["The Talpiot medical leadership program"--advancing the brightest young physicians and researchers to fill future leadership roles].

BACKGROUND: The modern medical world is dynamic and boundless. There is a need for the medical training system currently existing in Israel to undergo a thorough conceptual change in order to strive for excellence and innovation on the one hand and to prevent the "brain drain" from Israel on the other. OBJECTIVE: To report on the "Talpiot" program at the "Sheba Medical Center", which identifies, promotes and prepares the most talented young doctors to fill key positions in the fields of medicine and health in Israel. METHODS: This study is based on a project with the same name in the Israeli Defense Forces (IDF). It promotes an elite group of physicians and researchers at the medical center and includes the provision of scholarships, personal guidance and customized educational opportunities for its members. Conversely, every member in the program is committed to complete five years of training followed by another five years as a senior physician or a researcher at the medical center. RESULTS: Since 2002, there have been six cycles of "Talpionaires". The current 46 members of the program fill key leadership roles in the medical center and are considered leaders in their field. Among the program's alumni are managers of institutes, units and research institutes. This group is responsible for the publication of hundreds of scientific papers studies and dozens of patents in medical technology. Some of them have progressed academically far beyond their peers. CONCLUSIONS: Excellence programs are an integral part of any institution which considers itself a leader, both in medicine and beyond. The exciting and visionary "Talpiot" program is Sheba's contribution to the quality of the medical system in the country of Israel in the long run. Promoting young doctors and researchers to become leaders in the Israeli medical system is an integral part of national interests.

[Assessment of financial performance improves the quality of healthcare provided by medical organizations].

Today, medical organizations have to contend with a highly competitive environment, an atmosphere saturated with a multitude of innovative new technologies and ever-increasing costs. The ability of these organizations to survive and to develop and expand their services mandates adoption of management guidelines based on the world of finance/commerce, adapted to make them relevant to the world of medical service. In this article the authors chose to present a management administration assessment which is a process that ensures that the management will effectively administer the organization's resources, and meet the goals set by the organization. The system demands that hospital "centers of responsibility" be defined, a management information system be set up, activities be priced, budget be defined and the expenses assessed. These processes make it possible to formulate a budget and assess any possible deviation between the budget and the actual running costs. An assessment of deviations will reveal any possible deviation of the most significant factor--efficiency. Medical organization managers, with the cooperation of the directors of the "centers of responsibility", can assess subunit activities and gain an understanding of the significance of management decisions and thus improve the quality of management, and the medical organization. The goal of this management system is not only to Lower costs and to meet the financial goals that were set; it is a tool that ensures quality. Decreasing expenditure is important in this case, but is only secondary in importance and will be a result of reducing the costs incurred by services lacking in quality.

[The complexity of medical organizations in the 21st century].

Our conception of medicine in the 21st Century is different from the way it was conceived in the 20th Century, and parallel to that, and medical organizations have changed and become more complex. These changes demand transition in traditional thought patterns and perception of the medical system as a "Complex Adaptive System" (CAS). In this article, the authors describe medical organizations as macro systems comprised of micro systems. They present a model of a Complex Adaptive System that permits us to address the challenges that face medical systems in the 21st Century. Management actions can no longer be based on a linear thought pattern and solutions such as "Planning-Study-Action". Action must be innovative and based on the advantages latent in micro systems, as an effective way to realize the macro system mission. In hospitals, for example, a clinical department consisting of the physician and medical staff, certainly a focal point of clinical knowledge and skill, can advance the quality of medicine, and the service and performance of the entire organization. But this is with the stipulation that synchronization is maintained between the micro system and macro system, which ensured that the organization function will serve the goals and vision of the hospital, while still contending with the challenges and competitive environment of the 21st Century.

[A clinical, health, economic and satisfaction simulation model, CHESS: a tool for healthcare organization management].

The management of medical organizations is based on a profound understanding of the essence of the organization, its vision and missions, as well as the methods the organization utilizes to gather and analyze information. In order to maintain a maximal function level in an ever-changing environment, all organization components must function in tandem. In a previous article the authors presented medical organizations as macro systems composed of micro systems, and discussed the challenges these organization face today. Basing optimal system management on micro medical systems allows the organizations to make maximum use of the advantages that professionalism encompasses, in a flexible micro-system environment. In this article, the authors attempt to present an interactive solution for performing assessments and management in the medical arena--the CHESS model. This solution was developed at the Sheba Medical Center. The CHESS Simulator (Clinical Health Economic and Satisfaction Simulator) was formulated to function as a clinical organizational intelligence system, whose function was to supply quantitative, analyzed data regarding activity on the clinical production floor. The system is unique in that it has a differential view of the complex medical procedures which are highly variable, and also has the capability to locate elements that are based in a common similarity. Data gathering will be based on an online system computerized medical file (EMR), which is a priority for a functioning system. This solution allows medical organization (macro-system] managers and the departments (micro system) directors to make informed decisions that will ensure that the organization's goals are achieved. This is defined as evolving from a reactive management pattern to a proactive management pattern that is mandatory in the competitive atmosphere of the 21st Century.

9-cis beta-carotene-rich powder of the alga Dunaliella bardawil increases plasma HDL-cholesterol in fibrate-treated patients.

The effect of fibrates on high density lipoprotein (HDL)-cholesterol levels is suggested to be mediated by its binding to peroxisome proliferator-activated receptor-alpha (PPARalpha). Upon ligand binding, PPARalpha heterodimerizes with the 9-cis retinoic acid receptor (RXR) and it is this heterodimer which regulates gene expression. We assessed the hypothesis that a combined treatment with fibrate plus 9-cis beta-carotene-rich powder of the alga Dunaliella bardawil, as a source of 9-cis retinoic acid, would improve the drug's effect on HDL-cholesterol levels. In an open-labeled first trial, 20 fibrate-treated men with plasma HDL-cholesterol levels below 40 mg/dl were given Dunaliella capsules, providing 60 mg beta-carotene/day, containing all-trans and 9-cis beta-carotene (1:1 ratio, w/w). Twenty-two fibrate-treated patients participated in a double-blind placebo-controlled second trial. Eleven patients were treated with Dunaliella capsules, and 11 patients were treated with beta-carotene-deficient Dunaliella capsules. Following 6 weeks of the dual treatment plasma HDL-cholesterol increased by 24.5 and 12.7% in the first and second trials, respectively (P=0.002 and 0.012). The dual treatment also increased HDL-cholesterol levels in human apolipoprotein A-I transgenic mice by 87.5% (P=0.021). The results show that a combination treatment of fibrate plus 9-cis beta-carotene-rich Dunaliella powder amplifies the effect of the drug on HDL-cholesterol levels.

Perspectives in multiple sclerosis health care: special focus on the costs of multiple sclerosis.

Brain disorders are amongst the leading causes of disease and disability worldwide, accounting for 35% of the burden of all diseases in Europe. Despite their enormous personal and national impact the knowledge of the financial and economic impression of brain disorders has been relatively little researched. Recently it has been estimated that there are nearly 400,000 multiple sclerosis (MS) patients in Europe, which is 0.003% of all brain disease patients in the continent. In MS economic consequences are predominantly the early loss of work capacity and the impact of physical and psychological disabilities in a population of young adults, hospitalization during severe disease exacerbations and the need for assistance in activities of daily living. In the last decade the introduction of new immunomodulatory treatments led to an increase in direct costs due to the cost of these drugs, but also led to a more intensive management of patients. However, most studies of MS costs were carried out prior to the widespread use of newer treatments. In the present study we estimated the economic impact of MS in Israel and compared the traditional-vertical management model with the integrated-multidisciplinary model of health service delivery following the introduction of immunomodulatory treatments. Mean direct health cost was 8,554 euros and 5,599 euros in the traditional and integrative models, respectively (p<0.01). After 1-year follow-up, full-time employment decreased by 10% in the traditional model and increased by 17% in the integrated model (p<0.05). Analysis of variance demonstrated that the model of service delivery explained most of the difference in cost between the two models. Compared to mean annual costs in Europe that are estimated at 23,695 euros per case the cost of health services in Israel by MS patients is significantly lower. MS represents a high economic burden to society. In line with the findings from 15 studies published in Europe, we can conclude that studies agree with the following findings: a) costs outside the healthcare system, non-medical costs and informal care dominate the costs of MS, b) costs increase with increasing severity of the disease and c) an integrated service delivery model that is satisfying to patients on the one hand and cost effective on the other is to be recommended.

