Basi Neurobiologiche Delle Competenze Emotive

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Nafeez Zawahir, MD

CME Clinical Director, Medscape, LLC

Disclosure: Nafeez Zawahir, MD, has disclosed no relevant financial relationships.

From Medscape Education Cardiology

Sudden Cardiac Death From A to Z: Focus on Primary

Prevention CMEMichael R. Gold, MD, PhD; Michael J. Mirro, MD; Jeanne E. Poole, MD

CME Released: 11/09/2012; Valid for credit through 11/09/2013

Slide 1.

Michael R. Gold, MD: I am Michael Gold, and I am the chief of Cardiology at the Medical University of South

Carolina and a cardiac electrophysiologist.

Today, I am joined by 2 esteemed colleagues and experts in the field of cardiac arrhythmia who will be discussing

the prevention of sudden cardiac death (SCD): Dr Jeanne Poole from the University of Washington and Dr.

Michael Mirro from the Parkview Health System in Fort Wayne, Indiana.

What we are going to be talking about is the problem of sudden cardiac death. Sudden cardiac death is one of the

leading causes of death in the United States. It has been estimated that up to 1 person per minute dies due to

SCD. As such, this is possibly the largest cause of mortality in the United States and in other Western societies.

We have learned much about identifying patients at risk for SCD, and we have also learned about therapies that

can prevent this problem. Many of these deaths are due to underlying heart failure and coronary artery disease, so

any therapies that help prevent these problems are effective for preventing SCD.

http://www.medscape.org/cardiology






Slide 2.

Therefore, reducing cholesterol, controlling hypertension, and treating heart failure are all effective approaches.

However, in the groups of patients with the highest risk, these approaches are insufficient, and antiarrhythmic

drugs have not been found to be helpful. Accordingly, we have moved towards the implantable cardioverter-defibrillator (ICD), which is very effective for certain subgroups of patients. [1] Despite this being a class I

recommendation and multiple randomized studies showing that the ICD can reduce mortality, and sudden death,

in groups of patients at high risk for SCD, we have been disappointed by the penetration of this therapy in the

community.[2]



Slide 3.

There are a number of issues that are probably contributing to this lower penetration than expected or than is seen

with other drug therapies for SCD. These include confusion as to which groups would benefit most from

preventative medical therapy or ICD therapy, for instance, patients following a myocardial infarction (MI) vs those

patients with diabetic cardiomyopathy; the level of heart failure that patients may have; and concomitant medicaltherapies.

What has further confounded many has been the disconnect between what the guidelines tell us, what clinical

studies have told us, and what Centers for Medicare and Medicaid Services (CMS) coverage is for ICD therapy

payment. This has been further accentuated by investigations by the Department of Justice and other

investigations into billing for the use of many cardiac devices. Unfortunately in some situations, this has led to the

underuse of ICDs when their use is appropriate.



Slide 4.

What we would like to discuss is which patients are at high risk, which patients should receive an ICD; when is the

right time to give an ICD; and then, finally, what would be the appropriate bridging strategies for patients, if they

have not been optimally treated, or if they are in a time period in which an ICD is not yet indicated, because they

have had a recent revascularization or an MI.

Jeanne E. Poole, MD: Welcome to this program, “Sudden Cardiac Death From A to Z: A Focus on Primary

Prevention.” I am Jeanne Poole from the University of Washington in Seattle, Washington, and it is my pleasure to

moderate this session on this important topic, a topic I might add that while being of the utmost concern to health

care providers working in the cardiovascular arena, is also a source of confusion at times with respect to the CMS

guidelines.

We hope to clarify some of these gray areas over the next 15 to 20 minutes. Assisting me in this task is Michael

Mirro from Fort Wayne, Indiana.

Welcome, Mike.

Michael J. Mirro, MD: Jeanne, thank you for the introduction. I am an electrophysiologist in Parkview Health

System in Fort Wayne, Indiana, and I run the Clinical Research Center at that institution, and SCD has been a

particular area of interest for me and the institution for a number of years.

Dr Poole: Can you give us a precise definition of what we mean when we use the term sudden cardiac death?



Slide 5.

Dr Mirro: What we are referring to is the onset of cardiac arrest outside of the hospital. Typically most of these are

witnessed but many are unwitnessed arrests, and the patients have virtually no symptoms prior to the onset of

their hemodynamic collapse, and the arrest is arrhythmic in origin. That is the definition that we use pertaining to

the guidelines and primary prevention. The incidence of SCD is estimated as between 250,000 to 350, 000;however, it is difficult to know precisely based on the fact that reporting is geographically diverse from state to

state.[2,3]

Dr Poole: It remains one of the most important public health problems that we face in the United States.

