In patients with ischemic cardiomyopathy and an implantable cardioverter–defibrillator who had ventricular tachycardia, catheter ablation was associated with a lower rate of death, ventricular ...tachycardia storm, or ICD shock at 28 months than an escalation in antiarrhythmic drugs.
Ventricular tachycardia caused by the scarring that occurs after myocardial infarction carries a substantial risk of death, a risk that is significantly reduced by the placement of an implantable cardioverter–defibrillator (ICD).
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ICDs are implanted in more than 100,000 patients annually in the United States. Of these patients, 15% are initially treated with concomitant antiarrhythmic drug (AAD) therapy,
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and up to 38% receive an appropriate shock for ventricular arrhythmia within 5 years.
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ICDs effectively terminate ventricular tachycardia, but recurrent arrhythmias and ICD shocks may cause impairment in the quality of life,
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are associated with an increased risk of death, heart failure, . . .
Cardiac implantable electronic device infection is a major complication that usually requires device removal. PADIT (Prevention of Arrhythmia Device Infection Trial) was a large cluster crossover ...trial of conventional versus incremental antibiotics.
This study sought to investigate independent predictors of device infection in PADIT and develop a novel infection risk score.
In brief, over 4 6-month periods, 28 centers used either conventional or incremental prophylactic antibiotic treatment in all patients. The primary outcome was hospitalization for device infection within 1 year (blinded endpoint adjudication). Multivariable logistic prediction modeling was used to identify the independent predictors and develop a risk score for device infection. The prediction models were internally validated with bootstrap methods.
Device procedures were performed in 19,603 patients, and hospitalization for infection occurred in 177 (0.90%) within 1 year of follow-up. The final prediction model identified 5 independent predictors of device infection (prior procedures P, age A, depressed renal function D, immunocompromised I, and procedure type T) with an optimism-corrected C-statistic of 0.704 (95% confidence interval: 0.660 to 0.744). A PADIT risk score ranging from 0 to 15 points classified patients into low (0 to 4), intermediate (5 to 6) and high (≥7) risk groups with rates of hospitalization for infection of 0.51%, 1.42%, and 3.41%, respectively.
This study identified 5 independent predictors of device infection and developed a novel infection risk score in the largest cardiac implantable electronic device trial to date, warranting validation in an independent cohort. The 5 independent predictors in the PADIT score are readily adopted into clinical practice. (Prevention of Arrhythmia Device Infection Trial PADIT Pilot; NCT01002911)
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Background/objective
We compared health‐related quality of life (HRQoL) in patients randomized to escalated therapy and those randomized to ablation for ventricular tachycardia in the VANISH trial.
...Methods
HRQoL was assessed among VANISH patients at baseline and 3‐, 6‐, and 12‐month follow‐up visits. Four validated instruments were used: the SF‐36, the implanted cardioverter defibrillator (ICD) Concerns questionnaire (ICDC), the Hospital Anxiety and Depression Scale (HADS), and the EuroQol five dimensions questionnaire (EQ‐5D). Linear mixed‐effects modeling was used for repeated measures with SF‐36, HADS, ICDC, and EQ‐5D as dependent variables. In a second model, treatment was subdivided by amiodarone use prior to enrollment.
Results
HRQoL did not differ significantly between those randomized to ablation or escalated therapy. On subgroup analysis, improvement in SF‐36 measures was seen at 6 months in the ablation group for social functioning (63.5–69.3, P = 0.03) and energy/fatigue (43.0–47.9, P = 0.01). ICDC measures showed a reduction in ICD concern in the ablation group at 6 months (10.4–8.7, P = 0.01) and a reduction in ICD concern in the escalated therapy group at 6 months (10.9–9.4, P = 0.04). EQ‐5D measures showed a significant improvement in overall health in ablation patients at 6 months (63.4–67.3, P = 0.04).
Conclusion
Patients in the VANISH study randomized to ablation did not have a significant change in quality of life outcomes compared to those randomized to escalated therapy. Some subgroup findings were significant, as those randomized to ablation showed persistent improvement in SF‐36 energy/fatigue and ICD concern, and transient improvement in SF‐36 social functioning and EQ‐5D overall health.
Early Failure of the Biotronik Linox
Introduction
The Linox and Durata implantable cardioverter defibrillator (ICD) leads were introduced to British Columbia (BC) in 2008. We determined their ...performance and the potential risk factors for lead failure in a large population‐based patient registry.
