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Impact of restenosis after optimal directional coronary atherectomy on regional left ventricular function.

To assess the effect of optimal directional coronary atherectomy (DCA) on restenosis and left ventricular (LV) function, 95 patients who underwent DCA and adjunctive balloon angioplasty for de novo lesions were prospectively followed for 6 months. Absolute and relative coronary lumen measurements were analyzed with online quantitative coronary angiography. LV volumes, ejection fraction, and segmental wall motion were measured off-line according to the radial method for LV cineangiograms acquired in a right anterior oblique projection. Target vessels were the left anterior descending artery in 63 patients and right coronary artery in 32. Mean (+/- SD) reference diameter was 3.58 +/- 0.65 mm. Mean lumen diameter improved significantly after DCA from 1.19 +/- 0.44 to 3.03 +/- 0.45 mm, yielding a 14 +/- 10% residual stenosis. Overall angiographic restenosis rate (> 50% stenosis in diameter) at control was 23%. In patients without restenosis, there were no significant changes in LV volumes or in LV pressures. In this subgroup, ejection fraction improved significantly in the left anterior descending group (mean difference 3 +/- 10%, p < 0.04). Moreover, there was an increase in fractional shortening of all anterior segments (mean difference 11 +/- 16%, p < 0.005). Improvement in fractional shortening was less marked in the right coronary artery group even without restenosis. We conclude that: (1) optimal DCA can achieve a low restenosis rate in selected large vessels, (2) long-term beneficial effects on regional LV function are possible, particularly in patients with left anterior descending disease and in the absence of coronary restenosis.

Angioplasty, Balloon, Coronary↗

Long-term clinical follow-up after directional coronary atherectomy.

Although several studies have been done to assess the safety, efficacy, and angiographic restenosis rates of directional coronary atherectomy (DCA), there have been no studies to document the need for repeat revascularization of the target vessel based purely on recurrence of symptoms. To answer this question, clinical and angiographic data were obtained for 187 consecutive patients undergoing this procedure on a native coronary artery utilizing a lesion specific approach in a referral hospital. Most of the patients had anginal symptoms that were not well controlled with medical therapy. The decision to perform DCA was based on the lesion characteristics (i.e., eccentric, ulcerated, or irregular discrete lesions in a large epicardial vessel). The procedure was successful in 96% of patients. In-hospital major complications were seen in 6 patients (3%) including acute myocardial infarction in 3 (1.5%) and emergency coronary artery bypass surgery in the other 3 (1.5%). There were no deaths. Among 141 consecutive successful patients on whom the procedure was performed between January 1992 and June 1994, 128 (91%) were contacted. At 6 months, revascularization was required in 20 patients for recurrent anginal symptoms, and there were no deaths or myocardial infarctions. The clinical restenosis rate, therefore, was 15.6%. At long-term follow-up (25 +/- 9 months), revascularization was performed in 3 more patients. One patient had a myocardial infarction and 3 patients died of noncardiac causes. Among those without clinical restenosis, 83% patients were asymptomatic and the rest had infrequent chest pains effectively managed with medications. The patients in the study group were using an average of 1.2 cardiac medications. Quality of life improved in 74% of the patients. Thus, in this study utilizing a lesion specific approach, the success rate for DCA was comparable to the published trials and in-hospital complications were few. The long-term clinical outcome was favorable with a low rate of clinical restenosis requiring repeat revascularization.

Adult↗

Usefulness of directional coronary atherectomy in patients with acute anterior myocardial infarction.

To assess the usefulness of directional coronary atherectomy (DCA) in acute myocardial infarction (AMI), 139 consecutive patients with anterior wall AMI undergoing successful catheter intervention were studied. The reocclusion rate was significantly lower in the last 70 patients who underwent DCA as aggressively as possible compared with the first 69 patients treated with coronary balloon angioplasty (12.1% vs 3.0%, p <0.05).

Aged↗

Assessment of platelet activation by coronary sinus blood sampling during balloon angioplasty and directional coronary atherectomy.

