To the Editor:

In the July/August issue of Retina Today, an article titled “The Next Generation of Machines for Modern Vitrectomy,” by John Kitchens, MD, and his co-authors of the Vit/Buckle Society presented a review of currently available vitrectomy units. Considering recent advances, in particular the move to microincisional vitreous surgery, this review is particularly important for both beginning and seasoned retinal surgeons. The review of the equipment was presented in a “pro vs con” fashion and provided good (although sometimes subjective) information regarding the pluses and minuses of each platform. The review was adequate, but it would have been easier for the reader to compare the units if they had reviewed the same performance aspects of the different units. For example, a comparison of the lighting of one unit to another, one cutter to another, or one entry system to another, as well as highlighting the best feature of each unit, would have been helpful to enable the reader to quickly and easily assess each unit's strengths.

Although the platforms of the vitrectomy systems were mentioned, no detailed explanation was provided as to the difference between a venturi and a peristaltic vitrectomy unit. With the recent shift to microincisional vitrectomy, control of flow at the cutter tip is an important feature for the modern vitrectomy unit. Venturibased systems are vacuum-driven, requiring connection to a vacuum at the wall. Because vacuum is the only parameter that can be controlled, control of flow in a vacuum-based unit is accomplished by control of the cut rate or duty cycle of the handpiece. Since the early 1980s, vitrectomy in the United States has been predominated by venturi systems. Therefore, when smaller incisions required attention to flow, manufacturers responded by altering the cut rate and duty cycles of the hand cutters. It should be noted that flow can only be measured in the cassette once it has left the eye or by estimation in a vacuum-based or venturi system.

Peristaltic-based systems are flow-based and operate by displacement of fluid over time or by actual flow (mL/sec.) Therefore, the cut rate and duty cycle can be varied without an effect on flow. This allows full utility of the cutter handpiece and potentially could increase the versatility of the unit. In a peristaltic system, the cutter can be used to engage tissue of varying density without concern regarding flow. Additionally, because it does not require a vacuum, a peristaltic unit does not have to be tethered to the wall. Therefore, flow-based vitrectomy is very useful for vitreous base shaving with a mobile detached retina and/or membrane peeling over the retinal surface.

Finally, no fair comparison of equipment should be done without some reference to patient safety. Thankfully, the Department of Health and Human Services has a Manufacturer and User Device Experience (MAUDE) database that logs and documents complaints about surgical equipment. In fairness, it should be noted that a search of the MAUDE database of these units revealed that several complaints were logged against the Constellation (Alcon Laboratories Inc.), and none were logged against either the Stellaris (Bausch + Lomb) or the Associate (Dutch Ophthalmic USA), as of October 2011.

In closing, it is clear that all these systems provide a significant advance in vitreoretinal surgical techniques and efficiency. The authors presented a good discussion of the benefits and pitfalls of each unit but could have been more complete in providing accurate information for your subscribers to consider in their evaluation of this new technology.

SINCERELY,
KEITH A. WARREN, MD

Keith A. Warren, MD, is President and Chief Executive Officer of Warren Retina Associates in Overland Park, KS. He states that he is an advisor to and on the speaker's bureau for Alcon Laboratories Inc., Dutch Ophthalmic USA, and Genentech.

AUTHOR REPLY

To the Editor:

Dr. Warren correctly points out some critical shortcomings of our article. Because of the manner in which the machines were evaluated (each in an isolated manner by different surgeons in diverse OR environments on decidedly nonuniform patient populations) and the fact that each of the authors' opinions was formulated independently, it was difficult to directly compare parameters of each machine. Our attempt was more of a subjective description of hands-on experience with each machine. This approach precludes quantitative comparisons of lighting systems, cutter performance, and other features in a head-to-head fashion, but it is certainly a first step in the right direction.

Dr. Warren's comments accurately highlight the paucity of objective data available on the true performance of the multiple pars plana vitrectomy (PPV) platforms and the absolute absence of any comparative data collected in a scientific environment free of corporate bias. It is precisely this fact pattern that led to the Vit-Buckle Society forum at the 2011 Association for Research in Vision and Ophthalmology meeting upon which this article was based. To the best of our knowledge, this was the first time that a comparison of 3 different modern vitrectomy systems— as subjective and imperfect as it was—was even attempted.

There are several challenges to achieving the ideal scenario of a Consumer Reports-type objective evaluation of PPV systems and disposable instrumentation. Commercially available machines and available packs would have to be purchased outright and evaluated in a standardized environment without corporate knowledge or intervention. Standardized protocols would have to be developed to assess quantifiable variables that are clinically relevant for each gauge size and pack type for each machine. This may be relatively straightforward for certain measurements, such as light pipe performance (cone angle, spectral output, and intensity) or objectively measured duty cycle as a function of increasing cut rate. Quantifying how well different spectral outputs illuminate different ocular tissues becomes more subjective and difficult.

Clinically relevant measures of cutter performance in vitreous become very complicated and deserve special mention, as this is perhaps the most important performance feature of any vitrectomy platform. Cutter performance in water is easily determined but is only somewhat clinically relevant. The problem with vitreous is its heterogeneous and non-Newtonian nature across species and individuals, within different anatomical locations in the same eye, and at different points in time during the vitrectomy procedure. Animal eyes, human cadaver eyes, egg whites, and other substances as surrogates are too unpredictable and make collection of meaningful comparative data difficult. Meaningful quantitative cutter performance comparisons across surgical platforms require a vitreouslike substance that behaves reproducibly and can be used on different days in different labs. This substance is currently under development by a member of this author group (CDR) and will become available under the name Substivit in the calendar year 2012. We look forward to being able to access truly comparative, objective, clinically meaningful vitrectomy platform performance data at some point in the near to intermediate future.

Contrasting the differences between peristaltic and vacuum- based equipment is similarly complex and requires a keen understanding of the subtleties of cutter-vitreous interactions as a function of differing cut rates, duty cycles, vacuum levels, flow rates, and geographic location within the vitreous cavity. This discussion was beyond the scope of our article. Dr. Warren is correct in pointing out this deficiency, and we suggest that this topic warrants its own article on the pros and cons of each. This is especially true in larger gauge (20- and 23-gauge) surgery. Due to high internal resistance to flow through 25- and 27-gauge cutters, the differences between peristaltic (flow-controlled) and venturi (vacuum-controlled) systems are clinically less relevant in smaller gauge PPV. The Associate is the only machine to offer both 25- and 27-gauges and is also the only machine we discussed on which 27-gauge PPV is possible.

Dr. Warren's reference to patient safety is both critical and educational. Reference was certainly made to the recall of the Constellation machine in the article. At the time of the article's creation, the presence of the MAUDE searchable database of complaints logged against medical devices and the absence of any such complaints about the Stellaris PC and the Associate were unknown to the authors. We greatly appreciate Dr. Warren bringing this helpful database to our attention and applaud his valuable and relevant commentary on our article.

SINCERELY,
CHRISTOPHER D. RIEMANN, MD FOR THE VIT-BUCKLE SOCIETY RESEARCH GROUP

Christopher D. Riemann, MD, specializes in medical and surgical vitreoretinal diseases at the Cincinnati Eye Institute in Ohio. He states that he receives lecture fees from Iridex, is a paid consultant and receives royalties from MedOne, and holds intellectual properties and equity ownership in MaCor Industries.