As more elderly patients undergo the minimally invasive heart valve procedure called Transcatheter Aortic Valve Implantation (TAVR), concerns have been raised as to what causes some to be readmitted for heart failure after the procedure.
Now, University at Buffalo researchers, working in the Gates Vascular Institute, Kaleida Health, have published a paper that identifies a new way to predict which patients may be at higher risk. Vijay S. Iyer, MD, PhD, associate professor in the UB Department of Medicine, was the principal investigator.
TAVR is a minimally invasive procedure reserved for patients who have been turned down for a traditional aortic valve replacement by open heart surgery due to serious medical co-morbidities.
“For many patients, TAVR is a life-saving and life-enhancing procedure and most see significant improvements in their symptoms,” said Bhardwaj. “However, a small percentage may not benefit adequately with the procedure. Heart failure readmission is one of the most common cardiac-related readmissions within the first year after TAVR.”
To find out what might be putting these patients at higher risk, Bhardwaj and her colleagues conducted a retrospective study on 198 patients (mean age was 82 years) who underwent TAVR from 2012-16 at the Gates Vascular Institute in Buffalo.
They focused on a measure called elevated valvuloarterial impedance, also known as Zva, which is obtained noninvasively by a cardiac ultrasound. Zva incorporates both the aortic valve stenosis and the resistance encountered by the heart due to thickening of the arteries and blood vessels for pumping blood in the body.
While Zva has been shown to have prognostic significance in TAVR patients, there was no quantifiable data as to how useful it might be in predicting heart failure, Bhardwaj explained.
“Our study was the first to evaluate the role of Zva, which can be easily obtained non-invasively for predicting heart failure readmissions,” she said. “Identifying such prognostic markers would help reduce rehospitalizations and would eventually translate into reduced health care expenditures as well.”
The UB study found that among 41 patients who were rehospitalized after TAVR, nearly twice as many patients (34.2 percent vs. 18.1 percent) with a high Zva prior to undergoing TAVR were readmitted to the hospital after TAVR because of heart failure symptoms.
Another key finding was that patients in whom the Zva either increased or remained unchanged were three times more likely (18.2 percent vs. 6.3 percent) to die within one year of the procedure.
“For that reason, we recommend that Zva should be integrated as part of routine follow up post-TAVR,” Bhardwaj said, “and should be obtained serially during follow-up echocardiograms (ultrasounds of heart) for monitoring the risk of heart failure readmissions.”
Bhardwaj and her co-authors note that Zva may also have relevance to determining who should and should not undergo TAVR in the first place.
“Our findings suggest that Zva may play a key role in patients who fail to have clinical improvement post-TAVR and will most likely not benefit from the procedure,” she said, “so Zva has prognostic implications in evaluating patients who may or may not benefit with the procedure.”
The importance of such risk stratification has a significant impact, the authors said, as hospital administrations nationwide work to minimize heart failure readmissions while trying to identify patients at higher risk to utilize more resources in the outpatient setting.
“Zva can be utilized to identify patients at high risk for readmissions and accordingly, help divert resources to these patients by establishing transitional care programmes and close cardiologist follow-up in order to avoid readmissions in hospital,” Bhardwaj concluded. “This should translate to potential cost-savings and reduced health care expenditures.”

