scholarly journals Process Mapping Strategies to Prevent Subcutaneous Implantable Cardioverter-Defibrillator Infection

Author(s):  
Raul Weiss ◽  
George Mark ◽  
Mikhael El-Chami ◽  
Mauro Biffi ◽  
VINCENT PROBST ◽  
...  

Background: Infection remains a major complication of cardiac implantable electronic devices (CIEDs) and can lead to significant morbidity and mortality. Extrathoracic devices that avoid epicardial or transvenous leads, such as the subcutaneous implantable cardioverter-defibrillator (S-ICD), can reduce the risk of serious infection-related complications, such as bloodstream infection and infective endocarditis. While the 2017 AHA/ACC/HRS guidelines include recommendations for S-ICD use for patients at high risk of infection, currently, there are no clinical trial data that address best practices for the prevention of S-ICD infections. Therefore, an expert panel was convened to develop consensus on these topics. Methods: An expert process mapping methodology was used to achieve consensus on the appropriate steps to minimize or prevent S-ICD infections. Two face-to-face meetings of high-volume S-ICD implanters and an infectious diseases specialist, with expertise on cardiovascular implantable electronic device infections, were conducted to develop consensus on useful strategies pre-, peri-, and post-implant to reduce S-ICD infection risk. Results: Expert panel consensus of recommended steps for patient preparation, S-ICD implantation, and post-operative management were developed to provide guidance in individual patient management. Conclusion: Achieving expert panel consensus by process mapping methodology for S-ICD infection prevention was attainable, and the results should be helpful to clinicians in adopting interventions to minimize risks of S-ICD infection.

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J De Juan Baguda ◽  
J.J Gavira Gomez ◽  
M Pachon Iglesias ◽  
L Pena Conde ◽  
J.M Rubin Lopez ◽  
...  

Abstract Background The HeartLogic algorithm combines multiple implantable cardioverter-defibrillator (ICD)-based sensors into an index for prediction of impending heart failure (HF) decompensation. In patients with ICD and cardiac resynchronization therapy ICD remotely monitored at 13 Spanish centers, we analyzed the association between clinical events and HeartLogic alerts and we described the use of the algorithm for the remote management of HF. Methods The association between clinical events and HeartLogic alerts was studied in the blinded phase (from ICD implantation to alert activation – no clinical actions taken in response to alerts) and in the following active phase (after alert activation – clinicians automatically notified in case of alert). Results We enrolled a total of 215 patients (67±13 years old, 77% male, 53% with ischemic cardiomyopathy) with ICD (19%) or CRT-D (81%). The median duration of the blinded phase was 8 [3–12] months. In this phase, the HeartLogic index crossed the threshold value (set by default to 16) 34 times in 20 patients. HeartLogic alerts were associated with 6 HF hospitalizations and 5 unplanned in-office visits for HF. Five additional HeartLogic threshold crossings were not associated with overt HF events, but occurred at the time of changes in drug therapy or of other clinical events. The rate of unexplained alerts was 0.25 alert-patient/year. The median time spent in alert was longer in the case of HF hospitalizations than of in-office visits (75 [min-max: 30–155] days versus 39 [min-max: 5–105] days). The maximum HeartLogic index value was 38±15 in the case of hospitalizations and 24±7 in that of minor HF events. The median duration of the following active phase was 5 [2–10] months. After HeartLogic activation, 40 alerts were reported in 26 patients. Twenty-seven (68%) alerts were associated with multiple HF- or non-HF related conditions or changes in prescribed HF therapy. Multiple actions were triggered by these alerts: HF hospitalization (4), unscheduled in-office visits (8), diuretics increase (8), change in other cardiovascular drugs (5), device reprogramming (2), atrial fibrillation ablation (1), patient education on therapy adherence (2). The rate of unexplained alerts not followed by any clinical action was 0.13 alert-patient/year. These alerts were managed remotely (device data review and phone contact), except for one alert that generated an unscheduled in-office visit. Conclusions HeartLogic index was frequently associated with HF-related clinical events. The activation of the associated alert allowed to remotely detect relevant clinical conditions and to implement clinical actions. The rate of unexplained alerts was low, and the work required in order to exclude any impending decompensation did not constitute a significant burden for the centers. Funding Acknowledgement Type of funding source: None


Author(s):  
Victor Nauffal ◽  
Peter Marstrand ◽  
Larry Han ◽  
Victoria N Parikh ◽  
Adam S Helms ◽  
...  

