Άγγελος Παπανικολάου MD, Ειδικευόμενος Καρδιολογίας, A Πανεπιστημιακή Καρδιολογική Κλινική, ΓΝΑ Ιπποκράτειο

Transcription

1 Άγγελος Παπανικολάου MD, Ειδικευόμενος Καρδιολογίας, A Πανεπιστημιακή Καρδιολογική Κλινική, ΓΝΑ Ιπποκράτειο

2 Endovascular access & closure Seldinger SI. Catheter replacement of the needle in percutaneous arteriography; a new technique. In Acta Radiol May;39(5): Half a century of manual compression 2

3 Seldinger Technique Needle with cannula inserted Needle withdrawn until there is blood flow Inner cannula removed & guidewire inserted Needle removed Catheter over guidewire Guidewire removed leaving catheter in artery 3

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7 The Anatomy

8 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.

9 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

10 Radial Access: proximal to styloid process Not really the wrist!

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13 Complications of femoral approach

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15 HEMATOMA RETROPERITONIAL

16 AV FISTULA

17 PSEUDOANEURYSM

18 ARTERIAL THROMBOSIS

19 HEMATOMA

20 Radial Artery Complications 1372 Procedures Asymptomatic radial occlusion 4.7% Symptomatic radial occlusion 0.2% Significant hematoma 0.2% Significant pseudoaneurysm 0.2% Worst Complication Perforation Compartment Syndrome 1 Case GR. Barbeau, et.al. ACC 2006)

21 SPASM

22 HEMATOMA

23 FEMORAL HEMOSTASIS-MANUAL COMPRESSION

24 FEMORAL HEMOSTASIS-FEMOSTOP

25 25 Arterial femoral closure devices

26 Femoral Haemostasis Potential advantages of closure devices: bed rest increased comfort reduced cost pain and associated vagal reactions complications

27 27 Types of VCD

28 Closure devices Clips / Sutures Collagen & Thrombin StarClose Angiolink Onux Perclose X-site Sutura Angioseal Vasoseal Quickseal (gel foam) BioIntervention Syvek FloSeal Biodisc ExoSeal Duett

29 Duett Collagen and thrombin Intra arterial balloon during thrombin delivery Seals artery and tissue tract Balloon then removed Delivery followed by short period of manual compression 5F to 9F

30 existing sheath 3F Duett catheter

31 Vasoseal Extravascular collagen plug (un-anchored) Delivery followed by short period of manual compression VasosealVHD Vasoseal ES 5F to 8F

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33 AngioSeal 6F and 8F devices Components Biodegradable anchor (intra-arterial) collagen plug (extra-arterial) 3-0 Vycril suture (with clinch knot)

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35 Angioseal evidence Kussmaul WG 3rd, et al Rapid arterial hemostasis and decreased access site complications after cardiac catheterization and angioplasty: results of a randomized trial of a novel hemostatic device. J Am Coll Cardiol. 1995; 25: Ward SR et al Angio-Seal Investigators. Efficacy and safety of a hemostatic puncture closure device with early ambulation after coronary angiography. Am J Cardiol. 1998; 81: Chevalier B, et al Effect of a closure device on complication rates in high-local-risk patients: results of a randomized multicenter trial. Catheter Cardiovasc Interv. 2003; 58: Chung J, Lee DW, Kwon OS, Kim BS, Shin YS. Angio-Seal Evolution versus Manual Compression for Common Femoral Artery Puncture in Neurovascular Diagnostic Angiography : A Prospective, Non-Randomized Study. J Korean Neurosurg Soc Mar;49(3):153-6.

