Some of the slides and the video were supplied by a device manufacturer

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1 Financial Disclosure The Ins and Outs of Implantable Lead Extraction: The Value of Implementing a Complication Prevention and Management Initiative Some of the slides and the video were supplied by a device manufacturer I have no financial disclosures or arrangements with any of the device or equipment suppliers mentioned 2011 Spectranetics All Rights Reserved. Approved for External Distribution D Growing Need for Managing Leads Comparative Complication Rates* 6% 5.9% 1 Infection 4% Malfunction Redundant leads 3% from upgrades Venous occlusion 2% MR conditional devices 1% Quadripolar / IS-4 /DF-4 leads 0% 5% % 2 A-Fib Ablation 4-5% 3 PCIs 1-2% 3 2.2% 4 Lead Addition/Revision 1.4% 5 1.1%^ Lead Removal (LExICon) Procedural MAEs Procedural Mortality 0.28% 5 0.4% % 6 DFT 3 * See References on last slide ^ The LExICon study reports a procedural MAE rate of 1.4%, as defined by the 2000 NASPE Policy Statement. However, 0.3% (n=4) of the MAEs were bleeding requiring transfusion, which is no longer defined as an MAE by the 2009 HRS Expert Consensus Document 4

2 Objectives Relative Incidence of Procedural MAEs and Mortality is Low Briefly describe: How a thorough Complication Prevention and Management protocol can impact outcomes How involving your extended team to develop and Implement a Complication Prevention and Management protocol facilitates their understanding, collaboration and alignment to help every member make informed decisions that drive successful recovery How knowledge of potential complications, associated with the procedure, can help prevent major adverse patient events (MAE) The overall rate of procedural major adverse events during a lead extraction is low and decreasing with improvement in technology Survival from procedural MAEs can be high if proper procedural protocols are instituted and followed Year Procedural MAEs 2.0% 1.9% 1.4% Procedural Mortality 0.65% 0.6% 0.28% % MAE Patients Surviving (Data extracted from references) 67% 69% 80% 1. Wilkoff, B., L., et al. (1999). Pacemaker lead extraction with the laser sheath: Results of the Pacing Lead Extraction with Excimer Sheath (PLEXES) trial. JACC, 33(6). 2. Byrd, C., et al. (2002). Clinical study of the laser sheath for lead extraction: The total experience in the United States. Journal of Pacing and Electrophysiology, 125(5). 3. Wazni, O et. al. (2010). Lead extraction in the contemporary setting: The LExICon study: A multicenter observational retrospective study of consecutive laser lead extractions. J Am Coll Cardiol, 55, Defining Complications Major Complications Death Cardiac avulsion or tear requiring thoracotomy, pericardiocentesis, chest tube, or surgical repair Vascular avulsion or tear (requiring thoracotomy, pericardiocentesis, chest tube, or surgical repair) Pulmonary embolism requiring surgical intervention Respiratory arrest or anesthesia related complication leading to prolongation of hospitalization Stroke Pacing system related infection of a previously non-infected site 1. Wilkoff, B.L., Love, C.J., Byrd, C.L., Bongiorni, M.G., Carrillo, R.G., Crossley, G.H., et al. (2009).Transvenous lead extraction: Heart Rhythm Society expert consensus on facilities, training, indications, and patient management. Heart Rhythm, 6(7), Defining Complications Minor Complications Pericardial effusion not requiring pericardiocentesis or surgical intervention Hemothorax not requiring a chest tube Hematoma at the surgical site requiring reoperation for drainage Arm swelling or thrombosis of implant veins resulting in medical intervention Vascular repair near the implant site or venous entry site Hemodynamically significant air embolism Migrated lead fragment without sequelae Blood transfusion related to blood loss during surgery Pneumothorax requiring a chest tube Pulmonary embolism not requiring surgical intervention 1. Wilkoff, B.L., Love, C.J., Byrd, C.L., Bongiorni, M.G., Carrillo, R.G., Crossley, G.H., et al. (2009).Transvenous lead extraction: Heart Rhythm Society expert consensus on facilities, training, indications, and patient management. Heart Rhythm, 6(7),

