11 | ©2013 spectranetics. all rights reserved. approved for external distribution d014953-05 092013...

11 | ©2013 Spectranetics. All Rights Reserved. Approved for External Distribution D014953-05 0920131 | ©2013 Spectranetics. All Rights Reserved. Approved for External Distribution D014953-05 092013

KSPANMARCH 12, 2015

CURRENT TRENDS IN LEAD MANAGEMENT

RA LEAD RV LEAD

LV LEAD

CARDIAC LEAD PLACEMENT

33 | ©2013 Spectranetics. All Rights Reserved. Approved for External Distribution D014953-05 092013

Manage Every LeadSafely. Predictably. Responsibly.


Overview

This presentation will cover the following topics:

• Case Preview

• Growing Need for Lead Management

• Expanding Indications

• Safety and Efficacy

• Where Do You Fit In


THE GROWING NEED FOR LEAD MANAGEMENT


Growing Number of CRM Systems & Leads1-4

•7 million CRM devices worldwide

•13 million leads worldwide

•700,000 new devices annually

•1.4 million new leads annually


Changing Device & Patient Population5,6,7

• 35%8 of new implants are ICDs and CRT-Ds Characteristics of defibrillation leads:

• Larger size• Shocking coils promote more fibrosis• Complex design, higher malfunction rate

• CRT-Ds have more leads per device

• ICD patients are younger, live longer • More upgrades and replacements• Greater lead burden• Higher risk of infection


The Need to Manage ICD Leads is More Prevalent Today

1999 2009 2013

An estimated 65%10 of today’s extractions involve dual coil ICD leads

The annual failure rate of ICD leads increases progressively with time after implantation, reaching 20% in 10-year-old leads7


EXPANDING INDICATIONS


5% Estimated Annual Incidence and Growing

1% Infection• ≤0.5% infection rate for new

implants11

• 2-7% infection rate for replacements/upgrades11

2.5% Malfunction• 1.65%-20% annual ICD lead failure

based on age 7, 12

0.5% Occlusion• 9-35% of device replacement or

upgrade5,13

1% Redundant• +Advisory Leads• +MRI Conditional


HRS indications for lead extraction apply only to those patients in whom the benefits of lead removal outweigh the risks when assessed based on individualized patient factors and operator specific experience and outcomes. See HRS consensus document Class III indications for when lead removal is not recommended.

Growing Need for Lead ManagementExpanded Indications from 14 to 3014

CATEGORY INDICATION CLASS

Infection Pocket infection I Occult gram-positive bacteremia I Occult gram-negative bacteremia IIa

Chronic Pain Severe chronic pain IIa

Occlusion Ipsilateral occlusion w/o contralateral contraindication IIa

Functional Lead Due to design or failure, may pose immediate threat I Risk of interference with device operation IIb Due to design or failure poses potential future threat IIb Functional leads not being used (ICD upgrade) IIb To permit the implantation of an MRI conditional CIED system IIb Need MRI with no other imaging options for diagnosis IIb

Non Functional Lead Implant would require > 4 leads on one side or >5 leads through SVC IIa Need MRI with no other imaging options for diagnosis IIa To permit the implantation of an MRI conditional CIED system IIb Non functional lead at device/lead procedure IIb


Infection

59%

41%

Pocket Infection

Endovascular Infection37

(intact pocket)*

• >40% of all patients involve difficult-to-diagnose endovascular infections

– “Diagnosis usually made by combining clinical findings with microbiology and echocardiographic imaging studies”

• Many infection patients may be under-diagnosed

*A device pocket that appeared benign but who had systemic signs and symptoms of infection and a clinical history, supported by microbiology and occasionally echocardiographic imaging data that guided the treating team to the diagnosis of device-related infection


* Creatinine ≥2.0 mg/dl

0.28%

1.7%

4.3%

7.9%

12.4%

0.3%0%

2%

4%

6%

8%

10%

12%

14%

Pocket Infection

Device-related Endocarditis (DRE)

DRE + Diabetes

DRE + Renal Insufficiency*

All-cause in-hospital m

ortality

Laser-assisted Lead Extraction

Procedure

Mo

rtal

ity

No Infection

Lower mortality risk for laser lead extraction procedure than with infection and co-morbidities9


Advisory Leads- Sprint Fidelis®

15.5% failure at 99 months, increasing about 1.8% per year18

Sprint Fidelis® Model 6949 Lead Performance – May 2013

20% of 97 functioning Fidelis leads removed for reasons other than malfunction had evidence of fracture not due to lead extraction.19

20% of 97 functioning Fidelis leads removed for reasons other than malfunction had evidence of fracture not due to lead extraction.19

Fidelis is a registered trademark of Medtronic.


