Are Patients Who Chose Premium IOLs a Malpractice Risk?

By Anne M. Menke, RN, PhD

OMIC Risk Manager

Digest, Summer 2011

To view the tables referred to n this article, go to: http://www.omic.com/new/digest/Digest_2011Summer.pdf

Staff in OMIC ‘s Claims and Risk Management Departments field a significant number of calls from ophthalmologists about “premium” intraocular lenses (PIOLs), the name given to those IOLs for which patients are asked to pay extra. Questions range from whether physicians need to inform patients of the availability of PIOLs during the informed consent discussion to whether refunding the extra fees paid for them is an admission of liability. To determine if implantation of PIOLs has led to lawsuits, we conducted our first claims analysis of these lenses.

Thirty-four plaintiffs filed claims involving 47 PIOL implants against 40 OMIC-insured defendants. Thirty-five of these defendants were ophthalmologists, four were associated but separately-insured ophthalmology practices, and one was a separately-insured ambulatory surgery center. Forty-four of the PIOLs were implanted during cataract surgery and three during refractive lens exchange. We compared PIOL claims to cataract and refractive surgery claims; the former share the same procedure and the latter presumably have similar refractive goals and payment issues. Graph 1 on page 4 shows the number and type of PIOLs implanted, while Graph 2 gives the percentage of open, closed, and total claims for PIOL, cataract, and refractive claims. PIOL claims are still very infrequent and there are more open than closed claims, but it is too soon to predict whether claims from these relatively new devices will increase over time.

Many malpractice claims are dropped before a lawsuit is even filed and most close without any money being paid to the plaintiff. Table 1 on page 5 provides three more severity indicators: the median (middle), mean (average), and highest payments for PIOL, cataract, and refractive claims compared to all OMIC claim payments. Premium IOLs have the smallest percentage of claims that close with an indemnity payment, as well as the lowest median, mean, and high payments. In OMIC’s experience to date, PIOL claims are considered very low frequency/very low severity, while cataract claims are high frequency/moderate severity, and refractive surgery claims are low frequency/moderate severity. OMIC does not have data on the prevalence of use of PIOLs, so we cannot draw any conclusions about the relative risk of premium versus monofocal IOLs.

Premium IOL Causation Analysis

OMIC has developed a method of analyzing the primary driving force behind malpractice claims against ophthalmologists. In this analysis, which we call CPSP, we look at four factors: clinical, physician, system, and patient. Clinical issues are areas of controversy or of limits in knowledge or diagnostic/treatment modalities. They are identified during the investigation of a claim and derived in part from the opinions of physician expert witnesses. System issues cannot be attributed to a single individual; instead these are processes in which many individuals and entities are involved. Table 2 shows the primary and secondary causes of claims for premium IOLs in open and closed claims brought by 34 plaintiffs. System issues predominate; patient factors contribute about half as often, followed by clinical and physician ones. While physicians are the least likely contributor to claims against them, there is still much they can do to protect themselves starting with a review of the four contributing factors.

Candidacy issues emerged as the primary clinical issue: experts opined that the appropriateness of premium IOLs was not adequately evaluated for patients with multiple sclerosis, glaucoma, dry eye disease, posterior vitreous detachments, and monfocal IOLs in the fellow eye. Issues frequently seen in monofocal IOL cases were also found, such as when surgery is indicated, how long patients who wore contact lenses must be out of them before the IOL is chosen, and how to determine the dominant eye for monovision.

Experts pointed to faulty physician judgment as the most frequent way that ophthalmologists contribute to claims. An ophthalmologist was criticized by both plaintiff and defense experts for leaving an IOL whose haptic broke during surgery in the patient’s eye, since the defect could lead to the decentration issues the patient later encountered (this elderly patient did not pursue the claim). Plaintiff and some defense experts felt that repositioning a dislocated IOL five times caused the retinal detachment the patient developed (the case settled for $215,000, of which OMIC paid $122,500).

