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Presented by Wojciech Zareba, M.D., Ph.D., at the 15th Congress of the International Society of Holter and Noninvasive Electrocardiology May 30 - June 1, 2013, Timisoara, Romania
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15th Congress of the International Society of Holter and Noninvasive Electrocardiology May 30 - June 1, 2013, Timisoara, Romania Risk Stratification inMADIT II Type Patients • Principle Investigator: Wojciech Zareba, MD, PhD • University of Rochester, Rochester, NY • Study was funded by the NIH: R01 HL077478-01A1 • with additional support from: • Arrhythmia Research Technology, Inc. • Cambridge Heart • Gilead Sciences
Risk Stratification of Ventricular Tachycardia or Ventricular Fibrillation in Postinfarction Patients with EF≤35%: Results from a Multicenter ICD Risk Stratification Study Wojciech Zareba, James Daubert, Mark L. Andrews, AyshaArshad, Otto Costantini, Jean Philippe Couderc, Andrew E. Epstein, Scott McNitt, Arthur J. Moss, Eric Rashba, Spencer Rosero, Lawrence Rosenthal, Steven Shorofsky, Ken Stein, GioiaTuritto, Michal B. Weiss, Steve Winters, for M2Risk Investigators From: University of Rochester, Cardiology Unit, Rochester, NY, Duke University Medical Center, Durham, NC, Metro Health System, Cleveland, OH, Valley Health System, Ridgewood, NJ, University of Pennsylvania, Cardiology Unit, Philadelphia, PA, SUNY-Stony Brook Health Sciences Center, Stony Brook, NY, University of Massachusetts, Memorial Medical Center, Worcester, MA, University of Maryland Medical Center, Baltimore, MD, Cornell University, New York, NY (KS currently: Boston Scientific, Arden Hills, MN), New York Methodist Hospital, Brooklyn, NY, Electrophysiology Associates, Morristown, NJ Disclosure: This study was supported by NIH Grant R01 HL077478-01, with additional support from Arrhythmia Research Technology, Inc. Fitchburg, MA, Cambridge Heart, Tewksbury, MA, and Gilead Sciences, Palo Alto, CA
Study Objectives: We conducted a comprehensive NIH-funded Multicenter ICD Risk Stratification Study (M2Risk Study) to determine which clinical and novel ECG-based variables will predict arrhythmic events and death in post-MI patients with EF≤35%.
Endpoints in M2Risk Study • VT/VF requiring ICD therapy • Death, and • VT/VF or death
Data Collected at Enrollment • routine clinical data • 12-lead ECG • 24-hour Holter monitoring (Mortara Instruments, Milwaukee, WI) • signal-averaged ECG [SAECG] (Arrhythmia Research Technology Inc., Fitchburg, MA) • exercise-induced T wave alternans [TWA] (Cambridge Heart, Tewksbury, MA).
ECG-based Parameters • Heart rate variability • Heart rate turbulence, deceleration capacity • Ventricular arrhythmias on the 24-hour HolterQRS duration and QRS complexity • QTcduration and T wave complexity • Total QRS root mean square voltage (TRMS) from SAECG (80-250Hz Bi-Directional Butterworth Filter) • Late potentials parameters (fQRSd, RMS, LAS) from SAECG • TWA presence.
Study Patients and Outcome • 484 patients enrolled (17% females) • Age 64±10 years • Follow-up: 27±18 months • VT/VF occurred in 49 (10.1%) • Death in 44 (9.1%) • VT/VF or death in 94 (19.4%) patients
Clinical and ECG Characteristic of Patients with and without Events
M2Risk: Cumulative Probability of VT/VF by Key Statistical Significant Variables Heart Rate Turbulence Elevated BUN
M2Risk: Cumulative Probability of VT/VF by Key Statistical Significant Variables Decreased QRS Voltage <25uV in SAECG Frequent VPBs
M2Risk: Cumulative Probability of Death by Key Statistical Significant Variables Heart Rate Turbulence Elevated BUN
M2Risk: Cumulative Probability of Death by Key Statistical Significant Variables Decreased QRS Voltage <25uV in SAECG Frequent VPBs
M2Risk: Hazard Ratios fromMultivariateAnalysisforPredicting VT/VF, Death, and VT/VF/Death None of other ECG-based variables predicted VT/VF and none of other variables was predictive for mortality after adjustment for clinical covariates.
Combination of TRMS in SAECG and VPBs in Holter identify patients at high, intermediate and low risk for VT/VF
CONCLUSIONS • Arrhythmic events (VT/VF) in postinfarction patients receiving ICDs are predicted by frequent VPBs on Holter and low QRS voltage on the SAECG. • Low QRS voltage on the SAECG (TRMS<25μV) is a novel risk marker of ventricular tachyarrhythmias. • Death in such ICD patients is predicted by elevated BUN and abnormal heart rate turbulence. • Different clinical and ECG variables predict mortality and arrhythmic events: VPBs and low QRS voltage in SAECG favor ICD implantation whereas HRT might indicate use of CRT devices.