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The Fidelis data on this page will no longer be regularly updated. Current Product Surveillance Registry data will continue to be updated and is located at: http://wwwp.medtronic.com/productperformance/model/6949-sprint-fidelis.html |
Dual Coil, Active fixation
November 2015*
November 2015*
November 2015*
November 2015*
November 2015*
Single Coil, Active fixation
November 2015*
Dual Coil, Passive fixation
November 2015*
* Last reviewed by Independent Physician Quality Panel on 23 Oct 2015.
Medtronic strives to monitor product performance as accurately as possible. In May 2009, Medtronic started using the CareLink PLUS curve to follow FIDELIS performance. CareLink PLUS is a fracture based curve that includes data from CareLink transmissions PLUS returned product and save-to-disk analysis. Medtronic believes CareLink PLUS is the best representation of FIDELIS lead fractures available. Below is a definition of both the numerator and denominator used to create CareLink PLUS survival curves.
CareLink® PLUS |
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Numerator
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Denominator
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Medtronic recently consolidated all cardiac rhythm surveillance registries into the Product Surveillance Registry (PSR). A PSR survival curve is also shown for Models 6949 and 6931. This curve includes all lead related complications, including fractures. You will notice this name change in place of the former System Longevity Study (SLS). The curve is truncated when the sample size of leads in that interval is less than 50. The survival for Model 6948 is only tracked with the CareLink® PLUS curve, as the PSR study for 6948 does not have enough leads enrolled to create a survival curve.
Also shown is a breakdown of our 6949 CareLink PLUS data by center. Data from 1,006 centers is used to create the Model 6949 CareLink PLUS curve. The top and bottom 5% curves illustrate the range of fractures that exist within the CareLink PLUS dataset. A minimum of 10 implants per center was required for inclusion in this analysis. 440 centers met this requirement, as such, there are 22 centers in the top and bottom 5% curves.
Since the October 15, 2007 communication about the Sprint FIDELIS family of leads, Medtronic and the Independent Physician Quality Panel have continued to analyze performance data from the Medtronic Product Surveillance Registry (PSR) and the Medtronic CareLink Network, as well as third party data. The tables below show lead survival data and reported outcomes from third party publications (case studies and editorials were excluded).
Citation | Sample Size | Sample Size Notes | Survival-3 years | 4 years | 5 years | Last | Reported Outcome |
---|---|---|---|---|---|---|---|
Medtronic CareLink PLUS data* |
21,500 |
Multicenter analysis of model 6949 |
96.3% |
93.7% |
90.9% |
132 mo. |
Ongoing performance updates every 6 months. No change to patient management recommendations since April 2011. |
Frey et al, Circ PACE, 2015 |
137 |
2 Swiss centers |
98.5% |
94.2% |
94.3% |
96 mo. |
Survival is lower than other regularly used leads, but considerably better than Fidelis active-fix leads reported in previous studies. |
Piot et al, Archives of Cardiovascular Diseases, 2015 |
986 |
6 French centers |
92.6% |
86.1% |
79.3% |
60 mo. |
Multivariable analysis found patient ages >40 years, subpectoral implantation, and 6930 lead model were predicting factors for lead fracture. |
Janson C, et al. JACC, 2014. |
101 |
25 Fidelis |
69% |
44% |
84 mo. |
Study compared small diameter leads (Fidelis, Riata, Durata) to standard diameter leads in patients ≤ 30years old. Fidelis hazard ratio for lead failure is higher than other leads for pediatric patients. |
|
Yanagisawa S, et al. Circulation Journal, 2014. |
214 |
(75) 6949 |
95.1% |
89.8% |
88.0% |
84 mo. |
Study evaluated the performance of Fidelis in Japanese patients. No obvious differences in lead survival were observed between Japanese patients and Caucasian patients. |
Liu J, et al. Am J Cardoil, 2014. |
5,288 |
(623) 6949 |
91% |
89% |
Survival curves of recalled leads diverge from nonrecalled leads 2 years after implantation. |
||
Vollmann D, et al. Europace. 2013 Jun 28. |
429 |
Single center |
74.9% |
68.4% |
Failure rates of passive fixation Fidelis leads are similar to those of active fixation Fidelis leads reported in other studies. |
||
Parkash R, et al. Circulation, 2012 Dec 18; 126(25):2928-34 |
818 |
405 - ICD |
97.5% ICD |
96.5% ICD |
Analysis of Fidelis leads in RAFT study. RAFT patients with CRT had significantly higher fracture rates than patients with ICD (hazard ratio 2.42). |
||
Cheung, et al. Circ Arrhythm Electrophysiol, 2012 Oct: 5:906-912 |
