MedicalResearch.com Interview with: Dr. H. Jaap Bonjer, PhD, FRCSC Professor of Surgery Chair Department of Surgery VU University Medical Center Amsterdam Amsterdam Medical Research: What is...
MedicalResearch.com Interview with:
Marco Valgimigli, MD, PhD
Erasmus MC, Thoraxcenter,
Rotterdam The Netherlands
MedicalResearch: What is the background for this study? What are the main findings?
Dr. Valgimigli: Interventional cardiologists can choose between two entry sites in order to perform a diagnostic coronary angiography and or a percutaneous coronary intervention, namely an artery which is in the groin called femoral artery or an artery which is located in the wrist which is called radial artery. The latter is more superficial and has small calibre as compared to the former. Femoral artery is the entry site which is most frequently used in the world especially in US where the use of radial artery is relatively limited.
Our study randomly allocated 8,404 patients to undergo diagnostic coronary angiography and PCI, if clinically indicated, either vie the femoral or the radial artery.
The main results of our study are that radial access reduced the composite of net adverse clinical events driven by a reduction of mortality and of major bleeding, including transfusions and need for surgical repair or the entry site.
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MedicalResearch.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.
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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…)
MedicalResearch.com Interview with:
Dr. Anil Sood MD
Professor of Gynecologic Oncology and Reproductive Medicine
The University of Texas MD Anderson Cancer Center
Medical Research: What is the background for this study? What are the main findings?
MedicalResearch: What is the background for this approach? What are the main findings?
Dr. Sood: The background involves several different issues: management approaches have varied quite a bit across the US; definition of “optimal” surgery and rates of complete surgical removal of tumor (R0) have also varied. It is quite apparent that patients who benefit the most from surgery upfront are those who have removal of tumor resection. To address these issues, we have implanted a much more personalized approach whereby patients with suspected advanced ovarian cancer undergo laparoscopic assessment using a validated scoring system (based on the pattern and extent of disease noted during laparoscopic assessment); patients with a score <8 undergo upfront debulking surgery and those with a score ≥8 receive neoadjuvant chemotherapy followed by surgery after 3-4 cycles. To date, this program has been fully implemented as part of the Moonshot Program at M.D. Anderson. This program has already resulted in several benefits – for example, prior to this algorithm being put into place among all patients with suspected advanced ovarian cancer, around 20% would have removal of tumor resection; after the implementation of the algorithm, of those going to upfront debulking surgery (after laparoscopic assessment), almost 85% of times removal of tumor resection can be achieved. Also, this method of treatment is allowing for new and innovative clinical trial designs. (more…)
MedicalResearch.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.
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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.
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MedicalResearch.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.
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MedicalResearch.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).
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MedicalResearch.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.
MedicalResearch.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.
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MedicalResearch.com Interview with:
Ganesh Sivarajan, MD
Department of Urology
New York University Langone Medical Center
MedicalResearch.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…)
MedicalResearch.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…)
han 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.
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MedicalResearch.com Interview with:
Lars Peter Holst Andersen MD., Ph.d. Fellow / Læge, Ph.d. studerende
Department of Surgery Herlev Hospital
Gastroenheden, Herlev Hospital
Medical Research: What is the background for this study?
Dr. Andersen: The sleep hormone, melatonin is diverse molecule. Several experimental animal studies have documented significant antinociceptive effects in a wide range of pain models. In perioperative medicine, administration of melatonin has demonstrated anxiolytic, analgesic and anti-oxidant effects. Optimization of the analgesic treatment in surgical patients is required due to documented inadequate analgesia and the risk of adverse effects and complications caused by commonly used NSAIDs and opioids. Our goal was to investigate if melatonin was able to reduce pain scores or analgesic use in patients undergoing laparoscopic cholecystectomy.
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Medical Research.com Interview with:
Terrence Loftus, MD, MBA, FACS
Medical Director, Surgical Service & Clinical Resources
Banner Health
Phoenix, Arizona 85006
Medical Research: What are the main findings of the study?
Dr. Loftus: This study demonstrated that a standardized safe surgery program effectively and systematically implemented across a diverse healthcare system resulted in a significant reduction in serious reportable events (SREs), thereby improving the quality of patient care and leading to significant cost avoidance. For the purposes of the study, SREs were defined as any reported retained surgical item, wrong site, wrong patient or wrong procedure event. Following implementation of the Safe Surgery Program there was a 52% reduction in the SRE rate in the operating rooms and L&D areas in our system. The most dramatic change and greatest area of improvement was in wrong site events which demonstrated a 70% reduction for this type of serious reportable events.
This was achieved through a Safe Surgery Program which consisted of three main components.
