Connie Paladenech, RRT, RCP, manager of Cardiac and Pulmonary Rehabilitation at Wake Forest Baptist Health, defines cardiac rehabilitation and discusses its evidence-based benefits. She also reviews criteria for enrollment and describes the process of rehabilitation. CONNIE PALADENECH: And now I'd like to switch gears a little bit and talk about another very effective intervention that is nonpharmacologic, noninvasive, but yet has outcomes that are equivalent to all of those drugs and other interventions. And I'm going to move fairly quickly this afternoon to try to get us back on schedule. So if there's something that I miss that you would like me to talk more about, I'll be happy to talk with you after this session. OK. I don't have any disclosures, unfortunately. My objectives for this session are going to be to define cardiac rehabilitation, to discuss some of the evidence-based benefits of cardiac rehab, to review criteria for enrollment, and to describe the process of cardiac rehab. And if we have time, I'll show you just a little bit about our program here at Wake Forest. So for a very brief history of cardiac rehab-- just as many of our other interventions have evolved over the years, so, too, has cardiac rehab. It really has evolved over the last several decades. Initially, our cardiac care was primarily focused on limiting activity. And in fact, if you were unfortunate enough to have had an MI in the 1930s, you would have a month of bed rest. And I'll have to tell you, that would be awful. And I speak from between the bed sheets. I had an MI myself not long ago. And to imagine the thought that I would have to be in bed for 30 days, it just gives me goose bumps to even think about it. That would just be horrible. So finally, things progressed. And by about 1952, we were starting to get patients out of bed in about two days. By 1955, it was still common for people to be in bed for weeks. And then finally, in the '60s, we started to get a little braver and begin to mobilize people. And by '69, we were trying to get patients into cardiac rehab within three weeks of their event. And then from 1970 onward, the modern programs that we're working in today have finally taken shape. And a part of, a big piece of that reason for the progression of cardiac rehab actually goes to a physician by the name of Dr. Paul White. And he is actually credited as being the founder of preventive cardiology. A little bit about him. He was one of the early proponents of exercise. What he was proposing and-- initially, the attempts at exercise were, by the general medical community, they were felt not to be so prudent. So there was a lot of resistance to begin to push patients who had had cardiac events. But Dr. White was very wise and made the comment that a vigorous five-mile walk will do more for an unhappy but otherwise healthy adult then all of the medicine and psychology in the world. So that was a strong recommendation for the exercise component. Now in the '30s, another British cardiologist-- and this was the general consensus. His recommendation was that the patient is to be guarded by day and night nursing and helped in every way to avoid voluntary movement. And some of us who have been around for a while-- and by the way, this is my second stint at Baptist. I came to Baptist in 1964, left in 1969, and came back for this go-around in 1999. So I've actually witnessed some of this stuff that we're talking about. Because that's the way we did things then. Dr. White has another distinction, and that is that our 34th president of the US, Dwight Eisenhower, suffered a myocardial infarction in 1955. Dr. White was his physician. And one of the things about President Eisenhower's situation was that it did help to bring focus on cardiac care. So things began-- we got more attention, more funding. And so we began to progress a little more rapidly. And one of the good examples that he set also was that life could go on after an MI. It wasn't just that's all that you can do. Unfortunately, he suffered an additional six MIs until he died finally in 1969. So that brings us to cardiac rehab now. Initially, early efforts with cardiac rehab were focused on just closely monitored, very minimal, low-intensity exercise. That has now evolved into the cardiac rehab programs that we have today. And they have become comprehensive, multi-disciplinary, long-term programs that involve medical evaluation, prescribed exercise, cardiac risk-factor modification, education, counseling, and behavioral interventions that are aimed at reducing individuals' mortality and morbidity after they've suffered some sort of cardiac event. So these are very complex programs. Some of our goals now for patients who were enrolled in cardiac rehab include efforts to optimize cardiovascular risk reduction. That's a big, big focus of cardiac rehab, both in terms of primary prevention but also predominantly secondary disease prevention. We try to position the patient to help them get to the point that they won't have a second event. Encouragement of healthy behaviors and also to