As the number of patients with afib continue to increase in the US, there is a growing need for Afib ablations. With a limited number of EP labs and doctors, each hospital will have to find safe ways to increase their number of procedures to meet the demand. Our experience shows that by standardizing care and following guidelines and internal protocols, AF ablation programs can increase safety and efficacy while improving efficiency.

1. Dr. Jose Osorio
Shortening Procedure Times and
Improving Periprocedural Efficiency:
How to Treat More Patients
Per Day While Enhancing
Quality and Patient Experience
104763-190103

2. 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

3. • Clinical Inertia
• Efficacy
• Efficiency
• ~6000 EP labs
worldwide
• Long procedures
• Procedures/day
AF Ablation:
Barriers to Market Penetration

4. AF Ablation Program:
Optimizing the Process
EP
Referrals
New Afib
Patients
Afib
Ablations
Follow Up
Where should you focus?

5. • 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

6. 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

7. • 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

8. Room Turn Over Time

9. 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

10. 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

11. Anesthesia
Sedation/Recovery

12. 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

13. AF Ablation:
Efficiency, Efficacy
and Safety

14. 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
Always verify catheter tip location using fluoroscopy or IC signals and consult the CARTO® 3 System User Guide regarding recommendations for
fluoroscopy use. Pellegrino, P.L., Brunetti, N.D., Gravina, D., Sacchetta, D., De Sanctis, V., Panigada, S., Di Biase, L., Di Biase, M., and Mantica, M. (2013).
Nonfluoroscopic mapping reduces radiation exposure in ablation of atrial fibrillation. Journal of cardiovascular medicine 14, 528-533. Earley, M.J.,
Showkathali, R., Alzetani, M., Kistler, P.M., Gupta, D., Abrams, D.J., Horrocks, J.A., Harris, S.J., Sporton, S.C., and Schilling, R.J. (2006). Radiofrequency
ablation of arrhythmias guided by non-fluoroscopic catheter location: a prospective randomized trial. Eur Heart J 27, 1223-1229
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

15. 1. 40Watts
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

16. 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

17. 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

18. • 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

19. 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

20. Conclusion
• AF ablations will continue
to increase
• EP Community
• Efficiency solutions
• Lean Six Sigma Concepts
• Standardization
• Reducing waste
Increased
number of
ablations/day
End Result
 Reproducible
 Efficiency
 Efficacy
 Safety

21. 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