Spotlight: ON TECHNOLOGY AND TECHNIQUE
Size Matters
A new set of 25-gauge vitreoretinal tools makes procedures faster, safer and more patient-friendly.
BY CHRISTOPHER KENT, SENIOR ASSOCIATE EDITOR

One of the hallmarks of technological progress in medicine is that instruments tend to become smaller, while procedures become simpler and safer. And one of the surest signs of this is the gradual shift of a procedure away from a hospital environment to an ambulatory surgical center or office setting.

Surgical procedures involving vitrectomy have made huge advances in the past 20 years, but they still involve sufficient complexity and risk that surgeons perform them almost exclusively in hospitals. Now, newly approved vitrectomy instrumentation from Bausch & Lomb makes it possible to perform surgery through smaller incisions than ever before. That, in turn, makes it much more likely that these operations will one day soon take place in an office or ASC.

Sutureless surgery

Bausch & Lomb's Transconjunctival Standard Vitrectomy (TSV) 25 System allows you to perform surgery through microincisions. The system combines three elements:

• the Millennium Microsurgical System
• the new Entry Site Alignment (ESA) system, recently approved by the FDA. This is a 25-gauge cannula system developed jointly by Bausch & Lomb and the Doheny Retina Institute's Microsurgery Advanced Design Lab (MADLAB). It's unique, both because it's the smallest cannula system ever made for vitreoretinal surgery, and because it's designed to be placed through the conjunctiva and sclera.
• Bausch & Lomb's Lightning High-Speed Vitrectomy Cutter.

Previously, performing vitreoretinal surgery meant dissecting conjunctiva and making pars plana scleral incisions of about 1 mm that had to be closed with sutures. In contrast, the new ESA cannulas are only 0.5 mm in diameter (see above); incisions are much smaller and rarely require suturing.

The TSV 25 System uses the world's smallest cannula system for vitreoretinal surgery. Bottom: Comparing the size of a standard 20-gauge cannula system (left) with the TSV 25-gauge system (right).

This new system has several advantages:

Fewer steps to complete surgery. Using the TSV 25 System, the surgeon inserts three 25-gauge cannulas through the conjunctiva and sclera using an insertion trocar, and then introduces the cannula-based infusion line. Once the procedure is completed, the surgeon simply removes the cannulas. No suturing is necessary.

Significantly reduced surgery time. Eugene de Juan, Jr., M.D., of the Retina Institute at the University of Southern California, has performed more than 70 surgeries using the TSV 25 System. He reports that it shortens the time he needs to open, perform a vitrectomy and close from about 35 minutes to about 19 minutes. In some cases, he reports, surgery has only taken 12 minutes. (Needless to say, this could have a profound effect on a practice's bottom line.)

Less induced trauma and inflammatory response. Because it's transconjunctival, using the ESA system reduces post-op inflammation at sclerectomy sites. This, in addition to the small incision size and lack of sutures, minimizes patient discomfort and hastens post-op recovery.

Other advantages of the TSV 25 System include:

• Using the system doesn't require any significant changes in surgical technique.
• The system allows interchangeability of instruments between entry sites.
• The Lightning High-Speed Vitrectomy Cutter is the only electric cutter available. It delivers 1,500 cuts per minute and eliminates the pulsing associated with pneumatic cutters.
• A comprehensive array of reusable and disposable 25-gauge instruments is available to allow you to perform any key retinal procedure using the system.

The surgeon's perspective

Dr. de Juan first developed 25-gauge instruments for vitrectomy in 1990. More recently, he helped develop the TSV 25 System, which he believes is safer than previous vitrectomy systems and allows eyes to heal "almost instantly."

"This is an effective new standard for this type of surgery. By going from 20-gauge instruments to 25-gauge, you cut the diameter from 1 mm to 0.5 mm, which means the area required for the instruments to pass through is one quarter of the area previously required. This eliminates the need for dissection of the conjunctiva and sclera. That's why healing is so much faster; it's like recovering from having blood drawn."

Steven Schwartz, M.D., at UCLA's Jules Stein Institute, recently began using the TSV 25 System. "This will likely represent a major advance in vitreoretinal surgery," he says. "It may be as significant as the development of the panoramic viewing system and perfluorocarbon liquids."

Both surgeons expect the new system to be useful in multiple types of vitreoretinal surgery. "It's remarkably efficient and precise for macular procedures, such as treatment of macular puckers and macular holes," notes Dr. Schwartz. "I suspect it will also prove very helpful in the surgical treatment of retinopathy of prematurity."

Dr. de Juan finds the TSV 25 System particularly advantageous for procedures that don't require extensive vitreous dissection, such as vitrectomy for vitreous hemorrhage, epiretinal membrane peeling or uncomplicated retinal detachment repair, although he says that other procedures, such as complicated proliferative vitreoretinopathy or extensive vitreous dissection, might not enjoy the timesaving benefit. Dr. de Juan also points out that the system may be a boon for anterior segment surgeons who aren't comfortable suturing in an infusion line for cleaning up vitreous loss during cataract surgery.

	The TSV 25 cannulas are inserted directly through the conjunctiva and sclera. Here, a surgeon finishes inserting the second cannula. The infusion line has already been placed in the first cannula (top).

Faster, not simpler

Both surgeons agree about one caveat. "Unlike photodynamic therapy, this advance does not make vitreoretinal intervention easier," says Dr. Schwartz. "Rather, it compresses the cognitive portions of the case for the surgeon. The surgeries are shorter because you spend less time and effort opening and closing, but the surgery is no less difficult."

Dr. de Juan concurs. "It's important to understand that switching to smaller instruments cuts out time-consuming steps and makes the surgery safer and easier for the patient, but performing the surgery itself is just as complex as ever.

"In fact, it may require greater skill because of the smaller instruments. For example, many surgeons using 20-gauge instruments use them to move the eye aggressively once they're inserted. You can't force the eye into position with the smaller gauge needles. You have to use wide-field viewing instead."

Cutting surgery down to size

"Overall, the TSV 25 System has clear benefits for both the surgeon and the patient," says Dr. de Juan. "I think doctors will quickly accept this as the new standard, just as they did when we switched from 2.3-mm to 1-mm instruments."

The complete TSV 25 System should be available sometime in April, 2002. For more information, call (800) 338-2020, or visit www.bausch.com on the Web.

Are you aware of new products or technology that have made (or are likely to make) a significant difference in practice? Contact Christopher Kent at kentcx@boucher1.com  to find out about possible coverage in a future issue.