Author Interviews, Cleveland Clinic, Heart Disease, Lancet, Surgical Research / 15.03.2015

Prof Samir R Kapadia MD Director, Sones Cardiac Catheterization Laboratories Cleveland Clinic Cleveland, OH For patients with severe symptomatic aortic stenosis (AS) who are not candidates for surgical valve replacement, transcatheter aortic valve replacement (TAVR) offers superior benefit to standard therapy, as measured by all-cause mortality, cardiovascular mortality, repeat hospital admission and functional status. PARTNER 1B 5 year data were published simultaneously with PARTNER 1A 5 year data in 2 separate manuscripts in the Lancet (March 15 2105). In this landmark trial, TAVR produced a 22 percent survival benefit and a 28 percent reduced risk of cardiovascular mortality, compared with standard treatment. According to Cleveland Clinic interventional cardiologist Samir Kapadia, MD, lead author of PARTNER 1B, these findings have changed the treatment paradigm for severe Aortic Stenosis patients who can’t undergo surgical Aortic Valve Replacement. “This trial is the first—and will probably be the only—randomized AS trial that includes a standard treatment group, since these results will make it unethical to treat severe AS patients with medical therapy alone without aortic valve replacement. ” he says. Superior survival benefit with TAVR PARTNER 1B is the only rigorous randomized trial of extreme-risk aortic stenosis patients that has prospectively reported the outcomes of TAVR versus standard treatment in patients for whom the estimated probability of death or serious irreversible morbidity after surgical aortic valve replacement was 50 percent or greater. The trial enrolled 358 patients between May 11, 2007 and March 16, 2009; 179 patients were assigned to TAVR with the first-generation Sapien valve and 179 to standard therapy which includes medical therapy and balloon aortic valvuloplasty. TAVR was performed under general anesthesia with common femoral artery access. Guidance was provided by transesophagel echocardiography and fluoroscopy. The mean age of participants was 83. The primary endpoint was all-cause survival. Secondary endpoints included cardiovascular mortality, stroke, vascular complications, major bleeding and functional status. (more…)
Author Interviews, Heart Disease, NEJM, Surgical Research / 15.03.2015

Barnaby C. Reeves, D.Phil. Professor of Health Services Research, Clinical Trials & Evaluation Unit School of Clinical Sciences, University of Bristol Bristol Royal Infirmary BristolMedicalResearch.com Interview with: Barnaby C. Reeves, D.Phil. Professor of Health Services Research, Clinical Trials & Evaluation Unit School of Clinical Sciences, University of Bristol Bristol Royal Infirmary Bristol Medical Research: What is the background for this study? Response: Variable decisions are made about when to transfuse patients after cardiac surgery. The circumstances of particular patients influence decisions about whether to give a transfusion. Transfusion is a life-saving intervention when a patient is experiencing life-threatening bleeding but most patients have only one or two units of red cells transfused. These transfusions are given at varying levels of anaemia. Some doctors prefer to give a transfusion after cardiac surgery when a patient is only mildly anaemic, believing that the transfusion will promote recovery, while other doctors prefer to wait to transfuse until a patient is substantially anaemic, believing that a transfusion may do more good than harm and is wasteful if it is not needed. Therefore, we carried out a randomized controlled trial comparing restrictive (transfuse when haemoglobin <7.5 g/dL) and liberal transfusion thresholds (transfuse when haemoglobin <9.0 g/dL).* Medical Research: What are the main findings? Response: We obtained written informed consent before surgery but only randomized participants after surgery, in intensive care, if their Hb dropped below 9 g/dL. (Hence, we recruited over 3,500 patients but randomized only 2007.) This design avoids ‘diluting’ any difference between groups by including participants who would not usually be ‘considered’ for transfusion. The primary outcome was the occurrence of one or more serious complications: heart attack, stroke, acute kidney injury, bowel infarction, infection; this included/involved 35.1% of the patients in the restrictive-threshold group and 33.0% of the patients in the liberal-threshold group. This slight difference – more in the restrictive group – was not statistically significant. We then compared the percentages of patients who died; these were 4.2% in the restrictive group and 2.6% in the liberal group. The difference in this secondary outcome was of borderline statistical significance. Frequencies of other secondary outcomes (infections, ischaemic events, days in critical care and hospital, pulmonary complications) were not different in the two groups. We also carried out some pre-specified sensitivity analyses for the primary outcome and all-cause mortality. The two most important ones aimed to avoid dilution of the difference between groups as a result of patients having transfusions or outcome events before randomization. Excluding patients who were transfused before randomization shifted the treatment effect to favour the liberal threshold more strongly, for both the primary outcome and mortality. Excluding patients who experienced an outcome event in the first 24 hours after randomization did not change the treatment effect for either outcome. (more…)
Author Interviews, JAMA, Orthopedics, Surgical Research / 11.03.2015

Prof. Amar Rangan Clinical Professor, Trauma & Orthopaedic Surgery School of Medicine & Health, Durham University & Consultant Orthopaedic Surgeon The James Cook University Hospital MiddlesbroughMedicalResearch.com Interview with: Prof. Amar Rangan Clinical Professor, Trauma & Orthopaedic Surgery School of Medicine & Health, Durham University & Consultant Orthopaedic Surgeon The James Cook University Hospital Middlesbrough Medical Research: What is the background for this study? What are the main findings? Prof. Rangan: The majority of fractures of the proximal humerus (broken shoulders) occur in people older than 65 years. Although surgical treatment is being increasingly used for the more serious (displaced) fractures, it has been unclear whether surgical intervention (fracture fixation or humeral head replacement) produces consistently better outcomes than non-surgical treatment (arm-sling); both followed by physiotherapy. Our multicentre randomized controlled trial (ProFHER), funded by the UK National Institute for Health Research’s Health Technology Assessment Programme, recruited 250 patients aged 16 years or older (mean age, 66 years) who presented at the orthopedic departments of 32 acute UK National Health Service hospitals between September 2008 and April 2011 after sustaining the most common types of acute displaced fracture of the proximal humerus. Data for 231 patients (92.4% of 250) included in the primary analysis showed that there was no significant difference between the two treatment groups over two years or at 6, 12 and 24 months follow-up in self-reported pain and function scores. Nor were there significant differences on measures of health-related quality of life, complications related to surgery or shoulder fracture, later surgery or treatment for these complications, and death. (more…)
Author Interviews, Outcomes & Safety, Surgical Research / 05.03.2015

