29 minute read
Can C-Reactive Protein Levels Help Predict Anastomotic Leak?
C-Reactive Protein Levels: Ready for Prime Time In Assessing Anastomotic Leak? Time
By ETHAN COVEY
Tracking levels of C-reactive protein (CRP) in the body may help health care professionals to determine whether anastomotic leakage is occurring in patients who have recently undergone colorectal surgery.
According to a pair of recent studies, monitoring CRP levels may signal leakage, thus acting as an easy, early indicator appearing before other radiological and clinical signs (Sci Rep 2020:10[1]. doi:10.1038/s41598-020-58780-3; Br J Surg 2020:107:1832-1837).
“Anastomotic leakage is an undesirable complication of colorectal surgery, resulting in increased length of hospitalization, increased treatment costs, delayed return of intestinal homeostasis and decreased survival,” wrote the authors of a Brazilian study published in Scientific Reports. “Because vital signs and leukocyte numbers are slow in responding, it is important to identify tools to detect early leakage.”
Despite advances in surgical techniques, the mortality rate among patients with anastomotic leakage is estimated to approach 30% (J Am Coll Surg 2009;208:269-278), and delayed diagnosis has been found to increase mortality by 18% (J Am Coll Surg 1999;189:554-559).
The Brazilian study focused retrospectively on patients who underwent elective or emergency colorectal surgery with primary anastomosis at Carapicuíba General Hospital. The 90 patients were divided into two groups: 11 who experienced anastomotic leakage and 79 who did not.
Serum CRP level was evaluated on each of the first seven postoperative days (PODs), as were other clinical parameters such as abdominal pain, volume, return of bowel function and/or appearance of abdominal drainage.
Overall, surgical outcomes in patients who developed anastomotic leakage were far worse than in those who did not. Postoperative mortality was 18.2% in the group with leakage versus 1.3% in those without it; median hospital length of stay was 15 days for the leakage group compared with seven days in the nonleakage group; and 91.9% of patients in the group with leakage underwent surgical treatment.
When looking specifically at CRP level, the researchers found no significant differences during the first three days after surgery. However, starting on POD 4, patients with leakage experienced significant increases in serum CRP level. Peak CRP level occurred five days after surgery among patients with leakage. In contrast, in patients without leakage, CRP level peaked on POD 2 and fell from that point on.
“Serum CRP levels can be routinely analyzed in patients who undergo elective or emergency colorectal surgery. Decreased CRP levels after POD 2 can exclude anastomotic
—Peter K. Kim, MD
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leakage because they are not influenced by factors such as individual inflammatory response, type of approach or surgical indication,” the team of researchers concluded.
The liver produces CRP as an acute phase protein, so such a signal may be the fastest way to detect potential anastomosis in a patient.
“The liver is the sentinel of the body, tapping into bad things which may be happening in other parts of the body,” commented Peter K. Kim, MD, an associate professor in the Department of Surgery at Albert Einstein College of Medicine, in Bronx, N.Y.
Dr. Kim told General Surgery News that he has been tracking CRP levels among his patients as an early identification system for the “devastating complication” of anastomotic leak. He has found tracking CRP levels to be a simple, reassuring way of monitoring his patients. “CRP is not a difficult test—most hospitals have access to it,” he said.
Dr. Kim added that he focuses on other clinical and laboratory markers such as fever, heart rate, complaints of pain, return to bowel function and white blood cell count, but he noted that they can often be “soft signs of anastomotic leaks,” and may not appear until leakage is well underway. “You want to know earlier on whether patients are in trouble or not,” he said.
Dr. Kim did note, however, that the Brazilian study had a downside, in that it was a retrospective, single-institution study with relatively small numbers.
The second study in the British Journal of Surgery addresses many of those concerns.
This prospective study involved 833 patients recruited from 20 hospitals in Australia, New Zealand, England and Scotland between March 2017 and July 2018. Level of CRP was measured before operation and for five days after surgery.
Of the patients, 4.9% had anastomotic leakage with a median hospital length of stay of 16 days, compared with six days in the group without leakage.
The researchers determined that an increasing CRP level between any consecutive PODs had a sensitivity for predicting anastomotic leak, and a negative predictive value of 0.99.