External counterpulsation therapy improves endothelial function in patients with refractory angina pectoris.

OBJECTIVES: The goal of this study was to investigate the influence of short-term external counterpulsation (ECP) therapy on flow-mediated dilation (FMD) in patients with coronary artery disease (CAD). BACKGROUND: In patients with CAD, the vascular endothelium is usually impaired and modification or reversal of endothelial dysfunction may significantly enhance treatment. Although ECP therapy reduces angina and improves exercise tolerance in patients with CAD, its short-term effects on FMD in patients with refractory angina pectoris have not yet been described. METHODS: We prospectively assessed endothelial function in 20 consecutive CAD patients (15 males), mean age 68 +/- 11 years, with refractory angina pectoris (Canadian Cardiovascular Society [CCS] angina class III to IV), unsuitable for coronary revascularization, before and after ECP, and compared them with 20 age- and gender-matched controls. Endothelium-dependent brachial artery FMD and endothelium-independent nitroglycerin (NTG)-mediated vasodilation were assessed before and after ECP therapy, using high-resolution ultrasound. RESULTS: External counterpulsation therapy resulted in significant improvement in post-intervention FMD (8.2 +/- 2.1%, p = 0.01), compared with controls (3.1 +/- 2.2%, p = 0.78). There was no significant effect of treatment on NTG-induced vasodilation between ECP and controls (10.7 +/- 2.8% vs. 10.2 +/- 2.4%, p = 0.85). External counterpulsation significantly improved anginal symptoms assessed by reduction in mean sublingual daily nitrate consumption, compared with controls (4.2 +/- 2.7 nitrate tablets vs. 0.4 +/- 0.5 nitrate tablets, p <0.001 and 4.5 +/- 2.3 nitrate tablets vs. 4.4 +/- 2.6 nitrate tablets, p = 0.87, respectively) and in mean CCS angina class compared with controls (3.5 +/- 0.5 vs. 1.9 +/- 0.3, p <0.0001 and 3.3 +/- 0.6 vs. 3.5 +/- 0.5, p = 0.89, respectively). CONCLUSIONS: External counterpulsation significantly improved vascular endothelial function in CAD patients with refractory angina pectoris, thereby suggesting that improved anginal symptoms may be the result of such a mechanism.

Impact of left ventricular filling properties on the benefit of exercise training in patients with advanced chronic heart failure secondary to ischemic or nonischemic cardiomyopathy.

This study examined left ventricular (LV) filling properties and exercise hemodynamics noninvasively before and after an exercise training program in patients with chronic heart failure (HF). Although exercise training did not improve LV filling properties in patients with advanced HF, LV filling properties determined the hemodynamic benefit attainable from exercise in this patient group.

Effectiveness of establishing a dedicated acute stroke unit in routine clinical practice in Israel.

