Month: February 2020

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Minimally Invasive Pancreas Resection Clinical Practice Guidelines (2020) by International Study Group on Minimally Invasive Pancreas Surgery (I-MIPS)

The guidelines on minimally invasive pancreas resection (MIPR) were released in January 2020 by the International Study Group on Minimally Invasive Pancreas Surgery (I-MIPS), cosponsored by the International Hepato-Pancreato-Biliary Association, the Americas Hepato-Pancreato-Biliary Association, the Asian-Pacific Hepato-Pancreato-Biliary Association, the European-African Hepato-Pancreato-Biliary Association, the European Association for Endoscopic Surgery, Pancreas Club, the Society of American Gastrointestinal and Endoscopic Surgery, the Society for Surgery of the Alimentary Tract, and the Society of Surgical Oncology.

Distal and Central Pancreatectomy

Minimally invasive distal pancreatectomy (MIDP) for benign and low-grade malignant tumors is to be considered over open distal pancreatectomy (ODP), in that it is associated with a shorter hospital stay, reduced blood loss, equivalent complication rates, and better postoperative quality of life.

MIDP for pancreatic ductal adenocarcinoma appears to be a feasible, safe, and oncologically equivalent technique in experienced hands.

No evidence exists regarding the use of vascular resection in MIDP.

Both stapler and nonstapler closure can be used in MIDP; outcomes are comparable. Evidence to support routine staple-line reinforcement with any method or material is lacking.

No studies exist specifically comparing spleen-preserving MIDP with spleen-preserving ODP.

Both laparoscopic distal pancreatectomy (LDP) and robotic distal pancreatectomy (RDP) are safe and feasible. The choice of technique should be based on surgeons’ experience and local resources.

Minimally invasive central pancreatectomy has been reported to be feasible, but safety must be confirmed before it can be widely adopted. Comparative data on minimally invasive vs open central pancreatectomy are inadequate.

Minimally invasive enucleation of pancreatic lesions in selected patients is an appropriate alternative to open enucleation.

Pancreatoduodenectomy

Insufficient data exist to recommend minimally invasive pancreatoduodenectomy (MIPD) over open pancreatoduodenectomy (OPD). Both MIPD and OPD are valid approaches for selected patients with adenocarcinoma.

No comparative data exist regarding MIPD vs OPD for the treatment of pancreatic head adenocarcinoma after neoadjuvant therapy.

Limited comparative data exist regarding MIPD vs OPD for the treatment of pancreatic head ductal adenocarcinoma requiring vascular resection. MIPD with vascular resection should be performed only by highly experienced surgeons and in high-volume centers.

No evidence of superiority exists regarding laparoscopic pancreatoduodenectomy (LPD) vs robotic pancreatoduodenectomy (RPD) for the treatment of pancreatic head lesions. Surgeon training, experience, and available resources guide the choice of approach.

Patients and Technique

There are no contraindications for MIPR based on patient age, obesity, or previous abdominal surgery.

The evidence to suggest a relationship between comorbidity and the outcome of MIPR is limited.

No evidence exists that specifically addresses the relative benefits of any particular hemostatic technique in MIPR.

No evidence exists to clearly determine the appropriate timing or indication for conversion in MIPR. Elective conversion should be considered on the basis of surgeon experience, concern for patient safety, or failure to progress.

Training and Implementation

Participation in a structured training program is strongly recommended for all surgeons undertaking MIPR.

Single-surgeon learning curves for MIPR show improvements in operative time, blood loss, lymph node harvest, and complications with increased total volume/experience; the exact number remains to be defined.

No specific studies assess prerequisites for MIPR. Experience in pancreatic surgery, including a formal fellowship training or an established practice as a pancreatic surgeon, is advised. A two-surgeon approach can be beneficial in the learning curve.

Center volume strongly affects outcomes after MIPR; consideration of total pancreas resection volume along with MIPR-specific volume is critical. MIPD should be performed in high-volume centers; mortality (at < 10 MIPD/y) and morbidity (at < 20 MIPD/y) are worse in low-volume settings.

