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Dr. Jose Osorio
Improving Efficiency
While Enhancing Quality and Patient
Experience
in an AF Ablation Program
Disclosure
• I have received financial support/grants from:
• Boston Scientific: advisory board, consultant, research and
educational grants
• Biosense Webster: advisory board, consultant, research
and educational grants
• Abbott: research grants
• Epix: research grants
• Medtronic: research grants
• I will not discuss off label use and/or investigational use in
my presentation
CAGR
2013 – 2023
AF 16.51%
VT 7.01%
AFL 3.85%
SVT 2.91%
ALL 10.8%
178,010
193,930
213,060
235,800
262,480
293,170
327,830
366,000
407,130
450,330
494,740
0
50,000
100,000
150,000
200,000
250,000
300,000
350,000
400,000
450,000
500,000
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023
©2015 Millennium Research Group, Inc. All rights reserved. Reproduction, distribution, transmission or publication is prohibited.
Reprinted with permission. As these estimates are from a third party source, Biosense Webster does not make and hereby
disclaims any and all representations or warranties relating to the sufficiency and/or accuracy of the information provided by
Millennium Research Group and shall not in any way be liable for the same.
U.S. Ablation Volume
• Clinical Inertia
• Efficacy
• Efficiency
• ~6000 EP labs
worldwide
• Long procedures
• Procedures/day
AF Ablation:
Barriers to Market Penetration
AF Ablation Program:
Optimizing the Process
EP
Referrals
New Afib
Patients
Afib
Ablations
Follow Up
Where should you focus?
• Lean
•Toyota
•Focus: Eliminating Waste
• Six Sigma
•Motorola
•Focus: Reducing error and variability
• Synergistically
•Reduce waste and improve process efficiency
and quality
Quality
Efficiency
Reproducibility
Lean Six Sigma in Healthcare
Improving Lab and Procedural
Efficiency: Room Utilization
Cleaning
Getting New Patient
Anesthesia Prep
EP Prep
Patient Out of Lab
Patient Out of the Lab
Room Turn Over Time
Procedure Starts
Procedure Ends
EP study
Mapping
Merge/ICE/FAM
Ablation
Validation
3 hours
Recovery
Patient leaves Lab
Groin Care
Extubation
Room Turn Over Time
Afib Ablation
Procedure Time
Recovery Starts
1 hour
1 hour
• Standardization
•Protocol
• Ablation
• Anesthesia
•Repetition
• Eliminate waste and improve flow
•Duplication and non-value added steps
•Root Cause Analysis for outliers
•QI meetings
• Similar gains by addressing:
•Procedure
•Room Turn Over Time
Improving Lab and Procedural
Efficiency: Lean Six Sigma in EP
Room Turn Over Time
Variables Affecting TOT
• Recovery
• Cleaning
• PACU
• Patient Transport
• Prep time
•Anesthesia
•EP Prep
• EP doc
Cleaning
Getting New Patient
Anesthesia Prep
EP Prep
EP doc
Extubation
Recovery
Groin Care
Patient Leaves Lab
Procedure Ends
Procedure Starts
Improving Lab and Procedural
Efficiency: Room Turn Over Time
Improving Lab and Procedural
Efficiency: Room Turn Over Time
Cleaning
Getting New Patient
Anesthesia Prep
EP Prep
EP doc
Extubation
Recovery
Groin Care
Patient Leaves Lab
Cleaning
Getting New Patient
Anesthesia Prep EP Prep
Extubation
RecoveryGroin Care
Patient Leaves Lab
Procedure Ends
2
hour
Procedure Starts
Procedure Ends
1/2
hour
Procedure Starts
Anesthesia
Sedation/Recovery
1. Minimize instrumentation
2. Patient Prep
1. Anesthesia and EP together
3. Sedation
1. Propofol only
2. Minimize paralytics
4. Recovery
1. Start with isuprel infusion
2. Ventilator changes
3. Sheath removal
5. Post Anesthesia Recovery
1. At CATH/EP LAB Area
