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Rationale: Recent research shows that in-stent restenosis (ISR) occurs in half of the patients treated with stenting of femoral and popliteal artery for lower extremity arteriosclerotic occlusive disease (LEASO). Combined therapy is mainly used clinically to obtain better medium- and long-term treatment outcomes and reduce the occurrences of reintervention, among which, the combination of excimer laser ablation (ELA) and drug eluting balloon (DEB) is a new and effective choice., Patient Concerns: A 76-year-old male patient with ISR of right superficial femoral artery after stent implantation was reported., Diagnosis: Rechecking angiography indicated severe occlusion of the right superficial femoral artery. The physical examination showed that bilateral femoral and popliteal arteries were accessible whereas right dorsalis and posterior tibial arteries are unaccessible. Ankleolus brachial index (ABI) was 0.92 for left and 0.58 for right., Interventions: We performed the operation with ELA and drug balloon DEB on the right superficial femoral artery under local anesthesia and treated with oral antiplatelet drugs after operation., Outcomes: The combination treatment was very successful, and postoperative lower extremity arteriogram showed the blood flow was fluent and fast. No recurrence was discovered 3 months after the operation and he had no obvious symptom of claudication., Lessons: The combination of ELA and DEB is useful and effective for ISR of peripheral vessel after stent implantation, and this surgical method is worthwhile but need further clinical research for safety confirmation.

Background: Balloon catheters have been designed to facilitate pulmonary vein (PV) isolation in patients with paroxysmal atrial fibrillation (AF). The visually guided laser balloon (VGLB) employs laser energy to ablate tissue under direct visual guidance., Objectives: This study compared the efficacy and safety of VGLB ablation with standard irrigated radiofrequency ablation (RFA) during catheter ablation of AF., Methods: Patients with drug-refractory paroxysmal AF were enrolled in a multicenter, randomized controlled study of PV isolation using either the VGLB or RFA (control). The primary efficacy endpoint was freedom from protocol-defined treatment failure at 12 months, including symptomatic AF occurring after the 90-day blanking period. The primary efficacy and safety endpoints were powered for noninferiority., Results: A total of 353 patients (178 VGLB, 175 control) were randomized at 19 clinical sites. The mean procedure, ablation, and fluoroscopy times were longer with VGLB compared with controls. The primary efficacy endpoint was met in 61.1% in the VGLB group versus 61.7% in controls (absolute difference -0.6%; lower limit of 95% confidence interval [CI]: -9.3%; p = 0.003 for noninferiority). The primary adverse event rate was 11.8% in the VGLB group versus 14.5% in controls (absolute difference -2.8%; upper limit of 95% CI: 3.5; p = 0.002 for noninferiority), and was mainly driven by cardioversions. Diaphragmatic paralysis was higher (3.5% vs. 0.6%; p = 0.05), but PV stenosis was lower (0.0% vs. 2.9%; p = 0.03) with VGLB., Conclusions: Despite minimal prior experience, the safety and efficacy of VGLB ablation proved noninferior to RFA for the treatment of paroxysmal AF. (Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System-Adaptive Contact [EAS-AC] [HeartLight] in Patients With Paroxysmal Atrial Fibrillation [PAF] [HeartLight]; NCT01456000)., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: In-stent restenosis (ISR) after endovascular treatment of stenotic and occlusive disease of the infrainguinal arteries is still a clinical challenge. The purpose of this study is to evaluate the mid-term follow-up of a combination therapy using laser debulking and drug-eluting balloons for ISR., Methods: A prospective cohort of 14 patients (10 female, 4 male) with clinically relevant (Rutherford 3-6) ISR who were treated with excimer-laser angioplasty and drug-eluting balloons and a clinical follow-up of at least 9 months was evaluated., Results: Mean age was 78 ± 6.5 years (range, 67-88 years). The mean lesion length treated was 133.2 ± 107.2 mm (range, 10-380 mm). The mean time to occurrence of restenosis after initial treatment was 8.6 ± 4.7 months (range, 2-18 months). Technical success was 100%. Distal embolization occurred in 2 cases, and was treated successfully by endovascular means. No other periprocedural major adverse events occurred. All patients were available for clinical follow-up and 12 patients were available with Duplex follow-up. At a mean clinical follow-up of 19.1 ± 8.7 months (range, 9-38 months), 1 target lesion revascularization was seen (at 3 years after the ISR treatment). In the patients with critical limb ischemia (n = 7), no major amputations were needed. Twelve patients had Duplex control (mean follow-up, 19.4 ± 9.4 months; range, 9-38 months). Binary restenosis (>50%) was seen in 1 case at 36 months; it was the same patient who had TLR. A 25%-50% stenosis was seen in 4 patients (mean follow-up, 25 months; range, 19-38 months). No sign of neointimal hyperplasia was demonstrated in 7 patients (mean follow-up, 14.3 months; range, 9-19 months)., Conclusion: These mid- to long-term data compare favorably with results obtained with standard balloon angioplasty, cutting-balloon angioplasty, and balloon angioplasty using drug-eluting balloon. Longer follow-up and randomized trials are necessary to further define the role of combined excimer-laser debulking and drug-eluting balloon angioplasty in the treatment of ISR.

