24 minute read
Responses to “The Most Harm” Opinion Article From Last Month
Allowing Surgical Trainees to Struggle in the OR
[Re: “The Most Harm,” by Miguel Lopez-Viego, MD, November 2021, page 1]
To the Editor:
Kudos to Dr. Lopez-Viego for speaking up on this pandemic-like issue among the graduating residents and fellows. He has hit the nail on the head, summarizing what is currently going on in U.S. training programs, an issue which is only getting worse with senior residents/fellows being mere observers now in robotic surgery cases. I am currently a second-year attending, and I can’t emphasize how important it is to “struggle” in the OR. There is simply no amount of observing, reading or watching videos that can prepare you for the real world.
Dr. Lopez-Viego has rightly pointed out that senior residents/fellows are exploited for administrative tasks while the attending “gets through” the case for myriad reasons. Surgery is all about “see one, do one, teach one.” Unfortunately, this field is moving away from the “do one” aspect rather quickly. It is incumbent upon our leadership to act on this very important issue and ensure the graduating residents/fellows are up to the task that will be handed to them once they are practicing. This article highlights what happens to the unfortunate folks who are not prepared to face the music. As Dr. Lopez-Viego recounts, “All these surgeons eventually had to leave the community discouraged, disgraced, embarrassed and lacking any confidence.” Reiterating the point, the ACS leadership needs to intervene to avoid—despite multiple years of post-residency training—a pandemic of untrained surgeons. Adeel A. Shamim, MD, DABS Minimally Invasive and Bariatric Surgery Mercy Health, Fort Smith, Ark.
To the Editor:
I am a third-year general surgery resident and would like to share my sincerest compliments regarding the article “The Most Harm,” by Dr. Lopez-Viego. I strongly agree with his message and feel comforted knowing there are surgeon educators who recognize this issue and are speaking out about it with passion. Dylan Johnson, MD, PGY-3 General Surgery Residency Program HCA Brandon Regional Hospital, West Florida Division
To the Editor:
I thought this was one of the best articles in the history of General Surgery News. Dr. Lopez-Viego calls it like it is. I am not confident, even with the truth, that the problem will be fixed. I think any patient entering an academic institution should have to sign a waiver acknowledging that they may be operated on by a resident under supervision. Only by making this a standard protocol for all academic institutions will the problem be fixed. Patients who want the benefit of these prestigious and well-equipped training institutions will have to make a trade-off, and, if they don’t want that, they can go to a nonacademic center. The legal and administrative departments will be very hesitant, unfortunately, to fix this problem on their own.
Matt Pompeo, MD Dallas
To the Editor:
I’m a new general/bariatric surgeon, four months out from fellowship, and I just wanted to say how much I appreciated this article. I couldn’t agree more with Dr. Lopez-Viego. I just wish more academic surgeons took their responsibilities as educators as seriously as he does. Thank you, Dr. Lopez-Viego, for taking the time to write this article and for the countless hours you spend in the OR letting your trainees struggle. That really is the most important part of training.
Eric Rachlin, MD Houston
To the Editor:
Dr. Lopez-Viego’s vitriolic editorial, “The Most Harm,” is long on complaints and criticisms of current surgical education but short on solutions. He describes the ongoing devaluation of classic surgical education in general and intraoperative teaching specifically, yet offers no practical recommendations to remedy the situation.
The good doctor must realize that surgical education in academic centers is a historical accident. Its perpetuation into modern times is not necessarily the best way to teach residents how to operate. Academic departments of surgery are not fonts of education. These centers are multimillion-dollar businesses focused on financial stability. The dedicated, patient and selfless surgical educator described by Dr. Lopez-Viego does not exist because there is no RVU [relative value unit] for educational effort. That surgeon is an economic nonentity.
The literature on the fate of physicians who have won teaching awards reveals just how valuable the premier medical educator is in today’s environment (Medical Education Online. 2000;5:3. www.tandfonline.com/ doi/abs/10.3402/meo.v5i.4313; Perspect Biol Med 1999;42[2]:280-287. doi:10.1353/pbm.1999.0029).
The goals of the academic medical center are too diffuse to provide the type of surgical education sought by Dr. Lopez-Viego. The irrefutable fact is that academic surgeons chose their career path not to perfect their craft and pass it on to others, but to do what is required to become a professor. The goal is to write papers, increase a national profile, attend national meetings, obtain research grants, serve the American College of Surgeons and the American Board of Surgery, spend endless hours on committees and at retreats, and, if there is time—perhaps as an aside—instruct residents on the basic mechanics of clinical surgery.