Three markers of platelet activation (platelet-derived microparticles, fibrinogen binding and expression of P-selectin) were assessed by flow cytometry during diagnostic coronary angiography and therapeutic coronary interventions. In 24 patients undergoing diagnostic angiography, blood was collected to determine if our sampling techniques or coronary angiography caused platelet activation. Changes during diagnostic angiography were used to establish baseline values and interpret changes during coronary interventions. In 21 patients, blood samples were obtained at 5 time points during percutaneous transluminal coronary angioplasty (PTCA) (n = 17) or directional coronary atherectomy (DCA) (n = 4). During coronary interventions, mean values for the percentage of platelets expressing P-selectin or binding fibrinogen increased, but with considerable variation among patients. Individual responses for platelet activation markers in each patient were characterized using a twofold increase to indicate elevation related to the intervention. Patients were classified as having complicated or uncomplicated procedures based on the presence of acute closure, dissection, or thrombus observed by angiography. There were no differences in the percentage of elevated markers between patients with uncomplicated (12.5%) and complicated (19%) PTCA procedures. However, patients treated with DCA had more elevated markers (38%) than those treated with PTCA (15%) (p = 0.04). Our data suggest that the extent of platelet activation in individual patients cannot be predicted by common angiographic findings or complications. More markers of platelet activation were present after DCA and may reflect a greater degree of vascular trauma associated with this procedure.

Angioplasty, Balloon, Coronary↗

High-speed rotational atherectomy of human coronary stenoses: acute and one-year outcomes from the New Approaches to Coronary Intervention (NACI) registry.

High-speed rotational atherectomy (RA) is a new percutaneous procedure for treatment of coronary stenoses that operates by the unique mechanism of plaque abrasion. This article reports acute (in-hospital) outcomes and 1-year follow-up in a large cohort of patients treated with this device by NACI investigators. A total of 525 patients with 670 lesions treated with RA form the substrate of this report. Patients tended to be older (mean age 64.8 years) than those in previously reported series of percutaneous transluminal coronary angioplasty (PTCA), with more extensive disease and more complex lesions. Calcification was present in 54% of lesions, and eccentricity in 41%. Balloon angioplasty postdilation was performed after RA in 88% of cases. Angiographic and procedural success (angiographic success without death, Q-wave myocardial infarction [MI] or emergency coronary artery bypass graft [CABG] surgery) rates were 89% and 88%, respectively. Acute in-hospital events included 4 deaths (1%) and 1 emergency CABG surgery (0.4%). MI occurred in 6% of patients, consisting predominantly of non-Q-wave MI (5%). After RA, angiographic complications included coronary dissection (12%), abrupt closure (5%), side branch occlusion (3%), and distal embolization (3%). Most of these were resolved after postdilation except for coronary dissection, which was present in 15% of lesions treated. Mean length of stay was 3 days. At 1-year follow-up, 27% of patients required target lesion revascularization and 30% had experienced death, Q-wave MI, or target lesion revascularization. Preprocedural characteristics that independently predicted 1-year death, Q-wave MI, or target lesion revascularization were male gender, high risk for surgery, target lesions that were proximal to or in bifurcations, eccentric, long, or highly stenosed. RA, even when applied to lesions of traditionally unfavorable morphology, appears to provide reasonable procedural and angiographic success rates. Restenosis and progression of disease contribute to subsequent clinical and procedural events.

Aged↗

Platelet glycoprotein IIb/IIIa receptor blockade with abciximab reduces ischemic complications in patients undergoing directional coronary atherectomy. EPILOG Investigators. Evaluation of PTCA to Improve Long-term Outcome by c7E3 GP IIb/IIIa Receptor Blockade.

We determined the efficacy of abciximab, a platelet glycoprotein IIb/IIIa receptor antagonist, combined with low-dose weight-adjusted heparin in reducing ischemic complications in patients undergoing directional coronary atherectomy (DCA). The Evaluation of IIb/IIIa platelet receptor antagonist 7E3 in Preventing Ischemic Complications (EPIC) trial demonstrated a reduction in the incidence of non-Q-wave myocardial infarction in DCA patients who were treated with abciximab bolus and infusion plus heparin. This benefit, however, was associated with increased bleeding complications. Of the 2,792 patients who had coronary intervention in the Evaluation of PTCA to Improve Long-term Outcome by c7E3 GP IIb/IIIa receptor blockade (EPILOG) trial, 144 (5%) underwent DCA. Patients were randomly assigned to 3 treatment groups: placebo with standard-dose, weight-adjusted heparin; abciximab with low-dose weight-adjusted heparin; or abciximab with standard-dose weight-adjusted heparin. Study end points included 30-day and 6-month composite incidence of death, myocardial infarction, or revascularization. Compared with those undergoing percutaneous transluminal coronary angioplasty (PTCA), DCA patients had a higher rate of myocardial infarction (11.1 % vs 4.9%, p = 0.001) and predominantly non-Q-wave myocardial infarction (9.7% vs 4.4%, p = 0.004). Abciximab was associated with a 57% lower combined rate of death, myocardial infarction, or urgent revascularization within 30 days following DCA (20% placebo vs 8.7% abciximab with low-dose heparin) without excess risk of bleeding complications. A combined analysis of data from the EPIC and EPILOG trials demonstrates a reduction in the rate of death or myocardial infarction (19.9% vs 8.4%, p = 0.008) at 30 days that was sustained for up to 6 months in the abciximab-treated patients. These findings support the premise that non-Q-wave myocardial infarction in DCA patients are platelet mediated.

