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עמוד בית
Thu, 15.05.25

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April 2009
S. Policker, W. Haddad and I. Yaniv

Background: The TANTALUS System (MetaCure Ltd.) is a minimally invasive implantable device for the treatment of type 2 diabetes. The system detects food intake by sensing gastric electrical variations and applies electrical stimulation to the gut synchronized to natural gastric activity. The system is commercially available in Europe and Israel and is in clinical trials in the United States. It has been tested in 132 patients worldwide to date.

Objectives: To re-analyze previously reported data from different studies. This retrospective analysis of the type 2 diabetes subpopulation analyzed the expected benefit and characterize the significance of baseline A1c in the determination of the expected clinical outcome.

Methods: From the total cohort of 132 patients implanted with the TANTALUS device in 10 different centers in Europe and the U.S., 50 subjects (27 females, 23 males) who were obese with uncontrolled T2DM[1] on a stable regime of oral medication for 3 months prior to implant were identified. This population had similar inclusion/exclusion criteria as well as treatment protocols and were all treated for at least 24 weeks. The analysis was based on the A1c change compared to baseline.

Results: Data after 24 weeks demonstrate a reduction in A1c in 80% of the patients with average drop in A1c of 1.1 ± 0.1%. The average weight loss was 5.5 ± 0.7 kg.

Conclusions: The results suggest that the TANTALUS stimulation regime can improve glucose levels and induce moderate weight loss in obese T2DM patients.






[1] T2DM = type 2 diabetes mellitus



 
January 2009
October 2008
P. Rozen, Z. Levi, R. Hazazi, I. Barnes-Kedar, Z. Samuel, A. Vilkin and Y. Niv

Background: Dedicated, organ-specific screening clinics have been shown to significantly reduce cancer morbidity and mortality.

Objectives: To establish a dedicated clinic for Clalit Health Service patients at high risk for hereditary gastrointestinal cancer and to provide them with clinical and genetic counseling, diagnostic screening and follow–up.

Results: During the 3 years of the clinic's activity, 634 high risk families, including 3804 at-risk relatives, were evaluated. The most common conditions were hereditary colorectal syndromes, Lynch syndrome (n=259), undefined young-onset or familial colorectal cancer (n=214), familial adenomatous polyposis (n=55), and others (n=106). They entered follow-up protocols and 52 underwent surgical procedures.

Conclusions: Consistent public and professional education is needed to increase awareness of hereditary colorectal cancer and the possibility of family screening, early diagnosis and therapy. The public health services – i.e., the four health management organizations – should provide genetic testing for these patients who, at present, are required to pay for almost all of these available but costly tests. Dedicated colorectal surgical units are needed to provide the specialized therapeutic procedures needed by patients with familial colorectal cancer. Our future plans include adding psychosocial support for these at-risk patients and their families as well as preventive lifestyle and dietary intervention. 

April 2008
N. Shapira, P. Weill, R. Loewenbach

Background: As high dietary n-6 polyunsaturated fatty acids and n-6:n-3 PUFA[1] ratio may contribute to many western ailments, increasing n-3 PUFA in foods could be beneficial. The nutritional significance of n-3 PUFA-fortified egg vs. enzymatically competitive high n-6 PUFA diets is debatable.

Objectives: To evaluate the dietary contribution of 'field fortification' of eggs by adding n-3 PUFA to high n-6 PUFA hen feed and whether it meets consumer preferences.

Methods: Laying hens (n=3500) were fed n-3 PUFA-fortified (5% extruded linseed) feed or standard (control) feed for 5 weeks. Nutritional significance was evaluated for western (American, Israeli) populations.

Results: Compared to regular (control) eggs, fortified eggs yielded a 3.8-fold increase in total n-3 PUFA, 6.4-fold alpha-linolenic acid (18:3), and 2.4-fold docohexaenoic acid 22:6). N-6:n-3 PUFA ratio decreased 3.6-fold, and n-6:n-3 long chain PUFA ratio threefold (P < 0.0003). Sensory evaluations were not significantly different. Egg cost increased by 1.0–1.5%. Fortified egg n-3 PUFA content averaged 14.3% of the current intake of Americans and 15.9% of Israelis – 9.8 and 10.5% of upper Dietary Reference Intakes, respectively. Egg DHA content averaged 32.9 and 41.1% of upper DRI[2]. Current cholesterol intakes average 281 and 263 mg/day (median 214 and 184 mg/day) including 0.7 and 0.5 egg/day; reported hypercholesterolemia rates are 17.7 and 16.5%, respectively.

