uams.edu arpediatrics.org subcutaneous- icd implants in a pediatric center srikant das, md director,...
Post on 01-Jan-2016
218 Views
Preview:
TRANSCRIPT
uams.eduarpediatrics.org
Subcutaneous- ICD implants in a Pediatric center
Srikant Das, MDDirector, Electrophysiology and Pacing
Arkansas Children’s Hospital
uams.eduarpediatrics.org
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.
uams.eduarpediatrics.org
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)
uams.eduarpediatrics.org
S-ICD in children
uams.eduarpediatrics.org
Historical ICD Challenges
The ICD lead is considered the most fragile component of a transvenous ICD system. Source: Kleeman 2007
uams.eduarpediatrics.org
Historical ICD Challenges
The incidence of transvenous lead failure increases over time.Source: Kleeman 2007
uams.eduarpediatrics.org
A New Alternative: S-ICDTM System
The S-ICDTM System provides defibrillation therapy via a completely subcutaneous defibrillation system.
uams.eduarpediatrics.org
Clinical Benefits
Because the heart and vasculature remain untouched, the S-ICDTM System reduces the risks associated with TV-ICDs
uams.eduarpediatrics.org
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
uams.eduarpediatrics.org
System Components
In addition to the pulse generator and subcutaneous electrode, the S-ICDTM System includes an electrode insertion tool and programmer.
uams.eduarpediatrics.org
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
uams.eduarpediatrics.org
Registry Results
The complication free rate was 94% at 180 days Source: Lambiase 2014
uams.eduarpediatrics.org
Danish TV-ICD Registry Results
Complication rates: Danish TV-ICD and EFFORTLESS S-ICD registry results
uams.eduarpediatrics.org
Patient Screening
ECG Screening Tool
ECG Screening Configuration
QRS Evaluation
Lead Acceptability
uams.eduarpediatrics.org
Optimal Sensing Configuration
The optimal S-ICDTM System sensing configuration is a parasternal electrode and left lateral pulse generator. Source: Bardy 2001-2004
uams.eduarpediatrics.org
ECG Screening Tool
Pre-implant screening ensures the patient is a good candidate for S-ICDTM System implant and subcutaneous defibrillation therapy.
uams.eduarpediatrics.org
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
uams.eduarpediatrics.org
ECG Screening Configuration
Use a three-lead configuration that represents the intended location of the implanted pulse generator and subcutaneous electrodes.
uams.eduarpediatrics.org
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.
uams.eduarpediatrics.org
Sensing Vectors
The S-ICDTM System uses three sensing vectors to interpret subcutaneous ECG signals.
uams.eduarpediatrics.org
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.
uams.eduarpediatrics.org
QRS Evaluation
Ensure the entire QRS complex and T wave fit within the color profile.
uams.eduarpediatrics.org
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.
uams.eduarpediatrics.org
S-ICDTM System Implant X-ray Landmarks
Patient Preparation
Initial Incisions
Electrode Placement
Pulse Generator Placement
X-ray Assessment
uams.eduarpediatrics.org
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.
uams.eduarpediatrics.org
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.
uams.eduarpediatrics.org
Implantation Procedure
uams.eduarpediatrics.org
Patient Preparation
Refer to landmarks to mark incision sites and the sternal midline.
uams.eduarpediatrics.org
Patient Preparation
Drape to expose the incision sites and sternal midline.
uams.eduarpediatrics.org
Initial Incisions
Ensure the pulse generator pocket is below adipose tissue and deep enough to accommodate the pulse generator.
uams.eduarpediatrics.org
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.
uams.eduarpediatrics.org
Proximal Electrode Placement
Tie distal electrode tip to EIT. Place suture sleeve on electrode body, 1 cm from proximal sensing ring.
uams.eduarpediatrics.org
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.
uams.eduarpediatrics.org
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.
uams.eduarpediatrics.org
Pulse Generator Placement
Confirm the electrode connector pin is inserted halfway into pin receptacle. Gently tug electrode to confirm the connection is secure.
uams.eduarpediatrics.org
Post implant in patient # 4
uams.eduarpediatrics.org
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
uams.eduarpediatrics.org
Induction Testing Induction Setup
Induction Progress
Time to Therapy Evaluation
uams.eduarpediatrics.org
Time to Therapy Evaluation
Evaluate the time to therapy using an external ECG strip.
uams.eduarpediatrics.org
Appropriate vs Inappropriate Shocks
Dual-zone programming enhances AF/SVT vs VT/VF discrimination to determine the appropriateness of shock therapy. Source: Weiss 2013
uams.eduarpediatrics.org
Rhythm Discrimination
The S-ICDTM System analyzes static morphology, dynamic morphology, and QRS width to classify the subcutaneous ECG signal in the Conditional zone.
uams.eduarpediatrics.org
Algorithm Architecture Summary
uams.eduarpediatrics.org
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
uams.eduarpediatrics.org
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
uams.eduarpediatrics.org
X-ray Assessment
Optimal device placement
uams.eduarpediatrics.org
Reimbursement
• Currently, the S-ICD System is covered nationally by Medicare, Aetna, Cigna and others, and regionally by numerous private and Medicaid plans.
uams.eduarpediatrics.org
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.
top related