604 |
Single center |
93.5% |
85.3% |
Fidelis failures transition from an exponential to a linear pattern. After 3 years, failure rates stabilize at 4.5% per year. Risk is doubled for females. |
||
Lovelock J, et al. Heart Rhythm, 2012 Oct: 9(10):1615-1618. |
479 |
Model 6949 |
93.1% |
88.1% |
86% |
There were no significant differences in age, sex, or type of Fidelis lead in the group of patients with lead failure compared with those with normal lead function. |
|
Van Rees, et al. PACE 2012 June: 35 : 652-658. PACE 2010 Apr;33(4):431-6. |
396 |
Single Center |
94.8% |
92.7% |
Risk of Fidelis failure continues to accelerator over time. Adverse events were significantly reduced as a result of safety advisories. |
||
Tzogias L, et al. Journal of Interventional Cardiac Electrophysiology. 2012 Feb 9. |
971 |
Single Center |
90.3% |
No identified variable was predictive of lead failure. |
|||
Birnie DH, et al. Circulation. 2012 Feb 6. [Epub ahead of print]. |
3169 |
11 Centers in Canada |
94.7% |
89.4% |
83.2% |
Four independent predictors of failure; center, gender, access vein and previous lead failure. |
|
Girerd N, et al. Archives of Cardiovascular Disease. July 8, 2011; 104: 388-395 |
269 |
Single Center |
87.4% |
65.6% |
Sprint Fidelis lead failure is more frequent in younger patients. |
||
Van Rees, et al. Pacing Clinical Electrophysiology. 2010 Apr;33(4):431-6. |
372 |
Single Center |
30 mo. |
36 mo. |
42 mo. |
Implementation of advisory recommendations decreased occurrence of inappropriate shocks. |
|
Arias MA, et al. Revista Espanola de Cardiologia, 2011 Mar 4. |
378 |
9 Centers |
96.1% |
Higher Left Ventricular EF and hospital of implant were variables associated with lead failure. Similar survival to Medtronic data. |
|||
Hauser, et al. Circulation, 2011 Feb 1;123(4):358-63.1 Hauser, et al. Heart Rhythm. 2009 May;6(5):605-10. Hauser, et al. Heart Rhythm. 2008 Nov;5(11):1517-22. Hauser, et al. Heart Rhythm. 2007 Jul;4(7):892-6. |
1,023 |
Three centers |
92.6% |
87.0% |
2.81% Fidelis failure rate/yr |
||
Todd J Cohen. 2010 AHA abstract |
795 |
Leads implanted by five physicians at a single center. |
96.1% |
94.7% |
No difference in failure based on age, gender, EF or implant approach. Manufacturer reported failure rates do not underestimate clinical experience. |
||
Edmund Keung. HRS Conference Abstract: Cardio. 2010. |
4,659 |
VA National ICD Surveillance Program |
95.0% |
91.4% |
Survival appears to continuously decrease with time. |
||
Morrison, et al. Journal of Cardiovascular and Electrophysiology. 2010 Jun 1;21(6):671-7. |
1,314 |
Single Center |
30 mo. |
Patients < age 50 are at increased risk for lead failure compared to those >50. |
|||
RJ Beukema. Netherlands Heart Journal. 2010 Jan;18(1):12-7. |
619 |
Single Center |
94.4%* |
89.8%* |
Rate of Fidelis failure reaches 5.7% at mean follow-up of 32 months. |
||
Faulknier, et al. American Journal of Cardiology, 2010 Jan 1;105(1):95-9 |
426 |
Single center |
90.3% |
Failure rate increasing exponentially (power of 2.13). Higher fracture rate for patients with higher LVEF. Lead Model fracture rates similar. |
|||
Krahn, et al. Heart Rhythm. 2009 Apr;6(4):474-7. Krahn, et al. Heart Rhythm. 2008 May;5(5):639-42. |
6,215 |
Centers in Canada |
30 mo. |
32 mo. |
Analyses at 20, 25, 30, & 32 months. Accelerating course of failures |
||
Farwell, et al. Heart Rhythm. 2008 Oct;5(10):1375-9. |
480 |
Single center |
30 mo. |
36 mo. |
Failure rate increasing exponentially (power of 2.74). Cephalic vein access reduced risk of fracture. Higher fracture rate for patients with higher LVEF. |
Citation | Sample Size | Sample Size Notes | Reported Outcome |
---|---|---|---|
Krahn, et al. Circ Arrhythm Electrophysiol, 2014 September. |
266 |
133 patient scans with Fidelis lead fractures. |
Six parameters including lead slack, anterior/posterior tortuousity, craniocaudal pulse generator location, angle the lead exits the pocket, and SVC coil location (craniocaudal and mediolateral) were significantly associated with risk of fracture. |
Burri and Combescure. Europace, 2014 January. |
100,000 simulated patients |
Decision model based on published data |
Model indicates that Fidelis lead revision should be seriously considered at generator change. |
Ellenbogen K, et al. Circ Arrhythm Electrophysiol, 2013. |
12,793 LIA enabled ICDs and lead combinations |
1,556 Fidelis |
67% of Fidelis lead failures were detected by LIA and not by conventional impedance triggers. |
Verlato R, et al. Heart. 2013 Jun;99(11):799-804. |
976 |
508 Fidelis leads |
Clinical outcomes in patients with Fidelis leads are not worse than those in patients with Quattro leads up to 35 month follow-up. |
Lovelock J, et al. Heart Rhythm. October 2012; 9 (10): 1615-1618. |
