Micro-Access Sheaths with a 21g Needle Will Replace Conventional Access with 19g: The Patients Will Demand It Michael H. Wholey, MD, MBA San Antonio, TX 2/28/2011 5:10:00 PM

Financial Disclosures Patent on micropuncture system and efforts to commercialize

Basic Principle Unchanged in 55 years. Seldinger Technique Sven-Ivar Seldinger This changed some 50 years ago, when Dr. Sven Seldinger in Sweden developed a percutaneous technique of hollow needle access followed by insertion of a guidewire through the needle core. Catheters were subsequently introduced directly into the vessel. Although some modifications of the technique have occurred, including single anterior wall puncture rather than a through-and-through pullback method, the only major innovation has been the introduction of vascular sheaths some 20 years ago to simplify multiple catheter placement. During the 40 years after introduction of the Seldinger technique, external compression was the only established means of vessel closure. Despite a half century and tens of millions of cases, surprisingly little evidence base exists on optimal access and closure techniques. Basic Principle Unchanged in 55 years. Time to re-evaluate ?

Femoral Artery Anatomy CFA CFV Fem Nerve Target

Recommended Approach The above is our recommended algorithm for vascular access. First, anatomic locations A (inferior margin of the femoral head), B (center of femoral head) and C (approximate location of inguinal ligament) can be determined from plain fluoroscopy prior to needle puncture. The course of the common femoral artery (D) in the anterior-posterior view rarely varies from the location shown above. We insert the needle subcutaneously using fluoroscopic landmarks and palpation for the femoral pulse until the needle transmits pulsations felt just prior to arterial entry. At that point we fluoroscope one more time to make sure that it is approximately in the location in the panel on the left to be certain that it approximates the horizontal dotted line (at B) shown on the right and is neither too medial nor too lateral.

In 2010, the number of US arterial endovascular procedures is estimated to grow to over 6 million US Procedural Volumes - 2008 Source: Millennium Market Research

Arterial Access 18-19 Gauge Seldinger Needle

Arterial Access 18-19 Gauge Seldinger Needle 19 Gauge Single Wall Needle

18-19 Gauge Needles Angiographic Needle and Hub, Normal Wall, 18 G; 0.038 inch Guide Wire, 3.5 inch Lg 19 Gauge, 2.75” length, ultra thin wall

Arterial Access 18-19 Gauge Seldinger Needle 19 Gauge Single Wall Needle Micropuncture Set 21 Gauge Needle 0.018” short wire 4/5 French Coaxial Sheath

21 Gauge Needle Comparison to other Needle Sizes Needle Nominal Outer Dia. Nominal Inner Dia Nominal Wall Thickness 18 Gauge 1.27 mm 0.838 mm 0.216 mm 19 Gauge 1.067 mm 0.686 mm 0.191 mm 21 Gauge 0.819 mm 0.514 mm 0.152 mm Angiographic Needle and Hub, Thin Wall, 21 G; 0.021 inch Guide Wire, 2.75 inch Lg

21 Gauge Needle 55% Increase in Diameter Comparison to other Needle Sizes Needle Nominal Outer Dia. Nominal Inner Dia Nominal Wall Thickness 18 Gauge 1.27 mm 0.838 mm 0.216 mm 19 Gauge 1.067 mm 0.686 mm 0.191 mm 21 Gauge 0.819 mm 0.514 mm 0.152 mm 55% Increase in Diameter Angiographic Needle and Hub, Thin Wall, 21 G; 0.021 inch Guide Wire, 2.75 inch Lg

21 Gauge Needle Comparison to other Needle Sizes Needle Nominal Outer Dia. Nominal Inner Dia Nominal Wall Thickness 18 Gauge 1.27 mm 0.838 mm 0.216 mm 19 Gauge 1.067 mm 0.686 mm 0.191 mm 21 Gauge 0.819 mm 0.514 mm 0.152 mm 55% Increase in Diameter Major Incentive to Use a Smaller Needle: It hurts a lost less with a 21 gauge than an 18 gauge

US Arterial Access Two Approaches: Routine 18-19 Gauge needle followed by 5-6-7 vascular sheath Micro Needle Access and Approach Routine Micropuncture set Advance 0.035” wire Place vascular sheath

I. Steps with Conventional 18-19 Gauge Needle

Steps with conventional 18-19 gauge needle Puncture arterial wall with 19 gauge single wall Quick arterial blood return

18-19 Gauge Technique Advance 0.035” guidewire through needle

18-19 Gauge Technique Advance 4-8 Fr Vascular Sheath over the 0.035” guidewire Sheath Internal Dilator

18-19 Gauge Technique Finally, remove the internal dilator…ready to go

Local complications of FA access: 2-10% Hematoma (1-10%) 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 (0.2 – 0.9%) Thickening of the perivascular tissues Neural damage Infection Venous thrombosis Hypotensive Shock The local complications of femoral artery access have remained relatively high. The availability of vascular closure devices have not had any significant affect on these numbers. There are multiple reasons for continuing vascular access morbidity that will be discussed in detail in the following slides. Most common: hematoma Most lethal: retroperitoneal hemorrhage

