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Background: Radiofrequency catheter ablation of left-sided accessory pathways is becoming the first line of therapy for patients with symptomatic Wolff-Parkinson-White syndrome. Nevertheless, alternative ablation techniques merit development, at least as supplementary modalities for cases in which conventional ablation approaches may prove unsuccessful. We recently reported the short-term results with transcatheter laser balloon ablation from the coronary sinus in a canine model, proving that the procedure is feasible for the potential ablation of left-sided accessory pathways. We now report the effects of percutaneous transcatheter laser balloon ablation in a chronic canine model., Methods and Results: Twenty adult mongrel dogs were studied. After baseline coronary arteriography, left ventriculography, and coronary sinus angiography were obtained, 15 dogs received two or three consecutive laser doses from the coronary sinus of 30-40 W for 15-30 seconds, for a total cumulative energy of 1,200-2,400 J. The five remaining animals underwent a procedure consisting of balloon sham inflation without laser exposure and served as controls. After a mean follow-up of 6 weeks, the angiographic procedures were repeated, and the animals were killed. The mean extent of the fibrotic lesion was 15 mm long, 6 mm wide, and 4.5 mm deep and involved the coronary sinus wall, atrium, and, frequently, the summit of the posterior left ventricular wall. Six animals (four in the study group and two in the control group) showed asymptomatic narrowing of the coronary sinus lumen but always with total angiographic reconstitution due to extensive collateral circulation. The circumflex artery and mitral valve were intact angiographically and histologically in all animals., Conclusions: Percutaneous transcatheter laser balloon ablation via the coronary sinus produces a lesion that may be anatomically well suited for left-sided accessory pathway ablation. Although coronary sinus narrowing may occur, adverse physiological effects are unlikely due to the development of extensive collateral circulation. Systematic clinical studies of this new approach to catheter ablation appear warranted.

A multicenter clinical trial was initiated to test the potential safety and short-term efficacy of a percutaneous coronary application of laser balloon angioplasty, which has been shown experimentally to alleviate the common causes (dissection, recoil, thrombus) of suboptimal luminal results of conventional balloon angioplasty. Fifty-five patients, the majority (62%) of whom had relatively high risk lesions, were treated in 10 centers with a laser balloon that was identical in size (3 x 20 mm) to a balloon used for conventional balloon angioplasty performed on the same lesion immediately before laser balloon angioplasty. One or more neodymium:yttrium aluminum garnet (Nd:YAG) (1,060 nm) laser doses of 250 to 450 J were each delivered over a 20 s duration per exposure. Immediately and 1 day after laser balloon angioplasty no significant adverse effects on the arterial lumen were noted in any patient. By computerized image analysis of cineangiograms initial conventional balloon angioplasty failed to achieve a minimal luminal diameter greater than 1.5 mm in 14 patients (25%), including 3 patients with acute closure. However, after subsequent laser balloon angioplasty, minimal luminal diameter exceeded this value in all patients including this subgroup. Overall, minimal luminal diameter increased from 1.74 +/- 0.46 mm after conventional balloon angioplasty to 2.32 +/- 0.31 mm after laser balloon angioplasty (p less than 0.001) with no change found on 1 day and 1 month follow-up angiograms. Thus, laser balloon angioplasty is a safe, effective procedure for improving luminal dimensions after conventional balloon angioplasty.

Abrupt coronary occlusion and long-term restenosis continue to be the major problems associated with percutaneous transluminal coronary angioplasty (PTCA). Laser balloon angioplasty (LBA) is a technique designed to potentially alleviate these problems by sealing arterial dissections, smoothing the luminal surfaces, dehydrating thrombi, and reducing the elastic properties that tend to recoil the stretched artery to its original state. During LBA, laser energy is delivered circumferentially by a 100-microns optical fiber that terminates in a central diffusing tip within an angioplasty balloon. LBA is performed for 20 seconds during the final inflation of the angioplasty balloon. Achieved with decremental ramped laser dosimetry, Nd:YAG laser energy has been shown to be effective in welding experimental arterial dissections over a therapeutic temperature range of 95 degrees-120 degrees C. LBA treatment of rabbit iliac arteries has been superior to balloon angioplasty in inhibiting elastic recoil and causing acute and long-term luminal increment. LBA has also been effective for sealing acute dissections in atherosclerotic rabbit iliac arteries. Additionally, in a canine model, safety in the coronary circulation has been shown, that is, even at 1 month after LBA, angiography demonstrated a cast of the LBA balloon without luminal compromise. Since March 1988, more than 250 patients with symptomatic coronary artery disease have been treated with LBA with nearly uniform clinical success, including frequent reversal of abrupt closure. LBA seems to be a safe modality that may decrease the need for emergency operative procedures and late coronary revascularization after PTCA.

Transcatheter direct current electrical shocks for ablation of left-sided accessory pathways in Wolff-Parkinson-White patients have led to serious complications. We report the feasibility of percutaneous transcatheter laser balloon ablation of left-sided accessory pathways from the coronary sinus using a 1,064-nm, continuous wave Nd:YAG laser triple lumen catheter with an optical fiber terminating in a cylindrical diffusing tip within a 2-cm-long, 3-mm-diameter balloon transparent to Nd:YAG laser radiation. In eight mongrel dogs (18 to 31 kg), the laser balloon catheter was positioned via an 8 French guide catheter in the distal and proximal coronary sinus. During balloon inflation, two to three consecutive laser doses of 30 W x 20 sec were applied to each site (cumulative energy, 1,200 to 1,800 J). Coronary angiography, left ventriculography, and coronary sinus injection were performed before and after laser exposure. After percutaneous transcatheter laser balloon ablation, there was no evidence of mitral regurgitation, left circumflex artery, coronary sinus obstruction, or perforation. Coagulation necrosis and/or polymorphonuclear infiltrates involving the atrioventricular groove and left atrial wall over a mean length of 17 mm were present in all eight dogs sacrificed 6 +/- 1 hr postablation. In conclusion, percutaneous transcatheter laser balloon ablation from the coronary sinus is free of immediate major complications and may be feasible for potential interruption of left-sided accessory pathways.