Advisory Leads- Riata™

Riata is a registered trademark of St. Jude Medical.

• Riata's manufacturer, St. Jude Medical Inc., recalled these leads on Nov. 28, 2011, due to premature erosion of the insulation around the electrical conductor wires, known as insulation failure.22

• “Inside-out abrasion involves conductors being visible outside of the lead body through x-ray or fluroscopy.”20

• “Even moderate changes in lead impedance within normal limits at follow-up should prompt careful fluoroscopic evaluation”21

• “Since insulation defects at the level of the tricuspid valve occur late during follow-up, routine fluoroscopic examination of leads should be advised prior to elective generator change.”21

• Riata's manufacturer, St. Jude Medical Inc., recalled these leads on Nov. 28, 2011, due to premature erosion of the insulation around the electrical conductor wires, known as insulation failure.22

• “Inside-out abrasion involves conductors being visible outside of the lead body through x-ray or fluroscopy.”20

• “Even moderate changes in lead impedance within normal limits at follow-up should prompt careful fluoroscopic evaluation”21

• “Since insulation defects at the level of the tricuspid valve occur late during follow-up, routine fluoroscopic examination of leads should be advised prior to elective generator change.”21


Exposed Conductors


Advisory Leads- Riata™

Riata is a registered trademark of St. Jude Medical.

French SizeLeads with EC/Total

Leads (%)Implant

Duration (years)

7F (Riata ST Leads) 24/259 (9.3%) 4.8 (+/-) 0.9

8F (Riata Leads) 125/517 (24.2%) 6.5 (+/-) 1.6

Occurrence of Externalized Conductors Based on Fluoroscopic Imaging39


Venous Occlusion

Occlusions may pose a significant challenge during a device upgrade

or a malfunctioning lead replacement

Image courtesy of Dr. Avi Fischer

Occlusion Management Options

•Laser lead extraction

•Implant a new system on contralateral side

•Tunnel leads from contralateral side

•Implant and tunnel an epicardial lead

•Venoplasty to gain access


Redundant Leads23,24

Abandoned leads can be a risk factor:

• As a source for infection

• Venous and tricuspid lead burden

• For venous occlusion due to compromised vascular space

Image Courtesy of Dr. Adrian Almquist


MRI Contraindication

• Capped & Abandoned leads are a major contraindication for MRI

• MRI is the gold standard diagnostic tool for soft tissue imaging for neurologists, oncologists, and orthopedic surgeons.

• It is estimated that up to 75% of pacemaker patients will have a medical need for an MRI over the lifetime of their device.25


LASER ABLATION


Lasers and the Light SpectrumUltraviolet vs. Infrared

351 nm XeFl

248 nm KrFl


Photochemical

Photothermal

Photomechanical

Breaking molecular bonds

Producing thermal energy

Creating kinetic energy

Mechanisms of Action


1: Photochemical Mechanism Breaking molecular bonds

• UV light pulse hits tissue for 135 billionths of a second (135ns); the duration of the laser pulse

• 50 microns penetration • Billions of molecular bonds fractured per pulse• After 135 billionths of a second, laser energy is not emitted

0 - 135 billionths of a second


2: Photothermal MechanismProducing thermal energy

• Absorption vibrates the molecular bonds of the plaque• Vibration of bonds heats intracellular water• Water vaporizes, molecules break apart, therefore rupturing cells• Expanding vapor bubble forms in 100 millionths of a second (100

ms)• 1,000 times the duration of the actual laser energy emission

100 millionths of a second


3: Photomechanical Mechanism Creating kinetic energy

• Expansion and collapse of vapor bubble breaks down tissue and clears by-products away from tip

• By-products of ablation are water, gas, and small particles• Entire process time per pulse is 400 millionths of a second (400 μs) – 4,000 times the duration of the actual laser energy emission

400 millionths of a second


SAFETY & EFFICACY


Proven SafetyLaser Lead Extraction

* 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.