Centers undertaking MIPR should consider the following measures: implementing dedicated individual and team training; having more than one surgeon performing MIPR at the institution; monitoring outcomes of MIPR for quality assurance; and considering surgeon/institution volume of pancreas resections, including MIPR.

Instrumentation

No documented advantages for any specific energy device have been reported.

The development of instruments and enhanced visualization systems for MIPR should be encouraged.

Accountability

Inclusion of patient data into thoughtfully organized and maintained regional, national, and international registries supported by hepatopancreatobiliary organizations is strongly encouraged.

Because outcome monitoring of MIPD is essential for its safe and wide expansion, inclusion into validated regional, national, and international registries is highly recommended.

Development and expansion of MIPR should be encouraged and monitored by national and international societies through the promotion of working groups to drive training and registries.

For more information, please go to Laparoscopic Pancreatectomy and Pancreatosplenectomy and Spleen-Preserving Distal Pancreatectomy.

For more Clinical Practice Guidelines, please go to Guidelines.

Source : Medscape

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Salt Reduction Beneficial Even For Healthy Individuals

A new meta-analysis adds further fuel to the controversy over sodium and cardiovascular health, suggesting that reducing dietary sodium lowers blood pressure (BP) even among those whose starting systolic BP is as low as 120 mmHg.

Each 50-mmol reduction in 24-hour sodium excretion was associated with reductions in systolic BP of 0.66, 1.89, and 2.76 mmHg among normotensive patients, a mix of normotensive and hypertensive patients, and hypertensive patients, respectively.

“This is a quite important finding that it is beneficial not only in hypertensive individuals but those with normal blood pressure,” senior author Feng J. He, MD, Queen Mary University of London, United Kingdom, told theheart.org | Medscape Cardiology. “Also, the study showed quite clearly that the lower the salt intake achieved, the lower the blood pressure.”

The World Health Organization recommends a maximum dietary sodium intake of 2 g/day (5 g of salt) as a population-level intervention to reduce cardiovascular disease (CVD) and mortality. Previous studies, however, have reported that sodium reduction is of limited or no value in normotensive individuals.

Further questions were raised following evidence from the PURE study of a J-shaped relationship, in which both higher and lower sodium levels were associated with increased CVD risk.

Unlike the PURE study, which has been criticized for using spot urine tests to estimate sodium excretion, only 24-hour urine collection was used to estimate sodium excretion in the 133 randomized trials in the meta-analysis, He noted.

Among the 12,197 participants, each 50-mmol reduction in 24-hour sodium excretion was associated with a 1.10-mmHg reduction in systolic BP and a 0.33-mmHg reduction in diastolic BP (P = .03).

Falls in systolic BP were present across all subgroups, as classified by age, sex, and race, but were larger among those older than 55 to 65 years (– 3.88; 95% confidence interval [CI], –5.05 to –2.71), women (–1.32; 95% CI, –2.47 to –0.16), and blacks (–4.07; 95% CI, –6.14 to –2.00), the authors report in an article published online February 25 in the BMJ.

Reductions were also found for each group, as classified by mean baseline systolic BP:

  • <120 mmHg; –0.39 (95% CI, –.061 to –0.18)
  • ≥120 to <130 mmHg; –1.21 (95% CI, –1.87 to –0.55)
  • ≥130 to <140 mmHg; –2.23 (95% CI, –2.89 to –1.57)
  • ≥ 140 to <150 mmHg; –3.23 (95% CI, –3.88 to –2.59)
  • ≥150 to <160 mmHg; –2.68 (95% CI, –3.55 to –1.81)
  • ≥160 mmHg; –2.97 (95% CI, –4.34 to –1.60)

“It seems to me that the blood pressure barely changed in the normotensive individuals, so I think they exaggerate how much benefit there would be to the general population,” Suzanne Oparil, MD, a hypertension expert and director of the vascular biology and hypertension program at the University of Alabama at Birmingham, commented to theheart.org | Medscape Cardiology.

