Lead Management Syllabus

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Optimal Lead Selection:
An Extractor’s Guide to Lead Choice
and Implant Technique
Charles J. Love, MD FACC FAHA FHRS CCDS
Professor of Medicine
Director, Cardiac Rhythm Device Services
Wexner Medical Center at The Ohio State University
Columbus, OH USA
President, International Board of Heart Rhythm Examiners

Disclosures


Honoraria, research support and/or consulting with:
 Boston Scientific
 Cook Medical
 Leadexx
 Lake Region Medical
No off label uses of devices
or drugs will be part of this
 Medtronic
presentation.
 Spectranetics
 St. Jude Medical

Extraction “Experts” Have Learned!


Those that do a lot of extraction begin to
think!
 What

causes the problems to arise that result
in a need for an extraction
 How to modify our implant techniques and
device choices
 Avoid

increased risk of mechanical, vascular and
infectious complications.

 What

hardware might result in an easier and
safer extraction experience (for patient AND
doctor).

1

Many choices for many issues


First, understand where and how
complications occur
 This

will affect

 Implant

site
Access Techniques
 Lead choice
 Pocket tissue plane
 Venous

Lead Crush

Lead Crush

2

Fixation – Active versus Passive
Active Fixation

Passive Fixation

Lead Choice
 Fixation
Passive
 Tine

Length

• Longer tines are more difficult to extract
 Tined

leads in general more difficult to
extract due to fibrosis around tines!

LV Lead Designs

3

Lead Choice
 Active
Retractable

Helix

 Tissue

may grow into the fixation
mechanism

Fixed

Helix
4195 “Starfix”
* Note active fixation is NOT necessarily
isodiametric in all cases

Fixation: Active – Extendible/Retractable Helix

Helix deploys with rotation of terminal pin

Fixation: Active – Fixed Helix


Design Attribute

•

Helix fixed to lead body



Extraction
Considerations
Ex. Fixed Helix
• BSC FINELINE®*
• BSC THINLINE®*
• BSC SWEET TIP®
* - coradial

4

4195 Starfix

Starfix Extraction

Starfix Extraction

Courtesy Dr. Laurence Epstein

5

4195 Starfix

Connector


IS-1 / DF-1
 Has

a “yoke” around
which tissue grows
and has to be
dissected before the
lead can be pulled
through the tissues



IS-4/DF-4
 Eliminates

yoke and
reduces need for more
extensive dissection of
the lead from the
pocket

Lead Length
Leads that are longer than necessary
create a “plate of spaghetti” in the
pocket. Leads that are just the right
length need much less work to free
them from the fibrous pocket tissue.
 Excess lead also causes additional
pressure points and may lead to “Cold
Flow”


6

Silicone Failure: Mechanical
Abrasion: 11 Months

Abrasion: 4 years

Wear comes from contact with
other leads, yoke, device

Cold Flow: 1 year

Cold Flow comes from
repetitive forces or pressure

Lead Mounted Sensors


Sensors (such as pressure and oxygen
saturation) are being mounted onto the
lead body.
 Typically

NOT isodiametric
get hung up on fibrous sheath around
lead in vasculature preventing removal my
simple traction

 May

ICD Leads


Single vs Dual Coil
 2nd

coil typically positioned at most
vulnerable spots in the venous system
 Curve

from inominate into the SVC
of RA and SVC

 Junction

 Coils

are the site of most aggressive
fibrotic ingrowth; why add more ‘trouble”
 Proximal coil may “jam” in the sheath,
preventing forward or reverse movement

7

ICD Coil Attachment to the Venous System

Medtronic 6949 “Fidelis”

Lead Construction and Reliability


Lead integrity
 General

reliability (chronic lead
surveillance)
 Some models inherently more robust
 Have

high tensile strength
pull apart into components easily
 Tips don’t pop off from crimp/weld easily
 Don’t

Medical Adhesive Backfilled Coils (ICD)
 ePTFE coated Coils (ICD)


8

Tissue In-growth

Tissue In-Growth Solutions
Flatwire Design
+ Backfill

e-PTFE
Covering
Sleeve
Extraction Considerations
• Non-backfilled coils may have more tissue ingrowth possibly resulting in snowplowing of tissue: Try upsizing extraction sheath

Lead Construction and Reliability


General construction
 Unipolar
 Bipolar
 Multipolar



Conductor construction
 Coil
 Coradial

vs Coaxial

 Cable

9

Lead Body Design: MultiLumen Design
Design Attribute
• ICD leads have multiple lumens for High
Voltage Cables, Electrode conductors and
Crush lumens

Extraction

Integrated bipolar
uses RV coil as anode
for P/S

Guidant
BSX

Considerations

• Strip back insulation to verify distal
electrode conductor lumen insert lead
locking device for Lead Locking
Deployment.

