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Transluminal extraction coronary atherectomy
B H Annex1, M H Sketch, R S Stack
1Department of Medicine, Duke University Medical Center, Durham, North Carolina.
Insights
The TEC atherectomy catheter effectively removes atheroma and thrombus, showing favorable success rates in coronary lesions and bypass grafts. Further trials are needed to define its optimal role in interventional cardiology.
Area of Science:
- Interventional Cardiology
- Vascular Surgery
- Medical Device Technology
Background:
- The TEC (Transluminal Extraction Catheter) is an atherectomy device designed to excise and aspirate atheromatous plaque and thrombus.
- It received FDA marketing approval in 1993 for treating coronary vasculature lesions.
- Clinical investigation has spanned over six years prior to its widespread adoption.
Purpose of the Study:
- To evaluate the clinical and lesion success rates of the TEC atherectomy catheter in a large patient registry.
- To investigate the mechanisms of action and efficacy of the TEC in various lesion types, including those with intraluminal thrombus.
- To identify potential niches for the TEC in interventional cardiology, particularly in complex lesions and bypass grafts.
Main Methods:
- Analysis of data from the US TEC Multicenter Registry.
- Utilizing percutaneous angioscopy and intravascular ultrasound to visualize and understand the TEC's interaction with atheroma and thrombus.
- Assessment of procedural success in native coronary vessels and saphenous vein bypass grafts, including challenging angiographic features.
Main Results:
- Favorable overall clinical and lesion success rates were observed in the registry.
- Similar success rates were achieved in both native coronary arteries and saphenous vein bypass grafts.
- The TEC demonstrated efficacy in treating lesions with unfavorable features like ostial location, intraluminal thrombus, and total occlusions.
- Angioscopy confirmed thrombus removal, especially in unstable coronary syndromes, but noted frequent intimal disruptions post-procedure.
Conclusions:
- The TEC atherectomy catheter shows promise for treating complex coronary lesions, including those with intraluminal thrombus and in saphenous vein grafts.
- While effective, the device can cause intimal disruptions, necessitating further evaluation in randomized trials.
- Potential applications include managing diffusely diseased bypass grafts and as primary therapy for thrombotic lesions, possibly with adjunctive treatments.
Abstract:
The TEC is a forward-cutting atherectomy catheter that has the unique potential to excise and aspirate atheroma, especially intraluminal thrombus. This device has been under clinical investigation for more than 6 years and received final marketing approval by the FDA for the treatment of lesions in the coronary vasculature in 1993. In the US TEC Multicenter Registry, the overall clinical and lesion successes were favorable. The success rates were similar for both native coronary vessels and saphenous vein bypass grafts. Importantly, the procedural success rates were maintained even in the presence of several unfavorable angiographic features, such as ostial location, intraluminal thrombus, and total occlusion. Further insights into the mechanisms of action of the TEC were made from studies using percutaneous angioscopy and intravascular ultrasound. Angioscopy clearly demonstrated that the TEC was indeed able to remove intraluminal thrombus, especially loosely adherent red thrombus, in a population of patients with unstable coronary syndromes. However, the TEC frequently leaves behind multiple intimal disruptions which not only create a possible nidus for restenosis but also explain the frequent hazy angiographic appearance of the vessel after TEC atherectomy. As is true for all new interventional devices, the specific niche for the TEC in interventional cardiology will best be determined in randomized clinical trials. There are several areas in which the TEC appears promising. First, this device may have a role in the management of patients with diffusely diseased saphenous vein grafts. Second, the TEC may be an effective primary therapy in lesions with intraluminal thrombus. Treatment with the TEC may then be followed by an adjunctive therapy to maximize the final vessel diameters. Finally, the TEC may be valuable in the treatment of lesions in patients with high-risk unstable coronary syndromes.