Hahalis G - AIMRADIAL 2013 - Ulnar catheterization

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Ulnar catheterization

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Hahalis G - AIMRADIAL 2013 - Ulnar catheterization

  1. 1. AIM-RADIAL 2013 Thursday, September 26, 2013 Technical Aspects Ulnar Catheterization George Hahalis, University Hospital Patras Medical School, Rio, Patras, Greece
  2. 2. Disclosure: George Hahalis, M.D. Dr. Hahalis has no relevant financial interests to disclose
  3. 3. • Transradial route increasingly used over transfemoral access: • Dramatic reduction of bleeding complications • More convenient for the patient: earlier ambulation, shorter in-hospital length of stay • Cost-effective • Transulnar approach rarely used as a default strategy : • Potentially useful as an alternative to transradial route • Success rate much lower in non-randomized studies1-5 or similar in one randomized comparison with TR access6 • Much more challenging in our experience Terashima M, et al. Catheter Cardiovasc Interv. 2001;53:410 2 Limbruno U, et al. Catheter Cardiovasc Interv. 2004;61:56 3 Mangin L, Bertrand OF, et al. J Invasive Cardiol. 2005;17:77 4 Roberts EB, et al. J Invasive Cardiol. 2007;19:83 5 Vassilev D, et al. J Interv Cardiol. 2008;21:56 6 Aptecar E, et al: the PCVI-CUBA study. CatheterCardiovasc Interv. 2006;67:711 1
  4. 4. Transulnar Compared With Transradial Artery Approach as a Default Strategy for Coronary Procedures: A Randomized Trial (The AURA OF ARTEMIS -TrAnsUlnaR or TrAnsradial instead OF CoronARy TranfEMoral AngIographieS- Study) The aim of our study was to establish non-inferiority of a default transulnar relative to transradial approach in terms of feasibility and safety in consecutive patients with broad inclusions criteria • Randomized in either the transradial or the transulnar access
  5. 5. Methods I • Inclusion criteria • Consecutive patients >18 years old • Planned for Coro- and ad hoc PCI, if necessary • Primary and secondary STEMI-PCI / CABG patients included • Randomization before estimation of pulse quality • Regardless of Allen and “reversed” Allen test results • Limited exclusion criteria • Cardiogenic shock • Chronic hemodialysis • CABG with either bilateral IMA or bilateral radial artery use • No written informed consent Hahalis G, et al. Circ Cardiovasc Interv. 2013 Jun 1;6(3):252
  6. 6. Methods II Allen/reversed Allen test in all patients Allowed arterial puncture time: <15 min (<5 min for primary PCI) Catheters: •Diagnostic catheters (5F) : Conventional Judkins or Tiger •Guide catheters (6F, 7F): EBU, JL, JR, AL “Minimal pressure hemostasis” post-procedure Cross-over allowed to: •Either ipsilateral other forearm artery, if the initial artery was considered undamaged by the failed attempt, or •Contralateral forearm arteries, or •To femoral access at the discretion of the operators Same-day discharge (<6 hrs) of all coronary angio patients Five centers (annual radial PCI volume ≥80) and 6 operators (annual radial PCI volume ≥50) Hahalis G, et al. Circ Cardiovasc Interv. 2013 Jun 1;6(3):252
  7. 7. Study end-points •Primary end-point Composite of MACEs at 60 days, need for crossover, entry-site major access-site complications and arterial occlusion at 60 days [intention-to-treat (ITT) population] •Secondary study end-points •MACEs (death, MI, stroke and urgent revascularization ) at 60 days •Major in-hospital access site complications (occlusion, perforation, pseudoaneurysm, fistula, large hematomas, major bleeding) •Crossover •Arterial occlusion at 60 days Hahalis G, et al. Circ Cardiovasc Interv. 2013 Jun 1;6(3):252
