I S S U E S B A C K G R O U N D E R For information contact: Joni Morford, Communicore 714/721-8081 jmorford@communicore.com INADVERTENT TISSUE INJURY DURING LAPAROSCOPIC MONOPOLAR ELECTROSURGERY Overview During the past two decades, the development of minimally invasive laparoscopic surgery has offered patients and surgeons important benefits such as reduced hospital stays, recovery times, and healthcare costs. The use of monopolar electrosurgery during laparoscopic procedures has played a key role in this surgical revolution. Well-established in open surgery, the monopolar electrosurgical technique has since become the most widely used surgical approach for cutting and coagulation in laparoscopic surgical procedures. It has a wide range of surgical modes, from cutting and blood vessel coagulation (clotting) to surface fulguration (tissue destruction) and vessel coaptation (uniting), and can be used in a broad range of surgical procedures. Highly versatile and cost effective, the monopolar method nevertheless carries an important patient safety risk. Stray radio frequency electrical current beyond the surgeon's field of vision can injure a patient in several ways and cause grave complications. Although the precise scope of the problem is unknown, a number of published studies and clinical case histories suggest that patient injury due to stray electrosurgical energy occurs regularly. The risk of thermal injury to patients also has potential financial implications for the healthcare system at large. When a patient incurs an injury in the operating room, the costs of treatment--including extended hospitalization, pharmaceuticals, and emergency surgery--are high. In addition, the surgeon and hospital may be found liable and could face costly consequences. The nature and extent of this potential problem is currently under-appreciated, and efforts that have been made to prevent its occurrence have largely proven inadequate. In order to better protect patients, surgeons, and hospitals, it is imperative that more effective monitoring and safety measures are instituted wherever monopolar electrosurgery is performed. Increasing Use of Minimally Invasive Surgery In minimally invasive surgery (MIS), the generally long incision and visually large operating field of open surgery is replaced by a small incision and reduction of the visible surgical field. The insertion of optical instruments, such as a laparoscope, into the abdomen through the small incision provides the surgeon with a "keyhole" view of the surgical site. Minimally invasive, or laparoscopic, surgery was first introduced in the early 1970s, when it was used in a select group of gynecological procedures, such as tubal ligation, lysis (destruction) of adhesions, and diagnostic procedures. Over time, it became apparent that laparoscopic procedures offered patients and healthcare institutions attractive benefits: the smaller incisions resulted in less pain, quicker recovery, and minimal scarring; patients experienced a quicker return to work; surgeons were able to view the critical areas of the surgical field with an enhanced, magnified image; surgeons were able to increase patient safety and decrease morbidity by reducing blood loss and adhesions; some surgical procedures could be performed in outpatient clinics; and the overall cost of surgery was reduced as a result of shorter hospital stays. Since approximately 1990, the revolution of minimally invasive surgery has expanded to a wide range of general surgery procedures. Between 1990 and 1994, the annual number of general procedures performed laparoscopically in the United States experienced a dramatic 11-fold increase, from 107,000 to 1,232,000 procedures. Currently, cholecystectomies, appendectomies, hernia repairs, and bowel resections are routinely performed as minimally invasive procedures. According to a survey conducted by the Society of Laparoendoscopic Surgeons in 1993, by the year 2000, 40 percent of urology procedures, 50 percent of general surgery procedures, and 70 percent of gynecology procedures will be performed laparoscopically. Monopolar electrosurgery is only one technique of several used during minimally invasive surgery. It utilizes a radio frequency (RF) electrical energy to cut and coagulate tissue--common steps employed when removing adhesions or cauterizing blood vessels. Its effectiveness in greatly reducing loss of blood during a surgical procedure helps provide a dry surgical site, enabling the surgeon to focus more comfortably on the intricacies of the surgical procedure being performed. The monopolar techniques currently used in operating rooms differ only slightly from the original form of monopolar electrosurgery introduced in open surgical procedures in the 1920s. The technique is described as monopolar because only one electrical pole, the active electrode, is controlled by the surgeon. Largely because of its versatility, it has become a standard technique when performing minimally invasive surgery, and is preferred by surgeons in more than 80 percent of such procedures. Patient Risks Associated with Laparoscopic Electrosurgery While monopolar laparoscopic electrosurgery is the technique of choice for most surgeons performing MIS, radio frequency energy leaking from the shaft of the active electrode that directs current to the surgical site is associated with some risk. In particular, those electrosurgical techniques that require higher levels of electrical voltage also increase the risk that current will leak from the active electrode into surrounding non-targeted tissues, potentially resulting in tissue and organ injury. Many healthcare professionals are unaware of the hazards involved with monopolar laparoscopic electrosurgery, in part because they are not extensively documented. The most common hazard of minimally invasive electrosurgery is the burning of non-targeted tissues and organs outside the surgical site due to stray electrical energy. While the laparoscope provides a detailed view of the surgical site, only about 10 percent of the active electrode--the device that directs energy flow to the surgical site--is visible to the surgeon. In other words, 90 percent of the live electrical energy pathway is not within the surgeon's field of view. The electrode is designed to release electrical energy