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The objective of this study is to compare hemodynamic performances under different pulsatile control algorithms between Medos DeltaStream DP3 and i-cor diagonal pumps in simulated pediatric and adult ECLS systems. An additional pilot study was designed to test hemolysis using two pumps during 12h-ECLS. The experimental circuit consisted of parallel combined pediatric and adult ECLS circuits using an i-cor pump head and either an i-cor console or Medos DeltaStream MDC console, a Medos Hilite 2400 LT oxygenator for the pediatric ECLS circuit, and a Medos Hilite 7000 LT oxygenator for the adult ECLS circuit. The circuit was primed with lactated Ringer's solution and human packed red blood cells (hematocrit 40%). Trials were conducted at various flow rates (pediatric circuit: 0.5 and 1L/min; adult circuit: 2 and 4L/min) under nonpulsatile and pulsatile modes (pulsatile amplitude: 1000-5000rpm [1000 rpm increments] for i-cor pump, 500-2500rpm [500 rpm increments] for Medos pump) at 36°C. In an additional protocol, fresh whole blood was used to test hemolysis under nonpulsatile and pulsatile modes using the two pump systems in adult ECLS circuits. Under pulsatile mode, energy equivalent pressures (EEP) were always greater than mean pressures for the two systems. Total hemodynamic energy (THE) and surplus hemodynamic energy (SHE) levels delivered to the patient increased with increasing pulsatile amplitude and decreased with increasing flow rate. The i-cor pump outperformed at low flow rates, but the Medos pump performed superiorly at high flow rates. There was no significant difference between two pumps in percentage of THE loss. The plasma free hemoglobin level was always higher in the Medos DP3 pulsatile group at 4 L/min compared to others. Pulsatile control algorithms of Medos and i-cor consoles had great effects on pulsatility. Although high pulsatile amplitudes delivered higher levels of hemodynamic energy to the patient, the high rotational speeds increased the risk of hemolysis. Use of proper pulsatile amplitude settings and intermittent pulsatile mode are suggested to achieve better pulsatility and decrease the risk of hemolysis. Further optimized pulsatile control algorithms are needed.

Our hypothesis was that newborns of obese mothers would be more likely to be classified as small for gestational age (SGA) by their customized growth curves than by the standard growth curves when compared to newborns of normal-weight mothers.This is a retrospective cohort of primiparous patients delivering between 1 July 2008 and 30 June 2012. Normal-weight was defined as BMI ≤25 kg/m(2) and obese as BMI ≥ 30 kg/m(2). Infant birth-weight was characterized as SGA or non-SGA from the Lubchenco curve, the Fenton Preterm Growth Chart, and the customized growth curve.Infants were more likely to be classified as SGA on the customized curve compared with Lubchenco curve. Odds ratio was 2.8 (CI: 1.7-4.4; p = 0.001) for obese women and was 2.9 (CI: 1.7-5.1; p 0.001) for normal-weight women. Infants were also more likely to be classified as SGA based on the customized curve compared with the Fenton Preterm Growth Curve. The odds ratio was 2.3 (CI: 1.4-3.8; p = 0.001) for obese women and was 1.5 (CI: 1.01-2.33; p = 0.04) for normal-weight women.Population-based curves may mask SGA in obese women. Our study demonstrates that customized growth curves identify more SGA than population-based growth curves in obese and normal-weight women.

The Capiox RX25 and Quadrox-i Adult oxygenators are commonly used in clinical adult cardiopulmonary bypass circuits. This study was designed to test the effectiveness of two adult oxygenators in order to evaluate gaseous microemboli (GME) trapping capability and hemodynamic performance. A simulated adult CPB circuit was used and primed with Ringer's lactate and packed red blood cells (hematocrit 25%). All trials were conducted at flow rates of 2-5 L/min (1 L/min increments) with a closed and open arterial filter purge line at 35°C. The postcannula pressure was maintained at 100 mm Hg. After a 5 cc of bolus air was introduced into the venous line, an Emboli Detection and Classification system was used to detect and classify GME at the preoxygenator, postoxygenator, and precannula sites. At the same time, real-time pressure and flow data were recorded, and hemodynamic energy was calculated using a custom-made data acquisition system and Labview software. Our results showed that the oxygenator pressure drops of Quadrox-i Adult oxygenator were lower than Capiox RX25 at all flow rates. The Quadrox-i Adult oxygenator retained more hemodynamic energy across the oxygenator. Both oxygenators could trap the majority of GME, but Capiox RX25 did better than the Quadrox-i Adult oxygenator. No GME was delivered to the pseudo patient at all flow rates in the Capiox group. The Capiox RX25 venous reservoir could capture more GME at lower flow rates, while the Quadrox-i Adult venous reservoir performed better at higher flow rates. An open arterial filter purge line reduced GME slightly in the Capiox group, but GME increased in the Quadrox group. The Quadrox-i Adult oxygenator is a low-resistance, high-compliance oxygenator. The GME handling ability of Capiox RX25 performed well under our clinical setting. Further optimized design for the venous/cardiotomy reservoir is needed.

The objective of this study was to evaluate five small-bore arterial cannulae (6Fr and 8Fr) in terms of pressure drop and hemodynamic performance in simulated neonatal cardiopulmonary bypass (CPB) circuits. The experimental circuits consisted of a Jostra HL-20 roller pump, a Terumo Capiox Baby FX05 oxygenator with integrated arterial filter, an arterial and a venous tubing (1/4, 3/16, or 1/8 in × 150 cm), and an arterial cannula (Medtronic Bio-Medicus 6Fr and 8Fr, Maquet 6Fr and 8Fr, or RMI Edwards 8Fr). The circuit was primed using lactated Ringer's solution and heparinized packed human red blood cells (hematocrit 30%). Trials were conducted at different flow rates (6Fr: 200-400 mL/min; 8Fr: 200-600 mL/min) and temperatures (35 and 28°C). Flow and pressure data were collected using a custom-based data acquisition system. Higher circuit pressure, circuit pressure drop, and hemodynamic energy loss across the circuit were recorded when using small-bore arterial cannula and small inner diameter arterial tubing in a neonatal CPB circuit. The maximum preoxygenator pressures reached 449.7 ± 1.0 mm Hg (Maquet 6Fr at 400 mL/min), and 395.7 ± 0.4 mm Hg (DLP 8Fr at 600 mL/min) when using 1/8 in ID arterial tubing at 28°C. Hypothermia further increased circuit pressure drop and hemodynamic energy loss. Compared with the others, the RMI 8Fr arterial cannula had significantly lower pressure drop and energy loss. Maquet 6Fr arterial cannula had a greater pressure drop than the DLP 6Fr. A small-bore arterial cannula and arterial tubing created high circuit pressure drop and hemodynamic energy loss. Appropriate arterial cannula and arterial tubing should be considered to match the expected flow rate. Larger cannula and tubing are recommended for neonatal CPB. Low-resistance neonatal arterial cannulae need to be developed.

Restoration of joint stability during total shoulder arthroplasty can be challenging in the face of severe glenoid retroversion. A novel technique of humeral head component anterior-offsetting has been proposed to address posterior instability. We evaluated the biomechanical benefits of this technique in cadaveric specimens. Total shoulder arthroplasty was performed in 14 cadaveric shoulders from 7 donors. Complementary shoulders were assigned to either 10° or 20° glenoid retroversion, with retroversion created by eccentric reaming. Two humeral head component offset positions were tested in each specimen: The anatomic (posterior) and anterior (reverse). With loads applied to the rotator cuff and deltoid, joint contact pressures and the force and energy required for posterior humeral head translation were measured. The force and energy required to displace the humeral head posteriorly increased significantly with the anterior offset position compared to the anatomic offset position. The joint contact pressures were significantly shifted anteriorly, and the joint contact area significantly increased with the anterior offset position. Anterior offsetting of the humeral head component increased the resistance to posterior humeral head translation, shifted joint contact pressures anteriorly, and increased joint contact area, thus, potentially increasing the joint stability in total shoulder arthroplasty with simulated glenoid retroversion.

The objectives of this study were to investigate the relationship between revolution speed of a conventional centrifugal pump and negative pressure at the inlet of the pump by clamping the tubing upstream of the pump, and to verify whether negative pressure leads to gaseous microemboli (GME) production in a simulated adult extracorporeal life support (ECLS) system. The experimental circuit, including a Maquet Rotaflow centrifugal pump and a Medos Hilite 7000 LT polymethyl-pentene membrane oxygenator, was primed with packed red blood cells (hematocrit 35%). Negative pressure was created in the circuit by clamping the tubing upstream of the pump for 10 s, and then releasing the clamp. An emboli detection and classification quantifier was used to record GME volume and count at pre-oxygenator and post-oxygenator sites, and pressure and flow rate data were collected using a custom-based data acquisition system. All trials were conducted at 36°C at revolution speeds of 2000-4000 rpm (500 rpm increment). The flow rates were 1092.5-4708.4 mL/min at the revolution speeds of 2000-4000 rpm. Higher revolution speed generated higher negative pressure at the pre-pump site when clamping the tubing upstream of the pump (-108.3 ± 0.1 to -462.0 ± 0.5 mm Hg at 2000-4000 rpm). Moreover, higher negative pressure was associated with a larger number and volume of GME at pre-oxygenator site after de-clamp (GME count 10,573 ± 271 at pre-oxygenator site at 4000 rpm). The results showed that there was a potential danger of delivering GME to the patient when clamping pre-pump tubing during ECLS using a centrifugal pump. Our results warrant further clinical studies to investigate this phenomenon.

