Analysis of integrated clinical safety data of tadalafil in patients receiving concomitant antihypertensive medications.

This pooled safety analysis assessed the incidence of hypotension-related treatment-emergent adverse events (TEAEs) and major adverse cardiovascular events (MACEs) in patients with concomitant use of tadalafil and antihypertensive medications. Data were pooled from seventy-two Phase II-IV studies conducted on patients with a diagnosis of erectile dysfunction (ED) and/or benign prostate hyperplasia (BPH). Studies were categorized as either All placebo-controlled studies or All studies. The incidences of hypotension-related TEAEs and MACEs were analyzed by indication; by use of concomitant antihypertensive medications; and by the number of concomitant antihypertensive medications. A total of 15 030 and 22 825 patients were included in the analyses for All placebo-controlled studies and All studies, respectively. In the All placebo-controlled studies, the incidence of hypotension-related TEAEs and MACEs was ranging between 0.6-1.5% and 0.0-1.0%, respectively, across all indications. Tadalafil was associated with an increase in hypotension-related TEAEs only in the ED as-needed group not receiving any concomitant antihypertensive medications (p-value = .0070); no significant difference was reported between placebo and tadalafil in the groups of patients receiving ≥1 antihypertensive medication (p-values ≥ .7386). Similarly, no significant differences (p-values≥ .2238) were observed in the incidence of MACEs between tadalafil and placebo treatment groups, with or without concomitant use of antihypertensive medications, and across all indication categories. In the All studies group, results were similar. The pooled analysis showed no evidence that taking tadalafil alongside antihypertensive medications increases the risk of hypotension-related TEAEs or MACEs compared with antihypertensive medications alone.

Retrospective Observational Real-World Outcome Study to Evaluate Safety Among Patients With Erectile Dysfunction (ED) With Co-Possession of Tadalafil and Anti-Hypertensive Medications (anti-HTN).

BACKGROUND: Erectile dysfunction (ED) is a common condition affecting male adults and may be associated with hypertension, diabetes, hyperlipidemia, and obesity. Phosphodiesterase type 5 (PDE5) inhibitors, such as tadalafil, are the first-line drug therapy for ED. Studies and the current prescribing information of these PDE5 inhibitors indicate they are mechanistic mild vasodilators and, as such, concomitant use of a PDE5 inhibitor with anti-hypertensive medication may lead to drops in blood pressure due to possible drug-drug interaction. AIM: Evaluate risks of hypotensive/cardiovascular outcomes in a large cohort of patients with ED that have co-possession of prescriptions for tadalafil and hypertensive medications versus either medication/s alone. METHODS: A cohort study conducted within an electronic health record database (Optum) representing hospitals across the US. Adult male patients prescribed tadalafil and/or anti-hypertensive medications from January 2012 to December 2017 were eligible. Possession periods were defined by the time patients likely had possession of medication, with propensity score-matched groups used for comparison. OUTCOMES: Risk of hypotensive/cardiovascular outcomes were measured using diagnostic codes and NLP algorithms during possession periods of tadalafil + anti-hypertensive versus either medication/s alone. RESULTS: In total there were 127,849 tadalafil + anti-hypertensive medication possession periods, 821,359 anti-hypertensive only medication possession periods, and 98,638 tadalafil only medication possession periods during the study; 126,120 were successfully matched. Adjusted-matched incidence rate ratios (IRRs) for the anti-hypertensive only possession periods compared with tadalafil + anti-hypertensive periods of diagnosed outcomes were all below 1. Two outcomes had a 95% confidence interval (CI) that did not include 1.0: ventricular arrhythmia (IRR 0.79; 95% CI 0.66, 0.94) and diagnosis of hypotension (IRR 0.79; 95% CI 0.71, 0.89). CLINICAL IMPLICATIONS: Provides real world evidence that co-possession of tadalafil and anti-hypertensive medications does not increase risk of hypotensive/cardiovascular outcomes beyond that observed for patients in possession of anti-hypertensive medications only. STRENGTHS AND LIMITATIONS: EHR data are valuable for the evaluation of real world outcomes, however, the data are retrospective and collected for clinical patient management rather than research. Prescription data represent the intent of the prescriber and not use by the patient. Residual bias cannot be ruled out, despite propensity score matching, due to unobserved patient characteristics and severity that are not fully reflected in the EHR database. CONCLUSION: In the studied real world patients, this study did not demonstrate an increased risk of hypotensive or cardiovascular outcomes associated with co-possession of tadalafil and anti-hypertensive medications beyond that observed for patients in possession of anti-hypertensive medications only. Nunes AP, Seeger JD, Stewart A, et al., Retrospective Observational Real-World Outcome Study to Evaluate Safety Among Patients With Erectile Dysfunction (ED) With Co-Possession of Tadalafil and Anti-Hypertensive Medications (anti-HTN). J Sex Med 2022;19:74-82.

