Riata lead extraction- a single centre experience

Transcription

1 Riata lead extraction- a single centre experience Rebecca L Noad, Keith W Morrice, Vivek N Kodoth, Carol M Wilson, Michael JD Roberts. Royal Victoria Hospital, Belfast, United Kingdom

2 Background of previous CIED lead failures Previous lead failures Telectronics Accufix Pacing lead Medtronic Sprint Fidelis ICD lead Reported outcomes of extraction for lead failure have been variable Are the complications of extraction higher than the risks of actual or potential lead failure? 1-3 1) Kay GN et al. Risks of Spontaneous Injury and Extraction of an Active Fixation Pacemaker Lead : Report of the Accufix Multicenter Clinical Study and Worldwide Registry. Circulation. 1999;100: ) Maytin M et al. Multicenter experience with extraction of Sprint Fidelis Implantable Cardioverter-Defibrillator lead. JACC. 2010; 56:8: ) Parkash R et al. Complications Associated With Revision of Sprint Fidelis Leads : Report From the Canadian Heart Rhythm Society Device Advisory Committee. Circulation. 121:

3 Riata models Riata series 8F Silicone insulation Riata ST series 7F Silicone insulation (same thickness) Riata ST Optim , , F Optim insulation (copolymer of silicone and polyurethane)

4 World wide cases of externalised conductors were reported Inside-out failure Conductor cables inside the decompression space erode, and eventually breach the silicone outer insulation Our first Riata lead extraction was in 2006 Inappropriate shocks with evidence of insulation breach and externalised conductors on CXR

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6 Sept Elective Riata lead screening programme commenced in Belfast Results of which have been presented at ESC 2011 and ACC Dec Planned phase out of St Jude Riata and Riata ST 4.) Kodoth V et al. Riata lead failure; A report from Northern Ireland Riata lead screening programme. European Heart Journal. 2011;32(Abstract Supplement):310 5.) Hodkinson E et al. Follow-up Riata screening in Northern Ireland. J Am Coll Cardiol, 2012; 59:585

7 SJM advisory 11/28/11 For leads that exhibit externalized conductors with no electrical abnormality, continue to monitor lead and system performance as per HRS/EHRA guidelines. The value of routine x-ray or fluoroscopy for patients with leads having no electrical abnormalities is unknown at this time and is therefore not recommended. In addition, prophylactic explant or replacement of a lead without electrical dysfunction is not recommended. 6 6) Medical Device Advisory. St Jude Medical. 28 th November 2011

8 FDA Recall 12/14/11 Class 1 recall Riata and Riata ST because of the potential risk of serious injury or patient death if affected devices malfunction. The clinical implications of externalized conductors in a defibrillation lead without electrical anomalies are not fully known or understood at this time. 7 7.) FDA Voluntary Physician Advisory Letter on Riata and Riata ST Silicone Defibrillation Leads(URGENT MEDICAL DEVICE ADVISORY). 14 th December 2011

9 MHRA Device Alert 12/22/11 Continue to follow up all patients with Riata or Riata ST ICD lead Consider the need for further examination e.g. by ECG or X-ray, if a lead failure is suspected. Screen all Riata and Riata ST leads at pulse generator replacement with bi-plane fluoroscopy If evidence of a protruding conductor is found, the risks and benefits of lead replacement should be evaluated on a case by case basis in discussion with the patient. Prophylactic lead explantation is not recommended, other than in exceptional clinical circumstances. 8 8.) Medical Device Alert Ref: MDA/2011/112 MHRA Issued: 22 December 2011

10 No professional consensus as to the management of leads with insulation breach 9 Divergent data on safety of extraction of previously recalled leads 9.) Riata Lead Summit. Minneapolis Heart Institute Foundation. 20 th January 2012

11 Aims and Objectives To describe our experience of Riata lead extraction Do externalised conductors/ insulation breach have an influence on extraction outcome? To determine if this can be performed safely

12 Methods Retrospective analysis of CIED database to identify patients who had a Riata/Riata ST lead. Identification of patients who had undergone Riata lead extraction. Data on demographics, extraction indications, extraction techniques and patient outcomes were obtained.

13 Methods Continued Leads were classified by their fluoroscopic appearance prior to extraction Group A had insulation breach with externalised conductors (IB) Group B no insulation breach/externalised conductors (No IB) Indications for extraction and outcomes were classified according to HRS 2009 lead management consensus ) Wilkoff, BL et al. Transvenous Lead Extraction: HRS Expert Consensus on Facilities, Training, Indications and Patient Management. HRS 2009

14 Results 213 patients with 214 Riata ICD leads 101 8F Riata 1500 series 113 7F Riata ST 7000 series Implant period: Dec Mar leads were extracted from 26 patients. Extraction period: Oct Jan 2012

15 Demographics Demographics n=27 Age, mean ( SD) 59.7yrs ( 16.2) Sex Female Male ICD indication Primary Secondary LVEF <30% 13 NYHA I II III

16 ICD Lead Characteristics ICD Lead characteristics Duration of implant (mths) Median Interquartile range No. of implanted leads 2 3 Lead site RV apex Other Venous access Cephalic Subclavian Axillary GROUP A (IB)n=13 63 (40-79) GROUP B (No IB) n=14 28 ( )

