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Boston Scientific — Heart Rhythm Society (HRS) 2012
57 slides from Boston Scientific's conference presentation, June 2012
Slide 1: HRS 2012 S-ICD Clinical Highlights
HRS 2012 S-ICD Clinical Highlights CRM-88604-AA JUN2012
Slide 2: Disclaimer
Disclaimer The content in this presentation was presented at HRS, May 2012. This presentation is for educational purposes only and should not be copied or presented without the permission of Boston Scientific Corp. Like any other service, in spite of our best efforts the information in this presenta
Slide 3: Table of Contents
Table of Contents 1. Safety and Efficacy of a Subcutaneous Implantable Defibrillator (S-ICD®): HRS Late Breaking Clinical Trials Presented by: Martin C. Burke, DO 2. International Experience with a Subcutaneous ICD; Preliminary Results of the EFFORTLESS S-ICD Registry Presented by: Pier D. Lambiase,
Slide 4: Safety and Efficacy of a Subcutaneous Implantable Defibrillator (S-ICD)
Safety and Efficacy of a Subcutaneous Implantable Defibrillator (S-ICD®) HRS Late Breaking Clinical Trials Martin C. Burke, DO Professor of Medicine Interim Chief of Cardiology Director, Heart Rhythm Center CRM-88604-AA JUN2012 University of Chicago Heart Rhythm - May 2012; LB01-6 CE Mark Approved.
Slide 5: Subcutaneous-ICD System
Subcutaneous-ICD System Designed to sense, detect and treat malignant ventricular tachyarrhythmias S-ICD System is entirely subcutaneous CRM-88604-AA JUN2012 CE Mark Approved. Caution: S-ICD is an investigational device limited Burke, S-ICD, HRS 2012, Boston, MA to investigational use only under
Slide 6: S-ICD Study Design
S-ICD Study Design Prospective, Single-Arm Comparison to OPC Enrollment (N=330) • 33 Sites in the US, NZ, NL, UK 1o Efficacy Endpoint: Acute VF Conversion Rate • 2 consecutive successes out of 4 attempts • Lower Bound of 2-sided CI95% > 88% Optional Sub-Study • VF Conversion Rate at ≥150 Days 1o Saf
Slide 7: Eligibility
Eligibility Inclusion Age ≥ 18 years Met guidelines for ICD implantation3 or replacement of an existing ICD system An appropriate pre-operative ECG Key Exclusion Criteria Prior VT reliably terminated with anti-tachycardia pacing Existing epicardial patches or subcutaneous array Unipolar
Slide 8: S-ICD System IDE Study Results
S-ICD System IDE Study Results CRM-88604-AA JUN2012 Burke, S-ICD, HRS 2012, Boston, MA
Slide 9: Patient Enrollment
Patient Enrollment Patients Enrolled (N=330) Patients Withdrawn PRIOR to Implant (N=9) Implant Testing Implant Attempts Implant Testing Completed SAFETY COHORT Not Completed EFFECTIVENESS COHORT (N=321) (N=17) (N=304) • Not Discharged with System (N=7) • Exits after Hospital Discharge (N=12) • Death
Slide 10: Basic Patient Demographics
Basic Patient Demographics Demographic Category Value Age (years) 52 ± 16 Male 74% Height (cm) 174 ± 10 Weight (kg) 91 ± 25 BMI (kg/m2) 30 ± 7 Race Caucasian 65% African American 24% Hispanic or Latino 7% CRM-88604-AA JUN2012 Other 4% CE Mark Approved. Caution: S-ICD is an investigational device lim
Slide 11: Baseline Characteristics
Baseline Characteristics N=321 Attribute Statistic/Category n % Congestive Heart Failure 197 61 Hypertension 187 58 Myocardial Infarction 133 41 Co-morbidities Diabetes 90 28 History Atrial Fibrillation 49 15 Valve Disease 42 13 COPD 27 8 Stroke 18 6 Percutaneous Revascularization 92 29 CABG 48 15 C
Slide 12: Primary & Secondary Prevention Patient Distribution Similar to NCDR Registry
Primary & Secondary Prevention Patient Distribution Similar to NCDR Registry S-ICD System IDE Study NCDR ICD Registry n=321 patients n=486,025 patients Secondary Secondary Prevention Prevention 21% 22% Primary Primary Prevention Prevention 79% 78% CRM-88604-AA JUN2012 CE Mark Approved. Caution: S-IC
