Transcript Vascular Closer Device

June 14th MEET 2007. Multidisciplinary European Endovascular therapy
Peripheral vessel: mechanical
or chemical closure
Cardiovascular Interventional laboratoratory,
San Donato Milanese Hospital, Milano
Director Prof. Luigi Inglese
Nadia Mollichelli
Manual compression: the gold
standard
Seldinger technique, introduced in 1951,
obtained the hemostasis at the end of the
procedure by manual pressure for 10-15
minutes, followed by 6-8 hours of bed rest, in
patients with normal coagulation parameters.
Seldinger SI. Catheter placement of needles in percutaneous
arteriography; a new technique.
Acta Radiol 1953; 39: 368-76.
Mechanical compression
Later on the introduction of
mechanical methods as
Femostop, Compressar or
Clamp easy facilitated the
problem of manual
compression but didn’t
reduce the time of patient
bed rest and the rate of
hematoma formation.
Vascular closure device
The new interventional tecniques have increased
the use of new devices that require large sheaths,
periprocedural anticoagulation and most important
double antiplatelet therapy with a consequent
increase in the access site related complication of
up to 17%.
Waksman et Al. Predictors of groin complication after balloon and
new device coronary intervention. Am J Cardiol 1995; 75: 886-889.
Ideal closure device
• Easy device application
• High successful rate with short time to
hemostasis
• Low rates of complications
• Possibility of repeated vascular access
Available closure devices and their mechanisms of action
Manufacturer
Substrate/mechanism
Relation of VCD
to vascular wall
AngioSeal
Daig, Minnetonka, MN, USA
Bovine collagen
Intraluminal
VasoSeal
Datascope Corp., Montvale, NJ, USA
Bovine collagen
Extraluminal
Duett
Vascular Solutions, Inc., Minneapolis, MN, USA
Collage plus thrombin Extraluminal
QuickSeal
SUB-Q Inc., San Clemente, CA,USA
Gelatin
Extraluminal
NeoMend
MeoMend, Inc., Sunnyvale, CA, USA
Bioadhesive
Intraluminal
Perclose
Perclose, Abbott Lab., Redwood City, CA, USA
Suture
Intraluminal
X-SITE
X-SITE Medical, Blue Bell, PA, USA
Suture
Intraluminal
SuperStitch
Sutura, Inc., Fountain Valley, CA, USA
Suture
Intraluminal
EVS Vascular Closure
Angiolink Corporation, Taunton, MA, USA
Titanium staple
Extraluminal
Starclose
Abbott Laboratory, Redwood City, CA, USA
Nitinol staple
Extraluminal
Device type
Sealing devices
Suture-mediated devices
Staple-mediated devices
Major complications of VCD
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Hematoma requiring trasfusion or surgery
Pseudoaneurysm
Arteriovenous fistula
Retroperitoneal hematoma
Femoral artery thrombosis
Access site infection
Device embolization
Failure
Predictors of vascular complications
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Age and Gender
Severe PVD
Diabetes
Sheath size
Final ACT level
Peri PCI pharmacotherapy (thrombolitics, GP
IIb/IIIa inhibitors)
• Multiple arterial puncture attempts
• Operator learning curve
AngioSeal
The AngioSeal device was introduced in
Europe 1994. It consists of an anchor, a
collagen plug, and a suture. The
biodegradable collagen plug induces
platelet activation and aggregation, and
releases coagulation factors. AngioSeal
produces a sandwich closure of the
arteriotomy site between the anchor and
collagen plug
AngioSeal: hemostasis mechanisms
PRIMARY MECHANISM
MECHANICAL:
Anchor-Collagen Arteriotomy Sandwich
Suture
SECONDARY MECHANISM
BIOCHEMICAL:
Coagulation-inducing Properties of Collagen
Collagen
Sponge
Co-polymer
Anchor
Internal components of AngioSeal
Anchor: inside the artery, smooth, tapered
dome shape, blend of lactide and glycolide
polymers. Non thrombogenic. Breakdown
via hydrolisis in less than 90 days.
Collagen: bovine collagen, which is
pressed on the outer surface of the artery.
Break down through leukocytosis in less
than 90 days
Suture:
polyglicolic
acid.