To put it bluntly (and to some degree to keep up with Dr. Lopez-Viego), due to a lack of practice and volume of cases, academic surgeons with few exceptions rarely rise above the competency of the fellow. They remain largely unaware of their lack of operative skills. They exist in a world of arrested surgical development.
It’s as if you are climbing the White Mountains of New Hampshire all of your life, never realizing that there is a Mont Blanc.
A step forward to remedy the problems outlined in Dr. Lopez-Viego’s caustic essay—did he really equate delaying challenging cases to senior residents as a criminal act?—is to increase the number of rotations outside of the mother ship for surgical residents. I would guess that 95% of graduating residents who have had outside rotations would say that that is where they “learned to operate.”
Place a resident into a busy community surgical group performing 10 to 15 cases per week and that resident will learn how to operate safely and efficiently. That was always the appeal and value of a Veterans Administration [hospital] rotation. The community hospital and the VA have only one mission, not four competing missions. The surgical skills of private-practice surgeons greatly exceed those of academic surgeons. The latter never understand this and, in fact, for mysterious reasons, endlessly debase and ridicule community-based surgeons.
In addition to spending more time at community hospitals and Veterans Administration facilities, graduating surgical residents should be required to spend six months in a medically underserved part of the world. Many international opportunities are available. I am familiar with a recently graduated chief surgical resident who did this. He returned with a refined set of surgical skills. Those six months put him years ahead of his colleagues in surgical judgment and the ability to recognize and to manage complications. His personal initiative made up for the deficiencies Dr. Lopez-Viego describes. When a graduating resident takes a job, that resident must be certain that a mentor will be part of the employment contract. I am not talking about a half-hour latté schmooze-fest on a Tuesday morning. I am talking about an experienced, broadly trained mentor 10 or 15 years into practice who has a contractually vested interest in the new hire—an interest in the financial viability of that individual and a greater interest in correcting the failures of that individual. I am talking about a colleague who will appear at 0200 hours to help dig out the left ureter! I am talking about someone who recognizes the issues raised in Dr. LopezViego’s editorial and is going to do something about it—a true surgical leader who can correct current educational deficiencies.
The academic surgical construct is simply not designed to produce “cutting surgeons.” If the days of the cutting surgeon are gone, there is no reason to fret over this. Laparoscopy, robotics, interventional radiology and advanced endoscopic skills may make up for the demise of the cutting surgeon.
But if they are not gone, primary responsibility for surgical education needs to find a way to escape from the historical confines of academic centers.
Current graduates are not finished products. If they were, the resident farewell dinner would not be called a “commencement.”
Leo A. Gordon, MD Los Angeles Dr. Gordon is a member of the editorial advisory board of General Surgery News.
The ‘Difficult’ Gallbladder: Approaches to Different Clinical Scenarios
continued from page 1
To Drain or Not to Drain
Percutaneous cholecystostomy has historically been used as either a bridge to surgery or a definitive treatment in patients who are too frail to undergo surgery. Mortality related to the procedure is less than 0.5%, and percutaneous cholecystostomy is successful from a clinical point of view, relieving fever, pain and inflammatory markers in 85% to 90% of patients.
“When you look at our population of high-risk surgical patients, [percutaneous cholecystostomy] is superior to conservative management followed by delayed laparoscopic cholecystectomy,” said Raul Coimbra, MD, PhD, a professor of surgery at Loma Linda School of Medicine, in California. There are a couple of algorithms that can help guide what to do with patients after drain placement (Front Surg 2021;8:616320; Abdom Radiol 2020;45[4]:1193-1197). The second and simpler one advises following up on all patients at two weeks with cholangiography (Figure). “If the patient is a surgical candidate, they should undergo cholecystectomy; if they are not a surgical candidate, one option is percutaneous cholecystolithotomy, though that’s performed in the minority of patients,” Dr. Coimbra said.
A novel alternative to percutaneous cholecystostomy worth watching is endosonography-guided gallbladder drainage. “You locate the gallbladder through the stomach or duodenum, perform a cholecystogastric or cholecystoduodenal fistula through a stent, and remove the stones,” Dr. Coimbra said.
A recent multicenter, randomized controlled trial found this technique resulted in lower rates of recurrence, and fewer 30-day reinterventions, unplanned admissions, and 30-day and one-year adverse events than percutaneous cholecystostomy (Gut 2020;69[6]:1085-1091).
