Transcript Overview - Boston Scientific

CRM-88604-AA JUN2012
HRS 2012
S-ICD Clinical Highlights
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
presentation may become out of date over time. Nothing on this
presentation should be construed as the giving of advice or the making of a
recommendation and it should not be relied on as the basis for any decision
or action.
The materials are intended for educational purposes only. Boston Scientific
neither assumes nor accepts liability for the accuracy or completeness or
use of, nor any duty to update, the information contained in this
presentation.
Some information in this presentation describe products in development
that will require approvals or clearances by FDA prior to market release.
Some products may be investigational and limited by Federal law to
investigational use.
CRM-88604-AA JUN2012
Disclaimer
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
CRM-88604-AA JUN2012
2. International Experience with a Subcutaneous ICD; Preliminary Results of the
EFFORTLESS S-ICD Registry
Presented by: Pier D. Lambiase, MD, PhD
HRS 2012, Boston, MA
CE Mark Approved.
Caution: S-ICD is an investigational device limited to investigational
use only under US federal law. Not for sale.
Safety and Efficacy of a Subcutaneous
Implantable Defibrillator (S-ICD®)
HRS Late Breaking Clinical Trials
Professor of Medicine
Interim Chief of Cardiology
Director, Heart Rhythm Center
University of Chicago
Heart Rhythm - May 2012; LB01-6
Burke, S-ICD, HRS 2012, Boston, MA
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
CRM-88604-AA JUN2012
Martin C. Burke, DO
Subcutaneous-ICD System
 Designed to sense,
detect and treat
malignant
ventricular
tachyarrhythmias
CRM-88604-AA JUN2012
 S-ICD System
is entirely
subcutaneous
Burke, S-ICD, HRS 2012, Boston, MA
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
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
• Lower Bound of 2-sided CI95% > 79%
Semi-Annual Follow-Up Visits Through Study Close
Burke, S-ICD, HRS 2012, Boston, MA
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
CRM-88604-AA JUN2012
1o Safety Endpoint: 180-Day System Complication Free Rate
Eligibility
Inclusion
 Age ≥ 18 years
 Met guidelines for ICD implantation3 or replacement of an
existing ICD system
 An appropriate pre-operative ECG




Prior VT reliably terminated with anti-tachycardia pacing
Existing epicardial patches or subcutaneous array
Unipolar pacemakers
Severe renal dysfunction (GFR ≤ 29)
Burke, S-ICD, HRS 2012, Boston, MA
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
CRM-88604-AA JUN2012
Key Exclusion Criteria
CRM-88604-AA JUN2012
S-ICD System IDE Study Results
Burke, S-ICD, HRS 2012, Boston, MA
Patient Enrollment
Patients Enrolled
(N=330)
Patients Withdrawn PRIOR to Implant
(N=9)
Implant Testing
Not Completed
(N=17)
•
•
•
•
Active Patients
(N=294)
Burke, S-ICD, HRS 2012, Boston, MA
Implant Testing Completed
EFFECTIVENESS COHORT
(N=304)
Not Discharged with System (N=7)
Exits after Hospital Discharge (N=12)
Deaths unrelated to device or procedure (N=7)
Death unknown due to limited information from
overseas death (N=1)
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
CRM-88604-AA JUN2012
Implant Attempts
SAFETY COHORT
(N=321)
Basic Patient Demographics
Demographic Category
Age (years)
Male
Value
52 ± 16
74%
Height (cm)
174 ± 10
Weight (kg)
91 ± 25
BMI (kg/m2)
30 ± 7
Caucasian
65%
African American
24%
Hispanic or Latino
7%
Other
4%
Burke, S-ICD, HRS 2012, Boston, MA