She noted that 24-hour urinary collections can vary, depending on how conscientious the individual is, and that studies involving Russian cosmonauts have shown large variations in 24-hour sodium excretion day to day. “So there’s no gold standard there,” Oparil said.

In addition, Oparil noted that the investigators used casual BP measurements rather than 24-hour ambulatory BP measurements and dismissed data showing that very low sodium intake sometimes stimulates counter-regulatory mechanisms, such as the renin-angiotensin system, which tends to drive blood pressure up.

In addition, the findings are based on study-level rather than patient-level data and do not include CV outcomes, she said.

“Clearly if you have high blood pressure and you eat a lot of salt, decreasing the salt will lower the blood pressure, but for people who have essentially normal or nearly normal blood pressure and are not consuming very much salt, I just don’t believe that reducing the salt intake has demonstrable benefit,” Oparil said.

Senior investigator He said that evidence showing a lack of benefit with sodium reduction in normotensive individuals is based on very short-term studies and that activation of the renin-angiotensin system and adverse metabolic effects linked to large decreases in dietary sodium do not appear to be present in longer-term interventions.

In the meta-analysis, interventions to reduce sodium varied in length from no more than 7 days to more than 6 months.

No overall association was identified between intervention duration and the magnitude of either systolic or diastolic BP reduction, likely because of a lack of statistical power, because only 19% of studies included interventions that lasted longer than 30 days, and only 4% were longer than 6 months, He said.

Nevertheless, the effect of each 50-mmol reduction in 24-hour sodium excretion on systolic BP was approximately twice as large in studies with interventions longer than 14 days vs 14 days or less (2.13 mmHg vs 1.05 mmHg; P = .002).

Long-term reductions in dietary sodium can be difficult for individuals, but positive health benefits have been reported from national programs that combine salt-awareness campaigns and collaboration with food industry, He said.

For example, the investigators previously reported that the United Kingdom’s salt-reduction program, which sets voluntary, incrementally lower salt-reduction targets for more than 85 food categories, led to a 15% reduction in salt intake (from 9.5 g/day in 2003 to 8.1 g/day in 2011), a 2.7-mmHg fall in population systolic BP, and a decrease in mortality from stroke by 42% and ischemic heart disease by 40%.

Going forward, more ambulatory blood pressure monitoring data reflecting different dietary conditions would be useful, Oparil suggested. “It would be worthwhile knowing more about the effects of salt reduction on diurnal variation in blood pressure; we know that out-of-office blood pressure, particularly nocturnal blood pressure, seems to be more associated with outcomes than in-office blood pressure,” she said.

Source : Medscape

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Patients With Comorbidities Like DM, CVD Have Worse Prognosis for COVID-19 Infection

Indications so far are that people with diabetes and other chronic medical conditions, such as cardiovascular disease (CVD), will have a worse prognosis if they become infected with COVID-19, the novel coronavirus that has emerged from China.

There is also evidence that diabetes may increase risk for infection from COVID-19 two- to threefold, independently of other medical problems, such as CVD.

Although more detailed analysis is needed to show a clearly defined connection between conditions such as diabetes and worse prognosis with COVID-19, the statistics suggest that this virus hits hardest among the most vulnerable, ie, the elderly and people with multiple medical problems, especially those with diabetes of long duration that has not been well controlled.

“The message we want to emphasize is that emergencies unmask vulnerabilities in diabetes. The old and the sick are the most vulnerable,” Juliana C. N. Chan, MD, told Medscape Medical News in an interview.

Chan is director of the Hong Kong Institute of Diabetes and Obesity at the Chinese University of Hong Kong.

Chan and other experts are therefore calling for diabetes patients, those with CVD, and patients with other chronic medical conditions to be extra vigilant in their efforts to avoid contact with the virus, although they also note that individual responses vary greatly.

In past infectious disease outbreaks, including severe acute respiratory syndrome (SARS) and H1N1 flu, people with diabetes were at increased risk for severe illness and death.

