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1
Q

What is electrophysiology?

A

The study of electrical conduction system in the heart to diagnose an arrhythmia and determine the best course of action to treat it.

Electrophysiology is crucial for understanding heart rhythms and managing heart diseases.

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2
Q

Sound mapping cath

A

Uses ultrasound image to identify key anatomical features of the heart which are then traced, sliced, and combined by the lab tech to create a 3D image

Biosense Specific: Only supported with Sound Star NAV catheters

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3
Q

Fast Anatomical Mapping (FAM)

A

Uses a location sensor and electrical information to create a 3D model of the heart

Catheters that can create FAM maps: Lasso NAV, Penta Ray NAV, Deca NAV

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4
Q

Electrical Impedance Mapping

A

Uses impedance (the radio fo the voltage across the circut element to the current through the element) to create an anatomical map of the heart. Allows for any catheter to be used to map

Supported on the EnSite Precision Cardia Mapping System

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5
Q

Catheter electrode spacing basics

A

Electrode spacing: refers to the distance between 2 sequential electrde pairs

Smaller distance between the electrodes allows for electrical signals to be more discrete, more detailed and have higher fidelity

The size of the spacing is measured in millimeters**

Spacing choices are influded by: arrhythmia type, cardiac anatomy, the amount of detail desired and/or the ecetrophsiologists preference

*NOTE: every manufacturer measures the electrode spacing from edge to edge except Biosense Webster to uses center to center

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6
Q

Common Electrode Spacing

A

2mm: used for precise local mapping is needed to identify location during an ablation; provides the most discrete and cleanest signal detail

5mm: used for mapping of chambers with low amplitude electical signals (RVA & HRA) this spacing is more forgiving on catherer location because the electrode pairs measure a larger field of tissue

2-5-2mm spacing: combines 2mm & 5mm spacing to provide discrete signals over a larger area of tissue- this space is typically found on CS & mapping ablation catheters

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7
Q

Catheter size

A

EP Catheters are all around the same general length of 100cm**

<80cm are used with subclavian or IJ (neck) access

> 80cm are used with femoral (groin) access

EP catheters measure by French Size (Fr) - refers to the diameter of a catheter: 1 Fr = .33mm *most EP Catheters range from 4-8 Fr**

The larger the French Size, the stiffer the catheter & vice versa

Physicians are concerned about ventricular perforations may use a small french sized catheter

Physicians that prefer a more stable & supportive catheter will opt for a larger French size

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8
Q

Common Catheter Curves- fixed:

A

Josephson Curve: Commonly used in HRA & RV

Cournand Curve: Commonly used in HIS

Cournand –2 Curve: Commonly used in HIS

Damato Curve: commonly used in RV

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9
Q

Ablations where we have the most presence

A

Radiofrequency Ablation: Lasso ablation catheter positioned up near the pulminary vein (circular catheter) then you have the ablation catheter to deliever heat in a point by point. Manner- *take the ablation catheter and move it from one spot to the pnext making a complete line of scar tissue using heat stopping the conduction from making its way from the pulmonary veins to the left atrium

Cryo: a balloon or cryo balloon is inserted into the ostea or the opening of the pulmonary vein then inflated then a freezing solution is ran through that balloon and creates a scar using a freezing mechanism with the same result as the RF ablation

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10
Q

NSR – Normal Sinus Rhythm

A

“the rhythm that originates from the sinus node at the top of the heart and it describes the rhythm of the healthy human heart”

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11
Q

Supraventricular Tachycardia (SVT)

A
  • any tachycardia that originates above the ventricle and has a heart rate greater than 100 BPM”
  • Medication : calcium channel blockers and beta blockers to control the heart rate and rhythm

Cardioversion especially if the patient becomes unstable due to their heart rhythm - pads to shock patient back into rhythm

RF Ablation- EP study needed to see what type of SVT the patient has and that we can diagnose the proper rhythm and the proper tissue – if not and it is performed in the wrong location the patient will continue to have SVT and will not feel any benefits

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12
Q

AFL: Atrial Flutter

A

Treatment

Medication

Cardioversion

Ablation: FR ablation or heat and done often times without an EP study

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13
Q

Atrial Fibrillation

most common thing we see in the EP lab today- still “young” when determining course of treatment in the EP lab

A

Medication: calcium & beta blockers & blood thinners to prevent blood clots

Cardioversion: short term

RF ablation: long term that is preferred

Cryo ablation : long term that is preferrede

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14
Q

Recording System in Lab

A

The system that recieves & displays all the electrical recording from the electrodes that are in the heart along with the EKG on the body surface

Common systems: Workmate Claris- Abbot (st. Jude), CardioLab: GE, Labsystem Pro: Boston Scientific

