September 2021 | Issue 83
20 Advertorial
Issue 83 | September 2021
Advertorial 21
THIS ADVERTORIAL IS SPONSORED BY ARGON MEDICAL DEVICES
Reliability, ease-of-use and availability have made SkaterTM drainage catheters a go-to product Placing a drain is an important, quotidian, “bread and butter” procedure that often has a tremendous impact on patients’ lives. “A drain is a drain until it is not,” says Sean Calhoun, who outlines the benefits of the Skater all-purpose, nephrostomy and biliary drainage catheters (Argon Medical Devices). He hones in on their anti-kinking and locking mechanisms, ease of insertion and transition and compatibility with both alcohol and doxycycline. Calhoun also shares his excitement about the recent commercial launch of the Skater mini-loop drainage catheters in the USA and the European Union, telling Interventional News: “I am hopeful that this will eliminate the problem of losing access to the abscess cavity by having the catheter track smoothly through the wall and into a small cavity. It is also going to be very helpful for external biliary drains.”
“T
he Skater drainage catheter is consistent, reliable, extremely easy to use and is visualised well under fluoroscopy due to its good radiopacity,” says Calhoun, vice chair of the Radiology Department and an interventional radiologist, Atlantic Health System, Morristown, USA. “Additionally, the locking mechanism is simple,
Case 1:
Lymphocoele drainage and sclerosis with Skater all-purpose drainage catheter 57-year old male post robotic prostatectomy with right pelvic lymphocoele and infected left pelvic lymphocoele. The patient underwent CTguided drainage with placement of a 10Fr Argon Skater drainage catheter on the left yielding 40ml cloudy lymphatic fluid and an 8Fr Argon Skater pigtail drainage catheter on the right yielding 90ml of lymphatic fluid. After the acute infection had cleared, bilateral lymphocoele sclerosis was performed with 98% dehydrated alcohol. The Skater drainage catheter is compatible with alcohol, minimising the risk of catheter breakdown and alcohol extravasation. One day later, contrast studies through the drainage catheters revealed near complete resolution of the lymphocoeles with no further output from either catheter. Both catheters were removed intact. A subsequent CT performed for prostate cancer surveillance demonstrated complete resolution of both lymphocoeles.
intuitive and designed for patient comfort in that it is not bulky. The break-off tab is very easy to use and very easy to undo when it is time to remove the catheter—these catheters are also perceived to have excellent patency rates, which are the key features for any drainage catheter,” he adds. Drainage is often seen as a quotidian, relatively routine procedure, with interventional radiologists placing five to 10 drainage catheters a week under different imaging modalities depending on the location. Drains are placed under imaging guidance for a wide variety of indications, including abscesses, biliary and ureteral obstructions, pleural effusions and pneumothoraces, Calhoun, who is also programme director for the Radiology Residency, indicates.
Case 2:
Skater mini-loop drainage catheter 80-year-old female with history of ovarian cancer and complicated sigmoid diverticulitis causing obstruction of distal left ureter. The patient underwent left percutaneous nephrostomy and antegrade ureteral stent placement. Due to the small renal pelvis, it was difficult to reform the pigtail of a standard nephrostomy tube. Therefore, a Skater mini-loop drainage catheter was used as a covering nephrostomy tube and was easily reformed in the small renal pelvis without disturbing the proximal loop of the ureteral stent.
