Anesthesia in Children with Pulmonary Hypertension: Clinically Significant Serious Adverse Events Associated with Cardiac Catheterization and Non-Cardiac Procedures

2022 ◽  
Author(s):  
Mary Lyn Stein ◽  
Steven J. Staffa ◽  
Amy O'Brien Charles ◽  
Ryan Callahan ◽  
James A. DiNardo ◽  
...  
Keyword(s):  
Pulmonary Hypertension ◽  
Adverse Events ◽  
Cardiac Catheterization ◽  
Serious Adverse Events ◽  
Cardiac Procedures ◽  
Clinically Significant

4971Blood viscosity and its relevance to the diagnosis and management of pulmonary hypertension: a new elephant in the cathlab

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
A Kempny ◽  
K Dimopoulos ◽  
A E Fraisse ◽  
G P Diller ◽  
L C Price ◽  
...  
Keyword(s):  
Pulmonary Hypertension ◽  
Cardiac Catheterization ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
Pulmonary Vasculature ◽  
Pulmonary Vascular Disease ◽  
Significant Difference ◽  
The Difference ◽  
Clinically Significant ◽  
The Relationship

Abstract Background Pulmonary vascular resistance (PVR) is an essential parameter assessed during cardiac catheterization. It is used to confirm pulmonary vascular disease, to assess response to targeted pulmonary hypertension (PH) therapy and to determine the possibility of surgery, such as closure of intra-cardiac shunt or transplantation. While PVR is believed to mainly reflect the properties of the pulmonary vasculature, it is also related to blood viscosity (BV). Objectives We aimed to assess the relationship between measured (mPVR) and viscosity-corrected PVR (cPVR) and its impact on clinical decision-making. Methods We assessed consecutive PH patients undergoing cardiac catheterization. BV was assessed using the Hutton method. Results We included 465 patients (56.6% female, median age 63y). The difference between mPVR and cPVR was highest in patients with abnormal Hb levels (anemic patients: 5.6 [3.4–8.0] vs 7.8Wood Units (WU) [5.1–11.9], P<0.001; patients with raised Hb: 10.8 [6.9–15.4] vs. 7.6WU [4.6–10.8], P<0.001, respectively). Overall, 33.3% patients had a clinically significant (>2.0WU) difference between mPVR and cPVR, and this was more pronounced in those with anemia (52.9%) or raised Hb (77.6%). In patients in the upper quartile for this difference, mPVR and cPVR differed by 4.0WU [3.4–5.2]. Adjustment of PVR required Conclusions We report, herewith, a clinically significant difference between mPVR and cPVR in a third of contemporary patients assessed for PH. This difference is most pronounced in patients with anemia, in whom mPVR significantly underestimates PVR, whereas in most patients with raised Hb, mPVR overestimates it. Our data suggest that routine adjustment for BV is necessary.

scholarly journals The effect of the duration of the procedure on the risk of complications during pediatric cardiac catheterization

2020 ◽  
Vol 28 (3) ◽  
pp. 467-473
Author(s):  
Kübra Evren Şahin
Keyword(s):  
Risk Factors ◽  
Adverse Events ◽  
Cardiac Catheterization ◽  
Risk Score ◽  
Potential Risk ◽  
Pediatric Patients ◽  
Heart Catheterization ◽  
Serious Adverse Events ◽  
Cardiac Catheterization Laboratory ◽  
Study Results

Background: This study aims to evaluate the frequency of and associated risk factors for adverse events caused by cardiac catheterization procedures in pediatric patients. Methods: Between January 2009 and January 2012, a total of 599 pediatric patients (320 males, 279 females; mean age 5.4±4.7 years; range, 1 day to 21 years) who underwent cardiac catheterization in our cardiac catheterization laboratory were retrospectively analyzed. Demographic and clinical data of the patients including the duration of the procedure, management of anesthesia, the American Society of Anesthesiologists class, and Catheterization Risk Score for Pediatrics, and procedure-related serious adverse events were recorded. Results: The incidence of procedure-related serious adverse events was 9.18%. Potential risk factors associated with serious adverse events were identified as interventional heart catheterization, high scores obtained from the Catheterization Risk Score for Pediatrics, the use of endotracheal tube in airway control, and prolonged procedural duration. Conclusion: Our study results suggest that prolonged duration of catheterization is a potential risk factor for procedure-related adverse events and the duration of the procedure needs to be included as a variable in the Catheterization Risk Score for Pediatrics scoring system for predicting procedure-related adverse events.