Abciximab↗

Immediate and long-term outcomes of rotational atherectomy versus balloon angioplasty alone for treatment of diffuse in-stent restenosis.

This study was performed to compare the effects of rotational atherectomy (RA) plus balloon angioplasty (BA) with those of BA alone for treatment of diffuse in-stent restenosis. RA+BA or BA alone was performed in a consecutive, prospective (not randomized) manner in 81 patients with 81 diffuse in-stent restenotic lesions (lesion length > 10 mm): 36 patients underwent RA+BA, and 45 patients BA. Clinical recurrence was the primary end point of this study, and was defined as angina associated with objective evidence of myocardial ischemia on stress testing. Mean follow-up duration was 277 +/- 109 days. In the BA group, acute lumen gain after repeat intervention was significantly lower than that of the original stenting procedure (1.94 +/- 0.63 vs 2.37 +/- 0.51 mm, p <0.05). In the RA + BA group, however, acute lumen gain of repeat intervention was similar to that of the original stenting procedure (2.16 +/- 0.52 vs 2.26 +/- 0.66 mm). Clinical recurrence rate at 6 months follow-up was significantly lower in the RA+BA group than in the BA group (25% vs 47%, p <0.05). Clinical events (death, myocardial infarction, repeat intervention) occurred in 6.7% (3 of 45) of patients in the BA group, but in no patient in the RA+BA group during the follow-up period. The long-term angina-free survival rate was significantly higher in the RA+BA group than in the BA group (72% vs 49%, p = 0.02). In conclusion, RA+BA seems to be a more effective therapeutic modality than BA alone for treatment of diffuse in-stent restenosis.

Aged↗

Directional coronary atherectomy for the treatment of Palmaz-Schatz in-stent restenosis.

Management of in-stent restenosis has become a significant challenge in interventional cardiology. The results of balloon angioplasty have been disappointing due to the high recurrence of restenosis at follow-up. Debulking of the restenotic tissue within the stents using directional coronary atherectomy (DCA) may offer a therapeutic advantage. We report the immediate clinical and angiographic outcomes and long-term clinical follow-up results of 45 patients (46 lesions), mean age 63+/-12 years, 73% men, with a mean reference diameter of 2.9+/-0.6 mm, treated with DCA for symptomatic Palmaz-Schatz in-stent restenosis. DCA was performed successfully in all 46 lesions and resulted in a postprocedural minimal luminal diameter of 2.7+/-0.7 mm and a residual diameter stenosis of 17+/-10%. There were no in-hospital deaths, Q-wave myocardial infarctions, or emergency coronary artery bypass surgeries. Four patients (9%) suffered a non-Q-wave myocardial infarction. Target lesion revascularization was 28.3% at a mean follow-up of 10+/-4.6 months. Kaplan-Meier event-free survival (freedom from death, myocardial infarction, and repeat target lesion revascularization) was 71.2% and 64.7% at 6 and 12 months after DCA, respectively. Thus, DCA is safe and efficacious for the treatment of Palmaz-Schatz in-stent restenosis. It results in a large postprocedural minimal luminal diameter and a low rate of both target lesion revascularization and combined major clinical events at follow-up.

Angioplasty, Balloon↗

Clinical and angiographic predictors of recurrent restenosis after percutaneous transluminal rotational atherectomy for treatment of diffuse in-stent restenosis.

Due to the widespread use of stents in complex coronary lesions, stent restenosis represents an increasing problem, for which optimal treatment is under debate. "Debulking" of in-stent neointimal tissue using percutaneous transluminal rotational atherectomy (PTRA) offers an alternative approach to tissue compression and extrusion achieved by balloon angioplasty. One hundred patients (70 men, aged 58 +/- 11 years) with a first in-stent restenosis underwent PTRA using an incremental burr size approach followed by adjunctive angioplasty. The average lesion length by quantitative angiography was 21 +/- 8 mm (range 5 to 68) including 22 patients with a length > or = 40 mm. Twenty-nine patients had complete stent occlusions with a lesion length of 44 +/- 23 mm. Baseline diameter stenosis measured 78 +/- 17%, was reduced to 32 +/- 9% after PTRA, and further reduced to 21 +/- 10% after adjunctive angioplasty. Primary PTRA was successful in 97 of 100 patients. Clinical success was 97%, whereas 2 patients developed non-Q-wave infarctions without clinical sequelae. Clinical follow-up was available for all patients at 5 +/- 4 months without any cardiac event. Angiography in 72 patients revealed restenosis in 49%, with necessary target lesion reintervention in 35%. The incidence of rerestenosis correlated with the length of the primarily stented segment and the length of a first in-stent restenosis. Thus, PTRA offers an alternative approach to treat diffuse in-stent restenosis. Neointimal debulking of stenosed stents can be achieved effectively and safely. PTRA resulted in an acceptable recurrent restenosis rate in short and modestly diffuse lesion, whereas the restenosis rate in very long lesions remains high despite debulking.

