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Thrombectomy with the X-SIZER catheter system in the coronary circulation: initial results from a multi-center study
1Division of Cardiology, Klinikum Munchen-Bogenhausen, 81925 Munchen, Germany. Thomas.Ischinger@extern.lrz-munchen.de
Insights
The X-SIZER catheter effectively removes intracoronary thrombus in suitable vessels, improving blood flow and reducing stenosis safely. This novel device offers a promising solution for challenging thrombotic lesions in coronary interventions.
Area of Science:
- Interventional Cardiology
- Medical Device Technology
- Vascular Surgery
Background:
- Intracoronary thrombus poses significant challenges in catheter-based interventions, often leading to incomplete lesion treatment and distal embolization.
- Existing treatments like lytics, antiplatelet agents, stents, and thrombectomy devices have limitations in thrombus reduction and embolization risk.
- A novel device is needed to safely and effectively address soft atherothrombotic tissue in coronary arteries, vein grafts, and stents.
Purpose of the Study:
- To assess the clinical safety and efficacy of the X-SIZER catheter for removing soft atherothrombotic tissue.
- To evaluate the X-SIZER's impact on stenosis reduction and Thrombolysis in Myocardial Infarction (TIMI) flow grade.
- To analyze angiographic complications, adverse clinical events, and device-related technical failures associated with X-SIZER use.
Main Methods:
- The X-SIZER catheter was used as an initial device in 85 patients with angiographically suspected thrombus and significant stenosis or TIMI flow reduction.
- Inclusion criteria included target lesion stenosis >= 70% or >= 50% with TIMI flow reduction and a reference vessel diameter of 3 mm.
- Outcomes assessed included stenosis reduction, TIMI flow improvement, angiographic complications, adverse clinical events, and technical failures.
Main Results:
- The X-SIZER catheter successfully reached and activated in the target lesion in 84% of patients (71/85).
- X-SIZER success, defined by improved TIMI flow or >= 20% stenosis reduction without major adverse clinical events, was achieved in 85% of cases (60/71).
- Technical failures occurred in tortuous anatomy or vessels < 3 mm; minor complications like thrombus dislodgement (3 patients) and vessel perforation (1 patient) were observed without severe sequelae.
Conclusions:
- The X-SIZER Catheter System is safe and effective for treating soft atherothrombotic tissue in relatively large, non-tortuous coronary vessels.
- The device demonstrates significant potential in improving stenosis and TIMI flow, offering a valuable option for challenging thrombotic lesions.
- Future improvements in catheter design could expand its utility to more complex vascular anatomies.
Abstract:
Despite the use of lytics, aggressive antiplatelet agents, stents and thrombectomy devices, intracoronary thrombus remains a challenge for interventional catheter-based techniques, mainly due to insufficient reduction of thrombus and risk of distal embolization. This study assesses the clinical safety and efficacy of the X-SIZER catheter (EndiCOR Medical, Inc., San Clemente, California), a novel device designed to remove soft atherothrombotic tissue from native coronary arteries, saphenous vein grafts and restenotic stents. The X-SIZER was used during catheter-based intervention as the initial device in patients with angiographically suspected thrombus at the target. Inclusion criteria were target lesion stenosis of > or = 70% diameter stenosis (DS) or > or = 50% DS with Thrombolysis in Myocardial Infarction (TIMI) flow reduction and a reference diameter of 3 mm. Analyses were performed for reduction of stenosis, improvement of TIMI flow grade by X-SIZER alone (X-SIZER outcome) and after final adjunct procedure (final outcome), angiographic complications (dissection, embolization, perforation), adverse clinical events during hospitalization, and device-related technical failures. Eighty-five patients (age range, 31-82 years old; 69 male) were studied. Forty-four patients with unstable angina and 31 with acute myocardial infarction (MI) were treated, including 18 saphenous vein grafts and 17 re-occluded stents. In 71/85 patients (84%), the X-SIZER reached the target lesion and was successfully activated. Technical failures were associated with tortuous anatomy or vessel caliber < 3 mm. In 60/71 patients (85%), X-SIZER success was achieved by either improving TIMI flow by at least one grade or reducing DS by at least 20% (DS pre-X-SIZER = 88 +/- 19%; DS post-X-SIZER = 60 +/- 29%) without a major adverse clinical event (i.e., death, Q-wave MI, three-fold elevation of creatine kinase, or total occlusion or perforation requiring emergency bypass surgery or emergency stenting). Creatinine kinase rise greater than 3 times baseline occurred in 2 patients without preexisting acute MI. Thrombus dislodgement occurred in 3 patients and vessel perforation without clinical sequelae occurred in 1 patient. No other major procedural complications were noted. Adjunct interventions (balloon and stent) were employed in all except two X-SIZER stand-alone cases for a final DS of 11 +/- 18%. The X-SIZER Catheter System is simple to use, safe and effective for patients with relatively large, non-tortuous target vessels. Improved catheter characteristics may expand its use to more complex anatomy.