 means it can be difficult for healthcare providers to always make an accurate diagnosis. The start of autumn thus marks the onset of flu and fall allergy seasons, which may become all the more complicated during the ongoing 

, Lakiea Wright, MD, allergy and immunity, Brigham and Women’s Hospital, stressed that during this pandemic it becomes all the more essential for healthcare providers and clinicians to encourage their patients to receive their flu vaccination.

Many providers and healthcare system have developed novel strategies to ensure that individuals have easy and safe access to the vaccination. For example, drive-through flu clinics have become a more prevalent means of administering the vaccine.

, Wright explained that fever, sore throat, cough, and shortness of breath are typical overlapping symptoms between flu and allergies, as well as with COVID-19. Nonetheless, she emphasized the increasing necesseity to utilize the healthcare resources that are currently available.

“Even though that the symptoms overlap, it’s really important to make sure that patients are vaccinated, which will be really important for this upcoming season.” she said.

Videos

An expert discusses the importance of getting vaccinated for the flu this year as well as strategies healthcare systems are taking to ensure easy access for patients.

Lakiea Wright, MD: The Importance of Flu Vaccination

 (C. diff) infections represent a tremendous health burden in the US.

However, a team, led by Guy de Bruyn, MD, Sanofi Pasteur, evaluated the efficacy, immunogenicity, and safety of a toxoid vaccine candidate.

In the phase 3, multicenter, observer-blind, randomized, controlled trial, the investigators tested the new vaccine at 326 hospitals, clinics, and clinical research centers in 27 countries including the US and Canada in 9302 patients between July 2013 and November 2017.

Each participant was at least 50 years old and considered to be at an increased risk of C. diff infection due to 2 previous hospital stays of at least 24 hours and received systemic antibiotics in the previous 12 months or were anticipating being admitted to the hospital for 72 hours or more for elective surgery within 60 days of enrollment.

The eligible patients were stratified by geographical region, as well as by the 2 risk strata. Each participant was randomly assigned (2:1), with a fixed block size of 3, to receive either a C. diff toxoid vaccine candidate (n = 6201), containing toxoids A and B (C. diff vaccine candidate group) or a placebo vaccine (n = 3101). A total of 6173 (99.5%) of participants in the study vaccine group and 3085 (99.5%) in the placebo group received at least 1 dose of the vaccine.

Each participant received 1 dose of either the target vaccine or placebo intramuscularly on days 0, 7, and 30.

The investigators sought a primary outcome of the efficacy of the vaccine in preventing symptomatic C. diff infection, defined as having 3 or more loose stools in a period of 24 hours of less, loose stools for 24 hours or more, and a PCR-positive test for C. diff toxin B in a loose stool sample, within 3 years following the final vaccine dose.

The team measured the primary outcome in the modified intention—to-treat population, which included all participants who received at least 1 injection of the assigned vaccine.

However, the study was terminated following the first planned interim analysis due to futility.

In the C. diff vaccine group, there were 34 infections reported over 11,697.2 person years at risk (0.29 infections per 100 person-years; 95% CI, 0.20–0.41) compared with 16 infections over 5789.4 person-years at risk in the placebo group (0.28 infections per 100 person-years; 95% CI, 0.16–0.45).

This indicates the vaccine’s efficacy is -5.2% (95% CI, -104.1-43.5).

In the C. diff vaccine group, 2847 (46.6%) reported an adverse event within 30 days of injection, while 1282 (41.9%) in the placebo group reported an adverse event.

The proportion of patients who had an adverse event leading to discontinuation was 4.8% in both groups (296 participants in the C. diff vaccine candidate group and 146 participants in the placebo group) and 1662 (27.2%) participants in the C. diff vaccine candidate group reported at least 1 serious adverse event compared with 851 (27.8%) participants in the placebo group.

 infection,” the authors wrote. “Since the 

 vaccine candidate met the criteria for futility, the study was terminated and clinical development of this vaccine candidate was stopped.”

Safety, immunogenicity, and efficacy of a Clostridioides difficile toxoid vaccine candidate: a phase 3 multicenter, observer-blind, randomized, controlled trial

Articles

The trial was called off because of futility of the toxoid vaccine candidate.

