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Intracoronary ultrasound-defined plaque composition: computer-aided plaque characterization and correlation with histologic samples obtained during directional coronary atherectomy.

The ability to classify lesion composition accurately may be important for selecting or guiding interventional therapy and for understanding the pathophysiologic basis of individual lesions. To assess the usefulness of ultrasound in classifying lesions, intracoronary ultrasound images were obtained from 44 atherosclerotic lesions in patients before directional atherectomy. Lesions were classified by visual analysis and by computer-assisted gray-level statistics. Atherectomy samples were evaluated histologically for elastosis and calcium and quantitatively by morphometric analysis for various tissue components. The computer-assisted quantitative classification agreed well with the findings on visual analysis. Visual and computer-assisted quantitative ultrasound images were found to have distinctive histologic features. Lesions with predominantly echogenic plaque had a larger fraction of dense fibrous, elastic, or calcified tissue. Lesions with predominantly echolucent soft plaque had a greater fraction of loose fibrous, smooth-muscle, thrombotic, or necrotic elements. Thus intracoronary ultrasound allows accurate classification of lesion composition in patients.

Atherectomy, Coronary↗

Experimental directional atherectomy injury in arterial vessels: impact of trauma depth on cellular response.

This study investigates cellular alterations after directional atherectomy vessel injury (DI) in an experimental model in 50 pigs. Two hundred arteries were excised at eight different times (2 hours to 21 days) after DI and were examined by electron microscopy and immunohistochemistry. The extent of injury varied with the number of repetitive passes of the atherectomy catheter. According to the extent of injury the vessel segments with DI were assigned to three groups: intima injury (group 1), media injury (group 2), and adventitia injury (group 3). A myoproliferative response was found in relation to DI depth, increasing from group 1 (ratio tissue hyperplasia/media: 0.3 +/- 0.2; p < 0.001) to group 2 (ratio tissue hyperplasia/media: 1 +/- 0.5) and group 3. Intense neutrophil infiltration occurred in groups 2 and 3 (peak 12 hours after DI) and was followed by the early occurrence of synthetic smooth-muscle cells (SMC; > 50% of all SMC present). Volume fraction of desmin and actin was transiently reduced in injured media and myoproliferative tissue (7d: 9% vs > 90% normal media). SMC proliferation started in groups 2 and 3 at 48 hours and peaked at 7 days (+500% vs normal media, p < 0.001). After DI was done, vascular response started immediately and depended on injury depth. A transient myoproliferative response resulted, correlating with the extent of vessel trauma.

Actin Cytoskeleton↗

Directional coronary atherectomy of saphenous vein graft narrowings: multicenter investigational experience.

Directional coronary atherectomy (DCA) of saphenous vein graft lesions was performed at 21 centers between June 1988 and September 1990, which represents the multicenter investigational experience. A total of 318 procedures were performed and 363 vein graft lesions were treated. Angiographic success with DCA was achieved in 86% of lesions and clinical success was achieved in 85% (269 of 318) of patients. Major complications occurred in 2.5% of patients, with Q wave myocardial infarction (MI) in 1.3%, death in 0.9%, and urgent bypass surgery in 0.9%. Other complications included non-Q wave MI in 4.4%, distal embolization in 7.2%, coronary occlusion in 1.9%, and vessel perforation in 0.6%. Although there was a trend toward lower success rates with ostial vein graft lesions (82% vs 88% for other graft sites) and with diffuse (length > 20 mm) graft lesions (75% vs 87% for shorter lesions), the differences were not significant. Baseline clinical and angiographic factors did not identify predictors of lower success or more frequent complications in the study group. Overall restenosis rate in the 149 patients with angiographic restudy was 57%. The restenosis rate was significantly lower with primary vein graft lesions (38%) compared with a 75% restenosis rate for grafts with prior restenosis, p < 0.001. This initial multicenter investigational experience indicates that directional coronary atherectomy is a safe and effective therapy for selected saphenous vein graft disease. Although the overall restenosis rate is relatively high, the restenosis rate following DCA of primary vein graft lesions is significantly lower than for vein grafts having had prior intervention.(ABSTRACT TRUNCATED AT 250 WORDS)

Atherectomy, Coronary↗

Specific indications for directional coronary atherectomy: origin left anterior descending coronary artery and bifurcation lesions.

