Comparison of the Effect of Rosuvastatin 2.5 mg vs 20 mg on Coronary Plaque Determined by Angioscopy and Intravascular Ultrasound in Japanese With Stable Angina Pectoris (from the Aggressive Lipid-Lowering Treatment Approach Using Intensive Rosuvastatin for Vulnerable Coronary Artery Plaque [ALTAIR] Randomized Trial).

Diminishing yellow color, evaluated by coronary angioscopy, is associated with plaque stabilization and regression. Our aim was to assess the effect of aggressive lipid-lowering therapy with rosuvastatin on plaque regression and instability. Thirty-seven patients with stable angina or silent myocardial ischemia who planned to undergo elective percutaneous coronary intervention and had angioscopic yellow plaques of grade 2 or more were randomized to high-dose (group H, 20 mg/day, n = 18) or low-dose (group L, 2.5 mg/day, n = 19) rosuvastatin therapy for 48 weeks. Yellow plaque was graded on a 4-point scale of 0 (white) to 3 (bright yellow) by angioscopy, and plaque volume was determined by intravascular ultrasound for plaques with a length of 5 to 15 mm. Color and volume were assessed at baseline and after 48 weeks by the investigators blinded to the rosuvastatin dosage, and were compared between the 2 dosing groups. The level of low-density lipoprotein-cholesterol decreased from 130.3 ± 25.5 mg/dl to 61.7 ± 16.5 mg/dl (-50 ± 19%: high intensity) in group H (p <0.001) and from 130.9 ± 28.5 mg/dl to 89.7 ± 29.0 mg/dl (-30 ± 22%: moderate intensity) in group L (mean ± SD, p <0.001). The average color grade of yellow plaques decreased from 2.0 to 1.5 in group H (p <0.001) and from 2.0 to 1.6 in group L (p <0.001) after 48 weeks. Plaque volume decreased significantly in group H but not in group L. The percent change in plaque volume was significantly larger in group H than in group L (p = 0.005). In conclusion, both high-dose and low-dose rosuvastatin increased plaque stability. However, high-dose rosuvastatin was more effective than low-dose rosuvastatin in inducing plaque volume regression. Clinical Trial Registration No: UMIN-CTR, UMIN000003276.

The durability of pulmonary vein isolation using the visually guided laser balloon catheter: multicenter results of pulmonary vein remapping studies.

BACKGROUND: The visually guided laser ablation (VGLA) catheter is a compliant, variable-diameter balloon that delivers laser energy around the pulmonary vein (PV) ostium under real-time endoscopic visualization. While acute PV isolation has been shown to be feasible, limited data exist regarding the durability of isolation. OBJECTIVE: We sought to determine the durability of PV isolation following ablation using the balloon-based VGLA catheter. METHODS: The VGLA catheter was evaluated in patients with paroxysmal atrial fibrillation (3 sites, 10 operators). Following transseptal puncture, the VGLA catheter was advanced through a 12-F deflectable sheath and inflated at the target PV ostium. Under endoscopic guidance, the 30° aiming arc was maneuvered around the PV and laser energy was delivered to ablate tissue in a contiguous/overlapping manner. At ∼3 months, all patients returned for a PV remapping procedure. RESULTS: In 56 patients, 202 of 206 PVs (98%) were acutely isolated. At 105 ± 44 (mean ± SD) days, 52 patients returned for PV remapping at which time 162 of 189 PVs (86%) remained isolated and 32 of 52 patients (62%) had all PVs still isolated. On comparing the operators performing <10 vs ≥ 10 procedures, the durable PV isolation rate and the percentage of patients with all PVs isolated were found to be 73% vs 89% (P = .011) and 57% vs 66% (P = .746), respectively. After 2 procedures and 12.0 ± 1.9 months of follow-up, the drug-free rate of freedom from atrial fibrillation was 71.2%. CONCLUSIONS: In this multicenter, multioperator experience, VGLA resulted in a very high rate of durable PV isolation with a clinical efficacy similar to that of radiofrequency ablation.

Fluoroscopy-guided endovenous foam sclerotherapy using a microcatheter in varicose tributaries followed by endovenous laser treatment of incompetent saphenous veins: technical feasibility and early results.