C. Diff Vaccine Candidate Fails in Clinical Trial

A new study showed that leg length discrepancy is prevalent in early adolescent females and late adolescent males with homozygous 

. These discrepancies, which are attributed to leg shortening, were notably of mild to moderate severity.

Although sickle cell anemia has been known to affect linear body proportions, which may involve either leg shortening or lengthening among other abnormalities, there has been a lack of data assessing the different types and severities of leg length discrepancies in children with the condition.

Therefore, Eneh Ihuarula, MBBS, of Department of Pediatrics, of Enugu State University Teaching Hospital, Nigeria, evaluated the prevalence of leg length discrepancies in children as well as compared characteristics of these discrepancies among a pediatric sickle cell population and to those without sickle cell anemia. Overall, the main goal of this study was to support routine screening for leg length discrepancy in patients with sickle cell anemia.

The cross-sectional comparative study was conducted between June and August 2020, and included children attending the sickle cell disease clinic of the Enugu State University Teaching Hospital.

Ihuarula assessed 70 children, aged 1-18 years old and who were considered in a steady state—which she defined as crisis free for 4 weeks, no recent drop in the hemoglobin level, and no symptoms or signs of acute illness. The children also had confirmed HbSS by electrophoresis.

She excluded patients on chronic blood transfusion; with chronic renal, respiratory or cardiac diseases; history of cerebro-vascular accident; or prolonged steroid therapy.

Additionally, another 70 patients with hemoglobin genotype “AA” were consecutively enrolled from the children outpatient clinicals. She matched the control with subjects for age and sex.

For each patient, she determined true leg length, apparent leg length, and leg length discrepancy using a tape measure.

True leg length was measured from the anterior superior iliac spine (ASIS) to the distal tip of the medial malleolus (MM). Additionally, measurements were taken from the ASIS to the heel/floor (HEEL). These were recorded for each leg.

As for apparent leg length, Ihuarula measured from the umbilicus to the medial malleolus (UMB-MM) for both left and right legs.

Leg length discrepancy was defined as the difference in real or apparent length between the legs. The discrepancy values were then classified into mild (<2cm), moderate (2-5cm) severe (>5cm).

Thus, she found that the real leg length discrepancy between both legs, measured from ASIS-MM, was statistically significant for females aged 10-13 years. The mean discrepancy for females with sickle cell was 0.82 cm—as compared with 0.40 cm in the non-sickle cell female population (

Additionally, males aged 14-18 years had a more significant mean discrepancy, measured from ASIS-HEEL, than the control group— 1.63 cm vs 0.82 cm, respectively (

And finally, Ihuarula found that 81.4% of sickle cell patients presented with mild real leg length discrepancy, measured from ASIS-MM. Furthermore, 68.6% in the control group presented with the same level of severity (

Additionally, she noted, leg discrepancy across group characteristics generally were a result of the shortening of the left leg.

She concluded with a note that that leg length discrepancy of ≥1 cm may or may not cause functional changes in hips, pelvis, or spine. Therefore, she encouraged routine screening for leg discrepancy in children with sickle cell anemia.

Leg Length Discrepancies in Nigerian Children with Sickle Cell Anaemia

Journal of Advances in Medicine and Medical Research

These discrepancies are more pronounced in young, adolescent females and older adolescent males.

Sickle Cell Anemia Associated with Leg Length Discrepancies Among Adolescents

 (AKI) are common in patients suffering from the 

 (COVID-19), its pathogenesis is poorly understood.

A team, led by Tariq U. Azam, Division of Cardiology, Department of Internal Medicine, University of Michigan, began to shed light on the pathogenesis between AKI and COVID-19.

The urokinase receptor system could be a key regulator of the intersection between inflammation, immunity, and coagulation, while the soluble urokinase plasminogen activator receptor (suPAR) has been identified as an immunologic risk factor for acute kidney injuries. However, researchers do not know whether suPAR is linked with COVID-19-related AKI.

In the multinational, observational study, the investigators examined hospitalized adult COVID-19 patients. The researchers measured suPAR levels in plasma samples within 48 hours of hospital admission from 352 individuals and examined the association between suPAR levels and incident -in-hospital acute kidney injuries.

The mean age of the patient population was 61 years old.