The objective of this study was to compare the systemic inflammatory response and hemolytic characteristics of a conventional roller pump (HL20-NP) and an alternative diagonal pump with nonpulsatile (DP3-NP) and pulsatile mode (DP3-P) in simulated neonatal extracorporeal life support (ECLS) systems. The experimental neonatal ECLS circuits consist of a conventional Jostra HL20 roller pump or an alternative Medos DP3 diagonal pump, and Medos Hilite 800 LT hollow-fiber oxygenator with diffusion membrane. Eighteen sterile circuits were primed with freshly donated whole blood and divided into three groups: conventional HL20 with nonpulsatile flow (HL20-NP), DP3 with nonpulsatile flow (DP3-NP), and DP3 with pulsatile flow (DP3-P). All trials were conducted for durations of 12 h at a flow rate of 500 mL/min at 36°C. Simultaneous blood flow and pressure waveforms were recorded. Blood samples were collected to measure plasma-free hemoglobin (PFH), human tumor necrosis factor-alpha, interleukin-6 (IL-6), and IL-8, in addition to the routine blood gas, lactate dehydrogenase, and lactic acid levels. HL20-NP group had the highest PFH levels (mean ± standard error of the mean) after a 12-h ECLS run, but the difference among groups did not reach statistical significance (HL20-NP group: 907.6 ± 253.1 mg/L, DP3-NP group: 343.7 ± 163.2 mg/L, and DP3-P group: 407.6 ± 156.6 mg/L, P = 0.06). Although there were similar trends but no statistical differences for the levels of proinflammatory cytokines among the three groups, the HL20-NP group had much greater levels than the other groups (P > 0.05). Pulsatile flow generated higher total hemodynamic energy and surplus hemodynamic energy levels at pre-oxygenator and pre-clamp sites (P

This study investigated the total hemodynamic energy (THE) and surplus hemodynamic energy transmis- sion (SHE) of a novel adult extracorporeal life support (ECLS) system with nonpulsatile and pulsatile settings and varying pulsatility to define the most effective setting for this circuit. The circuit consisted of an i-cor diagonal pump (Xenios AG, Heilbronn, Germany), an XLung mem- brane oxygenator (Xenios AG), an 18 Fr Medos femoral arterial cannula (Xenios AG), a 23/25 Fr Estech RAP femoral venous cannula (San Ramon, CA, USA), 3/8 in ID × 140 cm arterial tubing, and 3/8 in ID × 160 cm venous tubing. Priming was done with lactated Ringer's solution and packed red blood cells (HCT 36%). The trials were conducted at flow rates 1-4 L/min (1 L/min increments) under nonpulsatile and pulsatile mode, with differential speed values 1000-4000 rpm (1000 rpm increments) at 36°. The pseudo patient's mean arterial pressure was kept at 100 mm Hg using a Hoffman clamp during all trials. Real- time flow and pressure data were collected using a custom- based data acquisition system. Mean pressures across the circuit increased with increasing flow rates, but increased insignificantly with increasing differential speed values. Mean pressure did not change significantly between pulsa- tile and nonpulsatile modes. Pulsatile flow created more THE than nonpulsatile flow at the preoxygenator site (P < 0.01). Of the different components of the circuit, the arterial cannula created the greatest THE loss. THE loss across the circuit ranged from 24.8 to 71.3%. Still, under pulsatile mode, more THE was delivered to the pseudo patient at low flow rates. No SHE was created with nonpulsatile flow, but SHE was created with pulsatile flow, and increased with increasing differential speed values. At

The primary objective of this study was to evaluate a novel electrocardiogram (ECG)-synchronized pulsatile extracorporeal life support (ECLS) system for adult partial mechanical circulatory support for adequate quality of pulsatility and enhanced hemodynamic energy generation in an in vivo animal model. The secondary aim was to assess end-organ protection during nonpulsatile versus synchronized pulsatile flow mode. Ten adult swine were randomly divided into a nonpulsatile group (NP, n = 5) and pulsatile group (P, n = 5), and placed on ECLS for 24 h using an i-cor system consisting of an i-cor diagonal pump, an iLA membrane ventilator, an 18 Fr femoral arterial cannula and a 23/25 Fr femoral venous cannula. Trials were conducted at a flow rate of 2.5 L/min using nonpulsatile or pulsatile mode (with assist ratio 1:1). Real-time pressure and flow data were recorded using a custom-based data acquisition system. To the best of our knowledge, the oxygenator and circuit pressure drops were the lowest for any available system in both groups. The ECG-synchronized i-cor ECLS system was able to trigger pulsatile flow in the porcine model. After 24-h ECLS, energy equivalent pressure, surplus hemodynamic energy, and total hemodynamic energy at preoxygenator and prearterial cannula sites were significantly higher in the P group than those in the NP group (P 0.05). The novel i-cor system performed well in the nonpulsatile and ECG-synchronized pulsatile mode in an adult animal ECLS model. The iLA membrane oxygenator had an extremely lower transmembrane pressure gradient and excellent gas exchange capability. Our findings suggest that ECG-triggered pulsatile ECLS provides superior end-organ protection with improved renal function and systemic vascular tone.

Purpose To derive specific maximal heart rate (HRmax) prediction equations for a coronary artery disease (CAD) population based upon status of β-blocker (BB) therapy and to compare these to prior HRmax equations (Fox and Brawner-specific for CAD). Methods We retrospectively reviewed stress echocardiogram treadmill tests in patients with CAD, dividing subjects into 3 groups based upon BB use on test day: not prescribed BB therapy (no BB group; n = 110); held for 12 to 24 hr prior (held BB group; n = 155); and continued taking (took BB group; n = 72). Results Derived HRmax equations for our CAD population were no BB = 200 - 0.79 × age; held BB = 193 - 0.71 × age; and took BB = 168 - 0.51 × age. Achieved HRmax mean was not significantly different between held BB and no BB groups; however, HRmax in the took BB group was significantly lower. Fox and Brawner (no BB)-HRmax equations significantly overestimated (+6 and +9 mean bias) and underestimated (-8 and -6 mean bias) achieved HRmax in no BB and held BB groups, respectively. The Brawner (no BB) equation intercept and slope were not significantly different from our CAD-held BB and no BB equations. The Brawner (on BB) equation intercept and slope were similar to our took BB equation, but greatly underestimated achieved HRmax (-17 mean bias). Conclusion For patients holding BB therapy on test day, a similar CAD HRmax estimation equation to those patients never on BB can be used, comparable to the Brawner (no BB) equation. Further research is needed to determine when patients should take their BB therapy in conjunction with exercise testing.

Objective Sepsis is a condition associated with a dysregulated inflammatory response to infection with significant morbidity. Recent advances have elucidated the vital role that the short chain fatty acid glycoprotein receptor 43 (FFA2/GPR43) plays in inflammatory and immunomodulatory pathways. We hypothesized that elevated whole blood GPR43 RNA expression would be associated with increased 30-day survival in patients admitted with sepsis. Patients (n = 93) admitted to the intensive care unit with the diagnosis of sepsis underwent quantitative real time PCR within 48 h of intensive care unit admission. Clinical and demographical parameters were retrospectively extracted from the chart and compared to quantitative measurements of GPR43 RNA expression. Results Utilizing logistic regression, we found that the odds of mortality decreased for every one-unit increase in GPR43 RNA expression for patients that survived to 30 days [OR = 0.71; 95% CI (0.50, 0.99) p = 0.049]. Using linear regression, we determined that the increase in whole blood GPR43 expression was not associated with whole blood white cell count [r = 0.04; 95% CI (−0.16, 0.24); p = 0.70] or body mass index [r = − 0.07; 95% CI (− 0.23, 0.18); p = 0.81]. We conclude that the GPR43 receptor plays an integral role in survival during and after sepsis.

