Experimental and clinical evaluation of a new synthetic, absorbable sealant to reduce air leaks in thoracic operations.

BACKGROUND: Air leaks after pulmonary resections may contribute to increased patient morbidity, delayed removal of chest drainage tubes, and prolonged hospitalization. OBJECTIVE: The purpose of this study was to investigate the effects of a new synthetic, absorbable sealant on the healing of healthy bronchial and lung tissues (experimental study) and its safety and efficacy to stop air leaks after lung resection (clinical study). METHODS: Fifteen large white pigs underwent a left upper lobectomy. All parenchymal surgical sites were sealed; the bronchial stump was either stapled, sealed, or both (n = 5 each). In the clinical study, 26 consecutive patients were prospectively randomized, intraoperatively, to standard closure of parenchymal surgical sites with (n = 15) or without (n = 11) the sealant. RESULTS: In the experimental study, no postoperative air leaks occurred, with intact bronchial closures and normal tissues at death. In the clinical study, 100% of intraoperative leaks were sealed versus 18% of control patients (P =.001). Although 77% (n = 10) of treated patients remained leak-free from the end of the operation to chest tube removal versus 9% (n = 1) of control patients (P =.001), there was no statistical difference in the duration of postoperative chest tube time, hospital stay, or cost. There were no acute or late undesirable side-effects related to the sealant application. CONCLUSIONS: The surgical adhesive investigated here demonstrated a compelling safety profile and significant clinical efficacy to stop air leaks after lung resections.

Systolic blood pressure trends in US adults between 1960 and 1980: influence of antihypertensive drug therapy.

Recent blood pressure trends reflect progress in hypertension control, but prevalent drug therapy precludes direct estimation of the component due to primary prevention. In data gathered on persons aged 35-74 years in three successive US health examination surveys (1960-1980), systolic blood pressure levels assuming no drug therapy were imputed by reassigning blood pressure to the upper end of the distribution for respondents reporting use of antihypertensive medication. Blood pressure was partitioned into four ordinal categories based on weighted percentiles of the 1960-1962 distributions for 35- to 44-year-old males and females who reported no use of antihypertensive medication. Cumulative logit models (alpha = 0.01) were used to estimate age- and sex-specific trends for blacks and whites within two strata (<25 or > or =25) of body mass index (BMI) (weight (kg)/height (m)2). Before imputation, systolic blood pressure decreased between 1960 and 1980; after imputation, significant decreases remained only in 35- to 44-year-olds. Strong associations of black race and BMI > or =25 with higher blood pressures were present in models with and without drug therapy. Thus, according to the models, there has been little progress in decreasing racial or BMI-related blood pressure differentials. Above the age of 44 years, blood pressure trends were largely attributable to medication use. In contrast, data for 35- to 44-year-olds suggest progress in primary prevention.

Viral load and disease progression in infants infected with human immunodeficiency virus type 1. Women and Infants Transmission Study Group.

BACKGROUND: There are only limited data on human immunodeficiency virus type 1 (HIV-1) RNA in perinatally infected infants. Understanding the dynamics of HIV-1 infection and its relation to disease progression may help identify opportunities for effective antiviral treatment in infected infants. METHODS: We obtained plasma samples from 106 HIV-infected infants at birth; at 1, 2, 4, 6, 9, 12, 15, and 18 months of age; and subsequently every 6 months. HIV-1 RNA was assayed by means of a reverse-transcription polymerase chain reaction. The infants were born between 1990 and 1993, and only 21 percent of the infants' mothers received any treatment with zidovudine during pregnancy. RESULTS: Plasma HIV-1 RNA levels increased rapidly after birth, peaked at 1 to 2 months of age (median values at 1 and 2 months, 318,000 and 256,000 copies per milliliter, respectively), and then slowly declined to a median of 34,000 copies per milliliter at 24 months. Newborns with a first positive HIV-1 culture within 48 hours after birth had significantly higher HIV-1 RNA levels, although only during the first two months of life, than those with a first positive culture seven or more days after birth. Infants with a rapid progression of disease had higher peak HIV-1 RNA levels in the first two months of life than those without rapid progression (median value, 724,000 vs. 219,000 copies per milliliter; P=0.006), as well as a higher geometric mean value during the first year of life (median value, 330,000 vs. 158,000 copies per milliliter, P=0.001). CONCLUSIONS: In perinatally infected infants, HIV-1 RNA levels are high and decline only slowly during the first two years of life. Infants with very high viral loads in the first months of life are at increased risk for a rapid progression of disease, which suggests that early treatment with antiretroviral agents may be indicated for these infants.

Subject-caregiver response comparability on global health and functional status measures for African American, Puerto Rican, and Caucasian elders and their primary caregivers.

Ethnic differences in response comparability and bias were evaluated for elderly African American, Puerto Rican, and non-Hispanic Caucasian elderly subjects with some degree of disability and their caregivers. Responses were compared for items assessing basic and instrumental activities of daily living, memory problems, confusion, and global health status. In general, for all ethnic groups, response comparability, based on kappa, was only poor to fair, with the lowest agreement found for items assessing memory problems and confusion. When disagreements occurred, caregivers tended to overestimate impairment relative to the elderly subjects, regardless of ethnicity. However, there were very few significant differences between the response patterns of the caregivers of these different ethnic groups. Thus, although three may be bias in the responses of caregivers relative to elderly persons, in general further bias is not introduced by ethnic differences in comparability of caregiver responses for elders with some degree of disability.