An important point he emphasises is that while a drain is seen as a standard piece of equipment, there are subtle differences that are not appreciated until you have a drain that fails, commenting that “a drain is a drain until it is not”. This is when you really appreciate the differences in the technology and design and the many advantages offered by drains such as Skater, he notes. Calhoun particularly draws attention to the hydrophilic coating, resistance to kinking and accordioning—three things that contribute to the ease of insertion and the reliability of the device. “During insertion, drains can certainly accordion because the multiple side holes create a relative weakness in the catheter. I have had catheters in the past in which the side holes accordion, particularly in tight biliary strictures. This makes it very difficult to advance the drain. The Skater catheter seems to track very well through firm cirrhotic livers. When using other catheters in the past where there was challenging cirrhotic liver and a tight stricture, I recall going through several catheters that just continually weakened; that has almost never been the case with the Skater line. Those difficult situations now seem like distant memories, because we have been using this product for 10 years. “The concept of durability and not having the catheter break down necessitates patients having to come in for avoidable changes, particularly when we start using the catheters for things like lymphocoele sclerosis and cyst sclerosis with alcohol, during which some catheters can break down and fragment. I have also seen patients come in with their catheters in all sorts of disarray; they can have kinks, be twisted and become occlusive. While many patients keep them in pristine condition, others do not, and we have observed that the catheter is twisted and wrapped around and coiled under a dressing that has not been well cared for, oftentimes with the catheter not draining in that situation. This might lead the physician to believe that the catheter is occluded, but in fact, there is a kink in the catheter under the dressing; we have seen that with other manufacturers in the past. The Skater catheter appears to be much more resistant to kinking.”
promote healing. The primary compound it has been our perception that the Skater that we use is alcohol, but doxycycline is catheters have a much lower rate of early another popular alternative these days with occlusion than some of the other catheters alcohol becoming less available due to that we have used in the past.” manufacturing shortages. Many of the other non-compatible catheters will break down Skater mini-loop launch during this sclerosing procedure. You hear received with enthusiasm horror stories of interventional radiologists Commenting on the recent commercial chasing catheter fragments in the cyst cavity, launch of the Skater mini loop catheter, an Sean Calhoun and trying to retrieve them can be very expansion of Argon’s Skater all-purpose difficult. Fragmentation is not only cumbersome, it and nephrostomy drainage portfolio, which uses a 40% puts the patient at risk. So, being able to confidently smaller loop to help secure the catheter and drain fluid use alcohol, or doxycycline, knowing that the catheter from smaller cavities, Calhoun says: “I have often been is going to stay intact is huge,” Calhoun elaborates. disappointed with the mini pigtail catheters available He also calls out the flow rates as being important. because the transition at the tip is unfortunately not “The fact that the Skater catheter has a consistent lumen even at the hub means that you avoid the problem of effectively putting in a smaller catheter than what you think you are putting in.”
Biliary drains and occlusions
Biliary drains can frequently be “management headaches” as patients, who are very sick with sepsis and life-threatening infections, can come in with occlusions. Early occlusions are very problematic for patients as they can lead to life-threatening infections. Other times it is just an inconvenience for the patient, notes Calhoun. “If there is poor drainage, it is often due to occlusion of the catheter side holes, so I think the skived side holes of the biliary drainage catheters certainly help to reduce the occlusion rates. All catheters are going to be subject to some rate of reocclusion, but
Two “promising” new devices for venous valve replacement presented at SVS VAM The progress of two “promising” new devices in the venous valve replacement space was outlined during a special session at the Society for Vascular Surgery’s Vascular Annual Meeting (SVS VAM 2021; 18–21 August, San Diego, USA and online) co-hosted by the American Venous Forum (AVF).
Skater is compatible with both doxycycline and alcohol
One major advantage of the Skater catheter is that it is compatible with both alcohol and doxycycline. Calhoun explains why this dual compatibility is important: “Patients who have undergone drainage of a symptomatic cyst, a symptomatic renal cyst, or a hepatic cyst, or postoperative lymphocoele, will often be sclerosed to avoid cyst recurrence or
Case 3:
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Photo 143676056 / Medical © Solarisys13 | Dreamstime.com
Skater biliary drain 75-year-old male with obstructive jaundice secondary to adenocarcinoma of the head of the pancreas and a history of endoscopic retrograde cholangiopancreatography-induced pancreatitis. Leftsided approach percutaneous biliary drainage was performed with placement of a 10Fr Skater biliary drainage catheter which passed easily across the common bile duct obstruction.
We have expanded our Skater inventory as there are multiple sizes and diameters available. We can always count on that catheter being on the shelf and having plenty of stock and it has now become our go-to product.”