Six system issues were identified (followed by the number of resulting claims): communication among team members (2), the diagnostic process (2), documentation (5), equipment (3), informed consent (20), the litigation process (4), and sterilization (1). Issues are presented for open and closed claims, but specific case examples are only provided for closed claims.

Communication breakdowns are more likely to occur when many physicians are involved in care, and when there are frequent patient hand-offs from one provider to another or from one setting to another. “Wrong” IOL and “wrong” patient errors are the most common examples of these communication breakdowns in ophthalmology, and one case occurred in this series. The ophthalmologist had correctly chosen and ordered the PIOL, but no one on the team had noticed that it was not in the OR. When the physician asked for it, he indicated the correct power but not that it was a PIOL. With the patient’s permission, he immediately exchanged the IOL, and he and the ASC performed the exchange at no charge to the patient (the suit settled for $15,000 on behalf of the physician; the ASC refused to contribute and blamed the physician for the mishap).

The diagnostic process is one of the most complex tasks physicians perform. Certain scenarios frequently lead to allegations of delay in diagnosis, as is the case for some open claims in which multiple providers and specialties tried to find the cause of non-specific symptoms, such as headache or decreased visual acuity.

Documentation issues included omissions and additions. Experts criticized ophthalmologists’ failure to document the specifics of the informed consent discussion, the process of aligning toric IOLs during surgery, and to note complications that occurred during surgery in the operative report. They questioned the accuracy of the medical record when physicians relied heavily upon templates, when scribes documented too uniformly at each visit, and when electronic medical record systems did not individualize the content for each specific patient or visit.

Equipment problems were the primary factor in two PIOL claims. A defective plunger caused a capsular rupture and prevented the ophthalmologist from implanting a Crystalens. The surgeon documented the equipment problem, disclosed it to the patient, reported it to the hospital and the manufacturer, and offered subsequent care at no cost (the plaintiff dropped the suit). A registered nurse who had no prior experience with phacoemulsification equipment caused a corneal abrasion (the non-OMIC ASC settled the case; the physician was dismissed).

An allegation of lack of informed consent accompanies many malpractice claims but rarely turns out to be the pivotal factor. PIOL claims proved to be an exception to this trend, as informed consent issues were the primary factor in eleven cases, and a secondary factor in nine. We concluded that an inadequate informed consent process was the single most important driver of PIOL malpractice claims. See Hotline article for recommendations on how to improve the consent process.

The litigation process itself was the primary factor in three claims and a secondary factor in one. In some cases, expert witnesses appeared to act as an advocate for the attorney who hired them rather than as neutral experts who explain the medicine. One physician accepted a referral from the plaintiff attorney and agreed to examine and treat a patient who was not satisfied with the quality of her vision provided by her Crystalens implant. The plaintiff expert testified at trial that the defendant ophthalmologist had erroneously placed the IOL in the sulcus, despite documented exams by three prior ophthalmologists that the IOL was in the capsular bag (the jury returned a defense verdict). In another case, the plaintiff expert did not carefully review the medical records provided by the plaintiff attorney and certified that the care was substandard; when challenged by the defense attorney during his deposition, the plaintiff expert acknowledged that far from substantiating his criticisms, the medical record demonstrated that the ophthalmologist had met the standard of care (a motion for summary judgment was granted).

Defense expert witnesses can also surprise the attorneys who hire them. A patient in her forties with preoperative visual acuity of 20/40 was offered cataract surgery with a PIOL. The plaintiff expert felt a more careful preoperative exam would have noted a posterior vitreous detachment, which he believed led to an inferior retinal tear. The defense expert was initially supportive and noted that the tear did not impact the patient’s vision. Only during deposition did the defendant and defense attorney learn that their expert was critical of the failure to perform glare testing before recommending cataract surgery (the timing of this reversal of opinion led to a $45,000 settlement).

