Total occlusion trial with angioplasty by using laser guidewire. The TOTAL trial.

AIMS: A randomized trial was performed to assess the safety and efficacy of a laser guidewire, in the treatment of chronic coronary occlusions. METHODS AND RESULTS: In 18 European centres, 303 patients with a chronic coronary occlusion were randomized to treatment with either the laser guidewire (n=144) or conventional guidewires (mechanical guidewire, n=159). The primary end-point of the study was treatment success, defined as reaching the true lumen distal to the occlusion by the allocated wire within 30 min of fluoroscopic time: laser guidewire vs mechanical guidewire; 52.8% (n=76) vs 47.2% (n=75), P=0.33. Serious adverse events following the initial guidewire attempt were 0% (laser guidewire) and 0.6% (mechanical guidewire), respectively. Angioplasty (performed following successful guidewire crossing) was successful in 179 patients (91%, laser guidewire n=79, mechanical guidewire n=100), followed by stent implantation in 149 (79%). At the 6-month angiographic follow-up, the difference in binary restenosis rate (laser guidewire vs mechanical guidewire; 45.5% vs 38.3 %, P=0.72) or reocclusion rate (25.8% vs 16.1%, P=0.15) did not reach statistical significance. At 1, 6 and 12 months, angina and event-free survival were 69%, 35% and 24% (laser guidewire) vs 74%, 40% and 31% (mechanical guidewire). CONCLUSION: Although laser guidewire technology was safe, the increase in crossing success did not reach statistical significance.

Conservative management for an extensive type A aortic dissection complicating coronary angioplasty.

Aortic dissection is a recognized, though rare complication of percutaneous revascularization procedures. We report a case of an extensive type A dissection that occurred during an attempt to recanalize a chronic total occlusion of a right coronary artery. The patient was treated conservatively and was followed for 36 months, during which he remained well. We conclude that, even though surgery remains the preferred option, conservative management could also be considered in certain patients.

Multicenter registry to evaluate the efficacy of the NIROYAL stent in de novo or restenotic coronary stenosis.

The purpose of this registry was to document the safety and efficacy of elective deployment of the NIROYAL stent (Boston Scientific SCIMED, Maple Grove, Minnesota) in coronary arteries. This was a prospective, multi-center international registry. NIROYAL stents (9, 16, 25 and 32 mm-long) were manually crimped onto coronary balloons and deployed in de novo or restenotic lesions in 165 male and female patients with angina pectoris and a reference vessel diameter of 2.0-4.5 mm. Stent deployment was successful in 98.8% of the lesions. Mean percent diameter stenosis decreased from 83.5+/-10.8% to 2.7+/- 6.2% after intervention. The interventional procedure of the treatment site was successful in 97.6% of patients. At six-month clinical follow-up, 88.5% had event-free survival [i.e., did not experience a major adverse cardiac event (MACE)] and 95.2% had no anginal symptoms. Furthermore, 87.3% of the patients were free of target vessel failure (defined as a composite of acute procedural failure, target vessel revascularization, myocardial infarction or death at six months). Only three MACE were observed within the first 30 days after stent implantation. A low left ventricular ejection fraction and the percentage stenosis pre-procedure were identified as statistically significant (p<0.05) predictive factors for MACE. The incidences of MACE and target vessel failure after six months follow-up were lower than that seen in other studies, and target lesion revascularization rates were low.

Stiff hydrophilic glidewire: a useful tool for percutaneous insertion of intraaortic balloon counterpulsation catheters.

Intra-aortic balloon catheters have a central lumen able to accommodate dedicated 0.030" guidewires but not conventional 0.035" guidewires. Due to its extreme lubricity, the 0.035" hydrophilic "glidewire" fits into these catheters and is particularly useful in its stiff, angled version for femoral percutaneous insertion in patients with severe calcific iliac disease.

Chronic radiodermatitis following cardiac catheterisation: a report of two cases and a brief review of the literature.

