Hemostatic Agents Illustrate Cost-Savings
Severe or excessive patient bleeding is one of the most common problems or complications experienced by OR personnel during surgery. It’s estimated that major bleeding occurs in anywhere from one-third to two-thirds of all open procedures.
The patient repercussions of severe bleeding can be severe – including, in a worst-case scenario, patient death. In fact, uncontrolled bleeding can raise the patient mortality rate up to 20 percent.
There’s also a financial cost to excessive bleeding and related complications, since they are associated with increased hospital utilization, extended surgery time and extended hospital stays.
Every Surgery is Impacted
“Bleeding control is a variable that impacts every surgery in every discipline in the operating room,” says Simona Buergi, vice president of sales and marketing for Tricol Biomedical Inc.
“Bleeding control occupies a significant share of a surgeon’s mind and time,” adds Dr. Terry Norchi, the CEO of Arch Therapeutics. Norchi points out other problems and complications related to excessive bleeding.
“Bleeding during surgical procedures puts extra stress on the patient’s organs, which can lead to other problems,” he says. “Also, when patients bleed significantly during surgical procedures, the visual field can become compromised for surgeons, which can increase the risk of error.”
There is an increased risk of bleeding for patients on antithrombotics (or blood thinners), Norchi adds.
Almost half of patients using over-the-counter blood thinner products do not inform their doctors, he notes.
“So, surgeons and patients are often faced with a difficult dilemma,” says Norchi. “Should the antithrombotic drug be stopped before the procedure? This challenge seems to be increasing given the significant increase in the use of antithrombotic drugs, including direct oral anticoagulants.”
Margaret A. Camp, RN, BSN, MSN, Division Director of Clinical Education for Healthone in Denver, Colorado, notes that the increase in the number of minimally invasive procedures in the OR and other clinical areas has also led to more problems and complications due to severe bleeding.
“In this scenario, traditional techniques like using pressure, sutures or cautery can’t be used,” she explains.
Patient factors can also contribute to the increased risk of surgical bleeding, says Dr. Richard Kocharian, Franchise Medical Director for Ethicon.
“Many elderly patients are on chronic antiplatelet and anticoagulant therapies and have a growing number of comorbidities like obesity, diabetes and chronic cardiovascular and liver disease,” he says. “These are all associated with an increased risk of surgical bleeding by adversely affecting the body’s natural clotting process.”
Due to the wide range of different types of bleeding scenarios, there is a variety of different methods that can be used to control bleeding during surgery, or hemostasis. These include conventional methods like clips, clamps, sutures, ties and electro-cautery, which can be effective in the right situations.
“However, these primary approaches often are not enough to control bleeding efficiently,” says Kocharian. “In these situations, adjunctive hemostats can help control bleeding and minimize blood loss.”
“For example, adjunctive hemostats are advantageous when bleeding is difficult to access or tissue topography is uneven, or when the surgeon wants to limit char and necrosis from simple energy devices,” Kocharian adds. “In these cases, using an adjunctive hemostat in addition to primary methods can result in faster time to complete hemostasis.”
Norchi points out that many of the tools surgeons use to stop bleeding can result in their own challenges.
“These include the risk of damaging vital structures when energy-based devices like cautery are used to achieve hemostasis,” he says.
“There is also a host of risks associated with the use of many hemostatic agents that are commonly, although not necessarily accurately, called biomaterials,” Norchi adds. These hemostatic agents include gelatin, collagen, cellulose, polymers, thrombin and fibrin sealants.
One of the biggest problems with using hemostatic agents to stop bleeding during surgery is that they are often unreliable, slow to work, and difficult to prepare or use, says Norchi.
“Many of them are known to be associated with a risk of foreign body reactions, infections, granuloma formation, inflammatory responses or adhesions in recipient patients,” he says. “And their efficacy is often challenged if a patient is taking an antithrombotic drug or does not have an intact clotting cascade.”
Also, certain agents sourced from animals have been reported to cause a potentially fatal immune response in some patients. Or they conflict with the religious beliefs and practices of some patients, says Norchi.
The good news on the hemostasis front is that technological advances are being made to address critical hemostasis needs in various surgical bleeding situations. One example of this is the EVARREST Fibrin Sealant Patch, which was developed by Ethicon.
“EVARREST is a unique, bioabsorbable adjunctive hemostat that drives durable clot formation by augmenting the human coagulation system,” explains Kocharian. “It’s an innovative product that stops problematic bleeding on the first attempt in indicated patients.”
According to Kocharian, clinical studies have demonstrated that EVARREST is greater than 94 percent effective in controlling bleeding across challenging patient types and surgical situations in soft tissue and adult liver bleeding when compared to the current standard of care for that time point.
Camp says that she is aware of positive clinical outcomes using EVARREST to achieve hemostasis in surgical bleeding situations.
“In my experience, it works quickly and is an effective and non-invasive way to control hemostatic events,” Camp says.
“Using the right product at the right time allows surgeons to control surgical bleeding efficiently,” Kocharian adds. “The optimal use of available hemostatic options may lead to significant cost savings for controlled surgical bleeding.”
Tricol Biomedical manufactures the GuardaCareXR Surgical temporary surgical hemostats. Buergi says these hemostats have the proven ability to control all levels of bleeding minutes, from oozing nuisance bleeding all the way to severe arterial bleeding in.
This technology utilizes Chitosan, which offers the ability to control bleeding independently of the clotting cascade, says Buergi.
“This means that it does not rely on the patient’s coagulation cascade to achieve a clot,” she explains.
Arch Therapeutics also manufactures products designed to stop surgical bleeding and control leaking.
“These products are made of peptides, which in turn are made up of amino acids,” explains Norchi. “What differentiates our technology from traditional peptides is that our peptides self-assemble – hence, the name self-assembling peptides, or SAP.”
He says that Arch Therapeutics’ primary product candidate, AC5 Surgical Hemostatic Device, is being designed to achieve hemostasis.
“When applied as a liquid or spray to a wound, AC5 locally self-assembles (or builds itself) into a nanofiber structure that provides a physical barrier on the tissue,” he explains. “This mechanically seals the wound in order to stop substances like blood from leaking.”
In tests, Norchi says that AC5 has demonstrated rapid average time to hemostasis when applied to a variety of animal tissues.
“Many of these tests have shown a time to hemostasis of under 15 to 30 seconds when AC5 was applied to bleeding wounds,” he says.
Norchi says that a human trial for AC5 is now underway as the company continues toward commercialization. The company expects to announce data and anticipates a CE Mark filing this summer.
“Controlling bleeding reliably saves procedural times and reduces blood loss, which ultimately improves patient safety and outcomes,” says Buergi.