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15
Q

UltraSound Console:

A

The console that displays vascular, transthoracic, transesophageal and intracardiac ultrasound images

Common Consoles: VivdidIQ: GE the 8 & 10 French aquanab & soundstar catheters can be used on, SE2000: Siemens * he 8 & 10 French aquanab & Siemens, soundstar catheters can be used on , ViewMate: viewflex, Abbot/ St. Jude catheters to be used on

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16
Q

Mapping System/Cardiac 3D Mapping System:

A
  • Assists with complex ablation procedures by creating 3D cardiac images with important voltage and timing data to aid in the diagnosis and treatment
  • Carto: Biosense Webster (market leader in the mapping space)

EnSite: Precision: Abbbot/ St. Jude (second market leader & have a full court press on Biosense Webster- just launched Ensite X)

Rhytmia: Boston Scientific

EPD: Philips (important because of the philips EPD partnership)

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17
Q

EP Cable Market Overview: who is the leader?

A

Leader: Biosense Webster

2nd: st. Jude medical

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18
Q

EP Cable OEM Competitors

A

Biosense Webster

St. Jude Medical

Irvine Biomedical Inc

Boston Scientific

Abbot Medical

Medtronic

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19
Q

EP Cable Reprocessor Competitors

A

SterilMed

Medline ReNewal

Innovative

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20
Q

EP Cable Reprocessing Overview

A

Visual Inspection

Any cables with visual damage or contamination are immediately rejected

Looking for damaged or exposed wires, cracked or broken pins, and kinking in the cable

Decontamination and Cleaning

Cleaned with medical grade cleaners and wiped down

Performance Testing (hospitals can NOT perform on their own they only sterilize them then send them back for use)

Electrical Performance Testing:

> HIPOT Test: electrical test that verifies the cables high potential or HIPOT safety requirements- a leakage test that verifies insulation strength between two wire pairs

> Continuity Test: open circuits, if wire or connection goes bad it is open-and the circuit is open and the continuity is not functional

> Isolation Test: method of testing insulation or isolation of electrical circuit – testing for shorts between conductors or wires – if isolation between the conductors is bad, the measured resistance value will be small with means they are shortened by some conducted medium – helps reject for noisy signals that can interfere with EP cases

Rejection of all Nonconforming Devices

Device Tracking: distinct barcode usage to ensure device is never reprocessed beyond maximum number of validated cycles

Sterilization: EO Sterilization

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21
Q

Diagnostic Catheters

What are they?

A

diagnostic electrophysiology (EP) catheters pace and transmit electrical signals from inside the heart

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22
Q

How Are different types of diagnostic caths distinguished?