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
CRM-88604-AA JUN2012
Race
Baseline Characteristics
Co-morbidities
History
Cardiac Surgical
History
Burke, S-ICD, HRS 2012, Boston, MA
Statistic/Category
Congestive Heart Failure
Hypertension
Myocardial Infarction
Diabetes
Atrial Fibrillation
Valve Disease
COPD
Stroke
Percutaneous Revascularization
CABG
TV-ICD
Valve Surgery
Pacemaker
n
197
187
133
90
49
42
27
18
92
48
43
18
4
%
61
58
41
28
15
13
8
6
29
15
13
6
1
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
CRM-88604-AA JUN2012
Attribute
N=321
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
Prevention
21%
Primary
Prevention
78%
CRM-88604-AA JUN2012
Primary
Prevention
79%
Secondary
Prevention
22%
Burke, S-ICD, HRS 2012, Boston, MA
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
Baseline Characteristics
Attribute
NYHA Class at
Enrollment
n
%
Class I
68
21
Class II
146
45
Class III
55
17
Class IV
1
<1
Unknown/Not Assessed
51
16
Mean ± SD (Median)
36 ± 16 (31)
CRM-88604-AA JUN2012
Ejection Fraction (%)
(n=299)
Statistic/Category
N=321
Burke, S-ICD, HRS 2012, Boston, MA
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
CRM-88604-AA JUN2012
Implant Success
Burke, S-ICD, HRS 2012, Boston, MA
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
Implant Attempts
 321 patients underwent implant procedure
 95% implanted using only anatomical landmarks (no
medical imaging)
CRM-88604-AA JUN2012
 No electrode or pulse generator movement in 99% of
implanted patients throughout follow-up period
Burke, S-ICD, HRS 2012, Boston, MA
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
CRM-88604-AA JUN2012
Effectiveness Results
Primary Effectiveness Endpoint
Burke, S-ICD, HRS 2012, Boston, MA
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
Primary Effectiveness Endpoint
Analysis Cohort
Acute Induction
Testing Not
Performed
(N=1)
Acute Induction
Testing Nonevaluable (N=16)
Burke, S-ICD, HRS 2012, Boston, MA
SAFETY COHORT/
Implant Attempts
(N=321)
Patients Withdrawn
PRIOR to Implant
(N=9)
EFFECTIVENESS
COHORT
(N=304)
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
CRM-88604-AA JUN2012
Patients Enrolled
(N=330)
Primary Effectiveness Endpoint Met
 Primary IDE Effectiveness Endpoint
 Hypothesis: Lower Bound of 2-sided CI95% >88%
 N=304 patients
Induction
Testing
Not
Performed
NonEvaluable
Patients
Successful
Failure
1
16
304
0
Evaluable Results
Conversion 95% Lower
Rate (%)
Bound (%)
98.8
CRM-88604-AA JUN2012
100.0
Burke, S-ICD, HRS 2012, Boston, MA
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
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
Induction
Testing
Not
Performed
NonEvaluable
Patients
Successful
Failure
1
16
304
0
100.0
98.8
1
5
304
11
96.5
93.8
Burke, S-ICD, HRS 2012, Boston, MA
Conversion 95% Lower
Rate (%)
Bound (%)
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
CRM-88604-AA JUN2012
Evaluable Results
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
Induction
Testing
Not
Performed
NonEvaluable
Patients
Successful
Failure
1
16
304
0
100.0
98.8
1
5
304
11
96.5
93.8
0
0
304
17
94.7
91.7
Burke, S-ICD, HRS 2012, Boston, MA
Conversion 95% Lower
Rate (%)
Bound (%)
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
CRM-88604-AA JUN2012
Evaluable Results
Spontaneous Episodes
VT/VF Episodes
Total
Discrete
Storm
Episodes
109
28
81
(4 events)
Patients
16
16
2
Evaluation
IDE Study
CRM-88604-AA JUN2012
All episodes successfully converted with 80J
or spontaneously converted
Burke, S-ICD, HRS 2012, Boston, MA
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
