MedicalResearch.com Interview with:
Jordan M. Cloyd, MD
Department of Surgery
Stanford University
Stanford, California
Medical Research: What is the background for this study? What are the main findings?
Dr. Cloyd: The motivation for the study was that, anecdotally, we had noticed that several of our patients who had been discharged on a weekend required readmission for potentially preventable reasons. We wanted to investigate whether the data supported the idea that weekend discharge was associated with a higher risk of hospital readmission.
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MedicalResearch.com Interview with:
Susan Ming Lee, MD, FRCPC, MAS (Clinical Research)
Clinical Instructor, Dept. of Anesthesia and Perioperative Care
University of California, San Francisco
Medical Research: What are the main findings?
Dr. Lee: Angiotensin receptor blockers (often referred to as ARBs) are common medications used to treat high blood pressure, heart disease, and kidney disease. Doctors sometimes stop these medications briefly around the time of surgery, since they are known to cause low blood pressure under general anesthesia. Doctors may hesitate to restart ARBs after surgery because they are worried about low blood pressure or kidney function. Prior to our research, there was little information to guide the optimal timing of restarting ARBs after surgery.
Medical Research: What are the main findings?
Dr. Lee: Our study of over 30,000 veterans shows that nearly one third of veterans admitted to hospital for non-cardiac surgery are not restarted on their usual ARBs within two days of their operation. This delay in resuming ARBs is associated with increased death rates in the first month after surgery. In fact, even accounting for factors that might contribute to why doctors would withhold ARB (such as low blood pressure, kidney dysfunction, or other comorbidities), 30-day postoperative mortality was increased approximately 50% in those without resumption of ARBs, and this effect was even greater in younger patients under age 60. Our findings of reduced rates of infections, pneumonia, heart failure, and kidney failure in those that resumed ARBs soon after surgery suggest that early resumption may also reduce complications after surgery.
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MedicalResearch.com Interview with:
Dr. Janet Martin PharmD, PhD
Director, Medical Evidence, Decision Integrity & Clinical Impact (MEDICI)
Assistant Professor, Department of Anesthesia & Perioperative Medicine
and Department of Epidemiology & Biostatistics
Schulich School of Medicine & Dentistry, Western University
London, ON Canada
Medical Research: What is the background for this study? What are the main findings?
Response: There remains some scepticism regarding the effectiveness of the safe surgery checklist (SSCL) to tangibly improve patient safety in the real world setting, especially with respect to relative benefits in high-income versus lower-income settings.
In general, push-back has been related to surgical teams doubting the power of a simple checklist to make significant impact for surgical settings. Despite their deceptive simplicity, checklists can be powerful tools to deal with the sheer volume of information that must be addressed in sequence in order to support safe surgery.
The objective of our study was to determine, through meta-analysis, whether clinically-relevant outcomes after implementation of the WHO Safe Surgery Checklist (SSCL) in the clinical trial setting and in the real world setting are improved, and whether greater benefit occurs in low-middle income countries (LMICs) than in high income countries (HICs).
A total of 13 studies (262,970 patients) met the inclusion criteria, including 12 cohort studies and 1 randomized trial. For SSCL versus control, the odds of death was significantly reduced by 21% (OR 0.79, 95%CI 0.67-0.93; p=0.003). The odds of surgical site infection was reduced by 28% (OR 0.72, 95%CI 0.62-0.84; p=0.001). Similarly, overall postoperative complications were significantly reduced by 30% (OR 0.70, 95%CI 0.59-0.82; p=0.009). While HIC and LMICs both experienced reductions in death, surgical site infections, and overall complications, the magnitude of reduction was generally greater for LMICs than in HICs. Sub-analysis by study design demonstrated generalizability between the clinical trial setting and the real world setting.
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MedicalResearch.com Interview with:
Wiliam C. Huang, MD FACS
Associate Professor of Urology
Division of Urologic Oncology
NYU Langone Medical Center/Perlmutter Cancer Center
Medical Research: What is the background for this study? What are the main findings?Dr. Huang: The presentation of kidney cancers has dramatically evolved over the past two decades with most kidney cancers being incidentally diagnosed at an early stage. We have begun to recognize that at this small size (< 4 cm), the tumors are frequently indolent in nature and some are completely benign. Consequently, the management options for these small cancers have expanded and evolved. Whereas the entire removal of the kidney was the treatment of choice in the past, alternative options including removal or ablation of the tumor-bearing portion of the kidney has become increasingly utilized. Similar to other early stage cancers, watchful waiting or observation is also becoming a reasonable treatment option.
