Άγγελος Παπανικολάου MD,

Ειδικευόμενος Καρδιολογίας,

A’ Πανεπιστημιακή Καρδιολογική Κλινική, ΓΝΑ ‘Ιπποκράτειο’

Endovascular access & closure

2

Seldinger SI. Catheter replacement of the needle in

percutaneous arteriography; a new technique. In Acta

Radiol. 1953 May;39(5):368-76.

Half a centuryof manual compression

3

Seldinger Technique

Needle with cannula

inserted

Needle withdrawn

until there is blood flow

Inner cannula removed

& guidewire inserted

Needle removed

Catheter over guidewire Guidewire removed

leaving catheter in

artery

6

The Anatomy

Allen’s Test - Can be performed ± Oximetry

test

Peripheral vascular diseases. Edgar van Nuys Allen, MD and others with associates in the Mayo

Clinic and Mayo Foundation; 2nd edition, Philadelphia, Saunders, 1955.

Allen’s Test - Can be performed ± Oximetry

test

We recommend that, in the presence of an abnormal AT, the RA should not be used for cardiac catheterization unless the risk of using the femoral approach is excessive. Greenwood et al. JACC Vol. 46, No. 11, 2005, 2005:2013–7

Radial Access: proximal to styloid process – Not really the wrist!

Complications of femoral approach

HEMATOMA RETROPERITONIAL

AV FISTULA

PSEUDOANEURYSM

ARTERIAL THROMBOSIS

HEMATOMA

Radial Artery Complications

• 1372 Procedures

Asymptomatic radial occlusion 4.7%

Symptomatic radial occlusion 0.2%

Significant hematoma 0.2%

Significant pseudoaneurysm 0.2%

• Worst Complication

Perforation →Compartment Syndrome 1 Case

GR. Barbeau, et.al. ACC 2006)

SPASM

HEMATOMA

FEMORAL HEMOSTASIS-MANUAL

COMPRESSION

FEMORAL HEMOSTASIS-FEMOSTOP

Arterial femoral closure devices

25

Femoral Haemostasis

Potential advantages of closure devices:

bed rest

increased comfort

reduced cost

pain and associated ‘vagal’ reactions

complications

Types of VCD

27

Closure devices

Clips / Sutures

Angioseal DuettVasosealStarClose

Angiolink

Onux

Perclose

X-site

SuturaQuickseal (gel foam)

BioIntervention

Syvek

FloSeal

Biodisc

ExoSeal

Collagen & Thrombin

Duett

Collagen and thrombin

Intra arterial balloon during thrombin delivery

Seals artery and tissue tract

Balloon then removed

Delivery followed by short period of manual compression

5F to 9F

3F Duett

catheter

existing

sheath

Vasoseal

Extravascular collagen plug (un-anchored)

Delivery followed by short period of manual compression

VasosealVHD

Vasoseal ES – 5F to 8F

AngioSeal

6F and 8F devices

Components

Biodegradable anchor (intra-arterial)

collagen plug (extra-arterial)

3-0 Vycril suture (with clinch knot)

Angioseal evidence

Kussmaul WG 3rd, et al Rapid arterial hemostasis and decreased access site complications after cardiac catheterization and angioplasty: results of a randomized trial of a novel hemostatic device. J Am Coll Cardiol. 1995; 25:1685–1692.

Ward SR et al Angio-Seal Investigators. Efficacy and safety of a hemostatic puncture closure device with early ambulation after coronary angiography. Am J Cardiol. 1998; 81:569 –572.

Chevalier B, et al Effect of a closure device on complication rates in high-local-risk patients: results of a randomized multicenter trial. Catheter Cardiovasc Interv. 2003; 58:285–291.

Chung J, Lee DW, Kwon OS, Kim BS, Shin YS. Angio-Seal™ Evolution™ versus Manual Compression for Common Femoral Artery Puncture in Neurovascular DiagnosticAngiography : A Prospective, Non-Randomized Study. J Korean Neurosurg Soc. 2011 Mar;49(3):153-6.

Evolution Registry

All CATH PCI P

Device successfully deployed

Hemostasis by device

(N = 1004)

99.7%

97.8%

(N = 575)

99.8%

99.0%

(N=429)

99.5%

96.3%

Value

0.581

0.005

Time to hemostasis (cumulative)

<1 min

1-5 min

Additional hemostasis methods required

85.4%

98.3%

2.8%

88.0%

98.9%

1.4%

81.9%

97.4%

4.6%

0.006

0.061

0.002

Minor adverse events

Bleeding requiring 30+ minutes of manual 1.4% 0.0% 3.3% <0.001

compression

Ipsilateral hematoma >10 cm

Any minor adverse events

1.0%

2.4%

0.5%

0.5%

1.6%

4.9%

0.108

<0.001

Evolution AngioSeal RegistryTCT 2009

Death

Any major adverse events

--

4 (0.4%)

