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1.
Cardiac pacemakers are part of a growing group of expensive implantable electronic devices; hospitals in which 100 pacemakers are implanted per year must budget over $300 000 for these devices. This cost represents a considerable burden to health care resources. Since the "life-span" of modern pacemakers often exceeds that of the patients who receive them, the recovery and reuse of these devices seems logical. Pacemakers can be resterilized and tested with current hospital procedures. Reuse should be acceptable under Canadian law, but the manner in which the pacemakers are recovered and the patients selected should follow careful guidelines. Every patient should provide written informed consent before receiving a recovered pacemaker. Properly executed, reuse of pacemakers should provide a high level of health care while maintaining or reducing the cost of these devices.  相似文献   

2.
New developments and expanding indications have resulted in a significant increase in the number of patients with pacemakers and internal cardioverterdefibrillators (ICDs). Because of its unique capabilities, magnetic resonance imaging (MRI) has become one of the most important imaging modalities for evaluation of the central nervous system, tumours, musculoskeletal disorders and some cardiovascular diseases. As a consequence of these developments, an increasing number of patients with implanted devices meet the standard indications for MRI examination. Due to the presence of potential life-threatening risks and interactions, however, pacemakers and ICDs are currently not approved by the Food and Drug Administration (FDA) for use in an MRI scanner. Despite these limitations and restrictions, a limited but still growing number of studies reporting on the effects and safety issues of MRI and implanted devices have been published. Because physicians will be increasingly confronted with the issue of MRI in patients with implanted devices, this overview is given. The effects of MRI on an implanted pacemaker and/or ICDs and vice versa are described and, based on the current literature, a strategy for safe performance of MRI in these patients is proposed. (Neth Heart J 2010;18:31-7.)  相似文献   

3.
BackgroundLymphohaematopoietic malignancies are common in the general population. There have been concerns that military service may be associated with increased risk as a result of occupational exposures. To date, few studies have demonstrated an increased risk, although a disability pension is payable to veterans who were present at nuclear tests and who develop leukaemia (other than chronic lymphocytic leukaemia). The aim of the study was to utilise data from the Scottish Veterans Health Study to examine the risk of lymphohaematopoietic malignancy following military service in a large national cohort of veterans.MethodsRetrospective cohort study of 57,000 veterans and 173,000 non-veterans born between 1945 and 1985 matched for age, sex and area of residence, adjusted for areal deprivation and followed up for up to 30 years, using Cox proportional hazard models to compare the risk of lymphohaematopoietic malignancy overall, by diagnosis and by sex and birth cohort.ResultsWe found no statistically significant difference in risk between veterans and non-veterans either for all leukaemias (Cox proportional hazard ratio 1.03, 95% confidence intervals 0.84–1.27, p = 0.773), Hodgkin lymphoma (hazard ratio 1.19, 95% confidence intervals 0.87–1.61, p = 0.272) or for non-Hodgkin lymphoma (hazard ratio 0.86, 95% confidence intervals 0.71–1.04, p = 0.110).ConclusionOur findings provide reassurance that service in the UK Armed Forces is not associated with increased risk of lymphohaematopoietic malignancy.  相似文献   

4.
BackgroundCardiac implantable electronic device (CIED) implantation is increasingly performed worldwide with improving safety. Outpatient CIED implantation has similar complication rates compared to those implants which are hospitalized. Here, we analyze patient preferences on discharge timing after CIED implantation.ObjectiveTo identify and understand the factors contributing to patient preferences towards same-day or next-day discharge after CIED implantation.MethodsOne hundred and two patients undergoing new CIED implants were included in the study at two separate hospitals in CT (CT group) and FL (FL group) from 2018-2019. A 7-question survey was administered to the patients after the procedure. Survey responses and demographic data were statistically analyzed.ResultsSeventy-four percent of CT group and 58% of the FL group responded with a 10 score (0-10) that they were ready to be discharged home the same day (p=0.09). Both groups reported a low number of patients feeling safer by having a remote monitor provided at the time of discharge (44% CT group, 28% FL group; p=0.123). The mean distance of patients living from the hospital in CT group (21.6 miles) was significantly lower than that for the FL group (35.5 miles); p=0.01. Hypertension (86% vs 52%; p=0.0002) and Diabetes mellitus (44% vs 21%; p=0.013) were more prevalent in the FL group compared to the CT group.ConclusionDespite the influence of local practices, the majority of patients preferred same-day discharge after CIED implantation. Improved patient education regarding the ability of remote monitors to provide real-time response to acute events is needed.  相似文献   