CONTEXT: Women with polycystic ovary syndrome (PCOS) have increased risk for pregnancy complications, possibly related to pre-existing obesity and excessive gestational weight gain (GWG). OBJECTIVES: To assess the contributions of diagnosis and preconception weight on GWG and perinatal outcomes. RESEARCH DESIGN AND METHODS: Prospective cohort study of singleton pregnancies in PCOS (n = 164) and ovulatory controls (n = 176) from infertility treatment. MAIN OUTCOME MEASURES: GWG, birthweight, pregnancy complications. RESULTS: From preconception baseline, normal-weight women with PCOS gained 2.3 pounds more during the first trimester (95% CI, 0.3 to 4.3; P = 0.02), and by the end of the second trimester, 4.2 pounds more than controls (95% CI, 0.7 to 7.7; P = 0.02). Women who were overweight with PCOS gained significantly more weight than did controls by the end of the second trimester (5.2 pounds; 95% CI, 0.2 to 10.2; P = 0.04), whereas women with obesity and PCOS and control women had similar weight gain throughout pregnancy. Within normal-weight, overweight, and obese groups, prevalence of pre-eclampsia and gestational diabetes did not differ between the PCOS and control groups, nor was there a difference in birthweight. Preconception body mass index (BMI) was significantly associated with GWG; for every 1-kg/m(2) increase in preconception BMI, GWG decreased by 0.62 pounds (95% CI, −0.85 to −0.40; P < 0.001). CONCLUSIONS: Women with PCOS who are of normal weight or are overweight before conception experience more GWG than do ovulatory controls. Within normal-weight, overweight, and obese groups, rates of perinatal complications do not significantly differ between women with PCOS and controls. Preconception BMI is the strongest predictor of GWG.

We sought to determine the time-course in androgen and semen parameters in men after weight loss associated with bariatric surgery with a prospective cohort study of 6 male subjects, age 18-40 years, meeting NIH bariatric surgery guidelines, conducted in 2005-2008, with study visits at baseline, then 1, 3, 6 and 12 months after surgery. All men had a Roux-en-y-Gastric-Bypass (RYGB) performed at Penn State Milton S. Hershey Medical Center. We collected at each visit biometric, questionnaire, serum, and urinary specimens as well as a semen analysis. Urinary integrated total testosterone levels increased significantly by 3 months after surgery, and remained elevated throughout the study. Circulating testosterone levels were also higher at 1 and 6 months after surgery, compared to baseline. Serum SHBG levels were significantly elevated at all time points post-operatively. After RYGB surgery, there were no significant changes in urinary estrogen metabolites (estrone 3-glucuronide) or serum estradiol levels, serial semen parameters, or male sexual function by questionnaire. This study supports the idea that a threshold of weight loss is necessary to improve male reproductive function by reversing male hypogonadism, manifested as increased testosterone levels. Further serial semen analysis results showed normal ranges for most parameters despite massive weight loss.

Arrhythmias are a frequent complication during extracorporeal life support (ECLS). A new ECLS system can provide pulsatile flow synchronized to the patient's intrinsic cardiac cycle based upon the R wave of the electrocardiogram (ECG). It is unclear how the occurrence of arrhythmias may alter the hemodynamic performance of the system. This in vitro study evaluated the effect of simulated arrhythmias on hemodynamics during R wave-triggered pulsatile ECLS. The ECLS circuit with an i-cor diagonal pump and iLA membrane ventilator was primed with whole blood at room temperature. Flow and pressure data were collected at 2.5 and 4 L/min for each condition using a customized data acquisition system. Pulsatile ECLS flow was R wave synchronized to an ECG simulator using 1:1, 1:2, and 1:3 assist ratios. Conditions tested included sinus rhythm at 45 and 90 bpm, supraventricular tachycardia (SVT), ventricular tachycardia (VT), and irregular rhythms such as ventricular fibrillation. Pulsatile mode was successfully triggered by ECG signals of normal sinus rhythm, SVT, VT, atrial fibrillation, atrial flutter, and ventricular bigeminy with assist ratios 1:1, 1:2, and 1:3. Regular rhythm at 90 bpm generated the best surplus hemodynamic energy (SHE). For SVT and VT, an assist ratio of 1:2 resulted in maximum pulsatile flow waveforms with optimal SHE at 2.5 L/min flow rate. At 4 L/min, SHE declined and the pressure drop increased independent of arrhythmia condition. Irregular rhythms still produced adequate pulsatile wave forms at lower pulsatile frequency. This study demonstrated the feasibility of generating pulsatile ECLS flow with the novel ECG-synchronized i-cor system during various simulated rhythms. The optimal rate for pulsatile flow was 90 bpm. During irregular rhythms, the lower pulsatile frequency was the more reliable synchronization mode for generating pulsatile flow.

The objective of this study is to investigate the impact of every component of extracorporeal life support (ECLS) circuit on hemodynamic energy transmission in terms of energy equivalent pressure (EEP), total hemodynamic energy (THE), and surplus hemodynamic energy (SHE) under nonpulsatile and pulsatile modes in a novel ECLS system. The ECLS circuit consisted of i-cor diagonal pump and console (Xenios AG, Heilbronn, Germany), an iLA membrane ventilator (Xenios AG), an 18 Fr femoral arterial cannula, a 23/25 Fr femoral venous cannula, and 3/8-in ID arterial and venous tubing. The circuit was primed with lactated Ringer's solution and human whole blood (hematocrit 33%). All trials were conducted under room temperature at the flow rates of 1–4 L/min (1 L/min increments). The pulsatile flow settings were set at pulsatile frequency of 75 beats per minute and differential speed values of 1000–4000 rpm (1000 rpm increments). Flow and pressure data were collected using a custom-based data acquisition system. EEP was significantly higher than mean arterial pressure in all experimental conditions under pulsatile flow (P

Apolipoprotein E (apoE) may play a critical role in modulating the response to neurological injury after car- diopulmonary bypass (CPB) in children. Plasma samples were collected from 38 pediatric patients. Half of the patients received nonpulsatile flow and the other half underwent pulsatile flow during CPB. Plasma samples were collected at three time points: at baseline prior to incision (T1), 1 h after CPB (T2), and 24 h after CPB (T3). The study included 38 pediatric patients undergoing heart surgery (mean age 2.5 ± 2.1 years). Baseline apoE levels were low (

The objective of this study is to evaluate three different diameters of arterial tubing and three diameters of arterial cannulae in terms of pressure drop, and hemodynamic energy delivery in simulated neonatal/pediatric cardiopulmonary bypass (CPB) circuits. The CPB circuit consisted of a Terumo Capiox Baby FX05 oxygenator (Terumo Corporation, Tokyo, Japan), arterial tubing (1/4 in, 3/16 in, or 1/8 in × 150 cm), and a Medtronic Bio-Medicus arterial cannula (8, 10, or 12 Fr; Medtronic, Inc., Minneapolis, MN, USA). The pseudo patient's pressure was maintained at 50 mm Hg. The circuit was primed using lactated Ringer's solution and heparinized packed human red blood cells (hematocrit 30%). Trials were conducted at different flow rates and temperatures (35 and 28°C). Flow and pressure data were collected using a custom-based data acquisition system. Using 8 Fr arterial cannula at 500 mL/min, small diameter arterial tubing generated higher circuit pressure (294.6 ± 0.1 mm Hg [1/8 in], 213.5 ± 0.5 mm Hg [3/16 in], 208.4 ± 0.4 mm Hg [1/4 in] at 35°C) and arterial line pressure drop (158.3 ± 0.1 mm Hg [1/8 in], 79.6 ± 0.1 mm Hg [3/16 in], 62.1 ± 0.1 mm Hg [1/4 in] at 35°C). Using 10 Fr arterial cannula at 1000 mL/min, pre-oxygenator pressures were 266.8 ± 0.2 mm Hg (3/16 in) and 248.0 ± 0.3 mm Hg (1/4 in); arterial line pressure drops were 111.6 ± 0.0 mm Hg (3/16 in) and 74.0 ± 0.1 mm Hg (1/4 in) at 35°C. When using 12 Fr arterial cannula at 1500 mL/min, preoxygenator pressures reached 324.4 ± 0.3 mm Hg (3/16 in) and 302.5 ± 0.4 mm Hg (1/4 in); arterial line pressure drops were 154.0 ± 0.1 mm Hg (3/16 in) and 92.0 ± 0.2 mm Hg (1/4 in) at 35°C. Pressure drops across arterial line tubing were main CPB circuit pressure drops. High flow rate, hypothermia, small diameter arterial tubing. and arterial cannula created more hemodynamic energy at the preoxygenator site, but energy loss across CPB circuit also increased. Although small diameter (

The objective of this study was to compare the effects of nonpulsatile and ECG-synchronized pulsatile extracorporeal life support on coronary and carotid blood flow velocities using transthoracic echocardiography and vascular ultrasound, respectively. Nine adult swine were randomly separated into nonpulsatile (NP, n = 5) and pulsatile (P, N = 4) groups and placed on ECLS for 24 h using an i-cor ECLS system. Noninvasive transthoracic images of the left and right coronary artery and the left carotid artery were acquired at the pre-ECLS (baseline), 30 min, 3, 6, 9, 12, and 24 h on-ECLS stages. The mean diastolic velocity of the left and right coronary arteries in the NP group significantly decreased after 24 h on ECLS compared to the baseline and 30 min ECLS stages (P 0.05). There was no statistical difference in the mean diastolic velocity of the coronary arteries in the P group at 30 min, 3-, 6-, 9-, 12-, and 24-h ECLS compared to baseline. The P group showed a smaller decrease in the mean diastolic velocity of coronary arteries between the 30-min ECLS and 3-, 6-, 9-, 13-, 24-h ECLS stages compared to the NP group. The diastolic velocity of the left carotid artery in the NP group significantly decreased during 24-h ECLS compared to the P group (P 0.05). An ECG-synchronized pulsatile ECLS system appeared to maintain coronary and carotid artery diastolic velocities better than conventional nonpulsatile ECLS. Further investigation of the perfusion modes during ECLS is warranted.

