[BRIDGE registry (safety and efficacy registry Bx Cyper stent in the RevascularIzation of patients with siGnificative risk of rEstenosis): protocol description and preliminary results].
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BACKGROUND: Adrenal cortical carcinoma is an uncommon tumor with a poor prognosis. The low incidence of this tumor makes it difficult to achieve reliable data on clinical manifestations, natural history, and the impact of therapies. The purpose of this study was to evaluate such aspects in a large series. METHODS: A retrospective series of 129 cases (55 men and 74 women, mean age of 49 years) was collected from 18 surgical institutions. At the time of diagnosis 45.7% of patients had endocrine symptoms. One hundred twenty-four patients underwent surgery, which was considered curative in 91 cases and palliative in 33. Sixty-three patients had local disease, 48 had regional disease, and 43 had distant metastases. RESULTS: This study confirmed a higher incidence in the 40- to 50-year-old population with a female prevalence; hormonal hyperincretion was more common in women, but it was not caused by advanced disease. The overall 5-year survival rate was 35%. Tumor stage and curative resection affected prognosis significantly. The influence of gender, side, age, and hormonal function has not been confirmed. Adjuvant therapies were ineffective in prolonging survival. Reoperated patients experienced better survival (mean, 41.5 months) than nonreoperated cases (mean, 15.6 months). CONCLUSIONS: The poor prognosis of adrenal cortical carcinoma may be improved by early diagnosis and complete resection. Radical surgery is the sole effective therapy, particularly in early stages. Surgical treatment of recurrence seems to improve survival and should be attempted systematically. Adjuvant therapies obtained contrasting results, and their role should be evaluated in prospective multicentric trials.
BACKGROUND AND OBJECTIVES: Regional registers of patients with acute myocardial infarction are scarce in Spain. The PRIMVAC register (Proyecto de Registro de Infarto agudo de Miocardio de Valencia, Alicante y Castellón) was initiated to obtain updated information on the management of these patients in the Valencia Autonomous Community. Data of the first twelve months of the register are presented. METHODS: The 17 participating hospitals cover 2,833,938 inhabitants. Demographic, clinical, procedural and outcome data as well as predictive variables of mortality were analysed in the patients with acute myocardial infarction during their stay in the coronary care units from 1 December 1994 to 30 November 1995. RESULTS: During 12 months, 2,377 patients were included. Mean age was 65.3 years (SD 11.9) and 23.2% were female. Left ventricular failure was present in 39.8%. Thrombolytic therapy was applied in 42.1% with a median time delay of 195 min from chest pain onset. This time was longer in the women (250 min) and in the elderly (210 min). The in-coronary-care-unit-mortality rate was 13.9%. Age, female gender, diabetes, previous myocardial infarction, Q wave and right ventricular infarction independently predicted increased early mortality. CONCLUSION: Present data show the feasibility of an acute myocardial infarction register in the Valencia Autonomous Community. Although an acceptable level of thrombolysis has been reached, the mortality rate is still high. The long delay in initiating thrombolysis, particularly in female and elderly patients is remarkable.
OBJECTIVE: The goal of this paper is to identify in the field of mechanical support as bridge to transplant, by statistical analysis, variables influencing survival during support (transplanted patients) and the overall survival (discharged after transplant). METHODS: Clinical factors are analysed in 258 patients in the period 1986-1993. All variables were analyzed by a univariate and multivariate analysis. RESULTS: The indications for mechanically circulatory support were hemodynamic deterioration before transplantation in 177 (69%), post acute myocardial infarction in 40 (15%), postcardiotomy cardiogenic shock in 20 (8%), graft failure in 12 (5%) and cardiac rejection 9 (3%). The devices implanted have been: pneumatic VAD in 145 cases (56%), electromechanical LVAS in 15 cases (6%), TAH in 78 cases (30%) and centrifugal pumps in 20 cases (8%). The patients were supported for period ranging from 2 h to 623 days (mean 18.3 days +/- 43.2). The type of support was: LVAD 50 cases (20%), RVAD 3 cases (1%), BVAD 127 cases (49%), and TAH 78 cases (30%). Bleeding occurred in 84 patients (32.5%), infections in 83 patients (32.1%); 21 embolic complications were reported in 16 patients (6%). Renal failure occurred in 64 cases (25%) requiring dialysis in 33 (13%); respiratory failure in 47 cases (18%); neurological impairment was noted in 22 patients (9%). One hundred-sixty patients were transplanted (62%) and 104 ultimately discharged (40% out of total 258 patients and 65% out of 160 transplanted patients). Among postoperative parameters, renal failure, TAH, neurological impairment and infection shown statistical power. Some pre- and post-operative variables were identified as independent risk factors for overall mortality: age, indication for graft failure, all indications different from cardiomyopathy, neurological impairment, renal insufficiency, infection, bleeding and any type of support different from LVAD. The improvement in the success rate in the last 2 years is statistically significant (P = 0.0282) considering both the percentage of transplanted patients and of discharged patients. CONCLUSIONS: The results are encouraging if mechanical support is performed in patients with deterioration while awaiting transplant, when LVAD is feasible and effective, when an ideal timing of transplant during support period is identified.