Abstract Aims  Risk stratification algorithms for sudden cardiac death (SCD) in hypertrophic cardiomyopathy (HCM) and regional differences in clinical practice have evolved over time. We sought to compare primary prevention implantable cardioverter defibrillator (ICD) implantation rates and associated clinical outcomes in US vs. non-US tertiary HCM centres within the international Sarcomeric Human Cardiomyopathy Registry. Methods and results We included patients with HCM enrolled from eight US sites (n = 2650) and five non-US (n = 2660) sites and used multivariable Cox-proportional hazards models to compare outcomes between sites. Primary prevention ICD implantation rates in US sites were two-fold higher than non-US sites (hazard ratio (HR) 2.27 [1.89–2.74]), including in individuals deemed at high 5-year SCD risk (≥6%) based on the HCM risk-SCD score (HR 3.27 [1.76–6.05]). US ICD recipients also had fewer traditional SCD risk factors. Among ICD recipients, rates of appropriate ICD therapy were significantly lower in US vs. non-US sites (HR 0.52 [0.28–0.97]). No significant difference was identified in the incidence of SCD/resuscitated cardiac arrest among non-recipients of ICDs in US vs. non-US sites (HR 1.21 [0.74–1.97]). Conclusion  Primary prevention ICDs are implanted more frequently in patients with HCM in US vs. non-US sites across the spectrum of SCD risk. There was a lower rate of appropriate ICD therapy in US sites, consistent with a lower-risk population, and no significant difference in SCD in US vs. non-US patients who did not receive an ICD. Further studies are needed to understand what drives malignant arrhythmias, optimize ICD allocation, and examine the impact of different ICD utilization strategies on long-term outcomes in HCM.


Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Atsushi Takahashi ◽  
Tsuyoshi Shiga ◽  
Daigo Yagishita ◽  
Keisuke Futagawa ◽  
Naoki Serizawa ◽  
...  

Purpose: Implantable Cardioverter Defibrillator (ICD) prevents sudden cardiac death in high risk patients with heart failure (HF). Worsening renal function (WRF) is associated with mortality in patients with myocardial infarction or HF, but its effect on lethal arrhythmia is unknown. We evaluated the influence of WRF on the occurrence of arrhythmic events in patients with nonischemic HF and ICD. Methods: A total of 286 nonischemic HF patients who underwent ICD implantation between 1990 and 2007 were studied. Estimated Glomerular Filtration Rate (eGFR) was calculated using the Modification of Diet in Renal Disease. Renal dysfunction was defined as eGFR <60mL/min/1.73m 2 and WRF was defined as 15mL/min/1.73m 2 per year. Differences in arrhythmia recurrences according to the eGFR and WRF were compared by Kaplan-Meier survival curves. Results: During a mean follow-up time of 2.2+/−1.0 years, 94 (33%) of 286 patients (mean age; 57+/−15 years, 72% male) experienced appropriate ICD shock therapy. There was a significantly higher cumulative rate of appropriate ICD shock therapy (p<0.05) and electrical storm (p<0.05) in patients with renal dysfunction than others. The patients with renal dysfunction at baseline experience WRF more frequently than other patients (53% vs. 23%, respectively, p<0.01). After correcting for age, sex, left ventricular ejection fraction (LVEF), indication for ICD implantation, and use of beta-blockers in a Cox regression model, WRF was still an independent predictor of the time to first appropriate shock (HR 2.21, 95% CI 1.32–3.69, p<0.05) and electrical storm (HR 2.22, 95% CI 1.19 – 4.13, p<0.05). The result of subgroup analysis of 147 patients with low LVEF (LVEF<35%) indicated that the patients with WRF experienced electrical storms more frequently (p<0.05). Conclusion: WRF is associated with increased rate of arrhythmic event in nonischemic HF patients. Especially, those patients with low LVEF and WRF experience more frequent ICD shocks.