The objective of this study was to assess the hemodynamic properties of the i-cor ECG-synchronized cardiac assist system for off-label use as a short-term cardiac assist device for neonatal and pediatric patients and compare nonpulsatile to pulsatile flow with different amplitudes. The circuit consisted of the i-cor diagonal pump with 3 feet of ¼ inch arterial and venous tubing and a soft-shell reservoir, primed with lactated Ringer's solution and human packed red blood cells (hematocrit 42%). Trials were conducted with three different sets of cannulas (8-Fr arterial 10-Fr venous, 10-Fr arterial 12 Fr-venous, and 12-Fr arterial 14-Fr venous) with increasing flow rates at varying pseudo-patient pressures (40, 60, 80, and 100 mm Hg) and under nonpulsatile mode and pulsatile mode with pulsatile amplitudes 2000, 2500, and 3000 rpm at 36°C. Pressure and flow waveforms were recorded using a custom-made data acquisition device for each trial. Energy equivalent pressure (EEP) was higher than mean pressure under pulsatile mode, and increased with increasing pseudo-patient's pressure and flow rate while EEP was the same as the mean pressure under nonpulsatile mode. Total hemodynamic energy (THE) levels increased with pressure and pulsatile amplitude and slightly decreased with increasing flow rate. The percent THE lost throughout the circuit increased with flow rate and pulsatile amplitude and decreased with pseudo-patient's pressure. SHE levels also increased with pseudo-patient pressure and pulsatile amplitude and decreased with increasing flow rate. The i-cor diagonal pump can be used as a short term cardiac assist device for neonatal and pediatric patients and is able to provide nonpulsatile as well as pulsatile flow. Compared with nonpulsatile flow, pulsatile flow can generate and deliver more hemodynamic energy to the patients.

The objective of this study was to evaluate a pulsatile extracorporeal membrane oxygenation (ECMO) system in terms of hemodynamic energy generation and transmission under various pulsatile amplitudes, flow rates, and pseudopatient pressures in a simulated adult ECMO circuit. Surplus hemodynamic energy (SHE), a measure of the quality of pulsatility, was used to quantify pulsatile flow. The circuit consisted of an i-cor diagonal pump, an adult XLung oxygenator, a 21 Fr Medtronic Biomedicus femoral arterial cannula, a 23/25 Fr Sorin RAP femoral venous cannula, and 3/8 in ID tubing for both arterial and venous lines. The circuit was primed with lactated Ringer's solution and then packed red blood cells (hematocrit 37%). Trials were conducted at 36°C with flow rates of 2-5 L/min (1 L/min increments) under nonpulsatile and pulsatile mode with pulsatile amplitudes of 1000-5000 rpm (1000 rpm increments). The pseudopatient pressure was maintained at 40-100 mm Hg (20 mm Hg increments). Real-time pressure and flow data were recorded for analysis using a custom-made data acquisition system. There was no SHE generated by the pump under nonpulsatile mode. Under pulsatile mode, SHE levels increased with increasing pulsatile amplitude and pseudopatient pressure (P 0.01) but decreased with increasing flow rate. SHE levels were significantly higher at flow rates of 2-4 L/min. In addition, the XLung oxygenator had acceptable pressure drops (36.1-104.9 mm Hg) and percentages of total hemodynamic energy loss (19.6-43.9%) during all trials. The novel pulsatile ECMO system can create nonpulsatile and pulsatile flow in an adult ECMO model. However, pulsatility gradually weakened with increasing flow rates. Pulsatile amplitude settings were found to have a great impact on pulsatility.

The objective was to assess the i-cor electrocardiogram-synchronized diagonal pump in terms of hemodynamic energy properties for off-label use in neonatal and pediatric extracorporeal life support (ECLS) circuits. The neonatal circuit consisted of an i-cor pump and console, a Medos Hilite 800 LT oxygenator, an 8Fr arterial cannula, a 10Fr venous cannula, 91 cm of 0.6-cm ID arterial tubing, and 91 cm of 0.6-cm ID venous tubing. The pediatric circuit was identical except it included a 12Fr arterial cannula, a 14Fr venous cannula, and a Medos Hilite 2400 LT oxygenator. Neonatal trials were conducted at 36°C with hematocrit 40% using varying flow rates (200-600 mL/min, 200 mL increments) and postarterial cannula pressures (40-100 mm Hg, 20 mm Hg increments) under nonpulsatile mode and pulsatile mode with various pulsatile amplitudes (1000-4000 rpm, 1000 rpm increments). Pediatric trials were conducted at different flow rates (800-1600 mL/min, 400 mL/min increments). Mean pressure and energy equivalent pressure increased with increasing postarterial cannula pressure, flow rate, and pulsatile amplitude. Physiologic-like pulsatility was achieved between pulsatile amplitudes of 2000-3000 rpm. Pressure drops were greatest across the arterial cannula. Pulsatile flow generated significantly higher total hemodynamic energy (THE) levels than nonpulsatile flow. THE levels at postarterial cannula site increased with increasing postarterial cannula pressure, pulsatile amplitude, and flow rate. No surplus hemodynamic energy (SHE) was generated under nonpulsatile mode. Under pulsatile mode, preoxygenator SHE increased with increasing postarterial cannula pressure and pulsatile amplitude, but decreased with increasing flow rate. The i-cor system can provide nonpulsatile and pulsatile flow for neonatal and pediatric ECLS. Pulsatile amplitudes of 2000-3000 rpm are recommended for use in neonatal and pediatric patients.

Background: High gestational weight gain is a major public health concern as it independently predicts adverse maternal and infant outcomes. Past interventions have had only limited success in effectively managing pregnancy weight gain, especially among women with overweight and obesity. Well-designed interventions are needed that take an individualized approach and target unique barriers to promote healthy weight gain. Objective: The primary aim of the study is to describe the study protocol for Healthy Mom Zone, an individually tailored, adaptive intervention for managing weight in pregnant women with overweight and obesity. Methods: The Healthy Mom Zone Intervention, based on theories of planned behavior and self-regulation and a model of energy balance, includes components (eg, education, self-monitoring, physical activity/healthy eating behaviors) that are adapted over the intervention (ie, increase in intensity) to better regulate weight gain. Decision rules inform when to adapt the intervention. In this randomized controlled trial, women are randomized to the intervention or standard care control group. The intervention is delivered from approximately 8-36 weeks gestation and includes step-ups in dosages (ie, Step-up 1 = education + physical activity + healthy eating active learning [cooking/recipes]; Step-up 2 = Step-up 1 + portion size, physical activity; Step-up 3 = Step-up 1 + 2 + grocery store feedback, physical activity); 5 maximum adaptations. Study measures are obtained at pre- and postintervention as well as daily (eg, weight), weekly (eg, energy intake/expenditure), and monthly (eg, psychological) over the study period. Analyses will include linear mixed-effects models, generalized estimating equations, and dynamical modeling to understand between-group and within-individual effects of the intervention on weight gain. Results: Recruitment of 31 pregnant women with overweight and obesity has occurred from January 2016 through July 2017. Baseline data have been collected for all participants. To date, 24 participants have completed the intervention and postintervention follow-up assessments, 3 are currently in progress, 1 dropped out, and 3 women had early miscarriages and are no longer active in the study. Of the 24 participants, 13 women have completed the intervention to date, of which 1 (8%, 1/13) received only the baseline intervention, 3 (23%, 3/13) received baseline + step-up 1, 6 (46%, 6/13) received baseline + step-up 1 + step-up 2, and 3 (23%, 3/13) received baseline + step-up 1 + step-up 2 +step-up 3. Data analysis is still ongoing through spring 2018. Conclusions: This is one of the first intervention studies to use an individually tailored, adaptive design to manage weight gain in pregnancy. Results from this study will be useful in designing a larger randomized trial to examine efficacy of this intervention and developing strategies for clinical application. Registered Report Identifier: RR1-10.2196/9220 [JMIR Res Protoc 2018;7(6):e150]