Break down via hydrolisis,
significant absorption at 30 days,
complete in 60-90 days
AngioSeal deployment: step 1
•Thread the arteriotomy
locator/insertion sheath
assembly over the guidewire
•When blood begins to flow
from the proximal drip hole the
insertion sheath is in the artery
•The dilatator/sheath
combination is withdrawn until
flow ceases and then reinserted
1-2 cm.
Distal Blood Inlet Hole
AngioSeal deployment:step 2
The locator system is removed
and the AngioSeal carrier tube
is introduced through the
hemostatic valve
Gently pullback on AngioSeal
device cap until resistance
felt,which deploys the anchor
AngioSeal deployment: step 3
Once the Device Cap is
locked into rear position,
fully withdraw device sheath
assembly until resistance is
felt, which indicates that the
anchor is against the inner
arterial wall. Grip Tamper
Tube and slide it down to
advance knot and collagen to
the artery, while maintaining
upward tension on suture. A
marker on the suture
indicates adequate depth
Angiography of the femoral
artery access site
The routine use of a femoral angiogram
through the original procedure sheath prior
to puncture closure with a closure device
can prevent complications associated with
sub-optimal vascular access, unrecognized
peripheral vascular disease, small diameter
vessels and other anatomical variants
Femoral puncture close to the biforcation
Collagen in arterial lumen, high risk of thrombosis
High FA biforcation
Artery diameter
AngioSeal is controindicated if the artery diameter is less
than 4mm because the anchor cannot deploy.
Femoral puncture close to a plaque
No perfect anchor adherence, collagen in arterial lumen,
high risk of thrombosis
Disadvantages of the collagen plug
• Potential risk of local infection in delayed closure
• Repeat puncture of the artery within 3 months is
not recommended because of the theoretical
possibility of disrupting or disloging the
hemostatic plug.
• Applegate showed that restick of the artery in
which Angioseal device has been deployed <90
days can be performed safely 1 cm above or below
the original stick. Cathet Cardiovasc Intervent 2003; 58:
181-84.
Studies investigating AngioSeal vascular closure devices
Study
No. of patients DF (%) Time to hemostasis (m)
VCD control VCD
VCD control p-value
Time to ambulation (h)
VCD control p-value
Complications (%)
VCD control p-value
Randomized controlled studies
Kuesmaul et al.
Ward et al.
Chevaller et al.
218
217
4
2,5
15,3 <0,0001
NA
NA
12
18
0,08
202
102
4
0,9
17
0,001
NA
NA
9
6
NS
306
306
3,2
5
52
<0,001
7,3
15,8
<0,001
5,9
18
<0,001
411
387
4
NA
NA
6
19
<0,01
5,6
11,65
<0,01
411
2099
5
NA
NA
NA
NA
2,9
3,1
0,96
516
5892
NA
NA
NA
NA
NA
19,4
11,5
<0,001
539
489
4,5
2
NA
2,6
NA
7,1
7,4
NS
524
1824
3
NA
NA
NA
NA
1,5
2,5
<0,05
123
39
15,4
NA
NA
NA
NA
9
9
NS
827
8
NA
NA
2,5
280
9
0,69
1,7
0,5
1317
3,3-4,2
NA
13,2
0,53
350
NA
NA
NA
2,8
Case-controlled and cohort studies
Cremonesi et al.
Cura et al.
Dangas et. al.
Duffin et al.
Applegate et al.
Assall et al.
Am J Cardiovasc Drugs 2006
Registries
Sesana et al.
Kapadia et. al.
Eggebrecht et al.
Kirchhof et al.
Vascular closure devices vs manual compression
A Meta-analysis. Nikolsky et al. JACC 2004; 44: 1200-9.
• Randomized, case control, cohort studies.
• A total of 30 studies, 37,066 patients
• Objective: safety of arteriotomy closure
device versus manual compression
• Primary endpoint: cumulative incidence of
vascular complications, including
pseudoaneurysm, arteriovenous fistula,
retroperitoneal hematoma.
Vascular closure device vs manual compression
A Meta-analysis. Nikolsky et al. JACC 2004; 44: 1200-9.
