Closure Devices. Peter F Ludman Advanced Angioplasty 2003
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1 Closure Devices Peter F Ludman Advanced Angioplasty 2003
2 Where Radials fear to tread Male, 46 yrs, ACS (CK to 792) Diabetes Morbid obesity Wheel chair bound Moderate LV dysfunction, LMS and RCA disease surgeons declined to operate Femoral access preferred >160Kg - poor imaging bifurcation LMS IABP
3 Where Radials fear to tread
4 Where Radials fear to tread Good coronary result Two femoral punctures sites.
5 External Guide Diameter Device 6F 7F 8F 9F Brachytherapy Novoste No Yes Yes Yes Cordis Yes Yes Yes Yes Emboli protection devices AngioGuard (Cordis) No No Yes Yes PercuSurge No No Yes Yes Angiojet Yes Yes Yes Yes Rotablation 1.5 Yes Yes Yes Yes 1.75 No Yes Yes Yes 2.15 No No Yes Yes 2.25 No No No Yes DCA 5 No Yes Yes Yes 6 No No No Yes 7 No No No Yes X-sizer No No Yes Yes
6 Femoral Haemostasis Potential advantages of closure devices: prolonged bed rest increased comfort reduced cost (LOS) pain and associated vagal reactions Improve use of physician / nurse time complications
7 Closure devices Primary Intention Clips and Sutures Collagen / thrombin / pads Angiolink Onux Perclose X-site Sutura Angioseal Vasoseal Duett Quick seal Sub Q (gel foam) BioIntervention Clo sure PAD Syvek Flo seal Biodisc Therus (Ultrasound)
8 Closure devices Primary Intention Clips and Sutures Collagen / thrombin / pads Angiolink Onux Perclose X-site Sutura Angioseal Vasoseal Duett Quick seal Sub Q (gel foam) BioIntervention Clo sure PAD Syvek Flo seal Biodisc Therus (ultrasound)
9 TechStar Perclose Redwood City, CA, USA 7F - 1 suture ProStar XL 8F and 10F 2 sutures The Closer 6F 1 suture Knot making tool 3-0 braided polyester (non-absorbable)
10 Perclose - Closer
11 Perclose - Closer
12 Perclose - Closer
13 Perclose - Closer
14 Perclose - Closer
15 Angioseal St Jude Medical, St. Paul, Minnesota, USA 6F and 8F devices Components Biodegradable anchor (intra-arterial) collagen plug (extra-arterial) 3-0 Vycril suture (with clinch knot)
16 Angioseal Modifications improved collagen weave pattern mono-fold sheath tip enhanced suture delivery and release mechanisms re-designed anchor anti-rotation sheath cap Improved indication markings
17 Angioseal
18 Angioseal
19 Vasoseal Datascope, Montvale, NJ, USA Extravascular collagen plug Delivery followed by short period of manual compression Vasoseal VHD Vasoseal ES 5F to 8F
20 Vasoseal ES
21
22 Duett Vascular Solutions Inc., Minneapolis, Minnesota, USA 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
23 Duett 3F Duett catheter Existing sheath Insert the Duett catheter into the artery via the existing introducer sheath. Inflate the balloon. Withdraw the Duett catheter and sheath as a unit until the balloon is positioned firmly against the inner arterial wall.
24 Duett Deliver the procoagulant directly to the puncture site through the sidearm of the introducer sheath. Continue procoagulant delivery until the entire tissue tract is filled.
25 Duett Tissue track also Rx Deflate balloon. Remove the Duett catheter and introducer sheath from the patient. Maintain direct pressure over the puncture site for 2-5 minutes.
