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Objectives: This study sought to assess safety and efficacy of implantation of the Catania Coronary Stent System with Nanothin Polyzene-F (CeloNova BioSciences, Newnan, Georgia) in human coronary arteries with clinical data and comprehensive intracoronary imaging., Background: Novel approaches to modify stents (e.g., bioactive agents, coatings) have been developed to address the limitations of bare-metal and drug-eluting stents (e.g., restenosis, target lesion revascularization [TLR], late thrombosis)., Methods: This first-in-man study using the Catania stent is a prospective, single center, nonrandomized, single-arm study of 55 patients with symptomatic ischemic heart disease with de novo, obstructive lesions of native coronary arteries., Results: Acute angiographic success was 100%. A core laboratory analyzed quantitative coronary angiography and intravascular ultrasound data immediately after stenting and at 6-month follow-up. Late lumen loss was 0.60 +/- 0.48 mm and the percent neointimal hyperplasia volume was 27.9 +/- 16.1%. In 15 of 55 randomly selected patients, 1,904 cross-sections (19,028 struts) were analyzed at 6 months by optical coherence tomography. Overall, 99.5% of struts were covered. Only 29 of 19,028 struts (0.15%) were malapposed. Binary angiographic restenosis was 6.8%. No death, myocardial infarction, or Academic Research Consortium-defined stent thrombosis was observed at 12 months. The incidence of TLR at 12 months was clinically driven TLR 3.6% (2 of 55) and nonclinically driven TLR 7.3% (4 of 55)., Conclusions: This first-in-man showed an excellent early and mid-term safety profile and high-level efficacy of the new Catania stent in the treatment of de novo coronary lesions in a fairly complex population. Polyzene-F coated stents may be an alternative to both bare-metal and drug-eluting stents with reduced late loss, restenosis, and the TLR without long-term dual antiplatelet therapy.

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.

From November, 1976, to June, 1983, 100 patients, 84 male and 16 female patients ranging in age from 13 to 74 years, were operated on for aortic insufficiency associated with an aneurysm of the ascending aorta. Twenty patients were in New York Heart Association Class I, 22 in Class II, 51 in Class III, and seven in Class IV. The surgical treatment in all cases consisted of total replacement of the ascending aorta with a tube graft containing a prosthetic aortic valve and reimplantation of the coronary arteries by an intermediate tube graft according to the technique already reported. In 68 patients an uncomplicated annulo-aortic ectasia existed, and in 32, an aortic dissection; nine of the latter group were operated on during the acute phase. The operative mortality for the entire group was 4% (four deaths). One patient has been lost to follow-up during a period ranging from 18 months to 8 years (average 54 months). The late mortality has been 11/96. Among the 84 survivors, clinical improvement is readily apparent (89% are in Class I or II). Twenty-five patients have been restudied by angiography, which revealed a satisfactory coronary and aortic appearance in all cases with neither stenosis nor aneurysm. The actuarial survival rate is 75% at 8 years. In conclusion, the treatment of aortic insufficiency associated with an aneurysm of the ascending aorta by insertion of a composite graft and reimplantation of the coronary arteries through an intermediate Dacron tube is a reliable method with low mortality and excellent long-term results.

