ep sales training chilli ii™ cooled ablation catheter
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Chilli II™ Cooled Ablation CatheterAgenda
Chilli II™ - Features Atrial Fibrillation Positioning Internal vs. External Brochure Competition Cabling Chart Evaluation Model How to Use Generators Troubleshooting Guide Clinical Evidence Conclusion
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Chilli II™ Cooled Ablation CatheterFeatures
Handle• Tension Control•Bi-wing Steering•Handle Ergonomics
Proximal Shaft•Torqueability•Pushability •Trackability
Tip Electrode•Tip Size•Cooling•Temperature Sensor
Distal Segment• Length & Curve Shape• Performance• Active Steering
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Chilli II™ Cooled Ablation CatheterFeature Summary
Blazer II™Blazer II™
HTDBlazer II XP™
Blazer II XP™ HTD
Chilli II™
Standard Medium
Extended
Standard Torque ------ ------ ------High Torque ------
Small ------ ------ ------ ------Standard
Large Asymmetric
Passive Active ------ ------ ------ ------
7f/4mm ------ ------ 8f/8mm Str ------ ------ ------8f/8mm VM ------ ------ ------ ------
Exposed Imbedded ------ ------ ------ ------
Thermistor Thermocouple ------ ------ ------ ------
Cooling
Tip Electrode
Temperature Sensor
CATHETER FAMILY CONFIGURATIONSDISTAL SHAFT
CHARACTERISTICS
Tubing Lengths
Tubing Firmness
Curve Shapes
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CircuCool ™ Pump Features
SettingsFlow Rate: Constant: 0.6 ml/sec or 36ml/min
Pressure Limit: Less than 300 psi
Dimensions and Weight Height: 9.0” (22.9 cm) Width: 11.0” (27.9 cm) Depth: 11.80” (30.0 cm) Weight: 9.6 pounds (4.4 kg)
Special Note: Pump comes with US power plug. Need to order appropriate EU country plug
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Chilli II™ Cooled Ablation Catheter Atrial Fibrillation
Anatomy & Conduction• Left Atrium
– Four PVs enter the left atrium (left, right, superior and inferior)
– A fib thought to originate in the PVs – Thought to be a triggered tachycardia
Three Types• Paroxysmal
– starts and stops spontaneously– Variable durations
• Persistent– starts spontaneously– stops only with electrical or medical
cardioversion• Permanent
– present all the time– restoring sinus rhythm is not possible
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Chilli II™ Cooled Ablation Catheter Atrial Fibrillation
Mapping Atrial Fibrillation• Dx placed in CS and in PVs
– CS = to pace the left atrium• Decapolar
– PVs = to check for electrical activity and isolation• Laso, Mesh, Constellation
catheters
• Rx in left atrium• Done with a transeptal
puncture across the septum
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Chilli II™ Cooled Ablation Catheter Atrial Fibrillation
Ablating Atrial Fibrillation• Various techniques but
essentially try to isolate the PVs by encircling and possibly making other connecting linear lesions
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Chilli II™ Cooled Ablation Catheter Atrial Fibrillation
Summary• Symptoms
– Palpitations– Dizziness– Short of Breath
• Rhythm– Narrow QRS– Irregular– Paroxysmal, Persistant and Permanent
• Ablation– Encirclement of the Pulmonary Veins– Possible other left atrial connecting lesions
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Chilli II™ Cooled Ablation CatheterPositioning DISEASE CATHETER
AVNRT Blazer IIFLUTTER Blazer XP
AFIB CHILLI II
Atrial FibrillationCLINICAL REQUIREMENTS CATHETER FEATURES
Deep lesions for the Roof, Foot, and MV of the LA where the Atrial Tissue is thick
Cooled 7f,4mm tip electrode
Reduce risks of secondary complications of coagulum/thrombus formation that may result in TIAs or strokes.
Cooled 7f,4mm tip electrode
Micromovement to create linear lesion Bi-Wing Steering Knob and Mechanical Steering Mechanism
Reduce risk of secondary complications of fluid overload such as venal hypertension, renal hyperactivity and pulmonary insufficiency.
Closed Loop, reciruculating cooling fluid
Stable tip contact throughout linear lesion HTD Distal + Proximal tubing
Access and moving around the entire LA Proximal tubing + Bi-directional Steering
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“Irrigated RF ablation: power titration and fluid management for optimal safety and efficacy”, Stevenson et al.
