Presenter Disclosure Information

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Presenter Disclosure Information
Valentina Kutyifa, MD, PhD Results From The
Prospective Registry Of Patients Using The
Wearable Defibrillator (WEARIT-II Registry)
DISCLOSURE INFORMATION The following
relationships exist related to this
presentation WEARIT-II was supported by ZOLL.
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Results From The Prospective Registry Of
Patients Using The Wearable Defibrillator
(WEARIT-II Registry)

• Valentina, Kutyifa, MD, PhD, Ilan
  Goldenberg, MD, Wojciech Zareba, MD, PhD, Helmut
  Klein, MD, Chingping Wan, MD, Bonnie MacKecknie,
  Mark L. Andrews, MS, Steve Szymkiewicz, MD and
  Arthur J. Moss, MD
• From the Cardiology Division of the Department
  of Medicine (VK, IG, WZ, HK, BM, MLA, AJM),
  University of Rochester Medical Center,
  Rochester, N.Y. Sheba Medical Center and Tel
  Aviv University, Israel (IG) and ZOLL,
  Pittsburgh, PA (SS, CW)

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Background Current Guidelines for Primary ICD
Therapy

• EF 35
• High-risk inherited arrhythmias
• AHA/ACC/HRS 2012 Guidelines

0.64
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BACKGROUND NEED FOR IMPROVED SELECTION OF
PATIENTS FOR PRIMARY ICD THERAPY

• MADIT-II
• Only one third of pts received appropriate ICD
  therapy over 4 years of FU
• Moss et al. NEJM 2002
• MADIT-RIT
• ICD programing to lt200 bpm is associated with
  increased risk for inappropriate Rx and mortality
• Rate of appropriate ICD shocks was only 4 (event
  rate 3 appr. ICD shocks per 100 pt-yrs)
• Moss et al. NEJM 2012

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LIFEVEST WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD)

• Can be used to bridge a decision for appropriate
  ICD therapy in
• Post-MI pts
• Following coronary revascularization
• New onset dilated (non-ischemic) CMP
• High risk patients until stabilization
• Inherited arrhythmic or congenital disorders
• Availability of response button can be used to
  reduce inappropriate Rx

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Study Purpose

• To provide prospective data on the safety and
  efficacy of a bridging strategy with the WCD in a
  real world setting

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WEARIT-II REGISTRY DESIGN

• WCD (LifeVest) prescription in the US
• Informed consent
• Acquisition of baseline clinical data
• Wearing time 3 months
• Clinical and Arrhythmic event acquisition
• WCD return end of use evaluation
• 12 month FU

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STUDY POPULATION

• N 2000 patients enrolled in the US
• Currently enrolling patients in Europe, Israel
• Study duration August 2011 December 2013
• Data management University of Rochester
• Ischemic cardiomyopathy 805 pts, 40.3
• Non-ischemic CMP 927 pts, 46.4
• Cong/inherited 268 pts, 13.4

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CONGENITAL,INHERITED HEART DISEASE

• Initial diagnosis at baseline (n268, 13.4)

Allows for multiple diagnoses.
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CHARACTERISTICS OF PATIENTS
All Patients N2000 Ischemic N805 Non-ischemic N927 Cong/Inherited N268
Age, yrs (median) 62 65 59 59
Female 30 23 36 30
EF (median) 25 30 25 25
HF symptoms 52 48 52 63
Diabetes 28 35 21 30
Prior ACA 9 11 7 7
p-value lt 0.05 ischemic, non-ischemic,
cong/inherited, p-value lt 0.05 ischemic,
non-ischemic Data are reported by patients
using a baseline evaluation form.
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ARRHYTHMIC EVENTS TOTAL POPULATION(WEAR DAYS
MEDIAN 90 days)
Patients () Events (events/pt) Event Rate Per 100 Pt-Year
Any VT/VF 41 (2.1) 120 (2.9) 22
NSVT 28 (1.4) 164 (5.9) 30
Atrial arrhythmias/SVT 72 (3.6) 561 (7.8) 121
Asystole 6 (0.3) 9 (1.5) 2
Treated VT/VF and those VTs that were
spontaneously terminated, response button use or
extended detection time.
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ARRHYTHMIC EVENTS WEARIT-II VS. MADIT-RIT
MADIT-RIT Arms BC
WEARIT-II
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ANY VT/VF BY DISEASE ETIOLOGY
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SAFETY END POINTS
TYPE TOTAL N2000
Inappropriate Rx, n () 10 (0.5)
Death, n () with the WCD 3 (0.2)
WCD detected asystole at the time of death No
death related to unsuccessful termination of
VT/VF 12-m FU data on death are still being
collected
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COMPLIANCE

• Daily wear hours median 22.5 hours

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COMPLIANCE BY DISEASE ETIOLOGY
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END OF USE BY ETIOLOGY
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DETECTED WCD ARRHYTHMIAS AND END OF USE DECISION
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CONCLUSIONS

• In a real world setting a management strategy
  that incorporates the WCD can be safely used to
  bridge a decision for appropriate ICD therapy in
  patients with acquired, inherited, and
  congenital, heart disease
• Safe termination of life-threatening arrhythmic
  events
• Low rate of inappropriate therapies
• Risk assessment tool to identify patients at
  higher risk for SCD who need subsequent ICD
  implantation

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Thank You