Riata TM Publications

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1 St. Jude Medical Implantable Electronic Systems Valley View Court Sylmar, CA USA Main Fax Riata TM Publications Citation Mean follow-up Data From Results Lorvidhaya P et al. "Prospective evaluation of cinefluoroscopy and chest radiography for Riata lead defects: Implications for future lead screening." Journal of Interventional Cardiac Electrophysiology :2 ( ). time from implant: 6.8±2.2 yrs for abnormal Riata, 6.2±2.2 for normal Riata Cardiac Arrhythmia Service, Warren Alpert Medical School of Brown University Cinefluoroscopy of 102 Riata lead patients showed externalized conductors in 33 patients (32 %). Twenty-five of 33 patients (76 %) who had abnormal cinefluoroscopic findings had abnormal CXR findings on blinded review. Liu J et al. Longitudinal Follow-Up of Externalized Riata Leads. The American Journal of Cardiology, Volume 112, Issue 10, 15 November 2013, Pages ±2.9 UPMC: n=329 Riata leads fluoroed Externalization was present in 76 patients (23%); of whom, 24 (32%) had the Riata lead replaced shortly after screening. The remaining 52 patients were followed for 7.9 ± 2.9. Prospective follow-up data on externalized Riata leads suggest an electrical failure rate in excess of 6% per year. Marcus G et al. "The year in review of clinical cardiac electrophysiology." Journal of the American College of Cardiology 24 December (25): N/A Review paper about studies from April 2012 through May 2013 Summarizes results from the VA, Abdelhadi, and Canadian HRS studies. Chuen M et al. "Single centre experience of implanted Riata and Riata ST Silicone coated leads at the Liverpool Heart and Chest Hospital." Europace (2013) 15 (suppl 4): iv4- iv8. doi: /europace/eut314 Steinberg C et al. "High annual incidence of new riata insulation defects in a prospective cohort." Canadian Journal of Cardiology :10 SUPPL. 1 (S193). 6.4 ± 1.2 Liverpool Heart and Chest Hospital (n=38) At a mean of 5.7±2.7 following implant, 21% of patients had externalized conductors and 10.8% had lead fractures. All leads with poor performance were 8Fr leads. Lead fractures occurred earlier and in younger patients than those w/ EC. 12 Quebec Sixty-nine patients (24.3%) had conductor externalization. The mortality rate at 12 showed no difference between visually abnormal and normal Riata leads (8.1% vs 8.8%, p=0.82). Significantly more patients with abnormal leads underwent lead revision (21.3% vs 3.4%, p<0.001). The overall incidence of new radiologic insulation defects was 12.1% (11/91 leads) over a period of one year follow-up. New lead breaches were most frequent in the 1590 lead model (21.4%) and in the 1580 model (12.2%). There were no further differences in electrical abnormalities between normal and abnormal Riata leads over the follow-up period.

2 Steinberg C et al. "Pa/lateral chest X-ray is non-inferior to fluoroscopy for the detection of insulation defects in riata defibrillation leads." Canadian Journal of Cardiology :10 SUPPL. 1 (S360). Steinberg C et al. "High voltage testing of riata defibrillation leads with insulation defects-a single center experience." Canadian Journal of Cardiology :10 SUPPL. 1 (S359- S360) Richardson T et al. "Comparative outcomes of transvenous extraction of sprint fidelis and riata defibrillator leads: a single center experience." Journal Of Cardiovascular Electrophysiology [J Cardiovasc Electrophysiol] 2014 Jan; Vol. 25 (1), pp Date of Electronic Publication: 2013 Sep 12. Segreti L et al. "Transvenous removal of recalled ICD leads: Riata vs. Sprint Fidelis." Eur Heart J (2013) 34 (suppl 1): doi: /eurheartj/eht309.P3654 Mahajan D et al. "Different manifestations of right ventricular ICD advisory leads using impedance and noise." Eur Heart J (2013) 34 (suppl 1): doi: /eurheartj/eht308.P1393 N/A Quebec The odds ratio to detect insulation defects on CXR was (95%CI ), which was significant for non-inferiority (p=0.026). The sensitivity of a PA/Lateral CXR was 97.3%, the specificity 88.9% and the test accuracy 93.2%. The total radiation dose of a PA/Lateral CXR was 0.09mSv compared to 0.23mSv with fluoroscopy. CXR was significantly less time-consuming and also less expensive than fluoroscopy. N/A Quebec (45 pts) Thirty-five patients with abnormal leads were compared to a control group of 10 patients with normal leads. Loss of lead integrity was observed in 2 abnormal leads after shock delivery. In one patient there was an undetectable HV-impedance post shock and the other showed an HVimpedance >200Ω. In the other patients, the pre- and post-shock HV-impedance showed no difference between abnormal and normal leads (53±12Ω vs 47±7Ωp=0.08). N/A Mean pacing period was 39.1±22.1 in conductor fracture group and 36.1±23.4 in externalized conductors group. Vanderbilt University Hospital University Hospital of Pisa, Pisa Italy There were significant differences between those undergoing extraction of a Sprint Fidelis (n=145) or Riata lead (n=47). In the Riata group, device-related endocarditis was a more common indication for extraction, the mean duration of implant was longer, and larger excimer laser sheaths were required. Lead malfunction was a more common indication in the Fidelis group. Extraction success in 93/94 (98.9%) with externalized conductor leads. No major complications occurred. N/A Boston Scientific 995 randomly selected pts with advisory leads were followed via remote monitoring system, and an automatic algorithm classified tachy episodes and impedance data from 579 Fidelis and 416 Riata leads. Most episodes were classified as Noise, not EMI by the experts. 24 Fidelis and 10 Riata patients had RV impedance 2000.