A total of 91 (25.9%) individuals developed a AKI during hospitalization, 25 (27.4%) of which required dialysis. The median suPAR level was 5.61 ng/ml, while AKI incidence increased in conjunction with suPAR tertiles, from a 6.0% incidence in patients with suPAR <4.60 ng/ml (first tertile) to a 45.8% incidence of AKI in patients with suPAR levels >6.86 ng/ml (third tertile).

However, no patient with a suPAR <4.60 ng/ml required dialysis during their hospitalization. In the multivariable analysis, the highest suPAR tertile was linked to a 9.15-fold increase in the odds of an acute kidney injury (95% CI, 3.64-22.93), as well as a 22.86-fold increase in the odds of requiring dialysis (95% CI, 2.77-188.75). The investigators also found the association was independent of inflammatory markers and persisted across different subgroups.

“Admission suPAR levels in patients hospitalized for COVID-19 are predictive of in-hospital AKI and the need for dialysis,” the authors wrote. “SuPAR may be a key component of the pathophysiology of AKI in COVID-19.”

In a separate observational study of 3235 hospitalized patients with COVID-19 across the Mount Sinai Health System in New York, acute kidney injuries occurred in 1406 patients (46%), of whom 280 (20%) required dialysis. The researchers found about 66% of these injuries were moderate to severe and the majority of patients had evidence of proteinuria.

There have been other large studies conducted in both New York and China that produced similar findings regarding COVID-19 and acute kidney injuries.

Earlier this year, investigators found a mathematical way to forecast whether patients are at a high risk of developing an 

In the diagnostic study, the investigators examined 495,971 adult hospital admissions between 3 university hospitals in Illinois. The researchers used data from patients with serum creatinine (SCr) measurements from Loyola University Medical Center (LUMC) from 2007-2017 (n = 200,613), University of Chicago (UC) from 2008-2016 (n = 48,463), and at NorthShore University Health System (NUS) from 2006-2016 (n = 246,895).

In a time-to-event analysis, the investigators found a probability cutoff of at least 0.057 predicted the onset of a stage 2 AKI a median (IQR) of 27 hours prior to the eventual doubling in SCr concentrations in the University of Chicago cohort, 34.5 hours in the NUS cohort, and 39 hours in the LUMC cohort.

Soluble Urokinase Receptor (SuPAR) in COVID-19–Related AKI

Journal of the American Society of Nephrology

The highest suPAR tertile was linked to a 9.15-fold increase in the odds of an acute kidney injury.

Investigators Identify Key Component in COVID-19, Kidney Injury Link

Findings of a recent study showed house dust mites and grass allergens to be the most common triggers of 

 was found to be a comorbidity closely associated with the skin disease.

Currently, the global prevalence of atopic dermatitis stands at 20% in children and 3% in adults. The investigators of the study noted that although the disease is triggered by antigens, it is not clear which precise allergens are triggering factors.

Ömer Kutlu, MD, MRCP, and Ahmet Metin, MD, used file records from Kayseri Develi State Hospital of patients who underwent skin prick testing due to atopic dermatitis. They used the test results to determine the most common triggering allergens as well as any association with specific demographic factors.

Overall, they assessed 144 patients, with 73.6% being female. The median age of the population was 18 years (range, 3-51). Additionally, 63.2% of patients had a family history of allergic disease.

The skin prick test was administered by the same dermatologist so as to ensure standardization across all patients. Following administration of the test, positive results were evaluated and categorized into 4 levels of positivity degree– with 1 designating erythema ≤ 15 mm and no edema, and 5 designating edema > 6 mm as well as pseudopod development.

Thus, the investigators found that the most frequent allergens with ≥3 positivity (edema 3-6 mm), were grasses (31.2%), grasses mix (24.3%), Cynodon dactylon (15.3%), D. pteronyssinus (9.7%), D. farinae (7.6%), F. domesticus (7%), and Olea europaea (5.6%).

Furthermore, 65.3% of patients presented with a ≥1 degree of positivity, while 43.1% had a ≥3 positivity. Within both groups, 19.2% and 21.0%, respectively, demonstrated a reaction to only 1 allergen.

