CHHS16/174

Canberra Hospital and Health ServicesClinical ProcedureRadial and Femoral Arterial Sheaths removal following Cardiac Catheterisation – Management and Care of Adult Patients Contents

Contents....................................................................................................................................1

Purpose.....................................................................................................................................2

Alerts.........................................................................................................................................2

Scope........................................................................................................................................ 2

Section 1 – Trans-Radial Band Deflation to Removal................................................................3

Section 2 – Digital Pressure Application after Femoral Sheath Removal..................................4

Section 3 – Femoral Sheath Removal – FEMOSTOP application...............................................5

Section 4 – Femoral Sheath Removal- Bedside Clamp Application...........................................7

Section 5 – Vascular Closure Devices........................................................................................8

Implementation...................................................................................................................... 10

Related Policies, Procedures, Guidelines and Legislation.......................................................10

References.............................................................................................................................. 11

Search Terms.......................................................................................................................... 12

Attachments............................................................................................................................12

Attachment 1: Vascular Access Site Complications and Management................................13

Attachment 2: Predictors of Vascular Access Site Bleeding and Complications..................17

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Purpose

The purpose of this procedure is to outline the process of safe removal of Trans Radial and Femoral Sheaths from patients following Cardiac Catheterisation at the Canberra Hospital Health Services (CHHS). This includes minimising patient discomfort and complications related to post sheath removal.

Cardiac Catheterisation can be performed via a Trans Radial or Femoral approach. Both methods can cause complications following sheath removal. Please see Vascular Access Site Complications and Management - Attachment 1 and Predictors of Vascular Access Site Bleeding and Complications - Attachment 2.

Trans Radial Sheaths: The radial arterial sheath is routinely removed immediately following the procedure

whilst the patient is still within the operating procedure room. The sheath is removed by the Proceduralist or the medical/nursing staff who are adequately trained and competent to undertake this procedure.

Femoral Sheath: The Femoral arterial sheath is routinely removed immediately after the patient is

transferred to the recovery area, be it in the Cardiac Catheter Laboratory (CCL), the Day ward (CLD) or in the Coronary Care Unit (CCU). The sheath is removed by the Proceduralist or the medical/nursing staff who are trained and competent to undertake this procedure.

Scope

Alerts

If both arterial and venous sheaths are being used then ensure that the arterial sheath is removed first then the venous sheath. This avoids the formation of an AV fistula. For example in the case of Coronary Angiogram and Right heart study.

Ensure adherence to the CHHS Patient Identification and Procedure Matching Procedure and the CHHS Clinical Handover policy at all times.

Adhere to documented medical orders for deflation of and removal of Sheaths. Ensure that the 5 Moments of Hand Hygiene and aseptic technique are adhered to.

Scope

This clinical procedure relates to the management of patients in the Cardiac Catheter Laboratory (CCL) at the Canberra Hospital who have had a cardiac catheterisation via a Trans Radial or Femoral approach.

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This document applies to the following CHHS staff working within their scope of practice: Cardiology Proceduralist, Cardiologists, Cardiology Registrars (Advanced Trainee

Practitioner and Basic Trainee Practitioner) Registered Nurses who have been deemed competent in removing Trans Radial or

Femoral Sheaths and working within their scope of practice in CCL and CCU Junior medical and new nursing staff to CCL who under who are under the direct

supervision of a practitioner who is competent in the procedure.

Section 1 – Trans-Radial Band Deflation to Removal

1.1 Equipment Hemodynamic monitoring ( attend baseline vital sign and MEWS score) Trans-Radial (TR) Band Syringe Sterile Gauze Clean Gloves Antiseptic/Alcohol Swabs Easifix Cohesive Crepe Bandage Tape Documentation Materials including the CCU observation chart with MEWS

1.2 Procedure: Application of TR Band Clean the radial site with an antiseptic solution and check for swelling, bruising and

bleeding around the site. Dry the site with sterile gauze and gently pull around 2 cm of the radial sheath from the

entry site. Apply the TR Band around the wrist with the green dot positioned ½ cm above the entry

site. Make sure the band is applied in a snug fit fashion. Inflate the TR Band with the appropriate amount of air causing haemostasis of the site.

