1 of 26 CRM AB Oct 2012 Physician Training THE S-ICD ® SYSTEM Patient Screening 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 of 26 CRM AB Oct 2012 © Boston Scientific 2012 Patient Screening Physician Training Topics

3 of 26 CRM AB Oct 2012 © Boston Scientific 2012 Patient Screening Overview: Why is ECG Screening Necessary? Overview: Why is ECG Screening Necessary? STEP 1: Collecting the Surface ECG STEP 1: Collecting the Surface ECG STEP 2: Evaluating the Surface ECG STEP 2: Evaluating the Surface ECG STEP 3: Determining an Acceptable Vector STEP 3: Determining an Acceptable Vector EXAMPLES: ECG Screening Examples EXAMPLES: ECG Screening Examples

4 of 26 CRM AB Oct 2012 © Boston Scientific 2012 Overview: Why is ECG Screening Necessary?

5 of 26 CRM AB Oct 2012 Overview : Why is ECG Screening Necessary? OVERVIEW: Why is Screening Necessary? STEP 1: Collecting the Surface ECG STEP 1: Collecting the Surface ECG STEP 2: Evaluating the Surface ECG STEP 2: Evaluating the Surface ECG STEP 3: Determining an Acceptable Vector STEP 3: Determining an Acceptable Vector EXAMPLES: ECG Screening Examples EXAMPLES: ECG Screening Examples  The purpose of pre-screening S-ICD ® patients is to identify the small number of patients whose S-ICD signals may be unusually challenging for detection and discrimination  The surface ECG is representative of the subcutaneous signal; therefore, a pre- operative screening process was developed to analyze a patient’s ECG without the need to first implant the S-ICD System  The Screening process is used to analyze QRS amplitude, QRS to T-wave amplitude ratios, QRS width and morphology consistency in sinus rhythm using multiple patient postures

6 of 26 CRM AB Oct 2012 © Boston Scientific 2012 Step 1: Collecting the Surface ECG

7 of 26 CRM AB Oct 2012  Collect a surface equivalent of the subcutaneous sensing vectors:  Collect the surface ECG in the location that represents the intended position of the implanted S-ICD ® System  If a non-standard S-ICD System electrode or pulse generator placement is desired, the surface ECG electrode locations should be modified accordingly Step 1: Collecting the Surface ECG OVERVIEW: Why is Screening Necessary? OVERVIEW: Why is Screening Necessary? STEP 2: Evaluating the Surface ECG STEP 2: Evaluating the Surface ECG STEP 3: Determining an Acceptable Vector STEP 3: Determining an Acceptable Vector EXAMPLES: ECG Screening Examples EXAMPLES: ECG Screening Examples STEP 1: Collecting the Surface ECG

8 of 26 CRM AB Oct 2012  Typically, the surface ECG electrodes should be positioned as follows: ECG Electrode LL:  Placed in a lateral location, at the 5th intercostal space along the mid-axillary line to represent the intended location of the implanted pulse generator ECG Electrode LA:  Placed 1 cm left lateral of the xiphoid midline to represent the intended location of the proximal sensing node of the implanted electrode ECG Electrode RA:  Placed 14 cm superior to the ECG Electrode LA, to represent the intended position of the distal sensing tip of the implanted electrode  A 14 cm guide is located at the bottom of the transparent screening tool Step 1: Collecting the Surface ECG OVERVIEW: Why is Screening Necessary? OVERVIEW: Why is Screening Necessary? STEP 2: Evaluating the Surface ECG STEP 2: Evaluating the Surface ECG STEP 3: Determining an Acceptable Vector STEP 3: Determining an Acceptable Vector EXAMPLES: ECG Screening Examples EXAMPLES: ECG Screening Examples STEP 1: Collecting the Surface ECG

9 of 26 CRM AB Oct 2012  Obtain a clean ECG:  Establish a stable baseline. If a wandering ECG is noted, steps should be taken to establish a stable baseline:  Addition of ground electrode  Skin prep, etc.  Record 10 – 20 seconds of ECG in each posture  ECG settings:  Leads:I, II and III  Sweep speed:25 mm/sec  ECG gain:5 – 20 mm/mV  Use the largest ECG gain that does not clip the peak of the QRS complex  To yield an acceptable signal for testing, the gain may be adjusted for each ECG lead independently Step 1: Collecting the Surface ECG OVERVIEW: Why is Screening Necessary? OVERVIEW: Why is Screening Necessary? STEP 2: Evaluating the Surface ECG STEP 2: Evaluating the Surface ECG STEP 3: Determining an Acceptable Vector STEP 3: Determining an Acceptable Vector EXAMPLES: ECG Screening Examples EXAMPLES: ECG Screening Examples STEP 1: Collecting the Surface ECG CLIPPING OF THE ECG PEAK

