1. Physician Training THE S-ICD® SYSTEM
Prior to using these devices please review the user's manual for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

2. Physician Training Topics
S-ICD® System Implant
Testing the System
Post Op Care
Programming

3. S-ICD® System Implant Animation
Implant Instructions
STEP 1: Pre-operative and Prepping the Patient
STEP 2: Implantation of the S-ICD System
STEP 3: Testing the System
STEP 4: Completing the Implantation
STEP 5: Post-op Care
STEP 6: Programming & 1-month F/U
EXAMPLES: The Implanted S-ICD System

4. S-ICD® System Implant Animation

5. Pre-operative & Prepping the Patient

6. Completing Implantation
Step 1: Pre-op and Prep
STEP 2:
Implanting the System
STEP 3:
Testing the System
STEP 4:
Completing Implantation
STEP 5: Post-op
STEP 6: Programming
STEP 1: Pre-op and Prep
While similar to transvenous procedures, there are some differences with the S-ICD® System implant:
Prep area is larger than with TV implantation
Locations of S-ICD System pulse generator and electrode incisions are unique
Patient positioning may be different to expose the left lateral thorax

7. Completing Implantation
Step 1: Pre-op and Prep
STEP 2:
Implanting the System
STEP 3:
Testing the System
STEP 4:
Completing Implantation
STEP 5: Post-op
STEP 6: Programming
STEP 1: Pre-op and Prep
Consider pre-op antibiotics 1 hr. before surgery
Examining recent chest x-ray will aid in electrode and PG positioning:
Electrode left vs. right side of sternum?
Evaluate need for surgical tools that are not common to a transvenous ICD implant:
Small curved needle for suture in the sternal and xiphoid incisions
Large retractors (i.e. Army/Navy)
Wand sleeve
Types and quantity of suture material:
Make sure there is sufficient suture material for the implant procedure (2-0 silk for creating EIT-Electrode loops)
Types of needles, 2-0 needle fits the eyelet of the electrode and EIT
All sutures should have pre-loaded needles

8. Completing Implantation
Step 1: Pre-op and Prep
STEP 2:
Implanting the System
STEP 3:
Testing the System
STEP 4:
Completing Implantation
STEP 5: Post-op
STEP 6: Programming
STEP 1: Pre-op and Prep
Gender Specific recommendations:
Consider having female patients wear/bring their bra to the pre-operative prep area
Mark bra lines with the patient sitting in an upright position to avoid implanting the device directly under bra straps
Mark preferred location for pocket incision to avoid the submammary area especially for female patients
Tunneling tool can puncture breast implants
Consider asking female patients to abandon the use of underwire bras as they could create areas of pressure on incisions and lead to infections

9. Completing Implantation
Step 1: Pre-op and Prep
STEP 2:
Implanting the System
STEP 3:
Testing the System
STEP 4:
Completing Implantation
STEP 5: Post-op
STEP 6: Programming
STEP 1: Pre-op and Prep
Comfort Specific recommendations:
Keep the PG suture material loose enough to allow normal range of motion. Ensure lateral PG placement
Consideration should be made for managing post operative pain

10. Completing Implantation
Step 1: Pre-op and Prep
STEP 2:
Implanting the System
STEP 3:
Testing the System
STEP 4:
Completing Implantation
STEP 5: Post-op
STEP 6: Programming
STEP 1: Pre-op and Prep
Placement of external defibrillation pads:
Use standard of care
Avoid operative area
Can use a wedge, rolled up towel or make use of a table that can rotate:
May give improved exposure for the pocket
May allow better prep of lateral/posterior area
If used, should be after incisions are marked
Position arm on a padded extension board at about 60-90º
Remove hair per facility protocol:
Recommend removing hair from the chest and axilla before the patient is brought to the implant suite