We used the most recent SEER-Medicare Data (2001 – 2009) to evaluate the management trends and outcomes of small kidney cancers in the new millennium. We believe that this is an important study as it provides important and practical findings, which are useful to both clinical researches as well as practicing physicians.
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MedicalResearch.com Interview with:
Tom E. Robinson
School of Population Health
University of Auckland, New Zealand
Medical Research: What is the background for this study? What are the main findings?Response: Diabetic foot disease affects up to 50% of people with diabetes and lower limb amputation is a serious complication that has a great impact both on patient quality of life and healthcare costs. Foot complications are however potentially preventable with good diabetes and foot care and early intervention. There is international evidence of unexplained ethnic variations in the incidence of lower limb amputation. This study found that ethnicity was strongly associated with risk of lower limb amputation. For example, New Zealand Maori people with diabetes have 63% higher rates of lower limb amputations and this increased risk is not altered by controlling for a range of demographic and clinical risk factors. Asian New Zealander's have much lower risks of amputation but this may, at least in part, be explained by the 'healthy migrant effect'. (more…)
MedicalResearch.com Interview with:
Mark L. Friedell, MD, FACS
Chairman Department of Surgery
University of Missouri Kansas City
School of Medicine
Kansas City, MO 64108
Medical Research: What is the background for this study? What are the main findings?
Response: The controversial practice of administering pre-surgery beta-blockers to patients having noncardiac surgery was associated with an increased risk of death in patients with no cardiac risk factors but it was beneficial for patients with three to four risk factors, according to a report published online by JAMA Surgery.
Pre-surgery β-blockade is a widely accepted practice in patients having cardiac surgery. But its use in patients at low risk of heart-related events having noncardiac surgery is controversial because of the increased risk of stroke and hypotension (low blood pressure).
Because of the persistent controversy, researcher Mark L. Friedell, M.D., of the University of Missouri-Kansas City School of Medicine, and coauthors analyzed data from the Veterans Health Administration to examine the effect of perioperative β-blockade on patients having noncardiac surgery by measuring 30-day surgical mortality.
The analysis included 326,489 patients: 314,114 (96.2 percent) had noncardiac surgery and 12,375 (3.8 percent) had cardiac surgery. Overall, 141,185 patients (43.2 percent) received a β-blocker. Of the patients having cardiac surgery, 8,571 (69.3 percent) received a β-blocker and 132,614 (42.2 percent) of the patients having noncardiac surgery got one.
The unadjusted 30-day mortality rates among patients having noncardiac surgery for those not receiving β-blockers were 0.5 percent for patients with no cardiac risk factors, 1.4 percent for patients with one to two risk factors and 6.7 percent for patients with three to four risk factors. For those patients having noncardiac surgery who did receive β-blockers, the unadjusted 30-day mortality rates for patients with no cardiac risk factors, one to two risk factors and three to four risk factors were 1 percent, 1.7 percent and 3.5 percent, respectively, according to the results.
The results suggest that among patients with no cardiac risk factors having noncardiac surgery, those patients receiving β-blockers were 1.2 times more likely to die than those not receiving β-blockers. The risk of death decreased for those patients with one to two risk factors but the reduction was not significant. However, for patients having noncardiac surgery with three to four cardiac risk factors, those receiving β-blockers were significantly less likely to die than those not receiving β-blockers, the authors found. The authors did not observe similar results in patients having cardiac surgery.
“β-blockade is beneficial perioperatively for patients with three to four cardiac risk factors undergoing NCS [noncardiac surgery] but not in patients with one to two cardiac risk factors. Most important, the use of β-blockers in patients with no cardiac risk factors appears to be associated with a higher risk of death, which has, to our knowledge, not been previously reported,” the study concludes.
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MedicalResearch.com Interview with:
Winfried Meissner, M.D.
Dep. of Anesthesiology and Intensive Care
Jena University Hospital
University Hospital Jena, Germany
Medical Research: What is the background for this study?
Dr. Meissner: Post-operative pain is managed inadequately worldwide. There are probably many reasons for this, one of which may be lack of evidence about outcomes of treatment in the clinical routine.