E. Patchen Dellinger, M.D. Professor of Surgery University of Washington, Box 356410 Seattle, Washington MedicalResearch.com Interview with: E. Patchen Dellinger, M.D. Professor of Surgery University of Washington Seattle, Washington Medical Research: What is the background for this study? What are the main findings? Dr. Dellinger: We know from previous large studies that use of checklists is associated with improvements in patient morbidity and mortality. However, recent large studies have also shown that mandating teams to use the checklist without providing the support required for adequate implementation does not result in better outcomes. This report reviews findings from studies examining checklist compliance and use. We found that when compliance with the checklist is poor it is not as effective as when the checklist is carried out as it is intended. Checklist use appears to be a marker for institutional culture of safety, and organizations with a more robust safety culture may be more likely to use the checklist in an effective manner with resulting improvements in patient safety. (more…)
Author Interviews, JAMA, Outcomes & Safety, Surgical Research / 03.03.2015

MedicalResearch.com Interview with: Dr. Stephen Duquette MD Indiana University Department of Surgery, Division of Plastic Surgery R.L Roudebush VA  Indianapolis, IN Medical Research: What is the background for this study? What are the main findings? Dr. Duquette: Carpal tunnel syndrome is the most common compressive peripheral neuropathy, causing pain, numbness and weakness.  Conservative treatment options include splinting, NSAID pain medications, and steroid injections.  Most often the definitive therapy is carpal tunnel release (CTR).  Over 500,000 procedures are performed in the US yearly, making it one of the most commonly performed hand surgery procedures.  In the United States it is most common to perform this operation in the operating room, under sedation and locoregional anesthesia.  Because it is a very common disease that is treated surgically, process improvement can have a major impact in time to OR, patient recovery, patient satisfaction, and overall throughput.  This is especially valuable in the Veterans Administration (VA) system, where recent problems have arisen due to lack of adequate resources to care for all veterans. This study examined the impact of opening an office-based procedure room in a VA to perform awake hand surgery under local anesthesia only.   This was compared to the prior practice of operating room carpal tunnel release though a number of performance metrics, including time to OR and complications.  Although office carpal tunnel releases are performed routinely in Canada, some surgeons still believe that the complications would increase outside the very sterile environment of the operating room. The current study showed that wait times from initial consultation and initial visit to surgical intervention were significantly decreased in the procedure room group compared to the operating room.  The complication rate was the same for both groups, showing that the procedure room and the operating room were both equally safe and efficacious in providing an environment that was ideal for the performance of carpal tunnel releases. (more…)
Author Interviews, Emory, Frailty, Surgical Research / 02.03.2015

MedicalResearch.com Interview with: Louis M. Revenig, MD and Kenneth Ogan MD, Department of Urology Emory University School of Medicine Atlanta, Georgia 30322 MedicalResearch: What is the background for this study? What are the main findings? Response: Numerous groups from a variety of institutions have investigated different methods of quantifying frailty in surgical populations. All have shown that frailty not only can be measured, but more importantly, reliably identifies the patients who are at higher risk for poor postoperative outcomes compared to their peers.  One obstacle to more widespread use of frailty assessments is the extra burden it places on an already busy clinical setting. In our study we chose what we thought was the already simplest and most clinically applicable frailty assessment, the 5-component Fried Frailty Criteria, and prospectively enrolled a large cohort of surgical patients and followed their outcomes. We critically analyzed the data to assess which components of the frailty assessment were most important. Our results showed that of the 5 components (weight loss, grip strength, gait speed, exhaustion, and activity level), weight loss and grip strength alone carried the same prognostic information for post-operative outcomes as the full assessment. Additionally, when combined with two already routinely collected pre-operative variables (serum hemoglobin and ASA score) we created a novel, simple, and easy to use risk stratification system that is more amenable to a busy clinical setting. (more…)
Author Interviews, Lancet, Surgical Research, Technology / 26.02.2015

MedicalResearch.com Interview with: Aidan Roche MBBS, PhD, BEng and Prof Oskar C Aszmann MD Director of the Christian Doppler Laboratory for Restoration of Extremity Function Division of Plastic and Reconstructive Surgery Department of Surgery Medical University of Vienna, Vienna, Austria Medical Research: What is the background for this study? What are the main findings? Response: The study was prompted by lack of techniques to restore hand function in patients with global plexopathies with avulsion of the lower roots. In simple terms, this is a tearing injury to parts of the brachial plexus. The brachial plexus is a complex junction of nerves that leaves the spinal cord and supplies the arm. If this junction of nerves is severely damaged, information cannot reach the hand to control it or to receive sensation from it.  In some of these cases, traditional reconstructive surgical techniques are only able to restore shoulder and elbow function, not the hand itself. In severe cases, this might leave the patient with a useless hand.  In previous clinical studies with existing amputees, advancing research has shown that good prosthetic control can be achieved by selectively transferring nerves. However, our study differs as our patients had intact, but functionless hands. The innovation here was to selectively transfer nerves and muscles to create useable signals for prosthetic control. Together with a comprehensive rehabilitation regime, followed by elective amputation, this formed the bionic reconstruction process. The main finding is that all three patients had excellent hand function restored through bionic reconstruction (as measured by the uniform improvement in all patients in the clinical outcome scores of the Action Research Arm Test, the Disability of Arm, Shoulder and Hand Questionairre, and the Southampton Hand Assessment Procedure and reported in detail in The Lancet). (more…)
Author Interviews, Education, Outcomes & Safety, Surgical Research, University of Pennsylvania / 25.02.2015

