Stephen F. Wendolowski[/caption]
Stephen F. Wendolowski
Research Assistant
Pediatric Orthopaedics
Cohen Children’s Medical Center
New Hyde Park, NY, 11040
MedicalResearch.com: What is LEAN?
Response: LEAN is a management principle that supports the concept of continuous improvement through small incremental changes to not only improve efficiency, but also quality. Particularly, we took interest in the 5S’s – Sort, Simplify, Sweep, Standardize, and Self-Discipline. We felt that Sort, Simplify, and Standardize were the most relevant to surgery.
Dr. Eric Jacobs[/caption]
Eric Jacobs, PHD
Strategic Director, Pharmacoepidemiology
American Cancer Society, Inc.
250 Williams St.
Atlanta, GA 30303
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Vasectomy is a common, inexpensive, and very effective method of long-term birth control. However, in 2014, an analysis from a large epidemiologic cohort study, the Health Professionals Follow-Up Study, found that vasectomy was associated with about 10% higher overall risk of prostate cancer and about 20% higher risk of fatal prostate cancer. Together with other researchers at the American Cancer Society, I analyzed the association between vasectomy and fatal prostate cancer among more than 363,000 men in the Cancer Prevention Study II (CPS-II) cohort, age 40 and older, who were followed for up to 30 years. This is the largest prospective analysis of vasectomy and fatal prostate cancer to date. We also examined vasectomy and prostate cancer in a subset of about 66,000 CPS-II study participants who were followed for new diagnoses of prostate cancer.
We found no link between having had a vasectomy and risk of either developing or dying from prostate cancer.
Dr. Eric E Smouha[/caption]
Eric E Smouha, MD
Professor, Otolaryngology
The Mount Sinai Hospital
New York Eye and Ear Infirmary of Mount Sinai
MedicalResearch.com: Would you tell us a little about yourself? How did you become interested in ENT and specifically middle ear problems?
Response: I am a neurotologist, i.e. , ENT physician specialized in disorders of the ear and skull base. Neurotologists treat problems of the middle ear and inner ear. Middle ear problems are interesting because they are prevalent, and surgery frequently results in restoration of function.
Tim Reese, president of Eagle Surgical Products, LLC,
Sales and distribution company for Electro Lube®
MedicalResearch.com: What is the background of Electro Lube®?
Response: Developed in 2004, Electro Lube® is an anti-stick solution for electrosurgery designed to keep instruments clean. The product is a mixture of natural, non-synthetic, non-flammable, non-allergenic biocompatible phospholipids without any known side effects associated with patient use.
Prof. Jenny Donovan[/caption]
Professor Jenny Donovan PhD
OBE FMedSci NIHR-SI AcSS FFPHM
Director, NIHR CLAHRC West
(National Institute for Health Research Collaboration for
Leadership in Applied Health Research and Care West)
at University Hospitals Bristol NHS Trust
Bristol, UK
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: PSA testing identifies many men with prostate cancer, but they do not all benefit from treatment. Surgery, radiation therapy and various programs of active monitoring/surveillance can be given as treatments for fit men with clinically localized prostate cancer. Previous studies have not compared the most commonly used treatments in terms of mortality, disease progression and patient-reported outcomes. In the ProtecT study, we used a comprehensive set of validated measures, completed by the men at baseline (before diagnosis), at six and 12 months and then annually for six years.
The main finding is that each treatment has a particular pattern of side-effects and recovery which needs to be balanced against the findings from the paper reporting the clinical outcomes (Hamdy et al).
Dr. Michael Gaglia[/caption]
Michael A. Gaglia Jr., MD, MSc, FACC, FSCAI
Scientific Lead, Population Research
Medstar Cardiovascular Research Network
Interventional Cardiology
Medstar Heart and Vascular Institute
Washington, DC 20010
MedicalResearch.com: What is the background for this study?
