"Hot tip": another method of laser vascular recanalization

This study is a preliminary report evaluating the use of laser radiation to heat a metal-capped fiber for arterial recanalization. The method was compared to the currently used bare-ended fiber for recanalization of occluded vessels. The model used was a human coronary artery xenograft transplanted in the femoral artery of the dog. At 4 weeks following the transplantation, laser recanalization was attempted using the heated metal probe ("hot tip") in five arteries and the bare fiber in another five arteries. Results: 1) Angiography demonstrated recanalization in all five arteries treated with the "hot tip" and three of the five arteries treated with the bare fiber. 2) Only one perforation occurred with the "hot tip," whereas three perforations occurred with the bare fiber. 3) The larger metal cap was capable of creating a wider channel in the occluded arterial segment. Although the trend favored the heated metal cap in terms of recanalization and less perforation than the bare fiber, the total number of experiments were not adequate to demonstrate statistical significance. Microscopic examination of the vessels recanalized by either technique was similar. Characteristic charring at the recanalization site was seen regardless of the technique used. These observations suggest that the effect of direct laser radiation on plaques is predominantly a thermal effect. Although these results would suggest utilization of a metal-capped fiber for vascular recanalization, more studies need to be done to confirm these preliminary findings.     

Design and evaluation of a fiberoptic fluorescence guided laser recanalization system

Current angioplasty techniques for recanalization of totally occluded arteries are limited by the inability to cross the occlusion and by the risk of perforation. A fiberoptic fluorescence guided laser recanalization system was developed and evaluated in vitro for recanalization of 17 human femoral or tibial totally occluded arterial segments (length 1.9-6.8 cm, diameter 2.5-6.0 mm). A 400 or 600 micron silica fiber was coupled to a helium-cadmium laser (lambda = 325 nm) for fluorescence excitation and to a holmium: YAG laser (lambda = 2.1 micron) for tissue ablation. Fluorescence was recorded during recanalization after every other holmium laser pulse. During recanalization, each arterial segment was bent 30-90 degrees with respect to the fiber to simulate arterial tortuosity. Ablation continued with fiber advancement as long as the fluorescence confirmed that the target tissue was atherosclerotic. Arterial spectra were classified as normal or atherosclerotic by an on-line computerized fluorescence classification algorithm (sensitivity 93%, specificity 95%). Normal fluorescence necessitated redirection of the fiber greater than 30 times per segment to continue recanalization. Fifteen of 17 totally occluded arteries had multiple recanalization channels created following total energy delivery of 40-1,016 Joules per segment with no angiographic or histologic evidence of laser perforation. Two heavily calcified arterial occlusions were not recanalized due to inhibition of holmium: YAG laser ablation by the recording of normal fluorescence spectra. Therefore, this fluorescence guided laser recanalization system appears safe and effective for recanalization of totally occluded arteries and merits in vivo evaluation. However, the lower sensitivity of fluorescence detection of heavily calcified plaques may limit the efficacy (but not safety) of fluorescence guided recanalization of heavily calcified occlusions.     

Recanalization of arterial occlusions with a lensed fiber and a holmium:YAG laser.

Laser recanalization of totally occluded swine iliac arteries was performed to assess the safety and efficacy of a lensed fiber laser angioplasty system with a holmium:YAG (2.1 microns) laser. Silica lenses of 1.0 mm, 1.3 mm, and 1.5 mm in diameter attached to the distal end of a 300-microns diameter silica fiber delivered fluences of 79.5 J/cm2, 31.4 J/cm2, and 25.5 J/cm2, respectively. The pulse duration of the laser was 250 microseconds and the repetition rate was 4 Hz. The mean length of the total occlusions was 5.3 +/- 2.0 cm (range 0.5 cm to 8.0 cm). Successful recanalization was obtained in 16/16 lesions without angiographic vessel perforation. Angiographically significant residual stenoses (greater than 50%) remained in every case following successful laser recanalization. Histologically there was minimal evidence of thermal or acoustic tissue injury; however, in 4 of 16 arteries there was evidence of deep arterial dissection following laser recanalization. We conclude that this lensed fiber coupled with a holmium:YAG laser is a safe and effective method for crossing total occlusions in the relatively straight iliac arteries of this animal model.     