Cardiac angiography produces one of the highest radiation exposures of any commonly used diagnostic x ray procedure. Recently, serious radiation induced skin injuries have been reported after repeated therapeutic interventional procedures using prolonged fluoroscopic imaging. Two male patients, aged 62 and 71 years, in whom chronic radiodermatitis developed one to two years after two consecutive cardiac catheterisation procedures are reported. Both patients had undergone lengthy procedures using prolonged fluoroscopic guidance in a limited number of projections. The resulting skin lesions were preceded, in one case, by an acute erythema and took the form of a delayed pigmented telangiectatic, indurated, or ulcerated plaque in the upper back or below the axilla whose site corresponded to the location of the x ray tube during cardiac catheterisation. Cutaneous side effects of radiation exposure result from direct damage to the irradiated tissue and have known thresholds. The diagnosis of radiation induced skin injury relies essentially on clinical and histopathological findings, location of skin lesions, and careful medical history. Interventional cardiologists should be aware of this complication, because chronic radiodermatitis may result in painful and resistant ulceration and eventually in squamous cell carcinoma.

Clinical experience with a new biocompatible phosphorylcholine-coated coronary stent.

AIMS: The BiodivYsio stent is a new stent coated with phosphorylcholine, a biocompatible molecule designed to reduce the formation of thrombus and potentially the risk of restenosis. The feasibility, safety, and efficacy of elective and urgent implantation of this coated coronary stent were prospectively studied. METHODS AND RESULTS: We studied 224 patients who underwent elective (67%) or bail-out implantation of 303 BiodivYsio stents in 286 lesions. Most lesions (62%) had unfavorable characteristics (type B2 or C) and half of them (50%) had thrombus and/or chronic total occlusion. Clinical follow-up was obtained in all patients at one month and in the first 132 patients at six months. Repeat angiography was undertaken in all patients with recurrent ischemia. Successful stent deployment was achieved in 284 lesions (99.3%). One emergency coronary artery bypass graft (CABG) was required. Angiographic success rate was 98.3% (281/286). There was 1 (0.4%) subacute stent thrombosis associated with Q-wave myocardial infarction and two (0.9%) in-hospital deaths. Reference vessel diameter was 2.82 +/- 0.32 mm. Minimum luminal diameter (MLD) increased from 0.38 +/- 0.25 mm to 2.97 +/- 0.35 mm and diameter stenosis decreased from 83.8 +/- 12.1% to 5.8 +/- 9.7%. Clinical restenosis rate was 6.1% (8/132 patients) at 6-month follow-up. Target vessel revascularization rate at 6-month follow-up was 5.4%. CONCLUSIONS: This initial clinical experience indicates that the implantation of stents coated with phosphorylcholine appears to be safe and efficacious in the treatment of complex coronary lesions and is associated with an extremely low target vessel revascularization rate.

Preliminary clinical experience with the Bard XT coronary stent.

BACKGROUND: The Bard XT stent is a balloon expandable stent with a new design, consisting of discrete zigzag modules welded onto a flexible longitudinal spine. METHODS: To assess the safety and efficacy of this recently introduced coronary stent, we studied 81 patients (107 lesions) who underwent implantation of 108 such stents (66% elective). RESULTS: Primary success in stent delivery was 97.1% and angiographic success was achieved in all cases. Reference segment diameter was 2.69+/-1.4 mm and average lesion length 10.9 mm. Mean minimal luminal diameter before the procedure was 0.79+/-1.11 mm and increased to 2.55+/-1.09 mm after stenting. Diameter stenosis decreased from 76%+/-24% to 9%+/-12%. One Q wave and 1 non-Q-wave myocardial infarction occurred but no other significant complications were observed. At 1-month follow-up, angiographically documented subacute thrombosis occurred in 2 cases at days 1 and 3. Conclusions These preliminary data suggest that the Bard XT stent has a promising design for the safe and effective treatment of coronary lesions, even in the presence of high-risk clinical and unfavorable angiographic characteristics.

Bilateral internal mammary angiography through a right radial approach: a case report.

This case report demonstrates that bilateral internal mammary angiography through a single right-radial approach is feasible and convenient. It avoids double-brachial or radial artery puncture, is adapted to the variable characteristics of right internal mammary artery origin, and may be considered when the femoral approach is contraindicated.

Recanalization of chronic coronary occlusions using a new hydrophilic guidewire.

Chronic total occlusion remains a relative contraindication and the main cause of failure of coronary angioplasty. Previously available hydrophilic guidewires had numerous limitations. The Crosswire is a new 0.014" hydrophilic nitinol guidewire which can be accommodated by very-low-profile balloon catheters and has a shapeable and highly radiopaque platinum-iridium coiled tip. This guidewire was used in 55 patients with 56 chronic coronary occlusions in which recanalization by conventional guidewires had failed. Clinical success was 79%. Coronary perforation occurred in two cases, one of them requiring pericardiocentesis for tamponade. These results illustrate the usefulness of this new guidewire in the treatment of chronic total occlusions.

