APPENDIX D

Lead Extraction Risks
October 2007

This attachment accompanies Medtronic’s physician letter dated October 15, 2007 and provides information concerning risks inherent in lead extractions.

Medtronic’s Independent Physician Quality Panel believes it is inappropriate to prophylactically remove Sprint Fidelis® leads except in unusual individual patient circumstances. We support this position.

Extraction of chronic leads entails substantial risks of patient morbidity and mortality. Reported complications1 include: lead breakage and migration; avulsion of veins, myocardium or the tricuspid valve; tears of the myocardium or veins; hemothorax, tamponade, perforation, emergency cardiothoracic surgery, pulmonary emboli, and death.

In evaluating whether to extract any cardiac lead, physicians must weigh the risks and benefits of leaving the lead in place in comparison to those of removal. Major complications from lead extraction, defined as death or the requirement of a significant surgical intervention, have been reported in multiple series to be in the range of 1.4-7.3% of patients.2,3 Factors reported to increase the risk of major complications include: duration of implant, female gender, and large removal sheaths.4,5

Medtronic Sprint Fidelis performance data indicate all-cause lead survival of 97.7% at 30 months (SLS, Medtronic CareLink® Network analysis). High voltage conductor fractures could result in the inability to deliver defibrillation therapy. Anode or cathode conductor fractures at either of the primary fracture locations may present clinically as increased impedance, oversensing, increased interval counts, multiple inappropriate shocks, and/or loss of pacing output. Utilization of the patient management recommendations will increase the likelihood that a fracture will be detected by Patient Alert™ and/or Medtronic CareAlert® notifications (see Appendix C) and decrease the likelihood of inappropriate therapies. Based on current information, we have identified five patient deaths in which a Sprint Fidelis lead fracture may have been a possible or likely contributing factor. (0.0018% of approximately 268,000 implants worldwide). By comparison, the risk of major complications (cardiac surgery or death) with lead extraction is 1.4-7.3%.

It has been reported that limited physician experience (< 50 procedures) may significantly increase the risk of complications from extraction.6 For this reason, Medtronic’s Independent Physician Quality Panel recommends that if a lead requires removal, the procedure be performed by a physician with extensive lead extraction experience.

These recommendations are consistent with the HRS Policy Statement on recommendations for extraction of chronically implanted leads.7


References

1

Byrd CL, Wilkoff BL, in Clinical Cardiac Pacing and Defibrillation, Ellenbogen, Kay and Wilkoff editors. WB Saunders 2000, Techniques and Devices for Extraction of Pacemaker and Implantable Cardioverter Defibrillator Leads: 695-709.

2

Byrd et al, Intravascular extraction of problematic or infected permanent pacemaker leads: 1994-1996. U.S. Extraction Database, MED Institute. PACE. 1999;22(9):1349-1357.

3

Bracke et al, Lead extraction for device related infections: a single-centre experience. Europace May 2004; 6(3):243-247.

4

Byrd et al. PACE. 1999;22(9):1349-1357.

5

Kennergren et al, Laser-assisted lead extraction: the European experience. Europace. August 2007; 9(8):651-656.

6

Byrd et al. PACE. 1999;22(9):1349-1357.

7

NASPE Policy Statement: Recommendations for Extraction of Chronically Implanted Transvenous Pacing and Defibrillator Leads: Indications, Facilities, Training. Love CJ, Wilkoff BL, et al. PACE. 2000; 23, 544-551.


If you have questions or concerns, please contact your Medtronic Representative or Medtronic Technical Services at 1-800-723-4636 (US).