Methods and Results
We used the BC Cardiac Registry, a mandatory Governmental database of ICD implants, to identify all recipients of Linox and Durata leads in BC between October 2008 and April 2012, and those subsequently undergoing reoperation. Lead failure was defined as recurrent nonphysiological high‐rate sensing unrelated to external electromagnetic interference or T‐wave oversensing; a sudden rise in impedance unrelated to perforation or lead dislodgement; or abnormal lead parameters with definite evidence of lead fracture or insulation failure. We determined the estimated cumulative lead survival by the Kaplan–Meier method, and the risk factors for lead failure in a proportional hazards model. Over a median of 39 (27–50) months, the Linox failed more frequently than the Durata (16/477 3.4% vs. 4/838 0.4%; P < 0.001), and had a significantly lower estimated cumulative survival (91.6 80.6–96.5% vs. 99.4 98.4–99.8% at 5 years; P < 0.0001). Linox failure was characterized by high‐rate nonphysiological sensing (11 cases), and/or a sudden impedance rise (7 cases). Insulation failure was clearly confirmed in 6 cases of Linox failure. Female sex was a significant risk factor for Linox failure (adjusted HR = 2.11.3–3.4; P = 0.004).
Conclusions
This multicenter registry indicates a high rate of Linox lead failure, particularly in female patients. Ongoing surveillance of the Linox ICD lead performance is recommended.
The St. Jude Medical Riata family of implantable cardioverter-defibrillator (ICD) leads has demonstrated a high rate of externalized conductors and electrical failure.
Given similar design elements ...of Durata to Riata, the purpose of this study was to assess the rates of failure of the Riata ST Optim and Durata lead families in Canada.
All Canadian ICD-implanting centers were invited to submit follow-up information on all Optim-coated ICD leads implanted. Electrical failure was defined as a rapid change in impedance or pacing capture threshold leading to lead revision, or oversensing due to noise. Externalized conductors were defined as appearance of conductor wires outside the lead body. Systematic fluoroscopic screening for externalized conductors was not performed.
As of December 1, 2012, 15 of 25 centers provided data on 3981 leads (44% of those sold in Canada during the same timeframe): 3477 Durata and 504 Riata ST Optim leads. The most common model numbers were 7122 (1516 leads 38%), 7121 (707 leads 18%), and 7120 (622 leads 16%). Mean follow-up duration from implant to December 1, 2012, was 4.47 ± 0.48 years for Riata ST Optim leads and 2.00 ± 1.10 years for Durata leads. The annual rate of lead failure was 0.27% per year for Riata ST Optim leads and 0.24% per year for Durata leads. No instances of externalized conductors were identified in the failed leads. No deaths were attributed to lead failure; however, 2 patients experienced inappropriate shocks due to lead failure.
The overall electrical failure rates of the Riata ST Optim and Durata leads appear to be low, and no instances of externalized conductors were observed.
Abstract A man aged 75 years and with nonischemic cardiomyopathy had implantation of a biventricular implantable cardiac defibrillator (ICD). Consistent biventricular pacing was limited by ...intermittent T-wave oversensing (TWOS). A strategy of left-ventricular-only pacing was used to eliminate TWOS. This strategy obviates the need to reduce ventricular sensitivity and thus may be an effective alternative to biventricular pacing complicated by TWOS.
Defibrillation threshold (DFT) testing has traditionally been a routine part of implantable cardioverter-defibrillator (ICD) implantation, despite a lack of compelling evidence that it predicts or ...improves outcomes. In the past, when devices were much less reliable, DFT testing seemed prudent; however, modern ICD systems have such a high rate of successful defibrillation that many electrophysiologists now question whether DFT testing is still worthwhile, particularly since DFT testing may now be the highest acute risk component of ICD implantation.
The purpose of this study was to systematically document complications directly attributable to intraoperative DFT testing.
We obtained data on DFT-related complications from all 21 adult ICD implant centers in Canada, covering the period from January 1, 2000, to September 30, 2006.
There were a total of 19,067 ICD implants in Canada during the study period. There were three DFT testing-related deaths, five DFT testing-related strokes, and 27 episodes that required prolonged resuscitation. Two patients had significant clinical sequelae after prolonged resuscitation.