only within the small area visible through the laparoscope. However, in spite of a layer of insulation covering much of the electrode, stray energy may nevertheless be released in areas outside the surgeon's field of view. The release of stray energy from the active electrode beyond the surgeon's field of view may occur in two ways: insulation failure or capacitive coupling. Long-term degradation or damage to the insulation lining the electrode during activation allows the direct leakage of energy to nearby tissue. Capacitive coupling, the transfer of energy from the active electrode to adjacent conductive materials such as metal instruments or actual tissue through intact insulation, is another well- documented source of electrosurgical injury. This energy release may cause serious tissue burns that can be particularly dangerous when they lead to vessel or organ necrosis (death of portion of organ) and subsequent perforation. Vessel perforation can lead to significant hemorrhaging, while perforation of an organ such as the bowel can lead to peritonitis (inflammation of the membrane lining the abdominal cavity, in this case produced by contamination of the otherwise sterile abdominal cavity). What makes the burns and perforations caused by stray electrical currents so potentially dangerous is that they often go unseen during surgery, occurring as they commonly do beyond the surgeon's field of vision through the laparoscope. When a burn to non-targeted tissue is identified, it is usually because of the presentation of symptoms several days after surgery. If not detected soon enough, the resulting hemorrhaging or peritonitis can result in significant morbidity or even death. For patients fortunate enough to receive effective treatment for laparoscopic electrosurgical complications, the exact cause of the complication may never be determined. As a result, it is difficult to deduce the exact incidence of complications that are a direct result of electrosurgical injury. Scope of the Problem Although documentation of patient injuries associated with monopolar laparoscopic electrosurgery is not extensive, case reports and statistics suggest that the problem is significant. Several studies have been conducted in the past few years, including a survey of surgeons belonging to the American College of Surgeons (ACS) published in 1995 and a statistical analysis of malpractice claims by the Physician Insurers Association of America (PIAA) published in 1994. The survey conducted at the ACS annual meeting in 1993 to investigate electrosurgical complications and surgical techniques during laparoscopy suggests that inadvertent electrosurgical burns are a significant problem. Of the 506 surgeons polled, a majority (52 percent) reported having performed more than 100 laparoscopic electrosurgical procedures. Eighty-six percent of all respondents acknowledged the potential for hazardous complications outside the view of the laparoscope during use of intact, fully insulated monopolar electrosurgical instruments. Eighteen percent of the participating surgeons responded that they had personally experienced complications due to capacitive coupling or insulation failure during laparoscopy, and a majority (54 percent) knew other surgeons who had experienced such complications. The PIAA survey focused directly on patient claims filed as a result of injuries incurred during laparoscopic procedures. While electrosurgery is not specifically identified as the cause of those injuries, it is likely that a substantial portion of the laparoscopic procedures reported involved electrosurgery, since it is the dominant technique for cutting and coagulation in MIS and carries an identified risk for patient injury. A majority of PIAA's medical malpractice insurance member firms in the United States--more than 70 percent--responded to the survey; the survey results are therefore suggestive of a national phenomenon. A total of 615 claims over a four-year period were reported, 331 (54 percent) of which described injuries sustained during laparoscopic cholecystectomies. The most common injuries reported were lacerated, transected, or punctured bile ducts (60 percent). Other injuries documented included laceration of hepatic ducts, laceration or puncture of the bowel and liver, and laceration of arteries and veins. Further surgery was stated to be the most likely treatment for these types of injuries (75 percent). This second surgery was usually performed at a later date, as the injury was not detected during the initial laparoscopic procedure and diagnosis was delayed. For 35 injured patients (11 percent), complications compounded by late diagnosis ultimately resulted in death. Medicolegal and Financial Risks Associated with Laparoscopic Electrosurgery While the study of surgeons at the ACS annual meeting suggests that many surgeons acknowledge that the potential for patient injury during minimally invasive electrosurgery exists, too many surgeons remain unaware of the issue, perhaps because of the relative scarcity of published data documenting the overall incidence of injuries due to laparoscopic electrosurgery. This lack of awareness on the part of surgeons is inevitably reflected in a lack of awareness on the part of hospital administrators, including risk managers. Under such a scenario, the potential for liability and the consequent medicolegal expense is significant. Physician insurance companies have begun to recognize the risk that monopolar laparoscopic electrosurgery poses to patients and surgeons. In the absence of a method to reduce the risk of unintended tissue burns during such procedures, physician insurers must turn to increases in premiums to cover the financial risk of such complications. In response to statistics such as those compiled in the aforementioned studies, some malpractice insurers have increased their rates 15-20 percent for surgeons who perform minimally invasive procedures. For example, it has been reported that in 1995 in Mississippi, annual premiums for laparoscopic surgeons were increased by more than $9,000. Looked at another way, a surgeon who performs one cholecystectomy per week must pay $173 per cholecystectomy to cover his or her insurance; since Medicare pays less than $700 for this procedure, more than 20 percent of the surgeon's reimbursement