Percutaneous transluminal excimer laser angioplasty in total peripheral artery occlusion in man

Laser angioplasty and laser-assisted angioplasty have become a clinical reality. Producing sharply defined borders of the ablated area with minimal adjacent thermal damage, excimer lasers offer several proven and some potential advantages over conventional systems. To evaluate the feasibility of excimer laser angioplasty, we have treated one patient using 308-nm radiation via a bare fiber in direct contact with the total occlusion of a right femoral artery. The lesion was successfully recanalized, thus allowing easy passage of the balloon catheter and subsequent dilatation. This percutaneous laser recanalization of an occluded peripheral artery is one of the first to be done in man using excimer laser radiation, thus demonstrating that the technique is feasible and the system is potentially useful.     

Experimental treatment of thrombotic vascular occlusion

The role of laser energy in the treatment of thrombotic vascular occlusion was evaluated in two sets of experiments. First, 10 polytetrafluoroethylene grafts were used to replace segments of the superficial femoral arteries in dogs and were thrombosed by distal ligation. Occlusion was maintained for one hour, or for 7, 14, 21, and 28 days in each of two grafts. Patency was restored in all 10 grafts without perforation or anastomotic disruption using a 2 mm hot tip probe powered by an Argon laser. However, increased organization of thrombus related to the duration of occlusion lead to decreased laser channel diameters, and 75% of the 28 day thrombus remained in the graft after recanalization. The second experiments tested the added benefit of thrombolytic infusion following laser recanalization. Bilateral external iliac artery thrombosis was induced in dogs by operative vessel isolation, de-endothelialization, and thrombin injection. At 7 days the efficacy of laser-assisted thrombolysis (LAT) versus enzymatic thrombolysis (ET) alone was compared. Eight vessels underwent ET by urokinase (4000 I.U./min.); 14 vessels were laser recanalized prior to thrombolytic infusion. LAT was performed from a carotid artery approach in 8 vessels (antegrade) and from a femoral artery in 6 vessels (retrograde). In contrast to studies using the hot tip alone, both ET and LAT accomplished complete thrombus removal. However, LAT lead to significant iliac arterial flow in 9 +/- 8 min. (antegrade) and 25 +/- 8 min. (retrograde) while ET required 109 +/- 47 min (p less than 0.01).(ABSTRACT TRUNCATED AT 250 WORDS)     

Percutaneous recanalization of arteries: Status and prospects of laser angioplasty with modified fibre tips

Percutaneous balloon dilatation of arterial stenoses is a firmly established non-surgical treatment of ischaemic disease. The number of percutaneous transluminal coronary angioplasties performed per year in the USA approaches the number of coronary artery bypass graft operations. A great number of novel percutaneous recanalization schemes address the major problems of balloon angioplasty: failure to cross the stenosis (occlusion), failure to dilate effectively (15–20%), acute complications (5%) and re-stenosis within six months (30–40%). Laser energy can effectively evaporate atheromatous plaque, but delivery by an unmodified bare fibre creates only a small channel and carries a high risk of vessel-wall perforation in the coronary arteries. It appears impossible to maintain an axial position in small, tortuous and moving arteries with multiple side-branches. Coronary lesions are anatomically and structurally heterogeneous. Reduction of the perforation risk is being approached by four strategies: (a) optimization of the power source; (b) enhancement of laser-light absorption by plaque relative to artery wall; (c) improvement of plaque recognition; and (d) modification of the delivery system, which is discussed in detail. Recanalization of occluded femoropopliteal arteries with the 2.0-mm metal laser probe has proved to be safe and effective in more than 100 patients. The 2.2-mm rounded sapphire contact probe has been used with success in the peripheral arteries of over 30 patients. The recanalization mechanism of both probes is not yet fully understood. Closed-chest attempts at recanalization of coronary arteries by the 1.7-mm metal laser probe have been reported in 13 patients, with success in the majority. There were no complications requiring emergency surgery. The possible occurrence of embolism or spasm in three cases warrants a cautious approach to application of the metal laser probe in the coronary catheterization room. The primary benefit of laser recanalization with modified fibre tips is the possible transformation of a candidate for surgery into a candidate for balloon angioplasty. It remains to be established whether prior laser debulking of the atheroma will reduce the incidence of acute complications of balloon dilatation and will reduce restenosis in the subsequent year. In the past two years an avalanche of laser and non-laser recanalization schemes have been developed. In peripheral arteries, early results of most methods have shown an acceptably low incidence of acute perforations or other complications. The human arterial wall can take a heavy beating, both mechanically and thermally. In the next decade, catheter intervention techniques will progressively contribute to the treatment of peripheral and coronary artery disease.     