Rate of Serious Adverse Events Associated with Diazoxide Treatment of Patients with Hyperinsulinism

2019 ◽  
Vol 91 (1) ◽  
pp. 25-32 ◽  
Author(s):  
Paul Thornton ◽  
Lisa Truong ◽  
Courtney Reynolds ◽  
Tyler Hamby ◽  
Jonathan Nedrelow
Keyword(s):  
Pulmonary Hypertension ◽  
Adverse Events ◽  
Retrospective Analysis ◽  
First Line ◽  
Serious Adverse Events ◽  
Infants Of Diabetic Mothers ◽  
Drug Agency ◽  
Different Types ◽  
The Difference ◽  
Diabetic Mothers

Introduction: Diazoxide is the first line and only Federal Drug Agency approved pharmacological agent for the treatment of hyperinsulinism. Its use has increased over the years to include patients with various genetic forms of hyperinsulinism, perinatal stress hyperinsulinism and infants of diabetic mothers with more babies than ever being exposed to this therapy. Methods: We performed a retrospective analysis of 194 patients with hyperinsulinism in our clinic and looked for those who had experienced serious adverse events (SAE) including pulmonary hypertension and neutropenia. We compared the rates of SAE in the different types of hyperinsulinism. Results: Out of 194 patients with hyperinsulinism, 165 (85.1%) were treated with diazoxide. There were 17 SAEs in 16 patients including 8 cases of pulmonary hypertension and 8 of neutropenia. These data show that overall the frequency of SAE associated with diazoxide use is 9.7%, but that those with perinatal stress hyperinsulinism have a much higher rate than those with genetic forms of hyperinsulinism (16.7 vs. 3.6%; p = 0.01). We also found diazoxide is associated with pulmonary hypertension (4.8% of patients treated). Although more patients with perinatal stress hyperinsulinism (7.6%) were affected than genetic hyperinsulinism (1.2%), the difference was not significant (p = 0.088). Conclusion: The rate of SAEs associated with (not necessarily caused by) diazoxide has been demonstrated. The rate of SAE in newborns with perinatal stress hyperinsulinism is significantly higher than that of otherwise healthy babies with genetic forms of hyperinsulinism, suggesting that caution should be used when prescribing diazoxide to this population. This information should help balance the risk benefit of treatment and provide guidance on screening for these complications in the population of treated patients.

Coronary artery perforation

2010 ◽  
pp. 541-555 ◽  
Author(s):  
Mark Gunning ◽  
Martyn Thomas
Keyword(s):  
Coronary Artery ◽  
Adverse Events ◽  
Cardiac Catheterization ◽  
Significant Risk ◽  
Serious Adverse Events ◽  
Catheterization Laboratory ◽  
Cardiac Catheterization Laboratory ◽  
Coronary Artery Perforation ◽  
Early Implementation ◽  
Catheter Laboratory

There are few scenarios in the cardiac catheterization laboratory quite as dramatic as a coronary artery perforation. While some instances of this mishap are subtle, others are quite dramatic. Fortunately this occurrence is rare, but carries with it a significant risk of serious adverse events. The potential for harm may be reduced by the brisk identification of the problem within the catheter laboratory, together with early implementation of treatment.

scholarly journals Sildenafil for bronchopulmonary dysplasia and pulmonary hypertension: a meta-analysis

2019 ◽  
Vol 9 (3) ◽  
pp. 204589401983787 ◽  
Author(s):  
Marisa van der Graaf ◽  
Leonne Arindah Rojer ◽  
Willem Arnold Helbing ◽  
Irwin Karl Marcel Reiss ◽  
Jonathan Richard Gregory Etnel ◽  
...  
Keyword(s):  
Systematic Review ◽  
Pulmonary Hypertension ◽  
Adverse Events ◽  
Preterm Infants ◽  
Bronchopulmonary Dysplasia ◽  
Complex Disease ◽  
Meta Analysis ◽  
Expression Patterns ◽  
Serious Adverse Events ◽  
Variable Expression