MDT

STJ

Ellenbogen, Kenneth A., et al. “Engineering and Clinical Aspects of Defibrillation Leads.” Clinical Cardiac Pacing and Defibrillation, 2 nd Ed.
151-165. W.B. Saunders Company, Philadelphia 2000.

Insulation
Silicone
Polyurethane
 Hybrids
 New compounds



Optim ® performance (as of Q1 2010)
Optim® Effects on SJM Tachy Lead Abrasion
(Kaplan-Meier Analysis of US Data)

Abrasion Failure Probability
After 38 Months of Implant

0.0020

0.00191

0.0015

®

Optim Provides a Significant
Reduction in Abrasion Risk
(p<0.0001 by log-rank test)

0.0010

0.0005
0.00016
>90% Reduction

0.0000

SILICONE Tachy Leads
(Riata 8F & Riata ST)

OPTIM® Tachy Leads
(Riata ST Optim & Durata)

Courtesy Dr. Mark Carlson

10

Sterile Technique


Meticulous attention to Sterile
Technique
 All

involved in the lab or admitted to the lab
during the operation should be thoroughly
educated in sterile technique
 This is NOT Cathlab sterile technique, it is
Operating Room sterile technique
 Minimize personnel traffic in and out of the
room, as well as number of people in the
room

Sterile Technique


Proper use of prophylactic antibiotics
 Type
 Time



of administration

Irrigation
 Not

clear whether this helps or not
Every person on the jury during
your malpractice trial will know you were an
idiot for not irrigating with antibiotic solution
 TyRx antibiotic pouch
 However:

Conclusion
Planning prospectively for an extraction
can make the subsequent operation
more rapid and safe, and may reduce
the need for counter-traction and cutting
sheaths
 Lessons learned from why leads fail can
lead to lead choices and implant
techniques that reduce the need for
subsequent lead extraction


11

7/1/2013

Early Lead Failures and
Recalls
Andrew E. Epstein, MD
Professor of Medicine, Cardiovascular Division
University of Pennsylvania
Chief, Cardiology Section
Philadelphia VA Medical Center
Philadelphia, PA

• In response to a FDA
RFP, registry founded in
1974 by Drs. Bilitch,
Parsonnet and Furman.
• Maintained data on
devices, leads and
programmers.
• Funding ceased 1981.
• Registry continued at
USC, NBIMC, and
Montefiore.
• Dr. Bilitch died in 1987.
• Registry ceased in 1994.

Major CRM Lead Advisories / Recalls
Manufacturer

Lead / Lead Family

Issue

Medtronic

6972 Family 80A Poly U Leads
4002 Family 80A Poly U Leads
4012 Family 80A Poly U Leads
4004 Family 80A Poly U Leads
4504 & 4504M / 4582 Poly U CapSure
/ Target Tip Tined Atrial J Leads

80A Poly U degradation
80A Poly U degradation
80A Poly U degradation
80A Poly U degradation
80A Poly U degradation

St Jude Med.

1016 & 1026 Pacing Leads

55D Poly U (very thin) inner
insulation degradation

Telectronics

AccuFix & Encor “J” lead Family (The
“801” lead)

J shape retention wire
extruded thru insulation

Medtronic

Transvene ICD family leads

80A Poly U degradation

BSI

Endotak DSP Family ICD Leads

IS-1 connector failures

Medtronic

Fidelis Family ICD Leads

Pace-sense & high V cables
and coil fractures

St Jude Med.

Riata & Riata ST silicone ICD leads

Inside-out silicone abrasion
externalized cables

St Jude Med.

