RECALLED LEADS: What to Do? When to Extract?€¦ · Salary Support: ACC (JACC EP) Speaker Bureau: None Unlabeled,Off-Label Use Disclosure: NA. Functional block diagram of implantable

RECALLED LEADS:

What to Do? When to Extract?

James P. Daubert, MD

Professor of Medicine

Director, Electrophysiology Section

Duke University Medical Center

Daubert: Presenter Disclosure Information (<2y)

Type of Support Entity

Consulting: Boston Scientific, Medtronic, VytronUS (DSMB), Northwestern Univ. (DSMB), Gilead (DSMB), Heart Metabolics, Orexigen (All

under $10,000 per year)

Advisory board: Biosense-Webster; Gilead (All under $10,000/y)

Honoraria for Educational

Symposia:

Boston Scientific, Medtronic, Sorin, St. Jude, Biotronik (All under

$10,000 per year)

Research Grants: Boston Scientific, Medtronic, Biosense-Webster, St. Jude,

Gilead. (All > $10,000 per year to Duke Univ.)

Institutional Fellowship

Support:

Boston Scientific, Medtronic, St. Jude, Biotronik, Biosense-

Webster, Bard (All > $10,000 per year to Duke Univ.)

Stock: None

Stock Options, Royalties: None

Salary Support: ACC (JACC EP)

Speaker Bureau: None

Unlabeled,Off-Label Use Disclosure: NA

Functional block diagram of implantable cardioverter defibrillator

(ICD) sense amplifier

Swerdlow C D et al. Circ Arrhythm Electrophysiol 2014;7:1237

Classification of oversensing


Classic features of pace-sense conductor fracture


JC: 33 yo male

• Nonischemic CMP with inducible VT

• ICD implanted

Fidelis Lead Design

Hauser et al, Heart Rhythm 2007;4:892

Actuarial survivals of 583 Sprint Fidelis model 6949 and 285 Sprint Quattro

model 6947 leads implanted at the Minneapolis Heart Institute.

Fidelis: Increasing Fracture Rate

Faulknier et al, AJC 2010;105:95

Fidelis Lead: Canadian Study

• 80 of 6181 (1.29%) failure rate at 21 months

• Sensing failure 75%, pacing failure 13%, HV failure 19%

• 45/80 had inappropriate shocks (median #=7)

Krahn et al, Heart Rhythm 2008;In Press

Vollmann D et al, Heart Rhythm, Volume 2, Issue 3, 2005, 307–309

Lead Failure-related inappropriate therapy triggers fatal proarrhythmia

Adverse Effects of ICD Shocks

• Electrical: Conduction block at high gradient

• Hemodynamic: Reduced BP, CO, systolic function, diastolic

function, lactate extraction.

• Pathological: changes near lead (fibrosis); mitochondrial changes;

• QOL: >5 shocks resulted in reduced QoL. [Heller, PACE 1998]

– Sears, Circ A/E 2011 : high incidence of anxiety, depression, PTSD in ICD patients predicted by age < 50, female, multiple shocks, poor social support, premorbid psychiatric diagnosis

– Pedersen et al: Shock-QOL effect depends upon baseline personality (Type D Personality Trait)

• Increased mortality with shocks for: VT or VF (Pacifico, Moss,

Poole…); with inapppropriate shocks in MADIT II, SCD-HeFT; possibly not with inappropriate shocks for oversensing (Saxon 2007)

Randomization ArmsArm A(Standard)

Arm B(High-rate)

Arm C(Duration-delay)

Zone 1 (VT): Zone 1 (VT): Zone 1 (VT):

>170 bpm, 2.5s delay 170 bpm >170 bpm, 60s delay

Onset/Stability Detection

Enhancements ON

Monitor only Rhythm ID Detection

Enhancements ON

ATP + Shock ATP + Shock

Zone 2 (VF): Zone 2 (VF): Zone 2 (VT):

>200 bpm, 1s delay >200 bpm, 2.5s delay >200 bpm, 12s delay

Quick Convert ATP

Shock

Quick Convert ATP

Shock

Rhythm ID Detection

Enhancements ON

ATP + Shock

Zone 3 (VF):