Bronchopulmonary dysplasia (BPD) is the most common complication in preterm infants and often complicated by pulmonary hypertension (PH), leading to substantial morbidity and mortality. Sildenafil is often used to treat PH and improve symptoms in this condition, even though evidence of safety and effectiveness is scarce. The aim of this study was to perform a systematic review and meta-analysis about the effectiveness and safety of chronic use of sildenafil in preterm infants with BPD-associated PH. Data sources were PubMed, EMBASE, and Medline. Studies reporting the effectiveness of sildenafil therapy in BPD-associated PH in newborns and infants were included. All-cause mortality, improvement in PH, improvement in respiratory scores, and adverse events were extracted. Five studies were included, yielding a total of 101 patients with 94.2 patient-years of total follow-up. The pooled mortality rate was 29.7%/year (95% confidence interval [CI] = 6.8–52.7). Estimated pulmonary arterial pressure improved > 20% in 69.3% (95% CI = 56.8–81.8) of patients within 1–6 months. Respiratory scores improved in 15.0% (95% CI = 0.0–30.4) of patients within 2–7 days. There were no serious adverse events during sildenafil therapy. This systematic review shows that in the treatment of BPD-associated PH in preterm infants, sildenafil may be associated with improvement in PAP and respiratory scores. However, there is no clear evidence of its effect on mortality rates. Considering BPD as a complex disease with variable expression patterns, these results support the need for a prospective registry and standardized approach.

scholarly journals Multiple-Ascending-Dose Phase 1 Clinical Study of the Safety, Tolerability, and Pharmacokinetics of CRS3123, a Narrow-Spectrum Agent with Minimal Disruption of Normal Gut Microbiota

2019 ◽  
Vol 64 (1) ◽  
Author(s):  
Barbara K. Lomeli ◽  
Hal Galbraith ◽  
Jared Schettler ◽  
George A. Saviolakis ◽  
Wael El-Amin ◽  
...  
Keyword(s):  
Adverse Events ◽  
Gut Microbiota ◽  
Phase 1 ◽  
Toxin Production ◽  
Trna Synthetase ◽  
Serious Adverse Events ◽  
Content Type ◽  
Clostridioides Difficile ◽  
Clinically Significant ◽  
Microbiome Data

ABSTRACT CRS3123 is a novel small molecule that potently inhibits methionyl-tRNA synthetase of Clostridioides difficile, inhibiting C. difficile toxin production and spore formation. CRS3123 has been evaluated in a multiple-ascending-dose placebo-controlled phase 1 trial. Thirty healthy subjects, ages 18 to 45 years, were randomized into three cohorts of 10 subjects each, receiving either 200, 400, or 600 mg of CRS3123 (8 subjects per cohort) or placebo (2 subjects per cohort) by oral administration twice daily for 10 days. CRS3123 was generally safe and well tolerated, with no serious adverse events (SAEs) or severe treatment-emergent adverse events (TEAEs) reported. All subjects completed their assigned treatment and follow-up visits, and there were no trends in systemic, vital sign, or laboratory TEAEs. There were no QTcF interval changes or any clinically significant changes in other electrocardiogram (ECG) intervals or morphology. CRS3123 showed limited but detectable systemic uptake; although absorption increased with increasing dose, the increase was less than dose proportional. Importantly, the bulk of the oral dose was not absorbed, and fecal concentrations were substantially above the MIC90 value of 1 μg/ml at all dosages tested. Subjects receiving either of the two lower doses of CRS3123 exhibited minimal disruption of normal gut microbiota after 10 days of twice-daily dosing. CRS3123 was inactive against important commensal anaerobes, including Bacteroides, bifidobacteria, and commensal clostridia. Microbiome data showed favorable differentiation compared to other CDI therapeutics. These results support further development of CRS3123 as an oral agent for the treatment of CDI. (This study has been registered at Clinicaltrials.gov under identifier NCT02106338.)

