1 of 26 CRM-106106-AB Oct 2012 Physician Training THE S-ICD ® SYSTEM Patient Screening Prior to...

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Physician TrainingTHE S-ICD® SYSTEMPatient ScreeningPrior 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.

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© Boston Scientific 2012

Patient Screening

Physician Training Topics

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Patient Screening

Overview: Why is ECG Screening Necessary?

STEP 1: Collecting the Surface ECG

STEP 2: Evaluating the Surface ECG

STEP 3: Determining an Acceptable Vector

EXAMPLES: ECG Screening Examples

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Overview:Why is ECG Screening Necessary?

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Overview:Why is ECG Screening Necessary?

OVERVIEW: Why is Screening

Necessary?

STEP 1:Collecting the Surface ECG

STEP 2:Evaluating the Surface ECG

STEP 3: Determining an

Acceptable Vector

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

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Step 1:Collecting the Surface ECG

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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


OVERVIEW:Why is Screening

Necessary?



Acceptable Vector


Examples


2. SELECT the colored profile. The largest QRS peak must be within a Peak Zone.

UNACCEPTABLELEAD

ACCEPTABLELEAD

3. VERIFY at least one lead is acceptable in all postures.

INCORRECTPROFILE

CORRECTPROFILEP

eak Zo

nes

14 cm

RA

LA

LL

LEAD I

1. RECORD: Supine+Standing 25 mm/s, 5-20 mm/mV

SIMULTANEOUS 3-LEAD ECG14 cm


UNACCEPTABLELEAD

ACCEPTABLELEAD


INCORRECTPROFILE

CORRECTPROFILEP

eak Zo

nes

14 cm

RA

LA

LL

LEAD I



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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



Necessary?



Acceptable Vector


Examples



UNACCEPTABLELEAD

ACCEPTABLELEAD


INCORRECTPROFILE

CORRECTPROFILEP

eak Zo

nes

14 cm

RA

LA

LL

LEAD I




UNACCEPTABLELEAD

ACCEPTABLELEAD


INCORRECTPROFILE

CORRECTPROFILEP

eak Zo

nes

14 cm

RA

LA

LL

LEAD I



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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



Necessary?



Acceptable Vector


Examples


CLIPPING OF THE ECG PEAK

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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



Necessary?



Acceptable Vector


Examples



UNACCEPTABLELEAD

ACCEPTABLELEAD


INCORRECTPROFILE

CORRECTPROFILEP

eak Zo

nes

14 cm

RA

LA

LL

LEAD I




UNACCEPTABLELEAD

ACCEPTABLELEAD


INCORRECTPROFILE

CORRECTPROFILEP

eak Zo

nes

14 cm

RA

LA

LL

LEAD I



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Step 2:Evaluating the Surface ECG

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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 profile2. Align the profile3. Evaluate the QRS complex



Necessary?


Acceptable Vector


Examples



400 300 200 150 100 90 80 70 60 50 40 30HEART RATE (25 mm/sec) 2 x RR FROM REFERENCE ARROW

200400

600800

100012000

14 cm GUIDE (Note: For screening, ECG electrodes should not extend beyond 14 cm arrows)


200400

600800

100012000

14 cm GUIDE (Note: For screening, ECG electrodes should not extend beyond 14 cm arrows)

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1. 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



Necessary?


Acceptable Vector


Examples





Peak Z

on

es

UNACCEPTABLELEAD

ACCEPTABLELEAD

3. VERIFY that one lead is acceptable in all postures.

INCORRECTPROFILE

CORRECTPROFILE

8 cm

SIMULTANEOUS 3-LEAD ECG



Peak Z

on

es

UNACCEPTABLELEAD

ACCEPTABLELEAD

3. VERIFY that one lead is acceptable in all postures.

INCORRECTPROFILE

CORRECTPROFILE

8 cm



200400

600800

100012000

8 cm GUIDE

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3. 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



Necessary?


Acceptable Vector


Examples




UNACCEPTABLELEAD

ACCEPTABLELEAD


INCORRECTPROFILE

CORRECTPROFILEP

eak Zo

nes

14 cm

RA

LA

LL

LEAD III

LEAD I



14 cm


UNACCEPTABLELEAD

ACCEPTABLELEAD


INCORRECTPROFILE

CORRECTPROFILEP

eak Zo

nes

14 cm

RA

LA

LL

LEAD III

LEAD I



14 cm

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Step 3:Determining an Acceptable Vector

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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


Necessary?


Examples



STEP 3:Determining an

Acceptable Vector

Inconsistent Morphology

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Examples:ECG Screening Examples

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ECG Screening Example 1:Subtle changes about the baseline…


Necessary?




Acceptable Vector


Examples

SUPINE STANDING

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Necessary?




Acceptable Vector


Examples

SUPINE STANDING

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Necessary?




Acceptable Vector


Examples

SUPINE STANDING

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ECG Screening Example 2:Varying notch morphology…


Necessary?




Acceptable Vector


Examples

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ECG Screening Example 3:Inconsistent amplitude and morphology…


Necessary?




Acceptable Vector


Examples

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ECG Screening Examples:Inconsistent amplitude and morphology…


Necessary?




Acceptable Vector


Examples

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Questions?

Thank you

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Brief SummaryThe 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.

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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.

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