TRI update Joint Meeting of Coronary Revascularization Dec , 2008 Busan, Korea

Transcription

1 TRI update 2008 Joint Meeting of Coronary Revascularization Dec , 2008 Busan, Korea Junghan Yoon, MD Yonsei University Wonju College of Medicine Wonju, KOREA

2 Our history is...

3 Do you agree that radial artery as a default vascular access route? Alternative vascular route in the past Default vascular access route at present for Diagnostic coronary angiography Elective coronary angioplasty Direct or rescue PCI in AMI Complex lesion PCI including CTO, bifurcating lesion

4 Main Advantages and Factoids of Transradial PCI Patient convenience Easy hemostasis with low access site complication Routine arterial route for expanded application even for complex lesions in AMI, CTO, and Bif lesions. Increased operator experience and technique Advances in device technology 1. Reduced balloon profile 2. Wider lumen guiding catheter with special curve including Sheathless guide system

5 Current Issues with TRI? 1. Still vascular access difficult? (I) Severe pain during radial access (II) Difficult radial artery puncture (III) Hemostasis 2. Repeated TRI, but limited access with only right radial approach? (IV) How about left Radial Approach? 3. (V) Improved techniques for good back-up support 4. (VI) Novel guiding system with wide inner lumen -Sheathless guide system 5. (VII) TRI: radiation exposure 6. (VIII) TRI-related complications Compartment syndrome of arm Mediastinal hematoma Radial artery occlusion Cardiovocal syndrome

6 (I) Severe pain during radial access To reduce the wrist pain using Eutectic mixture of EMLA cream During TRI, one of the discomfort of patients is the wrist pain during anesthetic infiltration and sheath insertion. EMLA cream,composed of lidocaine 2.5% and prilocaine 2.5%, is known to be an effective topical anesthetic agent.

7 Patient Discomfort and Radial Spasm with Relatively small radial artery Multiple puncture Patient anxiety/stress, Painful lidocaine infiltration Painful sheath insertion Radial artery spasm Radial puncture failure Difficulty in sheath removal Patient discomfort

8 Adrenoreceptors in the human radial artery Radial artery has a dominant α1-adrenoceptor function, but the post-junctional α2-adrenoceptor is also functional. Circulating catecholamines will mainly contract the human radial artery by activation of the α1- adrenoceptors and to a lesser extent also by α2- adrenoceptors. He GW, et al. J Thorac Cardiovasc Surg 1998;115: )

9 Comparative reactivity and mechanical properties of human isolated IMA and radial arteries Chamiot-Clerc P, et al. Cardiovascular Research ;

10 Comparative reactivity and mechanical properties of human isolated IMA and radial arteries Sensitivity to NE was found to be 7-fold higher for radial artery than for internal mammary artery. Data on the mechanical and reactive properties of radial and internal mammary arteries show that the radial artery displayed a higher potential for spasm than the internal mammary artery. Chamiot-Clerc P, et al. Cardiovascular Research ;

11 Radial Artery Spasm (RAS) During Trans-radial PCI The primary end point of the study: occurrence of RAS.

12 Patient Discomfort and Radial Spasm Using Local Anesthetic Application Multiple puncture Patient anxiety/stress, Painful lidocaine infiltration Painful sheath insertion Radial artery spasm Easy Radial puncture Reduction of difficulty in sheath removal and patient discomfort

13 Effect of Eutectic EMLA cream 1. Visual analogue scale (VAS) Patients were instructed to make a single vertical mark on a horizontally oriented, ungraduated 100-mm VAS labeled no pain at the far left and most pain possible at the far right. Ann Emerg Med 1996;27: Four-category Verbal Rating Scale (VRS- 4) Score 1 : no pain 2 : a little pain 3 : painful, but tolerable 4 : Most pain possible Control (n=73) Control (n=73) EMLA (n=69) Age (yr) 61±11 60± Sex (male %) 41 (56) 37 (54) 0.52 Diagnosis (%) 0.71 Stable angina 25 (34) 24 (34) Unstable angina 21 (29) 19 (27) AMI 6 (8) 5 (7) Puncture site 0.82 Right arm 29(40) 28(41) Left arm 44(60) 41(59) EMLA (n=69) VAS 49±24 19± VRS-4 2.3± ± p p Adverse drug reaction Kim JY. et al. J Invasive Cardiol 2007; 19: 6-9.

