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PubMed1991

Quantitative angiography after directional coronary atherectomy.

OBJECTIVE: To assess by quantitative analysis the immediate angiographic results of directional coronary atherectomy. To compare the effects of successful atherectomy with those of successful balloon dilatation in a series of patients with matched lesions. DESIGN: Case series. SETTING: Tertiary referral centre. PATIENTS: 62 patients in whom directional coronary atherectomy was attempted between 7 September 1989 and 31 December 1990. INTERVENTIONS: Directional coronary atherectomy. MAIN OUTCOME MEASURES: Increase in minimal luminal diameter of coronary artery segment. RESULTS: Angiographic success on the basis of intention to treat was obtained in 54 patients (87%). In four patients the lesion could not be crossed by the atherectomy device; all four had an uneventful conventional balloon angioplasty. Four of the 58 patients who underwent atherectomy were subsequently referred for coronary bypass surgery because of failure or complications; three of them sustained a transmural infarction. In the successful cases, coronary atherectomy resulted in an increase in the minimal luminal diameter from 1.1 mm to 2.5 mm with a concomitant decrease of the diameter stenosis from 62% to 22%. In the subset of 37 patients in which the changes induced were compared with conventional balloon angioplasty atherectomy increased the minimal luminal diameter more than balloon angioplasty (1.6 v 0.8 mm; p less than 0.0001). Conventional histology showed media or adventitia in 26% of the atherectomy specimens. In hospital complications occurred in six patients who had undergone a successful procedure: two transmural infarctions, two subendocardial infarctions, one transient ischaemia attack, and one death due to delayed rupture of the atherectomised vessel. All patients were clinically evaluated at one and six months. One patient had persisting angina (New York Heart Association class II), one patient sustained a myocardial infarction, one patient underwent a percutaneous transluminal coronary angioplasty for early restenosis, and one patient underwent coronary bypass surgery because of a coronary aneurysm formation. At six months 80% (36/47) of the patients were symptom free. CONCLUSIONS: Coronary atherectomy achieved a better immediate angiographic result than balloon angioplasty; however, in view of the complication rate in this preliminary series, which may be related to a learning curve, a randomised study is needed to show whether this procedure is as safe as a conventional balloon angioplasty.

Angioplasty, Balloon, Coronary↗
PubMedDate not supplied

Current status of atherectomy for peripheral arterial occlusive disease.

Atherectomy physically removes plaque by cutting, pulverizing, or shaving it in atherosclerotic arteries using a mechanical, catheter-deliverable endarterectomy device. Theoretically, atherectomy offers the following advantages over percutaneous transluminal angioplasty (PTA): It shows a greater immediate success rate with less dissection and acute occlusion, treats complex lesions, and reduces the restenosis rate. This article presents the unique features of four atherectomy devices designed to meet the above challenges: Simpson AtheroCath, Transluminal Extraction Catheter (TEC), Trac-Wright Catheter, and Auth Rotablator. The results, complications, and limitations reported by clinical investigators are discussed critically and realistically. A new device, the OmniCath, under investigative trial, is presented briefly. Clinical studies evaluating the Simpson AtheroCath have reported impressively high initial success rates (ranging from 82% to 100%) but disparate intermediate patency results (ranging from 35% to 84%). Complications associated with the device include hematoma, pseudoaneurysm, and distal embolization. Clinical studies show that the device is relatively ineffective for treating diffusely diseased and long-occluded lesions. Restenosis has also been a primary constraint of the Simpson device, with reported restenosis rates ranging from 11% to 55% at 6 months. The initial technical and clinical success rates reported with the TEC atherectomy device have been promising at 79% to 92%; however, short- and mid-term follow-up results have been either lacking or disappointing, with a reported patency of 67% at 6 months and 51% at 12 months. Furthermore, the problems of restenosis and reocclusion have limited its short-term benefits. The Trac-Wright catheter has demonstrated widely disparate technical success rates (from 58% to 100%) and clinical success rates (from 33% to 80%). Patency rates reported have been suboptimal, ranging from 25% to 68% at 6 months and 25% to 45% at 12 months. Furthermore, severe complications associated with the device include perforation, dissection, and embolization. Reocclusion also limits the applicability of the device. The reported immediate success rates of 72% to 94% using the Auth Rotablator are similar to those reported for other atherectomy devices. Patencies reported at 1 and 2 years are dismal, ranging from 31% to 61% and from 12% to 18%, respectively. Significant complications are associated with the device, including thrombosis, arterial spasm, hemoglobinuria, hematoma, and embolization. Contrary to previous studies and expectations, perforations and dissections have been encountered by some investigators. Late restenosis and reocclusion are also significant limiting factors of the Auth Rotablator. Atherectomy currently has limited applications for treatment of peripheral arterial occlusive disease. The intermediate- and long-term results obtained with the atherectomy devices are worse than those reported for PTA. Furthermore, all of the atherectomy devices have failed to reduce the restenosis and reocclusion rates from those reported for PTA. The problem of restenosis, reocclusion, and other complications must be solved before atherectomy can be used generally as an alternative to vascular reconstruction procedures such as PTA.

