Transesophageal Echocardiography in Patients Undergoing Elective Coronary Artery Bypass Surgery

Transesophageal echocardiography (TEE) has become a useful tool in monitoring the heart in patients during open-heart surgery. This study was undertaken to evaluate whether it is feasible to use TEE to assess left ventricular myocardial viability in anesthetized patients scheduled for coronary artery bypass grafting (CABG). A total of 84 patients were studied. To test myocardial viability, TEE and a low-dose dobutamine stress regimen were used. Echocardiographic data were analyzed off-line using a visual or semiautomatic analysis of segmental left ventricular wall motion (LVWM). Visual assessment was performed by readers blinded to the sequence of events. The agreement between readers in visual analysis of segmental LVWM in the transgastric short-axis view was 73% or higher. Segmental LVWM assessed by TEE was compared to hemodynamic data obtained by thermodilution pulmonary artery catheter (PAC) and coronary angiographic data. Also, using the same low-dose dobutamine stress regimen, TEE findings in the anesthetized patient perioperatively were compared with preoperative transthoracic echocardiography (TTE) findings in the awake patient. TEE was found to be feasible and adequate for testing left segmental ventricular viability. A concomitant increase in stroke volume assessed by PAC and decrease in LVWM-score assessed by TEE was found with dobutamine stimulation. Abnormal segmental LVWM corresponded to angiographically stenosed supplying coronary artery vessels. During dobutamine stimulation, 69% of the corresponding segments responded which is a sign of viability. The LVWM response to preoperative TTE and perioperative TEE dobutamine stress was comparable except for a significant difference in the apical segments. This study showed that perioperative TEE dobutamine stress could be used to test left ventricular viability and was also a valuable supplement to PAC, angiography and TTE. The acquired knowledge is important and suggest that further development of transesophageal ultrasound technology is warranted

Recombinant Bile Salt-Stimulated Lipase in Preterm Infant Feeding : A Randomized Phase 3 Study

Introduction Feeding strategies are critical for healthy growth in preterm infants. Bile salt-stimulated lipase (BSSL), present in human milk, is important for fat digestion and absorption but is inactivated during pasteurization and absent in formula. This study evaluated if recombinant human BSSL (rhBSSL) improves growth in preterm infants when added to formula or pasteurized breast milk. Patients and Methods LAIF (Lipase Added to Infant Feeding) was a randomized, double-blind, placebo-controlled phase 3 study in infants born before 32 weeks of gestation. The primary efficacy variable was growth velocity (g/kg/day) during 4 weeks intervention. Follow-up visits were at 3 and 12 months. The study was performed at 54 centers in 10 European countries. Results In total 415 patients were randomized (rhBSSL n = 207, placebo n = 208), 410 patients were analyzed (rhBSSL n = 206, placebo n = 204) and 365 patients were followed until 12 months. Overall, there was no significantly improved growth velocity during rhBSSL treatment compared to placebo (16.77 vs. 16.56 g/kg/day, estimated difference 0.21 g/kg/day, 95% CI [-0.40; 0.83]), nor were secondary endpoints met. However, in a predefined subgroup, small for gestational age infants, there was a significant effect on growth in favor of rhBSSL during treatment. The incidence of adverse events was higher in the rhBSSL group during treatment. Conclusions Although this study did not meet its primary endpoint, except in a subgroup of infants small for gestational age, and there was an imbalance in short-term safety, these data provide insights in nutrition, growth and development in preterm infants

Treatment with rhBSSL improves growth in SGA infants during the 4 week treatment period.

<p>A) Growth velocity during intervention for SGA/AGA-infants. Asterisk indicates significance for SGA infants; LS mean difference (rhBSSL-placebo) of 1.95 (95% CI; 0.38, 3.52) and no significance for AGA infants; LS mean difference of -0.10 (95% CI; (-0.76, 0.57). B) Infants with a growth <15g/kg/day, odds ratio (95% CI) 0.321 (0.098, 1.045), p = 0.0592. C) Feeding utilization (LS mean rhBSSL: 120.36 g/L, LS mean placebo: 107.68 g/L). LS mean difference (95% CI): 12.68 (0.94, 24.42), p = 0.0347.</p

Treatment with rhBSSL does not improve growth in preterm infants.

<p>A) Growth velocity during intervention (rhBSSL; N = 206, placebo; N = 204). CI; confidence interval, LS mean; least square mean. B) Body weight at baseline, 4 weeks, 3 months, and 12 months adjusted age. Box plot illustrating median and Q1/Q3. Whiskers extend to lowest/highest value within 1.5 interquartile range from Q1/Q3 and outliers are indicated. C) Body length and head circumference; change from baseline at 4 weeks. D) Growth restriction during intervention.</p

Adverse events during the study period (safety population^a).

<p>Adverse events during the study period (safety population<a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0156071#t002fn001" target="_blank">^a</a>).</p

CONSORT flow diagram of randomized patients.

<p>AE; adverse event.</p

Adverse events associated with gastrointestinal intolerability and necrotizing enterocolitis during the 4 week treatment period (safety population^a).

<p>Adverse events associated with gastrointestinal intolerability and necrotizing enterocolitis during the 4 week treatment period (safety population<a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0156071#t003fn001" target="_blank">^a</a>).</p

Clinical study design and number of patients.

<p>A) The LAIF study design. The asterisk indicates a visit specific for ADA positive infants at 3 months. B) Number of randomized patients.</p

Withheld enteral feeding for at least 24 hours (safety population^a).

<p>Withheld enteral feeding for at least 24 hours (safety population<a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0156071#t004fn001" target="_blank">^a</a>).</p