QuickSite & QuickFlex Bipolar Lds

Inside-out silicone abrasion
externalized cables (distal)
Courtesy of Mr. John Helland

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7/1/2013

Polyurethane Failure Mechanisms
External Surface
Contacts blood / tissue
Environmental Stress
Cracking (ESC)

Internal Surface
Contacts metal
conductors
Metal-Ion Induced
Oxidation (MIO)

80A Polyurethane
2 year explant
MDT 4058M
Courtesy of Mr. John Helland

MDT 4004
Pellethane 80A

MDT CRM Product Performance Report, 2006.

Telectronics AccuFix Lead
• Recalled in November
1994 after 2 deaths, 2
non-fatal injuries
• 45,000 worldwide
implants
• Risk of wire
fracture/protrusion
• Issue: More deaths
documented due to
extraction than lead
malfunction

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7/1/2013

260

40
Kay GN, et al. Circulation 1999;100:2344-2352.

Event-free Lead Function
(n=990)

Kleemann T, et al. Circulation 2007;115:2474-2480.

Transvene ICD Lead

Medtronic Product Performance Report, 2012.

3

7/1/2013

Sprint Fidelis ICD Leads
•
•
•
•
•

6930, 6931, 6948, and 6949
Market released in 2004
Smaller than previous ICD leads
268,000 implanted worldwide
172,000 implanted in the US

October 15, 2007
Voluntary suspension of distribution of Sprint Fidelis leads
High incidence of conductor fractures
90%: Low voltage conductor
• Distal portion of the lead, affecting the anode (ring electrode)
• Near anchoring sleeve, primarily affecting the cathode (tip/helix
electrode)

10%: High voltage conductor

Sprint Fidelis versus 4004

Fidelis

4004

Medtronic Product Performance Reports

Risk of Model 6949 Lead Failure

Farwell D, et al. Heart Rhythm 2008;5:1375-1379.

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7/1/2013

0.47% silicone abrasion over 9 years
Approximately 10% were inside-out
0.47% (abrasion) x 10% (externalization) =
0.047% Riata leads show externalized conductors

•
•
•
•
•

Usual monitoring
Lead parameters
Provocative testing: maneuvers, possibly fluoroscopy
Remote monitoring
Not prophylactic explant
St Jude Medical November 28, 2011.

5

7/1/2013

Analysis of OPTIMUM, SCORE, and
SJ4 Registries of Patients with
Durata and Riata ST Optim ICD Leads
Parameter

OPTIMUM

SCORE

SJ4

TOTAL

Enrollment years

2006-2009

2007-2012

2009-2010

—

Enrolled (n)

5929

3357

1534

10 820

Unique leads (n)

6016

3416

1573

11 005

3.5

2.3

2.7

3.0

Median follow-up (y)

Cairns J, et al. HRS LBCTs, May 9, 3013.

PHRI Analysis of St Jude Medical
Registries of Patients with Optiminsulated ICD Leads
Failure Rate (%)

Freedom from
Failure at 5 y (%)

All-cause mechanical failure

0.35

99.4

Conductor fracture

0.22

99.6

Insulation abrasion

0.07

99.9

0

100

End point

Externalized conductor

Cairns J, et al. HRS LBCTs, May 9, 3013.

Risk of Overreaction: Complications
Associated with ICD Replacement in
Response to Advisories
• 17 Canadian centers, 2915 recalled devices
• 533 (18.3%) replaced
• 66% primary prevention
• Complications in 43 pts (8.1%)
• Major requiring reoperation: 31 pts (5.8%)
• Death: 2 pts
• Minor complications: 12 pts (2.3%)
• Of explanted devices, 3 (0.1%) had malfunction
(early battery depletion), none with clinical
consequence
Gould PA, et al. JAMA 2006;295:1907-1911.

6

7/1/2013

Lessons Learned
• All leads have a finite failure rate.
• Goal of zero failure rate is unattainable.
• Resolution is in how failures are managed.
• Need post-marketing surveillance, not absence
of approval of new technology by requiring longterm follow-up before approval.
• Our responsibilities are to weigh the evidence
and make judgments of risk benefit ratios. This
requires data and understanding.

7

7/5/2013

Techniques for Lead Extraction
Oussama M. Wazni

Cardiac Electrophysiology
Cleveland Clinic

Scope
 250,000-275,000 ICD devices are implanted
yearly throughout the world.
 Up to 10% of all leads implanted may
require removal.

