Riata Lead Extraction. Thomas D. Callahan, MD, FACC, FHRS

Transcription

1 Riata Lead Extraction Thomas D. Callahan, MD, FACC, FHRS

2 Outline Riata lead history Lead design Lead Failure Extraction outcomes Techniques Special considerations

3 Riata Lead Background 8F introduced in March F introduced in June 2005 Remaining active implants ~39,800 US implants ~136,000

4 Riata Lead Design - Silicone insulation - Ethylene tetrafluoroethylene insulation around cables - No outer protective coating Hayes D, et al. Heart Rhythm 2013;10:

5 Riata Failure Rates Riata lead advisory was announced on November 28, 2011, Conductor externalization (CE) in up to 25% More common in 8F lead Electrical Failure (EF) far less common Not always in the presence of CE Parkash R et al. Heart Rhythm2015;12: )

6 Background Failure Free ICD Lead Survival Failure-free ICD lead survival for 5 major lead models from 3 manufacturers. Liu J et al. Longitudinal Follow-Up of Implantable Cardioverter Defibrillator Leads. The American Journal of Cardiology, Volume 113, Issue 1, 2014,

7 Incidence of Lead Failure Providencia R et al. J Am Heart Assoc. 2015

8 Incidence of Lead Failure Providencia R et al. J Am Heart Assoc. 2015

9 Case 1 68 y/o M with CAD, ICM, EF 30% ICD placed for primary prevention CE found with lead follow-up

10 Case 1 68 y/o M with CAD, ICM, EF 30% ICD placed for primary prevention CE found with lead follow-up

11 Riata Mechanism of Failure Silicone Inert and stable in biological environment Soft High coefficient of friction Insulation abrasion Outside-in Can-to-lead, lead-to-lead Inside-out Repetitive motion of ETFE coated cables within silicone-walled lumens Manifest by externalized cables Hauser RG, McGriff D, Retel LK. Heart Rhythm. 2012;9: Swerdlow C, Kalahast G, Ellenbogen K. JACC 2016;67:

12 Abrasion in Riata Providencia R et al. J Am Heart Assoc. 2015

13 RT Xray - ~80% of inside-out abrasions occur between the coils - ~10% under the coils

14 RT Xray - ~80% of inside-out abrasions occur between the coils - ~10% under the coils

15 Case 1 Incidental finding of Inside-Out abrasion Discussion with patient Continued lead monitoring

16 Case 2 62yo male w/ ICM (EF 35%) VVI ICD implant in 2005 Riata 1580 lead Apical aneurysm VT 3 prior ablations. Generator changed in 2013 About 1 y later, Noise and oversensing

17 Case 2

18 Decision Making for Lead Management Factors to Consider Mechanism of LF Clinical presentation of LF: frequent shocks, defibrillation failure, among others Incidence of LF: time course Age of patient Age of lead Indications for the ICD (primary vs. secondary prevention) Underlying rhythm True bipolar vs. integrated bipolar design DF-4 vs. DF-1 design Number of chronic or associated leads Management Options Observe with reprogramming Modify existing hardware configuration Insert new rate/sense lead Insert new ICD lead Insert defibrillation coil Extract and reimplant a new transvenous system Implant subcutaneous ICD system Implant hybrid system Advisory recommendations Prior cardiac surgery Comorbidities and prognosis Prior generator change Other clinical predictors of LF: risk factors predicting higher rate of LF Pacemaker dependence Risk of lead extraction: dual coil vs. single coil; length of implant; prior cardiac surgery; institution experience; operator experience; other risk factors Charles D. Swerdlow, Gautham Kalahasty, Kenneth A. Ellenbogen. Journal of the American College of Cardiology, Volume 67, Issue 11, 2016,

19 Case 2

20 Riata Failure Rates CE higher in 8Fr leads 8Fr 30.5% 7Fr 9.6% CE associated with 6x increase in EF Overall EF Rate 6.3% EF without externalization not trivial Zietler E et al. Heart Rhythm 2015;12:

21 Electrical Failure in Presence of Externalization Zietler E et al. Heart Rhythm 2015;12:

22 Electrical Failure in Presence of Externalization Zietler E et al. Heart Rhythm 2015;12:

23 Electrical Failure in Absence of Externalization Zietler E et al. Heart Rhythm 2015;12:

24 Electrical Failure in Absence of Externalization Zietler E et al. Heart Rhythm 2015;12:

25 Riata EF Presentations Lead Outcome Quattro Fidelis Riata Durata Reliance Functional lead, patient deceased, n (%) 264 (26) 77 (12) 198 (32) 46 (6) 847 (39) Functional leads replaced, n (%) 30 (3) 99 (16) 24 (4) 24 (3) 62 (3) Failed leads replaced, n (%) 11 (1) 47 (8) 38 (6) 18 (2) 26 (1) Mode of electrical failure Sensing/noise Impedance change High threshold Perforation/dislodgement High-voltage failure Unknown mechanism Liu J et al. Longitudinal Follow-Up of Implantable Cardioverter Defibrillator Leads. The American Journal of Cardiology, Volume 113, Issue 1, 2014,

26 Riata EF Presentations Lead Outcome Quattro Fidelis Riata Durata Reliance Functional lead, patient deceased, n (%) 264 (26) 77 (12) 198 (32) 46 (6) 847 (39) Functional leads replaced, n (%) 30 (3) 99 (16) 24 (4) 24 (3) 62 (3) Failed leads replaced, n (%) 11 (1) 47 (8) 38 (6) 18 (2) 26 (1) Mode of electrical failure Sensing/noise Impedance change High threshold Perforation/dislodgement High-voltage failure Unknown mechanism Liu J et al. Longitudinal Follow-Up of Implantable Cardioverter Defibrillator Leads. The American Journal of Cardiology, Volume 113, Issue 1, 2014,

27 RT Extraction Success and Complication Rates El-Chami M et al. Heart Rhythm 2015;12:

28 Multicenter Extraction Data Maytin M et al. Heart Rhythm 2014;11:

29 Multicenter Extraction Data Maytin M et al. Heart Rhythm 2014;11:

30 Multicenter Extraction Data Maytin M et al. Heart Rhythm 2014;11:

31 Multicenter Extraction Data Maytin M et al. Heart Rhythm 2014;11:

32 Cables attach to distal aspect of shocking coils Okamoto Y et al. Journal of Innovations in Cardiac Rhythm Management

33 Bongiorni M et al. Heart Rhythm2015;12:

34 Okamoto Y et al. Journal of Innovations in Cardiac Rhythm Management

35 Case 3 45 year old female with HCM Dec 2007: PPM implanted after myectomy (another institution) c/b CHB Sept 2008: Upgraded to ICD, abandoning RV pacing lead (another institution) Riata Lead No therapies + Dependent Oct 2013: Redo myectomy Venogram demonstrating patency of L SVC

36 Case 3

37 Case 3 using a very careful sharp dissection, we were able to extract the 2 ventricular leads from their fibrous sheaths in the right ventricle and then we took some time carefully mobilizing the leads from the large area of fibrosis that incorporated all 3 leads. We were able to slide the ventricular lead through the fibrous sheath, but the defibrillator coil had been incorporated into the fibrosis. We sharply dissected as far as we could proximally. We then cut the lead.

38 Case 3

39 Case 3

40 More SVC Coils 72 year old male CAD (1998 CABG), AF, ICM with EF 40-45% VT with ICD for secondary prevention 2007 with Riata Lead COPD, CKD3 Device infection with large vegetation, severe MR and TR

41 More SVC Coils

42 More SVC Coils The patient's leads were identified and removed. There was a large vegetation on the RV lead as well as the tricuspid valve annulus, which was removed. The pacemaker pocket on the left subclavicular line was exposed and the pacemaker was removed. The epicardial LV lead was then tunneled under the right clavicle and a pocket below our incision for the axillary cannulation.

43 More SVC Coils

44 More SVC Coils

45 Summary Riata lead associated with high rate of cable externalization Electrical failure rate of about 6% Not always associated with externalization In experienced centers, complete success of extraction ~99% with low rate of major complications Larger, powered sheaths often required for extraction Design features such as cable attachment to distal portion of shocking coils and lack of backfill in the 8Fr lead can present some technical challenges.

46 Thank You