3 Common Location of Binding Sites Location of Potential Complications Innominate / SVC Venous entry Subclavian vein tear / AV fistula Innominate tear / perforation High SVC tear / perforation SVC tear / perforation RA RA tip SVC / RA junction tear / perforation Atrial wall perforation Inferior Vena Cava RV RV tip Valvular damage Ventricular wall perforation Time to Intervention Is Critical A Prepared Extended Team is Essential Through the external review of fatal cases around the world, it was the strong consensus that when the superior vena cava was torn or perforated, delays from the injury to having open access to the heart of more then 5-10 minutes were often associated with a fatal outcome. Rescue efforts initiated within this time period have been usually successful. 1 MAEs are uncommon but require quick and appropriate response by multiple clinicians for optimal recovery. Each team member needs to understand the considerations for their decisions that may impact outcomes. Primary operator CT surgeon Anesthesia Fluoroscopy operator EXTENDED TEAM Scrubbed assistant Non-scrubbed assistant Echocardiographer Perfusionist 1. Wilkoff, B.L., Love, C.J., Byrd, C.L., Bongiorni, M.G., Carrillo, R.G., Crossley, G.H., et al. (2009).Transvenous lead extraction: Heart Rhythm Society expert consensus on facilities, training, indications, and patient management. Heart Rhythm, 6(7), Wilkoff, B.L., Love, C.J., Byrd, C.L., Bongiorni, M.G., Carrillo, R.G., Crossley, G.H., et al. (2009).Transvenous lead extraction: Heart Rhythm Society expert consensus on facilities, training, indications, and patient management. Heart Rhythm, 6(7),

4 Importance of Surgery Partnership Schedule An Extended Team Meeting A successful lead extraction program requires a team approach Cardiothoracic surgeon and surgical team is an integral part of the complication management plan Surgeon needs to be well-versed in the procedure and tools, as well as the potential complications and needs to be able to intervene within minutes of an occurrence The entire team must be involved in pre-case planning Bringing the extended team together facilitates understanding, collaboration and alignment that help drive successful recovery Why this procedure is performed How the procedure is performed Where complications may occur Considerations for each member in managing the complication Development/review and alignment of a protocol The team feels prepared; They know the plan and their role in it Repetition is key to rapid and appropriate management of complications Debriefing to assess positives and where improvement is needed Discuss Considerations for Managing MAEs During Lead Extraction Pre-case planning Case setup Patient prep Identifying of a complication Equipment considerations for rescue cart Patient considerations Surgical access and tools based on injury location Perfusion Considerations Anesthesia considerations Considerations for managing MAEs in the EP lab and OR 1. Wilkoff, B.L., Love, C.J., Byrd, C.L., Bongiorni, M.G., Carrillo, R.G., Crossley, G.H., et al. (2009).Transvenous lead extraction: Heart Rhythm Society expert consensus on facilities, training, indications, and patient management. Heart Rhythm, 6(7), Pre-Case Planning Review history and physical 1 Co-morbidities BMI Diabetes and/or renal insufficiency The ongoing need for device therapy American Society of Anesthesiologists (ASA) score Obtain all pacing and defibrillation lead information 1 Lead construction considerations Cardiac Rhythm Device Companies 2 : - Medtronic CRM Medical Records: St Jude CRM Medical Records: x3 - Boston Scientific CRM Medical Records: x4 - Biotronik CRM Medical Records: ELA Customer Service: Wilkoff, B.L., Love, C.J., Byrd, C.L., Bongiorni, M.G., Carrillo, R.G., Crossley, G.H., et al. (2009).Transvenous lead extraction: Heart Rhythm Society expert consensus on facilities, training, indications, and patient management. Heart Rhythm, 6(7), Phone numbers were obtained from the individual company websites.