“I don’t think it’s an overstatement to say that people with diabetes…are at higher risk of developing COVID-19, because the data are suggestive,” noted Chan, although she cautioned that longer-term research will give a much clearer picture.

Poor Control of Diabetes a Risk Factor for Infection

Chan was a senior coauthor on a study published last month in Diabetologia, as reported by Medscape Medical News, that found that mortality rates among people with diabetes in Hong Kong have plummeted in recent years ― except for young people, who may be more likely to have poorly controlled diabetes.

And — importantly within the context of the COVID-19 outbreak — although in that study deaths from most conditions such as CVD and cancer decreased among people with diabetes, deaths from pneumonia among people with diabetes remained about the same.

In serious cases of infection, the COVID-19 virus invades the cells that line the respiratory tract and lungs and enters the mucus, causing pneumonia. Severe lung damage from pneumonia can result in acute respiratory distress syndrome (ARDS), which in turn can cause septic shock.

ARDS and septic shock are the main causes of death from COVID-19.

So far, Hong Kong has had only 70 confirmed cases of COVID-19, although the first Hong Kong resident to die from the virus was a 39-year-old man with diabetes. That death was soon followed by a second death ― a 70-year-old man with diabetes and other medical problems, including high blood pressure and kidney disease.

“Our message is to ask people with diabetes to do things early in order to protect themselves and reduce their risk of having problems if anything happens,” Chan emphasized to Medscape.

Although the mechanism of this increased susceptibility remains unclear, research suggests that high blood glucose levels may lead to reduced functioning of the immune system.

Not Yet Pandemic, but Virus Has Claimed Many More Lives Than SARS

As of February 25, COVID-19 had infected about 80,000 people and had caused almost 2500 deaths worldwide.

Although the vast majority of these infections and deaths have been in China, there are now pockets of infection in Iran, Italy, Japan, and South Korea, as well as handfuls of cases in many other countries.

The World Health Organization (WHO) yesterday stopped short of calling the outbreak a pandemic but stressed that the status could change at any time.

Although COVID-19 appears to be highly transmissible, only a small percentage of people seem to develop severe illness, and an even smaller number die from the infection.

A recent study of 44,672 confirmed COVID-19 cases that had been reported through February 11 and that were analyzed by the Chinese Centers for Disease Control and Prevention (CCDC) shows that 80.9% of people in China who have been diagnosed with COVID-19 have had mild illness.

So far, the overall case fatality rate (CFR) in China is 2.3% ― less than previous coronavirus outbreaks caused by SARS (CFR: 9.6%) and Middle East respiratory syndrome (MERS) (CFR: 34.4%).

That said, because COVID-19 has infected far more people than SARS or MERS, the newest coronavirus on the block has already claimed many more lives.

This in turn raises the question: who is most at risk for severe illness and death from COVID-19?

Case fatality rates vary by factors such as age, sex, underlying medical conditions, and geography. Outside Hubei province in China, the epicenter of the outbreak, the CFR may be as low as 0.4%, compared to 2.9% within the province.

Case Fatality Rate for Diabetes Is High, but Interpretation Tricky

So far, for all age groups, the highest CFR is among people aged 80 years or older, at 14.8%. CFRs have been higher in people with other medical conditions than in healthy people.

CVD and diabetes top that list, at case fatality rates of 10.5% and 7.3%, respectively, compared to 0.9% for people without any prior disease, according to the aforementioned latest CCDC report.

Before publication of this report, two relatively small case series of patients who had been hospitalized for COVID-19 in Wuhan also suggested that older men with underlying medical problems, especially CVD and diabetes, are more likely to develop severe illness from the virus.

However, experts caution that for COVID-19 and similar infections, several factors may skew the data, making interpretation tricky.

“Cases that are identified tend to be in patients that have more severe illness, compared to younger, healthier individuals who just stay home and don’t seek medical care,” said Preeti N. Malani, MD, an infectious disease specialist and chief health officer at the University of Michigan Medical School, Ann Arbor.