Chilli II™ Cooled Ablation CatheterInternal vs. External
Not a major safety concern in most patients…. BUT:
Consider that 1l of normal saline contains 9grams of sodium chloride, which includes 3.6grams of sodium – patients with heart failure (CHF) or hypertension are typically advised to reduce the sodium in their diet to 2.4 grams daily. In addition to the volume load, each liter of saline irrigation contains 1,000 units of heparin. Thus, there is the potential for greater anticoagulation that would be achieved without open- irrigation.Factors that predispose to pulmonary edema:
• Heart Failure (CHF)• Heart disease (AV disease, MV disease, EF<35%, miocardial infarction)• Renal insufficiency• Diabetes mellitus• Advanced age• Multi-system disease (i.e. Autoimmune disease) or aggressive therapy (chemiotherapy or radiotherapy)
BSC Confidential. For Internal Use Only. Do not Copy or Distribute“Irrigated RF ablation: power titration and fluid management for optimal safety and efficacy”, Stevenson et al.
Chilli II™ Cooled Ablation CatheterInternal vs. External
Consequences of Saline Administration during Irrigation:• Increase of venous pressure• increase in renal excretion• pulmonary edema:
• increase respiratory rate• agitation• dyspnea• tachycardia• decrease of peripheral oxigen saturation • extremities edema
For this reasons eventual later treatment become necessary:• administration of oxygen• administration of intravenous diuretic drugs• administration of inotropic agents (i.e. dopamine)• endotracheal intubation and assisted ventilation
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Chilli II™ Cooled Ablation Catheter Brochure
ClinicalBenefits
OrderingInfo
POSITIONINGPOSITIONING
TechnicalInfo
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Chilli II™ Cooled Ablation Catheter Brochure
BSC Confidential. For Internal Use Only. Do not Copy or Distribute
Chilli II™ Cooled Ablation Catheter Brochure
ClinicalBenefits
OrderingInfo
POSITIONINGPOSITIONING
TechnicalInfo
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Chilli II™ Cooled Ablation Catheter Brochure
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Set Up GuideTroubleshooting GuideOrdering Info
Chilli II™ Cooled Ablation Catheter Brochure
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Chilli II™ Cooled Ablation Catheter Competition
COMPETITOR PRODUCT Medtronic Sprinkler™ St J ude Medical / IBI Therapy™ CoolPath Biosense Webster J ohnson & J ohnson
Thermocool™
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Chilli II™ Cooled Ablation Catheter Competition
Competitor ProductPUMP FLOW Steering Handle Cooling Manual/Auto Con/Var Uni/Bid Piston/B-w Int/Ext
Medtronic Sprinkler™ Manual Var Uni Piston Ext
St J ude/ IBI Therapy™ CoolPath Manual Var Uni Piston Ext
J &J Thermocool™ Auto with integrated Stockert Var Uni Piston Ext
BSC Chilli I I™ Auto Const Bid B-w Int
FEATURES
Con/Var --- Constant/Variable Uni/Bid --- Unidirectional/Bidirectional Piston/B-w --- Piston/B-Wing Int/Ext --- Internal/External
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Chilli II™ Cooled Ablation Catheter Cabling Chart
Catheter can be connected to: ▪ EPT 1000XP™ generator (BSC)
Serial Number above▪ Maestro 3000™ generator (BSC)▪ Stockert generator▪ Osypka generator
Chilli II™ cannot be used with Medtronic and IBI generators.
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Connection with Navx System (St Jude Medical)
Chilli II™ Cooled Ablation Catheter Cabling Chart
1 M0046 2062 0
1 M004 2071 01 ESI cable (42-04322) 1 ESI cable (42-04323)
1ESI filter box # 75-04452-001 before pod
Connect BSC to NAVx
Product Units Catheter Units Cable
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Chilli II™ Cooled Ablation Catheter Evaluation Model
When preparing the evaluation of new customer please follow the SIX easy steps outlined below:
STEP 1:
Schedule minimum two cases either the same or successive days:• Blazer - NO EXPERIENCE schedule one FLUTTER and one AFIB
case;• Blazer - EXPERIENCED schedule two AFIB cases.
STEP 2:
The evaluation is to be performed with a BSC RF Generator Maestro 3000™.
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STEP 3 (FOR FLUTTER ONLY):
Suggest to Physician to use the Blazer II XP™Large Curve with a high torque tubing, for added performance. If Physician is accustomed to using a sheath, comment HTD should eliminate this need but order a 5890ST just in case.
Chilli II™ Cooled Ablation Catheter Evaluation Model
Reach Reach and and
Large HeartsLarge Hearts
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STEP 4 (FOR AFIB ONLY): :
Suggest to the physician to use Chilli II™ Standard Curve and order a Large Curve as a backup for physicians with sheath manipulation and trackability issues.
Chilli II™ Cooled Ablation Catheter Evaluation Model
All- PurposeAll- PurposeAnd And
Most RobustMost Robust
Large HeartsLarge HeartsAnd And
Distal Flexibility Distal Flexibility
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STEP 5:
Utilize the following
chart of part numbers to identify ALL of the
components that you
should order for
the evaluation.
