scholarly journals Incidence and Predictors of Infections and All-Cause Death in Patients with Cardiac Implantable Electronic Devices: The Italian Nationwide RI-AIAC Registry

2022 ◽  
Vol 12 (1) ◽  
pp. 91
Author(s):  
Giuseppe Boriani ◽  
Marco Proietti ◽  
Matteo Bertini ◽  
Igor Diemberger ◽  
Pietro Palmisano ◽  
...  
Keyword(s):  
Patient Outcomes ◽  
Clinical Status ◽  
Electronic Devices ◽  
Clinical Event ◽  
Clinical Factors ◽  
Factors Associated ◽  
Cardiac Implantable Electronic Devices ◽  
Clinical Events ◽  
Event Score

Background: The incidence of infections associated with cardiac implantable electronic devices (CIEDs) and patient outcomes are not fully known. Aim: To provide a contemporary assessment of the risk of CIEDs infection and associated clinical outcomes. Methods: In Italy, 18 centres enrolled all consecutive patients undergoing a CIED procedure and entered a 12-months follow-up. CIED infections, as well as a composite clinical event of infection or all-cause death were recorded. Results: A total of 2675 patients (64.3% male, age 78 (70–84)) were enrolled. During follow up 28 (1.1%) CIED infections and 132 (5%) deaths, with 152 (5.7%) composite clinical events were observed. At a multivariate analysis, the type of procedure (revision/upgrading/reimplantation) (OR: 4.08, 95% CI: 1.38–12.08) and diabetes (OR: 2.22, 95% CI: 1.02–4.84) were found as main clinical factors associated to CIED infection. Both the PADIT score and the RI-AIAC Infection score were significantly associated with CIED infections, with the RI-AIAC infection score showing the strongest association (OR: 2.38, 95% CI: 1.60–3.55 for each point), with a c-index = 0.64 (0.52–0.75), p = 0.015. Regarding the occurrence of composite clinical events, the Kolek score, the Shariff score and the RI-AIAC Event score all predicted the outcome, with an AUC for the RI-AIAC Event score equal to 0.67 (0.63−0.71) p < 0.001. Conclusions: In this Italian nationwide cohort of patients, while the incidence of CIED infections was substantially low, the rate of the composite clinical outcome of infection or all-cause death was quite high and associated with several clinical factors depicting a more impaired clinical status.

P682Radiotherapy-induced malfunction in cancer patients with cardiac implantable electronic devices

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
J F Imberti ◽  
F Placentino ◽  
V L Malavasi ◽  
G Demarco ◽  
F Lohr ◽  
...  
Keyword(s):  
Medical Records ◽  
Electronic Devices ◽  
Clinical Event ◽  
Cardioverter Defibrillator ◽  
Cardiac Implantable Electronic Devices ◽  
Clinical Events ◽  
Number Of Patients ◽  
Mode 2 ◽  
Life Threatening ◽  
Partial Reset

Abstract Background The number of patients with cardiac implantable electronic devices (CIED) requiring a radiation therapy (RT) for cancer treatment is increasing over time. Nevertheless, the rate and predictors of CIED malfunctions are still controversial. Purpose The aim of our study is to estimate the prevalence and possible predictors of RT-related CIED malfunctions and to describe malfunction characteristics. Methods We retrospectively reviewed medical records of all pacemaker (PM)/implantable cardioverter defibrillator (ICD) patients who underwent RT at our centre between January 2004 and July 2018. We included data from the CIED interrogation performed before the RT course to the first interrogation after the end of the RT course. As a safety measure, during RT a magnet was applied to every ICD and, in all PM-dependent patients, the device was temporarily reprogrammed in V00. Device relocation from the RT field was performed in 2/150 (1.3%) RT courses. Results One hundred twenty-seven patients were included, who underwent 150 separate RT courses. Eighty one percent of patients had a PM, while 19% had an ICD. Of note 17.4% of patients were PM-dependent. Neutron producing RT was used in 37/139 (26.6%) patients, whereas marginal neutron producing and non-neutron producing RT was used in 9/139 (6.4%) and 93/139 (67%) patients respectively. The cumulative dose (Dmax) delivered to the CIED exceeded 5Gy only in 2/132 (1.5%) cases. Three device-related malfunctions were found (2%). None of them were life-threatening or lead to a clinical event. All dysfunctions were resolved by reprogramming the device and did not require CIED substitution or leads extraction. Details of dysfunctions included: 1) a partial reset of an ICD, leading to self-reprogramming in safety mode, 2) full reset of a PM, which required the re-initialisation of the device and 3) programming change of the magnetic PM frequency to 30bpm (instead of 90 bpm). In all cases the Dmax delivered to the CIED was <1Gy. A neutron producing RT was used in the first two cases, whereas a non-neutron producing RT was used in the last case. Conclusions In accordance with the current literature, our results show that RT in patients with CIED is substantially safe. Malfunctions are uncommon and do not result in clinical events, but can develop even if the Dmax delivered to the CIED is <1 Gy. Device interrogation on a regular basis is advisable to promptly recognise CIED malfunctions.