While doing this make sure you pull the sheath as you push the air into the TR Band. Document the amount of air in millilitres (mL’s) used to inflate the band and time

applied. Attend neurovascular observation prior to transfer to the recovery area as a baseline.

1.3 TR Band Sheath Removal and Post Removal CareIn recovery area or CCU Perform neurovascular checks on both arms and hands in order to establish a baseline.

This is to be done every 15 minutes for the first hour, then half-hourly for 2 hours thereafter.

Verify the amount of air used to inflate the TR Band and the time of inflation. Commence deflation of TR Band 30 minutes after the inflation time; this is done

according to the doctor’s orders as documented in the patient’s notes. Routinely 3 mLs of air is removed every 30 minutes and the TR Band is removed in 2 hours.

After each deflation observe for bleeding at the site. If bleeding occurs reinflate the same amount, leave for 30 minutes and begin deflation again.

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Patients may mobilise with the TR Band in situ in the ward. (Caution should be observed if the patient has received sedation).

After complete deflation, remove the TR Band and clean around the entry site with some antiseptic/alcohol swabs.

Place a small square of sterile gauze over the entry site and wrap it with the Easifix cohesive crepe bandage with light pressure.

Remind the patient not to use the affected hand if possible. Provide and explain to the patient the discharge instructions about his/her affected

hand. Advise the patient not to perform any strenuous activities with the affected arm for at

least 48 hours. As per the discharge information sheet provided, also advise the patient to report to the consultant or GP cases of swelling, pallor, decrease capillary refill, hematoma, pain, bruising, movement and sensation.

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Section 2 – Digital Pressure Application after Femoral Sheath Removal

2.1 Equipment A small pack of gauze IV fluids (on standby) Documentation Materials including the CCU observation chart with MEWS

2.2 Procedure Ensure the patient is lying flat on their back in a straight body alignment to enable the

visualisation of the anatomical structures prior to sheath removal. Clarify if any anticoagulants were given to the patient during the procedure or if the

patient’s oral anticoagulants were not ceased prior to the procedure. Check the patient’s vital signs prior to sheath removal. Position the bed at a comfortable height to ensure that adequate pressure can be

exerted through the arms and shoulders of the Clinician for the required amount of time.

Clean the site using aseptic technique. For a right femoral sheath, place the middle three fingers of the hand approximately 2–3

cm proximal to the puncture site. Remove the sheath slowly at the same angle at which it was inserted. Inspect the sheaths for clots and ensure the entire sheath is intact when removed. Apply firm pressure over the arteriotomy site once the sheath has been removed. Initial

pressure should be occlusive, but this should be decreased gradually after the first 2-5 minutes such that distal pulses can be felt.

Hold direct manual pressure for at least 10-15 minutes. Check the site for any oozing until evidence of bleeding has ceased.

Instruct the patient to lie flat for 2 hours. Attend neurovascular observations, femoral site checks and vital signs every 15 minutes

for the first 2 hours, then half hourly for the following 2 hours.

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Report any changes immediately to the attending Proceduralist and document them in the patient’s notes.

If there is evidence of bleeding or haematoma formation, then digital pressure is to be applied and patient must remain lying flat for the next 2 hours or until reviewed by a Medical Officer.

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Section 3 – Femoral Sheath Removal – FEMOSTOP application

3.1 Equipment Femostop bridge set Femostop disposable dome Femostop manometer device Gloves and eye shields (PPE) Gauze IV fluids (on standby) Hemodynamic monitoring Documentation materials including the CCU observation charts with MEWS 3.2 Pre Procedure Prior to applying the Femostop the following must be attended to: Ensure Patient IV access is available. Baseline vital signs and MEWS score. Locations of the peripheral pulses are marked. Colour, sensation and movement of the

peripheries are checked. Patient is positioned as per sheath removal with digital pressure( see section 2.2). If haematoma is present prior to the Femostop application, outline parameters with a

marker pen. Give sedation and analgesia prior to arterial sheath removal if required.

Figure 1

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3.2.1 Guidelines for using Femostop device The Femostop device is only to be applied by nursing staff adequately trained to

perform this procedure The Femostop device is not to be used on excessively obese patients, as adequate

haemostasis cannot be achieved. Digital compression still is the gold standard for these patients.

Compression times expressed in this clinical procedure are a guide only. The length of compression necessary will depend on the condition of the artery, the catheter size and the type of anticoagulant therapy used.