OBJECTIVES: To evaluate the technical feasibility and preliminary results of endovenous foam sclerotherapy using a microcatheter in varicose tributaries followed by endovenous laser treatment (EVLT) of incompetent saphenous veins. MATERIALS AND METHODS: From July 2005 to August 2006, 312 patients (M:F=139:173, mean age 45.8) who presented with varicose veins with reflux in the saphenofemoral, saphenopopliteal junction or tributaries were enrolled. Under ultrasound or fluoroscopy guidance, selective microcatheterization and endovenous foam slcerotherapy were first performed in varicose tributaries, followed by EVLT (980 nm) of incompetent saphenous veins. Follow-up at 1-week and 1-, 3-, and 6-month intervals was done. RESULTS: Technical success was seen in 410 of 411 limbs (99%). Continued closure of the saphenous veins and the complete sclerosis of varicose tributaries were noted in 332 of 373 limbs (89%) at the 1-month follow-up, all 307 limbs (100%) at the 3-month follow-up, and all 274 limbs (100%) at the 6-month follow-up. No serious complication was noted. CONCLUSION: Endovenous foam sclerotherapy using a microcatheter in varicose tributaries followed by EVLT in incompetent saphenous veins is a safe, effective, and technically feasible treatment for varicose veins. It not only reduces additional sclerotherapy and technical failure, but also makes multiple therapeutic sessions unnecessary.

[Intravascular laser irradiation of blood in complex treatment of obliterating atherosclerosis of the lower extremity vessels in elderly and senile patients].

The authors describe comparative results of treatment of 60 elderly and senile patients with obliterating atherosclerosis of the lower extremity vessels. In 50 patients treatment with traditional medicines was combined with intravascular laser irradiation of blood, 10 patients were treated with traditional medicines only. The data obtained by questionnaires concerning the patients' state, expert judgment of doctors in charge of the profile department, indices of instrumental examinations of regional hemodynamics (rheovasography of the lower extremity vessels), data of laboratory investigations of morphofunctional state of erythrocytes and hemorheology showed that laser irradiation of blood gave better results of treatment. Its therapeutic effect persisted during 3 months in most patients.

Direct visualization of coronary sinus ostium and branches with a flexible steerable fiberoptic infrared endoscope.

BACKGROUND: Placement of electrophysiology catheters and pacing leads in the coronary sinus is challenging in some patients, particularly those with dilated cardiomyopathy. We hypothesized that cannulation of the coronary sinus and its branches can be facilitated by direct visualization. This study reports our experience with navigation into and within the coronary sinus in a closed-chest animal preparation, using a flexible steerable fiberoptic infrared endoscope that allows visualization through flowing blood. OBJECTIVES: The purpose of this study was to assess the feasibility of direct visualization of endocardial structures through infrared endoscopy. METHODS: Internal jugular venous access was obtained in 10 healthy mongrel dogs (weight 35-45 kg). The infrared endoscope (2900 fiber imaging bundle, wavelength 1,620 nm, frame rate 10-30/s, 320 x 256 pixels) was advanced to the coronary sinus ostium and branches by direct visualization of anatomic landmarks, such as the tricuspid valve and inferior vena cava. Localization was confirmed by fluoroscopy, contrast injection, and pathologic examination. RESULTS: Structures such as the tricuspid valve and inferior vena cava were visualized at distances of 1 to 2 cm, allowing successful coronary sinus identification and engagement in all 10 dogs. Coronary sinus branch images closely resembled pathologic findings. CONCLUSION: Direct visualization of the coronary sinus ostium and branches is possible through infrared endoscopy. This technique likely will facilitate coronary sinus engagement and navigation for pacing lead and catheter placement.

Completion angioscopy following carotid endarterectomy by the eversion technique or the standard longitudinal arteriotomy with patch closure.

INTRODUCTION: Technical defects are a potential cause of peri-operative strokes following carotid endarterectomy (CEA) by either the eversion technique or the standard method of longitudinal arteriotomy with or without patch closure. AIM: A non-randomised retrospective study was undertaken to assess the value of angioscopy for the identification of technical errors following CEA and to compare those detected following eversion and standard endarterectomy with patch closure. MATERIALS AND METHODS: Intra-operative completion angioscopy was performed following 110 CEAs (56 eversion, 54 standard). Angioscopy was omitted in 5 patients because of technical problems (2) or extreme shunt dependency (3). RESULTS: Significant technical defects were identified and corrected in 10 cases (9%) and were equally distributed between the eversion and standard procedures. There was no peri-operative stroke or death in this series. CONCLUSIONS: Significant residual defects may occur after CEA by either technique. Angioscopy allows their correction peri-operatively and has the potential to reduce peri-operative stroke.

Local antithrombotic therapy using a novel porous balloon catheter.

The efficacy of local treatment of thrombosis with low-dose antithrombotic drugs (heparin: 30 U/kg, or argatroban: 0.02 mg/kg) was investigated using a novel porous balloon catheter. This novel balloon catheter can deliver drug into arterial walls without causing vascular trauma. Thrombus formation was significantly inhibited in balloon-injured and locally-treated iliac arteries compared with control balloon-injured arteries in 12 dogs. In the systemic high-dose delivery group (ten times as high as the low dose), thrombus formation in injured arteries was significantly less than that of controls in 7 dogs. Low-dose systemic delivery was not effective at inhibiting this thrombus formation. Thus, local treatment with an antithrombotic drug using this novel porous balloon catheter can prevent thrombosis without influencing systemic coagulability.

