Pulmonary Vein Isolation Using the Visually Guided Laser Balloon: A Prospective, Multicenter, and Randomized Comparison to Standard Radiofrequency Ablation.

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).

Coronary revascularization (surgical or percutaneous) decreases mortality after the first year in diabetic subjects but not in nondiabetic subjects with multivessel disease: an analysis from the Medicine, Angioplasty, or Surgery Study (MASS II).

BACKGROUND: It is currently unknown whether revascularization procedures are associated with an improvement in mortality among diabetic subjects, as compared with a more conservative medical treatment. METHODS AND RESULTS: In MASS II, a total of 611 patients with stable multivessel coronary disease were randomly assigned to medical treatment, surgery, or angioplasty. From these, 190 patients had diabetes (medical, 75 patients; angioplasty, 56 patients; surgery, 59 patients) and comprised the present study population. Mortality rates were analyzed for the entire 5 years of follow-up. Separate analyzes were also performed for mortality at 2 time intervals: during the first year and after the first year of follow-up. We calculated the probability of death conditional on surviving to the start of the interval analyzed. The cumulative 5-year mortality as well as the mortality during the first year of follow-up was not significantly different among treatment groups, both for diabetic and for nondiabetic subjects. Also, during years 2 to 5, the mortality of the 3 treatment groups was not different for nondiabetic subjects. Among diabetic subjects, however, patients randomized to angioplasty or surgery had a significantly lower mortality between years 2 and 5 than those allocated to medical treatment (P=0.039). CONCLUSIONS: Surgery, angioplasty, and medical treatment appear to be associated with similar mortality rates for non-diabetic subjects. For diabetic subjects, however, coronary revascularization (percutaneous or surgical) significantly decreased the risk of death after the first year and up to 5 years, compared with medical treatment alone.

[The angioplasty of chronic coronary occlusions with the excimer laser for debulking followed by stent implantation]. / Angioplastia de oclusões coronárias crónicas com laser excimer para debulking seguido de implantação de stent.

UNLABELLED: Coronary angioplasty (PCI) of chronic total occlusions (CTO), even when successful, are associated to less favourable long term results. The recent use of coronary stents has improved the long term outcome of those interventions. PURPOSE: To evaluate the short term results and long term occurrence of major adverse coronary events (MACE): death, MI, urgent revascularization and the need for a new target vessel revascularization (TVR) in patients with CTO who had previously been submitted to a PCI with excimer laser for plaque debulking followed by a provisional stent. POPULATION: From our database, we selected 19 patients with a mean age of 51 +/- 13 years (18 male) submitted to PCI between 1994 and 1998. Of those patients, 10 had had of a previous MI. Hypertension, smoking habits and hypercholesterolemia were present in 9 patients (42%). Two patients had diabetes. The main reason for PCI was stable angina in 16 patients (84%) and unstable in 3 patients (16%). Single-vessel disease was present in 18 patients (94%) and multiple-vessel in 1 patient (6%); left ventricular ejection fraction was preserved in 18 patients (94%). Single vessel PCI was performed in 16 patients (84%) and double vessel in 3 patients. Plaque debulking with excimer laser was performed in all patients, followed by 23 stents (Multilink--8; Gianturco Roubin--5; Palmaz Schatz--4; others--6). The mean clinical follow-up was 19 months. RESULTS: There were no major short-term clinical events (death, MI or urgent revascularization). During follow-up, TVR was only required in 5 patients (26%), all of them in the first 7 months after PCI. CONCLUSIONS: In the highly selected population, PCI for chronic total occlusion, with excimer laser plaque debulking followed by provisional stents, was a safe procedure with a very acceptable rate of new target vessel revascularization in the follow-up period.

No additional benefit from laser in balloon angioplasty of the superficial femoral artery.

