Israel Medical Association Journal

Historically physicians have had close relationships with the pharmaceutical or other medically related industry. This has come under close scrutiny by the public, with articles appearing in medical journals and the lay press. The reality is that physicians depend on industry to bring products to market as well as to assist in research and education, leaving physicians questioning what their relationship with industry should be. This review deals with this complex relationship, identifying ways that industry might affect decision making in the clinical context. We will highlight areas of potential concern in this relationship, identify attendant moral dilemmas, and provide some recommendations. Our intention in raising the consciousness of physicians and medical institutions to these potential areas of concern is to aid physicians in their efforts to provide the best medical care for patients and to practice with integrity.
 

Background: Cement vertebroplasty has been performed for over a decade to treat painful osteoporotic vertebral compression fractures (OVCFs). Kyphoplasty is considered a further step in the evolution of vertebral augmentation.

Objectives: To evaluate the efficiency and safety of the Confidence Vertebroplasty (CV) system in comparison with the Sky Kyphoplasty (SK) system in treating OVCF.

Methods: This prospective study included 45 patients with OVCF. Fourteen were treated with CV[1] and 31 with SK[2]. An imaging evaluation using a compression ratio (height of anterior vs. posterior wall) and local kyphotic deformity (Cobb angle) was performed prior to the procedure and 12 months later. Evaluation of pain was carried out using a visual analogue scale.

Results: The mean compression repair was 12% in the CV group compared to 25% in the SK group.

Mean kyphotic deformity restoration achieved using CV was 41% compared to 67% using SK. In both groups the pain severity was equally reduced by a mean of 43%.

Conclusions: The SK system has a technical superiority in restoring the vertebral height and repairing the kyphotic deformity, an advantage that was not manifested in pain relief – the most important variable. Both systems have a high level of safety. The cost-benefit balance clearly favors the CV system.

Acquired thrombotic thrombocytopenic purpura (TTP) is an uncommon disease in adults, characterized by fever, neurological manifestations, microangiopathic hemolytic anemia, thrombocytopenia, renal dysfunction, and the presence of antibodies against the enzyme ADAMTS13. Treatment with plasmapheresis has increased the survival from 10% to more than 90%. Still, there is a subset of patients with resistant TTP who fail to respond to plasmapheresis or remain dependent on this procedure. There is mounting evidence that rituximab may play an important role in remission induction of resistant/relapsing TTP; however, the extent of the remission is unknown. We present here four patients with chronic-relapsing TTP who responded favorably to rituximab. All four patients achieved prolonged remission of 23 to 82 months after the treatment.  One patient relapsed 6 years after the initial treatment with rituximab and re-entered remission following retreatment.

Background: As the lowest natural site on earth (-415 meters), the Dead Sea is unique for its high pressure and oxygen tension in addition to the unparalleled combination of natural resources. Furthermore, its balneotherapeutic resorts have been reported to be beneficial for patients with various chronic diseases.

Objectives: To evaluate the safety, quality of life (QoL), exercise capacity, heart failure, and arrhythmia parameters in patients with systolic congestive heart failure (SCHF) and implantable cardioverter defibrillator (ICD) following descent and stay at the Dead Sea.

Methods: The study group comprised patients with SCHF, New York Heart Association functional class II-III after ICD implantation. The following parameters were tested at sea level one week prior to the descent, during a 4 day stay at the Dead Sea, and one week after return: blood pressure, O₂ saturation, ejection fraction (echocardiography), weight, B-type natriuretic peptide (BNP), arrhythmias, heart rate, heart rate variability (HRV), and QoL assessed by the Minnesota Living with Heart Failure questionnaire.

Results: We evaluated 19 patients, age 65.3 ± 9.6 years, of whom 16 (84%) were males and 18 (95%) had ICD-cardiac resynchronization therapy. The trip to and from and the stay at the Dead Sea were uneventful and well tolerated. The QoL score improved by 11 points, and the 6 minute walk increased by 63 meters (P < 0.001). BNP levels slightly increased with no statistical significance. The HRV decreased (P = 0.018). There were no significant changes in blood pressure, weight, O₂ saturation or ejection fraction.

Conclusions: Descent to, ascent from, and stay at the Dead Sea resort are safe and might be beneficial in some aspects for patients with sCHF and an ICD.
 

Background: Obstructive sleep apnea syndrome (OSAS) is a sleep-related breathing disorder characterized by excessive daytime sleepiness, accidents and high medical expenses. The first line of treatment for OSAS is continuous positive airway pressure (CPAP).

Objectives: To examine attitudes and beliefs as well as physiological and sociodemographic factors affecting OSA patients' decision whether or not to purchase a CPAP device.

Methods: The study was divided into two stages; in the first, 83 subjects completed self-administered questionnaires prior to sleep examination (polysomnographic study). The questionnaires related to sleep habits, sleep disorders, questions organized around health belief model (HBM) concepts, sociodemographic information, health status and PSG[1] examination. In the second stage, 3 months later, 50 OSAS patients were interviewed by telephone, which included questions about their reasons for purchasing/not purchasing the CPAP device.