Consensus document on radiotherapy in patients with implantable pacemakers and cardioverter – defibrilators

2018 ◽  
Vol 2 (47) ◽  
pp. 27-31
Author(s):  
Lidia Chmielewska-Michalak ◽  
Ewelina Konstanty ◽  
Przemysław Mitkowski
Keyword(s):  
Current Knowledge ◽  
Clinical Status ◽  
Electronic Devices ◽  
Heart Rhythm ◽  
Complex Care ◽  
Consensus Document ◽  
Cardiac Implantable Electronic Devices ◽  
Number Of Patients ◽  
High Level ◽  
Emergency Mode

The number of patients with cardiac implantable electronic devices (CIED), who require oncological management including radiotherapy (RT) is still increasing. According to current knowledge the most frequent device dysfunction related to exposition to ionizing radiation is reprogramming to emergency mode (soft reset). There are uncommon cases of complete, irreversible device damage. CIED dysfunction during RT can be observed in approximately 3% of patients. In majority of cases they are asymptomatic, although in literature there are descriptions of deterioration of clinical status due to bradycardia or exacerbation of heart failure. The most important factor of device malfunction is radiotherapy with photons of energy >10 MV or protons despite energy used. So far there were no cases published with inadequate ICD therapies due to the presence of electromagnetic field interference during RT. Because patients with CIED undergoing RT need complex care to achieve high level of safety, experts of Heart Rhythm Society establish document, published in 2017 which summarized current knowledge about this group of patients. The document contains guidelines on peri-radiotherapy care of patients with CIED.

Canadian Registry of Electronic Device Outcomes: remote monitoring outcomes in the Abbott battery performance alert—a multicentre cohort

EP Europace ◽  
2021 ◽  
Author(s):  
Sharath Kumar ◽  
Jason Davis ◽  
Bernard Thibault ◽  
Iqwal Mangat ◽  
Benoit Coutu ◽  
...  
Keyword(s):  
Remote Monitoring ◽  
Primary Outcome ◽  
Electronic Device ◽  
Electronic Devices ◽  
Cardiac Resynchronization ◽  
Device Performance ◽  
Cardiac Implantable Electronic Devices ◽  
All Cause Mortality ◽  
Multicentre Cohort

Abstract Aims Cardiac implantable electronic devices with device advisories have the potential of device malfunction. Remote monitoring (RM) of devices has been suggested to allow the identification of abnormal device performance and permit early intervention. We sought to describe the outcomes of patients with and without RM in devices subject to the Abbott Premature Battery Depletion (PBD) advisory with data from a Canadian registry. Methods and results Patients with an Abbott device subject to the PBD advisory from nine implantable cardioverter defibrillator (ICD) implanting centres in Canada were included in the registry. The use of RM was identified from baseline and follow-up data in the registry. The primary outcome was detection of PBD and all-cause mortality. A total of 2666 patients were identified with a device subject to the advisory. In all, 1687 patients (63.2%) had RM at baseline. There were 487 deaths during follow-up. At a mean follow-up of 5.7 ± 0.7 years, mortality was higher in those without a remote monitor compared with RM at baseline (24.7% vs. 14.5%; P &lt; 0.001). Pre-mature battery depletion was identified in 36 patients (2.1%) with RM vs. 7 (0.7%) without RM (P = 0.004). Time to battery replacement was significantly reduced in patients on RM (median 5 vs. 13 days, P = 0.001). Conclusion The use of RM in patients with ICD and cardiac resynchronization therapy under advisory improved detection of PBD, time to device replacement, and was associated with a reduction in all-cause mortality. The factors influencing the association with mortality are unknown and deserve further study.

scholarly journals Risk factors associated with bleeding after multi antithrombotic therapy during implantation of cardiac implantable electronic devices