The authors found the results to be less definitive than those from retrospective studies, but commented that “there was evidence of value in CRP testing.”
“This large prospective analysis of the accuracy of CRP testing in diagnosing anastomotic leakage has shown that, although CRP trajectory and cutoff points are not as accurate as expected when subjected to a large multicenter study, they certainly have value in diagnosing and excluding this significant surgical condition,” the investigators added.
Despite these data, Yosef Nasseri, MD, a colorectal surgeon and the founding partner of Surgical Group LA, based at Cedars-Sinai Medical Center, in Los Angeles, cautioned that identifying anastomotic leak is a complicated task.
“Diagnosis of an anastomotic leak requires an astute clinical judgment that takes into account patient’s vital signs, clinical appearance and exams, various laboratory values including WBC [white blood cell count], neutrophils, lactic acid, creatinine and blood gases, and imaging modalities—most commonly CT scan of the abdomen and pelvis,” Dr. Nasseri said. “CRP is certainly not specific to an anastomotic leak, and a rise in CRP can be due to various other reasons for fever and/or infection postsurgically including urinary tract infection, pneumonia, DVT [deep venous thrombosis], pulmonary embolism and others.”
Either way, Dr. Nasseri noted that a significant change in CRP level over a 24-hour period “can be suggestive of a significant acute infectious issue which can raise suspicion for an anastomotic leak, leading to other more definitive investigatory workup.” Additionally, he commented that the “specific cutoff value for a concerning CRP and/or change in CRP should ideally be validated by others before it makes its way into standard practice.”
Yet, Dr. Nasseri said, monitoring CRP levels may, indeed, be beneficial when used in combination with other markers.
“Fortunately, it is a cheap test and can certainly help in conjunction with other parameters so long as it does not lead to unnecessary pursuit of expansive workup that can be exhaustive and costly.” ■
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EXTENDED WOUND CARE COVERAGE
Burn Care 101: Determining the Best Treatment Plan Treatment Plan
Tips for the Non-Burn Professional
By MONICA J. SMITH
General surgeons may not see burn patients every day, but burns are a major public health concern, afflicting more than 1 million people in North America every year. The injuries range from mild to life-threatening, and although they share similarities with any wound a surgeon might treat, they also present unique challenges.
“It’s really important for health care professionals to be able to diagnose and treat burns as quickly as possible,” said Maria Goddard, MD, CWS, a burn and wound care specialist at Goddard Medical, LLC, in Overland Park, Kan.
“Large burns have the potential to create systemic physiological changes in patients; they don’t behave like your typical wound patients because of that systemic inflammatory response,” she noted.
Burn Types and Degree
Burns fall into several categories: thermal (exposure to flame, scalding liquid, contact with hot surfaces), chemical (acid, alkali, organic compounds), electrical (lightning, high voltage, low voltage), and inhalation. Each type has its own concerns and considerations.
“With chemical burns, you’ll want to identify the chemical involved. For instance, patients exposed to hydrochloric acid will have pain out of proportion to the injury, and you’ll want to treat them with calcium gluconate,” Dr. Goddard said, speaking at the 2021 Symposium on Advanced Wound Care virtual spring meeting.
Patients with electrical burns may have hidden injuries and will most likely be seen in an acute care setting, while patients with inhalation injuries need to be checked for carbon monoxide exposure.
First-degree burns, such as sunburns, are superficial and unlikely to need a surgeon’s care. Second-degree burns are subdivided into superficial dermal, which present with blisters and pain, and deep dermal, in which patients might have some diminished sensation due to nerve damage.
“You’ll want to watch second-degree burns closely, as they can go either way—healing on their own or progressing toward coagulation and requiring intervention,” Dr. Goddard said.
Full-thickness third- and fourth-degree burns cause damage to all layers of the skin. “If it goes beyond the subdermis, you may see underlying structures, like bone and muscle,” Dr. Goddard said. “These patients will be at risk for fluid loss and will lose their ability to thermoregulate. We need to monitor these patients for infection as well, which is one of the most common complications.”
Calculating Burn Extent and Fluid Needs
Once you know the mechanism of injury, you’ll want to estimate the total burn surface area (TBSA), and there are a few methods for calculating it. James Howard, MD, a general surgeon in Kansas City, Kan., who is board certified in burn and wound and critical care, favors the rule of nines.