Samuel D. Pimentel Doctoral student Statistics Department Wharton School of the University of PennsylvaniaMedicalResearch.com Interview with: Samuel D. Pimentel Doctoral student Statistics Department Wharton School of the University of Pennsylvania   MedicalResearch: What is the background for this study? What are the main findings? Response: Surgical training has undergone major changes in recent years – including a reduction of six to twelve months of training time – and there is controversy about whether these changes have been good or bad for patient outcomes.   Our work partially addresses the issue by asking whether newly-trained surgeons perform better or worse than experienced surgeons.  We compared surgical patients treated by new surgeons to a similar group of patients treated by experienced surgeons using a new statistical technique called large, sparse optimal matching.  Our analysis found no significant differences in mortality rates between the two groups. (more…)
Author Interviews, Surgical Research / 22.02.2015

Dr. Y. Eltahir University Medical Centre Groningen Department of Plastic Surgery Groningen, The NetherlandsMedicalResearch.com Interview with: Dr. Y. Eltahir University Medical Centre Groningen Department of Plastic Surgery Groningen, The Netherlands Medical Research: What is the background for this study? What are the main findings? Dr. Eltahir: There are different options for breast reconstruction. They are divided into two main groups; autologous or implant breast reconstructions. all may have their effect on the quality of life and might have surgical complications. We were interested to know which breast reconstruction method may provide a better quality of life. However, we wanted to know this information from the patients point of view, that’s why we used the Breast-Q which is a case specific instrument, to compare the two groups. We found out that women with autologous breast reconstruction were more satisfied their breast than the implant group. However, this group has more secondary corrections than the control group. Further were no differences between the two groups. (more…)
Author Interviews, JAMA, Surgical Research, Weight Research / 09.02.2015

MedicalResearch.com Interview with: Torsten Olbers MD, PhD Assistant Professor of Surgery Sahlgrenska University Hospital Gothenburg, Sweden Medical Research: What is the background for this study? What are the main findings? Dr. Olbers: Until now there has been no consensus regarding preferred bariatric procedure for patients with a body mass index (BMI) above 50 kg/m2. We report on the 5-year outcomes from a randomized clinical trial of gastric bypass and duodenal switch published online by JAMA Surgery on February 4th. (more…)
Author Interviews, Hospital Readmissions, JAMA, Surgical Research / 03.02.2015

Dr. Ryan Merkow, M.D. M.S. American College of Surgeons Chicago, IllinoisMedicalResearch.com Interview with: Dr. Ryan Merkow, M.D. M.S. American College of Surgeons Chicago, Illinois     MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Merkow: The measurement of hospital readmissions has become an important quality and cost-containment metric. Hospitals, policy makers, and individual practitioners are closely tracking readmissions. For the past decade the focus has been primarily on three medical conditions (pneumonia, heart failure and myocardial infarction) and although controversial, many thought leaders and policy makers believed that readmissions were preventable, and stemmed from poor transition of care, outpatient follow up or simply a failure of the medical system to appropriately care for these patients. Recently, the Center for Medicare and Medicaid Services has become increasingly interested in using readmissions as a quality measure and is now mandated by the Hospital Readmission Reduction Program to track hospital-wide readmissions (including all surgical patients), and for the first time, after individual surgical procedures (i.e., total hip and knee replacement). Future inclusion of additional surgical procedures is anticipated. However, despite the growing focus on readmissions after surgery, there have been few studies comprehensively evaluating the underlying reasons and factors associated with readmissions after surgical hospitalizations. Furthermore, the relationship between readmissions and complications that occur during the initial hospitalization after surgery is not clearly established. Importantly, unlike medical conditions, surgical patients undergo a discrete invasive event with known risks of complications. By studying this topic, initiatives to decrease readmissions can be more precisely determined, and national policy decisions that are now targeting readmissions can be appropriately formulated. The primary findings of our study identified surgical site infections as the most frequent reason that patients are readmitted after surgery, Importantly, in >95% of patients this complication was new, occurring after they left the hospital. The other common reason for readmission was obstruction or ileus, which was the second most frequent reason for readmission, particularly after abdominal surgery. Overall, the vast majority of readmissions were the result of new postdischarge, postoperative complications. With respect to factors associated with readmissions, most of the variation was due to differences in patient factors, such as ASA class, renal failure, ascites and/or steroid use. (more…)
Author Interviews, Brigham & Women's - Harvard, Surgical Research / 01.02.2015

