ICD leads under advisory What should be done?

ICD leads under advisory What should be done? Shu Zhang, MD, PhD, FHRS, FESC Beijing Fu Wai Hospital Present by Chu-Pak Lau, MD Director, Cardiac Health Heart Centre Honorary Clinical Professor Queen Mary Hospital The University of Hong Kong

INTRODUCTION

Why do ICD leads fail and what s the consequences? Complex design with multiple cables Must tolerate high voltages Must tolerate high stress High frequency/low flex (heart/vasculature) Low frequency/high flex (shoulder) Manifestations of electrical and mechanical failure: inappropriate therapy failure to defibrillate loss of pacing -- mechanical injury to CVS structure or other leads, and/or thrombosis

Recent ICD leads under advisory Fidelis ICD leads (2009): FDA issued a Class I Recall of Medtronic Inc. Sprint Fidelis Defibrillator Leads, model numbers 6930, 6931, 6948 and 6949. Medtronic is advising physicians to stop implanting the leads and to return unused products to the firm. Riata ICD leads (2011): FDA is providing information and recommendations regarding safety concerns with the recalled Riata leads manufactured by St Jude Medical. These leads have an increased risk of premature insulation failure that can impact the lead s ability to function properly.

ICD LEAD FAILURE

Example of Sprint Fidelis Fracture Failure due to fracture of conductors: 90% of fractures are to pace-sense circuit, 10% to HV circuits Locations of fractures are highlighted in red above

Sprint Fidelis Performance Medtronic System Longevity Study*(SLS) and CareLink data 14.6% failure at 93 months, increasing 2% per year * System Longevity Study is a prospective and multi-center study to evaluate long-term performance of all Medtronic leads (29 years, over 75,000 leads evaluated proactively).

Example of Riata/Riata ST Inside-out Abrasion Failure due to inside out insulation defects leading to: externalized conductor cables (may be visible under fluoroscopy) short-circuiting between conductors internally Hauser, et al. Heart Rhythm May 2012; 9:742-749

Riata/Riata ST Performance 2013 St Jude Medical Phase I Results

RISK FACTORS FOR LEAD FAILURE

ICD Lead Failure in 990 ICD patients in 13 years Insulation defect is the most common type of lead failure Kleemann T, et al. Circulation 2007; 115:2474-2480

Age and gender impacting Lead Failure, e.g. Fidelis Fracture Hauser RG, et al. Circulation 2011; 123:358-363 Canadian Heart Rhythm Society Report Female gender, younger age and cardiac disease tend to have higher failure rate in Fidelis fracture (perhaps due to more active lifestyle and higher HR). Birnie DH, et al. Circulation 2012; 125:1217-1225

Venous Access and lead failure Canadian Heart Rhythm Society Report Birnie DH, et al. Circulation 2012; 125:1217-1225

Implant Procedure- Suture sleeve and Pocket location Subcutaneous Easy to access device/leads May predispose to erosion in thin patients Suture sleeve Submuscular More cosmetic looking Difficult to access device/leads Increase risk of adding stress or damaging connector, insulation and lead

Class I recall of ICD leads: A comparison of the Sprint Fidelis and Riata leads Sprint Fidelis: more likely to present with oversensing and inappropriate shocks Riata: showed a trend toward presenting with more high-voltage (shock) failure Liu J, et al. Heart Rhythm 2012; 9:1251-1255

MANAGEMENT OF LEADS UNDER ADVISORY

Manufacturer s Sprint Fidelis Patient Management Recommendations The Lead Integrity Alert (LIA) provides three days advance notice prior to inappropriate therapy to 76% of patients with lead fractures. As a result, we strongly recommend that all Sprint Fidelis patients who have the ability to upgrade to Lead Integrity Alert do so promptly. Also ensure that high voltage lead impedance alerts (maximum of 100 ohms) are programmed. When a lead fracture is suspected or confirmed, immediate patient attention is strongly recommended. Physicians should inform their patients to seek medical attention without delay if they experience unexpected shocks. If a Fidelis lead fracture of any type has occurred, we recommend implanting a new high voltage lead with or without extraction of the Fidelis lead. In patients with normal device function and no manifestation of lead fracture, no action is recommended. The risk of prophylactic intervention appears to be greater than serious injury resulting from lead fracture even for pacemaker dependent patients, except in select individual patient circumstances as determined by the physician. In the event of a device change-out or upgrade procedure, with no manifestation of lead fracture, consider the patient age and lead model data above, as well as patient life expectancy, co-morbidities, ease of extraction related to implant time, patient preference, etc., for the following options: Leave a properly performing lead intact. Implant a new ICD lead without extraction of the existing lead. Carefully consider all factors before prophylactic placement of a pace-sense lead given the data in Table 1, which shows an increased risk of high voltage conductor fracture if a pace-sense conductor fracture has previously occurred. Individual patient circumstances may warrant extracting and implanting a new ICD lead. If warranted, Medtronic s Independent Physician Quality Panel recommends the lead extraction procedure

