Pourquoi j utilise le STARCLOSE. P.Commeau Cardiologie et Radiologie Vasculaire Interventionnelles Polyclinique Les Fleurs Ollioules, Fr

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1 Pourquoi j utilise le STARCLOSE P.Commeau Cardiologie et Radiologie Vasculaire Interventionnelles Polyclinique Les Fleurs Ollioules, Fr

2 Consultant Abbott Medtronic Boston Scientific Braun Medical Biotronik Cordis

3 Evaluation of Outcomes with 1 st Generation Vascular Closure Devices Meta-analyses of outcomes with intra-vascular VCDs Manual compression may be safer Nikolsky et al JACC 2004;44:1200

4 Evaluation of Outcomes with Vascular Closure Devices 2001 ACC NCDR 4 th quarter 2003 VCDs safer Tavris et al JCI 2004;16:459 VCDs same as manual compression Tavris et al JCI 2005;17:644

5 Multivariate analysis of vascular complications in PCI at WFU 12,500 PCI; 80% Angioseal, 20% Perclose 35% reduction in vascular complications with VCD Applegate et al JACC CI 2008; 1:317-26

6 Vascular Complications VCDs offer a 50% reduction of vascular complications rate as compared with manual compression in appropriately selected patients undergoing diagnostic and therapeutic cardiac catheterization 5.00% 4.50% 4.00% 3.50% 3.00% 2.50% 2.00% 1.50% 1.00% 0.50% 0.00% 1.11% P = % P < % 0.52% MC VCD MC VCD Diagnostic 12,937 consecutive patients were studied for in hospital outcomes through a prospective registry from Jan 2002 to Dec 2005 (Brigham experience) PCI Arora et al. AHJ 2007; 53(4):

7 VCD vs MC Complications Wake Forrest Experience Applegate R, TCT 2007

8 Background Collagen plug-based devices are easy to use but no immediate reaccessibility, several contraindications, delayed complications (SFA occlusion ) Suture-based devices need proper training, aseptic technique Studies show that these 2 techniques in terms of success are worse or,at the best, identical than manual compression Although clearly effective, there is a small but clinically significant increase in the incidence of femoral endarteritis, infection, and vascular occlusion with the use of suture and collagen plug devices. Hollis HW, RehringT. Femoral endarteritis associated with percutaneous suture closure: new technology, challenging complications.jvascsurg2003;38: Need of a new vascular closure device

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10 Background Collagen plug-based devices are easy to use but no immediate reaccessibility, several contraindications, delayed complications (SFA occlusion ) Suture-based devices need proper training, aseptic technique Studies show that these 2 techniques in terms of success are worse or,at the best, identical than manual compression Although clearly effective, there is a small but clinically significant increase in the incidence of femoral endarteritis, infection, and vascular occlusion with the use of suture and collagen plug devices. Hollis HW, RehringT. Femoral endarteritis associated with percutaneous suture closure: new technology, challenging complications.jvascsurg2003;38: Need of a new vascular closure device

11 Clips et Agrafes Surgical stapling was first introduced in 1908 when Fischer and Hulti introduced their wound sealing device. Robicsek F. The birth of the surgical stapler. Surg Gynecol Obstet 1980;150; Clips and staples have a long history of providing safe and effective vascular repair and effective wound healing. ZeebregtsCJ, et al. Five years world experience with nonpenetrating clips for vascular anastomoses. Am J Surg2004;187:

12 CLIP Study Clip CLosure In Percutaneous Procedures: Diagnostic Arm Prospective, Multicenter, Randomized Controlled Study To Evaluate The Safety and Efficacy Of The StarClose Vessel Closure System Versus Standard Compression Clip Study Diagnostic Arm StarClose 136 pts Standard Compression 72 pts P value Mean Time to Hemostasis (mn) <0.001 Median Time to Hemostasis (mn) <0.001 Mean Time to Ambulation (min) <0.001 Major Complications (% pt based) Minor Complications (% pt based) Mean Time to Dischargeability (hours) < Subjects (inclusive of 113 lead-ins) - 17 US Sites, Diagnostic and Interventional Patients CLIP subjects were not challenged with early ambulation; all was institution standard of care Diagnostic patients who were randomized to StarClose device were asked to ambulate 2 hours after the procedure was complete Hermiller et al., JIC 2005;17:

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14 CLIP Study Clip CLosure In Percutaneous Procedures: Interventional Arm Prospective, Multicenter, Randomized Controlled Study To Evaluate The Safety and Efficacy Of The StarClose Vessel Closure System Versus Standard Compression Clip Study Interventional Arm StarClose 184 pts Standard Compression 91 pts P value Mean Time to Hemostasis (mn) <0.001 Median Time to Hemostasis (mn) <0.001 Mean Time to Ambulation (min) <0.137 Major Complications (% pt based) 1.1% 1.1% Minor Complications (% pt based) 4.3% 9.9% Procedural Success 98.9% 98.7% Subjects (inclusive of 113 lead-ins) - 17 US Sites, Diagnostic and Interventional Patients CLIP subjects were not challenged with early ambulation; all was institution standard of care Hermiller et al., JIC 2005;17:

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16 CLIP Study Clip CLosure In Percutaneous Procedures: Ultrasound Substudy Follow Up femoral Ultrasound at 30 days substudy of PCI patients Clip Study Ultrasound substudy-pci pts StarClose 71 pts Standard Compression 25 pts P value Common Femoral Artery Patency 100% 100% NA CFA Velocity (cm/sec) 116±33 111± Proximal SFA Patency 69/69 23/ Proximal SFA Velocity 96±22 109± Hematoma 0% 0% NA Pseudoaneurysm or AV Fistula 0% 0% NA 2 patients without F/U ultrasound velocity No subjects with soft tissue reaction or peri-arterial inflammation Hermiller et al., JIC 2005;17:

17 RISE Study A clinical evaluation of the StarClose VCS o Post-market study, diagnostic population o Prospective, multi-center, single-arm o Evaluation of subjects who are ambulated 20 minutes post cardiac or peripheral catheterization procedure 171 Subjects 11 US Sites First patient enrolled April 2006 Enrollment period = 7 months Clinical (Access Site) Assessment Baseline Post-procedure 30 Day Duplex Ultrasound (Sub-study of 34 subjects across 4 sites) Clinical trial designed and executed with the rigor of an IDE study

18 RISE Study Final Analysis Set Results Final Analysis Set population included all subjects who met inclusion/exclusion criteria RISE Safety & Efficacy FAS Population Endpoints N=171 Mean Time to Ambulation (min) 21.9 Mean Time to Hemostasis (min)* 4.1 Major Complications (%) 0 Minor Complications (%) 2.3% Mean Time to Dischargeability (min) 89.7 *RISE subjects received a protocol-required 3 minute groin hold prior to hemostasis check

19 RISE Study Per Protocol Results Per Protocol population included all subjects who successfully received the StarClose device RISE Safety & Efficacy Per protocol Population Endpoints N=156 Mean Time to Ambulation (min) 8.3 Mean Time to Hemostasis (min)* 3.5 Major Complications (%) 0 Minor Complications (%) 1.9% Mean Time to Dischargeability (min) 73 *RISE subjects received a protocol-required 3 minute groin hold prior to hemostasis check

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25 Personal Experience 3 seniors doing all interventional procedures cardiac & peripheral : 2100 procedures per year 1 femoralist practitionner & 2 radialist practitionners 1 exclusively Perclose 1 exclusively Angioseal 1 exclusively Starclose ( all the peripheral activity & part of PCI)

26 3.30% StarClose 3.20% 2.85%

27 StarClose Failure & Complications

28 StarClose :Complications

29 StarClose :Complications 16 patients = 0.8 % HEMATOMA <5 CM HEMATOMA > 5CM FALSE ANEURYSM 5 ARTERIAL RUPTURE FEMORAL OCCLUSION

30 From these studies, we can say that StarClose Allows a quick and safe hemostasis Allows a faster deambulation and dischargeability than MC Without local or general complications neither vessel injury Is as well simple to deliver as Angioseal But what about Starclose in some particular issues? Antegrade approach, frequently used in peripheral angioplasty ( SFA, BTK..) Larger sheath size (7F, 8F ) Re-puncture in the same site Brachial approach???

31 LARGER SHEATH SIZE

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35 StarClose & larger sheath size Feasible and safe but. Slight decrease of device success rate Slight increase of major and minor complications rate So use carefully

36 RE-PUNCTURE

37 We can redo a safe femoral approach Even if the interventionalist is a «Robin Hood»

38 Fowler S, Nguyen A, Kern M. Cathet Cardiovasc Interv 2007:70;62-64

39 BRACHIAL APPROACH

40 Only one published study Puggioni A, Boesmans E, Deloose K, Peeters P, Bosiers M Vascular ;16: patients Complications rate = 6.8 % (very large hematoma & brachial occlusion) Personal experience 10 patients 3 failure which 2 complications (very large hematoma & brachial occlusion requiring surgical repair in the 2 cases) Feasible but take care with this approach

41 Conclusion Advantages : Lack of infection (0% in published studies & in my personal series) Quick & easy to learn & use Limited amount of inert foreign materials Effective for wide range of patients Disadvantages : Barrel size Oozing Potential entrapment

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43 Conclusion One of my 2 preferred closure device but Learning curve Tips and Tricks in order to Getting the clip to the artery Presenting the clip to the vessel

44 STARCLOSE: UNE TECHNIQUE DE POSE DIFFÉRENTE? Voie Rétrograde, Voie Antérograde

45 Angiographic femoral assessment before antegrade approach Figure 1 B Deep iliac circumflex artery Common femoral artery Puncture site Femoral bifurcation Inferior epigastric artery Profunda femoral artery Superficial femoral artery

46 FH Centerline Cumulative Target Zone BIF Cette zone cible est en général l endroit du pouls maximal

47 Understanding groin anatomy Correct entry Femoral artery Inguinal ligament Fascia of Camper Fascia of Scarpa Obliquus externus abdominis Obliquus internus abdominis Transversus abdominis Deep inferior epigastric artery External iliac artery

48 Avoid puncture the posterior wall Puncture needle Femoral artery Guide wire Avoid femoral posterior wall External iliac artery

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51 221 consecutive patients treated with the StarClose device in a 12-month period in UK & France Overall technical success 94.6% Failure Device failure Obesity Groin scarring Unexplained Failure necessitating surgical closure 2 Serious vascular complication 1.8% (4)

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55 StarClose & antegrade approach Feasible and safe if we respect an accurate selection of the patients (exclusion of obese pts, scarred skin, involved CFA) a proper puncture ( open angle without long subcutaneous tract, non posterior wall puncture, adequate tissue spread for a free delivery tube movement ) a learning curve before the first cases Low complications rate