Local delivery of antithrombotic drug prevents restenosis after balloon angioplasty in atherosclerotic rabbit artery.

We investigated the ability of various antithrombotic drugs, delivered locally, to prevent restenosis after angioplasty in hypercholesterolemic rabbits. After dilating atherosclerotic iliac stenoses by balloon angioplasty, a low dose of heparin or a new antithrombotic drug, such as low molecular weight heparin (fragmin), argatroban, or batroxobin, was delivered locally using the balloon double-occlusion technique. In 1 group, high-dose heparin was administered intravenously. Animals that received no drugs served as a control group. After angioplasty, the stenotic segment was dilated and the mean percentage luminal stenosis fell from 89% to 9% in the group that received locally delivered heparin, from 88% to 7% in the group that received locally delivered argatroban, from 87% to 11% in the group that received locally delivered fragmin, from 88% to 15% in the group that received locally delivered batroxobin, from 82% to 18% in the group that received i.v. heparin (p < 0.0001 compared with before angioplasty in each case), and from 84% to 17% in the control group (p < 0.005 compared with before angioplasty). Twenty-eight days after angioplasty, the percentage luminal stenosis remained at 14% in the group that received locally delivered argatroban, 15% in the group that received locally delivered fragmin, and 28% in the group that received locally delivered batroxobin, whereas it increased to 45% in the group that received i.v. heparin, 30% in the group that received locally delivered heparin and 72% in the control group (p < 0.05 compared with after angioplasty in each case). Thus, local delivery low doses of new antithrombotic drugs prevents restenosis after angioplasty without affecting systemic coagulability; heparin, whether administered locally or intravenously, was less effective than the new drugs in preventing restenosis.

Influence of angioscopic vein graft preparation on development of neointimal hyperplasia in an organ culture model of human saphenous vein.

PURPOSE: Angioscopy for in situ vein graft preparation has been criticized on the basis that the trauma of instrumentation may predispose to accelerated intimal hyperplasia, jeopardizing patency rates following infrainguinal revascularization. The aim of this study was to assess the effects of angioscopic preparation on endothelial integrity and smooth muscle cell (SMC) behavior in an established organ culture model of human saphenous vein (HSV). METHODS: HSV was harvested from 12 patients during bypass surgery before and after angioscopic preparation. Endothelial integrity was evaluated by immunohistochemical staining with JC-70 and scanning electron microscopy (SEM); remaining segments of pre- and postangioscopy vein were maintained in culture for 14 days in medium supplemented with 30% fetal calf serum. Viability was confirmed by measurement of tissue adenosine triphosphate on day 14 and thickness of the neointima was measured by computerized image analysis of histologic sections. Monoclonal antibodies to proliferating cell nuclear antigen (PCNA) were used as an immunohistochemical marker for proliferating SMCs. RESULTS: There was a significant reduction in the percentage staining by JC-70 (71.3% versus 20.4%) in pre- versus postangioscopy vein (p = 0.002 by Wilcoxon's rank test; n = 12). This was supported by SEM images. Despite this, there were no significant differences between the pre- and postangioscopy HSVs after 14 days of culture with respect to neointimal thickness (61 versus 56 microns) and staining with PCNA (4.80 versus 4.08 nuclei per 10 microns), all according to Wilcoxon's rank test. CONCLUSIONS: Angioscopic vein graft preparation is associated with endothelial cell loss but does not induce additional neointimal hyperplasia in HSV in vitro. These results suggest that angioscopic manipulation does not alter SMC behavior.

Induction of thrombolysis and prevention of thrombus formation by local drug delivery with a double-occlusion balloon catheter.

The efficacy of the local delivery of an antithrombotic drug in preventing thrombosis and enabling thrombolysis was investigated in 29 dogs. An antithrombotic drug (heparin, 25 U/kg), or an antithrombin (argatroban, 0.05 mg/kg) was infused into injured canine iliac arteries, using a double-occlusion balloon catheter, and the preventive effect of the drug was evaluated. Local delivery of low-dose tissue-type plasminogen activator (t-PA; Tisokinase, 50,000 U; Kowa, Nagoya and Asahi Chemical Industries, Fuji, Japan) into thrombosed canine iliac arteries, using the same catheter, or intravenous infusion of low-dose or high-dose t-PA (30,000 U/kg) was also performed. Angiographically, stenotic thrombosis was 2% by local delivery of argatroban and 7% by local delivery of heparin (P < 0.01 vs each control; 47% and 51% respectively). Thrombotic stenosis, as observed by angiography, decreased from 91% to 9% after local delivery of t-PA, and from 94% to 52% in controls. Local delivery of t-PA effectively reduced the thrombus size (P < 0.01 vs control). After systemic intravenous delivery of low-dose t-PA, no reduction of residual thrombotic stenosis, was observed. Reduction of residual thrombotic stenosis after intravenous delivery of high-dose t-PA, was similar to that achieved by local delivery of the drug. Angioscopy demonstrated a similar trend. High-dose drug delivery reduced systemic coagulability. Local delivery of an antithrombotic drug, using a double-occlusion balloon catheter, effectively prevented thrombus formation, and local delivery of t-PA induced thrombolysis without exerting a significant influence on coagulability.