Timothy R. Smith, M.D., Ph.D., M.P.H. Pituitary/Neuroendoscopy Fellow Department of Neurosurgery Brigham & Womens Hospital Harvard University Boston, MA 02115MedicalResearch.com Interview with: Timothy R. Smith, M.D., Ph.D., M.P.H. Pituitary/Neuroendoscopy Fellow Department of Neurosurgery Brigham & Womens Hospital Harvard University Boston, MA 0211 Medical Research: What is the background for this study? What are the main findings? Dr. Smith: Defensive medicine is the practice of prescribing unnecessary medical treatment for fear of being sued – it is widely practiced in the United States and contributes to our rising healthcare costs. In high-risk specialties such as neurosurgery, the fear of litigation leads to defensive practices that actually impact clinical decisions. A 2009 American College of Emergency Physicians report created malpractice risk profiles for each state based on its legal atmosphere, tort reform, and insurance availability. Based on these profiles, each state was ranked from 1 to 50 and sorted into separate categories, ranging from A, for the best liability environment, to F, for the worst. We sent a 51-question, anonymous online survey, which covered topics ranging from patient characteristics to surgeon liability profiles, to board-certified US neurosurgeons in the American Association of Neurological Surgeons. The purpose was to determine how neurosurgeons’ perceptions of their medico-legal environments correlated with these established state risk profiles, as well as whether each state’s liability risk environment was a predictor of defensive medical practices. We found that though the average malpractice insurance premium was $103,000 per year, neurosurgeons from high-risk states paid significantly more ($128,000) than those from low-risk states did ($75,000). Even with these amounts, almost 70% of respondents felt that their insurance coverage was inadequate, and 90% felt that the insurance premium was a financial burden. Neurosurgeons from high-risk states were also twice as likely to have been sued as those from low-risk states were. More than 80% of respondents ordered additional imaging for defensive medical purposes, and more than 75% said they ordered additional laboratory tests and made unnecessary referrals for defensive purposes; this behavior was more prevalent in high-risk states. After controlling for important confounders, we found that for every letter-grade change from “A” to “F”, neurosurgeons are 1.5 times more likely to engage in defensive behaviors. For example, moving from a “D” state to an “A” state represents 4.5 fold difference in defensive behaviors. (more…)
Author Interviews, Colon Cancer, Journal Clinical Oncology, Race/Ethnic Diversity, Stanford, Surgical Research / 30.01.2015

Kim F. Rhoads, MD, MS, MPH, FACS Assistant Professor of Surgery Director, Community Partnership Program Stanford Cancer Institute Unit Based Medical Director, E3 Surgery and Surgical Subspecialties Stanford University Stanford, Ca 94305MedicalResearch.com Interview with: Kim F. Rhoads, MD, MS, MPH, FACS Assistant Professor of Surgery Director, Community Partnership Program Stanford Cancer Institute Unit Based Medical Director, E3 Surgery and Surgical Subspecialties Stanford University Stanford, Ca 94305 Medical Research: What is the background for this study? What are the main findings? Dr. Rhoads: Colon cancer is the 3rd most common cancer in US men and women and is the 2nd most common cause of cancer death. For at least 2 decades, minorities with colon cancer have suffered a 15-20% additional risk of death when compared with non-minority patients. Our study set out to understand the influence of the location where treatment was delivered and the quality of care received, on overall survival and racial disparities. We examined more than 30,000 patients who were diagnosed and treated for colon cancer in California from 2001 through 2006.  Using cancer registry data linked to state level inpatient data and hospital information, we compared the rates of National Comprehensive Cancer Network (NCCN) guideline adherence and mortality by location of care and by race. We found that patients treated within an integrated health system (IHS) received NCCN guideline based care at higher rates than those treated outside the system—about 3% higher rates of surgery; and more than 20% higher rates of stage appropriate chemotherapy. The rates of guideline based care were nearly equal between the racial groups treated inside the IHS.  Propensity score matched comparisons revealed a lower risk of death for all patients and no racial disparities associated with treatment within the Integrated system.  For patients treated outside IHS, the disparity in mortality was explained by accounting for differences in receipt of evidence based care by race. (more…)
Author Interviews, Heart Disease, Outcomes & Safety, Surgical Research / 23.01.2015

MedicalResearch.com Interview with: Keita Morikane, Director Division of Clinical Laboratory and Infection Control Yamagata University Hospital Medical Research: What is the background for this study? What are the main findings? Response: The risk factors for surgical site infection following cardiac surgery is extensively investigated, but those specifically of open heart surgery or coronary artery bypass remains unknown. The main findings were that the risk factors between the two types of cardiac surgery were considerably different. (more…)
Author Interviews, Brigham & Women's - Harvard, Geriatrics, Hospital Readmissions, JAMA, Surgical Research / 21.01.2015

Thomas C. Tsai, MD, MPH Departments of Surgery and Health Policy and Management Harvard School of Public Health, Boston, Massachusetts MedicalResearch.com Interview with: Thomas C. Tsai, MD, MPH Departments of Surgery and Health Policy and Management Harvard School of Public Health, Boston, Massachusetts Medical Research: What is the background for this study? What are the main findings? Dr. Tsai: Emerging evidence is suggesting that fragmented care is associated with higher costs and lower quality. For elderly patients undergoing major surgical procedures, fragmentation of care in the post-discharge period may be especially problematic. We therefore hypothesized that elderly patients receiving fragmented post-discharge care would have worse outcomes. We found that among Medicare patients who are readmitted after a major surgical operation, one in four are readmitted to a different hospital than the one where the original operation was performed. Even taking distance traveled into account, we find that this type of postsurgical care fragmentation is associated with a substantially higher risk of death. (more…)
Author Interviews, Brigham & Women's - Harvard, JAMA, Surgical Research / 18.01.2015