2016 ◽  
Vol 32 (3) ◽  
pp. 333-340 ◽  
Author(s):  
Kohei Ishibashi ◽  
Koji Miyamoto ◽  
Tsukasa Kamakura ◽  
Mitsuru Wada ◽  
Ikutaro Nakajima ◽  
...  
Keyword(s):  
Risk Factors ◽  
Antithrombotic Therapy ◽  
Electronic Devices ◽  
Factors Associated ◽  
Cardiac Implantable Electronic Devices

scholarly journals Consensus statement for implantation and follow-up of cardiac implantable electronic devices in India

2018 ◽  
Vol 18 (6) ◽  
pp. 188-192
Author(s):  
Shomu Bohora ◽  
Amit Vora ◽  
Aditya Kapoor ◽  
Vanita Arora ◽  
Nitish Naik ◽  
...  
Keyword(s):  
Consensus Statement ◽  
Electronic Devices ◽  
Cardiac Implantable Electronic Devices

scholarly journals Clinical and Genetic Risk Factors for Biofilm-FormingStaphylococcus aureus

2018 ◽  
Vol 62 (5) ◽  
Author(s):  
Megan K. Luther ◽  
Diane M. Parente ◽  
Aisling R. Caffrey ◽  
Kathryn E. Daffinee ◽  
Vrishali V. Lopes ◽  
...  
Keyword(s):  
Patient Outcomes ◽  
Clonal Complex ◽  
High Serum ◽  
Clinical Factors ◽  
Content Type ◽  
Factors Associated ◽  
Patient Demographics ◽  
Biofilm Production ◽  
Clinical Culture ◽  
Beta Toxin

ABSTRACTThe molecular and clinical factors associated with biofilm-forming methicillin-resistantStaphylococcus aureus(MRSA) are incompletely understood. Biofilm production for 182 MRSA isolates obtained from clinical culture sites (2004 to 2013) was quantified. Microbiological toxins, pigmentation, and genotypes were evaluated, and patient demographics were collected. Logistic regression was used to quantify the effect of strong biofilm production (versus weak biofilm production) on clinical outcomes and independent predictors of a strong biofilm. Of the isolates evaluated, 25.8% (47/182) produced strong biofilms and 40.7% (74/182) produced weak biofilms. Strong biofilm-producing isolates were more likely to be from multilocus sequence typing (MLST) clonal complex 8 (CC8) (34.0% versus 14.9%;P= 0.01) but less likely to be from MLST CC5 (48.9% versus 73.0%;P= 0.007). Predictors for strong biofilms werespatype t008 (adjusted odds ratio [aOR], 4.54; 95% confidence interval [CI], 1.21 to 17.1) and receipt of chemotherapy or immunosuppressants in the previous 90 days (aOR, 33.6; 95% CI, 1.68 to 673). Conversely, patients with high serum creatinine concentrations (aOR, 0.33; 95% CI, 0.15 to 0.72) or who previously received vancomycin (aOR, 0.03; 95% CI, 0.002 to 0.39) were less likely to harbor strong biofilm-producing MRSA. Beta-toxin-producing isolates (aOR, 0.31; 95% CI, 0.11 to 0.89) and isolates withspatype t895 (aOR, 0.02 95% CI, <0.001 to 0.47) were less likely to produce strong biofilms. Patient outcomes also varied between the two groups. Specifically, patients with strong biofilm-forming MRSA were significantly more likely to be readmitted within 90 days (aOR, 5.43; 95% CI, 1.69 to 17.4) but tended to have decreased 90-day mortality (aOR, 0.36; 95% CI, 0.12 to 1.06). Patients that harbored t008 and received immunosuppressants were more likely to have strong biofilm-producing MRSA isolates. Clinically, patients with strong biofilm-forming MRSA were less likely to die at 90 days but five times more likely to be readmitted.

Abstract 13030: Causes of Cardiovascular and Non-cardiovascular Mortality in the Ischemia Trial

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Mandeep S Sidhu ◽  
Karen P Alexander ◽  
Zhen Huang ◽  
Sean M O’Brien ◽  
Bernard R Chaitman ◽  
...  
Keyword(s):  
Management Strategies ◽  
Multivariable Analysis ◽  
International Study ◽  
Factors Associated ◽  
Clinical Events ◽  
All Cause Mortality ◽  
History Of ◽  
Multivariable Analyses ◽  
Clinical Events Committee