11. Completing Implantation
Step 1: Pre-op and Prep
STEP 2:
Implanting the System
STEP 3:
Testing the System
STEP 4:
Completing Implantation
STEP 5: Post-op
STEP 6: Programming
STEP 1: Pre-op and Prep
Pocket incision:
Establish landmarks by palpating the xiphoid and the 5th or 6th intercostal space or PMI
Post-sternotomy = no xiphoid
Visualize the desired location of the PG and mark the pocket incision accordingly:
Let the desired PG location dictate the incision, not vice versa
PG should be mid-axillary not anterior-axillary
Visualize and ensure that the heart will be directly in between the PG and the electrode
Pocket incision should be ~ 6cm in length
For large-breasted patients, nipple may not be a good landmark
Xiphoid incision:
Horizontal or angled mark about 3cm in length
Start from midline
Superior incision:
Mark the tunnel line, rather than the exact superior incision location

12. Ideal Implant Location

13. Completing Implantation
Step 1: Pre-op and Prep
STEP 2:
Implanting the System
STEP 3:
Testing the System
STEP 4:
Completing Implantation
STEP 5: Post-op
STEP 1: Pre-op and Prep
Skin prep:
Per standard of care skin prep
Cover the chest very liberally from at least 10 cm from the right of the midline to under the left axilla and all along the lateral left side to where the patient meets the table (or wedge)
Antimicrobial impregnated incision drape:
Apply the antimicrobial impregnated incision drape across the chest and down the left lateral side to where the patient meets the table (or wedge)
Be aware of displacement of incision marks in patients with significant adipose tissue.
Sterile drape:
Apply sterile draping to expose area from right of sternal midline to posterior axillary line
Swap photo

14. Step 1: Pre-op and Prep Infection Management
Implanting the System
STEP 3:
Testing the System
STEP 4:
Completing Implantation
STEP 5: Post-op
STEP 1: Pre-op and Prep
Surgical Suite:
Control attendance per policy
Patient Preparation:
Consider pre-operative prophylactic antibiotic
Remove hair - axilla and entire left chest to right of midline
Scrub per standard of care: Multiple washes starting right of midline to posterior of the left axillary line; include neckline to mid stomach
Drape using standard sterile drapes and antimicrobial impregnated incision drape
Intra-Operative:
Flush all incisions thoroughly (antibiotic solution per standard of care)
Close wounds using multiple suture layers
Ensure suture tails cannot extrude out of the skin
Post-Operative:
Consider post-op application of topical antiseptic covered with pressure dressing for all incisions
Consider prophylactic post-op antibiotic treatment
Advise patient against interfering with wound dressing

15. Implantation of the S-ICD® System

16. Step 2: Implanting the System
STEP 1: Pre-op and Prep
STEP 3:
Testing the System
STEP 4:
Completing Implantation
STEP 5: Post-op
STEP 6: Programming
STEP 2:
Implanting the System
The S-ICD® System may be associated with more post–op pain than a TV-ICD. Administering long acting local anesthesia in the pocket should be considered:
Consider limiting the number of needle sticks during administration of local anesthesia along the tunneling track
Creating the pocket:
PG should be placed in the vicinity of the left 5th and 6th intercostal spaces and at the mid-axillary line
The pocket should be deep, either under muscle or on the facial plane
In obese patients, care should be taken to ensure the pocket is below all adipose tissue
Establish good hemostasis in all incisional areas

17. Step 2: Implanting the System
STEP 1: Pre-op and Prep
STEP 3:
Testing the System
STEP 4:
Completing Implantation
STEP 5: Post-op
STEP 6: Programming
STEP 2:
Implanting the System
Make a horizontal incision beginning at the xiphoid midline - incision should be large enough to accommodate the suture sleeve:
Incision can be horizontal, vertical or angled
2 – 3 cm incision
Dissect down to the fascial plane
Apply two anchoring sutures in the xiphoid incision:
Space the sutures to match the distance between the grooves of the suture sleeve
Perform “tug test” to ensure adequate tissue fixation

