DOWNTOWN CAMPUS
INSTITUTE FOR CLINICAL RADIOLOGY
SECTION FOR INTERVENTIONAL RADIOLOGY
EVALUATION OF A NOVEL BIOABSORBABLE AND NON-SYNTHETIC
VASCULAR CLOSURE DEVICE: FISH IN DAILY ROUTINE
Marcus Treitl, MD; Maximilian F. Reiser, MD; Karla Maria Treitl, MD
INSTITUTE FOR CLINICAL RADIOLOGY
INTERVENTIONAL RADIOLOGY
UNIVERSITY HOSPITALS OF MUNICH®
INTRODUCTION
Manual compression (MC) for closure of arterial access
15 – 20 min followed by 4- 6h immobilization
Reported Time to Hemostasis (TTH): 16 Min (FDA PMA filing P930038)*
Patient discomfort, maybe leading to noncompliance
Bleeding
Limited in obese patients and with coagulopathy or anticoagulation
Since mid 1990s development of vascular closure devices (VCDs)
Safely achieve complete hemostasis and closure of arteriotomy
Reduction of access related complications
Promise of improving workflow and patient comfort
* Koreny M, Riedmu ̈ller E, Nikfardjam M, et al. Arterial puncture closing devices compared with standard manual compression after cardiac catheterization: Systematic review and metaanaly- sis. JAMA
2004;291:350–357. Pompa JJ, Satler LF, Pichard AD, et al. Vascular complications after balloon and new device angioplasty. Circulation 1993;88:1569–1578. Lewis‐Carey MB, Kee ST. Complications of arterial closure devices. Tech Vasc Interv Radiol 2003;6:103–106.
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Interventional Radiology: Bioabsorbable non-synthetic vascular closure device FISH in daily routine – M. Treitl
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INSTITUTE FOR CLINICAL RADIOLOGY
INTERVENTIONAL RADIOLOGY
UNIVERSITY HOSPITALS OF MUNICH®
DRAWBACKS OF VCDs
Especially active VCDs introduce foreign bodies
Collagen or Synthetics like PGA, PEG, etc.
Typically induce inflammatory response: Cause for scarred groin (frequent re-puncture!)
Many Contraindications
Puncture of SFA, PFA, bifurcation, above IEA, multiple punctures required
Heavy arterial calcification
Small arterial caliber
Vessel tortuosity
Re-puncture within 30 days
New complications
Distal embolization
Deployment failure
Infection
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Interventional Radiology: Bioabsorbable non-synthetic vascular closure device FISH in daily routine – M. Treitl
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INSTITUTE FOR CLINICAL RADIOLOGY
INTERVENTIONAL RADIOLOGY
UNIVERSITY HOSPITALS OF MUNICH®
Active VCD, under development since early 2000s
Morris Innovative Inc., Bloomington, IN, USA
Intra- and extravascular sealing with t-shaped and wired piece of porcine SIS (small intestinal mucosa; Cook Biotech™)
Biologic material known from therapy of burns
Less inflammatory response
Resorbed within 90 days
Benefits
Less scarring of access site
Less limitations than other VCD
Puncture site location, access vessel size (≥ 3mm), calcification
Might be used as working sheath in some versions
Lower risk of distal embolization since made from one piece
FISH: FEMORAL INTRODUCER SHEATH & HEMOSTASIS
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Interventional Radiology: Bioabsorbable non-synthetic vascular closure device FISH in daily routine – M. Treitl
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INSTITUTE FOR CLINICAL RADIOLOGY
INTERVENTIONAL RADIOLOGY
UNIVERSITY HOSPITALS OF MUNICH®
FISH: OVERVIEW
FISH Control close
6 and 7F
Cuff stabilizer
FISH Combi close
5, 6, 7 and 8F
No Cuff stabilizer
How it works
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Interventional Radiology: Bioabsorbable non-synthetic vascular closure device FISH in daily routine – M. Treitl
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INSTITUTE FOR CLINICAL RADIOLOGY
INTERVENTIONAL RADIOLOGY
UNIVERSITY HOSPITALS OF MUNICH®
FISH: AVAILABLE DATA
FDA approval for use in diagnostic procedures (PMA)
Preliminary study in the US (2004 – 6)
297 patients
FISH: 139 diagnostic / 52 interventional pts.
MC: 67 diagnostic / 39 interventional pts.
