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Introduction of the Transradial
Technique into a Busy Metropolitan
Interventional Radiology Practice:
The First 300 Cases
AM Fischman MD, RS Patel MD, JW Fung PA,
NB Lamberson RN, M Ort RN, E Kim MD,
FS Nowakowski MD FSIR, RA Lookstein MD FSIR
Assistant Professor of Radiology and Surgery
Division of Interventional Radiology
Icahn School of Medicine at Mount Sinai
New York, NY
Disclosures
„  AM Fischman MD
®  Terumo Interventional Systems – Consultant, Speaker
®  Surefire Medical Inc. – Consultant
®  Philips Healthcare – Speaker
„  E Kim MD
®  Philips Healthcare – Speaker
„  RS Patel MD
®  Arstasis Inc – Consulting
®  Sirtex Medical Inc. - Consulting
„  FS Nowakowski MD - None
„  RA Lookstein MD
®  Cordis Corp. – Consultant
®  Bayer Healthcare – Consultant
®  Boston Scientific Corp. – Advisory Board, Speaker
®  WL Gore & Associates, Inc. – DSMB
„  JW Fung PA, NB Lamberson RN, M Ort RN - None
TRA in IR
„  Classic IR
Textbook
„  Published
Sept 2013
„  What is going
on here????
Introduction - Why Radial?
„  Fewer vascular complications
„  Lower rate of access site
bleeding
„  Greater patient satisfaction
„  Immediate ambulation
„  Procedure cost savings
„  Long term cost savings?
„  LESS INVASIVE!
Bertrand et al. Comparison of transradial and femoral approaches for percutaneous coronary interventions: a systematic review and hierarchical
Bayesian meta-analysis. American heart journal. Apr 2012;163(4):632-648.
Romagnoli E, Biondi-Zoccai G, Sciahbasi A, et al. Radial versus femoral randomized investigation in ST-segment elevation acute coronary
syndrome: the RIFLE-STEACS (Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome) study. Journal of the
American College of Cardiology. Dec 18 2012;60(24):2481-2489.
Mehta et al. Effects of Radial Versus Femoral Artery Access in Patients With Acute Coronary Syndromes With or Without ST-Segment Elevation.
Journal of the American College of Cardiology. 10/12 2012.
Cooper CJ, El-Shiekh RA, Cohen DJ, et al. Effect of transradial access on quality of life and cost of cardiac catheterization: A randomized
comparison. American heart journal. 09/01 1999;138(3 Pt 1):7-7.
Background

„  177 cases via the radial artery
®  July 1999 to October 2002

„  65/70 patients (92.9%) replied that they would request
transradial approach next time

J Clin Gastroenterol 2003;37:412–417
Potential Advantages in Interventional Radiology
Obese patients
Patients with groin sensitivity
Faster discharge times
Immediate ambulation
No closure device
Many patients with
coagulopathy from liver
disease
„  Nausea/vomiting patients not
immobile
„  Different approach for
Replaced Right Hepatic Artery complex anatomy
„ 
„ 
„ 
„ 
„ 
„ 

Chemoembolization
Radial vs. Femoral Approach
Materials and Methods – Endpoints
„  18 month period,
single center
retrospective review

Splenic
Embolization
with Onyx

„  Technical Success
„  Major and Minor
Adverse Events
„  Cost

Hepatic
Radioembolization

Complex Renal
Aneurysm Repair
Materials and Methods - Demographics
„  300 procedures in 230 patients
®  180 male
®  50 female
®  mean age 65 (range 37-91)
„  Procedures:
®  Hepatic Chemoembolization (n=143)
®  Hepatic Radioembolization Y90 (n=117)
®  Uterine Fibroid Embolization (n=13)
®  Renal/Visceral Angioplasty/Stenting
(n=12)
®  Splenic Embolization (n=3)
®  Internal Iliac Artery Embolization (n=2)
®  Other Peripheral Embolization (n=6)
®  Iliofemoral Angioplasty/Stenting (n=2)
®  Subclavian Angioplasty/Stenting (n=1)
®  AAA Endoleak Embolization (n=1)
Uterine Fibroid Embolization

Hepatic Chemoembolization
Materials and Methods – Embolization Devices
® 
® 
® 
® 
® 
® 
® 
® 

N-BCA Glue
Onyx Liquid Embolic System
Calibrated Microspheres
Drug-eluting Microspheres
Yttrium-90 Microspheres
Gelfoam
Microcoils
Amplatzer Plug

