uams.edu arpediatrics.org subcutaneous- icd implants in a pediatric center srikant das, md director,...
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Subcutaneous- ICD implants in a Pediatric center
Srikant Das, MDDirector, 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 S-ICDTM 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 Electrode3.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 specificitySource: 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 Followup
1. 15,F Idiopathic 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 incisions92 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 incisions112 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 incisions120 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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