Transluminal laser treatment with metal-capped optical fibres of normal coronary arteries in live dogs: an angiographic and histological study of the acute effects

Transluminal laser treatment of coronary arteries with bare optical fibres frequently results in perforation, mainly owing to misalignment of the laser beam. To overcome this problem, a 300 μm-diameter optical fibre, fitted with a 1.5 mm metal cap, was used to convert argon-laser energy to heat. In 12 anaesthetized dogs, a 8.3 French Sones guiding catheter was placed, via the right carotid artery, in the left coronary ostium, and the optical fibre was advanced into the circumflex artery. After argon laser treatment at 6 W for 1s, the fibre was withdrawn by increments of 0.5–1.0 cm; laser treatment was repeated after each repositioning, by using 6W and increasing exposure times of 2, 3, 4 and 5 s. In six dogs the laser was applied in the beating heart, and in six in the asystolic heart, to assess the effects in the absence of a coronary blood flow. Angiography, before and after the laser treatment, did not reveal coronary perforation or other major acute complications. Post-mortem examination showed that the number of sites with evidence of intimal vaporization was higher in dogs treated in the asystolic heart than in the others (14 versus 6 sites, respectively,P<0.02). The post mortems confirmed that perforation did not occur in either case. Laser treatment for 5 s resulted in intimal vaporization in 11 of the 12 arteries (91%); for 4s in seven of the arteries (60%); and for 3 s in two arteries (16%). Thus, intimal vaporization of normal coronary arteries in both the beating and the asystolic dog heart can be achieved without perforation or other major acute complications by transluminal laser treatment with metal-capped optical fibres.     

Comparison of early clinical results of contact laser thermal angioplasty with a metal hot tip with balloon angioplasty

Contact laser thermal angioplasty with a metal hot tip heated by an Argon laser system (Trimedyne Inc.) was performed on 34 peripheral arterial occlusive or stenotic regions (7 iliac, 20 femoral and 7 popliteal arteries) in 22 patients with ASO. The early clinical results of laser angioplasty were investigated by comparing those of 15 patients treated by percutaneous transluminal balloon angioplasty (PTA). There was no perforation of the arterial wall caused by thermal ablation with the hot tip heated by repeated pulses under power conditions of 10 watts of laser energy for 5 seconds. Detachment of the hot tip caused by frequent healing without a sufficient period of tip cooling was observed in 2 cases. Acute thrombosis was observed in 1 patient during reconstruction of the proximal artery. The initial success rate of laser angioplasty and PTA was 91.2% and 86.7%, respectively. Re-stenosis or occlusion was observed in 7 of 31 regions 6 months after laser angioplasty. Satisfactory results were not obtained in the femoral artery. The overall patency rate of laser angioplasty and PTA was 77.4% and 69.2%, respectively. The initial success rate of laser angioplasty in totally obstructed arterial regions was higher than that of PTA.     