Dr Mirro: In patients who do not survive the cardiac arrest, the most frequent finding at autopsy is advanced

coronary disease, which, many times was undiagnosed.

Dr Poole: Tragic. When you think about the kinds of patients that are most l ikely to be victims of SCD, what risk

factors place these patients at risk for an arrhythmic event?



Slide 6.

Dr Mirro: The primary risk factor is heart failure. The clinical presence of significant left ventricular systolic

dysfunction is a very important factor, which is now the basis of our guidelines. The ejection fraction determination

has become one of the biggest predictors of SCD in the highest-risk population.

The presence of nonsustained ventricular tachycardia (nsVT) is a predictor. Of course, the presence of more

advanced sustained ventricular tachycardia (sVT), defined as 30 seconds or more of ventricular tachycardia, is

also a predictor. There are other factors that contribute to the risk, and it has been a challenge since the ejection

fraction, as we all know, has quite a bit of variability based on imaging studies: who is performing the study, how it

is interpreted, and whether the patients are on medical therapy. Other technologies have been evaluated, but no

other risk stratification tests have emerged that clearly identifies a subset of patients who are at risk for SCD. [2]

Dr Poole: Ejection fraction and a clinical history of heart failure, particularly moderate heart failure, were the risk

stratifiers that patients had to meet for enrollment into the major clinical trials. I think we can state, unequivocally,

that the randomized clinical trials that evaluated ICD therapy for primary prevention of SCD have established this

therapy modality as lifesaving. It certainly begs the question, why not just place an ICD in all of the patients who

are at similar risk?

Dr Mirro: Yes, that is a great question. Many of these patients have complex illnesses with comorbidities and

many patients have a life expectancy of less than a year. We would not want those patients to receive ICDs. We

also know there is a lot of variation in ejection fraction determination.

If you look at the overall SCD population,, the vast majority of people who suffered a sudden death, as pointed out

in Bob Myerburg's excellent review articles, had preserved ejection fractions. [3,4] It is a public health challenge as to

how we are going to identify these people. The ICD implant guidelines are based on these clinical trials and are

focused on the highest risk patients.[1] Also, CMS coverage decision requires, as you know, a 90-day waiting

period for nonischemic patients.[5]

Dr Poole: You bring up an interesting issue. There has been confusion about guidelines regarding appropriate

patients for implantation of an ICD vs what CMS states in their coverage decisions for reimbursement -- they are



not always in sync with each other. Can you comment about the differences between the guidelines and CMS

reimbursement?

Slide 7.

Dr Mirro: The guideline is focused on a waiting period of 40 days post-MI for patients who have ischemiccardiomyopathy. That is the only lockout in the guideline. With the nonischemic patients, there is no waiting period

with optimal medical therapy in the guideline. The waiting period emerged after the publication of the SCD-HeFT

trial where the CMS national coverage decision for primary prevention ICDs requires a 90-day waiting period after

optimal medical therapy has been implemented. [5,6]



Slide 8.

There is a lot of confusion in the medical community that this is a coverage decision for Medicare, not a guideline.

That is one of the reasons that the Heart Rhythm Society developed some new educational tools to educate

nonelectrophysiologists about the waiting periods and the reasoning for those waiting periods. The CMS coverage

decisions for primary prevention ICD use has been a significant area of confusion and continues to createconfusion in the general cardiology community.

Dr Poole: The CMS reimbursement determination restricts the implantation of an ICD for 90 days for patients who

have undergone coronary artery bypass graft surgery or percutaneous coronary intervention. They also restrict

payment for any patient who has an ICD implanted within 40 days of a MI.[5]

Interestingly, the time lockout for patients with heart failure is only applicable to patients who have a nonischemic

cause of their heart failure. The CMS did not enter a reimbursement restriction following the SCD-HeFT trial for

patients with an ischemic cause of heart failure.

Dr Mirro: Correct. The coverage decisions that CMS have issued have now been mirrored by most of the private

payers. Some of the private payers, unfortunately, have come up with their own waiting periods that are even

longer, which are not really based on science whatsoever. This has created an increased barrier for patients who

have an appropriate need for ICD protection. It continues to be a challenge for many electrophysiologists around

the country where they are facing challenges from private payers.

