Few areas of medicine are evolving more quickly or dramatically than endoscopy. That's why I attended the 2004 Society of American Gastrointestinal Endoscopic Surgeons (SAGES) meeting in Denver. As the materials manager for our surgery facility and a member of a 15-person committee that helps choose products for a 270-facility hospital-and-ASC chain, the technologies on display in the exhibit hall were of more than just passing interest. Here's what I discovered.
At least six papers at SAGES were devoted to the Lap-Band procedure. There's now a new version available. The Lap-Band VG is larger in diameter so it fits patients with thicker gastric walls or a body mass index of greater than 45. It's also said to require less dissection, and a new interior surface is said to prevent leaks. The other version is still available; each one costs the same.
If you're considering adding bariatric surgery, you may be able to get help from Auto Suture. The company offers programs for surgeons and staff designed to help get you get going, including CME courses, preceptorships, mini-fellowships, manuals, patient brochures and videos.
Several new instruments were also aimed at bariatric surgery. Olympus added a bariatric scope to its line of autoclavable EndoEye surgical videoscopes. The new scope, which lists for $16,400, is 390mm long. The camera is located at the scope's tip, meaning that the optics of a longer scope aren't an issue. The scopes come in 5mm and 10mm versions. They're available with either a 0-degree or 30-degree direction of view.
Ethicon Endosurgical showed a prototype 45cm version of its popular Harmonic Scalpel. The device, called the Ultracision Long Shears, features a special blade design designed for back scoring and enterotomy.
Inlet Medical's Closesure system will be also available in bariatric length. The prototype was about 4.5 inches long.
W.L. Gore has joined Synovis in offering staple line reinforcement for bariatric and other surgery. The new line, called Seamguard, underlies the staples, strengthening the staple line and offering hemostasis and leak prevention. In about six weeks, the material resorbs. Fit the cartridge on either an Ethicon and Autosuture gun, and a seam will be laid down underneath the staples. Each seam costs $160.
Two studies at SAGES were somewhat critical of staple line reinforcements. An animal study found no significant benefits from the strips and suggested that they might increase inflammation and adhesions. A group of Houston surgeons reported on three patients in whom the strips eroded, causing food debris to collect and block the anastomosis.
The surgical options to treat reflux disease are evolving quickly, as companies rush to develop effective, non-invasive solutions to the problem. Two brand-new approaches were on display at SAGES:
- Boston Scientific's Enteryx. This procedure is said to offer a less-invasive, pharmaceutically based method for treating GERD. Under conscious sedation, using a gastroscope, a special needle and fluoroscopy, surgeons inject a substance called Enteryx into and around the esophageal muscle. The procedure takes about 30 minutes. Apparently, inflammation and then encapsulation occurs, tightening the gastoesphogeal reflux barrier.
Enteryx is FDA-approved for adults, and Boston Scientific is now investigating the procedure for 14-to-18-year-olds. The kit lists for $1,695; Medicare reimbursement is about $1,750.
- NDO's Surgical Plicator. This system includes a gastroscope with an extra channel that exits about an inch behind the distal tip of the gastroscope. Surgeons navigate just past the gastroesophageal junction, retroflex the tip of the gastroscope, and deploy a special endoscopic tissue retractor through the aforementioned work channel, grasping and folding the tissue and then inserting a pre-tied 2-0 polypropylene suture full thickness to complete the plication.
The procedure allowed 74 percent of the patients in one study to cease protein pump inhibiting medications. The gastroscope costs about $8,000, and each disposable kit costs $1,695. Of interest: The procedure is reversible.
There was also news on two more established GERD surgeries. Stretta, the endoscopic procedure that tightens the esophagus to stop GERD, shows impressive clinical results. A study with three-year average follow-up shows a .02 percent complication rate, with 81 percent of patients able to cease medications after the procedure. That's significantly better than Nissen fundoplication.
You can get the Stretta generator for about $35,000, and the disposable catheters each cost $1,000 (you get three to six disposables for the original purchase price). The procedure takes about 45 minutes, so add OR time costs to the cost of the disposable and subtract it from $1,850 to figure your break-even point. If it's, say, $12 per minute, your profit would be about $300 per case and you would need about 100 cases to break even. It's also possible to lease or rent the device.
Meanwhile, Bard won a new indication for its Endocinch procedure: pediatric GERD. The condition can subside in adolescence, so the reversibility of the procedure is a plus.
Davol's new modified Kugel patch may make open hernia procedures easier and stronger. The surgeon makes a 4cm to 6cm incision, inserts the mesh into the opening and then flattens it with a finger. A "memory ring" inside the mesh helps the patch open smoothly. The surgeon places two stitches and cuts the holding strap, and the patch is in place. It's large enough to cover the entire groin, potentially preventing direct, indirect and femoral hernias. The patch costs about $750 on contract.
