Variability in implantable cardioverter defibrillator pulse generator longevity between manufacturers

被引:13
作者
Ellinor, PT [1 ]
Guy, ML [1 ]
Ruskin, JN [1 ]
McGovern, BA [1 ]
机构
[1] Massachusetts Gen Hosp, Cardiac Arrhythmia Serv, Div Cardiol, Boston, MA 02114 USA
来源
PACE-PACING AND CLINICAL ELECTROPHYSIOLOGY | 2003年 / 26卷 / 01期
关键词
implantable cardioverter defibrillator; pulse generator; elective replacement; malfunction; longevity;
D O I
10.1046/j.1460-9592.2003.00153.x
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
ICDs are used frequently to treat malignant ventricular arrhythmias. Despite the expanding role of these devices, little is known about the manufacturer variability in the performance of ICD generators. The purpose of this study is to explore the indications for ICD pulse generator replacement and to examine performance differences between the three major manufacturers of ICDs in the United States. The authors performed a retrospective review of ICD pulse generators that were implanted and replaced at Massachusetts General Hospital between February 1998 and March 2002. During the study period, 50 (7%) of the 707 devices in the study cohort were replaced. The most common indication for pulse generator replacement was related to battery performance followed by device recall, upgrade to a dual chamber device, and pulse generator malfunction. After exclusion of the recalled devices, a significantly higher number of pulse generators manufactured by St. Jude Medical (14/229) required replacement for battery depletion or prolonged charge times during the study period compared with devices from Guidant (2/220) or Medtronic (0/273), P = 0.003 and P < 0.0001, respectively. This difference was attributable to reduced longevity in the Angstrom series of defibrillators.
引用
收藏
页码:71 / 75
页数:5
相关论文
共 14 条
[1]   Inability to communicate with ICDs: An underreported failure mode [J].
Blitzer, ML ;
Marieb, MA ;
Schoenfeld, MH .
PACE-PACING AND CLINICAL ELECTROPHYSIOLOGY, 2001, 24 (01) :13-15
[2]   A randomized study of the prevention of sudden death in patients with coronary artery disease [J].
Buxton, AE ;
Lee, KL ;
Fisher, JD ;
Josephson, ME ;
Prystowsky, EN ;
Hafley, G .
NEW ENGLAND JOURNAL OF MEDICINE, 1999, 341 (25) :1882-1890
[3]   Runaway pacemaker in an implantable cardioverter defibrillator [J].
Carpenter, CM ;
Galvin, J ;
Guy, M ;
McGovern, BA .
JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, 1998, 9 (09) :1008-1011
[4]   Canadian implantable defibrillator study (CIDS) - A randomized trial of the implantable cardioverter defibrillator against amiodarone [J].
Connolly, SJ ;
Gent, M ;
Roberts, RS ;
Dorian, P ;
Roy, D ;
Sheldon, RS ;
Mitchell, LB ;
Green, MS ;
Klein, GJ ;
O'Brien, B .
CIRCULATION, 2000, 101 (11) :1297-1302
[5]  
*FDA, 2001, FDA ENF REP
[6]   Feasibility and initial results of an Internet-based pacemaker and ICD pulse generator and lead registry [J].
Hauser, R ;
Hayes, D ;
Parsonnet, V ;
Furman, S ;
Epstein, A ;
Hayes, J ;
Saksena, S ;
Irwin, M ;
Almquist, A ;
Cannom, D ;
Gross, J ;
Kallinen, L .
PACE-PACING AND CLINICAL ELECTROPHYSIOLOGY, 2001, 24 (01) :82-87
[7]   Unexpected ICD pulse generator failure due to electronic circuit damage caused by electrical overstress [J].
Hauser, RG ;
Hayes, DL ;
Almquist, AK ;
Epstein, AE ;
Parsonnet, V ;
Tyers, GFO ;
Vlay, SC ;
Schoenfeld, MH .
PACE-PACING AND CLINICAL ELECTROPHYSIOLOGY, 2001, 24 (07) :1046-1054
[8]   Failure rates of leads, pulse generators, and programmers have not diminished over the last 20 years: Formal monitoring of performance is still needed [J].
Kawanishi, DT ;
Song, S ;
Furman, S ;
Parsonnet, V ;
Pioger, G ;
Petitot, JC ;
Godin, JF .
PACE-PACING AND CLINICAL ELECTROPHYSIOLOGY, 1996, 19 (11) :1819-1823
[9]   Recalls and safety alerts involving pacemakers and implantable cardioverter-defibrillator generators [J].
Maisel, WH ;
Sweeney, MO ;
Stevenson, WG ;
Ellison, KE ;
Epstein, LM .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2001, 286 (07) :793-799
[10]  
McAnulty J, 1997, NEW ENGL J MED, V337, P1576