Experimental and clinical applications of angioscopic guidance for laser angioplasty

The role of angioscopic monitoring and aiming for control of laser intervention in the vascular system was initially investigated in 48 vessels in 33 dogs, and the techniques were then applied to 30 patients undergoing intraoperative or percutaneous laser-probe angioplasty treatment for long atherosclerotic occlusions of the femoral and popliteal arteries or well-localized lesions of the superficial femoral artery. Experimental bare argon fiber laser application in 20 normal canine arteries in vivo demonstrated that small-diameter laser fibers could be accurately aimed by manipulations of the scope. However, advancement of the fiber resulted universally in perforation, with extravasation and thermal damage of surrounding tissues after 2 seconds of argon laser energy at low power. In 28 canine and 2 human veins, angioscopically guided metallic-tipped laserprobes were used to divide 82 valve cusps in preparation for in-situ bypass, with satisfactory aiming and monitoring achieved expeditiously by manipulations of the angioscope. We conclude that angioscopic aiming of lasers is feasible in normal vessels or localized lesions. In contrast, angioscopy has a restricted role for guidance of laser angioplasty in atherosclerotic, occluded arteries, and does not prevent perforation. Postprocedural inspection allows immediate detection of complications and may avert or predict poor outcome.     

Effect of CO2 and blood media on laser probe temperature

Blood may limit laser ablation of arterial plaque by decreasing thermal energy transfer from metal-capped probes to arterial occlusions. Since a gas is a good insulator of heat, CO2 may be a better medium for laser recanalization. To study this possibility, a metal-capped fiber was positioned in a segment of blood-filled polyethylene tubing and activated with an argon laser. Probe temperatures were measured in blood and as the blood was displaced by flowing CO2 gas. Probe temperatures were higher at all powers studied in CO2 gas than in blood. Maximum probe temperatures averaged 518 +/- 24 degrees C after CO2 infusion versus 320 +/- 7 degrees C in blood, (P less than 0.0001). Blood aggregate formation was noted on the probe surface in blood but not in CO2 medium. Thus CO2 gas may be a preferable medium for laser recanalization, since higher probe temperatures are achieved, and the probe surface remains free of insulating blood coagulate.     

The effect of plaque composition on laser recanalization

Laser recanalization using metal-capped laser fibers and continuous-wave laser energy occurs by thermal ablation of atherosclerotic plaque. Different types of plaque respond differently to laser energy and plaque composition may be an important determinant of the success of laser recanalization. To investigate this hypothesis, 16 patients with symptomatic arterial occlusions in the mid and distal superficial femoral artery underwent B-mode ultrasound arterial imaging prior to attempted argon laser recanalization. The composition of the occlusions was classified as soft (echogenicity less than the adjacent arterial wall), dense (echogenicity equal to the adjacent arterial wall), or calcified (echoreflective). Recanalization was successful in 100% (8/8) of patients with soft occlusions versus 38% (3/8) with dense or calcified occlusions (P = 0.01). Thus, plaque composition as assessed by B-mode ultrasound imaging appears to be an important predictor of the success or failure of arterial recanalization using a thermal laser probe.     

Angioscopy as an adjunct to arterial reconstructive surgery: a preliminary report

To date our use of angioscopy as an adjunct to in situ vein grafting, arterial embolectomy, femoropopliteal bypass surgery, and laser recanalization has been studied in 11 patients. Three angioscopes have been used: a 1.7 mm optiscope, a 2.8 mm laser optiscope, and a 3.2 mm bronchoscope. Scopes were introduced through an arteriotomy and a clear field maintained by continuous saline infusion. Twenty-four angioscopic evaluations were performed in the 14 patients studied. Adequate visualization was achieved with all three scopes. Angioscopy showed total atherosclerotic occlusion of six superficial femoral and popliteal arteries, intimal flaps in two arteries, thrombus in two arteries and one graft, adequate valvulotomy in three saphenous veins used for in situ bypass grafting, and removal of thrombus after embolectomy in one artery. With the 2.8 mm laser optiscope, the optical fiber used for laser recanalization could be positioned at the site of arterial occlusion before lasing and recanalization were done under direct vision. The 1.7 mm scope could be passed through the recanalized artery to inspect the channel and confirm communication with the artery distal to the occlusion. Thus, angioscopy appears to be potentially useful as a diagnostic device in arterial occlusive disease and as an adjunct in in situ saphenous vein grafting or laser recanalization of occluded arterial segments.     