--

1 (0.2%)

--

3 (0.7%)

--

0.319

StarClose

5-6F femoral artery access site

nitinol clip

4mm diameter, 0.008” thick

Clip Study

Diagnostic Arm - ITT

Mean Time to Hemostasis (min)

Median Time to Hemostasis (min)

Mean Time to Ambulation (min)

Major Complications (% pt based)

Minor Complications (% pt based)

Mean Time to Dischargeability (hours)

Compression

72 pts

15.5

15.0

269

0

1.4%

5.2

P value

<0.001

<0.001

<0.001

--

1.000

<0.001

StarClose

136 pts

1.5

.3

163

0

2.2%

3.5

CLIP

Clip CLosure In Percutaneous Procedures

Hermiller et al., JIC 2005;17: 504-510

ExoSeal

6F extra-vascular closure device

painless deployment mechanism

delivers a poly-glycolic acid (PGA) plug atop the femoral artery

ECLIPSE trial led to CE mark (0% complications)

Perclose

TechStar

7F - 1 suture

ProStar XL

8F and 10F – 2 sutures

Closer

6F – 1 suture

Knot making tool

3-0 braided polyester (non-absorbable)

Techstar/Prostar evidence

Gerckens U, Grube E. Management of arterial puncture site after catheterization

procedures: evaluating a suture mediated closure device. Am J Cardiol. 1999 ;83:1658

–1663.

Baim DS, Suture-mediated closure of the femoral access site after cardiac

catheterization: results of the Suture To Ambulate aNd Discharge (STAND I and

STAND II) trials. Am J Cardiol. 2000; 85:864–869.

Carere RG. Suture closure of femoral arterial puncture sites after coronary

angioplasty followed by same-day discharge. Am Heart J. 2000; 139(pt 1):52–58.

Noguchi T. A randomised controlled trial of Prostar Plus for haemostasis in patients

after coronary angioplasty. Eur J Vasc Endovasc Surg. 2000;19:451– 455.

Rickli H Comparison of costs and safety of a suture mediated closure device with

conventional manual compression after coronary artery interventions. Catheter

Cardiovasc Interv. 2002; 57: 297–302.

Generation 1

25Fsurgical cutdown

Generation 2

21Fsurgical cutdown

Generation 3

18FPercutaneous

CoreValve TAVI & Prostar 10 XL

needles

Usually perfect results in 18 F holes

Arterial Closure Devices:

Additive Complications

Infection

Device embolization

Vascular obstruction – ischemia

VCDs vs manual compression

52

Nikolsky et al, JACC, 2004;44:1200-9Vaitkus, JIC, 2004;16:243-6

OR (95% Cl)

1.00.1Favors device

JACC meta-analysis

JIC meta-analysis

0.1 1.0 10.0

1.13[0.89,1.38]

1.00[0.96,1.03]

Heterogeneity test

P-value

0.22

Not available

10.0Favors manual compression

Nikolsky et al, JACC, 2004;44:1200-9

Vaitkus, JIC, 2004;16:243-6

Any Closure Device Versus Manual

Compression in PCI Studies

OR (95% Cl)

1.00.1Favors device

JACC meta-analysis

JIC meta-analysis

0.1 1.0 10.0

0.83[0.61,1.14]

0.51[0.45,0.58]

Heterogeneity test

P-value

NS

NS

AngioSeal Versus Manual Compression

in PCI Studies

10.0Favors manual compression

Nikolsky et al, JACC, 2004;44:1200-9

Vaitkus, JIC, 2004;16:243-6

4.94%

0.52%

1.11%

MC VCD MC VCD

Diagnostic PCI

P = 0.01

P < 0.001

2.35%

12,937 consecutive patients through a prospective registry from 2002 to 2005

Manual compression 2,941 (23%) and VCD 9,996 (77%)

Angioseal 82% Perclose 17% Other 1%

VCDs vs MC in registry data

Arora et al. AHJ 2007; 53(4): 606-611

50% reduction with VCDs

VCDs vs MC by propensity matching

56 Allen DS, Am J Cardiol. 2011 Jun 1;107(11):1619-23

Closure Device

(n = 1,162)

Manual Compression

(n = 1,162)

P Value

Major Bleeding

Entry Site

Other/Unknown

2.4%

0.6%

0.8%

5.2%

1.7%

1.8%

< 0.001

0.012

0.03

Stroke 0 0.5% 0.03

Pseudoaneurysm 0.3% 1.1% 0.03

In-Hospital Mortality 0.3% 0.9% 0.07

manual

compression;

6,5%

suture-based;

1,4%

collagen

plug-based;

3,4%

0,0%

2,0%

4,0%

6,0%

8,0%

P<0.001P<0.001

Rickli et al., Cath Card Interv 2002;57:297-302

P<0.001

reduction 13%

Cost:

Perclose vs Manual Compression

Resnic et al,

Am J Cardiol 2007, 99:766-770

Cost:

AngioSeal vs Manual Compression

Routine use of AngioSeal for PCI results in net cost savings of $44 in

the following conditions:

Cost of VCD< $235 and of MC > $67

Rates of access site bleeding < 2.5% with VCD and > 2.2% with MC

Rates of pseudoaneurysm < 1.67% with VCD and >1.01% with MC

Cost of access site bleeding > $2,104

Circulation 2 Nov 2010

Patients should undergo a femoral angiogram

(Class IC)

Vascular complications rates below 1% in 5F diagnostic angiography

(Class IC)

VCDs “reasonable” after PCI to achieve

faster hemostasis and shorter duration of bed rest,

and possibly increase patient comfort

(Class IIaB)

VCDs not routinely to reduce vascular complications

(Class IIIB)

Radial haemostasis

60

Hemostasis after TRA is successful

Zero bleeding

P. Agostoni’s meta-analysis

J Am Coll Cardiol. 2004 Jul 21;44(2):349-56.

S. Jolly RIVAL

Lancet. 2011 Apr 23;377(9775):1409-20.

Romangoli E. RIFLES-STEACS

TCT 2011

Manual compression

& rolled gauze

inexpensive,

widely available

too tight

not very secure,

personnel required

HemoBand

inexpensive,

widely available

venous pressure

hand discomfort

RadiStop

uncomfartable,

pt cannot use hand,

needs two hands to apply

Accumed band

easy to apply venous pressure,

no point compression

TR band

easy to apply,

visualizes puncture,

reduces occlusion by half,

patent hemostasis

moderately priced

Helix

inexpensive,

easy to apply,

visualizes puncture,

focused pressure,

patent hemostasis

Radial occlusion

68

Today’s TRA practice

Symptomatic radial occlusion

requiring medical attention

0.2% in radial group

NSTE-ACS and STEMI(n=7021)

Radial Access(n=3507)

98% of patients have a (+) Allen test

(+) Allen test patients do well

without the radial artery

Smaller sheaths lead to

less spasm & less occlusion

Dahm JB et al Cathet Cardiovasc Intervent 2002

Spaulding C et al. Cathet Cardiovasc Diagn 1996;39:365-70

100

80

No Heparin(n=49)

UFH2000-3000(n=119)

UFH5000(n=210)

71%

60

P<0.05

40

24%

20

4.3%

0

Heparin anti-coagulation prevents RAO

415

consecutive patients

Patent hemostasis prevents RAO

The PROPHET Study

Pancholy S et al. Cath and Card Interv 2008; 72:335–340

436 patients

75% decrease

Early and safe discharge

Bernat I et al, Am J Cardiol. 2011 Jun 1

Ulnar artery compression

to recanalize RAO

CABG patients do well

without the radial artery

76

No occurrence of hand ischemia in

over 3000 reported patients

undergoing radial artery grafts.

Taggart D., editorial in Heart 1999; 82:409-10

To achieve similar complications

(~2% RAO) in TRA we need to cath

150.000 patients

Conclusions for TRA

77

Compression with a device

Perform patent hemostasis

Anti-coagulation

Vasodilators intra-arterial

Smaller, shorter, hydrophilic sheaths

Ulnar compression if RAO.

The secret to a perfect closure…

….is a perfect and 1st puncture

Puncture

above CFA bifurcation and

below Inferior Epigastric Artery

NSTE-ACS and STEMI

(n=7021)

Radial Access

(n=3507)

Femoral Access

(n=3514)

Primary Outcome: Death, MI, stroke

or non-CABG-related Major Bleeding at 30 days

Randomization

RIVAL Study Design

Key Inclusion:

• Intact dual circulation of hand required

• Interventionalist experienced with both (minimum 50 radial

procedures in last year)

Jolly SS et al. Lancet 2011.

Blinded Adjudication of Outcomes

Other Outcomes

Radial(n=3507)

%

Femoral(n=3514)

%HR 95% CI P

Major Vascular Access Site Complications

1.4 3.7 0.37 0.27-0.52 <0.0001

Major Bleeding

TIMI Non-CABG Major Bleeding

0.5 0.5 1.00 0.53-1.89 1.00

ACUITY Non-CABG Major Bleeding

1.9 4.5 0.43 0.32-0.57 <0.0001

Jolly et al, Lancet 2011

RIVAL study

7021 patients with ACS

undergoing PCI

No difference in MACE

– death, MI, stroke

Trend for less major

bleeding with radial

access, depending on the

bleeding definition

Less vascular

complications with radial

access

Special benefit for radial

in STEMI pts

Jolly et al, Lancet 2011

Primary endpoint - NACE

Non CABG major bleeding