Arterial Occlusive Diseases↗
PubMed1993

Indications for directional coronary atherectomy: 1993.

New coronary devices are being developed in attempts to solve the limitations of balloon angioplasty. Directional coronary atherectomy was the first of these devices to gain Food and Drug Administration approval. Theoretically, directional atherectomy improves coronary stenoses by an entirely different mechanism than balloon angioplasty, removing atherosclerotic plaque and leaving a smooth surface with less elastic recoil. Nonrandomized experience has shown that directional atherectomy is most useful in proximal to mid-segment, noncalcified, large (> 2.5 mm) coronary arterial segments, yielding minimal residual stenosis and larger lumen diameters than are generally achieved with angioplasty. Experience suggests that directional atherectomy is most useful in ostial coronary lesions, bifurcation stenoses, proximal left anterior descending lesions, discrete saphenous vein graft stenoses, complex or thrombus-containing lesions, highly eccentric lesions, and lesions failing PTCA secondary to elastic recoil, recurrent thrombosis, or limited dissection. Dissection and out-of-catheterization-laboratory acute closure are infrequent and appear to be improved over balloon angioplasty. However, intimal hyperplasia leading to restenosis is not solved by directional atherectomy. Randomized studies such as the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT) will help to clarify further the overall utility of directional atherectomy compared with balloon angioplasty in the future, but due to the limited power of subgroup analyses, CAVEAT may not have fully defined all the specific lesion characteristics that may be improved by atherectomy over PTCA. Review of the data presented may help the clinician identify specific areas in which atherectomy appears to offer an advantage over angioplasty, although definitive answers await specifically targeted randomized trials.

Angioplasty, Balloon, Coronary↗
PubMed1993

Restenosis after directional coronary atherectomy and balloon angioplasty: comparative analysis based on matched lesions.

OBJECTIVES: Late lumen narrowing after directional coronary atherectomy was assessed by quantitative coronary angiography and compared with that after balloon angioplasty. BACKGROUND: Directional coronary atherectomy has been introduced as an alternative technique for balloon angioplasty and may reduce the incidence of restenosis. METHODS: A prospectively collected consecutive series of 87 native coronary artery lesions successfully treated with atherectomy were matched with 87 coronary artery lesions selected from a consecutive series of lesions that had been successfully dilated by balloon angioplasty. Late angiographic analysis was performed in 158 lesions. The net gain index represents the ultimate gain in minimal lumen diameter at follow-up study, normalized for the vessel size. This index is the result of the relative gain attained during the procedure (the ratio of the change in minimal lumen diameter and reference diameter) and the relative loss observed during the follow-up period (the ratio of the change in minimal lumen diameter during the follow-up period and the reference diameter). RESULTS: Matching for clinical and angiographic variables resulted in two comparable groups with similar baseline stenosis characteristics. Atherectomy resulted in a more pronounced increase in minimal lumen diameter than did balloon angioplasty (mean +/- SD 1.17 +/- 0.29 to 2.44 +/- 0.42 mm vs. 1.21 +/- 0.38 to 2.00 +/- 0.36 mm, p < 0.001). However, this favorable immediate result was subsequently lost during late angiographic follow-up, so that the minimal lumen diameter at follow-up and the net gain index did not differ significantly between the two groups (1.76 +/- 0.62 vs. 1.77 +/- 0.59 mm, p = 0.93, and 0.18 +/- 0.19 vs. 0.17 +/- 0.17, p = 0.70). Consequently, the relative gain and relative loss were higher in the atherectomy group. For both techniques, the relative gain was linearly related to the relative loss but the slope of the regression line was steeper for atherectomy, suggesting that the relative loss in the atherectomy group is proportionally even larger for a given relative gain compared with that in the angioplasty group. CONCLUSIONS: In matched groups of patients, atherectomy induces a greater initial gain in minimal lumen diameter than does balloon angioplasty. However, the vascular wall injury induced by the device is of a different nature (debulking vs. dilating) that leads to more relative loss over the follow-up period in the atherectomy group.

