The Psychological Impact of Implantable Cardioverter-Defibrillator Recalls and the Durable Positive Effects of Counseling

Background: It is known that patients with lifesaving devices such as implantable cardioverter-defibrillators (ICDs) may be alarmed and worried by recalls or alerts related to their ICDs.
Objectives: This study aimed to determine whether counseling has any short- or long-term benefits, and to look for characteristics that identify those most worried and those most in need of counseling.
Methods: Among 100 patients with recall or alert ICDs, 14 were pacer dependent; 50 had ICDs for 1° prevention and 22 were women. Patients completed a survey indicating how worried they were on learning of the recall or alert (0–10 scale). After counseling and advice in accordance with manufacturer guidelines, patients were asked to indicate their level of worry, and were again asked after 6 months.
Results: For all patients, the "worry level" at the initial interview was 5.0 ± 3.7, falling to 2.2 ± 3.0 after counseling (P < 0.001) and 1.4 ± 2.3 after 6 months (P < 0.001 vs both earlier levels). There were no significant differences between those implanted for 1° versus 2° prevention or for pacer dependency. Women were initially more worried than men, but not for the long term. The 49 patients whose ICDs could be managed by reprogramming or software fix had significant reduction in worry after counseling and at 6 months compared to others. The 18 patients recommended for operative intervention remained more concerned after counseling (3.5 ± 3.3 vs 1.9 ± 2.9, P = 0.043).
Conclusions: Patients' concerns resulting from ICD recalls or alerts can be reduced by appropriate counseling. Those patients whose ICDs could be reprogrammed to safer parameters had the most reduction in worry levels.     

Value of Pre-Hospital Discharge Defibrillation Testing in Recipients of Implanted Cardioverter Defibrillators

Opinions vary regarding the need to perform defibrillation testing prior to hospital discharge in recipients of state-of-the-art cardioverter defibrillators (ICDs). Our protocol is to perform predischarge ICD testing 1 day after implant. This report includes 682 consecutive implants. Adverse observations at testing were grouped into (1) risk of defibrillation failure, (2) surgical complications, (3) sensing/pacing issues or narrow defibrillation margin warranting closer follow-up, or (4) findings correctable by device reprogramming. Among the 682 patients, 63% had single-chamber and 37% dual-chamber or biventricular ICDs. In 48 patients (7%) there were 69 concerns and/or interventions, with overlaps among the four categories, including one failure to defibrillate (0.15%), and six other patients at risk. Surgical complications included 11 hematomas (1.6%), and six lead dysfunctions. Closer follow-up was indicated in 19 patients (2.7%), for high pacing thresholds in seven, sensing issues in seven, and <10 J defibrillation margin in five. Device reprogramming was needed in 31 patients (4.5%), for tachycardia detection and therapy settings in 12, and for pacing/sensing functions in 22 patients. In eight patients ventricular fibrillation could not be induced. There was no morbidity or mortality due to testing. The state-of-the-art ICDs delivering biphasic shocks are remarkably reliable. The routine pre-hospital discharge defibrillation testing of such ICDs may be optional and left to the physicians' discretion.     

Extension of Life-Table Methodology to Allow for Left-Censoring in Survival Studies of Pacing Devices Followed by Commercial Monitoring Services

The actuarial life-table is commonly used to describe lifetime data of living subjects and manufactured products. The life-table method allows subjects to come under observation at different times and, thus, to have differing lengths of follow-up, by assuming all subjects begin their lifetimes relative to the outcome of interest at some common point in time. As time progresses, subjects are withdrawn from the life-table when their period of observation has elapsed. This pattern of follow-up is often termed "right-censoring." An important feature of the classical life table approach is that the time at which the subject is placed at risk is known, and the status relative to the outcome of interest is known for the entire time at risk. Sometimes, however, subjects cannot be observed for some period after the beginning of their lifetimes. The example to be considered involves follow-up data collected by a commercial pacemaker monitoring service, to which patients subscribe, generally at some point following the actual implant of the pacemaker. Since the outcome of interest is device failure after implant, some means of dealing with the lack of information between implant and initiation of follow-up is needed. The extension of the actuarial life-table to accommodate this "left-censoring" will be described in this paper.     