encourage and provide support for individuals to comply with those behaviors, to reduce disability, and to promote an active lifestyle for patients with cardiovascular disease. Now, some of the benefits, just to sum these up, and there are many, many more, but what we know about cardiac rehab-- and we have very strong evidence to support that-- is that cardiac rehab improves heart health, the cardiometabolic factors, lipids, blood pressure measurements. It improves individuals' ability to participate in exercise. We can provide and often do provide support assisting patients to quit smoking, which is absolutely key. And also heart function for those with heart failure improves with cardiac rehab. Cardiac rehab also has been shown to reduce progression of heart disease, to reduce hospital re-admissions and emergency room visits, to reduce angina pain and the need for cardiac medications and the risk of further disability. Also there, as you can see, are a number of general health and well-being measures. So all in all, cardiac rehab, in general terms, reduces the risk of all-cause mortality by about 27% and cardiac mortality by about 31%, and in some cases, even more than that. We'll see a little bit about that in a bit. OK. So what about mortality? Well, one of the things that we saw-- and I could remember this well, because during that time, we at the national level through AACVPR and some other organizations, we were a little bit concerned. Would we really continue to need cardiac rehab? And the reason was that referrals tended to drop a little bit. But with further investigation, what we actually identified was that cardiac rehab had made significant contributions to the reduction of heart disease mortality in the US between 1980 and 2000. Also what we learned was that the risk reduction attributable to cardiac rehab was comparable to reductions that were attributed to post-event aspirin, beta blocker, angiotensin converting enzyme inhibitor, statin, warfarin therapy, as well as to risk reductions attributed to acute thrombolysis and revascularization. So that's a lot. Can it replace those things? Absolutely not. But it certainly can work in tandem with them. And cardiac rehab now is considered to be a class one indication after acute coronary syndrome and coronary revascularization procedures, as well as for stable angina. OK. There was one landmark study that was published in the Journal of American College of Cardiology in 2009. And it was a huge study. And I apologize for oversimplifying it. But it's a very, very good study. So one of the things that I would recommend is if you're wondering, should I refer my patient to cardiac rehab, I'd encourage you to take a few minutes to just scan this study. But basically, they looked at over 600,000 Medicare beneficiaries. And they examined one- to five-year mortality rates in cardiac rehab users and non-users. Out of this group of patients, only about 12.2% used cardiac rehab. So there was very low utilization of cardiac rehab. But what they did find was that there was a significantly lower one- to five-year mortality in the cardiac rehab users as compared to the non-users. Looking at the one-year mark, cardiac rehab participants-- and they defined that as being individuals who had attended 24 or more than 24 sessions. These folks had a 58% relative risk reduction for mortality. So how would you like to be in that boat? At five years, cardiac rehab participants had a 34% relative risk reduction for mortality. And that included AMI, revascularization procedures, and congestive heart failure patients. One of the things that we know-- and we see more and more and more evidence every day. And that is that we know that inactivity has been clearly identified as an independent risk factor for CAD. We know also that exercise capacity is a more powerful indicator of mortality among men than other established risk factors and also that if we are able to break up sedentary time, we do see improvements in patients' cardiometabolic profiles. So getting up and moving around-- and one of the things that concerns us-- we are seeing an increase in cardiovascular disease. And maybe a part of that reason can be related to our sedentary lifestyle. We have all these neat little cell phones now, so rather than walking to see somebody or talking, it's easier just to text them. And I don't think just thumb exercise is enough to protect our hearts. So I think we've got some good things and some bad things. But really, really important to emphasize-- get up and move. So as we'll talk more in just a bit, exercise is an extremely important component of cardiac rehab. These are some of the potential effects or benefits, if you will, of cardiac rehab, of physical activity. There are anti-atherosclerotic benefits, psychological benefits, anti-thrombotic benefits, anti-ischemic, anti-arrhythmic, so many, many benefits. And it's so good that in our lifestyle, our American lifestyle right now, I think one of the biggest advances that we haven't seen yet is if somehow somebody could take all of the benefits