OBJECTIVES: To evaluate the efficacy of the addition of plaque ablation by hot-tip laser to balloon angioplasty. DESIGN: Prospective randomised clinical trial. MATERIALS AND METHODS: Patients with either occlusion orf > 50% diameter stenosis less than 3 cm in length in the superficial femoral artery, and with two or three calf vessel run-off were eligible and randomised to receive either balloon angioplasty alone or with laser assistance. Treatment failure in follow-up was defined as reocclusion or recurrence of greater that 50% stenosis at the site of angioplasty. RESULTS: Ninety limbs (82 patients) were entered into the study. Forty-four patients had mild claudication, 32 more severe symptoms and 6 rest pain or ulceration. More patients with diabetes (5 of 5, p = 0.04, Fisher's exact test) and occlusions (16 of 22, p < 0.05, chi(2)) were randomised to the laser group. Initial technical success was obtained in all lesions. The median duration of follow-up was 1 year. Failure occurred in 40 limbs during follow-up. Three segments, all with initial occlusions and undergoing laser angioplasty re-occluded within 2 days, one requiring immediate thrombectomy. Another 20 limbs underwent further intervention. Overall success (+/- S.D.) (Kaplan-Meier) at 1 year was 67% (+/- 5%) and at 2 years 43% (+/- 7%). Only increased age, initial occlusion, female sex, and not smoking were significantly (p < 0.05, Cox's proportional hazards) associated with failure; on multivariate analysis, age and occlusion were the best independent predictors. There was no significant difference (p > 0.05) in outcome between limbs undergoing laser assisted balloon angioplasty and balloon alone either overall of within the stenosis or occlusion subgroups. CONCLUSIONS: This study found no significant benefit was gained by the addition of laser to balloon angioplasty and that the long term success was modest for lesions considered to be suitable for angioplasty.

Coronary interventions in Europe 1992. The Working Group on Coronary Circulation of the European Society of Cardiology.

The general practice of coronary interventions is influenced by various aspects, traditional, cultural, socioeconomic and personal. The aim of this survey was to collect the data on coronary intervention in all member countries of the European Society of Cardiology. The data from 12 of the 35 national members were missing or grossly incomplete and were therefore excluded from the analysis. CORONARY ANGIOGRAPHY: The total number of coronary angiograms was reported as 683,888, an incidence of 1009 +/- 1021 per million inhabitants (range 9 (Romania) to 3076 (Germany)). Germany (246,115 cases), France (144,754), the United Kingdom (76,296), Italy (45,517) and Spain (43,495) registered 81% of all the coronary angiograms performed. PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY: (PTCA) The total number of reported PTCAs was 147,729, which on average accounted for 19 +/- 11% (range 2 (Lithuania) to 53% (Netherlands)) of the coronary angiograms. Most of the PTCAs (82%) were confined to a single vessel. The highest incidence of multivessel PTCA was reported from Slovakia (28%). PTCA took place immediately after the diagnostic study in only 18% of cases. Adjusted per capita, Germany ranked first with 703 PTCAs per million inhabitants, followed by Iceland (619), France (614), Belgium (568) and Austria (485). A major in-hospital complication was reported in 2.5% of the patients undergoing PTCA: 0.4% hospital deaths, 1.0% emergency CABGs and 1.1% myocardial infarctions. NEW DEVICES: Stents were implanted in 3211 patients (2.7% of all PTCA patients), equally distributed between emergency situations (53%) and elective procedures. Other interventional devices were applied in 4133 cases (2.8% of all PTCA cases): directional atherectomy, rotablator, transluminal extraction catheter, laser and Rotacs accounted for 1452, 1232, 55, 558 and 222, respectively. Coronary ultrasound (1350 cases) and coronary angioscopy (373 cases) were rarely performed. CORONARY ARTERY BYPASS GRAFTING (CABG): A total of 63,477 patients underwent CABG in the reporting centres resulting in a PTCA/CABG ratio of 2.3. A significant under-reporting of surgery in the participating centres must be assumed. CONCLUSIONS: Although partial reporting might bias conclusions, several findings of this survey are noteworthy: (1) PTCA was a well accepted treatment for coronary artery disease, (2) PTCA was applied more frequently than CABG, (3) there was an extremely wide range of coronary angiography and PTCA performed per million inhabitants, (4) the most common additional procedure was stent implantation, but other new devices were only rarely applied.

[Laser-assisted angioplasty in chronic obliterative arteriopathies of the lower limbs. The authors' personal experience]. / L'angioplastica laser-assistita nelle arteriopatie obliteranti croniche degli arti inferiori. Esperienza personale.

