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Improvements in instruments, sterilization and anesthesia set stage for office-based vitreoretinal surgeries
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Remarkable advances in vitreoretinal surgery have occurred in the past 20 years. Diversified and miniaturized instruments have been produced, surgical time has dropped, and most procedures are done under local anesthesia, all of which have made hospitalization unnecessary in many cases. The number of vitreoretinal procedures performed in an outpatient setting has grown, and some surgeons feel that the time is about right to shift surgery to the office.
“There are currently 5,500 ambulatory surgical centers in the U.S. doing 25 million surgeries. We feel comfortable with it, at least in uncomplicated, routine cases,” Dante J. Pieramici, MD, said.
Pieramici’s group practice, California Retina Consultants, has 10 offices in different locations in California, and the doctors in the group operate in numerous ASCs and hospital-based ORs. They are outfitted with the best technology and specifically trained OR personnel. The vast majority of vitreoretinal procedures are performed under sedation and retrobulbar/peribulbar injection.
Image: Pieramici DJ
“The anesthesiologist is there to monitor sedation, and patients can usually be discharged 20 to 30 minutes after the procedure. Only a small minority of patients, about 5% to 10%, are referred to the hospital for general anesthesia, and only very rarely an overnight stay is needed,” Pieramici said.
Patients who may not qualify for ASC procedures include those with extreme coexisting medical conditions that can rapidly lead to life-threatening complications. ASCs do not have the most expedient emergency care and may require a hospital transfer in an ambulance in the case of a severe systemic complication. It is therefore advisable to have these patients operated on in a hospital-based setting; however, they are still done mostly on an outpatient basis, according to Pieramici.
“It happened in my practice. I had a patient who had an arrest during a vitreoretinal procedure. That’s why, if I foresee a possible risk, I prefer to operate on patients in a hospital where they can be revived by a code team and admitted immediately,” Pieramici said.
Another reason for hospital-based surgery and an overnight stay is lack of assistance and care at home.
“If patients don’t have someone to drive them home and to stay with them overnight at least for the first night, I make them stay. This is for their safety and to avoid medical-legal issues,” he said.
In-office could be the next step
Pioneers of the outpatient approach for vitreoretinal surgery published their results in the 1990s. Wilson and Barr found no difference in the technical and functional success rate of scleral buckling and vitrectomy procedures performed with general anesthesia in a hospital setting vs. local anesthesia and no hospitalization in a series of 255 patients. Cannon and colleagues reported positive results and high patient appreciation with 55 patients undergoing vitreoretinal surgery under local anesthesia and no hospitalization. In 2000, Trese carried this idea one step further by studying the feasibility of performing vitreous surgery for idiopathic macular hole in an office setting using autologous plasmin enzyme-assisted techniques. The interest in office-based surgery has grown exponentially since 2001, with the introduction of transconjunctival sutureless small-gauge vitrectomy and the use of local anesthesia.
In-office surgery could be the next step, but most U.S. surgeons may not be quite ready for it, according to Tarek S. Hassan, MD.
“There are currently only a small number of surgeons willing to do any significant vitreous removal in the office, mostly for vitreous hemorrhages, endophthalmitis, vitreous floaters/debris, indications that require straightforward clearing of the central media. And even these individuals are frankly reluctant to do it often,” he said.
While a vitrectomy procedure is reimbursed by most insurances, the facility fee, which accounts for reimbursement that would pay for the cost of the machine, instruments, equipment and anesthesia, is not.
“This fact alone, I believe, is the single most important reason that in-office vitrectomy is not done more at present. Hopefully, insurance companies, including U.S. government payers like Medicare and Medicaid, will realize that office-based care is highly cost-effective. They could save a significant amount of money by eliminating the extremely high facility fee given to hospital and ambulatory surgery centers for some cases. Instead, they could develop alternative payment models that make it economically worthwhile for surgeons to use currently available technology to do a variety of types of vitreoretinal procedures in the lower-cost environment of the office/clinic,” Hassan said.
Operating setup
The technology to do in-office vitrectomy may potentially improve in short order. Several companies offer fully functional vitrectomy machines with small, compact footprints, disposable equipment and a full range of instruments. There are also small portable operating microscopes, small laser and cryotherapy machines, and wireless indirect ophthalmoscopes that adapt to the office environment and allow performing vitreoretinal surgery on most pathologies at any gauge.
“With a reasonably sized procedure room, we can outfit a fully functional operating setup without much difficulty. Most cases can be done with peribulbar or retrobulbar anesthesia, with or without intravenous sedation, similar to the way it is delivered in many dentist offices. An anesthetist may be required or not, depending on the level of comfort of the surgeon,” Hassan said.
Although peribulbar anesthesia and retrobulbar anesthesia do not strictly require the presence of an anesthesiologist, having an anesthesiologist onsite is reassuring for the surgeon, Pieramici said.