of exercise and put it in a pill. That would probably drastically lower cardiac disease. OK. So some of the benefits you can see here. One of the things that we know is although we have very, very strong evidence of the benefits of cardiac rehab, nationally, what we know is that less than 30% of individuals that are eligible to participate in cardiac rehab actually do enroll in cardiac rehab after an event. So that's really, really low. There are many reasons for that. And some of those reasons are very complex. So let's take a minute and talk about what does happen in cardiac rehab. A lot of us, if we're not involved on a daily basis, yeah, we know they exercise. And to borrow a comment from my own sister, how dare her, to have the audacity, she came to see me one time while I was at work. And her comment was, gee, they pay you to do this? All you do is run around and play. No. There's a lot more to it than that. But we do try very hard to make it an enjoyable experience for patients, because we want them to enjoy it. And also, if they're going to sustain the benefits of cardiac rehab, it's important that they incorporate it into their lifestyle and that they make it a part of their lives going forward. So cardiac rehab actually begins with the index event. And when patients are hospitalized, we refer to this as being Phase 1, the inpatient phase. So the rehab piece of that-- there are many other things, obviously, that go on here. But we initially began working with ambulation and also with patient education, some of the basic, if you will, survival skills to get them out of the hospital and hopefully keep them there until they're ready to enroll in cardiac rehab. Then in Phase 2-- and it's kind of hard to see. They're pretty well camouflaged. But this is the early outpatient phase. And Medicare has actually divided that up into Phase 2A and Phase 2B. Phase 2A being the first 36 sessions of cardiac rehab, and then Phase 2B would be a subsequent, an additional 36 sessions for that particular event. Unlike pulmonary rehab, cardiac rehab, there is no finite lifetime limit. With pulmonary rehab, if a patient has a diagnosis of COPD, they are limited to 72 lifetime sessions period, end of story. There are other ways to address that. But with cardiac rehab, if an individual has another event, that does reset the clock. So they are actually an eligible for up to, with justification, medical necessity, up to another 72 sessions. So it does reset. So the outpatient phase really focuses on patients having an individualized exercise prescription that's specific for them, risk-factor reduction strategies that are supervised by a medical team, by the cardiac rehab team, that is headed by a physician. And another thing that we know about cardiac rehab, there is always a concern of, well, how soon can we start? Well, the sooner the patient is enrolled after cardiac rehab, as soon as they're medically stable, the more likely they are to enroll and to complete cardiac rehab. So we do encourage early referral. Then we have the maintenance phase. And this phase is really independent continuation of exercise and risk-factor reduction. This should be lifetime. The only catch to the Phase 3 is that this is out-of-pocket. There are no insurers, really, that will pay for maintenance, the maintenance phase. But this also gives us an opportunity. We'll talk in just a few minutes about diagnoses that are covered by insurance for cardiac rehab. One of the things that we know, as we learn more and more about the values of exercise and the other strategies that we use, there are so many patients that will benefit from these sorts of interventions. And it's important to enroll them in cardiac rehab. So one thing that I would say is if you have a tendency to look at a list of covered diagnoses, I would ask you if you think you have a patient that would benefit from cardiac rehab, let the cardiac rehab team worry about that diagnosis and see what they can do to provide help for that patient, because many times they can. And the cardiac rehab staff is expert at dealing with the insurance regulations and that sort of thing. So just if you think it's indicated for your patient, I would encourage you, go ahead and refer. And if we can't work something out, we will let you know. But in many cases, we can. And it's certainly to the benefit of the patient. These are really the core components of cardiac rehab. And they range the gamut from exercise training, physical activity counseling, and that is really, really so important as we mentioned earlier, making sure that patients just don't become couch potatoes. Because one of the things, as we all know, the heart is a muscle. And what happens to muscles when they don't get used? It's amazing that we haven't had more issues. What we were doing in the early days was absolutely the worst thing we could do for these patients, in many cases, because we just absolutely let them just become vegetables. So now we know that getting up and moving is so much better. So these are all smoking cessation, lipid management, diabetes