01 Step by Step Implant 17-02-2017

CRM Comprehensive Device
Training
Dr. Dieter De Cleen

Cardiologist – Electrophysiologist
AZ KLINA - UZA
Program
• Approach to new implant and generator change
• Recalled product
• Lead replacement
• Dependent patients and AV block
• Preparation and sterile technique
• Venous access
• Product selection
• Steps of the implant
• How to hook up analyzer cables to lead
• Evaluating the current of injury
• Measurements at implant
• ECG changes
• Managing procedural complications
• Post implant management for the patient
Approach : new implant
• New implant ≠ easy

• Many considerations
• Indication
• Patient factors
• Location of procedure and infrastructure
• Physician preferences
• …
• … be prepared
• Considerations
• Indication :
– Determines type of device
– Pacing indication : impulse generator and pacing
indication determines choice (single vs dual chamber)
– Tachytherapy indication : defibrillator
– Heart failure management (CRT-P and CRT-D)
– Choice of leads : RA/RV leads, active/passive fixation,
shock lead, LV leads and delivery tools, …
⇨ wide choice of devices
• Considerations
• Patient factors :
– Old (less active lifestyle, fragile, comorbidities) vs young
(active lifestyle, long life expectancy)
– Anxiety
– Overall health
– Expectations
⇨ not your core business, but an important part of your
work : you take part in an implant procedure in a real
patient
⇨ patients add unpredictability to a procedure
• Considerations
• Location of procedure and infrastructure :
– Preferably : cathlab or an operating theater
– Less preferable : Intensive Care Unit / Radiology
departement
– Radiology equipment
• Considerations
– Type of device
– Type of lead
– Implant technique
– …
⇨ physicians add an even greater unpredictability to a procedure

Approach : generator change
• Generator change ≠ easy

• Many considerations
• Patient factors and changes in status
• Location of procedures and infrastructure
• Previous implant (device, leads, indication, …)
• Compatibility of hardware
• … be prepared
• Considerations
– Previous implant :
• Change in indication (e.g. evolution from non-pacing-
dependent to pacing-dependent)
• Suboptimal pacing site
• Lead-tissue interface problem (myocardial infarction)
• Electric circuit :
• Lead insulation problem
• Lead integrity problem
• …
• Considerations
– Changes in patient status :
• Permanent AF : downgrading DDD → VVI system
• Worsening EF : upgrading pacing system → ICD
system
• Worsening HF and broad QRS complex : upgrading
to biventricular system
• Considerations
– Compatilibity of hardware :
• MRI vs non-MRI conditional
• Connector
Approach : new implant/change
• Knowlegde of the implanting physician

• Knowlegde of the facility and
infrastructure
• Knowlegde of the patient and implant
indication
• Specific to generator change: knowledge
of previously implanted hardware
Program
• Venous access
• ECG changes
Recalled product
• Recalled product = nuisance

• Recalled product = potentially life
threatening
Zhang S, Kriza C, Schaller S, Kolominsky- Rabas PL (2015) Recalls of Cardiac Implants in the Last Decade: What Lessons Can
We Learn? PLoS ONE 10(5): e0125987. doi:10.1371/journal. pone.0125987
Recalled product
• Recalled product ≠ replacement of the

product
• Actions to be undertaken will be determined
by the company and regulatory authorities
• Inform your customer, provide support:
• Reprogramming of device
• Remote monitoring
• When to replace the recalled product
• Return the replaced product to SJM
• Do not inform patients
Program
• Venous access
• ECG changes
Lead replacement
• Indication for replacement: lead failure

• Lead failure:
• 1%/ year in pacing leads
• A little higher in ICD leads due to more complexity
• High threshold/low sensing
• Conductor coil fracture
• Insulation failure
• Device/lead infection : indication for lead
extraction
Lead replacement
• Conductor coil fracture