3 Kouraki K et al. "Incidence of Riata lead failure in clinical practice: a single center experience." Eur Heart J (2013) 34 (suppl 1): doi: /eurheartj/eht308.P1405 Badenco N et al. "Riata and Riata ST defibrillator leads failure: cable externalization is one problem, but other electrical failures seem more preoccupant". Eur Heart J (2013) 34 (suppl 1): doi: /eurheartj/eht308.P1396 Fischer A et al. Contribution of ethylenetetrafluoroethylene (ETFE) insulation to the electrical performance of Riata silicone leads having externalized conductors. J Interv Card Electrophysiol Aug;37(2): Available at: doi: /s x. Epub 2013 Mar 26. Kubala M et al. Progressive decrease in amplitude of intracardiac ventricular electrogram and higher left ventricular ejection fraction are associated with conductors' externalization in Riata leads. Europace Aug;15(8): Available at: doi: /europace/eut015. Epub 2013 Feb 6. Liu J et al. Failure-free survival of the Durata defibrillator lead. Europace Jul;15(7): Available at: doi: /europace/eut010. Epub 2013 Feb 1. 3 Heart Center Ludwigshafen (Ludwigshafen am Rhein, Germany) 86 pts completed f/u of 74 N/A 2 AP-HP hospitals in France Bench testing: ETFEcoated conductors 57±30 Patients = 36. Leads: Riata 12 single-coil, 24 dual-coil (1570 N=4, 1580 N=12, 1582 N=7, 7000 N=7, 7002 N=6). Durata: 2.3±1.2. Riata: 3.2±2.1. Quattro: 3.5±2.7. Leads: Durata (n = 828), Riata [n = 627; 8 Fr. (n = 472) and 7 Fr. (n = 155)], or Sprint Quattro (n = 1020). During a follow-up time of three, 111 (16.3%) of the leads had to be replaced, 37 (5.4%) because of pacing/sensing problems and 74 (10.9%) because of lead failure. Overall failure rate was 32.5% (28 patients); all were observed in 8-French leads except for one patient. There were 10 pts with oversensing including 5 related to insulation damages and 5 without, none of them have shown cable externalization, 8 conductor fractures, 7 conductor externalizations without electrical abnormality, and 3 other isolated electrical problem such as impedance increase (11.6%, 9.3%, 8.1%, and 3.5% respectively). Mean time to failure was 62. Testing of ETFE-coated conductors following multiple preconditioning steps showed that ETFE serves as a redundant layer of insulation. In the event that the ETFE coating is breached, the potential gradient seen resulting from a highvoltage defibrillation shock was similar to a lead with no breach to the ETFE, even after 100 shocks. Externalized conductors were identified in 12 (33%) patients after a 53-month (13 114) mean delay. Detection of the conductors externalization was preceded by an electrical lead abnormality in 10 (83%) patients. Lead failure was defined as electrical malfunction resulting in lead replacement, excluding dislodgements or perforations. Annual electrical failure rates were 0.3%, 1.7, and 0.3% for the Durata, Riata, and Sprint Quattro leads, respectively (P < for the comparison of Durata to Riata and P = 0.01 for the comparison of Durata to Sprint Quattro). The failure-free survival of the Durata lead was significantly better than that of the Riata lead (P < ) and similar to that of the Sprint Quattro (P = 0.94). The 7 Fr. Riata ST lead had better survival compared with the 8 Fr. Riata lead (P = 0.050) and comparable survival with the Durata lead (P = 0.12).

