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Transradial Intervention and Guide Catheter Selection
38 RCTs 18,000 pts Transradial Intervention and Guide Catheter Selection Procedure With A Purpose David E. Kandzari, MD Director, Interventional Cardiology and Interventional Cardiology Research Piedmont Heart Institute Atlanta, Georgia david.kandzari@piedmont.org Disclosure Transradial Catheterization Perception, Belief… Should radial access become the default choice for PCI? www.theheart.org, May 25, 2009 Yes 51% N=666 respondents No 49% Transradial Catheterization Opportunity for Education What is the main reason not to use the radial approach? www.crtonline.org, May 14, 2009 Lack of Complex training/ Comfort PCI knowledge with TF 32% 36% 32% Transradial Catheterization Opportunity for Education The solution to this problem…. Is not introducing another! Transradial Guiding Catheter Considerations 1. What impact does guiding catheter selection have on TRI procedural outcomes? 2. Which guiding catheters are appropriate for TR PCI? 3. What are existing limitations of TR PCI guiding catheters? Are there TR specific guiding catheters? 4. Can complex PCI be performed with existing guiding catheters? 5. Practical suggestions related to guiding catheters and procedural success Transradial Guiding Catheter Considerations 1. What impact does guiding catheter selection have on TRI procedural outcomes? 2. Which guiding catheters are appropriate for TR PCI? 3. What are existing limitations of TR PCI guiding catheters? Are there TR specific guiding catheters? 4. Can complex PCI be performed with existing guiding catheters? 5. Practical suggestions related to guiding catheters and procedural success Contemporary Comparative Trials Evaluating Transradial PCI Agostini et al. JACC 2004 Meta-analysis: 3 224 patients/12 randomized trials Significant decrease in access site complications; increase in procedural failure Chase et al. Heart 2008 38 872 procedures in 32 822 patients in British Columbia were analysed (1999 to 2005) Tr-PCI associated with halving of transfusion rate; significant reductions in 30-day and 1-year mortality Rao et al. JACC Interv 2008 No differences in procedural success between tr-PCI and f-PCI Significantly decreased bleeding in high-risk subgroups Brueck et al. JACC Interv 2009 Higher procedural failure and time with tr-PCI Significantly lower access complications with tr-PCI Understanding Mechanisms and Predictors of TR PCI Procedural Failure Meta-Analysis of 12 RCTs TR vs TF (≤6 Fr), N=3,224 — Procedural Failure, 7.2% TR vs 2.4% TF, P<0.001 — Mechanisms of Failure? Radial artery access Arterial Spasm Anatomical limitations Inability to cannulate target vessel Inadequate guide support Agostoni et al. JACC 2004 Understanding Mechanisms and Predictors of TR PCI Procedural Failure 2,100 TR PCI Procedures (≤6 Fr) • Procedural Failure 4.7% • Number of Guiding Catheters — RCA: 1.2±0.6 Success vs 1.4±0.6 Failure, P=0.003 — LCA: 1.2±0.6 Success vs 1.6±1.0 Failure, P<0.0001 — TR Failures: Operators used 6 and 7 catheters for RCA and LCA, respectively, before crossover to TF Dehghani et al. JACC Intv 2009 Understanding Mechanisms and Predictors of TR PCI Procedural Failure TR PCI Procedural Failures (N=98) • Failure of arterial access Inadequate arterial puncture • • 13 (13) Failure to advance catheter into ascending aorta Radial artery spasm 33 (34) Radial artery loop/tortuosity 10 (10) Radial artery dissection 6 (6) Radial artery stenosis 1 (1) Failure to complete PCI due to lack of guide support Subclavian tortuosity 18 (18) Inadequate guide back up support 17 (17) Dehghani et al. JACC Intv 2009 Transradial Guiding Catheter Considerations 1. What impact does guiding catheter selection have on TRI procedural outcomes? 