Amiodarone: Value of Programmed Electrical Stimulation and Holter Monitoring

The value of programmed electrical stimulation (PES) and Holter monitoring in the assessment of amiodarone efficacy was reviewed. Many physicians have been disturbed by the persistent inducibility of arrhythmias in patients treated with amiodarone, who nevertheless do very well during the follow-up period. Noninducibility was associated with a favorable prognosis among 366 VT patients. Eighty-eight (24%) were noninducible on amiodarone, and 10% of these had recurrences, vs 39% in patients who remained inducible. Further, increased difficulty of induction with PES or induction of a slower or better tolerated VT may indicate a favorable outlook, and add to the value of PES. Few papers rigorously employed Holter monitoring in the assessment of amiodarone. In general, suppression of previously frequent arrhythmias implies excellent protection for patients with benign arrhythmias and moderate protection with malignant arrhythmias. By Holter assessment in 186 VT patients, arrhythmias were suppressed in 114 (61%), and 18% of these had recurrences vs 50% in patients whose arrhythmias were not suppressed. Studies attempting to correlate the results of PES and Holter monitoring in the same patients are lacking and may prove useful.     

Immunohistochemical analysis of Fas and FLIP in prostate cancers

Fas‐mediated apoptosis is considered a principal pathway for apoptosis induction in normal and cancer cells. Expression of Fas has been reported in prostate tissues several times, but the data were not consistent. Expression of FLICE‐like inhibitory protein (FLIP), an inhibitor of Fas‐mediated apoptosis, has not been studied by immunohistochemistry in prostate tissues. The aim of this study is to explore whether alterations of Fas and FLIP expression occur in prostate cancer tissues. We analyzed the expression of Fas and FLIP in 107 prostate adenocarcinoma tissues by immunohistochemistry using a tissue microarray approach. Normal glandular cells of the prostates strongly expressed both Fas and FLIP proteins. Prostate intraepithelial neoplasm also showed a strong Fas immunoreacitity. Fas expression was strongly positive in 60 cancers (56.1%), but the remaining 47 cancers showed no (6.5%) or markedly decreased (37.4%) Fas immunostaining compared with the normal glandular cells of the same patients. By contrast, FLIP expression was strong in most (103/107; 96.3%) of the cancers, and only four cancers (3.7%) showed decreased immunoreactivities compared with the normal cells. The decreased expression of Fas was not associated with pathologic characteristics, including FLIP expression, size of the cancers, age, Gleason score and stage. The decreased expression of Fas in a large fraction of prostate cancers compared with their normal cells suggested that loss of Fas expression might play a role in tumorigenesis in some prostate cancers possibly by inhibiting apoptosis mediated by Fas.     

Impact of oxidative stress on lung diseases

Reactive oxygen species (ROS) are products of normal cellular metabolism and are known to act as second messengers. Under physiological conditions, ROS participate in maintenance of cellular 'redox homeostasis' in order to protect cells against oxidative stress through various redox-regulatory mechanisms. Overproduction of ROS, most frequently due to excessive stimulation of either reduced nicotinamide adenine dinucleotide phosphate by cytokines or the mitochondrial electron transport chain and xanthine oxidase, results in oxidative stress. Oxidative stress is a deleterious process that leads to lung damage and consequently to various disease states. Knowledge of the mechanisms of ROS regulation could lead to the pharmacological manipulation of antioxidants in lung inflammation and injury.     

The outcome of cementless total hip arthroplasty in haemophilic hip arthropathy

Summary.  Total hip arthroplasty (THA) in haemophilic arthropathy is reported to be less successful than in non-haemophilic indications. Although preliminary results are encouraging, the survival and functional outcome of cementless THA in haemophilia are not known. The aim of this study was to analyse mid-term results of cementless THA in haemophilia. Twenty-seven consecutive cementless THAs with 23 patients performed between June 1995 and June 2003 were reviewed. Mean age at time of operation was 36 years and mean follow-up period was 92 months (range, 60–156). Radiographic assessment was done for fixation of components, loosening, osteolysis, wear and bone responses around the implants. The factor requirements, amount of transfusion and complications associated with bleeding were studied. The mean preoperative Harris hip score changed from 57 to 95.9 at the latest follow-up. The survival at mean follow-up was 95.2%. One patient with osteolysis around acetabular cup was re-operated with bone-grafting and change of polyethylene liner. One loose cup was revised with a cemented cup. All other components were deemed stable at the latest follow-up. A standardized management protocol and dedicated team approach comprising of haematologist, physicians, physical therapist, nurses and coordinators is needed for excellent results. The present retrospective study shows that the functional results of cementless THA in haemophilia are satisfactory as it happens in osteoarthritic patients according to the current literature, mainly the younger. Thus, taking into account that the majority of haemophilia patients requiring a THA are relatively young, cementless THA is currently recommended.