Covidien Endo Stitch(TM) Automated Suturing Device Reduces Hospitalization Costs and Operating Room Time

In a recent study, the Endo Stitch automated suturing device from Covidien was shown to lower mean hospital costs and operating room (OR) time during total laparoscopic hysterectomies treating benign conditions. In the study, the device reduced overall hospitalization costs by approximately $1800 and cut OR time by roughly 40 minutes, on average, when compared to those same procedures performed with robotic assistance.

Medgadget: How did the device make such dramatic time savings possible in this study? Also, could you explain what the device is like in terms of usability?

Hart: Laparoscopic suturing is a very difficult skill to obtain. This is partly because it is almost like you are operating with stilts. In open surgery, we are used to having a needle driver and we are holding the needle very closely with the needle driver close to where our hands are. Whereas in laparoscopic surgery, we have these long instruments. One of the big challenges is driving needles through tissue from the longer distance.

The other big issue is, in traditional laparoscopic surgery, the surgeon is looking at a two-dimensional screen while operating in three dimensions.

Basically, the [Endo Stitch] device automates the process of suturing. Instead of having to go through this steep learning curve of learning laparoscopic suturing, this extremely simple device allows you to suture with very little skill needed and there is little training involved. It’s not much more involved than any laparoscopic instrument we typically use.

Just the ease of use of the device makes such impressive time savings possible. It allows you to very easily drive sutures through tissue without having to learn those advanced skills. [...] When you automate the process, suddenly, that time goes down significantly. It just simplifies the whole process by automating it through the device. And it really adds significant time savings.

Medgadget: A somewhat related question: Doctors these days are forced to do more with less: thanks to a shortage of MDs and growing pressure to control costs in medicine. How do you think the Endo Stitch addresses these trends?

Hart: I think it is a really interesting question because cost containment is becoming one of the biggest issues [in medicine]. In this study, we looked at two things: we compared [the Endo Stitch] to robotic surgery and to traditional laparoscopic hysterectomies.

One of the challenges, as a physician who teaches courses in laparoscopic hysterectomies, is that the majority of hysterectomies, approximately 60–65% of them, are still being done through big open incisions. This is amazing because we have been doing them that way for more than 100 years and you would think that we would advance to a newer technology. But partly the reason that it is still being done open is the challenge of developing the laparoscopic skills.

What the da Vinci robot has done is they have come in with a very nice instrument that happens to be very expensive. It enables the physicians to suture much more naturally because [it gives them] that seven degrees of freedom on your wrist. Basically, you suture with the da Vinci robot almost identically to how you suture with an open surgery.

One of the biggest issues with the da Vinci robot, even though it is a very elegant and sophisticated piece of equipment that works very well, is the cost. Do we really need a $2 million robot to perform the majority of our hysterectomies? And getting back to the rate-limiting factor of performing laparoscopic hysterectomies, it is the suturing. So suddenly if you had an enabling technology like the EndoStitch that would enable you to suture very easily, quickly, and efficiently, it would take away the need for the very expensive robot because you could do it with a much-less expensive piece of equipment. And so that is why we compared it to the robot. And that is why we saw all of the time savings in the OR and obviously the significant cost savings. There have been other studies that looked at robotic versus traditional laparoscopic surgery for hysterectomy and also showed a cost savings.

Medgadget: Besides its ability to speed surgical procedures and to save costs, what else is noteworthy about the Endo Stitch?

Hart: It is a very straightforward instrument. It is very simple to train physicians to use it.

The best thing to compare it to is the $2-million piece of equipment: the da Vinci robots. You have to get additional training, robotic training, to use it. And not every hospital can afford to buy a robot. On top of that, even if they can afford to buy a robot, they usually can’t afford to buy more than one or two. So you are very limited in the ability to even use it.

“In this tough economic environment, hospitals, payors and patients all feel pressure to reduce costs and increase efficiency in the operating room,” said study co-presenter Stuart Hart, MD, FACOG, FACS, Co-Director, University of South Florida Center for the Advancement of Minimally Invasive Pelvic Surgery. “Minimally invasive procedures offer the potential to reduce pain and trauma to the body, as well as to enable quicker recovery resulting from smaller and fewer incisions. Despite the proven benefits, however, the vast majority of hysterectomies are still performed with open techniques.”

Laparoscopic suturing is a vital skill for advanced laparoscopic surgeons, but it is considered difficult to master when using traditional manual techniques. Automated suturing devices, such as Covidien’s Endo Stitch, assist in the process and have been shown to shorten the time needed to suture internal tissues through ports, when compared to other techniques.

“New technologies like automated suturing devices and surgical robots have made suturing inside the body easier, which may increase the number of surgeons who adopt laparoscopic techniques,” said co-presenter Craig Sobolewski, MD, Chief, Division of Minimally Invasive Gynecologic Surgery, Duke University Medical Center. “While robot-assisted suturing has been shown to be clinically effective, this data indicates that automated suturing with the Endo Stitch device during total laparoscopic hysterectomy in benign cases can be associated with less expensive and more efficient outcomes when the choice is between the two different enabling intracorporeal suturing technologies.”

According to the AAGL, fewer than 15% of the 600,000 hysterectomy procedures performed annually in the United States are done laparoscopically, largely due to lack of required training during a surgeon’s formal education program.1

“Covidien is committed to developing surgical instruments that enable minimally invasive surgery, while helping to reduce overall costs to the healthcare system.” said Dean J Geraci, Director, Healthcare Economics and Reimbursement, Covidien. “We are encouraged by these study results and look forward to continued exploration of the clinical and economic impact of enabling laparoscopic technologies.”

The study was a retrospective data analysis that compared the reported overall hospital costs and OR time when utilizing the Endo Stitch device, versus using robotic techniques, during total laparoscopic hysterectomy in benign cases, as well as using neither the Endo Stitch device nor robotic techniques in such cases.

The study analyzed inpatient hospitalization data from January 1, 2009, to June 30, 2010, taken from Premier’s Perspective(TM) Database (PPD). Multivariate analysis using Generalized Estimating Equations was used for the analysis, controlling for patient demographics and hospital characteristics. The analysis included clustering of patients receiving care from the same hospital.

A total of 5,731 patients were identified who underwent a total laparoscopic hysterectomy (primary ICD-9-CM code 68.41) without a primary diagnosis of cervical, uterine, ovarian or tubal cancers. Of those procedures, 13% (n=727) utilized the Endo Stitch device, 50% (n=2,853) used robotic assistance and 37% (n=2,151) used neither the Endo Stitch device nor robotic assistance during the procedure.

Outcomes were adjusted for patient age, race, severity of illness, co-morbidities, hospital bed-size, census region and teaching status, and clustering by provider. The Endo Stitch device use compared to robot use resulted in lower adjusted overall costs and less OR time: $7,820 vs. $9,689 (p=0.0096) and 173 minutes vs. 216 minutes (p = 0.0003), respectively.

Endo Stitch device use compared to neither devices used resulted in lower OR time: 173 minutes vs. 194 minutes (p=0.0022), respectively. As with other observational studies, some important factors may not have been controlled for in the analysis, therefore no direct causation can be definitively concluded.

Source:http://investor.covidien.com/phoenix.zhtml?c=207592&p=irol-newsArticle&id=1634080

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