14 Optimal Duration of EMLA cream application to Reduce Wrist Pain? VAS VRS-4 ADR (%) Control ( n = 73) 49 ± ± 0.6 0(0) EMLA 0-1 hour ( n = 48) 39 ± ± 0.6 0(0) EMLA 1-2 hour ( n = 73) 32 ± 24* 1.9±0.6 * 1(1.4) EMLA 2-3 hour ( n = 72) 25 ± 23 * 1.8±0.5 * 1(1.4) EMLA 3-4 hour ( n = 45) 19 ± 19* 1.6±0.5 * 3(6.6) * EMLA > 4 hour ( n = 59) 14 ± 18* + 1.5±0.5 * 7(11.9) * VAS: visual analogue scale, VRS-4 : four-category verbal rating scale * P value < 0.01 compare to control, + : P value < 0.01 compare to EMLA 1-2 hour Kim JY. et al. J Invasive Cardiol 2007; 19: 6-9.

15 (II) Hemostasis problem Improved Bleeding Control Using Hemostatic Pad with Gauze Compression or TR Band after TRI Gauze or device compression Not fixed at the wrist with device Increased local bleeding Compression time Pain at compression site Gauze compression Gauze compression TR band compression TR band compression

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17 Transradial access compared with femoral closure devices in PCI Sciahbasi A, et al. Journal of Cardiology 2008; xx- xxx xxx

18 Transradial access compared with femoral closure devices in PCI Sciahbasi A, et al. Journal of Cardiology 2008; xx- xxx xxx

19 Hemostasis with Clo-Sur P.A.D Closure PAD consist of biopolymer polyprolate acetate. This biopolymer is cationically charged and potent blood coagulation property. To compare the radial hemostasis using closure pad (Medtronic AVE, Santa Rosa, CA), compression device (Terumo Co, Japan) and gauze compression method.

20 Effect of Clo-Sur P.A.D Gauze compression Gauze compression TR band compression TR band compression Clo-Sur P.A.D with TR band Clo-Sur P.A.D with TR band By evaluating the Incidence of local complication Total compression time Pain scale of compression site Local complication was classified as any bleeding or hematoma, pulse loss and skin rashes. It consist of of biopolymer polyprolate acetate. This biopolymer is cationically charged and potent blood coagulation property.

21 Hemostasis Using Hemostatic Pad Gauze (n= 63) TR band ( n= 106) Clo-Sur PAD (n= 96) Sheath, Fr (75) 14 (22) 2 (3) 83 (78) 17 (16) 6 ( 6) 74 (77) 18 (19) 4 (4) Procedure C-angio PCI 47 ( 75) 16 (25) 83 (78) 23 (22) 74 (77) 22 (23)

22 Hemostasis Using Hemostatic Pad Gauze (n= 63) TR band ( n= 106) Clo-Sur PAD (n= 96) Local Cx 6 (9) 14 (13) 1 (1) * Hematoma Mild Moderate Severe 2 (3) * (26) 2 (2) 0 (0) 1 (1) * 0 (0) 0 (0) Absent pulse 4 (6) 5 (5) 0 (0) * *: p <0.05 compare to 1 group : p <0.05 compare to 2 groups

23 Hemostasis Using Hemostatic Pad Gauze (n= 63) TR band ( n= 106) Clo-Sur PAD (n= 96) Skin Cx 3 (4) 10 (9) 0 (0) * Pain need analgesics 19 (30) 44 (41) 9(9) * Compression time (hrs.) 10.5 ± ± 4.0 * 3.3 ± 1.2 * *: p <0.05 compare to 1 group : p <0.05 compare to 2 groups

24 Hemostasis Using Hemostatic Pad Summary The use of Clo-Sur P.A.D with Gause compression or TR band would be more effective in reducing vascular complication, hemostatic time, and the pain of compression site after transradial coronary procedure.

