Dr. Warshak[/caption]
Dr. Carri R. Warshak, MD
Associate Professor of Obstetrics & Gynecology
University of Cincinnati
MedicalResearch.com: What is the background for this study?
Response: Cesarean deliveries are the most common major surgical procedure performed in the United States. A common complication of cesarean section is wound infections that can include infections in the skin and incision site, or infections in the uterus itself after delivery. These complications can lead to prolonged hospitalization after delivery for antibiotics and even further surgery in severe infections. Often these wound complications lead to delayed healing, wound opening which can sometimes take several weeks to heal. Studies have demonstrated as many as 12% of women experience a surgical site infection after delivery.
Obesity is a strong risk factor for increased surgical site infections. Increasing maternal weight increases the risk of wound complications, with a two to five fold increase in risk, making surgical site infections and common and concerning complication of cesarean delivery in obese women.
Prof. Jean Louis MAS[/caption]
Prof. Jean-Louis MAS
Université Paris Descartes
INSERM UMR S 894
Service de Neurologie et Unité Neurovasculaire
Hôpital Sainte-Anne
Paris
MedicalResearch.com: What is the background for this study?
Response: Stroke is a major cause of death, disability and dementia affecting 17 million people each year worldwide. About 80% of strokes are ischemic strokes due to occlusion of a cerebral artery by a thrombus, itself the consequence of various arterial or heart diseases. In 30 to 40% of cases, no definite cause of ischemic stroke can be identified. Cryptogenic stroke is the term used to refer to these strokes of unknown etiology.
The patent foramen ovale (PFO) is a defect between the upper two heart chambers (called atria) though which a thrombus of venous origin may reach the systemic circulation and cause a stroke. This mechanism is called paradoxical embolism. Several case-control studies have shown an association between PFO and cryptogenic ischemic stroke, particularly in patients less than 60 years old, in those who have an atrial septal aneurysm (defined as an abnormal protrusion of the interatrial septum in the right or the left atrium or both) in addition to a PFO, and in those who have a PFO with a large right-to-left shunt. These findings suggested that a PFO might be responsible for stroke and that PFO closure with a device may decrease the risk of stroke recurrence. However, the causative relationship between PFO and stroke and the best strategy to prevent stroke recurrence have long been a hot topic of debate. Three previous randomized clinical trials failed to demonstrate any superiority of PFO closure over antithrombotic therapy.
Dr. Rai[/caption]
Raymond L. Chai, MD
Assistant Professor of Otolaryngology
Icahn School of Medicine at Mount Sinai.
MedicalResearch.com: What is the background for this study?
Response: Primary hyperparathyroidism is a common endocrine disorder affecting up to 1% of the general population. Surgical intervention is the only known durable cure for the disease. Untreated primary hyperparathyroidism can lead to number of health problems, including progressive osteoporosis and kidney stones. Although parathyroidectomy is a commonly performed surgical procedure by otolaryngologists, limited data exists regarding risk factors and rates of reoperation and readmission following surgery.
Dr. Goessl[/caption]
Mario Goessl, MD, PhD, FACC, FAHA, FESC, FSCAI
Director, Research and Education, Center for Valve and Structural Heart Disease
Director, LAAC/Watchman™ Program
Program Director, Fellowship in Advanced Adult Structural and Congenital Heart Disease Interventions and Interventional Cardiology Fellowship
Minneapolis Heart Institute | Abbott Northwestern Hospital, part of Allina Health
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: We wanted to investigate if asymptomatic patients with severe aortic stenosis benefit clinically from adherence to current national guidelines that suggest close follow up within 6-12 months.
Dr. You[/caption]
Nancy You, MD, MHSc, FACS
Department of Surgical Oncology
The University of Texas MD Anderson Cancer Center
Houston
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: This study was motivated by the emerging promise of precision medicine and the emerging evidence that immunotherapy may have phenomenal efficacy in particular molecular subtypes of cancers. This specific molecular subtype shows deficiency in DNA mismatch repair mechanisms and therefore is thought to be more immunogenic. DNA mismatch repair deficiency can arise from germline defects such as in the case of patients with Lynch Syndrome, an inherited cancer syndrome, or from epigenetic inactivation DNA mismatch repair genes.
Overall, pancreas cancer has seen limited success with conventional chemotherapy. In our study, we demonstrated that there is a particular molecular subtype of pancreas cancer that is characterized by defect in DNA mismatch repair genes and by microsatelie instability that has a different prognosis than other pancreas cancers. This subtype of pancreas cancer is suspected to also respond to immunotherapy.
Dr. Shroyer[/caption]
A. Laurie Shroyer, Ph.D., M.S.H.A.
WOC Health Science Officer
Northport VAMC
Research and Development Office (151)
Northport, NY 11768
Professor and Vice Chair for Research, Department of Surgery
Stony Brook University, School of Medicine
Stony Brook, NY
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Since the 1990’s, two different approaches have been commonly used by cardiac surgeons to perform an adult coronary artery bypass graft (CABG) procedure, these approaches have been referred to as “on-pump” (with cardiopulmonary bypass) or “off-pump” (without cardiopulmonary bypass) procedures. The Department of Veterans Affairs (VA) Randomized On/Off Bypass Follow-up Study” (ROOBY-FS) compared the relative performance of off-pump versus on-pump approaches upon 5-year patients’ clinical outcomes including mortality and major adverse cardiovascular events.
Dr. Jacobs[/caption]
Dr. Lisa K. Jacobs MD
Johns Hopkins School of Medicine
Baltimore, Maryland
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Breast preservation is the preferred treatment for many women diagnosed with breast cancer. The most common question that a patient will ask after the surgery is, “Did you get it all?” In the ideal case, this is accomplished in a single outpatient surgery with very good cosmetic results. In our study, Beyond the Margins-Economic Costs and Complications Associated with Repeated Breast-Conserving Surgeries we evaluated the detrimental effects of an unsuccessful initial surgery due to positive surgical margins. Using private insurance claims data, we found that 16% of patients planning breast preservation required a second breast-conserving surgery and an additional 7% converted to mastectomy. Of those patients that required additional surgery there was a 56% ($16,072) increase in cost and a 48% increase in complications. Those complications include infection, hematoma, seroma, and fat necrosis. This study demonstrates that repeated surgery has not only cosmetic consequences, but also has financial implications and increased risk.
Dr. Mont[/caption]
Michael A. Mont, MD
Department of Orthopaedic Surgery
Cleveland Clinic
Cleveland, OH
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Postoperative pain after total knee arthroplasty (TKA) is a major hurdle for both the patients and the orthopaedists. Many analgesic modalities are currently in use, and can be used alone or in combination in order to augment their effect. Addition of local anesthetic analgesia has been shown to improve pain control and reduce opioid consumption during postoperative period. However, the effects of this analgesia tend to dissipate with time, with the longest duration of action (bupivacaine) of approximately 12 hours. Therefore, long acting local anesthetic (liposomal bupivacaine) has been developed in order to expand the duration of effectiveness of pain relief for up to 96 hours. Many studies evaluated the effectiveness of this anesthetic and demonstrated contradictory results, however, they did not use the same methods and infiltration technique. Therefore, we conducted a prospective, randomized, double-blind, controlled study at 16 hospitals using optimal infiltration techniques. Our study demonstrated significant improvement in pain, decreased opioid consumption, increased time to first opioid rescue, more opioid free patients in liposomal bupivacaine cohort. In addition, there were no unexpected safety concerns.
Dr. Shepherd[/caption]
Dr. Joanna Shepherd
Centre for Trauma Sciences
Blizard Institute
Queen Mary, University of London
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Recent advances in resuscitation and treatment of life-threatening critical injuries means that patients with previously unsurvivable injuries are now surviving to reach hospital. However, many of these patients develop Multiple Organ Dysfunction Syndrome (MODS), which is a failure of several organs including the lung, heart, kidney, and liver.
We studied immune cell genes in the blood of critically injured patients within the first few minutes to hours after injury, a period called the ‘hyperacute window’. We found a small and specific response to critical injury during this window that then evolved into a widespread immune reaction by 24 hours. The development of MODS was linked to changes in the hyperacute window, with central roles for innate immune cells (including natural killer cells and neutrophils) and biological pathways associated with cell death and survival. By 24 hours after injury, there was widespread immune activation present in all critically injured patients, but the MODS signal had either reversed or disappeared.
Dr. Baron[/caption]
Suzanne J. Baron, MD, MSc
Saint Luke’s Mid America Heart Institute
School of Medicine
University of Missouri, Kansas City
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Transcatheter Aortic Valve Replacement (TAVR) has emerged as a viable treatment option for patients with severe aortic stenosis in patients at high and intermediate surgical risk. Prior studies have demonstrated that both TAVR and surgical AVR (SAVR) results in substantial quality of life benefit in patients at high surgical risk.