Atherectomy, Coronary↗

Coronary artery restenosis after atherectomy is primarily due to negative remodeling.

The primary cause of restenosis following directional coronary atherectomy (DCA) remains obscure. "Negative remodeling," a decrease in vessel area, is believed to be more causative than is increase in plaque area. The DCA technique used in these patients, designed to facilitate the removal of plaque, should allow a more precise evaluation of the relative roles of these two mechanisms. Twenty-five patients underwent DCA. In 17, complete angiographic and intravascular ultrasound (IVUS) images were obtained before and after DCA and at follow-up (6 to 9 months). Internal elastic lamina (IEL), lumen, and plaque areas were calculated at preatherectomy, postatherectomy, and follow-up. Postatherectomy, the mean IEL area increased by 32% and the mean plaque area decreased by 51%, resulting in a significant mean increase in lumen area, 500%. At follow-up when compared to postatherectomy, the change in IEL area was variable; however, the mean did not change significantly (p = 0.58). Plaque area change, when standardized for initial vessel size, was small (mean increase 2.8 +/- 3.5%). The mean lumen area did not decrease significantly at follow-up (p = 0.43). A highly significant correlation (r = 0.96) was noted between IEL area change and lumen area at follow-up. In contrast, the correlation between plaque area change and lumen area change over the same period was much less significant (r = 0.64). These data indicate that decrease in IEL area primarily is responsible for restenosis.

Atherectomy, Coronary↗

Quantitative assessment with intracoronary ultrasound of the mechanisms of restenosis after percutaneous transluminal coronary angioplasty and directional coronary atherectomy.

The mechanisms of immediate and late changes after percutaneous transluminal coronary angioplasty (PTCA) and directional coronary atherectomy (DCA) were assessed by serial ultrasound imaging in 18 patients treated with PTCA and 16 treated with DCA before, immediately after, and 6 months after coronary interventions. A reduction in plaque area was the main operative mechanism of DCA, explaining 66% of lumen enlargement. In the PTCA group, the increase in lumen area was the result of a more balanced combination of plaque reduction (52% of lumen increase) and increase in total lumen area (48%); p < 0.05 versus DCA. In the PTCA group, this last mechanism was prevalent (p < 0.05) in the lesions showing wall fracture or dissection after treatment and in the lesions with a mixed or calcific composition. In the PTCA group, concentric lesions showed a greater plaque compression than eccentric lesions (p < 0.02). Plaque increase was responsible for 92% and 32% of the late lumen loss after DCA and after PTCA, respectively (p < 0.05). In PTCA patients, a chronic reduction in total vessel area was the main operative mechanism of lumen reduction (67%) and was prevalent in lesions with a mixed or calcific composition. (p < 0.05).

Angioplasty, Balloon, Coronary↗

Effect of platelet glycoprotein IIb/IIIa integrin blockade on activated clotting time during percutaneous transluminal coronary angioplasty or directional atherectomy (the EPIC trial). Evaluation of c7E3 Fab in the Prevention of Ischemic Complications trial.

The activated clotting time (ACT) has been used during percutaneous transluminal coronary angioplasty (PTCA) to monitor the extent of thrombin inhibition and anti-coagulation from heparin in an attempt to minimize untoward thrombotic events and hemorrhagic complications. With the introduction of potent platelet inhibitors, such as the chimeric monoclonal antibody c7E3, to interventional cardiology, the utility of measuring and regulating procedural ACT has not been examined. To investigate the possible influence of platelet IIb/IIIa antagonism on procedural ACT, we reviewed data from the Evaluation of c7E3 Fab in the Prevention of Ischemic Complications (EPIC) trial. In the EPIC trial, 2,099 patients undergoing PTCA with a high risk of abrupt vessel closure were randomized to receive placebo (n = 696) or the IIb/IIIa platelet receptor antagonist c7E3 Fab (n = 1,403). Despite receiving less procedural heparin, and fewer patients receiving very high heparin doses (> 14,000 U) than the placebo group, those receiving c7E3 had a higher mean (401 vs 367 seconds, p < 0.001) ACT when corrected for body weight. The ACT is increased approximately 35 seconds by the platelet IIb/IIIa receptor antagonist c7E3 Fab. This has important implications for dosing conjunctive heparin therapy and performing PTCA or directional coronary atherectomy in the setting of IIb/IIIa-directed therapy.