BACKGROUND High gestational weight gain is a major public health concern as it independently predicts adverse maternal and infant outcomes. Past interventions have had only limited success in effectively managing pregnancy weight gain, especially among women with overweight and obesity. Well-designed interventions are needed that take an individualized approach and target unique barriers to promote healthy weight gain. OBJECTIVE The primary aim of the study is to describe the study protocol for Healthy Mom Zone, an individually tailored, adaptive intervention for managing weight in pregnant women with overweight and obesity. METHODS The Healthy Mom Zone Intervention, based on theories of planned behavior and self-regulation and a model of energy balance, includes components (eg, education, self-monitoring, physical activity/healthy eating behaviors) that are adapted over the intervention (ie, increase in intensity) to better regulate weight gain. Decision rules inform when to adapt the intervention. In this randomized controlled trial, women are randomized to the intervention or standard care control group. The intervention is delivered from approximately 8-36 weeks gestation and includes step-ups in dosages (ie, Step-up 1 = education + physical activity + healthy eating active learning [cooking/recipes]; Step-up 2 = Step-up 1 + portion size, physical activity; Step-up 3 = Step-up 1 + 2 + grocery store feedback, physical activity); 5 maximum adaptations. Study measures are obtained at pre- and postintervention as well as daily (eg, weight), weekly (eg, energy intake/expenditure), and monthly (eg, psychological) over the study period. Analyses will include linear mixed-effects models, generalized estimating equations, and dynamical modeling to understand between-group and within-individual effects of the intervention on weight gain. RESULTS Recruitment of 31 pregnant women with overweight and obesity has occurred from January 2016 through July 2017. Baseline data have been collected for all participants. To date, 24 participants have completed the intervention and postintervention follow-up assessments, 3 are currently in progress, 1 dropped out, and 3 women had early miscarriages and are no longer active in the study. Of the 24 participants, 13 women have completed the intervention to date, of which 1 (8%, 1/13) received only the baseline intervention, 3 (23%, 3/13) received baseline + step-up 1, 6 (46%, 6/13) received baseline + step-up 1 + step-up 2, and 3 (23%, 3/13) received baseline + step-up 1 + step-up 2 +step-up 3. Data analysis is still ongoing through spring 2018. CONCLUSIONS This is one of the first intervention studies to use an individually tailored, adaptive design to manage weight gain in pregnancy. Results from this study will be useful in designing a larger randomized trial to examine efficacy of this intervention and developing strategies for clinical application. REGISTERED REPORT IDENTIFIER RR1-10.2196/9220

The objective of this study was to evaluate three commercially available ECLS systems with rotary pumps in terms of circuit pressure, pressure drop, perfusion modes, and hemodynamic energy transmission in a simulated adult cardiogenic shock model. One circuit consisted of a Cardiohelp system, which included a Cardiohelp console and HLS Module Advanced 7.0 tubing set with integrated centrifugal pump and oxygenator. The alternative circuit was composed of a Quadrox-D Adult oxygenator connected in series with either an i-cor diagonal pump and console or a Rotaflow centrifugal pump and console. The circuit was primed with lactated Ringer's solution and packed red blood cells (hematocrit 40%). The trials were conducted at flow rates of 1-5 L/min with pseudo patient pressures of 60 mm Hg and 80 mm Hg. Pulsatile flow was tested when using the i-cor system. Mean pre-oxygenator pressure and pressure drop across ECLS circuit (including oxygenator and arterial tubing) were lower when using the Cardiohelp system as compared to the Rotaflow and i-cor systems (P 0.01). The i-cor system was able to deliver more hemodynamic energy to the pseudo patient because of its ability to produce pulsatile flow (P 0.01). The Cardiohelp HLS Module Advanced 7.0 integrated oxygenator had a lower resistance than the Quadrox-D oxygenator. Although the compact Cardiohelp system had a better hemodynamic performance when compared to Rotaflow and i-cor systems, the pulsatile flow of the i-cor system delivered more hemodynamic energy to the pseudo patient. This may render more physiological benefits in high-risk patients on ECLS.

The objective of this study was to compare three different hemoconcentrators (Hemocor HPH 400, Mini, and Junior) with two different neonatal ECMO circuits using a roller or a centrifugal pump at different pseudo-patient pressures and flow rates in terms of hemodynamic properties. This evidence-based research is necessary to optimize the ECMO circuitry for neonates. The circuits used a 300-mL soft-shell reservoir as a pseudo-patient approximating the blood volume of a 3 kg neonate, two blood pumps, and a Quadrox-iD Pediatric oxygenator with three different in-line hemoconcentrators (Hemocor HPH 400, Mini, and Junior). One circuit used a Maquet H20 roller pump and another circuit used a Maquet RotaFlow centrifugal pump. The circuit was primed with lactated Ringer's solution followed by heparinized packed red blood cells with a hematocrit of 40%. The pseudo-patient's pressure was manually maintained at 40, 60, or 80 mm Hg and the flow rate was maintained at 200, 400, or 600 mL/min with a circuit temperature of 36°C. Pressure and flow data was recorded using a custom-made data acquisition device. Mean pressures, diverted blood flow, pressure drops, and total hemodynamic energy (THE) were calculated for each experimental condition. The roller pump and centrifugal pump performed similarly for all hemodynamic properties with all experimental conditions. The Hemocor HPH Junior hemoconcentrator added the highest resistance to the circuit. The Hemocor HPH Junior provided the highest circuit pressures, lowest diverted blood flow, highest pressure drop across the circuit, and highest THE generated by the pump. The Hemocor HPH 400 added the least resistance to the circuit, providing the lowest circuit pressures, more diverted flow, lowest pressure drop, and the lowest THE generated by the pump. However, the THE delivered to the patient was the same for the three hemoconcentrators. While the three hemoconcentrators performed differently in terms of hemodynamic properties throughout the circuit, the THE transmitted to the patient was similar for all three hemoconcentrators due to the consistent pseudo-patient's pressure that was manually maintained for each trial. While the THE delivered to the patient indicates similar perfusion for these patients with any of the three hemoconcentrators, the differences in added resistance to the circuit may impact the decision of which hemoconcentrator is used. There was no clinically significant difference between the two circuits with the roller versus centrifugal pump in terms of hemodynamic properties in this study. Further in vivo research is warranted to confirm our findings.

The purpose of this study was to compare the Capiox FX15 oxygenator with integrated arterial filter to the Capiox RX15 oxygenator with separate Capiox AF125 arterial filter in terms of hemodynamic properties and gaseous microemboli (GME) capturing. Trials were conducted at varying flow rates (2.0 L/min, 3.0 L/min, 4.0 L/min), temperatures (30°C, 35°C), and flow modalities (pulsatile, nonpulsatile). Pressure and flow waveforms were recorded using a custom-made data acquisition system. GME data were recorded using an Emboli Detection and Classification Quantifier after injecting a 5 mL air bolus into the venous line. Maximum instantaneous pre-oxygenator flows reached 7.4 L/min under pulsatile conditions when the roller pump was set to a flow rate of 4 L/min. Mean pressure drops were slightly greater in the FX15 group (P 0.0001), and the diverted flow from the arterial purge line was slighter greater in the FX15 group at 3 L/min and 4 L/min (P 0.0001). There was a slight generation of surplus hemodynamic energy (SHE) at the pre-oxygenator site for both oxygenators under "nonpulsatile mode." However, higher pre-oxygenator SHE levels were recorded for both groups with "pulsatile mode." The RX15 and FX15 groups were both able to remove all microemboli from the circuit at 2 L/min and 3 L/min in "nonpulsatile mode." Microemboli were delivered to the patient at 4 L/min with pulsatile flows in both groups. The RX15 oxygenator with separate AF125 arterial filter and FX15 oxygenator with integrated arterial filter performed similarly in terms of hemodynamic performance and microemboli capturing. Pulsatile flows at 4 L/min produced instantaneous flow rates that surpassed the documented maximum flow rates of the oxygenators and might have contributed to the delivery of GME to the pseudo-patient.

STUDY QUESTION Do women with polycystic ovary syndrome (PCOS) seeking fertility treatment report smoking accurately and does participation in infertility treatment alter smoking? SUMMARY ANSWER Self-report of smoking in infertile women with PCOS is accurate (based on serum cotinine levels) and smoking is unlikely to change over time with infertility treatment. WHAT IS KNOWN ALREADY Women with PCOS have high rates of smoking and it is associated with worse insulin resistance and metabolic dysfunction. STUDY DESIGN, SIZE, DURATION Secondary study of smoking history from a large randomized controlled trial of infertility treatments in women with PCOS (N = 626) including a nested case-control study (N = 148) of serum cotinine levels within this cohort to validate self-report of smoking. PARTICIPANTS/MATERIALS, SETTING, METHODS Women with PCOS, age 18-40, seeking fertility who participated in a multi-center clinical trial testing first-line ovulation induction agents conducted at academic health centers in the USA. MAIN RESULTS AND THE ROLE OF CHANCE Overall, self-report of smoking in the nested case-control study agreed well with smoking status as determined by measure of serum cotinine levels, at 90% or better for each of the groups at baseline (98% of never smokers had cotinine levels

The Centers for Disease Control and Prevention recommends anemia screening for reproductive age women every 5-10 years and annually for those with risk factors. Due to the lower risk of anemia among males, screening for men is recommended only if risk factors exist. The study objective was to examine health care professionals' current anemia screening patterns for male and female adolescents. Data are from the 2001 -2004 National Ambulatory Medical Care Survey, a nationally representative sample of ambulatory visits to primary care practices. The frequency of anemia screening during preventive care visits by 12-21-year-olds was estimated by sex using a reported hemoglobin/hematocrit or complete blood count as an indicator of screening. Multivariable logistic regression identified patient, provider and practice-level factors associated with screening. During the study period, 1,263 preventive care visits occurred for 12-21 year-olds. In bivariate analysis, higher odds of anemia screening were observed for both younger females (OR 1.85; 95 % CI 1.09-3.14) and older males [1.83 (1.02-3.26)] compared to older females (≥ 16 years). In the multivariable model, odds of screening increased with non-white race [3.29 (1.84-5.88)], tobacco use [3.57 (1.94-6.58)], longer visit length [1.03 (1.01-1.06)], and practice site acceptance of managed care plans [2.08 (1.04-4.14)]. Patient sex and age were not statistically significant predictors of screening. Although anemia is more prevalent among older adolescent females, they were not more likely to be screened. This suggests providers are not targeting groups at highest risk of anemia for screening.

