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Assessment of Myocardial Scarring Improves Risk Stratification In Journal of the American College of Cardiology Vol. 60, No. 5, 2012 © 2012 by the American College of Cardiology Foundation ISSN 0735-1097/$36.00 Published by Elsevier Inc. http://dx.doi.org/10.1016/j.jacc.2012.02.070 Imaging in Heart Rhythm Disorders Assessment of Myocardial Scarring Improves Risk Stratification in Patients Evaluated for Cardiac Defibrillator Implantation Igor Klem, MD,*† Jonathan W. Weinsaft, MD,*† Tristram D. Bahnson, MD,† Don Hegland, MD,*† Han W. Kim, MD,*† Brenda Hayes, BS,* Michele A. Parker, MS,*† Robert M. Judd, PHD,*†‡ Raymond J. Kim, MD*†‡ Durham, North Carolina Objectives We tested whether an assessment of myocardial scarring by cardiac magnetic resonance imaging (MRI) would improve risk stratification in patients evaluated for implantable cardioverter-defibrillator (ICD) implantation. Background Current sudden cardiac death risk stratification emphasizes left ventricular ejection fraction (LVEF); however, most patients suffering sudden cardiac death have a preserved LVEF, and many with poor LVEF do not benefit from ICD prophylaxis. Methods One hundred thirty-seven patients undergoing evaluation for possible ICD placement were prospectively enrolled and underwent cardiac MRI assessment of LVEF and scar. The pre-specified primary endpoint was death or ap- propriate ICD discharge for sustained ventricular tachyarrhythmia. Results During a median follow-up of 24 months the primary endpoint occurred in 39 patients. Whereas the rate of ad- verse events steadily increased with decreasing LVEF, a sharp step-up was observed for scar size Ͼ5% of left ventricular mass (hazard ratio [HR]: 5.2; 95% confidence interval [CI]: 2.0 to 13.3). On multivariable Cox propor- tional hazards analysis, including LVEF and electrophysiological-study results, scar size (as a continuous variable or dichotomized at 5%) was an independent predictor of adverse outcome. Among patients with LVEF Ͼ30%, those with significant scarring (Ͼ5%) had higher risk than those with minimal or no (Յ5%) scarring (HR: 6.3; 95% CI: 1.4 to 28.0). Those with LVEF Ͼ30% and significant scarring had risk similar to patients with LVEF Յ30% (p ϭ 0.56). Among patients with LVEF Յ30%, those with significant scarring again had higher risk than those with minimal or no scarring (HR: 3.9; 95% CI: 1.2 to 13.1). Those with LVEF Յ30% and minimal scarring had risk similar to patients with LVEF Ͼ30% (p ϭ 0.71). Conclusions Myocardial scarring detected by cardiac MRI is an independent predictor of adverse outcome in patients being considered for ICD placement. In patients with LVEF Ͼ30%, significant scarring (Ͼ5% LV) identifies a high-risk cohort similar in risk to those with LVEF Յ30%. Conversely, in patients with LVEF Յ30%, minimal or no scarring identifies a low-risk cohort similar to those with LVEF Ͼ30%. (J Am Coll Cardiol 2012;60:408–20) © 2012 by the American College of Cardiology Foundation Sudden cardiac death (SCD) is a leading cause of mortality for an implantable cardioverter-defibrillator (ICD) (2–5). responsible for approximately 325,000 deaths annually in However, LVEF has limitations in predicting clinical the United States alone (1). Currently, risk stratification for events. Sudden cardiac death typically results from ventricular SCD emphasizes left ventricular ejection fraction (LVEF), and significant left ventricular (LV) dysfunction has become See page 421 the primary basis for determining the eligibility of a patient From the *Duke Cardiovascular Magnetic Resonance Center, Duke University Medical is owned by Northwestern University. Dr. Bahnson is a consultant to ChanRx and Sequel Center, Durham, North Carolina; †Division of Cardiology, Duke University Medical Pharmaceuticals; has received grant support from the NIH, Cardiofocus, and Medtronic; Center, Durham, North Carolina; and the ‡Department of Radiology, Duke University and has received speakers’ fees from Boehringer Ingelheim Pharmaceuticals, Janssen Medical Center, Durham, North Carolina. Dr. Weinsaft is currently at the Division of Pharmaceuticals/Johnson & Johnson. All other authors have reported that they have no Cardiology, Weill Cornell Medical College, New York. Funding for the research was relationships relevant to the contents of this paper to disclose. provided in part by National Institutes of Health Grant 2RO1-HL64726 (to Dr. Judd). Manuscript received January 4, 2012; revised manuscript received January 24, 2012, Drs. Kim and Judd are inventors of a U.S. patent on Delayed Enhancement MRI, which accepted February 21, 2012. JACC Vol. 60, No. 5, 2012 Klem et al. 409 July 31, 2012:408–20 Myocardial Scarring and ICD Risk Stratification tachyarrhythmias (6), and LVEF provides an indirect measure criteria for an ICD in 69 (50%) Abbreviations of the arrhythmic potential. Not surprisingly, in population patients; mild LV dysfunction and Acronyms not meeting criteria but with pal- coronary artery ؍ studies, up to 70% of patients suffering SCD have a preserved CAD LVEF and are not identified for prophylactic ICD insertion pitations, frequent premature disease confidence interval ؍ By contrast, in patients with poor LVEF—who are eligible ventricular contractions, and/or CI .