Experimental studies on argon laser angioplasty

To evaluate the safety and efficacy of recanalization of the occlusive arterial diseases by Argon laser, we investigated the effects of the laser irradiation using bare-ended probe (BEP) and metal-tip probe (MTP) on human cadaveric aorta and canine femoral arteries with thrombotic occlusion. In case of the BEP, the incidence of perforation of the arterial wall was high as compared with the MTP. However, laser angioplasty with angioscopic guidance could reduce the perforation rate, and made it possible to observe the new channel recanalized by laser. In case of the MTP, it was confirmed that the smaller MTP showed higher tip temperature and was more effective on plaques under the same laser energy. Optimal laser energy for single ablation was from 15J to 25J in case of 2.0mm tip and from 30J to 40J in case of 2.5mm tip. Application of the MTP equipped with thermal feedback control system could avoid the excessive thermal damage in comparison with the conventional MTP. It was considered that optimal temperature of the MTP equipped with thermal feedback control system ranged between 200 degrees C and 300 degrees C. It was concluded that laser angioplasty would be a useful treatment for the occlusive diseases of the peripheral arteries.     

Laser thermal probe recanalization of occluded arteries

Applications of laser energy for treatment of vascular disease have recently received much attention; metal-tipped laser probes are being investigated as a device for recanalization of occluded arteries, especially as an adjunct to balloon dilatation. Developments in instrumentation and techniques have reduced the incidence of complications, notably perforation, to an acceptable level. Initial data show that recanalization of iliac, femoral, and popliteal lesions can be accomplished in a majority of cases, with the chance of success being inversely proportional to the length of occlusion. Results in the tibial vessels are disappointing. Patency of the treated vessels at 12 months appears to be superior to that of percutaneous transluminal angioplasty for similar lesions but inferior to that of surgical bypass for all occlusions greater than 3 cm in length.     

Absence of distal emboli during in vivo laser recanalization

We used an argon laser to recanalize occluded arteries in vivo and to determine the extent of any particulate matter resulting from the procedure that might cause embolization. Thrombosis was achieved by balloon de-endothelialization and thrombin injection in 12 canine femoral or carotid arteries in six dogs. The resulting totally occlusive thrombi (2.5-8.5 cm in length) were laser treated in situ 2-29 days after formation, using laser tip power outputs of 0.8-3.4 W. The treated arterial segment was perfused before, during, and after the recanalization procedure with 1,000 ml of heparinized saline. All saline passing through the artery was collected and studied by filtration through 20-micron pore filter paper; 50-ml unfiltered aliquots were studied by automated, calibrated cell counting and microscopically after centrifugation and staining. All vessels except one were completely recanalized. Filtration yielded a thin reddish, dust-like residue. No large fragments were found in 11 of 12 effluents. The residue after centrifugation was almost entirely composed of erythrocytes plus one to four 20-30-micron strands of amorphous cellular material per high-power field. Cell counting showed that 99.1% of the material in the effluents was smaller than 9.37 micron. These results demonstrate the presence of some filterable debris following laser recanalization of intraarterial thrombi, but it probably lacks any physiologic significance. Further study of this effect of laser recanalization is needed.     

Recanalization of occluded biliary endoprostheses with pulsed laser radiation

The use of pulsed laser radiation to recanalize occluded biliary endoprostheses was examined. In vitro measurements demonstrated that a repetitively pulsed organic dye laser transmitted through a small diameter quartz fiber can recanalize an occluded stent in less than 10 sec without causing visible damage to the stent. The laser parameters required for recanalization do not result in significant damage to the common bile duct of a pig even when the laser energy is delivered directly into the tissue, indicating that biliary endoprostheses can be cleared with a large margin of safety. Although the duration of this effect is unknown, pulsed laser radiation is a simple, safe, and effective means of recanalizing occluded biliary endoprostheses and may be an alternative to stent replacement.     

True ablation of atheromatous plaques with laser energy. A phase I safety study.