Slide 13: Baseline Characteristics
Baseline Characteristics N=321 Attribute Statistic/Category n % Class I 68 21 Class II 146 45 NYHA Class at Enrollment Class III 55 17 Class IV 1 <1 Unknown/Not Assessed 51 16 Ejection Fraction (%) Mean ± SD (Median) 36 ± 16 (31) (n=299) CRM-88604-AA JUN2012 CE Mark Approved. Caution: S-ICD is an in
Slide 14: Implant Success
Implant Success CRM-88604-AA JUN2012 CE Mark Approved. Caution: S-ICD is an investigational device limited Burke, S-ICD, HRS 2012, Boston, MA to investigational use only under US federal law. Not for
Slide 15: Implant Attempts
Implant Attempts 321 patients underwent implant procedure 95% implanted using only anatomical landmarks (no medical imaging) No electrode or pulse generator movement in 99% of implanted patients throughout follow-up period CRM-88604-AA JUN2012 CE Mark Approved. Caution: S-ICD is an investigati
Slide 16: Effectiveness Results
Effectiveness Results Primary Effectiveness Endpoint CRM-88604-AA JUN2012 CE Mark Approved. Caution: S-ICD is an investigational device limited Burke, S-ICD, HRS 2012, Boston, MA to investigational use only under US federal law. Not for
Slide 17: Primary Effectiveness Endpoint
Primary Effectiveness Endpoint Analysis Cohort Patients Enrolled (N=330) Patients Withdrawn SAFETY PRIOR to COHORT/ Implant (N=9) Implant Attempts Acute Induction (N=321) Testing Not Performed (N=1) Acute Induction EFFECTIVENESS CRM-88604-AA JUN2012 Testing Non- COHORT evaluable (N=304) (N=16) CE Ma
Slide 18: Primary Effectiveness Endpoint Met
Primary Effectiveness Endpoint Met Primary IDE Effectiveness Endpoint Hypothesis: Lower Bound of 2-sided CI95% >88% N=304 patients Evaluable Results Induction Testing 95% Not Non- Conversio Lower Performe Evaluable n Rate Bound d Patients Successful Failure (%) (%) 1 16 304 0 100.0 98.8 CRM-88
Slide 19: Sensitivity Analysis Exceeds OPC
Sensitivity Analysis Exceeds OPC Primary IDE Effectiveness Endpoint Hypothesis: Lower Bound of 2-sided CI95% >88% Sensitivity Analysis Failure: Patients w/ incomplete testing and ≥1 failed shock N=315 patients Evaluable Results Induction Testing 95% Not Non- Conversio Lower Performe Evalua
Slide 20: All Analyses Exceed OPC
All Analyses Exceed OPC Primary IDE Effectiveness Endpoint Hypothesis: Lower Bound of 2-sided CI95% >88% Sensitivity Analysis Failure: Patients w/ incomplete testing and ≥1 failed shock Worst-Case Sensitivity All non-evaluable and 1 not tested deemed “Failures” N=321 patients Evaluable
Slide 21: Spontaneous Episodes
Spontaneous Episodes VT/VF Episodes Evaluation Total Discrete Storm 81 Episodes 109 28 (4 IDE Study events) Patients 16 16 2 All episodes successfully converted with 80J or spontaneously converted CRM-88604-AA JUN2012 CE Mark Approved. Caution: S-ICD is an investigational device limited Burke, S-ICD
Slide 22: Unnecessary Therapy Avoided
Unnecessary Therapy Avoided Algorithm prevents therapy for VT/VF rhythms that are likely to spontaneously terminate Therapy avoided in 63% of patients with VT/VF rhythms meeting criteria to charge without any reports of syncope VT/VF (Patients) 27 16 0% 20% 40% 60% 80% 100% CRM-88604-AA JUN2012
Slide 23: Example: Non-Sustained MVT
Example: Non-Sustained MVT Likely to receive therapy from TV-ICD DURATION: 16 seconds47 cycles CRM-88604-AA JUN2012 CE Mark Approved. Caution: S-ICD is an investigational device limited Burke, S-ICD, HRS 2012, Boston, MA to investigational use only under US federal law. Not for
Slide 24: Safety Results
Safety Results S-ICD System IDE Study CRM-88604-AA JUN2012 CE Mark Approved. Caution: S-ICD is an investigational device limited Burke, S-ICD, HRS 2012, Boston, MA to investigational use only under US federal law. Not for