Objective. To assess the impact of a locally applied vibrating device on outpatient venipuncture in children. Method. A retrospective review of survey data collected prospectively as part of a quality improvement project. Both patients and phlebotomists were surveyed. The sample consisted of 64 children aged 4 to 18 years (29 prior to the implementation of the vibrating device and 35 afterward) and 7 phlebotomists. Results. Prior to the use of the vibrating device, 17 children (59%) indicated that they wished something had been done to decrease venipuncture pain. Eighty percent of the cohort that used the vibrating device indicated that they would like it used for future procedures. Children with previous venipuncture experiences appeared to benefit most from use of the vibrating technique. The phlebotomists reported that vibration made the procedure easier in 81% of the cases; none reported that it complicated the procedure. Conclusions. Locally applied vibration appears to be a well-accepted technique to minimize pediatric venipuncture discomfort that may facilitate completion of the procedure.

The objective of this study is to evaluate two extracorporeal life support (ECLS) circuits and determine the effect of pulsatile flow on pressure drop, flow/pressure waveforms, and hemodynamic energy levels in a pediatric pseudopatient. One ECLS circuit consisted of a Medos Deltastream DP3 diagonal pump and Hilite 2400 LT oxygenator with arterial/venous tubing. The second circuit consisted of a Maquet RotaFlow centrifugal pump and Quadrox-iD Pediatric oxygenator with arterial/venous tubing. A 14Fr Medtronic Bio-Medicus one-piece pediatric arterial cannula was used for both circuits. All trials were conducted at flow rates ranging from 500 to 2800 mL/min using pulsatile or nonpulsatile flow. The post-cannula pressure was maintained at 50 mm Hg. Blood temperature was maintained at 36°C. Real-time pressure and flow data were recorded using a custom-based data acquisition system. The results showed that the Deltastream DP3 circuit produced surplus hemodynamic energy (SHE) in pulsatile mode at all flow rates, with greater SHE delivery at lower flow rates. Neither circuit produced SHE in nonpulsatile mode. The Deltastream DP3 pump also demonstrated consistently higher total hemodynamic energy at the pre-oxygenator site in pulsatile mode and a lesser pressure drop across the oxygenator. The Deltastream DP3 pump generated physiological pulsatility without backflow and provided increased hemodynamic energy. This novel ECLS circuit demonstrates suitable in vitro performance and adaptability to a wide range of pediatric patients.

Objectives This study explores bleeding risk of warfarin patients undergoing radial catheterization. Background Traditionally warfarin has been held prior to catheterization due to bleeding risk; however, this practice is being reconsidered with radial access. This study examined if radial patients receiving warfarin have similar hemostasis times to those not taking warfarin. Methods A convenience sample of patients undergoing radial catheterization was analyzed. Demographics, procedure characteristics, and pharmacologic therapies were reviewed. Hemostasis times, defined as compression band times, were compared. To exclude confounding effects of aspirin and clopidogrel, a separate analysis of band times for each medication was performed. Specifically, analysis of variance models and exact logistic regression models were used to assess means between usage or nonusage of medications (warfarin, aspirin, clopidogrel) while adjusting for other medications. Results Of 208 patients, 60 (29%) were taking warfarin. The breakdown of warfarin, aspirin, and clopidogrel use was as follows: 6 (3%) not taking medications; 14 (7%) warfarin alone; 88 (42%) aspirin alone; 2 (1%) clopidogrel alone; 39 (19%) both warfarin and aspirin; 52 (25%) clopidogrel and aspirin; and 7 (3%) warfarin, aspirin, and clopidogrel. No major complications occurred. Mean hemostasis times for warfarin and nonwarfarin patients were not different (118 vs. 116 min; P = 0.25). Likewise, there was no difference for aspirin (117 vs. 114 min; P = 0.70). There was a nonsignificant trend toward clopidogrel prolonging hemostasis (123 vs. 114 min; P = 0.09). Conclusion: There were no apparent differences in adequacy of hemostasis or duration of compression time between patients taking warfarin or not taking warfarin after controlling for antiplatelet therapy. © 2014 Wiley Periodicals, Inc.

One approach with the potential to improve morbidity and mortality rates following extracorporeal life support (ECLS) is the use of pulsatile perfusion. Currently, no ECLS pumps used in the United States can produce pulsatile flow. The objective of this experiment is to evaluate a novel diagonal pump used in Europe to determine whether it provides physiological pulsatility in a neonatal model. The ECLS circuit consisted of a Medos Deltastream DP3 diagonal pump, a Hilite 800LT polymethylpentene diffusion membrane oxygenator, and arterial/venous tubing. A 300-mL pseudopatient was connected to the circuit using an 8Fr arterial cannula and a 10Fr venous cannula. A clamp maintained constant pressure entering the pseudopatient. Trials (64 total) were conducted in nonpulsatile and pulsatile modes at flow rates of 200 mL/min to 800 mL/min. Flow and pressure data were collected using a custom-based data acquisition system. The Deltastream DP3 pump was capable of producing an adequate quality of pulsatility. Pulsatile flow produced increased mean arterial pressure, energy equivalent pressure (EEP), and surplus hemodynamic energy (SHE) at all flow rates compared to nonpulsatile flow. Pressure drop across the cannula accounted for the majority of pressure loss in the circuit. The greatest loss of SHE and total hemodynamic energy occurred across the arterial cannula due to its small diameter. The Deltastream DP3 pump produced physiological pulsatile flow without backflow while providing EEP and SHE to our neonatal pseudopatient. Further experiments are necessary to determine the impact of this pulsatile pump in an in vivo model prior to clinical use.

The objective of this study was to evaluate the pump performance of the third-generation Medos diagonal pump, the Deltastream DP3, on hemodynamic profile and pulsatility in a simulated pediatric mechanical circulatory support (MCS) system. The experimental circuit consisted of a Medos Deltastream DP3 pump head and console (MEDOS Medizintechnik AG, Stolberg, Germany), a 14-Fr Terumo TenderFlow Pediatric arterial cannula and a 20-Fr Terumo TenderFlow Pediatric venous return cannula (Terumo Corporation, Tokyo, Japan), and 3 ft of tubing with an internal diameter of in. for both arterial and venous lines. Trials were conducted at flow rates ranging from 250 mL/min to 1000 mL/min (250-mL/min increments) and rotational speeds ranging from 1000 to 4000 rpm (1000-rpm increments) using human blood (hematocrit 40%). The postcannula pressure was maintained at 60 mm Hg by a Hoffman clamp. Real-time pressure and flow data were recorded using a Labview-based acquisition system. The pump provided adequate nonpulsatile and pulsatile flow, created more hemodynamic energy under pulsatile mode, and generated higher positive and negative pressures when the inlet and outlet of the pump head, respectively, were clamped. After the conversion from nonpulsatile to pulsatile mode, the flow rates and the rotational speeds increased. In conclusion, the novel Medos Deltastream DP3 diagonal pump is able to supply the required flow rate for pediatric MCS, generate adequate quality of pulsatility, and provide surplus hemodynamic energy output in a simulated pediatric MCS system.

In the brain, the components of the fibrinolytic system, tissue plasminogen activator (tPA) and its endogenous inhibitor plasminogen activator inhibitor-1 (PAI-1), regulate various neurophysiological and pathological responses. Fibrinolytic balance depends on PAI-1 and tPA concentrations. The objective of this study is to compare the effects of pulsatile and nonpulsatile perfusion on fibrinolytic balance in children undergoing pediatric cardiopulmonary bypass (CPB). Plasma PAI-1 antigen and tPA antigen were measured in 40 children (n = 20 pulsatile and n = 20 nonpulsatile group). Plasma samples (1.5 mL) were collected (i) prior to incision, (ii) 1 h after CPB, and (iii) 24 h after CPB. PAI-1 and tPA levels were measured at each time point. PAI-1 and tPA levels were significantly increased at 1 h after CPB, followed by a decrease at 24 h. Nonpulsatile but not pulsatile CPB lowered PAI-1 : tPA ratio significantly at 24 h (median PAI-1 : tPA ratio 4.63 ± 0.83:1.98 ± 0.48, P = 0.03, for the nonpulsatile group and 4.50 ± 0.92:3.56 ± 1.28, P = 0.2, for the pulsatile group). These results suggest that pulsatile flow maintains endogenous fibrinolytic balance after pediatric cardiopulmonary bypass. Further studies are needed to define the clinical significance of these differences.

