Transluminal Extraction Research Articles

Acute results and long-term outcome of transluminal extraction catheter atherectomy for saphenous vein graft stenoses.

Distal embolization of atheroma and thrombus is a major concern when performing balloon angioplasty in coronary saphenous vein grafts (SVGs). The transluminal extraction catheter (TEC) is designed to remove this material and may improve the safety of percutaneous treatment of SVG disease. We assessed the acute results and long-term outcome of 67 patients (mean age 65.6 +/- 8.1 years; range 47-83 years) who underwent 73 separate TEC atherectomy procedures. Eighty-eight SVG lesions were treated (mean age 8.7 +/- 3.8 years from bypass surgery). Procedural success (< 50% final diameter stenosis and absence of major complications) was obtained in 63 patients (86%). Adjunctive balloon angioplasty and/or directional coronary atherectomy was required in 69 of the procedures (95%). Major complications, occurring in 8 patients (11%), were acute closure in 4 (5%), resulting in Q-wave myocardial infarction in 3 and urgent bypass surgery in 1, and distal embolization in 4 (5%; 1 associated with Q-wave myocardial infarction). Angiographic follow-up was available for 50 patients and restenosis was present in 26 (52%). These data suggest TEC atherectomy can be performed in SVGs with an acceptable procedural risk, but restenosis remains a significant limitation which will require other strategies to overcome.

Clinical and angiographic results of transluminal extraction coronary atherectomy in saphenous vein bypass grafts.

Transluminal extraction coronary (TEC) atherectomy is a relatively new device that has recently been approved by the Food and Drug Administration. Because of its ability to aspirate clot and atheromatous material, TEC atherectomy may be useful in patients with stenoses in saphenous vein bypass grafts. TEC atherectomy was performed on 158 saphenous vein graft lesions in 146 consecutive patients with a mean age of 65 +/- 8 years (78% men). Clinical indications for atherectomy included stable angina (37%), unstable angina (54%), and postinfarction angina after recent (< 1 month) myocardial infarction (8%). Patients with acute myocardial infarction and target vessels < 2 mm in diameter were excluded. The mean age of the bypass graft was 8.3 +/- 3.0 years, and 17% were diffusely diseased and degenerated. Complex lesion morphology included total occlusion (6%), eccentricity (64%), ulceration (18%), and thrombus (28%). The TEC atherectomy cutter was successfully advanced through 144 lesions (91%), but technical failures occurred in 14 lesions (9%), and these were subsequently managed by successful balloon angioplasty. Quantitative angiography revealed an increase in lumen diameter from 0.9 +/- 0.5 mm, to 1.5 +/- 0.7 mm after TEC atherectomy, to 2.3 +/- 0.8 mm after percutaneous transluminal coronary angioplasty (PTCA) (P < .001), which corresponded to decreases in diameter stenosis from 75 +/- 14%, to 58 +/- 20% after TEC atherectomy, to 36 +/- 22% after PTCA (P < .001). Device success was achieved in 39.2% (post-TEC atherectomy decrease in diameter stenosis > or = 20%), and procedural success was achieved in 84% (final diameter stenosis < 50% in the absence of a major complication). Angiographic complications were evident in 33 lesions (20.7%) immediately after TEC atherectomy and in 8 lesions (5%) after PTCA, including distal embolization (11.9%), no-reflow (8.8%), and abrupt closure (5.0%), but no perforations. Adjunctive PTCA (and other medical therapy) successfully managed 61% of angiographic complications. Serious clinical complications included in-hospital death in 3 patients (2.0%), emergency bypass surgery in 1 patient who died (0.7%), Q wave myocardial infarction in 3 patients (2.0%), non-Q wave myocardial infarction in 4 patients (2.7%), vascular injury requiring surgical repair and/or blood transfusion in 9 patients (6.1%), and hemorrhagic cerebral infarction in 4 patients (2.7%). Using a composite clinical end point defined as in-hospital death, emergency bypass surgery, or myocardial infarction, the strongest independent correlate (P < .001) of a severe clinical complication was the development of one or more serious angiographic complications (no-reflow, distal embolization, or abrupt closure) immediately after TEC atherectomy. Complete clinical follow-up was available in 118 (92%) of 128 eligible patients at an interval of 6.0 +/- 2.5 months after discharge. Late cardiac outcome included recurrent angina treated with medical therapy (18%), repeat percutaneous intervention on the original target lesion (26%), repeat coronary artery bypass surgery (5%), Q wave myocardial infarction (4%), and late cardiac death (7%). Angiographic follow-up in 105 (80%) of 132 eligible lesions revealed a restenosis rate of 69% (defined as a diameter stenosis > 50%), including 30 lesions (29%) with total occlusion of the original lesion. In patients with stenoses in saphenous vein bypass grafts, TEC atherectomy is limited by the frequent need for adjunctive balloon angioplasty to achieve adequate lumen enlargement and to manage TEC atherectomy-induced complications. Although the incidence of serious clinical complications is similar to that of other percutaneous interventions in vein grafts, there is a high incidence of restenosis and late vessel occlusion. Prospective randomized studies are needed to determine the best revascularization strategy for high-risk patients with old degenerated vein

Are residual stenoses after excimer laser angioplasty and coronary atherectomy due to inefficient or small devices? comparison with balloon angioplasty

Objectives. The purpose of this study was to determine whether residual stenoses after excimer laser angioplasty and atherectomy were due to inefficient tissue ablation/removal or to undersized devices.BackgroundSignificant residual stenoses are commonly observed after use of laser and atherectomy devices. It is not known whether these residual stenoses are due to inefficient or undersized devices,Methods. To determine the relative contribution of these factors, the minimal lumen diameter, percent diameter stenosis and normal reference diameter were measured immediately before and after coronary interventions in 696 lesions, including transluminal extraction atherectomy, high speed mechanical rotational atherectomy, excimer laser angioplasty and conventional balloon angioplasty, The ratio of the diameter of the device to the normal reference diameter (D/A, a measure of device sizing) and the ratio of the residual lumen diameter after use of the device to the device diameter (RLD/D, a measure of the efficiency of lumen enlargement) were calculated.Results. Baseline diameter stenoses were similar for all interventions. The percent diameter stenosis were greater immediately after extraction atherectomy (60 ± 21%), rotational atherectomy (54 ± 23%) and excimer laser angioplasty (61 ± 18%) compared with balloon angioplasty (26 ± 12%, p < 0.001). The DA ratio was smaller after extraction atherectomy (0.63 ± 0.14), rotational atherectomy (0.59 ± 0.17) and excimer laser angioplasty (0.51 ±0.11) compared with balloon angioplasty (1.05 ± 0.13, p < 0.001). The RLD/D ratio was similar after extraction atherectomy (0.73 ±0.24) and balloon angioplasty (0.71 ±0.11) but was greater after rotational athereetomy (0.92 ± 0.16, p < 0.001) and excimer laser angioplasty (0.85 ± 0.30, p < 0.01) compared with balloon angioplasty.Conclusions. Residual stenoses after extraction atherectomy, rotational atherectomy and excimer laser angioplasty were more severe than after balloon angioplasty but were due to undersized devices (low DA ratio), not to inefficient devices (low RLD/D ratio). Rotational atherectomy and excimer laser angioplasty were more efficient (higher RLD/D) than balloon angiopiasty, whereas extraction atherectomy and balloon angioplasty were similar.

Baseline characteristics and therapeutic goals in the New Approaches to Coronary Intervention (NACI) registry.

The New Approaches to Coronary Intervention (NACI) voluntary registry was designed to study the use, safety, and efficacy of new percutaneous transluminal interventional devices including directional coronary atherectomy, the transluminal extraction catheter, the rotablator, the Palmaz-Schatz stent, the Gianturco-Roubin stent, the Advanced Interventional Systems (AIS) laser, and the spectranetics laser. To date, more than 3800 consecutive patients treated for the first time with a new device at 41 centers have been entered into the registry. Complete detailed information about the patient, lesions, device characteristics, reasons for device selection, and procedural data, such as adjunctive use of conventional balloon angioplasty (PTCA), was available for the first 2835 patients. The registry shows that 88% of the 3233 attempts with a new device were intended as a definitive treatment of target lesions, frequently in combination with adjunctive PTCA. The remaining 12% of attempts with a new device were unplanned, prompted by unexpected complications, unsuccessful attempts, or suboptimal results with PTCA. Although there was some overlap in the indications for selecting a given interventional device, the variation from device to device was sufficiently large to caution users against any direct comparison of either safety or efficacy between devices without careful attention to the differences in baseline patient and lesion characteristics, treatment plans, and the circumstances of device use. This report provides the first comprehensive overview of how new interventional devices are currently being used in the treatment of coronary artery lesions at the 41 centers participating in the NACI registry.