D. farinae and D. pteronysssinus positivity were much more frequent in patients >18 years than in those <18 years (

 .007, respectively). Besides these differences, there were no other statistical differences between other allergens and the age of the patients.

And finally, they found a statistical difference between ≥3 positivity and allergic rhinitis (

 = .006). Additionally, those with allergic rhinitis were much likelier to have a ≥1 and ≥3 positivity.

Those with atopic dermatitis who had comorbid allergic rhinitis and a ≥3 positivity were more typically triggered by grasses (44.5%), grasses mix (37.0%), Cynodon dactylon (27.2%), D. farinae (9.9%), D. pteronyssinus (8.6%), and Canis familiaris (8.6%).

“Detection of allergens, particularly in patients with atopic dermatitis, is crucial for the treatment and prevention of the disease,” Kutlu and Metin emphasized.

They concluded by referencing previous literature that assessed the associations among specific characteristics, such as geographic locations, various types of allergens, and patients with atopic dermatitis. Yet, they noted there is still potential for more in-depth research.

“Further multicenter, comprehensive SPT [skin prick test] based studies on atopic dermatitis will illuminate the possible triggers of the disease in atopic dermatitis in different geographies,” they wrote.

Evaluation of Skin Prick Test Results in Patients with Atopic Dermatitis

D. farinae and D. pteronyssinus positive skin prick test results were much more frequent in patients >18 years.

House Dust Mites and Grass Allergens Are Common Triggers for Atopic Dermatitis

New data analysis of the ongoing French Cohort of Myocardial Infarction Evaluation (FRENCHIE) registry reveals a decline in hospital admission for 

Although the reasons for such findings can only be speculative, the investigators noted that this marked decrease should encourage public health officials to provide appropriate messages that especially target those that are wary of utilizing health services during the pandemic.

Jules Mesnier, MD, of the University of Paris, and colleagues used registry data to quantify changes in myocardial infarction-related hospital admissions following the lockdown in France. Their assessment also compared admission changes between patients with ST-elevation myocardial infarction (STEMI) and non-ST-elevation myocardial infarction (NSTEMI).

The FRENCHIE registry, which includes 21 participating centers, captures within 48 hours of symptom onset patients who present with either STEMI or NSTEMI. Therefore, Mesnier and colleagues used this timeframe to define recent acute myocardial infraction.

The investigators collected data over an 8-week period, which covered 4 weeks preceding lockdown and 4 weeks following it.

Patients admitted to the hospital due to COVID-19 who had subsequently developed myocardial infarction were excluded in their analysis. On the contrary, patients admitted for myocardial infarction who were then diagnosed with COVID-19 were included.

The primary outcome sought by the investigators was change in number of hospital admissions for all types of myocardial infarction, NSTEMI, and STEMI between the weeks preceding and following lockdown.

Additional objectives included further subgroup analyses of admission change and overall change in mortality between both periods.

Thus, the team reported that between February 17 and April 12, 2020, a total of 1167 patients were consecutively admitted to the hospital for recent acute myocardial infarction. Of the total, 583 had STEMI and 584 had NSTEMI.

Overall admission decreased from 686 to 481 between the periods (-30% [incidence rate ratio, 0.69; 95% CI, 0.51-0.70]).

Furthermore, admissions for STEMI decreased from 331 to 252 (-24% [IRR, 0.72; 95% CI, 0.62-0.85]), and admissions for NSTEMI decreased from 355 to 229 (-35% [IRR, 0.64; 95% CI, 0.55-0.76)].

Patients who were ≥80 years (n = 208) had a more noticeable decline than those who were younger (IRR, 0.64; 95% CI, 0.48-0.86).

They also noted that this decrease in admission had no association with regional COVID-19 prevalence or subgroup characteristics, such as gender, history of diabetes, history of hypertension, and smoking habits.

In-hospital mortality was numerically higher after the lockdown than before it—25 (5%) of 481 patients vs 23 (3%) of 686, respectively. However, the team did not consider it statistically significant.

Such trends, therefore, may likely be attributed to patient fears of exposure to the virus in the hospital.

“These concerns might have been amplified by the general message that people should stay at home.,” they wrote.

Another notable explanation may involve reduced exposure to air pollution, a known trigger of acute myocardial infarction. The investigators did not consider both explanations to be mutually exclusive.