Patient factors played an important role in PIOL claims, second only to system issues. Accepting an unsatis- factory outcome requires more resiliency than some patients possess or can develop; mental health issues thus were a primary cause in three and a secondary cause in seven claims. One patient had bilateral Crystalens implants but was not satisfied with the quality of her distance vision, so she asked that her distance vision be improved with LASIK at the cost of near vision. Although she acknowledged the need for glasses before she had the refractive procedure, she nonetheless filed a claim and wrote to the medical board when she then had to wear the glasses (the claim was dismissed, and the medical board supported the care). The feeling that the ophthalmologist “must have been done something wrong” was strongest in patients who developed a cascade of complications requiring multiple office visits, medications, consultations, and procedures. A patient with a long eye and a history of prior LASIK surgery experienced a ruptured capsule during surgery to implant a ReSTOR lens; postoperatively, she had a hyperopic surprise and developed bullous keratopathy. Not surprisingly, she was unhappy when her final visual acuity after an IOL exchange and DSAEK was only 20/80 (there was strong defense support for the care and the statute of limitations had expired; the defense motion for summary judgment was granted and the case was dismissed).

As specialists who develop and incorporate new technology at a rapid pace, all ophthalmologists can learn from this early report on malpractice claims related to premium IOLs and implement measures to ensure that patients are carefully selected as candidates for the latest advances and are fully engaged in the decision and care process. The AAO recently published a Focal Points module on MFIOLs and AIOLs in which authors Steven I. Rosenfeld, MD, and Terrence P. O’Brien, MD, provide a systematic approach to determining the cause of the patient’s complaint and how to best address it.1

1. “The Dissatisfied Presbyopia-Correcting IOL Patient.” Focal Points: Clinical Modules for Ophthalmologists. American Academy of Ophthalmology, September 2011.

Inform Cataract Patients of Anesthesia Risks

By Monica L. Monica, MD, PhD, and Daniel A. Long, MD

Argus, May, 1994

When informing patients about the risks and benefits of cataract surgery, the ophthalmologist should also discuss the type of anesthesia that will be used and its potential problems. Risks and complications may occur with either local or general anesthesia. This article will address the concerns of patients and ophthalmologists with regard to local anesthesia, including seventh nerve akinesia.

The federal mandate of 1986 requiring that all Medicare-reimbursed cataract surgery be done in an outpatient setting prompted ophthalmologists to seek anesthesia that would allow a safe and rapid recovery after surgery. Less invasive techniques such as the use of topical rather than injected anesthetic agents became desirable in short-stay facilities where early ambulation is required.

Currently, most cataract surgery is performed under local anesthesia and involves one or more of the following: retrobulbar anesthesia, peribulbar block or topical anesthesia.

Retrobulbar Anesthesia

Retrobulbar anesthesia has been routinely used for cataract surgery for many years. It affords a complete loss of orbital sensation, an eye that remains immobile throughout the operative procedure, and postoperative pain control lasting up to several hours. When securing preoperative consent, the ophthalmologist must communicate to the patient the risks of retrobulbar injections, including orbital hemorrhage, perforation of the globe and damage to the optic nerve. Rather than surprise a patient on the day of surgery, tell the patient in advance that surgery may have to be canceled and rescheduled if a complication such as a retrobulbar hemorrhage occurs.

As part of the informed consent process, ophthalmologists warn patients of possible loss of vision or blindness following cataract surgery. This warning is particularly significant should an anesthetic agent be inadvertently injected into the optic nerve sheath, or if the circulation to the optic nerve and retina is compromised from an injection that injures the ophthalmic artery.

Peribulbar Block

A peribulbar block, an alternative to retrobulbar anesthesia, offers the advantages of less pain from injection and no loss of vision in the immediate postoperative period. But it requires a longer waiting period for the anesthetic agent to take effect and a possible ecchymosis of the skin of the eyelid. Penetration of the globe has been known to occur with the use of small-bore sharp disposable needles.

Topical Anesthesia

Recently, ophthalmologists have been returning to a technique that was popularized during the early 1900s the use of topical anesthetic agents, employed particularly when the surgical incision is being made through clear cornea. Agents of choice are proparacaine or tetracaine. Tetracaine penetrates deeper into the cornea and is less toxic on the corneal epithelium. Both agents allow a rapid recovery and avoid the risks associated with injecting anesthetics around or behind the globe. The disadvantages of topical anesthetic agents include a less profound anesthesia (such as when agents like Miochol are used for myosis after the IOL is placed), an eye that may move at an inappropriate time, and possible sensitivity to the medication.

