Zoll Medical--LifeVest: Territory Manager: Sunny Brown Cell: (818) - - PowerPoint PPT Presentation

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Zoll Medical--LifeVest: Territory Manager: Sunny Brown Cell: (818) - - PowerPoint PPT Presentation

Zoll Medical--LifeVest: Territory Manager: Sunny Brown Cell: (818) 916-6520 Objectives Why the LifeVest device exist Review indications for Wearable Cardioverter Defibrillator (WCD) use Give a brief description of the LifeVest


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Zoll Medical--LifeVest:

Territory Manager: Sunny Brown

Cell: (818) 916-6520

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Objectives

  • Why the LifeVest device exist
  • Review indications for Wearable Cardioverter

Defibrillator (WCD) use

  • Give a brief description of the LifeVest Technology
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Why the LifeVest Exist

http://www.youtube.com/watch?v=gFLfNao-rR8

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  • Survival with AED 4-10% (1)
  • In-hospital survival to discharge 13-24% (2)
  • Casino 74% (3)
  • WCD 92-98%

Survival Statistics

(1) Nichol et al. Circ, April 21, 2008. (2) Peberdy, et al, RESUSCITATION 58 (2003) 297-308 (3) Valenzuela et al., NEJM. Oct 26, 1206-9, 2000.

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Cardiovascular Death

  • 1 out of every 3 deaths in US (1)
  • 2,150 Americans die each day from CVD (1 every 40

seconds) (1)

  • CVD claims more lives each year than all forms of cancer,

combined (1)

(1)AHA Heart Disease and Stroke Statistics-2015 Update

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CVD and SCD

  • SCA and it’s consequence; SCD, account for approximately

50% of all cardiovascular deaths (1)

  • At least 25% of these events are the patient’s first

symptomatic event (1,2)

(1)Myerburg RJ, Juntilla MJ. Sudden cardiac death caused by coronary heart disease. Circulation 2012;125:1043-52 Goldberger JJ, Buxton AE, Cain M, et al. Risk stratification for arrhythmic sudden cardiac death: identifying the roadblocks. Circulation. 2011;123:2423-30. (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 HRS Workshop. Circulation. 2010;122:2335-48. Myerburg RJ. Sudden cardiac death: exploring the limits of our knowledge. J Cardiovascular Electrophysiol. 2001;12:369-81.

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SCD & Out of Hospital Cardiac Arrest

  • In 2017 update of cardiovascular statistics from AHA,

estimated

  • Out of hospital cardiac arrest at 356,500 annually
  • Overall survival of out of hospital cardiac arrest is 10%
  • Among the subgroup of 70% out of hospital cardiac arrests that occur in

the home, survival rate is 6%

  • In 2011, of the 19,300 bystander-witnessed out of hospital

cardiac arrests, 31.4% survived.

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Out of Hospital Cardiac Arrest

  • Factors determining survival after out of hospital cardiac

arrest

  • Time between collapse and start of resuscitation
  • Time to defibrillation
  • Availability of AED’s in public
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In-Hospital Cardiac Arrest

  • 2017 AHA Update: 209,000 in-hospital cardiac arrests occur annually.

(1)

  • 2017: Rate of survival to D/C after in-hospital cardiac arrest is 24% (2)
  • 2013: NRCPR data (17,991 cardiac arrests/250 hospitals)
  • 17% survival rate in-hospital
  • -18% Daytime
  • -13% Night

(1) Merchant RM, Yang L, Becker LB et al. Incidence of treated cardiac arrest in hospitalized patients in the United States. Crit Care Med. 2011;39:2401-6. (2) Daya MR, Schmicker R, MaySH, et al. Current burden of cardiac arrest in the United States: report from the Resuscitation Outcomes Consortium. Paper commissioned by the Committee on the Treatment of Cardiac Arrest: Current Status and Future Directions. 2015.

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Gaps in out of Hospital SCD Protection?

  • Most from ventricular tachyarrhythmias
  • Outpatient defibrillation possibilities:
  • - Home AED
  • - EMS (Emergency Medical Services)
  • - ICD
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Gaps in SCD Protection?

Who doesn't receive SCD protection?