Riata TM Lead replacement and extraction recommendations

Recommendations from HRS/ESC Heart Rhythm Society Task Force on Lead Performance * (2009) Managing Lead on Advisory Notices Periodic device monitoring (remote or in-person as appropriate) Lead revision or replacement considered based on risk-benefit analysis Reprogramming to mitigate risk from a lead malfunction Factors to considering replacement/revision of normally functioning leads subject to advisory Both patient and lead, for example: pacemaker dependence, surgical risk, rate of abnormal performance, malfunction characteristics and mechanism ESC/EHRA Pacing Guidelines 2013 Remote monitoring should be considered to provide early detection * developed in collaboration with the American College of Cardiology (ACC) and the American Heart Association (AHA)

MANAGEMENT OF FAILED LEADS

Should we extract or abandon leads (failed or on advisory)? Canadian Experience with Fidelis Revisions and Complications Significantly more complications when lead removed (complications required reoperation and minor complications). Death and cardiac arrest were similar. No randomized trials of extraction against abandonment of failed or advisory leads Every patient is different (clinical co-morbidities, anatomic variations, lead types and numbers) Parkash R, et al. Circulation 2010; 121:2384-2387

Potential issues with abandoned leads Lower success of future lead removal Risk of failed lead removal doubles every 3 years 1 More Infection Risk of erosion from more pocket bulk 2 Risk of infection increases 2-7% at each device change 3 More venous lead burden Risk of venous thrombosis or occlusion (prevent access to new leads; right-sided implant Risk of clotting or SVC syndrome More tricuspid lead burden Risk of increased tricuspid regurgitation 4 Lead-to-lead interaction Risk of inappropriate shocks or inappropriate pace/sense behavior MRI Contraindication Risk of tissue damage or cardiac stimulation due to inadvertent heating of the capped leads or induced lead current 1. Byrd, PACE 1999 2 Bohm, PACE 2001 3 Wilkoff, HRS 2007 4 De Cook, PACE 2000

When should leads be extracted (failed or on advisory)? Transvenous Lead Extraction: Heart Rhythm Expert Consensus (2009) *Expanded from the original NASPE Indication in 2000 Category Indication Class FUNCTIONAL LEAD Due to design or failure, may pose immediate threat I NON FUNCTIONAL LEAD Risk of interference with device operation Due to design or failure poses potential future threat Functional leads not being used (e.g. ICD upgrade) Need MRI with no other imaging options for diagnosis To permit the implantation of an MRI conditional CIED system Implant would require >4 leads on one side or >5 leads through SVC Need MRI with no other imaging options for diagnosis To permit the implantation of an MRI conditional CIED system Non functional lead at time of indicated CIED procedure Lead extraction apply only in patients where the benefits of lead removal outweigh the risks when assessed based on individualized patient factors and operator specific experience and outcomes. Wilkoff, et al. Heart Rhythm 2009; 6(7):1085-1104 IIb IIb IIb IIb IIb IIa IIa IIb IIb

LEAD PERFORMANCE MONITORING

Failed lead analysis and post market study Returned Product and Complaints Provide insights to failure mechanism, but Significantly underestimates failure rate (failed leads are not often returned/reported) Post-market Lead Study Since 2008, FDA required manufacturers to conduct 5 year studies on new FDA-approved ICD leads (at least 1,000 patients for 5 years after implantation) Prior to 2008, most manufacturers tracked lead performance via returned product and complaints Analysis of manufacturers ICD lead database (such as over 72,000 Fidelis leads for analysis)

Lead Integrity Alert (LIA) LIA is an alert algorithm in Medtronic devices that addresses lead failure: Rapid oversensing trigger, Automatic NID extension and Impedance Blanck Z, et al. JCE 2011;22:1107-1114

Lead Integrity Alert (LIA) Ellenbogen et al - LIA found 67% more ICD lead failures across manufacturers (Medtronic, St Jude Medical and Boston Scientific) compared to impedance monitoring 1 LIA now FDA approved for monitoring of non-medtronic leads Detection for lead issues Biotronik Boston Scientific St Jude Medical Medtronic Lead impedance Yes Yes Yes Yes Oversensed signals (SIC*) X X X Yes Auto NID extension post-alert X X X Yes Alert Device-based (audible or vibration) X Yes Yes Yes Wireless Yes** Yes Yes Yes Diagnostics EGM storage for NSVTs Yes Yes X Yes Oversensed signals counter (SIC*) X X X Yes Auto Pre-storage EGM activation post-alert X X X Yes Published data Performance on alert X X X 75% of patients receive at least a 3 day notification; false positive rate 1 in 1285 patient years * SIC Sensing Integrity Counter ** Some Biotronik models only 1 Ellenbogen KA, et al. Circ Arrhythm Electrophysiol 2013;6:1169-1177

Remote monitoring of lead performance - Home Monitoring (BIOTRONIK, Berlin, Germany) - CareLink Network (Medtronic Inc., MN, USA) - Latitude Patient Management system (Boston Scientific, St. Paul, USA) - Merlin.net (St. Jude Medical, Sylmar, USA) - Smartview (Sorin CRM SAS, Clamart, France)

ICDs are life saving ICD leads are the weak link Summary Consider all factors before replacing or extracting an ICD lead under advisory Returned product/complain analysis underestimates failure rate and delays detection of poor performance, hence post-market lead study is now required by FDA for all new ICD leads Implant techniques may also help with ICD lead survival LIA and remote monitoring are recommended for lead monitoring sicd can be an alternative to lead failure

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