479 (72) |
72 leads underwent generator change. |
Failure rate of 20.8% in the year following changeout. Most failures are within 3 months of procedure. |
Maytin M, Epstein L. Heart Rhythm. September 2012; 9(9): 1446-1451. |
209 leads |
63.1% prophylactic removal |
Functionally normal Fidelis leads demonstrate an alarmingly high rate of “subclinical” fractures. Lead extraction at generator change may warrant reconsideration. |
Rordorf R, et al. Heart Rhythm, http://dx.doi.org/10.1016/j.hrthm.2012.10.017 |
190 leads |
185 were single coil Fidelis leads |
Failure rate of Fidelis leads was 4.8%/yr compared to 2.6%/year for Riata/RiataST and 0.8%/year in standard leads (>8Fr). |
Brumberg GE, et al. Pacing Clinical Electrophysiology. 2012 Apr 22. doi: 10.1111/j.1540-8159.2012.03401.x. [Epub ahead of print] |
671 leads |
Single center retrospective study |
The number of prophylactic Fidelis lead revisions has increased dramatically since 2008. Major procedural complication rates are greater among patients with BiV ICDs. |
Bernstein NE, et al. Pacing Clinical Electrophysiology. 2012 Apr 1. doi: 10.1111/j.1540-8159.2012.03357.x. [Epub ahead of print] |
176 leads |
3 Centers |
Active fix models 6949 and 6931 Right-sided implantation and subpectoral generator positioning were factors associated with premature lead malfunction. |
Ricci R.P., et al. Journal of Interventional Cardiac Electrophysiology. Published online September 1, 2011. |
414 |
Single Center |
Automatic algorithms based on device diagnostics may detect impending lead failure in nearly 50% of cases. Remote monitoring may prevent failure-related adverse events. |
Morrison, et al. JACC. 2011 July 12; Vol. 58, No. 3: 278-283 |
2,671 |
Multiple Centers |
This study compared all-cause mortality in patients with Fidelis and Quattro leads. Adjusted survival is similar between patients with Fidelis and Quattro leads. |
Pedersen S.S., et al. Europace. 2011 May 26; 13: 1292-1298 |
207 Fidelis |
Single Center |
ICD patients are generally able to cope with a device advisory, regardless of the mode used to inform them about the issue. |
Kallinen LM. Heart Rhythm, 2010 Aug;7(8):1048-55 |
461 |
Single Center |
LIA appears to be an effective method for detecting most Sprint Fidelis lead fractures and for decreasing the incidence and number of inappropriate shocks. |
Kreuz J, et al. Hellenic Journal of Cardiology. 2010 May-Jun;51(3):219-25 |
181 |
Single Center |
Only CRT patients were free from failure, suggesting a correlation between failure and increased activity. |
Ha, et al. Pacing Clinical Electrophysiology, 2010 Apr;33(4):437-43. |
471 |
N= 26 fractures |
Overall fracture rate of 6.4%. Patients with fractures had higher EF. Other factors: location of lead tip, lead slack, lead kinking and crimping of lead body within anchoring sleeve did not appear to increase risk of lead fracture. |
Swerdlow, et al. Circulation. 2008 Nov 18;118(21):2122-9. |
213 - LIA |
Prospective study to determine if LIA could reduce shocks. |
A manufacturer software download that upgrades previously implanted ICDs without surgical revision reduces inappropriate shocks caused by lead fractures. |
Krahn, Andrew D., et al. Heart Rhythm, 2016 |
5,976 |
Used CareLink cohort to create a replacement (n=2,988) and a control (n=2,988) group with matched lead implant duration, patient age, patient sex, and generator type |
Lead survival analysis demonstrated that lead performance since the first replacement procedure did not differ from that of the matched control group. |
Citation | Sample Size | Sample Size Notes | Extraction Details | Complication Rate | Reported Outcome |
---|---|---|---|---|---|
Richardson T, et al. J Cardiovasc Electrophys, January 2014 |
192 patients |
192 recalled leads |
93.8% removed w/powered sheath |
Major: 1.4% |
Fidelis and Riata leads have similar lead extraction procedural outcomes. |
Brunner M, et al. Heart Rhythm. 2013 Oct;10(10):1444-50. |
1079 patients |
436 recalled leads |
83.7% removed w/powered sheath |
Major: 1.4% |
Recalled leads were extracted with safety and efficacy comparable to that of non-recalled ICD leads. |
Maytin, et al. Journal of American College of Cardiology, 2010 Aug 17;56(8):646-50. |
349 leads |
Sprint Fidelis extractions at 5 high volume centers |
49.4% removed w/traction |
Minor: 0.57% |
Independent predictors for the need for CTS included longer implant times, younger patient age and absence of device infection. 3 in-hospital deaths due to overwhelming sepsis in patients who presented with sepsis/endocarditis.
|
Parkash R, et al. Circulation. 2010 Jun 8;121(22):2384-7. |
469 leads |
Fidelis |
61% removed w/traction |
Overall: 14.5% |
Overall rate of major complications that arose was significant. 2 deaths occurred early postoperatively. |