“Both are technically and clinically successful procedures, so both work. But it seems that the performance of the novel technique is much superior,” Dr. Coimbra noted.
Subtotal Cholecystectomy: A Safer Bailout
When a CBDI appears imminent during a difficult cholecystectomy, the default has been converting from laparoscopic to open surgery. But it might be counterintuitive for the most recent generation of surgeons, well trained in laparoscopy, to turn to a less familiar option when surgery becomes challenging.
“The truth of the matter is that inflammation doesn’t vanish when it’s exposed to air; a difficult gallbladder laparoscopically is a difficult gallbladder open,” said Sharmila Dissanaike, MD, the Peter C. Canizaro Chair of the Department of Surgery at Texas Tech University, in Lubbock.
Enter subtotal cholecystectomy, a relatively new approach that is gaining traction. “It’s probably accepted these days as the safest option to prevent severe bile duct injury,” Dr. Dissanaike said.
The two types, reconstituting and fenestrating, are both easy to perform laparoscopically and open, Dr. Dissanaike said. “The key is staying high, away from the danger zone; opening into the gallbladder anterolaterally; leaving only about 1 cm of infundibulum; taking as much of the posterior wall as you safely can; and clearing all the stones.”
How do you choose between the two? It’s a bit of a toss-up, weighing potential complications. “Fenestrating will usually give you a bile leak and it has slightly more reinterventions, but reconstituting seems to have more recurrent biliary symptoms,” Dr. Dissanaike said.
Finally, she recommended reserving subtotal cholecystectomy for the most difficult cases, when dissection is truly dangerous. “If we drop the threshold to perform subtotal cholecystectomy too low, we might have unacceptably high rates of patients needing reoperation,” Dr. Dissanaike said.
Cholecystitis and Cirrhosis: Managing the Sickest Patients
Patients with cirrhosis and cholecystitis are at increased risk for a number of complications and difficult surgery. The decision to proceed with surgery begins with an assessment of the patient’s capacity to tolerate it.
“Clearly there is a large spectrum of cirrhosis, and stratifying the perioperative mortality is important,” said Kristin Ellen Raven, MD, a transplant surgeon at Beth Israel Deaconess Medical Center and faculty member at Harvard Medical School, both in Boston.
For example, patients classified as Childs A are likely to survive surgery; similarly, those with a Model for End-stage Liver Disease (MELD) score less than 15 who have not been decompensated also have a relatively low mortality risk of 10% to 15%.
To further determine surgical risk in cirrhotic patients, Dr. Raven uses a calculator available on Mayo Clinic’s website that takes into account age and American Society of Anesthesiologists physical status in addition to MELD score (https://mayocl.in/32ICYIo). “I find this calculator extremely valuable to discuss risk with patients and family, and to provide solid data to nonsurgical colleagues who may be pushing for an operation.”
When surgery is deemed feasible, Dr. Raven advocates for the least invasive operation possible, noting that risk rises with procedure length. “The cumulative risk for perioperative complications is four times higher past two hours than it is for a 30- to 60-minute laparoscopic cholecystectomy. I have a low threshold to open.”
For decompensated patients, she recommends starting initial nonoperative management with NPO order and IV antibiotics. “I require that decompensated cirrhotics really force me to operate, meaning they’ve failed several days of conservative management,” Dr. Raven said.
But surgery is only part of the challenge in managing patients with cirrhosis. Postoperative care requires hemodynamic monitoring, possible ICU admission, optimal coagulopathy, management of ascites and other considerations.
“The ability of your institution to care for these patients postoperatively should weigh heavily in your decision to operate,” Dr. Raven said.
Managing Common Bile Duct Injury
Despite such precautionary measures as achieving a critical view of safety and bailing out to subtotal cholecystectomy, common bile duct injuries still occur in up to 0.4% of all laparoscopic cholecystectomies. Katherine Morgan, MD, suggested steps for managing this daunting complication.
“The first step, to quote my hilarious partner, is to take your own pulse; it’s terrifying to see an unexpected bile leak, which can compromise your judgment, so take pause,” she said.
Second, call a senior partner or phone an accessible hepato-pancreatico-biliary (HPB) surgeon for help, said Dr. Morgan, a professor of surgery and the head of the Division of Hepato-Pancreatico-Biliary Surgery, Medical University of South Carolina, in Charleston. Although she was trained to convert to open when laparoscopic cholecystectomy becomes difficult, like Dr. Dissanaike, Dr. Morgan thinks this approach may no longer be the safest option for surgeons trained more in minimally invasive surgery than open procedures. “Opening does not make this operation any easier,” she said.
