Hemophilia B: Rebinyn® Now Available To Treat Acute Bleeds and Surgical Bleeding

MedicalResearch.com Interview with:

Stephanie Seremetis, M.D. Corporate Vice President and Chief Medical Officer Biopharmaceuticals at Novo Nordisk

Dr. Stephanie Seremetis

Stephanie Seremetis, M.D.
Corporate Vice President and Chief Medical Officer
Biopharmaceuticals at Novo Nordisk


MedicalResearch.com:
What is the background for this announcement?

Response: We’re proud and excited to make Rebinyn® (Coagulation Factor IX (Recombinant), GlycoPEGylated) available as a new extended half-life treatment for hemophilia B management.

Rebinyn® is an injectable medicine used to treat and control bleeding in adults and children with hemophilia B. It can be used to treat bleeds when they occur and to manage bleeding during surgery. Rebinyn® is not used for routine prophylaxis or for immune tolerance induction in patients with hemophilia B.

Hemophilia B is a serious, chronic, inherited bleeding disease that affects about 5,000 people in the U.S. People living with hemophilia B have low levels of clotting Factor IX protein in the blood, often resulting in prolonged or spontaneous bleeding, especially into the muscles, joints or internal organs.  Continue reading

HoloLens Uses Mixed Reality To Facilitate Reconstruction in Trauma Patients

MedicalResearch.com Interview with:
Dr. Dimitri Amiras, FRCR
Consultant radiologist
Imperial College Healthcare NHS Trust
Dr. Philip Pratt PhD
Research Fellow
Department of Surgery & Cancer
Imperial College London at St Mary’s Hospital

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: We have used the Microsoft HoloLens to assist with complex reconstructive surgery on several patients at a major trauma centre at St Marys Hospital. We believe this is the first report of such a use in reconstructive surgery.

From dedicated CT scans we have been able to construct patient specific 3D models of the vascular channels supplying the skin to help the surgeon plan their surgical approach for the harvest of these skin flaps. These 3D models are then projected onto the patient as holograms using the Microsoft HoloLens making the information available and directly relevant at the time of the procedure.

The technique helps the surgeon in planning his approach for the patient as well saving time locating the correct vessels at the time of surgery. 

The surgeon's view. Credit: Philip Pratt, et al. Eur Radiol Exp, 2018

Surgical View Using Mixed Reality Image Created By HoloLens
Credit: Philip Pratt, et al.

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Teaching Deep Breathing Before Abdominal Surgery Reduced Post-Op Pneumonia

MedicalResearch.com Interview with:
Ianthe Boden

Titled Cardiorespiratory APAM, PhD Candidate, MSc, BAppSc
Manager Abdominal Surgery Research Group
Clinical Lead – Cardiorespiratory Physiotherapy, Physiotherapy Department
Allied Health Services
Tasmanian Health Services – North |
Launceston General Hospital
Launceston TA 

MedicalResearch.com: What is the background for this study?

Response: Major upper abdominal surgery involves opening up the abdomen – mainly to remove cancer or damaged bowel, liver, stomach, pancreas, or kidney.  It is, by far, the most common major surgical procedure performed in developed countries with millions of procedures performed per annum. Unfortunately a respiratory complication following these operations occurs relatively frequently with between 1 in 10 to almost a half of all patients getting some type of respiratory complication after surgery. Respiratory complications included problems such as pneumonia, lung collapse, respiratory failure, and an acute asthma attack. These complications, especially pneumonia and respiratory failure, are strongly associated with significant morbidity, mortality, increased antibiotic usage and longer hospital stay.

These breathing problems occur quite quickly after surgery, becoming evident usually within the first two to three days after surgery. In an effort to ameliorate these complications in developed countries it is common for physiotherapists/respiratory therapists to see a patient for the first time on the day after surgery and start patients doing breathing exercises. However as respiratory dysfunction starts occurring immediately following surgery it is debated that these breathing exercises are being provided too late. Initiating prophylactic treatment more than 24 hours after the end of surgery may not be as effective as starting prophylaxis immediately. Unfortunately, immediately after surgery patients are either very sleepy, in pain, feeling sick, or delirious. It may not be possible to effectively teach patients at this point on the importance of breathing exercises and get good performance.

One method to overcome this would be to meet patients before the operation to educate them about their risk of a postoperative chest infection and to motivate and train them to perform breathing exercises to do immediately on waking from surgery. Previous trials have indicated that this may help prevent postoperative respiratory complications, although evidence is inconclusive and weak.

We set out to robustly and conclusively see if respiratory complications could be prevented after major upper abdominal surgery if patients were taught breathing exercises to do as soon as they woke up after the operation. We ran this trial in two countries (Australia and New Zealand) and three different types of hospitals.  All patients were met by a physiotherapist at our hospitals’ scheduled pre-admission clinic appointment and either provided with an information booklet (control) or provided with an additional 30 minute education and training session with the physiotherapist. At this preoperative session the patient was educated about respiratory complications, their risk, and how to prevent them with breathing exercises. These exercises were then taught and practiced for just three repetitions. Patients were instructed to do these breathing exercises for 20 repetitions as soon as they woke from surgery and then 20 times every hour after surgery until they were up and out of bed frequently.

