Zoll Medical--LifeVest:

Transcription

1 Zoll Medical--LifeVest: Territory Manager: Sunny Brown Cell: (818)

2 Objectives Why the LifeVest device exist Review indications for Wearable Cardioverter Defibrillator (WCD) use Give a brief description of the LifeVest Technology

3 Why the LifeVest Exist

4 Survival Statistics Survival with AED 4-10% (1) In-hospital survival to discharge 13-24% (2) Casino 74% (3) WCD 92-98% (1) Nichol et al. Circ, April 21, (2) Peberdy, et al, RESUSCITATION 58 (2003) (3) Valenzuela et al., NEJM. Oct 26, , 2000.

5 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

6 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: Goldberger JJ, Buxton AE, Cain M, et al. Risk stratification for arrhythmic sudden cardiac death: identifying the roadblocks. Circulation. 2011;123: (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: Myerburg RJ. Sudden cardiac death: exploring the limits of our knowledge. J Cardiovascular Electrophysiol. 2001;12:

7 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.

8 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

9 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: (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

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

11 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

12 Where does LifeVest Fit? Trying to impact a small period of time

13 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

14 LifeVest

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19 Dry, comfortable electrodes Defibrillation electrode ECG electrode Gel capsules

20 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

21 Treatment Sequence

22 SS SS FB onset FB SS - 24 seconds between top and bottom - SS FB FB shock recovery

23 Example of Treatment Event

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26 2017 AHA/ACC/HRS Guidelines WCD = LifeVest

27 2017 AHA/ACC/HRS Guidelines WCD = LifeVest

28 2017 AHA/ACC/HRS Guidelines

29 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

30 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)

31 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

32 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%

33 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

34 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

35 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.

36 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

37 Medical Orders Last 12 Months Cumulative

38 Questions? Thank you!