“This is also the case with individuals who are sick enough to be hospitalized. There are more people with more chronic conditions, including diabetes [among hospitalized individuals],” Malani told Medscape via email.

“In general, diabetes can be a marker of other chronic health conditions like heart disease as well as obesity, which might contribute to the increased risk of infection,” Malani added.

“Diabetes is also much more common with age and will continue to be a marker of poor outcomes for [all of] these reasons,” she said.

Each Person With Diabetes Is Different; Use Common Sense

All of this makes it tricky to tease out diabetes’ individual contribution to infection risk.

“The proportion in which each medical condition contributes to…risk of infection is hard to dissect out,” explained Andrea Luk, MBChB, FHKCP, FHKAM.

Luk is an associate professor at the Chinese University of Hong Kong and is the other senior coauthor of the study in Diabetologia.

“Certainly a person with both diabetes and cardiovascular disease would have more risk than someone with diabetes and good glucose control and without any other comorbidities,” she continued.

But because every person with diabetes is different, it is important to consider the whole package, she stressed.

Whether someone with diabetes succumbs to infection has a lot to do with glycemic control, diabetes duration, and diabetes-related comorbid conditions, such as heart disease, kidney disease, and stroke, as well as their age, weight, and whether they smoke.

Chan further clarified: “We have to judge this case by case. You cannot apply it across the board to all people with diabetes. A person with well-controlled diabetes is very different from someone with poorly controlled diabetes. They have a different set of risk factors and complications.”

While awaiting more detailed analysis, Chan, Luk, and Malani all suggest common-sense measures for patients with diabetes, CVD, and other chronic conditions: staying up to date with vaccinations, avoiding large crowds, frequent hand washing, avoiding touching eyes or mouth (the so-called T-zone), and wearing face masks in areas where COVID-19 is prevalent.

People with symptoms should also wear a face mask to avoid spreading infection to others.

Also a Bad Year for Flu, Hard to Discern Between the Two

Malani added, “Although there is a lot of focus and concern about COVID-19, this has [also] been a terrible year for seasonable flu. I recommend flu shots, especially for…patients with diabetes.”

She also suggested being thoughtful about travel.

“This may not be a good time for nonessential travel to Asia, as the situation there is evolving. COVID-19 risk is still low, depending on where you go, but the risk of disrupted travel is real,” she noted.

Even without an emergency such as COVID-19, Chan and Luk say they cannot stress highly enough the importance of optimal glucose control for people with diabetes.

“People with diabetes or other chronic conditions should be extra vigilant about protecting themselves from infection,” Luk reiterated.

They should also have a lower threshold for seeking care if they feel they are developing symptoms of infection, she noted.

“It’s hard to tell at the beginning whether it’s influenza or COVID-19 because they present similarly,” she said.

Source : Medscape

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FDA Approves Novalung ECMO for Respiratory and Cardiopulmonary Failure

The US Food and Drug Administration (FDA) has cleared the Novalung heart and lung support system for the treatment of acute respiratory or cardiopulmonary failure.

Novalung, from Fresenius Medical Care North America (FMCNA), is the first extracorporeal membrane oxygenation (ECMO) system approved for long-term (>6 hours) extracorporeal life support.

Novalung is indicated for use in cases in which other available treatment options have failed and continued clinical deterioration is expected or the risk for death is imminent. These may include cases of failure to wean from cardiopulmonary bypass following cardiac surgery in adult patients and cases involving ECMO-assisted cardiopulmonary resuscitation in adults.

The system is portable and can be used in various clinical care settings, such as intensive care units, surgical suites, cardiac catheterization laboratories, and emergency departments, the company said in a news release.

“Novalung is a critical leap forward in providing heart and lung support therapy for a longer duration than ever available before,” Mark Costanzo, president of the renal therapies group at FMCNA, said in the release.

