CLINICAL GUIDELINE FOR THE SAFE DEPLOYMENT OF VASCULAR CLOSURE DEVICE 1. Aim/Purpose of this Guideline 1.1. This guideline applies to all medical practitioners trained in the deployment St Jude AngioSeal devices 2. The Guidance Only operators trained by and registered with St Jude Medical are recognised inplanters of the AngioSeal device. EQUIPMENT 1. Protective clothing as required by hospital policy, sterile gown and sterile gloves. 2. Sterile bag of heparinised saline flushing solution 1000 units in 500ml of sodium chloride 0.9%. 3. Chloraprep with tint 2% W/V/70% V/V Cutaneous Solution. 4. 2 20ml sterile luer slip syringes. 5. 1 10ml sterile luer lock syringe. 6. 10ml Ultravist 370 (contrast medium). 7. Sterile gauze. 8. Sterile blade with handle. 9. 6 french / 8 french Angio-Seal VIP vascular closure device complete with: Wire Arteriotomy locator Angio-seal insertion sheath Angio-seal device 10. Sterile dressing. 11. Sharps container. 12. Patient s documentation sheet as required by hospital policy. 13. Angio-seal patient information card. PROCEDURE ACTION 1. Ensure the operator has introduced the sheath through a single clean puncture. 2. Eplain the procedure to the patient and ensure understanding and obtain valid consent. 3. Ensure the patient has no allergies to beef products, collagen, absorbent sutures, polyglycolic or polylactic acid polymers. 4. Ensure patient has no religious reasons for not consuming beef products, eg they are of Hindu faith. 5. Ensure the patient is not receiving Warfarin or therapeutic thrombolysis. Page 1 of 9 RATIONALE To ensure the Angio-Seal can be deployed successfully. To obtain the patient s valid consent and co-operation. The collagen plug is made from bovine derived materials. The Angio-Seal components safety and
ACTION 6. Ensure the puncture has not been made through a vascular graft. 7. Ensure the patient does not have any clinically significant peripheral vascular disease. 8. Ensure patient does not have uncontrolled hypertension (>180mm Hg systolic). 9. Ensure the patient does not have a bleeding disorder, for eample thrombocytopenia (<100,000 platelet count), thrombasthenia, von Willebrand s disease or anaemia (Hgb<10mg/d1, Hct<30). 10. Ensure the patient does not have any preeisting auto-immune disease. 11. Ensure patient is not pregnant or lactating. 12. Wash hands thoroughly for the procedure ensuring a surgical scrub is used. 13. Put on a sterile gown and gloves using a technique which ensures sterility is maintained throughout. 14. Prepare a sterile field for the deployment of the Angio-Seal vascular closure device. 15. Using a 20ml sterile luer slip syringe, draw back on the side arm of the femoral artery sheath. If unable to draw back blood through the side arm of the femoral artery sheath do not proceed with Angio- Seal deployment. The sheath should be removed and haemostasis achieved using eternal pressure. 16. If able to draw blood back through the side arm of the femoral artery sheath, remove 20ml of blood. Then using a fresh 20ml luer slip syringe containing Heparinised saline, flush the sheath body through the side arm. It will take 5ml of Heparinised saline to achieve a thorough flush. 17. Once the patency of the femoral artery sheath is established, it is imperative that a femoral angiogram is performed through the procedure sheath. This is achieved RATIONALE Universal precautions. To ensure operator sterility is achieved prior to and during procedure. To ensure operator sterility is achieved prior to and during procedure thus reducing risk of infection. To ensure a sterile environment is available for the procedure thus reducing risk of infection. To ensure no clots are passed from sheath body into arterial circulation. To ensure the sheath body is free of blood and small clots. To ensure patency of sheath body. This can prevent failures and complications associated with sub-optimal vascular access, unrecognised peripheral vascular disease, small vessels and other Page 2 of 9
ACTION using a 10ml luer lock syringe and 10ml of Ultravist 370 (contrast medium), X-ray image is acquired by a Radiographer or other X-ray operator with nationally recognised training. 18. Attach the 10ml luer lock syringe to the procedure sheath sidearm, ensuring no air has entered the sheath and using preferably radiographic view Right Anterior Oblique 40 degrees, carry out a femoral angiogram. 19. If it is seen from the femoral angiogram that an Angio-Seal is not suitable, the procedure sheath should be removed and eternal pressure applied to obtain haemostasis. 20. If optimal location of the arterial puncture is demonstrated, closure using the Angio-Seal vascular closure device should be performed. 21. Insert the Angio-Seal guide wire into the patent main body of the femoral artery sheath via the obturator port. Ensure that half of the guide wires length remains outside of the sheath main body. 22. Remove the femoral artery sheath over the wire ensuring half the wires length remains in the patients femoral artery. 23. Thread the Angio-Seal arteriotomy locator / insertion sheath assembly over the guide wire, insert this assembly into the puncture tract. 