Embolization of Breast AVM with Onyx
Materials and Methods - Procedure Details
„  Sheath size:
®  6F – 8.3% (25/300)
®  5F – 86.3% (259/300)
®  4F – 5.3% (16/300)

„  Bands Used:
® 
® 
® 
® 

TR Band (297)
R Band (1)
Bengal Band (1)
RADAR (1)
Technique - Barbeau Test (Pulse Oximetry)

Barbeau et al. Am Heart J 2004;147:489–93
PRE-DILATE PROTOCOL

„  40mg of lidocaine cream (EMLA)
PLUS
„  30mg of nitroglycerin ointment
Technique - Arm Positioning
„  Left wrist used for all interventions below
diaphragm
„  Prop arm above left groin
„  Use towel roll and arm board if necessary
Technique - Vessel Access
„  Puncture
®  Micropuncture
single wall technique
®  US guidance in ALL cases!
®  .018 wire
Technique - Vessel Access
„  Hydrophilic sheath
„  IA cocktail:
® 
® 
® 

3000 U Heparin
2.5 mg Verapamil
200 mcg Nitroglycerin
Technique - Celiac/SMA Catheterization

5F Sarah Radial 110cm
(Terumo)
Technique - Catheters Used
„ 
„ 
„ 
„ 
„ 
„ 
„ 
„ 
„ 
„ 
„ 
„ 

5F
5F
5F
4F
4F
5F
5F
5F
5F
5F
5F
5F

Sarah Radial 110cm (Terumo)
Cobra 100cm (Terumo)
Jacky Radial 110cm (Terumo)
Aqua 125cm (Cordis)
Cobra 100cm (Cordis)
Envoy 100 Guidecath (Cordis)
JR4 100cm (Cordis)
MPA 100cm (Cordis)
Bern 120cm (Penumbra)
Sherpa AL1 Guide (Medtronic)
Sherpa HS1 Guide (Medtronic)
Launcher Guide (Medtronic)

„ 

Other shapes (Champ, MP1, RDC, MAC, IMA, SCR, SCL)

Longest Lengths in our lab:
Guiding sheath: 110cm
Guiding catheter: 110cm
Diagnostic catheter: 150cm
Technique - Patent Hemostasis
„  Maintain “nonocclusive pressure!
„  Should be able to feel
a distal RA Pulse
5F – 2 hours until band removal
4F – 1.5 hours until band removal

Samir Pancholy, et al Catheterization and Cardiovascular Interventions 72:335–340 (2008)
Results – Technical Success
„  97% Technical success (291/300)
® 
® 
® 
® 
® 

4 cases radial artery too small for cannulation
2 case Barbeau D waveform
1/9 radial loops unable to be navigated
1 subclavian occlusion
1 case radial occluded from prior intervention (unable to access)

9 Radial Loops Encountered - 3%

Loop reduced with 4F
Glidecath (Terumo) and .
016 Fathom wire (BSC)
Results – Adverse Events
„  No major adverse events
„  20 Grade I access site hematomas (6.7%)
„  6 cases of RAO (2%)
®  All asymptomatic
®  4 were reaccessed for repeat
procedure
„  1 mild hand pain/weakness (0.3%)
„  2 microperforation of branch vessel (0.6%)
®  Causing pain <= 24 hours
„  1 radial artery pseudoaneurysm (0.3%)
®  Treated with thrombin injection
Results - Cost Comparison
FEMORAL
„  5F standard sheath
„  19g needle
„  5F Sos 80cm
„  Closure Device

RADIAL
„  5F Glidesheath
„  Microneedle
„  5F glide cobra 100cm
(or 110 Sarah radial)
„  TR Band

Approx. $230

Approx. $130

Estimated direct cost savings during study – $30,000
Indirect costs were not measured
What are the limitations in IR?
„  Limited catheter
shape and length
„  Balloon and stent
systems don’t reach
below the iliac
arteries
„  Lack of training
programs
PTA Renal FMD
Conclusion
TRA for peripheral interventions and embolization
is:
„  Feasible in majority of patients
„  Safe and well tolerated with low complication
rates
„  Less costly than TFA
Where are we headed in 2014?
„  Randomized studies specific
to IR (particularly in
Interventional Oncology)
„  Quality of life surveys
(IPAD and SMS)
„  Training programs for IR
docs
Glue Embolization of
bleeding renal mass

„  Catheter and Guide design
underway…..

