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“Honestly, there’s nothing even close to it for thrombectomy on the arterial side of things,” according to Martyn Knowles, MD, a vascular and endovascular surgeon at University of North Carolina (UNC) Health Care in Raleigh, North Carolina, speaking about the Lightning Bolt 7 aspiration thrombectomy system.
“There’s really no other game in town,” Knowles continues. “Penumbra is leaps and bounds ahead of anybody else. And I think the thing that has made the Bolt work so well is the ability to use saline to modulate the aspiration and break up the friction within the catheter so clots are quicker and easier to remove in my experience.”
Knowles points to three prevailing ways in which computer-assisted vacuum thrombectomy (CAVT)—as enabled by the Lightning Bolt 7 device—has positively impacted acute limb ischemia (ALI) care in his practice. The first of these is the speed at which clot is removed, with algorithms working to optimize suction and clearance of the catheter; the second is a greater ability to ingest more complex clots more easily, allowing for the treatment of more chronic/ subacute cases; and the third is “really good blood-loss mitigation,” he says.
“You’ve got that saline interacting with the catheter,” Knowles explains, “and it augments those three things that I think are most important for successful thrombectomy—and every iteration that Penumbra provides makes that better.”
Shifting towards thrombectomy
“I finished training in 2014 and, at that time, treatments for ALI were really either thrombolysis—and, if that didn’t work, surgery—or just going straight to surgery,” Knowles states. He recalls that there were several devices that offered some hope in ALI patients back then, but that, ultimately, “none of that stuff ever really worked,” citing inconsistent outcomes and some “really frustrating results.”
“As time went on,” he continues, “I ended up using Penumbra’s CAT 6, CAT 5 and CAT 3 [catheters]. I started using them in ALI and I realized that they worked fairly well—and I figured that there was a place for thrombectomy-first in some of these cases.”
From 2015 onwards, Knowles employed thrombectomy more and more often, initially utilizing it in “easier” cases but—following device improvements, including CAVT technologies and larger, more optimized catheters—he was able to achieve increasing levels of success. As a result, he has essentially “flipped” his typical ALI approach from thrombolysis-first to endovascular-first, either deploying thrombectomy on its own or alongside surgery.
“I’ve been fairly consistent with that over the last three or four years, and I really like it,” he adds. “I never liked thrombolytics; I had some complications with people who bled, and so I was really happy to switch. And, as time has gone on, the devices have just gotten better and better, and better. To start with, they were pulled out of the ‘neuro’ world and, as they’ve tailored the devices for the peripheral arteries, it really has worked well.”
A hybrid approach
Knowles highlights the fact that using Lightning Bolt 7 does not burn any treatment bridges down the line. If for some reason the thrombectomy is not fully successful, then open surgery can be employed to gain full perfusion, and using Lightning Bolt 7 will make that surgery “much, much easier,” he explains.
With the other treatment options—lytics and surgery—“if you choose those frontline it is more difficult to change your treatment path,” he continues. “This hybrid approach with Lightning Bolt 7 frontline can be helpful in more challenging or complex cases.
“You’re able to go in and deal with long-level occlusions, and multiple vessels, and—a lot of the time—with one device, the Lightning Bolt 7, for everything from proximal tibial vessels, popliteal and SFA [superficial femoral artery], to bypass grafts. You really only need one catheter, so it has made those tougher cases—and that tougher clot—easier and easier for me.”
Asked to provide a message for his peers regarding the system, Knowles advises that the key is “to get in there quickly” and emphasizes the importance of patience in trickier ALI cases. “Coordinated approaches” to removing clot are vital, as is “making sure you have good sheath access,” Knowles adds.
What does the future hold for ALI treatment?
“I think there are two parts to it,” Knowles says. “I think there’s a large number of practicing vascular surgeons who have not given the device a ‘real go’ in ALI cases— they always go straight to [open] surgery or thrombolytics, and they have not really tried the newer devices.
“So, I think, in the next five-to-seven years, what’s going to happen is that more people are going to see that it works and start using it. And I think the move is going to be more and more towards endovascular-first treatments for ALI.
“Secondly, I think the people who are using it are going to be expecting and wanting even more improvements in the devices. Right now, the interesting thing is that we don’t want the arterial devices to be bigger; we’re at a good size.
“Most vascular surgeons want, at maximum, a 7F device, but we want it to work better and we don’t want a lot of blood loss. So, one thing I can possibly see over the next couple of years is a mechanical aspect to the Penumbra device—something that can assist the algorithm, not just in modulating the aspiration and pulling the clot out, but also in terms of how well the device interacts with the vessel wall as well as the lumen of the vessel.”
Knowles sees an increasing number of operators likely getting “more comfortable with [the endovascular-first approach], and realize that it works.” He reiterates the potential for endovascular thrombectomy as an “adjunct” that enables better outcomes than more traditional surgeries.
“It doesn’t need to be a standalone,” Knowles says. “I think the transition from the open era to the [endovascular]-first era is going to happen—it works, and it’s rare that I do an open thrombectomy by itself nowadays,” Knowles concludes. “A lot of the time, if I do a hybrid procedure, I find that it’s much, much more successful with angiography— and sometimes targeted thrombectomy to really optimize things, and get that patient out of trouble.
“That will be the push,” Knowles adds. “I think there’s going to be more and more endovascular-first, and the era of just pure open ALI treatment is probably going to be gone in the next couple of years.”
Martyn Knowles is a consultant for Penumbra, Inc. Procedural and operative techniques and considerations are illustrative examples from physician experience. Physicians’ treatment and technique decisions will vary based on their medical judgment. The clinical results presented herein are for informational purposes only, and may not be predictive for all patients. Individual results may vary depending on patient-specific attributes and other factors.
Caution: Federal (USA) law restrictions these devices to sale by or on the order of a physician. Prior to use, please refer to the Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use. For the complete Penumbra IFU Summary Statements, please visit www.peninc.info/risk. Please contact your local Penumbra representative for more information.