Mesnier and team acknowledged a need to conduct the study with a longer survey period beyond the first month and after the end of lockdown.

“Meanwhile, health authorities should be fully aware of the current situation in order to deliver appropriate public health messages,” they concluded. “This is crucial in countries still fighting COVID-19, but also in the case of a second wave in countries that are past the first wave of the pandemic, or in case another pandemic occurs in the future.”

Hospital admissions for acute myocardial infarction before and after lockdown according to regional prevalence of COVID-19 and patient profile in France: a registry study

This decrease in hospital admissions had no association with regional prevalence of COVID-19. 

COVID-19 Lockdown Linked to Decline in Acute Myocardial Infarction Hospitalizations

A better understanding of the cut points of 

 (IBD) biomarkers could help yield better pharmaceutical options for patients.

The neutrophil fecal biomarkers, calprotectin (FCP) and lactoferrin (LCT), and peripheral blood neutrophil CD64 surface receptor (nCD64) are biomarkers for mucosal inflammation in IBD. While FCP has been evaluated as a biomarker for mucosal healing in the past, cut points for LCT and nCD64 are less known.

A team, led by Ruben J. Colman, MD, Division of Gastroenterology, Hepatology and Nutrition, Cincinnati Children’s Hospital Medical Center, identified the cut points for LCT and nCD64 associated with FCP remission, while evaluating the relationship between biochemical outcomes and infliximab trough concentrations. 

The investigators analyzed FCP, LCT, and nCD64 both before and after infliximab induction in pediatric patients with Crohn’s disease. They defined week 14 FCP biomarker remission as FCP <250 µg/g and clinical response as a weighted Pediatric Crohn’s Disease Activity Index of an <12.5 or Δ>17.5 improvement.

Finally, the researchers calculated predictive outcomes by receiver operating characteristics (ROCs).

The study included a total of 56 patients with Crohn’s disease. The ROC analysis identified an infusion 4 LCT <8.06 (area under the receiver operator characteristics [AUROC], 0.934; 

 = 0.02) as the ideal cut points for week-14 FCP biomarker remission.

Both the end of induction infliximab-trough of >9.4 µg/mL (AUROC, 0.799; 

 = 0.002) and >11.5 µg/mL (AUROC, 0.835; 

 = 0.003) were linked with a FCP <250 and FCP <100, respectively.

The investigators also found patients achieving end of induction trough greater than 5 µg/mL had a median FCP improvement (dose 1-4) of 90% compared with a median of 35% with levels <5 µg/mL (

 = 0.024) with a similar median reduction in nCD64 (48% vs 20%; 

“This study establishes cut points in neutrophil stool and blood biomarkers for both biochemical remission and therapeutic trough levels following induction therapy,” the authors wrote. “Further studies that evaluate pharmacodynamic biomarker targets for endoscopic and histologic healing are warranted.”

Last year, investigators discovered the allele HLA-DQA1*05 could be a useful biomarker in predicting anti-drug antibodies for 

A team, led by Alekseis Sazonovs, Wellcome Sanger Institute, performed a genome-wide association study to identify variants linked to the time of development of anti-drug antibodies of 1240 biologic-naïve patients with Crohn’s disease starting anti-tumor necrosis factor (anti-TNF) drugs such as infliximab or adalimumab.

Anti-TNF has become the most widely used biologic drug to treat immunemediated diseases.

However, repeated administration can induce the formation of anti-drug antibodies. The ability to identify patients at increased risk for development of anti-drug antibodies could facilitate the selection of therapy and use of preventative strategies.

The HLA-DQA1*05 allele, which significantly increases the rate of immunogenicity (HR, 1.90; 95% CI, 1.60—2.25; 

 =5.88 × 1013), is carried by approximately 40% of Europeans.

Achieving Target Infliximab Drug Concentrations Improves Blood and Fecal Neutrophil Biomarkers in Crohn’s Disease

The cut points for LCT and nCD64 in Crohn’s disease were not previously known. 

Infliximab Effective Improving Biomarkers for Pediatric Crohn's Disease

Findings of a recent analysis indicated frozen fecal material from universal donors may be related to a higher rate of clinical remission among patients with 

The results produced positive evidence of the use of frozen fecal material.