Acute
No current
• Ω ↑↑↑
• loss of pacing
Chronic
Electrolytic current
•Ω ↑
• pacing sometimes possible
Electrolytic medium
Lead replacement
• Insulation failure
• Low impedance
• Myopotential inhibition
• Muscle stimulation
• Loss of capture
Program
• Venous access
• ECG changes
Dependent patients
• Generator change :
• Perform lead measurement?
• Back-up temporary pacing system?
• Fast generator change without lead measurement
(not recommended)
• Start with unipolar measurement, then bipolar
measurement
• New implant :
• Back-up temporary pacing system
• Be aware : lead manipulation may dislodge
temporary pacing wire
Patients with AV block
• AV block (2nd degree Mobitz type II of 3rd degree)

• Conduction tissue : pre-existing malfunction
• High risk of complete AV blok w/o escape :
• During lead manipulation
• After threshold testing
• If lead dislocation/dislodgement after succesful implant
• Be prepared, physicians may prefer that VVI
backup pacing at a rate of 40 bpm is always on
Patients with BBB
• Conduction tissue : pre-existing malfunction

• Right bundle branch block :
• usually no problem
• Left bundle branch block :
• risk of complete AV block
• conduction is dependent on the right
bundle branch
• introduction of the ventricular lead can
damage the right bundle branch
Program
• Venous access
• ECG changes
Preparation
• Be prepared !!!
• Systematic protocol for each implant :
• Know type of procedure
• If any : knowledge of already implanted products (if
possible)
• Verify exact location and time of procedure
• Be sure all necessary products are available
• Adequate timing (be early)
• Carry extra material of every necessary
product
Preparation
• Set up of PSA :
• Set up parameters prior to implant in order to
quickly acquire threshold measurements
• Connect PSA cable to PSA – some centres use a
single PSA cable to perform measurement
• physicians may prefer that VVI backup pacing at a
rate of 40 bpm (at high output, e.g. 5V) is always
on for emergency pacing if needed
Sterile technique
• Sterility of implant procedures is of utmost

importance
• CRM device = foreign body
• Measures to avoid infection include :
• Intermediate sterile environment (cathlab) or better
(operating room)
• Restriction of traffic in the operating room
• Thorough skin desinfection
• Sterile draping and sterile surgical equipment
• Antibiotic profylaxis
Sterile technique

• Dress code
Sterile technique

• Do not touch surgeons table
• If you hand over material to the surgeon :
– Open the wrapper flap farthest away from you first
– All wrapper edges should be secured when supplies are
presented to the sterile field
– Sterile items should be presented to the surgeon or
placed secure on the sterile field, peel pouches should
be presented to the surgeon to prevent contamination of
the sterile field
– All items should be delivered to the surgical field in a
manner that prevents nonsterile objects or persons from
extending over the sterile field
AORN’s Recommended Practices for Maintaining a Sterile Field
Program
• Venous access
• ECG changes
Venous access
• Access is possible in many ways

• Commonly, one of three variants is used :
• Cephalic venous cutdown
• Subclavian vein puncture
• Axillary vein puncture
• Knowledge of basic anatomy is necessary
• In case of difficulty : venogram
Venous access
• Anatomy
Venous access
• Anatomy
Venous access
• Cephalic vein cutdown :

• Most elaborate technique
• Extrathoracic access : minimal risk of
pneumothorax
• Minimal pressure on lead/leads ➝ reduced risk of
lead integrity breakdown
Venous access

• Contra-indications :
– Known occlusion of the cephalic vein
– Chronic ipsilateral venostasis
– Ipsilateral mastectomy, radical resection of lymph nodes
– Chronic ipsilateral lymphedema
– Extensive scarring of the incision site
– Ongoing ipsilateral phlebitis
• Indications :
– Lead placement
– Central venous acces for long-term infusion therapy
– Temporal central venous catheters
Venous access

• Outcomes :
– Cannulation can be achieved in 64-95% of cases
– Success can be increased by pre-operative ultrasound
mapping or venography
• Complications :
– Around 11%
– Local hematoma, vein thrombosis, chronic venostasis,
infection
– Not well studied in children, but appears to be safe and
feasible in the pediatric population
Venous access
Venous access
Venous access
Venous access
• Cephalic vein cutdown – possible

difficulties :
• Vein spasm -> use lidocaine
• Inability to advance wire :
– Use fluoroscopy
– Use hydrophilic wire
• Absence of cephalic vein in 5% of cases (re-
examine layers of already dissected tissue)
• Cephalic vein traverses over the clavicle -> use
axillary vein puncture
• Vein occlusion -> use alternative venous access
Venous access
• Subclavian vein puncture :