4 Moorman LP et al. Increasing lead burden correlates with externalized cables during systematic fluoroscopic screening of Riata leads. J Interv Card Electrophysiol Jun;37(1):63-8. doi: /s Epub 2012 Dec 20. Brunner M et al. Transvenous extraction of implantable cardioverter defibrillator leads under advisory a comparison of Riata, Sprint Fidelis, and non-recalled implantable cardioverter defibrillator leads. Heart Rhythm Jun 28. pii: S (13) Available at: 1 Cheung J et al. Mechanisms, Predictors and Trends of Electrical Failure of Riata Leads. Heart Rhythm (Uncorrected Proof.) Available at: 5. Larsen J et al. Nationwide fluoroscopic screening of recalled Riata defibrillator leads in Denmark. Heart Rhythm Jun;10(6): Available at: 0. Lau E et al. Differential Lead Component Pulling as a Possible Mechanism of Inside-Out Abrasion and Conductor Cable Externalization. Pacing Clin Electrophysiol Jun 7. doi: /pace [Abstract] Lau EW. Compression-bending of multicomponent semi-rigid columns in response to axial loads and conjugate reciprocal extensionprediction of mechanical behaviours and implications for structural design. Journal of The Mechanical Behavior of Biomedical Materials. 2013;17: N/A Patients = 48 (Riata 8F N = 23, Riata 7F N = 25). N/A Median: 4.1 Extraction procedures. Leads (N=2,056): ICD leads = 1,215 with 122 Riata, 309 Sprint Fidelis. Leads: Riata/ST (N=316) 1 (0.3%) model 1570, 160 (51%) model 1580, 15 (4.7%) model 1581, 76 (24%) model 1582, 2 (0.6%) model 1590, 50 (16%) model 7000, 2 (0.6%) model 7001, 10 (3%) model Center = ± 1.1 Patients = 299 with recalled Riata leads. Externalized cables were seen in ten patients (21 %). Another five patients (10 %) were determined to have abnormal cable spacing, likely denoting early or partial erosion. The remaining 33 (69 %) had normal fluoroscopic appearance. Procedural outcomes for Riata and Sprint Fidelis TLEs (transvenous lead extractions) were no different.. Rates of clinical success, failure, and major complications were no different in the recalled and nonrecalled ICD lead TLE procedures. During median follow-up of 4.1, the Riata lead electrical failure rate was 6.6%. The rate of externalized conductors among failed leads was 57%. Engineering analysis of 10 explanted leads revealed 5 (50%) leads with electrical failure due to breach of ethylene-tetrafluoroethylene (ETFE) conductor coating. The rate of Riata lead failure was initially noted to increase exponentially with a power of 2.1 but leads functioning past 4 had a linear pattern of failure with a power of 1.0. The prevalence of externalization was 32 of 298 (11%) at a mean dwell time of 5.1. The prevalence was 21 of 98 (21%) for 8-F leads and 11 of 200(6%) for 7-F leads. No association was observed between externalization and electrical function. Fluoroscopic diagnostic performance was good with positive and negative predictive values of 88% and 99%, respectively. N/A Bench testing Restitution from differential pulling followed three patterns: complete, partial without escalation, and incomplete with escalation. Only the last pattern (only shown by the Riata 8F and ST 7F leads) was associated with an increased risk to conductor cable externalization.

5 Hayes D et al. Prevalence of Externalized Conductors in Riata and Riata ST Silicone Leads: Results from the Prospective, Multicenter, Riata Lead Evaluation Study. Heart Rhythm, Available online 27 August Jayam V et al. Does the Riata Lead Deliver Adequate Defibrillation Shocks? A Single Center Experience in 289 Patients. Heart Rhythm The Riata Conundrum AB11-02 Goyal S et al. Lead Thrombi Associated with Externalized Cables on Riata ICD Leads: A Case Series. Journal of Cardiovascular Electrophysiology. doi: /jce Epub 2013 Apr 11. Greenslade J et al. Single centre experience with Riata defibrillator leads. Heart, Lung and Circulation. 2013;22: Available at: Kremers M et al. The National ICD Registry Report: Version 2.1 including leads and pediatrics for 2010 and Heart Rhythm. 2013; 10(4): e59-e65. Available at: 5. Patel D et al. Extraction of defibrillator leads recalled for cable externalization and failure. J Interv Card Electrophysiol Apr;36(3): doi: /s Epub 2012 Nov 21. Riata ST (7F): 4.8 ± 0.9 ; Riata (8F): 6.5 ± patients are included in the analysis: 517 with 8F leads, 259 with 7F leads patients; 266 leads were 8F, 21 leads were 7F Mean: 7.6 ± 1.5 Implanted between 2002 and Paper published in Therefore, follow-up = Implant to presentation with failure = 8 mo to 7 yrs. N/A Leads: Riata 1580 (N=4), Riata 1581 (N=1) Leads: Riata (N=100). The National ICD Registry. Leads: Riata 8-F (N=8755), Riata 7-F (N=3213), Fidelis (N=23234). Centers = N/A Patients = 627. Leads: Riata 1580, 1581, 1582, 1590 or Riata ST 7000 and Overall prevalence of externalized conductors in 7F leads is significantly lower than 8F leads (p < 0.001); For leads implanted 6, prevalence of EC was also significantly greater in 8F leads (18.8% or 32/170) compared with 7F leads (9.4% or 24/256, p=0.005); Overall there were 10 leads (1.3%, CI: %) with electrical dysfunction Externalized conductors was observed in 13.1% of 8F leads and 4.8% in 7F; failure of defibrillation efficacy only occurred in one patient; in 99% of this cohort, sensing and HV function remained intact. (Riata) leads should be screened for thrombi prior to potential lead extraction to determine the safest approach. Serial echocardiography may help detect progressive thrombus formation. The role of systemic anticoagulation for prevention or treatment of these thrombi remains unclear. Overall 9% of these Riata leads presented with indications of electrical failure. This resulted in three patients with failed therapy, and all nine required lead revision (N=5), 1571 (N=1), 1580 (N=1), 1581 (N=2). There were 8755 St Jude Medical Riata 8-F leads ( series model numbers) and 3213 Riata ST 7-F leads( series model numbers) identified. Of those functionally assessed, 715 (8.2%) 8-F leads and 236 (7.4%) 7-F leads functioned abnormally. These leads were extracted or abandoned in 929 (10.6%) and 345 (10.7%), respectively. 20 lead extraction cases. Reasons for extraction included electrical malfunction of the lead (n=8) such as increased pacing threshold or non-capture, electrical noise sensed on the lead, poor R wave sensing, or RV lead pacing or shocking impedance outside of the normal range, lead and device infection (n=5), and patient preference after becoming aware of the class I FDA recall (n=7).