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Introduction of Transradial Technique in Busy IR Practice: First 300 Cases (40

  • 1. Introduction of the Transradial Technique into a Busy Metropolitan Interventional Radiology Practice: The First 300 Cases AM Fischman MD, RS Patel MD, JW Fung PA, NB Lamberson RN, M Ort RN, E Kim MD, FS Nowakowski MD FSIR, RA Lookstein MD FSIR Assistant Professor of Radiology and Surgery Division of Interventional Radiology Icahn School of Medicine at Mount Sinai New York, NY
  • 2. Disclosures „  AM Fischman MD ®  Terumo Interventional Systems – Consultant, Speaker ®  Surefire Medical Inc. – Consultant ®  Philips Healthcare – Speaker „  E Kim MD ®  Philips Healthcare – Speaker „  RS Patel MD ®  Arstasis Inc – Consulting ®  Sirtex Medical Inc. - Consulting „  FS Nowakowski MD - None „  RA Lookstein MD ®  Cordis Corp. – Consultant ®  Bayer Healthcare – Consultant ®  Boston Scientific Corp. – Advisory Board, Speaker ®  WL Gore & Associates, Inc. – DSMB „  JW Fung PA, NB Lamberson RN, M Ort RN - None
  • 3. TRA in IR „  Classic IR Textbook „  Published Sept 2013 „  What is going on here????
  • 4. Introduction - Why Radial? „  Fewer vascular complications „  Lower rate of access site bleeding „  Greater patient satisfaction „  Immediate ambulation „  Procedure cost savings „  Long term cost savings? „  LESS INVASIVE! Bertrand et al. Comparison of transradial and femoral approaches for percutaneous coronary interventions: a systematic review and hierarchical Bayesian meta-analysis. American heart journal. Apr 2012;163(4):632-648. Romagnoli E, Biondi-Zoccai G, Sciahbasi A, et al. Radial versus femoral randomized investigation in ST-segment elevation acute coronary syndrome: the RIFLE-STEACS (Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome) study. Journal of the American College of Cardiology. Dec 18 2012;60(24):2481-2489. Mehta et al. Effects of Radial Versus Femoral Artery Access in Patients With Acute Coronary Syndromes With or Without ST-Segment Elevation. Journal of the American College of Cardiology. 10/12 2012. Cooper CJ, El-Shiekh RA, Cohen DJ, et al. Effect of transradial access on quality of life and cost of cardiac catheterization: A randomized comparison. American heart journal. 09/01 1999;138(3 Pt 1):7-7.
  • 5. Background „  177 cases via the radial artery ®  July 1999 to October 2002 „  65/70 patients (92.9%) replied that they would request transradial approach next time J Clin Gastroenterol 2003;37:412–417
  • 6. Potential Advantages in Interventional Radiology Obese patients Patients with groin sensitivity Faster discharge times Immediate ambulation No closure device Many patients with coagulopathy from liver disease „  Nausea/vomiting patients not immobile „  Different approach for Replaced Right Hepatic Artery complex anatomy „  „  „  „  „  „  Chemoembolization
  • 8. Materials and Methods – Endpoints „  18 month period, single center retrospective review Splenic Embolization with Onyx „  Technical Success „  Major and Minor Adverse Events „  Cost Hepatic Radioembolization Complex Renal Aneurysm Repair
  • 9. Materials and Methods - Demographics „  300 procedures in 230 patients ®  180 male ®  50 female ®  mean age 65 (range 37-91) „  Procedures: ®  Hepatic Chemoembolization (n=143) ®  Hepatic Radioembolization Y90 (n=117) ®  Uterine Fibroid Embolization (n=13) ®  Renal/Visceral Angioplasty/Stenting (n=12) ®  Splenic Embolization (n=3) ®  Internal Iliac Artery Embolization (n=2) ®  Other Peripheral Embolization (n=6) ®  Iliofemoral Angioplasty/Stenting (n=2) ®  Subclavian Angioplasty/Stenting (n=1) ®  AAA Endoleak Embolization (n=1) Uterine Fibroid Embolization Hepatic Chemoembolization