Response: Cardiovascular outcomes vary according to gender in a variety of disease states. For example, short-term mortality is higher among women presenting with an acute coronary syndrome in comparison to men. There is a similar trend for higher short-term mortality of women undergoing coronary artery bypass grafting, although this is in part due to a relatively higher burden of comorbidities. Female gender is also a well-established risk factor for bleeding complications after percutaneous coronary intervention.
In regards to women undergoing surgical aortic valve replacement for severe aortic stenosis (AS), however, the data is equivocal; some studies suggest higher mortality for women, whereas others suggest improved survival for women.
The emergence of transcatheter aortic valve replacement (TAVR) as the preferred therapeutic option for patients with severe AS at high or extreme risk for surgery offered another opportunity to examine gender disparities in outcomes. The evidence base for the impact of gender upon TAVR, however, is still evolving. A recent meta-analysis suggested improved long-term survival among women after TAVR. And in general, previous studies also suggest more vascular and bleeding complications in women when compared to men. The goal of this study was relatively simple: to compare outcomes between women and men undergoing TAVR at a single center.
Dr. Christian McNeely[/caption]
Christian A. McNeely, M.D.
Resident Physician - Internal Medicine
Barnes-Jewish Hospital
Washington University Medical Center
MedicalResearch.com: What is the background for this study?
Response: Prior research has demonstrated that readmission in the first 30 days after percutaneous coronary intervention (PCI) is common, reported around one in six or seven Medicare beneficiaries, and that many are potentially preventable. Since 2000, there have been significant changes in the management of coronary artery disease and the use of PCI. Additionally, in the last decade, readmission rates have become a major focus of research, quality improvement and a public health issue, with multiple resulting national initiatives/programs which may be affecting care. Therefore, in this study, we sought to examine contemporary trends in readmission characteristics and associated outcomes of patients who underwent PCI using the Medicare database from 2000-2012.
Dr. Matt Maciejewski[/caption]
Matthew Leonard Maciejewski, PhD
Professor in the Division of General Internal Medicine
Department of Medicine
Duke University School of Medicine
Research Career Scientist and Director of the Health Economics and Policy Unit in the Center for Health Services Research in Primary Care
Durham VA Medical Center
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: No study based on a US cohort undergoing current procedures has examined weight change comparing surgical patients and nonsurgical patients for as long as we have. This is the first study to report 10-year outcomes on gastric bypass patients and compare them to matched patients who did not get surgery. At 1 year, gastric bypass patients lost 31% of their baseline weight compared controls who only lost 1.1% of their baseline weight. At 10 years, gastric bypass had lost 28% of their baseline weight.
We also compared weight loss at 4 years for Veterans who received the 3 most common procedures (gastric bypass, sleeve gastrectomy, and adjustable gastric banding). At 4 years, patients undergoing gastric bypass lost more weight than patients undergoing sleeve gastrectomy or gastric banding. Given that few high quality studies have examined sleeve gastrectomy to 4 years, the 4-year sleeve outcomes contribute to filling this important evidence gap as the sleeve gastrectomy is now the most commonly performed bariatric procedure worldwide.
Dr. Marlous Hall[/caption]
Dr Marlous Hall PhD
Senior Epidemiologist
Leeds Institute of Cardiovascular and Metabolic Medicine
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: It is well known that death rates following heart attacks have fallen considerably over recent decades. Many studies have looked at the effect of medications and invasive strategies, and their association with better clinical outcomes is clear.
However, a big question remains: why have heart attack deaths fallen? Is it due to increased use of medications and treatment, is the risk of patients simply lower over time due to things like earlier diagnosis or are patients generally healthier with fewer comorbidities such as diabetes? Answering this is not straightforward - as gold standard studies like clinical trials on historic data cannot be done.
An alternative approach is to look for patterns in data observed from routine care to look at all these factors together. This study used a large and rich dataset covering heart attack care in the UK (Myocardial Ischaemia National Audit Project (MINAP)). This dataset was linked to outcome data from the Office for National Statistics to allow us to look at all the different factors that could influence the change in mortality over time.
