MedicalResearch.com Interview with:
Yigal Abramowitz, MD
Cedars-Sinai Heart Institute
Medical Research: What is the background for this study? Dr. Abramowitz: The number of elderly patients with severe symptomatic aortic stenosis (AS) that require aortic valve replacement has been significantly increasing in recent years. However, a decade ago, third of the patients were not referred to surgery, in particular because of advanced age, and /or multiple comorbidities. TAVR has emerged as a treatment option for elderly inoperable or high-risk surgical patients with severe aortic stenosis. There is scarce evidence on the feasibility and safety of TAVR in very old patients.
Medical Research: What are the main findings?Dr. Abramowitz: We compared 136 patients that were at least 90 years old at the time of TAVR (mean age: 92.4years) to 598 younger patients (mean age: 79.7years). Device success was excellent in both groups (96% for both). All-cause mortality at 30-days and 1-year was 2.9% and 12.5% vs. 2.8% and 12.3% in patients aged ≥ 90 and ˂ 90, respectively. All major complication rates were similar between groups.
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MedicalResearch.com Interview with:
Riyaz Bashir MD, FACC, RVT
Professor of Medicine
Director, Vascular and Endovascular Medicine
Department of Medicine
Division of Cardiovascular Diseases
Temple University Hospital
Philadelphia, PA 19140
Medical Research: What is the background for this study?
Dr. Bashir: Catheter-based thrombus removal also known as Catheter Directed Thrombolysis (CDT) is a minimally invasive therapeutic intervention that has evolved over the past two decades to reduce the incidence of post thrombotic syndrome (PTS), a very frequent and disabling complication of proximal deep vein thrombosis (DVT). Catheter-based thrombus removal has been shown to reduce this lifestyle limiting complication of DVT and as a result we have observed a significant increase in the utilization rates of CDT across United States. Recent nationwide observational data suggests that higher adverse events such as intracranial hemorrhage rates and need for blood transfusions are seen with CDT use. Nonetheless specific reasons for these findings have not been explored prior to this study. Thread veins, also known as spider veins, are small veins which can appear on your face, thighs or calves and are an issue that many patients want help with. However, they are a cosmetic issue rather than a medical problem. People who suffer from the spider veins often feel that they affect their appearance and confidence and question why do we get thread veins?
Medical Research: What are the main findings?Dr. Bashir: This study showed a significant inverse relationship between the institutional Catheter-based thrombus removal volumes and safety outcomes like death and intracranial hemorrhage. The institutions with higher volume of CDT cases annually (greater than or equal to 6 cases) were associated with lower in-hospital mortality rates and lower intracranial hemorrhage rates as compared to institutions, which performed less than 6 cases annually. This study also showed that at high volume institutions there was no difference in terms of death or intracranial bleeding rates between CDT plus anticoagulation versus anticoagulation alone.
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MedicalResearch.com Interview with:
Dr. Marc Schermerhorn, MD
Chief of Vascular and Endovascular Surgery
Beth Israel Deaconess Medical
Medical Research: What is the background for...
MedicalResearch.com Interview with:
Dr Scot GargFRCP PhD (Hons) FESC
Cardiology Department, Royal Blackburn Hospital
United Kingdom
Medical Research: What is the background for this study?
Dr. Garg: In contrast to other countries, in particular the United States, the UK has seen a vast expansion in the number of PCI centres operating without on-site surgical support. Part of the reason for this is that outcome data from these centres are from modest populations at short-term follow-up; consequently the ACC/AHA have failed to give delivery of PCI in centres without surgical back-up a strong endorsement. The study was ultimately driven therefore to show whether any differences existed in mortality between patients having PCI in centres with- and without surgical support at long-term follow-up in large unselected population cohort.
Medical Research: What are the main findings?
Dr. Garg: The study included the largest population of patients treated in centres without off-site surgical support (n=119,036) and main findings were that following multi-variate adjustment there were no differences in mortality for patients treated at centres with- or without surgical support at 30-days, 1-year or 5-year follow-up irrespective of whether patients were treated for stable angina, NSTEMI or STEMI. Furthermore, similar results were seen in a sensitivity analysis of a propensity matched cohort of 74,001 patients. (more…)
MedicalResearch.com Interview with: John A. Elefteriades, MD
William W.L. Glenn Professor of Surgery
Chief of Cardiothoracic Surgery
Director, Aortic Institute at Yale-New Haven
Yale University School of Medicine
Medical Research: What is the background for this study? What are the main findings?