University of Buffalohttp://tinyurl.com/ybofe59y

Standardizing clinical processes for open inguinal hernia repair reduced patients’ postoperative pain and unplanned returns to the emergency room after surgery, according to the results of a study presented at the American College of Surgeons Clinical Congress 2017. The authors, a group from Kaiser Permanente Southern California, reported on the region-wide implementation of an eight-step ambulatory surgery care protocol that spanned preoperative, intraoperative, and postoperative phases of care. Key elements included preoperative patient education and preferential use of monitored anaesthesia care (MAC).
The genesis of the current project began more than five years ago, when the time that patients were spending in the hospital for same-day surgery varied more than 100 percent across 25 Kaiser surgical locations in Southern California. In response, Kaiser researchers collected more than 40 local best practices for time-efficient patient flow and clinical processes, and implemented those practices throughout the health care system. The variation across facilities decreased, and more importantly, the time that patients spent in the hospital on the day of surgery was reduced by more than 50 percent in many cases, reported lead study author Sean O’Neill, MD, PhD.
The current eight-step protocol came about as a quality check on that improved efficiency. "Although we had reduced the amount of time that patients spent in the hospital, and thus were successful in sending them home faster, did that reduction simply mean that we were going to end up having more of them come back to the emergency department or urgent care?" said Dr. O’Neill.
Therefore, the group developed a standardized protocol that incorporated local best practices and enhanced recovery after surgery (ERAS) concepts from the literature. These elements included patient preoperative education, giving postoperative prescriptions to patients preoperatively, preoperative carbohydrate drinks, use of multimodal non-narcotic analgesia, preferential use of monitored anaesthesia care (MAC) when feasible, generous use of local anaesthetic and field blocks, limiting IV fluids to less than 500 mL intraoperatively, and a followup phone call within 72 hours of discharge. This protocol was rolled out region-wide and examined closely over a 14-month period from June 2015 to July 2016.
The researchers evaluated the effect of this protocol on several metrics, including total time spent in the hospital, maximum pain score in the post-anaesthesia care unit (PACU), postoperative nausea and vomiting, and rates of unplanned returns to care to the emergency department (ED) or urgent care (UC) after surgery for open inguinal hernia repair.
An unplanned visit to the ED or UC often indicates a failure in either the preoperative, intraoperative or postoperative phases of care, explained Steven R. Crain, MD, a general surgeon and principal study author. "When people return to the ED for pain control, urinary retention, constipation, or nausea and vomiting after same day inguinal hernia repair," said Dr. Crain, "we feel that those returns could have been prevented if our perioperative care routines had addressed them up front."
For the present study, the researchers collected data from 2,390 patients who had an ambulatory open inguinal hernia repair procedure in 2015-2016, calculated the rate of unplanned returns to a hospital emergency department or urgent care center, and identified the factors that had the most effect on patient outcomes in the immediate postoperative period.
The overall rate of unplanned visits to an emergency department or urgent care center was low: 6.3 percent for any reason, and 2.8 percent for preventable causes (pain, urinary retention, constipation, or nausea and vomiting). The authors found that two aspects of the protocol were particularly influential: preoperative patient education, and the use of monitored anesthesia care (MAC) instead of general anesthesia.
Patients who received comprehensive preoperative education were less likely to return to the hospital in the immediate postoperative period than their counterparts who did not receive the education. "The preoperative education was done both in the clinic when the operation was scheduled and on the same day of the procedure. Instead of handing the patient a packet of information and letting them read or interpret it later (or never), this educational process set expectations ahead of time so that patients would know what to do if they experienced the typical symptoms associated with less urgent postoperative events, including fluctuating levels of mild pain, constipation, and nausea. Many unplanned returns for care can be prevented if patients are educated and empowered to do the best things to care for themselves postoperatively," Dr. O’Neill said.
MAC, or twilight sleep, more effectively reduced postoperative pain scores than general anesthesia. "The use of monitored anesthesia care in our facilities varies widely. It is used only for about 20 percent of patients in some surgical centers and up to 80 percent in others. This form of anesthesia can never be used on all patients, because of conditions like sleep apnea or obesity, but it may be appropriate for far more patients than it is currently used for. As a result of this study, we have set specific goals for increasing the use of MAC yearly," Dr. Crain stated.
This standardized pathway for ambulatory surgical care, with a particular emphasis on patient education and preferential use of MAC, is being rolled out to additional surgical specialties across Kaiser Permanente Southern California. "With these standardized pathways, we’re able to improve the quality of care for the patient, and the efficiency of health care delivery for the organization," Dr. Crain concluded.
EurekAlert
www.eurekalert.org/pub_releases/2017-10/acos-sas102317.php

