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ABSTRACT: The purpose of this study was to describe the results of transluminal extraction coronary atherectomy in native coronary arteries.
Transluminal extraction coronary atherectomy was approved by the Food and Drug Administration for use in native coronary arteries and vein grafts.
Between December 1988 and July 1992, transluminal extraction coronary atherectomy was performed in 181 native coronary arteries in 175 patients. A detailed angiographic and clinical assessment was performed.
Quantitative angiography (mean +/- SD) revealed an increase in minimal lumen diameter from 1.0 +/- 0.6 mm before to 1.3 +/- 0.7 mm after atherectomy, to 2.1 +/- 0.8 mm after final treatment (p < 0.001), corresponding to a diameter stenosis of 70 +/- 16%, 61 +/- 21% and 36 +/- 21%, respectively (p < 0.001). Final procedural success (final diameter stenosis < 50%, no major complications) was achieved in 84%. Adjunctive angioplasty was used after atherectomy in 152 lesions (84%) to further enlarge lumen dimensions (130 lesions, 72%), salvage technical failures (2 lesions, 1%) and reverse atherectomy-induced abrupt closures (20 lesions, 11%). Clinical complications included death (2.3%), Q wave myocardial infarction (3.4%) and emergency bypass surgery (2.8%). The strongest independent correlate of major clinical complications was development of abrupt closure immediately after atherectomy (p = 0.01). Clinical follow-up of 92% of eligible patients revealed clinical restenosis (repeat intervention, late bypass surgery, myocardial infarction or death) in 28.5%. Angiographic follow-up of 83% of eligible lesions revealed a restenosis rate (diameter stenosis > 50%) of 61%.
Transluminal extraction coronary atherectomy is limited by a modest degree of lumen enlargement, frequent need for adjunctive angioplasty and a high restenosis rate. For complex lesions in native coronary arteries, transluminal extraction coronary atherectomy appears to offer no advantage over conventional balloon angioplasty.
Journal of the American College of Cardiology 03/1995; 25(4):848-54. · 14.16 Impact Factor
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ABSTRACT: Percutaneous transluminal coronary angioplasty (PTCA) is often required immediately after laser and atherectomy devices to enlarge lumen dimensions and to salvage device failures. Between January 1989 and June 1992, adjunctive PTCA was applied to 83% of narrowings treated with new interventional devices, including 85% of transluminal extraction atherectomy (n = 290), 72% of high-speed mechanical rotational atherectomy (n = 79), and 89% of excimer laser angioplasty (n = 118) lesions (p = NS). Device success was defined as a decrease in diameter stenosis > or = 20%; procedural success was defined as a final diameter stenosis < or = 50% after PTCA; and salvage PTCA was defined as use of PTCA to manage device-induced vessel occlusion. Although adjunctive PTCA was applied to 487 lesions, it was used to further enlarge the lumen after initial device success in 139 lesions (28.5%). In contrast, adjunctive PTCA was used after initial device failure in 348 lesions (71.5%), including after minimal or no change (decrease in diameter stenosis by 0 to 19%) in diameter stenosis in 244 lesions (50%) and after worsening of diameter stenosis in 104 lesions (21.5%). Salvage PTCA after device-induced vessel occlusion was performed in 61 lesions (12.6%). However, final procedural success after PTCA was achieved in 412 lesions (85%), with a low incidence of Q-wave myocardial infarction (3.5%), emergency bypass surgery (1.8%) and death (2.3%).
The American Journal of Cardiology 04/1994; 73(9):642-6. · 3.37 Impact Factor
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ABSTRACT: 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
Circulation 02/1994; 89(1):302-12. · 14.74 Impact Factor
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ABSTRACT: 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.
Significant 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.
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.
Baseline diameter stenoses were similar for all interventions. The percent diameter stenoses 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 D/A 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 atherectomy (0.92 +/- 0.16, p < 0.001) and excimer laser angioplasty (0.85 +/- 0.30, p < 0.01) compared with balloon angioplasty.
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 D/A ratio), not to inefficient devices (low RLD/D ratio). Rotational atherectomy and excimer laser angioplasty were more efficient (higher RLD/D) than balloon angioplasty, whereas extraction atherectomy and balloon angioplasty were similar.
Journal of the American College of Cardiology 11/1993; 22(6):1628-34. · 14.16 Impact Factor
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ABSTRACT: Several types of atherectomy devices have been developed recently for treatment of patients with ischemic heart disease.
Mechanical rotational atherectomy (MRA) using a high-speed rotational burr (Rotablator) was performed on 116 lesions in 104 patients. MRA alone was performed in 27 lesions (23%), and conventional balloon angioplasty (PTCA) was performed after MRA in 89 lesions (77%). Diameter stenosis decreased from 70 +/- 13% before MRA to 54 +/- 23% after MRA, and the final diameter stenosis (after MRA alone or with adjunctive PTCA) was 30 +/- 20% (P < .001). Minimal lumen diameter increased from 1.0 +/- 0.5 mm before MRA to 1.4 +/- 0.7 mm after MRA, and the final minimal lumen diameter was 2.3 +/- 0.7 mm (P < .001). MRA resulted in a decrease in diameter stenosis of 20% or more in 44% of lesions, and the final diameter stenosis (after MRA alone or after PTCA) was less than 50% in 75% of lesions. Considering the small diameter of available burrs, the magnitude of lumen enlargement was equal to 91% of the burr diameter, and only 9% of the burr diameter was "lost" due to elastic recoil or spasm. These angiographic results were obtained despite the presence of complex lesion morphology, including the presence of calcification in 17% of lesions and ostial location in 26% of lesions. Significant angiographic complications included abrupt closure (13 lesions, 11.2%), no reflow (8 lesions, 7%), severe coronary vasospasm (16 lesions, 13.8%), and guide wire fracture (3 lesions, 2.7%). There were no coronary artery perforations. Adjunctive therapy, including salvage PTCA, thrombolytic agents, and vasodilators, was successful in treating angiographic complications in 42 of 49 lesions (86%). Clinical complications included Q-wave myocardial infarction (5 patients, 4.8%), non-Q-wave myocardial infarction (3 patients, 2.9%), femoral vascular injury requiring surgery (3 patients, 2.9%) or blood transfusion (8 patients, 7.7%), abrupt closure requiring emergency bypass graft surgery (2 patients, 1.9%), and in-hospital death (1 patient, 1.0%). Angiographic follow-up (mean follow-up interval, 5.0 +/- 2.0 months) was available in 84% of successfully treated patients and revealed a restenosis rate of 51%, defined as a residual diameter stenosis of more than 50%. There was no significant difference in restenosis rates between de novo lesions (50%) and restenosis (54%) lesions.
These data suggest that for the treatment of most coronary stenoses, PTCA is required after MRA to achieve satisfactory lumen enlargement or to salvage complications. Angiographic complications appear to be more common after MRA, and salvage PTCA often is required to manage these device-induced complications. The combination of MRA and PTCA does not prevent restenosis.
Circulation 10/1993; 88(3):961-8. · 14.74 Impact Factor