The authors have used topical anesthesia for clear cornea cataract surgery in more than 300 cases and have followed the patients for up to one year. In addition to avoiding the risks associated with injections, patients need little, if any, medication for preoperative sedation. They are alert before, during and after the procedure, and are immediately ambulatory and able to leave the surgery area. Good communication is essential when topical anesthesia is used for cataract surgery. The ophthalmologist must give the patient thorough preoperative instructions, including:

They will be fully awake throughout the procedure and will be expected to communicate with the surgeon about any anxiety or discomfort they feel.

They may be required to move their eyes as directed by the surgeon or to keep it still and focused on a light throughout the surgery.

If necessary, the surgeon may give them a sedative during the procedure and the type of anesthesia used may change if the need arises.

Seventh Nerve Akinesia

Regional blocks of the seventh nerve often are used prior to cataract surgery. Patients should be forewarned of complications that may occur, most of which are not severe. If a Van Lint block is used, the authors believe that it should be done prior to the retrobulbar block to avoid the possibility of penetrating the globe in case the retrobulbar injection proptoses the eye. With Atkinson akinesia, care must be taken because hemorrhage from the superficial temporal blood vessels may occur when the injection is made along the zygomatic arch.

The O’Brien method blocks the facial nerve over the condyle of the mandible but, due to anatomic variations, sometimes does not accomplish complete akinesia. The Spaeth modification of the O’Brien technique is often more successful since it catches the nerve at the edge of the mandible before it divides into its branches.

Finally, the Nadbeth technique blocks the facial nerve after its emergence from the stylomastoid foramen. It is successful and easy to perform but occasionally leaves patients with a bitter taste in their mouths, something that should be mentioned prior to surgery. A few patients have reported dysphoria as well as swallowing and respiratory difficulties following Nadbeth blocks. Thin patients are more prone to complications. A long needle with a deep injection and the use of hyaluronidase should be avoided when injecting at the stylomastoid foramen.

Just as anesthesiologists are expected to communicate the risks of standby or general anesthesia to patients prior to cataract surgery, the operating surgeon is responsible for discussing and reviewing aspects of local anesthesia before surgery. An informed patient is more cooperative and suffers less anxiety before, during and after surgery.

Medicolegal Hazards of Local Anesthesia

By Jerome W. Bettman Sr., MD

Argus, April, 1996

Ophthalmologists usually associate retrobulbar injections with adverse claims arising from administration of local anesthesia. While more claims arise after retrobulbar injections than after other types of local anesthesia, these cases can be successfully defended.

Retrobulbar Injections

The hazards associated with retrobulbar injections are well known to ophthalmologists: penetration of the globe, optic atrophy, orbital hemorrhage, external ocular muscle palsies and, rarely, problems associated with injecting the fluid into the optic nerve sheath, which may result in respiratory arrest or a cavernous sinus syndrome.

Retrobulbar cases often are successfully defended in court because the defense experts can demonstrate for the jurors that the surgeon cannot see the needle tip, but can only attempt to judge its position based on the angle the luer is held and the depth of the injection. Jurors can be instructed that the orbits, the position of the globe, and the length of the eyeball vary from person to person, and that it is difficult to know the location of the needle tip at all times.

It also can be demonstrated that ophthalmologists cannot depend completely on their sense of touch because the sclera may be softer than usual and the tissues around the eye may deviate from what a surgeon normally expects. Given these factors, jurors can understand that complications arising from retrobulbar injections, although not common, can occur in anyone’s practice, no matter how skillful the surgeon. There are fewer complications with peribulbar injections, but the hazard of puncturing the globe does exist. Defending these cases is similar to retrobulbar cases.