Following surgery each patient had a standardised rehabilitation program and no respiratory therapy of any type was provided to the patients after surgery.

For the first two weeks after surgery patients were assessed daily for a respiratory complication by research assistants unaware of what treatment the patient had received before surgery.

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Medicaid Expansion Led To Better, More Timely Surgical Care

MedicalResearch.com Interview with:

Andrew Phillip Loehrer MD MPH Fellow in Surgical Oncology Department The University of Texas MD Anderson Cancer Center

Dr. Loehrer

Andrew Phillip Loehrer MD MPH
Fellow in Surgical Oncology Department
The University of Texas MD Anderson Cancer Center

MedicalResearch.com: What is the background for this study? What are the main findings? 

Response: A growing number of studies have examined the effects of the Affordable Care Act’s Medicaid expansion.  But none to date have looked at effects on surgical conditions, which are both expensive and potentially life-threatening.  We examined data for nearly 300,000 patients who presented to hospitals with common and serious surgical conditions such as appendicitis and aortic aneurysms.

We found that expansion of Medicaid coverage was linked to increased insurance coverage for these patients, but even more importantly, Medicaid expansion led patients to come to the hospital earlier before complications set in, and they also received better surgical care once they got there.

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Unnecessary Routine Preoperative Cataract Testing Costs Medicare Millions

MedicalResearch.com Interview with:
Catherine L. Chen, MD, MPH

Assistant Professor
UCSF Department of Anesthesia & Perioperative Care

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Routine preoperative medical testing (such as common laboratory tests looking at a patient’s blood cell counts and kidney function, or cardiac tests like an EKG) are not recommended in patients undergoing cataract surgery, but these tests still occur quite frequently among Medicare cataract surgery patients because these patients tend to be older and sicker than the general population. In the past, researchers have used a 30-day window counting backwards from the date of surgery to determine whether a given test should be categorized as a routine preoperative test. However, we know that testing often takes place outside this window and therefore, the frequency and cost of routine preoperative medical testing has generally been underreported.

In our study, we used a new method to figure out how to determine the start of the routine preoperative testing period. In cataract patients, ocular biometry is a diagnostic test that is performed in anticipation of cataract surgery, and this test is only performed in cataract patients who will be having cataract surgery in the near future. For each patient, we calculated the elapsed time between the ocular biometry and cataract surgery dates to get a better idea of when to start looking for unnecessary routine preoperative testing. Our goal was to identify all the routine preoperative medical testing that occurs once the decision has been made to operate and better estimate the cost to Medicare of this unnecessary testing.

In a previous study that we published in the New England Journal of Medicine, we reported a significant spike in the rate of routine preoperative medical testing that occurs in the 30 days before surgery compared to the baseline rate of testing. In our current study, we discovered that there is a second spike in testing that occurs in the 30 days after ocular biometry. In fact, even if you exclude the testing that takes place during the 30 days before surgery, there is still a 41% increase in testing rates during the interval between ocular biometry and cataract surgery over the baseline rate of testing. In addition, we found that the cost of routine preoperative testing was 47% higher when looking at the entire biometry to surgery timeframe compared to testing that occurs just in the 30 days before surgery.

We estimate that the cost to Medicare of all of this unnecessary testing approaches $45.4 million annually. Continue reading

Children with Heart Failure from Dilated Cardiomyopathy are Surviving Longer in the Most Recent Era

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Structural categories of cardiomyopathy Wikipedia image

MedicalResearch.com Interview with:
Rakesh K. Singh MD, MS

Department of Pediatrics, University of California–San Diego and
Rady Children’s Hospital
San Diego, California

Steven E. Lipshultz MD
Department of Pediatrics
Wayne State University School of Medicine and
Children’s Hospital of Michigan
Detroit, Michigan 

MedicalResearch.com: What is the background for this study?

Response: Dilated cardiomyopathy (DCM) is a disease characterized by dilation and dysfunction of the left ventricle of the heart. While DCM is a relatively rare disease in children, nearly 40% of children with DCM require a heart transplant or die within 2 years of diagnosis. Heart transplantation has improved the outcomes of children with DCM over the last 3 decades, but is limited by donor heart availability. Newer therapies, including advanced ICU care and artificial heart machines, are now being used to treat children with DCM.

This study published in the November 28, 2017 issue of the Journal of American College of Cardiology (JACC) sought to determine whether more children with DCM were surviving longer in the more recent era. Specifically, it investigated whether children with DCM were surviving longer without the need for heart transplantation. Rakesh Singh, MD is the first author and an Associate Professor of Pediatrics at UC San Diego/Rady Children’s Hospital, while the senior author is Steven Lipshultz, MD, Professor at Wayne State University School of Medicine/Detroit Medical Center’s Children’s Hospital of Michigan and Director of Children’s Research Center of Michigan.

