Pediatric center Srikant Das MD Director Electrophysiology and Pacing Arkansas Childrens Hospital Background An entirely subcutaneous ICD system SICD avoids the need for the placement of electrodes within the heart and can provide clinical advantages especially in pediatric population ID: 710317
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Slide1
Subcutaneous- ICD implants in a Pediatric center
Srikant Das, MD
Director, Electrophysiology and Pacing
Arkansas Children’s HospitalSlide2
BackgroundAn entirely subcutaneous ICD system (S-ICD) avoids the need for the placement of electrodes within the heart and can provide clinical advantages especially in pediatric population. Approved by the Food & Drug Administration (FDA) in
2012
G
ained
Category 1 CPT Codes in January
2015
S
hown
to be highly
effective.
We
describe the initial experience of S-ICD implants in four children in electrophysiology laboratory in Arkansas Children’s Hospital. Slide3
S-ICDTM System
Sensing Configuration
System Components
145g
(
78.2 X 65.5 X 15.7 mm)
Emblem 130g (69.1 X 83.1 X 12.7 mm)Slide4
S-ICD in childrenSlide5
Historical ICD Challenges
The ICD lead is considered the most fragile component of a transvenous ICD system.
Source:
Kleeman
2007 Slide6
Historical ICD Challenges
The incidence of transvenous lead failure increases over time.
Source:
Kleeman
2007 Slide7
A New Alternative: S-ICDTM
System
The S-ICD
TM
System provides defibrillation therapy
via a completely subcutaneous defibrillation system. Slide8
Clinical Benefits
Because the heart and vasculature remain untouched, the S-ICD
TM
System reduces the risks associated with TV-ICDs Slide9
Design of S-ICDThe S-ICD System is comprised of the following four devices: Pulse Generator80-J biphasic shock
Charge time to 80-J ≤ 10 seconds
5.1 year longevity
30 seconds post-shock pacing
Q-TRAK Subcutaneous Electrode
Q-GUIDE Electrode Insertion Tool (EIT)
Q-TECH ProgrammerSlide10
System Components
In addition to the pulse generator and subcutaneous electrode, the S-ICD
TM
System includes an electrode insertion tool and programmer. Slide11
START Study
The START study showed that the S-ICD
TM
System is equivalent to a TV-ICD in sensitivity and superior to a TV-ICD in specificity
Source: Gold 2011 Slide12
Registry Results
The complication free rate was 94% at 180 days
Source:
Lambiase
2014Slide13
Danish TV-ICD Registry Results
Complication rates: Danish TV-ICD and EFFORTLESS S-ICD registry results Slide14
Patient ScreeningECG Screening Tool ECG Screening Configuration
QRS Evaluation
Lead Acceptability Slide15
Optimal Sensing Configuration
The optimal S-ICD
TM
System sensing configuration is a parasternal electrode and left lateral pulse generator.
Source:
Bardy
2001-2004 Slide16
ECG Screening Tool
Pre-implant screening ensures the patient is a good candidate for S-ICD
TM
System implant and subcutaneous defibrillation therapy.Slide17
ECG Screening Configuration
Adjust the gain as needed to ensure the peak of each R wave is completely visible…. not clipped as shown here.