BACKGROUND: Clinical trials have demonstrated the superiority of managing acute stroke in a dedicated stroke unit over conventional treatment in general medical wards. Based on these findings, nationwide stroke unit care programs have been implemented in several countries. OBJECTIVE: To assess the effect of establishing a new dedicated acute stroke unit within a department of neurology on indicators of process of care and outcome of acute stroke in a routine clinical setting in Israel. METHODS: Stroke patients admitted to the Sheba Medical Center during the period March 2001 to June 2002 were included in a prospective study according to selection criteria. Data on demographics, risk factors, co-morbidities and stroke severity were collected. Indicators of process of care and outcome were assessed at hospital discharge and 30 days follow-up. Comparison between outcome variables by hospitalization ward was done using logistic regression analysis adjusting for confounders. RESULTS: Of 616 acute stroke patients (mean age 70 years, 61% men, 84% ischemic stroke), 353 (57%) were admitted to general wards and 263 (43%) to the stroke unit. Diagnostic procedures were performed more often and the infection rate was lower in the setting of the stroke unit. Poor outcome (modified Rankin scale > or = 3 or death) was present less often in patients managed in the stroke unit both at hospital discharge (adjusted odds ratio 0.5, 95% confidence interval 0.3-0.8) and at 30 day follow-up (adjusted OR 0.6, 95%CI 0.3-0.9). A Functional Independence Measure score < or = 90 or death at 30 day follow-up was less frequent among patients managed in the stroke unit than in general wards (adjusted OR 0.5, 95%CI 0.2-0.8). CONCLUSIONS: Improved outcomes and higher adherence to guidelines were observed in patients treated in a stroke unit within a department of neurology. The results suggest that patients with acute stroke should have access to treatment in a dedicated stroke unit.

Echogenic bowel in intrauterine growth restriction fetuses: does this jeopardize the gut?

OBJECTIVE: To investigate the association between intrauterine growth restriction (IUGR) fetuses with echogenic bowel and high resistance in the umbilical artery and increased risk of developing neonatal necrotizing enterocolitis. METHODS: We analyzed two groups: group 1, singleton IUGR fetuses with echogenic bowel or reversed diastolic flow in the umbilical artery, and group 2, neonates who were diagnosed as having neonatal necrotizing enterocolitis. In group 1, the pulsatility index of the superior mesenteric artery and celiac trunk were determined. In group 2, a retrospective analysis was carried out from the medical records of the neonates. RESULTS: Fifteen fetuses with echogenic bowel and severe IUGR were evaluated by Doppler studies, and 21 neonates with neonatal necrotizing enterocolitis were reviewed. In group 1, none of the IUGR fetuses developed neonatal necrotizing enterocolitis, whereas in group 2, only one neonate was defined as IUGR. The mean gestational age at delivery did not differ statistically between the two groups (28.8 +/- 2.3 weeks versus 30.1 +/- 3.3 weeks), whereas the mean birth weight was significantly lower in the first group (700 +/- 200 g versus 1431 +/- 466 g in the second group, P <.001). The mean pulsatility index +/- standard deviation in the superior mesenteric artery and celiac trunk of the IUGR fetuses were 1.5 +/- 0.14 and 1.2 +/- 0.17, respectively, both being found significantly lower than those of normal, appropriate controls (1.9 +/- 0.15 and 1.7 +/- 0.1, respectively, P <.005). CONCLUSION: Fetal echogenic bowel in IUGR fetuses is not associated with development of neonatal necrotizing enterocolitis. In these fetuses, vasodilatation in the superior mesenteric artery and celiac trunk have been demonstrated.

Intravenous recombinant tissue plasminogen activator therapy for acute ischemic stroke: initial Israeli experience.