Aged↗
PubMed1993

Sequential intravascular ultrasound characterization of the mechanisms of rotational atherectomy and adjunct balloon angioplasty.

OBJECTIVES: The purpose of this study was to use sequential intravascular ultrasound imaging before intervention, after rotational atherectomy and after adjunct balloon angioplasty to characterize the mechanisms of lumen enlargement after each. BACKGROUND: Rotational atherectomy uses a high speed, rotating, diamond-tipped elliptic burr to abrade atherosclerotic plaque to increase lumen size. In vitro studies have shown that high speed rotational atherectomy selectively abrades hard, especially calcified, plaque elements. However, rotational atherectomy procedures usually require adjunct balloon angioplasty. METHODS: Forty-eight lesions in 46 patients were treated with rotational atherectomy followed by adjunct balloon angioplasty in 44. Quantitative coronary arteriographic and intravascular ultrasound measurements of the target lesion were made before intervention, after rotational atherectomy and after balloon angioplasty. RESULTS: Before intervention, target lesion external elastic membrane area measured 17.3 +/- 5.9 mm2, lumen area measured 1.8 +/- 0.9 mm2 and plaque plus media area measured 15.7 +/- 4.1 mm2. After rotational atherectomy, lumen area increased, plaque plus media area decreased, arc of target lesion calcium decreased and 26% of the target lesions had dissection planes. After adjunct balloon angioplasty, external elastic membrane area increased, lumen area increased, plaque plus media area did not change and 77% of the target lesions had dissection planes. Arterial expansion was seen in 80% of lesions. The pattern of dissection plane location, which was predominantly within calcified plaque after rotational atherectomy, became predominantly adjacent to calcified plaque after adjunct balloon angioplasty (p = 0.008). CONCLUSIONS: Sequential intravascular ultrasound imaging shows that high speed rotational atherectomy causes lumen enlargement by selective ablation of hard, especially calcific, atherosclerotic plaque with little tissue disruption and rare arterial expansion. Adjunct balloon angioplasty further increased lumen area by a combination of arterial dissection and arterial expansion, especially of compliant, noncalcified plaque elements.

Aged↗
PubMed1995

Detailed clinical and angiographic analysis of transluminal extraction coronary atherectomy for complex lesions in native coronary arteries.

OBJECTIVES: The purpose of this study was to describe the results of transluminal extraction coronary atherectomy in native coronary arteries. BACKGROUND: Transluminal extraction coronary atherectomy was approved by the Food and Drug Administration for use in native coronary arteries and vein grafts. METHODS: 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. RESULTS: 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%. CONCLUSIONS: 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.

Aged↗
PubMed1998

Comparative early and nine-month results of rotational atherectomy, stents, and the combination of both for calcified lesions in large coronary arteries.

The aim of this study was to determine the preferred treatment modality for calcified lesions in large (> or = 3 mm) coronary arteries, resulting in the largest lumen dimensions and the most favorable late clinical responses. Three hundred six lesions in 306 patients (223 men, mean age 66 +/- 11 years) were treated with either rotational atherectomy plus adjunct balloon angioplasty (n = 147), Palmaz-Schatz stents (n = 103), or a combination of rotational atherectomy plus adjunct Palmaz-Schatz stents (n = 56). The procedural success rate was 98.0% to 98.6% for each treatment modality. Minimal lumen diameter (MLD) before therapy was similar for all therapies. Final MLD after combination of rotational atherectomy plus Palmaz-Schatz stents was larger than after stent therapy or rotational atherectomy plus balloon angioplasty (3.21 +/- 0.49 mm, 2.88 +/- 0.51 mm, and 2.29 +/- 0.55 mm, respectively, p <0.0001). Correspondingly, final percent diameter stenosis was lowest after the combination of rotational atherectomy plus stent therapy, and significantly higher for stents or rotational atherectomy plus balloon angioplasty (4.2 +/- 15.3%, 14.1 +/- 13.3%, and 26.7% +/- 16.9%, respectively, p <0.0001). Event-free survival at 9 months was higher for patients treated with the combination of rotational atherectomy plus stents than either stent therapy or rotational atherectomy alone (85%, 77%, and 67%, respectively, log-rank p = 0.0633). The only significant independent predictor of an event during the 9-month follow-up period was the MLD after intervention (odds ratio 0.495, 95% confidence interval 0.308 to 0.796, p = 0.0037). We conclude that preatheroablation using rotational atherectomy, followed by adjunct stent placement for calcified lesions in large arteries, is associated with infrequent complications, the largest acute angiographic results, and the most favorable late clinical event rates.