Soko Setoguchi, MD DrPH Assistant Professor of Medicine Harvard Medical School and Harvard School of Public Health Director of Safety and Outcome Research in Cardiology Associate Physician in the Division of Pharmacoepidemiology and Pharmacoeconomics Brigham and Women’s HospitalMedicalResearch.com Interview with: Soko Setoguchi, MD DrPH Assistant Professor of Medicine Harvard Medical School and Harvard School of Public Health Director of Safety and Outcome Research in Cardiology Associate Physician in the Division of Pharmacoepidemiology and Pharmacoeconomics Brigham and Women’s Hospital Medical Research: What is the background for this study? What are the main findings? Dr. Setoguchi: Medicare made a decision to cover Carotid Artery Stenting (CAS) in 2005 after publication of SAPPHIRE, which demonstrated the efficacy of Carotid Artery Stenting (CAS) vs Carotid endarterectomy (CEA) in high risk patients for CEA. Despite the data showing increased carotid artery stenting dissemination following the 2005 National Coverage Determination, peri-procedural and long-term outcomes have not been described among Medicare beneficiaries, who are quite different from trial patients, older and with more comorbidities in general population. Understanding the outcomes in these population is particularly important in the light of more recent study, the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST), which established CAS as a safe and efficacious alternative to CEA among non-high-surgical risk patients that also expanded the clinical indication of carotid artery stenting. Another motivation to study ‘real world outcomes in the general population is expected differences in the proficiency of physicians peforming stenting in trial setting vs. real world practice setting. SAPPHIRE and CREST physicians were enrolled only after having demonstrated CAS proficiency with low complication rates whereas hands-on experience and patient outcomes among real-world physicians and hospitals is likely to be more diverse. We found that unadjusted mortality risks over study period of 5 years with a mean of 2 years of follow-up in our population was 32%.  Much higher mortality risks observed among certain subgroups with older age, symptomatic patients and non-elective hospitalizations. (more…)
Author Interviews, JAMA, Surgical Research, Weight Research / 06.01.2015

David Arterburn, MD, MPH, FACP Associate Investigator Group Health Research Institute Seattle, WA 9810MedicalResearch.com Interview with: David Arterburn, MD, MPH, FACP Associate Investigator Group Health Research Institute Seattle, WA 98101   and David L. Maciejewski PhD Center for Health Services Research in Primary Care Durham VA Medical Center, Durham, North CarolinaDavid L. Maciejewski PhD Center for Health Services Research in Primary Care Durham VA Medical Center, Durham, North Carolina MedicalResearch.com: Why was this study needed? Response: There were several reasons to conduct this study.  First, although complications and death during and soon after bariatric surgery have progressively declined over the past several decades, there is simply very little long-term evidence on the survival benefits of bariatric surgery in Americans having surgical procedures that are being used today in routine practice. Second, we felt that it was important to look at the impact of bariatric surgery among veterans because they represent an older male cohort often with multiple medical comorbidities, which is different from the typical bariatric patient in the United States, who is often younger and female. MedicalResearch.com: How was your study conducted? Response: We conducted a retrospective observational study using high-quality data from national Department of Veterans Affairs electronic databases and the VA Surgical Quality Improvement Program. We identified veterans who underwent bariatric surgery in VA medical centers from 2000 to 2011. Three quarters of them were men. We matched them to control patients using an algorithm that included age, sex, VA geographic region, body mass index (BMI), diabetes, and Diagnostic Cost Group. We then compared survival across bariatric patients and matched controls using Kaplan-Meier estimators and stratified, adjusted Cox proportional hazards analyses.  MedicalResearch.com: What were the main findings of your study? Response: This study had three important results: 1)      Our analysis showed no significant association between bariatric surgery and death from all causes in the first year of follow-up. In other words, having bariatric surgery was not significantly related to a veteran’s chance of dying in the first year compared to not having surgery. 2)      We had an average follow-up of 6.9 years in the surgical group and 6.6 years in the matched control group. After one to five years, adjusted analyses showed significantly lower mortality in the patients who had surgery: 55% lower, with a hazard ratio of 0.45. The finding was similar at 5 or more years, with a hazard ratio of 0.47. This means that bariatric surgery was associated with lower long-term mortality – that is, better long-term survival among veterans, which is consistent with limited non-VA research that has addressed this same question. 3)      Finally, we also found that the relationship between surgery and survival were similar comparing men and women, patients with and without diagnosed diabetes, and patients who had bariatric surgery before versus after year 2006. (more…)
Annals Thoracic Surgery, Author Interviews, Heart Disease, Surgical Research, Yale / 02.01.2015

Karthik Murugiah MBBS Fellow in Cardiovascular Medicine Yale School of Medicine Center for Outcomes Research and Evaluation (CORE) New Haven, CT 06510MedicalResearch.com Interview with: Karthik Murugiah MBBS Fellow in Cardiovascular Medicine Yale School of Medicine Center for Outcomes Research and Evaluation (CORE) New Haven, CT 06510 Medical Research: What is the background for this study? What are the main findings? Response: Aortic valve disease is common among older people and frequently requires valve replacement. 1-year survival after open surgical aortic valve replacement is high (9 in 10 survive the year after surgery). Our study focuses on the experience of these survivors in terms of the need for hospitalization during the year after surgery. Among patients >65 years of age enrolled in Medicare who underwent surgical replacement of their aortic valve and survived at least one year, 3 in 5 were free from hospitalization during that year. Both, the rates of hospitalization and the average total number of days spent in the hospital in the year following surgery have been decreasing all through the last decade (1999 to 2010). (more…)
Author Interviews, JAMA, Surgical Research, Weight Research / 31.12.2014

Jeffrey A. Gusenoff, MD Associate Professor of Plastic Surgery Co-Director, Life After Weight Loss Program Co-Director, BodyChangers Director, Post-Bariatric Body Contouring Fellowship UPMC Department of Plastic SurgeryMedicalResearch.com Interview with: Jeffrey A. Gusenoff, MD Associate Professor of Plastic Surgery Co-Director, Life After Weight Loss Program Co-Director, BodyChangers Director, Post-Bariatric Body Contouring Fellowship UPMC Department of Plastic Surgery Medical Research: What is the background for this study? What are the main findings? Dr. Gusenoff: With the rise in massive weight loss patients from bariatric surgery or diet and exercise, more patients are choosing to have a thighplasty to remove excess skin of the inner thigh. Many techniques exist for treating this, but there aren't many studies that look into the safety of these procedures in massive weight loss patients. What we found is that  many patients have scars that go all the way down the thigh with a fairly high complication rate of almost 70%. (more…)
Author Interviews, Surgical Research, University Texas, Weight Research / 27.12.2014