18. Step 2: Implanting the System
STEP 1: Pre-op and Prep
STEP 3:
Testing the System
STEP 4:
Completing Implantation
STEP 5: Post-op
STEP 6: Programming
STEP 2:
Implanting the System
Tunnel from the xiphoid incision towards the pocket along the fascial plane (not superficial):
The tunneling tool should emerge in the PG pocket in the desired subcutaneous plane
Attach the electrode to the tunneling tool using a long suture loop:
The suture loop should be about the length of the tunneling tool (15-16 cm)
Pull the electrode through to the xiphoid incision until the proximal sense electrode is exposed at the xiphoid
Attach the suture sleeve to the electrode:
Maintain ~1 cm separation from the proximal sense ring
Use two non-absorbable sutures to secure suture sleeve to lead body
Placing the suture sleeve too far from sense ring will cause superior displacement of the coil
~1 cm

19. Step 2: Implanting the System
STEP 1: Pre-op and Prep
STEP 3:
Testing the System
STEP 4:
Completing Implantation
STEP 5: Post-op
STEP 6: Programming
STEP 2:
Implanting the System
Superior incision:
Use the electrode to measure the distance to the superior incision by holding the suture sleeve at the xiphoid incision and laying the electrode along the skin
Make the superior sternal incision about 2 cm in length, vertical or slightly angled
Pre-place one or two facial sutures in superior incision:
Select a non-absorbable suture material and size that provides for reliable knot-holding characteristics and long-term retention
Perform “tug test” to ensure adequate tissue fixation
Do not cut needle from suture as it will be used later to pass through the electrode tip

20. Step 2: Implanting the System
STEP 1: Pre-op and Prep
STEP 3:
Testing the System
STEP 4:
Completing Implantation
STEP 5: Post-op
STEP 6: Programming
STEP 2:
Implanting the System
Tunnel from the xiphoid toward the superior incision:
Tunnel should be parallel to the sternum
Use fingers on the surface of the sternum over the tip of the tunneling tool to help guide the tip and stay parallel to the sternum
Fingers can be used to create an initial sinus for the tunneling tool
Cut and retain the suture from the tunneling tool at the superior incision
Remove the tunneling tool
From the superior incision, pull the electrode into place using the retained suture:
Ensure that the coil is straight and parallel to the sternum

21. Step 2: Implanting the System
STEP 1: Pre-op and Prep
STEP 3:
Testing the System
STEP 4:
Completing Implantation
STEP 5: Post-op
STEP 6: Programming
STEP 2:
Implanting the System
First, secure the suture sleeve:
Attach the suture sleeve to fascia using the previously placed non-absorbable sutures at the xiphoid incision
Second, secure the electrode distal tip:
Attach the distal tip to fascia using the previously placed non-absorbable suture(s) at the superior incision
Bury the electrode tip deep at the facial plane to ensure the tip is not superficial

22. Step 2: Implanting the System
STEP 1: Pre-op and Prep
STEP 3:
Testing the System
STEP 4:
Completing Implantation
STEP 5: Post-op
STEP 6: Programming
STEP 2:
Implanting the System
End of Sense A connector block
End of pin cavity
Halfway
Insert the electrode into the PG header:
The electrode pin should extend past the connector block, half-way into the pin cavity
Use the torque wrench to secure the electrode:
Clicking will be heard when secure
If unscrewing, do not torque the wrench. When the screw is freely turning, the electrode can be removed

23. Proper Electrode Insertion1
1 Excerpted from the S-ICD® System User’s Manual (PN XXX)

24. Step 2: Implanting the System
STEP 1: Pre-op and Prep
STEP 3:
Testing the System
STEP 4:
Completing Implantation
STEP 5: Post-op
STEP 6: Programming
STEP 2:
Implanting the System
Pre-place an anchoring stitch in the PG pocket:
Secure to intercostal muscle with a deep tissue bite
Use a strong non-absorbable suture material
Perform tug test to ensure tissue fixation
Insert the PG in the pocket with excess electrode placed under the PG:
A specific orientation of the PG is not dictated; however:
A vertical orientation of the PG may offer the best long-term comfort
The PG should be placed “logo out” vs. “logo in” by determining the best header orientation for electrode slack placement
Anchor the PG using the previously placed suture