Author(s):  

Dilated cardiomyopathy (DCM) is a disease characterised as left ventricular (LV) or biventricular dilatation with impaired systolic function. Regardless of underlying cause patients with DCM have a propensity to ventricular arrhythmias and sudden cardiac death. Implantable Cardioverter Defibrillator (ICD) implantation for these patients results in significant reduction of sudden cardiac death [1-3]. ICD devices may be limited by right ventricle (RV) sensing dysfunction with low RV sensing amplitude. We present a clinical case of patient with DCM, implanted ICD and low R wave sensing on RV lead.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
J Bjerre ◽  
S M Rosenkranz ◽  
M Schou ◽  
C Jons ◽  
B T Philbert ◽  
...  

Abstract Background Patients with an implantable cardioverter defibrillator (ICD) are restricted from driving following initial implantation or ICD shock. It is unclear how many patients are aware of, and adhere to, these restrictions. Purpose To investigate knowledge of, and adherence to, private and professional driving restrictions in a nationwide cohort of ICD patients. Methods A questionnaire was distributed to all living Danish residents ≥18 years who received a first-time ICD between 2013 and 2016 (n=3,913). During this period, Danish guidelines recommended 1 week driving restriction following ICD implantation for primary prevention, and 3 months following either ICD implantation for secondary prevention or appropriate ICD shock, and permanent restriction of professional driving and driving of large vehicles (>3.5 metric tons). Questionnaires were linked with relevant nationwide registries. Logistic regression was applied to identify factors associated with non-adherence. Results Of 2,741 questionnaire respondents, 92% (n=2,513) held a valid private driver's license at time of ICD implantation (85% male; 46% primary prevention indication; median age: 67 years (IQR: 59–73)). Of these, 7% (n=175) were actively using a professional driver's license for truck driving (n=73), bus driving (n=45), taxi driving (n=22), large vehicle driving for private use (n=54), or other purposes (n=32) (multiple purposes allowed). Only 42% of primary prevention patients, 63% of secondary prevention patients, and 72% of patients who experienced an appropriate ICD shock, recalled being informed of any driving restrictions. Only 45% of professional drivers recalled being informed about specific professional driving restrictions (Figure). Most patients (93%, n=2,344) resumed private driving after ICD implantation, more than 30% during the driving restriction period: 34% of primary prevention patients resumed driving within 1 week, 43% of secondary prevention patients resumed driving within 3 months, and 30% of patients who experienced an appropriate ICD shock resumed driving within 3 months. Professional driving was resumed by 35%. Patients who resumed driving within the restricted periods were less likely to report having received information about driving restrictions (all p<0.001) (Figure). In a multiple logistic regression model, non-adherence was predicted by reporting non-receipt of information about driving restrictions (OR: 3.34, CI: 2.27–4.03), as well as male sex (OR: 1.53, CI: 1.17–2.01), age ≥60 years (OR: 1.20, CI: 1.02–1.64), receipt of a secondary prevention ICD (OR: 2.2, CI: 1.80–2.62), and being the only driver in the household (OR: 1.29, CI: 1.05–1.57). Conclusion In this nationwide survey study, many ICD patients were unaware of the driving restrictions, and many ICD patients, including professional drivers, resumed driving within the restricted periods. More focus on communicating driving restrictions might improve adherence. Acknowledgement/Funding Danish Heart Foundation, Arvid Nilsson Foundation, Fraenkels Mindefond


Author(s):  
Agnieszka Mlynarska ◽  
Rafal Mlynarski ◽  
Izabella Uchmanowicz ◽  
Czeslaw Marcisz ◽  
Krzysztof S. Golba