Aged↗
PubMed1992

Clinical, hemodynamic, electrocardiographic and mechanical events during nonocclusive, coronary atherectomy and comparison with balloon angioplasty.

The periprocedural events and myocardial function during nonocclusive coronary atherectomy by Rotablator or transluminal extraction catheter (TEC) may differ from events during balloon angioplasty. This may have important clinical consequences and needs to be defined further. Therefore, 17 patients undergoing Rotablator and 18 undergoing TEC atherectomy were assessed by clinical, hemodynamic and electrocardiographic monitoring and simultaneous transesophageal echocardiography. The findings were compared with similar parameters during subsequent balloon angioplasty performed in 16 of 17 patients undergoing Rotablator and 14 of 18 undergoing TEC atherectomy. Chest pain occurred more frequently during balloon inflation than during either atherectomy (p less than 0.02), whereas ST-segment and T-wave electrocardiographic changes were equally frequent. Transient second- or third-degree atrioventricular block occurred in 6 patients during Rotablator but in none during TEC atherectomy or balloon inflation (p less than 0.01 for each). Hemodynamic parameters and global left ventricular function remained unchanged during atherectomy. Regional myocardial function in the distribution of the target coronary artery, assessed by a wall motion score, was not affected during Rotablator, but deteriorated slightly during TEC atherectomy and more significantly during balloon inflation (score from 0.3 +/- 0.5 to 1.0 +/- 0.7 during TEC and 2.0 +/- 0.6 during balloon inflation, p less than 0.005 for both). Thus, chest pain is infrequent, whereas hemodynamics and global left ventricular function are preserved during Rotablator and TEC atherectomy. Transient atrioventricular block during Rotablator and regional myocardial dysfunction during TEC atherectomy may occur without significant consequences. These data suggest that these techniques may be preferable to balloon angioplasty for preserving intraprocedural left ventricular function.

Aged↗
PubMed1990

Combined percutaneous coronary atherectomy and coronary angioplasty: experience in 19 consecutive patients.

Among 82 patients undergoing coronary atherectomy, 19 (23%) underwent this procedure in combination with coronary angioplasty. The most frequently involved vessel was the left anterior descending coronary artery. In 11 patients (58%), attempted atherectomy preceded coronary angioplasty. In 6 of the 11, angioplasty was used after the atherectomy catheter could not be positioned across the lesion; 4 patients underwent "rescue" angioplasty after developing vessel occlusion related to atherectomy and 1 patient had an unsatisfactory result of atherectomy. The success rate of the combined intervention was 82% for these 11 patients. In eight patients (42%), atherectomy was performed after initial angioplasty. In four of the eight, atherectomy was a rescue procedure to manage vessel occlusion by thrombus or intimal dissection and was successful in three. In the other four, angioplasty was performed to establish an easier passage for the atherectomy catheter and was successful in three. Thus, the success rate of the combined intervention was 75% for these eight patients. The overall success rate for all 19 patients was 79%; there was one in-hospital death and one non-Q wave infarction, and one patient required immediate coronary artery surgery. Two other patients underwent coronary artery surgery before hospital discharge. Combined intervention with coronary angioplasty and atherectomy seems to be a relatively safe and effective approach in selected patients when either of these procedures alone is unsuccessful or is accompanied by acute coronary complications.

Adult↗
PubMed1995

Design and initial testing of an ultrasound-guided directional atherectomy device.