PAIN OUT was established as a multi-national research network and quality improvement project offering healthcare providers validated tools to collect data about pain-related patient reported outcomes and management after surgery. Patients fill in a questionnaire asking for pain intensity, pain interference and side effects of pain management. The questionnaire has now been translated into 20 languages. Data are collected electronically and clinicians are provided with feedback about management of their own patients, compared to similar patients in other hospitals. Furthermore, the findings are used for outcomes and comparative effectiveness research. PAIN OUT is unique in that outcomes of postoperative pain management can be examined internationally.
PAIN OUT was created in 2009 with funds from the European Commission, within the FP7 framework and has now been implemented in hospitals in Europe, USA, Africa and SE Asia. The findings allow us to gain insights as to how pain in managed in different settings and countries.
For this particular study, we compared management of pain in the US to other countries. We assessed a large group of patients who underwent different types of orthopedic surgery and compared their patient reported outcomes and management regimens. We included 1011 patients from 4 hospitals in the USA and 28,510 patients from 45 hospitals in 14 countries (“INTERNATIONAL”).
Medical Research: What are the main findings?
Dr. Meissner: Postoperative pain intensity of US patients was higher than in INTERNATIONAL patients; they felt more often negatively affected by pain-associated anxiety and helplessness, and more US patients stated they wished to have received more pain treatment. However, other patient-reported outcomes like time in severe pain or the level of pain relief did not differ.
We found that treatment regiments of American patients differed compared to INTERNATIONAL patients. More US patients received opioids, and their opioid doses were higher compared to INTERNATIONAL patients. In contrast, INTERNATIONAL countries use more nonopioid medications intraoperatively and postoperatively. Thus, under-supply with opioids cannot explain our findings.
Mean BMI of US patients was 30.3 while for INTERNATIONAL it was 27.4. However, insufficient evidence exists that this finding might account for differences in pain intensity.
Routine pain assessment was performed in almost all US patients, in contrast to about 75% in the INTERNATIONAL group. Obviously, routine pain assessment, as practiced in the United States, fails to result in lower postoperative pain. Perhaps it has the opposite effect by directing patients’ attention to the pain.
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MedicalResearch.com Interview with:
Anees B. Chagpar, MD, MSc, MPH, MA, MBA, FRCS(C), FACS, Associate Professor, Department of Surgery
Director, The Breast Center -- Smilow Cancer Hospital at Yale-New Haven, Assistant Director -- Global Oncology, Yale Comprehensive Cancer Center
Program Director, Yale Interdisciplinary Breast Fellowship
Yale University School of Medicine Breast Centerm
New Haven, CT,
Medical Research: What is the background for this study? What are the main findings?
Response: Every year in the US, nearly 300,000 women are diagnosed with breast cancer -- the majority of these will have early stage breast cancer, and will opt for breast conserving surgery to remove their disease. The goal of this operation is to remove the cancer with a rim of normal tissue all the way around it (i.e., a margin), but sadly, 20-40% of women will have cancer cells at the edge of the tissue that is removed, often mandating a return trip to the operating room to remove more tissue to ensure that no further disease is left behind. No one likes to go back to the operating room -- so we asked the question, "How can we do better?". Surgeons have debated various means of obtaining clear margins. Some have advocated taking routine cavity shave margins -- a little bit more tissue all the way around the cavity after the tumor is removed at the first operation. Others have argued that this may not be necessary; that one could use intraoperative imaging of the specimen and gross evaluation to define where more tissue may need to be removed (if at all) -- i.e., selective margins. We conducted a randomized controlled trial to answer this question. We told surgeons to do their best operation, using intraoperative imaging and gross evaluation, and removing selective margins as they saw fit. After they were happy with the procedure they had performed and were ready to close, we opened a randomization envelope intraoperatively, and surgeons were either instructed to close as they normally would ("NO SHAVE"), or take a bit more tissue all the way around the cavity ("SHAVE").
Patients in both groups were evenly matched in terms of baseline characteristics. The key finding was that patients who were randomized to the "SHAVE" group half as likely to have positive final margins and require a re-operation than patients in the "NO SHAVE" group. On their postoperative visit, we asked patients, before they knew which group they had been randomized to, what they thought of their cosmetic results. While the volume of tissue excised in the "SHAVE" group was higher than in the "NO SHAVE" group, the distribution of patient-perceived cosmetic outcomes were identical in both groups. Complication rate was also no different between the two groups. We will be following patients for five years for long-term cosmetic and recurrence outcomes. (more…)
MedicalResearch.com Interview with:
Prof. Dr. Robert Sanders MD
Assistant Professor, Anesthesiology & Critical Care Trials & Interdisciplinary Outcomes Network (ACTION)
Department of Anesthesiology
University of Wisconsin, Madison, WI
Medical Research: What is the background for this study? What are the main findings?