Conclusions: Effective concentration and transformation of supplemental n-3 PUFA/LCPUFA[3] from feed to egg substantially enhanced egg n-3 PUFA %DRI, particularly of DHA[4], critical for health but often deficient. Such land-based n-3 PUFA/LCPUFA fortification may be applicable to high n-6 PUFA diets, fitting within cholesterol limitations and market criteria. It may contribute to general health and specific requirements (i.e., pregnancy and lactation), with possibilities of wide accessibility and standardization.







[1] PUFA = polyunsaturated fatty acids

[2] DRI = Dietary Reference Intake

[3] LCPUFA = long chain PUFA (≥ C20)

[4] DHA = docohexaenoic acid (22:6 n-3)


S. Atias, S. Mizrahi, R. Shaco-Levy and A.Yussim

Background: In contrast to the relative scarcity of donor kidneys and hearts, the potential supply of deceased donor pancreata is exceeding the demand. However, this potential organ surplus is not being fully realized because in current transplantation practice the duration of pancreas storage before transplantation is limited and many organs with established or anticipated cold ischemia time exceeding 8–10 hours are discarded owing to the extreme vulnerability of pancreatic tissue to anaerobic damage caused by preservation.

Objectives: To reduce cold ischemic injury in order to increase the utilization of donor pancreases in Israel for whole-organ and cell transplantation.

Methods: We evaluated a novel two-layer preservation oxygenated cold storage method that uses perfluorocarbon to continuously supply oxygen to the pancreas during preservation in conventional University of Wisconsin solution.

Results: Pancreatic tissue morphology, viability and adenosine-triphosphate content were serially examined during preservation of the pig pancreas for 24 hours either by a two-layer or by conventional simple cold storage. Already after 12 hours of storage, the superiority of the two-layer method over the University of Wisconsin method was apparent. Starting at this time point and continuing throughout the 24 hours of preservation, the tissue architecture, mitochondrial integrity, cellular viability and ATP[1] tissue concentration were improved in samples preserved in oxygenated UW[2]/PFC[3] as compared to controls stored in conventional UW solution alone.

Conclusions: The UW/PFC two-layer preservation method allowed tissue ATP synthesis and amelioration of cold ischemic tissue damage during extended 24 hour pancreas preservation. This method could be implemented in clinical practice to maximize utilization of pancreata for whole-organ and islet transplantation as well as for pancreas sharing with remote centers.






[1] ATP = adenosine-triphosphate

[2] UW = University of Wisconsin

[3] PFC = perfluorocarbon


March 2008
I. Gotsman, S. Rubonivich and T. Azaz-Livshits

Background: Angiotensin-converting enzyme inhibitors and angiotensin receptor blockers improve prognosis in congestive heart failure and are the treatment of choice in these patients; despite this, the rates of ACE-I[1] usage in heart failure patients remain low in clinical practice.

Objectives: To evaluate the rate of ACE-I/ARB[2] treatment in hospitalized patients with CHF[3], and analyze the reasons for non-treatment.

Methods: We prospectively evaluated 362 consecutive patients hospitalized with CHF. Patients were evaluated for ACE-I/ARB usage at discharge and were followed for 1 year.

Results: At hospital discharge 70% of the patients were prescribed ACE-I/ARB treatment. Only 69% received recommended target or sub-target dosages, proven to improve prognosis. This decreased to 63% and 59% at 6 months and 12 months of follow-up respectively, due to a shift from sub-target levels to low dosages. Justified reasons for under-treatment were apparent in only 25% not optimally treated discharged patients and this decreased to 12% and 4% at 6 and 12 months follow-up, respectively. Common reasons for non-treatment at discharge were hyperkalemia and elevation in serum creatinine, while hypotension and cough were more prominent at follow-up. Clinical parameters associated with increased treatment rates were ischemic heart disease and the absence of chronic renal failure. Patients receiving treatment had lower hospitalization and mortality rates.

Conclusions: ACE-I/ARB treatment is still underutilized in patients discharged from hospital with a diagnosis of CHF. Increasing the awareness of the importance of these drugs may increase the number of patients treated.






