Purpose: Post-operative restrictions such as arm restraints (AR) and suction-less feeding are commonly used to decrease rates of oronasal fistulas after cleft surgery; however the utility of these restrictions remains unclear. We hypothesize that the use of arm restraints and suction-less feeding methods do not impact the rate of oronasal fistula development following palatoplasty.Methods: A retrospective case-control study identified clinical data for 105 primary palatoplasty patients from the multidisciplinary craniofacial clinics of 2 university hospitals from 2009 to 2020. Forty-nine patients underwent bottle feeds and did not have arm restraints (Limited Restrictions group, LR); 56 patients underwent suction-less feeding methods and used arm restraints (Highly Restricted group, HR). Primary outcomes included the rate of reoperations, post-operative length of stay (LOS), and the rate of oronasal fistula (ONF) development were compared.Results: The post-operative LOS for the LR and HR groups was 1.88 +/- 0.81 days and 2.05 +/- 1.33 days, respectively (P = .42). The rate of post-operative ONF development was 5/49 (10.2%) and 4/56 (7.1%) for the LR and HR cohorts, respectively (P = .73). There was no significant difference in the rate of reoperation between the LR and HR groups (LR: 5/49 [10.2%] vs HR: 2/56 [3.6%]; P = .24). The rate of oronasal fistula development did not vary by veau type or syndromic status.Conclusions: Our preliminary data suggest that restrictions do not impact the rate of oronasal fistula development in patients undergoing primary palatoplasty. Our findings also indicate that postoperative restrictions do not impact the rate of reoperation or LOS. In light of this, we recommend that practitioners reconsider the utility of highly restrictive post-operative protocols.
OBJECTIVE:Pediatric somatic symptom and related disorders (SSRDs) negatively impact patients' lives and can lead to hospitalization. No national U.S. studies have examined inpatient SSRD prevalence and health care utilization. We aimed to report demographic characteristics and health care utilization of patients admitted for pediatric SSRDs using the Pediatric Health Information System (PHIS) and identify characteristics associated with high utilization. METHODS:We included inpatient encounters from 2016 through 2023 for patients 5 to 21 years old with an admitting or primary SSRD diagnosis. We used descriptive statistics to summarize patient- and encounter-level variables and multivariable logistic regression to identify factors independently associated with high utilization (readmission or >75th percentile length of stay [LOS] or cost). RESULTS:There were 6820 encounters and 6297 patients from 48 hospitals. Most patients were 12 to 18 years old (n = 4889, 78%), female (74%, n = 4666), and non-Hispanic white (55%, n = 3449). Median LOS was 2 days (IQR, 1-4), and median encounter cost was $7946 (IQR, 4737-13 701). Four hundred sixteen patients (7%) had multiple admissions. Carrying 7 or more diagnoses and Northeast hospitalization were associated with higher odds of prolonged LOS, high cost, and readmission. Odds of prolonged LOS alone were higher with commercial insurance (odds ratio [OR], 1.19 [95% CI, 1.03-1.36]) and comorbid anxiety (OR, 1.29 [95% CI, 1.10-1.51]). Hispanic patients had higher odds of high-cost admission (OR, 1.57 [95% CI, 1.24-1.99]) compared with non-Hispanic white patients. CONCLUSIONS:An average of 853 admissions for SSRDs occur annually across 48 US tertiary care children's hospitals and affect a sociodemographically diverse population. Further investigation into drivers of disparate health care utilization is needed.
BackgroundThe River stent is the first stent specifically designed for intracranial venous sinuses. We report the 1-year results of the River trial, performed to obtain Humanitarian Device Exemption approval of the River stent in the United States (US).MethodsThe River trial was a prospective, open-label, multicenter, single-arm trial which enrolled 39 subjects at 5 US centers. Eligible patients had clinical diagnosis of idiopathic intracranial hypertension (IIH) with severe headaches or visual field loss and had failed medical therapy. The primary safety endpoint was the 1-year rate of major adverse events compared with cerebrospinal fluid (CSF) shunting using historical controls. The primary benefit endpoint was a composite at 1 year of clinical improvement and absence of venous sinus stenosis. Secondary endpoints included improvement in pulsatile tinnitus, visual symptoms, quality of life (QOL) scores, and medications.ResultsAll procedures were technically successful. There was one serious adverse event, a gastrointestinal hemorrhage observed 2 months after the procedure while the patient was still on dual antiplatelet therapy. The primary safety endpoint was met with a rate of major adverse event of 5.4% versus 51.7% for CSF shunts. The primary benefit endpoint was achieved in 60% of trial participants. Additional improvements were also observed in opening CSF pressure, headaches, papilledema, pulsatile tinnitus, visual symptoms, and QOL scores. Post hoc analysis demonstrated that subjects with minimal or absent papilledema at baseline showed similar improvement compared with subjects with papilledema at baseline, in terms of headaches, pulsatile tinnitus, and QOL.ConclusionsThe River study 1- year results establish safety and suggest efficacy for venous sinus stenting in IIH subjects who have failed medical therapy.
BACKGROUND:Functional tricuspid regurgitation (TR) arises from impaired valve integrity resulting from contractile dysfunction, chamber dilation, or myocardial tissue alterations. Whereas right ventricular (RV) dysfunction is a recognized driver of adverse outcomes in TR, the impact of myocardial tissue injury, particularly nonischemic septal fibrosis (NIsF), remains largely unexplored. OBJECTIVES:This study aims to evaluate the association of NIsF with adverse right-sided chamber remodeling and to assess its incremental prognostic value for mortality in patients with functional TR. METHODS:Patients with advanced (≥ moderate) functional TR underwent comprehensive cardiac magnetic resonance (CMR) evaluation. Late gadolinium enhancement (LGE) was used to identify NIsF, defined as hyperenhancement in the midmyocardial or epicardial regions of the interventricular septum. Cine CMR measured functional and geometric indices of the left and right sides of the heart. Follow-up data were obtained for all-cause mortality. RESULTS:A total of 663 patients with advanced TR (mean age: 63.8 ± 16.0 years; 53% male) were studied, and 29.4% were found to have NIsF. NIsF was strongly associated with adverse chamber remodeling, including larger left ventricular and RV volumes, reduced systolic function, and increased TR severity (all P < 0.001). TR regurgitant fraction increased stepwise with NIsF extent (no NIsF, 34.9% ± 1.5%; 1 segment, 38.1% ± 13.0%; 2 segments, 40.8% ± 13.8%; P < 0.001). Over a mean follow-up of 4.3 ± 4.3 years, 25.3% of patients died. NIsF was independently associated with mortality (HR: 1.79 [95% CI: 1.26-2.56]; P = 0.001), even after adjusting for conventional risk markers, including age, TR severity, RV dysfunction, and dilation. Kaplan-Meier analysis demonstrated significantly higher mortality risk among patients with NIsF compared with patients without NIsF (P < 0.001). CONCLUSIONS:Among patients with advanced TR, NIsF is an important marker of adverse right-sided chamber remodeling and provides incremental prognostic utility beyond conventional risk markers.
