Nelson Lim Bernardo, MD Washington Hospital Center Aortic Graft Workshop February 5, 2012 Prostar or Proglide for Percutaneous Access Closure Nelson Lim Bernardo, MD Washington Hospital Center

Faculty Disclosure Abbott Vascular – Training Site Cook Medical – Training Site Cordis Endovascular – Training Site Covidien/eV3 – Training Site Medtronic – Training Site Terumo Medical – Speaker No conflict of interest related to this presentation

Percutaneous Vascular Closure Totally percutaneous vascular access (with no cutdown) for insertion of large-bore sheaths (up to 26 French) under local anesthesia +/- conscious sedation Preclose technique via common femoral artery Utility in EVAR, TEVAR and TAVI High success rate ≈ 94%

Percutaneous Vascular Closure Impetus for growth: Avoid complications of femoral artery repair Avoid need for general anesthesia ‘High-risk’ patients Preclose technique via common femoral artery Deployment of closure device with a “smaller” arteriotomy size (6 - 8 French hole) prior to insertion of large-bore sheath/device

Percutaneous Vascular Closure Vascular Closure Device for percutaneous common femoral artery repair Preclose technique – deployment prior to insertion of large-bore sheath/device Suture-mediated devices Prostar XL - Approved for 10F “Cumbersome” suture-management Perclose ProGlide - Approved for 8F Pretied suture/knot, short learning curve ‘Need’ to use 2 devices

Keys to Success Evaluation of access site common femoral Artery – Pre-procedure imaging study

Preclose: Imaging Study The common femoral artery access site should be imaged and evaluated: Utility of CT-scan/angio Inspect for calcification Depth of artery Size of the vessel = diameter ??allow entry of large-bore sheath/device

Preclose: Imaging Study The common femoral artery access site should be imaged and evaluated: Utility of CT-scan/angio Inspect for calcification Depth of artery Size of the vessel = diameter ??allow entry of large-bore sheath/device

Keys to Success Evaluation of access site common femoral Artery – Pre-procedure imaging study A one (1)-stick to a ‘disease-free’ anterior wall of the common femoral artery is of foremost importance

Vascular Access: Simple Rules to Follow 1-stick – anterior wall only with good blood return “NO-NO” – multiple sticks, ‘through & through’ else: Don’t rush – compress until hemostasis is achieved Needle to access artery Use of micropuncture 21-gauge access needle 21-gauge ‘hole’ is more ‘forgiving’ if puncture fails For ultrasound guidance – Echogenic tip

Femoral Artery Access: Ultrasound Guided Real time ultrasound (US)-guided vascular access Allows real time visualization of vessel anatomy and advancement of needle into the lumen Real time/Dynamic imaging: Vascular probe in sterile sleeve + US machine Approaches for needle ‘entry’: Transverse Longitudinal

Real Time US-guided Vascular Access Longitudinal view Right CFA - SFA/DFA bifurcation  Introduce needle above bifurcation

Real Time US-guided Vascular Access Longitudinal view Transverse view Transverse view of right CFA

Real Time US-guided Vascular Access Longitudinal view Longitudinal view Transverse view Right CFA and CFV Center the vessel (CFA) in center of screen Center of imaging probe overlies center of vessel and serves as landmark for needle entry

Real Time US-guided Vascular Access Advance needle to artery  “tenting” of vessel wall and entry of needle into vessel lumen followed by blood return Common Femoral Artery Watch as guidewire is ‘freely’ advanced into lumen of artery

Vascular Access: Simple Rules to Follow After accessing the artery using the micropuncture needle, insert the 4F micropunture sheath. Before upsizing from the micropuncture sheath, perform angiography of the access site for location of arteriotomy Take angio of CFA - Ipsilateral 30-40O Note vessel morphology

Vascular Access: Simple Rules to Follow After accessing the artery using the micropuncture needle, insert the 4F micropunture sheath. Before upsizing from the micropuncture sheath, perform angiography of the access site for location of arteriotomy Take angio of CFA - Ipsilateral 30-40O Note vessel morphology If location not ‘ideal,’ pull out and re-access

Vascular Access: Simple Rules to Follow After accessing the artery using the micropuncture needle, insert the 4F micropunture sheath. Before upsizing from the micropuncture sheath, perform angiography of the access site for location of arteriotomy Take angio of CFA - Ipsilateral 30-40O Note vessel morphology If location not ‘ideal,’ pull out and re-access

VCD: When Not to Use Contraindications to Deployment Multiple sticks, posterior sticks ‘Low’ sticks PAD - Calcified tortuous vessel Arteriotomy through ‘plaque’ ‘Gut feeling’ – Trust instinct, if there is any doubt, do not deploy Inexperience/unfamiliarity with particular device

Keys to Success Evaluation of access site common femoral Artery – Pre-procedure imaging study A one (1)-stick to a ‘disease-free’ anterior wall of the common femoral artery is of foremost importance Know the closure devices by heart – deployment and trouble shooting

VCD: Prostar XL Deployment of two (2) sutures to approximate arteriotomy

Right CFA – Post Prostar Closure using Prostar XL Right CFA – Baseline Right CFA – Post Prostar

VCD: Perclose ProGlide Prostar XL suture To emulate the 2 sutures of Prostar to close arteriotomy Deployment of two (2) sutures to approximate arteriotomy - ??orthogonal

VCD: Perclose ProGlide Prostar XL suture To emulate the 2 sutures of Prostar to close arteriotomy Deployment of two (2) sutures to approximate arteriotomy - ??orthogonal

Left CFA – Post 2 Perclose Closure using Perclose Left CFA – Post 2 Perclose

Left CFA – Post 2 Perclose Closure using Perclose Left CFA – Post 2 Perclose

Percutaneous EVAR: Advantages Avoids post-anesthesia complications Local anesthesia Less ‘trauma’ - ‘scarring’ of common femoral artery Easier ‘access’ in the future Patient comfort Shorter hospital stay – no ICU stay $$Cost effective

WHC Experience: Percutaneous EVAR Single center experience, 89 patients for EVAR. 2 patients excluded: Patient #2 – needed right iliac bypass conduit; contralateral limb closed with Prostar. Patient #16 – “calcified” femoral artery, elective cutdown; contralateral limb closed with Prostar. Technique: Access obtained via both common femoral arteries using the Micropuncture technique. Pre-deployment of Prostar closure device. Local anesthesia +/- conscious sedation Successful hemostasis obtained = 87/87 100%

WHC Experience: Percutaneous EVAR Only drawback is . . . “no bragging rights of having had an aneurysm repair” CB

Keys to Success Evaluation of access site common femoral Artery – Pre-procedure imaging study A one (1)-stick to a ‘disease-free’ anterior wall of the common femoral artery is of foremost importance Know the closure devices by heart – deployment and trouble shooting No device is better, learning curve and what you are comfortable with

Keys to Success Evaluation of access site common femoral Artery – Pre-procedure imaging study A one (1)-stick to a ‘disease-free’ anterior wall of the common femoral artery is of foremost importance Know the closure devices by heart – deployment and trouble shooting No device is better, learning curve and what you are comfortable with Readily available surgical colleagues

Percutaneous Closure of Large-Bore Sheath The primary benefit is the reduction in surgical wound complications and its associated morbidity. Provides an alternative treatment option for patients with co-morbidities that are risks for surgery and general anesthesia. Proper training and appropriate case selection are critical to optimize outcomes & minimize complications.

Thank you. Have a Good Day! On the road to Mount Everest Yamdro Yumtso Lake