Whether these results applied to an intermediate risk population was unknown and so we performed a prospective study alongside the PARTNER 2A trial to compare both short- and long-term health status outcomes in intermediate-risk patients with AS treated with either TAVR or SAVR. The analysis included 1833 patients (950 TAVR, 833 SAVR), who were evaluated at 1 month, 1 year and 2 years post procedure. By 1 month, quality of life had improved in both the TAVR and SAVR groups, although the gain was significantly greater in patients treated with TAVR via the transfemoral approach as opposed to patients treated with SAVR or with TAVR via the transthoracic approach (i.e. direct aortic access or transapical access). At 1 and 2 years, both TAVR (via either approach) and SAVR were associated with similarly large, clinically meaningful improvements from baseline in both disease-specific and generic health status scales at 2 years.
Dr. Quick[/caption]
Jacob Quick, M.D.
Assistant professor of acute care surgery
University of Missouri School of Medicine
Dr. Quick also serves as a trauma surgeon at MU Health Care.
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: During five to seven years of surgical training, surgical faculty determine the level of clinical competency, confidence and decision-making skills of each resident physician through personal observations. This skill evaluation is based on a subjective assessment, which essentially is a gut feeling.
We monitored electrodermal activity, or EDA, using dermal sensors on the wrists of residents while they performed laparoscopic cholecystectomies. Our initial findings indicated that at crucial points during the procedures, residents’ EDA increased as much as 20 times more than experienced faculty performing the same surgery. However, over the course of the study, and as their proficiency developed, surgical residents’ EDA levels began to lower in accordance with their experience.
Mackenzie Herzog[/caption]
Mackenzie M. Herzog, MPH
PhD Candidate, Injury Epidemiology
The University of North Carolina at Chapel Hill
MedicalResearch.com: What is the background for this study?
Response: In 1999, a study by Arendt et al. reported that women were more likely to tear their ACL than men while playing the same sport. Since then, numerous studies have investigated this sex difference in ACL injury, and many prevention programs targeting youth athletes have been developed and tested. Although randomized trials have demonstrated the value of injury prevention programs in reducing the risk of ACL injury, the overall impact of these programs has not been examined in the general population. Our study investigated the net impact of research and prevention efforts over nearly 20 years in reducing ACL injuries by assessing time trends of ACL reconstruction, a consequence of ACL injury, among commercially-insured individuals in the United States.
Dr. Sun[/caption]
Virginia Sun, RN, PhD
Assistant Professor
Division of Nursing Research and Education
Department of Population Sciences
Cancer Control and Population Sciences Program
City of Hope Duarte, CA 91010
MedicalResearch.com: What is the background for this study?
Response: Surgery is one of the most effective and important treatment strategies for cancer. Surgical procedures are by definition invasive, and patients are at risk for unpleasant symptoms, impaired functional status, and poor quality of life. Traditionally, mortality has been the sole measure to assess the risk of most surgical procedures. However, as surgical mortality has sharply declined, focus has shifted toward other endpoints, including patient-centered outcomes. There are critical gaps to assessing and integrating patient-centered outcomes into the surgical oncology workflow.
We conducted this proof-of-concept study to assess the feasibility and acceptability of a wireless monitoring approach for patient-centered outcomes before and after a major abdominal cancer surgery.
Dr. Morrow[/caption]
Monica Morrow, MD, FACS
Chief, Breast Service
Department of Surgery
Anne Burnett Windfohr Chair of Clinical Oncology
Memorial Sloan Kettering
MedicalResearch.com: What is the background for this study?
Response: Although we know that bigger surgery does not result in better patient outcomes in breast cancer, since 2005 rates of lumpectomy have been decreasing accompanied by an increase in bilateral mastectomy for unilateral cancer.
High rates of second surgery after initial lumpectomy are one deterrent for patients. In 2013 the SSO and ASTRO developed an evidence based consensus guideline endorsing no ink on tumor as the standard negative margin width for women with stage 1 and 2 cancer having breast conserving surgery with whole breast irradiation. The purpose of our study was to examine time trends in the use of additional surgery after lumpectomy before and after guideline dissemination and to determine the impact of these trends on final rates of breast conservation.