Cardiovascular Outcome Risks in Patients With Erectile Dysfunction Co-Prescribed a Phosphodiesterase Type 5 Inhibitor (PDE5i) and a Nitrate: A Retrospective Observational Study Using Electronic Health Record Data in the United States.

BACKGROUND: Phosphodiesterase type 5 inhibitors (PDE5i) are first-line therapy for erectile dysfunction (ED). Approximately 1-4% of PDE5i recipients co-possess nitrates, despite this combination potentially producing clinically significant hypotension. Real-world data in these patients and insights into prescriber rationales for co-prescription are limited. AIM: This study investigated whether PDE5i and nitrate co-possession is associated with increased rates of cardiovascular (CV) outcomes. METHODS: Adult males with ED and PDE5i prescription and males with nitrate prescription were identified from a U.S. electronic health record database (2012-2016). Quantitative comparisons were made between patients with ED and co-possession (ED + PDE5i + nitrate), only nitrate possession (ED + nitrate and nitrate only [without ED]), and only PDE5i possession (ED + PDE5i). OUTCOMES: We quantified incidence of CV outcomes in co-possession and comparator periods, calculating incidence rate ratios after propensity score matching. Prescriber rationales were derived by reviewing virtual patient records. RESULTS: Over 168,000 patients had ≥1 PDE5i prescription (∼241,000 possession periods); >480,000 patients had ≥1 nitrate prescription (∼486,000 possession periods); and 3,167 patients had 3,668 co-possession periods. Non-significantly different or lower rates of CV outcomes were observed for co-possession periods vs ED + nitrate and nitrate only periods. Most CV outcome rates were non-significantly different between co-possession and ED + PDE5i periods (myocardial infarction, hospitalized unstable angina and fainting were higher with co-possession). From qualitative assessment of patient records with co-possession, 131 of 252 (52%) documented discussion with a physician regarding co-possession; 69 of 131 (53%) warned or instructed on safely managing these contraindicated medications. CLINICAL IMPLICATIONS: Findings from this real-world study indicate that co-possession of nitrate and PDE5i prescriptions is not associated with increased rates of CV outcomes, relative to possession of nitrates alone. Physicians should and often do discuss the risks of using both medications together with their patients. STRENGTHS & LIMITATIONS: Strengths of this study are the large size of the U.S. real-world patient cohort with data available for analysis, and our ability to utilize natural language processing to explore co-prescription rationales and patient-physician interactions. Limitations are the retrospective nature of the analysis and inability to establish whether recorded prescriptions were filled or the medication was consumed. CONCLUSION: Co-exposure of PDE5i and nitrates should continue to be avoided; however, co-possession of PDE5i and nitrate prescriptions is not necessarily associated with increased CV risk. Co-possession can be successfully managed in suitable circumstances. Nunes AP, Seeger JD, Stewart A, et al. Cardiovascular Outcome Risks in Patients With Erectile Dysfunction Co-Prescribed a Phosphodiesterase Type 5 Inhibitor (PDE5i) and a Nitrate: A Retrospective Observational Study Using Electronic Health Record Data in the United States. J Sex Med 2021;18:1511-1523.