5.
BackgroundInsertable cardiac monitors (ICMs) are often used for long-term monitoring of cardiac rhythm. The Medtronic’s LINQ Reveal ™ is a new generation wireless, automated, and patient responsive subcutaneous ECG monitoring device. Despite several advantages to its small size we have noted an unusually high incidence of extrusion at our center.Methods& Results: We conducted a retrospective case analysis to review Reveal LINQs implanted at our center. All devices were inserted using the provided insertion tools. Patients with extruded devices were identified and details regarding the site and technique of insertion, incision closure, use of peri-operative antibiotics, and follow-up details were collected. 81 patients underwent 85 Reveal LINQ implants at a tertiary care University Hospital referral center. The most common reason for implant was suspected arrhythmia with or without structural heart disease or unexplained syncope. There were 4 spontaneous extrusions occurring within 7–24 days after insertion with an incidence rate of 4.7%. One extruded device was anchored to subcutaneous tissue, and no pocket/device infections or hematomas were noted.ConclusionsDevice migration and erosion through skin are important potential adverse events for the Reveal LINQ implantable loop recorder. This study reports an unexpectedly high rate of extrusion without infection. The authors suggest that the depth of the incision is the main factor impacting extrusions. Larger studies are recommended, however, and a proposed measure to avoid spontaneous extrusion is the design of a longer manufacturer’s blade in order to increase the depth of the incision and insertion.  相似文献   

6.
BackgroundLeadless pacemakers have been designed as an alternative to transvenous systems which avoid some of the complications associated with transvenous devices. We aim to perform a systematic review of the literature to report the safety and efficacy findings of leadless pacemakers.MethodsWe searched MEDLINE and EMBASE to identify studies reporting the safety, efficacy and outcomes of patients implanted with a leadless pacemaker. The pooled rate of adverse events was determined and random-effects meta-analysis was performed to compare rates of adverse outcomes for leadless compared to transvenous pacemakers.ResultsA total of 18 studies were included with 2496 patients implanted with a leadless pacemaker and success rates range between 95.5 and 100%. The device or procedure related death rate was 0.3% while any complication and pericardial tamponade occurred in 3.1% and 1.4% of patients, respectively. Other complications such as pericardial effusion, device dislodgement, device revision, device malfunction, access site complications and infection occurred in less than 1% of patients. Meta-analysis of four studies suggests that there was no difference in hematoma (RR 0.67 95%CI 0.21–2.18, 3 studies), pericardial effusion (RR 0.59 95%CI 0.15–2.25, 3 studies), device dislocation (RR 0.33 95%CI 0.06–1.74, 3 studies), any complication (RR 0.44 95%CI 0.17–1.09, 4 studies) and death (RR 0.45 95%CI 0.15–1.35, 2 studies) comparing patients who received leadless and transvenous pacemakers.ConclusionLeadless pacemakers are safe and effective for patients who have an indication for single chamber ventricular pacing and the findings appear to be comparable to transvenous pacemakers.  相似文献   

7.
Magnetic resonance (MR) imaging has unparalleled soft-tissue imaging capabilities. The presence of devices such as pacemakers and implantable cardioverter/defibrillators (ICDs), however, is historically considered a contraindication to MR imaging. These devices are now smaller, with less magnetic material and improved electromagnetic interference protection. This review summarizes the potential hazards of the device-MR environment interaction, and presents updated information regarding in-vivo and in-vitro experiments. Recent reports on patients with implantable pacemakers and ICDs who underwent MR scan shows that under certain conditions patients with these implanted systems may benefit from this imaging modality. The data presented suggests that certain modern pacemaker and ICD systems may indeed be MR safe. This may have major clinical implications on current imaging practice.  相似文献   