Luciane de Fatima Caldeira, MS, and colleagues conducted a systematic review and meta-analysis to gather evidence on the efficacy and safety of fecal microbiota transplantation for IBD. They conducted searches in PubMed, Scopus, and Web of Science databases. The team searched for phrases including fecal microbiota transplantation, fecal microbiota, foecal microbiota, and faecal microbiota. Studies evaluated the efficacy/effectiveness or safety of fecal microbiota transplantation in patients of any age or gender diagnosed with IBD, with or without a treatment comparator and reporting response, remission, or adverse events.

Members of the team screened the titles and abstracts to identify irrelevant records. They used a standardized form to collect data on the general characteristics and clinical outcomes of the included studies.

The investigators included 60 studies for the qualitative synthesis and 36 were able to be used in the quantitative synthesis. The mean Newcastle-Ottawa Scale score for the quasi-experimental studies was 6 (range, 6-8).

The team noted 6 of 9 randomized controlled trials presented comparable data and were assessed in 2 meta-analyses—1 for clinical remission and 1 for clinical response. There were statistically significant differences observed for both outcomes, favoring fecal microbiota transplantation over placebo (355 patients, clinical remission: RR, 1.7 [95% CI, 1.12-2.56], I2=45%; clinical response: RR, 1.68 [95% CI, 1.04-2.72], I2=55%).

Overall, 24 quasi-experimental studies assessed clinical remission. An analysis resulted in a clinical remission prevalence of 32.3% (95% CI, 23.1-43.1), while the 9 randomized controlled trials resulted in a rate of 46% (95% CI, 31.4-61.4). There was an overall remission rate of 37% (95% CI, 28.8-45.9) and there was no significant difference between the 2 study designs (

In a stool type subgroup analysis, the clinical remission rate for fresh fecal material was 29.1%, while rates were 44.2% for frozen fecal matter, 57.2% when both types of stool were used, and 66.5% for capsules, with a statistical difference observed among the groups (

=.036).Patients who had Crohn disease presented a remission rate of 47.6% and those with ulcerative colitis demonstrated a remission rate of 35%.

For clinical response, 26 quasi-experimental studies and 7 randomized controlled trials resulted in a response of 53.5% and 54.4%, respectively. Those who received fresh fecal material had a clinical response of 52.1%, while patients who received frozen fecal material presented a response of 52.8%. If fecal material was received from relatives or acquaintances, the pooled clinical response was 37.1%. Those who received fecal material from universal donors had a response rate of 59.7%.

There was a frequency of 26.9% and 48.2% for adverse events among the quasi-experimental studies and randomized controlled trials, respectively. Among studies where fresh fecal material was transplanted, the frequency of any adverse event was 30.2%, while it was 43.2% among studies using frozen fecal material and 22.6% in those using capsules.

The investigators found fecal material transplantation for the management of patients with IBD demonstrated a response rate of 53.8% with a complete remission of 37%.

Fecal microbiota transplantation in inflammatory bowel disease patients: A systematic review and meta-analysis

Fecal material transplantation for the management of patients with IBD demonstrates a response rate of 53.8% with a complete remission of 37%.

Positive Effects of Fecal Material Transplantation for IBD Management

In late May, a surgery team at the Northwestern Medicine Lung Transplant Program executed a medical marvel: the first double lung transplant in the US for a severely ill patient with 

Ankit Bharat, MD, chief of thoracic surgery and surgical director for the program, shared the incredible story on the 

, highlighting what his team has found to be foundational evidence for a last-ditch procedure for patients failing to recover from the virus.

Though the successful transplant set a precedent for COVID-19 care, Bharat also sees it helping to confront another great US public health issue: the underutilization of donor lungs.

“Only 15% of all the lungs coming from donors get utilized,” he explained. “We have a huge opportunity to understand donor management and improve the utilization of those lungs.”

Approximately 2700 lung transplants were performed in the US last year, Bharat said—with many more opportunities for procedures left unanswered, and an even greater count of donor lungs expired.

Many factors influence the minimal rate of lung transplants, and one that seems to be a self-perpetuating issue is the mortality risk, which Bharat said is approximately 10% now.