25. Testing the System

26. Step 3: Testing the System
STEP 1: Pre-op and Prep
STEP 2:
Implanting the System
STEP 4:
Completing Implantation
STEP 5: Post-op
STEP 6: Programming
STEP 3:
Testing the System
Auto set up – Skip the postural optimization
Select the desired settings for induction testing. Clinical evaluation of the S-ICD® System was performed with the following settings:
Shock zone: 170 bpm
65 J, STD polarity initial shock
Consider approximating the pocket in order to ensure proper pulse generator to tissue contact:
Recommend 1-layer of closure prior to testing
Evaluate sensing markers during induced rhythm
Consistent tachy “T” markers indicate that tachyarrhythmia detection is occurring, and that capacitor charging is imminent

27. Step 3: Testing the System
STEP 1: Pre-op and Prep
STEP 2:
Implanting the System
STEP 4:
Completing Implantation
STEP 5: Post-op
STEP 6: Programming
STEP 3:
Testing the System
Determine rescue shock plan:
Discuss prior to induction
Induced arrhythmias are detected and treated in an average of 15 sec. (95% are treated within 21sec)
When an arrhythmia is induced clearly call out that the device is:
Sensing
Detecting
Charging
If the first 65J shock fails there will be an 80 J rescue shock from the S-ICD® System
Discuss the need for external rescue and when that rescue is to be done
Induction:
If VF is difficult to induce, check the placement of the PG and shock coil
Sub-optimal system placement not only makes defibrillation more difficult, it also can make induction more difficult
The induced arrhythmia and subsequent shocks are not stored in the device during testing. A recording can be obtained using real time printing from an external ECG source.

28. Step 3: Testing the System
STEP 1: Pre-op and Prep
STEP 2:
Implanting the System
STEP 4:
Completing Implantation
STEP 5: Post-op
STEP 6: Programming
STEP 3:
Testing the System
Troubleshooting During Testing
If an adequate safety margin is not achieved, the following steps should be considered:
Consider retesting device at alternate polarity
Assess device and electrode position using medical imaging
Verify the electrode pin is fully inserted within the header
Assure the device is in good contact with tissue

29. Step 3: Testing the System
STEP 1: Pre-op and Prep
STEP 2:
Implanting the System
STEP 4:
Completing Implantation
STEP 5: Post-op
STEP 6: Programming
STEP 3:
Testing the System
Troubleshooting During Testing
Response times may vary during induction testing depending on the amplitude variation of the induced arrhythmia.
If a high degree of amplitude variation is noted during the arrhythmia, a slight delay may be expected prior to capacitor charging or shock delivery.
If time to therapy is prolonged (>20 seconds), it is likely due to undersensing and drop out of the S-ECG signal and the following steps should be considered:
Use manual setup to assess other sense vectors/gains
Retest using a different sense vector
Reposition the device and/or electrode

30. Completing the Implantation

31. Step 4: Completing the Implantation
STEP 1: Pre-op and Prep
STEP 2:
Implanting the System
STEP 3:
Testing the System
STEP 5: Post-op
STEP 6: Programming
STEP 4:
Completing Implantation
Pocket antibiotics flush or antiseptic is recommended
Close pocket tissue layers in standard fashion:
At least two layers of closure
Close sternal incisions in standard fashion:
Apply standard wound dressings:
Pressure dressing
Include antiseptic/antimicrobial per preference or policy

32. Post-op Care

33. Completing Implantation
Step 5: Post-op Care
STEP 1: Pre-op and Prep
STEP 2:
Implanting the System
STEP 3:
Testing the System
STEP 4:
Completing Implantation
STEP 6: Programming
STEP 5: Post-op
Pre-discharge PA and left lateral X-Rays
Check system position for future reference
Patient recommendations:
Post operative pain management should be considered
Keep incisions dry as per standard of care
© Cameron Health, DN-15078, Rev A: For use with Algorithm Summary, Rev A (DN-12345)

34. Programming, 1-Month Follow Up

35. Completing Implantation
Step 6: Programming
STEP 1: Pre-op and Prep
STEP 2:
Implanting the System
STEP 3:
Testing the System
STEP 4:
Completing Implantation
STEP 5: Post-op
STEP 6: Programming
Considerations to reduce inappropriate shocks:
One vs. two zones:
Activating/setting a Conditional Shock Zone (dual-zone programming) allows for SVT/AF vs. VT/VF discrimination
Single-zone programming is based solely on measured heart rate
Dual-zone programming can significantly enhance SVT discrimination to determine appropriateness of therapy
Conditional shock zone program can be activated by simply moving the yellow or red slider bar
In the IDE study, patients with dual zone programming experienced significantly fewer inappropriate shocks due to SVT than those programmed with a single zone (2.7% vs. 10.2%; p-value=0.0085).