Dr. Elefteriades: The race to map the human genome was declared completed in 2003, at a cost of 3 billion dollars for the international collaborative university group and 300 million dollars for Craig Venter at Celera. Whole exome sequencing can now be performed at a cost of only several thousand dollars per individual. So, whole exome sequencing (also called Next Generation Sequencing) can now be applied to understand and treat diseases of many organ systems.
In this study, we applied whole exome sequencing to study over 100 patients with thoracic aneurysm.
In the late 1990s, both Dr. Diana Milewicz in Texas and our group at Yale had determined that many thoracic aortic aneurysms were genetically transmitted. Dr. Milewicz went on to identify many of the causative mutations. In this study, we were able to look, by whole exome sequencing performed on saliva, for all 21 mutations known to cause thoracic aortic aneurysm--all at one time in one comprehensive genetic test. We were able to protect patients with the most serious discovered mutations by early surgery, the need for which could not otherwise have been apparent. (more…)
MedicalResearch.com Interview with:
Brett D. Owens, MD
Professor of Orthopaedic Surgery
Brown University Alpert Medical School
Providence, RI
Medical Research: What is the background for this study? What are the main findings?
Response: Last year at this meeting we presented the results of a prospective multicenter study of collegiate contact athletes who experienced in-season shoulder instability events. While most were able to return to sport within a week, only roughly one quarter were able to successfully return without recurrent instability. We continued to follow this cohort and 39 athletes with additional eligibility the subsequent season. We found that 90% of the 29 who underwent arthroscopic stabilization successfully returned the next season compared with 40% of the 10 underwent nonoperative treatment (more…)
MedicalResearch.com Interview with:
Judy A. Tjoe, MD, FACS
Breast Oncology Surgeon
Aurora Health Care
Milwaukee, WI
Medical Research: What is the background for this study? What are the main findings?Dr. Tjoe: Numerous national health organizations have confirmed minimally invasive breast biopsy (MIBB), which uses a percutaneous core needle as opposed to open surgical techniques, as the biopsy procedure of choice when a patient’s diagnostic test reveals a breast lesion suggestive of malignancy. Unfortunately, despite the overwhelming evidence supporting use of MIBB, open breast biopsy rates in the United States remain as high as 24-39%. Our study was designed to determine if measuring individual practice patterns and providing subsequent feedback to surgeons across a large, multihospital healthcare system would improve their adherence to the quality metric of using minimally invasive breast biopsy to diagnose indeterminate breast lesions.
We found that the proportion of studied surgeons (n=46) appropriately adhering to the MIBB quality metric in every instance (i.e. those who achieved 100% adherence) significantly improved from 80.4% to 95.7% (p=0.0196) after receiving feedback on not only their own practice patterns, but those of their blinded peers. As might be expected, the handful of breast-dedicated surgeons (n=4) who cared for nearly half of the analyzed patient population achieved perfect adherence throughout the study, but interestingly, the gains made in total adherence were driven by the general surgeons (n=42), showing that the study’s direct educational efforts were effective in changing practice patterns for the better. These efforts included sending letters describing adherence to the quality metric to individual surgeons and organizational leadership. (more…)
MedicalResearch.com Interview with:
Robert J. Lewandowski, MD FSIR
Associate Professor of Radiology
Director of Interventional Oncology
Department of RadiologyNorthwestern University Feinberg School of Medicine
Medical Research: What is the background for this study? What are the main findings?
Response: Retrievable inferior vena cava filters (rIVCF) were designed to provide temporary prevention from pulmonary embolism and then be removed when no longer needed. With permanent United States Food and Drug Administration (FDA) indication, these devices now account for the majority of IVC filters placed. Most rIVCFs placed are never removed because of poor clinical follow up, failed retrieval procedures, or patients not being offered the opportunity for filter removal secondary to prolonged dwell time; the latter has previously been correlated with retrieval failure.
Retrievable IVCFs appear to be subject to greater device related complications (e.g., filter penetration of the IVC, filter migration, filter fracture) relative to permanent devices; furthermore, the rates of these complications appear to increase with filter dwell time. This prompted the FDA to issue a 2010 safety alert urging removal of rIVCFs once they are deemed no longer necessary.