>250 bpm, 2.5s delayQuick Convert ATP + Shock

* All programming is within approved labeling

MADIT-RIT: RANDOMIZATION ARMS*

Prolonged Detection Programming Meta-analysis

Scott P et al, Heart Rhythm 2014; 11: 828-835

ICD Lead Failure Rates, Predictors

Kleeman, Circulation 2007;115:2474

ICD Lead Failure Types, Predictors

Kleeman, Circulation 2007;115:2474

ICD Sensing Failure Patterns

Schoenfeld, Circulation 2007;115:638

6936 Lead Failures

Ellenbogen et al, JACC 2003;41:73

Early Cases of Riata Failure

Both had single coil, active fix ICD lead Riata 1582

• Case 1: 43 F with secondary indication for ICD; abrupt rise in pacing impedance and threshold at 44 months with separation of conductors in the defibrillation lead from the main body of the lead. Decision for extraction; locking stylet only to proximal aspect of RV coil; beyond the proximal end of the defibrillation coil; powered sheaths failed; locking stylet dislodged; femoral approach failed; lead disrupted extensively; thoracotomy.

• Case 2: 60 F with secondary indication for ICD; evidence of over-sensing; also with separation of conductors in the defibrillation lead from the main body of the lead; lead abandoned and new ICD lead

Richards M et al, Europace 2010

Riata Insulation Defects: Early Case Series

“To the best of our knowledge, insulation defects at the level of the tricuspid valve have only been described in 2 case reports.The present report indicates that this specific insulation defect at the level of the tricuspid valve may be considerably underestimated … difficulties in making the correct diagnosis in the absence of abnormal electrical parameters…specific design of the Riata high voltage leads may be responsible …possible conductor movement in the separate lumina of the lead—and especially under chronic mechanical stress like at the level of the tricuspid valve—the pairs of conductors are rubbing through the insulation material.”

Erkapic D et al, JCE Apr 2011

Riata Insulation Defects: Early Case Series

Erkapic D et al, JCE Apr 2011

St Jude Riata Lead Design

Heart Rhythm Society. Riata Lead Webinar. Dec 21, 2011.http://www.hrsonline.org/Education/SelfStudy/Webcasts/HRS-Webinar-on-the-Riata-Leads-Issue.cfm

http://www.hrsonline.org/Education/SelfStudy/Webcasts/

Extent of the Riata Problem

ShockCoils

Model #s Worldwide Rate of Externalized Conductors

Remaining US Leads in Service

Riata 8 Fr Single 1562, 1572, 1582, 1592 0.64% 2,000

Dual 1560, 1561, 1570, 1571, 1580, 1581, 1590, 1591

0.096% 48,000

Riata ST 7 Fr Single 7002, 7042 0.081% 2,000

Dual 7000, 7001, 7010, 7011, 7040, 7041

0.024% 27,000



Riata family ICD leads: Fluoroscopic grading scale

Parvathaneni SV et al, Heart Rhythm 2012;9:1218

Estimated rates of externalized conductors over time after

implantation.

Dominic A.M.J. Theuns et al. Circ Arrhythm Electrophysiol. 2012;5:1059-1063

Of the 147 leads with externalized conductors, 10.9% had abnormal electrical parameters

vs 3.5% in nonexternalized leads (P<0.001).

Riata Meta-analysis: Cable externalization and electrical failure

Zeitler, Heart Rhythm 2015; 12, 1233 #24939

Riata Meta-analysis: Cable externalization


Riata Meta-analysis: electrical failure






Lead-Can Abrasion may be Dominant

• Of 263 Riata leads returned to SJM in Canada, 43 (16.8%) had insulation abrasion.

• Most of the 43 had electrical abn. (65.4%) including noise (45.2%), inappropriate shocks (25.8%).

• Lead-can abrasion accounted for 70% overall; inside-out abrasion a higher proportion relatively in 8F (37.5%)

• Two deaths (2/43), one with full data (1/43), model 7000 in lead-to-can insulation abrasion group due to failed defibrillation for ventricular arrhythmia; after 3.2 y; noted at autopsy.