  8. 8. Statistical analysis • Non-inferiority margin (Δ) =4.87%: the difference in the procedural failure rate between radial and femoral access in a meta-analysis of 12 randomized trials (n=3224) • Sample size calculation: Estimated primary event rate:14.3%: 2.1% MACEs, 7.2% crossover rate, 0.3% major vascular complications and 4.7% occlusion rate. To obtain 90% statistical power (2-sided alpha=0.05) with a 5% dropout rate, enrollment was set to at least 2286 patients • Two interim analysis: After enrollment of the initial 40% and 70% of the patients Agostoni P, et al. J Am Coll Cardiol. 2004;44:349 Hahalis G, et al. Circ Cardiovasc Interv. 2013 Jun 1;6(3):252
  9. 9. Study flow chart Hahalis G, et al. Circ Cardiovasc Interv. 2013 Jun 1;6(3):252
  10. 10. Table 1. Demographic and baseline characteristics of analyzed patients by initial allocation access route Age (years) Male gender BMI(kg/m2) History -Diabetes mellitus -Smoking -Hypertension -Hypercholesterolemia -Prior CAD -Prior CABG Diagnosis at admission -STEMI -NSTE-ACS Radial N=440 64.6±11.9 343(78.0) 28.5±4.6 Ulnar N=462 64.3±10.8 362(78.4) 28.9±4.9 p-value 122(27.7) 194(44.1) 265(60.2) 231(52.5) 79(18.0) 16(3.6) 131(28.4) 203(43.9) 275(59.5) 259(56.1) 78(16.9) 20(4.3) 0.9 >0.99 0.8 0.3 0.5 0.6 0.9 58(13.2) 65(14.1) 169(38.4) 173(37.4) - Heart valve disease/stable 213(48.4) or suspected CAD Antithrombotic medication pre- or peri-procedural -Aspirin 297(67.5) -P2Y12 receptor antagonists 294(66.8) -IIb/IIIa inhibitor 11(2.5) -Bivalirudin 23(5.2) Unfractionated heparin -2500 IU 167(38.0) 224(48.5) -5000 IU 182(41.4) 167(36.1) -≥7500 IU 91(20.7) 109(23.6) -Warfarin 11(2.5) 10(2.2) 0.7 0.9 0.1 316(68.4) 309(66.9) 17(3.7) 13(2.8) 0.8 >0.99 0.3 0.09 0.3 186(40.3) 0.8
  11. 11. Table 2a. Angiographic and procedural data by initial allocation access route Radial N=440 Arterial sheath size 5F 6F 7F Sheath upgrade BMI/Sheath size PCI -STEMI, primary PCI -STEMI, rescue PCI -Elective PCI Diagnostic catheters used* -0 -1 -2 -≥3 PCI guide catheters used** -1 -2 -≥3 Ulnar N=462 p-value 271(61.6) 164(37.3) 5(1.1) 94(21.4) 12.0±2.1 144(32.7) 26(5.9) 2(0.5) 12(2.7) 269(58.2) 187(40.5) 6(1.3) 119(25.8) 12.2±2.2 168(36.4) 24(5.2) 3(0.6) 10(2.2) 0.3 0.3 >0.99 0.1 0.3 0.3 0.7 >0.99 0.7 5(1.1) 145(33.0) 234(53.2) 56(12.7) 2(0.4) 154(33.3) 245(53.0) 61(13.2) 0.3 0.9 >0.99 0.8 114(79.2) 22(15.3) 8(5.6) 138(82.1) 25(14.9) 5(3.0) 0.6 >0.99 0.3 *Zero indicates patients who underwent elective PCI only; **As a proportion of patients subjected to PCI;
  12. 12. Table 2b. Angiographic and procedural data by initial allocation access route Radial N=440 Vessels with significant disease (≥50%) -None 147(33.4) -1 136(30.9) -2 81(18.4) -3 74(16.8) Vessels treated* -1 123(85.4) -2 18(12.5) -3 3(2.1) Attempts until successful 1(1 to 2) arterial access Arterial access time (min) 3(1 to 5) Fluoroscopy time (min) 4.2(2.1 to 8.6) Total procedural time (min) 19.0(11.0 to 30.0) Coronary angiography time (min) 9.0(6.0 to 13.0) PCI time (min)** Contrast medium (ml) Doppler follow-up (days from catheterization) 24.5(15.0 to 38.8) 100.0 (60.0 to 177.1) 8.5(8 to 14) *As a proportion of patients subjected to PCI; **Only for patients undergoing PCI Ulnar N=462 p-value 155(33.5) 143(31.0) 89(19.3) 75(16.2) >0.99 >0.99 0.8 0.9 144(85.7) 23(13.7) 1(0.6) 3(2 to 6) >0.99 0.9 0.3 <0.001 6(3 to 12) 4.8(2.5 to 9.3) 24.5(15 to 40.3) 9.0(6.0 to 13.0) <0.001 0.04 <0.001 0.5 25.0(16.0 to 37.8) 111.9 (70.0 to 182.9) 8(8 to 15) 0.6 0.03 0.9
  13. 13.  In the ITT analysis, the composite primary endpoint at first interim analysis was significantly higher in the ulnar arm (42.2%) compared to the radial arm (18.0%) with a difference of 24.30% (12.26% to 35.44%, 99.99% CIs) between arms, Pinferiority<0.0001. Therefore the study was terminated early, because of inferiority of the transulnar over the transradial approach.