Anesthesia Protocol
For AF Ablation
Cleaning
Getting New Patient
Anesthesia Prep EP Prep
Extubation
Recovery
Groin Care
Patient Leaves Lab
Procedure Ends
Procedure Starts
Median time to
extubation 9 min
1st and 3rd quartile = 6-13
Anesthesia is not
a bottleneck
AF Ablation:
Efficiency, Efficacy
and Safety
2010
•Mapping system:
3D reconstruction
•Intracardiac Echo
2016
• EP Lab Efficiency
• Anesthesia Protocol
• Databases
• QI
2014
• Contact Force Sensing
• Workflow
• Integrating CF
• Visited Several EP Labs
Optimizing Efficiency and Efficacy
Standardizing AF Ablation
Standardized Afib Ablation Workflow
NumberofAFAblations/Year
0
100
200
300
400
500
600
700
800
900
1000
2010 2011 2012 2013 2014 2015 2016 2017 2018
Fluoroscopy Reduction
1. 40-45Watts
2. CF 10-15 g
3. Time:
1. 10-15s posterior wall
2. 15-20s anterior wall
4. Validation Protocol
1. Lesion set analysis
2. Adenosine and isuprel
Follow up
• 3, 6 and 12 months
• 4-day Holter at 6 and 12 months
• Event monitoring PRN
AF Ablation WorkFlow
Standardizing the Procedure
and Follow Up
Efficiency and Predictability in Paroxysmal
Atrial Fibrillation Ablation with Contact Force
Catheter and Stability Module Integration
Osorio J et al. Europace, Vol 19, Issue sppl_3, june 2017, page iii371
84.8%
9.8%
5.4%
15.2%
(N=112)
Success
Repeat
Ablation
1 year Success Rates - Single Procedure
A Comparison of Paroxysmal Atrial Fibrillation
Ablation Efficiency and Clinical Outcomes Across
Technologies in a High-Volume Center
Osorio J et al. Europace, Vol 19, Issue sppl_3, june 2017, page iii371
0.50
0.55
0.60
0.65
0.70
0.75
0.80
0.85
0.90
0.95
1.00
0 100 200 300 400 500 600 700 800
ProportionwithNoReablation
Days After First Ablation
Cryoballoon SmartTouch ThermoCool SF
Freedom from Reablation
• Should be the end result of
• Protocols and standardization
• Operator experience
• Efficiency is not the opposite of efficacy
• Safety
• Most important consideration
• Operator experience
• Ongoing data analysis and QI
Improving Lab and Procedural Efficiency
AF Ablation Efficiency
In-Hospital Complications Associated With Catheter Ablation of Atrial
Fibrillation in the United States Between 2000 and 2010, Volume: 128,
Issue: 19, Pages: 2104-2112, DOI:
(10.1161/CIRCULATIONAHA.113.003862)
Complication Rates and Operator Volume
Cleaning
Getting New Patient
Anesthesia Prep
EP Prep
Patient Out of Lab
Patient Out of the Lab
Room Turn Over Time
Procedure Starts
Procedure Ends
EP study
Mapping
Merge/ICE/FAM
Ablation
Validation
3 hours
Recovery
Patient leaves Lab
Groin Care
Extubation
Room Turn Over Time
Afib Ablation
Procedure Time
Recovery Starts
1 hour
1 hour
Cleaning Getting New Patient
Anesthesia Prep EP Prep
EP study
Mapping
Merge/ICE/FAM
Ablation Validation
Procedure Starts
Recovery
Patient leaves Lab
Groin Care
Extubation
Recovery Starts
15
min
90
min
15
min
Improving Lab and Procedural
Efficiency
EP LAB Use Time /
procedure
Afib Ablations / Day
4-5 hours  2-3 hours
2-3  3-4
Conclusion
•AF ablations will continue to increase
• EP Community
• Efficiency solutions
• QI / Lean Six Sigma Concepts
• Standardization
• Reducing waste
Increased
number of
ablations/day
End Result
 Reproducible
 Efficiency
 Efficacy
 Safety
Focus on the customer.
Identify and understand
how the work gets done.
Manage, improve and
smooth the process flow.
Remove Non-Value-Added
steps and waste.
• Redundant Steps
Lean Six Sigma in Healthcare
1
2
3
4
Manage by fact and
reduce variation.
• Protocols and
Standardization
Involve and equip the
people in the process.