6 Steinberg C et al. Detection of high incidence of Riata lead breaches by systematic posteroanterior and lateral chest X-ray in a large cohort. Europace2013;15(3): Mean time since implantation 6.7 for abnormal leads and 5.9 for others Patients = 284. Leads: Riata 1570, 1580, 1582, 1590, 1592, 7000, 7002, and The total frequency of radiological lead defects was 24.3%. Insulation breaches occurred at zones of major lead curvature. Abnormal CXRs were more frequent in 8F leads (31.4% vs. 6.3%; P, 0.001). Most defects occurred with lead models 1582 (41.2%) and 1580 (31.4%). Valk S et al. Long-term performance of the St Jude Riata ICD lead family. Neth Heart J Mar;21(3): Lindemann J et al. The Role of Lead Integrity Alerts and Remote Monitoring in Reducing Morbidity Associated With the St Jude Medical Riata ICD Lead. Heart, Lung and Circulation. 2013;22(1): S123. Available at: ( ) Median: 17 mo Patients = 374. Electrical abnormalities (mainly noise, 65 %) were observed in 20/257 patients (7.8 %). Definite conductor externalisation was confirmed with fluoroscopy or chest X-ray in 16 patients, and in one after extraction. Median time to conductor externalisation was 5 (IQR ). Lead externalisation was observed in 5.4 % (95 % CI ) at 5 and 22.7 % (95 % CI ) at 8. N = 103 normally functioning Riata leads. 39 on remote-monitoring. 61 with LIA enabled device. At a median follow up of 17, 8% (8/103) failed. The median time to failure was Fazal I et al. Comparison of Sprint Fidelis and Riata defibrillator lead failure rates. Int J Cardiol Nov 5. pii: S (12) Available at: doi: /j.ijcard [Epub ahead of print] Sprint Fidelis: 53.0±22.3 mo. Riata: 54.8±26.3 mo. Riata patients: 106. In the Riata lead group there were 13 lead failures (11.3%, 2.71% per year) over 54.8±26.3 follow-up with a mean time to failure of 53.5±24.5. Shen S et al. Prevalence and predictors of cable extrusion and loss of electrical integrity with the Riata defibrillator lead. J Cardiovasc Electrophysiol Nov;23: Available at: doi: /j x. Epub 2012 Jun 14. Mean: 67±25 mos Patients = /84 = Riata /84 patients (27.4%) had fluoroscopic evidence of cable extrusion. All 23 patients had normal electrical parameters on routine device interrogation. Fifteen of these 23 patients (65%) with extruded cables had high-voltage shocks within 12 of lead screening; only one patient demonstrated postshock electrical abnormalities. Sato A et al. Insulation Defects in Riata Implantable Cardioverter-defibrillator Leads. Intern Med. 2012;51(19): Epub 2012 Oct 1. Mean: 52 ± 9 Leads: Riata 1580 or 1581 (N = 10) The presence of externalized conductors was observed in 2/10 patients (20%).

7 Theuns D et al. Prevalence and presentation of externalized conductors and electrical abnormalities in Riata defibrillator leads after fluoroscopic screening: Report from the Netherlands Heart Rhythm Association device advisory committee. Circ Arrhythm Electrophysiol Dec;5: Steinberg C et al. High Prevalence of Riata Insulation Defects Detected by Systematic PA/Lateral Chest-X Ray - A Single Center Experience. Canadian Journal of Cardiology. 2012;28(5): S393-S394. Available at: Abraham P et al. High incidence of unexpected defibrillation coil retention during orthotopic heart transplantation. J Heart Lung Transp. 2012;31(8): Available at: 3. Median: Riata 71.7, Riata ST 51.1 Implanted Paper published in Therefore, follow-up = Mean: 36 ± 30 Leads: Riata (N = 484), Riata ST (N = 545) Centers = 31 N = 269 patients. Center = 1. Leads: 84 (Biotronik 12%, Boston Scientific 22%, Medtronic 30%; and St. Jude Medical 36%) Center = 1 The presence of externalized conductors was observed in 147/1029 patients (14.3%). A higher proportion of the 8-F Riata family had externalized conductors than the 7-F Riata ST family (21.4% vs. 8.0%; P < 0.001). Median time from implantation to detection of externalized conductors was The estimated rates of externalized conductors were 6.9% and 36.6% at 5 and 8 after implantation, respectively. Of the 147 leads with externalized conductors, 10.9% had abnormal electrical parameters vs 3.5% in nonexternalized leads (P<0.001). The overall prevalence of radiological insulation defects was 24.1%. Insulation breaches occurred at zones of major lead curvature. Most lead defects occurred in lead models 1582 (37.5%) and 1580 (31.8%). Abnormal CXR were more frequent with 8F leads (31.3 vs 6.5%; p<0.001) and with dual-coil leads (29.2% vs 14.4%; p=0.01). Abnormal leads had higher shocking lead impedances (69±14Ohm vs. 54±13Ohm; p=0.03) and higher capture thresholds (1.12±1.82V vs. 0.91±0.38V; p=0.01). Cable externalization was associated with significant lead dysfunction, mostly pathological pacing thresholds and sensing abnormalities. There was no difference in the incidence of inappropriate shocks. 7 out of 11 lead-related adverse events in orthotopic heart transplantations in the single center were associated with Riata With the usual cut, the defibrillation coil can easily stay in place, fibrously affixed to the vasculature. The authors suggest that the intersection of the ICD lead should not be done through the coil; instead, the lead should be cut through between the 2 coils. Liu J et al. Class I recall of defibrillator leads: a comparison of the Sprint Fidelis and Riata families. Heart Rhythm Aug;9(8): Epub 2012 Apr 3. Available at: 3. Riata: 3.2 ± 2.1 Fidelis: 2.7 ± 1.3 Quattro: 3.5 ± 2.7 Leads: Riata (N = 627), Sprint Fidelis (N = 623), Sprint Quattro (N = 1020). Riata (models 1580, 1581, 1582, and 1590; n = 472) or Riata ST (models 7000 and 7001; n = 155) The failure-free survival of the Sprint Quattro lead was significantly better than that of the Riata lead (P = ), which in turn was better than that of the Sprint Fidelis lead (P = ). Riata 8F silicone leads showed a significantly higher failure rate than Riata ST 7F silicone leads (p = ).