Novel Trocarless, Scarless Technique for Left Lobe Liver Retraction in Laparoscopic Upper Gastrointestinal Surgeries: Simple, Cost-effective and with Better Cosmesis.

Surgeons always look for ways to reduce the size and number of ports in laparoscopy, where in today's era, we have single-incision laparoscopic surgery (SILS). While doing so, principal 'adequate exposure' should not be compromised. For upper gastrointestinal laparoscopic surgeries, we have adopted a novel technique for retraction of the left lobe of liver, which is described here. Device can be made both single sling and double sling, with help of an infant feeding tube and any routinely used suture material. Placement of device does not require any incision, special energy source, or instrument. It can help in SILS. Detailed technique is described in the text. Operative times did not change significantly. Exposure was excellent. No special instruments or energy devices are required; thus, it is cost-effective. Reducing one port for liver retraction gives better cosmetic results. No liver injury due to the device was noticed in any of the cases. This technique is simpler and cheaper and also gives reasonable cosmetic results compared to other techniques described in the literature.

Definition and implications of novel pharyngo-glottal reflex in human infants using concurrent manometry ultrasonography.

OBJECTIVES: Glottal relationships during swallowing dominate the etiology of dysphagia. We investigated the pharyngo-glottal relationships during basal and adaptive swallowing. METHODS: Temporal changes in glottal closure kinetics (frequency, response latency, and duration) with spontaneous and adaptive pharyngeal swallows were defined in 12 infants using concurrent pharyngoesophageal manometry and ultrasonography of the glottis. RESULTS: Frequency, response latency, and duration of glottal closure with spontaneous swallows (n=53) were 100%, 0.27+/-0.1 s, and 1+/-0.22 s, respectively. The glottis adducted earlier (P<0.0001 vs. upper esophageal sphincter relaxation) within the same respiratory phase as swallow (P=0.03). With pharyngeal provocations (n=41), glottal adduction (pharyngo-glottal closure reflex (PGCR)) was noted first and then again with pharyngeal reflexive swallow (PRS). The frequency, response latency, and duration of glottal closure with PGCR were 100%, 0.56+/-0.13 s, and 0.52+/-0.1 s, respectively. Response latency to PRS was 3.24+/-0.33 s; the glottis adducted 97% within 0.36+/-0.08 s in the same respiratory phase (P=0.03), and remained adducted for 3.08+/-0.71 s. Glottal adduction was the quickest with spontaneous swallow (P=0.04 vs. PGCR), and the duration was the longest during PRS (P<0.005 vs. PGCR or spontaneous swallow). CONCLUSIONS: Glottal adduction during basal or adaptive swallowing reflexes occurs in either respiratory phase, thus ensuring airway protection against pre-deglutitive or deglutitive aspiration. The independent existence and magnitude (duration of adduction) of PGCR suggests a hypervigilant state of the glottis in preventing aspiration during swallowing or during high gastroesophageal reflux events. Investigation of pharyngeal-glottal relationships with the use of noninvasive methods may be more acceptable across the age spectrum.

Effect of postnatal maturation on the mechanisms of esophageal propulsion in preterm human neonates: primary and secondary peristalsis.