Undertake improvement
activity in a systematic
way.
5
6
7

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Quality Improvement in an AF Ablation Program

  • 1. Dr. Jose Osorio Improving Efficiency While Enhancing Quality and Patient Experience in an AF Ablation Program
  • 2. Disclosure • I have received financial support/grants from: • Boston Scientific: advisory board, consultant, research and educational grants • Biosense Webster: advisory board, consultant, research and educational grants • Abbott: research grants • Epix: research grants • Medtronic: research grants • I will not discuss off label use and/or investigational use in my presentation
  • 3. CAGR 2013 – 2023 AF 16.51% VT 7.01% AFL 3.85% SVT 2.91% ALL 10.8% 178,010 193,930 213,060 235,800 262,480 293,170 327,830 366,000 407,130 450,330 494,740 0 50,000 100,000 150,000 200,000 250,000 300,000 350,000 400,000 450,000 500,000 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 ©2015 Millennium Research Group, Inc. All rights reserved. Reproduction, distribution, transmission or publication is prohibited. Reprinted with permission. As these estimates are from a third party source, Biosense Webster does not make and hereby disclaims any and all representations or warranties relating to the sufficiency and/or accuracy of the information provided by Millennium Research Group and shall not in any way be liable for the same. U.S. Ablation Volume
  • 4. • Clinical Inertia • Efficacy • Efficiency • ~6000 EP labs worldwide • Long procedures • Procedures/day AF Ablation: Barriers to Market Penetration
  • 5. AF Ablation Program: Optimizing the Process EP Referrals New Afib Patients Afib Ablations Follow Up Where should you focus?
  • 6. • Lean •Toyota •Focus: Eliminating Waste • Six Sigma •Motorola •Focus: Reducing error and variability • Synergistically •Reduce waste and improve process efficiency and quality Quality Efficiency Reproducibility Lean Six Sigma in Healthcare
  • 7. Improving Lab and Procedural Efficiency: Room Utilization Cleaning Getting New Patient Anesthesia Prep EP Prep Patient Out of Lab Patient Out of the Lab Room Turn Over Time Procedure Starts Procedure Ends EP study Mapping Merge/ICE/FAM Ablation Validation 3 hours Recovery Patient leaves Lab Groin Care Extubation Room Turn Over Time Afib Ablation Procedure Time Recovery Starts 1 hour 1 hour
  • 8. • Standardization •Protocol • Ablation • Anesthesia •Repetition • Eliminate waste and improve flow •Duplication and non-value added steps •Root Cause Analysis for outliers •QI meetings • Similar gains by addressing: •Procedure •Room Turn Over Time Improving Lab and Procedural Efficiency: Lean Six Sigma in EP
  • 10. Variables Affecting TOT • Recovery • Cleaning • PACU • Patient Transport • Prep time •Anesthesia •EP Prep • EP doc Cleaning Getting New Patient Anesthesia Prep EP Prep EP doc Extubation Recovery Groin Care Patient Leaves Lab Procedure Ends Procedure Starts Improving Lab and Procedural Efficiency: Room Turn Over Time
  • 11. Improving Lab and Procedural Efficiency: Room Turn Over Time Cleaning Getting New Patient Anesthesia Prep EP Prep EP doc Extubation Recovery Groin Care Patient Leaves Lab Cleaning Getting New Patient Anesthesia Prep EP Prep Extubation RecoveryGroin Care Patient Leaves Lab Procedure Ends 2 hour Procedure Starts Procedure Ends 1/2 hour Procedure Starts
  • 13. 1. Minimize instrumentation 2. Patient Prep 1. Anesthesia and EP together 3. Sedation 1. Propofol only 2. Minimize paralytics 4. Recovery 1. Start with isuprel infusion 2. Ventilator changes 3. Sheath removal 5. Post Anesthesia Recovery 1. At CATH/EP LAB Area Anesthesia Protocol For AF Ablation Cleaning Getting New Patient Anesthesia Prep EP Prep Extubation Recovery Groin Care Patient Leaves Lab Procedure Ends Procedure Starts Median time to extubation 9 min 1st and 3rd quartile = 6-13 Anesthesia is not a bottleneck
