KOVAI MEDICAL CENTER AND HOSPITAL, COIMBATORE, INDIA Achieving arterial puncture site hemostasis in patients with coagulopathies – Tips and tricks. KOVAI MEDICAL CENTER AND HOSPITAL, COIMBATORE, INDIA

Introduction According to the latest data, more than 5 million diagnostic and therapeutic catheterizations are performed each year in the United States. Complications related to the access site result in more than 75,000 surgical procedures annually. Improved management of the access site itself is essential to achieve the greater goals of improved care and reduced cost, and this is more so in patients prone to excessive bleeding tendencies. We aim to make you understand techniques in prevention of puncture site complications in patients with coagulopathies

Puncture site complications MINOR Ecchymosis and bruises Bleeding from puncture site not needing transfusion or vascular surgery A small pseudoaneurysm Small hematoma MAJOR Thrombosis or loss of distal pulses Large pseudoaneurysm or arteriovenous fistula Bleeding with need for transfusion or vascular surgery. Sanborn TA, Gibbs HH, Brinker JA, Knopf WA, Kosinski EJ, Roubin GS. A multicenter randomized trial comparing a percutaneous collagen hemostasis device with conventional manual compression after diagnostic angiography and angioplasty. J Am Coll Cardiol 1993;22:1273-9

Factors predisposing to puncture site complications Procedural factors: Larger sheath size (greater than 8F) Excessive use of anticoagulants High (above inguinal ligament) and low (below common femoral artery) punctures Patient-specific factors: Bleeding diathesis History of hypertension Female sex Peripheral vascular disease Age Obesity Anticoagulation regimen

Achieving puncture site hemostasis in coagulopathies Preprocedure evaluation Intraprocedure precautions Site of entry Single wall puncture Small size sheath size whenever possible Post procedure Manual compression Mechanical compression devices Vessel closure devices

A] Patient workup/precautions prior to angiography Bleeding and clotting times Platelet levels > 75000 Prothrombin time < 15 / INR < 1.5. Fresh frozen plasma/Deficient factor transfused Vitamin K Withold heparin on table Monitor ACT and PT post procedure

B] Intraprocedure - Technique of puncture Localization of puncture site -- Under flouroscopic guidance Puncture site should be over the inferomedial quadrant of femoral head, to allow compression after the procedure -- Under ultrasound guidance Single wall - Single attempt by Single experienced personnel

Technique of single wall puncture

B] Intraprocedure - Technique of puncture Single wall vs Double wall Puncture Double wall puncture technique presumes that patient’s hemostatic mechanism will prevent excessive bleeding from the posterior wall. Hence in all patients with coagulopathies Single wall puncture technique is always preferred.

C] Approach to puncture site hemostasis PASSIVE / DELAYED CLOSURE 1.Manual compression 2. Passive closure : a)External patches with prothrombotic coatings/wire-stimulated track thrombosis b)Assisted compression with mechanical lamps, sandbags etc. ACTIVE / IMMEDIATE CLOSURE 1.Suture mediated closure devices 2.Collagen plug mediated devices 3. Clip closure system

Manual compression Technique Superficial femoral artery is compressed distal to the puncture site, the sheath is removed and 2 ml of blood is allowed to back bleed such that small thrombi are extruded. Three finger graded compression without obliterating distal vessels with steady moderated pressure for more than15 mins. Pressure reduced over next 5 mins. Pressure should never be abruptly terminated, else the platelet plug may get dislodged. Puncture site should be seen at all times. Distal pulses felt at the end of compression.

Indications for manual compression Puncture site is below the femoral bifurcation Common femoral artery is less then 5 mm in diameter Extensive plaque or calcification is present in the common femoral artery Extensive scar tissue is present at the access site Patient is obese Patient is on an anticoagulation regimen

Assisted compression Belt of the device is placed under the patient. After palpating the femoral artery the dome is placed over it, a few centimeters superior and medial to the sheath where the impulse is felt.

Assisted compression Remove the sutures at this point. Slightly withdraw the hub of the sheath (1-3 cm) out of the way of the dome. To confirm that the FemoStop plus device is working and positioned properly, the dome is gently inflated while continually assessing the pedal pulse (manually or via Doppler signal) which gets notably diminished.

Assisted compression Compression must be maintained at 90º to the site at all times. On inflating the dome ensure that it pushes primarily downward and straight. If positioning is not optimal, deflate, re-adjust and repeat until pressure is directly affecting the pedal pulse.

Assisted compression Dome is inflated to 60mmHg, following which the sheath is removed. Inflate the dome rapidly to 20mmHg above patient’s systolic pressure. Maintain this pressure for 3 minutes. Gradually deflate the dome over next 5 minutes, until the bulb pressure reads 100mmHg.

Assisted compression Even if the patient moves, the belt ensures correct position of the dome. Pressure is gradually dimished over next 1-1 ½ hours, after which the device may safely be removed.