Directional atherectomy removes plaque in a targeted portion of a vessel wall. In practice, orienting the cutter toward maximal plaque accumulation and assessing the depth of vessel excision is difficult with angiographic guidance alone. Accordingly, we designed and tested a prototype catheter that combines ultrasound imaging capability with directional atherectomy in a single device. Twenty-seven in vitro vessels (32 lesions) were treated with atherectomy alone or with atherectomy combined with ultrasound. Lesion characteristics before and after the procedure were similar in each group. A significant decrease in the incidence of subintimal tissue excision was observed in the atherectomy-ultrasound group (21.1%) compared to the group that had debulking with atherectomy alone (54.5%). In addition, among specimens with media and/or adventitia the relative amount of subintimal tissue was significantly less (p < 0.001) with ultrasound guidance than with atherectomy alone (11.2% +/- 10.1% vs 34.2% +/- 8.5%). We conclude that ultrasound-guided directional atherectomy is technically feasible and may aid in achieving maximal plaque debulking and reduce the amount of subintimal injury.

Arteriosclerosis↗
PubMed1994

Comparison of costs of new atherectomy devices and balloon angioplasty for coronary artery disease.

The in-hospital cost for 126 consecutive patients undergoing 1-vessel, single-lesion coronary atherectomy (atherectomy group) beginning January 1, 1991, was reviewed (65 directional, 44 rotational, and 17 extractional atherectomies), and compared with the cost for 126 consecutive patients matched by sex and age who underwent 1-vessel, single-lesion standard balloon coronary angioplasty (angioplasty group). The in-hospital cost for each patient was determined using charges divided by a correction factor for each hospital department involved. Six different cost fields were created. The overall cost/charge ratio was 0.72. Angiographic and clinical success was 91% and 90% in the angioplasty group and 93% and 90% in the atherectomy group, respectively. Patients who underwent angioplasty required 1.3 +/- 0.6 devices/procedure, as compared with those who underwent atherectomy (2.4 +/- 1 devices/procedure) (p < 0.0001). The mean cost of angioplasty was $7,301 +/- $4,637 and of atherectomy devices $9,345 +/- $8,856 (28% increase). The difference was principally related to an increase in cost of supplies: angioplasty $2,028 +/- $1,196 versus atherectomy $3,632 +/- $1,525 (79% increase). There were no significant differences in hospitalization cost, procedure-room cost, and pharmacy and laboratory costs. Thus, higher risk morphologic lesions can be approached with new atherectomy devices with clinical and complication rates similar to coronary angioplasty. However, these results were obtained at a 28% increase in cost.

Angioplasty, Balloon, Coronary↗
PubMed1992

Directional atherectomy for treatment of restenosis within coronary stents: clinical, angiographic and histologic results.

OBJECTIVES: The safety and long-term results of directional coronary atherectomy in stented coronary arteries were determined. In addition, tissue studies were performed to characterize the development of restenosis. METHODS: Directional coronary atherectomy was performed in restenosed stents in nine patients (10 procedures) 82 to 1,179 days after stenting. The tissue was assessed for histologic features of restenosis, smooth muscle cell phenotype, markers of cell proliferation and cell density. A control (no stenting) group consisted of 13 patients treated with directional coronary atherectomy for restenosis 14 to 597 days after coronary angioplasty, directional coronary atherectomy or laser intervention. RESULTS: Directional coronary atherectomy procedures within the stent were technically successful with results similar to those of the initial stenting procedure (2.31 +/- 0.38 vs. 2.44 +/- 0.35 mm). Of five patients with angiographic follow-up, three had restenosis requiring reintervention (surgery in two and repeat atherectomy followed by laser angioplasty in one). Intimal hyperplasia was identified in 80% of specimens after stenting and in 77% after coronary angioplasty or atherectomy. In three patients with stenting, 70% to 76% of the intimal cells showed morphologic features of a contractile phenotype by electron microscopy 47 to 185 days after coronary intervention. Evidence of ongoing proliferation (proliferating cell nuclear antigen antibody studies) was absent in all specimens studied. Although wide individual variability was present in the maximal cell density of the intimal hyperplasia, there was a trend toward a reduction in cell density over time. CONCLUSIONS: Although atherectomy is feasible for the treatment of restenosis in stented coronary arteries and initial results are excellent, recurrence of restenosis is common. Intimal hyperplasia is a nonspecific response to injury regardless of the device used and accounts for about 80% of cases of restenosis. Smooth muscle cell proliferation and phenotypic modulation toward a contractile phenotype are early events and largely completed by the time of clinical presentation of restenosis. Restenotic lesions may be predominantly cellular, matrix or a combination at a particular time after a coronary procedure.