Prof. Lars Wallentin[/caption]
Prof Lars Wallentin, MD PHD
Senior Professor Cardiology
Uppsala Clinical Research Center,
Uppsala University
MedicalResearch.com: What is the background for this study?
Response: The FRISC2 study was performed 1996 – 1998 and reported 1999 for the first time a significant reduction in death and myocardial infarction by early invasive compared to non-invasive treatment strategy in patients with non-ST-elevation acute coronary syndrome (NSTE-ACS). The results at 6 months, 1, 2 and 5 years were published in The Lancet and pivotal in changing the treatment guidelines and thereby improving outcomes in patients with NSTE-ACS. These findings were within the next few years verified in the TACTICS-TIMI18 and RITA3 trials. However the later performed ICTUS trial, starting after these results were published and accordingly with a substantial early crossover to the invasive arm, showed neutral results. Recently the reduction in event rates by an early invasive strategy was again validated in patients above 80 years of age, which were less well represented in the initial trials. These benefits of an early invasive strategy have previously been shown sustained for at least five years based on results from the FRISC2, RITA3, and ICTUS trials. The FRISC2 and TACTICS-TIMI18 trials also showed that the benefits with an early invasive strategy seemed confined to patients with signs of myocardial necrosis as indicated by elevated troponin level at entry. In addition the FRISC2 trial found that the benefits were larger in patients with signs of inflammatory activity as indicated by a high level of growth differentiation factor 15 (GDF-15) at entry. These pivotal results have been the basis for the current international treatment guidelines recommending an early invasive treatment strategy in patients with NSTE-ACS and elevated troponin and/or other indicators of a raised risk.
Dr. Jason Wasfy[/caption]
Jason H. Wasfy, MD, MPhil
Assistant Medical Director, Massachusetts General Physicians Organization
Director of Quality and Analytics
Massachusetts General Hospital Heart Center
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Reducing preventable readmissions after PCI is a way to both improve the quality of care for our patients and improve value for patients with coronary artery disease. Through a variety of tactics, we were able to reduce the 30 day readmission rate for patients after PCI by nearly half. Keep in mind that this is only the readmission rate to our hospital, so we will need to confirm these results with data including patients who may have been readmitted to other hospitals after a PCI at Mass General.
Dr. Gennaro Giustino[/caption]
Gennaro Giustino MD
Resident Physician - Department of Medicine
The Icahn School of Medicine at Mount Sinai
MedicalResearch.com: What is the background for this study?
Response: A period of dual antiplatelet therapy (DAPT) is required after percutaneous coronary intervention (PCI) with drug-eluting stents (DES). The pathophysiological rationale for DAPT after DES-PCI is predicated on the need to prevent stent-related thrombotic complications while vascular healing and platform endothelialization are ongoing, a process that seems to last between 1 and 6 months with new-generation DES. Whether to extend DAPT after this mandatory period in order to provide a broader atherothrombotic risk protection (for stent-related and non-stent-related atherothrombotic events) is currently a matter of debate. Current guidelines recommend at least 6 months of DAPT after PCI in patients with stable coronary artery disease (CAD) and at least 12 months of DAPT in patients presenting with acute coronary syndrome (ACS). While, several risk scores have been developed to guide clinical decision making for DAPT intensity and duration (namely the DAPT score and the PARIS risk scores) little attention has been payed so far to PCI complexity and the extent of CAD to guide duration of DAPT. In fact irrespective of clinical presentation, patients undergoing more complex PCI procedure (likely due to greater coronary atherosclerotic burden) may remain at greater risk for ischemic events and therefore may benefit of prolonged, or more intense, DAPT.
Dr. John Elefteriades[/caption]
John A. Elefteriades, MD
William W.L. Glenn Professor of Surgery
Chief of Cardiothoracic Surgery
Yale New-Haven Hospital
Director, Aortic Institute at Yale-New Haven
Yale University School of Medicine
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: In the late 1990’s, Dr. Milewicz’s group in Texas and our group at Yale recognized that thoracic aortic aneurysms and aortic dissections (internal tears of the aorta) ran in families.