10 of 26 CRM AB Oct 2012  Record ECG signals in at least two postures:  (1) Supine  (2) Standing  Other postures may be collected including: Seated, Left Lateral, Right Lateral, and Prone  If morphology changes are expected at elevated heart rates, screening ECGs can be collected during exercise testing for evaluation purposes  If the S-ICD ® System is to be implanted with a concomitant pacemaker, all ventricular morphologies (paced and intrinsic, if normal conduction is expected) should be collected Step 1: Collecting the Surface ECG OVERVIEW: Why is Screening Necessary? OVERVIEW: Why is Screening Necessary? STEP 2: Evaluating the Surface ECG STEP 2: Evaluating the Surface ECG STEP 3: Determining an Acceptable Vector STEP 3: Determining an Acceptable Vector EXAMPLES: ECG Screening Examples EXAMPLES: ECG Screening Examples STEP 1: Collecting the Surface ECG

11 of 26 CRM AB Oct 2012 © Boston Scientific 2012 Step 2: Evaluating the Surface ECG

12 of 26 CRM AB Oct 2012  Each surface ECG should be evaluated by analyzing all complexes in 10 seconds of QRS complexes in at least 2 different patient postures (supine, standing, sitting etc.)  If multiple morphologies are noted (e.g., bigeminy, pacing, etc.), all morphologies should be evaluated  The evaluation of each QRS complex is a three step process: 1.Select the colored profile 2.Align the profile 3.Evaluate the QRS complex Step 2: Evaluating the Surface ECG OVERVIEW: Why is Screening Necessary? OVERVIEW: Why is Screening Necessary? STEP 3: Determining an Acceptable Vector STEP 3: Determining an Acceptable Vector EXAMPLES: ECG Screening Examples EXAMPLES: ECG Screening Examples STEP 1: Collecting the Surface ECG STEP 2: Evaluating the Surface ECG STEP 2: Evaluating the Surface ECG

13 of 26 CRM AB Oct Select the colored profile from the Patient Screening Tool that best matches the amplitude of the QRS complex:  The peak of the QRS complex must fit within one of the Peak Zones as shown  For biphasic signals, the larger peak should be used to select the profile  ECG gains > 20 mm/mV are not permitted 2.Align the left edge of the selected colored profile with the onset of the QRS complex:  The horizontal line on the colored profile should be used as a guide for the ECG baseline Step 2: Evaluating the Surface ECG OVERVIEW: Why is Screening Necessary? OVERVIEW: Why is Screening Necessary? STEP 3: Determining an Acceptable Vector STEP 3: Determining an Acceptable Vector EXAMPLES: ECG Screening Examples EXAMPLES: ECG Screening Examples STEP 1: Collecting the Surface ECG STEP 2: Evaluating the Surface ECG STEP 2: Evaluating the Surface ECG

14 of 26 CRM AB Oct Evaluate each QRS complex:  Acceptable complex: Entire QRS complex and trailing T-wave are contained within the colored profile  Unacceptable complex: Some portion of the QRS complex or trailing T-wave extends outside of the colored profile  Repeat the evaluation process for all QRS complexes from all surface ECG leads in all collected postures Step 2: Evaluating the Surface ECG OVERVIEW: Why is Screening Necessary? OVERVIEW: Why is Screening Necessary? STEP 3: Determining an Acceptable Vector STEP 3: Determining an Acceptable Vector EXAMPLES: ECG Screening Examples EXAMPLES: ECG Screening Examples STEP 1: Collecting the Surface ECG STEP 2: Evaluating the Surface ECG STEP 2: Evaluating the Surface ECG

15 of 26 CRM AB Oct 2012 © Boston Scientific 2012 Step 3: Determining an Acceptable Vector

