Trans Radial Approach (TRA): Hands Up For This Technique? Thomas H Maloney, MHA, RCIS CRT 2011 Nurse & Technologist Symposium February 27 2011 90658710 1 of 59

Presenter Disclosure Information Within the past 12 months, the presenter or their spouse/partner have had a financial interest/arrangement or affiliation with the organization listed below. Thomas Maloney MHA, RCIS Company Name Relationship Boston Scientific Corp. Full Time Employee Federal law restricts the use of devices named in this presentation to sale by or on the order of a physician. Please review all directions for use including indications, contraindications, warnings, precautions and adverse events prior to clinical use. CRT 2011 Nurse & Technologist Symposium February 27 2011 90658710 2 of 59 2

“Looking back, I’m struck that we in interventional cardiology have never simply accepted the limitations placed before us. We’ve tried to overcome them through creative thinking – and then subject the results of that creativity to the crucible of evidence-based medicine knowing that sometimes we’ll win, and sometimes we’ll lose, but always, we move forward.” Don Baim MD 1949 - 2009

This is a Thing of the Past with TRA! Image courtesy of Tom Maloney with patient permission 90658710 5 of 59

Twenty-five year trends in PCI outcomes N=24,410 procedures at the Mayo Clinic Singh M., et. al. Circulation 2007 90658710 6 of 59

Complications of Contemporary PCI: Relative Importance of Bleeding Elective PCI Emergency CABG < 0.2% Abrupt Closure/Acute ST <0.7% Arrhythmia <0.01% LST = 0.2 - 0.3% per year Major/Minor TIMI bleeding >5% Patel’s Atlas of Transradial Intervention: The Basics Copyright © 2007 by Tejas Patel MD 90658710 7 of 59 6

Survival Free of Death from Any Causes and Myocardial Infarction COURAGE Survival Free of Death from Any Causes and Myocardial Infarction 1.0 Optimal Medical Therapy (OMT) 0.9 PCI + OMT 0.8 PCI does not improve mortality compared with medical therapy, but does improve Sx and quality of life In this context, every effort should be made to make PCI safer and more comfortable for patients 0.7 Hazard ratio: 1.05 95% CI (0.87-1.27) P = 0.62 0.6 0.5 0.0 1 2 3 4 5 6 7 Years Number at Risk Medical Therapy 1138 1017 959 834 638 408 192 30 PCI 1149 1013 952 833 637 417 200 35 Boden W., et al., N Engl J Med 2007 90658710 8 of 59 7

(95% Confidence Interval) Periprocedural Bleeding and Impact of 1-year Outcome Independent Predictors of 1-year Mortality: Pooled ISAR Trials Variable Hazard Ratio (95% Confidence Interval) P Value Bleeding within 30d 2.96 (1.96–4.48) <0.001 Myocardial infarction within 30 days 2.29 (1.52–3.46) Urgent revasc within 30 days 2.49 (1.16–5.35) 0.019 Age (yrs)* 2.27 (1.78–2.89) Diabetes 1.47 (1.11–1.96) 0.008 Multivessel CAD 2.72 (1.58–4.67) Elevated troponin† 1.77 (1.27–2.47) Left ventricular ejection fraction 0.71 (0.60–0.85) Creatinine level 1.10 (1.06–1.14) *Calculated for a 10-year increase in age; †calculated for a 0.25-mg increase in concentration. Retrospective study 5384 patients from study isar react, sweet,, smart 2, react 2 90658710 9 of 59 Ndrepepa et al. J Am Coll Cardiol 2008 8

Impact of Transfusion on Risk of 30-day Mortality 24,112 ACS patients from GUSTO IIb, PURSUIT, PARAGON B 0.10 0.02 0.04 0.06 0.08 No. at Risk Transfusion No Transfusion Randomization 2398 21 684 5 15 20 Log-rank P<.001 25 30 10 Day 2356 21 408 2317 21 248 2274 21 162 2237 21 102 2221 21 062 2189 20 884 Proportion Cumulative Mortality Rao et al JAMA 2004;292:1555-1562 90658710 10 of 59 9

Site of Bleeding Complications in an Unselected Cohort of Patients Undergoing PCI Rao, Cohen, Kandzari et al. J Am Coll Cardiol 2010;55:2187-2195 90658710 11 of 59

ICD – 9 Bleeding Description Among Transfused Patients Post PCI N = 544 Bleeding Events = 349 patients ~ 50% Maloney TH et al. Abstract Presentation. Heart Matters Conference 2010 Richmond VA 90658710 12 of 59

Outcome: Transfusion Patients vs. Non-Transfusion Patients No Transfusion (n=6,421) Outcome   Clinically Apparent Bleeding (%) 34.8 3.8 Clinically Apparent Bleeding with Transfusion (%) NA Inhospital Death (%) 11.0 0.8 Length of Stay (day) (Mean ± SD) 11.7 ± 9.7 2.6 ± 2.7 Cost of Hospitalization (Mean ± SD) $39,852 ± $32,283 $14,758 ± $8,503 Based on these figures a potential savings of $2.5MM could be realized by reducing groin related transfusions at Memorial Regional Medical Center alone! Maloney TH et al. Abstract Presentation. Heart Matters Conference 2010 Richmond VA 12 90658710 12 of 59 90658710 13 of 59