This paper explores for the first time the ages at which aortic dissections occur among members within a family. Interestingly, we found that once one family member has suffered an aortic dissection, other family members tend to suffer dissection at about the same age (mostly within ten years of the age of the original dissector).
Dr. Monica Morrow[/caption]
Monica Morrow, MD, FACS
Chief, Breast Service
Department of Surgery
Anne Burnett Windfohr Chair of Clinical Oncology
Memorial Sloan-Kettering Cancer Center
MedicalResearch.com: What is the background for this study?
Response: DCIS, ductal carcinoma in situ, intraductal cancer or Stage 0 cancer refers to what some people call the earliest form of cancer we can find and others term “precancerous”. This difference in terms is due to the fact that DCIS lacks the ability to spread to other parts of the body, a fundamental characteristic of cancer. The goal of treatment in DCIS is to prevent progression to invasive cancer which has the ability to spread. DCIS accounted for only 2-3 % of breast cancers seen in the pre-screening mammography era, but it comprises 25-30% of the malignancies detected in screening mammography programs.
For this reason it is uncommon in women under age 40, and more commonly seen in women over 50 years of age. Approximately 70% of the women in the US diagnosed with DCIS are treated with lumpectomy (removal of the DCIS and a margin of surrounding normal breast tissue), and additional surgeries to obtain clear, or more widely clear, margins are done in approximately 30% of women.
For this reason, the Society of Surgical Oncology, the American Society for Therapeutic Radiation Oncology, and the American Society of Clinical Oncology undertook the development of an evidence based guideline to determine the optimal clear margin for women with DCIS treated with lumpectomy and whole breast radiotherapy.
Dr. George Adams[/caption]
George Adams, M.D., M.H.S., F.A.C.C., F.S.C.A.I.
Director of Cardiovascular and Peripheral Vascular Research
Rex Hospital
Raleigh, North Carolina
Summary: The early findings of a novel all-comers PAD study (LIBERTY 360°) suggest that ‘watchful waiting’ in Rutherford class 2-3 and ‘primary amputation’ in Rutherford class 6 may not be necessary. Peripheral vascular intervention can be successful in these patient populations as well.
MedicalResearch.com: What is the background for this study?
Response: Approximately 18 million Americans have peripheral artery disease (PAD), and 2 million of these patients suffer from critical limb ischemia (CLI)1,2, the end stage of PAD3. CLI is highly prevalent in older patients with diabetes and/or end-stage renal disease4, and is associated with high risk of amputation and mortality5. Briefly, the LIBERTY 360° study6 is a prospective, observational, multi-center study with liberal inclusion criteria and few exclusions, meant to evaluate procedural and long-term clinical and economic outcomes of endovascular device interventions in patients with symptomatic lower extremity PAD, including CLI. The study included any FDA-approved technology to treat claudication and CLI. Four core laboratories were utilized for independent analysis.
Dr. Gil Wolfe[/caption]
Gil I. Wolfe, MD, FAAN
Irvin and Rosemary Smith Professor and Chair
Dept. of Neurology/Jacobs Neurological Institute
Univ. at Buffalo Jacobs School of Medicine and Biomedical Sciences/SUNY
Buffalo General Medical Center
Buffalo, NY 14203-1126
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Thymectomy has been used in myasthenia gravis (MG), in particular those patients who do not have a tumor of the thymus gland, known as a thymoma, for over 75 years without randomized data to support its use. A practice parameter in 2000 on behalf of the American Academy of Neurology stated that the benefits of thymectomy in this population of non-thymomatou smyasthenia gravis patients remained uncertain, classified thymectomy as a treatment option in this group, and called for rigorous, randomized studies.
What we found is that compared to an identical prednisone protocol alone, that extended transsternal thymectomy confers significant benefits to non-thymomatous MG patients over a period of three years after the procedure. The benefits include better disease status, reduced prednisone requirements, fewer hospitalizations to manage myasthenia gravis worsenings, and a lower symptom profile related to side effects from medications used to control the disease state.