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.
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)
BACKGROUND: CURRENT GUIDELINES
FOR PRIMARY ICD THERAPY
• EF ≤ 35%
Hazard Ratio
• High-risk inherited
arrhythmias
N=1016
0.52
AVID
1997
2000
Aborted cardiac arrest
0.77
N=659
CIDS
Aborted cardiac arrest
0.80
2000
AHA/ACC/HRS 2012
Guidelines
N=288
0.64
CASH
Aborted cardiac arrest
0.4
0.6
0.8
ICD Better
1.0
1.2
1.4
1.6
1.8
Conventional Rx Better
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
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
STUDY PURPOSE

To provide prospective data on the safety and
efficacy of a bridging strategy with the WCD in
a real world setting
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
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
 Non-ischemic CMP
 Cong/inherited

805 pts, 40.3%
927 pts, 46.4%
268 pts, 13.4%
CONGENITAL,
INHERITED HEART DISEASE

Initial diagnosis at baseline (n=268, 13.4%)
* Allows for multiple diagnoses.
CHARACTERISTICS OF PATIENTS
All Patients
N=2000
Ischemic
N=805
Non-ischemic
N=927
Cong/Inherited
N=268
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%
Age, yrs
(median)
* 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.
ARRHYTHMIC EVENTS: TOTAL POPULATION
(WEAR DAYS MEDIAN 90 days)
Patients (%)
Events
(events/pt)
Event Rate
Per 100 PtYear
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.
ARRHYTHMIC EVENTS:
WEARIT-II VS. MADIT-RIT
WEARIT-II
MADIT-RIT Arms B&C
ANY VT/VF BY DISEASE ETIOLOGY
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
COMPLIANCE

Daily wear hours: median 22.5 hours
COMPLIANCE BY DISEASE ETIOLOGY
END OF USE BY ETIOLOGY
DETECTED WCD ARRHYTHMIAS
AND END OF USE DECISION
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
Thank You