Frailty syndrome may cause cognitive decline and increased sensitivity to stressors. This can result in an increased incidence of anxiety and depression, and thus, concerns about life with an implantable cardioverter defibrillator (ICD). The aim of the study was to assess the impact of frailty syndrome on the increase in the number of device-related concerns after the implantation of an ICD. Material and methods: The study sample was a group of 103 consecutive patients (85 M; aged 71.6 ± 8.2) with an implanted ICD. The ICD Concerns Questionnaire (ICDC) was used to analyze their concerns about life with an ICD, and the Tilburg Frailty Indicator scale (TFI) was used to diagnose frailty. Results: In the group of patients with an ICD implanted, 73% had recognized frailty (83.3% women, 74.1% men); the average point value was 6.55 ± 2.67. The total ICDC questionnaire score for the patients with an implanted cardioverter defibrillator was 34.06 ± 18.15. Patients with frailty syndrome had statistically (p = 0.039) higher scores (36.14 ± 17.08) compared to robust patients (27.56 ± 20.13). In the logistic regression analysis, the presence of frailty was strongly associated with the total questionnaire score (OR = 1.0265, p = 0.00426), the severity of the concerns (OR = 1.0417, p = 0.00451), and device-specific concerns (OR = 1.0982, p = 0.00424). Conclusion: Frailty syndrome occurs in about 80% of patients after ICD implantation. The presence of frailty syndrome was strongly associated with concerns about an implantable cardioverter defibrillator.


2001 ◽  
Vol 47 (3) ◽  
pp. 459-463 ◽  
Author(s):  
Thomas Schlüter ◽  
Hannsjörg Baum ◽  
Andreas Plewan ◽  
Dieter Neumeier

Abstract Background: Implantable cardioverter defibrillator (ICD) implantation is a common approach in patients at high risk of sudden cardiac death. To check for normal function, it is necessary to test the ICD. For this purpose, repetitive induction and termination of ventricular fibrillation by direct current shocks is required. This may lead to minor myocardial damage. Cardiac troponin T (cTnT) and I (cTnI) are specific markers for the detection of myocardial injury. Because these proteins usually are undetectable in healthy individuals, they are excellent markers for detecting minimal myocardial damage. The objective of this study was to evaluate the effect of defibrillation of induced ventricular fibrillation on markers of myocardial damage. Methods: This study included 14 patients who underwent ICD implantation and intraoperative testing. We measured cTnT, cTnI, creatine kinase MB (CK-MB) mass, CK activity, and myoglobin before and at definite times after intraoperative shock application. Results: Depending on the effectiveness of shocks and the energy applied, the cardiac-specific markers cTnT and cTnI, as well as CK-MB mass, showed a significant increase compared with the baseline value before testing and peaked for the most part 4 h after shock application. In contrast, the increases in CK activity and myoglobin were predominantly detectable in patients who received additional external shocks. Conclusions: ICD implantation and testing leads to a short release of cardiac markers into the circulation. This release seems to be of cytoplasmic origin and depends on the number and effectiveness of the shocks applied.


Heart ◽  
2020 ◽  
Vol 106 (9) ◽  
pp. 671-676 ◽  
Author(s):  
Amar Mistry ◽  
Zakariyya Vali ◽  
Bharat Sidhu ◽  
Charley Budgeon ◽  
Matthew F Yuyun ◽  
...  

ObjectiveThere are large geographical differences in implantable cardioverter defibrillator (ICD) implantation rates for reasons not completely understood. In an increasingly multiethnic population, we sought out to investigate whether ethnicity influenced ICD implantation rates.MethodsThis was a retrospective, cohort study of new ICD implantation or upgrade to ICD from January 2006 to February 2019 in recipients of Caucasian or South Asian ethnicity at a single tertiary centre in the UK. Data were obtained from a routinely collected local registry. Crude rates of ICD implantation were calculated for the population of Leicestershire county and were age-standardised to the UK population using the UK National Census of 2011.ResultsThe Leicestershire population was 980 328 at the time of the Census, of which 761 403 (77.7%) were Caucasian and 155 500 (15.9%) were South Asian. Overall, 2650 ICD implantations were performed in Caucasian (91.9%) and South Asian (8.1%) patients. South Asians were less likely than Caucasians to receive an ICD (risk ratio (RR) 0.43, 95% CI 0.37 to 0.49, p<0.001) even when standardised for age (RR 0.75, 95% CI 0.74 to 0.75, p<0.001). This remained the case for primary prevention indication (age-standardised RR 0.91, 95% CI 0.90 to 0.91, p<0.001), while differences in secondary prevention ICD implants were even greater (age-standardised RR 0.49, 95% CI 0.48 to 0.50, p<0.001).ConclusionDespite a universal and free healthcare system, ICD implantation rates were significantly lower in the South Asian than the Caucasian population residing in the UK. Whether this is due to cultural acceptance or an unbalanced consideration is unclear.


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