  • 10. Materials and Methods – Embolization Devices ®  ®  ®  ®  ®  ®  ®  ®  N-BCA Glue Onyx Liquid Embolic System Calibrated Microspheres Drug-eluting Microspheres Yttrium-90 Microspheres Gelfoam Microcoils Amplatzer Plug Embolization of Breast AVM with Onyx
  • 11. Materials and Methods - Procedure Details „  Sheath size: ®  6F – 8.3% (25/300) ®  5F – 86.3% (259/300) ®  4F – 5.3% (16/300) „  Bands Used: ®  ®  ®  ®  TR Band (297) R Band (1) Bengal Band (1) RADAR (1)
  • 12. Technique - Barbeau Test (Pulse Oximetry) Barbeau et al. Am Heart J 2004;147:489–93
  • 13. PRE-DILATE PROTOCOL „  40mg of lidocaine cream (EMLA) PLUS „  30mg of nitroglycerin ointment
  • 14. Technique - Arm Positioning „  Left wrist used for all interventions below diaphragm „  Prop arm above left groin „  Use towel roll and arm board if necessary
  • 15. Technique - Vessel Access „  Puncture ®  Micropuncture single wall technique ®  US guidance in ALL cases! ®  .018 wire
  • 16. Technique - Vessel Access „  Hydrophilic sheath „  IA cocktail: ®  ®  ®  3000 U Heparin 2.5 mg Verapamil 200 mcg Nitroglycerin
  • 17. Technique - Celiac/SMA Catheterization 5F Sarah Radial 110cm (Terumo)
  • 18. Technique - Catheters Used „  „  „  „  „  „  „  „  „  „  „  „  5F 5F 5F 4F 4F 5F 5F 5F 5F 5F 5F 5F Sarah Radial 110cm (Terumo) Cobra 100cm (Terumo) Jacky Radial 110cm (Terumo) Aqua 125cm (Cordis) Cobra 100cm (Cordis) Envoy 100 Guidecath (Cordis) JR4 100cm (Cordis) MPA 100cm (Cordis) Bern 120cm (Penumbra) Sherpa AL1 Guide (Medtronic) Sherpa HS1 Guide (Medtronic) Launcher Guide (Medtronic) „  Other shapes (Champ, MP1, RDC, MAC, IMA, SCR, SCL) Longest Lengths in our lab: Guiding sheath: 110cm Guiding catheter: 110cm Diagnostic catheter: 150cm
  • 19. Technique - Patent Hemostasis „  Maintain “nonocclusive pressure! „  Should be able to feel a distal RA Pulse 5F – 2 hours until band removal 4F – 1.5 hours until band removal Samir Pancholy, et al Catheterization and Cardiovascular Interventions 72:335–340 (2008)
  • 20. Results – Technical Success „  97% Technical success (291/300) ®  ®  ®  ®  ®  4 cases radial artery too small for cannulation 2 case Barbeau D waveform 1/9 radial loops unable to be navigated 1 subclavian occlusion 1 case radial occluded from prior intervention (unable to access) 9 Radial Loops Encountered - 3% Loop reduced with 4F Glidecath (Terumo) and . 016 Fathom wire (BSC)
  • 21. Results – Adverse Events „  No major adverse events „  20 Grade I access site hematomas (6.7%) „  6 cases of RAO (2%) ®  All asymptomatic ®  4 were reaccessed for repeat procedure „  1 mild hand pain/weakness (0.3%) „  2 microperforation of branch vessel (0.6%) ®  Causing pain <= 24 hours „  1 radial artery pseudoaneurysm (0.3%) ®  Treated with thrombin injection
  • 22. Results - Cost Comparison FEMORAL „  5F standard sheath „  19g needle „  5F Sos 80cm „  Closure Device RADIAL „  5F Glidesheath „  Microneedle „  5F glide cobra 100cm (or 110 Sarah radial) „  TR Band Approx. $230 Approx. $130 Estimated direct cost savings during study – $30,000 Indirect costs were not measured
  • 23. What are the limitations in IR? „  Limited catheter shape and length „  Balloon and stent systems don’t reach below the iliac arteries „  Lack of training programs PTA Renal FMD
  • 24. Conclusion TRA for peripheral interventions and embolization is: „  Feasible in majority of patients „  Safe and well tolerated with low complication rates „  Less costly than TFA
  • 25. Where are we headed in 2014? „  Randomized studies specific to IR (particularly in Interventional Oncology) „  Quality of life surveys (IPAD and SMS) „  Training programs for IR docs Glue Embolization of bleeding renal mass „  Catheter and Guide design underway…..