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
27
(Patients)
0%
Burke, S-ICD, HRS 2012, Boston, MA
20%
16
40%
60%
80%
Non-Sustained
Sustained
(not shocked)
(shocked)
100%
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
CRM-88604-AA JUN2012
VT/VF
Example: Non-Sustained MVT
Likely to receive therapy from TV-ICD
CRM-88604-AA JUN2012
DURATION: 16 seconds 47 cycles
Burke, S-ICD, HRS 2012, Boston, MA
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
CRM-88604-AA JUN2012
Safety Results
S-ICD System IDE Study
Burke, S-ICD, HRS 2012, Boston, MA
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
Safety Results
Analysis Cohort
Patients Enrolled
(N=330)
Patients Withdrawn
PRIOR to Implant
Procedure
(N=9)
Burke, S-ICD, HRS 2012, Boston, MA
CRM-88604-AA JUN2012
SAFETY COHORT/
Implant Attempts
(N=321)
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
Primary Safety Endpoint Met
1.0
0.9
0.8
180-day Performance Goal (79%)
0.7
Freedom 0.6
from Type I
0.5
Complication
0.4
180-day Type I
Complication-Free Rate:
99.0% (97.9% LCL)
0.3
0.2
0.1
0
30
60
90
120
150
180
Post-op Days
Burke, S-ICD, HRS 2012, Boston, MA
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
CRM-88604-AA JUN2012
0.0
Freedom from all Device-, Labeling-, & Procedurerelated Complications
1.0
0.9
0.8
180-day Performance Goal (79%)
0.7
Freedom
0.6
from
0.5
Type I - III
Complication 0.4
0.3
0.2
0.1
0.0
0
30
60
90
120
150
180
Post-op Days
Burke, S-ICD, HRS 2012, Boston, MA
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
CRM-88604-AA JUN2012
180-day Device &
Procedure-related
Complication-free Rate:
92.1% (88.9% LCL)
CRM-88604-AA JUN2012
Safety Results
Infections
Burke, S-ICD, HRS 2012, Boston, MA
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
Few Infections Led to Explant
All Suspected &
Confirmed Infections
(N=18)
Superficial or Incisional Infections
Managed without System Explant
(n=14, 4.4%)
Managed w/ antibiotics (n=13)
Managed w/ sternal wound revision (n=1)
Burke, S-ICD, HRS 2012, Boston, MA
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
CRM-88604-AA JUN2012
System Explanted
(n=4, 1.3%)
Infections: Study-Wide Learning on Surgical Prep
350
All 4 infections
requiring explantation
occurred early in study
enrollment
250
200
150
100
ENROLLMENTS
300
50
Burke, S-ICD, HRS 2012, Boston, MA
Apr-11
Mar-11
Feb-11
Jan-11
Dec-10
Nov-10
Oct-10
Sep-10
Aug-10
Jun-10
May-10
Apr-10
Jul-10
4
0
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
CRM-88604-AA JUN2012
Infections
requiring explant
Mar-10
Feb-10
Jan-10
0
CRM-88604-AA JUN2012
Safety Results
Inappropriate Shocks
Burke, S-ICD, HRS 2012, Boston, MA
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
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
CRM-88604-AA JUN2012
 No patients experienced a shock due to
discrimination error in Conditional Shock (dual) zone
* 1 patient experienced multiple events
Burke, S-ICD, HRS 2012, Boston, MA
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
Dual-zone Programming Reduced Inappropriate
Shocks
14%
54%
relative
reduction
12%
10%
74%
relative
reduction
8%
6%
2%
0%
Single
Dual
Single
Dual
(n=88)
(n=226)
(n=88)
(n=226)
Oversensing
Burke, S-ICD, HRS 2012, Boston, MA
SVT
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
CRM-88604-AA JUN2012
4%
International Experience with a
Subcutaneous ICD; Preliminary Results of
the EFFORTLESS S-ICD Registry
PD Lambiase
Sponsor: Cameron Health, Inc.
San Clemente, CA
Heart Rhythm - May 2012; Vol 9:5(S1-33) AB07-2.
Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
CRM-88604-AA JUN2012
DAMJ Theuns, C Barr, R Knops,
F Murgatroyd, JB Johansen & L Boersma on behalf
of the EFFORTLESS S-ICD investigators
S-ICD System is entirely
subcutaneous and can be placed
using anatomical landmarks
Three sensing vectors to identify
most robust cardiac signal
Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA
Single-zone
programming
allows therapy to be
delivered solely on
measured heart rate
Dual-zone programming
activates SVT
discrimination algorithm
to determine
appropriateness of
therapy
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
CRM-88604-AA JUN2012
The S-ICD System Operation
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 implant
•
Retrospective and prospective patients implanted
since CE mark
•
Aiming to recruit up to 1000 patients
•
Centers to be included from all current commercial
countries
CRM-88604-AA JUN2012
•
Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
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
•
Cost effectiveness analysis by hospital resource
tracking and use of EQ-5D questionnaire
Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
CRM-88604-AA JUN2012
• Run by Tilburg University Core Lab- Professor Susanne
Pedersen
• SF-12, FPAS, ICDC, HADS, DS-14 & EQ-5D QOL
questionnaires
• Baseline, 3, 6, 12 months post implant
• Direct comparison to TV therapy via MIDAS study cohort
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 with interpretation of the study results
VT that is reliably terminated by ATP
Unipolar pacemakers
*Not applicable for centers enrolling under DN 15677, August 30, 2010
Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
CRM-88604-AA JUN2012
•
EFFORTLESS Registry
Site Participation in 9 Geographies
UK
(13)
NZ
(2)
SL(1)
CZ
(3)
P
(1)
DE
(10)
CRM-88604-AA JUN2012
NL
(7)
DK
(3)
I (4)
Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
EFFORTLESS Registry
Recruitment Overview
230
DK
(14)
NZ (1)
CZ
(17)
NL
(123)
CRM-88604-AA JUN2012
UK
(75)
Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
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
•
•
•
•
Active Patients
(N =210)
Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA
Withdrawn N=1 (heart transplant)
Deaths N=6*
Explants N=5
Inactive N=1
* No device related deaths
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
CRM-88604-AA JUN2012
Patients Implanted
(N =223)
EFFORTLESS Registry
Demographic Category
Value
N
49±19* (11-86)
227
74
227
Height (cm)
175±10
186
Weight (kg)
81±20
196
42±19 (35)
178
104±21
207
Age (yrs; range)
Male (%)
LVEF (%; median)
QRS (ms)
*Approx. 60% of patients (131/227) ≥ 50 yrs
Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
CRM-88604-AA JUN2012
Basic Patient Demographics
EFFORTLESS Registry
Attribute
Co-morbidities
Cardiac Surgical
History
Statistic/Category
Congestive Heart Failure
Hypertension
Myocardial Infarction
Diabetes
Renal Disease
Atrial Fibrillation
COPD
Stroke
Ablation
CABG
Valve Surgery
Prior TV ICD
Pacemaker
N=223
%
32
25
38
13
10
19
6
4
7
10
6
15*
3*
37 patients had previously implanted systems- 6 patients have concomitant PM/S-ICD
Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
CRM-88604-AA JUN2012
Standard ICD Baseline Characteristics
EFFORTLESS Registry
Heart Failure & Indication Characteristics
NYHA Class at
Enrollment
Statistic/Category
n
%
Class I
19
27
Class II
32
46
Class III
10
14
Class IV
0
0
Unknown/Not Assessed
9
13
Indication
Primary
Secondary
Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA
n
%
144
64
81
36
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
CRM-88604-AA JUN2012
Attribute
N=70
EFFORTLESS Registry
Broad Range of ICD Indications
CRM-88604-AA JUN2012
Patients from a broad range of indications have received the S-ICD
Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
EFFORTLESS Registry
Cardiac Medications at Enrollment
Medication
Amiodarone
Diuretics
ACE Inhibitors
Beta Blockers
