathy, and the vast majority of time.

Median Chad Vas score was two. Median HAS bled his score was one. That is consistent with many that we see in the country.

Something to keep an eye on, one of five patients and ablation model, that will increase and import data from trials target those with heart failure as we alluded to earlier to become available.

68 percent have hypertension, one in 10 have chronic obstructive pulmonary disease and one in five have prior catheter atrial fibrillation.

When we look at what medications patients are receiving at baseline, we see half patients are on an antiarrhythmic drug from when they were enrolled in the ablation model before their procedure and the most common antiarrhythmic drug was Amiodarone, followed by Flecainide, and Propofol.

Again, consistent with the guideline recommendations, the most common reason they underwent catheter ablation was that symptomatic paroxysmal teacher for ablation and tolerant to one or more medications and we had persistent symptomatic atrial fibrillation that was intolerant to one or more antiarrhythmic medications.

20 percent of patients had prior ablation and the vast majority was their first attempt.

If we look at anticoagulation procedures, the vast majority received and interrupted and I coagulation and, among those receiving uninterrupted anticoagulation, most patients were treated with either Apixaban or Rivaroxaban.

Procedural imaging was used as follows, 45 percent had those before the procedure and half had a CT or MRI and we had 83 percent and electronic anatomic mapping was used in 87 percent. One in 10 were with rotational angiography and that was something we will see more of in the future this was a hundred 86 minutes and the total time the median was 19 minutes and general anesthesia was used in most cases.

Cryaballoon was 14 percent of the cryoablation procedures.

PVI, either in a wide circumferential approach was the most commonly employed technique during these procedures. A little over a third of patients had ablation of the tricuspid and 16 percent had posterior wall isolation and I think we will see even more of that in the future. SEC I ablation was less than 5 percent as one may expect and Kathy targeting with the isolation was even less common.

Interestingly, provocation testing is shown here and surprisingly, at least for us here at Duke, we were surprised to see the pacing was the most common with isoproterenol and then adenosine being performed in one in five cases.

When one looks at complications, looking at this data is reassuring so this is systematic reporting at each site and is not a survey where we are asking people to share their experience with us. This is patient level abstraction and we saw any complication rate of 5.5 percent with no cases of death with .3 and stroke of less than .1 percent and you may argue this is a relatively small sample, and that is true, but it is more than a thousand patients.

When one compares the data to a worldwide survey, it was not patient level data reporting done in a systematic fashion, we see the total complication rate is 1 percent lower and they all cause death rate is higher at .15 percent. I think the early safety data is very reassuring, particularly, with respect to stroke tamponade and death.

Three of the outcomes that we all worry a great deal about.

Oral anticoagulation at discharge was achieved in 97 percent of patients consistent with guideline recommendations. Most of the patients were taking an inhibitor. In conclusion, the guideline a-fib module, ablation module captures significant information was treatment selection and characteristics in a contemporary cohort of patients undergoing ablation in the United States.

AF ablation in the United States is largely consistent with guideline recommendations and 84 percent are being performed for class one or class to a indications and half are for symptomatic a February factory two and a rhythmic drugs contact force guided radiofrequency ablation is the most common method of atrial fibrillation ablation in the US.

Here than half procedures utilize pre- procedural imaging and the most common sets include posterior wall ablation and firm.

Complications including stroke and tamponade are frequent to rare and greater than 97 percent of patients are discharged on oral anticoagulant. Very promising data, that I think speaks very well to the experience that patients have across the United States when we compare to other data sets.

We will certainly have time for questions at the end of the next segment, but at this time I want to turn it over to my colleague Jeanne who will be talking to us about patient management tool itself.

>>: Thank you. Good afternoon everyone and for some of you good morning. I am Jeannie Rasch and today I will be reviewing some of the changes that have recently been made to getting with the guidelines, data collection tool as it pertains to the ablation procedures.

Dr. Piccini reviewed a lot updated done through studies and data collected through the guidelines tool and we have enhanced some of the data collection, but most importantly, we have recently enhanced the reporting capabilities of getting with the guidelines to allow hospitals to report and obtain some of the same information that he just reported on.