  • 15. 2010 •Mapping system: 3D reconstruction •Intracardiac Echo 2016 • EP Lab Efficiency • Anesthesia Protocol • Databases • QI 2014 • Contact Force Sensing • Workflow • Integrating CF • Visited Several EP Labs Optimizing Efficiency and Efficacy Standardizing AF Ablation Standardized Afib Ablation Workflow NumberofAFAblations/Year 0 100 200 300 400 500 600 700 800 900 1000 2010 2011 2012 2013 2014 2015 2016 2017 2018 Fluoroscopy Reduction
  • 16. 1. 40-45Watts 2. CF 10-15 g 3. Time: 1. 10-15s posterior wall 2. 15-20s anterior wall 4. Validation Protocol 1. Lesion set analysis 2. Adenosine and isuprel Follow up • 3, 6 and 12 months • 4-day Holter at 6 and 12 months • Event monitoring PRN AF Ablation WorkFlow Standardizing the Procedure and Follow Up
  • 17. Efficiency and Predictability in Paroxysmal Atrial Fibrillation Ablation with Contact Force Catheter and Stability Module Integration Osorio J et al. Europace, Vol 19, Issue sppl_3, june 2017, page iii371 84.8% 9.8% 5.4% 15.2% (N=112) Success Repeat Ablation 1 year Success Rates - Single Procedure
  • 18. A Comparison of Paroxysmal Atrial Fibrillation Ablation Efficiency and Clinical Outcomes Across Technologies in a High-Volume Center Osorio J et al. Europace, Vol 19, Issue sppl_3, june 2017, page iii371 0.50 0.55 0.60 0.65 0.70 0.75 0.80 0.85 0.90 0.95 1.00 0 100 200 300 400 500 600 700 800 ProportionwithNoReablation Days After First Ablation Cryoballoon SmartTouch ThermoCool SF Freedom from Reablation
  • 19. • Should be the end result of • Protocols and standardization • Operator experience • Efficiency is not the opposite of efficacy • Safety • Most important consideration • Operator experience • Ongoing data analysis and QI Improving Lab and Procedural Efficiency AF Ablation Efficiency In-Hospital Complications Associated With Catheter Ablation of Atrial Fibrillation in the United States Between 2000 and 2010, Volume: 128, Issue: 19, Pages: 2104-2112, DOI: (10.1161/CIRCULATIONAHA.113.003862) Complication Rates and Operator Volume
  • 20. Cleaning Getting New Patient Anesthesia Prep EP Prep Patient Out of Lab Patient Out of the Lab Room Turn Over Time Procedure Starts Procedure Ends EP study Mapping Merge/ICE/FAM Ablation Validation 3 hours Recovery Patient leaves Lab Groin Care Extubation Room Turn Over Time Afib Ablation Procedure Time Recovery Starts 1 hour 1 hour Cleaning Getting New Patient Anesthesia Prep EP Prep EP study Mapping Merge/ICE/FAM Ablation Validation Procedure Starts Recovery Patient leaves Lab Groin Care Extubation Recovery Starts 15 min 90 min 15 min Improving Lab and Procedural Efficiency EP LAB Use Time / procedure Afib Ablations / Day 4-5 hours  2-3 hours 2-3  3-4
  • 21. Conclusion •AF ablations will continue to increase • EP Community • Efficiency solutions • QI / Lean Six Sigma Concepts • Standardization • Reducing waste Increased number of ablations/day End Result  Reproducible  Efficiency  Efficacy  Safety
  • 22. Focus on the customer. Identify and understand how the work gets done. Manage, improve and smooth the process flow. Remove Non-Value-Added steps and waste. • Redundant Steps Lean Six Sigma in Healthcare 1 2 3 4 Manage by fact and reduce variation. • Protocols and Standardization Involve and equip the people in the process. Undertake improvement activity in a systematic way. 5 6 7

Editor's Notes

  • #7: Lean elimination of the eight kinds of waste defects, over-production, waiting, non-utilized talent, transportation, inventory, motion and extra-processing. Six Sigma identifying and removing the causes of defects (errors) and minimizing variability in (manufacturing and business) processes. Synergistically reduce waste and improve process efficiency and quality.