Third, and most important, obtain drainage. “Controlling the bile leak will prevent sepsis and allow for the inflammatory physiology to resolve to allow the patient to be prepared for a more definitive repair later on,” Dr. Morgan said.
Finally, consider an early referral to an HPB center. “Management of CBDI really is a multidisciplinary effort. It involves the therapeutic endoscopist, interventional radiology and HPB surgery,” she said, noting that attempting CBDI repair at the primary hospital has been identified as an independent risk factor for poor outcomes. ■
Cannabis
continued from page 19
which included self-reporting of cannabis use (which may create underreporting); the researchers’ inability to quantify the amount, duration or type of cannabis use; and a lack of categorization of other recreational drug use.
Marco Echeverria-Villalobos, MD, an assistant professor of anesthesiology at The Ohio State University Wexner Medical Center, in Columbus, said the primary challenge in studies such as this is accurately estimating the percentage of cannabis users in a population of surgical patients.
“Despite the wide use that cannabis or cannabinoids have as recreational or medical drugs, the percentage of patients that can be identified preoperatively as recreational or medical cannabis users by self-disclosure is still very low (4.0%-4.2%), as we can observe in other studies that have included larger sample sizes [Int Orthop 2019;43:283-292]. This continues to be an important limiting factor of studies that seek to accurately estimate the real impact of cannabis use on perioperative outcomes.” ■
Cheaper to Pay Your Doctor
continued from page 1
have created multiple layers of complexity that have siphoned off the majority of the health care dollars into a giant black hole. The problem is individuals and employers seeking health care plans feel they have little choice and, therefore, humbly agree every year to another price increase, to pay for the “rising costs” of pharmaceutical, hospital and specialty care. Clearly, there needs to be better options.
While technology has moved the practice of medicine from the hospital to the office, to the patient’s home, the established health care system has not modernized to meet the new requirements. Hospital workflows have become increasingly burdened with a bureaucracy designed for corporate compliance rather than patient wellness. Doctors have had to constantly adjust and conform to protocols that impede, redirect and distract from properly implementing treatment in a timely manner. That is why the job burnout rate is so high and patient satisfaction so low.
It took a pandemic to push us into the future, allowing us to reprioritize care, adopting new technologies while streamlining others. Outpatient joint replacements, for example, are now becoming the new standard, and with improved outcomes, and telemedicine has emerged as an important addition to nearly every practice. In short, doctors have found new ways to work around the system and they are taking their patients with them. There is no price transparency in health care. No one ever claims to know the exact price of services, although the balance sheet clearly shows what insurers haven’t paid. Fee schedules are exaggerated to give insurers a chance to bargain. However, spoiler alert: It’s actually much cheaper just to pay a transparent fee for a specific service. It’s expensive to bill, collect and obtain authorizations, and nowadays many patients have such high plan deductibles that they are paying out of pocket anyway. More and more often, paying with insurance can cost more, especially when it comes to medications. Patients should demand to know the price, and many doctors now oblige, and it would behoove hospitals to do the same.
The consumers drive demand and health care is no different. Buying insurance no longer guarantees a doctor’s time; on the contrary, it limits it. But going to a doctor doesn’t cost as much as a premium. With the advent of telemedicine, good doctors can see their patients more efficiently, lowering the cost for both the office and the patient. Hospitals can also change the equation by offering better access through pricetransparent models. There are a number of places where patients can find affordable options for pharmaceuticals, imaging and specialty care, including surgery. Primary care physicians have been the first to see the value in direct pay models, but now every specialty is joining the movement. Employers are discovering medical cost-sharing plans that save companies—big and small—millions of dollars, and as more physicians participate, the market will shift back to the patients. Even the government sees the benefit in direct pay models.
The innovations in medicine in the past decade have been remarkable, but physicians and their patients can’t take advantage of all of them because of an archaic system built on principles that no longer apply. The best care is always found nearby, but when an employee works in another state, then what happens? The costs have not and will not be controlled by restrictive insurance networks. Coverage will always be necessary, but in a direct-pay world, the majority of encounters can be paid for out of pocket. In this case, less is more, and keeping people out of the doctor–patient equation saves both time and money. ■
Denver, CO
SAVE THE DATE
March 16-19, 2022
Program Chairs: Jacob Greenberg, MD, EdM and Archana Ramaswamy, MD, MBA
—Dr. Muto is a general surgeon; the founder and CEO of UBERDOC, a digital health platform connecting patients and doctors; and the director of the Vein Center at Muto Surgical, in North Andover, Mass. Dr. Muto’s Twitter handle is twitter.com/paulamutomd.