Slide 25: Safety Results
Safety Results Analysis Cohort Patients Enrolled (N=330) Patients Withdrawn PRIOR to Implant Procedure SAFETY COHORT/ (N=9) Implant Attempts (N=321) CRM-88604-AA JUN2012 CE Mark Approved. Caution: S-ICD is an investigational device limited Burke, S-ICD, HRS 2012, Boston, MA to investigational use on
Slide 26: Primary Safety Endpoint Met
Primary Safety Endpoint Met 1.0 0.9 0.8 180-day Performance Goal 0.7 (79%) Freedom 0.6 from Type I Complicati 0.5 on 0.4 180-day Type I 0.3 Complication-Free 0.2 Rate: 99.0% (97.9% LCL) 0.1 0.0 CRM-88604-AA JUN2012 0 14 28 42 56 70 84 98 112 126 140 154 168 Post-op Days CE Mark Approved. Caution: S-
Slide 27: Freedom from all Device-, Labeling-, & Procedure-related Complications
Freedom from all Device-, Labeling-, & Procedure- related Complications 1.0 0.9 0.8 180-day Performance Goal 0.7 (79%) Freedom 0.6 from Type I - III 0.5 Complicatio 180-day Device & 0.4 n Procedure-related 0.3 Complication-free 0.2 Rate: 92.1% (88.9% LCL) 0.1 0.0 CRM-88604-AA JUN2012 0 14 28 42 56 7
Slide 28: Safety Results: Infections
Safety Results Infections CRM-88604-AA JUN2012 CE Mark Approved. Caution: S-ICD is an investigational device limited Burke, S-ICD, HRS 2012, Boston, MA to investigational use only under US federal law. Not for
Slide 29: Few Infections Led to Explant
Few Infections Led to Explant All Suspected & Confirmed Infections (N=18) Superficial or Incisional Infections System Explanted Managed without System (n=4, 1.3%) Explant (n=14, 4.4%) Managed w/ antibiotics (n=13) Managed w/ sternal wound revision CRM-88604-AA JUN2012 (n=1) CE Mark Approved. Caution
Slide 30: Infections: Study-Wide Learning on Surgical Prep
Infections: Study-Wide Learning on Surgical Prep 350 300 All 4 infections 250 ENROLLMENTS requiring 200 explantation occurred early in 150 study enrollment 100 50 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 1 1 1 1 -1 -1 r-1 r-1 y-1 -1 -1 l-1 -1 -1 t-1 t-1 v-1 c-1 -1 -1 r-1 r-1 r-1 y-1 n b n n g p c c n b Ja
Slide 31: Safety Results: Inappropriate Shocks
Safety Results Inappropriate Shocks CRM-88604-AA JUN2012 CE Mark Approved. Caution: S-ICD is an investigational device limited Burke, S-ICD, HRS 2012, Boston, MA to investigational use only under US federal law. Not for
Slide 32: Inappropriate Shocks
Inappropriate Shocks 38 patients* experienced shocks due to non-VT/VF event 15 patients: SVT > Discrimination zone 24 patients: Oversensing Rate of inappropriate therapy is consistent with current transvenous ICDs No patients experienced a shock due to discrimination error in Conditional S
Slide 33: Dual-zone Programming Reduced Inappropriate Shocks
Dual-zone Programming Reduced Inappropriate Shocks 14% 54% 74% 12% relative relative reduction reduction 10% 8% 6% 4% 2% Single Dual Single Dual (n=88) (n=226) (n=88) (n=226) CRM-88604-AA JUN2012 0% Oversensing SVT CE Mark Approved. Caution: S-ICD is an investigational device limited Burke, S-ICD, H
Slide 34: International Experience with a Subcutaneous ICD; EFFORTLESS S-ICD Registry
International Experience with a Subcutaneous ICD; Preliminary Results of the EFFORTLESS S-ICD Registry PD Lambiase DAMJ Theuns, C Barr, R Knops, F Murgatroyd, JB Johansen & L Boersma on behalf of the EFFORTLESS S-ICD investigators Sponsor: Cameron Health, Inc. CRM-88604-AA JUN2012 San Clemente, CA H
Slide 35: The S-ICD System Operation
The S-ICD System Operation S-ICD System is entirely Single-zone Dual-zone programming subcutaneous and can be placed programming activates SVT using anatomical landmarks allows therapy to discrimination algorithm be delivered solely to determine Three sensing vectors to identify on measured heart ap
