Survival After ICD Implant and Incidence of Device Therapy in Patients Less Than Thirty Years Old. The ALTITUDE Study Group

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1 Survival After ICD Implant and Incidence of Device Therapy in Patients Less Than Thirty Years Old The ALTITUDE Study Group Leslie A. Saxon, John P. Boehmer, John D. Day, F. Roosevelt Gilliam, III, Paul W. Jones, Milan Seth, David L. Hayes University of Southern California, Los Angeles, CA, Penn State, Hershey, PA, Intermountain Medical Center, Murray, UT, Cardiology Associates of NE Arkansas, Jonesboro, AR, Boston Scientific, St. Paul, MN, Mayo Clinic, Rochester, MN,

2 Disclosures L. Saxon Boston Scientific, St. Jude Medical, Medtronic J. Boehmer Boston Scientific J. Day Boston Scientific, St. Jude Medical F. Gilliam III Boston Scientific P. Jones Boston Scientific M. Seth Boston Scientific D. Hayes Boston Scientific, Medtronic, St. Jude Medical, Biotronik 2

3 Background The majority of adults receive ICD s for primary prevention indications in the setting of heart failure with systolic dysfunction. The average age at ICD implant is 68 years and much of what is known about survival after implant and device behavior is from data collected in this group There is a paucity of descriptive or outcome data from a large cohort of ICD recipients under 30 years of age Saxon LA et al: Circulation, 2010 Hammill et al: Heart Rhythm

4 Objective The ALTITUDE study group sought to evaluate ICD, programming, survival, first shock incidence and outcomes in recipients under 30 years old that were implanted with Boston Scientific devices across the United States and were enrolled in the LATITUDE remote monitoring system 4

5 Methods The ALTITUDE study group prospectively defines queries and study design to analyze ICD and CRT-D data transmitted through a remote monitoring system (LATITUDE, Boston Scientific) We analyzed 57,632 patients implanted with ICDs from 1/1/2004 to 1/1/2010 and followed on the LATITUDE system The first device implanted during this period was included in the analysis Shock therapy was collected from the device memory and first shocks adjudicated for rhythm type and appropriateness Percentage pacing was evaluated from pacing histograms at the first remote upload 5

6 ALTITUDE Adjudication Committee Leslie Saxon, MD, ALTITUDE Panel Chair University of Southern California Brian Powell, MD, EGM Panel Chair Mayo Clinic Samuel Asirvatham, MD Mayo Clinic Michael Cao, MD University of Southern California David Cesario, MD University of Southern California Yongmei Cha, MD Mayo Clinic Camille Frazier-Mills, MD Duke University F. Roosevelt Gilliam, MD Cardiology Associates of NE Arkansas Soraya Samii, MD Penn State 6

7 Results Examples: VF, VT, Noise 7

8 Methods Survival status was obtained by cross-reference to the Social Security Death Index Deaths occurring between implant and 1/1/2010 were included Cox proportional hazard model analysis Cumulative shock incidence was estimated adjusting for the competing risk of death Kaplan Meier and Cox models, adjusted for age and gender, were used assess the association between shock rhythm and mortality 8

9 Results Clinical Characteristics Over 30 Under 30 Overall Number of Patients 56, ,632 Follow-up (Months ± Std Dev) Age (Years at implant ± Std Dev) Gender (Percent female) 38 ± ± ± ± ± 6 65 ± 13 25% 46% 26% 9

10 Number Of Devices Results Distribution of Devices Age Group at Implant 10

11 Results Survival All Patients Under 30 Under 30 Over 30 Over Months post Implant Under 30: Over 29: % 96% 95% 94% 92% 91% 89% 88% 87% 86% 95% 91% 88% 85% 81% 78% 75% 72% 69% 66% 11

12 Survival (%) Results Survival by Age Group-LATITUDE Under Over Months post Implant % 98% 96% 95% 95% 95% 94% 94% 93% 93% 98% 95% 92% 89% 86% 84% 81% 78% 75% 73% 12