In the present study, we sought to determine whether rIVCF dwell time affects technical success of the retrieval procedure. Over a six-year period, 648 retrieval procedures were performed at our institution, with filter dwell times ranging from 0-108 months. We found that filter dwell time did not negatively impact IVC filter retrieval success nor did it increase our adverse events from the retrieval procedure. With advanced, adjunctive IVC filter retrieval techniques, rIVCFs can be safely and reliably removed despite long dwell times.
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MedicalResearch.com Interview with:
Judy Huang, M.D.
Professor of NeurosurgeryProgram Director, Neurosurgery Residency ProgramFellowship Director, Cerebrovascular Neurosurgery
Johns Hopkins Hospital
Medical Research: What is the background for this study? What are the main findings?
Dr. Huang: Residents are medical school graduates who are in training programs working alongside and under supervision of more senior physicians, known as attendings. Patients are sometimes wary of having residents assist in their operations, but an analysis of 16,098 brain and spine surgeries performed across the United States finds that resident participation does not raise patient risks for postoperative complications or death.
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MedicalResearch.com Interview with:
Paul M. Sethi, MD
Orthopaedic & Neurosurgery Specialists
Greenwich, CT
MedicalResearch: What is the background for this study?Dr. Sethi: Propionibacterium acnes is one of the most significant pathogens in shoulder surgery; the cost of a single infection after shoulder arthroplasty may be upwards $50,000. Residual P. acnes may be found on the skin 29% of the time immediately after surgical skin preparation and in 70% of dermal biopsy specimens. Identifying more ideal skin preparation may help reduce the risk of infection.
MedicalResearch: What is the purpose of this study?Dr. Sethi: The purpose of this study was to evaluate the ability of topical benzoyl peroxide (BPO) cream, along with chlorhexidine skin preparation, to reduce the chance of identifying residual bacteria after skin preparation. Our hypothesis was that adding topical benzoyl peroxide to our skin preparation would reduce the number of positive P. acnes cultures identified during surgery.
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MedicalResearch.com Interview with:
Dr. Bahman Guyuron MD
Cleveland and Lyndhurst, Ohio From the Department of Plastic Surgery, University Hospital Case Medical Center;...
MedicalResearch.com Interview with:
John Maret-Ouda MD, PhD candidate
Upper Gastrointestinal Surgery
Department of Molecular medicine and Surgery
Karolinska Institutet
Stockholm, Sweden
MedicalResearch: What is the background for this study? What are the main findings?Dr. Maret-Ouda : This review is part of the BMJ series “Uncertainties pages”, where clinically relevant, but debated, medical questions are highlighted and discussed. The present study is assessing treatment of severe gastro-oesophageal reflux disease, where the current treatment options are medical (proton-pump inhibitors) or surgical (laparoscopic antireflux surgery). The clinical decision-making is often left to the clinician and local guidelines. We evaluated the existing literature to compare the two treatment options regarding reflux control, complications, future risk of oesophageal adenocarcinoma, health related quality of life, and cost effectiveness.
The main findings were that surgery might provide slightly better reflux control and health related quality of life, but is associated with higher risks of complications compared to medication. A possible preventive effect regarding oesophageal adenocarcinoma remains uncertain. Regarding cost effectiveness, medication seems more cost effective in the short term, but surgery might be more cost effective in the longer term. Since medication provides good treatment of severe gastro-oesophageal reflux disease, but with lower risks of complications, this remains the first line treatment option.
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MedicalResearch.com Interview with:
Vanita Ahuja, MD, MPH
Department of General Surgery
York Hospital, York, Pennsylvania
MedicalResearch: What is the background for this study? What are the main findings?Dr. Ahuja: Robotic-assisted surgery has been slowly accepted within the medical community. Felger et al. (1999), Falk et al. (2000), and Loumet et al. (2000) state that specific to cardiac surgery, the advantages of the robot in coronary artery bypass grafting (CABG) and valvular operations were demonstrated with increased visualization, ease of harvest, and quality of vascular anastomoses as early as 1999. However, Giulianotti, et al. (2003), Morgan et al. (2005), and Barbash et al. (2010) suggest that although safety and efficacy are supported, it is not conclusive yet that robot-assisted surgery is cost-effective, given the high cost of the robot itself, longer operating times, and the short life of the robotic instruments. The purpose of our paper was to compare outcomes of complications, length of stay (LOS), actual cost, and mortality between non-robotic and robotic-assisted cardiac surgery.