may go toward insurance. The additional medical costs incurred as a result of electrosurgical complications are significant. Patients who are inadvertently severely burned by stray electrical energy generally return to the hospital after experiencing unexplainable pain or other severe symptomatology. As they commonly require further surgery and other intensive care to deal with these complications, the costs of such care can be significant. Clearly, if appropriate safety mechanisms were instituted, the savings in physical, emotional, and financial terms could be enormous. The increasing number of malpractice claims citing laparoscopic injury prompted the American Trial Lawyers Association in 1994 to form a special Laparoscopic Litigation Group to pool information about, and resources on, liability claims involving laparoscopic surgery. The risk of liability to surgeons who perform minimally invasive electrosurgery--and to hospital administrators who are responsible for procedures and guidelines--is significant and can have a very costly outcome, as exemplified by a recent malpractice case against a Minnesota obstetrician. In this case, the patient claimed that her doctor's negligence resulted in the perforation of her colon while he was cauterizing endometriosis, leading to a severe infection that required her to undergo two colostomies. The plaintiff was awarded $2.8 million for pain, disability, disfigurement, embarrassment, and emotional distress. Past Efforts to Address the Issue of Patient Injury During Electrosurgery The need for surgeons--and hospital administrations--to take the necessary precautions to protect their patients from electrosurgery-related injury and themselves from potential liability claims related to such injuries is obvious. Prior to its incorporation into laparoscopic procedures, monopolar electrosurgery was commonly used in open procedures. Many patients emerged from the operating room with skin burns resulting from poor contact between the patient and the return electrode. The incidence of this problem has been greatly reduced through increased awareness among surgeons and surgical staff of its potential occurrence, improved training to handle it, and the introduction of return electrode monitoring, a technology to monitor the connection between the patient and the return electrode. Nowadays, patients rarely suffer skin burns during open monopolar electrosurgery. The precedent of this good example of effective risk management suggests a similar approach to the inadvertent internal burn potential arising from monopolar electrosurgery during laparoscopic surgery. Certain precautions have been used for some time by surgeons and nurses in an attempt to reduce the incidence of complications associated with the release of stray energy during laparoscopic electrosurgery. These procedures and precautions include specific training of medical and technical personnel, use of all-metal cannulas rather than plastic or hybrid systems, standard visual testing of electrodes for insulation failure, and immediate disposal of single-use electrodes. A variety of technological solutions have also been attempted, including bipolar electrodes, laser energy, and the "harmonic scalpel." Unlike monopolar surgery, bipolar electrosurgery uses an instrument with both electrical poles mounted on its end. The bipolar technique is not as versatile as the monopolar method since it is useful only for desiccation and deep coagulation--newly developed bipolar methods capable of cutting tissue are inefficient, and bipolar instruments cannot supply sufficient voltage for superficial fulguration or management of capillary bleeding. Furthermore, because the two electrodes are on the same instrument, precise placement and greater time are required to control major bleeding. Other cutting and coagulation techniques used in MIS, including laser energy and the rapidly vibrating harmonic scalpel, have not been widely accepted. The capital equipment involved is costly, both techniques require extensive training, and their applications are limited. Neither technique coagulates blood as well as does electrosurgery, and the harmonic scalpel is only truly effective for cutting. A majority of laparoscopic surgeons prefer to use the monopolar technique in MIS because of its clear advantages over alternative modalities. Yet, the risk of internal injury out of view of the laparoscope as a result of electrical energy released from the shaft of the extended electrosurgical instrument continues to call for the adoption of measures that will ensure the safe use of this versatile and widely accepted technique. One procedure proposed by manufacturers of electrosurgical instruments is the use of lower-power settings on the electrosurgical instrument. In some clinical situations, however, high-power surgical modes such as fulguration are essential. Indeed, the risk of patient injury can actually be increased by the use of low-power settings, as the latter tend to be less effective at coagulating. If ineffective coagulation results in uncontrolled bleeding, the surgeon has no alternative other than to return to high-power settings. In this emergency situation, where achieving hemostasis becomes urgent, the opportunity for patients to be injured due to inadvertent surgeon error is inevitably increased. Conclusion Even when safety procedures are followed meticulously, they can only partially reduce the risk. Tissue burns to non-targeted sites are an inherent part of the surgical environment during laparoscopic monopolar electrosurgery. As such, improvements in user skill and training, and protocols to inspect equipment for insulation integrity alone cannot eliminate them. Clearly, a modification of the electrosurgical environment is required, and a technological solution would appear to be appropriate for what is ultimately a technological problem. Ideally, such a technology would completely eliminate the risk of stray electrical energy, and thus completely preclude the opportunity for patient injury from this source. Such a technology--active electrode monitoring--is now available and should be embraced in the interests of patient safety and the economic well-being of surgeons and healthcare delivery organizations alike (see Technology Backgrounder). End of document.