2. Which guiding catheters are appropriate for TR PCI? 3. What are existing limitations of TR PCI guiding catheters? Are there TR specific guiding catheters? 4. Can complex PCI be performed with existing guiding catheters? 5. Practical suggestions related to guiding catheters and procedural success Transradial Guiding Catheter Shape Selection Left Coronary Artery Right Coronary Artery Left Radial Standard catheters Right Radial XB/EBU ↓0.5 Amplatz L Ikari Left SVG Left radial: Standard guiding catheters JR 5>4 Amplatz R/L Ikari Left or Right Right radial: Amplatz, Ikari Left, JR, XBR LIMA JR 3.5/4, IMA Transradial Guiding Catheter Shape Selection Extra Back Up Catheters Transradial Guiding Catheter Shape Selection Bypass Grafts Transradial Guiding Catheter Shape Selection Bypass Grafts Ikari Guide Catheters Fcosθ = fcosθ’ + λ λ θ’ θ fcosθ ’ + λ Fmax = ――――― cosθ Maximum backup force is acheved if θ=90 degree;�θ’= 0 degree; or� λ is large Ikari et al. J Invasive Cardiol 2005 ;17:636-41 Ikari Left Guide Catheters A A B B Curve A to fit angle of brachiocephalic artery Straight portion (20 mm) B to generate strong back-up force supported by opposite side of aorta wall Ikari Left Guide Catheters Comparison with Judkins Left Judkins Judkins Ikari Transradial Guiding Catheter Shape Selection Ikari Left Relationship Between Back Up Support and Static Friction (Resistance) 15mm 25mm 35mm 45mm Relationship Between Back Up Support and Static Friction (Resistance) E * A * * B * C D E Transradial Guiding Catheter Shape Selection Ikari Left ‘Power Position’ Ikari Right Guide Catheters IR: Ikari Right A A B Curve A to fit angle of brachiocephalic artery Straight portion B to generate strong back-up force supported by opposite side of aorta wall. B Ikari Right Guide Catheters Judkins Judkins Ikari Transradial Guiding Catheter Shape Selection Ikari Right Ikari Right and Left Guide Catheters for RCA Judkins-R Ikari-R Ikari-L for RCA The area of contact on the contralateral aorta of IR & IL for RCA is greater than the JR. Therefore, IR & IL for RCA generate greater backup force than the JR. Ikari Right and Left Guide Catheters for RCA Judkins-R Ikari-R Ikari-L for RCA Judkins-R is forced to an aerial PCI, because backup force is insufficient. However, Ikari-R & Ikari-L produce greater backup force, these enable stable PCI Transradial Guiding Catheter Shape Selection Ikari Right or Left for RCA Ikari Right Ikari Left Transradial Guiding Catheter Considerations 1. What impact does guiding catheter selection have on TRI procedural outcomes? 2. Which guiding catheters are appropriate for TR PCI? 3. What are existing limitations of TR PCI guiding catheters? Are there TR specific guiding catheters? 4. Can complex PCI be performed with existing guiding catheters? 5. Practical suggestions related to guiding catheters and procedural success Distribution of Radial Artery Diameter Female Male 6Fr 7Fr 8Fr Saito S, et al. Catheter Cardiovasc Interv 1999; 46: 173-8. Guide Catheter Size for TR PCI: Smaller, Bigger…Better? 3, 4 and 5 Fr Guiding Catheters Accessability Mizuno et al. CCI 2010;75:985-988 Takeshita et al. CCI 2010;75:735-739 Mizuno et al. CCI 2010;75:985-988 Hamon et al. CCI 2002:55;340-343 7 Fr and 8 Fr Guiding Catheters Gioia G, et al. CCI 2000;51:234 –238 Wu SS, et al. J Invasive Cardiol 2000;12:605–609 Complications Procedural Failure Advanced Guiding Catheter Technologies Asahi Eaucath 7.5 Fr Sheathless Hydrophilic Guiding Catheter Smaller outer diameter < 6Fr sheath, Inner diameter > 7 Fr guide Catheter external diameter: 2.49mm (5.5 Fr) 6F Sheath external diameter: 2.62 mm Mamas MA et al, CCI 2008;72:357‒364; Liang et al. CCI 2010;75:222-224 Advanced Guiding Catheter Technologies Asahi Eaucath Liang et al. CCI 2010;75:222-224 Complex PCI with 6 Fr Guiding Catheters Procedural Outcomes with Ikari Catheter N=601 Angiographic Characteristics Left main 5.6% Bifurcation 17.4% Multivessel PCI 32.9% CTO 16.3% ACC/AHA Class B2/C Lesion 89.3% Right and left in same procedure (same catheter) 98.1% Procedural and In-Hospital Outcomes Device success 96.6% Procedure success 98.2% Ali A, et al. EuroInterv. 