Results: Only 48% of the OSAS patients purchased the CPAP device. The significant factors positively affecting the decision included higher levels of physiological factors such as body mass index (coefficient 0.36, P < 0.05) and respiratory disturbance index (coefficient 0.16, P < 0.05), higher income levels (coefficient 3.26, p < 0.05), and higher levels of knowledge about OSAS (coefficient -2.98, P < 0.1).

Conclusions: Individuals who are more aware of their own health condition, are better informed about OSAS and have higher incomes are more likely to purchase the device. We suggest reducing the level of co-payment and providing patients with more information about the severe effects of OSAS.

Background: Cardiac patients express elevated levels of B-type natriuretic peptide and the amino terminal segment of its prohormone (NT-proBNP). However, there are non-cardiac causes of NT-proBNP level elevation.

Objectives: To determine the upper limit of NT-proBNP for pediatric patients with acute non-cardiac disease.

Methods: We compared NT-proBNP concentrations in healthy children and children with acute non-cardiac, mostly febrile, and acute cardiac disease. We used the Student t-test and Mann-Whitney test for group comparisons, and Pearson's and Spearman's correlation coefficients to test relationships between variables. 

Results: In 138 patients with acute non-cardiac diseases (mean age 3.7 years, 53% male), median NT-proBNP concentration was 162 pg/ml, upper limit (95% percentile) 1049 pg/ml. The level did not vary significantly by disease category; was negatively correlated with weight, weight percentile, age and hemoglobin level; and positively correlated with creatinine level. Multivariant analysis showed weight to be the only factor influencing NT-proBNP level. Levels were higher in children with acute non-cardiac diseases versus healthy children (median 88 pg/ml, P < 0.001, n= 59), and lower than levels in patients with acute cardiac disease (median 29,986 pg/ml, P < 0.001, n=29). Receiver operating characteristic analysis showed good NT-proBNP performance for differentiation between children with acute cardiac versus non-cardiac disease (area under the curve 0.958), at a cutoff of 415 pg/ml.

Conclusions: NT-proBNP levels are higher in children with acute non-cardiac diseases than in healthy children, but lower than in children with acute cardiac disease. NT-proBNP negatively correlated with weight and weight percentile.
 

Background: Transjugular kidney biopsy (TJKB) was first described in 1990. Indications for TJKB include uncorrectable bleeding disorders and conditions precluding the prone position. Objectives: To describe our initial experience with TJKB.

Methods: Between February 2008 and December 2009 all patients in whom percutaneous biopsy was contraindicated or unsuccessful underwent image-guided TJKB using a standard set with a 19 gauge core biopsy needle. Prospectively collected data included indication, number of needle passes, contrast dose, tissue yield, and complications.

Results: Twelve patients, age range 15–76 years (mean 55), underwent 14 TJKB procedures. Indications for the transjugular route included bleeding diathesis, dyspnea, ventral hernia, ascites, marked obesity, need for concomitant liver biopsy or concomitant insertion of tunneled dialysis catheter, discrepant kidney size, and failed percutaneous attempt. Thirteen biopsies were performed in 11 patients; in one patient TJKB was abandoned due to unfavorable renal vein anatomy. Four patients were premedicated with desmopressin and one with platelet transfusion, due to prolonged bleeding time. Three to six passes (mean 3.8) were made per biopsy, with an overall yield of 9.6 ± 8.2 glomeruli, providing a definite diagnosis in nine patients and a probable diagnosis in two. In two patients the first biopsy attempt yielded insufficient tissue, necessitating a repeat procedure. There were two minor bleeding episodes not requiring intervention. Serum creatinine was unchanged after the procedure and hemoglobin levels asymptomatically dropped by 0.3 ± 1.0 g/dl within 48 hours, requiring no treatment.

Conclusions: TJKB appears to safely allow adequate tissue diagnosis in patients at increased risk for complications from or contraindications to percutaneous renal biopsy.
 

Background: Surgery is considered the mainstay of treatment for esophageal carcinoma. Transhiatal esophagectomy with cervical esophagogastric anastomosis is considered relatively safe with an oncological outcome comparable to that using the transthoracic approach.

Objectives: To review the results of the first 100 transhiatal esophagectomies performed in a single Israeli center.

Methods: The records of all patients who had undergone transhiatal esophagectomy during the period 2003–2009 were reviewed. The study group comprised the first 100 patients. All patients who had undergone colon or small bowel transposition were excluded. Indications for surgery included esophageal cancer, caustic injury and achalasia.

Results: The median follow-up period was 19.5 months. The anastomotic leakage rate was 15% and all were managed successfully with local wound care. The benign stricture rate was 10% and all were managed successfully with endoscopic balloon dilation. Anastomotic leakage was found to be a risk factor for stricture formation. Overall survival was 54%. Response to neoadjuvant therapy was associated with a favorable prognosis.

Conclusions: Transhiatal esophagectomy is a relatively safe approach with adequate oncological results, as long as it is performed in a high volume center.