24. Slowly insert the arteriotomy locator / insertion sheath assembly until blood slows or stops flowing from the drip hole. 25. Hold the insertion sheath steady, without moving it into or out of the artery. 26. Remove the arteriorotomy locator and guide wire from the insertion sheath. 27. Carefully grasp the Angio-Seal device at the bypass tube. Cradle the Angio-Seal carrier tube in the palm of the hand and with the reference indicator facing up, insert the bypass tube/carrier tube through the haemostatic valve into the insertion sheath. Page 3 of 9 RATIONALE anatomical variants. This demonstrates optimal location of the arterial puncture and its suitability for deployment of the Angio-Seal device. Thus eliminating the possibility of an incorrectly deployed Angio-Seal. To facilitate echange of the femoral artery sheath for the Angio-Seal. To maintain vascular access. Flow of blood through the arteriotomy locator indicates vascular access This indicates that the tip of Angio-Seal insertion sheath has eited the artery. To ensure the position of the sheath within the artery is not changed. To allow the insertion sheath to be used as deployment access for the Angio-Seal device. To ensure proper orientation of the Angio- Seal device within the sheath. 28. With one hand continue to hold the To prevent movement of the sheath into insertion sheath cap steady. or out of the artery. 29. With the other hand, grasp the device To ensure correct positioning of Angio-
ACTION cap and slowly pull back. Slight resistance will be felt when the device cap is pulled out from rear holding position. 30. Continue pulling on the device cap until resistance from the anchor catching on the distal tip of the insertion sheath is felt. 31. After the anchor position has been confirmed, while maintaining grip on the insertion sheath pull the device cap into the full rear locked position. 32. Slowly and carefully withdraw the device / insertion sheath assembly along the angle of the puncture tract. 33. When the insertion sheath clears the skin, a tamper tube will appear. At this stage grip the tamper tube with your left hand and gently advance the collagen, whilst maintaining tension on the suture with your right hand. 34. Continue to withdraw the insertion sheath and device until the clear stop on the suture appears. Pull until all of the suture has been deployed. The suture will then lock within the device cap where it is attached, maintain tension on the suture. 35. Continue to maintain tension on the suture, advance the collagen again with the tamper tube following the puncture tract angle. When resistance is felt indicating the seal is complete, a black compaction marker will be revealed. Maintain tension on the suture for approimately 10 seconds 36. Cut the suture between the clear stop and the black compaction marker. Remove the tamper tube using a slight twirling upward motion. 37. Gently pull on the suture. Using a sterile blade, cut the suture below the skin level, making sure to cut below the black compaction marker. 38. Clean the puncture site with Chlorheidine solution. 39. Apply a sterile dressing to the puncture site. 40. Complete all legally required documentation as per RCHT policy. Ensure Angio-Seal patient information card is correctly completed. RATIONALE To ensure correct positioning of Angio- To ensure correct deployment of Angio- To position the anchor against the vessel wall. To allow the collagen plug to be advanced. To ensure correct deployment of Angio- To ensure correct deployment of Angio- To allow removal of introduction components of Angio-Seal device. To ensure all ecess suture is removed reducing the risk of infection. To reduce the risk of infection. For sterility and so the puncture site can be observed during recovery. To provide a point of reference in the event of any queries. To provide accurate records. Page 4 of 9
Please note: St Jude Medical recommend if re-puncture at the same location of previous Angioseal device at less than, or equal to 90 days, re-enter 1 centimetre proimal to previous access site (Applegate R., Rankin, K., Little, W., Kahl, F, & Kutcher, M (2003) Restick following initial angioseal use in Catheterisation and Cardiovascular interventions, Official Journal of the Society for Cardiac Angiography and Interventions, Feb 2003; 58, (2), pp181-184 3. Monitoring compliance and effectiveness Element to be monitored Lead Complications during and post implant Cardiac Catheter Laboratories Manager Tool Verbal reports received from colleagues, Wound site observations, Patient notes, patients contacting department (patients are issued with an information card and requested to contact the department in case of complications) Frequency Reports on ad hoc basis, new implanters to perform ten supervised device deployments as part of training Reporting MHRA, Governance meetings arrangements Acting on Recommendations from Lead CCL Consultant and CCL Manager recommendations and Lead(s) Change in practice and lessons to be shared Change of practice will be implemented by CCL Manager and CCL Lead Consultant. Sharing of lessons through governance meetings. 4. Equality and Diversity 4.1. This document complies with the Royal Cornwall Hospitals NHS Trust service Equality and Diversity statement. 4.2. Equality Impact Assessment The Initial Equality Impact Assessment Screening Form is at Appendi 2. Page 5 of 9