OBJECTIVES: The changes in esophageal propulsive characteristics during maturation are not known. Our aim was to define the effects of postnatal maturation on esophageal peristaltic characteristics in preterm human neonates. We tested the hypotheses that: (i) maturation modifies esophageal bolus propulsion characteristics, and (ii) the mechanistic characteristics differ between primary and secondary peristalsis. METHODS: Esophageal motility in 10 premature neonates (mean 27.5 weeks gestational age) was evaluated twice at 33.8 weeks (time 1, earlier study) and 39.2 weeks (time 2, later study) mean postmenstrual age. Esophageal manometry waveform characteristics (amplitude and duration, peristaltic velocity, and intrabolus pressure domains) were analyzed during spontaneous primary peristalsis and infusion-induced secondary peristalsis. Repeated-measures and unstructured variance-covariance or compound symmetry matrixes were used for statistical comparison. Values stated as least squares means+/-s.e.m. or percent. RESULTS: A total of 200 primary peristalsis and 227 secondary peristalsis events were evaluated. Between time 1 and time 2: (i) proximal esophageal waveform amplitude increased (P<0.02), with primary peristalsis (38+/-6 vs. 48+/-7 mm Hg) and with secondary peristalsis (34+/-6 vs. 46+/-5 mm Hg); (ii) distal esophageal waveform amplitude was similar (P=NS), with primary peristalsis (42+/-4 vs. 43+/-4 mm Hg) and secondary peristalsis (29+/-3 vs. 32+/-4 mm Hg); (iii) proximal esophageal waveform onset to peak duration decreased (P=0.02) with primary (2.6+/-0.3 vs. 1.9+/-0.1 s, P<0.003) and with secondary peristalsis (2.2+/-0.2 vs. 1.8+/-0.1 s); (iv) distal esophageal waveform onset to peak duration decreased (P=0.01) with primary (2.4+/-0.3 vs. 1.8+/-0.1 s) and with secondary peristalsis (1.9+/-0.2 vs. 1.5+/-0.1 s); (v) effects of identical stimulus volume on intrabolus pressure were similar (P=NS); however, greater infusion volumes (2 vs. 1 ml) generated higher intrabolus pressure at both time 1 and time 2 (both Ps<0.05). Between primary and secondary peristalsis (mechanistic variable): (i) no differences were noted at either period, with proximal esophageal waveform amplitudes (P=NS); (ii) differences were noted with distal esophageal waveform amplitudes at each time period (P=0.0002); (iii) no differences were noted with both esophageal waveforms duration at either period (P=NS); (iv) peristaltic velocity was faster with secondary peristalsis than with primary peristalsis at either period (at earlier study, 7.9+/-1.4 vs. 2.5+/-1.4 cm/s and at later study 6.2+/-1.6 vs. 1.2+/-1.5 cm/s, both Ps<0.01). CONCLUSIONS: In preterm neonates, longitudinal maturation modulates the characteristics of primary and secondary peristalsis. Differences in proximal striated muscle and distal smooth muscle activity during peristalsis are evident. Peristaltic velocity is faster with secondary peristalsis. These findings may represent maturation of central and peripheral neuromotor properties of esophageal bolus propulsion in healthy preterm human neonates.

Evaluation and management of neonatal dysphagia: impact of pharyngoesophageal motility studies and multidisciplinary feeding strategy.

BACKGROUND AND OBJECTIVES: Abnormal swallowing (dysphagia) among neonates is commonly evaluated using the videofluoroscopic swallow study (VSS). Radiological findings considered high risk for administration of oral feeding include nasopharyngeal reflux, laryngeal penetration, aspiration, or pooling. Our aims were to determine pharyngoesophageal motility correlates in neonates with dysphagia and the impact of multidisciplinary feeding strategy. METHODS: Twenty dysphagic neonates (mean gestation +/- standard deviation [SD] = 30.9 +/- 4.9 weeks; median 31.1 weeks; range = 23.7-38.6 weeks) with abnormal VSS results were evaluated at 49.9 +/- 16.5 weeks (median 41.36 weeks) postmenstrual age. The subjects underwent a swallow-integrated pharyngoesophageal motility assessment of basal and adaptive swallowing reflexes using a micromanometry catheter and pneumohydraulic water perfusion system. Based on observations during the motility study, multidisciplinary feeding strategies were applied and included postural adaptation, sensory modification, hunger manipulation, and operant conditioning methods. To discriminate pharyngoesophageal manometry correlates between oral feeders and tube feeders, data were stratified based on the primary feeding method at discharge, oral feeding versus tube feeding. RESULTS: At discharge, 15 of 20 dysphagic neonates achieved oral feeding success, and the rest required chronic tube feeding. Pharyngoesophageal manometry correlates were significantly different (P < 0.05) between the primary oral feeders versus the chronic tube feeders for swallow frequency, swallow propagation, presence of adaptive peristaltic reflexes, oral feeding challenge test results, and upper esophageal sphincter tone. VSS results or disease characteristics had little effect on the feeding outcomes (P = NS). CONCLUSIONS: Swallow-integrated esophageal motility studies permit prolonged evaluation of swallowing reflexes and responses to stimuli under controlled conditions at cribside. The dysfunctional neuromotor mechanisms may be responsible for neonatal dysphagia or its consequences. Manometry may be a better predictor than VSS in identifying patients who are likely to succeed in vigorous intervention programs.