The Pediatric Cardiomyopathy Registry (PCMR) is a National Heart, Lung, and Blood Institute (NHLBI) sponsored registry from 98 pediatric centers in United States and Canada created to study the outcomes of children with various heart muscle disorders known as cardiomyopathies. For this study, outcomes of 1,199 children diagnosed with DCM from 1990-1999 were compared with 754 children diagnosed with DCM from 2000-2009.

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Antibiotic Resistance Common In Infections After Ocular Surgery

MedicalResearch.com Interview with:

Dr-Penny Asbell

Dr. Asbell

Penny Asbell, MD
Icahn School of Medicine
Mt. Sinai, New York City.

MedicalResearch.com: What is the background for this study?

─     Bacterial endophthalmitis is a serious, although infrequent, complication of ocular surgery, typically caused by perioperative introduction of bacterial flora from the patient’s own conjunctiva and skin.

─     Prophylactic measures such as perioperative antibiotic treatment may minimize the risk for endophthalmitis, but can be complicated by antibiotic resistant bacteria.

─     The ongoing Antibiotic Resistance Monitoring in Ocular micRoorganisms (ARMOR) study is the only nationwide antibiotic resistance surveillance program specific to ocular pathogens.

─     The purpose of this presentation is to report on the antibiotic susceptibility profiles of bacterial isolates from the vitreous and aqueous humor collected in the ARMOR study expanding upon earlier findings.

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Anesthesia, Sterility Measures Contribute To Large Carbon Footprint of Health Care Systems

MedicalResearch.com Interview with:
 <a href="https://www.flickr.com/photos/armymedicine/6127836005">“surgery”</a> by <i> <a href="https://www.flickr.com/people/armymedicine/">Army Medicine</a> </i> is licensed under <a href="https://creativecommons.org/licenses/by/2.0"> CC BY 2.0</a>Andrea MacNeill MD MSc FRCSC

Surgical Oncologist & General Surgeon
University of British Columbia
Vancouver General Hospital
BC Cancer Agency

MedicalResearch.com: What is the background for this study?

Response: Climate change is one of the most pressing public health issues of the present era, responsible for 140,000 deaths annually.  Somewhat paradoxically, the health sector itself has a considerable carbon footprint, as well as other detrimental environmental impacts.  Within the health sector, operating rooms are known to be one of the most resource-intensive areas and have thus been identified as a strategic target for emissions reductions.

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Aravind Eye Care System Reduces Waste and Carbon Footprint From Cataract Surgeries

MedicalResearch.com Interview with:

Cassandra Thiel, PhD Assistant Professor in the Departments of Population Health and Opthamology at NYU Langone Health, and Assistant Professor at NYU Wagner and NYU Tandon School of Engineering

Dr. Thiel

Cassandra Thiel, PhD
Assistant Professor in the Departments of Population Health and Opthamology at NYU Langone Health, and Assistant Professor at NYU Wagner and
NYU Tandon School of Engineering

MedicalResearch.com: What is the background for this study?

Response: Everyone is concerned about the health impacts of climate change, from the United Nations to the Lancet. While other industries are trying to monitor and minimize their environmental footprint, healthcare services have been largely overlooked. Yet, the US healthcare sector emits 10% of the US’s total greenhouse gases.

Cataract surgery is one of the most commonly performed procedures in the world. In the US, these surgeries generate large quantities of waste due to the use of single-use, disposable materials and supplies. However, at Aravind Eye Care System in southern India, the outcomes for this procedure are the same as in the US, but the materials they use are mostly reusable. This study assessed the environmental footprint of Aravind’s surgical process, to determine how their process design and material selection affected their emissions.

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Weight Loss After Bariatric Procedures Mostly Sustained Over Time

MedicalResearch.com Interview with:

Anita P. Courcoulas MD, MPH Professor of Surgery, Chief MIS Bariatric & General Surgery University of Pittsburgh Medical Center

Dr. Courcoulas

Anita P. Courcoulas MD, MPH
Professor of Surgery, Chief MIS Bariatric & General Surgery
University of Pittsburgh Medical Center

MedicalResearch.com: What is the background for this study?

Response: This study is the main long term outcomes report from The Longitudinal Assessment of Bariatric Surgery (LABS) Study, an NIH-NIDDK ( National Institute of Diabetes and Digestive and Kidney Diseases) funded study at 10 hospitals in 6 clinical centers and a data coordinating center.  It was a multicenter, prospective three phase longitudinal cohort study that began recruitment of participants in 2006 when gastric bypass and laparoscopic adjustable banding were the two most common bariatric procedures performed in the U.S.

The goal of this particular study from LABS was to address the longer-term durability and variability of weight loss and the assess the longer-term impact of bariatric surgery on major health conditions including diabetes, dyslipidemia, and hypertension. Continue reading