Is a vaginal preparation of sildenafil citrate capable of alleviating acute menstrual pain in patients with primary dysmenorrhea (PD)?A vaginal preparation of sildenafil citrate is capable of alleviating acute menstrual pain in patients with PD with no observed adverse effects.Oral preparations of nitric oxide (NO) donor drugs augment relaxant effects of NO on myometrial cells, reverse the vasoconstriction caused by prostaglandins and successfully alleviate pain, but the incidence of side effects is too high for routine clinical use. Sildenafil citrate inhibits type 5-specific phosphodiesterase (PDE5), thus preventing the degradation of cyclic guanosine monophosphate (cGMP) in the muscle and augmenting the vasodilatory effects of NO. Therefore, by inhibiting PDE5, the tissue remains relaxed and more blood can circulate through. It has been used previously in a vaginal form with no observed side effects, and it enhances endometrial blood flow.A double-blind, randomized, controlled trial comparing vaginal preparation of sildenafil citrate (100 mg single dose) to a placebo in 62 PD patients at the time of painful menstruation was conducted. The primary outcome was total pain relief over 4 consecutive hours (TOPAR4) comparing sildenafil citrate to placebo, where higher TOPAR4 scores represent better pain relief. Secondary outcomes were pain relief as measured by the visual analog scale (VAS) and uterine artery pulsatility index (PI). Subjects were recruited from December 2007 to January 2011. The trial was stopped due to closeout of the funding for the study.Participants were women in good health, were aged 18-35 years and suffered from moderate to severe PD. They were randomized to either vaginal placebo or 100 mg vaginal sildenafil citrate in a 1:1 ratio using random permuted blocks having a block size of 4. At baseline and 1, 2, 3, and 4 h post-treatment, patients were asked to provide assessment of their degree of pain using two scales: (i) pain on the 5-level ordinal scale used for TOPAR4 calculation and (ii) pain level on the VAS. The study ended 4 h after treatment initiation.Twenty-five subjects completed the study. Using the TOPAR4 score, the sildenafil citrate group had significantly better pain relief compared with the placebo group [mean (SD): 11.9 (3.2) versus 6.4 (2.1), respectively; difference in means = 5.3; 95% CI: (2.9,7.6); P0.001)]. On the VAS, sildenafil citrate provided better pain relief than placebo at each time point. At the 2-h time point, the PI was significantly lower in the sildenafil citrate group compared with the placebo group [mean (SD): 1.6 (0.6) versus 2.3 (0.5), respectively; difference in means = -0.7; 95% CI: (-1.2, -0.1); P = 0.01)].Since we did not meet our sample size due to the loss of funding and could not confirm our primary hypothesis, larger studies of longer duration, likely multi-center, are needed to confirm the findings from this study.A number of medications have been investigated to improve the treatment options for PD, but most have proven unsuccessful or to have an unfavorable risk/benefit ratio. Since PD is a condition that most women suffer from and seek treatment for at some point in their lives, our study offers hope that vaginal sildenafil citrate is a safe and effective option for patients who do not desire or are unresponsive to treatments now available on the market.Funding for this study was provided by National Institutes of Health (NIH) grants RO3 TW007438 and K24 HD01476. The authors report no relevant conflicts of interest.NCT00123162 (Clinical trials.gov).

Cardiopulmonary bypass (CPB) is used for a variety of procedures in pediatric patients. Flow settings of the CPB pump have dramatic effects on patient outcome, and gaseous microemboli delivery within the CPB circuit has been linked to neurological complications. To ensure the ongoing improvement of pediatric CPB, consistent evaluation and improvement of the equipment is necessary. In this study we analyze the Jostra HL-20 roller pump (Jostra USA, Austin, TX, USA) and a Medos Deltastream DP3 diagonal pump (MEDOS Medizintechnik AG, Stolberg, Germany) which has not yet received Food and Drug Administration approval. An infant CPB model with heparinized human blood is used to quantify the gaseous microemboli delivery (via an Emboli Detection and Classification Quantifier), as well as the hemodynamic energy delivered under flow rates of 400, 800, and 1200 mL/min. Results show that at most flow settings the DP3 delivers fewer microemboli than the Jostra roller pump at the pre-oxygenator site, with an exception at 1200 mL/min under pulsatile mode. The total volume and the number of gaseous microemboli greater than 40 μm in diameter were lower in the DP3 group. The HL-20 exhibits less stolen blood flow (except at 1200 mL/min) and oxygenator pressure drops in both pulsatile and nonpulsatile mode. Additionally, under pulsatile flow the DP3 delivers greater surplus hemodynamic energy. Both pumps produce relatively few microemboli and deliver adequate hemodynamic energy to the pseudo-patient, with the DP3 performing slightly better under most flow settings.

The Medos Deltastream DP3 system is made up of a novel diagonal pump and hollow-membrane oxygenator that provides nonpulsatile and pulsatile flows for extracorporeal life support (ECLS). The objectives of this study are to (i) evaluate the efficacy of the hemodynamic energy provided by Medos Deltastream DP3 system in nonpulsatile and pulsatile mode and (ii) to evaluate the pulsatile mode under different frequencies. The experimental ECLS circuit was used in this study, primed with Ringer's lactate and packed red blood cells (hematocrit 35%). All trials were conducted at flow rates of 500, 1000, 1500, and 2000 mL/min with modified pulsatile frequencies of 60, 70, 80, and 90 bpm at 36°C. Simultaneous blood flow and pressures at the pre/postoxygenator and pre/postcannula sites were recorded for quantification of the pulsatile perfusion-generated energy-equivalent pressure (EEP), surplus hemodynamic energy (SHE), and total hemodynamic energy (THE). The experiments showed that under pulsatile flow conditions, at all flow rates and frequencies, (i) the EEP, SHE, and THE were significantly higher when compared with the nonpulsatile group and (ii) the pressure drop was minimal at lower flow rates and lower pulsatile frequencies but was significant when either the flow rate or the pulsatile frequency was increased. The Medos Deltastream DP3 System can provide nonpulsatile flow and physiologic quality pulsatile flow for pediatric ECLS. When the Medos DP3 pediatric ECLS system is used with pulsatile flow, there is more surplus hemodynamic energy and total hemodynamic energy than nonpulsatile flow.

Background— Previous studies show that the rise in skin blood flow and cutaneous vascular conductance during heat stress is substantially attenuated in chronic heart failure (CHF) patients. The mechanisms responsible for this finding are not clear. In particular, little is known regarding the responses of skin sympathetic nerve activity (SSNA) that control the skin blood flow during heat stress in CHF patients. We examined the effects of a modest heat stress to test the hypothesis that SSNA responses could be attenuated in CHF. Methods and Results— We assessed SSNA (microneurography) from the peroneal nerve and skin blood flow (forearm laser Doppler) in 9 patients with stable class II–III CHF and in matched healthy subjects during passive whole-body heating with a water-perfused suit. Whole-body heating induced similar increases in internal temperature (≈0.6°C) in both groups. Whole-body heat stress evoked similar SSNA activation in CHF patients (Δ891±110 U/min) and the control subjects (Δ787±84 U/min; P =0.66), whereas the elevation in forearm cutaneous vascular conductance in patients with CHF was significantly lower than that in healthy control subjects (Δ131±29% vs Δ623±131%; P =0.001). Conclusions— The present data show that SSNA activation during a modest whole-body heat stress is not attenuated in CHF. Thus, the attenuated skin vasodilator response in CHF patients is not attributable to a reduction in total activity of sympathetic outflow to skin.