Dr Poole: The only time lockout that is the same for CMS reimbursement and the most recent 2008 guidelines is

the waiting period for 40 days post-acute MI.[1,5] What are the data supporting that time lockout?

Dr Mirro: There are a number of clinical trials that demonstrate that implantation of an ICD immediately following

MI protects patients from arrhythmic death, but all-cause mortality is higher in the ICD implant group. [6,7] The

etiology of the increased mortality appears to be primarily related to heart failure. The speculation is that there may

be an issue with having an ICD lead implanted early post-MI while the heart is still remodeling. That is the basis ofthat waiting period. There is also confusion about why that exists. As you pointed out, CMS requires a 90-day

waiting period if the patient has an acute MI and is revascularized. This has been the basis for the US Department



of Justice’s investigation of 400 of the 1,600 hospitals in the National Cardiovascular Data Registry (NCDR) ® ICD

Registry™ for what they think may be inappropriate or overuse of primary-prevention ICDs.[8]

Slide 9.

In fact, what was done was to data mine claims data looking at coding from the hospital on MI determining whethera patient had an intervention or bypass surgery and then look at when the ICD was implanted. There was an

average expected frequency of patients that fell within the 40-day period, but there were reasons patients needed

ICDs that were not covered under the guidelines. If hospitals had an increased frequency well beyond the

average, then they were targeted for investigation.

Dr Poole: I think we can agree that in the early days of the ICD Registry, there probably were cases where the

data was not submitted correctly. This was because individuals and hospitals were learning how to use the registry

and people were just being trained on how to look at patient charts and code patients properly.

Dr Mirro: That is a good point. Implanting electrophysiologists should be aware that participation in the ICD

Registry is part of the CMS bil ling process for the hospital, so to not fill out the information correctly is essentially

not coding the patient correctly. It is an error in billing, which could be interpreted by a not-so-benevolent group of

people such as the Department of Justice as fraud. It is imperative that the implanting electrophysiologist who has

the National Provider Identifier coupled with that implant needs to be very careful about how the forms are filled

out -- that they are filled out accurately and submitted so the data quality remains high.

As you pointed out, in the early days of the ICD Registry, we saw many institutions that were not providing the

oversight that they needed to ensure that their data quality was high. Subsequently, I think it has gotten better. I

think that the electrophysiology community has been enlightened by some of the things that have gone on in the

ICD Registry. It has random audit processes conducted, which have helped. The data quality has improved quite a

bit, but as you pointed out, in the early days some of the data is probably not that clean.

Dr Poole: Let us go back to what we were talking about earlier regarding patients that we worry a lot about interms of their SCD risk, yet we are not going to be putting ICDs into them; specifically patients who are post-MI or



have had recent revascularization. What alternative methods might we consider to take care of these patients

during these waiting periods?

Slide 10.

Dr Mirro: At our institution we have developed an algorithm to educate not just the physician staff but all of thecardiovascular nursing staff, the cardiovascular surgeons, all of the other members of the care system that is in

place for cardiac patients post-MI. We identify patients based on their ejection fraction and the other risk factors

such as heart failure and presence or absence of ventricular arrhythmia.





Slide 12.

Dr Poole: The Heart Rhythm Society has an algorithm that is quite similar to the one that you have been using, is

that correct? ( Editor’s Note: The Heart Rhythm Society has the following disclaimer posted accompanying the

SCD algorithm: The 'Sudden Cardiac Death Primary Prevention Protocols' pathway utilized in this document

represents a recommendation based on the expertise and consensus opinions of a Heart Rhythm Society (HRS) physician working group. It does not represent a consensus view of the Heart Rhythm Society and is not derivative

of or reflect current and published clinical guidelines. This quick reference pathway is intended to assist physicians

in the diagnosis and treatment of patients at risk of SCA. Ultimately diagnosis and appropriate decisions regarding

medical treatment can only be made by the treating physician with his or her patient taking into consideration the

specific facts and circumstances of each unique case. This document is not a substitute for the medical judgment

of the treating physician)

Dr Mirro: Yes, that is correct, Jeanne. This suggested pathway was developed to educate all of the staff at our

institution, so we made it an institution-wide procedure where it gets the entire cardiac care team focused on

ejection fraction and patients, who have low ejection fractions, are identified by coming through the

echocardiogram departments, the cath labs or the nuclear medicine departments. These are typically inpatients,so the inpatients have an analog sticker placed in their chart that flags them and asks that the physicians consider

making sure that they are getting optimal medical therapy and they are strongly encouraged to get a heart rhythm

specialist to see the patient, and to utilize a WCD in patients they feel are at high risk for SCD. This has been very

effective in promoting a system-wide approach.