Here is a list of the new measure set that has been added to the guidelines of atrial fibrillation and is a set of 19 separate reports that are available to any hospital who is participating and they get with the guidelines a PIP program who is subscribing to the ablation tab.

These reports vary in terms of what information is available, but the overall purpose is to provide participants with tools where they can examine their performance on the ablation procedures.

These were added to the program last week on October 18.

Next slide.

As I just mentioned, the reports or this measure set is available to any hospital that is participating and we get with the guidelines atrial fibrillation program and you must subscribe separately to the ablation tab or the ablation data set. In the online tool, this will look like a separate tab and the account and it is available at no charge to any hospital that wants to utilize it and it is pretty easy to have enabled this tab in your get with the guidelines program and you simply need to just contact to get with the guidelines help and request that tab and, when you log into the tool you will see the tab associated data elements that are available.

I would recommend that if you are interested in seeing what is available you can request it and take a look at the elements and the reporting capabilities and decide if you want to continue entering for all patients or just some of the records. That is an option.

Sites that do activate the ablation tab, they will automatically have access to these reports and the reports are available with and that configuring measures report and, those who are currently participating in go with the guidelines, you will be familiar with this menu.

There is an option to choose which measured set that you want to report on and you will see on the left-hand side of the screen is a list of all of the new reports available and a user can go in and select individual reports or one report if they want. Just as a matter of convenience on the side of the screen we do offer a measure said or a bundle where one click allows you to produce reports for all of those 19 measures that are now available.

Pretty standard with a way of reporting this menu driving and this specifies the time. That we want to report on and it is easy menu access to run the reports.

Here is a examples of what the output looks like. Just as a few sample reports, but general format for most of the get with the guideline reports are those that hospitals use are the bar charts.

Depending on what is being examined you will see an X axis with criteria. You can also see how many records you may have in the denominator and also in the numerator.

The real value for getting with the guidelines is that in addition to examining your hospitals results it is also a capability of comparing your results with comparison groups. There are several different types of groups available. You can compare your results with all hospitals that are in your same state.

If you are starting to examine your results, sometimes the question is not clear and, obviously, we want to be at a hundred percent if possible, but sometimes it is also useful to compare with what you are doing with the other side's. Tool provides you a feature to compare with other hospitals.

Just an example with what the output looks like, you will notice one of the attachments for the webinar includes sample reports for the whole measure set and you can take a closer look at these when it is more convenient for you.

And other format that we utilize and getting with the guidelines is what we call the patient records format. I think this feature or this format is underutilized for hospitals and I think it is a real value to hospitals and the processes for performance improvement.

Say that you run a report in the bar chart format and you see the numerators and denominators and the performance is less than ideal. Maybe it is just not a hundred percent so you as a quality improvement professional, you want to identify where the gaps in care are and do more of a root cause analysis.

This format allows you to do that. You run it on one of those reports for the metrics and you can get a listing of all of the patients and it will indicate if the patient is included in the results or included in the denominator and not the numerator or if they meet the exclusion criteria.

This example is an output for the procedure in certain times in fluoroscopy and this overall procedure time as this is demonstration data that may or may not make sense to those of you who are performing these procedures or our surveyor. It is just sample demonstration data. It does provide, with what the times were for each patient and, for those patients that you feel that times are in adequate, you could identify the patient specifically. Go back to the medical record and identify what may be leading to these questions in the overall results.

This has been available with and get with the guidelines and atrial fibrillation. I want to highlight this today because I do know it is underutilized and is a great tool for hospitals and it would be very useful for hospitals that are examining their ablation results.

Here, we have some more bar charts and here I just went to illustrate that in addition to just looking at total results for the hospital, you have this ability to filter the results. If you are wanting to drill down even further to look at specific types of patients or other specific criteria, there are about a dozen filter options. You can look at certain types of patients. This example on the right, I filtered in comparison with both the diagnosis of atrial fibrillation and those with butter. You can't examine if there is a difference and times for these two diagnoses, we have those filters built in. Again, this is a standard feature of get with the guidelines, it may prove extremely useful when you are examining this new measure set.