• Frequently fast, easy access
• Higher risk of pneumothorax
• Risk of subclavian crush phenomenon
Venous access
• Axillary vein puncture

• Best of both worlds:
– Fast access to venous system
– Extrathoracic ➝ minimal risk for pneumothorax
– Low risk of lead integrity breakdown
• Expertise …
Venous access
• Chest X-ray reveals difference in the

entrance in the thoracic cavity
Venous access
• Puncture techniques
• Double puncture technique
– Two individual punctures for venous access
– Minimal friction/interaction between leads in venous
system
– Recommended sheath french size can be used for each
lead
• Single puncture technique
- one introducer, two leads
• Large veinotomy necessary to accomodate large
sheet
• Friction between leads very likely
Venous access
• Puncture techniques
• Single puncture : retained guidewire
– One puncture needed, reduced risk related to puncture
– Upsize two frech sizes to accomodate first lead and wire
– Retain wire while peeling sheath after placement of first
lead
– Use recommended sheath size for second lead implant
• Single puncture : two guidewires
- One puncture needed, reduced risk related to puncture
- Use recommended sheath size, remove obturator and
introduce second guidewire next to first guidewire
- Remove sheath, leave two guidewires
- Use recommended sheath size for lead introduction
Program
• Venous access
• ECG changes
Product selection
• Sheaths :
• Peel away sheaths w/o hemostatic valve
• Necessary when using puncture for venous access
• Usefull when introduction of a lead through a
venous cutdown is difficult (due to angulation) :
– Perform venous cutdown
– Introduce hydrophylic guidewire and advance to superior
vena cava
– Introduce sheath over the guidewire and remove
guidewire
– Introduce lead through the sheath
Product selection
• Sheaths :
Product selection
• Leads :
• Passive fixation leads :
– Typically tined leads
– Designed to become entrapped within trabeculae
– Low rate of dislodgement
– Good for apical placement in the ventricle
– Good for atrial appendage placement with J-shaped lead
– More difficult to extract
• Active leads :
Product selection
• Leads :
• Active fixation leads :
– Extendable screw, causes trauma to endocardium
– Higher stimulation threshold, can be countered by
steroid eluting tip
– Can be placed at various sites in the ventricle or atrium
– Low dislodgement rate
– More easy to extract compared to passive fixation leads
Product selection
• Leads :
• Physician preference
Product selection
• Leads :
• Unipolar
• bipolar
Product selection
• Device :
• Standard device vs MRI conditional device
• Up to 75% of patients implanted with a cardiac
rhythm device will develop an indication for a MRI
examination owing to medical co-morbidities
• Potential adverse events of MRI on CRM devices :
– Heating of lead tips
– Changes in capture threshold
– Pacing inhibition
– Transient reed switch activation
– Asynchronous pacing (potentialy leading to induction of
arrhythmias)
Product selection
2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. Aurichio et al. Eur Heart J 2013;34:22
Product selection
• Device :
• If new device : preferably MRI conditional device
• If replacement :
– Older system with non-compatible leads : standard
device
– If compatible leads: prefer MRI conditional device
• Note : local regulations and prices may differ
between countries/regions/hospital deals and
policies, which may influence choice of device
Program
• Venous access
• ECG changes
Steps of the implant
• Preparation of the operating room

• Monitoring (ECG, O2 pulse, blood pressure)
• Resuscitation equipment
• X-ray equipment
• Cauterisation instruments
• Surgical instruments and drapings
• Analyzer and cables
• Team availability
• Preparation of the patient

• Premedication if necessary (benzo’s)
• Peripheral IV (side of implantation) and
administration of antibiotics (e.g. cefazolin)
• Preparation of the operation region :
– Clipping of body hair (shaving is not recommended) and
cleansing of skin
– Broad desinfection of the skin (povidone-iodine solution,
or – in case of allergy – chlorhexidine or hexachlorophene)
– Application of sterile drapes around operation region
– Self adhesive plastic drape (impregnated with iodoform
solution) over the operation region
• Local anesthesia
• Fast acting and long lasting
• Skin incision
1
1. Subclavian approach
2. Cephalic approach
• Dissection of subcutaneous tissue