“But the gap can absolutely be overcome by how many donors are already there,” Bharat said. “I don’t personally think that’s a challenge we can’t overcome.”

Along with showing capability to better a respiratory distress-generating disease like COVID-19, surgeons have become capable of safely transplanting hepatitis C patient donor lungs—a previously taboo practice—as well as using ex vivo lung perfusion circuits to give second life to donor lungs.

“We certainly hope with the success we’ve had, and other centers on the east coast and west coast similarly performing these transplants and getting these patients through, the OPTN (Organ Procurement and Transplantation Network) includes COVID-19 as a diagnosis code in their registration of these recipients,” Bharat said.

Listen to Bharat’s perspective on improving lung transplants, as well as his team’s miraculous procedure, on Lungcast.

Low annual donor use and high mortality rates could be correlatively improved with greater embrace of opportunities.

How a COVID-19 Procedure Helps the Case for Better Lung Transplant Use

Findings of a recent study do not indicate nocturnal oxygen has a positive or negative effect on survival or progression to long-term oxygen therapy in patients with chronic obstructive pulmonary disease (COPD).

Still, the trial was underpowered as it did not reach full enrollment.

Yves Lacasse, MD, and colleagues designed a double-blind, placebo-controlled, randomized trial to determine whether nocturnal oxygen provided for a period of 3-4 years would decrease mortality or the worsening of disease so patients could meet current specifications for long-term oxygen therapy. Patients included had COPD with nocturnal arterial oxygen desaturation without qualifying for long-term oxygen therapy. All patients had stable disease for at least 6 weeks before enrollment and had been nonsmokers for at least 6 months. The team defined nocturnal desaturation as a nocturnal home oximetry recording of at least 30% of the recording time with an oxygen saturation of less than 90%.

Lacasse and the investigators randomly assigned patients 1:1 to receive either home nocturnal oxygen from an oxygen concentrator or ambient air from a sham concentrator (placebo). At baseline, the team took clinical measurements including the Charlson comorbidity index, spirometry, lung volumes, carbon monoxide diffusion capacity, and arterial blood gas.

The nocturnal oxygen was delivered overnight from an electrically powered oxygen concentrated. Patients used supplemental oxygen throughout the night. The goal was to maintain a nocturnal oxygen saturation of more than 90% for at least 90% of the recording time. Oxygen adjustment was performed at home, starting with a rate of 2 liters per minute during a first test night and increased by increments of 1 liter per minute per night, up to 4 liters per minute.

Those in the control group received ambient air delivered through identical concentrators rendered ineffective by bypassing the sieve beds. Patients in this group also underwent a sham flow-rate adjustment procedure.

The primary outcome of the study was a composite of death from any cause or a requirement for long-term oxygen therapy. Additional outcomes included adherence to the intervention, exacerbation and hospitalization rates, and quality of life.

Overall, 243 patients were enrolled in the study—123 were randomly assigned to receive nocturnal oxygen and 120 received placebo. Of the patients, 79% met the definition for nocturnal desaturation on the 2 oximetry studies. There were 242 patients at the three-year follow-up and 231 patients at the four-year follow-up.

A majority of the patients, 97.5% who received oxygen had nocturnal saturation during the treatment within the target flow rate and 78.2% were given oxygen at a flow rate of 2 liters per minute. At 3 years of follow-up, 39% of those assigned to nocturnal oxygen and 42% of those assigned to placebo met the NOTT-defined criteria for long-term oxygen therapy or died (difference, -3 percentage points; 95% CI, -15.1 to 9.1; 

The investigators noted at 3 and 4 years of follow-up, the absolute differences between the 2 trial groups in the percentage of patients with a primary outcome event, the separate component of death, or the separate component of a requirement for long-term oxygen therapy were all no more than 6.5 percentage points. There was no significant difference between nocturnal oxygen and placebo in the composite outcome (HR, .87; 95% CI, .61-1.25; 

=.44) or its separate components of death (HR, .98; 95% CI, .6-1.63) and a requirement for long-term oxygen therapy (HR, .87; 95% CI, .57-1.34).

Randomized Trial of Nocturnal Oxygen in Chronic Obstructive Pulmonary Disease

All News