Next slide.

The measure set contains 19 new measures or reports. A few of these are specific to post discharge and the others are more looking at the metrics or the ablation procedure itself. This is important and examining the patients and what some of the post discharge outcomes may be. There are four reports that are specific to post discharge meeting that if you are interested in reporting on these four metrics, you are going to need to collect data to support that.

Within get with the guidelines tool we do have a separate form called a follow-up form allowing hospitals to collect data with these post discharge outcomes.

The form will be available when you have the ablation tab turned on, if you requested, the form is available from the patient grid on the next slide illustrating how you see this new form. Those of you who are familiar with other modules we also have a follow-up form.

Here is a sample of what the follow-up form is and this is a single tab and there are not a lot of elements on here, but we need to collect what is necessary for the four new metrics. This is very similar to the other elements found throughout the atrial fibrillation form and same kind of features with information that pertains to the patient's outcome at a time after discharge. When we are looking for 180 days post follow-up, we do shorten the range a little and extended for patients who follow up may happen for a little sooner.

Here is a picture of what we call the patient grid. This is available and get with the guidelines tool and it is a list of the records that have been entered into the tool. You can access this form from the patient grid and you can see the column for post ablation follow-up and the user has the ability to create, or if there is a form that has been created, you can edit it similar to the in hospital form.

Another thing we have built in because we know it is hard for hospitals to keep track of different data collection at different times, we have built in some parts here. The screen will display from the time of the discharge indicating that a follow-up form should be completed. You can see with that symbol with the red that I have circled saying that for this record, from the time of discharge it is time to enter the follow-up data and then you are able to run the reports on the records with a follow-up form been completed.

Again, it is easy to access the ablation tab and the reports and even the follow-up. We offer this as a value to hospitals so that you can better track and better monitor the ablation population.

Again, next slide, we can see what steps you may need to take to access all of this information. It is a separate tab and you do have to participate and get with the guidelines atrial fibrillation. You have to specifically request the ablation tab and make sure it is enabled and you can do that by contacting get with a guidelines help desk and they will assure it is turned on for you.

No additional charge to activate this tab and have access to all of the very useful new measures or reports that are now available.

If you have any questions about the ablation tab or get with the guidelines you can always contact the helpdesk or your local get with a guidelines quality assistance improvement staff.

The next slide just list contact details for those people and hopefully if you are participating in get with the guidelines already, you have that information to phone or e-mail the support and within the tool, there is a link for that directly. I encourage you to access that if you are interested. We also have our customer support offered through the quality assistance improvement staff who could possibly even do a demonstration for you or share additional information about the program or the new ablation measures.

Again, as a reminder, there is a handout of the sample report so you can examine what information is now available within that tool. For those sites that are currently participating in get with the guidelines atrial fibrillation, there is a document outlining what changes have been made to the data collection tool. In addition to offering this new major sets, we have made slight changes to the data elements. We have added data elements just to allow for comprehensive reporting. Also tweak some options available to be in line and to be able to assess the different aspects of the procedure.

Those are the changes that have been made and the new features. I think we are finished with the presentation now so if we went to open it up to questions, I think we can do that.

>>: Thank you. I want to start with saying that many of our audience have experienced technical issues so if you are able to submit your questions, please do so now. For those of you who are able to hear, there will be a recording sent out following today's call if you are one of those experiencing audio issues. As a reminder, you can still submit questions through the questions panel so we will see if any of those come in.

We will also be collecting questions from the recording panel as well and for those of you who were experiencing technical issues, thank you as you have done a wonderful job and we want to thank everyone for attending today's webinar. If you have any questions be sure to contact us and let us know. As I said earlier, there will be a recording sent out to those who were experiencing audio difficulties and we apologize for that. We hope that you are able to get the information from the recording and it will also be posted to our online website.

On behalf of the American Heart Association and presenters, thank you for joining us today and have a great rest of your day.

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