8.
BackgroundBeginning in 1996 US military personnel served as peacekeeping forces in Bosnia/Kosovo. No studies have assessed the long-term post-deployment health of this US cohort. Based on the health concerns raised in studies of military personnel from other countries, this study focused on mortality due to Leukemia, respiratory disease, respiratory cancer, and heart disease.MethodsThis study compared the post-war cause-specific mortality of 53,320 veterans who deployed to Bosnia/Kosovo between 1996–2002 to that of 117,267 veterans who also served in the military between 1996–2002, but were not deployed to Bosnia/Kosovo. Expressed as standardized mortality ratios (SMR)s the cause-specific mortality for both deployed and non-deployed were compared separately to that of the US general population. Cause-specific mortality risks among Bosnia/Kosovo veterans relative to that of non-deployed veterans were assessed using Hazard Ratios (HR)s generated by Cox proportional-hazards models.ResultsThe overall mortality of both deployed and non-deployed veterans was almost half that of the US population, SMR = 0.59, 95%, C.I., 0.55–0.62 and SMR = 0.66, 95%, C.I., 0.64–0.68, respectively. Neither group of veterans had any excess of disease related mortality compared to that of the US population. Compared to non-deployed, deployed veterans did not experience any increased risks for any of the diseases of a priori interest.ConclusionIt does not appear that US military deployed to Bosnia/Kosovo have any increased risks of disease related mortality. However, this study would not have been able to detect increased risk of cancers with latency periods that exceeded the 18 years of follow-up available in this study.  相似文献   

9.
ObjectiveTo review the clinical findings in the first 1000 veterans seen in the Ministry of Defence’s Gulf war medical assessment programme to examine whether there was a particular illness related to service in the Gulf.DesignCase series of 1000 veterans who presented to the programme between 11 October 1993 and 24 February 1997.SubjectsGulf war veterans.Results588 (59%) veterans had more than one diagnosed condition, 387 (39%) had at least one condition for which no firm somatic or psychological diagnosis could be given, and in 90 (9%) veterans no other main diagnosis was made. Conditions characterised by fatigue were found in 239 (24%) of patients. At least 190 (19%) patients had a psychiatric condition, which in over half was due to post-traumatic stress disorder. Musculoskeletal disorders and respiratory conditions were also found to be relatively common (in 182 (18%) and 155 (16%) patients respectively).ConclusionMany Gulf war veterans had a wide variety of symptoms. This initial review shows no evidence of a single illness, psychological or physical, to explain the pattern of symptoms seen in veterans in the assessment programme. As the veterans assessed by the programme were all self selected, the prevalence of illness in Gulf war veterans cannot be determined from this study. Furthermore, it is not known whether the veterans in this study were representative of sick veterans as a group.

Key messages

  • Many Gulf war veterans present with a wide variety of symptoms
  • No single cause has been found to explain these symptoms
  • From a clinical standpoint the variety and multiplicity of symptoms makes it unlikely that any single cause will be found to underlie Gulf war illness
  • Some of the illnesses may be an example of a postwar syndrome
  相似文献   

10.

Background

Due to an ageing population and demographic changes worldwide, a higher prevalence of heart disease is forecasted, which causes an even higher demand for cardiac implants in future. The increasing high incidence of clinical adverse events attributed especially to high-risk medical devices has led an advocated change from many stakeholders. This holds especially true for devices like cardiac implants, with their high-risk nature and high complication rates associated with considerable mortality, due to their frequent use in older populations with frequent co-morbidities. To ensure patients’ safety, the objective of this study is to analyze different cardiac implants recall reasons and different recall systems, based on an overview of the recalls of cardiac implant medical devices in the last decade. On the basis of the results from this structured analysis, this study provides recommendations on how to avoid such recalls from a manufacturer perspective, as well as how to timely react to an adverse event from a post-surveillance system perspective.