“It’s probably the easiest to remember and is relatively straightforward. Nothing’s 100% accurate, but it’s a good starting guide and will help you with your fluid resuscitation,” he said.
The rule of nines breaks down the body into proportions corresponding to the head, trunk and extremities (e.g., one arm represents 9%). If less than an entire portion is burned, you’d want to take that into account. “Say the burn is only to the anterior portion of the arm, you’d make it 4.5%, or if it’s a smaller area, 2%,” Dr. Goddard said.
Fluid resuscitation comes into the picture when the TBSA is 20% or more. “About 20% is where hypovolemic shock can occur and typically where we would start resuscitation,” Dr. Howard said.
“These patients need a lot of fluid, but the pathophysiology is different than what you’d see with a splenic or liver laceration. You can’t just throw fluid at them, but you need to keep up with their ongoing fluid losses. Sometimes without doing calculations people who don’t often see burn wounds will just give liter after liter, but there really is a ‘Goldilocks spot’ with resuscitation.”
The Parkland formula, 4 mL per hour per percent TBSA, is the calculation most commonly used for determining the volume of lactated Ringer’s needed. “For example, if you have a 20% TBSA, you’ll multiply that by the fluid rate in milliliters and also multiply that by the patient’s weight in kilograms,” Dr. Goddard said.
But this amount may vary a bit. The American Burn Association (ABA) recommends 2 mL per hour for flame burns, 3 mL per hour for pediatric patients and 4 mL per hour for electrical burns.
“The key is to monitor the patient’s urine output and gauge whether you need more or less,” Dr. Goddard said.
Another concern unique to burn patients is their nutritional needs. They may experience a hypermetabolic phase that could last months, even years. “They’ll need greater intake in the acute phase, when they’re the most hypermetabolic. These nutritional needs are reassessed at different stages,” Dr. Goddard said.
Patients who can’t consume adequate nutrition orally may need supplemental nutrition via nasogastric tube, but this raises another problem seen in burn patients: securing any type of tube or line.
“That’s a challenge for every burn center,” Dr. Howard said. “When you can’t secure an IV with tape because the wound is too weepy, suturing is the best and easiest thing to do. Endotracheal tubes can also be difficult—sometimes tying it around the patient’s head with an endotracheal tie is the easiest thing.” into rior f it’s
Treatment Details
The initial management of a burn wound is a nonlinear cluster of events: removing clothing and jewelry, cooling the wound with warm water (not cold), covering the wound to manage pain and reduce the risk for infection, and optimizing pain control.
“Start with oral medications before you proceed to IV. You’ll want to have frequent discussions with patients regarding their pain level,” Dr. Goddard said.
The mainstay of nonmajor burn care is topical treatment such as silver sulfadiazine (SSD) or mafenide. Prophylactic antibiotics are not recommended.
Dressings are handled as for any wound: Manage exudate, use dressings that reduce infection risk, and consider patient economics and access to care. “Make sure you have adequate pain control to tolerate the changes, and avoid wound cleansers like hydrogen peroxide that could be cytotoxic,” Dr. Goddard said.
Reevaluate within 24 to 48 hours to see if the wound is likely to heal on its own or if excision will be needed.
“For wounds that won’t heal, consider enzymatic debridement before surgery to remove some of the top layer before you need to perform sharp excision. Excision and skin graft placement can be performed in single or multiple steps,” Dr. Goddard said.
“In a patient with a larger TBSA burn where you’ll be limited for donor sites for skin grafting, you’ll want to be more cautious, especially if it’s in the early stages. If your patient can’t go to the operating room, you can use cellular or tissue-based products to aid with the closure of fourth-degree burns,” Dr. Goddard said.
—Maria Goddard, MD, CWS
Transfer to Burn Center
Most surgeons would be comfortable managing second-degree burns and doing a skin graft, “say, a 5% or 10% burn on a nonfunctional or noncosmetic area,” Dr. Howard said.
