BACKGROUND: Despite the widespread and growing use of implantable cardioverter-defibrillators (ICDs), little information is available regarding their performance or the impact of advanced pacing functions on ICD reliability and longevity. OBJECTIVES: The purpose of this study was to examine the performance of contemporary ICD pulse generators that failed or were replaced because of manufacturers recalls. METHODS: ICD data were entered prospectively by nine participating centers. ICD pulse generator failure was defined as removal from service because the device was not functioning according to the manufacturer's specifications. A recalled ICD was a normally functioning pulse generator that was replaced as the result of a recall or advisory. RESULTS: From 1998 to 2005, 1,220 ICDs failed and 135 were recalled and replaced. The average implant time of failed ICDs was 4.4 +/- 1.5 years and of recalled ICDs was 1.7 +/- 0.8 years. The average implant time of single- and dual-chamber ICDs with rate responsive or cardiac resynchronization (CRT-D) pacing capabilities was significantly shorter than the average implant time of single- or dual-chamber devices without these features (P <.001). ICDs that provided rate responsive or CRT-D pacing failed earlier because of battery depletion (P <.001) and were significantly more prone to unexpected electronic or housing failure (9% vs 5%, P = .008) and recalls (25% vs 1%, P <.0001). Major adverse events included death (n = 2), failure to convert ventricular tachyarrhythmias (n = 6), and inappropriate shocks (n = 11). CONCLUSION: Based on our analysis of failed and recalled devices, the performance of contemporary ICDs has been adversely affected by premature battery depletion, electronic failure, and manufacturers' recalls. Additional studies are needed to precisely estimate ICD longevity and to determine the incidence of unexpected ICD failure.
BACKGROUND: Despite the widespread and growing use of implantable cardioverter-defibrillators (ICDs), little information is available regarding their performance or the impact of advanced pacing functions on ICD reliability and longevity. OBJECTIVES: The purpose of this study was to examine the performance of contemporary ICD pulse generators that failed or were replaced because of manufacturers recalls. METHODS:ICD data were entered prospectively by nine participating centers. ICD pulse generator failure was defined as removal from service because the device was not functioning according to the manufacturer's specifications. A recalled ICD was a normally functioning pulse generator that was replaced as the result of a recall or advisory. RESULTS: From 1998 to 2005, 1,220 ICDs failed and 135 were recalled and replaced. The average implant time of failed ICDs was 4.4 +/- 1.5 years and of recalled ICDs was 1.7 +/- 0.8 years. The average implant time of single- and dual-chamber ICDs with rate responsive or cardiac resynchronization (CRT-D) pacing capabilities was significantly shorter than the average implant time of single- or dual-chamber devices without these features (P <.001). ICDs that provided rate responsive or CRT-D pacing failed earlier because of battery depletion (P <.001) and were significantly more prone to unexpected electronic or housing failure (9% vs 5%, P = .008) and recalls (25% vs 1%, P <.0001). Major adverse events included death (n = 2), failure to convert ventricular tachyarrhythmias (n = 6), and inappropriate shocks (n = 11). CONCLUSION: Based on our analysis of failed and recalled devices, the performance of contemporary ICDs has been adversely affected by premature battery depletion, electronic failure, and manufacturers' recalls. Additional studies are needed to precisely estimate ICD longevity and to determine the incidence of unexpected ICD failure.
Authors: Sergio Dubner; Angelo Auricchio; Jonathan S Steinberg; Panos Vardas; Peter Stone; Josep Brugada; Ryszard Piotrowicz; David L Hayes; Paulus Kirchhof; Günter Breithardt; Wojciech Zareba; Claudio Schuger; Mehmet K Aktas; Michal Chudzik; Suneet Mittal; Niraj Varma Journal: Ann Noninvasive Electrocardiol Date: 2012-01 Impact factor: 1.468
Authors: Jay Sengupta; Arthur C Kendig; Marlene Goormastic; Eui-Seock Hwang; Elizabeth A Ching; Roy Chung; Bruce D Lindsay; Patrick J Tchou; Bruce L Wilkoff; Mark J Niebauer; David O Martin; Niraj Varma; Oussama Wazni; Walid Saliba; Mohamed Kanj; Mandeep Bhargava; Thomas Dresing; Tyler Taigen; Christopher Ingelmo; Mohamed Bassiouny; Edmond M Cronin; Bradley Wilsmore; John Rickard; Mina K Chung Journal: Heart Rhythm Date: 2012-07-03 Impact factor: 6.343
Authors: Paul Chun Yih Lim; Audry Shan Yin Lee; Kelvin Chi Ming Chua; Eric Tien Siang Lim; Daniel Thuan Tee Chong; Boon Yew Tan; Kah Leng Ho; Wee Siong Teo; Chi Keong Ching Journal: Singapore Med J Date: 2016-07 Impact factor: 1.858
Authors: Christian G Wollmann; Dirk Böcker; Andreas Löher; Hans H Scheld; Günter Breithardt; Rainer Gradaus Journal: Herzschrittmacherther Elektrophysiol Date: 2009-02-11
Authors: Andrew D Krahn; Christopher S Simpson; Ratika Parkash; Raymond Yee; Jean Champagne; Jeffrey S Healey; Doug Cameron; Bernard Thibault; Iqwal Mangat; Stanley Tung; Laurence Sterns; David H Birnie; Derek V Exner; Soori Sivakumaran; Ted Davies; Benoit Coutu; Eugene Crystal; Kevin Wolfe; Atul Verma; Elizabeth A Stephenson; Shubhayan Sanatani; Robert Gow; Sean Connors; Felix Ayala Paredes; Mike Turabian; Teresa Kus; Vidal Essebag; Martin Gardner Journal: Can J Cardiol Date: 2009-07 Impact factor: 5.223
Authors: Coen W Hurkmans; Joost L Knegjens; Bing S Oei; Ad J J Maas; G J Uiterwaal; Arnoud J van der Borden; Marleen M J Ploegmakers; Lieselot van Erven Journal: Radiat Oncol Date: 2012-11-24 Impact factor: 3.481