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Slide1
HRS
2012
S-ICD
Clinical Highlights
Slide2Disclaimer
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Like any other service, in spite of our best efforts the information in this presentation may become out of date over time.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.
Slide3Table of Contents
1. Safety
and Efficacy of a Subcutaneous Implantable Defibrillator (
S-ICD
®): HRS Late Breaking Clinical Trials Presented by: Martin C. Burke, DO2. 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.
Slide4Safety and Efficacy of a Subcutaneous Implantable Defibrillator (S-ICD®)
HRS Late Breaking Clinical Trials
Martin C. Burke, DO
Professor of Medicine
Interim Chief of CardiologyDirector, Heart Rhythm CenterUniversity 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.
Slide5Subcutaneous-ICD System
Designed to sense, detect
and
treat
malignant ventricular tachyarrhythmiasS-ICD Systemis 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.
Slide6S-ICD Study Design
Prospective, Single-Arm Comparison to OPC
Enrollment (N=330)
33 Sites in the US, NZ, NL, UK
1
o Efficacy Endpoint: Acute VF Conversion Rate 2 consecutive successes out of 4 attempts
Lower Bound of 2-sided CI
95%
> 88%
Semi-Annual
Follow-Up Visits Through Study Close
Optional
Sub-Study
VF
Conversion Rate at ≥150 Days
1
o
Safety
Endpoint: 180-Day
System Complication Free
Rate
Lower Bound of 2-sided CI
95%
> 79%
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.
Slide7Eligibility
Inclusion
Age ≥ 18 years
Met guidelines for ICD
implantation3 or replacement of an existing ICD systemAn appropriate pre-operative ECGKey Exclusion CriteriaPrior VT reliably terminated with anti-tachycardia pacingExisting epicardial patches or subcutaneous array Unipolar pacemakersSevere 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.
Slide8S-ICD System IDE Study Results
Burke,
S-ICD, HRS 2012, Boston,
MA
Slide9Patient Enrollment
Implant Testing Completed
EFFECTIVENESS COHORT
(N=304)
Implant Testing Not Completed
(N=17)
Active Patients
(N=294)
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)
Patients Withdrawn PRIOR to Implant
(N=9)
Implant Attempts
SAFETY COHORT
(N=321)
Patients Enrolled
(N=330)
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.
Slide10Basic Patient Demographics
Demographic Category
Value
Age (years)
52 ± 16
Male
74%
Height (cm)
174 ± 10
Weight (kg)
91 ± 25
BMI (kg/m
2
)
30 ± 7
Race
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.
Slide11Baseline Characteristics
Attribute
Statistic/Category
N=321
n
%
Co-morbidities
History
Congestive Heart Failure
197
61
Hypertension
187
58
Myocardial Infarction
133
41
Diabetes
90
28
Atrial Fibrillation
49
15
Valve Disease
42
13
COPD
27
8
Stroke
18
6
Cardiac Surgical
History
Percutaneous
Revascularization
92
29
CABG
48
15
TV-ICD
43
13
Valve Surgery
18
6
Pacemaker
4
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.
Slide12Primary & Secondary Prevention Patient
Distribution Similar to NCDR Registry
Secondary Prevention
21%
Secondary Prevention
22%Primary Prevention79%Primary Prevention78%
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.
Slide13Baseline Characteristics
Attribute
Statistic/Category
N=321
n
%
NYHA Class at Enrollment
Class I
68
21
Class II
146
45
Class III
55
17
Class IV
1
<1
Unknown/Not Assessed
51
16
Ejection Fraction (%)
(n=299)
Mean ± SD (
Median)
36
±
16
(
31)
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.
Slide14Implant 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.
Slide15Implant 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
Burke,
S-ICD, HRS 2012, Boston, MACE Mark Approved.Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.
Slide16Effectiveness 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.
Slide17Primary Effectiveness Endpoint
Analysis Cohort
Patients Enrolled
(N=330)
Patients Withdrawn PRIOR to Implant (N=9)
SAFETY COHORT/Implant Attempts
(N=321)
EFFECTIVENESS COHORT
(N=304)
Acute Induction Testing Not Performed
(N=1)
Acute Induction Testing Non-evaluable (N=16)
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.
Slide18Primary Effectiveness Endpoint Met
Primary IDE Effectiveness
Endpoint
Hypothesis: Lower Bound of
2-sided CI95% >88%N=304 patients
Induction Testing Not PerformedNon-Evaluable Patients
Evaluable Results
Conversion
Rate
(%)
95%
Lower Bound (%)
Successful
Failure
1
16
304
0
100.0
98.8
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.