Taylor S. Riall, MD, PhD Professor, John Sealy Distinguished Chair in Clinical Research Department of Surgery, University of Texas Medical Branch, Galveston, TXMedicalResearch.com Interview with: Taylor S. Riall, MD, PhD Professor, John Sealy Distinguished Chair in Clinical Research Department of Surgery, University of Texas Medical Branch, Galveston, TX Medical Research: What is the background for this study? What are the main findings? Dr. Riall: In patients who have symptoms related their gallstones – most commonly sharp right upper quadrant abdominal pain (often associated with fatty meals), nausea, and vomiting - the current recommendation is to remove the gallbladder (perform cholecystectomy). However, in older patients there are multiple factors that make this decision difficult. Older patients have more associated medical problems (like diabetes, heart disease, etc.) making elective surgery higher risk. On the flip side, older patients are at higher risk of developing complications from their gallstones, and once they do, their mortality (death from gallbladder disease) and complications increase substantially. In recent study of Medicare beneficiaries with symptomatic gallstones, we found that fewer than 25% underwent elective removal of the gallbladder after an initial episode of pain or symptoms related to their gallbladder. We then developed a model that predicted the likelihood of these same patients requiring emergent gallstone-related complications if they did not have their gallbladder removed electively. This information prompted the current study. We sought to determine if the patients getting their gallbladders removed were the ones at highest risk for complications. Similar to the previous study, we found that only 22% of Medicare beneficiaries in this study (a different population) underwent elective gallbladder removal. We divided patients into three groups based on our risk prediction model – those with <30% risk, 30-60% risk, and >60% risk of requiring acute gallstone-related hospitalization. Please note that while we call the <30% risk group “low” risk, a 17% chance of hospitalization is actually a significant risk – much higher than seen in other medical conditions for which surgery or other interventions may be considered.
  • First, our model worked well – the ACTUAL hospitalization rate was 17%, 45%, and 69% in the two years after the first symptoms.
  • Second, whether patients had their gallbladder removed seemed unrelated to risk. 22% of patients in the lowest risk group, 21% in the middle risk group, and 23% in highest risk group had their gallbladder removed. Even more striking, in the healthiest patients – those with no medical problems and no reason not to perform elective surgery - cholecystectomy rates actually decreased with increasing risk of emergent admission. Cholecystectomy was performed in 34% of patients in the low risk group, 25% of patients in the moderate risk group, and 26% of patients in the highest risk group.
  • In addition, fewer than 10% of patients who didn’t have their gallbladder removed were ever seen by a surgeon, suggesting that this decision is being made at the level of the primary care or emergency physician and not necessarily patient choice.
(more…)
Author Interviews, JACC, Surgical Research / 26.12.2014

Dr. Mary T. Hawn Center for Surgical, Medical Acute Care Research, and Transitions, Birmingham Veterans Affairs Medical Center University of Alabama at Birmingham, BirminghamMedicalResearch.com Interview with: Dr. Mary T. Hawn MD, MPH Center for Surgical, Medical Acute Care Research, and Transitions, Birmingham Veterans Affairs Medical Center Section of Gastrointestinal Surgery, Department of Surgery, University of Alabama at Birmingham, Birmingham, Alabama Medical Research: What is the background for this study? What are the main findings? Dr. Hawn: Cardiac risk factors and surgical risk factors contribute to the development of postoperative adverse cardiac events, but the relative contribution of each has not been quantified. In this study, we sought to determine the incremental risk of surgery following coronary stent placement on adverse cardiac events. To answer this question we used a retrospective cohort study of VA patients with coronary stents placed during 2000-2010 undergoing non-cardiac surgery within two years of stent placement matched to patients with coronary stents not undergoing surgery.  The patients were matched on stent type (drug-eluting versus bare metal) and cardiac risk factors at the time of stent placement.  Our outcome of interest was a composite variable of myocardial infarction and coronary revascularization occurring within 30 days of surgery.  We calculated adjusted risk differences over time from stent placement using generalized estimating equations. When comparing the two cohorts, we found a higher rate of composite cardiac events in the surgical cohort compared to the cohort not undergoing surgery. The main findings in the study were that the incremental risk of surgery was greatest when the surgery occurred in the first 6 weeks following stent placement and decreased to approximately 1% after 6 months, where it remained stable out to 24 months. Surgical characteristics associated with a significant reduction in the incremental risk after 6 months following stent placement included elective, inpatient procedures, and in the setting of a drug eluting stent. (more…)
Author Interviews, Brigham & Women's - Harvard, Psychological Science, Surgical Research / 20.12.2014

Brian I. Labow, MD Director, Adolescent Breast Clinic Assistant in Surgery Assistant Professor of Surgery Harvard Medical School PrimaryMedicalResearch.com Interview with: Brian I. Labow, MD Director, Adolescent Breast Clinic Assistant in Surgery Assistant Professor of Surgery Harvard Medical School Primary   Medical Research: What is the background for this study? What are the main findings? Dr. Labow:  This study is part of our larger Adolescent Breast Disorder Study, in which we examine the impact of several breast disorders on adolescent girls and boys and measure the effect of treatment. In this present study we have found breast asymmetry, defined as having at least 1 cup size difference between breasts, can have a significant impact on the psychological wellbeing of adolescent girls.  Validated surveys were given to adolescent girls with breast asymmetry, macromastia (enlarged breasts), and healthy unaffected girls between the ages of 12-21 to assess a wide array of health domains. Girls with breast asymmetry had noted deficits in psychological wellbeing and self-esteem when compared to healthy girls of the same age.  These impairments were similar to those of girls with macromastia, a condition known to have significant negative mental health effects. Interestingly, these negative psychological outcomes did not vary by patient’s age or severity of breast asymmetry. Older and younger adolescents were negatively impacted similarly, as were those with lesser and greater degrees of breast asymmetry. (more…)
Author Interviews, BMJ, Surgical Research / 14.12.2014