The Scientific Greats: A Series of Drawings
By MOISES MENENDEZ, MD, FACS
Sven Ivar Seldinger (1921-1988)
Central venous catheterization was first performed in 1929. Since then, central venous access has become a mainstay of modern clinical practice. It is likely that this procedure is being done in medical centers and clinics by the thousands around the world.
From its infancy, central venous access was fraught with significant complications, and, at the time, difficult to master or even perform. Surgeons are also familiar with the classic venous cut-down for vascular access, which also carried the risk for complications and was difficult to perform. Arterial access was done in a similar way. Prior to using this technique, a common practice was to puncture the vein with a large needle, such as a 14 G, aspirate blood, and then immediately cannulate the vessel with a smaller-caliber catheter through the needle. This technique, like the others, was fraught with complications and later abandoned after the Seldinger technique became part of practice.
At the end of the 20th century, no surgical procedure had more impact for its simplicity and ease of use than percutaneous vascular access. The most acclaimed pioneer of this technique was Sven Seldinger. Dr. Seldinger was a radiologist from Sweden who developed a technique for visualization of the human blood vessels. In 1953, he introduced the Seldinger technique as a method of obtaining safe access to blood vessels and other hollow organs. This technique remains the backbone of all modern-day interventional and endovascular procedures. The major advantage of the Seldinger technique is that it allows for the insertion of a catheter that is larger in diameter than the needle used. The Seldinger technique’s addition of a flexible, round-ended, metal leader (guide wire) was unique. The sequence included: • needle puncture of the vessel; • a guide wire threaded through the needle; • removal of the needle; • a flexible catheter threaded over a guide wire; and • removal of the guide wire.
This process enabled a catheter of the same bore as the needle to be inserted percutaneously, rather than requiring surgical exposure or a large-bore needle. Today, it is used not only in radiology, but also in the emergency room, gastroenterology, thoracic surgery, cardiac surgery and other surgical specialties.
Sven Seldinger was born in the small town of Mora, Sweden, where his parents ran the Mora Technical Institute. He trained in medicine at the famed Karolinska Institute, in Stockholm, from 1940 to 1948, and went on to train in radiology at the Karolinska Hospital. He remained there for his entire career.
Dr. Seldinger first published this technique for obtaining percutaneous access to blood vessels in 1953, in the journal Acta Radiologica. He described the method of using a catheter with the same size as the needle, and which was used at Karolinska Sjukhuset since April 1952. The main principle of the technique consisted of the catheter being introduced on a flexible leader through the puncture hole after withdrawal of the puncture needle. Dr. Seldinger also presented cases of arterial catherizations using his technique. Procedures were done using local anesthesia, and the complications were few and minimal. However, Dr. Seldinger’s chief at the Department of Radiology at the Karolinska did not think his invention and the obvious potential benefits—all the arteries in the human body could be reached by this simple procedure—were enough to form the basis for a thesis. So, Dr. Seldinger had to start on a second project—the development of percutaneous cholangiography. The Seldinger process of intravenous cannulation was a major advance in safety, reliability, reduction of complications, and the ability to place multilumen and specialty devices. One major difference from previous techniques was that the Seldinger technique used a much smaller needle to access the vessel, making it less prone to injure adjacent structures. In 1975, the New York Academy of Medicine gave Seldinger the Ferdinand C. Valentine Award. The Swedish Society of Medical Radiology and the German Roentgen Society awarded him an honorary membership to their organizations. In 1984, Dr. Seldinger received an honorary doctorate from the Faculty of Medicine at Uppsala University, in Sweden. He died at home in Dalarna, Sweden, on Feb. 21, 1998. He is survived by his wife and three daughters. ■
CLASSIFIEDS
Sven Ivar Seldinger (1921-1988) 2019 This work was done on an Arches white paper, 11 x 16, using only charcoal pencils. Artist: Moises Menendez, MD, FACS
Sources
Adas J, et al. Dr. Seldinger and his wire. Michigan College of Emergency Physicians. November/December 2016 Newsletter. Greitza T. Sven-Ivar Seldinger. Am J Neuroradiol. 1999;20(6):1180-1181. Seldinger SI. Catheter replacement of the needle in percutaneous arteriography: a new technique. Acta Radiologica. 2008;434:47-52. Smith RN, Nolan JP. Central venous catheters. BMJ. 2013;347:f6570. Sternbach G. Sven Ivar Seldinger: catheter introduction on a flexible leader. J Emerg Med. 1990;8(5):635-637. Van de Laar A. Under the Knife. A History of Surgery in 28 Remarkable Operations. St. Martin’s Press; 2018:87.