Slide19Sensitivity Analysis Exceeds OPC
Primary IDE Effectiveness
Endpoint
Hypothesis: Lower Bound of
2-sided CI95% >88%
Sensitivity AnalysisFailure: Patients w/ incomplete testing and ≥1 failed shockN=315 patientsInduction Testing Not Performed
Non-Evaluable Patients
Evaluable Results
Conversion
Rate
(%)
95%
Lower Bound (%)
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
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
Slide20All Analyses Exceed OPC
Primary IDE Effectiveness
Endpoint
Hypothesis: Lower Bound of 2
-sided CI95% >88%
Sensitivity AnalysisFailure: Patients w/ incomplete testing and ≥1 failed shockWorst-Case SensitivityAll non-evaluable and 1 not tested deemed “Failures”N=321 patientsInduction Testing Not Performed
Non-Evaluable Patients
Evaluable Results
Conversion
Rate
(%)
95%
Lower Bound (%)
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
CE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
Slide21Spontaneous
Episodes
Evaluation
VT/VF
Episodes
TotalDiscrete
Storm
IDE Study
Episodes
109
28
81
(4 events)
Patients
16
16
2
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.
Slide22Unnecessary 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
Burke,
S-ICD, HRS 2012, Boston,
MACE Mark Approved.
Caution: S-ICD is an investigational device limited
to investigational use only under US federal law. Not for sale.
Slide23Example: Non-Sustained MVT
Likely to receive therapy from TV-ICD
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.
Slide24Safety 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.
Slide25Safety Results
Analysis Cohort
Patients Enrolled
(N=330)
SAFETY COHORT/
Implant Attempts(N=321)
Patients Withdrawn PRIOR to Implant Procedure
(N=9)
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.
Slide26Primary Safety Endpoint Met
Freedom from Type I Complication
180-day Type I Complication-Free Rate:
99.0% (97.9% LCL
)
Post-op Days180-day Performance Goal (79%)
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.
Slide27Freedom from all Device-, Labeling-, & Procedure-related Complications
180-day
Device & Procedure-related Complication-free Rate
:
92.1% (88.9
% LCL)Post-op Days180-day Performance Goal (79%)Freedom
from
Type
I - III Complication
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.
Slide28Safety 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.
Slide29Few Infections Led to
Explant
All Suspected & Confirmed Infections
(N=18)
Managed w/ antibiotics (n=13)
Managed w/ sternal wound revision (n=1)Superficial or Incisional InfectionsManaged without System Explant
(n=14, 4.4%)
System Explanted
(n=4, 1.3%)
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.
Slide30Infections: Study-Wide Learning on Surgical Prep
Infections requiring explant
4
0
All 4 infections requiring
explantation
occurred early in study enrollment
ENROLLMENTS
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.
Slide31Safety 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.
Slide32Inappropriate Shocks
38 patients* experienced shocks due to non-VT/VF event
15 patients: SVT > Discrimination zone
24 patients:
OversensingRate of inappropriate therapy is consistent with current transvenous ICDsNo 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.
Slide33Dual-zone Programming Reduced Inappropriate Shocks
54% relative reduction
74% relative reduction
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.
Slide34International 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
Heart Rhythm - May 2012; Vol 9:5(S1-33) AB07-2.Sponsor: Cameron Health, Inc. San Clemente, CA
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.
Slide35The S-ICD System Operation
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
S-ICD System is entirely
subcutaneous and can be placed using anatomical
landmarksThree sensing vectors to identify most robust cardiac signal
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.
Slide36E
valuation
o
F
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
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.
Slide37The 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 & EQ-5D QOL questionnaires
Baseline, 3, 6, 12 months post implant
Direct comparison to TV therapy via MIDAS study cohort
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.
Slide38EFFORTLESS 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.
Slide39EFFORTLESS Registry
Site Participation in 9 Geographies
UK
(13)
NL
(7)DK(3)
SL(1)
CZ (3)
I (4)
P
(1)
DE
(10)
NZ
(
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.
Slide40EFFORTLESS Registry
Recruitment Overview
NL
(123)
UK
(75)
CZ
(17)
DK
(14)
NZ (1)
230
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.
Slide41EFFORTLESS Registry
Patient Status as of April 27, 2012
Average FU
389±282 days, max 981 daysActive Patients
(N =210)Withdrawn N=1 (heart transplant)Deaths N=6*Explants N=5
Inactive N=1
Missing Data N=4
Withdrawn due to ineligibility N=2
Consented not implanted N=1
Patients Implanted
(N =223)
Patients Enrolled
(N=230)
* No device related deaths
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.