The operator must remain with the patient while high pressures are used to totally occlude the artery.

An assistant will be required to position the device and assist until sheath is removed and haemostasis is achieved.

Bed rest must be maintained for a minimum of four to six (4-6) hours post arterial sheath removal.

3.3 Procedure: Lie patient flat and position the femostop belt under patient’s hips in line with the

puncture site. Attach dome to the compression arch and lock by rotating dome clockwise. See Figure 1

above. Attach pump to dome, using a stopcock if desired. If using the stopcock ensure the

handle is accessible. To remove arterial sheath: Inflate the dome: Aim to inflate dome to 10-20mmHg above

patient's systolic BP, while simultaneously removing sheath. Continue to increase pressure until haemostasis is achieved. Maintain this pressure

(“initial haemostasis pressure”) for approximately 2 minutes. While maintaining haemostasis, lower pressure enough to locate a pedal/tibial pulse.

Maintain this pressure for 30 minutes, unless bleeding occurs. If bleeding occurs, re-inflate to initial haemostasis pressure for a few minutes then try again.

Lower pressure in 15 mmHg increments every 15 minutes until a pressure of 40 mmHg is reached, and haemostasis is maintained.

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Maintain a pressure of 40 mmHg for 30 minutes then completely deflate dome. Ask patient to cough to ensure haemostasis is maintained before final removal of the device.

Document in the patient’s clinical notes.

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Section 4 – Femoral Sheath Removal- Bedside Clamp Application

4.1 Equipment Bedside “C” clamp Bedside clamp’s disposable disc for compression Gloves and eye protection (PPE) Hemodynamic monitoring Sterile gauze IV fluids (on standby) Documentation materials including CCU observation chart with MEWS Access to emergency call system

4.2 Procedure Position patient Document the vital signs including the neurovascular observations as a baseline. Place the base of the clamp under the mattress and position so that the extension arm

of the clamp will rest over the skin directly over the puncture site. The compression button and extension arm are placed on the clamp and brought down into position over the femoral artery (See figure 2).

Manual downward pressure is applied to the “C” clamp arm while the arterial sheath is gently removed from the site.

The clamp should be applied in such a manner that haemostasis is achieved but the pedal pulses are only diminished and not obliterated.

Figure 2:

High pressure is applied over the artery for 5-10 minutes to ensure haemostasis. Moderate pressure is applied for 20 to 30 minutes with close monitoring to the

posterior tibial and dorsalis pedis pulses to ensure adequate blood flow to the affected limb.

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If active bleeding or a hematoma develops, the clamp must be released and reapplied to increase the pressure.

The clamp may be applied as a prophylactic measure to prevent bleeding in high risk patients.

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Section 5 – Vascular Closure Devices

Vascular Closure Devices (VCD) are contraindicated in patients who are obese (BMI greater than 30), in patients with multiple punctures and posterior femoral artery wall punctures and in patients who are allergic to any component of the VCD (i.e. collagen or bovine products). The Canberra Hospital Cardiac Catheter Laboratory uses the St Jude Angioseal (VIP and Evolution) and the Abbott Proglide Perclose dependent upon the interventionist’s choice and patient suitability.

The patient can ambulate normally in 2 hours following Perclose device placement. However, factors such as use of anticoagulants, access issues, and overall patient status (both general and cardiac) need to be considered while deciding the length of bed rest before ambulation.

5.1 Angio-SealThe Angio-Seal vascular closure device quickly seals femoral artery punctures following catheterisation procedures. This allows for early ambulation and hospital discharge. The device creates a mechanical seal by sandwiching the arteriotomy between a bioabsorbable anchor and collagen sponge, which dissolve within 60 to 90 days.

Advantages One of the easiest devices to learn and use. Has a very high initial success rate. The collagen plug in the tract also acts to reduce oozing from the site. The retained components of the device are completely reabsorbed over the course of

weeks to months after insertion.

Disadvantages The intravascular anchor has the potential to further obstruct a heavily diseased vessel. Although extremely rare, embolisation of the intravascular anchor is a possibility. Repeat access of the same vessel within 90 days of device deployment should be

avoided using the same puncture site to avoid disrupting the plug; the manufacturer recommends puncture 1 cm proximal to the initial site. Depending on the location of the initial site, going 1 cm above is not always possible.

