Medicolegal Issues in E n d o s c o p i c Si n u s S u r g e r y and Complications James A. Stankiewicz,

MD*,

Jeffrey Hotaling,

MD

KEYWORDS  Complications  Malpractice  Prevention  Injury  Blindness  Brain injury  Diplopia KEY POINTS  Complications of endoscopic sinus surgery can and do result in medical malpractice suits.  Complications that are treatable and prevent orbit or brain injury are rarely involved in a suit; surgeon communications and documentation are essential with any complication.  Orbital and brain injuries are the most common litigated complications.  Working closely with the defense lawyer is essential.  Expert review using a time expert is very important.

INTRODUCTION

Every endoscopic sinus surgeon should consider preparing a check list of items to check off before, during, and after surgery. This check list, in the same vein as a pilot uses when flying, can ensure better patient care and decrease risk of litigation. This list can be mental or written (print or IT; Box 1. See also the article by Eloy elsewhere in this issue, which provides an overview of complications in endoscopic sinus surgery [ESS]). PREOPERATIVE

The initial history and physical examination presents an excellent opportunity to prepare for a surgery, anticipate needs for the surgery, and plan the procedure recognizing possible increased risks. As part of the history, previous sinus surgery should be noted. Revision surgery is always more problematic given equal disease severity. Any previous complications should be noted. Medical therapy for chronic sinusitis

Division of Rhinology and Sinus Surgery, Department of Otolaryngology-Head and Neck Surgery, Loyola University Medical Center, 2160 South First Avenue, Maywood, IL 60153, USA * Corresponding author. E-mail address: [email protected] Otolaryngol Clin N Am - (2015) -–http://dx.doi.org/10.1016/j.otc.2015.05.014 0030-6665/15/$ – see front matter Ó 2015 Elsevier Inc. All rights reserved.

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Box 1 ESS preoperative, operative, and postoperative check lists ESS Preoperative Check List 1. Review all patient data for problem areas. 2. Review CT scans, checking anatomy. 3. Use endoscope to review anatomy at beginning of surgery. 4. Control bleeding. ESS Operative Check List 1. Use landmarks as a guide for surgery. 2. Know and observe areas of thin bone orbit and medial ethmoid skull base. 3. Control bleeding during surgery. 4. Use an instrument for measurement to know distances; make sure image guidance is properly calibrated. 5. Observe eyes during surgery. 6. Use bulb press test to test for lamina papyracea dehiscence. 7. Use microdebrider carefully adjacent to orbit or skull base. 8. Any sudden bleeding near skull base, suspect cerebrospinal fluid leak. ESS Postoperative Check List 1. Check patient mental status. 2. Observe for any eye or orbital changes or vision loss. 3. Observe for severe headache or clear fluid drainage, nausea, or vomiting. 4. In clinic, ask about clear fluid leakage. Abbreviation: ESS, endoscopic sinus surgery.

and/or polyps should be noted and the success of treatment. Duration of treatment with oral and topical steroids and antibiotics by the surgeon or other treating physicians should be noted. Medical therapy should be noted in an attempt to make sure the patient has used “maximal” medical therapy before undergoing any planned surgery. Smell should be ascertained on a severity scale on and off prednisone or by using scratch and sniff smell testing. All of these assessments should be documented as part of the database necessary to make an informed decision regarding the patient’s need for surgery. Many of these historical points may be critical to the defense of malpractice suits, where indications for surgery or loss of smell are contested. The physical examination, and especially the endoscopic examination, are important from a medicolegal standpoint. The extent of disease can be qualified and quantified, and changes in anatomy identified. Anatomy creating exposure problems needs to be identified. For example, a septal deviation that narrows the surgical field may direct the surgeon too lateral toward the orbit (Fig. 1). This issue has been raised in medicolegal circumstance questioning proper visualization and exposure as a cause of a complication. A middle turbinate that is compromised by disease or associated with a low-lying skull base is hazardous. Anatomy totally distorted or obscured by severe polypoid disease is potentially problematic. Revision surgery with partially or totally missing landmarks is hazardous. This usually comes into play with frontal sinus surgery and altered middle turbinates with scarring or sphenoid sinus surgery.

Medicolegal Issues in ESS

Fig. 1. Endoscopic view showing severe septal deviation, making endoscopic sinus surgery problematic.