Total Costs of Sprint Fidelis Recall

Mehrotra AK, Heart Rhythm Aug 2011

5-year cost of 175,000 Fidelis leads to Medicare ~$287,000,000

32

HRS Consensus Indications for ExtractionInfection Class

Infective endocarditis I

Pocket infection I

Occult gram-positive bacteremia I

Refractory Chronic Pain IIa

Thrombus/Venous stasis

Symptomatic thromboembolic events I

Bilateral subclavian or SVC occlusion I

Ipsilateral SVC occlusion IIa

Lead Indications

Life-threatening arrhythmia, interfere with device function/ Cancer Rx I

To permit MRI IIb

Functioning leads that carry future risk IIb

HRS Lead Extraction Consensus. Heart Rhythm. 2009

Riata Lead Management

• Normal leads should not be replaced

• Electrically abnormal leads should be replaced

• Electrically normal/structurally abnormal leads must be considered on a patient by patient basis– Extractions should be performed only in experienced extraction

centers per the 2009 HRS Extraction Consensus

• All removed leads should be returned



Shock Failure despite Normal Noninvasive Results

Shah et al, JCE May 2012

Replace Generator Only or Fidelis Also?

• “Thus, in keeping with the Heart Rhythm Society Task Force on Lead Performance Policies and Guidelines, which state, “lead revision or replacement should be considered if the risk of malfunction is likely to lead to patient death or serious harm, and the risk of revision or replacement is believed to be less than the risk of patient harm from the lead malfunction,” we contend that in patients undergoing generator replacementwho do not have substantial life-limiting comorbidities, Fidelis lead removal should be considered at experienced centers. Later removal after lead failure is likely to be more difficult and associated with a higher risk of complications, in addition to the potential consequences of lead failure.”

Maytin M and Epstein L, JACC Jan 2012

And Generator Change Accelerates Failure of SF

Lovelock J et al, Heart Rhythm Oct 2012

Incidence of venous obstruction post ICD implant

• Venogram at time of 105 ICD generator (1st) replacement procedures

• Complete occlusion 9%, severe stenosis 6%, moderate stenosis 10%

• Prior PM (before ICD) 67%

• Dual coil lead higher venous obstruction (but not 2nd ICD lead(?))

Lickfelt L et al, Europace 2004 6(1): 25-31

Dual Coil Lead Extraction: More Difficult and Riskier

Journal of the American College of Cardiology 61(9): 987-989 7 Centers

El-Chami, Heart Rhythm 2015 #24938 Emory and UPMC

Recalled Lead Extraction Outcomes: Fidelis and Riata

• Retrospective analysis of extraction procedures involving Fidelis (n=360) and Riata (n=102) leads at 2 centers (2007-2013)

• Riata procedures involved more leads: 1.8 ± 0.9 vs 1.3 ± 0.7

• Riata leads had longer dwell time: 5.5 ± 2.5 vs 4.3 ± 2.0 years

• Complete procedural success higher in Fidelis group: 99.4% vs96.1%; , P =0.024)

• Major complications: Fidelis 1.1% vs Riata 2.0% (p=NS)

• Total mortality 0.65% (p=NS); 2 SVC/RA laceration; PEA

• Riata more requirement for powered sheaths

• Riata were introduced earlier and recalled later than Fidelis

• Indication: malfunction 83%; malfunction more common in Fidelis extraction cohort and infection relatively

Multi-center Riata Extraction Study

• 2003-2013: 577 Riata/Riata ST (16%) leads extracted

• Mean age 64 [52-73 IQR]

• Mean implant duration: 44.7 months (0-124.6 months)

• Indication: infection 53%, malfunction 35.7%

• 34.9% had eternalized cables; those with EC had been implanted longer

• Complete procedural success: 99.1%.

• Major complications: n=5; 0.87% included: 3 SVC, RV laceration (death), tamponade. All in dual coil leads; 4/5 very experienced operators (15y); mean lead dwell time 44 mos.

Maytin M Heart Rhythm Sep 2014

Large Single Center Extraction Experience

• 2002-2012: 1079 pts underwent TLE; 430 with recalled (121 Riata, 308 Fidelis) and 649 pts with non-recalled ICD leads; 2056 leads extracted (59% ICD).

• 96.8% complete procedural success; 0.9% failure; 3.9% minor complication; 1.5% major complication.

• Fideis and Riata TLE outcomes similar.

• Lead implant duration less and complete procedural success higher in recalled lead procedures (98.6% vs 95.7%).