In the outpatient setting, some of the tools we have developed are electronic clinical decision support tools that

flag patients for physicians with a diagnosis of heart failure and low ejection fraction, and ask them to document

why an ICD is used or not used. That has been helpful.

Dr Poole: These tools are so important and clearly need to be considered at all medical centers. We have learned

from a number of studies, one of them in particular, the IIMPROVE Heart Failure study that has clearly shown that

we underutilize ICD and cardiac resynchronization therapy (CRT) therapy. [11] Using these education tools in

appropriately indicated patients can improve utilization.



Slide 13.

Dr Mirro: I am glad that you brought up IMPROVE HF, which was a large registry study where charts were

audited in numerous practices. Over 35,000 charts were audited. Patients with ischemic and nonischemic

cardiomyopathies with a clinical diagnosis of heart failure were followed for 2 years, and were analyzed for the use

of ICD therapy as well as adherence to other process measures such as beta blocker use, angiotensin convertingenzyme inhibitor and angiotensin receptor blocker use, and aldosterone inhibitor use. It looked at how they could

improve adherence to guideline-recommended therapy through the use of educational tools.[11]



Slide 14.

The investigators rolled out these tools to these practices and demonstrated that at the beginning of the audit the

use of primary-prevention ICDs was extremely poor, in the range of 40% to 45% on average. It did improve over

time. Over a 2-year period, it improved to about 65%, which, unfortunately, is still a significant underpenetration of

the appropriate use of primary-prevention therapy in these patients.

There is still room for significant improvement, and the use of educational tools such as those the Heart Rhythm

Society has been rolling out has been very helpful to continue to educate the general cardiology community on the

guidelines but also the differences between the guidelines and the CMS coverage decision.

Dr Poole: All of these efforts are critical and hopefully can be embraced by a broader community. We need to do

this in order to continue to address the public health problem of SCD and capture appropriate patients for ICD

therapy. I want to thank you for your time today. Mike, do you have any final pearls of wisdom that we should keep

in mind?

Dr Mirro: It is important that electrophysiologists take a lead at their institutions in developing a system-wide

approach to SCD prevention at the local and grassroots level. Having an energized cardiovascular nursing staff

like the one at our institution is incredibly helpful in screening patients and taking ownership of the patients with

low ejection fractions, in order to ensure that these patients receive proper care. It is key that the

electrophysiologists continue to take a leadership role in this area. It is the best thing for our patients, and it is the

best thing for the medical community.



Slide 15.

Dr Poole: Thank you so much, Mike, for your insights on how to better manage ICD therapy for patients, and

thank you for listening in to this activity. I hope that you found it informative. You may now take the CME posttest

by clicking on the “Earn CME Credit” link. Please also take a moment to complete the program evaluation that

follows. Thank you.

This transcript has been edited for style and clarity.

This article is a CME certified activity. To earn credit for this activity visit:

http://www.medscape.org/viewarticle/771023

Abbreviations

ACC = American College of Cardiology

ACEI = angiotensin converting enzyme inhibitor

AHA = American Heart Association

AMI = acute myocardial infarction ARB = angiotensin receptor blocker

CABG = coronary artery bypass graft

CAD = coronary artery disease

CDS = clinical decision support

CHF = coronary heart failure

CMS = Centers for Medicare and Medicaid Services

CRT = cardiac resynchronization therapy

EF = ejection fraction

EP = electrophysiology

HIT = health information technology

HRS = Heart Rhythm SocietyICD = implantable cardioverter-defibrillator

ICM = ischemic dilated cardiomyopathy

LDL = low-density lipoprotein





LV = left ventricular

LVEF = left ventricular ejection fraction

MADIT-II = Multicenter Autonomic Defibrillator Implantation Trial 2

MI = myocardial infarction

NCDR = National Cardiovascular Data Registry

NICM = nonischemic dilated cardiomyopathynsVT = nonsustained ventricular tachycardia

NYHA = New York Heart Association

PTCA = percutaneous transluminal coronary angioplasty

SCD = sudden cardiac death

SCD-HeFT = Sudden Cardiac Death in Heart Failure Trial

sVT = sustained ventricular tachycardia

VF = ventricular fibrillation

VT = ventricular tachycardia

WCD = wearable cardioverter-defibrillator

References

1. Epstein AE, DiMarco JP, Ellenbogen KA, et al; Writing Committee Members; ACC/AHA Task Force

Members. ACC/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities:

executive summary. Circulation. 2008;117:e350-408. Abstract

2. Fishman GI, Chugh SS, Dimarco JP, et al Sudden cardiac death prediction and prevention: report from a

National Heart, Lung, and Blood Institute and Heart Rhythm Society Workshop Circulation.