Device kept in situ for a period of 6 hours Manual compression applied till active bleeding stops and then the Femoral artery compression device applied. The device is positioned and tightened until adequate pressure is achieved. Distal pulses should be felt A cotton gauze placed over the puncture site Device kept in situ for a period of 6 hours Femoral artery compression device

Disadvantages of manual compression Uncomfortable for the patient Immobilization of leg for 6 hrs Is fatiguing and time-consuming for staff Necessitates several hours of costly in-hospital observation In addition, it may be ineffective in achieving hemostasis, especially in the setting of systemic anticoagulation or following the use of large-bore devices Doesn’t provide immediate hemostasis Post compression bandaging is not fail proof.

Indications for use of closure device Femoral puncture entry point in the common femoral artery, 1 or 2 cm above the femoral bifurcation Patient has undergone many procedures and has extensive fibrosis around the artery Artery is very calcified (collagen plug) Vessel is free from excessive calcium and severe fibrosis (suture-mediated closure)

Vascular closure devices There are at least eight hemostatic vascular closure devices that are currently approved by the FDA for access site closure after femoral arterial catheterization. Since their introduction over a decade ago, they have undergone multiple iterations while maintaining their core concept . Angioseal

Angioseal – Vascular closure device Marketed by St. Jude Medical (St. Paul, MN). It has a Collagen plug which is held in place over the outside wall of the vessel by providing tension by an anchor plate positioned within the vessel, thereby achieving hemostasis. The system is delivered placing the AngioSeal sheath within the vessel over a guidewire.

Parts of angioseal device

Steps of insertion: Puncture site angiography to know the site of puncture Arteriotomy locator inserted in angioseal insertion sheath with correct alignment of reference indicator. Maintain the vascular access by passing a guidewire through sheath in situ. The sheath is then removed . A small skin incision may be required to accommodate a large size angioseal.

Steps of insertion: The Angio-Seal arteriotomy locator / insertion sheath assembly is threaded over the guidewire With the reference indicator on the insertion sheath facing up. The device is inserted when the sheath is about 1.5 cm into the artery, blood will begin to flow from the drip hole in the locator

Steps of insertion: Remove the arteriotomy locator and guidewire from the insertion sheath by flexing the arteriotomy locator upward at the sheath hub. Keeping the insertion sheath in place, carefully advance the Angio-Seal™ Device in small increments until completely inserted into the insertion sheath. The sheath cap and the device sleeve will snap together when properly fitted.

Steps of insertion: Insert the angioseal device into the sheath until you hear a “CLICK” Gently pull back on the locking cap until you hear another “CLICK” The anchor is now locked in place and device is ready to be deployed

Steps of insertion: Gently pull back on the angioseal device until the suture has stopped spooling. Maintain upward tension on the device and gently advance the compaction tube until resistance is felt. Cut the suture and remove the device.

Issues with Angioseal Hemostasis rate of 95% to 98%. Although the anchorplug is made of reabsorbable material, it requires nearly 30 days to be fully absorbed. Few complications have resulted due to this property of the anchorplug, which include: - Intravascular downward displacement of the in-dwelling anchor plug resulting in distal vessel embolization. This would necessitate surgical removal of the plug. - Another significant downside of the device is the recommendation that the puncture site not be re-punctured for at least 90 days.

Issues with Angioseal OTHER COMPLICATIONS OF ANGIOSEAL IMMEDIATE: -Device non-deployment EARLY: - Allergic reaction - Foreign body reaction - Infection DELAYED: - AV fistula - Pseudoaneurysm

Precautions about using Angioseal Should not be used if the temperature indicator dot on package has changed from light gray to dark gray or black. Should not be used if the package is damaged or any portion of the package has been previously opened. Should not be used when puncture site is at the level of superficial femoral artery Should not be used when the puncture site is proximal to the inguinal ligament as this may result in a retroperitoneal hematoma.

Angioseal over Manual compression ADVANTAGES OF ANGIOSEAL - Early mobilization of patient - Decreased patient discomfort - Decreased in-hospital observation - Useful in coagulopathies DISADVANTAGES - Increased cost - May fail to achieve hemostasis

Detecting complications at puncture site- What to look for ? Ask for history of Swelling at puncture site, excessive pain in whole limb, backache (in case of retroperitoneal hematoma) Look for ecchymosis, pulsatile swelling or signs of inflammation at puncture site. Check distal pulses. In case of suspicion - USG with Colour Doppler - Contrast enhanced CT Angiography

Detecting complications at puncture site- What to look for ? Groin hematoma seen 24 hours after removal of vascular sheath

Uncommon puncture sites: Radial puncture: Hemostasis achieved by manual compression bands Brachial puncture: Manual compression.

Radial artery compression device Compression bandage applied Sheath is withdrawn from the radial artery Compression device is applied for a period of 2 hours

Summary Modified puncture techniques and use of puncture closure device are keys to successful completion of endovascular procedures in patients with coagulopathies.

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