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 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

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

12 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:

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

14 Sterile Technique Courtesy Dr. John Eidt, UAMS.

15 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

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

17 Vascular Closure Devices Active Approximators mechanically secures arteriotomy effects closure through approximation of margins or mechanical fixation using a clip, a suture or a plug Passive Approximators devices which assist or accelerate hemostasis, enhance coagulation, utilizing gels or sealants Novel devices simulate manual compression or create short intramural tracts to achieve hemostasis Topical hemostasis patches which accelerate hemostasis

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

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

20 Perclose (Abbott Vascular) Suture-Mediated active approximation

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

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

23 StarClose SE (Abbott Vascular) Active Approximation

24 Passive Approximation MynxGrip Vascular Sealants ExoSeal (Cordis) AccessClosure

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

26 Closure Begins with Access Morris Innovative, Inc. Axera Device( Arstasis ) Femoral Introducer Sheath and Hemostasis Small intestinal submucosa wrapped Around introducer

27 Topical Hemostatic Patches Passive Approximation NON-INVASIVE Patch coated with clot promoting substance No foreign body No risk of infection or vessel damage Murine Chitin Poly-D-glucosamine Poly-N-acetyl Glucosamine Thrombin Carboxy-methyl-cellulose Calcium alginates Chito-Seal, Clo-Sur P.A.D., D-Stat, Neptune, Stasys, Syvek

28 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

29 10 The Importance of Operator Experience % Suture-Mediated Vessel Closure Patients Balzer et al. CCI 2001; 53: 174

30 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

31 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

32 Figure-of-8 for Venous Access Closure

33 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

34 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