Beyond that, the ABA has identified specific populations of burn patients who should be seen at a burn center: partial-thickness burns greater than 10% TBSA, all full-thickness burns, pediatric burns, inhalation injury, electrical or chemical injury, special anatomic areas (face, hands, joints), burns in combination with trauma, and patients with multiple medical comorbidities.
“Burn wounds are a constant threat to our community, so make sure that even the patients you see in clinic are keeping their water temperatures at appropriate levels and checking their smoke detectors, because we want to protect as many people as possible with prevention,” Dr. Goddard said. ■
By CHASE DOYLE
Time may not be able to heal wounds, as the saying goes, but the body can—with proper medical and nutritional support, according to recent data for targeted nutrition therapy.
During the Symposium on Advanced Wound Care Spring 2021 virtual meeting, Maritza Molina, RDN, and David G. Armstrong, PhD, DPM, of the Keck School of Medicine of USC, in Los Angeles, discussed how incorporating nutrition as part of the overall treatment plan can promote healing, decrease treatment duration and improve patients’ overall quality of life.
Nutrition Assessment and Treatment
As a registered dietitian at USC, Ms. Molina’s primary role is nutrition optimization, which means improving wound healing through a nutrition-focused approach. With tools such as nutrition-focused physical assessment, 24-hour recalls and lab work, Ms. Molina assesses the overall nutritional status of patients before and after surgery and manages nutrition-related diseases like diabetes and renal disease through intervention and education.
These macronutrient and micronutrient plans are individualized based on disease state and/or malnutrition risk. Ms. Molina noted the following key ingredients to support wound healing: • Arginine: A conditionally essential amino acid and precursor of nitric oxide, arginine is involved in vasodilation and blood flow support and plays a role in collagen synthesis. In combination with vitamin
C, oral nutritional supplements containing arginine have led to greater improvement in pressure injury healing. • Glutamine: Another conditionally essential amino acid, glutamine plays a role in collagen production, supports nitrogen metabolism and supports the immune system. A study of 40 patients with burns showed that supplemental glutamine led to improved healing and fewer wound infections (J Parenter Enteral Nutr 2003;27[4]:241-245). • HMB (beta-hydroxy-beta-methylbutyrate):
A metabolite of leucine, HMB slows protein breakdown, enhances protein synthesis and stabilizes the muscle cell membrane. A systematic review of seven randomized controlled trials of patients 65 years of age and older demonstrated greater muscle mass in the groups that received HMB (Arch
Gerontol Geriatr 2015;61[2]:168-175). • Collagen protein: Hydrolyzed collagen protein stimulates internal collagen production, which has been shown to increase the rate of wound healing.
In addition to these ingredients, Ms. Molina noted the following micronutrients that support the wound healing process: • Zinc: important for skin integrity, mucosal membranes and immune response; • Vitamin C: promotes collagen synthesis for tensile strength, modulates immune function and acts as an antioxidant;
• Vitamin E: plays a role in immune response and inflammation; and • Vitamin B12: important in the maintenance of red blood cells and supports wound strength.
Although there are clinical data to support each individual micronutrient, said Ms. Molina, when taken together, there is likely a better balance in tissue repair, wound healing and remission.
These macronutrients and micronutrients also have been shown to support wound healing at every stage of the healing process, including the hemostasis/inflammatory, proliferative and maturation phases. However, vitamin therapy should only be provided when deficiencies are present or there is poor oral intake, Ms. Molina said. Providers should consider conducting a 24-hour nutrition recall to determine whether more than 75% of estimated oral intake needs are being met.
“It’s important not to overwhelm patients with nutritional information,” Ms. Molina added. “Remember to use your clinical judgment and take it one step at a time.”
step at a time.’ —Maritza Molina, RDN
The Diabetic Foot: Common, Complex and Costly
Dr. Armstrong, a professor of surgery and the director of the Southwestern Academic Limb Salvage Alliance at USC, reported that lower extremity complications in diabetes have become more expensive than the five most expensive cancers in the United States. Diabetic foot ulcers also are associated with similar rates of fiveyear mortality (approximately 30%).
According to Dr. Armstrong, the best available data have shown that after one year of follow-up, approximately 40% of patients will experience another foot ulcer, and at five years, nearly 75% of patients will develop another one.
