Engelstein ED, Zipes DP. Sudden cardiac death. In: Alexander RW, Schlant RC, Fuster V, eds. The heart, arteries and veins. New York: McGraw-Hill, 1998:1081–1112.
Heart Rhythm Society. Sudden Cardiac Death Primary Prevention Protocols -- Version 2. Last reviewed September 10, 2013. http://www.hrsonline.org/content/download/8564/375099/file/SCD%20Primary%20Prevention%20Protocols.pdf . Accessed May 23, 2016.
Solomon SD, Zelenkofske S, McMurray JJ, et al. Sudden death in patients with myocardial infarction and left ventricular dysfunction, heart failure, or both. N Engl J Med. 2005;352:2581-2588. Abstract
Hohnloser SH, Kuck KH, Dorian P, et al. Prophylactic use of an implantable cardioverter-defibrillator after acute myocardial infarction. N Engl J Med. 2004;351:2481-2488. Abstract
Steinbeck G, Andresen D, Seidl K, et al. Defibrillator implantation early after myocardial infarction. N Engl J Med. 2009;361:1427-1436. Abstract
Goldberger JJ, Passman R. Implantable cardioverter-defibrillator therapy after acute myocardial infarction: the results are not shocking. J Am Coll Cardiol. 2009;54:2001-2005. Abstract
Epstein AE, Abraham WT, Bianco NR, et al. Wearable cardioverter-defibrillator use in patients perceived to be at high risk early post-myocardial infarction. J Am Coll Cardiol. 2013;62:2000-2007. Abstract
Kutyifa V, Moss AJ, Klein H, et al. Use of the wearable cardioverter defibrillator in high-risk cardiac patients: data from the Prospective Registry of Patients Using the Wearable Cardioverter Defibrillator (WEARIT-II Registry). Circulation. 2015;132:1613-1619. Abstract
Klein HU, Goldenberg I, Moss AJ. Risk stratification for implantable cardioverter defibrillator therapy: the role of the wearable cardioverter-defibrillator. Eur Heart J. 2013;34:2230-2242. Abstract
Zishiri ET, Williams S, Cronin EM, et al. Early risk of mortality after coronary artery revascularization in patients with left ventricular dysfunction and potential role of the wearable cardioverter defibrillator. Circ Arrhythm Electrophysiol. 2013;6:117-128. Abstract
Kutyifa V, et al. One-year follow-up of the prospective registry of patients using the wearable defibrillator (WEARIT-II Registry). Abstract presented at: Cardiostim 2016; June 8-11, 2016; Nice, France.
Piccini JP, Sr., Allen LA, Kudenchuk PJ, et al. Wearable cardioverter-defibrillator therapy for the prevention of sudden cardiac death: a science advisory from the American Heart Association. Circulation. 2016;133:1715-1727. Abstract
ClinicalTrials.gov. Vest prevention of early sudden death trial and VEST registry. NCT01446965. https://clinicaltrials.gov/ct2/show/NCT01446965. Accessed May 17, 2016.
LifeVest Network, https://lifevestnetwork.zoll.com/. Accessed May 23, 2016.

As an organization accredited by the ACCME, Medscape, LLC, requires everyone who is in a position to control the content of an education activity to disclose all relevant financial relationships with any commercial interest. The ACCME defines "relevant financial relationships" as financial relationships in any amount, occurring within the past 12 months, including financial relationships of a spouse or life partner, that could create a conflict of interest.

Medscape, LLC, encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration, at first mention and where appropriate in the content.

Author(s)

Niraj Varma, MD, PhD

Staff, Cleveland Clinic, Cleveland, Ohio

Disclosures

Disclosure: Niraj Varma, MD, PhD, has disclosed the following relevant financial relationships:
Served as an advisor or consultant for: BIOTRONIK; Medtronic, Inc.; Sorin Group; St. Jude Medical
Served as a speaker or a member of a speakers bureau for: BIOTRONIK; Medtronic, Inc.; Zoll Medical Corporation
Received grants for clinical research from: Boston Scientific; Medtronic, Inc.; St. Jude Medical

Dr. Varma does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by the FDA for use in the United States.

Dr. Varma does not intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.