The risk of severe complications from intraoperative DFT testing appears small, even allowing for the underestimation of its true rate with the current study methodology. These slight but measurable risks must be considered when assessing the risk-benefit ratio of the procedure. Additional data from ongoing prospective ICD registries and/or clinical trials are required.
There is a relative paucity of data linking inappropriate implantable cardioverter-defibrillator (ICD) shocks to adverse clinical outcomes.
To examine the association between inappropriate ICD shocks ...and mortality or heart transplantation in a large population cohort.
A cohort study which included all subjects who underwent ICD implantation between 1998 and 2008 and were followed up at our institution.
Multivariable Cox regression analyses were conducted to investigate the effect of inappropriate shocks on the risk of death and heart transplantation. Appropriate and inappropriate ICD therapies were modelled as time-dependent covariates.
A total of 1698 patients were included. During a median follow-up of 30 months, there were 246 (14.5%) deaths and 42 (2.5%) heart transplants. The incidence of inappropriate shocks was 10% at 1 year and 14% at 2 years. In the adjusted model, inappropriate shocks were not associated with death or transplantation (HR=0.97, 95% CI 0.70 to 1.36, p value=0.873). In contrast, appropriate shocks were associated with adverse outcomes (HR=3.11, 95% CI 2.41 to 4.02, p value<0.001). The lack of association between inappropriate shocks and outcomes persisted for those with severely impaired left ventricular function (ejection fraction <30%) and for those receiving multiple inappropriate treatments.
In this study, we observed no association between inappropriate ICD shocks and increased mortality or heart transplantation, even among those with severely impaired cardiac function. These findings question whether inappropriate ICD shocks lead to adverse outcomes.
Prevention of Arrhythmia Device Infection Trial Krahn, Andrew D.; Longtin, Yves; Philippon, François ...
Journal of the American College of Cardiology,
12/2018, Letnik:
72, Številka:
24
Journal Article
Recenzirano
Odprti dostop
Infection of implanted medical devices has catastrophic consequences. For cardiac rhythm devices, pre-procedural cefazolin is standard prophylaxis but does not protect against methicillin-resistant ...gram-positive organisms, which are common pathogens in device infections.
This study tested the clinical effectiveness of incremental perioperative antibiotics to reduce device infection.
The authors performed a cluster randomized crossover trial with 4 randomly assigned 6-month periods, during which centers used either conventional or incremental periprocedural antibiotics for all cardiac implantable electronic device procedures as standard procedure. Conventional treatment was pre-procedural cefazolin infusion. Incremental treatment was pre-procedural cefazolin plus vancomycin, intraprocedural bacitracin pocket wash, and 2-day post-procedural oral cephalexin. The primary outcome was 1-year hospitalization for device infection in the high-risk group, analyzed by hierarchical logistic regression modeling, adjusting for random cluster and cluster-period effects.
Device procedures were performed in 28 centers in 19,603 patients, of whom 12,842 were high risk. Infection occurred in 99 patients (1.03%) receiving conventional treatment, and in 78 (0.78%) receiving incremental treatment (odds ratio: 0.77; 95% confidence interval: 0.56 to 1.05; p = 0.10). In high-risk patients, hospitalization for infection occurred in 77 patients (1.23%) receiving conventional antibiotics and in 66 (1.01%) receiving incremental antibiotics (odds ratio: 0.82; 95% confidence interval: 0.59 to 1.15; p = 0.26). Subgroup analysis did not identify relevant patient or site characteristics with significant benefit from incremental therapy.
The cluster crossover design efficiently tested clinical effectiveness of incremental antibiotics to reduce device infection. Device infection rates were low. The observed difference in infection rates was not statistically significant. (Prevention of Arrhythmia Device Infection Trial PADIT Pilot PADIT; NCT01002911)
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Abstract We report a case in which a patient with dilated cardiomyopathy presented with syncope, terminated by a shock from his implantable cardioverter defibrillator. However, subsequent ...interrogation of the device revealed no tachycardia detection or treatment parameters. The mystifying details of the case were unravelled by remote consultation with the staff electrophysiologist and the use of smart phone-transmitted live images. This case highlights the use of mobile phone-facilitated video conferencing in urgent management of intracardiac device therapy. Judicious use of this technology has the potential to deliver effective and cost-effective solutions for many device-related emergencies in patients at remote settings.
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