Lead Extraction Overview Haitham Badran, MD, FESC Lecturer of Cardiology Ain Shams University
DO WE NEED IT
Indications for Extraction Infection (sepsis) Damaged leads (arrhythmias, venous trauma) Unable to implant additional leads Thromboembolic events resulting from a retained lead Lead that interferes with the operation of another implanted device
Infection Reported in 4-7% of implants Erosion occurs when the generator and / or leads exit through the skin Staph Epi is the most common microbe while Staph Aureus (MRSA) more virulent Can be located in: The pacemaker pocket Along the lead (in biofilm) Within a compromised lead
To eradicate an infection, it is universally recognized that you must first: REMOVE ALL HARDWARE
Damaged Leads Can be caused by : Trauma to the lead Lead reaction to the hostile human body and subsequent material degradation Faulty implant technique Result of a lead extraction of another lead
Lead Failure: Fractured lead
ACCUFIX J LEAD TELECTRONICS INC.
ACCUFIX J LEAD TELECTRONICS INC.
Damaged Leads What are the problems? 1. Arrhythmias (Due to broken leads striking the epicardial wall) 2. Muscle stimulation 3. Endothelial wall damage 4. Potential puncture of heart wall and large vessel (J-wire design)
Unable to implant additional leads Too much implanted hardware Large vein occlusion Re-implanting through the same tract as that of the removed lead is the key
WHAT IS THE BIG DEAL TO PULL IT LIKE A MAN!!!!
The Chronic Lead 1. Binding scar tissue How does this happen?
The Problem.Adhesions - can occur wherever lead contacts the vessel wall Lead in contact with vessel wall
Scar tissue locations 36% 72% 48% Superior Approach 80% 41% 16% 71% Femoral Approach (20%)
The Chronic Lead 2. Poor lead design 3. Fragile materials
The Chronic Lead 4. Implant technique and lead entry location 5. Patient anatomy and physiology Everyone s different
Lead Extraction Minimal invasive transvenous approach Superior approach Access by the subclavian vein Access by the jugular vein Femoral Approach Access by the femoral vein
Superior Approach PROCEDURE PREPERATION: - Surgical Team on stand-by - Pericardiocentisis Set - Typed and crossed blood - TEE - High quality fluoroscopy - Thoracotomy tray (where appropriate)
Lead Extraction - Categories Lead Control locking stylet lead extender Vessel entry Evolution Shortie mechanical dilator sheath set Bryd Dilator stainless steel sheath sets Extraction superior approach Dilator sheath sets Poly & TFE Perfecta EDS Evolution mechanical dilator sheath set Needle s Eye Snare Extraction femoral approach Needle s Eye Snare Accessories
Lead Extraction - Categories Lead Control locking stylet lead extender Vessel entry Evolution Shortie mechanical dilator sheath set Bryd Dilator stainless steel sheath sets Extraction superior approach Dilator sheath sets Poly & TFE Perfecta EDS Evolution mechanical dilator sheath set Needle s Eye Snare Extraction femoral approach Needle s Eye Snare Accessories
Locking stylet Universal size: Single model is compatible with all known leads possessing an inner-lumen. [.016 -.032 inch]
LIBERATOR Locking Stylet In Action
LIBERATOR Locking Stylet In Action
LIBERATOR Locking Stylet In Action
LIBERATOR Locking Stylet In Action 30 2/20/2014
Lead Extraction - Categories Lead Control locking stylet lead extender Vessel entry Evolution Shortie mechanical dilator sheath set Bryd Dilator stainless steel sheath sets Extraction superior approach Dilator sheath sets Poly & TFE Perfecta EDS Evolution mechanical dilator sheath set Needle s Eye Snare Extraction femoral approach Needle s Eye Snare Accessories
BULLDOG lead extender Secures lumenless leads.
