Complications associated with revision of Sprint Fidelis leads: report from the Canadian Heart Rhythm Society Device Advisory Committee.
BACKGROUND
It has been observed that replacement of an implantable cardioverter-defibrillator generator in response to a device advisory may be associated with a substantial rate of complications, including death. The risk of lead revision in response to a lead advisory has not been determined previously.


RESULTS
Twenty-five implantable cardioverter-defibrillator implantation and follow-up centers from the Canadian Heart Rhythm Society Device Advisory Committee were surveyed to assess complication rates as a result of lead revisions due to the Sprint Fidelis advisory issued in October 2007. As of June 1, 2009, there had been 310 lead failures found in 6237 Sprint Fidelis leads in Canada (4.97%) over a follow-up of 40 months. There were 469 leads to be revised, 66% for confirmed fracture. Of the patients who underwent revision, 95% had a new lead inserted, whereas 4% had a pace/sense lead added. The lead was removed in 248 cases (53%), by simple traction in 61% and by laser lead extraction in 33%. Complications were encountered in 14.5% of the lead revisions; 7.25% of these were major, whereas 7.25% were minor. There were 2 deaths (0.43%). The overall risk of complications (19.8%) was greater in those who underwent lead removal at the time of revision than in those whose leads were abandoned (8.6%; P=0.0008).


CONCLUSIONS
The overall rate of major complications that arose from lead revision due to the Sprint Fidelis advisory was significant. This must be taken into account when lead revision is planned in those patients who have not yet demonstrated an abnormality in lead performance.
Parkash
Ratika
R
Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia. parkashr@cdha.nshealth.ca
Crystal
Eugene
E
Bashir
Jamil
J
Simpson
Christopher
C
Birnie
David
D
Sterns
Laurence
L
Exner
Derek
D
Thibault
Bernard
B
Connors
Sean
S
Healey
Jeffrey S
JS
Champagne
Jean
J
Cameron
Doug
D
Mangat
Iqwal
I
Verma
Atul
A
Wolfe
Kevin
K
Essebag
Vidal
V
Kus
Teresa
T
Ayala-Paredes
Felix
F
Davies
Ted
T
Sanatani
Shubhayan
S
Gow
Robert
R
Coutu
Benoit
B
Sivakumaran
Soori
S
Stephenson
Elizabeth
E
Krahn
Andrew
A
D026683:Advisory Committees / Q000592:standards*; D002170:Canada; D017147:Defibrillators, Implantable / Q000009:adverse effects*; D018795:Device Approval / Q000592:standards*; D004567:Electrodes, Implanted / Q000592:standards; D004868:Equipment Failure; D005500:Follow-Up Studies; D006323:Heart Arrest / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology; D006339:Heart Rate; D006801:Humans; D011183:Postoperative Complications / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology*; D012955:Societies, Medical / Q000592:standards*