36 Device successfully deployed Hemostasis by device Time to hemostasis (cumulative) <1 min 1-5 min Additional hemostasis methods required Minor adverse events All CATH PCI P (N = 1004) 99.7% 97.8% 85.4% 98.3% 2.8% (N = 575) 99.8% 99.0% 88.0% 98.9% 1.4% (N=429) 99.5% 96.3% 81.9% 97.4% 4.6% Value Bleeding requiring 30+ minutes of manual 1.4% 0.0% 3.3% <0.001 compression Ipsilateral hematoma >10 cm Any minor adverse events Death TCT 2009 Any major adverse events Evolution AngioSeal Registry % 2.4% 4 (0.4%) 0.5% 0.5% -- 1 (0.2%) 1.6% 4.9% -- 3 (0.7%) < Evolution Registry

37 StarClose 5-6F femoral artery access site nitinol clip 4mm diameter, thick

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39 CLIP Clip CLosure In Percutaneous Procedures Clip Study Diagnostic Arm - ITT StarClose 136 pts Compression 72 pts P value Mean Time to Hemostasis (min) Median Time to Hemostasis (min) <0.001 <0.001 Mean Time to Ambulation (min) Major Complications (% pt based) < Minor Complications (% pt based) 2.2% 1.4% Mean Time to Dischargeability (hours) <0.001 Hermiller et al., JIC 2005;17:

40 ExoSeal 6F extra-vascular closure device painless deployment mechanism delivers a poly-glycolic acid (PGA) plug atop the femoral artery ECLIPSE trial led to CE mark (0% complications)

41 Perclose TechStar 7F - 1 suture ProStar XL 8F and 10F 2 sutures Closer 6F 1 suture Knot making tool 3-0 braided polyester (non-absorbable)

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43 Techstar/Prostar evidence Gerckens U, Grube E. Management of arterial puncture site after catheterization procedures: evaluating a suture mediated closure device. Am J Cardiol ;83: Baim DS, Suture-mediated closure of the femoral access site after cardiac catheterization: results of the Suture To Ambulate and Discharge (STAND I and STAND II) trials. Am J Cardiol. 2000; 85: Carere RG. Suture closure of femoral arterial puncture sites after coronary angioplasty followed by same-day discharge. Am Heart J. 2000; 139(pt 1): Noguchi T. A randomised controlled trial of Prostar Plus for haemostasis in patients after coronary angioplasty. Eur J Vasc Endovasc Surg. 2000;19: Rickli H Comparison of costs and safety of a suture mediated closure device with conventional manual compression after coronary artery interventions. Catheter Cardiovasc Interv. 2002; 57:

44 CoreValve TAVI & Prostar 10 XL Generation 1 25F surgical cutdown Generation 2 21F surgical cutdown Generation 3 18F Percutaneous

45 needles

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47 Usually perfect results in 18 F holes

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50 Arterial Closure Devices: Additive Complications Infection Device embolization Vascular obstruction ischemia

51 VCDs vs manual compression

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53 Any Closure Device Versus Manual Compression in PCI Studies JACC meta-analysis OR (95% Cl) 1.13[0.89,1.38] Heterogeneity test P-value 0.22 Nikolsky et al, JACC, 2004;44: Vaitkus, JIC, 2004;16:243-6 JIC meta-analysis 1.00[0.96,1.03] Not available 0.1 Favors device Favors manual compression Nikolsky et al, JACC, 2004;44: Vaitkus, JIC, 2004;16:243-6

54 AngioSeal Versus Manual Compression in PCI Studies JACC meta-analysis OR (95% Cl) 0.83[0.61,1.14] Heterogeneity test P-value NS JIC meta-analysis 0.51[0.45,0.58] NS 0.1 Favors device Favors manual compression Nikolsky et al, JACC, 2004;44: Vaitkus, JIC, 2004;16:243-6

55 VCDs vs MC in registry data 50% reduction with VCDs 4.94% P < P = % 1.11% 0.52% MC VCD MC VCD Diagnostic 12,937 consecutive patients through a prospective registry from 2002 to 2005 Manual compression 2,941 (23%) and VCD 9,996 (77%) Angioseal 82% Perclose 17% Other 1% PCI Arora et al. AHJ 2007; 53(4):