Subconjunctival and Subtenons Injections

The liability and defense issues are more problematic when penetration of the globe occurs after subconjunctival and subtenons injections. The seriousness of this complication and whether a claim arises depends upon the dose and what material is mistakenly injected into the eye — some anesthesias are retinotoxic and some are tolerated by the eye. Defending these cases is more difficult than retrobulbar cases. The plaintiff will allege that the surgeon should have moved the needle point to be sure it was not engaged in the sclera unless the needle point could be seen at all times, because if it were visible, the penetration could not have happened. Jurors will have much less difficulty finding negligence for something the ophthalmologist should have been able to see.

Topical Drops

Instilling topical anesthetic drops can precipitate a malpractice claim in two types of situations. First, if an untoward reaction occurs after instillation, the plaintiff may assert that the wrong drops were used or the medication was not properly manufactured. A claim that the wrong drops were used is more likely to be based on an incident in the operating room. This mistake can usually be avoided by having only one bottle of drops on the tray at any one time. If there is an untoward incident, secure the drops and other related devices in a safe place so they can be analyzed and tested if necessary.

Second, when topical anesthetics are prescribed for home use, the patient may inadvertently traumatize the anesthetized eye, or if a corneal ulcer is present, topical anesthesia may impede its healing. When prescribing drops for home use, document that the patient understands how to instill the drops, knows the signs and symptoms of complications, and knows to contact the office immediately if problems occur.

Given the potential for complications, the ophthalmologist should warn the patient that vision loss is a possibility in all ocular operations.

Injectable Anesthesia – How Risky Is It?

By Dean C. Brick, MD

Digest, Spring 1998

It remains one of the most dreaded events in ophthalmic surgery. The eye is prepped for retrobulbar anesthesia. The injection is attempted, but the patient moves and the surgeon is unable to accurately gauge the position of the needle and perforates the globe. Surgery is canceled and attention turns to managing the ensuing complications. Despite prompt treatment and follow-up, the patient’s visual outcome is 20/400.

Fortunately, such events are uncommon, and improved techniques for administering local anesthesia to the eye have some practitioners questioning whether they should occur at all. Others suggest it may be time for a new standard of care so local ocular anesthesia is no longer the potentially riskiest part of routine cataract surgery.

But is injectable anesthesia so risky? While it’s true that regional injection is implicated in 87% of all anesthesia claims against OMIC insureds, this is to be expected given that it is the most common method of anesthesia used in ophthalmic surgery. A review of 598 closed and 218 open OMIC claims showed that over a 10-year period only 31 claims were filed because of complications from all types of ophthalmic anesthesia. Compare this to cataract surgery, which accounts for one-third of OMIC claims, or to retinal cases, which make up 17% of the total.

Reported complications following injectable anesthesia include needle perforation, orbital hemorrhage, central retinal artery occlusion, central retinal vein occlusion, optic atrophy and diplopia. Needle perforation of the globe is the most common complication, accounting for 19 of the 53 claims related to ophthalmic anesthesia in this review, 31 of which are OMIC and 22 non-OMIC. The clinical outcomes of these 19 needle perforation cases reveal that most were associated with a poor visual outcome; of course, it should be recognized that patients with a good visual outcome are less likely to file a claim in the first place. Seven of these cases occurred during the administration of peribulbar anesthesia and 12 during retrobulbar anesthesia. Patients who had a perforation from a peribulbar injection tended to do better than those whose perforation resulted from a retrobulbar injection.

In 12 cases, the perforation was recognized prior to surgery, the case was canceled and the patient was referred to a retinal specialist. These cases were analyzed separately to see if this had any affect on visual outcome, but there was no indication among this small group of patients that their outcomes were any better than those in whom the perforation was not recognized until postoperatively.

Three of the 19 needle perforation cases closed without payment; six settled for an average indemnity of $145,000; two non-OMIC cases resulted in plaintiff verdicts averaging $1.9 million; four closed with defense verdicts; and four remain open. Closer examination reveals final vision better than 20/100 in all three cases closed without payment and weak causation arguments or limited damages in the four defense verdicts. Pre-trial settlements and plaintiff verdicts were more likely when the patient suffered decreased vision or lost visual field as a result of the needle perforation.