Preliminary experience with the NIR coronary stent.

We prospectively studied 223 patients (288 lesions) who underwent elective or bail out implantation of 309 NIR stents (Scimed, Boston Scientific Corporation, Galway, Ireland). Most lesions (68.4%) had unfavorable characteristics (type B2 or C). Primary success in stent deployment was achieved in 305 (98.6%). There was no Q-wave myocardial infarction. Emergency coronary artery bypass grafting (CABG) was required in 1 patient and 1 death occurred. Subacute thrombosis rate was 0.4%. Reference diameter was 2.65+/-0.67 mm. Minimum luminal diameter (MLD) increased from 0.62+/-0.45 to 2.69+/-0.57 mm and diameter stenosis decreased from 78.3+/-13.4% to 12.7+/-5.9%. Clinical follow-up was performed in the first 135 patients for 5.3+/-1.6 months and repeat angiography was undertaken in 35 (16%) with recurrence of symptoms at 4.6+/-1.3 months. Clinical restenosis rate was 9.6%. We conclude that the NIR coronary stent exhibits favorable performance characteristics and appears to be safe and efficacious in the treatment of coronary lesions even in the presence of high-risk characteristics.

Direct stent implantation without predilatation using the MultiLink stent.

The standard coronary stent implantation technique requires routine predilatation of the target lesion with a balloon catheter. In this study, we prospectively studied the feasibility and efficiency of elective coronary stent implantation without predilatation. In 94 patients who presented with various ischemic syndromes, direct implantation of 100 balloon expandable ACS MultiLink stents (7 over-the-wire, 93 rapid exchange) was attempted in 100 coronary lesions selected to have favorable characteristics. The stent crossed the lesion without predilatation in 97 cases (97%) and was successfully deployed in 93 (95.8%). In 4 patients, adjunctive high-pressure postdilatation was necessary to achieve optimal stent expansion. Reference vessel diameter was 3.12+/-0.77 mm and lesion length 8.8+/-2.7 mm. Minimal luminal diameter increased from 0.95+/-0.38 mm to 2.98+/-0.28 mm and diameter stenosis decreased from 71+/-11% to 8+/-11% after stenting. One occlusive dissection was treated by a second stent. There were no major in-hospital complications. At 1 month follow-up, 1 subacute thrombotic occlusion occurred. These results indicate that in a carefully selected coronary lesion subset, elective stent implantation without predilatation can be safely and effectively performed. The long-term results of this approach and possible advantages over the conventional implantation techniques remain unclear and need to be evaluated in further clinical studies.

Recanalization of total coronary occlusions using a laser guidewire (the European TOTAL Surveillance Study).

The success rates of coronary angioplasty for the treatment of chronic total occlusions are less favorable than for coronary stenosis. Therefore, a new laser guidewire (LW) was designed to facilitate the crossing of chronic total occlusions. We report on the results of a European multicenter surveillance study, evaluating the laser guidewire performance. Between May 1994 and July 1996, 345 patients (age 59 +/- 10 years, 291 men) with chronic total occlusions were enrolled in 28 European centers. The median age of occlusion was 29 weeks (range 2 to 884), the occlusion length 19 +/- 10 mm. LW recanalization was successful in 205 patients (59%/). LW perforation occurred in 73 patients (21%), with hemodynamic consequences in 4 (1%). There were no deaths, emergency coronary artery bypass graft surgery, or Q-wave myocardial infarctions. In a multivariate regression analysis an occlusion age of <40 weeks (p = 0.001, RR = 1.34) and an occlusion length <30 mm (p = 0.01, RR = 1.59) were independent predictors of success. Results indicate that the LW is an effective and safe tool in the treatment of chronic total occlusion refractory to conventional guidewires.

Early deterioration after excimer laser-assisted coronary angioplasty.

Coronary lumen changes after excimer laser coronary angioplasty, after adjunct percutaneous transluminal coronary angioplasty, and at 24 hours after intervention were assessed using quantitative coronary angiography. Lesions treated with this combined technique showed significant early deterioration within 24 hours.