Clinical Characteristics and Outcomes of Elderly Patients Treated With ICD and CRTD in Real World Setting: Data From the Israeli ICD Registry M. Suleiman, M. Haim, JE. Schliamser, M. Boulos, S. Viskin, M. Swissa, N. Gavrielov-Yusim, T. Fuchs, M. Ilan, I. Goldenberg6, and M. Glikson6 April 23, 2013

BackgroundBackground Elderly patients (eg, age ≥75 or 80 years) and patients with major co-morbidities were excluded from some of the major ICD/CRTD trials, and few patients over age 75 were enrolled in any of the trials It is not known, therefore, what survival benefit elderly patients derive from device- based therapy Elderly patients (eg, age ≥75 or 80 years) and patients with major co-morbidities were excluded from some of the major ICD/CRTD trials, and few patients over age 75 were enrolled in any of the trials It is not known, therefore, what survival benefit elderly patients derive from device- based therapy

PurposePurpose To evaluate, the outcomes of elderly patients who received device-based therapy (ICD or CRT-D) in a “real- world” scenario

MethodsMethods Israeli ICD Registry Database Israeli ICD Registry Database Period: Jul 2010-June 2012 Period: Jul 2010-June 2012 Study end points Death Appropriate ICD therapies for VA Readmission to hospital for HF The combined endpoints of HF or death, VA or death Need for device related surgical re- intervention. Israeli ICD Registry Database Israeli ICD Registry Database Period: Jul 2010-June 2012 Period: Jul 2010-June 2012 Study end points Death Appropriate ICD therapies for VA Readmission to hospital for HF The combined endpoints of HF or death, VA or death Need for device related surgical re- intervention.

Baseline Characteristics Variable Age Group ≤65(n=137 8) (n=863) >75(n=566 ) p Percent of total population Female gender (%) Ethnicity Jews788893<0.001 Arabs22117<0.001 Medical History Heart Failure (%) NYHA I-II NYHA III NYHA IV122

Baseline Characteristics (cont’) Variable (%) Age Group ≤65(n=137 8) (n=863) >75(n=566 ) p Previous MI <0.001 CABG223843<0.001 PCI (61%)0.003 Dilated non-ischemic CM 30%1715<0.001 Atrial fibrillation162629<0.001 Cerebrovascular disease 611 <0.001 Diabetes334337<0.001 Hypertension557172<0.001 Dyslipidemia5060 <0.001 Chronic lung disease

Baseline Characteristics (cont’) Variable (%) Age Group ≤65(n=137 8) (n=863) >75(n=56 6) p Beta Blockers1130 (83%)699 (81%)445 (79%)0.2 ACE- I/ARB1009 (74%)648 (81%)420 (75%)0.48 Diuretics914 (67%)646 (75%)432 (77%)<0.001 Anti-arrhythmic drugs180 (14%)167 (20%)142 (26%)<0.001 Amiodaron128 (10%)116 (14%)101 (18%) Diagnostic studies LVEF<30%733 (54%)470 (55%)319 (57%) QRS duration, mean (ms)114±30122±30125±31<0.001 QRS>120 ms438 (32)365 (43%)254 (45%)<0.001 Electrophysiologic study205 (15%)155 (18%)104 (19%)0.06

Device implanted P<0.001 IndicationIndication

OutcomesOutcomes 1218 (84% male; age≤65, n=612; 66-75, n=376; >75, n=230) unselected registry patients were prospectively followed for the occurrence of clinical outcomes.

Death o HF in the General Population

Death or HF According to Device Type In ICD recipients In RCTD recipients

Death or VA in the General Population

Device-Related Complications Aassociated with Surgical Re-interventions

Multivariate analysis: Risk of HF/Death by age category (reference group =age<65) EndpointTotal PopulationICD RecipientsCRTD Recipients HRp P p HF or death Age < Age> < < HF Age Age>

Multivariate analysis: Risk of VA/Death by age category (reference group =age<65) EndpointTotal PopulationICD RecipientsCRTD Recipients HRp P p VT/VF or death Age Age> < < VT/VF Age Age>

Main Findings Of new ICDs and CRTDs implanted in Israel, >50% are in patients >65 yo and >20% in patients >75 yo Elderly patients have higher risk profile more likely to receive CRTD device > secondary prevention indication Of new ICDs and CRTDs implanted in Israel, >50% are in patients >65 yo and >20% in patients >75 yo Elderly patients have higher risk profile more likely to receive CRTD device > secondary prevention indication

Main Findings Our data add to and support the existing evidence from previous studies that the association between advanced age and adverse clinical outcomes is attenuated in elderly patients implanted with CRT-D devices.

Main Findings Elderly patients implanted with ICDs experienced a significant increase in the cumulative probability of the combined end- points of appropriate ICD therapy or death and HF or death In contrast, the risk of both HF and arrhythmic outcomes was attenuated among elderly patients implanted with CRT-D devices. Elderly patients implanted with ICDs experienced a significant increase in the cumulative probability of the combined end- points of appropriate ICD therapy or death and HF or death In contrast, the risk of both HF and arrhythmic outcomes was attenuated among elderly patients implanted with CRT-D devices.