8 Liu J et al. Fluoroscopic screening of asymptomatic patients implanted with the recalled Riata lead family. Circ Arrhythm Electrophysiol Aug 1;5(4): doi: /CIRCEP Epub 2012 Jul 11. Ng J et al. St Jude Medical Riata High Voltage ICD Lead Long Term Performance Report a Single Centre Experience. Heart, Lung and Circulation. 2012;21(1): S138-S139. Available at: Parvathaneni S et al. Fluroscopic Grading Scale and Correlation to Lead Extraction in Failed SJM Riata Family ICD Leads. Heart Rhythm 2012;9(5):S13. AB06-03 Median: 5.6 Mean: 40 mo (0-86 mo) Mean: 5.67 Leads = 245, centers = 1 Leads: N = 171 Riata leads (49% 7000, 32% 1580, 11% 1581, 6% 7001 and the remainder; 1570, 1571 and 7040). Pt: N = 161. Leads screened = 52, centers = 1 53 of 245 leads (21.6%) exhibited externalized conductors (median implant time 5.6 ). Externalized conductor rates were similar in equal numbers of leads examined between time periods and > 6.2 after implant, suggesting a possible plateau in externalized conductors rates after 6.2 from implantation date. Riata 8F leads accounted for 87% of leads with externalized conductors. 17% (29/171) required intervention. Presenting problems (not mutually exclusive) were infection 2.5%, noise 5.0%, inappropriate shocks 6.2%, high thresholds and or small R wave 8.1%, sudden impedance change 3.1%, dislodgement 3.1%, t-wave over-sensing 0.6%, late perforation 0.6%. 34.6% (18/52) of Riata leads had externalized conductors. 22.2% (4/18) of these leads had significant lead or shock impedance changes. Parvathaneni SV, Ellis CR, and Rottman JN. High prevalence of insulation failure with externalized cables in St. Jude Medical Riata family ICD leads: fluoroscopic grading scale and correlation to extracted leads. Heart Rhythm. 2012;9(8): Sung R et al. Long-term electrical survival analysis of Riata and Riata ST silicone leads: National Veterans Affairs experience. Heart Rhythm Dec;9: Available at: doi: /j.hrthm Epub 2012 Aug 4. Sung RK, et al. Survival Analysis of St. Jude Medical Riata and Riata ST High-Voltage Leads in Comparison to Medtronic Sprint Quattro, Fidelis and Boston Scientific Endotak Leads. Heart Rhythm 2012;9(5):S13. Abstract AB06-01 Wright J et al. Varying Modes of Presentation of Lead Failure in the 8F Silicone Riata ICD Lead. Heart, Lung and Circulation. 2012;21(supp 1): S142. Available at: Mean: 5.9±3.45 Riata 15xx: 6.35±1.2. Riata 7xxx: 4.07±0.7. Up to 10 OR 60 survival Leads screened: Riata = 87. Centers = 1. Leads: 1,403 Riata + Riata ST, 6,091 Quattro, 5,072 Fidelis, 2,401 Endotak Reliance G/SG. Centers = VA NCDSC remote monirtoring Leads: 1,262 Riata + Riata ST, 5,608 Quattro, 5,076 Fidelis, 2,401 Endotak Reliance G/SG, centers = VA NCDSC remote monirtoring Median: 58 mo Lead: 432 Riata. Center = 1. Externalized cables was seen in 33.3% (29/87) of the patients. 31% (9/29) of the leads with exposed cables showed electrical failure, and 29.7% (19/64) of the leads with normal electrical data contained externalized cables. Time from implant 5 predicted structural lead failure (P < 0.05). X-ray grade compared with extracted leads demonstrated a sensitivity and specificity of 86% and 100% respectively. Riata/Riata ST lead survival at 5 was significantly higher than Fidelis (97.5% vs. 89.6%), but lower than Quattro (99.2%) and Endotak (99.5%). 60-month survival probability: Riata: 97.5%, Quattro: 99.2%, Endotak: 99.5%, Fidelis: 89.6%. Riata survival significantly higher than Fidelis, but lower than Quattro and Endotak. Lead failure resulted in 10% of Riata leads undergoing revision during long term follow-up. Noise and changes in impedance related to insulation failures being the most common abnormality.. DFT testing should be routinely performed at generator change to ensure normal function. Remote monitoring may be of

9 value to allow earlier detection of potential lead problems. Van Rees J et al. Update on small-diameter implantable cardioverter-defibrillator leads performance. Pacing Clin Electrophysiol Jun;35(6): doi: /j x. Epub 2012 Feb 21. Parkash R et al. Riata Leads Failure: Report from the CHRS Device Committee. Heart Rhythm 2012;9(5):S13. AB Parkash R, Exner D, Champagn J, et al. Failure rate of the Riata lead under advisory: A report from the CHRS Device Committee. Heart Rhythm. 2013;10(5): Available at: 8. Hauser R et al. Riata implantable cardioverter-defibrillator lead failure: analysis of explanted leads with a unique insulation defect. Heart Rhythm. 2012;9(5): Hauser R et al. Deaths Caused By the Failure of Riata and Riata ST Implantable Cardioverter-Defibrillator Leads. Heart Rhythm Aug;9: Available at: 8. Epub 2012 Mar 23. Hauser R et al. Deaths caused by Riata ICD Lead failure: Analysis of the U.S. FDA Device Database. European Heart Journal SUPPL. 