Background: In the ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) trial, all-cause mortality was similar in patients with stable ischemic heart disease (SIHD) randomized to invasive (INV) and conservative (CON) management strategies. This analysis details specific causes of cardiovascular (CV) and non-CV mortality by treatment group. Methods: In ISCHEMIA, 289 deaths occurred after a median follow-up of 3.2 years; 145 (5.6%) in INV and 144 (5.6%) in CON (HR 1.05, CI 0.83-1.32). Deaths were adjudicated by an independent Clinical Events Committee as CV, non-CV with or without a CV contributor or undetermined. The protocol defined CV death as deaths from CV causes, non-CV causes with CV contributor, and cause undetermined; non-CV death was defined as death from non-CV causes without a CV contributor. Multivariable analyses were used to identify factors associated with cause-specific death. Results: CV death was similar between groups [INV 92 (3.6%), CON 111 (4.3%); HR 0.87 (CI 0.66, 1.15)], but INV had more non-CV death [INV 53 (2.0%), CON 33 (1.3%); HR 1.63 (CI 1.06, 2.52)]; fewer undetermined deaths [INV 12 (0.5%) and CON 26 (1.0%); HR 0.48 (0.24, 0.95)] and more malignancy deaths [INV 41 (1.6%), CON 20 (0.8%); HR 2.11 (1.24, 3.61)]. In multivariable analysis, risk factors associated with CV death were age [HR 1.42 (CI 1.19-1.70) per 10-year increase], diabetes [HR 1.39 (CI 1.03-1.87)], history of heart failure [HR 1.96 (CI 1.33-2.91)], and eGFR [HR 1.18 (CI 1.11-1.26) per 5-ml/min decrease below 80ml/min]. Factors associated with non-CV death were age [HR 2.31 (CI 1.75-3.03) per 10-year increase] and randomization to INV [HR 1.76 (CI 1.13-2.75)]. Conclusions: In ISCHEMIA, all-cause mortality was similar for the INV and CON strategies. Excess non-CV deaths in INV with a higher number of deaths from malignancy but a higher number of undetermined deaths in CON requires further evaluation.

2402Reduced heart rate variability is linked to clinical status in patients with a systemic right ventricle

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
T E Zandstra ◽  
P Kies ◽  
S Man ◽  
A C Maan ◽  
M Bootsma ◽  
...  
Keyword(s):  
Heart Failure ◽  
Heart Rate ◽  
Congestive Heart Failure ◽  
Autonomic Function ◽  
Clinical Status ◽  
Clinical Event ◽  
Healthy Controls ◽  
Significant Determinant ◽  
Systemic Right Ventricle ◽  
Event Score

Abstract Background Adult patients with congenital heart disease and a systemic right ventricle (sRV) are prone to develop heart failure. Decreased heart rate variability (HRV), a measure of autonomic dysfunction, is associated with morbidity and mortality in patients with congestive heart failure. The standard deviation of all intervals between normal sinus beats (SDNN) is a HRV parameter commonly reported as an indicator of autonomic function in these patients. Data about HRV and its clinical implications in patients with a sRV are scarce. Purpose To compare HRV parameters between patients with a sRV and healthy controls, and to assess their association with clinical status. Methods All available 24-hour Holter monitoring records of sRV patients under follow-up in our center and one record per healthy control subject were analysed. Holters with non-sinus rhythm were excluded. Time and frequency domain parameters were calculated and compared between both groups. Clinical landmarks such as arrhythmias or an episode of congestive heart failure, which occurred up until the time of the ambulatory ECG, were combined in a clinical event score. Determinants of SDNN were investigated with mixed model linear regression in the patients and with multivariate linear regression in the controls. Baseline characteristics, medication use, global longitudinal strain, validity as measured with bicycle exercise testing, and the clinical event score were taken into account. Results 113 Holters of 43 patients and 39 Holters of healthy controls were analysed. The patient group included 30 patients (70%) late after Mustard or Senning correction for transposition of the great arteries, and 13 patients with congenitally corrected transposition of the great arteries (30%). Age and gender were comparable in patients and controls. Several HRV parameters were significantly worse in patients compared with controls, including SDNN (138 in patients vs. 161 in controls, p=0.021). In the patients, clinical event score was the only significant determinant of a lower SDNN (p<0.001). In the controls, age was the only significant determinant of a lower SDNN (p=0.039). Conclusion Contrary to the healthy population, in patients with a sRV, HRV is associated with clinical status rather than age. This indicates that disease progression affects autonomic function more than ageing in this group. Further research is needed to clarify the relation between clinical outcome and autonomic function in sRV patients. Acknowledgement/Funding The Department of Cardiology of the LUMC received research grants from Medtronic, Biotronik, Boston Scientific and Edwards Lifesciences

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