Actins↗
PubMed1993

Atherectomy of the subclavian artery for patients with symptomatic coronary-subclavian steal syndrome.

OBJECTIVES: This study addresses the efficacy of directional atherectomy in the subclavian artery for the relief of angina in patients with the coronary-subclavian steal syndrome. In addition, we review the histologic findings from the atherectomy specimens. BACKGROUND: The coronary-subclavian steal syndrome may occur after internal mammary-coronary artery bypass grafting. It is due to a stenosis in the subclavian artery proximal to the origin of the internal mammary artery and causes frank ischemia to the area supplied by the graft. Currently, surgery is the corrective procedure of choice. METHODS: In three patients with severe subclavian artery stenoses and unstable angina, directional atherectomy was performed using a peripheral atherectomy catheter through a percutaneous femoral approach. The patients ranged from 43 to 71 years of age and had undergone internal mammary-coronary artery bypass grafting 3 to 10 years previously. Each patient had severe peripheral vascular and cerebrovascular disease. RESULTS: All three patients had immediate symptomatic relief after the atherectomy, and postprocedure exercise testing demonstrated improved cardiac function. Two patients remain asymptomatic at 7 and 8 months, respectively; the third patient developed unstable angina 9 months later because of severe restenosis that was again successfully treated with atherectomy. Histologic examination of the specimens revealed atherosclerotic plaque, occasionally with adventitia. The specimen from the repeat atherectomy showed severe intimal hyperplasia. CONCLUSIONS: Directional atherectomy appears to be a safe and effective treatment for coronary-subclavian steal syndrome. This procedure may be the treatment of choice for patients in whom a vascular bypass operation is not feasible.

Adult↗
PubMed1994

Qualitative and quantitative contrasts in the mechanisms of lumen enlargement by coronary balloon angioplasty and directional coronary atherectomy.

OBJECTIVES: This study was designed to define and contrast the mechanisms of lumen enlargement from coronary balloon angioplasty and directional coronary atherectomy using intracoronary ultrasound imaging in vivo. BACKGROUND: The mechanisms of lumen enlargement produced by percutaneous transluminal coronary balloon angioplasty and directional coronary atherectomy are not known because the coronary artery wall has not previously been studied both before and after dilation. METHODS: We used intracoronary ultrasound to quantitate coronary lumen, vessel and plaque area both before and immediately after successful coronary angioplasty (n = 30) and directional coronary atherectomy (n = 25) at the site of most severe stenosis. RESULTS: Angioplasty increased lumen area by 2.80 +/- 0.25 mm2 (mean +/- SE, p < 0.0001). Eighty-one percent of this lumen gain resulted from an increase in vessel area and the remaining 19% from a reduction in plaque area. Lumen gain of individual lesions was separated into three groups: 67% had an increase in vessel area (vessel expansion), 13% had a decrease in plaque area and 20% had a combination of both. In contrast, vessel expansion contributed only 22% of the lumen gain with directional coronary atherectomy, with the majority (78%) of increase in lumen size coming from a reduction in plaque area. Directional coronary atherectomy increased lumen area from 2.36 +/- 0.05 to 7.00 +/- 0.28 mm2 (p < 0.0001). Plaque reduction was the sole mechanism in 60% of lesions, vessel expansion was the sole mechanism in 12% and a combination of both mechanisms occurred in 28%. Lumen enlargement of eccentric lesions treated with directional coronary atherectomy was more commonly associated with plaque reduction (p < 0.02), whereas eccentricity did not affect the mechanism of lumen enlargement with coronary angioplasty. CONCLUSIONS: This is the first study to systematically examine the coronary artery wall in vivo at the site of a severe stenosis both before and after catheter-based interventions in humans. Lumen enlargement from coronary angioplasty occurs predominantly from vessel expansion or stretching, although a reduction in plaque area contributes to the lumen gain in many patients and is the sole mechanism in a few. Lumen gain from directional coronary atherectomy is predominantly from reduction in plaque area (probably owing to tissue removal), although vessel stretching (balloon effect) occurs and is the sole mechanism in a small minority of vessels. Plaque reduction is more common in directional coronary atherectomy of eccentric lesions.

