Trans-Radial Interventions Eli Lev, MD Director of Interventional Cardiology Hasharon Hospital, Rabin Medical Center and Tel-Aviv University, Israel Objectives • Learn the main scientific literature supporting radial access for PCI • Learn the basic methodology in performing trans-radial PCI History Transradial catheterization first described by Radner in 1948. In 1989, Campeau et al revisited Radner’s idea & reported on percutaneous entry into distal radial artery for selective coronary angiography in 100 pts. In 1992, Kiemeneij et al used Campeau’s work as the basis for developing TRI. 1. Radner S. Thoracal aortography by catheterization from the radial artery; preliminary report of a new technique. Acta radiol. 1948;29:178-80. 2. Campeau L. Percutaneous radial artery approach for coronary angiography. Cathet Cardiovasc Diagn. 1989;16:3-7. 3. Kiemeneij F, Laarman GJ, de Melker E. Transradial coronary artery angioplasty. Am Heart J. 1995;129:1-7. Risk of vascular complications associated with femoral and radial access Retrospective review of 5,234 cath and PCI Vascular complications by BMI: lower rate of vascular complications using TR vs. TF approach for obese and non obese patients 6.0% 5.0% 5.3% 4.0% 4.00% 3.0% 2.0% P= 0.048 P= 0.040 2.1% 1.0% 0.7% 0.0% Non-obese Obese Femoral Radial Cox, N. Am J Cardiol 2004; 94 1174-1177 Radial versus femoral access for coronary angiography or PCI: A systematic review and meta-analysis of randomized trials (total of 4458 patients) Jolly SS et al. Am Heart J 2009;157:132-40 Radial vs. femoral access for coronary angiography or PCI: A systematic review and meta-analysis of randomized trials Jolly SS et al. Am Heart J 2009;157:132-40 RIVAL Study Design NSTE-ACS and STEMI (n=7021) Key Inclusion: • Intact dual circulation of hand required • Interventionalist experienced with both (minimum 50 radial procedures in last year) Randomization Radial Access Femoral Access (n=3507) (n=3514) Blinded Adjudication of Outcomes Primary Outcome: Death, MI, stroke or non-CABG-related Major Bleeding at 30 days Jolly SS et al. Lancet 2011. Baseline Characteristics Radial (n =3507) Femoral (n =3514) 62 62 Male (%) 74.1 72.9 Diabetes (%) 22.3 20.5 UA (%) 44.3 45.7 NSTEMI (%) 28.5 25.8 STEMI (%) 27.2 28.5 Mean Age (years) Diagnosis at presentation Jolly et al, Lancet 2011 Primary and Secondary Outcomes Radial Femoral HR 95% CI P 4.0 0.92 0.72-1.17 0.50 3.2 0.98 0.77-1.28 0.90 (n=3507) (n=3514) % % 3.7 3.2 Primary Outcome Death, MI, Stroke, Non-CABG Major Bleed Secondary Outcomes Death, MI, Stroke Jolly et al, Lancet 2011 Other Outcomes Radial Femoral HR 95% CI P (n=3507) (n=3514) % % 1.4 3.7 0.37 0.27-0.52 <0.0001 TIMI Non-CABG Major Bleeding 0.5 0.5 1.00 0.53-1.89 ACUITY Non-CABG Major Bleeding 1.9 4.5 0.43 0.32-0.57 <0.0001 Major Vascular Access Site Complications Major Bleeding 1.00 Jolly et al, Lancet 2011 RIVAL study 7021 patients with ACS undergoing PCI No difference in MACE – death, MI, stroke Trend for less major bleeding with radial access, depending on the bleeding definition Less vascular complications with radial access Special benefit for radial in STEMI pts Primary endpoint - NACE Non CABG major bleeding Jolly et al, Lancet 2011 R I V A L Subgroups: Primary Outcome Death, MI, Stroke or non-CABG major Bleed Overall Age <75 ≥75 Gender Female Male BMI <25 25-35 >35 Radial PCI Volume by Operator ≤70 70-142.5 >142.5 Radial PCI Volume by Centre Lowest Tertile Middle Tertile Highest Tertile p-value Interaction 0.786 0.356 0.637 0.536 0.021 Diagnosis at presentation NSTE-ACS STEMI 0.025 