26 Early trial data Complications with devices Less forgiving of poor puncture location Most require large arterial diameter (i.e. CFA) More sensitive to PVD and vessel calcification
27 Puncture site retroperitoneal haemorrhage External Iliac Optimal A-V fistula pseudoaneurysm thrombosis vessel laceration Profunda femoris Superficial femoral
28 Profunda femoris pseudoaneurysm Kumar S, Bury RW, Roberts DH, Heart 2002;88:215
29 Femoral Artery Anatomy Schnyder G Cathet and Cardiovasc Int 2001;53: patients for coronary angiography 60% male Mean age 64 yrs 30% diabetes 18% with >25% CFA stenosis
30 Puncture location Schnyder G Cathet and Cardiovasc Int 2001;53:289 % where puncture will be above bifurcation 54.5% 81.5% 94.5% 98.5%
31 Published Data Evolving PCI techniques Sheath sizes Anti-thrombotic regimens Evolving closure equipment mechanical differences modifications to deployment methods Trials small patient numbers few randomised important differences in data presented Variable length FU learning curve variably incorporated
32 Recent trials Ellis SG et al The SEAL trial AHJ 2002;143:612-9 Carey D et al. Complications of Femoral artery closure devices Cathet and Cardiovasc Int 2001;52:3-7 Cura FA et al Safety of Femoral Closure Devices after PCI in the era of GP IIb/IIIa platelet blockade Am J Cardiol 2000;86: Applegate RJ Vascular closure devices in patients treated with anticoagulation and IIb/IIIa receptor inhibitors during percutaneous revascularization JACC 2002;40:78-83
33 SEAL Randomised (ratio 3:5) Duett v manual compression FA angio in all 30/7 post discharge FU Ambulation No antithrombotics 5F 6F 1-2 hrs 7F 8F 2-4 hrs With Heparin during procedure 5F 6F 3-4 hrs 7F 4-5 hrs 8F 5-6 hrs 9F 6-7 hrs Ellis SG, AHJ 2002;143:612-9
34 SEAL Ellis AHJ 2002;143:612-9 Duett Total n=392 PCI n=266 GP inhib n=94 Manual Total n=238 PCI n=155 GP inhib n=58
35 SEAL Ellis AHJ 2002;143:612-9 Duett Manual 8F sheath or larger 48% 59% GP IIb/IIIa blockers 24% 24.5% Time to haemostasis 14 min 195 min Time to ambulation 338 min 705 min
36 SEAL Ellis AHJ 2002;143:612-9 P=NS for all With GP IIb/IIIa blocker Duett Manual % Major comps Surgery for comps Transfusion Major comps 0
37 SEAL Ellis AHJ 2002;143: % distal limb ischaemia (Duett)
38 Power calculations Assume Major complication rate 3% Interested in a change to 1.5% 85% chance of detecting change 5% level of statistical significance n= 4000 (2000 in each arm) Pseudoaneurysm rate 0.3% change to 0.15% n>>10,000 in each arm
39 Vasoseal / Angioseal / Techstar Carey D, Cathet and Cardiovasc Int 2001;52:3-7 Registry - prospective data collection 4 eras Techstar Angioseal n=1001 n=742 Vasoseal Control n=937 n=1019
40 Carey D, Cathet and Cardiovasc Int 2001;52:3-7 % % Interventional Closures Manual Vasoseal Angioseal Techstar Use of IIb/IIIa Inhibitors Manual Vasoseal Angioseal Techstar No FA angios FA angio routine
41 Vasoseal / Angioseal / Techstar Carey D, Cathet and Cardiovasc Int 2001;52:3-7 Infection % Manual Vasoseal Angioseal Techstar
42 Vasoseal / Angioseal / Techstar Carey D, Cathet and Cardiovasc Int 2001;52:3-7 % Acute Femoral Closure n=5 n=2 Manual Vasoseal Angioseal Techstar
43 Closure after PCI with GP IIb/IIIa inhibitors Cura FA Am J Cardiol 2000;86: Perclose (n=408) / Angio-seal (n=411) / Manual (n=2,099) FA angio all patients Antibiotics diabetics immunocompromised very obese prolonged procedure Registry - Closure method up to the operator GP IIb/IIIa inhibitor 59% of patients (ACT target 200 to 250) 98% abciximab