Results
Mean time to hemostasis: 6 minutes
Mean time to mobilization: 2 hours
Technical success: 97.9% (4 device failures)
FISH: One severe bleeding (0.72%), 3 hematoma, 2 pseudoaneurysms
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Interventional Radiology: Bioabsorbable non-synthetic vascular closure device FISH in daily routine – M. Treitl
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Picture taken by FISH™ customer during non-trial cut-down procedure at Regional Medical Center of Acadiana.
INSTITUTE FOR CLINICAL RADIOLOGY
INTERVENTIONAL RADIOLOGY
UNIVERSITY HOSPITALS OF MUNICH®
AIM OF STUDY
To evaluate the
Feasibility
Efficacy
Safety
...of remodeled FISH Control close aVCD for routine use in
peripheral endovascular intervention
Pilot study
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Interventional Radiology: Bioabsorbable non-synthetic vascular closure device FISH in daily routine – M. Treitl
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INSTITUTE FOR CLINICAL RADIOLOGY
INTERVENTIONAL RADIOLOGY
UNIVERSITY HOSPITALS OF MUNICH®
PATIENT SELECTION
Prospective evaluation with ethics committee approval
Consecutive patients with indication for endovascular treatment of peripheral artery disease of the lower limb
Inclusion criteria:
Informed consent to participate in study
Procedure done with 6 or 7F access sheath
Access vessel diameter ≥ 3mm
Exclusion criteria:
Skin infection at access site
Other VCD than FISH recently implanted within last 30 days at planned access site
INR > 1.5
Denial of study participation
No influence of: thrombolysis, puncture site, BMI, anticoagulation, renal failure, stage of PAOD, sex, recent use of FISH at same access site
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Interventional Radiology: Bioabsorbable non-synthetic vascular closure device FISH in daily routine – M. Treitl
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INSTITUTE FOR CLINICAL RADIOLOGY
INTERVENTIONAL RADIOLOGY
UNIVERSITY HOSPITALS OF MUNICH®
STUDY ENDPOINTS
Primary efficacy endpoints
Time to hemostasis (TTH) in [sec]
time from sheath removal until stop of arterial bleeding
Time to ambulation (TTA) in [hours]
time from sheath removal until patient comfortable walking 10 m
Safety endpoints
Major complications
Require little to major therapy, prolonged hospital stay, maybe permanent sequelae
Minor complications
No or nominal therapy, no consequence; no prolonged hospital stay
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According to SIR guidelines for VCDs:
acceptable major complication rates for
• Manual compression: reported 0 – 3, acceptable 0-3
• VCD use: reported 0 – 7, accepatble 0 – 3%
Sheth RA et al for the Society of Interventional Radiology Standards of Practice Committee. J Vasc Interv Radiol 2014; 25:73–84
• Bleedings requiring transfusion • Pseudoaneurysm (PA) • Device embolization • Acute occlusion of the access
vessel • Access site infection
• Small hematomas
INSTITUTE FOR CLINICAL RADIOLOGY
INTERVENTIONAL RADIOLOGY
UNIVERSITY HOSPITALS OF MUNICH®
PROCEDURE AND FOLLOW UP
Procedure: always 5.000 IU Heparin i.v.
Antegrade or retrograde puncture of common femoral artery (CFA)
Implantation of FISH according to IFU
Physician has used > 20 devices prior to study
Short manual compression until hemostasis
Sterile wound dressing
Immobilization and sand sack for 1hr
In case of device failure / prolonged manual compression until hemostasis
Compression bandage for 24hrs / immobilization for 6hrs
Post-procedural follow-up the next day / prior to discharge / 6months:
Clinical inspection and palpation
Duplex ultrasound of access site and outflow (embolization of device?)
