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Device Replacement (device + replacement)
Device-Related Infection Among Patients With Pacemakers and Implantable Defibrillators: Incidence, Risk Factors, and ConsequencesJOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 7 2010
PABLO B. NERY M.D.
Risk Factors and Complications of Pacemaker and ICD Infection.,Background: Device-related infection is a major limitation of device therapy for cardiac arrhythmia. Methods: The authors analyzed the incidence and risk factors for cardiac device infection (CDI) among consecutive patients implanted with pacemaker (PM) or implantable cardioverter defibrillator (ICD) (including cardiac resynchronization therapy devices) at a tertiary health center in Hamilton, Ontario, Canada. Most patients with device-related infections were identified by an internal infection control system that reports any positive wound and blood cultures following surgery, between 2005 and the present. A retrospective review of patient records was also performed for all patients who received an ICD or PM between July 1, 2003 and March 20, 2007. Results: A total of 24 infections were identified among 2,417 patients having device surgery (1%). Fifteen of these infections (60%) were diagnosed within 90 days of the last surgical procedure. Univariate analysis showed that patients presenting with CDI were more likely to have had a device replacement, rather than a new implant, had more complex devices (dual/triple chamber vs single), and were more likely to have had a prior lead dislodgement. Multivariate analysis found device replacement (P = 0.02) and cardiac resynchronization therapy (CRT)/dual-chamber devices (P = 0.048) to be independent predictors of infection. One patient developed septic pulmonary emboli after having laser-assisted lead extraction. No patient died and 22 patients received a new device. Conclusion: CDI occurs in about 1% of cases in high volume facilities. Pulse generator replacement surgery and dual- or triple-chamber device implantation were associated with a significantly increased risk of infection. (J Cardiovasc Electrophysiol, Vol. pp. 786-790, July 2010) [source]
Safety of Deferring the Reimplantation of Pacing Systems After Their Removal for Infectious Complications in Selected Patients: A 1-Year Follow-Up StudyJOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 5 2010
ELOI MARIJON M.D.
Introduction: Recent expert consensus guidelines mention that one of the principles for infected device replacement following removal is to "reevaluate carefully if there is a continued need for a new cardiac device replacement." This is a Class I recommendation, which nevertheless suffers from a very low level of evidence (level of evidence C), since no study has revisited the systematic practice of reimplanting the same device based on a meticulous clinical reassessment. In the present paper, we examined the safety of withholding the implantation of pacing systems in selected patients. Methods and Results: Between January 2005 and December 2007, 188 consecutive patients underwent extractions of infected pacing systems at 2 medical centers. "Low-risk" patients were identified by (1) a spontaneous heart rate >45 bpm, (2) no symptomatic asystole during monitoring, (3) QRS duration <120 ms when history of AV block was noted, (4) no high-degree AV block during continuous monitoring. They remained device-free, unless an adverse clinical event occurred mandating the reimplantation. The primary study endpoint was rate of sudden death and syncope after a 12-month follow-up. Among the 74 (39.4%) "low-risk" patients, a single patient suffered a bradycardia-related syncopal event corresponding to a 1.3% (95% CI, 0.0,3.9) rate of primary endpoint. Pacing systems were also reimplanted in 24 patients (32.4%) for syncope (n = 1), nonsevere bradycardia-reated symptoms (n = 17), cardiac resynchronization (n = 2), and for reassurance in 4 asymptomatic patients. Conclusion: After removal of infected pacing systems, these preliminary data demonstrated that a strategy of nonsystematic device reimplantation associated with close surveillance was safe in "low-risk" patients, allowing the administration of antimicrobials in a device-free state. (J Cardiovasc Electrophysiol, Vol. 21, pp. 540-544, May 2010) [source]
To Replace or Not to Replace: A Systematic Approach to Respond to Device AdvisoriesJOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 2 2009
Ph.D., SILVIA G. PRIORI M.D.
Aim: The decision of whether and when to replace a device in response to an "advisory" letter requires careful consideration, because device replacement carries related risks and is influenced by the clinical characteristics of the patient. Methods and Results: The risk/benefit of device replacement depends on four parameters: expected annual sudden cardiac death rate; residual device life; difference in failure rate between the device listed on the advisory letter and the replacement device; and the replacement procedure mortality risk. Using these four factors, we have developed an equation that provides the "number needed to replace" (NNR) to save one life. Per our model, patients implanted with a device with a failure rate approaching 1% and a probability of requiring device intervention ,25% per year,in particular, pacemaker-dependent patients,have an NNR <250. Pacemaker-dependent patients, with devices having three or more years longevity, but with device failure rates ,0.5%, have an NNR <100. Patients with arrhythmic risk ,2.5% per year and those with devices having failure rates <0.1% have a high NNR and stand more risk to be harmed than benefited from device replacement. Conclusions: Pacemaker-dependent patients and those with high arrhythmic risk (,25% annually) when having "advisory" devices with high failure rate (,1%) have an NNR <250 and, hence, could be considered for device replacement. Conversely, patients with arrhythmic risk ,2.5% per year and those with devices having failure rates ,0.1% have a high NNR or even risk of "harm" from device replacement. In all the intermediate cases, the NNR will quantify the benefit/risk ratio of replacement, thus helping physicians and patients decide on the preferred approach. The NNR methodology proposed here is also applicable to advisory notices issued to leads, but the high morbidity associated with lead replacement will generally rule out interventions to replace leads. [source]
Clinical Judgment Versus Decision Analysis for Managing Device AdvisoriesPACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 10 2008
MITESH S. AMIN M.D.
Introduction: Implantable cardioverter-defibrillator (ICD) and pacemaker (PM) advisories may have a significant impact on patient management. Surveys of clinical practice have shown a great deal of variability in patient management after a device advisory. We compared our management of consecutive patients in a single large university practice with device advisories to the "best" patient management strategy predicted by a decision analysis model. Methods: We performed a retrospective review of all patients who had implanted devices affected by an advisory at our medical center between March 2005 and May 2006 and compared our actual patient management strategy with that subsequently predicted by a decision analysis model. Results: Over 14 months, 11 advisories from three different manufacturers affected 436 patients. Twelve patients (2.8%) were deceased and 39 patients (8.9%) were followed at outside facilities. Management of the 385 remaining patients varied based on type of malfunction or potential malfunction, manufacturer recommendations, device dependency, and patient or physician preferences. Management consisted of the following: 57 device replacements (15.2%), 44 devices reprogrammed or magnets issued (11.7%), and 268 patients underwent more frequent follow-up (71.3%). No major complications, related to device malfunction or device replacement, occurred among any patient affected with a device advisory. Concordance between the decision analysis model and our management strategy occurred in 57.1% of cases and 25 devices were replaced when it was not the preferred treatment strategy predicted by the decision model (43.9%, 37.3% when excluding devices replaced based on patient preference). The decision analysis favored replacement for all patients with PM dependency, but only for four patients with ICDs for secondary prevention. No devices were left implanted that the decision analysis model predicted should have been replaced. Conclusions: We found that despite a fairly conservative device replacement strategy for advisories, we still replaced more devices when it was not the preferred device management strategy predicted by a decision analysis model. This study demonstrates that even when risks and benefits are being considered by experienced clinicians, a formal decision analysis can help to develop a systematic evidence based approach and potentially avoid unnecessary procedures. [source]