Nonphysiologic noise early after defibrillator implantation in Canada: incidence and implications: a report from the Canadian Heart Rhythm Society Device Committee.

BACKGROUND: Following recent cases of nonphysiologic noise noted early after defibrillator implantation, the Canadian Heart Rhythm Society Device Committee decided to evaluate the implications of this problem. OBJECTIVE: To determine the incidence and consequences of nonphysiologic noise early after defibrillator implantation. METHODS: The Canadian Heart Rhythm Society Device Committee surveyed all Canadian defibrillator implanting centers regarding their implant volumes and number of cases where nonphysiologic noise had been noted early (< 24 hours) after implant over the preceding 2 years. For such cases, information regarding the manufacturer and occurrence of inappropriate shock or inhibition of pacing was reported. RESULTS: Responses were obtained from 20 of 23 surveyed implanting centers, with a total implant volume of 4960 defibrillators per year. The occurrence of nonphysiologic noise early after implantation was noted in 25 cases over the preceding 2 years (0.25%). Noise was detected in devices of all 3 of the leading volume device manufacturers. There were 2 cases of inappropriate shocks and 2 cases of symptomatic pacing inhibition. In 4 cases, removal of the lead from the header and retesting with the analyzer confirmed normal lead function. In all cases, the noise resolved within 24 hours. CONCLUSION: Nonphysiologic noise early after defibrillator implantation was noted in 0.25% of procedures and was not limited to one specific manufacturer. This noise may result in an inappropriate shock or inhibition of pacing in a pacemaker-dependent patient. This transient phenomenon, possibly related to fluid and/or air in the header, appears to always resolve without surgical intervention.

Peritoneal macrophages from patients with cirrhotic ascites show impaired phagocytosis and vigorous respiratory burst.

Cirrhotic patients (CPs) are susceptible to spontaneous bacterial peritonitis (SBP). Aim of this study was to examine if this susceptibility was related to peritoneal macrophages' (PMs) altered host defence. Absorbance of phagocytosed particles by PMs from CPs was lower than that of control (31.88% vs. 77.2%). Particle opsonisation increased the absorbance to 41% in CPs' PMs, and this value remains lower than the control; 77.2%. Respiratory burst (RB) was expressed as fluorescence index values, and these were higher in PMs from CPs than in controls (82 vs. 41, 73 vs. 26 and 71 vs. 26). IFN-γ made no further increase of RB values in PMs from CPs. CD14 expression was also higher in CPs' PMs. IFN-γ significantly downregulated CD14 expression in both CPs' PMs and control. Reduced phagocytosis by predominantly CD14-positive PMs from CPs could be related to intense RB. Findings suggest altered host defence that could contribute to susceptibility to SBP.

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. 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.

Formation of a national network for rapid response to device and lead advisories: The Canadian Heart Rhythm Society Device Advisory Committee.

The Canadian Heart Rhythm Society (CHRS) Device Advisory Committee was commissioned to respond to advisories regarding cardiac rhythm device and lead performance on behalf of the CHRS. In the event of an advisory, the Chair uses an e-mail network to disseminate advisory information to Committee members broadly representative of the Canadian device community. A consensus recommendation is prepared by the Committee and made available to all Canadian centres on the CHRS Web site after approval by the CHRS executive. This collaborative approach using an e-mail network has proven very efficient in providing a rapid national response to device advisories. The network is an ideal tool to collect specific data on implanted device system performance and allows for prompt reporting of clinically relevant data to front-line clinicians and patients.

Utilization of a national network for rapid response to the Medtronic Fidelis lead advisory: the Canadian Heart Rhythm Society Device Advisory Committee.

BACKGROUND/OBJECTIVE: The Canadian Heart Rhythm Society (CHRS) Device Advisory Committee was commissioned in 2006 to develop a mechanism for responding to advisories regarding cardiac rhythm device and lead performance. METHODS: In the event of an advisory, the Chair classifies the advisory as urgent, semi-urgent, or routine based on the nature of the threat to the patient and the number of patients affected. The Chair uses an e-mail network with the committee members to disseminate advisory information and to assemble a consensus recommendation. Committee membership is broadly representative of the Canadian device community, including both academic and nonacademic centers, adult and pediatric specialists, and includes balanced regional representation. Recommendations are approved by the CHRS executive and made available to all implant and follow-up centers on the CHRS website. RESULTS: With the Medtronic Fidelis lead advisory of October 15, 2007, the Chair classified the advisory as semi-urgent and initiated an e-mail discussion and preliminary survey of all Canadian implantable cardioverter-defibrillator (ICD) centers within 3 hours of advisory announcement. A CHRS membership statement was issued within 48 hours. Within 5 working days, sample letters to physicians and patients were posted for local adaptation and distribution. Complete data collection was obtained from all Canadian defibrillator centers. Analyses at 20, 25, 30, and 32 months suggest an accelerating course of failures (3.91% at 32 months, P <.0001), with a reduced likelihood of presentation with inappropriate shocks (from 56% to 21%, P = .0003). CONCLUSION: A collaborative approach using an e-mail network provides a mechanism for a rapid national response to device advisories. The network allows collection of focused data on implanted device system performance and facilitates timely reporting of clinically relevant data to patients and clinicians.

Outcome of the Fidelis implantable cardioverter-defibrillator lead advisory: a report from the Canadian Heart Rhythm Society Device Advisory Committee.

BACKGROUND: The Medtronic Sprint Fidelis family of leads has recently been the subject of a widespread advisory. Lead failure rates are estimated at 2.3% at 30 months, 2.6 times the failure rate of the reference Medtronic 6947 lead. OBJECTIVE: The purpose of this study was to contact pediatric and adult implantable cardioverter-defibrillator (ICD) implant centers across Canada to determine the short-term response to the October 15, 2007 Medtronic Fidelis lead advisory. METHODS: All centers completed an 11-part survey to assess the frequency and presentation of lead failure, operator characteristics, and center's response. RESULTS: Lead failure was noted in 80 (1.29%) of 6,181 patients at 21.0 months, with inappropriate shocks experienced in 45 (56%) of the 80 patients (overall risk 0.73%). No deaths were attributed to lead failure. Sensing was the primary form of failure, seen in 60 leads (75%), with pacing failure in 10 (13%), and high-voltage failure in 15 (19%). Assessment of the previous routine ICD interrogation prior to the advisory or lead failure demonstrated evidence of altered lead performance in only 8 (10%) of the 80 leads. Inappropriate shocks typically were multiple (median 7, range 1-122), with a single shock seen in only 5 patients. Lead failure was noted in 18 of 23 centers, representing 89.8% of leads implanted, with at least one failure noted in 15 of 16 centers that implanted more than 200 leads. Forty-seven of the 135 operators in the 23 institutions implanted the 80 leads that subsequently failed. Only 16 operators were involved in more than a single lead that subsequently failed; seven operators participated in three or more leads that subsequently failed. Seven centers planned to replace leads in most pacing-dependent patients, and two centers planned to replace leads in patients unable to hear the alert tone. CONCLUSION: This national experience suggests a Fidelis lead failure rate of 1.29% at 21 months, most often presenting with multiple inappropriate shocks without evidence of impending failure from routine lead follow-up. Lead failure did not appear to cluster around specific operators or around high-volume or low-volume implant centers.