Radiologic evaluation is not only important in noting the extent of disease, but it is more important from a medicolegal standpoint to identify anatomic pitfalls. Together with the preoperative endoscopic examination, the surgeon has a great picture of where danger lurks. The article by Zinreich elsewhere in this issue is dedicated to looking into CT changes and measurements important to any sinus surgeon hoping to avoid complications and should be reviewed. Every sinus surgeon should review the actual CT scan before any surgery and have that CT scan present in the operating room for quick reference. Every CT should be checked for skull base or orbital dehiscence, evidence of trauma jeopardizing the skull base or orbit, and ascertaining lowlying skull base involving the cribriform plate, fovea ethmoidalis, or both1 (Figs. 2 and 3). Large vertical maxillary sinus and short vertical ethmoid distances are important to judge ethmoid height. Patients with orbital trauma to the lamina papyrcea with orbital tissue protruding into the ethmoid or the hypoplastic maxillary sinus with the uncinate process contacting the orbit are situations where actual medicolegal proceedings arose out of orbital injury (Fig. 4). There have been several legal cases involving skill base injury where a low skull base was present and not noted by the surgeon radiographically. Even more troublesome is the actual circumstance where a CT

Fig. 2. (A) Orbital tissue in the ethmoid sinus secondary to microdebrider, preoperative image. (B) Orbital tissue in the ethmoid sinus secondary to microdebrider, postoperative image.

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Fig. 3. Low-lying skull base images on CT.

Fig. 4. Hypoplastic left maxillary sinus with uncinate lateralized into the orbit.

Medicolegal Issues in ESS

that showed anatomic variations or abnormalities was not in the operating room during the surgery, and catastrophic brain complications occurred. Refer to the article by Zinreich elsewhere in this article. The use of image guidance has been advocated by some surgeons as the standard of care for ESS. No group or society has advocated officially image guidance as the standard of care. An attempt has been made in a few legal cases to argue that image guidance is the standard of care, but so far unsuccessfully. As far as whether the use of image guidance reduces complications, an excellent paper by Ramakrishnan and colleagues2 shows the risk of complications is the same whether image guidance is used or not. This author has personally had several cerebrospinal fluid (CSF) leaks and the appearance of orbital fat/periorbita occur even though image guidance was used during the surgery. A planned margin using image guidance between the skull base and ethmoid or orbit adds to safe sinus surgery and can offset calibration errors (Fig. 5). It is important that the suction probe be checked when calibrated. Sometimes the initial calibration looks great, but when the probe or suction is attached, a bent or faulty tip may lead to error. Always check against known landmarks. Image guidance is not to be used in a “paint by number” manner, but as confirmation of location and anatomy. Kingdom and Ramakrishnan address image-guided sinus surgery and complications in a separate article elsewhere in this issue for review. Informed consent is almost always contested in medicolegal proceedings unless it is well-documented and signed by the patient. It is important that the patient understand what the treatment options are and participate in the selection of surgery. A review of risks and complications is necessary. Anesthesia risks, vision loss or change (blindness or double vision), CSF leak, brain injury, loss of smell, and hemorrhage are

Fig. 5. Image guidance with planned margin between skull base and ethmoid roof for safety.

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all part of a prudent informed consent form. These complications and others the surgeon would like to discuss should be listed in the clinic note and/or consent with the patient reading and signing the consent. If documentation is not present, it becomes a doctor-versus-patient verbal issue, which is invariably contested. There are several studies documenting tape recorded or video recorded evidence of informed consent with the patient remembering little of the conversation when queried after the discussion.3 Documentation is essential. A question is often raised about just how in depth complications should be discussed. Should only complications occurring >1% of the time be discussed? If that were the case, in ESS, we would have no risks or complications to discuss. However, because ESS occurs adjacent to the orbit and brain, it would be prudent to discuss the risks of orbital or brain injury. Interestingly, complications from general anesthesia also include orbital and brain injury. Although very rare, these injuries are usually not discussed unless directly related to the surgery performed. Another medicolegal issue related to nose and sinus surgery which has occurred is blindness owing to injection of lidocaine (Xylocaine) and epinephrine during septoplasty, turbinate surgery, and sinus surgery. This complication is extremely rare and occurs through no fault of the surgeon in most cases. Blindness occurring from an injection of lidocaine with epinephrine is not discussed by most surgeons, which includes any surgeon, namely, plastic, eye, general, oral, neurosurgeon, dermatologist, and so on, owing to the rarity of the occurrence and lack of general knowledge in the literature on the subject. Some surgeons often inject nasal polyps with steroids. Blindness has occurred with these injections. The use of a low particle steroid like triamcinolone acetonide (Kenalog) is recommended to avoid this complication (see also the articles by Poetker and Smith, and Martin and Patadia on complications of medical therapy and rare complications of ESS, elsewhere in this issue). OPERATIVE MEDICOLEGAL CONCERNS