Methods and Findings

A systematic search of cardiac implant recalls information has been performed in the PubMed, ScienceDirect and Scopus databases, as well as data sources in regulatory authorities from 193 UN Member States. Data has been extracted for the years 2004-2014 with the following criteria applied: cardiac implant medical device recalls and reasons for recall, associated harm or risk to patients. From the data sources described above, eleven regulatory authorities and 103 recall reports have been included in this study. The largest cardiac implant categories include ICDs 40.8%, pacemakers 14.5% and stents 14.5%. Regarding the recall reasons, the majority of reports were related to device battery problems (33.0%) and incorrect therapy delivery (31.1%). From a total of 103 recall reports, five reported death and serious injuries. Our review highlights weaknesses in the current cardiac implant recall system, including data reporting and management issues and provides recommendations for the improvement of safety information and management.

Conclusion

Due to the mortality associated with the nature of cardiac implants, the traceability and transparency of safety hazards information is crucial. By a structured analysis of recall reasons and their efficient management, important knowledge is gained to inform an effective safety-reporting system for monitoring the safety of cardiac implanted patients, ideally by building up cardiac implant registries worldwide in the future.  相似文献   

11.
BackgroundWe demonstrate a case series of 8 pediatric patients, all under 30 kg, who had leadless pacemaker implants via the internal jugular vein.MethodsA retrospective review of pediatric leadless pacing placement via the internal jugular vein at the University of Minnesota Masonic Children's Hospital and UC Davis Medical Center from 2018 through 2021 was performed. Rationales for pacing, demographics of patients, pacing thresholds, and longevity of devices were recorded.ResultsEight internal jugular pacemaker insertions were performed successfully in patients weighing between 10.9 kg and 29 kg. Five patients had Micra implantation via the right internal jugular vein, whereas 3 patients had insertion via the left internal jugular vein. No surgical cut-downs were performed. No venous complications occurred. Up to 3 years of follow-up were noted.ConclusionLeadless pacemaker implantation, via left or right internal jugular veins, is feasible without surgical cutdown in patients <30 kg  相似文献   

12.
ObjectIn MRI, implants and devices can be delineated via susceptibility artefacts. To discriminate susceptibility voids from proton-free structures, different positive contrast techniques were implemented. The purpose of this study was to evaluate a pulse sequence-based positive contrast technique (PCSI) and a post-processing susceptibility gradient mapping algorithm (SGM) for visualization of iron loaded mesh implants in patients.ResultsOn GRE, the iron-loaded meshes generated distinct susceptibility-induced signal voids. PCSI exhibited susceptibility differences including the meshes as hyperintense signals. SGM exhibited susceptibility differences with positive contrast. Visually, the different algorithms presented no significant differences. Overall, the diagnostic value was rated best in GRE whereas PCSI and SGM were barely “sufficient”.ConclusionBoth “positive contrast” techniques depicted implanted meshes with hyperintense signal. SGM comes without additional acquisition time and can therefore be utilized in every patient.  相似文献   

13.

Background

As more inhaled corticosteroid (ICS) devices become available, there may be pressure for health-care providers to switch patients with asthma to cheaper inhaler devices. Our objective was to evaluate impact on asthma control of inhaler device switching without an accompanying consultation in general practice.

Methods

This 2-year retrospective matched cohort study used the UK General Practice Research Database to identify practices where ICS devices were changed without a consultation for ≥5 patients within 3 months. Patients 6–65 years of age from these practices whose ICS device was switched were individually matched with patients using the same ICS device who were not switched. Asthma control over 12 months after the switch was assessed using a composite measure including short-acting β-agonist and oral corticosteroid use, hospitalizations, and subsequent changes to therapy.

Results

A total of 824 patients from 55 practices had a device switch and could be matched. Over half (53%) of device switches were from dry powder to metered-dose inhalers. Fewer patients in switched than matched cohort experienced successful treatment based on the composite measure (20% vs. 34%) and more experienced unsuccessful treatment (51% vs. 38%). After adjusting for possible baseline confounding factors, the odds ratio for treatment success in the switched cohort compared with controls was 0.29 (95% confidence interval [CI], 0.19 to 0.44; p < 0.001) and for unsuccessful treatment was 1.92 (95% CI, 1.47 to 2.56; p < 0.001).