Needle management Avoid multiple sticks with 18 g needles Stop and compress if failed puncture . Failed or multiple punctures with 18 g needles ,especially posterior wall can result in significant undetected bleed. 18g could become obsolete. Post wall bleed with 18 g needle

Better Technique  Better Result

19g needle, several punctures with painful false aneurysm. Killion 19g needle, several punctures with painful false aneurysm. Managed by coiling with microcath within 5 fr cath False Aneurysm from puncture of circumflex femoral

II. Traditional Micro Access Needle and Sheath System

Traditional Micro Access Set 21 Gauge Needle 0.018” Short guidewire Stainless Steel with Nitinol Tip Coaxial Sheath 3 Fr Inner Introducer 4/5 Fr Outer Introducer

Traditional Micro Access Advance 0.018” guidewire through 21 Gauge needle Remove the needle

Traditional Micro Access Advance the outer and inner sheath over the 0.018” wire into the artery 5 Fr O.D. 2.5 Fr O.D.

Traditional Micro Access Once the outer sheath is advanced into the vessel lumen, the internal dilator is then removed

Traditional Micro Access The 0.018” wire is replaced with a 0.035” wire

Traditional Micro Access Advance 4-8 Fr Vascular Sheath over the 0.035” guidewire Sheath Internal Dilator

Traditional Micro Access Finally, remove the internal dilator…ready to go

Traditional Micro Access Set 21 Gauge Needle Short 0.018” wire 5 Fr Micro access set sheath Conventional Vascular Sheath with sheath and internal dilator

Benefits of Micro Access Set Patient Comfort 21 Gauge needle VS 18-19 Less Bleeding Less haematomas Essential in access of brachial and radial arteries Pediatric and small women femoral access Ability to provide initial injection in difficult access cases

Benefits of Micro Access Set Radial Access for Coronary Caths Lower Brachial Access

Benefits of Micro Access Set Getting started in difficult arterial access cases Another difficult case getting started

Benefits of Micro Access Set Lesion treated with self-expandable stent Lesions that lie close to puncture site

Benefits of Micro Access Set Easier Antegrade Stick

Grow the Micro Access Market Educate Physicians Introduce key benefits to Cardiologists Radial Approach requires micro access Highlight importance of minimal access complications and patient comfort 19 gauge technology basically unchanged since 1950’s Continue to push with Radiology and Vascular Surgery

Radial Artery Access A trend toward increased use of radial PCI in the first quarter of 2007, with the database showing an overall rate of about 3.5% of total PCI procedures In parts of Europe, for instance, radial access accounts for as much 30-40% of all catheterizations

RADIAL ARTERY ACCESS

III. Novel Micro Access Set Technique: Wholey Mini Wire and Access Sheath Set

Novel Micro Access Set Technique: Wholey Mini Wire and Access Sheath Set Advance 0.018” Wholey Mini guidewire through 21 Gauge needle Remove the needle

Wholey Mini Wire and Access Sheath Set Advance 4-8 Fr Vascular Sheath over the Wholey Mini 0.018”guidewire Sheath Internal Dilator

Wholey Mini Wire and Access Sheath Set Advance 4-8 Fr Vascular Sheath over the Wholey Mini 0.018”guidewire Sheath Internal Dilator

Wholey Mini Wire and Access Sheath Set Advance Vascular Sheath into the vessel lumen Sheath Outer Sheath

Wholey Mini Wire and Access Sheath Set Traditional 21 Gauge Needle 0.018” Wholey Mini Guidewire (Platinum tipped, Extremely Torquable) Tapered Inner Dilator That Tracks over 0.018” Guidewire Outer 5-8 French Vascular Sheath Radiopque distal sheath marker

Technique with Novel Wholey Mini Wire and Access Sheath Set Provide anesthesia to the skin site Access artery with 21 gauge needle Advance 0.018” guidewire Remove needle Advance the coaxial sheath Remove wire and inner dilator Advance 0.035” wire Remove outer dilator Advance with 5-8 Fr Sheath

Conclusions: Why Patients Demand a Micropuncture Set for Arterial Access 21 Gauge Needle Versus 18-19 Gauge It hurts a whole lot less Go stick yourself with a 18 gauge needle

Conclusions: Why Patients Demand a Micropuncture Set for Arterial Access 21 Gauge Needle Versus 18-19 Gauge Less Trauma to the vessel wall and adjacent structures (nerve/vein) Possibly less complications: Pseudoaneurysms Hematomas Back wall puncture complications Arteriovenous Fistulas

Conclusions: Why Patients Demand a Micropuncture Set for Arterial Access 21 Gauge Needle Versus 18-19 Gauge Benefits of micropuncture set system Radial access a must Pediatric, small females crucial Ultrasound used in conjunction Small microsheath Ability to inject contrast in crucial situations Ability to use as a sheath for microcatheter for infants