• Venous access :
• Cephalic cutdown
• Subclavian puncture / axillary puncture
• Pacemaker pocket :
• Above the fascia of the underlying muscle (m.
pectoralis major)
• Under the subcutaneous fat
• Big enough to fit pacemaker without skin stress at
edges
• Lead placement :
• Ventricular lead :
– PVC’s will occur as the lead enters the ventricle
– If PVC’s do not occur, likely the lead is in the coronary
sinus
– Prolapsing technique probably less traumatic compared to
direct entry through the tricuspid valve with stiff lead tip
– Preshaping the stylet will help to enter the right ventricle
– Apical position most common (frequently only stable
position in passive fixation leads)
– Alternative sites if needed (close to the tricspid valve,
septal position, higher on the interventricular septum,
right ventricular outflow tract)
– Check position (fluoroscopy PA, ROA, LAO – certainly
when using alternative pacing sites)
– Lead testing (look at ECG during pacing, the paced QRS
complex has to be positive in lead I) : sensing,
impedance, threshold
– Confirm absence of phrenic nerve / diafragmatic
stimulation (unlikely if septal position of lead)
– Check stability and slack of the lead (during respiration,
during coughing)
• Ventricular lead : measurements during implant
– Connect lead to PSA using analyzer cables (IS-1)
ring electrode
tip electrode
– Connect lead to PSA using analyzer cables (IS-4)
Ring 3 electrode
Ring 2 electrode
Ring 1 electrode
tip electrode
– Connect lead to PSA using analyzer cables (DF-4)
High voltage ring electrode
Low voltage
tip electrode
– Unipolar lead testing :
• Connect anode to a true indifferent electrode or
metal instrument placed in the pocket
• Do not clip the alligator clamp to the
subcutaneous tissue
ring electrode
tip electrode
• Ventricular lead testing :
– Sensing :
» Acceptable R-wave measurements : ≥ 5,0 mV
» Slew rate
• Ventricular lead testing :
– Impedance :
» Measurement of tissue contact
» Good tissue contact means lower impedance
» Electrode characteristics are important!
• Area ↓ impedance ↑
• Polarization impedance
» Stable value = stable contact
» High impedance → less current drain (hence,
longevity ↑)
– Threshold measurement :
» Test mode : VVI or VOO
» Increase pacing rate above patients rate
» Utilize intracardiac electrograms on PSA
» Dismiss PVC’s and following R-wave
» Check for intrinsic rhythm when ending threshold
test
Pacing threshold testing inducing ventricular fibrillation following acute rate control of atrial fibrillation.
Geoffrey at al. J Cardiovasc Electrophysiol 2009;20(12):1405-1407.
– Phrenic nerve or diaphragmatic stimulation :
» Test at 10 Volts
» May be positional : check during deep breaths
» RV has thin wall and diaphragmatic proximity
» RV perforation
» Placement in coronary sinus
» Less common in septal position
» If present reposition lead
– Phrenic nerve or diaphragmatic stimulation :
• Atrial lead :
Atrial appendage
Primary target
• Atrial lead :
– Target : right atrial appendage
– Alternative : low atrial septum (cave : dislocation),
lateral wall (pectinate muscle)
– In appendage : lead movement with cardiac contraction
resembles windscreen wiper
– Monitor ECG and fluoroscopy while J-stylet is withdrawn
• Atrial lead :
• Atrial lead :
– Check position (fluoroscopy PA, ROA, LAO – certainly
when using alternative pacing sites)
– Lead testing : sensing, impedance, threshold
– Confirm absence of phrenic nerve / diafragmatic
stimulation (unlikely in atria, but not impossible)
– Check stability and slack of the lead (during respiration,
during coughing)
• Atrial lead testing :
– Sensing :
» Acceptable P-wave measurements : ≥ 1,5 mV
» Slew rate
• Atrial lead :
» Test mode : AAI (or AOO) if patient is not dependant
and look for R-wave conduction
» If testing in DDD mode : extend AV delay
» Increase pacing rate above patients rate by 20-30
bpm
» Utilize intracardiac electrograms on PSA
» Check for intrinsic rhythm when ending threshold
test
• Atrial lead :
» If 2:1 AV block : increase atrial pacing rate to 100 bpm,
ventricular events should be documented at a rate of 50
bpm
» If 3rd degree AV block: prefer DDD pacing (or back-up
by temporary pacing system)
» AAI testing in 3rd degree AV block is only possible if the
patient has a good and stable escape rhythm
• Lead fixation :
• Use suture sleeves Superior knot
• Tie knot to muscle Lead
• Minimum 2 sutures Suture sleeve
Inferior knot
Muscle
• Lead connection to device :