KCENTRA® (Prothrombin Complex Concentrate [Human]) For Intravenous Use, Lyophilized Powder for Reconstitution Initial U.S. Approval: 2013 BRIEF SUMMARY OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Kcentra safely and effectively. See full prescribing information for Kcentra.
WARNING: ARTERIAL AND VENOUS THROMBOEMBOLIC COMPLICATIONS
Patients being treated with Vitamin K antagonists (VKA) therapy have underlying disease states that predispose them to thromboembolic events. Potential benefits of reversing VKA should be weighed against the potential risks of thromboembolic events, especially in patients with the history of a thromboembolic event. Resumption of anticoagulation should be carefully considered as soon as the risk of thromboembolic events outweighs the risk of acute bleeding. • Both fatal and non-fatal arterial and venous thromboembolic complications have been reported with Kcentra in clinical trials and post marketing surveillance. Monitor patients receiving Kcentra for signs and symptoms of thromboembolic events. • Kcentra was not studied in subjects who had a thromboembolic event, myocardial infarction, disseminated intravascular coagulation, cerebral vascular accident, transient ischemic attack, unstable angina pectoris, or severe peripheral vascular disease within the prior 3 months. Kcentra may not be suitable in patients with thromboembolic events in the prior 3 months.
------------------------------------INDICATIONS AND USAGE----------------------------------
Kcentra, Prothrombin Complex Concentrate (Human), is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with: • acute major bleeding or • need for an urgent surgery/invasive procedure.
-----------------------------DOSAGE AND ADMINISTRATION--------------------------------For intravenous use after reconstitution only.
• Kcentra dosing should be individualized based on the patient’s baseline International Normalized Ratio (INR) value, and body weight. • Administer Vitamin K concurrently to patients receiving Kcentra to maintain factor levels once the effects of Kcentra have diminished. • The safety and effectiveness of repeat dosing have not been established and it is not recommended. • Administer reconstituted Kcentra at a rate of 0.12 mL/kg/min (~3 units/kg/min) up to a maximum rate of 8.4 mL/min (~210 units/min).
Pre-treatment INR 2–< 4 4–6 > 6
Dose* of Kcentra (units† of Factor IX) / kg body weight 25 35 50
Maximum dose‡ (units of Factor IX) Not to exceed 2500 Not to exceed 3500 Not to exceed 5000
* Dosing is based on body weight. Dose based on actual potency is stated on the vial, which will vary from 20 31 Factor IX units/mL after reconstitution. The actual potency for 500 vial ranges from 400-620 units/vial. The actual potency for 1000 unit vial ranges from 800-1240 units/vial. † Units refer to International Units. ‡ Dose is based on body weight up to but not exceeding 100 kg. For patients weighing more than 100 kg, maximum dose should not be exceeded.
---------------------------------DOSAGE FORMS AND STRENGTHS--------------------------
• Kcentra is available as a white or slightly colored lyophilized concentrate in a single-use vial containing coagulation Factors II, VII, IX and X, and antithrombotic Proteins C and S.
--------------------------------------CONTRAINDICATIONS ------------------------------------
Kcentra is contraindicated in patients with: • Known anaphylactic or severe systemic reactions to Kcentra or any components in Kcentra including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin. • Disseminated intravascular coagulation. • Known heparin-induced thrombocytopenia. Kcentra contains heparin.
----------------------------------WARNINGS AND PRECAUTIONS----------------------------
• Hypersensitivity reactions may occur. If necessary, discontinue administration and institute appropriate treatment. • Arterial and venous thromboembolic complications have been reported in patients receiving Kcentra. Monitor patients receiving Kcentra for signs and symptoms of thromboembolic events. Kcentra was not studied in subjects who had a thrombotic or thromboembolic (TE) event within the prior 3 months. Kcentra may not be suitable in patients with thromboembolic events in the prior 3 months. • Kcentra is made from human blood and may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
-----------------------------------ADVERSE REACTIONS----------------------------------------
• The most common adverse reactions (ARs) (frequency 2.8%) observed in subjects receiving Kcentra were headache, nausea/vomiting, hypotension, and anemia. (6) • The most serious ARs were thromboembolic events including stroke, pulmonary embolism, and deep vein thrombosis.