The laser represents one of the most interesting new methods of vascular surgery. As for laser-assisted angioplasty, the major clinical experience has come with Nd: Yag and Argon lasers. The authors comment on the 1989-1992 series of cases consisting of 51 arteries recanalized with a Nd:Yag laser--the patients were 42 men and 9 women, their mean age being 56.6 years. Four iliac obliterations, 36 femoropopliteal and 11 popliteotibial obliterations were treated surgically, according to the single anatomical radiologic circumstances. The immediate results showed 41 recanalizations (80.4%) 3 perforations (5.9%), 6 dissections (11.8%) and 2 distal emboli (3.9%). The long-term results, with a follow-up period ranging 6 months to 4 years (average: 1.8 years), were investigated with seriated c.w. Doppler, Doppler US and digital venous angiography and showed, in 34 examined patients, 22 patencies (64.7%), 8 stenoses > 50% (23.5%) and 3 occlusions (11.8%). These findings prove the value of laser-assisted--both percutaneous and surgical--angioplasty in the treatment of arterial occlusions both alone and combined with surgery. The results, whose positivity comes also from an eclectic interaction with surgery, and mostly from a systematic enhancement of the laser channel with balloon angioplasty, could be markedly improved upon by means of more selective and effective equipment.

Acute complications of excimer laser coronary angioplasty: a detailed analysis of multicenter results. Coinvestigators of the U.S. and European Percutaneous Excimer Laser Coronary Angioplasty (PELCA) Registries.

OBJECTIVES: The aim of this study was to document and analyze the incidence and consequences of complications of excimer laser coronary angioplasty. BACKGROUND: Excimer laser coronary angioplasty has been reported to be a safe and feasible alternative or adjunct to conventional balloon angioplasty, but serious and unique complications have been observed. METHODS: Data on 1,595 interventions of excimer laser coronary angioplasty in 1,521 patients were analyzed, using a merged data base from the U.S. and European Percutaneous Excimer Laser Coronary Angioplasty (PELCA) registries. RESULTS: Procedural success was achieved in 89.3% of interventions. Stand-alone laser angioplasty was performed in 17.8% of interventions. Complications included dissection (22.0%), vasospasm (6.1%), filling defects (4.8%), abrupt reclosure (6.1%), embolization (2.3%), perforation (2.4%), arrhythmia (0.7%) and aneurysm formation (0.3%). Major complications were non-Q wave myocardial infarction (2.3%), Q wave myocardial infarction (1.0%), coronary artery bypass grafting (3.1%) and death (0.7%). Logistic regression analysis revealed correlation between dissections and the use of larger catheter size (p = 0.0005), high energy per pulse levels (p = 0.0001 for native vessels), lesion length > 10 mm (p = 0.001) and presence of a side branch (p = 0.01). The incidence of perforations was higher in women (p = 0.004), in treatment of total occlusions (p = 0.02) and in the presence of a side branch (p = 0.03). Fatal complications were correlated with patients with multivessel disease (p < 0.0001), patients with acute myocardial infarction (p = 0.0009) and older patients (> 70 years old, p = 0.004). The incidence of major complications decreased after performance of 50 laser angioplasty procedures at one institution (p = 0.02). CONCLUSIONS: This analysis defines both the learning curve and the profile of complications for excimer laser angioplasty and provides insight into the selection of appropriate patients and proper performance of the procedure.

Analysis of late lumen narrowing after excimer laser-facilitated coronary angioplasty.

OBJECTIVES: The purpose of this study was to analyze the quantitative angiographic factors affecting restenosis after excimer laser-facilitated coronary angioplasty. BACKGROUND: Restenosis after balloon angioplasty, directional atherectomy and coronary stenting has been analyzed using both dichotomous (> or = 50% diameter stenosis) and continuous (late lumen narrowing) end points, leading to the conclusion that achieving a large lumen diameter at the time of the procedure is associated with a lower risk of angiographic restenosis. METHODS: Quantitative angiographic measurements were made before treatment, after laser angioplasty, after adjunctive balloon angioplasty and at 6-month angiographic follow-up in 168 patients with 179 treated lesions. RESULTS: The immediate increase in lumen diameter (total acute gain 1.45 +/- 0.71 mm [mean +/- SD]) was due to the combination of laser treatment (0.79 +/- 0.61 mm) and subsequent adjunctive balloon angioplasty (0.66 +/- 0.55 mm). At follow-up, the minimal lumen diameter had decreased (late loss 0.71 +/- 0.84 mm), yielding an overall restenosis rate of 50% (defined dichotomously by > or = 50% diameter stenosis). Multivariable regression analyses showed that restenosis was related to vessel diameter, as well as minimal lumen diameter, achieved immediately after the procedure. CONCLUSIONS: Although the restenosis rates for the small vessels typically treated with excimer laser angioplasty were high, the lowest restenosis rates were seen in large vessels with the largest postprocedural minimal lumen diameters. The goal of this procedure should be to safely achieve the largest lumen possible with the combination of laser treatment and adjunctive balloon dilation.