Poor Outcomes Follow Retrobulbar Blocks

Other complications related to injection of local anesthesia in this review included six cases of retrobulbar hemorrhage, five cases of optic neuropathy, five cases of vascular occlusion, six deaths, two seizures and three miscellaneous complaints. Of the six patients suffering retrobulbar hemorrhages, all had retrobulbar blocks and five had poor visual outcomes (< 20/200). One patient was on Coumadin at the time of surgery; another was a hemophiliac who did not receive factor 8 before or after surgery and suffered a delayed hemorrhage after leaving the surgery center. In several cases, a lateral canthotomy was performed following the hemorrhage and in another the orbital hemorrhage was drained, but despite these measures, there was a poor visual outcome in all cases. Four of the six cases had closed at the time of this review, three without payment and the fourth settled for an undisclosed amount.

All five cases of optic neuropathy followed retrobulbar anesthesia and all had poor visual outcomes. Four of the cases closed with defense verdicts and one non-OMIC case closed with a plaintiff verdict of more than $500,000. Four of the five cases of diagnosed or presumed central retinal artery occlusion following retrobulbar injection had poor visual results. One of these closed with a plaintiff verdict for $225,000 and three closed without payment. Both seizure cases were canceled and closed without payment as the patients suffered no residual damage. The three miscellaneous complications following retrobulbar injection included a serious stroke, diplopia and persistent facial numbness. Two of the cases closed without payment; the other remains open.

In almost every instance of death following local anesthesia injection, the patient was seriously ill at the time of the procedure: a post-cardiac transplant patient, a uremic patient on dialysis, an alcoholic patient with liver failure, and two patients with poorly controlled diabetes. Cardiopulmonary arrest was the stated cause of death in five of the six cases. One patient who had received large amounts of antihypertensives to treat elevated blood pressure during the procedure became very hypotensive following the procedure and arrested. The uremic patient who died at home later that night was found to have elevated serum potassium. Four of the six cases were settled and two closed without payment.

The anesthesiologist was the primary target in most of these cases; however, the ophthalmic surgeon was involved in some of the settlements as well.

Other Techniques Present Risks Too

These findings remind us that claims against ophthalmologists also arise from the use of general and topical anesthesia. Of five cases involving general anesthesia, two patients died following the anesthetic, one suffered an expulsive hemorrhage after gagging on the endotracheal tube, another suffered a transient ischemic attack, and the fifth developed adult respiratory distress syndrome. The last two patients fully recovered and their cases closed without indemnity while the expulsive hemorrhage case was settled with the anesthesiologist for $135,000. In the two cases involving topical anesthesia, the patients experienced suprachoroidal hemorrhages and had poor visual outcomes. A defense verdict was delivered in one case and the other settled for $150,000.

In summary, OMIC has experienced 31 cases related to ophthalmic anesthesia over the past 10 years. This represents only about 4% of all claims and is a small part of the 33% of claims related to cataract surgery, indicating that ophthalmic anesthesia needn’t be considered the riskiest part of cataract surgery. No standard of care exists with respect to choice of anesthetic technique and serious complications can occur with each method of anesthesia. The surgeon should choose the technique best suited to the needs of the patient and most appropriate for the procedure.

Risk Reduction Guidelines for Ophthalmic Anesthesia

1. Stay alert to symptoms (sudden loss of vision or severe pain) and signs of needle perforation (hypotony, decreased red reflex, vitreous hemorrhage, hyphema or increased intraocular pressure) when administering injections around the eye.
2. If a perforation is recognized, abort the procedure, advise the patient of the complication and obtain an immediate retinal consult. A patient whose complication is recognized and treated early may have a better final outcome.
3. Consider general, topical or blunt cannula local infiltration anesthesia in high-risk patients, i.e., high myopes, patients with prior scleral buckling or patients with a bleeding tendency, but remember these alternatives carry their own risks.
4. The ophthalmic surgeon may be held liable for damages even if an anesthesiologist or CRNA administers the anesthesia. Ascertain and document that the anesthesiologist or CRNA is adequately trained to give ocular injections and alert them to any risk factors that might increase the possibility of needle perforation such as increased axial length, previous scleral buckle or posterior staphyloma.
5. Consult with the patient’s primary care physician in cases where the severity of a pre-existing condition or illness could increase the patient’s anesthesia risks and document that you did so.
6. Needle perforation is a rare but potentially serious complication of local anesthesia injection and may be explained as such in the informed consent discussion or document.

