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Transfemoral Access Devices & Tips for Closure Devices
James P. Zidar, M.D., F.A.C.C., F.S.C.A.I Clinical Professor of Medicine, UNC Health Systems UNC Health System Physician-in-Chief, Heart & Vascular Corporate Chief of Cardiology, Rex Healthcare Raleigh, North Carolina
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Disclosures In the past year, I have been on a scientific advisory board, worked as a consultant for, or conducted clinical research for: Abbott Vascular, BSC, Medtronic, and Siemens
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Closure Devices 3
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Compaction & Compressive Sealing Force
Angio-Seal™ Evolution™ Compaction & Compressive Sealing Force What is compressive sealing force? Force between the collagen and the anchor after completion of Angio-Seal™ deployment Critical part of achieving hemostasis Consistent Collagen Compaction Forces
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Why Big Holes? 26 Fr 23 Fr 18 Fr 14 Fr 12 Fr Introduction of lower profile Endovascular thoracic and abdominal devices have expanded the market to a potential of 5 million people Closure devices have facilitated the adoption of transcatheter aortic valves, AAA endografts and LV support devices for high risk PCI
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Most physicians currently use Abbott’s closure devices for large access closure1,2
Suture-based Prostar XL and Perclose ProGlide are used to “pre-close” EVAR access sites1,2 Perclose is the preferred device due to its easy of use1
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Femoral Anatomy Landmarks
Anterior superior iliac spine Inguinal skin crease ligament Femoral head Common femoral artery Superficial Profunda X CFA PFA SFA
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Our Standard Approach Learn from the CTA
Anterior superior iliac spine Inguinal skin crease ligament Femoral head Common femoral artery Superficial Profunda Learn from the CTA Puncture the contralateral femoral artery and perform an arteriogram with Rim or pigtail catheter make a cross with 2 small needles with the maximum pulse vertically and the groin grease horizontally If CKD, advance pigtail to mid femoral head and give 2 cc of contrast If height is perfect, puncture vessel in the center of the circle Place a short 6Fr sheath over a standard J wire. Some groups use U/S guidance
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Abbott Vascular – Perclose® Device How Does it Work?
Locate anterior wall of artery Needles deploy suture on either side of the arteriotomy Deploy 2 ProGlides at 10 and 2 positions and secure with hemostats Exchange for stiff wire with the 1st dilator Perform TAVR or EVAR Tissue is pulled closed with sutures at end of procedure with hand pressure upstream Options with higher risk patient Occlude aorta with a soft Cook Coda balloon in distal aorta Advance a .018” Steelecore wire over a Rim catheter into distal SFA from contralateral groin Pull TAVR sheath back to mid EIA and occlude CIA with an 8 x40 mm balloon at low pressure while pulling the TAVR sheath and tightening sutures.
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Most physicians use suture based closure systems to “pre-close” the large arteriotomies
Step 1: The device is deployed over a wire prior to any interventions1 Step 2: The deployed device is removed leaving the sutures in place around the arteriotomy1 Step 3: Interventional devices are tracked through the vasculature with the sutures in place1 Step 4: Following interventions, the vessel is closed with pre-deployed sutures1 S
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Complications of Pre-close technique
Inadequate closure 5-20% failure rate Suture breakage Device misfire Embolism Infections Hematoma
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Pre-close technique: 2 ProGlide devices are crossed at 40o and “pre-closed”
Each Perclose (6Fr) device costs ~$390, which equals to ~$780/case Prostar XL 10 approved for 8.5 to 10Fr closure; Each costs ~$900
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The InSeal VCD (Vascular Closure Device)
Acute After biodegradation Clinic Experience 80+ patients were treated with the InSeal VCD FIH study in Brazil (20 pts) followed by studies in EU & Israel No chronic complication (most followed by ultrasound for 12M) Tether (biodegradable) Sealing membrane (biodegradable) Nitinol frame
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InClosure Deployment – 4 Easy steps
The InClosure VCD is easy & effective. It takes just minutes to learn and master the system… Prof. Ran Kornowski, MD, FESC, FACC InSeal Medical Confidential
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CLOSURE DEVICE Fully synthetic absorbable low-profile implant
No sutures, collagen or clips Easy post-procedure deployment CLINICAL EXPERIENCE > 100 patients Sapien 3, Evolut R, Lotus, Core Valve, Portico MAE 0% (all time points) CE Mark approved
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Essential Medical - MANTA Closure
Proven Concept, New Application 14F & 18F versions For 10-25F PUNCTURES Simple and Quick Closure Fast Hemostasis
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MANTA Principle of Operations
Innovative positioning, control and release
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MANTA CE MARK Approval Trial (n=50) Procedure Specifics
Procedure Sheath Sheath OD (F) n MANTA BAV and VAD 12 & 14F Cook 3 14F Evolut R Sheathless – 14F 18 13 Direct Flow 18F Direct Flow 22 5 18F Lotus (23mm) Small Lotus – 18F Sapien 3 (23 and 26mm) 14F eSheath 23 9 (25 and 27mm) Large Lotus – 20F 24 (29mm) 16F eSheath 24.5 Other Various 7
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Hemostasis time < 10 min
ENDPOINTS N=50 All-cause Mortality 4 (8%) Disabling Stroke Minor Stroke 1 (2%) Major vascular Complications covered stent Minor Vascular Complications Need for Packed Cells Transfusions 9 (18%) None device related Hemostasis Success 47 (94%) Hemostasis time < 10 min Deployment time 1-2 minutes Median Time to Hemostasis 23 seconds
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Vascular Closure Devices Have Patient Limitations
Peripheral vascular disease Bifurcation sticks Small femoral vessels Obesity/Low BMI
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Caveats Initial Access Matters Learning Curve
Spend the extra minute to make an adequate tissue track We still do not have the ideal device
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