Directional coronary atherectomy is emerging as the treatment of choice for many patients with significant lesions involving left anterior descending coronary artery origin or vessel bifurcations. It offers the potential advantages of safe, reliable, and predictable treatment of these selected complex lesions. Future modifications and improvements in the design of the atherectomy device (AtheroCath; Devices for Vascular Intervention, Redwood City, CA) may further expand its application to smaller and calcified vessels.

Angioplasty, Balloon, Coronary↗

Is 40% to 70% diameter narrowing at the site of previous stenting or directional coronary atherectomy clinically significant?

Traditional binary definitions of coronary restenosis based on 6-month continuous angiographic measurements (e.g., > 50% diameter stenosis) may give confusing results for lesions whose late percent stenosis falls near the arbitrary threshold. To determine the long-term clinical consequences of such lesions, the overall correlation between follow-up percent stenosis and the performance of subsequent ischemia-driven target vessel revascularization (triggered by significant angina or a positive exercise study result, or both) was examined in 443 consecutive lesions treated with directional coronary atherectomy or Palmaz-Schatz coronary stenting. Follow-up angiograms (available in 355 lesions, 82%) were stratified into 3 groups: severe late stenosis (> 70% stenosis, n = 59), moderate late stenosis (40% to 70% stenosis, n = 72), and minimal late stenosis (< 40% stenosis, n = 224). With an average clinical follow-up of 933 +/- 394 days, 92% of lesions in the "severe late stenosis" group were treated with ischemia-driven target vessel revascularization, compared with 0% of the lesions in the "minimal late stenosis" group. Ischemia-driven target vessel revascularization was performed in 38% of patients in the "moderate late stenosis" group. However, patients in this group who did not undergo revascularization (despite the fact that 43% of them had a late stenosis of > 50%) showed a similarly favorable long-term clinical outcome to patients with a minimal late stenosis. These results support a strategy of conservative management for the 20% of patients who have a moderate (40% to 70%) late stenosis after stenting or atherectomy, but do not have evidence of ischemia.

Atherectomy, Coronary↗

Aortic dissection during directional coronary atherectomy.

Directional coronary atherectomy has been applied to aorto-ostial lesions with higher success and lower complication rates than conventional balloon angioplasty. Aortic injuries have been reported with this technique, most resulting from the tip of the catheter. In this report, an aortic dissection caused by the shaft of the directional coronary atherectomy catheter is described.

Aortic Dissection↗

Observational versus randomized medical device testing before and after market approval--the atherectomy-versus-angioplasty controversy.

Percutaneous transluminal coronary angioplasty was developed in the late 1970s as a nonsurgical alternative for revascularization of atherosclerotic coronary arteries. It gained widespread acceptance without a controlled trial. Introduced in 1986, directional coronary atherectomy was the first of other recently developed coronary devices that sought to improve on the results of angioplasty. It was approved in 1990 by the Food and Drug Administration (FDA) on the basis of observational data. Its use expanded rapidly, reaching over 35,000 procedures in 1992, accounting for more than 10% of all interventions. After premarket approval, two major randomized trials tested the hypothesis that atherectomy would be superior to angioplasty. Their results raised a cautionary flag and stood in contrast to projections made from prior observational data. It is concluded that randomized controlled trials validate claims of relative efficacy and safety of competing medical technologies, a lesson reflected in recent changes in policy at the FDA.

Angioplasty, Balloon, Coronary↗

Randomized trial of Rotational Atherectomy Versus Balloon Angioplasty for Diffuse In-stent Restenosis (ROSTER).