Atrial lead
• Clear air in lead port Ventricular lead
• First ventricular lead
• Next atrial lead
• Secure screws
• Gently pull lead to control connection

• Lead connection to device

• Insert torque wrench in preslit
center at 90° angle
• this will relieve pressure
build-up from the lead port

• Fully insert the lead
• Lead terminal pin passes beyond connector block


• Gently apply downward pressure on the torque wrench, make sure it is
perpendicular to the connector block
• Tighten the setscrew by slowly turning the torque wrench clockwise
until it ratchets once, additional rotations are not necessary

• Remove wrench
• Apply gentle traction to each individual lead terminal
• Lead connection to device :

• Ventricular lead connection
• Atrial lead connection

• Place the device in the pocket

• Leads under pacemaker can
• Try to make nice loop
• Avoid tension of at edges of pocket
• Wound irrigation if included in protocol

• Povidone iodine
• Antibacterial solution : rifamycin, bacitracin –
polymyxin – gentamycin
• Wound closure
• Approximation of subcutaneous tissue by single or
multiple layers :
– Interrupted or running sutures
– Absorbable semisynthecic fairly strong suture wire (2-0 or
3-0)
• Skin closure :
– Subcuticular running suture using 4-0 semisynthetic
absorbable suture wire
– Interrupted sutures with non-resorbable wire
– Surgical staples
– Removal of staples of non-resorbable sutures after 7 – 10
days
• Dry sterile dressing
• After (or during with RF) closure AND before

physician leaves the operating room :
• Verify appropriate pacing
• Use surface ECG en EGM
• Set up final programmed parameters and
program device, AutoCapture turned ON
• Final measured data (capture, sensing, impedances)
• Print data and place in chart
Program
• Venous access
• ECG changes
Current of injury
• Why should one reposition a lead?

• Bad sensing
• Elevated threshold
• But :
• Is the sensing that we measure real?
• Is the elevated threshold correct? How will it
change over time?
• Are there indicators that predict future
measurements?
Current of injury
• What happens?
• Fixation of the lead is responsible for cellular
damage
• Cellular damage is responsible for polarization
(higher potassium ion concentration)
• Higher potassium ion concentration leads to
inactivation of sodium channels, which results in
temporary higher thresholds
• The current of injury reflects appropriate
lead – tissue contact
Current of injury
• How to measure / visualize the COI

• Use PSA (or ECG), unipolar measurement is best
• COI is consistent with good endocardial contact
– 1 mV for atrial leads
– 5 mV for ventricular leads
– ST segment elevation > 25% of the intrinsic amplitude
Current of injury

• Ventricular lead
Current of injury

• Atrial lead
Current of injury
• Evolution of COI
Current of injury
• How to recognize overestimation of the