A laser system coupling pulsed dye laser to a 2-mm fiberoptic catheter with incorporated angioscope has been developed for recanalization of occluded arteries. Nine patients with superficial femoral artery occlusions of 4.5 to 49 cm in length were operated on and the recanalized artery harvested for pathologic examination. There were two arterial perforations. The ease of recanalization was determined by plaque composition. Heavily calcified and yellow fibro-fatty lesions were rapidly removed. Smooth white fibrous lesions resisted laser ablation. Direct angioscopy often disclosed discontinuous areas of occlusion that were more susceptible to recanalization. These were not seen on preoperative arteriograms. Microscopic examination of the specimens showed a central core of ablation. There was no evidence of acute damage to the vessel wall, with intact internal elastic lamina demonstrated in the recanalized segments. It appears that fibrous lesions will require a different laser for ablation; however, the delivery/angioscope systems function satisfactorily.     

Histopathology of human laser thermal angioplasty recanalization

Laserprobe thermal-assisted balloon, angioplasty (LTBA) has demonstrated promising initial clinical results in recanalizing stenotic or occluded superficial femoral and popliteal arteries. Over the past year we have obtained six specimens of laserprobe thermal (LT) and LTBA treated total occlusions (avg. length 12 cm) for histopathologic examination from patients who were treated for limb salvage. Three tissue specimens were obtained acutely, and one was obtained at 6, 8, and 13 days, respectively, after laser angioplasty at the time of revision for complications or failed procedures. Serial histologic sections of the treated LT segments demonstrated recanalization of atherosclerotic lesions to approximately 60-70% of the probe diameter. The LT channels were lined by a thin layer of carbonized or coagulated tissue and several layers of cell necrosis. The histology of the thermal injury was similar regardless of whether it was produced by the heated metal cap or by free argon laser energy. Stellate balloon angioplasty fractures were frequently filled with thrombus. Analysis of these human LT and LTBA specimens revealed that the thermal device produces a confined injury through the path of least resistance. Balloon dilatation produces fragmented cracks in the vessel wall, which appear to be more thrombogenic than the carbonized LT surface. With improved guidance methods, LTBA shows potential for continuing development.     

Effects of blood flow on laser probe temperature in human arteries

Laser recanalization using metal capped fibers occurs by thermal vaporization of occluding plaque. However, little is known about the effects of blood and flow on the temperature of the laser probe or the arterial wall during lasing. To study this, probe and arterial wall temperatures were measured while a metal capped fiber, activated by an argon laser, was held stationary in a stenotic human peripheral artery. Arteries were perfused with saline and blood, and flow was varied from 0 to 140 cc/min. Probe temperatures were significantly higher in blood than in saline. However, the increased probe temperature achieved in blood was not transferred to the arterial wall. Increasing flow decreased probe temperature in both media, but again arterial wall temperatures were minimally affected. Thus, the presence of blood and flow may significantly affect heat generation and heat transfer during arterial recanalization using metal capped fibers.     

Effect of laser-heated tip angioplasty on human atherosclerotic coronary arteries

Effects of laser-heated-tip angioplasty on arteries is not fully understood. We report histology, ultrasound image properties, and vasoreactivity of human atherosclerotic coronary arteries after exposure to the laser-heated tip catheter. Segments of isolated human coronary arteries were obtained within 5-8 hours postmortem. Side branches were ligated and perfused with Krebs-Ringer solution. Coronary occlusions were recanalized during perfusion using a 1.5-mm tip heated twice with a 10 W argon laser for 10 seconds while two-dimensional 12-MHz ultrasound images were recorded. Images documented vessel recanalization and an increase in ultrasound refractile properties of vessel walls adjacent and 2-5 mm distal to the heated tip. Histologic studies showed charring along the neolumen and extensive coagulation pattern within the plaque. Vasoreactivity was assessed by measuring flow rate changes during perfusion with 100 ml of 10(-5) M serotonin followed by washout with serotonin-free solution. Recanalized arteries showed a 50% increase in magnitude of vasospasm, which was persistent for 5 hours, compared to control atherosclerotic vessels, which relaxed within 30 minutes. In conclusion, laser-heated-tip-irradiated vessels demonstrated plaque coagulation, increased ultrasound refractile properties of plaque, and increased vasospasm, which persisted for several hours.