“We’re speaking at a wound healing meeting, but can we really heal anyone in this patient population in the big scheme of things?” Dr. Armstrong said. “Even when these patients are supposedly healed, recurrence is likely.”
One strategy proven to be effective in diabetic foot ulcers, however, is oral nutritional supplementation. A randomized study of Juven (Abbott), a unique blend of HMB, arginine, glutamine, hydrolyzed collagen protein and other macronutrients, demonstrated significantly improved wound healing of stage 1A diabetic foot ulcers in patients at risk for poor limb perfusion and/or low albumin levels (Diabet Med 2014;31[9]:1069-1077). No differences in healing were identified with supplementation in nonischemic patients or those with normal albumin levels.
“When we looked at the addition of this supplement as an adjunct to standard of care, it appears that the more [the patient] needs, the better it starts to work, which is usually the opposite of what we see in many clinical trials,” Dr. Armstrong said.
“It’s time to start paying attention to nutrition and measuring what we manage,” he added. “We’ve ignored this issue for far too long.” ■
Updated Skin Antisepsis Guidelines Aim to Reduce Surgical Site Infections
By BOB KRONEMYER
Since its introduction in the 19th century, skin antisepsis has helped to reduce the incidence of health care–associated infections.
Updated guidelines from the Association of periOperative Registered Nurses (AORN) now offer new evidence to help interdisciplinary teams make decisions and standardize preoperative skin antisepsis protocols.
“Standardization eliminates variability, resulting in less waste, fewer errors and improved quality outcome,” said lead author Karen deKay, MSN, RN, CNOR, CIC, a perioperative practice specialist at AORN, in Denver. “Skin antisepsis is a broad term that includes several interventions to reduce the microbial load on the patient’s skin and inhibit rapid rebound growth of microorganisms from the skin where the incision will be made.”
Skin antisepsis is important because the removal of soil and transient microorganisms, as well as the reduction of resident microorganisms, minimize the number of bacteria on the skin near the surgical site, according to Ms. deKay.
“The intervention most perioperative personnel are familiar with is surgical site preparation. When an incision is made, it compromises our body’s coat of armor and increases the likelihood of introducing microorganisms internally,” she said. “Hence, reducing the number of microorganisms near the incision site decreases the chance of skin microorganisms entering the surgical site through the incision, thereby decreasing the change for a surgical site infection [SSI].”
Clinical practice guidelines for SSI prevention from various health agencies and professional societies recommend decolonization, alcohol-based skin antiseptics and bundles to decrease the incidence of SSIs.
“Most clinicians are aware of the benefit of decolonization in reducing SSIs,” Ms. deKay said. “However, they may not be aware that decolonization is not indicated for all surgical patients and that community, hospital and procedure risk factors need to be evaluated by an interdisciplinary team to determine which surgical population would benefit the most from decolonization.”
Likewise, clinicians are mindful of the need to decolonize for colonization
Using Machine Learning to Predict Surgical Site Infections
continued from page 1
emeritus of surgery at Weill Cornell Medicine, in New York City, and the executive director of the Surgical Infection Society Foundation for Education and Research.
“Studies of SSI prevalence are challenging to perform and interpret if not done prospectively, using trained observers inspecting each incision,” Dr. Barie told General Surgery News. “Retrospective studies always leave doubt as to what exactly was observed, whether patients were omitted inadvertently because of sporadic reporting from the outpatient setting, or if data reporting is incomplete. Moreover, thousands of patients are required to achieve adequate statistical power to study clean operations owing to the low prevalence of infection.”
One study, conducted by researchers at Mayo Clinic in Rochester, Minn., addressed the problem of missing data, which can skew retrospective analyses and subsequent prospective predictions of SSIs.
“The nice thing about machine learning is that it allows the system to refine a model as it evolves, as long as you can get data for the system to look at; we wanted to know what the impact of missing data is on the ability to model infections,” said Robert Cima, MD, a professor of surgery at Mayo Clinic College of Medicine and Science, in Rochester, Minn.
“What we found is that unless you do certain corrections, your model is going to suffer from it.”
To evaluate a method for handling missing data, Dr. Cima and his colleagues compared a Bayesian-Probit regression model with multiple imputation (BPMI) with a generalized linear model (GLM) in predicting colorectal deep organ-space SSIs (C-OSIs, e.g., postoperative intraabdominal abscess).