BACKGROUND: Various autopsy and intravascular ultrasound (IVUS) studies have shown neointimal proliferation as the main mechanism of in-stent restenosis (ISR) responsible for >95% of luminal narrowing while stent struts are not compressed. ISR of diffuse type has a high incidence of recurrence (up to 70%) after balloon angioplasty (PTCA). Tissue ablation with percutaneous rotational coronary atherectomy (PRCA) may be more efficacious compared to tissue compression or extrusion after PTCA for the interventional treatment of diffuse ISR. METHODS: The Rotational Atherectomy Versus Balloon Angioplasty for Diffuse In-Stent Restenosis (ROSTER) trial is a single-center, randomized trial comparing PRCA to PTCA (both with IVUS guidance) in the treatment of diffuse ISR in 200 patients. In the PRCA group (n = 100), rotablation was performed using a burr-to-artery ratio >0.7 followed by adjunctive balloon dilatation at low pressure (4-6 atm). In the PTCA group (n = 100), high-pressure (>12 atm) balloon dilatation was performed using an optimal size balloon. The study's primary end point was target lesion revascularization (TLR) at 9 months and secondary end points included clinical events at 1 year and angiographic restenosis in a substudy of the last 75 patients enrolled. RESULTS: Baseline clinical and angiographic variables were comparable between the 2 groups with similar procedural and angiographic success, but a higher rate of repeat stenting occurred in the PTCA group (31% vs 10%; P <.001). Although the angiographic acute luminal gain was similar between the 2 groups, IVUS analysis revealed lower residual intimal hyperplasia area after PRCA versus PTCA (2.1 +/- 0.9 mm2 vs. 3.3 +/- 1.8 mm2; P =.005). At a mean follow-up of 12 +/- 2 months, there were 2 deaths, 3 myocardial infarctions, and 3 coronary artery bypass graft procedures in each group. TLR incidence was 32% in the PRCA group and 45% in the PTCA group (P =.042), with a similar trend noted in the angiographic substudy. CONCLUSION: The ROSTER trial for diffuse ISR revealed both PRCA and PTCA to be safe and effective, but PRCA resulted in less residual intimal hyperplasia, lower repeat stent use, and decreased TLR.

Aged↗

Comparison of directional coronary atherectomy and stenting versus stenting alone for the treatment of de novo and restenotic coronary artery narrowing.

Late lumen loss after directional coronary atherectomy (DCA) is mainly determined by arterial remodeling. We hypothesized that stent implantation after optimal lesion debulking could be an effective approach to reduce restenosis. A total of 753 patients with de novo or restenotic coronary lesions were prospectively randomized to DCA plus stenting (n = 381) or stenting alone (n = 372). The patients were followed for 12 months. Procedural success was achieved in 91.5% versus 97.3% (p = 0.0007) of patients treated with DCA plus stent versus stent alone. Optimal atherectomy (<20% residual stenosis) was achieved in 26.5% of patients. The final minimal luminal diameter and the acute gain were similar in the 2 groups. There was no increase in 30-day major adverse cardiac events in the DCA plus stent group (3.9% vs 2.4%, p = 0.30). The primary end point, angiographic restenosis at 8 months, occurred in 26.7% of patients treated with DCA plus stents and in 22.1% of patients treated with stents alone (p = 0.237). Clinical follow-up to 1 year showed no difference in mortality (1.3% vs 0.8%, p = 0.725), acute myocardial infarction (4.2% vs 3.5%, p = 0.706), and target vessel failure (composite of death, Q-wave myocardial infarction, and target vessel revascularization) (23.9% vs 21.5%, p = 0.487) between patients with DCA plus stents and those with stents alone. This study failed to support the hypothesis that DCA before stenting lowers the angiographic restenosis rate compared with stents alone. At 12-month follow-up, there were no significant differences between the 2 groups in rates of death, reinfarction, or target vessel failure.

Adult↗

Long-term outcomes after treatment of diffuse in-stent restenosis with rotational atherectomy followed by beta-radiation therapy with a 188Re-MAG3-filled balloon.

BACKGROUND: Intracoronary radiation therapy for in-stent restenosis has been demonstrated to reduce restenosis and major adverse cardiac events. However, long-term angiographic and clinical outcomes after beta radiation therapy have not been sufficiently evaluated. METHODS: We evaluated the long-term angiographic and clinical outcomes of 50 consecutive patients who had received beta-radiation therapy with a 188Re-MAG3-filled balloon after rotational atherectomy for diffuse in-stent restenosis (lesion length>10 mm) in native coronary arteries. The radiation dose was 15 Gy at a depth of 1.0 mm into the vessel wall. RESULTS: The mean lesion length was 25.6+/-12.7 mm. Radiation was delivered successfully to all patients without any procedural or in-hospital complications. At the 6-month angiogram, the restenosis rates was 10% (5/50). There were no major adverse cardiac events (MACE), such as death, myocardial infarction, and target lesion revascularization (TLR) by 6-month follow-up. Long-term clinical follow-up data were obtained in all patients during 30.1+/-4.5 months. No myocardial infarction and one noncardiac death occurred during follow-up. Two-year follow-up angiogram was performed in 26 (58%) of 45 patients who showed a patent radiation segment at the 6-month angiogram. Significant narrowing of diameter stenosis of more than 50% occurred in 6 (23%) of 26 patients between 6 and 24 months after beta-radiation. Late TLR was performed in 6 patients. The rate of 30-month death-free survival and MACE-free survival were 98.0+/-2.0% and 86.9+/-5.0%. CONCLUSION: Beta-radiation using a 188Re-MAG3-filled balloon after rotational atherectomy is associated with favorable long-term angiographic and clinical outcomes.