Chilli II™ Cooled Ablation Catheter Evaluation Model
Product Units Catheter Units CableCHILLI II 2 M004 EPT9031K2 0 2 M004 681 0
2 M004 EPT9031 0 2 M004 681 0
CircuCool 1 M004 8500 0 1 M004 3536010 204 M00435 2104 0
MAESTRO 1 M004 21000TC 0 2 M004 3536010 201 M004 21870T 0 5 M004 354 0
2 M004 653S 02 M004 613 0
1 M0046 2062 0
1 M004 2071 01 ESI cable (42-04322) 1 ESI cable (42-04323)
1ESI filter box # 75-04452-001 before pod
Connect BSC to NAVx
AFIB EVALUATION CATHETER CHECKLIST
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STEP 6: Before doing the ablation make the test on Maestro 3000™ - as described in the following slide.The test must be done in order to verify the compatibility of the generator with the recording system installed in the cat lab.
Tester required.
Chilli II™ Cooled Ablation Catheter Evaluation Model
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Chilli II™ Cooled Ablation Catheter Evaluation Model
BSC Confidential. For Internal Use Only. Do not Copy or Distribute
Connection with Navx System (St Jude Medical)
Chilli II™ Cooled Ablation Catheter Evaluation Model
1 M0046 2062 0
1 M004 2071 01 ESI cable (42-04322) 1 ESI cable (42-04323)
1ESI filter box # 75-04452-001 before pod
Connect BSC to NAVx
Product Units Catheter Units Cable
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Chilli II™ Cooled Ablation Catheter How to Use
POWER TEMP TIMEAFIB 35W 47ºC 30sec
FLUTTER 45W 47ºC 30sec
Generator Maximum ValuesArrhythmia
Hi FlowLo Flow/
Coag Coronary
Sinus15W ----- 41ºC 30 sec
Scar Tissue 30W 25W 47ºC 30sec
Thick Tissue 30W 25W 47ºC 30sec
Cardiac Tissue
Generator Initial SettingsPOWER
TEMP TIME
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ECG keysAFIB: PV isolation (no double potential where previously seen)Ablation ProblemHigh impedance: • Char or coagulum on the catheter tip: wipe catheter• Poor contact: need better reposition for better tip contact
Noisy Signals during ablation• Verify amplification, clipping and filtering parameters of recording
machine are properly set.• Verify cable connections are not loose or faulty• Verify generator on separate electric circuit from recording machine• Disconnect and turn off non-essential equipment.• Verify tip electrode is clean.• Consider changing AMP or POD
Chilli II™ Cooled Ablation Catheter How to Use
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11 error codes exist. Here listed meaning & solution.Brochure available.
Chilli II™ Cooled Ablation Catheter Maestro 3000™ Troubleshooting
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“Clinical study of the efficacy of a cooled-tip catheter ablation system for common atrial flutter.”Okishige K et Al.Cardiovascular Center, Yokohama Red Cross Hospital, Japan. [email protected] J. 2004 Jan;68(1):73-6.
Chilli II™ Cooled Ablation Catheter Clinical Evidence
PRODUCT Chilli™ SUCCESS RATES 100% NUMBER of PATIENTS 33
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“Prospective randomized comparison of cooled radiofrequency versus standard radiofrequency energy for ablation of typical atrial flutter.”Atiga WL, et Al.University of Pittsburgh Medical Center, Pennsylvania, USAPacing Clin Electrophysiol. 2002 Aug;25(8):1172-8.
PRODUCT Chilli™ SUCCESS RATES 98% NUMBER of PATIENTS 28
Chilli II™ Cooled Ablation Catheter Clinical Evidence
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“Randomized comparison of efficacy of cooled tip catheter ablation of atrial flutter: anatomic versus electrophysiological complete isthmus block.”Madrid AH, et Al.Cardiology Department, Ramon y Cajal Hospital, Madrid, Spain.Pacing Clin Electrophysiol. 2001 Oct;24(10):1525-33.
PRODUCT Chilli™ SUCCESS RATES 100% NUMBER of PATIENTS 8 pigs
Chilli II™ Cooled Ablation Catheter Clinical Evidence
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“Prospective randomized comparison of irrigated-tip versus conventional-tip catheters for ablation of common flutter.”Jais P et Al.Hopital Cardiologique du Haut-Leveque, Bordeaux-Pessac, France.Circulation. 2000 Feb 22;101(7):772-6.
PRODUCT Thermocool™ Biosense Webster SUCCESS RATES 100% NUMBER of PATIENTS 24
Chilli II™ Cooled Ablation Catheter Clinical Evidence
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“Pattern of isthmus conduction recovery using open cooled and solid large-tip catheters for radiofrequency ablation of typical atrial flutter.”Ventura R, University Hospital Hamburg-Eppendorf, Hamburg, Germany.