The objective of this study was to evaluate the hemodynamic performance and gaseous microemboli (GME) handling ability of a simulated neonatal extracorporeal life support (ECLS) circuit with an in-line continuous renal replacement therapy (CRRT) device. The circuit consisted of a Maquet RotaFlow centrifugal pump or HL20 roller pump, Quadrox-iD Pediatric diffusion membrane oxygenator, 8-Fr arterial cannula, 10-Fr venous cannula, and Better-Bladder (BB) with "Y" connector. A second Quadrox-I Adult oxygenator was added postarterial cannula for GME experiments. The circuit and pseudo-patient were primed with lactated Ringer's solution and packed human red blood cells (hematocrit 40%). All hemodynamic trials were conducted at ECLS flow rates ranging from 200 to 600 mL/min and CRRT flow rate of 75 mL/min at 36°C. Real-time pressure and flow data were recorded with a data acquisition system and GME were detected and characterized using the Emboli Detection and Classification Quantifier System. CRRT was added at distinct locations such that blood entered CRRT between the pump and oxygenator (A), recirculated through the pump (B), or bypassed the pump (C). With the centrifugal pump, all CRRT positions had similar flow rates, mean arterial pressure (MAP), and total hemodynamic energy (THE) loss. With the roller pump, C demonstrated increased flow rates (293.2-686.4 mL/min) and increased MAP (59.4-75.5 mm Hg) (P 0.01); B had decreased flow rates (129.7-529.7 mL/min), and MAP (34.2-45.0 mm Hg) (P 0.01); A maintained the same when compared to without CRRT. At 600 mL/min C lost more THE (81.4%) (P 0.01) with a larger pressure drop across the oxygenator (95.6 mm Hg) (P 0.01) than without CRRT (78.3%; 49.1 mm Hg) (P 0.01). C also demonstrated a poorer GME handling ability using the roller pump, with 87.1% volume and 17.8% count reduction across the circuit, compared to A and B with 99.9% volume and 65.8-72.3% count reduction. These findings suggest that, in contrast to A and B, adding CRRT at position C is unsafe and not advised for clinical use.

SummaryObjective To study the effects of oral contraceptive pills (OCP), the first-line treatment for PCOS, on high-density lipoprotein cholesterol (HDL-C) function (reverse cholesterol efflux capacity) and lipoprotein particles measured using nuclear magnetic resonance spectroscopy in obese women. Design Secondary analysis of a randomized controlled trial (OWL-PCOS) of OCP or Lifestyle (intensive Lifestyle modification) or Combined (OCP + Lifestyle) treatment groups for 16 weeks. Patients Eighty-seven overweight/obese women with PCOS at two academic centres. Measurements Change in HDL-C efflux capacity and lipoprotein particles. Results High-density lipoprotein cholesterol efflux capacity increased significantly at 16 weeks in the OCP group [0·11; 95% confidence interval (CI) 0·03, 0·18, P = 0·008] but not in the Lifestyle (P = 0·39) or Combined group (P = 0·18). After adjusting for HDL-C and TG levels, there was significant mean change in efflux in the Combined group (0·09; 95% CI 0·01, 0·15; P = 0·01). Change in HDL-C efflux correlated inversely with change in serum testosterone (rs = −0·21; P = 0·05). In contrast, OCP use induced an atherogenic low-density lipoprotein cholesterol (LDL-C) profile with increase in small (P = 0·006) and large LDL-particles (P = 0·002). Change in small LDL-particles correlated with change in serum testosterone (rs = −0·31, P = 0·009) and insulin sensitivity index (ISI; rs = −0·31, P = 0·02). Both Lifestyle and Combined groups did not show significant changes in the atherogenic LDL particles. Conclusions Oral contraceptive pills use is associated with improved HDL-C function and a concomitant atherogenic LDL-C profile. Combination of a Lifestyle program with OCP use improved HDL-C function and mitigated adverse effects of OCP on lipoproteins. Our study provides evidence for use of OCP in overweight/obese women with PCOS when combined with Lifestyle changes.

The development of echocardiographic ventricular wall motion abnormalities and ST segment changes with exercise may enhance the detection of myocardial ischemia in children with aortic valve stenosis (AS). This study aimed to assess the relationship between the exercise wall motion index (WMIe), ST segment depression (STd), and overall functionality in asymptomatic children with isolated AS. A prospective interpretation of collected stress echocardiographic images was performed. The 98 children who met the inclusion criteria had a mean age of 12.8 years and a male/female ratio of 4/1. Group 1 (mild AS) was composed of 70 children, and group 2 (moderate or severe AS) was composed of 28 children. Abnormal WMIe was seen in 8 patients (5 in group 1 and 3 in group 2), and significant STd was observed in 13 children (3 in group 1 and 10 in group 2). Four (50 %) of the eight patients with abnormal WMIe also had significant STd. Severity of stenosis was associated with STd (odds ratio [OR], 12.0; 95 % CI 3.0-49.0), logistic regression). A significant association also existed between abnormal WMIe and STd (OR, 9.0; 95 % CI 1.9-42.0, logistic regression). Exercise duration was significantly shorter in group 2 (12 ± 4.52 min) than in group 1 (13 ± 5.28 min) (p = 0.02, analysis of covariance). The appearance of wall motion abnormalities and STd during exercise may be helpful in detecting inducible, functionally important myocardial ischemia in asymptomatic children with AS. Stress echocardiography may be a useful adjunct to more traditional exercise testing in risk stratifying asymptomatic children with AS.

A novel pulsatile rotary flow pump has been used in clinical extracorporeal life support (ECLS) in Europe.The objective of this study is to evaluate the Medos Deltastream DP3 diagonal pump (Medos Medizintechnik AG, Stolberg, Germany) in a simulated pediatric ECLS system. The ECLS circuit consisted of a Medos Hilite 800LT hollow fiber membrane oxygenator (Medos Mediz- intechnik AG), a Medos Deltastream DP3 diagonal pump, a 10Fr Terumo TenderFlow Pediatric Arterial Cannula (Terumo Corporation, Tokyo, Japan), and an arterial/ venous tubing. All trials were conducted at flow rates ranging from 200-800 mL/min (in 200 mL/min increments) under a blood temperature of 35°C using human blood (hematocrit 40%). The postcannula pressure was main- tained 60 mm Hg by a Hoffman clamp. Real-time pressure and flow data were recorded using a Labview-based acqui- sition system (National Instruments, Austin, TX, USA). The results showed that the Medos Deltastream DP3 can generate effective pulsatile flow without backflow, provide higher flow rates and pressures than nonpulsatile flow, and then create surplus hemodynamic energy and more total hemodynamic energy than nonpulsatile flow. Pulsatility increased with increased speed differential values and flow rates, while the oxygenator pressure drop increased at an acceptable level. The Medos Deltastream DP3 diagonal pump can provide adequate quality of pulsatility without backflow, and generate more hemodynamic energy under pulsatile mode in a simulated pediatric ECLS sys- tem. Key Words: Pulsatile flow—Novel diagonal pump —Medos DP3—Cardiopulmonary bypass—Extracor- poreal life support—Pediatric.

A simple, inexpensive pediatric pulsatile roller blood pump has been utilized for routine cardiopulmonary bypass (CPB) procedures, extracorporeal life support (ECLS), and left/right ventricular assist systems (LVAS/RVAS) for decades in France. This particular nonocclusive pulsatile system has many advantages including several safety features for patients as well as an extremely lower cost. The objective of this study is to evaluate the performance of this particular system for CPB, ECLS, and LVAS/RVAS in pulsatile mode. This pediatric nonocclusive system was evaluated with pump flow rates of 500, 750, and 1000 mL/min under normothermic (35°C) and hypothermic (25°C) conditions in CPB, ECLS, and LVAS/RVAS circuits using clinical disposables and settings. Energy equivalent pressure (EEP), surplus homodynamic energy (SHE), and total hemodynamic energy (THE) were calculated for each experimental stage. The pump generated near physiological quality of pulsatile flow without backflow in the three simulated pediatric circuits. With increased flow rates, more hemodynamic energy was delivered to the pseudo patient. This particular nonocclusive pediatric pulsatile system performed well during all of the experimental conditions and generated adequate quality pulsatile pressure-flow waveforms using CPB, ECLS, and LVAS/RVAS circuitry. Although this novel concept was first introduced in the 1990s, we believe that there is still need for this technology (with engineering modifications) because of significant advantages including safety and cost.

The objective of this study is to evaluate the impact of an open or closed recirculation line on flow rate, circuit pressure, and hemodynamic energy transmission in simulated neonatal extracorporeal life support (ECLS) systems. The two neonatal ECLS circuits consisted of a Maquet HL20 roller pump (RP group) or a RotaFlow centrifugal pump (CP group), Quadrox-iD Pediatric oxygenator, and Biomedicus arterial and venous cannulae (8 Fr and 10 Fr) primed with lactated Ringer's solution and packed red blood cells (hematocrit 35%). Trials were conducted at flow rates ranging from 200 to 600 mL/min (200 mL/min increments) with a closed or open recirculation line at 36°C. Real-time pressure and flow data were recorded using a custom-based data acquisition system. In the RP group, the preoxygenator flow did not change when the recirculation line was open while the prearterial cannula flow decreased by 15.7-20.0% (P 0.01). Circuit pressure, total circuit pressure drop, and hemodynamic energy delivered to patients also decreased (P 0.01). In the CP group, the prearterial cannula flow did not change while preoxygenator flow increased by 13.6-18.8% (P 0.01). Circuit pressure drop and hemodynamic energy transmission remained the same. The results showed that the shunt of an open recirculation line could decrease perfusion flow in patients in the ECLS circuit using a roller pump, but did not change perfusion flow in the circuit using a centrifugal pump. An additional flow sensor is needed to monitor perfusion flow in patients if any shunts exist in the ECLS circuit.