The novel approach of using excimer laser in a contrast medium for treating an under-expanded stent in a calcified coronary artery is described. In this first reported case, the laser in a contrast medium was used to treat an under-expanded stent deployed 18 months prior in a calcified non-dilatable coronary artery lesion. The normal laser approach in saline medium flush during lasing to clear any contrast was not effective. The use of concurrent contrast during lasing was effective and successful to help expand the stent with a successful outcome.

Lower extremity peripheral arterial occlusive disease poses a unique challenge to traditional angioplasty-based endovascular therapies. The diffuse nature of lower extremity atherosclerotic disease, the presence of chronic total occlusions, poor distal runoff, and the presence of critical limb ischemia all have contributed to the disappointing results of balloon angioplasty for complex infrainguinal arterial disease. These challenges have spawned the development of a host of new technologies in an attempt to improve the safety and effectiveness of percutaneous revascularization for lower extremity peripheral arterial occlusive disease. This review summarizes the recent advances in available technologies, including novel angioplasty balloons; nitinol stents, stent grafts, and drug-eluting stents; excisional, laser, and rotational atherectomy devices; devices for crossing total occlusions; true-lumen reentry devices; thrombectomy catheters; and embolic protection devices.

Background and Purpose: We present the results of endovascular photoacoustic recanalization (EPAR) treatment for acute ischemic stroke from the Safety and Performance Study at 6 centers in Europe and North America. The objectives of mechanical thrombolysis are rapid vessel recanalization and minimal use of chemical thrombolysis., Methods: This study was a prospective, nonrandomized study. The National Institutes of Health Stroke Scale (NIHSS) score and the modified Rankin Scale (mRS) score were recorded before treatment. The presence of recanalization was assessed by angiography. To measure outcome, follow-up examinations were performed at 24 hours, 7 days, and 30 days after stroke onset., Results: Thirty-four patients (median NIHSS 19) were enrolled. Ten patients had internal carotid artery occlusion, 12 patients had middle cerebral artery occlusion, 11 patients had vertebrobasilar occlusion, and 1 patient had posterior cerebral artery occlusion. The overall recanalization rate was 41.1% (14/34). Complete EPAR treatment was possible in 18 patients (median NIHSS 18), with vessel recanalization in 11 patients (61.1%) after EPAR. The average lasing time was 9.65 minutes. Incomplete EPAR treatment (16/34, median NIHSS 19) was defined as intention to treat with EPAR and that the EPAR microcatheter entered the patient. Additional treatment with intraarterial application of rTPA occurred in 13 patients. An adverse event associated with use of the device occurred in 1 patient. Symptomatic hemorrhages occurred in 2 patients (5.9%). The mortality rate was 38.2%., Conclusions: This study demonstrates the safety and technical feasibility of EPAR. This new technique may provide another treatment option in the therapeutic armamentarium for patients with acute ischemic stroke.