[1] ACE-I = angiotensin-converting enzyme inhibitors

[2] ARB = angiotensin receptor blockers

[3] CHF = congestive heart failure


February 2008
O. Amir, H. Paz, R. Ammar, N. Yaniv J.E. Schliamser and B.S. Lewis
 
Background: Serum natriuretic peptide levels are useful diagnostic and prognostic markers in patients with acute decompensated heart failure, but have been little used to stratify urgency of treatment in the outpatient situation.

Objectives: To examine the use of natriuretic peptide to guide priority of patient referral to a heart failure center.

Methods: We analyzed data from 70 consecutive patients with chronic heart failure (NYHA class 2-4) referred for first evaluation in a specialized outpatient heart failure center. Serum NT-proBNP[1] was measured at the initial patient visit. We examined correlates and predictive value of mid- and upper tertile NT-proBNP for mortality in comparison with other known prognostic indicators using univariate and multivariate logistic regression analysis.

Results: Mortality at 6 months was 26.0% in patients with upper tertile (> 1958 pg/ml) NT-proBNP, 8.7% in the middle tertile group and 0% in the lowest tertile (P = 0.017). Patients with upper tertile serum NT-proBNP levels (group 3) had lower left ventricular ejection fraction, were more often in atrial fibrillation (P = 0.04) and more often had renal failure (P = 0.03). Age-adjusted logistic regression analysis identified upper tertile serum NT-proBNP level as the strongest independent predictor of 6 month mortality with a sixfold risk of early death (adjusted odds ratio 6.08, 95% confidence interval 1.58–47.13, P = 0.04). NT-proBNP was a more powerful predictor of prognosis than ejection fraction and other traditional outcome markers.

Conclusions: In heart failure patients referred to an outpatient specialized heart failure center, an upper tertile NT-proBNP level identified patients at high risk for mortality. A single high > 550 pg/ml NT-proBNP measurement appears to be useful for selecting patients for care in a heart failure center, and a level > 2000 pg/ml for assigning patients to high priority management.






[1] NT-proBNP = - N-terminal pro-brain natriuretic peptide


B. Kessel, K. Peleg, Y. Hershekovitz, T. Khashan, A. Givon, I. Ashkenazi and R. Alfici

Background: Non-operative management following abdominal stab wounds is possible in selected patients who are both hemodynamically stable and do not have signs of peritonitis. However, the rate of failure of non-operative management is higher in Israel than in western countries.

Objectives: To assess the patterns of injury following abdominal stabbing.

Methods: Data from the Israeli Trauma Registry were used to identify all patients with abdominal stab injury admitted to eight different trauma centers between 1997 and 2004.

Results: The number of patients admitted per year more than doubled between 1997 and 2004, from 257 to 599. The percentage of patients with severe injury (Index Severity Score ≥ 16) increased from 9.4% to 19.0%. The incidence of multiple stab injuries almost doubled, from 37% to 62%.

Conclusions: Review of the data in the Israeli Trauma Registry indicates an increase in both absolute rate and relative incidence of serious stab injuries. This indicates that patterns of injury following stab wounds are not necessarily similar, not even within the same geographical area over time.
 

January 2008
Y. Shoenfeld, B. Gilburd, M. Abu-Shakra, H. Amital, O. Barzilai, Y. Berkun, M. Blank, G. Zandman-Goddard, U. Katz, I. Krause, P. Langevitz, Y. Levy, H. Orbach, V. Pordeus, M. Ram, Y. Sherer, E. Toubi and Y. Tomer
Y. Shoenfeld, G. Zandman-Goddard, L. Stojanovich, M. Cutolo, H. Amital, Y. Levy, M. Abu-Shakra, O. Barzilai, Y. Berkun, M. Blank, J.F. de Carvalho, A. Doria, B. Gilburd, U. Katz, I. Krause, P. Langevitz, H. Orbach, V. Pordeus, M. Ram, E. Toubi and Y. Sherer
Y. Shoenfeld, M. Blank, M. Abu-Shakra, H. Amital, O. Barzilai, Y. Berkun, N. Bizzaro, B. Gilburd, G. Zandman-Goddard, U. Katz, I. Krause, P. Langevitz, I.R. Mackay, H. Orbach, M. Ram, Y. Sherer, E. Toubi and M.E. Gershwin
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