5 Pre-Case Planning cont d Review X-ray May provide evidence of areas of difficulty 1 leads crossing over each other 2 Photos courtesy of Dr. Rohit Mehta Pre-Case Planning cont d Review X-ray May provide evidence of areas of difficulty 1 possible binding site if the lead does not straighten out with traction during the procedure 2 Photos courtesy of Dr. Rohit Mehta 1. X-ray analysis may not indicate any potential areas of difficulty even if difficulty is encountered during the procedure. 2. The appearance of leads overlapping upon X-ray analysis does not necessarily confirm lead on lead interaction or the potential for difficulty during the procedure. 1. X-ray analysis may not indicate any potential areas of difficulty even if difficulty is encountered during the procedure. 2. Lead positional changes with traction may not indicate the absence of a binding site or lack of positional change does not confirm a binding site location. Multiple factors must be considered when observing lead(s) under fluoroscopy. Pre-Case Planning cont d Pre-Case Planning cont d Review X-ray May provide evidence of areas of difficulty 1 possible lead perforation; transvenous lead extraction is contra-indicated for perforated leads 2 *Photos courtesy of Dr. Roger Carrillo 1. X-ray analysis may not indicate any potential areas of difficulty even if difficulty is encountered during the procedure. 2. X-ray may not provide sufficient information for determining lead perforation or normal placement. Is a venogram indicated? Informed consent signed and all questions answered Inventory checked for all extraction and CIED implant tools Laser equipment function confirmed CT Surgeon identified (if not primary operator), notified, and confirmed for surgical back-up Blood typed and crossed and immediately available Device interrogated and re-programmed if necessary Determine pacemaker dependency Turn off all anti-tachycardia therapies Turn off rate responsiveness These items are provided as considerations in the pre-case planning process derived from multiple hospitals and the HRS Consensus Statement (Wilkoff, B.L., Love, C.J., Byrd, C.L., Bongiorni, M.G., Carrillo, R.G., Crossley, G.H., et al. (2009).Transvenous lead extraction: Heart Rhythm Society expert consensus on facilities, training, indications, and patient management. Heart Rhythm, 6(7), ). Each hospital is responsible for establishing protocols and processes for any procedure it performs.

6 Case Set-Up Case Set-Up cont d Patient prepped and draped consistent with hospital protocols Standard device implant prep Chest prep for thoracotomy/sternotomy Femoral site prep Anesthesia administered IV sedation versus general Anesthesia cart should be immediately available if using IV sedation CIED pacemaker tray opened Pericardiocentesis tray in the room, but not opened Cardio-pulmonary machine immediately available Extraction cart in the room These items are provided as considerations in the case set-up process derived from multiple hospitals and the HRS Consensus Statement (Wilkoff, B.L., Love, C.J., Byrd, C.L., Bongiorni, M.G., Carrillo, R.G., Crossley, G.H., et al. (2009).Transvenous lead extraction: Heart Rhythm Society expert consensus on facilities, training, indications, and patient management. Heart Rhythm, 6(7), ). Each hospital is responsible for establishing protocols and processes for any procedure it performs. Echocardiography equipment immediately available if not being utilized during the procedure Venous access Peripheral IV(s) Large bore femoral venous sheath Fluid resuscitation Emergent temporary pacing wire Femoral access for additional lead management if necessary Arterial line placed Baseline blood pressure established and recorded Continuous monitoring initiated and visible to primary operator Rate, rhythm and A-line blood pressure These items are provided as considerations in the case set-up process derived from multiple hospitals and the HRS Consensus Statement (Wilkoff, B.L., Love, C.J., Byrd, C.L., Bongiorni, M.G., Carrillo, R.G., Crossley, G.H., et al. (2009).Transvenous lead extraction: Heart Rhythm Society expert consensus on facilities, training, indications, and patient management. Heart Rhythm, 6(7), ). Each hospital is responsible for establishing protocols and processes for any procedure it performs. Case Set-Up cont d Equipment Time out conducted per hospital protocol Right Patient Right site Right procedure Right equipment Etc. Team Huddle Extended lead management team discusses the procedure, the objective of the case and potential concerns specific to the patient These items are provided as considerations in the case set-up process derived from multiple hospitals and the HRS Consensus Statement (Wilkoff, B.L., Love, C.J., Byrd, C.L., Bongiorni, M.G., Carrillo, R.G., Crossley, G.H., et al. (2009).Transvenous lead extraction: Heart Rhythm Society expert consensus on facilities, training, indications, and patient management. Heart Rhythm, 6(7), ). Each hospital is responsible for establishing protocols and processes for any procedure it performs. Extraction Cart Considerations EKG electrodes Defibrillator patch Skin prep kit Sterile magnet Pacemaker tray / Surgical instruments Sterile fib cord Sterile light handle Sterile Bovie Stylet wires Temporary pacing wire Pacemaker or ICD programmer Pacing catheter Sterile gauze dressing Culture containers, sterile specimen swabs Arterial mean kit Steri-strips or Dermabond Pacing analyzer and sterile PSA cable Cardiothoracic drape Temporary pacemaker 9F and 10F long sheaths for lead implant IntraCardiac Ultrasound (ICE) or TEE Sutures / ligatures (various) 4 8F sheaths for arterial and venous access Spectranetics Laser Glasses* LLD EZ * 12F, 14F and 16F Spectranetics Laser Sheaths* Lead Extender** Bulldog Spectranetics accessories* Spectranetics VisiSheath Dilator Sheaths* Gooseneck Snare*** Needle s Eye snare** Byrd Workstation w/ basket & deflectable guidewire** *Products of Spectranetics Corporation **Products of Cook Medical Incorporated ***Products of EV3 Incorporated - This list is compiled from consultation with several hospitals and is for educational purposes only. This list should not be seen as an allinclusive list. Individual hospital policies and procedures (including equipment lists), along with physician choice, should dictate standards of care. Spectranetics does not endorse any specific protocols or equipment lists.