“It means that there is someone immediately available for the management of emergencies and allows us to focus on surgery rather than splitting our time and attention between surgery and monitoring sedation,” he said. “Of course, we have to consider that an anesthesiologist is an extra cost.”
The affordability of the process is a big obstacle to progress in this area. Technology has advanced to allow the performance of the procedure in the office setting, but payment models have not.
“Until the major surgical equipment and device manufacturers develop alternative methods of paying for surgical packs, for example, and payers turn the distribution of reimbursement away from the fixed high cost of working in a hospital and toward the physicians to be able to afford in-office surgery, this will not be done to a significant degree,” Hassan said.
In-office surgery could be affordable and economically beneficial to all involved, he said, except for existing hospital and surgical center environments that now profit from the high facility fees. He anticipates that payers, including the government, will soon determine such a move to be in their best interest.
Laminar airflow
One of the biggest technological advances to make in-office vitrectomy even more possible is the development of portable ultra-clean laminar airflow systems. One device, SurgiCube (SurgiCube International), creates a separation of the “unclean” air outside of the surgical environment from “ultra clean air” in the surgical arena, which contains the scrubbed surgeon, the scrubbed assistant, surgical equipment, sterilized instrumentation, anesthesia if desired and the prepped patient. Another device, Operio Mobile (Toul Meditech), is a portable unit that produces a directed, non-turbulent ultra-clean airflow over the surgical site and instruments. Both units reduce bacterial pathogens in the air to less than 5 colony-forming units per cubic meter in the sterile air zone, which is less than required by all standards.
“Physicians using sterile techniques and the aforementioned ultra-clean air filtration and circulation systems can operate in-office settings that are at least as sterile as most operating rooms worldwide. At this point, sterility concerns should not limit progression toward more in-office vitreoretinal surgery,” Hassan said.
According to Pieramici, laminar airflow systems are a good option but may be more important for surgeries with large wounds such as abdominal surgery.
“Our wounds are as small as an injection; therefore, there are no major concerns even in offices that do not have the controlled ventilation system of operating theaters, not as long as the equipment is sterile and not sitting out for a long period of time. I am not sure if the SurgiCube would ever be cost-effective but rather make an expensive procedure even more expensive,” he said. “Many eye surgeries are performed worldwide without laminar flow already, citing few infectious complications.”
European practices
In a review last year, D’Amico published his personal observations on the different practices and preferences of vitreoretinal specialists in the U.S. and Europe. He found that the results of surgery, the availability and choice of instruments and vitrectomy systems, and the knowledge and availability of information were comparable. However, U.S. vitreoretinal surgeons seem to be more likely to use local anesthesia and to perform surgery in an outpatient setting. He reflected on the complexity of causes that lie behind different choices, which include not only cost but also “national health care regulations and practices, patient expectations, possible pressure on hospitals to maintain and grow numbers of operative procedures and many other factors.”
Stricter regulations and unfavorable reimbursement systems are making the transition to outpatient slower and more difficult in most European countries.
A study carried out at the Medical University of Vienna, Austria, reviewed the overall postoperative conditions of 164 consecutive patients who had undergone vitreoretinal surgery. As the current protocol requires, they had spent the first postoperative night at the hospital.
“Ninety-five percent of the patients had no problem at all, 4% had pain during the night due to corneal erosion or sutures, and 2% had hyper- or hypotony. No treatment had been performed during the first postoperative night in the hospital. So, all patients could have gone to their home; some would have had pain there and probably would have decided themselves to wait until morning,” Michael Georgopoulos, MD, said.
He specified that in this study all types of indications, from macular hole to complicated retinal detachment surgery, were included. For routine cases, he believes that outpatient surgery will be the future in Austria. However, for complicated cases, including patients with comorbidities and medical emergencies such as retinal detachment, facilities for an overnight stay should be provided.
“Emergency cases are increasing in number in the university setting while routine cases are decreasing, so I think outpatient is fine but in a hospital. Clinics that do not have the backup of beds must be very careful selecting their patients, and it is not always easy to do it before surgery. They would need a referral center where they can immediately send patients if something happens. In Austria, this is not feasible at present; it would take a complete change of the system,” Georgopoulos said.
In his opinion, vitreoretinal surgery will be possibly the last type of eye surgery done in an in-office setting in Austria.
“If an office could provide a fully equipped operating room including pre- and postoperative facilities, vitreoretinal surgery would be possible then, but I would no longer call this setting ‘in-office’ surgery,” he said.
Regulations and reimbursement
Based on personal experience, Albert J. Augustin, MD, estimates that 50% of patients are not able to manage postoperative care at home. Particularly when head-down positioning is required, competent caregivers must be there to deal with possible complications and to inject heparin if the patient is old.
“If there is silicone oil in the eye, the first days are very critical and so maybe we can shorten the hospitalization period, but many of those patients cannot skip it completely,” he said.
In Germany, rules are strict, and even without general anesthesia, hospitalization is required for the first 24 hours. On the other hand, procedures performed under general anesthesia mandatorily require a recovery room and a postoperative care unit.