Conclusion

Switching ICS devices without a consultation was associated with worsened asthma control and is therefore inadvisable.  相似文献   

14.
BackgroundDespite ACC/AHA guidelines indicating implantable cardioverter defibrillator (ICD) as class I therapy for primary prevention of sudden cardiac death in patients with EF≤35%, ICD utilization rates in real world practice have been low.ObjectiveTo determine the rate of ICD implantation at a tertiary care academic center and to assess the reasons for under-utilization of the same.MethodsReview of a prospectively collected database which included all patients diagnosed with an EF≤35% was performed to assess the rate of ICD implantation and mortality. Reasons for non-implantation of ICD were then assessed from detailed chart review.ResultsA total of 707 patients (age 69.4 ± 14.1 years) with mean EF of 26±7% were analyzed. Only 28% (200/707) of patients had ICDs implanted. Mortality was lower in the group with ICD (25% vs 37%, p=0.004). When patients who either died or were lost to follow-up prior to 2005 were excluded, ICD utilization rate was still low at 37.6%. The most common reason for non-implantation of ICD was physicians not discussing this option with their patients. Patient refusal was the second most common reason.ConclusionsICD Implantation rates for primary prevention of SCD in patients with EF≤35% is low. Physician and patient education should be addressed to improve the utilization rates.Key words: Implantable cardioverter-defibrillator, Outcomes, sudden cardiac death  相似文献   

15.
BackgroundTransvenous Lead Extraction (TLE) is a standard treatment for some late Cardiac Implantable Electronics Device (CIED) complications. The outcome of transvenous lead extraction procedure in Thailand is not robust.MethodsA Single-center retrospective cohort of TLE procedures performed at Ramathibodi hospital between January 2008 and December 2020 was studied.ResultsThere were 157 leads from 105 patients who underwent lead removal procedure during the specified period. Data analysis was performed from 79 TLE patients due to incomplete data and lead explant procedure of the excluded subjects. Mean patients’ age was 57.7 ± 18.7 years, with 70.9% male. There were 82 pacemaker leads, 35 ICD leads, and 5 CS leads (mean number of leads were 1.54 ± 0.66 per patient), with mean implanted duration of 87.8 ± 68.2 months. Main indication for TLE was infection-related, which accounted for 67.1% of the cases.Overall clinical success rate was 97.5%. Mean operative time was 163.8 ± 69.5 min. Major complications occurred in 4 patients (5.1%) with one in-hospital mortality from severe sepsis.ConclusionTLE using laser sheath and rotating mechanical sheath for transvenous lead extraction is effective and safe, even outside high-volume center.  相似文献   

16.
BackgroundThe impact of left ventricular ejection fraction (LVEF) changes after sudden cardiac arrest (SCA) on implantable defibrillator (ICD) utilization and long-term survival is not known. We therefore evaluated the influence of LVEF on these parameters in SCA survivors.MethodsData were collected on consecutive SCA survivors who had ≥1 echocardiogram after SCA and who survived to hospital discharge (n = 655). The median time from baseline to first follow-up echocardiogram was 162 days. LVEF ≥50% was defined as normal. Patients were classified into 4 groups according to baseline (LVEFb) and follow-up (LVEFf) myocardial function: normal LVEFb and LVEFf (group1, n = 261); reduced LVEFb and normal LVEFf (group 2, n = 104); normal LVEFb but reduced LVEFf (group 3, n = 41); and reduced LVEFb and LVEFf (group 4, n = 249). All-cause mortality and time to ICD implantation were examined in all groups.ResultsOver a median follow up of 4.3 years, death occurred in 279 (42%) of patients. Compared with patients in group 1, patients with any reduced LVEF at any time (groups 2–4) had significantly higher mortality, even after adjusting for unbalanced covariates (HR = 1.44, 95.0% CI 1.05–1.95, p = 0.022). ICDs were most commonly implanted in patients with persistently reduced LVEF (group 4: HR = 1.72, 95% CI = 1.26–2.35, p = 0.001).ConclusionWe demonstrate that, in survivors of SCA, a reduced LVEF at or after the index event is associated with higher mortality but that patients with persistently reduced LVEF were most likely to receive ICD therapy. These findings have implications on the management of SCA survivors.  相似文献   