Angioscopy after laser and balloon coronary angioplasty.

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.

Percutaneous excimer laser coronary angioplasty: results in the first consecutive 3,000 patients. The ELCA Investigators.

OBJECTIVES: We report the comprehensive results of the first consecutive 3,000 patients treated in an excimer laser coronary angioplasty registry. BACKGROUND: Excimer laser coronary angioplasty involves the use of a pulsed, 308-nm ultraviolet laser transmitted by optical fibers to reduce coronary stenoses. Preliminary reports have described safety and efficacy profiles in small numbers of patients. METHODS: Patients were enrolled in a prospective, nonrandomized manner. The catheters used were 1.3, 1.6, 2.0, 2.2 and 2.4 mm in diameter, at energy densities up to 70 mJ/mm2. Procedures were performed by standard angioplasty technique with conventional guide catheters. RESULTS: Seventy-five percent of patients were male, 68% were in Canadian Cardiovascular Society functional class III or IV and the cohort included 3,592 lesions. Procedural success (final stenosis < or = 50% without in-hospital Q wave myocardial infarction, coronary artery bypass surgery or death) was 90% and did not differ between the first 2,000 and the last 1,000 patients treated. There was no significant difference in success or complication rates with respect to lesion length, nor were there differences between selected complex and simple lesions. Complications included in-hospital bypass surgery (3.8%), Q wave myocardial infarction (2.1%) and death (0.5%). Coronary artery perforation occurred in 1.2% of patients (1% of lesions) but significantly decreased to 0.4% in the last 1,000 patients (0.3% of lesions). Angiographic dissection occurred in 13% of lesions, transient occlusion in 3.4% and sustained occlusion in 3.1%. Comprehensive lesion morphologic data collected in the latter portion of the study showed the procedure predominantly limited to American College of Cardiology-American Heart Association type B2 and C lesions, with no significant difference in short-term outcome between groups. CONCLUSIONS: Excimer laser angioplasty can be safely and effectively applied, even in a variety of complex lesions not well suited for percutaneous transluminal coronary angioplasty. These types may include aorto-ostial, long lesions, total occlusions crossable with a wire, diffuse disease and vein grafts. Most recent data show a trend for the selection of predominantly complex lesions and a reduction in the incidence of perforation. This procedure may broaden the therapeutic window for the interventional treatment of selected complex coronary artery disease.

Clinical results of coronary excimer laser angioplasty: report from the European Coronary Excimer Laser Angioplasty Registry.

From January 1991 to January 1993 the clinical and angiographic data of 470 patients were included in the European Coronary Excimer Laser Angioplasty Registry. Symptoms were CCS class 3 in 23% and CCS class 4 in 14.7%; unstable angina was present in 14.7% and 6.6% of patients had acute myocardial infarction. Of 477 treated lesions, 60% were type B2, and 19% type C. The lesion was located in the LAD in 61%, in the LCX in 16%, in the RCA in 20%, in a protected left main stem in 1.3% and in a saphenous vein graft in 2.5%, respectively. Failure of laser angioplasty occurred in 56 (12%) interventions. By multivariate analysis failure was associated with the intention to treat long segmental lesions (risk ratio (RR) 3.6, confidence interval (CI) 2.9 to 4.4; P = 0.0005), segments with severe prestenotic tortuosity (RR 3.5, CI 2.4 to 4.6; P = 0.02) and total occlusions (RR 2.1; CI 1.4 to 2.8; P = 0.05). Complications included vasospasm (13.4%), dissection (14.7%), flow limiting dissection (4%), reclosure (7.8%), and perforation (1.9%). Myocardial infarction occurred in 2.1%, CABG was requested in 1.9%, and the mortality was 1.5%. Procedural success was achieved in 89%. Individual morphological criteria for a reduced procedural success were the presence of a thrombus (RR 6.4; CI 5.0 to 7.7; P = 0.007) and vessel calcification (RR 2.6; CI 1.9 to 3.2; P = 0.005). Procedural success was slightly lower in type C lesions (86%) than in type B2 (88%) type B1 (95%), and type A lesions (92%), respectively.(ABSTRACT TRUNCATED AT 250 WORDS)

Excimer laser coronary angioplasty in The Netherlands: preamble for a randomized study.

