Association between an elevated inter-arm systolic blood pressure difference, the ankle-brachial index, and mortality in patients with diabetes mellitus / Asociación entre una diferencia elevada de presión arterial sistólica entre brazos, el índice tobillo-brazo y la mortalidad en pacientes con diabetes mellitus

OBJECTIVES: To estimate the prevalence of an inter-arm blood pressure difference greater than 10mmHg in patients with type 2 diabetes, and the association of this measurement with the presence of a low ankle-brachial index and mortality at 5-year follow-up. METHOD: A validated blood pressure measurement protocol was used. The blood pressure was calculated for each arm to obtain mean systolic differences. Peripheral arterial disease was confirmed by an ankle-arm index less than 0.9. The medical history of the patient was reviewed in the computerized clinical notes after 5 years of follow-up. RESULTS: The study included 139 patients with a mean age of 70.1 years (49% male), and a mean duration of diabetes mellitus of 10.8 years. A total of 50 (36%) patients had an inter-arm systolic blood pressure difference greater than 10mmHg. Patients with an inter-arm systolic blood pressure greater than 10 mmHg had lower ankle-arm index (0.91 ± 0.30 vs. 1.04 ± 0.28, P = 0.005), and higher mortality rates from all causes (48.0% vs. 28.9%; hazard ratio 1.64; 95% confidence interval: 1.06-2.53; P = 0.03), compared with those with lower inter-arm systolic blood pressure difference. CONCLUSION: A high proportion of patients with type 2 diabetes have an elevated systolic blood pressure difference between arms. A significant relationship was found between elevated inter-arm systolic blood pressure difference, lower ankle-brachial index and greater all-cause mortality

OBJETIVOS: Estimar la prevalencia de una diferencia de presión arterial entre brazos superior a 10mmHg en pacientes con diabetes tipo 2, y su asociación con el índice tobillo-brazo y la mortalidad a los 5 años de seguimiento. MÉTODO: Se utilizó un protocolo validado de medición de presión arterial. La presión sanguínea se calculó para cada brazo para obtener diferencias sistólicas medias. La enfermedad arterial periférica fue confirmada por un índice tobillo-brazo inferior a 0,9. El estado vital del paciente se revisó en la historia clínica electrónica a los 5 años de seguimiento. RESULTADOS: Estudiamos a 139 pacientes con una edad media de 70,1 años (49% hombres) y una duración media de diabetes mellitus de 10,8 años. Un total de 50 (36%) pacientes tenía una diferencia de presión arterial sistólica entre brazos mayor de 10 mmHg. Los pacientes con diferencia elevada de presión arterial sistólica entre los brazos mostraron un menor índice tobillo-brazo (0,91 ± 0,30 vs. 1,04 ± 0,28; P = 0,005), y una mayor tasa de mortalidad por todas las causas (48,0% vs. 28,9%; cociente de riesgo 1,64; intervalo de confianza al 95%: 1,06-2,53; P = 0,03), respecto a los pacientes con menores diferencias de presión sistólica entre brazos. CONCLUSIÓN: Encontramos una alta proporción de pacientes con diabetes tipo 2 que tenían una diferencia elevada de presión arterial sistólica entre los brazos. Existe una asociación significativa entre la diferencia elevada de la presión arterial sistólica entre brazos, el índice tobillo-brazo y mortalidad

Association between an elevated inter-arm systolic blood pressure difference, the ankle-brachial index, and mortality in patients with diabetes mellitus.

OBJECTIVES: To estimate the prevalence of an inter-arm blood pressure difference greater than 10mmHg in patients with type 2 diabetes, and the association of this measurement with the presence of a low ankle-brachial index and mortality at 5-year follow-up. METHOD: A validated blood pressure measurement protocol was used. The blood pressure was calculated for each arm to obtain mean systolic differences. Peripheral arterial disease was confirmed by an ankle-arm index less than 0.9. The medical history of the patient was reviewed in the computerized clinical notes after 5 years of follow-up. RESULTS: The study included 139 patients with a mean age of 70.1 years (49% male), and a mean duration of diabetes mellitus of 10.8 years. A total of 50 (36%) patients had an inter-arm systolic blood pressure difference greater than 10mmHg. Patients with an inter-arm systolic blood pressure greater than 10mmHg had lower ankle-arm index (0.91±0.30 vs. 1.04±0.28, P=0.005), and higher mortality rates from all causes (48.0% vs. 28.9%; hazard ratio 1.64; 95% confidence interval: 1.06-2.53; P=0.03), compared with those with lower inter-arm systolic blood pressure difference. CONCLUSION: A high proportion of patients with type 2 diabetes have an elevated systolic blood pressure difference between arms. A significant relationship was found between elevated inter-arm systolic blood pressure difference, lower ankle-brachial index and greater all-cause mortality.

