Presenting “remarkable results” from the JETi registry—a prospective, multicenter, observational study which collected real-world data on the safety, performance and clinical benefits of the JETi peripheral thrombectomy system—speaker Mahmood K. Razavi (Children’s Health of Orange County, Orange, USA) relayed the positive outcomes seen with the “powerful” Jeti device (Abbott) to audience members at the 2023 International Vein Conference (April 27–29, Miami).
Of their main objectives, the research team set about analyzing JETi outcomes in patients with deep venous thrombosis (DVT), to ultimately determine if iliocaval and iliofemoral DVT in a single session is feasible. Speaking to Vascular Specialist, Razavi explained that “Jeti was one of the earlier devices that came into market that had the capability for single-session treatment of patients—so this was the basis of our intention-to-treat analysis, to evaluate the effectiveness, outcomes and feasibility of the device for this purpose.”
Treating 53 limbs in 47 patients, Razavi stated that around a fifth—21%—had symptoms longer than 14 days, placing them in the sub-acute category. Their primary efficacy endpoint was acute procedural success defined as the establishment of unobstructed flow from the limb in a single session. Another “critical” secondary endpoint Razavi highlighted was the evaluation of haemoglobinuria due to the Jeti’s differing mechanism of action in comparison to other devices such as the AngioJet (Boston Scientific) device. “People often confuse the [Jeti] mechanism of action with Angiojet. They are different. Jeti can be described as a hydrodynamic thrombectomy device, although this is not commonly a used term” Razavi explained.
The Jeti system is designed to deliver a stream of high-pressure saline via a pump to the distal tip of the catheter, while aspirating thrombotic material. The saline jet acts to macerate the clot inside the catheter and prevent clogging. Hence no intravascular clot maceration and no haemoglobinuria.
Razavi, describing their findings, stated that re-establishment of unobstructed flow after a single session was seen in 89% of patients with Jeti alone at a mean procedure time of 90 minutes. Overall, complete flow was reestablished in 94% after Jeti combined with stenting. Iliocaval thrombosis was present in 12 patients included in this cohort, their clot extending into the inferior vena cava (IVC). Furthermore, in nine of these 12 the researchers found the clot to be behind an IVC filter—“this meant that the entire infrarenal IVC was thrombosed and yet we achieved these kind of results—it was somewhat surprising to us.”
Breaking their results down further, Razavi stated that in these patients prior to stenting, flow restoration with Jeti alone was seen in 86% of patients with a clotted IVC (100% after stenting), 75% in iliofemoral (92% after stenting) and 100% of the isolated femoropopliteal patients, respectively. “This is a very different aspiration system, [Jeti] was far more efficacious than we anticipated,” Razavi opined.
Although their team did not evaluate long-term clinical outcomes, they did assess 30-day Jeti-related efficacy via ultrasound, a measure which Razavi averred has been correlated with long-term patency and the development of post-thrombotic syndrome, as seen in the ATTRACT trial. Referring to the rate of clot absence during ultrasound follow-up, in the common femoral it was 87.2%, and in the femoral vein, 71.7%.
“Not only was this a highly effective treatment in 90 minutes, but the mid-term outcomes were also fairly good and comparable to other studies such as the ClotTriever outcomes [CLOUT] registry” Razavi continued. “At the time this system became available there were multiple studies that had been published and none could consistently achieve single-session thrombectomy in patients with iliofemoral DVT, let alone iliocaval,” said Razavi. “We had made the observation that this is a very efficacious system—but can we successfully treat DVT in a single session? Is Jeti a superior system as compared to devices that were used before? It would be a game-changer if we could treat iliocaval and iliofemoral DVT in a single session with mid-term patency rates similar to thrombolysis.”
Of his concluding thoughts, Razavi hopes that the team’s experiences throughout this trial will help European and US practitioners alike choose “more carefully as to what works and what does not”, and to “go with the system that is proven to work without causing vessel wall injury”, which may perhaps mean taking up and employing an unfamiliar device and system.