• Major complications; n=10 (SVC=2, RV=1); predictor was procedure duration

Brunner et al, Heart Rhythm Oct. 2013 [Cleveland Clinic]

Predictors of Extraction Complications

• 5521 leads (4137 PM, 1384 ICD) extracted in 2999 TLE procedures; pt age 67.2, 30.2% female, lead dwell 4.7 [2.4, 8.3] years, 2.0 [1.0, 2.0] leads per TLE

• Powered sheaths 74.9%• 95.1% complete procedural success, 1.1% failure, 3.62 %

minor complication, 1.8% major complication• 30-day mortality 2.2%; procedural mortality (n=11; 0.4%);

vascular laceration 0.4%, cardiac avulsion 0.3%; tamponade (0.23%)

• Multivariate predictors of major complication: lead age, EF < 15, platelet ct, need for sheath; not operator volume; notprior cardiac surgery (0.08)

• Multivariate predictors of mortality: BMI<25, ESRD, NYHA, Hgb, INR, infection indication, dual coil lead, lead age

Brunner, M. P., et al. (2014). Heart Rhythm 11(5): 799-805 Cleveland Clinic

“An additional sensitivity analysis found that the probability of procedure related death with extraction would have to be 1.85% in order for capping to be the preferred strategy with 100% certainty. A procedure related death with extraction of 0.90% would result in 50% certainty that capping was the optimal strategy and 50% certainty that extraction was the optimal strategy.”

Cost Effectiveness of Active Management of Sprint Fidelis at Generator Change

• Costs:– Abandon lead electively: $5084.39

– Extract lead electively $17,647.60

– Abandon lead urgently after fracture: $18,226.86

– Extract lead urgently after fracture: $31,002.34

• Proactive strategy: 6-month monitor, new lead at ERI; assuming 2/3 extract 1/3 abandon

• Reactive strategy: new lead only after fracture

• 90% chance that proactive strategy is cost-effective; abandoning; if shift toward abandon 2/3 then even more cost-effective

Bashir J Heart Rhythm Dec 2013

Lead Failure Detection Algorithm

1. Two NST w RR<200 ms < 1 week

2. SIC ≥10/d or >300.

3. Impedance change from baseline

*Both SIC or one & impedance.

Gunderson et al, J Am Coll Cardiol 2004;44:1898Note

Currently Implanted Leads have a low failure rate:

Minimum sample size for 80% power to detect differences

among failure rates in 3 manufacturers.

Daniel B. Kramer et al. J Am Heart Assoc 2015;4:e001672

RECALLED LEADS: What to Do? When to Extract?

• ICD leads are complex and inevitably prone to failure, in several different general modes, with two recent specific case design flaw examples leading to a high prevalence of recalled leads; PM leads have not had frequent recent recalls

• ICD lead failure can be more devastating than PM lead failure due to not only pacing loss but also failure of VT/VF protection (sensing or shock delivery) and especially inappropriate shocks.

• Aggressive monitoring (remote) & targeted programming are critical.

• Preemptive replacement decisions should be based on the likelihood of harm in the case of lead failure (PM dependency, 2ndary prevention), the expected failure rate, the risks of the procedure, and the competing risk-profile of the patient.

• Replacement choices include extraction vs abandon/replace vs S-ICD

Duke EP Lead Management Program

Jonathan PicciniJames DaubertCT Surgeons and CT anesthesia; nurses, techs

Donald HeglandRobert Lewis

Challenging Lead Recall Case 1

Infection post generator change, Riata (1581) RV lead

– Locking stylet only to mid RA (EZ; also tried #1)

– 3591 pulses with the 80 Hz 14 Fr laser 44 seconds

– 13F tightrail unsuccessful

– 4446 pulses with the 80 Hz 16 Fr laser 54 seconds; needed large outer sheath to remove RV lead; 16F laser only to mid RV distal coil; locking stylet broke during 16F laser

– Binding sites: innominate, svc, to RA in SVC/RA, TV, RV

Challenging Lead Recall Case 1

Failing (?) Lead: When to Intervene?

Documents

RECALLED LEADS: What to Do? When to Extract?€¦ · Salary Support: ACC (JACC EP) Speaker Bureau: None Unlabeled,Off-Label Use Disclosure: NA. Functional block diagram of implantable