PLEXES153 pts / 9 centers

Total US1,684 pts / 89 centers

LExiCon1,449 pts / 13 centers

SLS®SLS®SLS®SLS® SLS® IISLS® IISLS® IISLS® II

1.10%*1.10%*


Lead Extraction in the Contemporary Setting9

97.7% Clinical Success Rate


• Leads implanted <10 years

• >60 laser lead extraction cases over 4 years

• Use procedure protocols defined by lead extraction guidelines

• Body mass index <25 kg/m2

• Leads implanted ≥10 years

• Low volume centers with ≤60 laser lead extraction cases over 4 years

• Higher all-cause in-hospital mortality associated with endocarditis (4.3%), endocarditis and diabetes (7.9%), or endocarditis and renal insufficiency** (12.4%)

Factors associated with higher procedural and/or clinical success

Factors associated with higher procedural and/or clinical success

Factors associated with higher complications or lower success*

Factors associated with higher complications or lower success*

* Procedural and/or clinical success** Creatinine ≥2.0 mg/dl

Lead Extraction in the Contemporary Setting9


Perceptions of Laser Lead Extraction Safety35

* 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

1.1%*

Procedural MAEs Procedural Mortality

Perceived Acceptable LExICon34 Perceived Acceptable LExICon34


0%

1%

2%

3%

4%

5%

6%

A-Fib Ablation DFT

5.9%40

0.08-0.23%41

PCIs

4-5%42

1-2%42

0.4%45

* 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

Procedural MAEs

Procedural Mortality

0.07%45

Lead Removal(LExICon)

1.4%44

0.28%44

2.2%43

Lead Addition/Revision

1.1%^

Comparative Complication Rates*


Infection

Malfunction

Quadripolar Leads

Occlusion

Redundant

MR Conditional

Comprehensive Lead Management

Program

The Need to Provide a Comprehensive Lead Management Program Continues to Grow


Benefits- Laser Lead Management Program• Quality and comprehensive patient care

• Manage patients leads from implant to removal – Low complication rate32-34

– High success rate32-34

– Efficient procedural time32

• LLE is a procedure that can differentiate your hospital from others

• Hospital Benefits– Class I indicated patients no longer need to be transferred to another hospital

for device and hardware removal


A Prepared Extended Team is Essential • EP/Physician Extractor• Lab Staff (RN, RT, LPN)

– Pre-Op, PACU, Cardiac

• Anesthesia• CV Surgeon • Perfusion• OR staff• Administration• Echo operator (TEE, TTE or ICE)


Next Step is to develop a Team Approach• Bringing the extended team together facilitates

understanding, collaboration and alignment that help drive successful outcomes.

• Understanding of:– Why this procedure is performed

– How the procedure is performed

– Where complications may occur

– Considerations for each member in managing the complication

• The team feels prepared; They know the plan and their role in it


Pre-Op Patient Considerations• Cardiac device pocket examination• INR• CBC• Chem Panel• LFT• PT/PTT/INR

• CONSENT for lead extraction, possible or definite re-implant

• Work up similar to CABG


Post-Op Considerations• BP• Heart Rhythm (Paced or Non)• Site checks• Femoral site checks• O2 Sats

• Monitor as if a post-op CABG


Conclusions

• Changing markets and changing patient needs facilitate a need for lead management

• HRS recognized this need through expanded indications

• Treatment decisions should be patient focused

• Lead extraction is proven to be a safe and effective treatment option


Questions and Comments???

• Good or BAD excepted!!!


Important Safety Information

GlideLight™ Laser SheathThe GlideLight Laser Sheath is intended for use with other lead extraction tools in patients who are suitable candidates for removal of implanted pacemaker and defibrillator leads. The use of the GlideLight Laser Sheath may be unsafe in some patients, or with certain leads, or when the leads cannot be extracted through the superior veins (that is, when groin or surgical extraction is required). Rarely a patient undergoing lead extraction may require urgent surgical treatment for a complication; therefore, patients should not undergo lead extraction with a laser sheath in centers where emergency surgical procedures cannot be performed. Leads not intended for extraction may be damaged during the procedure and may require replacement. Ask your doctor if you are a candidate for lead extraction with the GlideLight Laser Sheath.

Potential minor adverse events associated with lead extraction procedures that may or may not require medical or surgical treatment include: a tear or damage to the blood vessels, the heart or its structures; bleeding at the surgical site; or collapsed lung.

Rare but serious adverse events that require emergency medical or surgical procedures may include: a tear or damage to the blood vessels, the heart, lungs or their structures; blood clot or obstruction of the blood vessels or lungs by debris or lead fragments. Other serious complications may include: irregular heartbeat, weakened heart muscle, infection, respiratory failure or complications associated with anesthesia, stroke or death.

This information is not intended to replace a discussion with your healthcare provider on the benefits and risks of this procedure to you.