Adult↗
PubMed1996

Increased risk of non-Q wave myocardial infarction after directional atherectomy is platelet dependent: evidence from the EPIC trial. Evaluation of c7E3 for the Prevention of Ischemic Complications.

OBJECTIVES: We sought to determine the effects of platelet glycoprotein IIb/IIIa receptor blockade on adverse outcomes, especially non-Q wave myocardial infarction, in patients undergoing directional atherectomy in the Evaluation of c7E3 for the Prevention of Ischemic Complications (EPIC) trial. BACKGROUND: Randomized trials comparing directional atherectomy with percutaneous transluminal coronary angioplasty (PTCA) have demonstrated modest benefits favoring atherectomy but at a cost of increased acute ischemic complications, notably non-Q wave myocardial infarction. The mechanism for this excess risk is unknown. METHODS: Of 2,038 high risk patients undergoing coronary intervention in the EPIC trial, directional atherectomy was performed in 197 (10%). Patients randomly received the chimeric glycoprotein IIb/IIIa antibody 7E3 (c7E3), as a bolus or a bolus and 12-h infusion or placebo. Study end points included death, myocardial infarction, repeat intervention or bypass surgery. RESULTS: Patients undergoing directional atherectomy had a lower baseline risk for acute complications but had a higher incidence of any myocardial infarction (10.7% vs. 6.3%, p = 0.021) and non-Q wave myocardial infarction (9.6% vs. 4.9%, p = 0.006). Bolus and infusion of c7E3 reduced non-Q wave myocardial infarctions by 71% after atherectomy (15.4% for placebo vs. 4.5% for bolus and infusion, p = 0.046). Non-Q wave myocardial infarction rates after PTCA were not affected by c7E3, although Q wave myocardial infarctions were reduced from 2.6% to 0.8% (p = 0.017). CONCLUSIONS: The EPIC trial confirmed the increased risk of non-Q wave myocardial infarction with directional atherectomy use compared with PTCA. A bolus and 12-h infusion of the glycoprotein IIb/IIIa receptor inhibitor c7E3 abolished this excess risk. Directional atherectomy-related non-Q wave myocardial infarction appears to be platelet aggregation dependent.

Abciximab↗
PubMed1993

A comparison of directional atherectomy with coronary angioplasty in patients with coronary artery disease. The CAVEAT Study Group.

BACKGROUND: Directional coronary atherectomy is a new technique of coronary revascularization by which atherosclerotic plaque is excised and retrieved from target lesions. With respect to the rate of restenosis and clinical outcomes, it is not known how this procedure compares with balloon angioplasty, which relies on dilation of the plaque and vessel wall. We compared the rate of restenosis after angioplasty with that after atherectomy. METHODS: At 35 sites in the United States and Europe, 1012 patients were randomly assigned to either atherectomy (512 patients) or angioplasty (500 patients). The patients underwent coronary angiography at base line and again after six months; the paired angiograms were quantitatively assessed at one laboratory by investigators unaware of the treatment assignments. RESULTS: Stenosis was reduced to 50 percent or less more often with atherectomy than with angioplasty (89 percent vs. 80 percent; P < 0.001), and there was a greater immediate increase in vessel caliber (1.05 vs. 0.86 mm, P < 0.001). This was accompanied by a higher rate of early complications (11 percent vs. 5 percent, P < 0.001) and higher in-hospital costs ($11,904 vs $10,637; P = 0.006). At six months, the rate of restenosis was 50 percent for atherectomy and 57 percent for angioplasty (P = 0.06). However, the probability of death or myocardial infarction within six months was higher in the atherectomy group (8.6 percent vs. 4.6 percent, P = 0.007). CONCLUSIONS: Removing coronary artery plaque with atherectomy led to a larger luminal diameter and a small reduction in angiographic restenosis, the latter being confined largely to the proximal left anterior descending coronary artery. However, atherectomy led to a higher rate of early complications, increased cost, and no apparent clinical benefit after six months of follow-up.

Aged↗
PubMed1993

A comparison of directional atherectomy with balloon angioplasty for lesions of the left anterior descending coronary artery.