“The logistics are not so easy to manage. The system should change completely,” Augustin said.
In addition, even the best reimbursement rate per procedure could not currently cover the additional costs of equipment, maintenance, disposables, staff, and postoperative and follow-up visits.
“Who would pay for the additional costs? I cannot imagine that patients could afford them as co-payment out of their own pocket,” Augustin said.
There is pressure from governments to move toward outpatient procedures to reduce the number of hospital beds and to save money, time and resources, but current reimbursement systems in most European countries make vitreoretinal outpatient procedures result in loss of income.
“If we’ll ever manage to make this transition, reimbursement will be the driving factor,” Georgopoulos said. “But there is concern that if we change from inpatient to outpatient, the reimbursement will be even lower because surgery will appear to be easy and allow insurances to think it should be cheaper, while it is more expensive with the new techniques.”
Patient point of view
Patients prefer day surgery and going back to their own home as long as they have someone to look after them, and only a few feel the need for special care, according to a study carried out at the Flinders Eye Centre in Adelaide, Australia.
“The surgery we investigated was done in an operating room as day surgery. For many patients, it was their first episode of retinal surgery. There was a degree of hesitation about going home, but when they went home with clear instructions for care and knew there was someone they could contact in case any problem arose, they were quite happy to go home, provided there was someone to look after them. For those who were having a second or third episode of retinal surgery, it depended very much on whether the first operation and home recovery were uneventful and pain-free,” Christine McCloud, PhD, said.
Being proactive in pain management and making sure there is someone responsible who can look after the patient in the first 24 hours after surgery are the two key factors that make outpatient procedures a positive, safe experience, she said. The interviews with patients showed that pain management was a factor that decided whether going home was a successful move or not in their view.
“The other important factor is availability of someone patients can call who can speak to them and give advice in case problems arise at any time of the day and night,” McCloud said.
It is reassuring for patients to know what kind of pain they can expect and to be covered by medications as much as possible.
“In our study, patients came back the following morning and were visited by the ophthalmologist and the nurse. If pain management was not sufficient, we offered them a different type of oral pain management like paracetamol or NSAID for the next few days, and they came back for yet another visit the next morning,” McCloud said.
Head-down positioning has been used less often in her surgery unit, but a few patients still needed it and it was important in those cases to make sure the proper assistance was provided.
“Head-down positioning at home is not a problem provided patients have someone who can help them with toileting, showering and getting food. For most of the people we interviewed, there was very limited positioning, mainly the first night and usually for retinal detachment surgery,” McCloud said. – by Michela Cimberle
- References:
- Cannon CS, et al. Br J Ophthalmol. 1992;doi:10.1136/bjo.76.2.68.
- Creuzot-Garcher C, et al. J Fr Ophtalmol. 2008;31(9):871-876.
- D’Amico DJ. Curr Opin Ophthalmol. 2016;doi:10.1097/ICU.0000000000000261.
- Hilton GF, et al. Retina. 2002;22(6):725-732.
- McCloud C, et al. J Adv Nurs. 2012;doi:10.1111/j.1365-2648.2011.05720.x.
- McCloud C, et al. J Clin Nurs. 2014;doi:10.1111/jocn.12572.
- Trese MT, et al. Ophthalmology. 2000;doi:10.1016/S0161-6420(00)00210-4.
- Wilson D, et al. Ophthalmic Surg. 1990;21(2):119-122.
- For more information:
- Albert J. Augustin, MD, can be reached at Department of Ophthalmology, Klinikum Karlsruhe, Moltkestrasse 90, 76133 Karlsruhe, Germany; email: albertjaugustin@googlemail.com.
- Michael Georgopoulos, MD, can be reached at Medical University of Vienna, Währinger Gürtel 18-20, 1090 Vienna, Austria; email: michael.georgopoulos@meduniwien.ac.at.
- Tarek S. Hassan, MD, can be reached at Associated Retinal Consultants, 3535 W. 13 Mile Road, Suite 344, Royal Oak, MI 48073; email: tsahassan@yahoo.com.
- Christine McCloud, PhD, can be reached at Sturt West Wing, GPO Box 2100, Adelaide 5001, South Australia; email: christine.mccloud@flinders.edu.au.
- Dante J. Pieramici, MD, can be reached at California Retina Consultants, 525 E Micheltorena St., Suite C, Santa Barbara, CA 93103; email: dpieramici@yahoo.com.
Disclosures: Hassan reports he is a consultant for Alcon Laboratories, Allergan, ArcticDx, Bayer, Genentech, Hoffman La Roche, Insight Instruments, Novartis, Ocugenix and Regeneron, is an equity owner in ArcticDx and has patents/royalties with Insight Instruments. Pieramici reports he is a consultant for Genentech and does research for Genentech, Regeneron, Allergan, Alcon, ThromboGenics and Santen. Augustin, Georgopoulos and McCloud report no relevant financial disclosures.
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