MicroAccess Sheaths with a 21 g Needle Will

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Micro-Access Sheaths with a 21 g Needle Will Replace Conventional Access with 19 g:

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

Financial Disclosures n Patent on micropuncture system and efforts to commercialize

Financial Disclosures n Patent on micropuncture system and efforts to commercialize

Seldinger Technique Sven-Ivar Seldinger Basic Principle Unchanged in 55 years. Time to re-evaluate ?

Seldinger Technique Sven-Ivar Seldinger Basic Principle Unchanged in 55 years. Time to re-evaluate ?

Femoral Artery Anatomy CFA CFV Fem Nerve Target

Femoral Artery Anatomy CFA CFV Fem Nerve Target

Recommended Approach

Recommended Approach

In 2010, the number of US arterial endovascular procedures is estimated to grow to

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

Arterial Access n 18 -19 Gauge Seldinger Needle

Arterial Access n 18 -19 Gauge Seldinger Needle

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

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

18 -19 Gauge Needles Angiographic Needle and Hub, Normal Wall, 18 G; 0. 038

18 -19 Gauge Needles Angiographic Needle and Hub, Normal Wall, 18 G; 0. 038 inch Guide 19 Gauge, 2. 75” length, ultra thin wall

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

Arterial Access n 18 -19 Gauge Seldinger Needle n 19 Gauge Single Wall Needle n Micropuncture Set 21 Gauge Needle n 0. 018” short wire n 4/5 French Coaxial Sheath n

21 Gauge Needle Comparison to other Needle Sizes Nominal Outer Dia. Inner Dia Wall

21 Gauge Needle Comparison to other Needle Sizes Nominal Outer Dia. Inner Dia 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 Comparison to other Needle Sizes Nominal Outer Dia. Inner Dia Wall

21 Gauge Needle Comparison to other Needle Sizes Nominal Outer Dia. Inner Dia 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 Nominal Outer Dia. Inner Dia Wall

21 Gauge Needle Comparison to other Needle Sizes Nominal Outer Dia. Inner Dia 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

US Arterial Access n Two Approaches: n Routine 18 -19 Gauge needle followed by

US Arterial Access n Two Approaches: n Routine 18 -19 Gauge needle followed by 5 -67 vascular sheath n Micro Needle Access and Approach n Routine Micropuncture set n Advance 0. 035” wire n Place vascular sheath

I. Steps with Conventional 18 -19 Gauge Needle

I. Steps with Conventional 18 -19 Gauge Needle

Steps with conventional 18 -19 gauge needle • Puncture arterial wall with 19 gauge

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 0. 035” guidewire through needle

18 -19 Gauge Technique • Advance 4 -8 Fr Vascular Sheath over the 0.

18 -19 Gauge Technique • Advance 4 -8 Fr Vascular Sheath over the 0. 035” guidewire Internal Dilator Sheath

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

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

 • • Local complications of FA access: Hematoma (1 -10%) 2 -10%Retroperitoneal hemorrhage

• • Local complications of FA access: Hematoma (1 -10%) 2 -10%Retroperitoneal hemorrhage Pseudoaneurysm (1 -6%) AV fistula (<1%) Vessel laceration (<1%) n • Intimal dissection n • Free bleeding Ante- or retro-grade Acute vessel closure (<1%) n n n (0. 2 – 0. 9%) Thickening of the perivascular tissues Neural damage Infection Venous thrombosis Hypotensive Shock Thrombosis (small artery lumen) Most common: hematoma Most lethal: retroperitoneal hemorrhage

Needle management n Avoid multiple sticks with 18 g needles n Stop and compress

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

Better Technique Better Result

Better Technique Better Result

19 g needle, False Aneurysm several punctures from puncture of with painful false circumflex

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

II. Traditional Micro Access Needle and Sheath System

II. Traditional Micro Access Needle and Sheath System

Traditional Micro Access Set 21 Gauge Needle n 0. 018” Short guidewire n n

Traditional Micro Access Set 21 Gauge Needle n 0. 018” Short guidewire n n n Stainless Steel with Nitinol Tip Coaxial Sheath 3 Fr Inner Introducer n 4/5 Fr Outer Introducer n

Traditional Micro Access • Advance 0. 018” guidewire through 21 Gauge needle • Remove

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”

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,

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”

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”

Traditional Micro Access • Advance 4 -8 Fr Vascular Sheath over the 0. 035” guidewire Internal Dilator Sheath

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

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

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 n Patient Comfort n n Less Bleeding n n

Benefits of Micro Access Set n Patient Comfort n n Less Bleeding n n Less haematomas Essential in access of brachial and radial arteries n n 21 Gauge needle VS 18 -19 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 Radial Access for Coronary Caths Lower Brachial Access

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

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

Benefits of Micro Access Set Lesions that lie close to puncture site Lesion treated

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

Benefits of Micro Access Set Easier Antegrade Stick

Benefits of Micro Access Set Easier Antegrade Stick

Grow the Micro Access Market n Educate Physicians n Introduce key benefits to Cardiologists

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

Radial Artery Access n A trend toward increased use of radial PCI in the

Radial Artery Access n 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 n In parts of Europe, for instance, radial access accounts for as much 30 -40% of all catheterizations

RADIAL ARTERY ACCESS

RADIAL ARTERY ACCESS

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

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

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

Wholey Mini Wire and Access Sheath Set • Advance 4 -8 Fr Vascular Sheath over the Wholey Mini 0. 018”guidewire Internal Dilator Sheath

Wholey Mini Wire and Access Sheath Set • Advance 4 -8 Fr Vascular Sheath

Wholey Mini Wire and Access Sheath Set • Advance 4 -8 Fr Vascular Sheath over the Wholey Mini 0. 018”guidewire Internal Dilator Sheath

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

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

Wholey Mini Wire and Access Sheath Set • Traditional 21 Gauge Needle • 0.

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

Technique with Novel Wholey Mini Wire and Access Sheath Set Provide anesthesia to the skin site n Access artery with 21 gauge needle n Advance 0. 018” guidewire n Remove needle n Advance the coaxial sheath n Remove wire and inner dilator n Advance 0. 035” wire n Remove outer dilator n Advance with 5 -8 Fr Sheath n

Conclusions: Why Patients Demand a Micropuncture Set for Arterial Access n 21 Gauge Needle

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

Conclusions: Why Patients Demand a Micropuncture Set for Arterial Access n 21 Gauge Needle

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

Conclusions: Why Patients Demand a Micropuncture Set for Arterial Access 21 Gauge Needle Versus

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