BACKGROUND: Restenosis is a major limitation of coronary angioplasty. Directional coronary atherectomy was developed with the expectation that it would provide better results than angioplasty, including a lower rate of restenosis. We undertook a randomized, multicenter trial to compare the rates of restenosis for atherectomy and angioplasty when used to treat lesions of the proximal left anterior descending coronary artery. METHODS: Of 274 patients referred for first-time, non-surgical revascularization of lesions of the proximal left anterior descending coronary artery, 138 were randomly assigned to undergo atherectomy and 136 to undergo angioplasty; 257 of 265 eligible patients (97 percent) underwent follow-up angiography at a median of 5.9 months. Computer-assisted quantitative measurements of luminal dimensions were determined from the angiograms obtained before and immediately after the procedure and at follow-up. The primary end point of restenosis was defined as stenosis of more than 50 percent of the vessel's diameter at follow-up. RESULTS: Quantitative analysis showed that the procedural success rate was higher in patients who underwent atherectomy than in those who had angioplasty (94 percent vs. 88 percent, P = 0.061); there was no significant difference in the frequency of major in-hospital complications (5 percent vs. 6 percent). At follow-up, the rate of restenosis was 46 percent after atherectomy and 43 percent after angioplasty (P = 0.71). Despite a larger initial gain in the minimal luminal diameter with atherectomy (mean [+/- SD], 1.45 +/- 0.47 vs. 1.16 +/- 0.44 mm; P < 0.001), there was a larger late loss (0.79 +/- 0.61 vs. 0.47 +/- 0.64 mm; P < 0.001), resulting in a similar minimal luminal diameter in the two groups at follow-up (1.55 +/- 0.60 vs. 1.61 +/- 0.68, P = 0.44). The clinical outcomes at six months were not significantly different between the two groups. CONCLUSIONS: The role of atherectomy in percutaneous coronary revascularization remains to be fully defined. However, as compared with angioplasty, atherectomy did not result in better late angiographic or clinical outcomes in patients with lesions of the proximal left anterior descending coronary artery.

Aged↗
PubMed1995

Mechanisms of luminal enlargement and quantification of vessel wall trauma following balloon coronary angioplasty and directional atherectomy.

OBJECTIVES: The purpose of this study was to assess the dual action of lumen enlargement and vessel wall damage following either balloon angioplasty or directional atherectomy, using intracoronary ultrasound, and angioscopy. BACKGROUND: Differences in the mechanisms of action of balloon angioplasty and directional atherectomy may have a significant bearing on the immediate outcome and the restenosis rate at 6 months. METHODS: A total of 36 patients were studied before and after either balloon angioplasty (n = 18) or directional atherectomy (n = 18). Ultrasound measurements included changes in lumen area, external elastic membrane area and plaque burden. In addition, the presence and extent of dissections were assessed to derive a damage score. Angioscopic assessment of the dilated or atherectomized stenotic lesions was translated into semi-quantitative dissection, thrombus and haemorrhage scores. RESULTS: Atherectomy patients had a larger angiographic vessel size compared with the angioplasty group (3.55 +/- 0.46 mm vs 3.00 +/- 0.64 mm, P < 0.05); however, minimal lumen diameter (1.18 +/- 0.96 mm vs 0.85 +/- 0.49 mm) and plaque burden (17.04 +/- 3.69 vs 15.23 +/- 4.92 mm2) measurements did not differ significantly. As a result of plaque reduction, atherectomy produced a larger increase in luminal area than the angioplasty group (5.80 +/- 1.78 mm2 vs 2.44 +/- 1.36 mm2, P < 0.0001). Lumen increase after angioplasty was the result of 'plaque compression' (50%) and wall stretching (50%). Additionally, in both groups there was indirect angioscopic evidence of thrombus 'microembolization' as an adjunctive mechanism of lumen enlargement. Angioscopy identified big flaps in six and small intimal flaps in 11 of the atherectomized patients as compared with five and 12 patients in the angioplasty group. Changes in thrombus score following both coronary interventions were identical (0.72 +/- 3.42 points atherectomy vs -0.38 +/- 3.27 points balloon angioplasty, ns). CONCLUSIONS: Lumen enlargement after directional atherectomy is mainly achieved by plaque removal (87%), whereas balloon dilation is the result of vessel wall stretching (50%) and plaque reduction (50%). Despite the fact that the luminal gain achieved by directional atherectomy is twice that achieved with balloon angioplasty, the extent of trauma induced by both techniques seems to be similar.

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