Starclose device
StarClose
CLIP
 Made of Nitinol
 4 mm diameter, 0.2 mm
thick
 2 long tines provide tissue
apposition of arteriotomy
 4 short tines keep the clip
extravascular and secure it in
place
Vessel locator
Starclose vessel locator is
designed to provide tactile
feedback for device
positioning in the artery
Made of Nitinol
Starclose advantage
Vessel locator retracts
completely before Clip fire
with an extraluminar closure
of the artery
Starclose: click 1
Starclose: click 2-Vessel locator
deployment
Starclose: advance the thumb advancer
Starclose:click 3
Starclose: click 4-clip deployment
Raise the device less than 90°
And then press the trigger
to deploy the clip
CLIP Study
The Clip study is the first randomized multicenter trial that
compares Starclose device to manual compression.
- 596 patients
“The clinical results of this study demonstrate that
starclose is non inferior to manual compression with
respect to the primary safety endpoint of major vascular
events in subjects who undergo percutaneous
interventional procedure” Hermiller et al.Catheterization and
Cardiovascular Interventions 2006. 68: 677-683.
Non randomized trial of manual
compression, angioseal and starclose in
common femoral artery puncture
Angioseal
(n=167)
Starclose
(n=151)
Manual P-value
(n=108)
Deployment
failure
10 (5.9%)
11(7.3%)
NS
Deployed but
hemostasis non
achieved
4 (2.4%)
18(11.9%)
<0.0001
Minor
complications
7 (4.2%)
8 (5.3%)
4(3.7%)
NS
Major
complications
5 (2.9%)
3 (1.9%)
4 (3.7%)
NS
Lakshmi et al. Cardiovasc.Intervent.Radiol.(2007) 30: 182-88
Peripheral vascular disease
• 188 patients, 144 procedures were diagnostic, 76
were intervention
• Time to mobilization: within 1 h for 6 F, 3 hours
for 8F
• Same day discharge
• Only two complications: one pseudoaneurysm and
one femoral artery occlusion.
The use of AngioSeal device for femoral artery closure. Abando et
al. J Vasc Surg.2004; 40: 287-90.
Suture mediated percutaneous closure device in
antegrade puncture. Duda et al. Radiology 1999; 210: 47-52
End Points
No. of patients (%)
Procedural success
77 (96)
Crossover to compression
2 (2)
Major complication
Retroperitoneal hematoma
1 (1)
Minor complication
Pseudoaneurysm
1 (1)
Groin hematoma
3 (4)
Localized infection
0 (0)
Lymphatic fistula
1 (1)
Distal embolization
0 (0)
Peripheral artery disease: AngioSeal efficacy in
antegrade puncture Mukhopadhyay et al. EJR 2005: 56: 409-12.
 21 patients with antegrade puncture had a 6 F
sheath angioseal for haemostasis
 Only one small haematoma and one ischaemia in a
82 years old diabetic man.
 Advantage: immediate removal of the introducer
sheath without compromising blood flow to the
distal extremity with prolonged manual
compression for hemostasis
Off label used of VCD
• From december 2003 to May 2007, 50 patients
with AAA were excluded with Gore Excluder in
our cath. lab. The 12 F sheath introducer of the
controlater leg was closed with AngioSeal 8 F, as
well as 12 and 13 long sheath used for
decoartation of thoracic aorta.
• We recordered 100% success in acheiving
hemostasis, only three minor complications (small
hematoma).
Patch technology
The patch improves the efficacy
of manual compression,
particularly in anticoagulated
patients. It is applied externally
and accelerates the coagulation
process.
Patch technology
Where to Use the Patch
Tecnology
Non-Femoral approaches
Femoral approach
diagnostic angiography
with 4 or 5 F sheath
Conclusion 1
• Vascular closure device can obtain hemostasis
rapidly also in presence of fully anticoagulation
and antiplatelet agents, with less discomfort and
early mobilization of the patient
• The existing evidence suggests that complication
rates vs manual compression are not increased
significantly.
• The use of a VCD has improved the efficiency and
productivity of our Cath. Lab.
Conclusion 2
• None of the devices on the market is dramatically different
with regard to efficacy and complications
• We prefer AngioSeal to Starclose in calcified arteries, in a
large arteriotomies and in obese patients
• In all other patients we generally use the Starclose device
because in our experience the only complication observed
is the immediate failure of the device (no pseudoaneurysm,
retroperitoneal hematoma, femoral artery thrombosis or
access site infection have been observed with starclose in
our cath. lab.).