Evaluación de tres sistemas de determinación rápida de hemoglobina A1c para monitorización del control glucémico en pacientes con diabetes mellitus / Accuracy of three hemoglobin A1c point-of-care systems for glucose monitoring in patients with diabetes mellitus

OBJETIVOS: El uso de sistemas de determinación rápida de HbA1c proporciona resultados inmediatos y reduce inconvenientes para los pacientes. Hemos comparado las características de tres sistemas de diagnóstico rápido de HbA1c respecto al método de referencia constituido por la cromatografía líquida de alta resolución (HPLC). MATERIAL Y MÉTODOS: Preseleccionamos un total de 40 muestras de sangre conservadas en EDTA cuyos valores de HbA1c (media: 6,6% [49 mmol/mol]; rango: 4,6 a 9,9% [27-87 mmol/mol]) habían sido medidos por el método de referencia HA 8160 (Menarini Diagnostics, Akray Factory Inc. Koji, Konan-Cho, Koka Shi, Shiga, Japón). Las alícuotas de estas muestras fueron testadas con los sistemas rápidos Afinion AS100 (Axis-Shield, Oslo, Noruega), DCA Vantage System (Siemens Healthcare Diagnostics Inc. Tarrytown, NY, EE. UU.) e In2it (Bio-Rad Hercules, CA. EE. UU.). Según las recomendaciones del Clinical Laboratory Standards Institute determinamos linealidad (regresión y coeficiente de correlación), sesgo (análisis de Bland-Altman) y coeficiente variación (%).Utilizamos los criterios de aceptabilidad publicados por el National Glycohemoglobin Standardization Program. RESULTADOS: Los coeficientes de correlación fueron 0,98, 0,98 y 0,83 para Afinion AS100, DCA Vantage System e In2it, respectivamente. El intervalo de confianza al 95% del error (sesgo) fue en Afinion AS100 -0,41% y +0,34% (p = 0,22), en DCA Vantage System -0,62% y +0,05% (p = 0,57) y en In2it -1,15% y +1,26% (p < 0,001). El coeficiente de variación intraensayo fue 1,80, 3,74 y 7,14% para Afinion AS100, DCA Vantage System e In2it, respectivamente. CONCLUSIONES: Solo el sistema Afinion AS100 cumplió los 3 requerimientos de aceptabilidad

OBJECTIVES: Use of hemoglobin A1c point-of-care devices in physician offices provides immediate results and reduces inconveniences for the patients. We compared the analytical performances of 3 point-of-care HbA1c analyzers to high pressure liquid chromatography (HPLC). MATERIAL AND METHODS: We preselected a pool of 40 EDTA-preserved whole blood samples from our laboratory with HbA1c results obtained by HPLC (mean 6.6% [49 mmol/mol] and range: 4.6-9.9% [27-87 mmol/mol]). Aliquots of theses samples were tested by Afinion AS100, DCA Vantage and In2it point-of-care systems. According the Clinical Laboratory Standards Institute EP-09 protocol we determined linearity (linear regression and correlation coefficient between point-of-care and reference methods), bias (Bland-Altman analysis) and coefficient of variation (%). We used the acceptability criteria endorsed by the National Glycohemoglobin Standardization Program. RESULTS: The calculated correlation coefficients (r) were 0.98, 0.98 and 0.83 for Afinion AS100, DCA Vantage and In2it systems, respectively. The 95% confidence interval of the error between point-of-care systems and the reference method was -0.41% and +0.34% (p =.22) for Afinion AS100, -0.62% and +0.05% (p=.57) for DCA Vantage, and -1.15% and +1.26% (p < .001) for the In2it. The coefficients of variation for Afinion AS100, DCA Vantage and In2it systems were 1.80, 3.74 and 7.14%, respectively. CONCLUSION: Only the Afinion AS100 point-of-care system met all NGSP performance criteria

Accuracy of three hemoglobin A1c point-of-care systems for glucose monitoring in patients with diabetes mellitus.

OBJECTIVES: Use of hemoglobin A1c point-of-care devices in physician offices provides immediate results and reduces inconveniences for the patients. We compared the analytical performances of 3 point-of-care HbA1c analyzers to high pressure liquid chromatography (HPLC). MATERIAL AND METHODS: We preselected a pool of 40 EDTA-preserved whole blood samples from our laboratory with HbA1c results obtained by HPLC (mean 6.6% [49 mmol/mol] and range: 4.6-9.9% [27-87 mmol/mol]). Aliquots of theses samples were tested by Afinion AS100, DCA Vantage and In2it point-of-care systems. According the Clinical Laboratory Standards Institute EP-09 protocol we determined linearity (linear regression and correlation coefficient between point-of-care and reference methods), bias (Bland-Altman analysis) and coefficient of variation (%). We used the acceptability criteria endorsed by the National Glycohemoglobin Standardization Program. RESULTS: The calculated correlation coefficients (r) were 0.98, 0.98 and 0.83 for Afinion AS100, DCA Vantage and In2it systems, respectively. The 95% confidence interval of the error between point-of-care systems and the reference method was -0.41% and +0.34% (p =.22) for Afinion AS100, -0.62% and +0.05% (p =.57) for DCA Vantage, and -1.15% and +1.26% (p<.001) for the In2it. The coefficients of variation for Afinion AS100, DCA Vantage and In2it systems were 1.80, 3.74 and 7.14%, respectively. CONCLUSION: Only the Afinion AS100 point-of-care system met all NGSP performance criteria.