Among the 2,376 elective colorectal resections performed at Mayo Clinic between 2006 and 2014, the C-OSI rate was 4.6% (108). The BPMI model identified 57 of these patients: a sensitivity of 56%, compared with the GLM’s sensitivity of 47%. The BPMI model lost its advantage when the model was built to use extrainstitutional data (i.e., based on the American College of Surgeons National Surgical Quality Improvement Program), which reduced its sensitivity to 47%.
They concluded that for optimal performance, the BPMI model should be built using “data specific to the individual institution” (Surg Infect 2021;22[5]:523-541).
“We’re going to be seeing more and more of these models, and people need to understand the limitations of them, and how to use them in their institution,” Dr. Cima said.
“My concern is that somebody will develop a big model based on a very heterogeneous data set that may not reflect the risk profile or the patient profile of an individual hospital. I’d hate to see them penalized or made to look like they’re not performing well when the model was never designed to be used in their environment,” Dr. Cima said.
Because retrospective chart review is cumbersome, other investigators have sought to automate the process using machine learning and natural-language processing. The other study, which specifically investigated the generalizability of SSI-detection machine learning–generated algorithms, found that machine learning models designed at one center worked just as well at another.
“We’re at the beginning of an acceleration of having machine learning and AI used more widely in health care, but the work to validate models isn’t always done optimally. In many instances, we expect it to be like a ‘plug-and-play’ technology, where you install the solution in and it works. But the truth is, in some cases there is a degradation in performance or the need for more optimization,” said Genevieve Melton-Meaux, MD, PhD, a professor of surgery and Institute for Health Informatics core faculty at the University of Minnesota Medical School, in Minneapolis.
To do so, Dr. Melton and her colleagues tested automated SSI-detection algorithms developed and validated using electronic health record (EHR) data from 8,883 patients at their institution, and then applied those algorithms to 1,473 patients at the University of California, San Francisco.
Looking at the detection of superficial, incisional, organ-space and total SSI complications, the researchers found no difference in area under the curve for any outcome. They concluded that the algorithms developed at one site are generalizable to another (J Am Coll
‘We’re at the beginning of an acceleration of having machine learning and AI used more widely in health care, but the work to validate models isn’t always done optimally. In many instances, we expect it to be like a “plug-and-play” technology, where you install the solution in and it works.’ —Genevieve Melton-Meaux, MD, PhD Surg 2021;232[6]:P963-P971). “Currently there is no standard way SSIs are documented in the EHR that would make it easier for a person to extract the data—if they are documented at all. Here, they’re using machine learning and AI to go through records looking for certain terms that correlate with the presence of an SSI, saying that the process of screening might be automated, with a particular advantage that the need to manually review low-risk cases might be eliminated,” Dr. Barie commented. “Basically, they’ve developed a tool that makes it easier for the surveillance people to find these SSI cases accurately.” So, what explains the discrepancy in generalizability between the two papers? Both Drs. Cima and Melton suspect it has to do with characteristics of the institutions, the types of patients they see and the way their surgeons practice, and the questions that each of the algorithms are designed to answer. “In our case, it appears that what we used to build the model is robust and good, but it’s unclear if that would scale across the country. These were both academic health systems; it might be different at a smaller center, or with different patient populations or over time as surgical practices change,” Dr. Melton said. “These are important questions that we’re going to need to be able to answer more and more.” ■
Antisepsis
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of methicillin-resistant Staphylococcus aureus (MRSA). “However, they may not be cognizant of the need to also decolonize for methicillin-susceptible Staphylococcus aureus colonization,” Ms. deKay said. “Patients with both methicillin-susceptible and methicillin-resistant S. aureus in their nares or on their skin are more likely to develop Staphylococcus aureus SSIs.”
Bernard Camins, MD, the medical director of infection prevention for the Mount Sinai Health System, in New York City, and a member of the AORN Guidelines Skin antisepsis is important because the removal of soil and transient microorganisms, as well as the reduction of resident microorganisms, minimize the number of bacteria on the skin near the surgical site.