management. So again, you can see nutrition, very, very comprehensive interventions to help these folks maximize their lifestyle. Again, this is just looking at that in a little more detail and I'm going to scoot on over it. One of the big questions that people have that are not really familiar with cardiac rehab is oh, my gosh. This patient has had a cardiac event. How safe, really, is cardiac rehab? So to answer that question, cardiac rehab programs use a risk-stratification strategy with the categories A through D to determine what's safe and how will we approach things. So Class A would be individuals that are apparently healthy. They have no clinical evidence of increased cardiovascular risk with exercise. Class B has established heart disease that is clinically stable. Their overall risk of cardiovascular complications with vigorous exercise is low. And then finally, class C, moderate or high risk of cardiac complications. Maybe they've had multiple MIs or suffered a cardiac arrest. They are New York Heart Association Class 3 or 4. They have an exercise capacity of less than six METs or significant ischemia on their exercise test. Those folks are good candidates. And it's important, really important for those individuals to be encouraged to enroll in cardiac rehab, because we can actually work with them. And this is the safest place to put them. They are monitored while they are exercising. And we can tell immediately if they need intervention. The Class D patients are folks who have unstable disease, for whom exercise at that particular point in time would be contraindicated. It's important that they have supervision and that supervision, generally, should be continued for about eight to 12 weeks, until we're sure that they can exercise safely. There's a low risk of events, as you can see here, for patients in the B and C categories. And in fact, in 2007, the American Heart Association issued a statement on exercise, stating that the acute cardiovascular event rate is estimated at one event in 60,000 to 80,000 hours of supervised exercise. And they defined event as being a cardiac arrest, death, or MI. Anybody know how many hours there are in a year? And I don't think we're going to be exercising 24 hours a day, right? So a little over 6,000 hours. So that's years of exercise. So that event rate is very, very exceedingly low. The mortality rate in that setting, if you will, is 1 per 784,000 patient hours. Non-fatal MI rate was found to be 1 per 294,000 patient hours. Now, some of you who work at Baptist may say, hmm. I'm not sure about that. We hear you guys call rapid response or very rarely do we call a code blue. Well, that doesn't necessarily-- most of our codes are called to get help because we've detected something that could be a risk and especially if the patient doesn't receive the intervention it could go worse. So really, most of our calls for rapid response and other interventions are just that. They are preemptive interventions rather than actually dealing with a cardiac arrest. It just is so, so rare. OK. There are some absolute contraindications to exercise, having said that. And this is a list of those. And these are available in your handout. In the interest of time, I'm not going to go into those. But if anyone has questions, we'll be more than happy to talk with you. There are also some relative contraindications that need to be evaluated on an individual basis in particular patients. Reimbursement considerations are another thing. And this has been one of the challenges with cardiac rehab as well as pulmonary rehab getting reimbursement. It has been an interesting trip, if you will, dealing over the years with Medicare. In 2006, Medicare did provide expanded coverage for valve repair and replacement, PTCA or stents, and heart and lung transplant. They also extended the time frame, but they still didn't do anything for CHF. Finally, we got that. So just very quickly, here is a list of diagnoses that are covered now by Medicare for cardiac rehab. The MIs, the CABGs, and notice that CHF is there. Again, the thing that I would like to emphasize is if you have a patient, regardless of the diagnosis, that you think would benefit from participation in cardiac rehab, I would say refer them. I would strongly encourage that you refer them to the cardiac rehab program and let the cardiac rehab staff sort that out to see what can be done to provide coverage, because it's that important. Private insurers will also now sometimes cover cardiac rehab for peripheral vascular disease as well as cardiomyopathy, not all, and sometimes it's case-specific. For CHF, there are some specific criteria. These are defined here. And some considerations for incorporating CHF patients into cardiac rehab, really are here. CHF patients tend, not always, but they do tend to be older. They certainly do tend to have more co-morbidities. And they tend to be less fit than the usual cardiac rehab population. But once you get them there, there they do improve. Another thing about CHF patients, a larger percentage of them do