Slide 36: EFFORTLESS S-ICD Registry Design
Evaluation oF FactORs AffecTing the CLinical Outcome and Cost EffectiveneSS of the S-ICD – The EFFORTLESS S-ICD Registry Design • International, standard of care Registry to collect short, mid and long-term operational and clinical outcome data on the Cameron Health S-ICD system • 5 year data post i
Slide 37: The EFFORTLESS Registry Design
The EFFORTLESS Registry Design Protocol includes • Documentation of system related outcomes and clinical events • Prospective, Quality of Life sub-study to assess patients perception of their therapy • Run by Tilburg University Core Lab- Professor Susanne Pedersen • SF-12, FPAS, ICDC, HADS, DS-14 &
Slide 38: Inclusion/Exclusion Criteria
EFFORTLESS Registry Inclusion/Exclusion Criteria Inclusion Criteria • ≥ 18yrs* at time of consent • Eligible for implantation of an S-ICD system per local clinical guidelines or currently implanted with an S-ICD Exclusion Criteria • Participation in any other investigational study that may interfere
Slide 39: Site Participation in Geographies
EFFORTLESS Registry Site Participation in 9 Geographies UK (13) DK NL (3) (7) NZ SL(1) (2) CZ P (3) (1) DE (10) CRM-88604-AA JUN2012 I (4) CE Mark Approved. Caution: S-ICD is an investigational device limited Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA to investigational use only under
Slide 40: Recruitment Overview
EFFORTLESS Registry Recruitment Overview 230 DK NZ (1) (14) CZ (17) NL UK (123) (75) CRM-88604-AA JUN2012 CE Mark Approved. Caution: S-ICD is an investigational device limited Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA to investigational use only under US federal law. Not for
Slide 41: Patient Status as of April 27, 2012
EFFORTLESS Registry Patient Status as of April 27, 2012 Average FU 389±282 days, max 981 days Patients Enrolled (N=230) • Missing Data N=4 • Withdrawn due to ineligibility N=2 • Consented not implanted N=1 Patients Implanted (N =223) • Withdrawn N=1 (heart transplant) • Deaths N=6* • Explants N=5 CR
Slide 42: Basic Patient Demographics
EFFORTLESS Registry Basic Patient Demographics Demographic Category Value N Age (yrs; range) 49±19* (11-86) 227 Male (%) 74 227 Height (cm) 175±10 186 Weight (kg) 81±20 196 LVEF (%; median) 42±19 (35) 178 QRS (ms) 104±21 207 *Approx. 60% of patients (131/227) ≥ 50 CRM-88604-AA JUN2012 yrs CE Mark Ap
Slide 43: Standard ICD Baseline Characteristics
EFFORTLESS Registry Standard ICD Baseline Characteristics N=223 Attribute Statistic/Category % Congestive Heart Failure 32 Hypertension 25 Myocardial Infarction 38 Diabetes 13 Co-morbidities Renal Disease 10 Atrial Fibrillation 19 COPD 6 Stroke 4 Ablation 7 CABG 10 Cardiac Surgical Valve Surgery 6 H
Slide 44: Heart Failure & Indication Characteristics
EFFORTLESS Registry Heart Failure & Indication Characteristics N=70 Attribute Statistic/Category n % Class I 19 27 Class II 32 46 NYHA Class at Class III 10 14 Enrollment Class IV 0 0 Unknown/Not Assessed 9 13 Indication n % Primary 144 64 CRM-88604-AA JUN2012 Secondary 81 36 CE Mark Approved. Cauti
Slide 45: Broad Range of ICD Indications
EFFORTLESS Registry Broad Range of ICD Indications Patients from a broad range of indications have received the S-ICD Ischemic (38%) Channelopathy (13%) Congential (3%) Non ischemic CM (10%) HCM (13%) ARVD (3%) Idiopathic VF (20%) CRM-88604-AA JUN2012 CE Mark Approved. Caution: S-ICD is an investiga
Slide 46: Cardiac Medications at Enrollment
EFFORTLESS Registry Cardiac Medications at Enrollment Medication n % Amiodarone 15 7 Diuretics 93 41 ACE Inhibitors 93 41 Beta Blockers 151 67 Digoxin 11 5 Lipid Lowering (incl. statins) 48 21 None 33 15 CRM-88604-AA JUN2012 CE Mark Approved. Caution: S-ICD is an investigational device limited Lambi
