A response to the SAGES TAVAC assessment of the da Vinci Surgical System.

Abstract

In response to the technology assessment written by SAGES’ Technology and Value Assessment Committee (TAVAC) and published in this journal, Intuitive Surgical welcomes the opportunity to comment on the methodology and conclusions presented in the analysis. The TAVAC authors reviewed the da Vinci Surgical System technology and evaluated clinical and economic evidence within the specialty area of gastrointestinal surgery. As the scientific representatives of Intuitive Surgical Inc., we have three main concerns with the methodology presented by the TAVAC. First, throughout the assessment, laparoscopic surgery is used as the sole comparator for robotic-assisted surgery. However, robotic-assisted surgery provides a minimally invasive surgery (MIS) option to patients who otherwise would have undergone an open procedure. By limiting the comparator to laparoscopic surgery, the analysis does not account for the substantial number of patients still receiving open procedures in general surgery in the USA (over 50 % of colectomies, over 80 % of rectal surgeries and over 70 % of ventral hernia repairs, for example). Additionally, year-over-year modality comparison data illustrate that the adoption of robotic-assisted surgery has resulted in a decrease in the proportion of open surgery procedures, not a decrease in the proportion of laparoscopic surgical techniques. In fact, for some procedures, the proportion of laparoscopic surgical techniques has increased with the adoption of robotic-assisted surgery (Figure 1A, B). Therefore, we contend that the appropriate comparator for robotic-assisted surgery in this assessment is predominantly open surgery, not laparoscopy. Robotic-assisted surgery is an enabling technology that has been shown to increase the number of patients receiving MIS across large patient populations. Determining which patients receive which type of MIS approach is an important issue for the surgical community. Patient populations matter, and defining the appropriate patient population for different surgical techniques should be a focus of future research. Our second concern is with the methodology for selecting studies included by the TAVAC. These types of assessments typically use a rigorous methodology for identifying and reviewing qualified peer-reviewed literature. The selection criteria used by the Committee are not described, and a broader review shows that the authors omit a significant portion of relevant literature. The assessment primarily uses data that are more than 5 years old—while disregarding more current data that are often at a higher quality and evidence level. Based on our own systematic literature search (filtering for English language and \3b LOE), we found 250 additional, relevant publications that are not included in the technology assessment (Fig. 2; See supplementary online material for references and an appendix for the definition of level of evidence). Electronic supplementary material The online version of this article (doi:10.1007/s00464-015-4679-7) contains supplementary material, which is available to authorized users.