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Femoral Vascular Access: Technique, Closure Devices, and
TCT 2011 November 7-11, 2011 Femoral Vascular Access: Technique, Closure Devices, and Complications Robert J Applegate, M.D. Professor of Internal Medicine-Cardiology Disclosures • Advisory Board Abbott Vascular • Research Grants Abbott Vascular St Jude Medical Terumo Corporation • Consultant Abbott Vascular St Jude Medical 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 Vascular Access Overview Femoral (6-9 mm) Brachial (4-7 mm) Ease of access ++++ Learning curve short some ++++ ++ + no yes yes +++ ++ + Flexibility in sheath size Anticoagulation (cath) Complication rates ++ Radial (3-5 mm) + yes Femoral Artery Access Optimal accessAbove bifurcation Below inferior epigastric artery Courtesy Dr Z Turi Femoral Artery Access • Landmarks/strategies for achieving access • Inguinal crease • Bony landmarks • Floroscopy over femoral head • Doppler guided • Ultrasound guided Femoral Artery Access Can you pick out the skin crease?? Courtesy Dr Z Turi 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 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 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 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 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 Femoral Access Site Closure Manual Compression The gold standard; but competency often taken for granted A patient’s perspective An attending’s perspective Femoral Artery Closure – Manual Compression –Works Best when CFA Accessed Courtesy Dr Z Turi Limitations of Manual Compression • Delayed ambulation • Patient dissatisfaction/discomfort • Time and personnel intensive • Vascular complications in anticoagulated pts after successful hemostasis still occur 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 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 Current FDA Approved Closure Devices Vendor Abbott Vascular Product Perclose AT Perclose Proglide Perclose ProStar XL Starclose SE Access Closure Mynx Cadence Arstasis Arstasis One Cardiva Medical Boomerang Catalyst III Arteriotomy tampanode Cordis Exoseal Extravascular PGA plug Morriss Innovative FISH SIS arterial plug St Jude Medical Angio-Seal VIP Angio-Seal Evolution Mechanical seal Interventional Therapies Nobles Medical Vascular Solutions Thombin/collagen pro-coagulant Closure Method Suture Suture Suture Nitinol clip Extravascular PEG sealant Reentry closure QuickClose Super Stitch Duett Pro Suture and knot Suture and knot 2011 Buyers Guide Endovascular Today 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 Boomerang Catalyst Consider for non CFA sites when manual compression may be challenging Catalyst III Protamine coated Arstasis 1 2 3 4 5 6 O Going TCT 2009 FISH (Femoral Introducer and Sheath Hemostasis Device) SIS Small Intestinal Submucosa (porcine) Self sealing concept Limited clinical data 3 R Patioloa TCT 2009 Mynx * Bioabsorbable PEG Seal arteriotmy 1 2 Expose PEG Extra vascular closure Consider for non CFA closure Remove device Tissue tract 3 Exoseal Bioabsorbable PGA Introduce through existing sheath Identify vessel wall Unsheath vascular plug Brief manual compression Perclose Perclose ProGlide/Prostar Now VCD of choice for large sheath closure Starclose SE * a From the case control portion of the study only (analysis of other variables was from the entire patient cohort). StarClose Angio-Seal * * a From the case control portion of the study only (analysis of other variables was from the entire patient cohort). Angio-Seal Evolution Automated Compaction Anchor Set 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 Engaged Rack Precisely engineered for forward movement while user pulls back on the device. This forward movement guides the compaction tube forward. “Automated Collagen Compaction” Ease of use made it market leader Consistent compaction force 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 Anatomic Challenges in Using VCDs • Low or bifurcation stick • High stick • Significant ASCVD of CFA • Significant calcification of CFA • Prior VCD use • Severe angulation of sheath entry 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 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) Evaluation of Outcomes with 1st gen Vascular Closure Devices Meta-analyses of outcomes with VCDs (mainly 1st gen devices) Manual compression may be safer Manual compression may be safer Koreny et al JAMA 2004;4291:350 Nikolsky et al JACC 2004;44:1200 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; 53:174-181 Studies with 10,000 or More Patients: VCD vs Manual Compression Complication Rates Study Year published # patients Study type Endpoint Hematoma VCD MC P Value OR 1.34 CI 1.01-1.79 P < .05 Nikolsky 2004 36,066 Trial and Registry MetaAnalysis Tavris 2004 166,680 National Registry (NCDR) any VC 1.10% 1.70% P<0.001 Tavris 2005 13,878 National Registry (NCDR) any VC OR 0.99 CI 0.77-1.28 P=ns Arora 2007 12,937 Single Center Registry any VC 2.40% 4.90% P < 0.01 Ahmed 2007 13,563 Multicenter registry Bleeding/VC OR: 0.72 CI 0.59-0.89 P=0.02 Applegate 2008 35,016 Single Center Registry any VC 1.60% 2.10% P=0.03 Sanborn 2009 11,621 ACUITY post hoc Access site bleeding 2.50% 3.30% P=0.01 Marso 2010 1,522,935 National Registry (NCDR) Peri-procedural OR= odds ratio OR: 0.77 bleeding Dauerman et al JACC 2011; 58:1-10 CI 0.73-0.80 P < 0.05 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; 303:2156-2164 Types of Vascular Complications after Femoral Artery Access Hematoma * Occlusion A-V fistulae RPH Psuedoaneurym Infection * * Courtesy Dr Z Turi Nerve Injury Incidence of Vascular Complications after Femoral Artery Access Vascular Complication(%) Wake Forest (1998-2003) ACC-NCDR (2001) Turi (2004) Bleeding RP bleed Vascular repair Infection Death 0.6 0.3 0.2 -0.03 1.1 ---0.09 0.2-2 0.2-2.0 -<1 -- Hematoma Pseudoaneursym A-V fistulae 0.7 0.3 0.1 -0.4 0.05 1-12 1-6 <1 White (2004) <3 1-3 1-3 <0.2 -<6 1-3 <0.4 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 Manual compression vs VCD use • Patient Very thin or obese; gender; renal disease • Clinical Emergency procedure; shock; AMI 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 Iliac Artery or “High” Sticks Angiography CT Scan * Closure Device use in “High Stick”? Cause for Concern Study Risk of RPH VCD compared to manual compression OR 95% CI Farouque Ellis Tiroch 2.13 2.80 1.27 Farouque et al JACC 2005; 45(3):363-368; Ellis et al CCI 2006; 67:541-545; Tiroch et al CCI 2007; TCT 2007 0.62-7.33 1.95-4.00 0.31-5.26