Advisory Board, noted the guidelines will decrease the risk for developing infections after surgery, “therefore decreasing the risk of death, hospitalization, prolonged recovery and even long-term complications. By reducing complications, the guideline promotes patient safety.”
Dr. Camins said the current and previous versions of the AORN guidelines “provide clinicians the tools necessary to reduce the bioburden found on the skin to avoid contamination of the surgical wound. Skin antisepsis is one of the most important measures to prevent infections during surgery.”
Following the recommendations of the guidelines and the manufacturer’s instructions for using antiseptic solution carefully “will result in a lower risk for the development of SSIs,” he said.
However, one potential obstacle in implementing the guidelines is the time and resources required to form an interdisciplinary team or using a facility’s current SSI prevention task force “to take a closer look at how preoperative patient skin antisepsis elements can contribute to a reduction in the facility’s SSIs,” Ms. deKay said. And if these elements are already part of a facility’s SSI bundle, “you need to provide the resources necessary to establish a process that will closely monitor adherence to these practices, as regular observation of processes can identify inconsistencies and areas for improvement.” ■
White Light Imaging
Firefly imaging is not visible in white light imaging mode.
Standard Firefly Mode
In Standard mode, the image is displayed as a fluorescent green overlay on a black and white background view. The closer the endoscope is to the tissue, the stronger (more intense green) the signal appears.
Sensitive Firefly Mode
In Sensitive mode, the system attempts to automatically adjust the signal intensity and brightness to be consistent, whether the endoscope is moved closer or farther away from the tissue.
Note: Sensitive Firefly mode is only available with Endoscope Plus.
Scan to learn more about the evolution of surgery
Images above show porcine pelvic vasculature using the da Vinci Xi Endoscope Plus.
*Total da Vinci Practice refers to the transferable value of da Vinci surgery across procedures in surgeon’s minimally invasive surgery (MIS) practice. It is at the surgeon’s discretion to determine when a patient is a candidate for
MIS surgery and whether da Vinci surgery is an option.
Adjust Your Perspectice Using the da Vinci Firefly Imaging System
The da Vinci Xi® and da Vinci X™ surgical systems with integrated fluorescence imaging capability provide you with real-time endoscopic visible and near-infrared fluorescence imaging. This fluorescence imaging capability provides you with the opportunity for visual assessment of at least one of the major extra-hepatic bile ducts, as well as the cystic artery during cholecystectomy procedures performed using the da Vinci® system. It can also be used to assess vessels, blood flow, and related tissue perfusion during cases across your da Vinci Total Practice* when indicated.
Firefly Fluorescence Imaging
The da Vinci fluorescence imaging vision system (Firefly® fluorescence imaging) is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vinci fluorescence Imaging vision system enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow, and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near infrared imaging.
Fluorescence imaging of biliary ducts with the da Vinci fluorescence imaging vision system is intended for adjunctive use only, in conjunction with standard of care white light and when indicated, with intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.
Intuitive’s ICG packs are available for sale in the U.S. ONLY. Intuitive’s ICG packs are cleared for commercial distribution in the U.S. for use in combination with the fluorescence-capable da Vinci HD vision system and Firefly integrated hardware. Intuitive-distributed ICG contains necessary directions for use of ICG with Firefly fluorescence imaging. Using generic ICG with Firefly fluorescence imaging is considered off-label and is not recommended. Anaphylactic deaths have been reported following ICG injection during cardiac catheterization. Total ICG dosage should not exceed 2 mg/kg per patient. Anaphylactic or urticarial reactions have been reported in patients with or without histories of allergy to iodides.
Important safety information
For Important Safety Information, indications for use, risks, full cautions and warnings, please refer to www.intuitive.com/safety.
Da Vinci Xi/X system precaution statement
The demonstration of safety and effectiveness for the specific procedure(s) discussed in this material was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of cancer (overall survival, disease-free survival, local recurrence) or treatment of the patient’s underlying disease/condition. Device usage in all surgical procedures should be guided by the clinical judgment of an adequately trained surgeon.
© 2021 Intuitive Surgical, Inc. All rights reserved. Product and brand names/logos are trademarks or registered trademarks of Intuitive Surgical or their respective owner. See www.intuitive.com/trademarks.