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INSTITUTE FOR CLINICAL RADIOLOGY
INTERVENTIONAL RADIOLOGY
UNIVERSITY HOSPITALS OF MUNICH®
PATIENT CHARACTERISTICS
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Patient count 132
Sex 88 male / 44 female
Mean age 71.5yrs (41 – 98yrs)
Mean BMI 28.2 (23 – 35)
Renal failure 32 (24.2%)
Critical limb ischemia 55 (41.7%)
Hypertension 59 (44.7%)
Thrombocytes 280.000
Mean INR 1.1
ASA or Clopidogrel alone 85%
Dual anti-platelet regimen 13%
Anticoagulation / Heparin 17%
Glycoprotein IIb/IIIA inhibitors 0
INSTITUTE FOR CLINICAL RADIOLOGY
INTERVENTIONAL RADIOLOGY
UNIVERSITY HOSPITALS OF MUNICH®
PROCEDURAL CHARACTERISTICS
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Interventional Radiology: Bioabsorbable non-synthetic vascular closure device FISH in daily routine – M. Treitl
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Patient count 132
Prior intervention same access site (no other VCD) 37 (28%)
Antegrade puncture 95 (72%)
6F 125 (94.7%)
Mean access vessel diameter 6.5 (3.8 – 8.2)
Visible calcification of punctured vessel 52 (39.4%)
Heavily calcified 8 (6.1%)
Thrombolysis with rt-PA during procedure 7 (5.3%)
Re-puncture after FISH
next day n = 6
within 12 months n = 12
Palpable scarring / resistance 0
Device displacement 0
INSTITUTE FOR CLINICAL RADIOLOGY
INTERVENTIONAL RADIOLOGY
UNIVERSITY HOSPITALS OF MUNICH®
RESULTS
04.12.2014
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FISH Control Close Own pilot study
Patients (n) 132
Technical success 97% (n=128)
Device failures 1.5% (n=2)
TTH [sec] 45 [0 – 136]
TTA [hrs] 1.1 [1 – 4]
Major complications 2 PA (1.5%)
Minor complications 3 SH (2.3%)
Pain during implant n = 6 (4.5%)
Late device failures 0
+Sheth RA et al for the Society of Interventional Radiology Standards of Practice Committee. J Vasc Interv Radiol 2014; 25:73–84 *Kussmaul WG, Buchbinder M, Whitlow PL, et al. J Am Coll Cardiol 1995; 25:1685–1692. Applegate RJ, Grabarczyk MA, Little WC, et al. J Am Coll Cardiol 2002; 40:78–83. Chevalier B, Lancelin B, Koning R, et al. Cathet Cardiovasc Interv 2003; 58:285–291.
FISH Historical data
191
97.9%
2.1% (n=4)
360
2
1 Bl (0.72%)
3 SH / 2 PA (2.6%)
N/A
-
Manual compression (published data+)
-
-
-
960 – 1,500
-
0 – 3%
N/A
Sometimes observed
-
AngioSeal (published data*)
435 – 4,525
-
N/A
< 60
-
0.8 – 3.6%
7%
Often observed
N/A
INSTITUTE FOR CLINICAL RADIOLOGY
INTERVENTIONAL RADIOLOGY
UNIVERSITY HOSPITALS OF MUNICH®
IMMEDIATE RE-PUNCTURE 1 DAY AFTER FISH 6F Male, 40yrs
Treatment for right renal
artery occlusion 1 day before
6F FISH used for closure,
successfully
Acute re-occlusion the next day
re-puncture necessary
No intraluminal visible foreign
body
No device displacement
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Interventional Radiology: Bioabsorbable non-synthetic vascular closure device FISH in daily routine – M. Treitl
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INSTITUTE FOR CLINICAL RADIOLOGY
INTERVENTIONAL RADIOLOGY
UNIVERSITY HOSPITALS OF MUNICH®
FOLLOW-UP AFTER 6F FISH
Male, 78yrs
Repeat treatment for
multi-focal PAOD
Retrograde 6F
procedure and FISH
left CFA 12 months
ago
Angiographic follow-up
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6 Months 12 Months
INSTITUTE FOR CLINICAL RADIOLOGY
INTERVENTIONAL RADIOLOGY
UNIVERSITY HOSPITALS OF MUNICH®
CONCLUSION
FISH Control close device is
Easy-to-use, safe, and potent vascular closure device for interventional procedures
Mean TTH 45 sec
No device embolization / infection / displacement, even in case of failure!
comparable low major complication rate of 1.5%
In our observation no palpable / relevant scarring of access site
No device displacement / embolization in case of early re-puncture observed
Broader range of suitable vessel diameters starting from 3mm
Is not contraindicated in case of calcification (device failure may occur)
Remark:
Adequate preparation of puncture channel necessary (oozing possible)
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INSTITUTE FOR CLINICAL RADIOLOGY
INTERVENTIONAL RADIOLOGY
UNIVERSITY HOSPITALS OF MUNICH®
THANK YOU VERY MUCH FOR YOUR ATTENTION!
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CORRESPONDING AUTHOR:
Priv.-Doz. Dr. med. Marcus Treitl, MD, MBA
University Hospitals of Munich - Ludwig-Maximilians-University of Munich
Institute for Clinical Radiology
FON: +49 – 89 – 44005 – 9240
E-Mail: [email protected]
Internet: www.klinikum.uni-muenchen.de
www.radiologie-lmu.de