The most common (in reality uncommon) complications during surgery of medicolegal concern are related to orbital or brain complications. The most commonly litigated complications are double vision, blindness, CSF leak with meningitis, and brain injury. The same issues that cause problems in all surgery—exposure, bleeding, and visualization—are at play in ESS. Obstruction related to a marked septal deviation or severe disease might lead the surgeon directly toward the eye or skull base whereupon orbital tissue or brain is entered (see Fig. 1). To ensure visualization and exposure, a septoplasty or preliminary polypectomy may be necessary so that landmarks are uncovered and viewed endoscopically. Bleeding control is essential or visualization is impaired. The use of cautery, pledgets, injections of lidocaine with epinephrine, and anesthesia techniques to lower blood pressure are all important (see the article by Woodard elsewhere in this issue). Developing a repeatable approach to the sinuses is very useful. Going back posteriorly and low in the ethmoid and coming anterior and high in the ethmoid is an example of a repeatable approach. In any approach selected, identifying landmarks step by step is important. Understanding the walls (lamella) of the ethmoid sinuses and knowing distances to each lamella is a good and safe way to approach the ethmoid (Fig. 6). It is important that the lamina papyracea be identified early on in ESS so that it is not damaged or penetrated. The easiest way to identify the lamina is to note that the superior rim of the antrostomy is the lamina papyracea and laterally is the floor of the orbit. Great care has to be taken when creating the antrostomy. A backward biting instrument in the antrostomy can bite into the vertical maxillary line, which just laterally

Medicolegal Issues in ESS

Fig. 6. Distance measurements in ethmoid sinus. (From Stankiewicz JA. Complications of endoscopic sinus surgery. Otolaryngol Clin North Am 1989;22:749–58; with permission.)

encases the nasolacrimal duct, a very common injury in the early days of ESS.4 Changes in the operative approach to the uncinate process and antrostomy have lessened nasolacrimal duct injury. Originally, the uncinate process was removed via an anterior incision at the uncinate process insertion into the maxillary line. The vertical incision was made with a sickle knife or elevator. Occasionally, surgeons immediately entered the orbit with this incision and were unaware. Orbital injury occurred right at the beginning of sinus surgery. Once the incision was made, a backward biter placed in the anterior antrostomy was used to open the antrostomy anteriorly coming across the duct. Today, the uncinate is incised with a backward biter entering into the hiatus semilunaris. The antrostomy is dilated and opened posteriorly. It is the biting anteriorly in the antrostomy that injures the nasolacrimal duct. The location where the medial rectus is most commonly injured is found at the level of the vertical basal lamella, where it joins the lamina papyracea 5 cm from the nasal spine. At that point, the medial rectus muscle essentially sits on the orbital side of the lamina (Fig. 7). Any created or existing dehiscence of bone exposes periorbita and medial rectus. Optic nerve injury occurs most commonly owing to entrance into the orbit causing hemorrhage (orbital hematoma) or direct injury. It is very rare to injure the optic nerve in an Onodi suprasphenoid cell or in the sphenoid sinus at the optic chiasm, even though the optic nerve is dehiscent in 5% to 20% of patients. The optic nerve has been injured by bone chips or fragments pushed into the nerve, cautery, or direct injury. The best way to determine the integrity of the lamina papyracea is the bulb press test first described in 1987 by Stankiewicz and associates.5 The lamina papyracea is observed with the endoscope while simultaneously palpating or pressing on the eye globe (Fig. 8). The slightest crack or dehiscence in the lamina papyracea will show movement. Orbital fat is yellow and shiny. Looking closely, fat goblets are noted. A problem for any surgeon and the patient is to not recognize orbital fat and keep removing tissue into the orbit, including nerve and muscle, which has happened. Another point related to potential orbital muscle injury is to make sure the bulb press test is used before removing or biopsying anything close to the orbit. A medicolegal situation occurred where a biopsy was taken of orbital tissue that did not seem to

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Fig. 7. Medial rectus on axial view touching the lamina papyracea at the basal lamella.