Effect of Radial Approach on Procedural Outcomes 1.0 Higher risk for any complication Lower risk for any complication Unadjusted Adjusted for patient differences patient & procedure differences N = 593,094 PCI procedures 2004-2007 606 sites Adjusted for center clustering in each model Rao SV, et. al. JACC: CI 2008 90658710 14 of 59 13

Association Between PCI Vascular Access Site and Outcomes N=21 studies, 5600 patients Rao SV, et. al. JACC: CI 2008 Rao SV, et. al. JACC: CI 2008 Jolly et al. Am Heart J 2009 90658710 15 of 59

Brueck et al. J Am Coll Cardiol Intv 2009 Transradial Diagnostic and Interventional Studies Randomized Trial of Femoral vs Radial Access Transradial (n = 512) Transfemoral (n = 512) p Value Access failure 18 (3.5) 1 (0.2) <0.0001 PCI 178 (34.8) 192 (37.5) 0.40 Procedural failure of PCI 6 (3.4) 1 (0.5) 0.06 Vascular closure device — 179 (93.2) Median procedural time, min (IQR) 40.2 (24.3–50.8) 37.0 (19.6–49.1) 0.046 Median fluoroscopy time, min (IQR) 9.0 (3.9–10.7) 5.8 (1.7–7.5) 0.001 Median contrast amount, ml (IQR) 132 (80–160) 129 (90–160) 0.43 Median DAP, Gycm2 (IQR) 41.9 (22.6–52.2) 38.2 (20.4–48.5) 0.034 Access-related complications 3 (0.58) 19 (3.71) 0.0008 Cerebrovascular accidents 0 (0) 2 (0.39) 0.50 Brueck et al. J Am Coll Cardiol Intv 2009 90658710 16 of 59

Potential Health Economic Benefits of Transradial Approach Reduction in bleeding ($6300 avg cost/bleed¹) No need for femoral vascular closure device Fewer catheters needed when using specialty curves Fewer hours needed for staffing (“sheath pulling”) based on my experience Decreased nursing intensity post procedure based on my experience Same-day PCI ¹Cohen DJ, et al. J Am Coll Cardiol. 2004;44:1792–1800. . 90658710 17 of 59 16

200 pts randomized to tr-PCI vs f-PCI Quality of Life and Patient Preference: Medical College of Ohio Experience 200 pts randomized to tr-PCI vs f-PCI QOL metrics at baseline, 1 day, 1 week post PCI Patients Strongly Preferred Radial Access (P<0.0001) Costs  $2299 To $2010 (P<0.0001) LOS  10.4 To 3.6 Hr (P<0.0001) Less discomfort, back pain with improved walking ability reported Strongly Prefer Radial NO Preference Strongly Prefer Femoral Cooper CJ et al. Am Heart J 138:430, 1999 90658710 18 of 59 17 17

Happy Patient Post Radial PCI Image courtesy of Tom Maloney with patient permission 90658710 23 of 59

% OF RADIAL FOR PCI ? Bertrand OF, et al. JACC Cardiovasc Interv. 2010 Dec 1;76(7):1022-31 90658710 19 of 59

TRA PRACTICE IN THE FUTURE ? 68.4% 50% Bertrand OF, et al. JACC Cardiovasc Interv. 2010 Dec 1;76(7):1022-31 90658710 20 of 59

Image courtesy of Google Images

Primary Outcome: Death, MI, stroke or major bleeding at 30 days RIVAL study: RadIal Vs. femorAL access for coronary intervention in patients with acute coronary syndromes study Non STEACS and STEMI (n=7000) Intent to treat Analysis Randomization Radial Access (n=3500) Femoral Access (n=3500) 30 day follow up 30 day follow up Primary Outcome: Death, MI, stroke or major bleeding at 30 days

Protocol courtesy of Tom Maloney MRMC Protocol Protocol courtesy of Tom Maloney 90658710 57 of 59

Nurse & Tech Obtaining Radial Artery Access Arkansas Heart Hospital “Our techs are now very adept at gaining radial access on their own” Image courtesy of Cath Lab Digest Cath Lab Digest Feb. 2011: Vol. 19, No.2: 24-6

Image courtesy of Tift Mann MD Having nurses attuned to nonocclusive compression and rapid removal of hemostasis devices is now a very impt part of tr procedures Image courtesy of Tift Mann MD 90658710 58 of 59 25

Image courtesy of Kimberly Skelding MD Tough patients, but lots to gain from this approach and it’s always interesting ! Image courtesy of Kimberly Skelding MD 90658710 59 of 59