Vascular Closure Techniques

Transcription

1 Vascular Closure Techniques Femoral Approach Clifford J Kavinsky, MD, PHD Professor of Medicine and pediatrics Associate Director, Center for Congenital and Structural Heart Disease Rush University Medical Center

2 How to Improve Safety Take time to do puncture right Use fluoroscopy and/or ultrasound Angiogram every femoral puncture

3 Local Complications of FA Access: 2-10% Hematoma (1-12%) Pseudoaneurysm (1-6%) AV fistula (<1%) Vessel laceration (<1%) Free bleeding Intimal dissection Ante- or retro-grade Acute vessel closure (<1%) Thrombosis (small artery lumen) Retroperitoneal hemorrhage ( %) Thickening of the perivascular tissues Neural damage Infection Venous thrombosis Pericatheter clot Montreal Heart CCI 3/ %/4% (7,953/3,868) Complications persist despite availability of vascular sealing devices.

4 Why Complications of Manual Closure Persist Puncture technique Sheath management Adjunctive drug therapy Sicker population Age, gender, comorbidity Coexistent vascular disease Inherent limitations of technique

5 How to Decrease Complications Courtesy of Zoltan Turi

6 How to Decrease Risk of Complications Courtesy of Zoltan Turi

7 Femoral Head and the CFA Bifurcation 1.5% 4.0% V IV III II 17% 22% 55.5% I Number of patients I: 111 II: 44 III: 34 IV: 8 V: 3 Below inferior border At inferior border Below center of head At center of head Above center of head n=200

8 Consequences of Low Arterial Puncture Low puncture into the SFA and PF: Pseudoaneurysm 2 inability to compress AV fistula Thrombosis - embolism Occlusion with large sheaths Primarily due to Low stick Inadequate compression time Aggressive anticoagulation

9 High Puncture High puncture of the femoral artery: Increases risk of retroperitoneal bleeding

10 Predictors of Complications Age (>70) Female sex Diabetes Body Surface Area (<1.6 m 2 Sheath size Renal failure or Cr > 2mg/dL Emergent Procedure Periprocedural use of Glycoprotein IIb/IIIa inhibitors Comorbidities Multilesion and more complex lesion interventions Use of intra-aoortic balloon pump Piper WD et al 2003, Am Heart J 145:1022

11 The Promise of Vascular closure Devices Patient comfort and convenience Decreased Time to hemostasis Early ambulation Shorter hospital stay Decreased overall procedure-related hospital costs Decreased complication rates

12 Closure Device Market $1 billion $900 $800 $700 $600 $500 $400 $300 $200 $100 $0 Medtech Insight

13 VCDs-The Promise Meta-analysis of 30 randomized trials Efficacy Shorter time to hemostasis- mean difference 17 min Decreased duration of bedrest- mean difference 10.8 hours Decreased hospital length of stay- mean difference 0.6 days Koreny, Riedmuller and Nikfardjam et al., JAMA. 2008;291:

14 VCDs-The Promise Decreased Vascular Complication rate Pseudo aneurysm Arteriovenous fistula Retroperitoneal hematoma/hemorrhage Femoral artery dissection Bleeding Femoral artery thrombosis

15 Complications Specific to VCDs Device-related: Embolization Infection Vessel obstruction Direct mechanical Injection into vessel Bleeding Mechanical secondary to device Secondary to early sheath pull

16 Sterile Technique Courtesy Dr. John Eidt, UAMS.

17 VCDS-Reduced Complications Lack of large randomized trials compared VCDs to std. manual hemostasis Multiple different devices Lack of homogeneous endpoints Small sample size Operator experience Level of anti-coagulation and adjunctive pharmacotherapy Selection bias

18 Complication Rate OR (95% CI) Heterogeneity test P-value Dx studies 1.44 [0.43, 4.82] 0.66 [0.18/, 2.38]* PCI studies 1.11 [0.94, 1.33]* 1.35 [0.87, 2.11]* Both Dx+PCI studies 1.83[1.15,2.90] 1.15 [0.67, 1.98]* All studies 1.34 [1.01, 1.79] 1.30 [0.90,1.87]* < Favors Closure Device Favors Manual Compression Nikolsky et. al. JACC 2004;44:1200

19 Propensity Score Analysis Appelgate et.al.,cci 2006, 67:556

20 Compilation of Meta- and Propensity Analyses Turi,Z., Endovascular Today 2008,7:28

21 Vascular Closure Devices Active Closure mechanically secures arteriotomy effects closure either through approximation of margins or mechanical fixation of a plug Passive Closure devices which assist with compression (clamps), assist or enhance coagulation, and sealants

22 Current FDA-Approved VCDs Caputo RP, 2012 Card Int Today 6:70

23 Anchored Plugs Active Approximation Angio-Seal (St.Jude Medical) Collagen Thrombosing agent Advantages- High success rate, short learning curve, short deployment time Disadvantages-vascular occlusion, potential infection

24 Perclose (Abbott Vascular) Suture-Mediated active approximation

25 Balloon Aortic Valvuloplasty-12F Preclosure PVAD F Percutaneous Valve Technology F Endovascular Aneurysm Repair F

26 Preclosure Success Rates % Success Lee WA et al: J Vasc Surg French Size N = Patients n = 258 Success = 93.8%

27 StarClose SE (Abbott Vascular) Active Approximation

28 Passive Approximation MynxGrip Vascular Sealants ExoSeal (Cordis) AccessClosure

29 No footprint devices Passive approximation Catalyst II (Cardiva Medical) Advantages-No foreign body No thrombosing or sealing agents

30 Closure Begins with Access Femoral Introducer Sheath and Hemostasis Axera Device( Arstasis ) Morris Innovative, Inc.

31 Topical Hemostatic Patches Passive Approximation NON-INVASIVE Chito-Seal, Clo-Sur P.A.D., D-Stat, Neptune, Stasys, Syvek

32 Which Device to Use? Patient and Vessel specific Heavily anti-coagulated- invasive active approximation Diseased vessel- passive approximation Residual oozing- thrombosing sealing agent or topical hemostatic patch Operator experience/competence

33 10 8 The Importance of Operator Experience % Patients Balzer et al. CCI 2001; 53: 174

34 Learning Curve With Angio-Seal 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 14 % 3.5 % 1st 50 2nd 50 3rd 50 4th 50 last 50 Success Failure Complication Warren, Warren and Miller, CCI 1999, 48:162

35 Moral of the Learning Curve Learn one or two devices and learn them extremely well Consider an additional device for special circumstances Remember that manual compression is always an option

36 Figure-of-8 for Venous Access Closure

37 AHA Recommendations 1. Use of VCDs is reasonable after invasive cardiovascular procedures performed via the femoral artery to achieve faster hemostasis, shorter duration of bedrest, and possibly improved patient comfort 2. VCDs should not be used routinely for the specific purpose of reducing vascular complications in patients undergoing invasive cardiovascular procedures via the femoral artery approach Patel et al 2010 Circ 122:1882

38 Thank you