Neuromotor markers of esophageal motility in feeding intolerant infants with gastroschisis.

BACKGROUND: Feeding problems in neonates with gastroschisis are commonly attributed to foregut dysmotility. However, the dysmotility mechanisms are not well understood. OBJECTIVE: Our aim was to differentiate the pharyngoesophageal motility characteristics in neonates with gastroschisis compared with the controls. Specifically, the characteristics of swallowing, upper esophageal sphincter (UES), esophageal body, and lower esophageal sphincter (LES) were evaluated during basal state and upon provocation. PATIENTS AND METHODS: Surgically repaired and recovered study infants with persistent feeding difficulties (n = 8; 36 +/- 2 weeks gestational age) and controls (n = 8; 38 +/- 2 weeks gestational age) were evaluated at 40 +/- 2 weeks and 42 +/- 2.5 weeks postmenstrual age, respectively. The basal and adaptive pharyngoesophageal motility characteristics were evaluated using a specially designed esophageal motility catheter with UES and LES sleeves and pneumohydraulic micromanometric water perfusion system at the crib side. Analysis of variance, chi-square, and t tests were applied; data are shown as mean +/- standard deviation, and P < 0.05 was considered significant. RESULTS: Birth weight was less in gastroschisis (P < 0.03, vs controls) and length was less at motility study (P < 0.01, vs controls). The study group (vs controls) needed prolonged respiratory support (21 +/- 23 vs 1 +/- 2 days; P < 0.001) and prolonged gavage feeding (167 +/- 100 vs 9 +/- 16 days; P < 0.01). Compared with the controls, the gastroschisis group had lower frequency (P < 0.05) and poor propagation of spontaneous swallows (P < 0.001), UES relaxation time was shorter (P < 0.05), rate of relaxation was faster (P < 0.001), and esophageal peristaltic propagation velocity was slower (P < 0.05). Upon esophageal provocation with air and liquids, frequency occurrence of the esophageal reflexes was low (P < 0.05) with respect to primary peristalsis, secondary peristalsis, UES contractile reflex, and LES relaxation reflex. CONCLUSIONS: In gastroschisis feeding milestones and respiratory milestones were delayed, basal pharyngoesophageal peristaltic failure was common, adaptive peristaltic reflexes were less frequent and failed to occur, and frequency occurrences of UES and LES responses were impaired. These neuromotor markers may provide clues to define the esophageal motor function abnormalities in infants with an abnormality thought to be limited to the intestine.

Spatiotemporal characteristics of acid refluxate and relationship to symptoms in premature and term infants with chronic lung disease.