1 (540) Abstract Sprint Fidelis: 3.4±1.5 yr. Riata 8-F: 4.6±2.6 yr. Riata 7-F: 2.9±1.3 yr. Benchmark: 3.4±2.7 yr. Mean: 4.1 Mean: ± 18.6 Riata: 61 ± 21 Riata ST: 36 ± 7 Leads: Fidelis (N=396), Riata 8-F (N=165), Riata 7- F (N=30), benchmark cohort (N=1602). Riata leads (N = 4704): 60% Riata 8F, 40% Riata ST 7F, centers = 22 Riata leads (N = 4358, as of Mar 2012): Riata 8F 65.3%, Riata 7F 32.4%, unknown 2.3%. centers = 21 MAUDE Database (Sept 2011), SJM lead return analysis reports, leads = 105 with inside-out abrasion MAUDE Database The yearly lead failure rate of the Sprint Fidelis lead, 7-F Riata lead, 8-F Riata lead, and the benchmark cohort was 3.54%, 2.28%, 0.78%, and 1.14%, respectively. In comparison to the benchmark cohort, the adjusted hazard ratio of lead failure was 3.7 (95% confidence interval [CI] , P < 0.001) for the Sprint Fidelis lead and 4.2 (95% CI , P < 0.05) for the 7-F Riata lead. 7.1% of leads were replaced 3.7% for confirmed lead failure. There were 26% that underwent extraction, 16% by laser lead, the remainder by manual traction. Electrical abnormalities were reported in 4.6% of the affected leads; 8.0% of these were found to have concomitant radiographic evidence of externalization. The rate of electrical failure was higher in the 8-F (5.2%) vs7-f(3.3%) leads(p <.007). Among the leads that were replaced, 21% were extracted. Two major complications (1.0%) were attributed to extraction of these leads. A total of 226 insulation defects were found in 105 Riata and Riata ST leads. 32 leads were reported to show exposed cables or externalized conductors. Over 8, 133 deaths associated with Riata leads were identified in the MAUDE database: 71 involving Riata silicone and Riata ST silicone leads and 62 involving Quattro Secure leads. 20% of deaths (27/133) were lead-related. Of these, 22 were caused by Riata or Riata ST lead failure and 5 were caused by Quattro Secure lead failure. Riata/ST lead failure deaths were typically caused by short circuits between high-voltage components. No death was due to externalized conductors.

10 Hauser R et al. Riata ICD lead failure: Results of the manufacturer s analysis of returned leads. JACC. 2012;59(13): E584. Available at: Hauser RG, et al. Riata ICD lead failure: results of the manufacturer's analysis of returned leads. JACC ( 2012 ) vol. 59 issue 13 ( Abstract Supplement ) Saltzman H et al. Conductor exteriorization in the Riata lead experience in a major extraction center. JACC. 2012;59(13): E598. Available at: Hodkinson E et al. Follow-Up Riata Screening in Northern Ireland. JACC ( 2012 ) vol. 59 issue 13 (Abstract Supplement) Hodkinson E, Kodoth V, Ashfield K, et al. FOLLOW-UP RIATA SCREENING IN NORTHERN IRELAND. JACC. 2012;59(13): E585. Available at: Fazal I et al. Incidence of Riata Defibrillator Lead Failure Higher than Previously Reported. Europace 2012; 14(1). Abstract 96P.63. Hauser R, et al. Performance of Riata ICD leads: results from an independent multicenter study. European Heart Journal SUPPL. 1 (539) Abstract Jordaens L et al. Analysis of the Riata 1580, 1581 and 1582 Leads. Europace 2012; 14(1). Abstract 96P.59. Theuns D et al. Impact of fluoroscopic screening on failure rates of the Riata highvoltage implantable defibrillator lead. European Heart Journal SUPPL. 1 (540) Abstract ±18.6 mo MAUDE database. Lead: 105 returned Riata and Riata ST leads Time from implant to extraction: 5 to 108 mos 239 days additional from 1st screening Mean: 52.7±26.2 Riata: 4.3 ± 2.6 Riata ST: 3.3 ± 1.7 Mean: 1705 ± 828 days Median: 4.9 Extraction records from 2009 to Leads: 23 silicone based Riata. 1st screening: 165 leads in Dec nd screening: leads screened = 139 leads, centers = insulation defects (2.11/lead) were found, including 143 inside-out insulation defects (1.36/lead), 34 outside-in defects (0.32/lead), 36 defects caused by the ICD can (0.34/lead), and 9 unspecified defects. Of the 143 inside-out insulation defects, 93 (65.0%) were distal to the proximal shocking coil and 33 (31%) had exposed conductor cables. The ETFE high voltage cable insulation was abraded in 22 of 43 (51.2%) leads reported. Clinical signs of failure included: noise/oversensing (45/105; 42.8%); impedance changes (23/105; 21.9%); high threshold or loss of capture (11/105; 10.4%); and other (26/105; 24.7%) including 7 externalized cables. 9/23 patients had conductor exteriorization (CE) or electrical malfunction (EM). 