“A long-term, effective ECMO solution gives critically-ill patients the time and support needed to heal,” Robert Bartlett, MD, professor emeritus of surgery, University of Michigan School of Medicine, Ann Arbor, said in the release. “The system’s pressure sensor technology ensures continuous monitoring and accurate flow control of each patient’s blood, allowing the care team the flexibility needed to treat the underlying health issues.”

The company expects Novalung to be available in the United States later this year.

Source : Medscape

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Elder-Friendly Emergency Care Can Increase Positive Outcomes

Adopting the EASE (Elder-Friendly Approaches to the Surgical Environment) model in an emergency general surgical setting led to a reduction in complications and deaths, in a nonrandomized controlled study.

“The aging population and extended lifespans mean a growing number of emergency surgeries are being performed on older and frailer patients,” Dr. Rachel Khadaroo of the University of Alberta told Reuters Health by email. “Some suggest such patients should not be eligible for emergency surgery because of the increased risks, but I believe a better approach is to introduce standardized screening for frailty and improved post-surgical care for vulnerable patients.”

“A patient’s age alone should not determine appropriateness for surgery,” she said.

Dr. Khadaroo and colleagues at two hospitals reviewed data on 684 elderly patients who underwent emergency abdominal general surgery procedures (mean age, 76; close to half, women), including 139 (20.3%) who were frail. One hospital provided only usual care. At the other hospital, researchers implemented the intervention and conducted a before-and-after analysis.

Most patients were living independently in the community.

Overall, between April 2014 and March 2017, 544 patients received standard care, including 153 at the intervention site before implementation of EASE in September 2015; 140 patients received EASE. Palliative care and trauma cases were excluded.

As reported in JAMA Surgery, the intervention included integration of a geriatric assessment team, optimization of evidence-based elder-friendly practices, promotion of patient-oriented rehabilitation, and early discharge planning.

At the intervention site, in-hospital major complications or death decreased by 19% with EASE (33.3% vs. 13.6% pre-EASE) and the mean Comprehensive Complication Index decreased by 12.2 points, according to the report.

Minor complications also decreased significantly, whereas they increased at the control site (35.3% to 27.1% vs. 32% to 49.5%).

A comparison of pre- and post-EASE findings showed statistically significant decreases in the use of urinary catheters (76.5% to 63.6%) and total parenteral nutrition (27.5% to 13.6%), and participants were mobilized more quickly after surgery (mean time, 46.4 hours to 29.1 hours).

The median length of stay decreased by three days (10 days vs. 7) with EASE compared to no change at the control site, and fewer patients required an alternative level of care at discharge (39.9% vs. 20.7%).

Further, the incidence of delirium was reduced by half (25.5% to 12.9%) with EASE, whereas no significant change was found at the control site,

Dr. Khadaroo said, “The interventions we took through this study are relatively low-cost, due to savings related to fewer complications and readmissions and shorter hospital stays. We anticipate that EASE interventions can be adapted to fit many surgical centers to benefit older patients.”

“Following an operation, it improves the chances a patient will return home healthy,” she noted. “We can get the patient better with fewer complications and a shorter hospital stay if we have a coordinated elder-friendly team approach.”

Dr. Shelley McDonald of Duke University Medical Center in Durham, coauthor of a related editorial, commented by email, “The physiological complexities of older age can be medically challenging to care for and (patients’) social circumstances even more so, because basic information such as who they live with or how they manage their daily affairs often is not recorded in the medical record.”

“Older adults have usually overcome many circumstances in life to get where they are and deserve to have the time and attention paid to what is really most important to them about their medical care,” she noted. “Until we have multidisciplinary, interprofessional teams working together, it is incumbent on each provider to take a little extra time to connect and have a conversation with your older patients about these things and to also document their preference in the medical record.”

“Performing this kind of ‘whole person’ evaluation creates an opportunity to recognize hidden risks and provide earlier interventions – often at lower costs – to more effectively treat someone when urgent needs, like surgery, arise,” she said. “This will require continued change in our healthcare system toward policies and payment that emphasize team-oriented, person-centered, value-based care.”

Source : Medscape