1. 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.

2. 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)

3. Background: Current Guidelines for Primary ICD Therapy
EF ≤ 35%
High-risk inherited arrhythmias
AHA/ACC/HRS 2012 Guidelines
0.64

4. 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 <200 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

5. 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

6. Study Purpose
To provide prospective data on the safety and efficacy of a bridging strategy with the WCD in a real world setting

7. 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

8. 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 pts, 46.4%
Cong/inherited pts, 13.4%

9. CONGENITAL, INHERITED HEART DISEASE
Initial diagnosis at baseline (n=268, 13.4%)
* Allows for multiple diagnoses.

10. CHARACTERISTICS OF PATIENTS
All Patients
N=2000
Ischemic
N=805
Non-ischemic
N=927
Cong/Inherited
N=268
Age, yrs (median) 62 65
59†
59*
Female
30%
23%
36%†
30%*
EF (median)
25%
25% †
25% *
HF symptoms
52%
48%
63%*
Diabetes
28%
35%
21%†
Prior ACA 9%
11%
7%† 7%
* p-value < 0.05 ischemic, non-ischemic, cong/inherited, † p-value < 0.05 ischemic, non-ischemic
Data are reported by patients using a baseline evaluation form.

11. 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 VT’s that were spontaneously terminated, response button use or extended detection time.

12. ARRHYTHMIC EVENTS: WEARIT-II VS. MADIT-RIT
MADIT-RIT Arms B&C

13. ANY VT/VF BY DISEASE ETIOLOGY

14. SAFETY END POINTS TYPE TOTAL N=2000 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

15. COMPLIANCE
Daily wear hours: median 22.5 hours

16. COMPLIANCE BY DISEASE ETIOLOGY

17. END OF USE BY ETIOLOGY

18. DETECTED WCD ARRHYTHMIAS AND END OF USE DECISION

19. 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

20. Thank You