Slide 47: Registry Results
Registry Results CRM-88604-AA JUN2012 CE Mark Approved. Caution: S-ICD is an investigational device limited Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA to investigational use only under US federal law. Not for
Slide 48: Effective Conversion of Induced VT/VF
EFFORTLESS Registry Effective Conversion of Induced VT/VF Patient Data n % Implant Conversion test data available 204 Successful conversion within 1 procedure 201 98. -Successful at 65J 197 5 -Successful at 80J 201 Patients requiring repositioning 1.5 -Successful conversion following repositioning
Slide 49: 93% of Events Treated in Less Than 21 Seconds
EFFORTLESS Registry 93% of Events Treated in < than 21secs 93% <21 seconds N=86* 40 37.2% 34.9% 35 Mean ± SD: 30 15.9±3.8 Median: % of Events 15.0 25 20 17.4% 15 10 5 3.5% 3.5% 3.5% 0 <12 12-14.9 15-17.9 18-20.9 21-23.9 ≥24 CRM-88604-AA JUN2012 Seconds *No data available for retrospective patients C
Slide 50: 100% Conversion of Spontaneous VT/VF
EFFORTLESS Registry 100% Conversion of Spontaneous VT/VF • 16 discrete VT/VF episodes from 11 patients EPISODES Type II 1st S-ICD 2nd S-ICD Discrete spontaneous System Shock System Shock Episodes Patients Termination Conversion Conversion 16 11 2 13 1 • 32 VT/VF storm episodes from 2 patients both w
Slide 51: Annual Inappropriate Shock Rate of 7%
EFFORTLESS Registry Annual Inappropriate Shock Rate of 7% • 15 patients received inappropriate shocks (7%) • No inappropriate shocks have been recorded for AF/SVT within a programmed conditional shock zone 20 Percent 15 10 5 Rate > Shock 7% Zone Oversensin CRM-88604-AA JUN2012 0 g CE Mark Approved.
Slide 52: Appropriate vs. Inappropriate Episodes
EFFORTLESS Registry Appropriate vs. Inappropriate Episodes 60 Total of 72 Episodes 50 Episodes 40 30 (67%) 20 10 (28%) 0 Appropriate Inappropriate Episode CRM-88604-AA JUN2012 not stored CE Mark Approved. Caution: S-ICD is an investigational device limited Lambiase, EFFORTLESS S-ICD Registry, HRS 20
Slide 53: Clinical Event Definitions
EFFORTLESS Registry Clinical Event Definitions • Clinical Event • Any untoward medical occurrence • Categories • Complications: Invasive intervention required • Observations: Conservative therapy required • Type I-III Clinical Events • Device-, labeling-, or procedure-related • Type IV Clinical Even
Slide 54: Device & Procedure-Related Events
EFFORTLESS Registry Device & Procedure-Related Events Category Complications Observations Device-related (Type I) 2 16 Labeling-related (Type 0 0 II) Procedure-related (Type 15 19 III) 17 CRM-88604-AA JUN2012 CE Mark Approved. Caution: S-ICD is an investigational device limited Lambiase, EFFORTLESS
Slide 55: Device-Related Events - Type I
EFFORTLESS Registry Device-Related Events - Type I Complicatio Observatio Category ns ns Inappropriate Shock - oversensing 1 14 Discomfort 0 1 Premature battery depletion 1 0 Inability to communicate with 0 1 device Total 2 16 CRM-88604-AA JUN2012 CE Mark Approved. Caution: S-ICD is an investigation
Slide 56: Procedure-Related Events - Type III
EFFORTLESS Registry Procedure-Related Events - Type III Complicatio Observation Category ns s Infection/suspicion of infection 6 2 Inappropriate Shock - rate > shock 1 5 zone Suboptimal electrode position 5 0 Hematoma 1 2 Redness/irritation 0 3 Discomfort 0 2 Keloid formation 0 1 Phantom shocks/vibr
Slide 57: Infection Management
EFFORTLESS Registry Infection Management All Suspected Infections* (N=8) Medically Managed Electrode System without Explanted Explanted System (n=1, 0.4%) (n=4, 1.8%) Explant (n=3, 1.3%) Electrode S-ICD *No reported Re-implant Re-implant CRM-88604-AA JUN2012 endocarditis or blood (n=1) (n=1) born in