SLS® II Laser SheathThe Spectranetics Laser Sheath (SLS II) is intended for use with other lead extraction tools in patients who are suitable candidates for removal of implanted pacemaker and defibrillator leads. The use of the SLS II Laser Sheath may be unsafe in some patients, or with certain leads, or when the leads cannot be extracted through the superior veins (that is, when groin or surgical extraction is required). Rarely a patient undergoing lead extraction may require urgent surgical treatment for a complication; therefore, patients should not undergo lead extraction with a laser sheath in centers where emergency surgical procedures cannot be performed. Leads not intended for extraction may be damaged during the procedure and may require replacement. Ask your doctor if you are a candidate for lead extraction with the SLS II Laser Sheath.

Potential minor adverse events associated with lead extraction procedures that may or may not require medical or surgical treatment include: a tear or damage to the blood vessels, the heart or its structures; bleeding at the surgical site; or collapsed lung.

Rare but serious adverse events that require emergency medical or surgical procedures may include: a tear or damage to the blood vessels, the heart, lungs or their structures; blood clot or obstruction of the blood vessels or lungs by debris or lead fragments. Other serious complications may include: irregular heartbeat, weakened heart muscle, infection, respiratory failure or complications associated with anesthesia, stroke or death.

This information is not intended to replace a discussion with your healthcare provider on the benefits and risks of this procedure to you.


References1. Medtronic CRDM Product Performance Report, Mar 2013. Eucomed (2012)2. Boston Scientific CRM Product Performance Report, Q1 2013. Eucomed (2012)3. St. Jude Medical CRM Product Performance Report, Apr 2013. Eucomed (2012)4. Biotronik Product performance Report, JAN 2013. 5)Millennium Research Group, Global Markets for Cardiac Rhythm Management Devices 2013. 5. Fields, Michael E., et al. How to select patients for lead extraction. Heart Rhythm, Vol 4, Issue 7, July 2007.6. Voight, Andrew, et al. Rising Rates of Cardiac Rhythm Management Device Infections in the United States: 1996 through 2003. JACC Vol. 48, No. 3, 2006: 590-1.7. Kleeman Thomas, et al. Annual Rate of Transvenous Defibrillation Lead Defect in Implantable Cardioverter-Defibrillators over a Period of >10 Years. Circulation 2007; 115:2474-2490.8. Millennium Research Group, Global Markets for Cardiac Rhythm Management Devices 2011.9. Wazni, O et. al. Lead Extraction in the Contemporary Setting: The LExICon Study: A Multicenter Observational Retrospective Study of Consecutive Laser Lead Extractions, J Am Coll Cardiol, 55:579-

586.10. Spectranetics Case Log date May to August of 201211. Wilkoff, Bruce L. , et al. How to treat and identify device infections. Heart Rhythm, Vol 4, No 11, 2007, 1467-1470.12. Hauser, Robert, et. al., The Increasing Hazard of Sprint Fidelis Implantable Cardioverter-Defibrillator Lead Failuree, Heart Rhythm, Vol. 6, No 5, May 2009.13. Worley, Seth J. Implant Venoplasty: Dilation of Subclavian and Coronary Veins to Facilitate Device Implantation: Indications, Frequency, Methods, and Complications. Journal of Cardiovascular

Electrophysiology Vol. 19, No. 9, September 2008, 1004-7.14. 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. Retrieved May 13, 2009, from www.hrsonline.org/Policy/ClinicalGuidelines/leadextract_cieds.cfm 15. Cabell, CH, et al. Increasing rates of cardiac device infections among Medicare beneficiaries: 1990-1999. Am Heart J 2004; 582-6.16. Voight, Andrew, et al. Continued Rise in Rates of Cardiovascular Implantable Electronic Device Infections in the United States: Temporal Trends and Causative Insights. PACE Vol. 33, No. 4, 2010: 414-9.17. Diabetes Mellitus and heart failure. Baddour, L.M., et. al., Update on Cardiovascular Implantable Electronic Device Infections and Their Management: A Scientific Statement From the American Heart

Association, Circulation, 121:458-477.18. Medtronic, Product-Advisories, Medtronic Website, Downloaded on May 18, 2013, http://www.medtronic.com/product-advisories/physician/sprint-fidelis/6949-LEAD-PERFORMANCE19. Maytin, M., et al., Fractures Found in Prophylactically Removed Sprint Fidelis Leads: The Iceberg?, Abstract, Heart Rhythm (2011) Volume 8, No. 5, May Supplement, S19.20. St Jude Medical, Product Advisories, St Jude Website, Downloaded July 15, 2011:

http://www.sjmprofessional.com/Media/DownloadResource.aspx?id=%7B59163A28-D8BA-4310-AECD-6ECB40A28C53%7D21. Erkapic, Damir, et al. Insulation Defect of Thin High-Voltage Leads: An Underestimated Problem? Journal of Cardiovascular Electrophysiology, published online April 1, 2011.22. Downloaded on January 21, 2013 from http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm314930.htm23. Bohm, Adam, et al. Complications Due to Abandoned Noninfected Pacemaker Leads. PACE, Vol 24, No 12, 2001, 1721-1724.24. de Cock CC, et al. Long-term outcome of patients with multiple (> or = 3) noninfected leads: a clinical and echocardiographic study. PACE, Vol 23, No 4, 2000, 423-6