17 ICD Lead Characteristics Cont d ICD Lead characteristics Size 8F 7F Coil number Single Dual Fixation Active Passive Group A (IB) n= Group B (No IB) n=

18 Primary Indication for Extraction- Group A (IB) 2 Noise 9 2 Inappropriate shocks Insulation breach only

19 Primary Indication for Extraction- Group B (No IB) Noise/undersensing 5 4 Inappropriate shocks Lead displacement Pain Patient request Infection/erosion

20 Indication for Extraction: HRS Classification GROUP A (IB) GROUP B (No IB) Class I Class IIa Class IIb

21 Principal Method of Extraction Extraction method Manual traction only Locking stylets/ sheaths only GROUP A (IB) n=13 GROUP B (No IB) n= Electrosurgical dissection (EDS) 4 2 Laser sheath 6 3

22 Markers of Procedural Difficulty Rating of difficulty Mild Moderate Severe Fluoroscopy time (mins) Median Interquartile range Procedure time (mins) Median Interquartile range GROUP A (IB) n= (7-28) 150 ( ) GROUP B (No IB) n= (6.5-33) 165 ( )

23 Procedural Outcomes Defined in HRS 2009 as:- Complete procedural success achieved in all cases

24 Complications

25 Complications One major complication (2009) 31 yr old female: secondary prevention 1581 model: 8F, dual coil, active fixation, implanted for 79 mths Inappropriate shocks and insulation breach on fluoroscopy Extensive fibrosis at SVC coil requiring EDS 9F & 11F Sustained tear at SVC/RA junction whilst using 11F Cook Evolution sheath Immediate surgical repair, with full recovery

26 Recognized Predictors of Difficulty Duration of implant 11&12 Non infection 11&12 Younger patient 12 Female 13 Contributing factor? 8F Riata, dual coil, no backfill 11) Bracke F et al. Extraction of Pacemaker and ICD leads: Patient & Lead characteristics in relations to the requirement of extraction tools. J Pacing and Clinical Electrophysiology. 2002;25: ) Byrd C et al. Intravascular extraction of problematic or infected PPM leads PACE 1999;22: ) Byrd C et al. Clinical Study of the Laser Sheath for lead extracion. The total experience in the United States. PACE;25:804-8

27 Observations on Externalised Conductors May not be able to advance a locking stylet to tip of Riata lead A larger sheath may be required to accommodate externalised conductors May occur intraprocedurally (2 cases in our series)

28 Case 85 yr old man admitted with device infection 1582 model: 8F, dual coil, active fixation, implanted 87 mths No insulation breach or externalised conductors on high resolution preoperative fluoroscopy Extracted using a LLD EZ locking stylet and 14F and 16F Spectranetics laser sheaths (SLS2)

29 Pre-procedural fluoroscopy

30 Intra-procedural externalisation of conductors

31 Riata lead extraction

32 Limitations Small, single centre study Retrospective Different periods of follow up for 8F & 7F

33 Conclusions Complete extraction of Riata leads with insulation breach and externalised conductors can be achieved with comparable levels of success and expected complications to those with intact insulation. In our experience it is feasible to extract Riata leads, mindful of the need for fully informed patient consent and the experience of the operating team.

34 Thank you!

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36 Lead Diameter/ Coil Group A (IB) n=13 7F Single 0 3 7F Dual 2 7 8F Single 9 2 8F Dual 2 2 Group B (No IB) n=14

37 Extraction Rates by Lead Models Lead model No. implanted No. extracted % extracted 1570 (8F, Passive, Dual) (8F, Passive, Dual) (8F, Passive, Single) (8F, Active, Dual) (8F, Passive, Dual) (8F, Active, Single) (7F, Active, Dual) (7F, Active, Single)

38 Predictors of Difficulty Duration of implant (mths) (median= 46.5) Mild- 22 (4-41.5) Mod ( ) Sev ( ) Age (yrs) Mild- 64 ( ) Sev- 52 ( )

39 Predictors of Difficulty 2 SEX Female Mild-5 Mod- 0 Sev- 2 Infection Mild- 2 Mod- 1 Severe- 2 Male Mild- 8 Mod- 8 Sev- 4

40 Predictors of Difficulty 3 7F Operator difficulty Mild- 5 Mod- 5 Sev- 1 8F Operator difficulty Mild- 7 Mod- 3 Sev- 5 Case time: 147 ( ) Case time: 284 ( ) Fluoro time 18 (6.3-36) Fluoro time 12.1 (7.8-26)

41 Single coil Mild- 7 Mod-4 Sev-3 Dual coil Mild-6 Mod-4 Sev-3 Predictors of Difficulty 4

42 Riata models Riata Riata ST 8Fr Diameter 7Fr Diameter

43 Surgical Option? Logistic EuroSCORE, Median (IQR) 3.56 ( ) European system for cardiac operative risk evaluation- measure of operative risk but developed for a different scenario

44 Learning Points Riata 1500 series coils were not backfilled Higher chance of tissue ingrowth Lead to vessel adhesions Beware of SVC/ RA junction, particularly in dual coil leads Riata 1500 series coils were also not covered Shown to be more difficult to extract than eptfe covered coils 6. 6.) Cori A et al. Transvenous Extraction Performace of eptfe covered ICD leads in comparison to traditional ICD leads in humans. PACE 2010;33: