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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Needle withdrawn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