EPS: A growing demand
3 million implanted ICDs
180,000 pacing systems
Increasing indications
Aging population

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7/5/2013

Complications of Implantable
Cardiac Devices
 Non infectious
– Hematoma (5%)
– Lead dislodgement (2%)
– Pacing threshold evaluation (1%)
– Lead fracture (<1%)

 Infectious
– Erosion or incipient erosion (0.75 per 100 pts)
– All other infections (0.7 per 100 pts)
Klug et al Circulation 2007;116

Infection

Infection

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7/5/2013

Lead Fracture

Technique Failure

Venous Occlusion

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7/5/2013

Bilateral Occlusion

Poor
Judgment

Fibrotic Attachments

4

7/5/2013

Tissue Ingrowth

Extraction Risks
 Lead extraction risks:
– Rupture of SVC
– Perforation (with tamponade) of SVC with new lead
placement
– Cardiac tamponade
– Failure to extract an infected lead
– Low cardiac output
– Lead breakage and migration
– Avulsion of veins and myocardial tissue
– Death

5

7/5/2013

Tensile Strength

Locking Stylets

Apply Suture
Connect suture from lead outer insulation to closest LLD loop.

Example: 0 Ethibond
tied with 2 “throws”
for low profile

6

7/5/2013

Prepare the Target Lead(s)
 Exposing the inner coil
– Bipolar lead: must remove outer insulation, outer coil,
and inner insulation to expose inner coil

Inner Coil

One Tie

7

7/5/2013

Bull Dog

Liberator™

Wilkoff & Spectranetics Lead Locking
Devices

Wilkoff™ Locking Stylet 0.17” – 0.19”

Lead Locking Device® or LLD2

8

7/5/2013

Lead Locking Device® (LLD)
 Provides stable traction by
locking along the entire
contacted lead lumen
 Can be unlocked and
repositioned
Locked
Unlocked

Tensile Strength

9

7/5/2013

Countertraction
Sheaths

Counter Pressure
Push

Encapsulating
Tissue
Vein

Lead
Sheaths

Pull

Locking
Stylet

Lead

Counter
Traction

Locking Stylet
(Pull)

Lead
Body

Counteraction
Sheath
(Push)

Inverted Tined
Lead Tip Being
Extracted

10

7/5/2013

Counter-Traction
SLS II

Outer Sheath

Target Lead

Scar Tissue

Scar Tissue

Using SLS II Alone

Using the Outer Sheath

Lead Extraction Tools

 Locking Stylets

– Cook Locking Stylet – 1989
– Liberator Locking Stylet - 2000

 Mechanical sheaths
– Mechanical Sheaths
 Polypropylene (1989)
 Teflon (1990)
 Steel (1992)

 Byrd Femoral Workstation – 1990
– Dotter Basket/Tip Deflecting Guidewire -1990
– Needles-Eye-Snare - 1996

 Evolution – 2006
 One tie
 Bull dog

11

7/5/2013

Powered Lead Removal
Technologies







12F - Excimer Laser – 1994 (Clinical Trial)
12F – Excimer Laser – 1997 (FDA approval)
Lead Locking Device (LLD™) –1999
14F & 16F Excimer Laser Electrosurgical Dissection Sheaths - 2001
SLSII – 12F, 14F, 16F – 2003

Locking Stylet™ by COOK®

CVX-300® Excimer Laser
 Generates light at 308 nm
wavelength in the
ultraviolet spectrum
 Excimer laser enables
photoablation of lipids and
proteins
 Laser Medium = XeCI gas

12

7/5/2013

Mechanisms of Action






Photochemica Photothermal
l

Photomechanica
l

Dissolving
molecular bonds

Creating
kinetic energy

Produces photothermal energy

SLS II and Outer Sheath Options
 12 Fr

 14 Fr

Teflon outer
sheath offers
blunt and
beveled ends

 16 Fr

Electrosurgical Dissection
System sheath

13

7/5/2013

Electrosurgical Dissection
System sheath

Evolution

Evolution

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Evolution

Evolution

Evolution

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Conclusion

In the right patients if you know what you
are doing extraction is useful and safe

22



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