Transluminal extraction atherectomy and adjunctive balloon angioplasty for restenosis after palmaz‐schatz coronary stent implantation

Two patients who developed restenosis after implantation of Palmaz-Schatz coronary stents were successfully treated by transluminal extraction atherectomy and there has been no recurrence on follow-up angiograms. The optimum strategy for managing restenosis after coronary stenting remains unclear, but transluminal extraction atherectomy appears to be a safe and effective option.

Mechanical dilatation rather than plaque removal as major mechanism of transluminal coronary extraction atherectomy.

Atherectomy with the transluminal extraction endarterectomy catheter (TEC) is a new approach for treatment of coronary artery disease, which continues to undergo FDA investigational studies. The major mechanism of the TEC device should be excision of plaque and its removal due to suction applied through an attached vacuum. We report about the acute results in 24 patients treated with TEC atherectomy in native vessels and the outcome of 18 patients who, until recently, underwent follow-up catheterization after 6 months. The procedure was successful (residual stenosis less than 50%) in 7 of 24 patients with TEC atherectomy alone (29%); 15 of 24 patients (65%) required additional PTCA in order to achieve angiographic success (10 of 24) or to treat total occlusion (2 of 24) or distal embolization (3 of 24) following atherectomy. One TEC attempt failed due to guiding catheter problems, another major complication was a vessel perforation leading to a non-Q wave infarction. The minimal residual diameter after passage of the stenosis (prior to additional PTCA) with the 5.5 Fr catheter (n = 14) was 1.5 +/- 0.2 mm, with the 6 Fr catheter (n = 9) 1.8 +/- 0.4 mm, and 2.2 +/- 0.2 mm using the 7 Fr catheter (n = 10). The histologic findings revealed intimal cells, fibrous tissue, and homogenate with no identifiable tissue in five cases (21%), whereas in 17 patients (72%) light microscopy could only assess blood cells.(ABSTRACT TRUNCATED AT 250 WORDS)

Results of coronary angioplasty using the transluminal extraction catheter

To assess the procedural results after coronary angioplasty using the transluminal extraction catheter (TEC) in patients with complex lesion anatomy, experience with 51 patients undergoing this procedure was reviewed. One or more adverse lesion morphologic features were present in 45 patients (88%) and ≥2 adverse features were present in 38 (74%). Procedural success (<50% final diameter stenosis and the absence of major complications) was obtained in 42 patients (82%); major complications occurred in 7 patients (death, 3; Q-wave myocardial infarction, 4; emergency bypass operation, 2). Distal embolization was noted in 5 patients with thrombus-containing saphenous vein graft stenoses. Only lesion thrombus correlated with an unsuccessful outcome. After TEC use, diameter stenosis was reduced from 76 ± 13 to 50 ± 22% (p < 0.001). Adjunct balloon angioplasty was used in 44 procedures (86%), further reducing the diameter stenosis to 32 ± 22% (p < 0.001 compared with post-TEC). High-frequency intracoronary ultrasound was performed in 11 patients after TEC use. Plaque fissuring was present in all lesions and intraluminal dissection was noted in 4 (36%). Residual plaque after TEC use was found in virtually all lesions. During the 5.2 ± 2.8-month follow-up period, 17 patients (40%) developed recurrent symptoms. Coronary bypass surgery was performed in 4 patients and repeat coronary angioplasty was required in 3. In addition, 3 patients died from cardiac causes. It is concluded that coronary angioplasty using the TEC may be a useful alternative to balloon angioplasty in patients with complex coronary anatomy, although distal embolization may still occur in thrombuscontaining saphenous vein graft lesions.

Thromboembolectomy with the Transluminal Extraction Catheter (TEC) as an Adjunct to Thrombolysis

Multiple surgical and percutaneous interventional radiologic techniques have been used to restore blood flow in an acutely ischemic extremity. The transluminal extraction catheter (TEC) system was used as a mechanical thromboembolectomy device to supplement pharmacologic thrombolysis in one patient. In this case, 40 hours of direct intraarterial infusion of urokinase into the occluded vascular segments of a threatened lower extremity resulted in incomplete thrombolysis. Therefore, a 7-F TEC system was advanced percutaneously through the occluded vessels with restoration of luminal patency in all vessels treated. No distal embolization occurred. The TEC system facilitated prompt recanalization of vessels occluded by acute thrombus superimposed on atherosclerotic disease.