Dr. Sanders: While it is known that chronic raised blood pressure exerts important effects on long term health outcomes, it is unclear how pre-operative blood pressure levels effect risk from surgery. In this study we show that after adjustment for other diseases, high blood pressure does not increase perioperative risk. Rather low blood pressure is associated with an increase in risk of death following surgery and anesthesia.
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MedicalResearch.com Interview with: Mr Matthew Nankivell
MRC Clinical Trials Unit at University College London
Institute of Clinical Trials and Methodology
Aviation House, London
UK
Medical Research: What is the background for this study? What are the main findings?
Response: Ovarian cancer is diagnosed in over 7000 women each year in the UK. Over 75% of these already have advanced disease, for which the standard treatment is surgery followed by platinum based chemotherapy. The prognosis for these patients remains poor however, with less than 25% surviving for 5 years. There is consistent evidence that achieving optimal debulking (meaning less than 1cm of residual tumour after surgery) is key to increasing survival. The theory tested in Chorus is that giving the chemotherapy before surgery (neo-adjuvantly) would be as least as effective as giving it post-operatively, and may in fact increase the chance of achieving optimal debulking, and subsequently living for longer.
In Chorus we randomised 552 women to receiving either the current standard of immediate surgery followed by chemotherapy, or chemotherapy followed by surgery. The trial met its primary aim of showing that neo-adjuvant chemotherapy was no worse than post-operative chemotherapy, with median survival times of 24.1 and 22.6 months respectively. The proportion of women achieving optimal debulking increased from 41% in the post-operative chemotherapy group to 73% in the neo-adjuvant chemotherapy group. Additionally we saw that fewer women experienced serious post-operative complications having had neo-adjuvant chemotherapy (14% vs 24%), and fewer women died within 28 days of surgery (<1% vs 6%).
There is a planned meta-analysis, to combine the data from Chorus with those from a similar European trial, which will allow further investigations to take place, and may allow the identification of groups of women who are more likely to benefit from one or other of the approaches.
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MedicalResearch.com Interview with:
Robert A. Meguid, MD MPH FACS
Assistant Professor Section of General Thoracic Surgery
Division of Cardiothoracic Surgery Department of Surgery
University of Colorado Denver | Anschutz Medical Campus
Aurora, CO 80045
Medical Research: What is the background for this study? What are the main findings?
Dr. Meguid: The surgical literature on adverse outcomes after surgery on pregnant patients is conflicting. We know that the majority of surgery performed on pregnant patients is not elective (and just over 50% of it in the database studied was emergency surgery). We expected to find an increased rate of adverse outcomes in those pregnant patients. However, when we matched the pregnant and non-pregnant women who underwent surgery in the database, with excellent matching on all available preoperative characteristics and on the actual operation performed, we found similar, low rates of 30-day postoperative death and complication. In this study, pregnant patients had undergone a broad spectrum of different types of operations, including general, vascular, thoracic, head and neck, non-obstetric gynecologic and urologic, orthopedic, reconstructive, and neuro-surgery. Given the concern that we as surgeons have over operating on pregnant patients, both for the well-being of the patient and her child, our findings are reassuring. This suggests that we as a medical profession are diligent in minimizing risk to pregnant women who need surgery that cannot be delayed until after the child's birth. Again, this study faces the limitations of being unable to assess any short term harm done to the fetus and the subsequent long term outcome of the child.
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MedicalResearch.com Interview with:
Bernadette A.M. Heemskerk-Gerritsen, Ph.D.
Department of Medical Oncology
Erasmus MC Cancer Institute
Roterdam, the NetherlandsMedical Research: What is the background for this study? What are the main findings?