References25. Kalin R, Stanton MS. Current clinical issues for MRI scanning of pacemaker and defibrillator patients. PACE. April 2005;28(4):326-328.26. Global Industry Analysts, Inc. Magnetic Resonance Imaging (MRI) Equipment – A Global Strategic Business Report. San Jose, CA. 2002.27. National Cancer Institute. April 2009. US estimated complete prevalence (including counts) by age on 1/1/2006. Based on November 2008 SEER data submission;

DCCPS, Surveillance Research Program, Statistical Research and Applications Branch.28. Lawrence RC, Helmick CG, Arnett FC, et al. Estimates of the prevalence of arthritis and selected musculoskeletal disorders in the United States. Arthritis Rheum. May

1998;41(5):778-799.29. American Heart Association. Heart Disease and Stroke Statistics – 2010 Update: Learn and Live. Prevalence of stroke by age and sex (NHANES: 2003-2006).30. Byrd, CL, et al. Intravascular extraction of problematic or infected permanent pacemaker leads: 1994-1996. U.S. Extraction Database, MED Institute. PACE 1999;

22:1348-1357.31. Levine, GN, et al. Safety of Magnetic Resonance Imaging in Patients with Cardiovascular Devices. Circulation, Vol. 116, 2007, 2878-2891.32. Wilkoff, Bruce, L., et al. Pacemaker Lead Extraction with the Laser Sheath: Results of the Pacing Lead Extraction with Excimer Sheath (PLEXES) Trial. JACC, Vol 33, No.

6, May 1999.33. Byrd, Charles, et al. Clinical Study of the Laser Sheath for Lead Extraction: The Total Experience in the United States. Journal of Pacing and Electrophysiology. Vol l25,

No. 5, May 2002.34. Wazni, O et. al. Lead Extraction in the Contemporary Setting: The LExICon Study: A Multicenter Observational Retrospective Study of Consecutive Laser Lead

Extractions, J Am Coll Cardiol, 55:579-586.35. Data on file at Spectranetics. Lead Extraction Survey, conducted by in2ition for Spectranetics. January 2010.36. Baddour, L.M., et. al., Update on Cardiovascular Implantable Electronic Device Infections and Their Management: A Scientific Statement From the American Heart

Association, Circulation, Volume 121, Issue 3, January 26th 2010, pp 458-47737. Tarakji, K, et al. Cardiac implantable electronic device infections: presentation, management, and patient outcomes, Heart Rhythm, Vol. 7, No. 8, 2010: 1043-7.38. Lovelock JD et al. Generator exchange is associated with an increased rate of Sprint Fidelis lead failure, Heart Rhythm 2012 Oct;9(10):1615-8. doi:

10.1016/j.hrthm.2012.06.009. Epub 2012 Jun 6.39. St Jude Medical Riata Defibrillation Leads Product Performance Information, St Jude Website , Downloaded August 19,

2013:http://professional.sjm.com/resources/product-performance/riata-important-info/physician-information/direct-to-physician40. Cappato R, Calkins H, Chen SA, et al. Worldwide Survey on the Methods, Efficacy, and Safety of Catheter Ablation for Human Atrial Fibrillation. Circulation 2005;

111:1100-1110541. Cappato R, Calkins H, Chen SA, et al. Prevalence and causes of fatal outcome in catheter ablation of atrial fibrillation. J Am Coll Cardiol 2009; 53:1798-1803. 42. Kern M. SCAI Interventional Cardiology Board Review Book. Lippincott Williams & Wilkins 2006; p.165. 43. Poole, J. et. al., Complication Rates Associated with Pacemaker and ICD Generator Replacements when Combined with Planned Lead Addition or Revision, American

Heart Association, November 15, 2009.44. Wazni, O et. al. Lead Extraction in the Contemporary Setting: The LExICon Study: A Multicenter Observational Retrospective Study of Consecutive Laser Lead

Extractions, J Am Coll Cardiol, 55:579-586.45. Brignole, M. et. al., Defibrillation testing at the time of implantation of cardioverter defibrillator in the clinical practice: a nation-wide survey, Europace 2007 Vol. 9

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