Slide42EFFORTLESS 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
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.
Slide43EFFORTLESS Registry
Standard ICD Baseline Characteristics
Attribute
Statistic/Category
N=223
%
Co-morbidities
Congestive Heart
Failure
32
Hypertension
25
Myocardial Infarction
38
Diabetes
13
Renal Disease
10
Atrial Fibrillation
19
COPD
6
Stroke
4
Cardiac Surgical
History
Ablation
7
CABG
10
Valve
Surgery
6
Prior TV ICD
15*
Pacemaker
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.
Slide44EFFORTLESS Registry
Heart Failure & Indication Characteristics
Attribute
Statistic/Category
N=70
n
%
NYHA Class at Enrollment
Class I
19
27
Class II
32
46
Class III
10
14
Class IV
0
0
Unknown/Not Assessed
9
13
Indication
n
%
Primary
144
64
Secondary
81
36
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.
Slide45EFFORTLESS Registry
Broad Range of ICD Indications
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.
Slide46EFFORTLESS Registry
Cardiac Medications at Enrollment
Medication
n
%
Amiodarone15
7
Diuretics
93
41
ACE Inhibitors
93
41
Beta Blockers
151
67
Digoxin
11
5
Lipid Lowering (incl. statins)
48
21
None
33
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.
Slide47Registry 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.
Slide48EFFORTLESS Registry
Effective Conversion of Induced VT/VF
Patient Data
n
%
Implant Conversion test data available204
Successful conversion within 1 procedure
-Successful at 65J
-Successful
at
80J
201
197
201
98.5
Patients
requiring repositioning
-Successful conversion following repositioning
-Awaiting retesting (non inducible)
1
2
1.5
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.
Slide490
5
10
15
20
25
30
35
40
<12
12-14.9
15-17.9
18-20.9
21-23.9
≥24
Seconds
% of Events
93% <21 seconds
N=86*
Mean
± SD:
15.9±3.8
Median
:
15.0
3.5%
37.2%
34.9%
17.4%
3.5%
3.5%
*
No data available for retrospective patients
EFFORTLESS Registry
93
% of Events Treated in < than 21secs
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.
Slide50Discrete
Episodes
Patients
EPISODES
Type
II spontaneous Termination
1
st
S-ICD System Shock
Conversion
2
nd
S-ICD
System Shock
Conversion
16
11
2
13
1
Storm Events
Episodes
Patients
EPISODES
S-ICD System Shock
Conversion
4
32
2
32 (100%)
EFFORTLESS Registry
100% Conversion of Spontaneous VT/VF
16 discrete VT/VF episodes from 11 patients
32 VT/VF storm
episodes
from 2 patients both with electrolyte imbalances (post dialysis and post
surgery)
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.
Slide51EFFORTLESS Registry
Annual
Inappropriate Shock Rate of 7%
0
5
10
15
20
Rate > Shock Zone
Oversensing
Percent
7%
15 patients received inappropriate shocks (7%)
No inappropriate shocks have been recorded for AF/SVT within a programmed conditional shock zone
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.
Slide52EFFORTLESS Registry
Appropriate vs. Inappropriate Episodes
0
10
20
30
40
50
60
Appropriate
Inappropriate
Episode
not stored
Episodes
(67%)
(28%)
Total of 72
Episodes
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.
Slide53EFFORTLESS Registry
Clinical Event Definitions
Clinical Event
Any untoward med
ical occurrenceCategoriesComplications: Invasive intervention required
Observations: Conservative therapy requiredType I-III Clinical EventsDevice-, labeling-, or procedure-relatedType IV Clinical EventsRelated to patient condition
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.
Slide54EFFORTLESS Registry
Device & Procedure-Related Events
Category
Complications
Observations
Device-related (Type I)
2
16
Labeling-related (Type II)
0
0
Procedure-related (Type III)
15
19
17
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.
Slide55EFFORTLESS Registry
Device-Related Events - Type I
Category
Complications
Observations
Inappropriate
Shock -
oversensing
1
14
Discomfort
0
1
Premature
battery depletion
1
0
Inability to communicate
with device
0
1
Total
2
16
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.
Slide56EFFORTLESS Registry
Procedure-Related Events - Type III
Category
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
Total
15
19
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.
Slide57EFFORTLESS Registry
Infection Management
All Suspected Infections*
(N=8)
Medically Managed without System Explant
(n=3, 1.3%)System Explanted
(n=4, 1.8%)
Electrode Explanted
(n=1, 0.4%)
Electrode
Re-implant
(n=1)
S-ICD
Re-implant
(n=1)
*No reported endocarditis or blood born infection
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.