Transcript Management of Children with Cardiac Devices

Subcutaneous- ICD implants in a
Pediatric center
Srikant Das, MD
Director, Electrophysiology and Pacing
Arkansas Children’s Hospital
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Background
• An 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
• Gained Category 1 CPT Codes in January 2015
• Shown to be highly effective.
• We describe the initial experience of S-ICD implants in four
children in electrophysiology laboratory in Arkansas Children’s
Hospital.
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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)
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S-ICD in children
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Historical ICD Challenges
The ICD lead is considered the most fragile component of a transvenous ICD
system.
Source: Kleeman 2007
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Historical ICD Challenges
The incidence of transvenous lead failure increases over time.
Source: Kleeman 2007
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A New Alternative: S-ICDTM System
The S-ICDTM System provides defibrillation therapy
via a completely subcutaneous defibrillation system.
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Clinical Benefits
Because the heart and vasculature remain untouched, the SICDTM System reduces the risks associated with TV-ICDs
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Design of S-ICD
The S-ICD System is comprised of the following four devices:
1. Pulse Generator
– 80-J biphasic shock
– Charge time to 80-J ≤ 10 seconds
– 5.1 year longevity
– 30 seconds post-shock pacing
2.Q-TRAK Subcutaneous Electrode
3.Q-GUIDE Electrode Insertion Tool (EIT)
4.Q-TECH Programmer
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System Components
In addition to the pulse generator and subcutaneous electrode, the S-ICDTM
System includes an electrode insertion tool and programmer.
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START Study
The START study showed that the S-ICDTM System is equivalent
to a TV-ICD in sensitivity and superior to a TV-ICD in specificity
Source: Gold 2011
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Registry Results
The complication free rate was 94% at 180 days
Source: Lambiase 2014
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Danish TV-ICD Registry Results
Complication rates: Danish TV-ICD and EFFORTLESS S-ICD registry results
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Patient Screening
 ECG Screening Tool
 ECG Screening Configuration
 QRS Evaluation
 Lead Acceptability
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Optimal Sensing Configuration
The optimal S-ICDTM System sensing configuration is a parasternal
electrode and left lateral pulse generator.
Source: Bardy 2001-2004
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ECG Screening Tool
Pre-implant screening ensures the patient is a good candidate for S-ICDTM System
implant and subcutaneous defibrillation therapy.
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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 2015
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ECG Screening Configuration
Use a three-lead configuration that represents the intended location of
the implanted pulse generator and subcutaneous electrodes.
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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.
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Sensing Vectors
The S-ICDTM System uses three sensing vectors to interpret
subcutaneous ECG signals.
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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.
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QRS Evaluation
Ensure the entire QRS complex and T wave fit within the color profile.
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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.
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S-ICDTM System Implant
 X-ray Landmarks
 Patient Preparation
 Initial Incisions
 Electrode Placement
 Pulse Generator Placement
 X-ray Assessment
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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.
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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.
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Implantation Procedure
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Patient Preparation
Refer to landmarks to mark incision sites and the sternal
midline.
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Patient Preparation
Drape to expose the incision sites and sternal midline.
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Initial Incisions
Ensure the pulse generator pocket is below adipose tissue and deep
enough to accommodate the pulse generator.
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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.
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Proximal Electrode Placement
Tie distal electrode tip to EIT. Place suture sleeve on electrode body, 1 cm from
proximal sensing ring.
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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.
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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.
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Pulse Generator Placement
Confirm the electrode connector pin is inserted halfway into pin receptacle. Gently
tug electrode to confirm the connection is secure.
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Post implant in patient # 4
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Age (y)
Diagnosis
Screen
DFT
Device
Procedure Follow
up
1. 15,F
Idiopathic
ventricular
fibrillation; s/p
cardiac arrest
Leads
I,II,III
65 J
S-ICD 145g
3 incisions
(78.2 X 65.5 X 15.7 92 min
mm)
9 mo
2. 17,M
Heart transplant
Leads
with ischemic
I,II,III
cardiomyopathy and
LVEF < 30%
65 J
S-ICD 145g
3 incisions
(78.2 X 65.5 X 15.7 112 min
mm)
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 mo
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Induction Testing
 Induction Setup
 Induction Progress
 Time to Therapy Evaluation
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Time to Therapy Evaluation
Evaluate the time to therapy using an external ECG strip.
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Appropriate vs Inappropriate Shocks
Dual-zone programming enhances AF/SVT vs VT/VF
discrimination to determine the appropriateness of shock
therapy.
Source: Weiss 2013
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Rhythm Discrimination
The S-ICDTM System analyzes static morphology, dynamic morphology, and
QRS width to classify the subcutaneous ECG signal in the Conditional zone.
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Algorithm Architecture Summary
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Advantages:
• Eliminates potential for infection and
damage to venous system
• May be implanted using anatomical
landmarks without fluoroscopy
• Potential for less inappropriate shocks in
children
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Disadvantages:
• Size
– Twice that of current T-ICD
• Battery life
– 5 to 6 years as opposed to >8-10 with TV-ICD
• Does not provide anti-tachycardia pacing
(ATP) or bradycardia pacing
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X-ray Assessment
Optimal device placement
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Reimbursement
• Currently, the S-ICD System is covered
nationally by Medicare, Aetna, Cigna and
others, and regionally by numerous private
and Medicaid plans.
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Conclusion
• The 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.
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