13 Results Single / Dual Coil Leads Percent of Patients Having ICD Lead Type* Over 30 Under 30 Single Coil 4.2% 21.1% Dual Coil 94.3% 75.0% Have had both single and dual coil 1.2% 3.1% Epicardial 1.1% 1.5% SubQ Coil 0.1% 0.7% SubQ Patch 0.2% 0.2% *Includes all devices for patients in cohort, including earlier ICDs 13

14 Results Device Type Single Chamber Dual Chamber Number Percent Number Percent Total Under % % 904 Over % % % %

15 Results Pacing Right Atrial Pacing Age Band Number Median Mean ± Std Dev Under 10: % 41.5% ± 43.0% 10-19: % 18.6% ± 27.5% 20-29: % 18.3% ± 28.4% Total Under 30: % 19.0% ± 28.8% Over 30: % 30.2% ± 35.1% Right Ventricular Pacing Age Band Number Median Mean ± Std Dev Under 10: % 13.8% ± 34.6% 10-19: % 6.2% ± 20.4% 20-29: % 7.6% ± 24.0% Total Under 30: % 7.4% ± 23.5% Over 30: % 17.4% ± 31.2% 15

16 Results RV Pacing and Survival Decreased risk of mortality RV Pacing Above 0% Increased risk of mortality HR (95% CI) Over ( ) Under ( ) Adjusting for gender and Brady mode (VVI vs. other) p-value for pacing by age group interaction in combined model: p=

17 Results Tachycardia Detection Programming Over 30 Under 30 Number of Zones Percent of Patients 21% 55% 24% Average VF Average VT Average VT ATP Active 71% Percent of Patients 38% 37% 25% Average VF Average VT Average VT ATP Active 41% 10% of patients under 30 had monitor only zone 4% of patients over 30 had a monitor only zone 17

18 Results Cumulative Incidence of Any Shock Under 30 Under 30 Over 30 Over 29 HR: 1.48 ( ) p< Months Post Implant Under 30: Over 29: Under 30 0% 17% 23% 27% 30% 33% 34% 36% 39% 40% 40% 0% 9.4% 14% 18% 21% 24% 26% 29% 31% 32% 33% 0% 17% 23% 27% 30% 33% 34% 36% 39% 40% 40% Over 30 0% 9% 14% 18% 21% 24% 26% 29% 31% 32% 33% 18

19 Results Cumulative Incidence of Shock by Rhythm Cumulative Incidence of Shock VT/VF SVT/ST AF/flutter Other Months Post Implant VT/VF SVT/ST AF/flutter Other

20 Results Percent of Shock Episodes by Rhythm Rhythm Group Over 30 Under 30 Monomorphic VT 44.9% 15.7% VF/ Polymorphic VT 15.6% 32.3% AF/AFlutter 13.4% 9.4% Sinus Tach / SVT 12.6% 24.9% Polymorphic and monomorphic VT 9.6% 12.9% Noise/artifact 2.2% 2.8% Non-Sustained VT 1.2% 1% Oversensing 0.4% 0.4% 20

21 Results Shock and Survival by Rhythm in Patients Under 30 Rhythm HR 95% CI p-value AF/Aflutter <.01 Monomorphic VT VF/Polymorphic VT Polymorphic and monomorphic VT Sinus Tach / SVT Male vs. Female age (per 1 year increase)

22 Limitations Limited clinical data regarding co-morbidities for adjustment No data on ICD indication

23 Conclusions In this large cohort of young ICD recipients Survival is excellent after ICD implant Shock rates are higher VF incidence is twice that of an adult cohort and SMVT less frequent Inappropriate shocks are most often due sinus tachycardia or SVT Shocks for AF/Fl but not ventricular arrhythmias, predict worsened mortality outcome 23

24 Discussion Differing disease substrates in younger versus older patients most likely explain these findings Hypertrophic cardiomyopathy and heritable arrhythmia syndromes have differing natural history than dilated cardiomyopathy with heart failure The reason for worsened outcomes in the setting of shocks for AF/flutter may be associated with the disease state (HCM, repaired congenital heart disease) Our observed high survival rates confirm that VF, if treated results in excellent outcomes in this group Berul CI et al: JACC,