1. 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

2. Financial Disclosures
Patent on micropuncture system and efforts to commercialize

3. 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 ?

4. Femoral Artery Anatomy
CFA
CFV
Fem Nerve
Target

5. 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.

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

7. Arterial Access
18-19 Gauge Seldinger Needle

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

9. 18-19 Gauge Needles
Angiographic Needle and Hub, Normal Wall, 18 G; inch Guide Wire, 3.5 inch Lg
19 Gauge, 2.75” length, ultra thin wall

10. 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

11. 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; inch Guide Wire, 2.75 inch Lg

12. 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; inch Guide Wire, 2.75 inch Lg

13. 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

14. US Arterial Access Two Approaches:
Routine Gauge needle followed by vascular sheath
Micro Needle Access and Approach
Routine Micropuncture set
Advance 0.035” wire
Place vascular sheath

15. I. Steps with Conventional 18-19 Gauge Needle

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

17. 18-19 Gauge Technique
Advance 0.035” guidewire through needle

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

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

20. 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

21. 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

22. Better Technique  Better Result

23. 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

24. II. Traditional Micro Access Needle and Sheath System

25. 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

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

27. 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.

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

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

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

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

32. 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

33. 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

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

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

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

37. Benefits of Micro Access Set
Easier Antegrade Stick

38. 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

39. 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 % of all catheterizations

40. RADIAL ARTERY ACCESS

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

42. 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

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

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

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

46. 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

47. 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

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

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

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