Alon Barsheshet, MD

Adjunct Assistant Professor, University of Rochester, Rochester, New York; Rabin Medical Center, Tel Aviv University, Tel Aviv, Israel

Disclosures

Disclosure: Alon Barsheshet, MD, has disclosed no relevant financial relationships.

Dr. Barsheshet does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by the FDA for use in the United States.

Dr. Barsheshet does not intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.

Valentina Kutyifa, MD, PhD

Research Assistant Professor, University of Rochester, Rochester, New York

Disclosures

Disclosure: Default disclosure statement (modify if necessary): Valentina Kutyifa, MD, PhD, has disclosed the following relevant financial relationships:
Served as a speaker or a member of a speakers bureau for: Boston Scientific; Zoll Medical Corporation
Received grants for clinical research from: Boston Scientific; Zoll Medical Corporation

Dr. Kutyifa does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by the FDA for use in the United States.

Dr. Kutyifa does not intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.

Editor

George Boutsalis, PhD

Scientific Director, Medscape, LLC

Disclosures

Disclosure: George Boutsalis has disclosed no relevant financial relationships.

CME Reviewer

Amy Bernard, MS, BSN, RN-BC

Lead Nurse Planner, Medscape, LLC

Disclosures

Disclosure: Amy Bernard, MS, BSN, RN-BC, has disclosed no relevant financial relationships.

CME

Addressing Patients at High Risk for SCA: Evaluating WEARIT-II

Authors: Niraj Varma, MD, PhD; Alon Barsheshet, MD; Valentina Kutyifa, MD, PhD
CME Released: 6/13/2016
THIS ACTIVITY HAS EXPIRED FOR CREDIT
Valid for credit through: 6/13/2017, 11:59 PM EST

Start Activity

Target Audience and Goal Statement

This activity is intended for cardiologists, emergency medicine physicians, and critical care specialists.

The goal of this activity is to address the risk of sudden cardiac death (SCD) during the 90-day period following a cardiac event, as well as the management of patients and the utility of a wearable cardioverter defibrillator (WCD) during this period.

Upon completion of this activity, participants will be able to:

Describe the management of patients in the 90-day period following a cardiac event and the risk of SCD during this time period
Review guideline recommendations in managing patients at risk of SCD

Disclosures

Author(s)

Niraj Varma, MD, PhD

Staff, Cleveland Clinic, Cleveland, Ohio

Disclosures

Disclosure: Niraj Varma, MD, PhD, has disclosed the following relevant financial relationships:
Served as an advisor or consultant for: BIOTRONIK; Medtronic, Inc.; Sorin Group; St. Jude Medical
Served as a speaker or a member of a speakers bureau for: BIOTRONIK; Medtronic, Inc.; Zoll Medical Corporation
Received grants for clinical research from: Boston Scientific; Medtronic, Inc.; St. Jude Medical

Dr. Varma does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by the FDA for use in the United States.

Dr. Varma does not intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.

Alon Barsheshet, MD

Adjunct Assistant Professor, University of Rochester, Rochester, New York; Rabin Medical Center, Tel Aviv University, Tel Aviv, Israel

Disclosures

Disclosure: Alon Barsheshet, MD, has disclosed no relevant financial relationships.

Dr. Barsheshet does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by the FDA for use in the United States.

Dr. Barsheshet does not intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.

Valentina Kutyifa, MD, PhD

Research Assistant Professor, University of Rochester, Rochester, New York

Disclosures

Disclosure: Default disclosure statement (modify if necessary): Valentina Kutyifa, MD, PhD, has disclosed the following relevant financial relationships:
Served as a speaker or a member of a speakers bureau for: Boston Scientific; Zoll Medical Corporation
Received grants for clinical research from: Boston Scientific; Zoll Medical Corporation

Dr. Kutyifa does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by the FDA for use in the United States.

Dr. Kutyifa does not intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.

Editor

George Boutsalis, PhD

Scientific Director, Medscape, LLC

Disclosures

Disclosure: George Boutsalis has disclosed no relevant financial relationships.

CME Reviewer

Amy Bernard, MS, BSN, RN-BC

Lead Nurse Planner, Medscape, LLC

Disclosures

Disclosure: Amy Bernard, MS, BSN, RN-BC, has disclosed no relevant financial relationships.