36. Completing Implantation
Step 6: Programming
STEP 1: Pre-op and Prep
STEP 2:
Implanting the System
STEP 3:
Testing the System
STEP 4:
Completing Implantation
STEP 5: Post-op
STEP 6: Programming
Considerations to reduce inappropriate shocks:
Exercise testing and template formation
Prophylactic exercise testing is recommended for patients with a predisposition to rate dependent aberrancies
Sense vector can be analyzed during exercise
Template can be formed during exercise
1-month F/U:
To ensure adequate sensing, postural assessment should be performed
Isometrics should be performed to look for muscle artifact
Exercise testing can be optionally performed especially in young patients

37. Examples of the implanted S-ICD® System

38. Sub-optimal placement:
Lateral electrode…

39. Sub-optimal placement:
Lateral electrode…

40. Sub-optimal placement:
Superficial tip…

41. Sub-optimal placement:
Slightly anterior PG…

42. Sub-optimal placement:
Slightly anterior PG…

43. Sub-optimal placement:
Slightly anterior PG…

44. Sub-optimal placement:
Anterior PG…

45. Optimal placement:
Female patient…

46. Optimal placement:
10 year old girl… 46

47. Questions? Thank you

48. Brief Summary The S-ICD® System from Boston Scientific CRM
Indications for Use: The S-ICD System is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing.
Contraindications: Unipolar pacemakers are contraindicated for use with the S-ICD System.
Warnings and Cautions: The S-ICD System contains sterile products for single use only. Do not resterilize. Handle the components of the S-ICD System with care at all times and maintain proper sterile technique. All Cameron Health implantable components are designed for use with the Cameron Health S-ICD System only. Connection of any S-ICD System components to any other ICD system will result in failure to deliver lifesaving defibrillation therapy.
General:
External defibrillation equipment should be available for immediate use during the implantation procedure and follow-up.
Placing a magnet over the SQ-RX Pulse Generator suspends arrhythmia detection and therapy response. Removing the magnet resumes arrhythmia detection and therapy response.
Battery depletion will eventually cause the SQ-RX Pulse Generator to stop functioning. Defibrillation and excessive numbers of charging cycles shorten the battery longevity.
The S-ICD System has not been evaluated for pediatric use.
The S-ICD System does not provide long-term bradycardia pacing, Cardiac Resynchronization Therapy (CRT) or Anti-Tachycardia Pacing (ATP).
Potential Adverse Events related to implantation of the S-ICD System may include, but are not limited to, the following:
Acceleration/induction of atrial or ventricular arrhythmia; Adverse reaction to induction testing; Allergic/adverse reaction to system or medication; Bleeding; Conductor fracture; Cyst formation; Death; Delayed therapy delivery; Discomfort or prolonged healing of incision; Electrode deformation and/or breakage; Electrode insulation failure; Erosion/extrusion; Failure to deliver therapy; Fever; Hematoma; Hemothorax; Improper electrode connection to the device; Inability to communicate with the device; Inability to defibrillate or pace; Inappropriate post-shock pacing; Inappropriate shock delivery; Infection; Keloid formation; Migration or dislodgement; Muscle stimulation; Nerve damage; Pneumothorax; Post-shock/post-pace discomfort; Premature battery depletion; Random component failures; Stroke; Subcutaneous emphysema; Surgical revision or replacement of the system; Syncope; Tissue redness, irritation, numbness or necrosis.

49. Abbreviated Statement (CE Mark)
All cited trademarks are the property of their respective owners. CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Information for the use only in countries with applicable health authority product registrations.