BACKGROUND: Intravenous recombinant tissue plasminogen activator therapy within 3 hours of stroke onset is a proven effective treatment for acute ischemic stroke. OBJECTIVE: To assess the feasibility and safety of rt-PA therapy for reperfusion in routine clinical practice in Israel, in the setting of a dedicated stroke unit. METHODS: Consecutive patients presenting within less than 3 hours of stroke onset were evaluated by an emergency physician and the neurology stroke team. After brain computerized tomography, eligible patients were treated with intravenous rt-PA (0.9 mg/kg, maximum dose 90 mg) according to an in-hospital protocol corresponding to recommended criteria. Patients were admitted to the acute stroke unit. Safety and clinical outcome were routinely assessed. Recanalization was assessed by serial transcranial Doppler. RESULTS: The study group comprised 16 patients, mean age 61 years (range 47-80 years), male to female ratio 10:6, whose median baseline National Institutes of Health stroke scale was 13 (range 6-24). They were treated within a mean door-to-CT time of 39 minutes (range 17-62 min), door-to-drug time 101 minutes (range 72-150), and stroke onset-to-drug time 151 minutes (range 90-180). There was an early improvement within 24 hours (of > or = 4 points in the NIHSS score) in 7 patients (44%) and no early deteriorations. There were no protocol deviations, no symptomatic intracranial hemorrhages, and no major systemic hemorrhage within 36 hours of rt-PA treatment. Three asymptomatic hemorrhagic transformations of the infarct were noted on routine follow-up brain CT associated with neurologic improvement. Outcome data were comparable to the National Institute of Neurological Disorders and Stroke rt-PA Stroke Study. CONCLUSION: Intravenous rt-PA treatment within 3 hours of stroke onset in routine clinical practice in Israel is feasible and appears safe in the setting of a neurology stroke unit and team. Careful implementation of rt-PA therapy for selected patients in Israel is encouraged.

Management by constraints: considering patient volume when adding medical staff to the emergency department.

BACKGROUND: The emergency department is one of the hospital's busiest facilities and is frequently described as a bottleneck. Management by constraint is a managerial methodology that helps to focus on the most critical issues by identifying such bottlenecks. Based on this theory, the benefit of adding medical staff may depend on whether or not physician availability is the bottleneck in the system. OBJECTIVE: To formulate a dynamic statistical model to forecast the need for allocating additional medical staff to improve the efficacy of work in the emergency department, taking into account patient volume. METHODS: The daily number of non-trauma admissions to the general ED was assessed for the period 1 January 1992 to 1 December 1995 using the hospital computerized database. The marginal benefit to shortening patient length of stay in the ED by adding a physician during the evening shift was examined for different patient volumes. Data were analyzed with the SAS software package using a Gross Linear Model. RESULTS: The addition of a physician to the ED staff from noon to midnight significantly shortened patient LOS: an average decrease of 6.61 minutes for 80-119 admissions (P < 0.001). However, for less than 80 or more than 120 admissions, adding a physician did not have a significant effect on LOS in the ED. CONCLUSIONS: The dynamic model formulated in this study shows that patient volume determines the effectiveness of investing manpower in the ED. Identifying bottleneck critical factors, as suggested by the theory of constraints, may be useful for planning and coordinating emergency services that operate under stressful and unpredictable conditions. Consideration of patient volume may also provide ED managers with a logical basis for staffing and resource allocation.

Clinical surveillance of a tined, bipolar, silicone-insulated ventricular pacing lead.

AIMS: This study assesses short- and long-term performance of the S80TB ventricular lead manufactured by Sorin Biomedica, Italy. METHODS AND RESULTS: Three hundred and thirty leads were implanted and had complete follow-up with us for a minimum of 60 months or up to failure, removal, and/or patient death (mean 40 months, range: 1 day to 81 months). Thirty-two patients (9.6%) had spontaneous lead-related complications: 7 (2.1%) occurred during the first week; 25 (7.6%) had chronic complications, of which 20 (6.1%) necessitated re-operations; 3 (0.9%) were lead material failures. Of the 110 re-operations (90 pacemaker replacements and 20 operations due to complications), 7 additional cases (6.4%) were complicated by unique connector damage that occurred during disconnection of the lead from the connector block. The Kaplan-Meier estimated 5-year lead survival free of lead material failure and free of any significant lead complication were 97.9 and 87%, respectively. CONCLUSION: The S80TB lead demonstrates an acceptable rate of acute and chronic spontaneous complications and very few lead material failures over 5 years of follow-up. However, there seems to be a relatively high incidence of connector damage during disconnection from the connector block. Extra caution is required during those procedures in patients with this lead.