Accreditation Statements

For Physicians

Medscape, LLC is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Medscape, LLC designates this enduring material for a maximum of 0.50 AMA PRA Category 1 Credit(s)™ . Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Medscape, LLC staff have disclosed that they have no relevant financial relationships.

Contact This Provider

For questions regarding the content of this activity, contact the accredited provider for this CME/CE activity noted above. For technical assistance, contact [email protected]

Instructions for Participation and Credit

There are no fees for participating in or receiving credit for this online educational activity. For information on applicability and acceptance of continuing education credit for this activity, please consult your professional licensing board.

This activity is designed to be completed within the time designated on the title page; physicians should claim only those credits that reflect the time actually spent in the activity. To successfully earn credit, participants must complete the activity online during the valid credit period that is noted on the title page. To receive AMA PRA Category 1 Credit™, you must receive a minimum score of 70% on the post-test.

Follow these steps to earn CME/CE credit*:

Read the target audience, learning objectives, and author disclosures.
Study the educational content online or printed out.
Online, choose the best answer to each test question. To receive a certificate, you must receive a passing score as designated at the top of the test. We encourage you to complete the Activity Evaluation to provide feedback for future programming.

You may now view or print the certificate from your CME/CE Tracker. You may print the certificate but you cannot alter it. Credits will be tallied in your CME/CE Tracker and archived for 6 years; at any point within this time period you can print out the tally as well as the certificates from the CME/CE Tracker.

*The credit that you receive is based on your user profile.

From Medscape Education Cardiology

CME

Addressing Patients at High Risk for SCA: Evaluating WEARIT-II

Authors: Niraj Varma, MD, PhD; Alon Barsheshet, MD; Valentina Kutyifa, MD, PhDFaculty and Disclosures

THIS ACTIVITY HAS EXPIRED FOR CREDIT

CME Released: 6/13/2016

Valid for credit through: 6/13/2017, 11:59 PM EST

processing....

Addressing Patients at High Risk for SCA: Evaluating WEARIT-II
[ CLOSE WINDOW ]

Slide 1.

Panelists
[ CLOSE WINDOW ]

Slide 2.

Learning Objectives
[ CLOSE WINDOW ]

Slide 3.

Burden of CVD and Risk of SCD^[1]
[ CLOSE WINDOW ]

Slide 4.

Heart Rhythm Society: SCD Primary Prevention Protocols^[2]
[ CLOSE WINDOW ]

Slide 5.

VALIANT Study^[3]
[ CLOSE WINDOW ]

Slide 6.

DINAMIT^[4]
[ CLOSE WINDOW ]

Slide 7.

IRIS^[5]
[ CLOSE WINDOW ]

Slide 8.

Why Did the ICD Fail Early Post-AMI?^[6]
- The DINAMIT and IRIS trials showed no overall mortality benefit of early implantation of an implantable cardioverter defibrillator (ICD), possibly due to the very strict selection criteria for these trials (less than 2% of all screened patients enrolled in the IRIS trial)
  - By improving risk stratification and patient selection methods, the ICD may show beneficial effects
  - In the absence of such methods, the use of a wearable cardioverter defibrillator (WCD) serves to cover the 90-day period before an ICD is indicated
[ CLOSE WINDOW ]

Slide 9.

WCD registry^[7]
- The WCD can help improve risk stratification and provide a bridge of protection until an ICD is implanted in a patient who has ventricular tachyarrhythmic events or multiple nonsustained ventricular tachycardia (NSVT) episodes and is at high risk of sudden cardiac arrest (SCA)
[ CLOSE WINDOW ]

Slide 10.

LifeVest Wearable Cardioverter Defibrillator (WCD)^[8,9]
[ CLOSE WINDOW ]

Slide 11.

WEARIT-II: Characteristics of Patients^[8]
[ CLOSE WINDOW ]

Slide 12.

WEARIT-II Compliance^[8]
- Patients wearing the WCD for at least 2 weeks improved their compliance with daily use of the device
  - After a 2-week period when patients are getting used to this technology and figuring out how to use it, compliance is very high
[ CLOSE WINDOW ]

Slide 13.

WEARIT-II Arrhythmic Events: Total Population (Median Wear Time, 90 days)^[8]
[ CLOSE WINDOW ]

Slide 14.