Abciximab↗

Directional atherectomy of coronary and saphenous vein graft ostial stenoses.

Directional coronary atherectomy (DCA) has been proposed as an alternative to balloon dilatation for treating coronary ostial stenoses, but the long-term efficacy of this procedure has not been well studied. To determine the procedural success and long-term efficacy of DCA for ostial stenoses, clinical data from 1 large registry database and from 2 single centers were retrospectively reviewed. Patients included in the study underwent DCA of aortocoronary (left main or right coronary artery), non-aortocoronary (left anterior descending or circumflex), or vein graft ostial stenoses. In 158 patients undergoing DCA of 160 lesions (30 left main or right coronary, 73 left anterior descending or circumflex, and 57 vein graft stenoses), overall procedural success, defined as < 50% residual stenosis without death, Q-wave myocardial infarction, or need for urgent bypass graft surgery, was 87%. The major complication rate was 0.6%. There were no deaths or Q-wave infarctions; only 1 patient required urgent bypass surgery. Other complications included non-Q-wave myocardial infarction (9%), arterial dissection (9%), abrupt closure (4%), and distal coronary embolization (4%). Angiographic follow-up was available for 65% of the 138 eligible patients. The overall 6-month angiographic restenosis rate, defined as > 50% diameter stenosis at the site of DCA, was 48% (de novo lesions 40% and restenotic lesions 61%). Restenosis rates for de novo and restenotic lesions were: aortocoronary (33%/50%), native coronary (38%/35%), and vein graft (47%/93%), respectively. We conclude that DCA of ostial stenoses is an effective revascularization strategy associated with a high procedural success rate and a low incidence of major complications.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

Comparative long-term results of laser-assisted balloon angioplasty and atherectomy in the treatment of peripheral vascular disease.

BACKGROUND: Early results of laser-assisted balloon angioplasty (LABA) and peripheral directional atherectomy (PDA) are encouraging. The true value of these procedures has remained in doubt, however, because of the absence of data on long-term objective patency rates. PATIENTS AND METHODS: From August 1988 through October 1993, LABA and PDA were performed on 151 limbs of 124 patients. Presenting symptoms were mild-to-severe claudication in 128 limbs (63 LABA, 65 PDA) and rest pain or necrosis in 23 (7 LABA, 16 PDA). Seventy-seven percent of the atherosclerotic lesions were localized in the iliofemoral tract (77% LABA, 76% PDA). Seventy limbs were treated with LABA and 81 with PDA. RESULTS: Initial hemodynamic and arteriographic success was achieved in 46 LABA limbs (66%) and 75 PDA limbs (93%) (P < 0.002). Mean follow-up was 16 +/- 2 months after LABA and 18 +/- 1 months after PDA. During this time, 32 failures were recorded in limbs treated with LABA, and 29 in limbs treated with PDA. The patency rate at 40 months was 23% in the LABA group and 45% in the PDA group (P < 0.005). Patency rates were not affected by the length or site of the arterial lesion or the runoff score. CONCLUSIONS: PDA had a better long-term patency rate than LABA, but long-term results were dismal with both techniques. PDA appears to have a limited role and LABA no role in the treatment of lower extremity occlusive disease.

Adult↗

Directional atherectomy in the treatment of anastomotic neointimal hyperplasia associated with prosthetic arterial grafts: technique and preliminary results.

The development of anastomotic neointimal hyperplasia is a common cause of late prosthetic arterial bypass graft failure. The cost and morbidity of graft failure are high, hence the widespread use of graft surveillance programmes in order to detect graft-related stenoses before they progress to occlusion. However, the optimal treatment of stenoses secondary to neointimal hyperplasia is not clear, with a number of authors reporting poor results with both balloon angioplasty and surgical revision. We report our early experience with the Simpson atherectomy catheter in the treatment of anastomotic neointimal hyperplasia associated with prosthetic arterial grafts at eight sites in seven patients. A high technical success rate may be expected and further long-term studies of this mode of treatment are indicated.

Aged↗