Angioplasty, Balloon, Coronary↗

Comparison of angiographic and clinical outcomes between rotational atherectomy versus balloon angioplasty followed by radiation therapy with a rhenium-188-mercaptoacetyltriglycine-filled balloon in the treatment of diffuse in-stent restenosis.

BACKGROUND: The purpose of this study was to compare the efficacy of rotational atherectomy (RA) with simple balloon angioplasty, prior to beta-radiation therapy with a rhenium-188-mercaptoacetyltriglycine (188Re-MAG3)-filled balloon for diffuse in-stent restenosis (ISR). METHODS: After completing 50 cases with RA prior to beta-radiation (Group I), we performed optimal balloon angioplasty followed by beta-radiation in the next 53 consecutive patients (Group II) for the treatment of diffuse ISR. The radiation dose was 15 Gy at a depth of 1.0 mm into the vessel wall. RESULTS: The baseline clinical and angiographic characteristics were similar between the two groups. The mean length of the lesion was 25.6+/-12.7 mm in Group I and 22.9+/-8.6 mm in Group II (p=0.26). Radiation was successfully delivered to all patients, with a mean irradiation time of 179+/-55 s. The 6-month angiographic restenosis rate was 10% (5/50) in Group I versus 33% (17/51) in Group II (p=0.007). No adverse event including myocardial infarction, death, or stent thrombosis occurred during the 1-year follow-up period. The risk of a target lesion revascularization or a major adverse cardiac event was significantly lower in Group I than in Group II (two patients in Group I vs. nine patients in Group II; OR, 0.20; 95% CI, 0.04-0.96; p=0.04). CONCLUSION: Concomitant treatment with rotational atherectomy and beta-irradiation using a 188Re-MAG3-filled balloon for diffuse ISR has a synergistic effect, in terms of 6-month angiographic restenosis and 1-year cardiac event-free survival.

Angioplasty, Balloon, Coronary↗

Meta-analysis of randomized trials of percutaneous transluminal coronary angioplasty versus atherectomy, cutting balloon atherotomy, or laser angioplasty.

OBJECTIVES: We conducted a systematic overview (meta-analysis) of randomized trials of balloon angioplasty versus coronary atherectomy, laser angioplasty, or cutting balloon atherotomy to evaluate the effects of plaque modification during percutaneous coronary intervention. BACKGROUND: Several mechanical approaches have been developed that ablate or section atheromatous plaque during percutaneous coronary interventions to optimize acute results, minimize intimal injury, and reduce complications and restenosis. METHODS: Sixteen trials (9,222 patients) constitute the randomized controlled experience with atherectomy, laser, or atherotomy versus balloon angioplasty with or without coronary stenting. Each trial tested the hypothesis that ablative therapy would result in better clinical or angiographic results than balloon dilation alone. RESULTS: Short-term death rates (<31 days) were not improved by the use of ablative procedures (0.3% vs. 0.4%, odds ratio [OR] 0.94 [95% confidence interval 0.46 to 1.92]), but periprocedural myocardial infarctions (4.4% vs. 2.5%, OR 1.83 [95% CI 1.43 to 2.34]) and major adverse cardiac events (5.1% vs. 3.3%, OR 1.54 [95% CI 1.25 to 1.89]) were increased. Angiographic restenosis rates (6,958 patients) were not improved with the ablative devices (38.9% vs. 37.4%, OR 1.06 [95% CI 0.97 to 1.17]). No reduction in revascularization rates (25.2% vs. 24.5%, OR 1.04 [95% CI 0.94 to 1.14]) or cumulative adverse cardiac events rates up to one year after treatment were seen with ablative devices (27.8% vs. 26.1%, OR 1.09 [95% CI 0.99 to 1.20]). CONCLUSIONS: The combined experience from randomized trials suggests that ablative devices failed to achieve predefined clinical and angiographic outcomes. This meta-analysis does not support the hypothesis that routine ablation or sectioning of atheromatous tissue is beneficial during percutaneous coronary interventions.

