Femoral Vascular Access: Technique, Closure Devices, and Complications

Transcription

1 TCT 2011 November 7-11, 2011 Femoral Vascular Access: Technique, Closure Devices, and Complications Robert J Applegate, M.D. Professor of Internal Medicine-Cardiology

2 Disclosures Advisory Board Research Grants Abbott Vascular Abbott Vascular St Jude Medical Consultant Terumo Corporation Abbott Vascular St Jude Medical

3 Choosing the Vascular Access Site Determine type of procedure/sheath size needed Coronary Renal, ilio-femoral Infra-inguinal Support devices; percutaneous AV Consider access sites-any limitations/obstructions Femoral Brachial Radial Co-morbid illnesses/diseases CKD; PVD Bleeding risk

4 Vascular Access Overview Femoral Brachial Radial (6-9 mm) (4-7 mm) (3-5 mm) Ease of access Learning curve short some yes Flexibility in sheath size Anticoagulation (cath) no yes yes Complication rates

5 Femoral Artery Access Optimal access- Above bifurcation Below inferior epigastric artery Courtesy Dr Z Turi

6 Femoral Artery Access Landmarks/strategies for achieving access Inguinal crease Bony landmarks Floroscopy over femoral head Doppler guided Ultrasound guided

7 Femoral Artery Access Can you pick out the skin crease?? Courtesy Dr Z Turi

8 Femoral Artery Access Double fluoroscopy technique: Identify skin entry site over femoral head with hemostats Re-assess needle entry site just before entering artery Best chance to hit target zone

9 Ultrasound Guided Femoral Artery Access Better resolution, and depth than possible previously Site-Rite5, Bard Access, Inc. 18g needle guide #9001C0212 Courtesy Dr A Seto

10 Ultrasound Guided Femoral Artery Access Better resolution, and depth than possible previously Site-Rite5, Bard Access, Inc. 18g needle guide #9001C0212 Courtesy Dr A Seto

11 Femoral Artery Access Sticking until you hit the artery is not a sound or safe strategy! Good access will allow good closure Fellows in July The patient is NOT a pin cushion!! Courtesy Drs Z Turi, And J Hermiller

12 Femoral Artery Access Front wall stick desirable-micropuncture desirable Pulsatile flow before advancing wire Wire exits needle without resistance-don t push Gain familiarity with exchange catheters Gain familiarity with hydrophilic wires Don t be afraid to ask for help

13 Femoral Access Site Closure Manual Compression The gold standard; but competency often taken for granted A patient s perspective An attending s perspective

14 Femoral Artery Closure Manual Compression Works Best when CFA Accessed Courtesy Dr Z Turi

15 Limitations of Manual Compression Delayed ambulation Patient dissatisfaction/discomfort Time and personnel intensive Vascular complications in anticoagulated pts after successful hemostasis still occur

16 Vascular Closure Devices VCDs clinically introduced 1994-Vasoseal, and Perclose; Angioseal introduced in 1996 Addressed need for more aggressive anticoagulation and larger bore sheaths for 1st gen stents and atherectomy Early devices failed 10-20% of time Device modifications (x 8) have stream lined and simplified use, and substantially reduced failures

17 Anatomic Requirements per IFU Closure Devices Common femoral artery (CFA) access location Minimal lumen diameter CFA 4-6 mm (device specific) Absence of severe ASCVD Absence of severe calcification Need femoral angiogram before deployment! 2011 Buyers Guide Endovascular Today

18 Current FDA Approved Closure Devices Vendor Product Closure Method Abbott Vascular Perclose AT Suture Perclose Proglide Suture Perclose ProStar XL Suture Starclose SE Nitinol clip Access Closure Mynx Cadence Extravascular PEG sealant Arstasis Arstasis One Reentry closure Cardiva Medical Boomerang Catalyst III Arteriotomy tampanode Cordis Exoseal Extravascular PGA plug Morriss Innovative FISH SIS arterial plug St Jude Medical Angio-Seal VIP Mechanical seal Angio-Seal Evolution Interventional Therapies QuickClose Suture and knot Nobles Medical Super Stitch Suture and knot Vascular Solutions Duett Pro Thombin/collagen pro-coagulant 2011 Buyers Guide Endovascular Today

19 Mechanism of Closure Closure Devices Active approximation-angio-seal; Perclose; QuickClose; Starclose Passive closure (extravascular)-duett; Exoseal; Mynx; VasoSeal Facilitated manual compression-arstasis; Catalyst Novel- FISH Patch-D-Stat; Neptune; Syvek; etc 2011 Buyers Guide Endovascular Today

20 Boomerang Catalyst Consider for non CFA sites when manual compression may be challenging Catalyst III Protamine coated

21 Arstasis O Going TCT 2009

22 FISH (Femoral Introducer and Sheath Hemostasis Device) SIS Small Intestinal Submucosa (porcine) Self sealing concept Limited clinical data 3 R Patioloa TCT 2009

23 Mynx * Bioabsorbable PEG

24 Seal arteriotmy 1 2 Extra vascular closure Consider for non CFA closure Expose PEG Remove device 3 Tissue tract

25 Exoseal Bioabsorbable PGA Introduce through existing sheath Identify vessel wall Unsheath vascular plug Brief manual compression

26 Perclose

27 Perclose ProGlide/Prostar Now VCD of choice for large sheath closure

28 Starclose SE * a From the case control portion of the study only (analysis of other variables was from the entire patient cohort).