7 had macroscopic CE. Of the 7 pts with CE, 4 had EM. Of the 6 pts with EM, 4 had CE. Most CE occurred just proximal to a high energy coil. Of the 7 pts with CE, 5 had fluoroscopic evidence of CE prior to extraction; 2 had CE found during extraction. Of the 6 pts with EM, 2 had reduced shock impedance, and 4 had noise sensing. From first screening: 25 leads were positive for insulation breach with conductor separation. From second screening: 26 (19%) were classified as positive for externalized conductors, 3 (2%) borderline and 110 (79%) negative. Overall, lead failure incidence of 2.6%/year and a prevalence of 19%. Riata (N = 69), centers = 1 The Riata lead failure rate was 10.4% (2.4% per year). Leads: Riata (N = 773), Riata ST (N = 287), Quattro (N = 1,668 ), centers = 7 62 out of 1060 (5.8%) of Riata and Riata ST leads failed, including 45 electrical malfunctions (7 with externalized conductors) and 17 normally functioning leads with externalized conductors. Leads = 374 Riata 1580, 1581, 1582 series had a 13.6% failure rate at 7. Leads: Riata (N = 374), Riata ST (N = 78) Post Riata lead recall, 58/452 (12.8%) of Riata silicone leads (8F: N = 374, 7F: N = 78) evaluated by fluoroscopy had externalized conductors. The cumulative failure rate was 6.7% at 5 and 39.7% at 8.

11 Abdelhadi R et al. Independent Multicenter Study of Riata and Riata ST ICD Leads. Heart Rhythm LBCT Abstract SP09 Abdelhadi RH, Saba SF, Ellis CR, et al. Independent multicenter study of Riata and Riata ST implantable cardioverter-defibrillator leads. Heart Rhythm. 2013;10(3): Cohen T et al. The Pacemaker and Defibrillator Lead Survival and Malfunctions Study: Which Core Lead Design Elements Influence Leads Failure? Heart Rhythm 2012;9(5): S13. AB Corbisiero R et al. Incidence of Externalized Conductors in ICD Leads Using PA and Lateral Chest X-Ray Imaging. Heart Rhythm 2012;9(5): S236. PO3-44. Johansen J et al. Defibrillator Lead Diameter as a Predictor of Lead Survival Time. Heart Rhythm 2012;9(5): S60. AB Johansen J et al. Poor Survival of Defibrillator Leads with Small Diameter. Europace 2012; 14(1). Abstract 96P.58. Noad R et al. Riata lead extraction a single center experience. Heart Rhythm 2012;9:S60. AB Rordorf R et al. Failure of Implantable Cardioverter Defibrillator Leads: Is It a Matter of Lead Size? Heart Rhythm 2012;9(5): S60. AB Rordorf R, Poggio L, Savastano S, et al. Failure of Implantable Cardioverter Defibrillator Leads: Is It a Matter of Lead Size?. Heart Rhythm 2013;10(2): Rordorf R et al. Incidence of ICD lead fracture: comparison of small vs standard-diameter leads implanted in a single center. European Heart Journal SUPPL. 1 (539) Abstract Mean: Riata 8F: 4.2±2.4, Riata ST 7F: 3.3±1.7 Longest: 15, SJM ~8 Leads: Riata (N = 774), Riata ST (N = 307), Quattro (N = 1,668 ). Centers = 7. Leads (N = 2,967) 531 BSX, 840 SJM (85% Riata), 1596 MDT (52% Fidelis). Centers = 1. N/A Leads: Riata (N = 122), Riata ST (N = 191), Durata (N=76), centers = 1 Longest: SJM leads with advisory ~7, SJM leads without advisory ~3.5 Danish ICD Registry. 4 groups: 9+F (N = 2911), SJM 7 and 8F on advisory (N = 310), SJM 7F and 8F not on advisory (N = 458), Fidelis 7F (N = 572), centers = 5 N/A Extracted leads = 26, centers = 1 Median: 33 Leads: Fidelis (N = 190), Riata ST (N = 182), Optim (N=99), standard-size leads (N = 419). Center = 1 Riata 8F leads had a statistically lower survival compared to Sprint Quattro leads (Riata all-cause failure rate: 1.93% per pt yr; Quattro: 0.43% per pt yr). Riata ST 7F leads had similar survival compared to Sprint Quattro leads (Riata ST all cause failure rate: 0.5% per pt yr vs. Quattro: 0.43% per pt yr). 10% of 1081 leads were examined for the presence of externalized conductors and externalized conductors were observed in 25% of examined leads. BSX vs MDT [Hazard ratio (HR) = 0.36 (95% CI: )]; SJM vs MDT [HR = 0.47 ( )]; BSX vs SJM [HR = 0.54 ( )]. Externalized conductors were observed in 6 leads (5 Riata, 1 Riata ST, 0 Durata). The mean time to externalized conductors was 3.86, up to 5.4. One lead with an EC had decreased shock impedance 1.5 after externalized conductors noted. All other leads are functioning normally 1.61 post observation of externalized conductors. All groups < 9F had lower survival compared to 9+F. 7F and 8F leads had lower survival than 9+F leads. 12 out of 26 extracted leads had insulation breach. Out of 12 leads with insulation breach, 10 were Riata 8F leads and 2 were Riata ST 7F leads. Comparable extraction of Riata leads with insulation breach can be achieved with comparable levels of success and expected outcomes to those without insulation breach. The overall fracture rate was 6.3% at a median follow-up of 33. The rate of fracture was: 15.7% for Fidelis, 7.6% for Riata leads, and 2.6% for standard size leads. No cases of lead failure were recorded in the Optim group. Small-diameter (hazard ratio[hr]5.03, , P o.001), Sprint Fidelis (HR 6.3, , P<0.001), or Riata/RiataST (HR4.5, , P<0.001) leads and age < 60 (HR2.3, , P<0.005) were found to independently increase the risk of lead failure.