Dr. Heemskerk-Gerritsen: Women with a BRCA1 or BRCA2 mutation have substantially higher risks of developing both primary and contralateral breast cancer (BC) and ovarian cancer than women from the general population. Options to reduce these increased cancer risks include risk-reducing mastectomy (RRM) and/or risk-reducing salpingo-oophorectomy (RRSO). The latter intervention obviously reduces the risk of developing ovarian cancer, but has been reported also to reduce the risk of developing a subsequent breast cancer with approximately 50%. However, studies on the efficacy of risk-reducing surgery in BRCA1/2 mutation carriers are confined to observational studies, thus challenging several methodological issues. Consequently, previous studies on breast cancer risk-reduction after RRSO may have been influenced by bias associated with selection of study subjects, bias associated with start of follow-up, or by confounding, and breast cancer risk-reduction may have been overestimated.
In the current study, we revisited the association between risk-reducing salpingo-oophorectomy and breast cancer risk in BRCA1/2 mutation carriers, focusing on the impact of different analytical methods and potential types of bias.
First, we replicated the analyses of four previously performed studies, to examine if our Dutch cohort was comparable with the cohorts used in the previous studies. We replicated the approximately 50% breast cancer risk reduction after RRSO in the Dutch cohort.
Second, we estimated the effect of RRSO on breast cancer risk in the Dutch cohort using a revised analytical approach for observational studies in BRCA1/2 mutation carriers in order to minimize bias as much as possible. Using this method of analysis, we found no evidence of first BC risk-reduction after RRSO in BRCA1/2 mutation carriers.
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MedicalResearch.com Interview with:
Robert J Canter MD
Associate Professor of Clinical Surgery
Division of Surgical Oncology
University of California at Davis
Medical Research: What is the background for this study?
Dr. Canter: Our data suggest that surgeons are improving in their ability to select patients for surgical intervention in cancer patients near their end of life. Our research suggests that surgeons may be operating on healthier patients who are anticipated to have a better recover from a palliative operation. These are patients who can perform activities of daily living without assistance, for example.
Our interest in the appropriate surgical care of people with late-stage cancer grew from observing terminally ill patients whose acute problems were addressed through surgery, and who then suffered complications resulting in lengthy stays in intensive care units, and even in death.
Unfortunately, it is quite common that this group of disseminated malignancy patients end up dying in the intensive care unit instead of being managed with less invasive interventions with hopes of returning home with their families, including with hospice care.
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MedicalResearch.com Interview with:
Emily Finlayson, MD, MS
Department of Surgery, Division of General Surgery
Department of Medicine, Division of Geriatrics
Philip R Lee Institute for Health Policy
University of California, San Francisco
Director, UCSF Center for Surgery in Older Adults
Medical Research: What is the background for this study? What are the main findings?
Dr. Finlayson: In general, the goal of lower extremity revascularization is to preserve the leg so that patients can maintain the ability to ambulate and maintain functional independence. We evaluated the results of this operation in older nursing home residents in the United States. We found that over the 3 year study period, over 10,000 nursing home residents underwent this procedure. Most of them were functionally dependent before surgery, 3/4 were unable to walk, and over half had dementia.
After 1 year, half of the residents had died. Among residents who could not walk before surgery, 89% were dead or non ambulatory 1 year after surgery.
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MedicalResearch.com Interview with:
Dr. Joseph Bosco MD III
Orthopedic Surgery
The New York University Langone Medical Center
Medical Research: What is the background for...
MedicalResearch.com Interview with:
Anthony Delitto, PT, Ph.D, FAPTA
Professor and Chair
Department of Physical Therapy
Associate Dean for Research, SHRS
School of Health and Rehabilitation Sciences
University of Pittsburgh
Medical Research: What is the background for this study? What are the main findings?
Dr. Delitto: I work with a team, many of whom were authors on the paper, and we see a lot of patients with lumbar spinal stenosis. Some of them did very well with Physical Therapy and avoided surgery. Some people didn’t do well and we ended up having surgery. We really wanted to do a study that compared, in a randomized format, doing surgery vs. a non-surgical approach to lumbar spinal stenosis. The idea we had was to really put the two approaches head to head – a randomized trial of surgery vs. physical therapy for people with lumbar spinal stenosis. We decided only to recruit patients after they had consented to surgery in order to avoid the pitfalls of previous studies where people crossed over after being assigned to a group, for example, being assigned to surgery and then deciding against having surgery.