Background and Purpose: The goal of this study was to determine safety and long-term outcome of the excimer laser-assisted high-flow extracranial/intracranial (EC/IC) bypass in patients with symptomatic carotid artery occlusion (CAO) at high risk of recurrent stroke., Methods: In a prospectively collected cohort of 103 patients with symptomatic CAO, 15 patients were selected for excimer laser-assisted EC/IC bypass surgery on the basis of predefined selection criteria: (1) transient or moderately disabling symptoms of focal cerebral ischemia, not symptoms of the retina only; (2) continuing symptoms after documentation of the CAO; (3) evidence of a possible hemodynamic origin of symptoms; and (4) informed consent of the patient., Results: Eleven patients underwent the operation without complications One patient had a severely disabling stroke (Rankin grade 4) 11 days after the operation; the bypass was found occluded on reoperation. Two other patients had a moderately disabling stroke (Rankin grade 3) immediately after the operation. One patient died of myocardial infarction 1 day after surgery. Median follow-up time was 27 months. Of the 11 patients who underwent the operation without complications, 1 died 17 months after the operation of a brainstem stroke, and another patient had a new stroke ipsilateral to his CAO 10 months after the operation but without a change in Rankin grade., Conclusions: The excimer laser-assisted high-flow EC/IC bypass operation is a potentially promising procedure in patients with symptomatic CAO and a presumably high risk of recurrent stroke, but the procedure carries a definite risk. This risk is probably related not only to the procedure itself but also to the selection of patients.

We report the use of excimer-laser angioplasty for the treatment of Wiktor and Gianturco-Roubin in-stent restenosis of in two patients. Case 1-a 48-year-old man presented unstable angina five months after Wiktor stent was deployed in right coronary artery. Cardiac catheterization revealed stenosis (95%) within the stent. Case 2-a 65-year-old man presented stable angina four months after Gianturco-Roubin stent was deployed in left anterior descending artery. Cardiac catheterization revealed stenosis (80%) within the stent. Excimer-laser angioplasty within the stent reduced the stenosis to 19% and 30%, respectively. The patients recovered and currently, six months post-procedure, are free of chest pain, and cardiac catheterization revealed stenosis to 30% and 35%, respectively, within the stent. Therefore, the procedure was an effective means of treating restenosis after coronary stent placement, and a prospective comparison of excimer-laser angioplasty and other management alternatives to in-stent restenosis is needed.

Objectives: Percutaneous intracoronary angioscopy was used to study the morphologic changes occurring in coronary arteries after balloon or laser angioplasty., Background: Angioscopy is thought to provide details of the coronary vessel lumen and the inner wall., Methods: Coronary lesions were studied in 44 patients with a 4.5F Imagecath angioscope before and after each interventional procedure. Balloon and laser angioplasty were performed in 21 (group I) and 23 patients (group II), respectively. There was no difference in age, gender or angiographic lesion appearance before the procedure between the two groups., Results: Circumferential visualization of the target lesion was successfully completed in 17 group I and 19 group II patients. A larger lumen than that observed at baseline was seen in all 17 group I and in 13 of the 19 group II patients. Tissue remnants were observed in all group I and II patients. Laser irradiation resulted in characteristic sharp-edged craters. Dissection was identified in 2 of 19 patients before versus 9 of 19 patients after balloon angioplasty (p < 0.05) and in 0 of 23 patients before versus 4 of 23 patients after laser angioplasty (p = NS). Subintimal hemorrhage was observed in 3 of 19 patients before versus 11 of 19 patients after balloon angioplasty (p < 0.05) and in 2 of 23 patients before versus 4 of 23 patients after laser angioplasty (p = NS). The frequency of hemorrhage was higher in group I than in group II (11 of 19 vs. 4 of 23, respectively, p < 0.02)., Conclusions: Angioscopy provides valuable information on lesion morphology after coronary interventions. Balloon dilation results in a high rate of dissection and subintimal hemorrhage. Laser angioplasty is able to ablate obstructing tissue and results in a lower rate of subintimal hemorrhage than balloon dilation.