44 Closure after PCI with GP IIb/IIIa inhibitors Immediate Haemostasis Cura FA Am J Cardiol 2000;86: P< % 98% 95% 93% % No GP inhibitor GP IIb/IIIa inhibitor 20 0 P=0.87 Angio-seal P=0.71 Perclose
45 Closure after PCI with GP IIb/IIIa inhibitors Cura FA Am J Cardiol 2000;86:
46 Closure after PCI with GP IIb/IIIa inhibitors Retroperitoneal Haematoma Cura FA Am J Cardiol 2000;86: % Manual Angio-seal Perclose No GP inhibitor GP inhibitor
47 Closure after PCI with GP IIb/IIIa inhibitors All femoral complications Cura FA Am J Cardiol 2000;86: No GP IIb/IIIa inhibition Femoral complications % P=0.34 P=0.45 P=0.14 Manual Angio-seal Perclose GP IIb/IIIa inhibitor
48 Recent large clinical experience Applegate RJ JACC 2002;40: ,525 consecutive patients All PCI with abciximab (ACT 200 to 250) Intention to device close all FA angio in all no closure if puncture below bifurcation if extensive calcification if CFA < 5 mm diameter Manual (n=1,824)/ Angioseal (n=524)/ Perclose (n=2,177) Choice of device by interventionalist buddy wire in last 399 angioseals 1% epinephrine to tissue tract
49 Recent large clinical experience Applegate RJ JACC 2002;40:78-83 < >
50 Recent large clinical experience Applegate RJ JACC 2002;40:78-83 Manual Angioseal Perclose Closure success 96.5% 97.1% 93.9% Failure / Femostop 3.5% 2.9% 6.1% P<0.05
51 Recent large clinical experience Applegate RJ JACC 2002;40:78-83 Manual Angioseal Perclose % p=ns Haem > 10cm A-V fistula Pseudoan Vessel occ Bleeding Vasc repair FA vasc death
52 Recent large clinical experience Applegate RJ JACC 2002;40:78-83 All Outcomes 2.5 p=ns Manual (n=1,824) Device (n=2,553) Minor Major Both Any Complications
53 Recent large clinical experience Outcomes excluding lab failed device closure P<0.05 P<0.05 Applegate RJ JACC 2002;40: Manual (n=1,824) Device (n=2,553) Minor Major Both Any Complications
54 Summary Devices work Satisfying to use Fiddle Device specific issues
55 New complications Skin tract ooze Failed closure Device Infection Arterial obstruction
56 Lessons learned Device specific issues Biamino G, University Leiptzig Techstar/Prostar Learning curve Infection Presentation often delayed for 3 to 4 days Careful aseptic technique Re-glove etc. Antibiotics? Femoral puncture location FA angiography should be routine
57 The End
58 Re-puncture Perclose Immediate Angioseal Immediate Vasoseal Duett
59 Femoral Access Guide catheter size Distal embolus protection devices PercuSurge Guardwire: 8 F Angioguard (Cordis):8F (lumen 7F 0.081) Angiojet (Possis): 6F and 7F Rotablation DCA TEC Bifurcations with kissing balloons
60 Perclose Redwood City, CA, USA TechStar : 7F 1 suture, ProStar XL: 8F and 10 F - 2 sutures The Closer 6F : 1 suture 3-0 braided polyester (non-absorbable)
61 Vasoseal ES
62 Femoral Artery Anatomy Schnyder G Cathet and Cardiovasc Int 2001;53:289
63 Vasoseal / Angioseal / Techstar Carey D, Cathet and Cardiovasc Int 2001;52:3-7
64 Summarise some of the data Carey 2001 for prgressive development of things Cura for good failry current and gp2b3a Applgate good current practice real world Dangas prob not helpful SEAL for duett ( and randomised), chamberlain? For vasoseal, and shrake - show poor conflictin data
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