Angioplasty, Balloon, Coronary↗

Peripheral atherectomy in TransAtlantic InterSociety Consensus type C femoropopliteal lesions for limb salvage.

BACKGROUND: The optimal therapy for TransAtlantic Societal Consensus (TASC) type C femoropopliteal lesions remains a critical issue in the treatment of infrainguinal occlusive disease. The purpose of this study was to evaluate the outcome of limbs with TASC C femoropopliteal lesions and critical limb ischemia treated with the FoxHollow SilverHawk atherectomy catheter. METHODS: From September 2004 to September 2005, 18 consecutive femoropopliteal procedures performed in 17 limbs in 16 patients were reviewed. Demographic data, baseline angiographic findings, and indications for the procedures were recorded. Clinical outcomes including symptom resolution and limb salvage were determined for the 17 primary procedures. Hemodynamic improvement was compared by using the paired Student t test. Stenosis-free patency was determined by the Kaplan-Meier method. RESULTS: The mean age was 72.5 years (range, 47-88 years). Fifty percent of the patients had four or more of the following risk factors: hypertension, diabetes, tobacco use, hyperlipidemia, renal insufficiency, and coronary artery disease. The indication was tissue loss in 13 limbs and rest pain in 4. All patients had a second level of disease, either inflow or tibial/pedal, which was treated concurrently when appropriate. Initial resolution of symptoms was achieved in 12 limbs, and partial healing was achieved in 2 others. Early amputation was necessary in the remaining three patients, but this was likely due to severe inframalleolar disease and advanced forefoot ischemia at the time of presentation. Five patients have remained symptom-free without restenosis at a mean follow-up of 6 months. Two patients have required late amputation for hemodynamic failure. The ankle-brachial index improved from 0.39 +/- 0.08 (mean +/- SEM) before surgery to 0.75 +/- 0.08 in the immediate postoperative period (P = .02). However, it returned toward baseline at 6 months after surgery, with a mean of 0.48 +/- 0.07. Stenosis-free patency of the femoropopliteal segment was 22% at 12 months. CONCLUSIONS: Peripheral atherectomy can achieve good early clinical and hemodynamic success in patients with TASC C lesions and critical limb ischemia. However, mid-term restenosis rates are high in this challenging cohort of patients.

Arterial Occlusive Diseases↗

Effectiveness of tranilast on restenosis after directional coronary atherectomy.

Tranilast is an antiallergic drug used widely in Japan that also inhibits the migration and proliferation of vascular smooth muscle cells. This pilot study was undertaken to determine the effectiveness of tranilast on restenosis after successful directional coronary atherectomy. After the procedure, 40 patients (56 lesions, tranilast group) were treated with oral tranilast for 3 months, and 152 patients (188 lesions, control group) did not receive tranilast. Angiographic and clinical variables were compared between the two groups. The minimal lumen diameter was significantly larger in the tranilast group than in the control group at both 3-month (2.08 vs 1.75 mm, p = 0.004) and 6-month follow-up (2.04 vs 1.70 mm, p = 0.003). The diameter stenosis in the tranilast group was smaller than that in the control group both 3 months (28% vs 40%, p = 0.0007) and 6 months (30% vs 43%, p = 0.0001) after the procedure, with a lower restenosis rate (percent diameter stenosis > or =50) in the tranilast group at 3 months (11 % vs 26%, p = 0.03). The number of clinical events over the 12-month period after the procedure was significantly reduced by tranilast administration (p = 0.013). These findings suggest that the oral administration of tranilast strongly prevents restenosis after directional coronary atherectomy.

Aged↗

Impact of target lesion calcification on coronary stent expansion after rotational atherectomy.