2010;122;2335-2348.

3. Myerburg RJ, Junttila MJ. Sudden cardiac death caused by coronary heart disease. Circulation.

2012;125:1043-1052. Abstract

4. Myerburg RJ, Hendel RC. Expanding risk-profiling strategies for prediction and prevention of suddencardiac death. J Am Coll Cardiol. 2010;56:215-217. Abstract

5. Centers for Medicare and Medicaid Services, Department of Health and Human Services. CMS Manual

System, Pub. 100-03 Medicare National Coverage Determinations.

http://www.cms.gov/transmittals/downloads/R29NCD.pdf. Published March 4, 2005. Accessed October 9,

2012.

6. Bardy GH, Lee KL, Mark DB, et al; for the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT)

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7. Hohnloser SH, Kuck KH, Dorian P, et al; DINAMIT Investigators. Prophylactic use of an implantable

cardioverter-defibrillator after acute myocardial infarction. N Engl J Med. 2004;351:2481-2488. Abstract

8. Al-Khatib SM, Hellkamp A, Curtis J, et al. Non-evidence-based ICD implantations in the United States.JAMA. 2011;305:43-49. Abstract

9. Moss AJ, Zareba W, Hall WJ, et al; Multicenter Automatic Defibrillator Implantation Trial II Investigators.

Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection

fraction. N Engl J Med. 2002;346:877-883. Abstract

10. Heart Rhythm Society. SCD Primary Prevention Protocols. http://www.hrsonline.org/News/Sudden-

Cardiac-Arrest-SCA-Awareness/SCA-Provider-Resources/Primary-Prevention-Protocols. Published 2012.

Accessed October 9, 2012.

11. Fonarow GC, Albert NM, Curtis AB, et al. Improving evidence-based care for heart failure in outpatient

cardiology practices: primary results of the Registry to Improve the Use of Evidence-Based Heart Failure

Therapies in the Outpatient Setting (IMPROVE HF). Circulation. 2010;122:585-596. Abstract

12. Hunt SA, Abraham WT, Chin MH; American College of Cardiology; American Heart Association TaskForce on Practice Guidelines; American College of Chest Physicians; International Society for Heart and

Lung Transplantation; Heart Rhythm Society. ACC/AHA 2005 Guideline Update for the Diagnosis and

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Management of Chronic Heart Failure in the Adult: a report of the American College of

Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update

the 2001 Guidelines for the Evaluation and Management of Heart Failure): developed in collaboration with

the American College of Chest Physicians and the International Society for Heart and Lung

Transplantation: endorsed by the Heart Rhythm Society. Circulation. 2005;112:e154-235. Abstract

13. Bonow RO, Bennett S, Casey DE Jr, et al; American College of Cardiology; American Heart AssociationTask Force on Performance Measures (Writing Committee to Develop Heart Failure Clinical Performance

Measures); Heart Failure Society of America. ACC/AHA clinical performance measures for adults with

chronic heart failure: a report of the American College of Cardiology/American Heart Association Task

Force on Performance Measures (Writing Committee to Develop Heart Failure Clinical Performance

Measures) endorsed by the Heart Failure Society of America. J Am Coll Cardiol. 2005;46:1144-1178.

Abstract

14. Medtronic, Inc. IMPROVE HF. http://www.improvehf.com/. Accessed October 15, 2012.

Disclaimer

The material presented here does not necessarily reflect the views of Medscape, LLC, or companies that support

educational programming on medscape.org. These materials may discuss therapeutic products that have not beenapproved by the US Food and Drug Administration and off-label uses of approved products. A qualified healthcareprofessional should be consulted before using any therapeutic product discussed. Readers should verify allinformation and data before treating patients or employing any therapies described in this educational activity.

Medscape Education © 2012 Medscape, LLC








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