As with all devices with retained components, this device is a potential risk for infection. Cutting the suture below the skin surface is important for minimizing this risk.

Within the first 2 hours post deployment have the patient apply digital pressure over puncture site to support the site when coughing, straining or sneezing.

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5.2 Perclose ProglideThe Perclose ProGlide Suture-Mediated Closure (SMC) System is designed to deliver a single monofilament polypropylene suture to close femoral artery puncture sites following diagnostic or interventional catheterisation procedures.

Advantages Guide wire access is maintained until at least partial haemostasis is confirmed. This

advantage is important in situations where device failure may have serious consequences.

May be used to “preclose” the vessel (see discussion below) for procedures requiring very large sheaths.

Effective use results in effective closure with only suture in the wall of the vessel, with no bulky or thrombogenic material in the lumen.

A single device closes arteriotomies in the 5–8 Fr range. Re-access of the vessel has no restrictions. The device needles enter the artery from above (in contrast to the Prostar devices), thus

minimizing the risk of getting the needles stuck if the device fails.

Disadvantage Difficult to use in calcified vessels, as the needles may fail to penetrate the arterial wall,

causing the device to fail.

5.3 General Instructions for Patients who has had an Angio Seal or a Perclose Proglide After deployment of the VCD, the site is cleaned with an antiseptic solution and dried

with a sterile gauze. A piece of sterile gauze is folded into a small square and placed over the top if the

insertion site. A waterproof clear dressing (i.e. Tegaderm) is applied over the gauze which is covering

the insertion site to protect it from contamination and from being wet. The care of these patients who have had these devices are the same as the Digital

Pressure Application post sheath removal (Section 2.2), with the differences of these instructions below:o After deployment, patients can sit up at 30 degrees.o 30 minutes after device deployed, sit patient up to 45 degrees for 30 minutes if

clinically stable and the puncture site is dry.o Ambulation after 1 hour post deployment or as directed by the Medical Officer.o The groin dressing has to be removed after 24 hours following application.

The plug is a collagen based device which may be felt as a small pea-size lump when the site is palpated.

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5.4 Oozing from puncture site: This may be coming from the tissue track Apply light manual pressure over the site for 5 minutes Once haemostasis obtained apply bandaid, continue to monitor

5.5 Active bleeding: This is more likely from the artery incorrect deployment of the device Apply digital pressure 1-2 cm above puncture site (as per sheath removal protocol) until

bleeding stopped Lay patient flat Monitor for further complications Notify team leader/medical staff Refer to the MEWS and MET criteria if this incident occurs.

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Implementation

This clinical procedure will be incorporated into: Existing educational programs Orientation to CCL and CCU Ward meetings and ward communication book In services Ward education sessions Department’s intranet/website

The Nursing and Medical Staff will be deemed competent after: Demonstrating 5 supervised successful femoral sheath removals using digital pressure,

femostop and 5 supervised high risk complicated femoral sheath removals Demonstrating 5 supervised successful low risk uncomplicated trans-radial band

deflations and 5 supervised complicated high risk trans-radial band deflations Registered Nurses and Medical Officers who will be performing these tasks also need to

pass a competency based training which will be reflected in Capabiliti

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Related Policies, Procedures, Guidelines and Legislation

CHHS Central Venous Access Device (CVAD) Management - Children, Adolescents and Adults (NOT Neonates)CHHS Intra-Aortic Balloon Pump - management ofCHHS Consent and Treatment Policy and ProcedureACT Health Nursing and Midwifery Continuing Competence Policy and Procedure CHHS Aseptic Non Touch Procedure CHHS Patient identification and Procedure Matching Procedure

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CHHS Vital Signs and Early Warning Scores CHHS Patient Identification and Procedure Matching Policy

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References

http://micunursing.com/sheathremoval.htm

http://ccn.aacnjournals.org/content/29/1/39.full

http://patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2007/jun4(2)/Pages/58.aspx

http://www.bcis.org.uk/resources/FEMORAL_ARTERY_PUNCTURE_MANAGEMENT.pdf

http://www.kfshrc.edu.sa/annals/Old/192/98-174.html

http://journals.tums.ac.ir/upload_files/pdf/12581.pdfhttp://ccn.aacnjournals.org/content/32/5/16.full.pdf