be fat. The biopsy was placed in saline, noting that fat floats—the “fat floats” test. The tissue sank and the surgeon felt comfortable with the biopsy. However, a bulb press test was then performed and orbital tissue moved in the biopsy area. After the operation, the patient had a medial rectus palsy and pathology showed the tissue biopsied to be muscle. The most common orbital injury in medicolegal cases today is the use of the microdebrider against a lamina papyracea dehiscence (Fig. 9). The periorbita is pulled into the ethmoid and fat and muscle is removed or eye muscle is traumatized. The microdebrider has also been placed in the orbit with devastating results (see the article by Lal on orbital injury, elsewhere in this issue). The most common reason the carotid artery is injured is a mistake in distance location by the surgeon. The average distance to the anterior wall of the sphenoid sinus is 7 cm from the nasal spine.3 Without measurement, sometimes the surgeon is actually in the sphenoid sinus when they think they are in the posterior ethmoid sinus. In this scenario, the surgeon, thinking he is in the posterior ethmoid, opens the “front” wall

Fig. 8. (A) Bulb press test maneuver: pressing the globe while looking at the lamina papyracea endoscopically. (B) Bulb press test maneuver. (From [A] Stankiewicz JA. Endoscopic sinus surgery: primary. In: Flint PW, Haughey BH, Lund VJ, et al, editors. Cummings otolaryngology-head and neck surgery. 5th edition. Philadelphia: Mosby/Elsevier; 2010. p. 750, with permission; and [B] Stankiewicz JA. Complications of endoscopic sinus surgery. Otolaryngol Clin North Am 1989;22:749–58, with permission.)

Medicolegal Issues in ESS

Fig. 9. Orbit microdebrider injury scenario. (A) Microdebider in ethmoid sinus touching lamina papyracea. (B) Lamina papyracea perforation is created with microdebrider. (C) Periorbita, Medial rectus muscle and fat sitting on the eye side of the lamina are pulled by the microdebrider suction into the ethmoid sinus. (D) The medial rectus muscle is transected and fat removed by the microdebrider in the ethmoid sinus. (From Bhatti MT, Giannoni CM, Raynor E, et al. Ocular motility complications after endoscopic sinus surgery with powered cutting instruments. Otolaryngol Head Neck Surg 2001;125:501–9; with permission.)

of the sphenoid only to be greeted by a torrent of bleeding from the internal carotid. The carotid artery is dehiscent like the optic nerve in 5% to 20% of patients. Other mechanisms of injury reported are the removal of a sphenoid septa that is connected to the carotid canal or biopsying/removing tissue in the sphenoid adjacent to where a carotid dehiscence is present. Removing tissue posterior and laterally in the sphenoid is fraught with hazard and should be done very carefully or just simply not done (see Fig. 9) (The article by Woodard expounds on sphenoid carotid injury and management, elsewhere in this issue). The skull base is set by the identification of the sphenoid sinus. The lateral fovea ethmoidalis, which is the roof of the ethmoid sinus, is 10 times thicker than the medial fovea ethmoidalis. This contacts the lateral lamella of the middle turbinate on the ethmoid sinus side. The area of thinned skull base runs in a line from the frontal ostia medially to the sphenoid sinus. This line of weakened bone is the most common area for a CSF leak to occur. If you add a low-lying skull base as determined by CT, the skull base for this circumstance has been described as an “invitation to disaster.”6 A potential medicolegal situation is created by operating too high and medial in a low-lying ethmoid sinus in a nasal polyp case. The skull base is entered, a CSF leak occurs,

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or, worse, brain tissue is removed thinking that tissue is polyp tissue. If a microdebrider is used, remarkable brain injury has occurred. This includes frontal lobe injury, cerebral artery injuries, brain hemorrhage, CSF leaks, and meningitis. Two article elsewhere in this issue deal with orbital and brain complications and their management (see the articles by Lal and Welch). POSTOPERATIVE MEDICOLEGAL ISSUES