2007;3:475-481 Transradial Catheterization and Intervention Complex Lesion Treatment with 6 Fr Guiding Catheters 100% 100% 95% 95% 75% 75% 75% 95% Stent Stent Stent Stent Transradial vs Transfemoral Left Main PCI Procedural and Clinical Complications Transradial N=353 Transfemoral N=468 P value 97% 96% 0.57 MACE 4.0% 3.2% 0.57 TIMI Major Bleeding 0.6% 2.8% 0.02 Hospital stay (days) 8.5±5.9 9.9±5.9 0.001 Procedural and In-Hospital Outcomes Procedural success (%) Late Clinical Outcomes (Mean 17 mos) Cardiac Death 1.4% 1.7% 0.74 Non-fatal MI 4.0% 2.6% 0.26 LM specific TLR 5.7% 5.8% 0.95 MACE 10.2% 9.2% 0.63 Yang, Kandzari et al., JACC Interv In Press Effect of TR- vs TF- Primary PCI on Bleeding, Time to Revascularization and 1-Year Outcomes P<0.001 P<0.001 Door to Balloon Time (min) Radial Femoral P Value 123±63 129±81 NS P<0.001 P<0.007 P=NS In-Hospital Arzamendi et al. Am J Cardiol 2010 1-Year Transradial Guiding Catheter Considerations 1. What impact does guiding catheter selection have on TRI procedural outcomes? 2. Which guiding catheters are appropriate for TR PCI? 3. What are existing limitations of TR PCI guiding catheters? Are there TR specific guiding catheters? 4. Can complex PCI be performed with existing guiding catheters? 5. Practical suggestions related to guiding catheters and procedural success Transradial Guiding Catheter Suggestions • Advancing guiding catheter to ascending aorta Hydrophilic wires Exchange with extra support wire 4 Fr support catheter within catheter • Engaging coronary artery Advance catheter and rotate over wire deep into aortic cusp of interest • Maintaining guide support Second wire (ideal for ostial lesions) Guideliner mother-and-child catheter extension Anchor balloon technique Transradial Guiding Catheter Suggestions and Solutions Transradial Guiding Catheter Suggestions and Solutions Transradial Guiding Catheter Suggestions and Solutions Transradial Guiding Catheter Suggestions and Solutions Guiding Catheter Selection in Transradial PCI • Guiding catheter engagement and support represent significant barriers to transradial procedural success (more than we might think!) • In most instances, knowledge of guide catheter selection and technique enable successful PCI • Complex PCI is achievable with existing equipment • Development of TR specific guiding catheters and sheathless guiding catheters is evolving • Keep familiar with the literature and evolving technique and technology • Share your successes and failures • Train cath lab staff • Standardize protocols to include equipment selection Ongoing Trials Evaluating the Transradial Approach ClinicalTrials.gov Identifier Comparison Sample Size Outcomes NCT01014273 Radial vs. femoral approach to PCI in UA, NSTEMI, STEMI 7,000 30-day death, MI, stroke, or major bleeding NCT00815997 4- vs. 6-F guide catheter for transradial PCI 160 Radial artery patency 2 days post-procedure NCT00329979 Radial vs. femoral diagnostic catheterization in severe aortic stenosis 152 Acute brain injury assessed by diffusionweighted brain MRI NCT00597324 Transradial catheterization in patients with normal and abnormal Allen test results 180 30-day levels of capillary lactate in the thumb of instrumented hand NCT00821106 Right radial vs. left radial approach for diagnostic and interventional procedures 1,500 NCT00638586 Radial vs. femoral access for PCI 160 Fluoroscopy time and patient radiation dose Post-procedure anxiety, pain, satisfaction