WEARIT-II Safety Endpoints^[8]
- The WCD provided protection from sudden cardiac death (SCD) and provided some potential for the patient to interact with the device and withhold therapy as long as they are conscious
[ CLOSE WINDOW ]

Slide 15.

WEARIT-II Arrhythmic Events (Median Wear Time 90 days)
[ CLOSE WINDOW ]

Slide 16.

Arrhythmic Events: WEARIT-II vs MADIT-RIT^[8]
[ CLOSE WINDOW ]

Slide 17.

WCD Use Early After Coronary Revascularization^[10]
- Among patients who underwent percutaneous coronary intervention (PCI) and had a low ejection fraction (EF), 1.3% of patients who wore the WCD received an appropriate defibrillation
  - This may not be attributable solely to the shock delivered by the WCD, but possibly because patients wearing a WCD had better follow-up and monitoring
  - It is possible there was a selection bias in this study; however, repeated analyses adjusting for multiple variables and for propensity score matching produced the same results
[ CLOSE WINDOW ]

Slide 18.

ICD Implantation Rate by Disease Etiology^[8]
[ CLOSE WINDOW ]

Slide 19.

Detected WCD Arrhythmias Facilitating End of Use Decision^[8]
[ CLOSE WINDOW ]

Slide 20.

One-Year Follow-Up of the Prospective Registry of Patients Using the Wearable Defibrillator (WEARIT-II Registry)^[11]
[ CLOSE WINDOW ]

Slide 21.

WEARIT-II Registry: Probability of 1-Year Mortality^[11]
[ CLOSE WINDOW ]

Slide 22.

Congenital, Inherited Heart Disease^[8]
- Patients with congenital heart disease seem to be the highest risk group
  - In WEARIT-II, physicians prescribing the WCD preselect this very high-risk cohort for temporary protection with the WCD
[ CLOSE WINDOW ]

Slide 23.

Indications for WCD Use: Bridging Period for ICD or Heart Transplantation^[12]
- According to a recent American Heart Association (AHA) science advisory, one group of patients received a Class 2A indication for the wearable defibrillator:
  - Patients who already have an indication for an ICD and the main focus is to provide a bridge to ICD implantation or heart transplantation, such as patients who need device extraction due to active infection, or patients indicated for an ICD but who cannot or should not be implanted due to other comorbidities (eg, patients with bleeding disorders or patients on chemotherapy)
[ CLOSE WINDOW ]

Slide 24.

Recommendations for WCD Use: Risk Stratification^[12]
- The group of patients who received a Class 2B indication for the WCD includes patients who do not currently have an indication for an ICD but are at high risk for SCD
  - The main purpose of the WCD is to improve risk stratification and provide protection by treating tachyarrhythmic events, such as in patients with low EF during the 40 days after acute myocardial infarction (MI), in patients with low EF during the 90 days after PCI, in patients with new-onset nonischemic cardiomyopathy, or in other cases where the prognosis is unknown
- The AHA advisory did not take the WEARIT-II study into consideration
  - The level of evidence for all of these indications is C, which means there are limited data available
  - The WEARIT-II data and some other retrospective registries provide more information on the safety and efficacy of this management strategy in high-risk patient populations
  - The currently ongoing randomized VEST trial will provide further information and potentially increase the level of evidence for this indication^[13]
[ CLOSE WINDOW ]

Slide 25.

LifeVest Network^[14]
- Remote monitoring has become the standard of care with permanent implantable devices, associated with a Class 1 recommendation with a level of evidence A
  - Remote monitoring applies to patient populations who may have lower risk than the group of patients receiving a WCD after an acute MI or revascularization
  - The benefits of remote monitoring may be even greater in this 90-day period, as the information can be relayed within 24 hours, allowing physicians to act on significant events more quickly to prevent patient morbidity
[ CLOSE WINDOW ]

Slide 26.

Summary
[ CLOSE WINDOW ]

Slide 27.

Thank You
[ CLOSE WINDOW ]

Slide 28.

This content has been condensed for improved clarity.

CME Information Download Slides

Print
Like Tweet

Disclaimer

The educational activity presented above may involve simulated case-based scenarios. The patients depicted in these scenarios are fictitious and no association with any actual patient is intended or should be inferred.