ELLEN DILLAVOU, ASSOCIATE professor of Vascular Surgery at Duke University Medical Center in Durham, USA, placed a lens over the BlueLeaf system (InterVene) and the VenoValve (Hancock Jaff Laboratories). “The history of venous valve replacement is long and usually not successful,” Dillavou told attendees. Both autogenous and non-autogenous valves have been tried for years to replace those that have been damaged or congenitally absent in the leg, she continued, but “on the horizon we now have two very promising new products.” The BlueLeaf system, Dillavou explained, is an endovascular means to create a mono- or bicuspid valve. The system “takes the thickened intima of a post-thrombotic vein that is damaged and, with a dissector, gets a wire through that thickened vein wall, and then uses hydrodissection, balloon dissection and a mechanical dissector to form a pocket,” she said, adding: “Intravascular ultrasound (IVUS) is critical during the procedure—both in choosing the vein site as well as looking at the final result.”
Early results, which are in publication, indicate a 93% technical success rate “of creating at least a monocuspid valve,” with the researchers testing the system producing a mean of 1.3 valves per patient. The investigators reported having 10 patients at one-year followup, with no thrombotic events recorded, Dillavou noted. “Although they did not have a difference in the popliteal reflux time, they did have a decrease in the Venous Clinical Severity Score (VCSS).” Additionally, nine out of nine venous ulcers either healed or improved at the last follow-up, she added. Two-year post-VenoValve implantation data were reported by Jorge Ulloa (Fundacion Santa Fe-Universidad de los Andes, Bogota, Colombia), the principal investigator for the first-in-human VenoValve trial. Key highlights from Ulloa’s presentation indicate that: ■ Reflux decreased from an average of 1.95 to an average of 0.72 (a 63% improvement) ■ Disease manifestations (measured by revised Venous Clinical Severity
ideal to get into a small abscess cavity. In these small cavities, you do not have a lot of guidewire purchase, so you want the catheter to track smoothly and easily through the wall, so that you can situate it without losing purchase. In my experience the transition is much smoother and uniform with the Skater range than the other catheters out there, so I am hopeful that this will eliminate that problem. It is also going to be very helpful for external biliary drains. If it performs the same as the other catheters in terms of drainage and reliability, then we have hit a home run.”
Product support and availability matter
While the pandemic seems to have impacted the availability of product ranges across the board, the Skater device has been relatively unaffected. “My technologists are regularly flagging back orders. Matters can come to a head when a patient is already here, and we have to pivot to find other alternatives. That has not been the case with Skater catheters, or any of the Argon products, which are all manufactured in the USA. They have always been available and the product support has been excellent. We have expanded our Skater inventory as there are multiple sizes and diameters available. We can always count on that catheter being on the shelf and having plenty of stock and it has now become our go-to product,” says Calhoun.
Score [rVCSS]) decreased from an average of 13.38 to an average of 5.38 (a 60% improvement) ■ Pain (measured by Visual Analogue Scale [VAS] scores) decreased from an average of 7.25 to an average of 0.5 (an improvement of 93%) ■T here were no safety issues or venous ulcer recurrences The data reported are for a group of eight patients who participated in the VenoValve first-in-human study and who agreed to participate in a one-year poststudy follow-up. Three additional first-inhuman patients elected to not participate in the one-year post-study follow-up but reported no negative VenoValve-related events during the one-year follow-up period. The average post-VenoValve implantation time for this cohort of patients is two years, and the comparative results are based on pre-VenoValve levels compared to the patients’ most recent office visit. Marc Glickman, Hancock Jaffe’s
Structure of normal and varicose veins
senior vice president and chief medical officer stated, “These data are exactly the results that we were looking for as we begin our VenoValve SAVVE [Surgical anti-reflux venous valve endoprosthesis] pivotal trial.” The SAVVE US pivotal trial for the VenoValve will include 75 patients at up to 20 sites. The primary endpoints will be the same as for the first-in-human trial: the primary safety endpoint is the occurrence of a major adverse event (MAE) in less than 10% of patients at 30 days post-VenoValve implantation, and the primary effectiveness endpoint is improvement of reflux equal to or greater than 30% at six months following VenoValve surgery. MAEs are defined as the composite of all-cause mortality, deep wound infection, major bleeding, ipsilateral deep vein thrombosis (DVT), or pulmonary embolism. Improvement of VCSS and VAS scores are also included in the SAVVE study as secondary endpoints.