Dr. Mahmoudi[/caption]
Elham Mahmoudi, PhD, MS
Section of Plastic Surgery, University of Michigan Medical School
Ann Arbor, Michigan
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: About one-third of all women diagnosed with breast cancer undergo mastectomy. In recent years, owing to advancements in screening and treatment, life expectancy after being diagnosed with breast cancer has increased. Research has shown that for patients who undergo mastectomy, breast reconstruction offers many psychological benefits such as improved self-esteem, reduced sexual dysfunction, decreased anxiety, and overall improvement in quality of life. After the passage of the Women’s Health and Cancer Rights Act in 1998, the coverage of post-mastectomy breast reconstruction (PBR) by any type of health insurance became mandatory. However, there are large and widening racial and ethnic disparities in PBR, with White women having a higher rate of PBR than women from other racial and ethnic groups.
In 2011, the State of New York enacted a law mandating that surgeons advise their patients undergoing mastectomy about available breast reconstruction options, insurance coverage, and referral to a plastic surgeon. We evaluated the effect of this law on racial/ethnic disparities in immediate PBR.
Our results did not show any effect on the overall rate of immediate post-mastectomy breast reconstruction or on disparities between white and African-American women; however, we found that White-Hispanic and White-other racial/ethnic group disparities in immediate PBR were reduced by 9 and 13 percentage points, respectively. This is a substantial reduction in disparity within only a year after the passage of the law, which demonstrates the importance of physician-patient communication.
Dr. Haymart[/caption]
Megan Rist Haymart MD
Assistant Professor
University of Michigan
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Thyroid cancer is typically treated with thyroid surgery. It is common practice for physicians to inform patients that the risk of vocal cord paralysis or hypoparathyroidism with thyroid surgery is 1-3%.
However, most of these estimates are based on single institution studies with high volume surgeons. In our study we evaluated surgical risks in a population-based cohort. Using the Surveillance, Epidemiology, and End Results-Medicare database, we found that 6.5% of thyroid cancer patients developed general post-operative complications (fever, infection, hematoma, cardiopulmonary and thromboembolic events) and 12.3% developed thyroid surgery specific complications (hypoparathyroidism/hypocalcemia, vocal cord/fold paralysis).
Older patient age, presence of comorbidities, and advanced stage disease were associated with the greatest risks of surgical complications.
Dr. Ibrahim[/caption]
Andrew Ibrahim, M.D., M.Sc
Institute for HealthCare Policy and Innovation
University of Michigan
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The laparoscopic gastric band was approved by the FDA in 2001 and widely adopted for the surgical treatment of morbid obesity. Reported rates of reoperation to revise or remove the device ranged from 4 to 60 percent in small scale studies, but no population estimates in the United States existed.
In a review of Medicare Claims data between 2006 and 2013, we observed that reoperation was common with 18% of patients requiring at least one reoperation. More over, we found that on average, patients who did need a reoperation often underwent an average of 3.8 additional procedures. Taken together, nearly half (47%) of the $470 million paid by Medicare for device related procedures was for reoperations.
Dr. Agarwal[/caption]
Nayan Agarwal MD
Intervention Cardiology Fellow,
University of Florida,
Gainesville, FL
MedicalResearch.com: What is the background for this study?
Response: Long term anticoagulation is indicated in patients with mechanical heart valves, prior thromboembolic events, atrial fibrillation etc, to prevent recurrent thrombo-embolic episodes. About 20-30% of these patients also have concomitant ischemic heart disease requiring percutaneous coronary intervention (PCI).
Post PCI, patients require treatment with dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor (clopidogrel, prasugrel, ticagrelor) to prevent stent thrombosis. Thus, these patients may end up needing triple antithrombotic therapy with oral anticoagulant (OAC) and DAPT, which increases the bleeding risk.
Both American College of Cardiology(ACC) and European Society of Cardiology (ESC), currently recommend triple therapy in these patients. Recently new evidence has emerged that such patients can be managed with dual therapy of a single antiplatelet (SAPT) and OAC. Hence, we decided to do a systematic review of these studies to evaluate safety and efficacy of dual therapy of SAPT and OAC against triple therapy of DAPT and OAC.
Dr. Beohar[/caption]
Nirat Beohar, MD
Vice-Chief of Cardiology
Director Cardiac Catheterization Laboratory
Director Structural Heart Disease Program
Director Interventional Cardiology Fellowship program
Cardiac Catheterization Laboratory
Columbia University Division of Cardiology,
Mount Sinai Medical Center
Miami Beach, Miami, FL 33140
MedicalResearch.com: What is the background for this study?
Response: Nirat Beohar MD, Director of the Cardiovascular Catheterization Laboratory and Vice-Chief of Cardiology at the Columbia University Division of Cardiology at the Mount Sinai Medical Center and co-authors report the effect of trans-catheter aortic valve replacement (TAVR) on subsequent renal function and outcomes in high-risk and inoperable patients presenting with baseline renal dysfunction (eGFR < 60 ml/min/1.73 m2). This was a sub-study of patients undergoing TAVR in the PARTNER 1 trial and continued access registry that was conducted in 25 centers in the United States and Canada.
