1 Jeffrey J. Popma, MD Professor of Medicine Harvard Medical School Director, Interventional Cardiology Beth Israel Deaconess Medical Center Boston, MA Radial Artery Access: The Basics

2 Radial Artery Access: The Basics History of Radial Artery Access Patient Selection Anatomic Considerations Procedural Tips and Tricks Equipment Selection Expanding Evidence Base

3 Stig Radner - Sweden

4 Ferdinand Kiemeneij - Amsterdam  First radial PTCA  First radial stent  First outpatient radial PCI

5 Humble Beginnings of TRI Ferdinand Kiemeneij, Amsterdam Early 1990s

6 Palmaz-Schatz from the Wrist: 1993 Kiemeneij CCD 1993; 30: 173

7 Kiemeneij et al JACC 1997;29: % 2.0% 0% ACCESS: Earliest RCT Radial V. Femoral There were no differences in MACE but reduced access site complications in this low risk population

8 Impact of TRI on Outcomes My favorite Jennifer Tremmel’s Quote “It’s not that easy ….. but it’s not that hard” Lack of training, education systems, additional CPT reimbursement, and time commitment required by operators is the major barrier to expanded use of transradial intervention but we need clinical trial data for: FDA – Society Guidelines – CMS endorsements

9 Radial Artery Access: The Basics History of Radial Artery Access Patient Selection Anatomic Considerations Procedural Tips and Tricks Equipment Selection Expanding Evidence Base

10 Use of Radial Access Varies by Country

11 Radial Artery Access is Expanding in US Feldman Circulation 2013

12 No Randomized Data Needed Femoral Access Not Possible Obese Patients Anticoagulated Patients

13 Hildick-Smith CCI 2004; 61:60-68 No Randomized Data Needed

14 Therapy with vitamin K antagonists was maintained in all patients No bleeding complication except one patient had epistaxis at 8 days Provides evidence for safety of this approach in patients on warfarin therapy

15 Radial Artery Access: The Basics History of Radial Artery Access Patient Selection Anatomic Considerations Procedural Tips and Tricks Equipment Selection Expanding Evidence Base

16 Basic Forearm Anatomy Radial arteryRadial artery –Smaller than ulnar –More superficial –Not a terminal artery –Anatomic communication with ulnar artery Gray's Anatomy, 20th U.S. edition of Gray's Anatomy of the Human Body, 1918

17 Recurrent Radial Artery Gray's Anatomy, 20th U.S. edition of Gray's Anatomy of the Human Body, 1918

18 Images courtesy of Mladen I. Vidovich, MD Radial Artery Loops

19 Arteria Lusoria  Aberrant right subclavian artery  Runs posterior to esophagus  Incidence ~ 1% Copyright Dr. Michell Royon, Wikipedia Commons under the GNU Free Documentation License

20 Radial Artery Access: The Basics History of Radial Artery Access Patient Selection Anatomic Considerations Procedural Tips and Tricks Equipment Selection Expanding Evidence Base

21 Radial Artery Access: Equipment

cc SC lidocaine—small bleb w/ 20G needle - too much local anesthetic can obliterate pulse). User-friendly transradial sheath kits (21-G single-entry “Seldinger technique”/sleeve or sheath). Recommended: Access 1-2 cm proximal flexor crease Exact location of stick much less important than for transfemoral approach. Enter at degree from horizontal (more shallow than femoral) Radial Artery Access: Equipment The Stick

23 Radial Artery Spasm with Initial Puncture Courtesy of Kintur Sanghvi MD FACC FSCAI Deborah Heart and Vascular Sublingual nitroglycerin tablet 0.4 mg Subcutaneous nitroglycerin 100 mcg More Conscious sedation

24 Radial artery angiogram is extremely useful to understand radial loop/dissection/ perforationRadial artery angiogram is extremely useful to understand radial loop/dissection/ perforation Downsizing the sheath to 4 French sheath due to a small radial artery diameterlDownsizing the sheath to 4 French sheath due to a small radial artery diameterl Radial Artery Access: Trouble Shooting Difficulty Advancing Sheath – Don’t Push Lubricious 0.35 guide wireLubricious 0.35 guide wire Magic Torque of Wholey wire  HydrophilicMagic Torque of Wholey wire  Hydrophilic Tactile feedback + fluoroscopyTactile feedback + fluoroscopy Avoid engaging carotids/vertebralsAvoid engaging carotids/vertebrals 300 cm “exchange-length” wire after access300 cm “exchange-length” wire after access Tall pts > 6’4” or sleeve > 36  longer catheterTall pts > 6’4” or sleeve > 36  longer catheter Shoulder Tortuosity