To evaluate the outcomes of unrelated bone marrow transplantation facilitated by TCTMDR, we focused on 48 marrow transplants performed in Taiwan during the period May 1994 to June 1997. Follow-up of these 48 cases was made up to 30 May 1998. The average length of follow-up was 328 days (range 7-1385 days). All the donor/recipient pairs were HLA-A, B and DR matched and were divided into two risk groups based on diagnosis and stage of disease. There were 24 standard risk and 24 high risk patients. Engraftment occurred in 40 patients (83.3%). Acute and chronic GVHD was observed in 80% of evaluable patients and accounts for 41% of deaths. The second leading cause of death was infection, accounting for 35% of deaths. The overall probability of survival for the 48 patients after BMT over 2 years was 33.3% (95% CI 19.67-46.32%). The probability of survival for standard risk and high risk groups was 54% and 8%, respectively. In multivariate analysis, patients who were younger, in the standard risk group, or with a shorter search interval showed a higher survival probability.
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PURPOSE OF STUDY: In recent years, a progressive increase in the need of renal replacement therapy has been noted for patients with diabetes mellitus. The present report is based on an analysis of the data of the 'Registre de Malats Renals de Catalunya' (RMRC). It was the aim to identify (i) the incidence and prevalence of diabetic patients on renal replacement therapy, (ii) associated diseases, (iii) the relative risk of different modes of treatment, and (iv) the rate of death compared to non-diabetic patients on renal replacement therapy and in the general population. RESULTS: Of the 936 diabetic patients starting renal replacement therapy during the period 1984-1994, 24.8% were classified as DN and IDDM, 65.7% as DN and NIDDM, and in 9.5%, diabetes accompanied renal failure from standard primary renal disease. The incidence of diabetic patients has increased from 3 per million population (pmp) in 1984 to 26.6 pmp in 1994. At any given age the risk of requiring renal replacement therapy with diabetes was 1.5-fold higher in males than in females. Of diabetic patients who were < 45 years of age, 55% received a renal transplant and > 50% lived with a simultaneous kidney/pancreas graft. For diabetic patients above this age, haemodialysis was the most prevalent form of treatment. Morbidity in diabetic patients was higher than in the overall RMRC population. Cardiac and vascular disease were the most prominent complications. Mortality of diabetic patients on renal replacement therapy was twice that of the overall population of RMRC and 16-fold higher than in the general population of Catalunya. The risk of death increased with age and was higher in patients with reduced functional autonomy. Transplanted patients had a smaller risk than patients on haemodialysis or CAPD. Survival has increased for patients starting treatment after 1990 compared to the period 1984-1989. CONCLUSION: In conclusion, diabetes mellitus is one of the main causes leading to renal replacement therapy in Catalunya. Diabetic patients are more multimorbid than the rest of the population of the Registre de Malats Renals de Catalunya. These observations call for the institution of primary or secondary prevention.
The usefulness of a clinical database depends strongly on the quality of the collected data. Data quality assurance should start with deciding in advance the uses to which the database is going to be put, developing an explicitly defined minimum data set, and setting up a user-friendly interface. The quality of the collected data can be assessed by computer validation, during which computerized range and consistency checks are based on information within the database itself. Also, note validation can be used, which implies a comparison of the original database against medical records. A number of related methodological issues are discussed in this article.
BACKGROUND: Cardiogenic shock remains the leading cause of death of patients hospitalized with acute myocardial infarction (MI). This study was conducted to examine (1) the current spectrum of cardiogenic shock, (2) the proportion of patients who are potential candidates for a trial of early revascularization, and (3) the apparent impact of early revascularization on mortality. METHODS AND RESULTS: Nineteen participating centers in the United States and Belgium prospectively registered all patients diagnosed with cardiogenic shock. Two hundred fifty-one patients were registered. The mean age was 67.5 +/- 11.7 years, and 43% were women. Acute mitral regurgitation or ventricular septal rupture was the cause of shock in 8%. Concurrent conditions contributing to the development of shock were noted in 5%, and 2% had isolated right ventricular shock. Among the remaining 214 patients, nonspecific findings on the ECG associated with "nontransmural" MI were seen in 14%. The median time to shock diagnosis after MI was 8 hours. The overall in-hospital mortality was 66%. Patients clinically selected to undergo cardiac catheterization were significantly younger and had a lower mortality than those not selected (51% versus 85%, P < .0001) even if they were not revascularized (58%). Mortality for patients undergoing percutaneous transluminal coronary angioplasty (PTCA) was 60% (n = 55) and 19% (n = 16) for coronary artery bypass graft surgery (CABG). Sixty percent (n = 150) of registered patients were judged eligible for a trial of early revascularization. Trial-eligible patients were significantly younger (65.4 +/- 11.0 versus 70.6 +/- 11.9 years, P < .001), had an earlier median time to shock onset after MI (6.5 versus 17.5 hours, P = .003), and had lower mortality (62% versus 73%, P = .077) than ineligible patients. CONCLUSIONS: Patients diagnosed with cardiogenic shock complicating acute MI are a heterogeneous group. Those eligible for a trial of early revascularization tended to have lower mortality. Patients selected to undergo cardiac catheterization had lower mortality whether or not they were revascularized. Emergent PTCA and CABG are promising treatment modalities for cardiogenic shock, but biased case selection for treatment may confound the data. Whether PTCA and CABG reduce mortality and which patient subgroups benefit most remain to be determined in a randomized clinical trial.
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