A study led by scientists at The Wistar Institute describes a novel immunotherapeutic strategy for the treatment of cancer based on the use of synthetic DNA to directly encode protective antibodies against a cancer specific protein. This is the first application of the new technology, called DNA-encoded monoclonal antibody (DMAb), for cancer immunotherapy.
Prostate cancer is the second most common cancer in men worldwide. Traditional treatments are invasive and can impair the quality of life of patients, underscoring the need for alternative therapeutic strategies, including immunotherapy. One of the immunotherapeutic approaches that has been explored thus far relies on the use of monoclonal antibodies that specifically target a protein present on the surface of prostate cancer cells called prostate specific membrane antigen (PSMA) to elicit an anti-tumour immune response and control the cancer. Although promising, this strategy is limited by the production cost required to make these therapeutic antibodies. Additionally, multiple infusions are often required to achieve efficacy.
Wistar researchers devised a novel DNA-based approach in which an engineered DNA plasmid is constructed and used to deliver the instructions to make the desired anti-PSMA antibody so that the therapy can be generated in the patient’s body in a sustained manner. This research has important implications for the use of DNA-encoded monoclonal antibody technology as a platform for delivering the next generation of immunotherapies for cancer and many human diseases.    
“This is an important demonstration of the possibilities opened up for immunotherapy by DMAb technology to direct in vivo production of antibodies of major relevance to human cancer,” said David B. Weiner, Ph.D., executive vice president of The Wistar Institute, director of The Wistar Institute Vaccine & Immunotherapy Center, W.W. Smith Charitable Trust Professor in Cancer Research, and senior author of the study. “There is a great need for such new approaches for prostate disease as well as many other cancers. As recent data suggest, PSMA is an important cancer antigen expressed on many human prostate, bladder, renal as well as ovarian cancers, so additional study of the possible benefits of this therapy are important.”
The new technology was tested in mice for the ability to generate antibodies in their blood stream that would target human PSMA as well as target PSMA-positive tumours. Results showed that antibodies were able to bind to the cancer cells and recruited specific immune cells called natural killer cells, resulting in shrinkage of the tumour, significantly improving survival.
“Our data provide proof of concept that DMAb engineered DNA plasmids can be successfully used to target important cancers,” said Kar Muthumani, M.Sc., Ph.D., assistant professor in the Translational Tumor Immunology Program at Wistar, member of the Vaccine & Immunotherapy Center and lead author of the study. “The unique features of our synthetic DNA-based system make it a promising novel approach for cancer therapy, alone or in combination with other treatments.”
This work was supported in part by the W.W. Smith Charitable Trust Professorship, a Basser Foundation award and a DARPA award. This study was conducted in collaboration with Inovio Pharmaceuticals, Inc., which also provided funding for some of the work.

The Wistar Institute
www.wistar.org/news-and-media/press-releases/wistar-scientists-develop-novel-immunotherapy-technology-prostate-canc

EKF Diagnostics, the global in vitro diagnostics company, has published a guide to ‘Diabetes and HbA1c testing’ which can be found at EKF’s new Diabetes Portal (www.ekfdiagnostics.com/diabetes-portal.html). This new educational guide draws on EKF’s expertise in the diagnosis and monitoring of diabetes and associated conditions. It provides an overview of the global diabetes ‘epidemic’, symptoms and complications, through to discussion on methods for diagnosis and monitoring using both glucose and HbA1c testing, with consideration given to factors influencing their measurement.
Diabetes is a growing issue, particularly in developing countries, with five million people dying from diabetes related complications in 2015 alone. Although not an ‘epidemic’ in the conventional sense, there are currently 415 million people living with diabetes and this is predicted to grow to 642 million by 2040. Approximately 46% of people living with diabetes are doing so without a full and proper diagnosis with subsequent complications, and associated healthcare costs.
There are multiple options for the diagnosis of diabetes, most of which involve measuring the level of glycemic control a person exhibits. In addition to methods such as fasting plasma glucose and two-hour plasma glucose, another option is to use glycated hemoglobin (HbA1c) which reflects average plasma glucose over an 8-12 week period. As well as lab-based testing, WHO has approved HbA1c for diabetes diagnosis with a Point of-Care-Testing (POCT) device, providing the test is undertaken by a trained professional adhering to an appropriate External Quality Assurance scheme and using a methodology traceable to the IFCC reference method. POCT HbA1c testing gives a strong indication of both diabetes and pre-diabetes within a timeframe that enables immediate intervention.
Since it is not impacted by the same issues as blood glucose monitoring, HbA1c testing is fast becoming the preferred technique for diabetes and pre-diabetes diagnosis and monitoring. There are situations where use of HbA1c is not appropriate though. EKF’s new Guide includes discussion on both glucose and HbA1c testing and where factors may influence measurement of both diagnostic markers.
“The often ‘low to no’ maintenance approach to disease management of diabetes is not only dangerous but can also significantly contribute to ongoing healthcare costs. At present, approximately 12% of global health expenditure is spent on diabetes, and without significant changes to the way patients and health systems monitor glycemic control this will surely rise,” said Gavin Jones, Global Product Manager for Diabetes Care at EKF Diagnostics. “To enhance patient outcomes and reduce the cost for long-term healthcare of the diabetic and pre-diabetic population, we aim to improve patient access to diabetes care techniques, whatever their location. This can be achieved by providing affordable, easy-to-use POCT analysers and chemistry assays for both diabetes diagnosis and monitoring.”
EKF’s expertise and product range cover all aspects of diabetes care, from research and hospital laboratories to diabetes clinics, emergency rooms and GP surgeries. Products include the Biosen C-Line glucose analyser, which uses chip sensor technology to provide low cost, fast and lab accurate glucose results. Quo-Test and Quo-Lab point-of-care HbA1c analysers that deliver results meeting NGSP and IFCC POC requirements in four minutes. And lastly, to aid the diagnosis and monitoring of diabetes related conditions such as ketoacidosis, EKF offers Beta-Hydroxybutyrate LiquiColor Reagent and the handheld STAT-Site M β-HB strip-based analyser.
www.ekfdiagnostics.com

