Presentation on theme: "Presenter Disclosure Information"— Presentation transcript:
1Presenter Disclosure Information Valentina Kutyifa, MD, PhDResults From The Prospective Registry Of Patients Using The Wearable Defibrillator (WEARIT-II Registry)DISCLOSURE INFORMATIONThe following relationships exist related to this presentation:WEARIT-II was supported by ZOLL.
2Results 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, MDFrom 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)
3Background: Current Guidelines for Primary ICD Therapy EF ≤ 35%High-risk inherited arrhythmiasAHA/ACC/HRS 2012 Guidelines0.64
4BACKGROUND: 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 FUMoss et al. NEJM 2002MADIT-RIT:ICD programing to <200 bpm is associated with increased risk for inappropriate Rx and mortalityRate of appropriate ICD shocks was only 4% (event rate: 3 appr. ICD shocks per 100 pt-yrs)Moss et al. NEJM 2012
5LIFEVEST WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) Can be used to bridge a decision for appropriate ICD therapy in:Post-MI ptsFollowing coronary revascularizationNew onset dilated (non-ischemic) CMPHigh risk patients until stabilizationInherited arrhythmic or congenital disordersAvailability of response button can be used to reduce inappropriate Rx
6Study PurposeTo provide prospective data on the safety and efficacy of a bridging strategy with the WCD in a real world setting
7WEARIT-II: REGISTRY DESIGN WCD (LifeVest) prescription in the USInformed consentAcquisition of baseline clinical dataWearing time: 3 monthsClinical and Arrhythmic event acquisitionWCD return: end of use evaluation12 month FU
8STUDY POPULATION N= 2000 patients enrolled in the US Currently enrolling patients in Europe, IsraelStudy duration: August 2011 – December 2013Data management: University of RochesterIschemic cardiomyopathy 805 pts, 40.3%Non-ischemic CMP pts, 46.4%Cong/inherited pts, 13.4%
9CONGENITAL, INHERITED HEART DISEASE Initial diagnosis at baseline (n=268, 13.4%)* Allows for multiple diagnoses.
10CHARACTERISTICS OF PATIENTS All PatientsN=2000IschemicN=805Non-ischemicN=927Cong/InheritedN=268Age, yrs (median)626559†59*Female30%23%36%†30%*EF (median)25%25% †25% *HF symptoms52%48%63%*Diabetes28%35%21%†Prior ACA9%11%7%†7%* p-value < 0.05 ischemic, non-ischemic, cong/inherited, † p-value < 0.05 ischemic, non-ischemicData are reported by patients using a baseline evaluation form.
11ARRHYTHMIC EVENTS: TOTAL POPULATION (WEAR DAYS MEDIAN 90 days) Patients (%)Events (events/pt)Event RatePer 100 Pt-YearAny VT/VF *41 (2.1%)120 (2.9)22NSVT28 (1.4%)164 (5.9)30Atrial arrhythmias/SVT72 (3.6%)561 (7.8)121Asystole6 (0.3%)9 (1.5)2*Treated VT/VF and those VT’s that were spontaneously terminated, response button use or extended detection time.
12ARRHYTHMIC EVENTS: WEARIT-II VS. MADIT-RIT MADIT-RIT Arms B&C
14SAFETY END POINTS TYPE TOTAL N=2000 Inappropriate Rx, n (%) 10 (0.5%) Death, n (%) with the WCD3 (0.2%)** WCD detected asystole at the time of deathNo death related to unsuccessful termination of VT/VF12-m FU data on death are still being collected
18DETECTED WCD ARRHYTHMIAS AND END OF USE DECISION
19CONCLUSIONSIn 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 eventsLow rate of inappropriate therapiesRisk assessment tool to identify patients at higher risk for SCD who need subsequent ICD implantation