If, in the operating room, as the patient is moved to recovery, any subjective or objective change in the patient’s status requires evaluation. Is the eyelid swollen? Is ecchymosis present? Is the patient’s mental status of question? All need attention and documentation. Do the nurses in the recovery room know what to look for in the postoperative sinus surgery patient, that is, changes in vision, eye swelling, bleeding, mental status change, and clear fluid dripping from the nose? Often, the surgeon leaves the recovery room and is unavailable. If anything untoward occurs in the recovery room, the surgeon needs to act on the information provided, which may require coming back to the recovery room to evaluate the patient. Documentation is very important from both the nurse and the surgeon, giving an account of the problem and the solution. Any time orbital fat is noted in surgery, special observation of the eyes in the recovery room looking for orbital hematoma is necessary. The nursing staff should be advised about what to look for. Likewise, any question of skull base dehiscence needs observation for a CSF leak, headache, or mental status change. The operative report is best dictated within 24 hours of surgery documenting any intraoperative or immediate postoperative problems. Notes written several days or weeks after a patient complication event often become a medicolegal and hospital bylaws issue. Once the patient leaves the recovery room for home, the surgeon and the surgeon’s office staff have to be alert to any phone calls indicating a possible complication: increased bleeding, excruciating headache, mental status change, orbit/eye swelling or vision change. The surgeon needs to respond with a plan. Office staff needs to alert the surgeon about any potential complication event. There are medicolegal issues that have occurred over all the listed situations and the failure to respond or a delayed response to a patient or family call. Once in the clinic postoperatively, the surgeon needs to ask appropriate questions about potential complications, especially if there are concerns from surgery about the orbit or skull base. Packing in place can tamponade and mask a CSF leak. If during debridement or on endoscopic examination clear fluid is noted, a workup for a CSF leak is in order. Initial eye swelling from surgery where orbital fat was noted may mask a complaint of double vision. If double vision is a complaint and confirmed on examination, an ophthalmologist needs to be consulted for diagnosis and therapy recommendations. Emergently, however, in the operating room or in the recovery room where an orbital hematoma causes a compromise in vision, an ophthalmologist is usually not available. The surgeon needs to decompress the orbit if vision loss or high orbital pressure persists and one cannot wait for the eye specialist to arrive. Quick action is essential. There is no reason to delay treatment by sending the patient for a CT or MRI. That just makes matters worse and may lead to blindness, which has occurred. Again, timing in this circumstance is essential to save vision. Injury to vision can occur in as little as 15 to 30 minutes. At all times postoperatively, communication with the family and patient is important, and these discussions must be documented. If the complication progresses to a medicolegal issue, documentation is vital to the surgeon’s case. Do not change records or act in a dishonest way. Truth is important.

Medicolegal Issues in ESS

The sending or not sending of pathology for surgical pathology review is rarely an issue in a medicolegal case, unless tumor diagnosis is a problem. In most cases of chronic rhinosinusitis, the sending of tissue for pathology may be unnecessary.7,8 SUMMARY

Complications of ESS can and do result in medical malpractice suits. Complications that are treatable and prevent orbit or brain injury are rarely involved in a suit. Surgeon communications and documentation are essential with any complication. Orbital and brain injuries are the most common litigated complications. Working closely with the defense lawyer is essential. Expert review using a time expert is very important. REFERENCES

1. Myers RM, Valvisorri G. Interpretation of anatomic variations of computed tomography scans of the sinuses: a surgeon’s perspective. Laryngoscope 1998;108(3): 422–5. 2. Ramakrishnan VR, Kingdom TT, Nayak JV, et al. Nationwide incidence of major complication in endoscopic sinus surgery. Int Forum Allergy Rhinol 2012;2(1): 34–9. 3. Cherla DV, Sanghvi S, Choudhry OJ, et al. Readability assessment of interestbased patient materials related to ESS. Laryngoscope 2012;122:1649–59. 4. Bolger WE, Parson DE, Mair EA, et al. Lacrimal drainage system injury in functional endoscopic sinus surgery. Arch Otolaryngol Head Neck Surg 1992;118(11): 1979–84. 5. Stankiewicz J, Lal D, Welch K, et al. Complications in endoscopic sinus surgery: a 25 year Experience. Laryngoscope 2011;121:2684–701. 6. Stankiewicz JA, Chow JM. The low skull base: an invitation to disaster. Am J Rhinol 2004;18:35–40. 7. Romashko A, Stankiewicz J. Routine histopathology in endoscopic sinus surgery: is it necessary? Otolaryngol Head Neck Surg 2005;132:407–12. 8. Yeh D, Wong J, Hoffman S, et al. The utility of routine polyp histopathology after endoscopic sinus surgery. Int Forum Allergy Rhinol 2014;4(11):926–30.

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Medicolegal Issues in Endoscopic Sinus Surgery and Complications.

Complications occur during and after endoscopic sinus surgery. Complications leading to temporary or most commonly permanent injury often are involved...
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