25 (III) Difficult radial artery puncture? Systematic Overview and Meta-Analysis of 12 Randomized Trials (n=3,224) Agostoni P et al. J Am Coll Cardiol 2004;44:349 56

26 Overall Risk of Puncture Failure Radial vs. Femoral Approach for Percutaneous Coronary Procedures Agostoni P et al. J Am Coll Cardiol 2004;44:349 56

27 Causes of Radial Artery Puncture Failure Weak radial pulse Deep seated or movable radial artery Difficulty in introducing GW through the needle even after the successful needle puncture Radial artery tortuosity or anomaly Radial artery spasm related Several attempts of arterial puncture Patient anxiety and severe pain during lidocaine infiltration or sheath insertion Radial artery spasm-related patient discomfort Several attempts of arterial puncture Patient anxiety Painful lidocaine infiltration or sheath insertion

28 (IV) How about left radial approach? Right radial approach Left radial approach

29 Right radial vs. Left radial approach Right (n=614) Left (n=711) Age (years) 62±11 62±10 Male sex (%) Hypertension 38.3% 37.8% DM 21.9% 22.8% Hyperlipidemia 40.2% 35.7% Clinical diagnosis(%) AMI UA SA Others 42.6% 31.7% 18.5% 6.6% 38.2% 35.7% 18.1% 9.2% All values are no statistically significant.

30 Right radial vs. Left radial approach Target vessels (%) LAD LCX RCA Lt. main Right (n=614) 50.4% 21.3% 26.5% 1.8% Left (n=711) 53.0% 21.1% 25.3% 2.5% Reference diameter (mm) 3.16 ± ± 0.49 Pre-MLD (mm) 0.43 ± ± 0.33 Pre-DS (min) 86 ± ± 11 1 Vessel Disease (%) 47.7% 48.0% All values are no statistically significant, MLD: minimal luminal diameter, DS: diameter stenosis

31 Right radial vs. Left radial approach No. of guide catheter Right (n=614) Left (n=711) Total procedure time (min)* 32.3± ±17.6 Fluoroscopy time (min) 16.9± ±7.9 Vascular access time (min) 2.3± ±3.5 Cross-over rate (%)* 28(4.6) 19(2.7) * One catheter (%) 523(93) 632(95) More than 2 catheter (%) 91(7) 79(5) No of guide catheter* 1.21± ±0.33 GC size; 5Fr/6Fr/7Fr/8Fr (%) 5/81/13/1 7/77/14/1 *: p<0.05, : p<0.01, GC: guide catheter

32 Right radial vs. Left radial approach Right (n=614) Left (n=711) Procedural success 592 (95.4) 684 (96.2) Cross-over rate(%)* 28 (4.6) 19 (2.7) Puncture failure 5 6 Small vessel with spasm 0 4 Vessel tortuosity and loop * 10 4 Poor guide support * 12 5 In-hospital MACE (%) 13 (2.1 ) 18(2.5) Major vascular Cx (%) 2 (0.3) 0(0) P=0.04

33 Right radial vs. Left radial approach Summary The baseline clinical and angiographic characteristics of patients were similar. There was no difference of puncture failure rate ( less than 1%) and puncture time. (Rt.: 2.3 ± 2.9 vs. Lt.: 2.4 ± 3.5 min; p=ns). The crossover rate was lower in the Lt group than Rt group (2.7 % vs. 4.6%; P=0.04). Total procedural time (32.3 ± 25.4 vs ± 17.6 min; P = 0.03) and fluoroscopy time (16.9 ± 12.6 vs ± 7.9 min; p=0.01) were shorter in the Lt group.

34 Right radial vs. Left radial approach Summary There was no difference in selecting the shape of guide catheter. However, number of guide catheter usage was higher in the Rt than Lt group (1.21±0.48 vs. 1.08±0.33; p=0.04) The overall procedural success rate was similar in both groups (Rt group; 95.4% vs. Lt group; 96.2%, p=ns) There was no difference in hospital MACE. (Rt. group; 2.1 % vs. Lt. group; 2.5%, p=ns) and a major vascular complication in both groups (Rt. group; 0.3 % vs. Lt. group; 0%, p=ns)

35 Left radial approach Conclusion Left radial approach may provide increased procedural efficacy for transradial PCI compared to the right radial approach.