Laser dosimetry for thermal fusion of plaque-wall separations during laser balloon angioplasty (LBA) is dependent upon the optical properties of the atheromatous arterial wall during one or more exposures to cw Nd:YAG laser radiation. An integrating sphere technique was used to measure relative transmission and reflection continuously during irradiation of human postmortem atheromatous aortic sections. Tissue luminal surface temperature was recorded continuously with a thermographic video imager during repetitive 20-30-sec, 8-15-watt exposure of a 3-mm nominal spot. In all specimens, transmission fell progressively during each exposure by 10-70% of baseline values. This effect was reversible with normalization of transmission during the initial phase of each subsequent exposure. Changes in transmission were inversely related to temperature over a 50-170 degrees C range, whereas relative reflection remained constant. Accompanying reversible transmission changes was the observation that the weld strength of plaque-aortic wall separations was unchanged by repetitive laser welding and tissue separation of individual sections. In conclusion, temperature-dependent reversible optical and physical properties of plaque occur during exposure to 1.06 microns cw laser radiation.

Laser Balloon Angioplasty (LBA) is a technique that may improve the results of balloon angioplasty by thermally sealing arterial dissections and reducing elastic recoil. To define the relationship between laser-exposure duration and the strength of thermal welds made between separated layers of arterial wall, 360 1-cm discs of human postmortem aorta were lased for six different exposure intervals at three different temperature ranges, comparing shear strength of thermal welds in the different groups. Twenty discs were lased to achieve plateau adventitial temperatures of 95 degrees C-104 degrees C (group A), 105 degrees C-114 degrees C (group B), or 115 degrees C-124 degrees C (group C) at each of the exposure periods (5, 10, 15, 20, 25, and 30 sec). A 400-micron fiberoptic coupled to a 1.06 micron continuous wave neodymium:YAG laser was placed perpendicularly 8 mm above the luminal surface of each disc, which had been split midway between the intimal and adventitial surface and reapposed. Mean laser energy ranged 78-378 J delivered in a decremental stepwise fashion to achieve quickly and maintain the target plateau tissue temperature. Mean weld strength increased in relation to both achieved tissue temperature and laser-exposure duration, with at least 10 sec necessary, at temperatures greater than 95 degrees C, for reliable thermal welding. Laser exposure for greater than 20 sec provided no statistical increment in weld strength. In the anticipated clinical performance of LBA, these data suggest that when thermal fusion of disrupted arterial tissues is desired, a laser-exposure duration of 10-20 sec is optimal.

Thermal fusion of intimal plaque with the arterial wall during coronary balloon angioplasty may significantly reduce the incidence of abrupt closure and may reduce the occurrence of delayed restenosis by improvement of luminal size and shape. Although Nd:YAG laser energy has been shown to be effective in the thermal fusion of plaque-arterial wall separations in vitro, the most efficient manner of energy delivery for rapid achievement of therapeutically useful equilibrium tissue temperature during laser exposure has not been defined. A comparison of weld strength achieved was therefore made between two formats of laser delivery: constant power vs. decremental power with an initial high dose followed by the minimal serial decrements necessary to maintain tissue temperature constant for 15 seconds. One hundred sixty-six tissue discs of human postmortem aorta of 11 mm diameter were studied. Intimal plaque was separated from the media, the two layers were juxtaposed, a force of 4 pounds was applied, and a fiberoptic-delivered laser beam was directed perpendicular to the tissue over a 3-mm-diameter nominal spot size. Weld strength was measured as the shear force required to separate completely the two tissue layers. The mean weld strength (75 g) achieved by use of the decremental power format was significantly higher (P less than .01) than the mean strength (32 g and 56 g) achieved by using constant power for 20 and 30 seconds, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)

Dehiscence of portions of atheromatous plaques fractured during percutaneous transluminal coronary angioplasty may contribute to both abrupt reclosure and gradual restenosis. Laser balloon angioplasty has been shown to be effective in welding human plaque-arterial wall separations in vitro by heating tissues with a Nd:YAG laser during balloon inflation. To define the potentially useful therapeutic range of tissue temperature required to achieve thermal welds, 220 1-cm diameter discs of human postmortem atheromatous aortic tissue, the intimal plaque of which had been separated from the media, were exposed to 3-25 watts of Nd:YAG laser radiation delivered over a 12-mm2 nominal spot size for 20 seconds via a 400-micron core optical fiber. As measured with a thermistor, adventitial temperature reflected the temperature at the plaque-media junction to within 10 degrees C. The degree of tissue temperature elevation was related to delivered energy, while effective tissue penetration increased to maximum depth of 3 mm at the highest power density. Strength of tissue welds was defined as the force required to shear opposing layers of welded segments. Adventitial tissue temperatures below 80 degrees C were not associated with appreciable welds, while equilibrium temperatures between 95 degrees C and 140 degrees C were consistently associated with effective mean weld strengths, which increased linearly from 25 to 110 g, respectively. Temperatures greater than 150 degrees C were associated with rapid tissue dehydration and charring. These data suggest that the therapeutic range of tissue temperature that provides effective thermal fusion of intima-media separations is broad and that the depth and degree of thermal coagulation can be controlled by manipulation of laser energy delivery.