7 Equipment Identifying a Complication Rescue Cart Considerations* Thoracotomy and Sternotomy tray Saw with blades (battery pack X2 or power cord) Pericardiocentesis tray Pericardial pigtail Pericardial needles X2 Alligator clamps X2 Chest tubing Suction canisters Pleurovac Internal defibrillator paddles Intubation tubes Yankauer without filter Sutures Surgical scrub kit Rapid infuser Syringes various sizes Surgical scalpels Central line kit Anesthesia medicine cart Epicardial pacing wires Hemodynamics Rate Rhythm Continuous blood pressure Fluoroscopy Comparison to cine taken at beginning of case ( roadmap ) Border changes Heart movement Opacification of pleural space Echocardiography wall abnormalities, effusions, etc. Transthoracic echocardiography (TTE) Transesophogeal echocardiography (TEE) Intracardiac echocardiography (ICE) * This list is compiled from consultation with several hospitals and is for educational purposes only. This list should not be seen as an allinclusive list. Individual hospital policies and procedures (including equipment lists), along with physician choice, should dictate standards of care. Spectranetics does not endorse any specific protocols or equipment lists. 1. Wilkoff, B.L., Love, C.J., Byrd, C.L., Bongiorni, M.G., Carrillo, R.G., Crossley, G.H., et al. (2009).Transvenous lead extraction: Heart Rhythm Society expert consensus on facilities, training, indications, and patient management. Heart Rhythm, 6(7), Rescue Plan Rescue Plan Drill Develop a plan and process to specifically address if a complication occurs Points to consider: Designate responsibilities to specific roles (i.e., circulator) May choose to keep it broad enough to encompass multiple scenarios (i.e., not trying to address all potential complications individually) Develop with the entire team to gain agreement Distribute the plan to anyone who may be involved and post in areas that the procedure takes place Identify the tools that need to be on the rescue cart Include a reporting template to fill out and send in to the FDA * These considerations are provided for educational purposes only. This list should not be seen as an all-inclusive list nor must an individual hospital s rescue plan include all of the items listed above. Individual hospital policies and procedures, along with physician choice, should dictate standards of care. Spectranetics does not endorse any specific protocols or rescue plans. Designed to provide a simulated lead extraction procedure and the response to a simulated complication The purpose is to: Ensure that the extraction cart has all needed equipment Ensure that the rescue cart has all needed equipment and to test that the equipment is fully functional Ensure that the rescue protocol is in place and understood by all participants Ensure that participants understand their role in responding to a complication Educate participants on the potential complications and possible approaches to manage those complications Frequency of training needs to be established by each individual institution, but may consider a minimum of once per year

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