Vascular Closure Device: A to Z Owayed M Al Shammeri, MD, FSCAI Interventional Cardiologist AlRayyan Hospital, HMG Riyadh
Femoral artery Anatomy
Disparities still exist
Vascular Closure Devices Suture base Perclose A-T, Abbott Proglide, Abbott Prostar, Abbott Non-suture base Angeoseal, St Jude Starclose, Abbott Mynx, Cordis Exoseal, Cordis
Perclose A-T, Abbott 5-8 Fr access Braided polyster Automated knot tying Reduced procedure time
Proglide, Abbott 5-8 Fr Access Polypropylene monofilament suture Retains Knotted tensile strength Automated knot tying with pretied, heat set knot No vessel re-access restrictions
Prostar XL, Abbott Hydrophilic coat Four Nitinol needles deployed from below the arteriotomy Two braided polyster sutures 8.5-10 Fr
Manual tying of clinch knot
Manual tying of clinch knot Common Mistakes No Enough dissection of the skin Knot trapping before the arteriotome Too short tying arm May not see to assess the knot Not too wet sutures Not able to slide done to the arteriotome to seal it Removing the ipsilateral wire Losing the access for bail out addition closure device No contralateral access for cross over access Crucial for larger size sheath
Creating mechanical seal by sandwiching the arteriotomy between a bioasrbable anchor and collagen sponge which dissolve withing 90 days Angioseal, St Jude
StarClose, Abbott Thru-the-sheath Automated closure Nitinol clip Extravascular Mecahnical closure Circumferential
Mynx, Cordis 5-7 Fr access Thru-the sheath Novel, water soluble polyethylene glycol (PEG) sealant that seals both puncture site and tissue track Dissolves in 30 days Extravascular
The Mynx Sealant Hydrophilic, bio-inert? Thrombotic Commonly used in: Tylenol gel cap Visine eye drop Duraseal cranial sealing
Exoseal, Cordis Through-the-sheath Easy to use Extra-vascular Bioabsorbable polyglycolic acid plug No Anchor left
Nikolsky et al. JACC 2004
Nikolsky et al. JACC 2004
Recent Meta-analysis 34 RCT 5,659 pt had manual compression vs 8,742 pts had VCD Similar Overall complication Howere: Shorter hemostasis time, ambulation and discharge 13% reduction in cost (Hospital stay) Cox T yet al. Surg technol Int 2015 Nov;27:32
Examples of indication Need for rapid recovery time Back pain High INR Large French size (>7) High Stick access When anticipated manual compression not effective TAVI EVAR
Requirements for VCD Suture-base Cumbersome technique should be mastered Avoid in calcification Wet Wet Wet Sutures Non-suture base Vessel diameter > 5mm Avoid in calcifications Away from Profunda bifurcations
Complication 1 70 year-old patient underwent PCI to LAD using 6 Fr sheath. The ACT at the end of the procedure was 300 seconds Upon applying the Perclose sutures, the white suture was pulled making the knot away from the arteriotomy site Solution: Master the technique and maintain wire all the time. Get another device or Manual compression
Complication 2 86 year old man who had successful TAVI. The right common femoral artery was heavily calcified. Despite of applying both knots of ProStar securely, there was still significant bleeding. Solution: Cross over guide wire was secured for anticipated complication to be treated promptly. Viabahn stent graft was used.
Watch not to jail the Profunda Ipsilateral 45 degree will show the CFA bifurcation Easy Procedure by Vascular Surgery
Complication 3 Two patients in a raw had diagnostic cardiac cath and StarClose were used. Each was one had severe pain upon deployment of the clip Retroperitoneal hemorrhage, treated conservatively Acute closure of the right common femoral artery, successful balloon angioplasty resulted in resolution of symptoms Extra-Training is mandatory for some VCD
Retroperitoneal Hemorrhage Rare but potentially catastrophic complication Incidence is 0.5% Mortality is 10% Most likely mechanism is high stick High index of suspicion should be always considered in case of HYPOTENSION Severe flank pain, abdominal pain, back pain and even lower extremity pain from femoral nerve compression Falling hematocrit Vasovagal reaction
Retroperitoneal Hemorrhage Diagnosis: Non-contrast CT Treatment: Conservative Close hemodynamic monitoring Bed rest Volume expansion Catheter bases therapy Balloon tamponade Covered stent Coiling
Complication 4 45 year-old lady morbidly obese had cardiac cath for chest pain and showed normal coronary angiogram. Mynx was used. The patient developed acute limb ischemia Solution: The patient was taken immediately to the cath lab and acute occlusion of the below knee popliteal artery was found secondary to embolization of PEG. Failure of embolectomy and balloon angioplasty was done resulted in good flow to crurial vessels
Extreme caution needs to be employed when using the Mynx device especially if the artery is significantly calcified and the size is borderline
Complication 5 60 year old gentleman morbidly obese. He had complex PCI to distal left main. Angioseal was attempted but unable to pull the sheath of the delivery system of angioseal Solution: Maximum tack was performed under fluoro to ensure that the bioabsorbable anchor against the arteriotomy site. No push of the collagen was done and the case transformed to manual compression. Remember at what digit there was spray of blood
Use common sense
Complication 6 CFA Occlusion secondary to suture base closure device Inadvertent posterior wall puncture
Acute CFA occlusion is Acute Limb Ischemia Acute Limb Ischemia is a life threatening condition. Acute Limb Ischemia has high mortality rate (50%) if not corrected due to endotoxic shock causing end-organ damage (may exceed the mortality rate of cardiogenic shock)
Acute CFA occlusion after sutured base VCD Treated by Cutting balloon Angioplasty Regular balloon may be tried Vascular surgery
Conclusion Vascular closure devices are divided into suture base and nonsuture base. Each require different skills, therefore Master one of them. Correct technique in a correct anatomy are mandatory for safe use in any device Know the potential complication and there bailout strategies
Manual Compression remains the gold standard THANK YOU