sensing?
Current of injury
• Clinical use :
• If COI is present good wall contact and fixation
• If COI is present and pacing threshold is elevated
– Check anatomic position of lead : suitable or not?
– If yes wait 10 minutes and see
– Stimulation threshold expected to fall > 0,1 V at 4 minutes
– If so, encourage operator to wait before repositioning the
lead
• Absence of COI :
– High chronic threshold
– Increased incidence of lead dislodgement
Current of injury predicts adequate active fixation lead fixation in permanent pacemaker/defibrillation
leads. Saxonhouse at al. JACC 2005;45(3):412-417.
Program
• Venous access
• ECG changes
Influence on implant measurements
• Frequent mistakes
• Stylet
• PSA measure cable defect
– Control measurement with shortcircuited cable
• Contact between alligator clamp and electrode
connector
• Contact with wound or skin
• Polarity switched
• Wedensky effect
• = hysteresis in stimulation threshold
• What happens ?
– Threshold measurement : progressive decrease in output
until loss of capture (LOC)
– Increase output without capture untill a much higher
output eventually results in capture
• Wedensky effect
• Explanation :
– Effect not completely clarified
– Wenckebach factor ?
– Subthreshold stimulation blocks Na/K/Ca channels
• What to do ?
– Measure threshold again at lower stimulation frequency
• Stability issues
• Stimulation an 1,0 V or 2 x stimulation threshold
(whichever is greatest)
• Ask patient to cough and take deep breaths
• Check for loss of capture
• Wenckebach effect :
• 2nd degree AV block type I (Wenckebach AV block)
is situated in AV node
• Progressive conduction delay in the AV node untill
impulse is completely blocked in the AV node
• Etiology
– Medication : betablocking agents, calcium channel
blockers, digitalis, …
– Ischemia
– Conduction tissue fibrosis
• Atrial threshold measurement can be complicated
if tested in AAI at Wenckbach point
• Test threshold at lower frequency, below
Wenckebach point
• Test threshold at higher frequency at which 2:1
block is seen
• Test in DDD mode
• Endocardial/myocardial injury
– Sensing reduced a few days after implant
– Returns to approximately 85% of acute sensing in 6 to 8
weeks after implant
– Slew rate reduces by 50%
– Effect less pronounced in steroid-eluting leads
• Endocardial/myocardial injury
• Active fixation leads :
– Acute drop in sensing amplitude and slew rate
– Recovery of sensing amplitude within 20 to 30 minutes
– Etiology : trauma of screw
– If COI is present and pacing threshold is elevated
» wait 10 minutes and see
» Stimulation threshold expected to fall > 0,1 mV at 4
minutes
» If so, encourage operator to wait before
repositioning the lead
Program
• Venous access
• ECG changes
Procedural complications
• Venous access :
• Pneumothorax :
– Often asymptomatic
– If symptoms : pleuritic pain, cough, dyspnea
– Tension pneumothorax : hypotension, tachycardia,
desaturation, trachea shift
– Diagnosis : X-ray (or fluoroscopy)
– Treatment depends on severity of pneumothorax
» 100 % O2 via face mask if only small pneumothorax
» Needle aspiration if small or tension pneumothorax
» Chest tube if ≥ 10%
• Venous access :
• Hemothorax:
– uncommon
– Injury of subclavian artery by large sheath or dilator
– Injury of subclavian vein or intrathoracic vessel (less
common)
– Treatment :
» Consult with vascular surgeon or interventional
radiologist
» If large sheath mistakenly inserted into artery, leave
it in place
• Angiographic evaluation might be recommended
• Venous access :
• Air embolism :
– When sheath in central vein
– Hiss of air sucked into sheat when patient deeply
inspires (e.g. heavily sedated patients)
– Mostly well tolerated
– Symptoms : chest pain, respiratory distress,
hypotension, desaturation
– Treatment :
» Oxygen administration
» Catheters aspiration
» Inoptropic agents if necessary
» Repeatedly ‘push and pull’ electrode through RVOT
• Venous access :
• Air embolism :
– Prevention :
» Hydrate well
» Elevate legs (cushion underneath lower limbs)
» Valsalva maneuver when sheat is open
» Awaken patient and caution against deep inspiration
» Use small sheaths if possible (recommended French
size)
» Consider use of sheaths with hemostatic valve
• Arrhythmia :
– bradyarrhythmia :
» Manifestation of underlying electrophysiology
» Vagal reaction
» Excessive local anesthesia
» Inadevertant disruption of a pacing system (e.g.
accidental dislocation of temporary pacing wire)
» Injury to conduction tissue during lead manipulation
(e.g. trauma to right bundle branch in patient with
pre-existing left bundle branch block)
• Arrhythmia :
– bradyarrhythmia :
» Treatment :
• Medication : atropine, isoproterenol
• Transcutaneous pacing (sedate patient!)
• Temporary transvenous pacing
• Establish effective pacing
• Arrhythmia :
– Tachyarrhytmia :
» Due to stimulation of myocardium by a lead or
guidewire
» Atrial :
• Atrial fibrillation
• Predisposing factors : heart failure, left atrial
enlargement, pulmonary disease, sick sinus
syndrome
• Usually transient
• Arrhythmia :
– Tachyarrhytmia :
» Ventricular :
• Rarely sustained
• Predisposing factors for malignant arrhythmia :
hypoxia, ischemia, pharmacologic therapy
(sympathomimetics), asynchronous pacing
• Removal of pacing lead from irritating position
– Watch monitor / electrocardiogram !!!
• Perforation (w/o hemopericardium) :
– Clinical sequellae may not occur (underestimated)
– If symptoms (due to tamponade) : hypotension, chest
pain, tachycardia, distress
– Diagnosis : echocardiography (golden standard), lead
projecting beyond cardiac border on fluoroscopy
– Lead measurements :
» biphasic EGM if tip is perforated and tip is located
at endocardium
» EGM negative if in pericardial space
» Impedance ↑↑ (> 200 Ω)
– Treatment : retraction of perforating lead,
pericardiocentesis with catheter drainage
• Unintended endocardial left atrial/ventricular
position:
– Lead enters heart through atrial septal defect or
ventricular septal defect
– Lead introduction into arterial structure and passed
retrograde across the aortic valve
– Diagnosis :
» ECG : lead I is negative and lead V1 has RBBB like
pattern
» X-ray : posterior location of the lead on oblique /
lateral view
RV pacing
LV pacing
• Damage to heart valve
• Damage to lead :
– Loss of insulation integrity : low lead impedance
– Conductor fraction : high lead impedance
• Generator :
• Improper or inadequate connection of lead
• Pocket hematoma :
– Aspiration of effusion should be avoided
– Exploration of pacemaker pocket if suspicion of infection
Program
• Venous access
• ECG changes
Postoperative management
• Cardiac rhythm monitoring :