Local treatment with an antithrombotic drug reduces thrombus size in coronary and peripheral thrombosed arteries.

Since the treatment of thrombotic disease by antithrombotic drugs may be associated with bleeding complications, a local delivery technique for administration of the drug may be useful. The efficacy of low-dose local delivery of an antithrombotic drug on thrombosis was investigated in 73 dogs. The antithrombotic drug (heparin, 25 U/kg, antithrombin: argatroban, 0.05 mg/kg, or defibrinogenating agent: batroxobin, 0.05 U/kg) was infused locally to a 1-h-old thrombus, and no drug was given in controls. The effect of the local delivery on the thrombus was evaluated. Low- and high-dose systemic drug delivery was also evaluated. The mean reduction in thrombotic coronary stenosis observed by angiography was 30.3% with argatroban, 22% with heparin, and 20.8% with batroxobin (P < 0.005 vs controls). Systemic delivery of low-dose heparin or argatroban did not induce any change in thrombus size. With high-dose systemic drug delivery (heparin 250 U/kg, argatroban 0.5 mg/kg), the mean reduction of thrombotic stenosis was 15.2% with heparin and 32.8% with argatroban (P < 0.005 vs controls). In the iliac arterial thrombosis, after local delivery of the drugs, the mean reduction of thrombotic stenosis observed by angiography was 24.4% in the argatroban group, and 19.2% in the heparin group (P < 0.05 vs controls, respectively). With high-dose systemic heparin delivery, the mean reduction of the thrombotic stenosis was 13.2% (P < 0.01 vs control). Angioscopy also demonstrated a similar trend. The high-dose drug delivery reduced systemic coagulability. Thus, local delivery of an antithrombotic agent can reduce the thrombus size in the coronary and iliac arteries without having any significant influence on coagulability.

Angiographic, ultrasonic, and angioscopic assessment of the coronary artery wall and lumen area configuration after directional atherectomy: the mechanism revisited.

The purpose of the present study was to use the complementary information of angiography, intravascular ultrasound, and intracoronary angioscopy before and after directional atherectomy to characterize the postatherectomy appearance of vessel wall contours and the mechanism of lumen enlargement. Directional coronary atherectomy aims at debulking rather than dilating a coronary artery lesion. The selective removal of the plaque may potentially minimize the vessel wall damage and lead to subsequent better late outcome. Whether plaque removal is the main mechanism of action has only to be assessed indirectly by angiography and warrants further investigation with detailed analysis of luminal changes and vessel wall damage by ultrasound and direct visualization with angioscopy. Twenty-six patients have been investigated by quantitative angiography, intravascular ultrasound, and intracoronary angioscopy (n = 19) before and after atherectomy. In addition, all retrieved specimens were microscopically examined. Ultrasound imaging showed an increase in lumen area from 1.95 +/- 0.70 mm2 to 7.86 +/- 2.16 mm2 at atherectomy. The achieved gain mainly resulted from plaque removal because plaque plus media area decreased from 18.16 +/- 4.47 mm2 to 13.13 +/- 3.10 mm2. Vessel wall stretching (i.e., change in external elastic lamina area) accounted for only 15% of lumen area gain. Luminal gain was higher in noncalcified (6.52 +/- 2.12 mm2) lesions than in lesions containing deeply located calcium (5.19 +/- 0.99 mm2) and lowest in superficially calcified lesions (5.41 +/- 2.41 mm2). Ultrasound imaging identified an atherectomy byte in 85% of the cases, whereas angioscopy revealed such a crevice in 74%. The complementary use of the three techniques revealed an underestimation of the presence of dissection/tear and new thrombus by angiography (10% and 4%) and ultrasound imaging (12% and 0%) compared with angioscopy (26% and 21%). The combined use of angiography, ultrasound, and angioscopy reveals that the postatherectomy luminal lining is not as regular and smooth as that seen by angiography. Luminal enlargement with atherectomy is achieved by plaque excision rather than arterial expansion.