BACKGROUND: Calcified lesions carry the risk of suboptimal stent expansion. The purpose of this study was to investigate the impact of target lesion calcification on intracoronary ultrasound (ICUS) guided stent expansion after rotational atherectomy. METHODS: Stent expansion was assessed by ICUS in 39 patients with the aid of the proximal stent/proximal reference lumen, the minimal stent/mean reference lumen, and the minimal stent/minor reference lumen ratios as well as the symmetry index. Thirty-nine stent implantations in uncalcified lesions served for comparison. RESULTS: Relative stent expansion ranged between 76.3% +/- 6.7% and 98.4% +/- 16.4%. Categorization according to an ICUS-derived arc of superficial lesion calcium of <180 degrees (average 102 +/- 74 degrees) or >180 degrees (average 248 +/- 71 degrees) revealed decreased stent symmetry in calcified lesions >180 degrees compared with the control group (P <.05). Despite a trend toward less expansion with increasing calcium load, no significant differences of the lumen area ratios between the study groups was present. CONCLUSION: Rotational atherectomy before ICUS-guided stent implantation enables adequate stent expansion even in significant superficial target lesion calcification.

Aged↗

Assessing a strategy of initial stand-alone extractional atherectomy followed by staged stent placement in degenerated saphenous vein graft lesions.

To assess whether a staged strategy (initial stand alone transluminal extraction atherectomy and coumadin therapy followed by stenting six weeks later) could reduce ischemic complications in degenerated saphenous vein graft (SVG) interventions, we studied 72 patients undergoing percutaneous interventions of degenerated SVG. Patients were divided into two groups; 28 were treated with a staged strategy (group I) and 44 with similar lesion characteristics were treated with a definitive initial procedure with transluminal extraction atherectomy +/- adjunctive balloon angioplasty and stenting (group II). Procedural success, major in-hospital complications (death, Q-wave myocardial infarction, and emergent coronary bypass surgery), and incidence of distal embolization were compared between the 2 groups. Procedural success was lower (92% vs 100%, p = 0.14) and major in-hospital complications were higher (0% vs 11%, p = 0.14) in group II. Distal embolization occurred in 11% of the patients in group I compared with 23% of the patients in group II (p = 0.19). At 6 week follow-up (group I), 9 patients (33%) had negative symptoms, 11 (41%) underwent stent implantation, 3 (11%) did not require any further therapy (without significant stenosis), and 4 (14%) had total occlusions. We therefore conclude that this staged strategy in degenerated SVG appears to reduce distal embolization but most importantly avoids major in-hospital complications, including any deaths either at the time of initial procedure or during the 6-week follow-up period.

Aged↗

Relation between preintervention remodeling and late arterial responses to coronary angioplasty or atherectomy.

We used the serial intravascular ultrasound (IVUS) data from the Serial Ultrasound REstenosis trial to explain why positive remodeling lesions have a higher rate of clinical restenosis after non-stent interventions. Serial IVUS was performed before intervention and immediately and 1 and 6 months after percutaneous transluminal coronary angioplasty (n = 35) or directional coronary atherectomy (n = 26). External elastic membrane, lumen, and plaque + media (external elastic membrane minus lumen) areas were measured at the reference and stenosis. Stenoses were divided into 3 groups: positive remodeling (lesion greater than proximal reference external elastic membrane), intermediate remodeling (lesion external elastic membrane smaller than proximal reference but larger than distal reference), and negative remodeling (lesion equal to or less than distal reference external elastic membrane). The early (postintervention to 1 month) and late (1- to 6-month) changes in lesion external elastic membrane and plaque + media areas were compared. An early increase in plaque + media area was associated with an equal or greater increase in external elastic membrane area in positive (r = 0.78, p < 0.0001), intermediate (r = 0.69, p < 0.0001), and negative (r = 0.59, p = 0.0003) remodeling lesions. A late (1- to 6-month) decrease in external elastic membrane area correlated inversely with the early increase in plaque + media area in positive (r = 0.77, p = 0.0002) and intermediate (r = 0.45, p = 0.0003), but not in negative (r = 0.02, p = 0.9) remodeling lesions. In positive remodeling lesions, the early increase in plaque + media area was associated with both an exaggerated early increase and late decrease in external elastic membrane area. Positive remodeling lesions have an exaggerated early increase in external elastic membrane area and, especially, an exaggerated late decrease in external elastic membrane area after percutaneous transluminal coronary angioplasty and directional coronary atherectomy. This may explain that the increased clinical restenosis after positive remodeling lesions is treated with non-stent interventions.

Analysis of Variance↗