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3124904/

http://www.slideshare.net/CaliforniaCathy/femoral-site-complications

http://www.penncnsjobs.com/images/PCI.pdf

http://www.bing.com/search?q=vascular+access+site+sheath+removal&src=IE-SearchBox&Form=IE8SRC

http://radiology.rsna.org/content/249/3/1058.full

http://ccn.aacnjournals.org/content/32/5/16.full

http://gradworks.umi.com/3336688.pdf

http://rahmoodle.net/moodle/pluginfile.php/14919/mod_resource/content/1/Angioseal.pdf

http://www.nursingtimes.net/nursing-practice/clinical-zones/cardiology/removal-of-a-femoral-sheath-following-ptca-in-cardiac-patients/199505.article

http://content.onlinejacc.org/article.aspx?articleid=1135792

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Search Terms

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Haemostasis, radial, femoral, arterial sheaths, Femostop, vascular, sheath removal, sheath

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Attachments

Attachment 1: Vascular Access Site Complications and ManagementAttachment 2: Predictors of Vascular Access Site Bleeding and Complications

Disclaimer: This document has been developed by ACT Health, <Division of Medicine / Cardiology Unit> specifically for its own use. Use of this document and any reliance on the information contained therein by any third party is at his or her own risk and Health Directorate assumes no responsibility whatsoever.

Date Amended Section Amended Approved ByEg: 17 May 2016 Section 1 ED/CHHSPC Chair

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Attachment 1: Vascular Access Site Complications and Management

Table 1. Vascular access site complications and managementComplication Description Clinical Findings ManagementHaematomaIncidence:5% to 23%

The most common vascular access site complication.A collection of blood located in the soft tissue.Occurs because of blood loss at the arterial and/or venous access site or perforation of an artery or vein.May occur if the arterial puncture is below the femoral bifurcation so the femoral head is not available to assist the compression

Swelling surrounding the puncture site (visible).Area of hardening under the skin surrounding the puncture site (palpable).Varies in size.Often associated with pain in the groin area that can occur at rest or with leg movement.Can result in decrease in haemoglobin and blood pressure and increase in heart rate, depending on severity.

Apply pressure to the site.Mark the area to evaluate for any change in size.Provide hydration.Monitor serial FBC.Maintain/prolong bed rest.Interrupt anticoagulant and antiplatelet medications if necessary.Neurovascular assessment and observations should be done ASAP.Blood transfusion, if indicated.If severe, may require surgical evacuation.Many haematomas resolve within a few weeks as the blood dissipates and is absorbed into the tissue.

Retroperitoneal haemorrhageIncidence:0.15% to 0.44%

Bleeding that occurs behind the serous membrane lining the walls of the abdomen/pelvis.May occur if the arterial wall puncture is made above the inguinal ligament, resulting in perforation of a suprainguinal artery or penetration of the posterior wall.Can be fatal if not

Moderate to severe back pain.Ipsilateral flank pain.Vague abdominal or back pain.Ecchymosis and decrease in haemoglobin and hematocrit are late signs.Abdominal distension.Often not associated with obvious swelling.

Provide hydration.Perform serial blood cell counts.Maintain/prolong bed rest.Interrupt anticoagulant and antiplatelet medications if necessary.Blood transfusion, if indicated.If severe, may require surgical evacuation.

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Complication Description Clinical Findings Managementrecognised early. Hypotension and

tachycardia.Diagnosed by computed tomography.

Pseudo aneurysmIncidence:0.5% to 9%

A communicating tract between the tissue and, usually, one of the weaker walls of the femoral artery, causing blood to escape from the artery into the surrounding tissue.Possible causes include difficulty with arterial cannulation, inadequate compression after sheath removal, and impaired haemostasis.May occur if the arterial puncture is below the femoral bifurcation so the femoral head is not available to assist with compression.

Swelling at insertion site.Large, painful haematoma.Ecchymosis.Pulsatile mass.Bruit and/or thrill in groin.Pseudo aneurysms can rupture, causing abrupt swelling and severe pain.Suspect nerve compression when pain is out of proportion to size of haematoma.Nerve compression can result in limb weakness that takes weeks or months to resolve.Diagnosed by ultrasound.