Long-term performance of screw-in atrial pacing leads: a randomized comparison of J-shaped and straight leads.

OBJECTIVE: In this prospective, randomized, control study we compared performance of J-shaped (JL) and straight atrial leads (SL) with active (screw-in) fixation mechanism, over a 5-year follow-up period. SUBJECTS AND METHODS: A total of 208 consecutive patients were randomized for implantation with a Medtronic 4568 JL model (n = 103) versus a Medtronic 4068 SL model (n = 105), and all lead-related measurements and complications were recorded. RESULTS: Lead-related complications occurred in JL and SL with similar frequency (6% and 9%, respectively, P = 0.45). Lead dislodgment occurred in 8 (7.8%) cases in SL versus none in JL (P = 0.004). Lead malfunction and excessive pacing thresholds without macrodislodgment occurred more frequently in JL (11; 10.7%) than in SL (4; 3.8%), P = 0.055. Lead material failure (insulation break) occurred only once in SL at the 5-year checkup. Most complications occurred during the first year after implantation. Other events occurred in both leads with similar frequency and included: death in 39 and 35, loss of follow-up in 8 and 6, and development of atrial fibrillation in 9 and 15 patients, respectively. Of those who completed follow-up, lead impedance and pacing threshold increased significantly in both groups. P wave decreased in SL but not in JL. CONCLUSION: More dislocations occurred in SL, but were counterbalanced by more lead malfunctions and excessive pacing thresholds in the JL group. Both leads demonstrated minor deterioration in electrical measurements during follow-up, with only 1 case of lead material failure in SL. Overall, both groups demonstrated favorable lead performance throughout follow-up.

Cancer incidence in multiple sclerosis and effects of immunomodulatory treatments.

Multiple sclerosis (MS) has been linked to reduced rates of cancer prior to the era of immunomodulating treatments. We assessed the incidence of cancer in a cohort of 1338 MS patients and evaluated the effect of exposure to immunomodulatory treatment. Cancer incidence in the MS population was compared with the expected age- and gender-matched incidence rates in the Israeli population for the period 1960-2003. Time-dependant Cox model analysis was used to estimate hazard ratios for glatiramer acetate, beta-interferons (1a and 1-b) and intravenous immunoglobulins (IVIg). Among 892 female MS patients, 15 (1.7%) developed breast cancer, and 31 (3.5%) developed cancers of any type. Seventeen of 446 (3.8%) male MS patients developed cancer. The standardized incidence ratios (SIRs) computed until the time of first immunomodulatory treatment were 0.60 (95% CI, 0.38-0.92, p = 0.02) for all female cancer, and 1.11 (95% CI, 0.64-1.91) for all male cancer. Time-dependent covariate analyses for female breast cancer yielded a relative risk for glatiramer acetate of 3.10 (95% CI, 0.86-11.1) and 0.52 (95% CI, 0.07-4.05) for beta-interferons. For IVIg, the analyses were uninformative. Our findings indicate that cancer incidence is significantly lower in female MS patients than in the general population. Female MS patients treated with glatiramer acetate showed an elevated rate of breast cancer and all MS patients treated with beta-interferons showed an elevated risk of non-breast cancers though not statistically significant (p = 0.122 and 0.072, respectively). Further study is needed to assess possible associations between long-term exposure to the novel immunomodulatory treatments in MS and rate of cancer.

Longitudinal disability curves for predicting the course of relapsing-remitting multiple sclerosis.