seem to have some cognitive issues. And so because of all of these things, they do put a bigger demand on staff. So our usual one-to-five staff-to-patient ratio might not be adequate for patients with CHF, especially if they are at a very low functional level. So what do we do? We're focusing on the exercise training as well as counseling. These are some of the topics that we emphasize for them. These are some of the participation rates that we see with cardiac rehab. And notice, even in Canada, in Europe, the participation is still low. So I think going forward, this is certainly one of the things that we need to work on. Our rates in the US, actually, depending on where you are, vary from a low of about 12% to a high of about 38% to 40% in some areas. Again, much lower than they should be, especially looking at benefits. One of the strongest links to participation in cardiac rehab is the strength of the physician recommendation. So if a physician doesn't recommend cardiac rehab to a patient, they're less likely to consider it to be important. Because it does take time. If the physician encourages it and really emphasizes the importance and the benefits, patients are much more likely to enroll and to complete their cardiac rehab. These are some of the reasons that we've seen with our program for non-participation. Facilities are not close enough. Some people are just not interested. They just don't understand the importance. There may be financial reasons, a hospice, palliative care, skilled nursing, job hours. They've done it before. Or they have no transportation. And another group of folks that we see, the very elderly, sometimes there's a tendency not to refer those people to cardiac rehab. They can benefit, too. So just because someone is 80 years old is not a reason not to refer them. So going forward to the future, many of our programs will probably see some changes. And as I'm looking into a crystal ball, these are some of the things that I think we can expect to see in the future-- telephone-based programs, internet-based programs, case-managed programs, and other home-based programs, especially for individuals that fall in the two lowest-risk categories. Program certification is very important for cardiac rehab. This is a way of ensuring that the programs that are offering cardiac rehab are up-to-date and following current guidelines. Yet only about 37% of an estimated 2,600 programs in the US are certified by AACVPR. The program at Baptist is. So let's look at ours again. This is the oldest, the first cardiac rehab program in the state of North Carolina. Dr. Henry Miller, on the left, was the founder of that program. And since 2004, Dr. Killian Robinson has been a wonderful medical director and supporter of cardiac rehab. Some of our milestones-- I'm not going to go into these. We've already exceeded our 2,000th patient enrollment. So we've been busy. This was the first program here at Wake, the original. This is our current site in the Sticht Center. This is the Davie cardiac rehab program. OK. And these are our Phase 1 nurses, who do the inpatient counseling and really our lifeline. They're wonderful about referring patients to cardiac rehab. This is our current team. This is our Davie team. And these are some of our medical students and fellows who have helped us with some of our research. I'm going to flip through this very quickly. This is in the handout so you can see it. These are some of our outcomes here at Wake Forest, some of the things that we're looking at. And this is what it's all about. This individual started cardiac rehab this past January. He had a three-vessel CABG and aortic valve replacement, ascending aortic aneurysm repair. And this was done last November, almost a year ago. The first day he came to cardiac rehab, he was able to get on a treadmill. He walked at 2.7 miles per hour, no grade, for 16 minutes. And he was whipped. He was able to achieve, in terms of exercise capacity, 3.1 METs. His hemoglobin A1c was 7% on 1,000 milligrams a day of metformin. He just reached his milestone of day 100. And that was on the 6th, so this past Tuesday. This past Tuesday, Theresa, our exercise physiologist, had his treadmill set. She's using a high-intensity interval training now. He was able to exercise at 4.5 miles per hour at a 2 and 1/2% grade. He also has completely stopped his diabetes meds. And his hemoglobin A1c on no medication now is 6.5. So it's lower than when he was receiving 1,000 milligrams of metformin a day. The t-shirt he's wearing was actually a birthday present from his wife. And honestly, you could not beat him away from cardiac rehab now with a stick. He is a very staunch supporter, again, because he feels so much better. And that's one thing. Patients do become very attached to cardiac rehab. It actually serves as a safety net for individuals, especially folks who have lower function or more serious disease. So in summary, right now, I think it's time with cardiac rehab that we let the cat out of the bag. So with that, anyone have questions? If not, thank you. It's been great.