scholarly journals A First-in-Human Study To Assess the Safety and Pharmacokinetics of LYS228, a Novel Intravenous Monobactam Antibiotic in Healthy Volunteers

2019 ◽  
Vol 63 (7) ◽  
Author(s):  
Megan Osborn ◽  
Noah Stachulski ◽  
Haiying Sun ◽  
Johanne Blais ◽  
Vinay Venishetty ◽  
...  
Keyword(s):  
Adverse Events ◽  
Healthy Volunteers ◽  
Treatment Options ◽  
Human Study ◽  
Multidrug Resistant ◽  
Serious Adverse Events ◽  
Antibiotic Resistant ◽  
Content Type ◽  
Injection Site Reactions ◽  
Clinically Significant

ABSTRACT Infections caused by antibiotic-resistant Gram-negative bacteria expressing extended-spectrum β-lactamases and carbapenemases are a growing global problem resulting in increased morbidity and mortality with limited treatment options. LYS228 is a novel intravenous monobactam antibiotic targeting penicillin binding protein 3 with potent activity against Enterobacteriaceae, including multidrug-resistant clinical isolates expressing serine and metallo-β-lactamases. In this study, we evaluated the safety, tolerability, and pharmacokinetics of single and multiple intravenous doses of LYS228 in healthy volunteers. LYS228 was safe: no serious adverse events were reported. Adverse events, with the exception of catheter-related events, occurred sporadically, with similar incidences between LYS228 and placebo groups. No apparent adverse event-dose relationship was identified. LYS228 was not associated with any clinically significant dose-related hematologic, hepatic, or renal laboratory abnormalities. The most frequently observed adverse events were local injection site reactions, noted in 91.7% and 75.0% of subjects administered multiple doses of LYS228 and placebo, respectively. LYS228 demonstrated pharmacokinetic properties consistent with those of other β-lactam antibiotics, with systemic exposures slightly greater than dose proportional, short terminal half-lives (between 1.0 and 1.6 h) with no significant accumulation, and rapid clearance predominantly through urinary excretion.

scholarly journals Worldwide Assessment of Linezolid's Clinical Safety and Tolerability: Comparator-Controlled Phase III Studies

2003 ◽  
Vol 47 (6) ◽  
pp. 1824-1831 ◽  
Author(s):  
Ethan Rubinstein ◽  
Raul Isturiz ◽  
Harold C. Standiford ◽  
Leon G. Smith ◽  
Thomas H. Oliphant ◽  
...  
Keyword(s):  
Adverse Events ◽  
Safety Data ◽  
Multidrug Resistant ◽  
Community Acquired Pneumonia ◽  
Phase Iii ◽  
Serious Adverse Events ◽  
Clinical Safety ◽  
Clinical Benefits ◽  
Safety Assessments ◽  
Clinically Significant

ABSTRACT Linezolid, an oxazolidinone antibiotic, has 100% oral bioavailability and favorable activities against gram-positive pathogens including multidrug-resistant staphylococci, enterococci, and pneumococci. Safety assessments were conducted for 2,046 linezolid-treated patients and 2,001 comparator drug-treated patients from seven controlled clinical trials comparing the activities of linezolid and comparator drugs against nosocomial and community-acquired pneumonia, skin and skin structure infections, and methicillin-resistant staphylococcal infections. Drug-related adverse events were primarily transient. The most frequent (≥2%) adverse events caused by linezolid and the comparator drugs were diarrhea (4.3 and 3.2%, respectively; P = 0.074), nausea (3.4 and 2.3%, respectively; P = 0.036), and headache (2.2 and 1.3%, respectively; P = 0.047). Treatment discontinuations due to drug-related events (2.4 and 1.9%, respectively), serious adverse events (11.4 and 10.6%, respectively), and deaths (4.8 and 4.9%, respectively) were similar. No clinically significant drug-related hematologic events were reported, and laboratory safety data were comparable. In the first 6 months of postmarketing surveillance, hematologic abnormalities were reported in 0.1% of linezolid-treated patients, but no irreversible blood dyscrasias were documented. The risk for transient, reversible hematologic effects from treatment with linezolid should be considered together with the clinical benefits associated with its use.

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