Digoxin
%
7
93
93
151
11
41
41
67
5
48
33
21
15
CRM-88604-AA JUN2012
Lipid Lowering (incl. statins)
None
n
15
Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
CRM-88604-AA JUN2012
Registry Results
Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
EFFORTLESS Registry
Effective Conversion of Induced VT/VF
Patient Data
n
Implant Conversion test data available
204
Successful conversion within 1 procedure
201
-Successful at 65J
-Successful at 80J
Patients requiring repositioning
1
2
98.5
1.5
CRM-88604-AA JUN2012
-Successful conversion following repositioning
-Awaiting retesting (non inducible)
197
201
%
Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
EFFORTLESS Registry
93% of Events Treated in < than 21secs
93% <21 seconds
40
37.2%
% of Events
35
N=86*
34.9%
Mean ± SD:
Median:
30
15.9±3.8
15.0
25
17.4%
20
15
10
5
3.5%
3.5%
3.5%
<12
12-14.9 15-17.9 18-20.9
21-23.9
≥24
Seconds
*No data available for retrospective patients
Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
CRM-88604-AA JUN2012
0
EFFORTLESS Registry
100% Conversion of Spontaneous VT/VF
• 16 discrete VT/VF episodes from 11 patients
EPISODES
Discrete
Episodes
Patients
Type II
spontaneous
Termination
16
11
2
1st S-ICD
System Shock
Conversion
2nd S-ICD
System Shock
Conversion
13
1
• 32 VT/VF storm episodes from 2 patients both with
electrolyte imbalances (post dialysis and post surgery)
Storm
Events
Episodes
Patients
S-ICD System Shock
Conversion
4
32
2
32 (100%)
Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
CRM-88604-AA JUN2012
EPISODES
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
15
10
5
7%
0
Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA
Rate > Shock Zone
Oversensing
CRM-88604-AA JUN2012
Percent
20
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
EFFORTLESS Registry
Appropriate vs. Inappropriate Episodes
Total of 72
Episodes
60
40
30
20
(67%)
(28%)
10
0
Appropriate
Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA
Inappropriate
Episode
not stored
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
CRM-88604-AA JUN2012
Episodes
50
EFFORTLESS Registry
Clinical Event Definitions
• Clinical Event
•
Any untoward medical occurrence
• Categories
•
•
Complications:
Observations:
Invasive intervention required
Conservative therapy required
• Type I-III Clinical Events
•
Device-, labeling-, or procedure-related
• Type IV Clinical Events
Related to patient condition
CRM-88604-AA JUN2012
•
Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
EFFORTLESS Registry
Device & Procedure-Related Events
Category
Complications
Observations
Device-related (Type I)
2
16
Labeling-related (Type II)
0
0
15
19
Procedure-related (Type III)
Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA
CRM-88604-AA JUN2012
17
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
EFFORTLESS Registry
Device-Related Events - Type I
Category
Complications Observations
1
14
Discomfort
0
1
Premature battery depletion
1
0
Inability to communicate with device
0
1
Total
2
16
CRM-88604-AA JUN2012
Inappropriate Shock - oversensing
Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
EFFORTLESS Registry
Procedure-Related Events - Type III
Complications Observations
Infection/suspicion of infection
6
2
Inappropriate Shock - rate > shock
zone
1
5
Suboptimal electrode position
5
0
Hematoma
1
2
Redness/irritation
0
3
Discomfort
0
2
Keloid formation
0
1
Phantom shocks/vibration
0
3
Transfusion
1
0
PG Movement/Revision
1
0
15
19
Total
Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
CRM-88604-AA JUN2012
Category
EFFORTLESS Registry
Infection Management
Medically
Managed
without System
Explant
(n=3, 1.3%)
*No reported endocarditis
or blood born infection
Lambiase, EFFORTLESS S-ICD Registry, HRS 2012, Boston, MA
Electrode
Explanted
(n=1, 0.4%)
System
Explanted
(n=4, 1.8%)
Electrode
Re-implant
(n=1)
S-ICD
Re-implant
(n=1)
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
CRM-88604-AA JUN2012
All Suspected
Infections*
(N=8)