12 Saltzman H et al. Conductor Exteriorization in the Riata Leads Experience in a Major Extraction Center. JACC ( 2012 ) vol. 59 issue 13 ( Abstract Supplement ) range: 5 to 108 leads extracted = 23 silicone Riata, centers = 1 Externalized conductors were observed in 7 extracted leads: 4 showed no electrical malfunctions. Externalized conductors had no impact on the extraction process. Saltzman HE, Subzposh F, Saari C, et al. The Riata ICD Lead: Extraction Experience For Conductor Exteriorization and Electrical Malfunction. Heart Rhythm. 2012;9(5): S69. AB31-03 See V et al. Variable Pattern of Lead Defects in Riata Family ICD Leads. Heart Rhythm. 2012;9(5): S454. PO Steinberg C et al. High Incidence of Riata Lead Breaches A Single Center Experience. Heart Rhythm. 2012;9(5): S60. AB Wright J et al. Long Term Outcomes of ICD Leads: A Difference in Failure Mechanisms. Heart Rhythm 2012;9(5): S297. PO Zhu D et al. High Incidence of Externalized Conductors in SJM Riata Leads: Results of Fluoroscopic Surveillance From A Single Center in US. Heart Rhythm. 2012;9(5):S445. PO Mean: 38.4 ± 28.7 Mean: 6.6 for abnormal leads vs 5.7 for normal leads Mean: 57 ± 28 Mean: Riata 8F: 6.4 ± 0.7, Riata ST 7F: 4.8 ± 0.5 Leads = 105, centers = 1 Leads = 106 Riata, centers = 1 Leads: 432 Riata/Riatai/Riata ST (N=432), Endotak (N = 326), centers = 1 Leads: Riata (N = 10), Riata ST (N = 12), centers = 1 4 leads (3.7%) had evidence of compromise requiring invasive management (extraction or lead implant). Insulation breach resulting in inappropriate therapy was observed in 2 leads. Externalized conductors were observed in one lead on fluoro without any electrical issues. Time from implant longer in lead defect group (55.6 +/ 17.8 vs /- 28.7, p = NS) PA and lateral chest x-ray showed 21.7% leads with externalized conductors. Abnormal CXR was more frequent with 8F leads compared to 7F leads (28% vs. 7%). 6.2% leads failed during 57 +/- 28. Out of 22 leads screened by fluoro, externalized conductors were detected in 5 Riata leads, and no externalized conductors were detected in Riata ST leads. No significant electrical abnormalities were observed in any leads with externalized conductors. Schmutz M et al. Prevalence of asymptomatic and electrically undetectable intracardiac inside-out abrasion in silicon-coated Riata and Riata ST implantable cardioverter defibrillator leads. Int J Cardiol. 2013;167(1): Available at: Mean: 71±18 Leads: Riata and Riata ST (N=52) 1570 n=7, 1580 n=30, 1582 n=1, 7000 n=6, and 7002 n=8. Center = 1 At a mean time of 71±18 since implantation, intracardiac inside-out abrasion was confirmed by fluoroscopy in 6 patients (out of 52, 11.5%). Mean time from lead implantation to detection of intracardiac inside-out abrasion was 79±14. In all patients with an intracardiac inside-out abrasion, ICD interrogation showed normal and stable electrical parameters. Retrospectively, in 4 of these 6 patients, a coronary angiography performed 25±18 before diagnosis of intracardiac inside-out abrasion already showed the defect. 2 of these 4 patients experienced adequate antitachycardia pacing and ICD-shocks.

13 Kodoth V et al. Riata lead failure; A report from Northern Ireland Riata lead screening programme. European Heart Journal ( 2011 ) 32 ( Abstract Supplement ), 310. Abstract #1838. Kodoth VN, Hodkinson EC, Noad RL, et al. Fluoroscopic and Electrical Assessment of a Series of Defibrillation Leads: Prevalence of Externalized Conductors. Pacing and Clin Electrophysiol. 2012;35: Available at: doi: /pace Epub 2012 Oct ± 1.43 Patients = 212. Leads screened = 165 (five were of model 1570, one of 1571, four of 1572, 13 of 1580, 55 of 1582, 46 of 7000, 31 of 7002, six of 7040, two of 7042, and two of 7022). Centers = 1 After fluoroscopy screening, 15% of leads were classified as positive for externalized conductors.