A

of electrodes & fixed or steerable curve

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23
Q

number of electrodes: quadripolar catheters

A

4

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24
Q

number of electrodes: decapolar cath

A

10

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25
number of electrodes: due-decapolar cath
20 electrodes
26
what is a fixed curve catheter
the curve of the catheter cannot be altered for any kind or steering mechanism, little variance in where it goes which is great for EP’s that want it to go to a specific spot- ex: Josephson
27
what is a steerable curve cath
have a steerable mechanism on the handle so the distal tip can deflect or curve on a specific shape so the catheter can form to different shapes of the heart
28
who are the 3 largest manufacturers of diagnostic caths
Biosense Webster, Abbott Laboratories, Boston Scientific
29
what other reprocessors are in the diagnostic cath market
SterilMed & Innovative, and SSS
30
what makes up the anatomy of a diagnostic cath
- Plunger- Style Deflection Actuator – Ep uses their thumb to push towards cable connector and that will create the deflection to manipulate the wires inside to steer the distal end of the catheter - Shaft: the inner wires are responsible for sending signals – important for catheters to steer consistently while maintaining isolation
31
what is the functionality of a diagnostic cath
EP Diagnostiic cathers are the main tool and EP uses to capture intracardiac electrical signals for display and diagnostic purposes Equipped with platinum electrodes that detect electical signals in the heart
32
how does a diagnostic cath work
Detect: each electrode has a wire that has a wire connected to it that goes down the length of the catheter record local electrical activity for that specific area of tissue in the heart Pacing: introducing some electricity to pace the heart to interrupt the normal functionality to help diagnose different arrythmias or function
33
Reprocessing Overview of Diagnostic cath
dentity Control: ACID Machine- process to track lifecycle of this device Decontamination: cleaned with medical grade cleaners and wiped down and soaked Visual Inspection: Performance Testing: Electrical Profile Testing: measurement/ calculation of impedance, resistance, leakage current, and handle strength, continuity Mechanical Integrity: tests the torsion, deflection, 3 point bending, buckling, flexion fatigue, connector, and simulated use to determine mechanical fuctionality and reliability of the reprocessed catheters *DEVICE CURVES* : measured against standard templates to ensure direction shape and plane of the curve meet the established criteria Tip protectors are places on FIXED curve catheters to ensure the radius of the curve remains unchanged Rejection & Nonconforming Devices Device tracking: distinct barcode usage to ensure device is never reprocessed beyond max number of cycles Sterilization: EO sterilization
34
Stryker Steerable Sheath
Access to the hard to reach sites *improving performance and experience for EPs* both on the therapeutic and diagnostic portion of the procedure Enhance clinician capability for transsptal puncture, cardiac mapping, and therapeutic ablation in left atrium or ventricle Found in: EP & Cath Lab
35
Reprocessed Agilis' Features
8.5F bi-directional 180/90 degrees deflection Curl options: small (16.8mm), Medium (22.4mm), Large (50mm) Braided Shaft Provides: torquability, pushability, kink resistance Ergonomic handle provides more comfort
36
Stryker Steerable Sheath Features
8.5 and 12F bi-directional 180/180 deflection Curl options include: small (15mm), Medium (22mm), Large (42mm), 12F-Standard Only (50mm) Double braided shaft provides: torquability, pushability, kink resistance Ergonomic handle provides more comfort
37
what is the difference between Agilis & Stryker Sheath
One consistant modality** (unlike agilis) Handle allows Curl sizes
38
Sheath Market leaders & OEM competitors
Leaders: St. Jude (agilis utilization), medtronic (cryo balloon with flex cath), biosense webster - OEM Competitors: Biosense Webster, Abbott St. Jude, boston scientific, abbott medical, medtronic
39
Sheath market overview: what are the other reprocessors
SterilMed, Innovative *dont have their own manufactored steerable sheath because it is an OEM
40
what % of the market does SSS agilis have
SSS 4%: with Agilis but room for growth with steerable sheeth
41
Sheath Functionality
Higher Rates: Completer pulmonary vein isolation- RF or Cryo all about good solid consistant contact on the veins No atrial fibrillation at 6- and 12- months post ablation Single procedure success rate post ablation Resolution of atrial fibrillation Reduced Antiarrhythmic medications after six months Re ablation procedures Procedure time Fluoroscopy time *why? Better consistency* Total radiofrequency (RF) energy usage
42
Steerable Sheath Anatomy
Note dialator is locked into place when you hear it click 3. Hemostatic valve: air emblemism – designed to PREVENT IT- avoid moving too fast 4. 3 way stopcock; the pressurized saline is connected to the sheath itself 5. steering control mechanism: allows the ep maneuver the sheath and deflect it bidirectionally up to 180 degrees in both directions *1-1 torque response- allows for immediate response when they rotate the handle 6. device handle: reprocess the handle! While we replace the sheath each time 7. introducer sheath: propriety shaft designed to minimize kinks and bends and overall degrenatin of the sheath during long procesures – also better curve retention and durability Steerable section: deflection capability Radiopaque marker: distal tip of our device prevents the tip from causing damage
43
What parts of the sheath do we reprocess?
Modular design to reprocess just the handle: side port, stopcock, everything to the shaft of the sheath will be replaced every single time
44
how many reprocessing turns does the sheath have
ONLY 1
45
Reprocessing overview for sheath