16 of 26 CRM AB Oct 2012  Evaluate each surface ECG lead independently for acceptance  A surface ECG lead (sense vector) is acceptable only if all of the following conditions are met: 1.All QRS complexes and morphologies from the surface ECG lead pass the QRS evaluation. 2.The morphology of the QRS is stable across postures. No significant change to the QRS is noted as a result of postural changes. 3.The surface ECG lead must be deemed acceptable in all tested postures.  A patient is considered suitable for implant if at least one surface ECG lead (sense vector) is acceptable for all tested postures  Unacceptable or marginal sense vectors may result in inappropriate or failure to deliver therapy Step 3: Determining an Acceptable Sense Vector OVERVIEW: Why is Screening Necessary? OVERVIEW: Why is Screening Necessary? EXAMPLES: ECG Screening Examples EXAMPLES: ECG Screening Examples STEP 1: Collecting the Surface ECG STEP 2: Evaluating the Surface ECG STEP 2: Evaluating the Surface ECG STEP 3: Determining an Acceptable Vector STEP 3: Determining an Acceptable Vector Inconsistent Morphology

17 of 26 CRM AB Oct 2012 © Boston Scientific 2012 Examples: ECG Screening Examples

18 of 26 CRM AB Oct 2012 ECG Screening Example 1: Subtle changes about the baseline… OVERVIEW: Why is Screening Necessary? OVERVIEW: Why is Screening Necessary? STEP 1: Collecting the Surface ECG STEP 2: Evaluating the Surface ECG STEP 2: Evaluating the Surface ECG STEP 3: Determining an Acceptable Vector STEP 3: Determining an Acceptable Vector EXAMPLES: ECG Screening Examples EXAMPLES: ECG Screening Examples SUPINE STANDING

19 of 26 CRM AB Oct 2012 ECG Screening Example 1: Subtle changes about the baseline… OVERVIEW: Why is Screening Necessary? OVERVIEW: Why is Screening Necessary? STEP 1: Collecting the Surface ECG STEP 2: Evaluating the Surface ECG STEP 2: Evaluating the Surface ECG STEP 3: Determining an Acceptable Vector STEP 3: Determining an Acceptable Vector EXAMPLES: ECG Screening Examples EXAMPLES: ECG Screening Examples SUPINE STANDING

20 of 26 CRM AB Oct 2012 ECG Screening Example 1: Subtle changes about the baseline… OVERVIEW: Why is Screening Necessary? OVERVIEW: Why is Screening Necessary? STEP 1: Collecting the Surface ECG STEP 2: Evaluating the Surface ECG STEP 2: Evaluating the Surface ECG STEP 3: Determining an Acceptable Vector STEP 3: Determining an Acceptable Vector EXAMPLES: ECG Screening Examples EXAMPLES: ECG Screening Examples SUPINE STANDING

21 of 26 CRM AB Oct 2012 ECG Screening Example 2: Varying notch morphology… OVERVIEW: Why is Screening Necessary? OVERVIEW: Why is Screening Necessary? STEP 1: Collecting the Surface ECG STEP 2: Evaluating the Surface ECG STEP 2: Evaluating the Surface ECG STEP 3: Determining an Acceptable Vector STEP 3: Determining an Acceptable Vector EXAMPLES: ECG Screening Examples EXAMPLES: ECG Screening Examples

22 of 26 CRM AB Oct 2012 ECG Screening Example 3: Inconsistent amplitude and morphology… OVERVIEW: Why is Screening Necessary? OVERVIEW: Why is Screening Necessary? STEP 1: Collecting the Surface ECG STEP 2: Evaluating the Surface ECG STEP 2: Evaluating the Surface ECG STEP 3: Determining an Acceptable Vector STEP 3: Determining an Acceptable Vector EXAMPLES: ECG Screening Examples EXAMPLES: ECG Screening Examples

23 of 26 CRM AB Oct 2012 ECG Screening Examples: Inconsistent amplitude and morphology… OVERVIEW: Why is Screening Necessary? OVERVIEW: Why is Screening Necessary? STEP 1: Collecting the Surface ECG STEP 2: Evaluating the Surface ECG STEP 2: Evaluating the Surface ECG STEP 3: Determining an Acceptable Vector STEP 3: Determining an Acceptable Vector EXAMPLES: ECG Screening Examples EXAMPLES: ECG Screening Examples

24 of 26 CRM AB Oct 2012 © Boston Scientific 2012 Questions? Thank you

25 of 26 CRM AB Oct 2012 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.

26 of 26 CRM AB Oct 2012 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.