0.25 Jolly et al, Lancet 2011 1.00 Radial better 4.00 Femoral better Hazard Ratio (95% CI) Other Outcomes Radial Femoral (n=3507) (n=3514) Access site Cross-over (%) 7.6 2.0 <0.0001 PCI Procedure duration (min) 35 34 0.62 Fluoroscopy time (min) 9.3 8.0 <0.0001 2.6 3.1 0.22 90 49 <0.0001 Persistent pain at access site >2 weeks (%) Patient prefers assigned access site for next procedure (%) • No differences in PCI success rate P RIFLE-STEACS study (Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome) • 1001 pts with ST elevation ACS randomized TRI vs TFI at high volume centers • NACE at 30 days (cardiac death, stroke, MI, TVR, bleeding): 13.6% TRI VS. 21% TFI (P=0.003) • Cardiac mortality : 5.2% TRI vs. 9.2% TFI (P=0.02) • Bleeding: 7.8% TRI vs. 12.2% TFI (p=0.026) • Shorter hospital stay with TRI Romagnoli et al JACC, 2012 Meta-analysis of Radial vs. Femoral in STEMI pts Mortality Access site complications Bleeding Mamas et al Heart 2012 Adoption of Radial Access and Comparison of Outcomes to Femoral Access in Percutaneous Coronary Intervention An Updated Report from the National Cardiovascular Data Registry )2007–2012( Dmitriy N. Feldman DN et al, Circulation. 2013;127:2295-2306 NCDR registry, >2,800,000 patients, >1300 sites Trends of use of r-PCI over time The proportion of r-PCI procedures accounted for 6.33% of total procedures (n=178,643), increasing from 1.18% in the 1st quarter of 2007 to 16.07% in the 3rd quarter of 2012 (P<0.01). Outcomes Main Findings 1. 2. 3. 4. 5. Use of ↑ r-PCI X13 over 6 yrs in the US Lower risk of bleeding and vascular complications with r-PCI Underuse of r-PCI at ↑ risk groups for bleeding (older, women, ACS) The greatest benefit of r-PCI in terms of the absolute reduction of bleeding & vascular complications is seen in high-risk groups of pts aged ≥75 years, women, & pts with ACS r-PCI associated with longer fluoroscopy times 100% 90% 80% 70% 60% femoral radial 50% 40% 30% 20% 10% Q2_07 Q3_07 Q4_07 Q1_08 Q2_08 Q3_08 Q4_08 Q1_09 Q2_09 Q3_09 Q4_09 Q1_10 Q2_10 Q3_10 Q4_10 Q1_11 Q2_11 Q3_11 Q4_11 0% Frequencies of transradial and transfemoral interventions from April 2007 until December 2011, Rabin Medical Center G. Greenberg et al . A Comparative Matched-Analysis of Clinical Outcomes Between Transradial versus Transfemoral PCI. Under Review….. The Anatomy The Anatomy Allen’s Test - Can be performed ± Oximetry test Peripheral vascular diseases. Edgar van Nuys Allen, MD and others with associates in the Mayo Clinic and Mayo Foundation; 2nd edition, Philadelphia, Saunders, 1955. Allen’s Test - Can be performed ± Oximetry test We recommend that, in the presence of an abnormal AT, the RA should not be used for cardiac catheterization unless the risk of using the femoral approach is excessive. Greenwood et al. JACC Vol. 46, No. 11, 2005, 2005:2013–7 Optimal Candidates for TR Access • • • • Most of the population who have dual circulation to the hand Obese individuals who are at increased risk of complications from TF access Individuals with severe PVD or AAA Diagnostic procedures (e.g. prior to cardiac surgery) Today TR is the default approach in many centers Radial Access: proximal to styloid process – Not really the wrist! Technical Tips for Successful Transradial Cannulation • • • Use a 21 G x 2.5 cm thin wall needle to cannulate the radial artery Advance a 0.025 inch guidewire through the needle After the introducer is inserted, give “cocktail” of Verapamil 2 mg diluted in saline, or 100-200 mcg of nitroglycerine, with by 50 units/kg heparin bolus Quesada et al, “Transradial