Dr. Brummett[/caption]
Chad M. Brummett, M.D.
Associate Professor
Director, Clinical Anesthesia Research
Director, Pain Research
Department of Anesthesiology
Division of Pain Medicine
University of Michigan Medical School
Ann Arbor, MI 48109
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The opioid epidemic has received tremendous attention in recent years, but most of the focus has been on chronic pain, opioid abuse and overdose. Far less attention has been paid to the importance of acute care prescribing (e.g. surgical pain) in patients that are not chronic opioid users.
We found that 5-6% of patients not using opioids prior to surgery continued to fill prescriptions for opioids long after what would be considered normal surgical recovery. Moreover, the rates of new chronic use did not differ between patients having major and minor surgeries, suggesting that patients continue to use these pain medications for something other than simply pain from surgery. Building on other work by our group, and the few additional studies done on the topic to date, these data suggest that pain medications written for surgery are a major cause of new chronic opioid use for millions of Americans each year.
Dr. Devereaux[/caption]
Dr. PJ Devereaux MD, PhD, FRCP(C)
Director of the Division of Cardiolog
Scientific Leader of the Anesthesiology, Perioperative Medicine and
Surgical Research Group at the Population Health Research Institute
Professor and University Scholar in the Departments of Health Research Methods, Evidence, and Impact and Medicine
McMaster University
MedicalResearch.com: What is the background for this study?
Response: Although the majority of patients undergoing noncardiac surgery benefit from surgery and do well, even when a small proportion of these patients have a serious complication it represents a major population issue. A recent publication in JAMA Cardiology established that >5 million Americans age ≥45 years undergo major in-patient noncardiac surgery annually, and 1.3% of these patients die in the hospital. This means 65,000 of these patients die, and cardiovascular causes are a dominant cause.
Dr, Brilakis[/caption]
Emmanouil S. Brilakis, MD, PhD
Director, Center for Advanced Coronary Interventions
Minneapolis Heart Institute
Minneapolis, Minnesota 55407
Adjunct Professor of Medicine
University of Texas Southwestern Medical School at Dallas
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Calcification in the coronary arteries might hinder lesion crossing, equipment delivery and stent expansion and contribute to higher rates of in-stent restenosis, as well as stent thrombosis. In this project we sought to examine the impact of calcific deposits on the outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) in a contemporary, multicenter registry.
We analyzed the outcomes of 1,476 consecutive CTO PCIs performed in 1,453 patients between 2012 and 2016 at 11 US centers. Data collection was performed in a dedicated online database (PROGRESS CTO: Prospective Global Registry for the Study of Chronic Total Occlusion Intervention, Clinicaltrials.gov Identifier: NCT02061436).
Dr. Tadros[/caption]
Audree Tadros, MD, MPH
Chief Administrative Fellow, Breast Surgical Oncology Training Program
Department of Breast Surgical Oncology
MD Anderson Cancer Center and
[caption id="attachment_33988" align="alignleft" width="120"]
Dr. Kuerer[/caption]
Henry M. Kuerer, MD, PhD, FACS
Executive Director, Breast Programs
MD Anderson Cancer Network
PH and Fay Etta Robinson Distinguished Professor in Cancer Research
Dept of Breast Surgical Oncology
Director, Breast Surgical Oncology Training Program
MedicalResearch.com: What is the background for this study?
Response: Neoadjuvant chemotherapy (NCT) has the ability to confer a pCR (pathologic complete response-when no residual cancer is found) in both the breast and axillary lymph nodes. We know that this is most likely to occur in women with HER2 positive and triple negative disease. The high rate of pCR among these patients raises the question of whether surgery is still required, particularly among those who will receive adjuvant radiation therapy.
Until recently, we lacked the ability to pre-operatively predict patients who achieved a breast pCR. Recently, we completed a clinical feasibility trial examining the ability of image-guided biopsy to predict a pCR after neoadjuvant chemotherapy. Our biopsy technique was able to accurately predict a pCR in 98% of patients with only a 5% false negative rate. Based upon these findings, we believe we can accurately determine which patients achieve a breast pCR. This led us to develop a clinical trial to see if breast surgery is redundant in patients who achieve a pCR. An important question that remained was if we are going to omit breast surgery in these exceptional responders, can we also omit axillary surgery?