CRM-151903-AC FEB
2015Slide18
ECG Screening Configuration
Use a three-lead configuration that represents the intended location of the implanted pulse generator and subcutaneous electrodes.Slide19
Sensing Configuration
The pulse generator is implanted at the mid-axillary line. The proximal sensing ring is placed near the xiphoid, and the distal sensing ring in the superior sternum. Slide20
Sensing Vectors
The S-ICD
TM
System uses three sensing vectors to interpret subcutaneous ECG signals. Slide21
QRS Evaluation
Select the color profile that best matches the QRS complexes on the ECG strip. Align left edge of color profile to QRS onset. Slide22
QRS Evaluation
Ensure the entire QRS complex and T wave fit within the color
profile. Slide23
Lead Acceptability
A patient is considered suitable for an S-ICD
®
System implant if at least one ECG lead is acceptable for each tested posture. Slide24
S-ICDTM System Implant X-ray Landmarks
Patient Preparation
Initial Incisions
Electrode
Placement
Pulse Generator Placement
X-ray Assessment Slide25
X-Ray Landmarks
In the AP view, the sensing rings are parallel and about 1 cm from the sternal midline. The pulse generator is at the mid-axillary line. Slide26
X-Ray Landmarks
In the left lateral view, the sensing rings appear to lie on the sternal surface. The pulse generator is at the mid-axillary line, in a position that is neither too anterior or too posterior. Slide27
Implantation ProcedureSlide28
Patient Preparation
Refer to landmarks to mark incision sites and the sternal midline. Slide29
Patient Preparation
Drape to expose the incision sites and sternal midline. Slide30
Initial Incisions
Ensure the pulse generator pocket is below adipose tissue and deep enough to accommodate the pulse generator. Slide31
Initial Incisions
Make a 2 to 3 cm horizontal incision just left and 1 cm above of the xiphoid midline. Place two sutures, spaced to match the grooves of the suture sleeve. Slide32
Proximal Electrode Placement
Tie distal electrode tip to EIT. Place suture sleeve on electrode body, 1 cm from proximal sensing ring. Slide33
Distal Electrode Placement
Use distal electrode to identify and mark superior incision site. Tunnel along sternum from xiphoid to superior incision. Pull suture with attached distal electrode through tunnel. Slide34
Pulse Generator Placement
Use suture to anchor pulse generator in pocket and secure the electrode at the xiphoid and superior incisions. Keep sutures loose enough to allow for range of motion. Slide35
Pulse Generator Placement
Confirm the electrode connector pin is inserted halfway into pin receptacle. Gently tug electrode to confirm the connection is secure. Slide36
Post implant in patient # 4Slide37
Age (y)Diagnosis
Screen
DFT
Device
Procedure
Follow
up
1.
15,FIdiopathic
ventricular fibrillation; s/p cardiac arrest
Leads I,II,III
65 J
S-ICD 145g
(78.2 X 65.5 X 15.7
mm)
3 incisions
92 min
9 mo
2.
17,M
Heart transplant
with ischemic cardiomyopathy and LVEF < 30%
Leads I,II,III
65 J
S-ICD 145g
(78.2 X 65.5 X 15.7 mm)
3 incisions
112 min
9 mo
3.
16,F
Hypertrophic
cardiomyophy s/p transvenos ICD; inappropriate shocks and lead failure
Leads II,III
65 J
S-ICD Emblem 130g (69.1 X 83.1
X 12.7 mm)
2 incisions
120 min
3 mo
4.
16,F
s/p sudden cardiac arrest; idiopathic ventricular fibrillation
Leads I,II,III
65 J
S-ICD Emblem 130g (69.1 X 83.1 X 12.7 mm)
2 incisions
80 min
3 moSlide38
Induction Testing Induction Setup Induction Progress
Time
to Therapy Evaluation Slide39
Time to Therapy Evaluation
Evaluate the time to therapy using an external ECG strip. Slide40
Appropriate vs Inappropriate Shocks
Dual-zone programming enhances AF/SVT
vs
VT/VF discrimination to determine the appropriateness of shock therapy.
Source: Weiss 2013 Slide41
Rhythm Discrimination
The S-ICD
TM
System analyzes static morphology, dynamic morphology, and QRS width to classify the subcutaneous ECG signal in the Conditional zone. Slide42
Algorithm Architecture SummarySlide43
Advantages:Eliminates potential for infection and damage to venous systemMay be implanted using anatomical landmarks without fluoroscopy Potential for less inappropriate shocks in childrenSlide44
Disadvantages:SizeTwice that of current T-ICDBattery life5 to 6 years as opposed to >8-10 with TV-ICDDoes not provide anti-tachycardia pacing (ATP) or
bradycardia
pacingSlide45
X-ray Assessment
Optimal device placement Slide46
Reimbursement Currently, the S-ICD System is covered nationally by Medicare, Aetna, Cigna and others, and regionally by numerous private and Medicaid plans.Slide47
ConclusionThe S-ICD system represents a viable alternative to conventional
TV-ICD
therapy in patients at risk of death from VT/VF
Low rate of major complications thus far in clinical studies
Young patients could benefit the most from this system.
The implantation can be safely performed in catheterization laboratory in children.