  • Therapy delays
  • Surgical contraindications (example: infection)
  • Temporary SCA risk
  • Heart transplant listing
  • Terminal or potentially terminal condition
  • Evaluation for SCA risk
  • 90 or 40 day waiting periods (post revascularization / newly diagnosed)
  • Waiting for therapeutic effects
  • Changing risk factors
  • High risk groups not yet studied for ICD effectiveness
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Where does LifeVest Fit? Trying to impact a small period of time

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The LifeVest Wearable Defibrillator

  • Primary Functions:
  • Detect ventricular fibrillation
  • Detect ventricular tachycardia
  • Deliver patient responsiveness test
  • Defibrillate
  • Secondary Functions:
  • Arrhythmic event monitor
  • Symptomatic event ECG recorder
  • Heart Failure Management Tools (Remote Monitoring: LifeVest Network)
  • Heart Rate / Pedometer / Body Angle While Sleeping / HF daily questionnaire
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LifeVest

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Gel capsules Defibrillation electrode ECG electrode

Dry, comfortable electrodes

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LifeVest Features

  • Self gelling defibrillation electrodes
  • No gel, no adhesive ECG electrodes
  • Lightweight (1.8 lb monitor)
  • Consciousness test before shock
  • 150-joule biphasic shock
  • Captures ECG 30 seconds before event
  • Stores up to 75 minutes of ECG
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Treatment Sequence

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SS FB SS FB SS FB SS FB

  • 24 seconds between top and bottom -
  • nset

shock recovery

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Example of Treatment Event

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2017 AHA/ACC/HRS Guidelines

WCD = LifeVest

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2017 AHA/ACC/HRS Guidelines

WCD = LifeVest

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2017 AHA/ACC/HRS Guidelines

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Insurance Coverage

The LifeVest is covered by most health plans in the United States, including commercia, state and federal

  • plans. This list summarizes the types of patient conditions and situations that are covered. The patient’s

specific health plan coverage policy should be reviewed to determine coverage for prescribing a LifeVest

  • Primary prevention (EF<35% and MI, NICM or other DCM) including:
  • after recent MI (coverage during the 40 day ICD waiting period)
  • Before and after CABG or PTCA (Coverage during the 90 day ICD waiting period)
  • Listed for cardiac transplant
  • Recently diagnosed nonischemic cardiomyopathy (coverage during the 3 to 9 month ICD waiting

period)

  • NYHA class IV heart failure
  • Terminal disease with life expectancy of less than 1 year
  • ICD indications when patient condition delays or prohibits ICD implantation
  • ICD explantation
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LifeVest Experience

  • First shock conversion success: 98%.
  • Shocked event survival (conscious ER arrival or stayed at

home): 94%.

  • Most (77%) treated within 60 seconds (remaining delayed

from response button use or VT programming)

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WCD may be used for

  • Bridge to ICD
  • Outpatient, immediate, automatic, non-invasive protection against SCD, until ICD, or

until no longer at risk

  • Time For SCA Risk Assessment
  • Outpatient, immediate, automatic, non-invasive protection against SCD, until ICD, or

until no longer at risk

  • Scheduling Tool
  • Patient overflow
  • Discharge Planning Tool
  • Weekends
  • Holidays
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LifeVest Experience

  • Experience with over 100,000 patients
  • Average duration of use is 91 days
  • Median daily use is 22.3%
  • Survival After Deployment >94%
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Case #1: First Month after MI

  • Male patient, 62 years old
  • Post MI with non-sustained VT
  • EF was 15-20%
  • Received LifeVest at discharge from hospital
  • Treated for VT> 250 bpm by LifeVest during sleep: not once,

but twice in the same night

  • Patient originally insisted he was not shocked
  • Two days later was treated again
  • He has no recollection of any of the shocks
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Case #2 Staged PCI Case Study

  • Patient with STEMI underwent staged PCI with deployment of 2

drug-eluting stents

  • Circumflex artery was staged 2 days later with successful

deployment of a drug eluting stent

  • Patient experienced episode of VF 5 days after D/C and was

converted to NSR by a LifeVest shock

  • Case illustrates importance of appropriately identifying

physiological risk factors to protect to provide protection from SCA

  • Patient had triple vessel disease and low EF = CADILLAC score

6

  • Additional co-morbidities

Kooshkabadi Case Study

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Case #3: Trapped in the Hospital

  • Male patient, 37 years old, NICM
  • Hospitalized until transplant because an implanted ICD was

unable to terminate VF. He required simultaneous 300 joule shocks from two separate AEDs during the EP study.

  • The LifeVest successfully terminated three induced episodes of

VF with a single 150 joule shock. He was home for Christmas.

  • As an outpatient, he was shocked successfully five times.
  • After 14 months of waiting, he received a new heart.
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Summary

  • Constant monitoring and protection of SCD with superb

results: 98% first shock conversion

  • Designed for transitional SCD risk periods (the coverage

“gaps” in ICD policy)

  • Medicare and numerous insurances, including many

Medicaid programs, cover wearable defibrillator use

  • Allows time to determine long term course of treatment as

well as ensuring patient returns for follow-up visit

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Medical Orders Last 12 Months Cumulative

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Questions?

Thank you!