BACKGROUND: Multiple sclerosis (MS) is a lifelong disease affecting young adults that ultimately can lead to significant neurological disability. Identifying the rate of progression of disability for an individual patient early in the disease process can influence treatment decisions as well as enable monitoring of the disease overtime. OBJECTIVE: The aims of the present study were to develop longitudinal disability curves to assess disease progression in patients with relapsing remitting MS. The construction of these disability curves was based on the mean yearly Expanded Disability Status Scale (EDSS) scores, represented as a major percentile group. To determine their predictive ability, validation of the percentile curves was performed. METHODS: Using the Multiple Sclerosis Center computerized database of 1540 patients' records, we identified 1317 subjects with a definite MS and a relapsing-remitting disease course. Longitudinal disability curves were constructed for a subgroup of relapsing-remitting patients (n = 1001) with consecutive (3-6 months) EDSS assessments for a period of up to 10 years since onset. The constructed disability curves were then validated in an additional subgroup of relapsing-remitting MS patients (n = 268) with continuous follow-up visits for a period of 10 years. RESULTS: Statistical procedures using parametric and nonparametric regression procedures were applied to the data in two stages. In the first stage, selected major percentiles were generated for up to 10 years from disease onset with a variety of parametric procedures including moving averages. In the second stage, the empirical percentiles were smoothed to obtain the final disability progression curves. The log-rank test for equality demonstrated a significant adjustment between the initial percentile assignment and disability progression (P < 0.001). Life table analysis demonstrated that the probability of deviating from the initially assigned percentile to a higher percentile over time, representing more severe disability than expected, is in the range of 6.5% for the 50th percentile to 10.4% for the 75th percentile. CONCLUSION: Longitudinal disability curves can be used in MS to assess individual patient disability, can contribute to the overall clinical impression of disease progression and can add to the evaluation of immunomodulating treatment effects overtime.

Bone strength in multiple sclerosis: cortical midtibial speed-of-sound assessment.

It has been previously suggested that multiple sclerosis (MS) patients are at increased risk for osteoporosis due to reduced mobility, decreased exposure to sunlight and recurrent steroid treatment. In order to systematically evaluate bone strength we assessed 256 MS patients (171 females, 75 males) through quantitative ultrasound measurement of cortical bone. Tibial speed of sound (SOS, m/sec) was measured at midpoint of the tibial shaft using a Soundscan 2000 (Myriad Ultrasound Systems, Rehovot, Israel) and results were compared to age- and gender-matched population norms. T-score distribution in male MS patients was similar to normal population. In contrast, for female MS patients T-score distribution was significantly different from population norms, reflected by increased SOS in 30.4% (T-score intervals 1-2 and >2 above normal values; P=0.001), compared with 7.4% in controls. These findings held true for both female patients younger and older than 45 years of age. Increased neurological disability and specifically motor involvement were more frequent in female patients with increased SOS (P<0.05). Bone strength was preserved in MS patients. In a subgroup of female patients increased SOS was conceivably related to spasticity.

Managing pacemaker safety alerts: experience with three successive models of a single manufacturer.

This report describes the experience of a large pacemaker center during three successive replacement operations due to safety alerts involving three models from the same manufacturer. Between March 1993 and May 1999, 210 patients were implanted with three DDD pacemaker models (Sorin Biomedica, Saluggia, Italy) that were subsequently subject to safety alerts. Pacemaker records were reviewed for complications related to device malfunction, and those secondary to the replacement procedure. Pacemaker malfunction was observed in 16.4% of units despite much lower estimates from the company (range 1-4%). With the exception of one, all units were replaced. Malfunctions were discovered in 7 of 20 pacemakers following an urgent call for follow-up issued as a result of the alert. Twenty units implanted as substitutes for those replaced following the first alert turned out to be subject to the third alert. Significant clinical consequences of malfunction occurred in 5.3% of patients including a near fatal event in one case, while complications related to the replacement procedure occurred in 8.3% of patients, including one fatality. On the issuance of a safety alert, failure rates in a particular center may be higher than published by the manufacturer, and should prompt action by the center to weigh local incidence of device failure against complications of replacement procedures. When device failure mechanism is not entirely clear, particularly in cases of successive model failures, replacement devices from a different manufacturer should be considered.