  14. 14. Treatment differences transulnar-transradial with 95% CI’s
  15. 15. Table 3 Crossover rates by initial allocation access route Original allocation Original allocation Total Radial Ulnar N=902 N=440 N=462 1(0.2)* 6(1.4) 19(4.3) 26(5.9) 134(29.0) 2(0.4)* 13(2.8) 149(32.3) Final access site Radial Ulnar Femoral Total *crossover to contralateral forearm 135(15.0) 8(0.9) 32(3.5) 175(19.4)
  16. 16. Multivariate predictors of the primary endpoint
  17. 17. Multivariate predictors of the primary endpoint In pat ers in: v crosso Less males In group on p-value<0.001llocati la n sradia nulatio e tran an In th rtery c a pts for 3 attem < ts w i th ien
  18. 18. Stratified analyses of arterial access crossover Risk reduction for crossover favoring the radial artery in patients who either did not develop spasm or required multiple artery access attempts
  19. 19. Ulnar artery complications • 10 transulnar non-RCT’s (N=483 coronary procedures)1 • U-Pseudo-aneurysms: n=2 • U-Perforations: n=1 • U-Occlusions: n=1 • No ulnar nerve palsy reported U-Vascular follow-up in only half of these trials • 2 transulnar RCT’s (N=681 coronary procedures)2,3 •1 A-V fistula Roberts EB, et al. J Invasive Cardiol 2007 Feb;19(2):8 2 Aptecar et al. Cath CV Intrvn 2006 3 Li YZ, et al .J Chin Med 2010) 1
  20. 20. Aura of Artemis: Ulnar pseudo-aneurysm (A 81 year old male after a 5F TU diagnostic cath with 5000 U heparin) •Tender forearm pulsatile mass and pain during the active flexion of the little finger 10 days post-procedure •Week radial artery pulse •U/S: Ulnar artery patency. Proximal radial artery narrowing •Surgical closure of the aneurysm •Thrombin injection or compression were not considered Ulnar artery pseudoaneurysm
  21. 21. Aura of Artemis: Ulnar A-V fistula (A 63 year old male after 6F TU-PCI with 7500 U heparin) •Routine US follow-up 10 days later. No symptoms •PE: Palpable ulnar pulse •U/S: Ulnar artery patency; small AV fistula •Treatment: Ulnar AV-Fistula •Watchful waiting •Mild compression •Surgical closure if necessary Ulnar Artery
  22. 22. Spasm: “Aggressive Prevention” is Necessary •Correlates with radial1 and ulnar2 endothelial dysfunction In the Aura-of-Artemis trial P=0.06 17% 12% •Independent predictor of artery occlusion •Main reason for crossover in the transradial group N=78 N=54 Radial artery Ulnar artery Spasm Spasm Deftereos S et al. . Cath and Cardiov Interventions 2011 Deftereos S, …Hahalis G, et al. . Cath and Cardiov Interventions 2012 (in press) 1 2
  23. 23. Predictors of Arterial Occlusions in our Study
  24. 24. 1997 0.0 F 0.8 mann ,6 P=NS F 10.5 Uhle Aura 1.1Artemis of 1.0 e 0.9 ann, 5 3.6 Plant 4.6 Uhle m 1.1 10.4 Shigh Chronic press ion 3.0 Rath ore Zank l Bern Ulna r com at (39 /440)4.9 Rath or e 4.7 Radial group 5.8 Li, UA 5.0 LI, RA 5.7 o 8.7 Ulnar group Schia n 5.9 t hem holy ostas is (48/462) Paten 10.5 Pguid ed Acute Panc 9.0 Zhou Panc Conv holy ent Panc ional Pate nt He holy most as Cube ro, TR is Cube band ro, M A 2.8 5.0 Dahm , 5F Dahm , 6F Ap t e car, R A Apte c a r, U A Sanm artin 5.3 Naga i Stella Kiem eneij 0 Incidence of Arterial Occlusions in 19 Studies 58 30 12 13.7 9.5 8.9 8.0 6.6 5.1 4.3 3.6 1.7 0.6 2013
  25. 25. Conclusions A default strategy of transulnar approach is inferior to transradial access in terms of the need for crossover • •More cumbersome and time-consuming •The radial artery should therefore remain the first option for coronary interventions •After successful cannulation, the transulnar route appears non-inferior to transradial in terms of procedural time, major access-site complications and large hematomas •In selected cases the transulnar route may serve as a second-line arterial approach

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