Infradiagnóstico de enfermedad arterial periférica en pacientes con diabetes mellitus atendidos en consultas de segundo nivel / Underdiagnosis of peripheral arterial disease in patients with diabetes mellitus attending a hospital outpatient clinic

OBJETIVO: Determinar la prevalencia de enfermedad arterial periférica no diagnosticada en pacientes con diabetes mellitus. MÉTODO: Estudio transversal en 360 pacientes con diabetes mellitus, mayores de 50 años de edad, con capacidad para deambular, que fueron atendidos en el departamento de Medicina de nuestro hospital. Se excluyeron pacientes con edema extremo o inflamación en miembros inferiores, presencia de amputación o revascularización o aquellos hemodinámicamente inestables o previamente diagnosticados de enfermedad arterial periférica. Evaluamos el rendimiento diagnóstico del cuestionario de Edimburgo y del examen de pulsos pedios. La presencia de enfermedad arterial periférica se definió por un índice tobillo-brazo medido por Doppler inferior a 0,90. RESULTADOS: La prevalencia de enfermedad arterial periférica fue del 27% (IC95%: 22-32%), siendo en el 16% sintomática y en el 11% asintomática. En 3 grupos de edad considerados 50-60 años, 61-70 años y más de 70 años, la prevalencia de enfermedad arterial periférica fue del 18, 24 y 36%, respectivamente (p < 0,001). No hubo diferencias en la prevalencia de enfermedad arterial periférica entre hombres y mujeres (28 vs. 25%; p = 0,083). El rendimiento diagnóstico conjunto del cuestionario de Edimburgo y la ausencia de algún pulso pedio tuvo una sensibilidad del 77% (IC95%: 68-84%) y una especificidad del 62% (IC95%: 59-65%). CONCLUSIONES: Los pacientes con diabetes mellitus atendidos en el hospital muestran una elevada prevalencia de enfermedad arterial periférica no conocida. El bajo rendimiento del cuestionario de Edimburgo y de la exploración del pulso pedio justifican realizar rutinariamente el índice tobillo-brazo

OBJECTIVE: To determine the prevalence of undiagnosed peripheral arterial disease in patients with diabetes mellitus. METHOD: We conducted a cross-sectional study on 360 patients > 50 years of age with diabetes mellitus, who were able to walk and be treated at our Department of Medicine. We excluded patients with severe oedema or swelling in the lower limbs, amputation or revascularization procedures, and those who were hemodynamically unstable or previously diagnosed with peripheral arterial disease. We evaluated the diagnostic performance of the Edinburgh questionnaire, and the absence of dorsalis pedis pulses. Peripheral arterial disease was defined by an ankle-brachial index measured by Doppler of less than 0.90. RESULTS: The prevalence of peripheral arterial disease was 27% (95% CI: 22%-32%), distributed into 16% symptomatic peripheral arterial disease and 11% asymptomatic peripheral arterial disease. The prevalence of peripheral arterial disease in the three age strata, 50-60 years, 61-70 years, and over 70 years was 18%, 24% and 36%, respectively (P < 0.001). There was no difference in the prevalence of peripheral arterial disease between men and women (28% vs. 25%, P = 0.083). The overall diagnostic yield of the Edinburgh questionnaire and the dorsalis pedis pulses examination had a sensitivity of 77% (95% CI: 68%-84%) and a specificity of 62% (95% CI: 59%-65%) CONCLUSIONS: Patients with diabetes mellitus treated at the hospital showed a high prevalence of undiagnosed peripheral arterial disease. The low diagnostic performance of the Edinburgh questionnaire and dorsalis pedis pulse examination justifies the implementation of the anklebrachial index routinely

Accuracy of ankle-brachial index obtained by automated blood pressure measuring devices in patients with diabetes mellitus.

BACKGROUND: Upper arm automated blood pressure devices are widely available and could be used to estimate the ankle-brachial index. METHODS: We conducted a trial to determine the equivalence of ankle-brachial index estimated by an upper arm blood pressure measuring device as index method compared to the handheld Doppler method as the reference standard. A total of 110 patients with diabetes mellitus were sequentially examined by two methods. RESULTS: The prevalence of peripheral arterial disease was 32%. The index method obtained valid measurements in 104 (95%) patients. Ankle-brachial index was lower with the index method compared to the reference standard (mean difference: -0.05; 95% confidence interval [CI]: -0.50 to 0.39). This confidence interval was above the boundaries clinically established as equivalence margins in our study. The kappa agreement between two methods was 0.45. The performance of the index method was: sensitivity: 67%; specificity: 87%; positive likelihood ratio: 5.25; negative likelihood ratio: 0.18; positive predictive value: 71%; negative predictive value: 85%; and the area under the receiving operating characteristic curve: 0.87 (95% CI: 0.78-0.93). CONCLUSION: Upper arm automated blood pressure measuring devices cannot replace the handheld Doppler method to estimate the ankle-brachial index in patients with diabetes mellitus.