• Immediately after surgery
• Until discharge
• Bed rest : not recommended
• Restriction of movement : controversy
• Strict restriction for 48 hours using sling
• Moderate restriction of movement for 4 – 6 weeks :
» No elevation above 90°
» Restriction of lifting weights
• Chest X-ray after surgery :

• Anteroposterior and lateral views
• Documentation of lead position
• Electrocardiogram :
• With and without magnet
• Documentation of sensing and capture
• Pacemaker interrogation :
• Before discharge
• Sensing and threshold measurements
• Necessity of rate adaptive parameters
• Wound care :
• Dry sterile dressing in operating room
• Wound control before discharge
• Keep wound dry until ambulatory wound control
• Ambulatory wound control at 7 -10 days after
surgery
• Sutures removed at time of wound control
• Driving restrictions :
• Refer to local legislation

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CRM Comprehensive Device

Dr. Dieter De Cleen

• New implant ≠ easy

⇨ physicians add an even greater unpredictability to a procedure

• Generator change ≠ easy

• Knowlegde of the implanting physician

• Recalled product = nuisance

• Recalled product ≠ replacement of the

• Indication for replacement: lead failure

• Conductor coil fracture

• AV block (2nd degree Mobitz type II of 3rd degree)

• Conduction tissue : pre-existing malfunction

• Sterility of implant procedures is of utmost

• Measures to avoid infection include :

• Measures to avoid infection include :

• Access is possible in many ways

• Cephalic vein cutdown :

• Cephalic vein cutdown :

• Cephalic vein cutdown :

• Cephalic vein cutdown – possible

• Subclavian vein puncture :

• Axillary vein puncture

• Chest X-ray reveals difference in the

• Preparation of the operating room

• Preparation of the patient

• Dissection of subcutaneous tissue

High voltage ring electrode

• Lead connection to device :

• Gently pull lead to control connection

• Lead connection to device

• Lead connection to device

• Lead connection to device

• Lead connection to device

• Lead connection to device

• Lead connection to device :

• Atrial lead connection

• Place the device in the pocket

• Wound irrigation if included in protocol

• After (or during with RF) closure AND before

• Why should one reposition a lead?

• How to measure / visualize the COI

• How to measure / visualize the COI

• How to measure / visualize the COI

• How to recognize overestimation of the

• Cardiac rhythm monitoring :

• Chest X-ray after surgery :

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