Simpler, easier method for performing biopsy can improve patient care
A simpler biopsy procedure than the one traditionally used can give equally good results while reducing stress for patients and workers, and allowing for faster diagnosis, according to a study.
During various procedures performed by gastrointestinal endoscopists, small tissue samples are taken from the patient for examination, which is known as biopsy. The traditional endoscopic forceps biopsy method can be labour intensive as well as stressful for the workplace environment.
With this method, each specimen is removed and placed in fixative vial for identification. This is labour intensive, adding to the length of the procedure and the time under sedation. Biopsy samples from each site are filtered to remove fixative, inspected to record specimen number and size, and transferred to a container to undergo several more processing steps before being mounted on slides to be examined for abnormalities or disease.
According to the study authors, diagnosis is delayed by this complex and costly protocol. In addition, staff may be affected by ergonomic stress and workplace risk from exposure to sharps, toxic fixative, infectious material, and soil.
The researchers aimed to test a faster way of collecting, handling and processing the samples to slides through a method called endoscopic multiple biopsy (MB).
MB uses a single endoscope pass within the patient to obtain up to 25 biopsy specimens during withdrawal of the endoscope. These are collected and stored in a plastic chamber inside the removable metal tip of the endoscope. After completing the biopsy series, the metal tip is cut off, immersed in fixative, and sent to pathology. There, the plastic storage chamber’s design supports rapid logging of specimens, diagnosis by frozen section and microwave (one hour) or routine paraffin processing (four to six hours) of the specimen tissue.
For the study, biopsies were performed during colonoscopy, upper GI endoscopy, and endoscopic retrograde cholangiopancreatography (ERCP). The blinded retrospective study compared 125 colon surveillance biopsies in 15 patients who underwent MB with 15 patients who underwent forceps biopsies performed on the same day.
The researchers found that the processed MB specimens were not significantly different from batched processed forceps biopsy specimens for depth, orientation (done manually), fixation, artifacts, and diagnostic information. Multiple biopsy colonic specimens were significantly (26%) smaller but had better epithelial (cellular covering) preservation than forceps specimens. Each biopsy saves 61 seconds during withdrawal.
The authors concluded that single-pass MB reduces biopsy time with less specimen damage, work, workplace risk, and soiling. Diagnostic quality is equal to forceps biopsy with better cellular preservation, although 26% smaller. In pathology, the plastic chamber reduces work and workplace risk. MB speeds diagnosis and improves productivity in endoscopic biopsy and histopathologic processing (microscopic examination of biopsy samples for signs of or disease). They encourage larger studies at multiple centers to determine the value of MB for diagnosing a larger set of GI diseases.

American Society for Gastrointestinal Endoscopy
www.asge.org/home/about-asge/newsroom/news-list/2017/08/04/august-gie-studies-show-promising-results-for-patients-with-endoscopic-treatments