36 (V) Specific techniques To improve the back-up support of guiding catheter Use of special shaped guiding catheter Deep seating technique Buddy wire technique 5-in-6 catheter

37 VI) PCI Using Sheathless Guide Catheter φρομ Ασαηι Ιντεχχ Χο, ϑαπαν O.D mm 5Fr S 6.5Fr SLG 6Fr S 7.5Fr SLG S: Sheath SLG: Sheathless guide

38 6.5Fr Sheathless PCI Guide Catheter

39 7.5 Fr Sheathless PCI Guide Catheter

40 Sheathless PCI Guide Catheter 2.00mm 2.16mm 2.29mm 2.49mm 2.62mm 4Fr Sheath Introducer 6.5Fr SheathLess Eaucath 5Fr Sheath Introducer 7.5Fr SheathLess Eaucath 6Fr Sheath Introducer SheathLess Eaucath 6.5Fr prossesses about the same size O.D. as a 4Fr sheath introducer and 7.5Fr possesses about the same size O.D. as a 5Fr sheath introducer therefore it enables to perform PCI with a smaller puncture site.

41 Sheathless PCI Guide Catheter

42 Sheathless PCI Guide Catheter

43 Sheathless PCI Guide Catheter Tick Outer Layer & Large Inner Lumen Enhances kink resistance and backup support, yet maintains a large inner lumen for easy insertion of other PCI devices. Hydrophilic Coating Enhances catheter trackability even in tortuous vessels. It also reduces the occurrence of spasms during catheter manipulation. 16 Wire Braiding (8 broad wires & 8 thin wires) The flat wires help to maintain a large lumen. Two different types of braiding patterns provide optimal torqueability and flexibility. 6.5Fr: Fr:0.081 PTFE Liner Stainless Steel Braiding Hydrophilic Coating

44 PCI Using Sheathless Guide Catheter Mamas MA, et al. Catheterization and Cardiovascular Interventions 72: (2008)

45 Sheathless PCI Guide Catheter Summary of 16 Cases Performed With 7.5 F Sheathless Guide Catheters Mamas MA, et al. Catheter Cardiovasc Interv ;72(3):

46 Sheathless PCI Guide Catheter (A) Hydrophilic PBU 3.5 guide catheter illustrated with central dilator in packaging. (B) Central dilator inserted into guide catheter. (C) Following cannulation of radial artery, introducer sheath removed and sheathless guide passed over 150-cm guide wire (D) until catheter has reached proximal ascending aorta where central dilator and guide wire removed. (E) After cannulation of coronary artery. (F) Postprocedure with local radial compression device for hemostatis. Mamas MA, et al. Catheter Cardiovasc Interv ;72(3):

47 Sheathless PCI Guide Catheter The sheathless guide catheter system is a hydrophilic catheter with a central dilator that does not require an introducer sheath during transradial percutaneous coronary intervention. Conventional sheath introducers are often 1- to 2F larger than the catheter itself; therefore, this system enables the use of a larger French catheter during procedures than would otherwise be possible using conventional techniques. With sheathless system, we could secure the enough guide lumen size even for the kissing stent technique in bifurcation lesion

48 VII) TRI: more radiation exposure? Brasselet C, et al. European Heart Journal (2008) 29, 63 70

49 Radiation protection devices for operators, i.e. low leaded flaps and leaded glass (0.5 mm leadedequivalent for each) Brasselet C, et al. European Heart Journal (2008) 29, 63 70

50 Baseline characteristics Brasselet C, et al. European Heart Journal (2008) 29, 63 70

51 Radiation exposure, fluoroscopy time, and procedural duration according to arterial routes and procedures. Brasselet C, et al. European Heart Journal (2008) 29, 63 70

52 Relationship between radiation exposure according to arterial routes and procedures Brasselet C, et al. European Heart Journal (2008) 29, 63 70

53 Measures for minimizing radiation exposure to patient/operator Collimation, filters Use few magnified views Keep SID as narrow as possible Keep patient as far as possible from the x-ray tube Keep kvp as high as practical to keep ma as low as possible Keep number of exposure to minimum Use pulsed fluoroscopy Use lowest framing rate possible Shielding