29 StarClose

30 Angio-Seal * * a From the case control portion of the study only (analysis of other variables was from the entire patient cohort).

31 Angio-Seal Evolution Anchor Set Ease of use made it market leader Gear Mechanism Designed with precision engineering to rotate as the device is pulled back by the user. Accurately manages the compressive sealing force. Standardized Deployment Rack Precisely engineered for forward movement while user pulls back on the device. This forward movement guides the compaction tube forward. Automated Collagen Compaction Automated Compaction Rack Engaged Consistent compaction force

32 Optimize Use of VCDs Take the time to learn how to use closure devices Commit to a device and gain expertise with it Follow the guidelines for use and perform femoral angios prior to all deployments Monitor your outcomes VCDs may fail; become occlusive; or infected Be vigilant and recognize these potential complications

33 Anatomic Challenges in Using Low or bifurcation stick High stick VCDs Significant ASCVD of CFA Significant calcification of CFA Prior VCD use Severe angulation of sheath entry

34 Factors that Influence Outcome of VCD Use Patient characteristics Anticoagulation and anti-platelet therapy Procedure type Access site anatomy Device features and performance Operator and institutional experience

35 Evaluation of Outcomes with Vascular Closure Devices Not one large randomized clinical trial of closure device vs manual compression!! No compelling evidence that 1st generation VCDs lower rates of vascular complications No convincing evidence that one VCD is better than another; although data support notion that Vasoseal was harmful (compared to manual)

36 Evaluation of Outcomes with 1 st gen Vascular Closure Devices Meta-analyses of outcomes with VCDs (mainly 1 st gen devices) Manual compression may be safer Koreny et al JAMA 2004;4291:350 Manual compression may be safer Nikolsky et al JACC 2004;44:1200

37 Vascular Closure Devices There is a substantial learning curve with VCDs! Greater experience, multiple modifications of VCDs benefitting efficacy and safety! Balzer et al CCI 2001; 53:

38 Studies with 10,000 or More Patients: VCD vs Manual Compression Study Complication Rates Year published # patients Study type Endpoint VCD MC P Value Nikolsky ,066 Trial and Registry Meta- Analysis Hematoma OR 1.34 CI P <.05 Tavris ,680 National Registry (NCDR) any VC 1.10% 1.70% P<0.001 Tavris ,878 National Registry (NCDR) any VC OR 0.99 CI P=ns Arora ,937 Single Center Registry any VC 2.40% 4.90% P < 0.01 Ahmed ,563 Multicenter registry Bleeding/VC OR: 0.72 CI P=0.02 Applegate ,016 Single Center Registry any VC 1.60% 2.10% P=0.03 Sanborn ,621 ACUITY post hoc Access site bleeding 2.50% 3.30% P=0.01 Marso ,522,935 National Registry (NCDR) Peri-procedural OR: 0.77 CI P < 0.05 OR= odds ratio bleeding Dauerman et al JACC 2011; 58:1-10

39 Strategy of VCD and Bivalirudin vs Compression VCD-4307 no VCD=7,314 ACC NCDR 300,000 high risk PCI pts 62% Marso et al JAMA 2010; 303:

40 Types of Vascular Complications after Femoral Artery Access Hematoma * A-V fistulae Psuedoaneurym Occlusion RPH Infection * Nerve Injury * Courtesy Dr Z Turi

41 Incidence of Vascular Complications after Femoral Artery Access Vascular Wake Forest ACC-NCDR Turi White Complication(%) ( ) (2001) (2004) (2004) Bleeding <3 RP bleed Vascular repair Infection <1 <0.2 Death Hematoma <6 Pseudoaneursym A-V fistulae <1 <0.4

42 Why Do (femoral) Vascular Complications Persist? Anatomic Stick location; femoral vs radial; vessel size; PVD Procedural Poor puncture technique ; PCI; multiple procedures; anticoagulation; GPI Closure Patient Clinical Manual compression vs VCD use Very thin or obese; gender; renal disease Emergency procedure; shock; AMI

43 VCD Specific Complications Device failure in anti-coagulated patient to Unable remove device from artery/groin Embolization of device into artery Foreign body reaction to device Infection Nerve entrapment

44 Iliac Artery or High Sticks Angiography CT Scan *

45 Closure Device use in High Stick? Cause for Concern Risk of RPH VCD compared to manual compression Study OR 95% CI Farouque Ellis Tiroch Farouque et al JACC 2005; 45(3): ; Ellis et al CCI 2006; 67: ; Tiroch et al CCI 2007; TCT 2007