The Onux Salute Q-ring hernia mesh fixation system presents an interesting alternative to more established systems. The device leaves a short stainless-steel suture in the shape of a Q. The design leaves a relatively smooth surface, and the company claims it results in fewer adhesions than the more popular fixation systems. The company touts a recent 67-patient study of laparoscopic hernia repair showing good results with the device: no fistulas and seemingly lower pain scores than with other devices. The Salute system is available in both laparoscopic and open versions; the company consigns the instruments, which are reusable with the exception of one small disposable implant cartridge inside. The company sells the devices loaded for 10, 20 or 50 shots; the prices range from $225 to $725 per laparoscopic device. The system we currently use requires us to buy a minimum of 30 in one gun. The contract price is $400.
Polyester may be making a comeback - as a hernia mesh. Animal studies show that a polyester mesh with an absorbable collagen coating on one side (made by French company Sofradim) promotes strong tissue ingrowth on the abdominal wall side and yet minimizes bowel adhesions. The key is the construction of polyester itself. Each fiber is made up of hundreds of tiny braided filaments. The micropores between these filaments encourages tissue ingrowth while the macropores in the fabric as well as the collagen coating (which resorbs in 28 days) help keep the viscera away from the abdominal wall.
Rigid endoscopy systems
The business end of Viking's Vista Endosite system actually incorporates two separate image pathways, each with its own set of fibers and image processors. The result is a stereoscopic, 3D image that should in theory allow surgeons to gauge depth more accurately. You see the images through an ultralight heads-up display. When I tried it, I did see a difference; I could see each vessel in depth. The picture was clear and crisp. The system is voice-activated, and you can bring up radiology images into your display with just a couple simple voice commands. The actual camera is very light as well, and seems comfortable to use.
The HUD, camera, scope and processor cost about $50,000. If you want a Viking tower, it costs another $50,000, but the company says the device works with third-party towers. The camera is not autoclavable.
Stryker Instruments has also been busy, unveiling the following within the last year:
- A high-definition camera called the 1088 HD. It boasts 1280 x 1024 resolution and progressive-scan technology.
- A 19-inch diagonal flat-panel display capable of displaying high-definition and traditional signals. The arm that holds the display offers 75 degrees of tilt.
- The SDC digital capture device. A neat feature is a USB port, enabling surgeons to quickly download photos or video into their personal data assistants to show patients' families in the waiting room.
- New proprietary Visum lights and Hercules equipment booms designed to work with the company's digital OR system. The lights boast 135,000 lux. The booms can accommodate a variety of devices, including smoke evacuators.
- A user-friendly central control station. Big button-like images are easy to follow and there is a special screen for new users that holds their hand through any task. If that fails, there's even a special screen displaying the number for a live technical help line.
- Improvements to the company's SIDNE voice-activation system. Surgeons no longer have to spend 30 minutes recording a $250 voice card; the machine can now interpret anyone's commands.
Smaller facilities may now be able to afford a Karl Storz OR1 digital OR set-up. The S4 and the S6 are off-the-shelf pre-engineered systems, allowing a nurse to control lighting, cameras, insufflators and displays from a single touch screen. The company says the system works with most third-party lights and tables.
Karl Storz has improved its Image1 cameras. Its newest top-of-the-line camera head is autoclavable. New, free software allows you to control the light source with the camera head buttons. You can "pause" the light so it doesn't blind a staff member or set a drape on fire while you change scopes.
More software, called TwinVideo, enables picture in picture so you can view two images from, say, a C-arm and an endoscope. You can zoom either image, using the Image1 camera head buttons.
Storz also has the Medi-Pack, a camera, processor, light source and display that is about the size of a laptop computer with a fairly thick bottom. Although not meant to supplant your tower, the device is small enough to fit on a Mayo stand and could work well for video intubation. The cost is about $20,000. Only single-chip cameras are compatible.
Richard Wolfe has also expanded its digital OR offering. The company's cart-based RIWO-NET Mobil is still available, but now Wolfe also offers permanent boom-based digital OR systems and a full-blown image-management system that displays video, radiology and ultrasound from both image capture devices and files stored on a network. Medical records software is available as well.
Wolfe also has a new "third-arm" laparoscope holder with a remote control feature. You place the remote control in the surgeon's palm under his sterile glove. The remote is autoclavable; it lasts for 10 uses. The holder costs about $50,000.