MedicalResearch.com Interview with:
Michael S. Calderwood, MD MPH
Division of Infectious Diseases
Brigham and Women's Hospital
Boston, MA
Medical Research: What are the main findings of the study?
Dr. Calderwood: "In our study, we found that the risk of surgical site infection (SSI) following total hip arthroplasty and coronary artery bypass graft (CABG) surgery is higher for Medicare patients undergoing surgery in U.S. hospitals with lower surgical volume. This suggests that volume leads to experience, and experience leads to improved outcomes."
"We found a significantly higher risk of surgical site infection in U.S. hospitals performing <100 total hip arthroplasty procedures and <50 CABG procedures per year on Medicare patients. In the lowest volume hospitals, 1 out of 3 infections following total hip arthroplasty and 1 out of 4 infections following CABG were in excess of expected outcomes based on experience in the highest volume hospitals."
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MedicalResearch.com Interview with:
Dennis Kim, MD
Los Angeles Biomedical Research Institute Researcher
Medical Research: What are the main findings of the study?
Dr. Kim: Laparoscopic cholecystectomy, a minimally invasive procedure to remove the
gallbladder, is one of the most common abdominal surgeries in the U.S. Yet
medical centers around the country vary in their approaches to the procedure
with some moving patients quickly into surgery while others wait. Our study
found gallbladder removal surgery can wait until regular working hours
rather than rushing the patients into the operating room at night.
The gallbladder is a pear-shaped organ on the upper right side of the
abdomen that collects and stores bile, a digestive fluid produced by the
liver. Gallbladders may need to be removed from patients who suffer pain
from gallstones that block the flow of bile.
In a laparoscopic cholecystectomy, surgeons insert a tiny video camera and
special surgical tools through small incisions in the abdomen to remove the
gallbladder. Occasionally, surgeons may need to create a large incision to
remove the gallbladder, and this is known as an open cholecystectomy.
We conducted a retrospective study of 1,140 patients at two large urban
referral centers who underwent gallbladder removal surgeries. We found 11%
of the surgical procedures performed at night (7 a.m.-7 p.m.) were converted
to the more invasive procedure, open cholecystectomies. Only 6% of those who
underwent the surgery during the day required the more invasive form of
surgery.
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MedicalResearch.com Interview with:
Achih H. Chen, MD, FACS, FAACS
Georgia Center for Facial Plastic Surgery, Evans, Ga and the Division of Facial Plastic and Reconstructive Surgery, Department of Otolaryngology–Head and Neck Surgery
Georgia Regents University, August, Ga
Medical Research: What is the significance of the study?
Dr. Chen : This is the first time that facial rejuvenation surgery using surgical approaches in three planes combined with ablative resurfacing has been reported in the medical literature. This approach was not previously thought possible in a single surgical setting because of the concern about disrupting the facial blood supply that may result in loss of the skin. The study demonstrates the safety of this “Total Face” approach. This approach allows simultaneous tightening of the jawline and neck, recreating the lost youthful volume of the midface region, and restoring of the smooth skin texture so characteristic of a young face. This allows for a more complete or “Total Face Rejuvenation” for patients while allowing them the flexibility for a single recovery period or downtime.
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MedicalResearch.com: Interview with:
Isabelle Bedrosian, M.D., F.A.C.S.
Associate Professor, Department of Surgical Oncology, Division of Surgery
Medical Director, Nellie B. Connelly Breast Center
The University of Texas MD Anderson Cancer Center, Houston, TX
Medical Research: What are the main findings of the study?
Dr. Bedrosian:
• National BCT (breast conserving therapy) rates have increased during the last two decades.
• Disparities based on age, geographic facility location and type of cancer treatment facility have lessened over time.
• Insurance type and travel distance remain persistently associated with underutilization of breast conserving therapy.
• Annual income of less than $35K may be emerging as a new association with underutilization of breast conserving therapy.
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MedicalResearch.com Interview with:
Dr. Juliane Bingener-Casey, M.D.
Mayo Clinic in Rochester, Minn
Medical Research: What are the main findings of the study?
Dr. Bingener: Other investigators have shown that preoperative quality of life is a predictor for postoperative survival in colon and pancreas cancer surgery. In this study we looked as preoperative quality of life as a predictor for postoperative complications. The main findings of the study were that patients who had a deficit in their quality of life before surgery had a 3 times higher risk of a serious complication before leaving the hospital than patients who had normal quality of life (16% vs 6 %), independent of gender, race, tumor stage or laparoscopic or open colectomy. Patients with serious complications before leaving the hospital also were older and had more other medical problems than patients without complications. Further, patients who had a complication stayed in the hospital longer and their postoperative quality of life was worse (more…)