In general surgery and subspecialties, the use of the robot has increased significantly over the past few years. It has been noted that robotic surgery improves on laparoscopic surgery by providing increased intra-cavity articulation, increased degrees of freedom, and downscaling of motion amplitude that may reduce the strain on the surgeon.
The biggest growth in robotic surgery has been seen in the fields of gynecology and urology. Recently, Wright et al. reported an increase in robotic assisted hysterectomy from 0.5 percent of the procedures in 2007 compared to 9.5 percent in 2010 for benign disease. In their study, robotic assisted surgery had similar outcomes to laparoscopic surgery but higher total cost of $2,189 more per case. In urologic surgery, Leddy et al. reported in 2010 that radical prostatectomy remains the biggest utilization of robotic assisted surgery in urology with 1% in 2001 to 40% of all cases in 2006 performed in the United States.
Utilizing a nationwide database from 2008-2011, subjects were propensity matched by 14 patient characteristics to reduce selection bias in a retrospective study. The patients were then divided into three groups by operation types: valves, vessels and other type. Univariate analysis revealed that robotic-assisted surgery, compared to non-robotic surgery, had higher cost ($39,030 vs. $36,340), but lower LOS (5 vs. 6 days) and mortality (1% vs. 1.9%, all p<0.001). For those who had one or more complications, robotic-assisted cardiac surgery had fewer complications (27.2%) to non-robotic cardiac surgery (30.3%, p < .001).
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MedicalResearch.com Interview with:
Dr. Andrea Tricco Ph.DDalla Lana School of Public Health
University of Toronto
Medical Research: What is the background for this study? What are the main findings?
Dr. Tricco: We were commissioned by Health Canada to assess the safety and effectiveness of serotonin (5-HT3) receptor antagonists in patients undergoing surgery. In order to examine this research question, we conducted a systematic review and network meta-analysis including >450 studies.
We found that more patients receiving granisetron plus dexamethasone experienced arrhythmia compared to all other interventions and placebo. No differences were observed regarding mortality and QT prolongation in meta‐analysis; no studies reported on PR prolongation or sudden cardiac death. Granisetron plus dexamethasone was often the most effective antiemetic, with the number needed to treat ranging from two to nine. We found that ondansetron plus droperidol intravenous (IV) was also a highly effective antiemetic for decreasing the risk of vomiting and post-operative nausea and vomiting (PONV). (more…)
MedicalResearch.com Interview with:
Dr. Alexander Golberg Ph.D.
Center for Engineering in Medicine
Department of Surgery, Massachusetts General Hospital
Harvard Medical School, and Shriners Burns Hospital
Boston, MA, 02114
Porter School of Environmental Studies
Tel Aviv University, Israel
MedicalResearch: What is the background for this study? What are the main findings?Dr. Golberg: Well, the population grows and becomes older. Degenerative skin diseases affect one third of individuals over the age of sixty. Current therapies use various physical and chemical methods to rejuvenate skin; but since the therapies affect many tissue components including cells and extracellular matrix, they may also induce significant side effects, such as scarring.
We report on a new, non-invasive, non-thermal technique to rejuvenate skin with pulsed electric fields. The fields destroy cells while simultaneously completely preserving the extracellular matrix architecture and releasing multiple growth factors locally that induce new cells and tissue growth. We have identified the specific pulsed electric field parameters in rats that lead to prominent proliferation of the epidermis, formation of microvasculature, and secretion of new collagen at treated areas without scarring. Our results suggest that pulsed electric fields can improve skin function and thus can potentially serve as a novel non-invasive skin therapy for multiple degenerative skin diseases.
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MedicalResearch.com Interview with:
Leslee L. Subak, MD
University of California, San Francisco
Professor, Departments of Obstetrics, Gynecology & Reproductive Sciences, Urology and Epidemiology & Biostatistics
Chief of Gynecology, SF Veterans Affairs Medical Center
UCSF Women's Health Clinical Research Center
MedicalResearch: What is the background for this study? What are the main findings?Dr. Subak: Urinary incontinence is very common, affecting an estimated 30 million adults in the U.S., and may account for as much as $60 billion in annual medical costs. Incontinence can cause significant distress, limitations in daily functioning, and reduced quality of life. Obesity is an important risk factor, with each 5-unit increase in body mass index – a ratio of someone’s weight divided by the square of their height – above normal weight associated with far higher rates of incontinence. The prevalence of incontinence has been reported to be as high as 70 percent among severely obese women, and 24 percent among severely obese men (BMI greater than 40, or more than about 100 pounds greater than ideal body weight).