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 been approved by the US Food and Drug Administration and off-label uses of approved products. A qualified healthcare professional should be consulted before using any therapeutic product discussed. Readers should verify all information and data before treating patients or employing any therapies described in this educational activity.

References

Faculty and Disclosures

Author(s)

Niraj Varma, MD, PhD

Alon Barsheshet, MD

Valentina Kutyifa, MD, PhD

Editor

George Boutsalis, PhD

CME Reviewer

Amy Bernard, MS, BSN, RN-BC

CME

Addressing Patients at High Risk for SCA: Evaluating WEARIT-II

Target Audience and Goal Statement

Disclosures

Author(s)

Niraj Varma, MD, PhD

Alon Barsheshet, MD

Valentina Kutyifa, MD, PhD

Editor

George Boutsalis, PhD

CME Reviewer

Amy Bernard, MS, BSN, RN-BC

Accreditation Statements

For Physicians

Instructions for Participation and Credit

Addressing Patients at High Risk for SCA: Evaluating WEARIT-II

Addressing Patients at High Risk for SCA: Evaluating WEARIT-II

Slide 1.

Panelists

Slide 2.

Learning Objectives

Slide 3.

Burden of CVD and Risk of SCD[1]

Slide 4.

Heart Rhythm Society: SCD Primary Prevention Protocols[2]

Slide 5.

VALIANT Study[3]

Slide 6.

DINAMIT[4]

Slide 7.

IRIS[5]

Slide 8.

Why Did the ICD Fail Early Post-AMI?[6]

Slide 9.

WCD registry[7]

Slide 10.

LifeVest Wearable Cardioverter Defibrillator (WCD)[8,9]

Slide 11.

WEARIT-II: Characteristics of Patients[8]

Slide 12.

WEARIT-II Compliance[8]

Slide 13.

WEARIT-II Arrhythmic Events: Total Population (Median Wear Time, 90 days)[8]

Slide 14.

WEARIT-II Safety Endpoints[8]

Slide 15.

WEARIT-II Arrhythmic Events (Median Wear Time 90 days)

Slide 16.

Arrhythmic Events: WEARIT-II vs MADIT-RIT[8]

Slide 17.

WCD Use Early After Coronary Revascularization[10]

Slide 18.

ICD Implantation Rate by Disease Etiology[8]

Slide 19.

Detected WCD Arrhythmias Facilitating End of Use Decision[8]

Slide 20.

One-Year Follow-Up of the Prospective Registry of Patients Using the Wearable Defibrillator (WEARIT-II Registry)[11]

Slide 21.

WEARIT-II Registry: Probability of 1-Year Mortality[11]

Slide 22.

Congenital, Inherited Heart Disease[8]

Slide 23.

Indications for WCD Use: Bridging Period for ICD or Heart Transplantation[12]

Slide 24.

Recommendations for WCD Use: Risk Stratification[12]

Slide 25.

LifeVest Network[14]

Slide 26.

Summary

Slide 27.

Burden of CVD and Risk of SCD^[1]

Heart Rhythm Society: SCD Primary Prevention Protocols^[2]

VALIANT Study^[3]

DINAMIT^[4]

IRIS^[5]

Why Did the ICD Fail Early Post-AMI?^[6]

WCD registry^[7]

LifeVest Wearable Cardioverter Defibrillator (WCD)^[8,9]

WEARIT-II: Characteristics of Patients^[8]

WEARIT-II Compliance^[8]

WEARIT-II Arrhythmic Events: Total Population (Median Wear Time, 90 days)^[8]

WEARIT-II Safety Endpoints^[8]

Arrhythmic Events: WEARIT-II vs MADIT-RIT^[8]

WCD Use Early After Coronary Revascularization^[10]

ICD Implantation Rate by Disease Etiology^[8]

Detected WCD Arrhythmias Facilitating End of Use Decision^[8]

One-Year Follow-Up of the Prospective Registry of Patients Using the Wearable Defibrillator (WEARIT-II Registry)^[11]

WEARIT-II Registry: Probability of 1-Year Mortality^[11]

Congenital, Inherited Heart Disease^[8]

Indications for WCD Use: Bridging Period for ICD or Heart Transplantation^[12]

Recommendations for WCD Use: Risk Stratification^[12]

LifeVest Network^[14]