Issue: June 2015
June 01, 2015
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Phacovitrectomy system offers flexible options for customized surgery

Already established in Europe, the EVA phacovitrectomy system recently obtained approval for sale in Japan and the US.

Issue: June 2015
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Technology combining phacoemulsification and vitrectomy allows for efficient surgery with reduced risk of complications, lower patient burden, and reduced cost and time for the procedure, according to two surgeons interviewed by Ocular Surgery News.

“Today, because of advances in microincision vitreoretinal surgery machines and microincisional cataract surgery, there is little or no inflammation created in the eye using phacovitrectomy, and as a result, postoperative synechiae are no longer an issue,” Peter Stalmans, MD, PhD, a vitreoretinal surgeon at Leuven University Hospital, Belgium, said.

“If patients aged 50 years or more are given the choice of vitrectomy alone or combined phacovitrectomy, over 90% choose phacovitrectomy. The majority of vitreoretinal surgeons in Japan perform phacoemulsification surgery as well, so phaco capability in vitrectomy surgical platforms is important,” Shunji Kusaka, MD, PhD, a professor of ophthalmology at Sakai Hospital Kinki University, Osaka, Japan, said.

Shunji Kusaka

Launched by DORC in 2013, the EVA phacovitrectomy system is currently used in more than 250 centers in Europe, with more than 250,000 procedures performed. In Japan, the system was registered in January 2015. The FDA granted 510(k) clearance in the U.S. in March 2015.

“It was installed in my OR on March 9. Since then, I have used it in around 32 phacovitrectomy procedures, 18 vitrectomy alone and 70 cataract surgery alone. In addition, before registration, I used it within a clinical trial for 20 vitrectomy cases in March 2014,” Kusaka said.

According to Stalmans, the EVA system is flexible, reliable and user-friendly, three pivotal factors to consider when selecting a vitreoretinal surgical system with combined phaco capability.

“Over-engineering, often involving too many ‘bells and whistles,’ can at times make a surgical device impractical to use or prone to breakdown and recall. EVA was designed to suit all surgeons, with customizable options for fluid control, LED illumination color temperature and wireless foot pedal mode, as well as automated infusion compensation (AIC) for stable IOP. This AIC does exactly what you want, inducing more infusion pressure when you are aspirating fluid,” Stalmans said.

Dual fluid control system

Typically in cataract surgery, the physician has to choose between using a Venturi vacuum-based system or a peristaltic pump flow control system. Both have their advantages and disadvantages, Stalmans explained.

“The new fluid control system in the EVA platform incorporates a fluidics system driven by pistons and closure valves that work in very small flow chambers, capable of delivering both vacuum and flow-control aspiration, with an instantaneous switchover between selected modes,” he said. “Compared to a Venturi-type system, the EVA pump system works even faster because the vacuum rise time is even shorter, which is a major advantage. When working in flow mode, fluid displacement is more stable than that seen using a peristaltic system. Personally, when performing phacoemulsification, I switch instantaneously between vacuum and flow control mode for the different surgical steps, which you cannot do with Venturi-only surgical systems.”

This choice is advantageous, especially with a detached or mobile retina, Kusaka said.

“Most of the time I use a peristaltic or flow control pump for phaco and Venturi pump for vitrectomy. But I sometimes use a peristaltic pump during vitrectomy, especially during vitreous shaving at the peripheral retina, or in cases of retinal detachment, when seeking to avoid the risk of iatrogenic retinal tears, which can be easily created by a high vacuum setting with a Venturi pump,” he said.

Faster cutting speed, adjustable illumination

With the twin duty cycle (TDC) cutter of the EVA, the vitreous can be cut at double the standard cutting rate because cuts are made during both the forward and backward movements of the blade. As a result, cutting speed can build up to 16,000 cpm.

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“But more importantly, the port of the TDC vitrectome is never closed, which means there is uninterrupted flow of fluid, providing added control for delicate intraoperative maneuvers. If you move too close to the retina using a standard vitreous cutter, you will sometimes aspirate the retina and possibly create a break. The likelihood of that happening using the TDC cutter in combination with flow control is much lower,” Stalmans said.

Flexible options are also offered by the LEDStar illumination system, which allows light emission in 20 individually adjustable color grades from white to yellow. Moreover, it provides more light output than other illumination systems currently available, Stalmans said.

“I’ve been using the LEDStar illumination system for more than 2 years now, and it is extremely helpful during surgery because there are three output options. I use one source for the light pipe, one for chandelier lighting and the other for laser,” Kusaka said.

Only one feature of the EVA system needs further improvement, in his opinion.

“Phaco-fragmentation capability is still slightly inferior to other machines, such as Constellation (Alcon) or Stellaris (Bausch + Lomb),” he said. “In cases with very hard nucleus, cataract surgery can be a bit tough. In my practice, however, such cases are less than about 2%.”

Stalmans said that DORC plans to introduce a modified phaco handpiece for the system. – by Michela Cimberle

Disclosures: Kusaka reports no relevant financial disclosures. Stalmans reports he received travel reimbursement from DORC International.