17.
18.
AimsLimited data exist on outcomes in very elderly ICD recipients. We describe outcomes in new ICD and Cardiac Resynchronisation Therapy with Defibrillator (CRT-D) implants in octogenarians at our institution.MethodsPatients aged 80 years and above who underwent de novo ICD or CRT-D implantation from January 2006 to July 2012 were identified. Clinical data were collected from the procedural record, medical and ICD notes. Baseline characteristics were compared using independent sample t test for continuous variables and Fisher’s exact test for categorical variables. Kaplan-Meier curves were constructed.ResultsTen per cent of all new ICD/CRT-D implants were aged 80 years and over. Median age was 83.0 years. Median follow-up was 29 months. Death occurred in 17 (34%). Median time to death was 23 months. Three deaths (6%) occurred within 12 months of ICD implantation. Appropriate therapy (ATP or shock) occurred in 19 (38%). Inappropriate therapy occurred in 6 (12%).Rates of appropriate shocks and inappropriate therapy (shocks and ATP) and significant valvular incompetence were higher amongst deceased patients (P=0.03 OR 5.9 95% CI 1.3-27) and (P=0.02 OR 12 95% CI 1.3-112). Univariate analysis identified diuretic use (P=0.008 95% C.I. 0.05 to 0.63) and appropriate shock (P= 0.025 95% C.I. 1.25 to 26.3) as predictors of mortality.ConclusionOctogenarians make up a small but increasing number of ICD recipients. This study highlights high survival rates at one year with acceptable rates of appropriate and inappropriate device therapy. Ongoing debate regarding the appropriateness of ICD in very elderly patients is warranted.Key words: sudden cardiac death, implantable defibrillators, octogenarians  相似文献   

19.
ObjectiveTo compare risks of cardiovascular outcomes between patients with type 2 diabetes and patients with established coronary heart disease.DesignCross sectional study and cohort study using routinely collected datasets.SettingTayside, Scotland (population 400 000) during 1988-95.SubjectsIn the cross sectional study, among patients aged 45-64, 1155 with type 2 diabetes were compared with 1347 who had had a myocardial infarction in the preceding 8 years. In the cohort study 3477 patients of all ages with newly diagnosed type 2 diabetes were compared with 7414 patients who had just had a myocardial infarction.ResultsIn the cross sectional study the adjusted risk ratio for death from all causes was 2.27 (95% confidence interval 1.82 to 2.83) for patients who had had myocardial infarction compared with those with diabetes, and the risk ratio for hospital admission for myocardial infarction was 1.33 (1.14 to 1.55). In the cohort study, patients who had just had a myocardial infarction had a higher risk of death from all causes (adjusted risk ratio 1.35 (1.25 to 1.44)), cardiovascular death (2.93 (2.54 to 3.41)), and hospital admission for myocardial infarction (3.10 (2.57 to 3.73)).ConclusionsPatients with type 2 diabetes were at lower risk of cardiovascular outcomes than patients with established coronary heart disease.

What is already known on this topic

A recent influential study suggested that patients with type 2 diabetes without established cardiovascular disease have as high a risk of cardiovascular events and death as non-diabetic patients who have had a myocardial infarctionSome clinicians therefore advocate aggressive treatment of cardiovascular risk factors in the presence of diabetes

What this study adds

Patients with type 2 diabetes are at lower risk of death from all causes or cardiovascular causes and of hospital admission for myocardial infarction than patients with established coronary heart disease  相似文献   

20.
Cardiac resynchronization therapy device (CRT-P and CRT-D) implantation has increased tremendously with increasing operator experience, eligible patients and expansion of indications. Refinements in devices and algorithms now aid physicians to improve biventricular pacing and optimize CRT. We report a case in which an interesting device program was used to achieve biventricular pacing after repeated dislodgement of the atrial lead in a patient implanted with CRT-D.  相似文献   

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