54 VIII) rare TRI-related complication Compartment syndrome of arm Mediastinal hematoma Radial artery occlusion Cardiovocal syndrome

55 Less complication with Radial Access? Systematic Overview and Meta-Analysis of 12 Randomized Trials (n=3,224) Agostoni P et al. J Am Coll Cardiol 2004;44:349 56

56 Less complication with Radial Access? Systematic Overview and Meta-Analysis of 12 Randomized Trials (n=3,224) The risk of MACE was similar for the radial versus femoral approach. Lower rate of entry site complications with radial access However, higher rate of procedural failure. Gaining radial access requires higher technical skills, thus yielding an overall lower success rate. The radial approach for coronary procedures appears as a safe alternative to femoral access. Agostoni P et al. J Am Coll Cardiol 2004;44:349 56

57 Less complication with Radial Access? Systematic Overview and Meta-Analysis of 12 Randomized Trials (n=3,224) Agostoni P et al. J Am Coll Cardiol 2004;44:349 56

58 Mediastinal hematoma after cardiac catheterization: A rare but real complication of the transradial approach A. Coronary angiogram (AP caudal projection) showing tight stenosis in the left circumflex coronary artery. B. Chest X-ray (AP view) C. Chest CT scan showing a huge mediastinal hematoma located left of the aortic arch. D. Follow up chest CT showing almost complete resorption of the previous hematoma. KW Park. et al. Int J Cardiol 2008;130:e89-92

59 Mediastinal hematoma after cardiac catheterization: A rare but real complication of the transradial approach A.Diagnostic coronary angiogram showing a patent left main stent with stable disease in the left circumflex artery. B.Chest X-ray showing bulging of the right cardiac and aortic border. C.A chest CT scan showing a large hematoma in the anterior mediastinum around the aortic arch. D.Follow up chest CT scan after recurred chest pain showing increased hematoma in the anterior mediastinum. KW Park. et al. Int J Cardiol 2008;130:e89-92

60 TIZON-MARCOS H, and BARBEAU GR. J Interven Cardiol 2008;21: ) 60

61 Compartment Syndrome after Transradial Approach TIZON-MARCOS H, and BARBEAU GR. J Interven Cardiol 2008;21: ) 61

62 TIZON-MARCOS H, and BARBEAU GR. J Interven Cardiol 2008;21: ) 62 Compartment syndrome of the forearm (CSF) Diagnosis based on symptoms 5 P : pain, pallor, painful stretching of muscle, paresthesia, and pulseless Incidence very low 0.4% Causes unrecognized perforation of secondary branches unsuccessful compression at puncture site radial artery laceration/rupture by sheath

63 Compartment syndrome of the forearm (CSF) If any complaint of pain, swelling, or induration in the forearm or arm: 1. Apply a pressure cuff at the site of induration. 2. Inflate cuff up to 15 mm Hg below the systolic pressure for 15 minutes. 3. Monitor arterial flow with oxymeter clamp; adjust cuff pressure to obtain signal. 4. Call the physician in charge. a. If high blood pressure, consider intravenous medication to lower blood pressure. b. If ongoing glycoprotein IIb/IIIa inhibitors, consider stopping. c. If using recent heparin or low molecular weight heparin, consider partial reversal by protamine. d. Consider analgesia. If persistence of swelling, pain, or induration after two inflations of 15 minutes, consider urgent surgical consultation. 63 TIZON-MARCOS H, and BARBEAU GR. J Interven Cardiol 2008;21: )

64 Conclusions Transradial approach would be a routine vascular access site with more patient comfort in performing TRI by applying the followings; Application of pain reducing cream at the wrist and hemostatic pad with compression dressing Understanding of radial or brachial variation and use of 014 GW will improve the radial artery puncture success. Left radial approach should be another potential route comparable to the right radial artery. Various techniques with improved back-up support will be helpful for the successful TRI procedures. We also have to pay attention to the radiation exposure and careful handling of hydrophilic guidewire to prevent rare complication.

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