New technologies for the treatment of obstructive arterial disease

The well-known limitations of balloon angioplasty include unpredictable abrupt closure, chronic total occlusion, diffuse disease, and restenosis, among other factors. These limitations have prompted the development of new technologic approaches to angioplasty including laser applications for plaque ablation, mechanical device applications for plaque removal/debridement, and stent devices for structural maintenance of vascular lumen patency. Devices which directly apply laser energy for ablation of plaque material include a balloon-centered laser angioplasty system, excimer laser ablation catheter systems, and a fluorescence-guided spectral feedback laser system. Experience with these devices indicates that plaque can be successfully ablated by using laser energy. Vessel perforation and dissection are complications reported with these devices and the effects of laser angioplasty on restenosis remain unclear. Indirect application of laser energy has been tested by using a "hot tip" catheter and a laser balloon angioplasty system. Although the hot tip device has received FDA approval for use in peripheral arteries, it appears to have very limited applications in the coronary arteries. Laser balloon angioplasty appears to be beneficial in the setting of threatened acute closure; the device continues to be evaluated for potential beneficial impact on restenosis. Mechanical atherectomy catheters are designed to remove atherosclerotic plaque from the arterial system and include the AtheroCath, the Transluminal Extraction Catheter (TEC), and the Pullback Atherectomy Catheter (PAC). The Rotablator is an atheroablation device which debrides the obstructing plaque material with distal embolization of the particulate debris. Successful removal/debridement of atherosclerotic plaque has been demonstrated with the AtheroCath, Rotablator, and the TEC device. Pre-clinical studies demonstrate successful removal of plaque material with the PAC device. Despite the theoretic advantage of removing plaque material when performing angioplasty with these devices, there has been little or no reduction in restenosis rates based on a significant experience with the AtheroCath and the Rotablator. Intravascular stent devices including one self-expanding device design and two balloon-expandable device designs have been employed successfully in the elective setting to treat recurrent restenosis lesions. Two of the devices have been successfully tested in the setting of threatened acute closure. Early follow-up studies suggest some improvement in restenosis rates in certain clinical settings following intravascular stenting. Acute and subacute thrombosis remain substantial problems for stent devices and very aggressive anticoagulation regimens are necessary to minimize the adverse events. In summary, a number of a new technologic approaches for treatment of atherosclerotic lesions have been developed and are undergoing significant clinical evaluation.(ABSTRACT TRUNCATED AT 400 WORDS)

Efficacious and safe transluminal extraction atherectomy in patients with unfavorable coronary lesions

Efficacious and safe transluminal extraction atherectomy in patients with unfavorable coronary lesions

New Reperfusion Devices: The Kensey Catheter, the Atherolytic Reperfusion Wire Device, and the Transluminal Extraction Catheter

Substantial interest exists in the development of reperfusion and recanalization devices that would aid in the management of both peripheral vascular and coronary artery occlusive disease. Several of these devices are now in multicenter investigative trials. The atherolytic reperfusion wire incorporates a 0.035-inch guide wire with a modified tip to recanalize the lumen through the totally obstructed vascular segment. Clinical experience in the initial 12 patients has been successful. The Kensey catheter, a high-speed rotational recanalization device, has been used in 110 patients in a multicenter trial. Technical success has been reported in 77% of the patients and clinical success in 55% of the patients, with follow-up periods of 3 months to 1 year. The transluminal extraction catheter (TEC) is a torque-controlled atherectomy catheter that incorporates an aspiration device into a distal rotational cutter. Consequently, distal embolization has not been a clinical problem in the 95 patients treated with the TEC catheter for peripheral vascular disease. Technical success has been accomplished in 87 (92%) patients. Three-month follow-up studies in 16 patients showed that restenosis occurred in four, two of whom had undergone combined atherectomy and angioplasty.

Transluminal extraction of catheter fragments from the heart and pulmonary artery in children

Transluminal extraction of catheter fragments from the heart and pulmonary artery in children

NONTHORACOTOMY RETRIEVAL OF INTRALUMINAL CARDIOVASCULAR FOREIGN BODIES: Clinical and Experimental Aspects

Regardless of the specific technique employed, we strongly advocate pre-extraction angiographic evaluation to determine the exact position of the foreign body and detect significant thrombi. Transluminal extraction of foreign bodies is then a safe and expedient procedure. A direct surgical approach is necessary only if associated thrombosis is significant or if a transluminal approach has failed for specific anatomical or technical reasons. In most instances the risk and expense of laparotomy, thoracotomy, and cardiotomy can be avoided by this uncomplicated, safe, nonoperative method.