Vascular Closure Techniques

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1 Vascular Closure Techniques CLIFFORD J. KAVINSKY MD, PHD PROFESSOR OF MEDICINE AND PEDIATRICS DIRECTOR, CARDIOVASCULAR FELLOWSHIP TRAINING PROGRAM DIRECTOR, RUSH CENTER FOR ADULT STRUCTURAL HEART DISEASE

2 Disclosures None relevant to this Presentation

3 Objectives Will focus on Femoral vessel closure Arterial Venous Devices for Vascular Closure Techniques for percutaneous closure of large bore arterial and venous access Complications of vascular access and closure

4 Complications of Femoral Vessel Access Hematoma (1-12%) Pseudo aneurysm (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

5 Predictors of Vascular Complications Older age Female Gender Diabetes Small body surface area Sheath size Emergency procedure Intensity of anticoagulation and Platelet inhibition Comorbidities Piper WD et al 2003, Am Heart J 145:1022

6 How to Avoid Vascular Complications A-bottom of femoral head B-The approximate location of the inguinal ligament estimated from a line drawn between the anterior superior iliac spine and the symphysis pubis C-the line described above D-The actual location of the inguinal ligament can be assessed angiographically and corresponds to the lowest excursion of the inferior epigastric artery E-Inferior epigastric artery F-Inguinal crease Courtesy of Zoltan Turi

7 Avoiding Vascular Complications Sagittal View Courtesy of Zoltan Turi

8 Consequences of Errant puncture Low Puncture into SFA or PF Pseudo aneurysm AV fistula Thrombosis Embolism Occlusion High Puncture Retroperitoneal Hemorrhage

9 Promise Of Vascular Closure Devices Patient Comfort and Convenience Decreased time to hemostasis Early ambulation Shorter hospital stay Decreased overall hospital-related procedure costs Decreased vascular complication rates

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

11 Vascular Closure Devices Active Approximators Mechanically secures arteriotomy closure through approximation of margins or mechanical fixation using clip, suture, or 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 Accelerate hemostasis

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

13 Angio-Seal Vascular Closure Device Active and passive St. Jude Medical Bioresorbable endovascular anchor attached to Extra-vascular collagen Via polymer filament

14 Perclose Abbott Vascular Suture Mediated closure Delivers two needles through anterior wall of artery deploying Non-bioresorbable polypropylene suture

15 Preclosure for Large Arteriotomies Percutaneous Valve implantation Percutaneous Left Ventricular Assist devices Balloon Valvuloplasty Endovascular Aneurysm Repair

16 Suture Mediated Preclosure Two preclose devices deployed orthogonally Contralateral vascular access with proximal balloon occlusion Creighton, D and Holper, EM 2014, Card Int Today 8:53

17 Preclosure Success Rates N = Lee WA et al: J Vasc Surg 2007 Patients n = 258 Success = 93.8%

18 Starclose Clip Mediated Closure Abbott Vascular Clip Mediated active approximation Deployed though sheath Closure via deployment of disc-shaped nitinol clip Permanent implant

19 Passive Approximation MynxGrip ExoSeal (Cordis)

20 Cardiva Vascade Device Passive Approximation Nitinol disc deployed in artery aids hemostasis Latest iteration deploys collagen plug at arteriotomy site No endovascular footprint

21 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

22 Impact of VCDs on Vascular 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

23 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

24 Angiogram After Angio-Seal Deployment

25 Infection After Angio-Seal Courtesy Dr. John Eidt, UAMS.

26 Suture Assisted Venous Hemostatsis

27 Summary-Avoiding Vascular Complications Use fluoroscopic and angiographic guidance Employ micropuncture technique Puncture above CFA bifurcation and below Inferior Epigastric Artery Target lower half of femoral Head

28 Summary-Vascular Closure Devices Enhance patient comfort, early ambulation and discharge Unclear whether decreases vascular complications Has own intrinsic complications Avoid in small vessels (<5 mm) Be comfortable with 1-2 VCDs Manual compression is always acceptable

29 Vascular Closure Techniques CLIFFORD J. KAVINSKY MD, PHD PROFESSOR OF MEDICINE AND PEDIATRICS DIRECTOR, CARDIOVASCULAR FELLOWSHIP TRAINING PROGRAM DIRECTOR, RUSH CENTER FOR ADULT STRUCTURAL HEART DISEASE

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