Smith & Nephew joins the digital imaging fray with its new ED-3 Plus three-chip camera head and its 350 and 360 camera control units. Perhaps most remarkable, though, is its DORAWEB (Digital Operating Room Application) system. The system provides image management, allowing you to retrieve images from anywhere on your network. You can also use it to schedule patients for surgery and to assemble post-op reports, complete with photos. You can then access the data from any PC on your network and over a secure Web connection. The system is Oracle-based and has password protection for HIPAA compliance. It's also backward compatible.
The Bovie IDS-300 Electrosurgical Generator incorporates a technology the company says enables it to sample tissue impedance 5,000 times per second. It uses the feedback to titrate the power, enabling surgeons to achieve the desired result with low power. The result is smooth cautery with low collateral damage. A spokesperson said the difference would be most remarkable in wet field surgeries. You can trade in your old Bovie and get a $1,000 credit toward the IDS-300. It's usable with other companies' pencils and pads.
The Gyrus bipolar "vapor pulse" coagulation generator automatically tunes to the handpiece according to the tissue you are working on. You can override the settings if you want. It's foot-controlled only. You can hook up two probes at the same time, such as a scissors and a grasper. There's a black button on the footpedal to deactivate one device while you're using the other. The unit costs $18,000.
Valleylab's LigaSure reusable sealer/divider now comes in a 5mm version. Surgeons grasp tissue or vessel to activate the device. It heats the collagen and elastin in the vessel to the melting point and fuses it, eliminating any lumen. The generator automatically cuts the power and beeps when the task is complete. You can then cut the tissue without bleeding. A company rep said that thermal spread is limited to 1.5mm from the site of the seal.
A high-tech ligature/cutter from Surgrx appears to work on a similar principle to the LigaSure device, but the Enseal system employs semiconductors in the jaws. The company says each tiny area on the jaw acts as its own temperature switch, shutting down when the proximal tissue reaches 105'C, the fusing temperature for collagen. The advantage, the company says, is virtually complete absence of collateral thermal damage. The device works with three different ESU's including Conmed and Valleylab. To use the device, you must buy a controller called the Enseal that fits between the ESU and the generator. It fits through a 5mm port. The company says it can handle vessels from 1mm to 7mm. The devices are disposable and come in six-packs.
If surgeons at your facility do laparoscopic common bile duct exploration when indicated during lap choles, using a flexible rather than rigid choledochoscope, you may want to explore a simple but ingenious device from Lapsurgical Systems. After making the incision in the CBD, the surgeon slides the Multiple Instrument Guide, a curved plastic tube, through the sheath. The right-angle bend at the end of the sheath helps point baskets, balloons, lasers and other instruments right at the stone. The device should prevent scope damage; repairs cost anywhere from $3,000 to $5,000. The company claims that it knocks an hour off the procedure. This device along with the flexible scope may enable surgeons to do complicated gall bladder procedures in the ambulatory setting. The device costs $100.
A new axial needle holder from Aesculap could make laparoscopic suturing easier. Instead of a pistol grip, the device employs a cylindrical handle; you engage and disengage the holder by squeezing the handle. The device was very light and comfortable. A company spokesperson says the jaws hold the suture tightly, with no rotation.
Pilling has a new reusable "passive-active ratchet" handle that lets the doctor ratchet - or not - at his option. If you have surgeons with both preferences, this may save you, because you only need one handle. The price is from $135 to $145 for the handle.
Snowden-Pencer has a new set of ergonomically designed laparoscopic instruments called "Diamond Drive." The instrument handles are aligned with the surgeon's arm; he operates the device by pushing down on a lever with the thumb. The company says the device minimizes hand fatigue and increases tactile feedback. It's autoclavable and available for needle holders, graspers and clamps. It costs around $1,100.
The company also now distributes the Par' Quik-Stitch endoscopic needle driver with pre-tied sutures. We don't currently use this device at our facility, but I can see where it could reduce procedure times.
Microline has a neat idea for saving money on laparoscopic instruments: sets comprised of one or two handles and many disposable tips, allowing you to dispose of just the tips.
Next, there's a new and improved Endocutter from Ethicon. The new device is said to provide smoother and more consistent stapling, and the knife remains sharper longer.
Two devices from U.S. Endoscopy could make endoscopy a little easier. The familiar Roth net polyp and foreign-body retrieval device now has a stiffer wire loop that may make polyp and foreign-body retrieval easier. A new net design makes visualization easier. Physicians can use the net to retrieve even large foreign bodies and multiple polyps without extubating.
The company's new Carr-Locke disposable injection needle is highly kink-resistant thanks to a stainless-steel- Teflon-coated spring sheath. As a result, it deploys even when the elevator is fully engaged, enabling endoscopists to navigate even very difficult anatomical circumstance. The company guarantees the device will work and will give you a new one if it malfunctions.