56 VCDs vs MC by propensity matching Major Bleeding Entry Site Other/Unknown Closure Device (n = 1,162) 2.4% 0.6% 0.8% Manual Compression (n = 1,162) 5.2% 1.7% 1.8% P Value < Stroke 0 0.5% 0.03 Pseudoaneurysm 0.3% 1.1% 0.03 In-Hospital Mortality 0.3% 0.9% ,0% 6,0% 4,0% 2,0% 0,0% manual compression; 6,5% suture-based; 1,4% collagen plug-based; 3,4% 56 Allen DS, Am J Cardiol Jun 1;107(11):

57 Cost: Perclose vs Manual Compression reduction 13% P<0.001 P<0.001 P<0.001 Rickli et al., Cath Card Interv 2002;57:

58 Cost: AngioSeal vs Manual Compression Routine use of AngioSeal for PCI results in net cost savings of $44 in the following conditions: Cost of VCD< $235 and of MC > $67 Rates of access site bleeding < 2.5% with VCD and > 2.2% with MC Rates of pseudoaneurysm < 1.67% with VCD and >1.01% with MC Cost of access site bleeding > $2,104 Resnic et al, Am J Cardiol 2007, 99:

59 Patients should undergo a femoral angiogram (Class IC) Vascular complications rates below 1% in 5F diagnostic angiography (Class IC) VCDs reasonable after PCI to achieve faster hemostasis and shorter duration of bed rest, and possibly increase patient comfort (Class IIaB) VCDs not routinely to reduce vascular complications (Class IIIB) Circulation 2 Nov 2010

60 60 Radial haemostasis

61 Hemostasis after TRA is successful Zero bleeding P. Agostoni s meta-analysis J Am Coll Cardiol Jul 21;44(2): S. Jolly RIVAL Lancet Apr 23;377(9775): Romangoli E. RIFLES-STEACS TCT 2011

62 Manual compression & rolled gauze inexpensive, widely available too tight not very secure, personnel required

63 HemoBand inexpensive, widely available venous pressure hand discomfort

64 RadiStop uncomfartable, pt cannot use hand, needs two hands to apply

65 Accumed band easy to apply venous pressure, no point compression

66 TR band easy to apply, visualizes puncture, reduces occlusion by half, patent hemostasis moderately priced

67 Helix inexpensive, easy to apply, visualizes puncture, focused pressure, patent hemostasis

68 68 Radial occlusion

69 Today s TRA practice NSTE-ACS and STEMI (n=7021) Radial Access (n=3507) Symptomatic radial occlusion requiring medical attention 0.2% in radial group

70 98% of patients have a (+) Allen test (+) Allen test patients do well without the radial artery

71 Smaller sheaths lead to less spasm & less occlusion Dahm JB et al Cathet Cardiovasc Intervent 2002

72 Heparin anti-coagulation prevents RAO consecutive patients % No Heparin (n=49) 24% UFH (n=119) P< % UFH5000 (n=210) Spaulding C et al. Cathet Cardiovasc Diagn 1996;39:365-70

73 Patent hemostasis prevents RAO The PROPHET Study 436 patients 75% decrease Pancholy S et al. Cath and Card Interv 2008; 72:

74 Early and safe discharge

75 Bernat I et al, Am J Cardiol Jun 1 Ulnar artery compression to recanalize RAO

76 CABG patients do well without the radial artery No occurrence of hand ischemia in over 3000 reported patients undergoing radial artery grafts. Taggart D., editorial in Heart 1999; 82: To achieve similar complications (~2% RAO) in TRA we need to cath patients 76

77 Compression with a device Conclusions for TRA Perform patent hemostasis Anti-coagulation Vasodilators intra-arterial Smaller, shorter, hydrophilic sheaths Ulnar compression if RAO. 77

78 The secret to a perfect closure.is a perfect and 1 st puncture Puncture above CFA bifurcation and below Inferior Epigastric Artery

79 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 (n=3507) Femoral Access (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.

80 Other Outcomes Radial (n=3507) % Femoral (n=3514) % HR 95% CI P Major Vascular Access Site Complications Major Bleeding TIMI Non-CABG Major Bleeding ACUITY Non-CABG Major Bleeding < < Jolly et al, Lancet 2011

81 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

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