Appendi 1. Governance Information Document Title Date Issued/Approved: 29 th November 2013 Date Valid From: 29 th November 2013 Date Valid To: 29 th November 2016 Clinical Guideline for the Safe Deployment of Vascular Closure Device Directorate / Department responsible (author/owner): Tina Prestwood, Cardiac Catheter Laboratories Manager Contact details: 01872 252227 Brief summary of contents Deployment of Angio Seal vascular closure device Suggested Keywords: Target Audience Eecutive Director responsible for Policy: Angio Seal, vascular closure RCHT PCH CFT KCCG Medical Director Date revised: 29th November 2013 This document replaces (eact title of previous version): Approval route (names of committees)/consultation: NA Cardiology Governance Divisional Manager confirming approval processes Name and Post Title of additional signatories Signature of Eecutive Director giving approval Publication Location (refer to Policy on Policies Approvals and Ratification): Document Library Folder/Sub Folder Links to key eternal standards Related Documents: Training Need Identified? Stella Ellis Not Required {Original Copy Signed} Internet & Intranet Intranet Only Clinical/Cardiology None None Training supplied by St Jude Medical Page 6 of 9
Version Control Table Date Version No Summary of Changes Changes Made by (Name and Job Title) 1 Jun 10 V1.0 Initial Issue Z Evans, J Hope 29 Nov 13 V2.0 Reformat to Trust standard. Tina Prestwood, Cardiac Catheter Laboratories Manager All or part of this document can be released under the Freedom of Information Act 2000 This document is to be retained for 10 years from the date of epiry. This document is only valid on the day of printing Controlled Document This document has been created following the Royal Cornwall Hospitals NHS Trust Policy on Document Production. It should not be altered in any way without the epress permission of the author or their Line Manager. Page 7 of 9
Appendi 2. Initial Equality Impact Assessment Form Name of Name of the strategy / policy /proposal / service function to be assessed (hereafter referred to as policy) (Provide brief description): Clinical Guideline for the Safe Deployment of Vascular Closure Device Directorate and service area: Is this a new or eisting Policy? Acute Medicine and ED Eisting policy Name of individual completing Telephone: assessment: Tina Prestwood 1. Policy Aim* Who is the strategy / policy / proposal / service function aimed at? 01872 252227 To deploy vascular closure device following best practice. Aimed at medical practitioners and registered nurses 2. Policy Objectives* To ensure the safe deployment of vascular closure device 3. Policy intended Outcomes* 4. *How will you measure the outcome? 5. Who is intended to benefit from the policy? 6a) Is consultation required with the workforce, equality groups, local interest groups etc. around this policy? To provide guidance and ensure patient safety Successful haemostasis Patients and Staff No b) If yes, have these *groups been consulted? C). Please list any groups who have been consulted about this procedure. Consultant Cardiologists, Clinical Director. Superintendent Radiographer 7. The Impact Please complete the following table. Are there concerns that the policy could have differential impact on: Equality Strands: Yes No Rationale for Assessment / Eisting Evidence Age Page 8 of 9
Se (male, female, transgender / gender reassignment) Race / Ethnic communities /groups Disability - learning disability, physical disability, sensory impairment and mental health problems Religion / other beliefs Marriage and civil partnership Ensure patient has no religious reasons for not consuming beef products (e.g. Hindus) as collagen plug is made from bovine derived materials Pregnancy and maternity Seual Orientation, Biseual, Gay, heteroseual, Lesbian You will need to continue to a full Equality Impact Assessment if the following have been highlighted: You have ticked Yes in any column above and No consultation or evidence of there being consultation- this ecludes any policies which have been identified as not requiring consultation. or Major service redesign or development 8. Please indicate if a full equality analysis is recommended. Yes No 9. If you are not recommending a Full Impact assessment please eplain why. There are no other concerns regarding this policy. Signature of policy developer / lead manager / director Date of completion and submission Tina Prestwood Names and signatures of members carrying out the Screening Assessment 1. 2. Keep one copy and send a copy to the Human Rights, Equality and Inclusion Lead, c/o Royal Cornwall Hospitals NHS Trust, Human Resources Department, Knowledge Spa, Truro, Cornwall, TR1 3HD A summary of the results will be published on the Trust s web site. Signed Date Page 9 of 9