A unique percutaneous transluminal coronary angioplasty system using new infrared therapy laser with infrared glass fiber delivery under novel angioscope guidance was described. Carbon monoxide (CO) laser emission of 5 mm in wavelength was employed as therapy laser to achieve precise ablation of atheromatous plaque with a flexible As-S infrared glass fiber for laser delivery. We developed the first medical CO laser as well as As-S infrared glass fiber cable. We also developed 5.5 Fr. thin angioscope catheter with complete directional manipulability at its tip. The system control unit could manage to prevent failure irradiations and fiber damages. This novel angioplasty system was evaluated by a stenosis model of mongrel dogs. We demonstrated the usefulness of our system to overcome current issues on laser angioplasty using multi-fiber-catheter with over-the-guidewire system.

Excessive vascular damage causes excessive vascular repair, which results in restenosis. To limit the thickness of the coagulation layer in laser balloon angioplasty, we used a carbon monoxide (CO) laser, which has high tissue absorption, as a therapy laser source instead of a Nd: YAG laser. To investigate the benefit of short-penetration CO laser light to vascular tissue, excised human abdominal aorta was irradiated with a CO laser through a 30 microns polyethylene membrane. The temperature of the vascular tissue was continuously monitored during irradiation. CO laser irradiation of 20 W/cm2 was performed in either a continuous mode or an intermittent mode with various duty ratios (exposure/interval duration). With a total fluence of 200 J/cm2, the adventitial temperature decreased as the duty ratio was reduced. The adventitial temperature at a duty ratio of 1:2 was 43 degrees C. Microscopic examination of aorta which had been intermittently irradiated duty ratio of 1:2 showed thermal coagulation localized within the intima and a flattened intimal surface. These results suggest that intermittent laser irradiation with a CO laser can be used to limit the depth of thermal coagulation, and can selectively weld the intima without excessive thermal damage. Laser balloon angioplasty using a CO laser may help to prevent restenosis.

The excimer laser has several potential advantages over conventional balloon angioplasty in the management of stenoses of the native coronary arteries and of the ostia of saphenous vein grafts. Its use in nine patients, eight of whom were classed as high risk, is described. Four lesions involved the ostia of saphenous vein grafts, three of protected left main stems, and two of native right coronary arteries. Stand alone laser was used in seven cases and laser with additional balloon angioplasty was used in two vein graft stenoses. Acute laser success was achieved in all cases, with a mean reduction of stenosis from 82% to 34% after laser alone and to 28% when balloon angioplasty was used as well. One patient died during laser angioplasty to a non-ostial lesion (procedural success rate 89%) and a second died ten weeks after the procedure. In one patient recurrent angina developed (clinical recurrence rate 25%) and restenosis was confirmed on angiography. Follow up angiography was also performed on the other six surviving patients, all of whom were symptom free and none of whom showed evidence of significant restenosis (restenosis rate 14%). With a mean follow up of 19.7 months the overall success rate was 67%.

Sixteen segments of normal human aorta were irradiated by Nd:YAG laser beam delivered via domestically made metal cap and sapphire tip fibre systems. It was found that the metal tip fibre caused more target tissue damage and adhesion than the sapphire tip fibre. The sapphire tip fibre caused an ablation crater with a smoother edge, less carbonization layer and smaller thermal necrotic zone than the metal tip did. The metal cap and sapphire tip fibre were applied to 2 cases of iliac artery stenosis and 5 cases of coronary stenosis, all showing an immediate ablation.