25 Radial Artery Access: The Basics History of Radial Artery Access Patient Selection Anatomic Considerations Procedural Tips and Tricks Equipment Selection Expanding Evidence Base

26 Guide Catheter choice EBU XB VODA JL 3.5 AR1 MAC 3.0 JR4

27 International Survey of Radialist J Am Coll Cardiol Intv. 2010;3(10): doi: /j.jcin

28 Guide Liner Extra Support

29 Radial Artery Access: The Basics History of Radial Artery Access Patient Selection Anatomic Considerations Procedural Tips and Tricks Equipment Selection Expanding Evidence Base

30 Meta-Analysis: Major Bleeding is Reduced Jolly SS, et al. Am Heart J. 2009;157:

R I V A L NSTE-ACS and STEMI (n=7021) Radial Access (n=3507) Femoral Access (n=3514) Primary Outcome: Death, MI, stroke or non-CABG-related Major Bleeding at 30 days Randomization RIVAL - Trial Design Key Inclusion: Intact dual circulation of hand required Interventionalist experienced with both (minimum 50 radial procedures in last year) Jolly SS et al. Am Heart J. 2011;161: Blinded Adjudication of Outcomes

NSTE/ACS STEMI NSTE/ACS STEMI NSTE/ACS STEMI NSTE/ACS STEMI NSTE/ACS STEMI Radial better Femoral better Interaction p-value 2NRadial Femoral % Primary Outcome Death, MI or stroke Death Non CABG Major Bleed Major Vascular Complications R I V A L Outcomes stratified by STEMI vs. NSTEACS

A Registry-Based Randomized Trial Comparing Radial and Femoral Approaches In Women Undergoing Percutaneous Coronary Intervention: The Study of Access site For Enhancement of PCI for Women (SAFE-PCI for Women) Trial Sunil V. Rao MD, Connie N. Hess MD, Britt Barham, Laura H. Aberle BSPH, Kevin Anstrom PhD, Tejan B. Patel MD, Jesse P. Jorgensen MD, Ernest L. Mazzaferri MD, Sanjit S. Jolly MD, Alice Jacobs MD, L. Kristin Newby MD, C. Michael Gibson MD, David F. Kong MD, Roxana Mehran MD, Ron Waksman MD, Ian C. Gilchrist MD, Brian J. McCourt, Eric D. Peterson MD MPH, Robert A. Harrington MD, Mitchell W. Krucoff MD on behalf of the SAFE-PCI for Women Investigators LBCT TCT 2013 Tuesday Oct 29, 2013

Trial conduct After 1120 women had been randomized, routine review of trial endpoints by DSMB –Primary efficacy event rate markedly lower than expected –Trial unlikely to show a difference at the planned sample size –Recommended termination of the trial No harm noted in either the radial or femoral groups Steering committee voted to continue study until enrollment in a quality-of-life substudy was complete (N=300)

Results – Primary efficacy and feasibility endpoints Total randomized cohort Interaction term for primary efficacy endpoint not significant for PCI vs. no PCI Most common reason for needing to convert from radial to femoral access to complete the procedure was radial artery spasm (43.6% of crossovers) Only one patient did not have the procedure successfully completed – was randomized to femoral Radial (N=893) Femoral (N=894) OR (95% CI) P BARC 2, 3, 5 bleeding or Vasc Complications 0.6%1.7%0.3 ( )0.03 Access site crossover 6.7%1.9%3.7 ( )<0.001

Results – Secondary endpoints PCI cohort Radial (N=290) Femoral (N=291) P Procedure duration (min)51.6 ± ± Total radiation dose (mGy)1604 ± ± Total contrast volume (mL)152.7 ± ± day death, vascular complications, or unplanned revasc 5.2%3.4%0.26 Patient prefers assigned access site for next procedure 71.9%23.5%

37 The Future: Transradial Lounge St. Joseph’s Heart and Vascular Institute Images courtesy of Jack P. Chen, MD