Coumadin and Ocular Anesthesia

By Paul Weber, JD

Digest, Spring 1998

Recently, I took an incident report from an insured who stopped a patient’s Coumadin five days prior to surgery. Two days after surgery, the patient suffered a devastating stroke. The specific risks of discontinuing Coumadin were not discussed with this patient prior to surgery. It was the first time an incident of this kind was reported to OMIC, although the question of whether to stop Coumadin prior to cataract (or intraocular) surgery has come up a number of times. Quite often, an important risk management issue such as this one will raise both clinical and legal issues. When this occurs, we are fortunate to be able to collaborate on the clinical issues with ophthalmologists from OMIC’s Board and Committees.

In this case, Risk Management Committee Chairman Dean C. Brick, MD, a cornea specialist in Tucson, addressed the prevalent clinical issues. We realize this is a controversial topic and would appreciate hearing from our readers on this one.

Q  Should I discontinue a patient’s Coumadin prior to cataract (or intraocular) surgery?
A  This is a difficult situation since Coumadin puts both patient and surgeon at increased risk. If you continue the patient on Coumadin, you risk being sued if the patient develops bleeding problems. If you discontinue the Coumadin and the patient suffers a stroke, you may be sued for not advising the patient of the risks involved in stopping the medication. Two critical decisions must be made in these patients.

The first is whether the patient needs to be maintained on full doses of Coumadin prior to and during surgery. In many cases, patients are on Coumadin for prophylactic reasons and may safely discontinue it for a few days prior to surgery to allow the INR to decrease but not to a normal level. This option should be discussed with the primary care physician monitoring the patient’s anticoagulant and the discussion and decision reviewed with the patient and documented in the chart. If the decision to stop Coumadin is made, routine technique and anesthesia (including retrobulbar anesthesia) are appropriate.

Q  What surgical technique or anesthesia should I use in patients whose anticoagulant cannot be discontinued or decreased such as those with artificial heart valves?
A  This leads to the second critical decision: Should you change your technique of surgery or anesthesia? If a patient’s INR remains significantly elevated prior to surgery, the patient faces the risk of retrobulbar hemorrhage following retrobulbar or peribulbar anesthesia as well as the possibility of a more severe suprachoroidal hemorrhage. It might seem that topical anesthesia would be the technique of choice in these cases; however, OMIC has had two cases of suprachoroidal hemorrhage associated with topical anesthesia in which the patients complained of pain during surgery. It was alleged that the patient’s pain and discomfort resulted in elevated blood pressure and hemorrhage. Even though there are still risks of complications, topical anesthesia is probably the technique of choice for such patients provided the physician and anesthetist are experienced with its application.

If not, the surgeon should refer the patient to a surgeon who is experienced with this technique or modify his or her technique to fit the circumstances.

Q  If after weighing the options, it is decided that injectable anesthesia is the technique to use on a patient, how can I minimize the risk of complications?
A  Use a Greenbaum cannula or blunted needle to administer the anesthetic. A prolonged massage following the injection will prevent the formation of a large hemorrhage, which would compromise circulation to the globe or optic nerve. Closely observe the patient for signs of hemorrhage prior to, during and after surgery. Provide instructions before the patient leaves the hospital on how to recognize the signs of hemorrhage and how to contact you if any of these symptoms occur. Always be prepared to respond to emergencies. There are health risks to the patient and concomitant liability risks to the surgeon with any decision in situations like this. Discuss all the options and risks with the patient and document the reasons for the final decision in the chart.