Register to receive periodic updates on the performance of the Sprint FIDELIS lead.

Current Product Surveillance Registry data is located at: 
http://wwwp.medtronic.com/productperformance/model/6949-sprint-fidelis.html

Sprint FIDELIS Lead Performance

November 2015 Website Update

Sprint FIDELIS® Model 6949 Lead Performance

Dual Coil, Active fixation

November 2015*


Sprint FIDELIS® Model 6949 Center Fracture Data

November 2015*


Sprint FIDELIS® Model 6949 Age Data

November 2015*


Sprint FIDELIS® Model 6949 Gender Data

November 2015*


Sprint FIDELIS® Model 6949 Device Data

November 2015*


Sprint FIDELIS® Model 6931 Lead Performance

Single Coil, Active fixation

November 2015*


Sprint FIDELIS® Model 6948 Lead Performance

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

Numerator

  • Fractures determined by CareLink® Transmissions
  • Returned Product Analysis of explanted leads
  • Analysis of Save-to-Disk files from returned devices that were associated with FIDELIS leads

Denominator

  • Number of active FIDELIS leads in CareLink cohort based on Medtronic registry data

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.

Lead Performance Information

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).

FIDELIS Lead Survival Publications

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.
80.3%

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 
Passive fix Fidelis 6948 leads

98.5%

94.2%

94.3%

96 mo. 
89.6%

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 
18 6930s 
525 6931s 
60 6948s 
383 6949s

92.6%

86.1%

79.3%

60 mo. 
79.3%

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 
Single center

69%

44%

84 mo. 
0%

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 
Single center
Japanese patients

95.1%

89.8%

88.0%

84 mo. 
69.8%

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
Single center

91%

89%

Survival curves of recalled leads diverge from nonrecalled leads 2 years after implantation. 
Note that the rates are estimates based on the article’s survival curve figure.

Vollmann D, et al. Europace. 2013 Jun 28.

429

Single center
96.5% passive

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 
413 - CRT

97.5% ICD 
95% CRT

96.5% ICD 
90.5% CRT

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
98% 6949

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 
62% 6931

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
706 men
265 women

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% 
(+/- 2.6%)

65.6%
(+/- 7.5%)

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. 
94.8%

36 mo. 
94.0%

42 mo. 
89.0% 
(+/-4.9%)

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
N=1,007 Model 6469
N=14 Model 6931
N=2 Model 6948

92.6%

87.0%

2.81% Fidelis failure rate/yr
Risk of failure higher in younger patients, women, individuals with hypertrophic cardiomyopathy and patients who have arrhythmogenic right ventricular dysplasia or channelopathies.

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
N = 18 Fidelis fractures
N = 6 Quattro fractures

30 mo. 
89.3%

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
31% Model 6931
69% Model 6949
92.1% axillary implants

90.3%
(+3.5 / -3.4)

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. 
96.8%

32 mo.
96.1%

Analyses at 20, 25, 30, & 32 months. Accelerating course of failures
2 failures of 32 pediatric implants (6.3%)

Farwell, et al. Heart Rhythm. 2008 Oct;5(10):1375-9.

480

Single center
Model 6949

30 mo. 
91.5%*

36 mo.
90.3%*

Failure rate increasing exponentially (power of 2.74). Cephalic vein access reduced risk of fracture. Higher fracture rate for patients with higher LVEF.

Other FIDELIS Publications

Citation Sample Size Sample Size Notes Reported Outcome

Krahn, et al. Circ Arrhythm Electrophysiol, 2014 September.

266

133 patient scans with Fidelis lead fractures. 
133 patient scans with normally functioning Fidelis leads

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
5,114 Boston Scientific Endotak 
6,123 SJM Riata or Durata

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 
468 Other Sprint lead

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 
510 control

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
Model 6931

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
N = 52 controls

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 
213 - Control

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.

FIDELIS Extraction Publications

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 
(145 Fidelis, 47 Riata)

93.8% removed w/powered sheath

Major: 1.4% 
Minor: 4.1%

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
(s314 Fidelis, 122 Riata)

83.7% removed w/powered sheath
11.2% No tools required

Major: 1.4%
Minor: 2.3%

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
50.6 removed w/counter traction sheath (CTS)

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
33% removed w/laser

Overall: 14.5%
Major: 7.25%

Overall rate of major complications that arose was significant. 2 deaths occurred early postoperatively.

Figure 1

Figure 1