Maintain/prolong bed rest.Neurovascular assessment and observations should be done ASAP.Small femoral pseudo aneurysms should be monitored; they commonly close spontaneously after cessation of anticoagulant therapy.Large femoral pseudo aneurysms can be treated by ultrasound guided compression, surgical intervention, or ultrasound-guided thrombin injection.

Arteriovenous fistulaIncidence:0.2% to 2.1%

A direct communication between an artery and a vein that occurs when the artery and vein are punctured.The communication occurs once the sheath is removed.Risk factors:

Multiple access attempts.Punctures above or below proper site levelImpaired clotting.

Can be asymptomatic.Bruit and/or thrill at access site.Swollen, tender extremity.Distal arterial insufficiency and/or deep venous thrombosis can result in limb ischemia.Congestive heart failure.Confirmed by ultrasound.

Some arteriovenous fistulas resolve spontaneously without intervention.Some arteriovenous fistulas require ultrasound-guided compression or surgical repair.

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Complication Description Clinical Findings ManagementArterial occlusionIncidence:<0.8%

Occlusion of an artery by a thromboembolism.Most common sources: mural thrombus originating in cardiac chambers, vascular aneurysms, or vascular atherosclerotic plaques.Thromboemboli can develop at sheath site or catheter tip: embolisation occurs during sheath removal.Prevention or at least reduction can be obtained by anticoagulation, vasodilators, and nursing vigilance.

Classic symptoms include the 5 Ps:PainParalysisParasthesiasPulselessnessPallorDoppler studies help localize the area.Angiogram is required to identify exact location of occlusion site.

Treatment depends on size/type of embolus, location and patient’s ability to tolerate ischemia in affected limb.Neurovascular assessment and observations should be done ASAP.Small thromboemboli in well perfused arterial areas may undergo spontaneous lysis.Larger thromboemboli may require thromboembolectomy, surgery, and/or thrombolytic agents.Distal embolic protection devices (i.e. Filters) may be placed if necessary.

Femoral neuropathyIncidence:0.21%

Nerve damage caused by injury of the femoral nerve (s) during access and/or compression of nerves by a haematoma.

Pain and/or tingling at femoral access site.Numbness at access site or further down the leg.Leg weakness.Difficulty moving affected leg.Decreased patellar tendon reflex.

Identification and treatment of the source.Neurovascular assessment and observations should be done ASAP.Treatment of symptoms.Physiotherapy.

InfectionIncidence:<0.1%

Colonization by a pathogen.Causes:Compromised technique.Poor hygiene.Prolonged indwelling sheath time.Femoral access closure device (closure devices have been linked with

Pain, erythema, swelling at access site.Purulent drainage at access site.Increased white blood cell count.

Treatment of symptoms (eh pain).Antibiotics.

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Complication Description Clinical Findings Managementincreased occurrence of infection).

VasovagalIncidence: 2.3%

Pressure on a large artery and pain can stimulate the vagus nerve, causing slowing of the heart rate a drop in blood pressure.Anxiety pain and discomfort at the puncture site may also result in a vasovagal reaction.

Early signs include pallor, nausea and/or yawning, which often present with a slowing of the heart rate before a drop in blood pressure. Vasovagal reactions may lead to irreversible shock if untreated.

IV atropine and IV fluids should be administered as ordered.Oxygen should be administered via a mask @ 6 l/min and the bed tilted to head low position.Vasovagal reactions may occur whilst applying pressure to the groin therefore another person should be present to administer treatment while pressure on the site is maintained. Refer to the MEWS and MET criteria if this incident occurs.

From Crit Care Nurse. 2012 Oct;32(5):16-29;

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Attachment 2: Predictors of Vascular Access Site Bleeding and Complications

Patient Related Factors: Female Elderly Kidney Disease Hypertension Low body weight High BMI Peripheral arterial disease Acute Myocardial Infarction

Technique Related Factors: Large sheath size Presence of intra-aortic balloon pump or other hemodynamic devices Femoral access site (Arterial puncture above the inguinal ligament) Prolonged arterial sheath dwelling time Ineffective vascular closure device Ineffective manual compression techniques Multiple punctures

Pharmacotherapy Factors: Over anticoagulation with heparin Glycoprotein IIb/IIIa inhibitors Anti-coagulants/anti-platelets

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