Since obesity is a risk factor for incontinence, several studies have examined whether weight loss is a treatment for incontinence among obese people with the condition. Clinical trials have shown the low calorie diets, behavioral weight reduction, and bariatric surgery are associated with improvement in incontinence in obese women and men through one year, but evidence on the durability of this effect is lacking.
We performed this study to examine changes in urinary incontinence and identify factors associated with improvement among women and men in the first 3 years following bariatric surgery.
This study included 1987women and men in the Longitudinal Assessment of Bariatric Surgery-2 (LABS-2) study performed at 10 hospitals at 6 clinical centers in the U.S. who underwent bariatric surgery between 2005 and 2009. The study participants ranged in age from 18 to 78 years old – the median age was 47. The analysis controlled for factors such as age, race, smoking status and recent pregnancy. Nearly 79 percent of the participants in the study were women with 49% reporting at least weekly incontinence, compared with 2% of men reporting incontinence.
Following surgery and large weight loss of 29% for women and 26% for men, substantial improvements in incontinence were observed, with a majority of women and men achieving remission at 3 years post-surgery. The more weight lost, the higher the chances of improvement. While the risk of relapse rose with each gain of about 10 pounds, overall there was substantial improvement for both women and men. People who were older, had severe walking limitations or were recently pregnant showed less improvement.
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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 is the background for this study? What are the main findings?Dr. Bedrosian: There have been a number of reports on the rates of Breast Conserving Therapy (BCT) and mastectomy among women with early stage breast cancer. These reports have been discordant, with some suggesting that index mastectomy rates have increased and others suggestion Breast Conserving Therapy rates have actually increased. We hypothesized that these differences in reporting may be due to data source (ie tertiary referral centers vs population based studies) and turned to the NCDB, which captures 70% of cancer cases in the US and as such provides us with the most comprehensive overview on patient treatment patterns.
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MedicalResearch.com Interview with:
Mariusz Kowalewski, MD
Department of Cardiac Surgery, Dr Antoni Jurasz Memorial University Hospital
Bydgoszcz,
Systematic Investigation and Research on Interventions and Outcomes
Medicine Research Network, Poland
Medical Research: What is the background for this study? What are the main findings?
Dr. Kowalewski: Sternal wound infections occurring after heart surgery performed via median sternotomy, and in particular, after coronary artery bypass grafting (CABG), although rare, still pose serious postoperative complications that increase the length of hospital stay and healthcare costs. One of many ways to prevent them from happening, except from optimal glucose control, tight-fixed closure of the sternum at the end of surgery and perioperative iv. antibiotics, is to insert a gentamicin collagen sponge between two sternal edges, just before wiring them together. High local concentrations of gentamicin were shown to eliminate any microbial growth in the area, in the same time, not affecting the kidneys, as would be the case with systemic administration. Gentamicin sponges are widely used in orthopadic, gastro-intestinal and vascular surgery and were shown to reduce postoperative infection rates. Although extensively tested in the field of heart surgery, findings of one recent multicenter study have questioned their true benefit. We aimed to perform a comprehensive meta-analysis of studies assessing the efficacy of implantable gentamicin-collagen sponges in sternal wound infection prevention.
After screening multiple databases, a total of 14 studies (N = 22,135 patients, among them 4 randomized controlled trials [N = 4,672 pts]) were included in the analysis. Implantable gentamicin-collagen sponges significantly reduced the risk of sternal wound infection by approximately 40% when compared with control (risk ratio [RR], 0.61; 95% confidence interval [CI], 0.39-0.98; P = .04 for randomized controlled trials and RR, 0.61; 95% CI, 0.42-0.89; P = .01 for observational studies). A similar, significant benefit was demonstrated for deep sternal wound infection (RR, 0.60; 95% CI, 0.42-0.88; P = .008) and superficial sternal wound infection (RR, 0.60; 95% CI, 0.43-0.83; P = .002). The overall analysis revealed a reduced risk of mediastinitis (RR, 0.64; 95% CI, 0.45-0.91; P = .01). The risk of death was unchanged.
In addition, we investigated, by means of meta-regression, the correlation between sternal wound infections and extent to which the bilateral internal thoracic artery (BITA) was harvested. We found that the benefit provided by the gentamicin sponge was attenuated when BITA was harvested; these results suggest that another potentially preventive measure must be taken in such patients, as with severely reduced blood supply to the sternum (as is the case with BITA), sponge itself might not be enough to prevent wound infection.
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MedicalResearch.com Interview with:
Joseph A. Ladapo, MD, PhD
Assistant Professor of Medicine
Section on Value and Effectiveness
Department of Population Health
NYU Langone School of Medicine
Medical Research: What is the background for this study? What are the main findings?
Dr. Ladapo: Routine tests before elective surgery are largely considered to be of low value, and they may also increase costs. In an attempt to discourage their use, two professional societies released guidance on use of routine preoperative testing in 2002. We sought to examine the long-term national effect of these guidelines from the American College of Cardiology/American Heart Association and the American Society of Anesthesiologists on physicians' use of routine preoperative testing. While we found that overall rates of routine testing declined across several categories over the 14-year study period, these changes were not significant after accounting for overall changes in physicians’ ordering practices. Our findings suggest that professional guidance aimed at improving quality and reducing waste has had little effect on physician or hospital practice.
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MedicalResearch.com Interview with:
Kristina H. Lewis, MD, MPH, SM
Kaiser Permanente Georgia, Center for Clinical and Outcomes Research, Atlanta
Department of Population Medicine
Harvard Medical School/Harvard...
MedicalResearch.com Interview with:
Louise Sun, MD SM FRCPC
Assistant Professor Department of Anesthesiology,
University of Ottawa Staff | Division of Cardiac Anesthesiology
University of Ottawa Heart Institute
Medical Research: What is the background for this study? What are the main findings?Dr. Sun: Preoperative testing provides important information for perioperative
planning and decision-making. However, given the rapid increase in health
care costs, there has been growing emphasis on the more rational use of
resources and thus the need to better understand the utilization patterns
of specific tests. Preoperative pulmonary function tests (PFTs) are
important in helping perioperative physicians identify patients at risk
for postoperative pulmonary complications, but few appropriate use
guidelines exist for this test. We conducted a population-based study
using linked administrative databases in Ontario, Canada to describe
temporal trends in preoperative pulmonary function tests
and assess whether the recent 2006 American College of Physicians (ACP) guidelines on risk assessment and prevention of postoperative pulmonary complications for non-cardiothoracic surgery influenced these trends.
We examined 511,625 individuals undergoing non-cardiothoracic surgery, amongst whom
3.6% underwent preoperative pulmonary function tests while 3.3% had non-operative PFTs.
Preoperative pulmonary function tests rates decreased over the study period and following the 2006 ACP guidelines while non-operative rates remained stable. By 2013,
preoperative pulmonary function tests were performed in fewer than 8% of Ontario patients with risk factors for pulmonary complications, while preoperative testing
rates among individuals without known respiratory disease had approached
rates seen in the non-operative setting. The decreasing preoperative pulmonary function tests rates contrast starkly against concurrent increases in rates of other
perioperative interventions such as preoperative anesthesia consultations
and stress testing.
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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.
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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:
Yigal Abramowitz, MD
Cedars-Sinai Heart Institute
Medical Research: What is the background for this study?
Dr. Abramowitz: The number of elderly patients with severe symptomatic aortic stenosis (AS) that require aortic valve replacement has been significantly increasing in recent years. However, a decade ago, third of the patients were not referred to surgery, in particular because of advanced age, and /or multiple comorbidities. TAVR has emerged as a treatment option for elderly inoperable or high-risk surgical patients with severe aortic stenosis. There is scarce evidence on the feasibility and safety of TAVR in very old patients.
Medical Research: What are the main findings?
Dr. Abramowitz: We compared 136 patients that were at least 90 years old at the time of TAVR (mean age: 92.4years) to 598 younger patients (mean age: 79.7years). Device success was excellent in both groups (96% for both). All-cause mortality at 30-days and 1-year was 2.9% and 12.5% vs. 2.8% and 12.3% in patients aged ≥ 90 and ˂ 90, respectively. All major complication rates were similar between groups.
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