Identity Control Devices are rejected for: damage or kinks, shaft and or tip damage, Missing dilator Tagged with a Unique ID#: Labeled on the stopcock Decontaminatino & Cleaning Partial Disassembly Use of channel brushes High pressure flow of cleaning agents through the interior lumen of the sheaths and dilators Use of enzymatic cleansers for cleaning inner and outer surfaces 3 stages completed 1:1 pump to Agilis/dilator Magnified visual inspections Reassembly: New sterile stopcock New Hemostasis Valve Cap (bio compatible glue) Valve cap reassembly fixture (coated with silicon) Performance Testing Leaky Decay Testing: sheaths & dilators tested to ensure hemostasis pressure has been maintained Entire sheath assembly has been evaluated for blockages Lamination: relaminated Performance Testing Bi Directional Steering range Curve profile: validated curve fixtures Sterilized Evaluated under 10x magnification before sterilized and packaged
46
What is an ICE cath
used for visualization of cardiac anatomy as well as other devices within the heart” either 2D or 3D - found in EP labs and Cath labs or IR (interventional radiology)
47
Commons ICE caths in the field
AcuNav, SoundStar, ViewFlex AcuNav & SoundStar: 2 most common french sizes 8 & 10F ViewFlex only 1 French size: 9F
48
how to identify what mapping systems are used with what ICE
AcuNav: teal & white Soundstar: black & teal Viewflex: green& gray
49
what are the 2 dominant players in the ICE marker
biosense webster (3D soundstar eco & 2D mapping acunav) and St. Jude Abbott (2D viewflex)
50
what are the other reprocessors in the ICE market
sterilmed, (tied to biiosense webster) innovative (medline- low prices)
51
what is the functionality of 2D ICE
captured in 2D images or slices images of the hearts anatomical structures using pulsed phase array technology from a transducer located in the tip of the ice catheter- FAM map: F (fast) A (anatomical) M (map) Used to visualize the transceptal puncture and use a lasso to create a single fam map
52
what is the functionality of a 3D ICE
he cardosound software module on the cardo mapping system enables conversion of 2D ultrasound image to create a 3D sound map these are used to create an image of the hearts anatomical structure
53
What kind of ICE cath is Viewflex
2D - SJM/Abbot Connects to the Viewmate ultrasound Console Not integrated with a mapping sys
54
what kind of ICE is AcuNav
2D Biosense webster Connects to the GE or Siemens Ultrasound Console Not integrated with a mapping sys
55
what kind of ICE is a Soundstar
biosense webster 3D Connects to the GE or Siemens ultrasound console *ONLY compatible with the cardo mapping system*
56
ICE Reprocessing Overview
Visual Inspected: Any visible damage or contamination are immediately rejected Looks for damange, kinks, or excess bioburden Decontaminating & Cleaning Prolonged soaking, cleaning, and rinsing with enzymatic cleansers and sanitizers Performance Testing Transducer testing Image Quality Mechanical Performance Electrical Testing Device Trackng Distinct barcode(on proximal end) usage to ensure device is never reprocessed beyond max number of times Sterilization EO sterilization
57
what are ddvanced mapping catheters
Advanced mapping catheters help evaluate the electroanatomic layout of the heart and surrounding area. They are typically used to identify problems within the heart such as arrhythmias
58
where are advanced mapping caths found
EP & Cath lab
59
who owns the largest share of the mapping cath marker
68% biosense webster
60
who are the other reprocessors in the advanced mapping cath space
sterilmed, and innovative
61
non mapping vs mapping cath
non-mapping: no magnetic sensor mapping: when a magnetic sensor is present on the catheter- this is used by the OEM clinical specialist to create map of the heart
62
do non mapping and mapping catheters share the same purpose? t or f
false
63
do mapping catheters create data points of the heart? t or f
true
64
for "noise" or feel/deflection what testing is done that helps combat these objections
noise: isolation and continuity testing feel: curve testing/validation process
65
flow of electrical signals from a cath:
Heart tissue--> to electrodes-->through catheter-->to & through the cable-->to recording/mapping system
66
how to combat common objections for ICE caths of impage quality?
educate user on our image quality testing process. We measure 6 different parameters during testing (including contact & noise ratio, noise floor, axel resolution, lateral resolution depth of penetration, and image of arifacts) Case Support: OEM case support- ex. Biosense Webster threatened to pull case support if a reprocessed ICE cath is being used. Know Viewflex and AcuNav catheters do NOT require OEM clinical support, and they can be operated with the staff in the lab
67
what ultrasound console does Acunav plug into
Simens or GE ultrasound
68
what ultrasound console does Viewflex plug into
VIewmate Zonare or Phillips CX5
69
do both Viewflex & AcuNav plug into mapping systems?
FALSE they have NO integration with those systems- they create a 2D image
70
which company is the only one to offer 3D ICE Cath & what is it's name?
Biosense Webster: soundstar
71
Differences between 2D AcuNav and 3D Soundstar by Biosense Webster
**PIGTAIL** You see the same plug in for the ultrasound on both the Acunav and the Soundstar- bronze computer chip (they both plug into the Siemens and GE Ultrasound Console)- the plug has nothing to do with mapping or clinical support Soundstar: **side plug**(pigtail plug) that plugs into the mapping system for Biosense That plug in is where it is able to take that 2D image it creates and send it into the Biosense Webster CARTO3 Mapping system to get converted to 3D- that conversion requires clinical support Soundstar: 2D and can convert to 3D imaging Biosense Webster: they plant clinical support specialists in there who sit at the 3D mapping systems to provide case coverage and creating the 3D renderings- EP labs don’t know how to do it on their own- they have the control
72
types of trocars
bladed, bladeless, blunt tip, optiview (offered by ethicon)
73
How to identify troccar category & what do the letters stand for?
Category: CB (cannula ONLY) B (bladeless) D (dialating tip) H (blunt tip)
74
what diameters do the torcars come in?
5, 8, 11, 12, 15
75

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