The immediate outcome of ELCA by XeCl excimer laser radiation is described in 53 patients who were selected to undergo ELCA from December 1990 to September 1991 in two centers that are currently performing ELCA in the Netherlands. Immediate success rates on the basis of visual assessment of the angiogram were as follows. Laser success (> 20% reduction of diameter stenosis after ELCA alone) was observed in 77% of patients, procedural success (< 50% residual stenosis after ELCA with or without adjunctive balloon dilatation [PTCA]) in 91%, and clinical success (procedural success without clinical complications) in 83% of patients. Quantitative coronary angiography by automated contour detection was performed in 31 patients who underwent ELCA in the Thoraxcenter. The minimal luminal diameter (mean +/- SD) of the treated coronary segments increased from 0.77 +/- 0.41 mm to 1.24 +/- 0.25 mm after ELCA and further to 1.67 +/- 0.29 mm after adjunctive PTCA in 25 patients. The present experience is put in perspective of results initially reported by other centers and compared with data from multicenter registries of ELCA. Finally, a short description is given of the design of a prospective, randomized trial of ELCA versus conventional PTCA (AMRO trial).

[Laser versus rotation angioplasty in the recanalization of chronic femoropopliteal arterial occlusions]. / Laser- versus Rotationsangioplastie bei der Rekanalisation chronischer femoropoplitealer Arterienverschlüsse.

Between June 1987 and July 1989 laser angioplasty, and between July 1989 and December 1991 rotation angioplasty was used as the method of choice for the recanalisation of chronic (minimal duration 3 months) arterial occlusions in the femoro-popliteal region. The technical success rate and final results following supplementary balloon dilatation were identical and there was no significant difference between the two groups (laser 87%, rotation 87.7%). For long occlusions (more than 150 mm), the success rate for rotation angioplasty was 60% and significantly higher than for laser angioplasty at 40%. Complication rates for rotation angioplasty were 24.3%, higher than laser angioplasty with 20.3%. This was due to the higher incidence of emboli of 12.1% compared with the laser technique of 7.3%. Cumulative patency rates after two years showed no significant difference (uncorrelated/correlated: laser 53.4%/67.8%; rotation 56.6%/67.5%). Using lytic and aspiration techniques, the higher incidence of embolisation during rotation angioplasty had no adverse effect on final outcome. If both methods are available, it is advisable to treat long occlusions by rotation angioplasty because of the high immediate success rate, whereas short occlusions are best dealt by laser angioplasty because of the lower incidence of embolisation.

Intracoronary ultrasound predictors of adverse outcomes after coronary artery interventions.

OBJECTIVES: The purpose of this study was to determine the association between qualitative and quantitative lesion characteristics as assessed by intracoronary ultrasound imaging and adverse outcomes after coronary artery interventions. BACKGROUND: Restenosis and other adverse outcomes after coronary artery interventions may be difficult to predict from clinical or angiographic data. Intracoronary ultrasound imaging provides additional data that could prove useful. METHODS: Immediately after successful coronary artery interventions (angiographic residual stenosis < or = 50%), 69 patients underwent intracoronary ultrasound imaging. Images were assessed qualitatively for plaque composition and topography and for dissection. Quantitative data included measurement of minimal lumen diameter, lumen area, plaque area and percent area stenosis at the treatment and adjacent reference sites. Adverse outcome was defined as death, coronary bypass surgery, myocardial infarction or angiographic restenosis. RESULTS: Of the 69 patients, 1 died, 3 had bypass surgery and 1 had a myocardial infarction before planned 6-month repeat catheterization. Two patients were lost to follow-up study. Of the remaining 62 patients, 56 (90%) agreed to follow-up catheterization and 25 (45%) of the 56 had restenosis. Thus, 30 patients had an adverse outcome and 37 had no adverse event. The incidence of dissection detected by ultrasound imaging after an intervention was significantly greater in patients with than in those without a subsequent adverse event (63% vs. 35%, p < 0.05). The severity of dissection also appeared to be related to outcome (p < 0.05). Other qualitative and quantitative variables were not significantly different between the two patient groups. CONCLUSIONS: Dissection, as assessed by intracoronary ultrasound imaging after a coronary artery intervention, can identify patients at increased risk of subsequent adverse events. Additional studies are warranted to explore whether such imaging may allow modification of interventional procedures to improve outcome.