BULLDOG lead extender Used to extract lumen-less pacemaker and defibrillator leads. Other uses for Bulldog To extend a broken lead To extend a broken Liberator
Lead Extraction - Categories Lead Control Liberator locking stylet Bulldog lead extender Vessel entry Bryd Dilator stainless steel sheath sets Evolution Shortie mechanical dilator sheath set Extraction superior approach Dilator sheath sets Poly & TFE Perfecta EDS Evolution mechanical dilator sheath set Needle s Eye Snare Extraction femoral approach Needle s Eye Snare Accessories
Manual Mechanical Telescoping Stainless steel Dilator Sheath Sets STAINLESS STEEL
Lead Extraction - Categories Lead Control Liberator locking stylet Bulldog lead extender Vessel entry Bryd Dilator stainless steel sheath sets Evolution Shortie mechanical dilator sheath set Extraction superior approach Dilator sheath sets Poly & TFE Perfecta EDS Evolution mechanical dilator sheath set Needle s Eye Snare Extraction femoral approach Needle s Eye Snare Accessories
Lead Extraction - Categories Lead Control Liberator locking stylet Bulldog lead extender Vessel entry Bryd Dilator stainless steel sheath sets Evolution Shortie mechanical dilator sheath set Extraction superior approach Dilator sheath sets Poly & TFE Perfecta EDS Evolution mechanical dilator sheath set Needle s Eye Snare Extraction femoral approach Needle s Eye Snare Accessories
LEAD EXTRACTION Manual Mechanical Telescoping Dilator Sheath Sets PTFE POLYPROPYLENE
Counter-Traction Bruce Wilkoff MD, Cleveland Clinic Foundation
What is Countertraction? 1 2 3
Lead Extraction - Categories Lead Control Liberator locking stylet Bulldog lead extender Vessel entry Bryd Dilator stainless steel sheath sets Evolution Shortie mechanical dilator sheath set Extraction superior approach Dilator sheath sets Poly & TFE Perfecta EDS Evolution mechanical dilator sheath set Needle s Eye Snare Extraction femoral approach Needle s Eye Snare Accessories
EDS - Electrosurgical Dissection Sheath Radiofrequency Ablation of fibrous adhesions PERFECTA Introduced into Europe ~ 2001
Analysis Group 1988 93 Early cases * 1994 95 Accufix * 1994 95 Non-Accufix * 1996 97 Mechanical * 1996 97 Laser * 1999 2000 Electrosurgical Ten Years of Lead Extraction Procedures Number It appears of Years that Removal the Outcome Cases Implanted Complete Partial Failed mechanical approach seems 1251 patients 2110 leads 985 patients 1237 leads 1011 patients 1743 leads 1456 patients 2279 leads 636 patients 1155 leads Major Complications 4.7 ± 3.8 86% 8% 6% 2.0% to be the safes approach 265 patients 459 leads 3.1 ± 2.0 94% 4% 2% 1.4% 4.5 ± 4.1 91% 6% 2% 1.5% Mechanical has a lower adverse 4.2 ± 3.8 93% 5% 2% 1.5% event rate than powered 5.8 ± 4.0 94% 4% 1% 2.7% sheaths 8.4 ± 5.0 95..9% 3..5% 0.6% 2.6% *Data presented at XIth World Symposium on Cardiac Pacing and Electrophysiology in Berlin, Dr Bruce Wilkoff
Lead Extraction - Categories Lead Control Liberator locking stylet Bulldog lead extender Vessel entry Bryd Dilator stainless steel sheath sets Evolution Shortie mechanical dilator sheath set Extraction superior approach Dilator sheath sets Poly & TFE Perfecta EDS Evolution mechanical dilator sheath set Needle s Eye Snare Extraction femoral approach Needle s Eye Snare Accessories
EVOLUTION Mechanical Dilator Sheath Sheath rotates when the trigger handle is squeezed for maximum operator control The patented threaded barrel tip provides succinct passage past fibrous binding sites without the forward depth of cut of other powered sheaths Available in four sizes that are compatible with both pacing and defibrillator leads: 7, 9, 11 & 13 Fr. (I.D.)
Lead Extraction - Categories Lead Control Liberator locking stylet Bulldog lead extender Vessel entry Bryd Dilator stainless steel sheath sets Evolution Shortie mechanical dilator sheath set Extraction superior approach Dilator sheath sets Poly & TFE Perfecta EDS Evolution mechanical dilator sheath set Needle s Eye Snare Extraction femoral approach Needle s Eye Snare Accessories
Alternative Approaches Pulling.. Weighed Traction Thoracotomy Or..
Femoral Approach NEEDLE S EYE snare Byrd Workstation Intravascular Retrieval Set
Femoral Techniques Capture of lead is normally attempted in the body of the right atrium RA RV
Needles-Eye Snare Fix
HRS Lead Extraction Consensus
Clinical Goals Elimination of infection pocket infection, device related endocarditis Venous access in an occluded vessel Elimination of an identified risk: lead or portion of a lead Perforation, arrhythmia Preservation of desired pacing mode Removal of all non-functional leads Resolution of pocket related symptoms pain HRS Lead Extraction Consensus - 2009
Major Complications Death Cardiac avulsion or tear Vascular avulsion or tear Pulmonary embolism Respiratory arrest or anesthesia related complication Stroke HRS Lead Extraction Consensus - 2009
Minor Complications Pericardial effusion Hemothorax Hematoma Arm swelling or thrombosis Vascular repair Pacing system related infection Air embolism Lead fragment migration Blood transfusion Pulmonary embolism HRS Lead Extraction Consensus - 2009