BACKGROUND AND OBJECTIVES: The prevalence of gastroesophageal reflux (GER) is high among infants with chronic lung disease (CLD), and the associated pathogenic mechanisms are not clear. The relationship of symptoms to the extent or duration of acid reflux events (AREs) is not well known in preterm or term infants. Our aim was to evaluate the relationship between spatial (height) and temporal (duration) characteristics of AREs (pH <4.0) with symptoms in CLD. We tested the hypothesis that in infants with CLD, AREs into the pharynx are associated with increased symptom occurrence and delayed clearance. METHODS: Nine infants born at 29.8 +/- 5.5 wk gestation (mean +/- SD, range 24.7-39.0 wk) with CLD were evaluated for GER at 49.7 +/- 8.0 wk postmenstrual age (mean +/- SD, range 39.9-67.4 wk). Esophageal manometry was first performed to determine the nares-lower esophageal sphincter (LES) distance. A pH-impedance probe was placed at 87% of the nares-LES distance, and a recording was performed for about 24 h at cribside. Symptoms (respiratory, sensory, and movement) were documented by nurses that were blinded to the pH-impedance recordings. A symptom was considered associated with an ARE if it occurred 2 min before, during, or 2 min after the ARE. The proximal extent and associated clearance mechanisms were correlated with symptom sensitivity index (SSI = number of AREs with symptoms/total AREs *100). Multiple logistic regression methods, analysis of variance (ANOVA) models, and chi(2) tests were performed. Data are described as median, mean +/- SD, or %. RESULTS: A total of 511 AREs, based on pH-Impedance methods, were analyzed from 203 h of recordings in the nine infants. The distal esophagus was the maximal height reached in 80% of AREs (P < 0.001, compared to other esophageal segments). Overall 33% of the AREs were associated with symptoms, and an SSI of 77% was noted with high AREs into the pharynx. The average acid clearance time was prolonged with symptomatic AREs versus nonsymptomatic AREs by 3.5-fold (P < 0.001). CONCLUSIONS: The occurrence and frequency of symptoms with AREs depend on the most proximal extent of the ARE and the acid clearance time.

Pharyngeal swallowing: defining pharyngeal and upper esophageal sphincter relationships in human neonates.

OBJECTIVE: To test the hypothesis that the sensorimotor characteristics of the reflexes evoked on stimulation with air and water infusions differ by studying the effect of pharyngeal stimulation on pharyngeal-upper esophageal sphincter (UES) interactions in healthy neonates. STUDY DESIGN: Pharyngo-UES-esophageal manometry was recorded in 10 neonates at 39 +/- 4 weeks postmenstrual age. Pharyngeal infusions (n = 155) of air (0.1 to 2.0 mL) and sterile water (0.1 to 0.5 mL) were given. Two types of reflexes were recognized: pharyngeal reflexive swallowing (PRS) and pharyngo-UES-contractile reflex (PUCR). Frequency occurrence, distribution of reflexes, threshold volume, response time, and stimulus-response relationship were evaluated. RESULTS: The reflex response rates were 30% for air and 76% for water (P < .001). PRS was more frequent than PUCR with air and water (P < .05), even though the stimulation thresholds and response latencies were similar. Graded volumes of water but not air resulted in an increased frequency of PRS (P < .01). CONCLUSIONS: PRS is more frequent than PUCR, and the 2 reflexes have distinctive characteristics in air and water stimuli. Both PRS and PUCR have implications for the evaluation of swallowing in infants.

Esophago-glottal closure reflex in human infants: a novel reflex elicited with concurrent manometry and ultrasonography.

BACKGROUND AND AIMS: Our aims were to identify and characterize the glottal response to esophageal mechanostimulation in human infants. We tested the hypotheses that glottal response is related to the type of esophageal peristaltic response, stimulus volume, and respiratory phase. METHODS: Ten infants (2.8 kg, SD 0.5) were studied at 39.2 wk (SD 2.4). Esophageal manometry concurrent with ultrasonography of the glottis (USG) was performed. The sensory-motor characteristics of mechanostimulation-induced esophago-glottal closure reflex (EGCR, adduction of glottal folds upon esophageal provocation) were identified. Mid-esophageal infusions of air (N = 41) were given and the temporal relationships of glottal response with deglutition, secondary peristalsis (SP), and the respiratory phase were analyzed using multinomial logistic regression models. RESULTS: The frequency occurrence of EGCR (83%) was compared (P < 0.001) with deglutition (44%), SP (34%), and no esophageal responses (22%). The odds ratios (OR, 95% CI) for the coexistence of EGCR with SP (0.4, 0.06-2.2), deglutition (1.9, 0.1-26), and no response (1.9, 0.4-9.0) were similar. The response time for esophageal reflexes was 3.8 (SD 1.8) s, and for EGCR was 0.4 (SD 0.3) s (P < 0.001). Volume-response relationship was noted (1 mL vs 2 mL, P < 0.05). EGCR was noted in both respiratory phases; however, EGCR response time was faster during expiration (P < 0.05). CONCLUSION: The occurrence of EGCR is independent of the peristaltic reflexes or the respiratory phase of infusion. The independent existence of EGCR suggests a hypervigilant state of the glottis to prevent retrograde aspiration during GER events.