Dr Aneel Bhangu Clinical Lecturer in Surgery Queen Elizabeth Hospital, Edgbaston, Birmingham UKMedicalResearch.com Interview with: Dr Aneel Bhangu Clinical Lecturer in Surgery Queen Elizabeth Hospital, Edgbaston, Birmingham UK Medical Research: What is the background for this study? What are the main findings? Dr. Bhangu: Randomised clinical trials are widely regarded as the type of evidence in medical research most likely to change practice and improve patient care. However, they are challenging to perform, expensive to deliver and rely on patients’ willingness to participate for the benefit of their wider community. Results of these studies should be disseminated widely in order to promote new medical knowledge. Unfortunately, some clinical trials are terminated early or fail to reach publication after completion. This leads to lost data and wastage of finite resources. Clinical trials within surgical disciplines present unique challenges, which may further impact on dissemination of evidence. We aimed to investigate the fate of surgical trials. Disappointingly, we found that 1 in 5 surgical trials are terminated early before completion, most commonly due to poor recruitment of research participants. Of trials which do reach completion, 1 in 3 are not published, indicating a significant waste of resources. A systematic approach to contact trial investigators during the study proved largely unsuccessful, implicating further hidden barriers to identifying trial data. (more…)
Author Interviews, NYU, Surgical Research / 12.12.2014

Ganesh Sivarajan, MD Department of Urology New York University Langone Medical CenterMedicalResearch.com Interview with: Ganesh Sivarajan, MD Department of Urology New York University Langone Medical Center

  Medical Research: What is the background for this study? What are the main findings? Dr. Sivarajan: The surgical robot was designed to facilitate laparoscopic surgery. The surgeon sits at a console several feet away from the patient and is linked to a multi-armed robot which translates the surgeon’s movements from the console to surgical instruments inside the patient’s insufflated abdomen. The robot is equipped with a high resolution three dimensional camera which improves visualization over traditional open surgery and allows the manipulation of instruments in directions and angles which are difficult in traditional open surgery. In light of these apparent advancements, the robot was rapidly adopted for use during radical prostatectomy. The outcomes data for men undergoing robotic versus open prostatectomy, however, have not demonstrated any clear advantage of robotic surgery, with some studies demonstrating benefit and other demonstrating harm. This fact coupled with the relatively high cost of the robot and its disposable equipment have led many to criticize robotic surgery and its rapid adoption. Partial nephrectomy is a procedure performed for renal cancer in which just the malignant tumor is excised while the remaining healthy kidney is saved. It is increasingly considered to be preferable to the previous gold standard operation – radical nephrectomy or removal of the entire kidney largely secondary to the benefits accrued from preserving renal function. Despite actual changes in the treatment guideline recommending increased use of partial nephrectomy it remains vastly underutilized nationwide likely because of the technical challenges associated with its performance. It has been suggested that the surgical robot facilitates the performance of partial nephrectomy, but this has not been definitively demonstrated in a model which controls for important variables as the effects of changing guidelines, secular trends supporting increased utilization over time and a variety of other hospital-level characteristics. We sought to determine whether acquisition of the surgical robot was independently associated with increased utilization of partial nephrectomy – a guideline-supported procedure. If true, it would suggest that the acquisition of the surgical robot may have improved the quality of care of renal cell carcinoma patients. (more…)
Author Interviews, Case Western, Education, JAMA, Surgical Research / 10.12.2014

Ravi Rajaram MD Division of Research and Optimal Patient Care, American College of Surgeons Surgical Outcomes and Quality Improvement Center (SOQIC), Department of Surgery and Center for Healthcare Studies in the Institute for Public Health and Medicine Feinberg School of Medicine, Northwestern University, Chicago, IllinoisMedicalResearch.com Interview with: Ravi Rajaram MD Division of Research and Optimal Patient Care, American College of Surgeons Surgical Outcomes and Quality Improvement Center (SOQIC), Department of Surgery and Center for Healthcare Studies in the Institute for Public Health and Medicine Feinberg School of Medicine, Northwestern University, Chicago, Illinois Medical Research: What is the background for this study? What are the main findings? Dr. Rajaram: The Accreditation Council for Graduate Medication Education (ACGME) first implemented restrictions to resident duty hours in 2003. In surgical populations, these reforms have not been associated with a change in patient outcomes. However, in 2011, the ACGME further restricted resident duty hours to include: a maximum of 16 hours of continuous duty for first-year residents (interns), direct supervision of interns at all times, a maximum of 4 hours for transitions in care activities for residents in-house for 24 hours, and that these residents be given 14 hours off prior to returning to work. The association between the 2011 ACGME resident duty hour reform with surgical patient outcomes and resident education has not previously been reported. The 2011 resident duty hour reform was not associated with a change in death or serious morbidity in the two years after the reform was implemented. Additionally, the 2011 duty hour reform was not associated with a change in any of the secondary outcomes examined, including any morbidity, failure to rescue, surgical site infection, and sepsis. Furthermore, common measures of surgical resident education, such as in-training examination scores and board certification pass rates, were unchanged after the implementation of the 2011 duty hour reform when compared to scores prior to the reform. (more…)
Author Interviews, JAMA, Surgical Research / 30.11.2014

