Intuitive Surgical Emphasises da Vinci's Safety Through Minimally-Invasive Surgery Study
Espicom View : After a number of reports have been released that question the safety of robotic surgery, Intuitive Surgical is keen to highlight any study results that say otherwise. With growth of procedure rates slowing and da Vinci system sales declining, Intuitive Surgical will have to do a lot more than point out a few studies that show its system works. The company will need to prove safety and perhaps increase training on its system to regain consumer confidence in da Vinci.
Intuitive Surgical has highlighted results from a study, published online in the September issue of Urology (2013;3: 579-583), which showed that minimally-invasive surgery for prostate cancer (PCA) significantly reduces complications when compared with open surgery. The study found that minimally-invasive surgery for PCA, including laparoscopic and robotic-assisted surgery, was associated with lower transfusion rates, shorter length of hospital stay, and lower serious postoperative complication and mortality rates compared with open prostatectomy.
In the study, the authors evaluated the National Surgical Quality Improvement Program (NSQIP) database, a national, prospective perioperative database reflecting diverse practice settings, from 2005 to 2010, for laparoscopic or robotic-assisted prostatectomy and open retropubic prostatectomy. Compared with other administrative databases that capture only in-patient events, the NSQIP database identifies complications up to 30 days postoperatively, providing more detailed characterisation of complications after prostatectomy. The perioperative outcomes that were examined included surgical and total operation duration, transfusion rates, length of stay, major morbidity (cardiovascular, pulmonary, renal and infectious) and mortality.
The study identified 5,319 radical prostatectomies: 4,036 minimally-invasive radical prostatectomy (laparoscopic and robotic-assisted) and 1,283 open. Although operating time was longer in the minimally-invasive robotic-assisted prostatectomy group (270 vs 252 minutes, p<0.0001), there were significantly fewer perioperative blood transfusions (21 vs 1.3%, p<0.0001) and shorter mean length of stay (1.8 vs 3.2 days).
The overall complication rate after minimally-invasive radical prostatectomy was 5% compared with 9% in open prostatectomy (p<0.001). Mortality was low in both groups, although it was significantly lower in the minimally-invasive radical prostate surgery group (0.05%) compared with the open prostatectomy group (0.4%, p=0.01).
While Intuitive Surgical is touting this article as demonstrating the safety of robotic surgical systems and in turn the safety of its own system, the da Vinci, the publicly available information from this study does not name the da Vinci system, rather it just refers to robotic-assisted surgery.
Intuitive Surgical noted that in late 2011 and 2012, several large-scale clinical studies on da Vinci surgery were published and demonstrated the benefits of da Vinci surgery. Since da Vinci surgery for prostatectomy is the most mature procedure, many of these large studies used population databases to assess the clinical impact of da Vinci surgery for prostate surgery when compared with the prior standard, open surgery. Intuitive Surgical believes that as other clinical areas of da Vinci surgery mature, clinical evidence will continue to trend toward lower complication rates compared with open surgery. However, a number of studies have been released that highlight issues with robotic surgery and the under reporting of adverse events when using robotic surgical systems. The under reporting seen with robotic surgical systems could be due to the lack of clarity as to whether the system or the surgeon was at fault. This appears to be having an impact on Intuitive Surgical's da Vinci system, with growth in procedure rates starting to slow.
Intuitive Surgical develops, manufactures and markets the da Vinci surgical system, a surgical platform designed to enable complex surgery using a minimally-invasive approach. The da Vinci surgical system consists of an ergonomic surgeon console or consoles, a patient-side cart with three or four interactive arms, a high-performance vision system and proprietary EndoWrist instruments. Powered by state-of-the-art technology, the surgical system is designed to scale, filter and translate the surgeon's hand movements into more precise movements of the EndoWrist instruments. By providing surgeons with visualisation, enhanced dexterity, greater precision and ergonomic comfort, Intuitive Surgical believes the da Vinci surgical system makes it possible for skilled surgeons to perform more minimally-invasive procedures involving complex dissection or reconstruction. A number of surgeons have complained about the lack of tactile feedback from robotic systems, inability to tell the firmness of where they are cutting makes it difficult to ensure that they are making the appropriate incisions.
According to reports, the procedures most commonly associated with death while using a robotic systems were gynaecologic (22 of the 71 total reported deaths), urologic (15 deaths) and cardiothoracic (12 deaths). The cause of death was most often excessive bleeding. In cases where patients survived, hysterectomy by far had the most complications (43% of injuries). With reports that bring these issues to light being released, Intuitive Surgical will have to do more than mention some results that briefly touch upon robotic-assisted surgery to prove that its system is safe.