J Cardiovasc Electrophysiol. 2004 Oct;15(10):1131-2.
PRODUCT Thermocool™ Biosense Webster SUCCESS RATES 100% NUMBER of PATIENTS 65
Chilli II™ Cooled Ablation Catheter Clinical Evidence
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“Effect of isthmus anatomy and ablation catheter on radiofrequency catheter ablation of the cavotricuspid isthmus.”Da Costa A, et Al.University Hospital Jean Monnet, Saint-Etienne, France.
Circulation. 2004 Aug 31;110(9):1030-5.
PRODUCT Thermocool™ Biosense Webster SUCCESS RATES 97% NUMBER of PATIENTS 30
Chilli II™ Cooled Ablation Catheter Clinical Evidence
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“Use of different catheter ablation technologies for treatment of typical atrial flutter: acute results and long-term follow-up.”Marrouche NF, et Al.Cleveland Clinic Foundation,Cleveland,USA.
Pacing Clin Electrophysiol. 2003 Mar;26(3):743-6.
PRODUCT Chilli I I™ SUCCESS RATES 100% NUMBER of PATIENTS 39
Chilli II™ Cooled Ablation Catheter Clinical Evidence
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“Prospective randomized comparison of closed cooled-tip versus 8-mm-tip catheters for radiofrequency ablation of typical atrial flutter.”Schreieck J, et Al.Deutsches Herzzentrum Munchen, Munich, Germany.
Cardiovasc Electrophysiol. 2002 Oct;13(10):980-5
PRODUCT Chilli I I™ SUCCESS RATES 99% NUMBER of PATIENTS 50
Chilli II™ Cooled Ablation Catheter Clinical Evidence
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“Primary closed cooled tip ablation of typical atrial flutter in comparison to conventional radiofrequency ablation.”Spitzer SG, et Al.Institute of Cardiovascular Research, Dresden, Germany.
Europace. 2002 Jul;4(3):265-71.
PRODUCT Chilli I I™ SUCCESS RATES 98% NUMBER of PATIENTS 100
Chilli II™ Cooled Ablation Catheter Clinical Evidence
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“Prospective randomised comparison of irrigated-tip and large-tip catheter ablation of cavotricuspid isthmus-dependent atrial flutter.”Scavee C, Jais P, Haissaguerre M, et Al.Hopital Cardiologique du Haut-Leveque, Bordeaux-Pessac, France.
Eur Heart J. 2004 Jun; 25(11): 963-9.
PRODUCT Chilli I I™ SUCCESS RATES 55% NUMBER of PATIENTS 20
Chilli II™ Cooled Ablation Catheter Clinical Evidence
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“Predictors of recurrence following catheter ablation of atrial fibrillation using an irrigated-tip ablation catheter.”Vasamreddy CR, et Al.Johns Hopkins University School of Medicine, Baltimore, USA.J Cardiovasc Electrophysiol. 2004 Jun;15(6):692-7.
PRODUCT Chilli I I™ SUCCESS RATES 100% NUMBER of PATIENTS 75
Chilli II™ Cooled Ablation Catheter Clinical Evidence
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“Saline-cooled versus standard radiofrequency catheter ablation for infarct-related ventricular tachycardias.”Soejima K, et Al.Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.Circulation. 2001 Apr 10;103(14):1858-62.
PRODUCT Chilli I I™ Thermocool™ Biosense Webster
SUCCESS RATES 90% NUMBER of PATIENTS 33
Chilli II™ Cooled Ablation Catheter Clinical Evidence
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“Catheter ablation of ventricular tachycardia in patients with structural heart disease using cooled radiofrequency energy: results of a prospective multicenter study.” Calkins H, et Al.Johns Hopkins University School of Medicine, Baltimore, USA.
J Am Coll Cardiol. 2000 Jun;35(7):1905-14.
PRODUCT Chilli I I™ SUCCESS RATES 81% NUMBER of PATIENTS 73
Chilli II™ Cooled Ablation Catheter Clinical Evidence
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Chilli II™ Cooled Ablation CatheterConclusion
Chilli IIPositioning
AFIB
ClinicalNeeds
•Minimize Coagulum•Minimize secondary complications•Linear Ablation•Tip Contact•Access Anatomy•Deep Lesion
Customer Evaluation
•1 x AFL + 1 x AFIB Cases•BSC Generator•STD & K2 backup•Order per List
Catheter Features
•Cooled 7f/4mm Tip•Closed loop cooling•Bi-wing Knob & mechanical steering•HT Distal and Proximal•Active Steering & proximal tubing•Cooled 7f/4mm