Coronary Interventions”, Interventional Cardiology Secrets, 2003, pp. 203-210 Sedation and Verapamil / Nitro Virtually Eliminate the Spasm Problem Before After Radial Loop and Radial Recurrent Artery How do you deal with tortuousity? • • • • • Use a Benson or Wholey or Terumo wires into the ascending aorta. Pull the wire into the shaft of the catheter in order to facilitate torquing for coronary cannulation. Low threshold for crossing over to femoral Always use a diagnostic catheter and then exchange for a stiffer guiding catheter. Use JR or MP as your initial catheter to access the ascending aorta and then exchange for the PCI catheter Quesada et al, “Transradial Coronary Interventions”, Interventional Cardiology Secrets, 2003, pp. 203-210 The Learning Curve: Transradial Pitfalls • • • • • • • Getting access Radial Artery Spasm Prevention and management Anatomical Variations Tortousity, vascular anomalies Transversing the subclavian – Rt vs. Lt Respiration maneuvers Need for TF conversion Catheter shape selection for cannulation Catheter control and backup support “Patent Haemostasis” after pulling out the sheath Commonly Used Guiding Catheter Shapes Left Arm Approach For Lesions in LCA - XB 3.5 - JL 4 - Kimny For Lesions in RCA - JR 4 - AL I or AL II - HS 1 & 2 - Kimny Right Arm Approach For Lesions in LCA - JL 3.5 - XB/EBU 3.0 - Kimny For Lesions in RCA - JR 4 , 3DRC - HS1, AL I - Barbeau - Kimny Sheathless Catheters Patent Haemostasis Developments with trans-radial equipment • Dedicated and better TR access tools N=57 hydrophilic sheaths Sheathless guiding catheters Single catheter diagnostics (e.g. Tiger) • 5 French compatible PCI equipment • Ability to perform complex interventions STEMI, bifurcations, CTO, LM, long lesions etc. Transradial Access Site Complications • • • • • • • Radial artery occlusion (≈5%, higher rates when routine doppler is used, mostly asympt.) Forearm hematoma and/or pain Radial artery pseudoaneuyrsm Radial or brachial or artery perforation Uncontrolled bleeding with resultant compartment syndrome Pain during catheter insertion Need for femoral conversion (5-10%) Radial Artery Occlusion Factors • • • • • Artery size: higher incidence with smaller artery Larger catheter (>6 French) Lack of heparinization or ↓ heparin dose Artery spasm: pretreatment with verapamil / nitro Hemostasis device: minimize over-compression Ruo S, EHJ 2012 Radial Artery Complications • • 1372 Procedures Asymptomatic radial occlusion Symptomatic radial occlusion Significant hematoma Significant pseudoaneurysm Worst Complication Perforation →Compartment Syndrome 4.7% 0.2% 0.2% 0.2% 1 Case GR. Barbeau, et.al. ACC 2006) Radial Access - Disadvantages • • • • • • Associated with a significant operator learning curve Has limited compatibility with very large equipment Elderly patients may have increased tortuousity of the radial and subclavian arteries which makes the procedure more challenging May have limited guiding catheter support in most challenging PCI scenarios (tortousity, heavy calcifications, complex bifurcations) Associated with upper limb arterial complications (rare) Higher radiation exposure to the operator Radial Access - The Advantages • Decrease the incidence of major vascular complications • Decrease the incidence of bleeding complications • Appears to decrease MACE in patients with ACS • Better control over vascular access and hemostasis for obese and overall patients • Decreased time to ambulation • Improved patient movement and comfort • Allows early discharge policy • May decrease cost Thank you