(7) nonsustained ventricular tachy- -delayed ؍ for ICD prophylaxis—many do not benefit. Recent trials DE-CMR suggest that approximately 14 to 18 patients with ventric- cardia in 22 (16%); evaluation of enhancement ular dysfunction need to have an ICD implanted to prevent wide-complex tachycardia in 25 cardiovascular magnetic 1 death (3,5). Moreover, considering the substantial cost (8) (18%); syncope in 17 (13%); and resonance electrophysiology ؍ and the potential for complications (9), improved risk presumed cardiac arrest in 4 (3%). EPS stratification to identify patients who would benefit most Of the 137 patients that were en- study hazard ratio ؍ from ICD implantation remains an important public health rolled, cardiac MRI was per- HR implantable ؍ challenge. formed for research purposes (only ICD Myocardial scar tissue is known to serve as a substrate for this specific protocol) in 109 pa- cardioverter-defibrillator interquartile range ؍ malignant ventricular tachyarrhythmias in both ischemic tients, and scan results were not IQR left ventricular ؍ and nonischemic cardiac disorders (12,13). Impor- used to guide clinical decision- LV (10,11) left ventricular ؍ tantly, the presence and extent of scarring might not be making. The remaining 28 pa- LVEF concordant with LVEF. For instance, some patients with tients were screened concurrently ejection fraction magnetic resonance ؍ extensive scarring might have preserved LVEF either be- and in the same prospective man- MRI imaging cause the scar is not full-thickness and/or because there is ner but had a clinically ordered ؍ hyperkinesia of remote segments (14,15). Conversely, some scan for the assessment of LVEF. NYHA New York Heart Association patients without myocardial scarring might have severely This group was similar to the 109 sudden cardiac ؍ scanned only for the purpose of SCD reduced LVEF (16,17). research with respect to age, sex, death We postulated that an assessment of myocardial scarring ventricular ؍ prevalence of coronary artery dis- VT would improve risk stratification for SCD beyond that pro- ease (CAD), LVEF, prevalence tachycardia vided by LVEF. Delayed-enhancement cardiovascular mag- and extent of scar, as well as netic resonance (DE-CMR) provides high spatial resolu- clinical outcome during follow-up (all p Ͼ 0.10). All tion images of scar tissue that directly correlate with patients gave written informed consent. The study was pathology (18,19). Additionally, DE-CMR has shown approved by the Duke Institutional Review Board. prognostic utility above and beyond common clinical and A comprehensive medical history including CAD risk functional indexes in a variety of cohorts with ischemic factors, heart failure functional class (New York Heart (20–23) or nonischemic (19,20,24) cardiac disorders. How- Association [NYHA]), and medications at the time of ever, in most studies evaluating prognosis, there were few cardiac MRI was obtained in all patients. Additionally, hard events, and the primary endpoint was a composite 12-lead electrocardiography was performed a median of 2 including hospitalization for heart failure. Thus, additional days (interquartile range [IQR]: 1 to 5 days) from cardiac studies evaluating the prognostic value of DE-CMR are MRI and interpreted blinded to clinical and cardiac MRI essential. data. Established criteria (3) were used to categorize pa- The present investigation was designed to directly tients as having ischemic or nonischemic heart disease: compare the predictive value of scar to LVEF—both ischemic disease was considered present if there was Ն70% simultaneously assessed during the same cardiac magnetic stenosis of a major epicardial coronary artery on x-ray resonance imaging (MRI) session—for adverse outcome angiography (25), history of enzymatically proven myocar- in patients being considered for ICD implantation. dial infarction, or evidence of ischemia or infarction on clinical stress-testing. Most patients (n ϭ 122, 89%) had previously undergone x-ray coronary angiography. Methods Follow-up. Information concerning arrhythmic events and Population and design. We prospectively screened pa- mortality status were obtained at regular intervals of 6 tients referred to the electrophysiology service and sched- months via: 1) telephone interview with the patient or, if uled for an electrophysiology study (EPS) and/or ICD deceased, with family
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