Complications Associated With Revision of Sprint Fidelis Leads Report From the Canadian Heart Rhythm Society Device Advisory Committee

被引：70

作者：

Parkash, Ratika ^{[1
]}

Crystal, Eugene ^{[2
]}

Bashir, Jamil ^{[3
]}

Simpson, Christopher ^{[4
]}

Birnie, David ^{[5
]}

Sterns, Laurence ^{[6
]}

Exner, Derek ^{[7
]}

Thibault, Bernard ^{[8
]}

Connors, Sean ^{[9
]}

Healey, Jeffrey S. ^{[10
]}

Champagne, Jean ^{[11
]}

Cameron, Doug ^{[12
]}

Mangat, Iqwal ^{[13
]}

Verma, Atul ^{[14
]}

Wolfe, Kevin ^{[15
]}

Essebag, Vidal ^{[16
,17
]}

Kus, Teresa ^{[17
]}

Ayala-Paredes, Felix ^{[18
]}

Davies, Ted ^{[19
]}

Sanatani, Shubhayan ^{[20
]}

Gow, Robert ^{[21
]}

Coutu, Benoit ^{[22
]}

Sivakumaran, Soori ^{[23
]}

Stephenson, Elizabeth ^{[24
]}

Krahn, Andrew ^{[25
]}

机构：

[1] Queen Elizabeth 2 Hlth Sci Ctr, Halifax, NS, Canada

[2] Sunnybrook Med Ctr, Toronto, ON, Canada

[3] St Pauls Hosp, Vancouver, BC V6Z 1Y6, Canada

[4] Queens Univ, Kingston, ON, Canada

[5] Univ Ottawa, Inst Heart, Ottawa, ON, Canada

[6] Royal Jubilee Hosp, Victoria, BC, Canada

[7] Libin Cardiovasc Inst, Calgary, AB, Canada

[8] Montreal Heart Inst, Montreal, PQ H1T 1C8, Canada

[9] Mem Univ Newfoundland, Hlth Sci Ctr, St John, NF, Canada

[10] Hamilton Hlth Sci Ctr, Hamilton, ON, Canada

[11] Laval Hosp, Quebec Heart Inst, Quebec City, PQ, Canada

[12] Univ Hlth Network, Toronto, ON, Canada

[13] St Michaels Hosp, Toronto, ON M5B 1W8, Canada

[14] Southlake Reg Hlth Ctr, Newmarket, ON, Canada

[15] St Boniface Gen Hosp, Winnipeg, MB R2H 2A6, Canada

[16] McGill Univ, Ctr Hlth, Montreal, PQ, Canada

[17] Hop Sacre Coeur, Montreal, PQ H4J 1C5, Canada

[18] CHU Sherbrooke, Sherbrooke, PQ J1H 5N4, Canada

[19] Scarborough Centenary Hosp, Scarborough, ON, Canada

[20] British Columbia Childrens Hosp, Vancouver, BC V6H 3V4, Canada

[21] Childrens Hosp Eastern Ontario, Ottawa, ON K1H 8L1, Canada

[22] Ctr Hosp Notre Dame, Montreal, PQ, Canada

[23] Univ Alberta Hosp, Edmonton, AB T6G 2B7, Canada

[24] Hosp Sick Children, Toronto, ON M5G 1X8, Canada

[25] London Hlth Sci Ctr, London, ON, Canada

来源：

CIRCULATION | 2010年 / 121卷 / 22期

关键词：

complications; follow-up studies; implantable defibrillators; CARDIOVERTER-DEFIBRILLATOR REPLACEMENT; EXPERIENCE;

D O I：

10.1161/CIRCULATIONAHA.109.924357

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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. Methods and 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. (Circulation. 2010; 121: 2384-2387.)

引用

页码：2384 / 2387

页数：4

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