Medical Research: What should clinicians and patients take away from your report?Dr. Delitto: Probably the biggest point to put across to physicians, patients and practitioners, one of the things we realized was: patients don’t exhaust all of their non-surgical options before they consent to surgery. And physical therapy is one of the non-surgical options. The obvious finding is, when you compare the two groups, they seem to do the same. The results were equivalent at two years. Now, embedded in that, there are patients who did well in surgery, and patients who failed in surgery. There are patients who did well in Physical Therapy, and there are patients who failed with PT. But when we looked across the board at all of those groups, their success and failure rates were about the same. So it tells us that for the most part there were equivalent outcomes at two years.
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MedicalResearch.com Interview with:
Lyn McDivitt Duncan, MD
Professor of Pathology, Harvard Medical School
Chief, Dermatopathology Unit and
Su Luo, MD Dermatology Resident
Massachusetts General Hospital
Boston, MA 02114Medical Research: What is the background for this study? What are the main findings?
Response: We studied 475 patients with cutaneous melanoma diagnosed at the Massachusetts General Hospital (MGH) who also had a sentinel lymph node biopsy procedure performed. There is a practice gap in the sentinel lymph node biopsy procedure ranging from removal of one “sentinel” lymph node to removing the hottest lymph node and any lymph nodes with radioactive tracer of 10% or more of the hottest lymph node’s counts (with an average of three lymph nodes removed). At the MGH we use this latter method. We examined the sentinel lymph nodes in each case to determine whether the positive cases with microscopic melanoma metastases had metastases only in the most radioactive, or "hottest", node or whether tumor was also present in the less hot nodes. We found that in 19% of positive cases there were metastases present only in the less hot nodes. We also performed survival analysis and showed that the less hot nodal positive cases are of equivalent prognostic significance. We found that removal of only the hottest lymph node would have led to under-staging of 19% of patients with melanoma.
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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:
Uzma Samadani, MD, PhD
Chief of Neurosurgery, New York Harbor Health Care System
Assistant Professor, Departments of Neurosurgery, Psychiatry, Neuroscience and Physiology
Co-Director, Steven and Alexandra Cohen Veterans Center
NYU Langone Medical Center
Medical Research: What is the background for this study? What are the main findings?
Response: The purpose of this study was to determine the current and future incidence of chronic subdural hemorrhage in the United States civilian and Veterans' Administration populations. It's main findings are that, as the population ages, the incidence of subdural hemorrhage is increasing.
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MedicalResearch.com Interview with:
Dr. Adil Haider, MD, MPH
Kessler Director of the Center for Surgery and Public Health (CSPH)
at Brigham and Women’s Hospital
Medical Research: What is the background for this study? Response: Disparities in the quality of care received by minority and low-income patients have been reported for years across multiple medical conditions, types of care, and institutions.
To determine whether clinicians’ unconscious race and/or social class biases correlated with a lower quality of care for minority patients and those of lower socioeconomic status, my colleagues and I conducted a web-based survey among 215 physicians at an academic, level one trauma center. Participants were asked to review eight clinical vignettes, and then respond to three questions about management of care after each. Following their response, a test known as an Implicit Association Test (IAT Test) was used to assess any unconscious preferences.
Medical Research: What are the main findings?Response: We found that race and class biases, as measured by response time to a standardized Implicit Association Test, had no relationship to the way that patients were clinically treated.
Whether the lack of association found between implicit bias and decision making in this study represents a true lack of association or the failure of clinical vignettes to capture the nuances of how implicit biases translate into management decisions remains unclear. Existing biases might influence the quality of care received by minority patients and those of lower socioeconomic status in real-life clinical encounters. (more…)
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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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.
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MedicalResearch.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…)
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. 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…)
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…)
MedicalResearch.com Interview with:Aidan Roche MBBS, PhD, BEng and
Prof Oskar C AszmannMD
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…)
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.
(more…)
MedicalResearch.com Interview with:
Dr. Y. EltahirUniversity Medical Centre Groningen
Department of Plastic SurgeryGroningen, 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…)
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MedicalResearch.com Interview with:
Jordan M. Cloyd, MD
Department of Surgery
Stanford University
Stanford, California
Medical Research: What is the background for this study? What are the main findings?
Dr. Cloyd: The motivation for the study was that, anecdotally, we had noticed that several of our patients who had been discharged on a weekend required readmission for potentially preventable reasons. We wanted to investigate whether the data supported the idea that weekend discharge was associated with a higher risk of hospital readmission.
(more…)