The relationship between somatic growth and in vivo esophageal segmental and sphincteric growth in human neonates.

BACKGROUND: Measurement of aerodigestive tract length is an important determinant for accurate placement of esophageal probes and gavage tubes at the desired location. The relationship of esophageal body, upper esophageal sphincter (UES) and lower esophageal sphincter (LES) lengths with somatic growth in neonates is not well understood. OBJECTIVES: Our objectives were to (1) evaluate a relationship between segmental esophageal lengths and somatic growth parameters and (2) ascertain the relationship between segmental esophageal lengths and gestational age (GA) and postmenstrual age (PMA) in preterm and full-term born human neonates. DESIGN/METHODS: One hundred esophageal manometry studies were performed in 75 infants (30-60 weeks PMA) and the high-pressure zones of LES and UES identified. The distance from nares to LES and from nares to UES, esophageal body length, length of UES and LES derived from the manometry studies were correlated with somatic growth parameters. Growth rate of different esophageal segments was also determined in 26 subjects that underwent longitudinal studies. Analysis of variance and linear regression analysis were performed. RESULTS: Seventy-five neonates of 23.0-40.6 weeks gestational age (0.6-4.4 kg) were studied at 29.1-58.6 weeks PMA (1.0-6.4 kg). Significant correlation (P < 0.001) of PMA and physical growth parameters with the growth of nares-LES (R = 0.8), esophageal body length (R = 0.6) and nares-UES (R = 0.4) were noted. Nares-to-LES length increased at a rate of 0.25 cm/wk PMA during 33.0-36.0 weeks of age. CONCLUSIONS: In vivo esophageal segmental lengths correlated strongly with somatic growth parameters and PMA in neonates. We speculate that this approach has many practical applications with the use of esophageal probes and catheters.

Correlation of glottal closure using concurrent ultrasonography and nasolaryngoscopy in children: a novel approach to evaluate glottal status.

OBJECTIVES: Endoscopic procedures to assess aerodigestive symptoms by evaluating glottal motion are not practical in neonates because of small nares, respiratory difficulties, or additional stress. Our objective was to determine the temporal correlation between concurrent nasolaryngoscopy (NLS) and ultrasonography (USG) evaluation of glottal motion. METHODS: Simultaneous USG of the glottis was performed in 10 subjects (5 males, 5 females, age = 4.5 months to 7.1 years) that underwent diagnostic flexible outpatient NLS. The USG transducer was placed on the anterior neck at the level of the vocal cords. The video signals from NLS and USG were integrated and synchronized into real-time cine loops of 1-min duration. RESULTS: Frame-by-frame evaluation of 10,800 frames identifying glottal opening and closure time was compared between the two modalities by three observers and the timing of glottal closure was marked. Two investigators, blinded to NLS images, identified ultrasonographically determined glottal closure with 99% and 100% accuracy, and the mean probability of missing a closure frame was 0.007 (95% CI = 0.0008-0.024). CONCLUSIONS: Temporal characteristics of glottal motion can be quantified by USG with perfect reliability and safety. This method can be useful in measuring the presence and the duration of laryngeal adduction.