Hong Ryul Jin, MD Professor and Chair Department of Otorhinolaryngology-HNS Seoul National University Boramae Medical Center, Seoul, KoreaMedicalResearch.com Interview with: Hong Ryul Jin, MD Professor and Chair Department of Otorhinolaryngology-HNS Seoul National University Boramae Medical Center, Seoul, Korea Medical Research: What is the background for this study? What are the main findings? Response: Although autologous rib cartilage is a useful graft material for rhinoplasty, surgeons sometimes encounter unpleasant complication such as warping or donor-site morbidity. These complications are not infrequent, but there has been no systematic review with regarding this matter. For evidence-based practice, we aimed to assess the long-term safety of using rib cartilage by means of meta-analysis. By reviewing the 10 selected, eligible articles after extensive screening, we found that rates of warping, resorption, infection, and displacement were 3.1, 0.2, 0.6, and 0.4%, respectively. Hypertrophic scar at chest was found in 5.5%, with highest report of 23.8%. Warping and hypertrophic chest scarring showed relatively higher rates, warranting a surgeon’s attention (more…)
Author Interviews, CMAJ, Orthopedics, Surgical Research / 27.11.2014

MedicalResearch.com Interview with: NatNathan Evaniew MD Division of Orthopaedics McMaster Universityhan Evaniew MD Division of Orthopaedics McMaster University   Medical Research: What is the background for this study? Dr. Evaniew: Symptomatic cervical and lumbar spinal disc diseases affect at least 5% of the population and they cause a great deal of pain, disability, social burden, and economic impact. For carefully selected patients that fail to improve with nonsurgical management, conventional open discectomy surgery often provides good or excellent results. Minimally invasive techniques for discectomy surgery were introduced as alternatives that are potentially less destructive, but they require specialized equipment and expertise, and they may involve increased risks for technical complications. (more…)
Author Interviews, Cancer Research, JAMA, Surgical Research, Toxin Research / 24.11.2014

MedicalResearch.com Interview with: Naveed Nosrati MD Indiana University School of Medicine Staff Surgeon, Roudebush VAMC Medical Research: What is the background for this study? Dr. Nosrati: We originally began this study as a broader project investigating the effect of trauma induced by biopsies on the spontaneous clearance of a non-melanoma skin cancer. As part of that, we created a large database with many patient variables. Since we undertook this project at our local VA hospital, one of the variables available to us was Agent Orange exposure. Shortly after completing the study, Clemens et al published their study linking Agent Orange exposure to higher rates of invasive non-melanoma skin cancer. Their study was a pilot study of only 100 patients. As we had well over 1,000 patients, we decided to pursue a side project of how Agent Orange specifically affects our results. Our study was operating under the hypothesis that trauma induced by biopsies led to an inflammatory response that often led to the immunologic clearance of the remaining skin cancer. We actually coined the term “SCORCH” lesion, or spontaneous clearance of residual carcinoma histologically, for this phenomenon. With that mind, we would expect patients exposed to Agent Orange to theoretically have a more invasive form of malignancy and thus have lower rates of spontaneous clearance. (more…)
Author Interviews, Breast Cancer, JAMA, Surgical Research, Vanderbilt / 20.11.2014

MedicalResearch.com Interview with: Dr. Kristy Lynn Kummerow MD Division of Surgical Oncology and Endocrine Surgery Vanderbilt University Medical Center Tennessee Valley Healthcare System, Veterans Affairs Medical Center Geriatric Research, Education, and Clinical Center Nashville, Tenn Medical Research: What is the background for this study? What are the main findings? Dr. Kummerow: This study looked at how we are currently treating early stage breast cancer in the US – early stage breast cancer includes small cancers with limited or no lymph node involvement and no spread to other body site – it was prompted by something we observed an our own cancer center, which is that more and more women seem to be undergoing more extensive operations than are necessary to treat their cancer.  It is helpful to understand the historical context of how we treat early breast cancer.  Prior to the 1980s, the standard of care for any breast cancer was a very extensive procedure, which involved removal of the entire breast, as well as underlying and overlying tissues and multiple levels of lymph nodes drained by that area.  Informative clinical trials were completed in the 1980s demonstrated that these extensive procedures were unnecessary, and that equivalent survival could be achieved with a much more minimal operation, by removing only the tumor, with a margin of normal breast tissue around it, and performing radiation therapy to the area; this technique is now known as breast conservation surgery, also known as lumpectomy with radiation.  In the 1990s, breast conservation was established by the national institutes of health and was embraced as a standard of care for early stage breast cancer; performance of breast conservation surgery also became a quality metric – accredited breast centers in the US are expected to perform breast conservation surgery in the majority of women who they treat for breast cancer.  However, what our research team observed at our institution didn’t fit – over time it appears more aggressive surgical approaches are being used for more women.  This has been found in other institutions as well, and is supported by smaller national studies.  We wanted to understand how surgical management of early breast cancer is changing over time at a national level using the largest data set of cancer patients in the United States. (more…)
Author Interviews, JAMA, Surgical Research / 14.11.2014

Rachel Bhak MS Department of Veterans Affairs Cooperative Studies Program Coordinating Center West Haven, ConnecticutMedicalResearch.com Interview with: Rachel Bhak MS Department of Veterans Affairs Cooperative Studies Program Coordinating Center West Haven, Connecticut Medical Research: What is the background for this study? What are the main findings? Ms. Bhak: Abdominal aortic aneurysms (AAA) and their rupture are potentially fatal, so monitoring and understanding their expansion is of utmost importance. This study sought to characterize factors associated with Abdominal aortic aneurysms expansion, as well as their different growth patterns. The main findings are that current smoking and diastolic blood pressure are associated with increased linear expansion rate, diabetes with a decreased linear expansion rate, and diastolic blood pressure and baseline abdominal aortic aneurysms diameter with an accelerated expansion rate. (more…)