Among 268 patients undergoing percutaneous transluminal coronary angioplasty between February 1980 and January 1983, a total of 21 patients had variant angina, documented before angioplasty in 14 and after angioplasty in 7. Before angioplasty, all 21 patients had rest angina and 17 also had effort angina; single vessel coronary artery disease with 60 to 95% stenosis was present in all patients and the left anterior descending coronary artery was involved in all but 3 patients. Coronary angioplasty was successful in 19 patients (90%). Eight of the 19 patients remained symptom-free without coronary restenosis after successful angioplasty; in the other 11 patients, angina reappeared within 4 months, usually in association with restenosis. Of the nine patients with coronary restenosis, six had repeat angioplasty (five successful procedures and one failure), two received medical therapy and one underwent coronary bypass surgery. Patients in whom calcium channel antagonists were discontinued immediately after angioplasty had an exceedingly high coronary restenosis rate (8 [80%] of 10 successful attempts), but when calcium antagonists were continued for an average of 6 +/- 4 months after angioplasty, the restenosis rate was low (3 [21%] of 14 successful attempts). After a mean (+/- SD) follow-up period of 33 +/- 13 months, 1 patient had died and the 20 others (95%) were symptom-free; among these 20, 15 patients (75%) had been taking no antianginal drugs for more than 1 year, 2 still received calcium channel antagonists and 3 had had coronary bypass surgery. Repeat coronary arteriography performed 14 +/- 7 months after angioplasty in the 17 patients without angioplasty-related infarction or surgery showed 50% or less coronary stenosis in 13 patients.(ABSTRACT TRUNCATED AT 250 WORDS)

To evaluate the changes in left ventricular filling associated with acute cardiac rejection, serial Doppler echocardiographic examinations were prospectively performed on the same day as endomyocardial biopsy in 55 consecutive patients who successfully underwent orthotopic transplantation and were free of a previous episode of rejection. On average, 8.6 Doppler studies per patient were performed within a 6 month period after transplantation. Recordings of mitral flow were made with pulsed Doppler and two-dimensional echocardiography from an apical four chamber view; isovolumic relaxation time, peak early mitral flow velocity and pressure half-time were measured. The patients were classified into two groups on the basis of the histopathologic findings: group I (25 patients with at least one episode of mild or moderate rejection) and group II (30 patients without rejection). In group I, rejection was associated with a significant decrease of isovolumic relaxation time (p less than 0.005) and especially pressure half-time (p less than 0.0005) with no change in heart rate and peak early mitral flow velocity. In group II, Doppler indexes remained unchanged. These changes were not associated with alterations in left ventricular systolic function assessed by echocardiography. Isovolumic relaxation time and pressure half-time both returned to values similar to baseline values after immunosuppressive therapy (p less than 0.05 and p less than 0.0005, respectively). With 20% decrease in pressure half-time as a criterion for acute rejection, sensitivity was 88%, specificity 87% and positive predictive value 85%. Thus, Doppler echocardiographic evaluation of left ventricular diastolic function provides an excellent tool for early detection of acute rejection and noninvasive monitoring of the cardiac transplant recipient.

Percutaneous transluminal coronary angioplasty is an accepted treatment for selected patients with single vessel disease but has not been rigorously evaluated in patients with double vessel disease. Among 769 patients undergoing transluminal coronary angioplasty between 1980 and 1984, 74 with double vessel stenosis of 50% or more underwent double vessel coronary angioplasty. Primary success was obtained for both lesions in 63 patients (85%), for one lesion in 11 patients (15%) and for 137 (93%) of 148 segments overall. Except for myocardial infarction in one patient, no serious complication occurred. Before coronary angioplasty, 15 patients had unstable angina, 14 had Canadian Cardiovascular Society class III and 32 class I to II effort angina and only 2 were asymptomatic. Six months after coronary angioplasty, 27 were asymptomatic, 27 had class I to II and 5 had class III effort angina and 2 had sustained an episode of unstable angina. During the follow-up study, two patients had an infarction and one had coronary artery bypass surgery. Coronary arteriography was performed at a mean of 5.5 +/- 2.1 months after coronary angioplasty in all but three patients. Restenosis was found in 30 (23%) of 132 segments with angiographic control. Restenosis was present in one vessel in 17 patients and in both vessels in 4; 40 patients (66%) had no restenosis. Of the 34 patients with definite or probable angina, 50% had restenosis and 19% of patients with restenosis were symptom free.(ABSTRACT TRUNCATED AT 250 WORDS)

Right heart catheterization was performed in 28 patients 1 week and 6 to 24 months after orthotopic cardiac transplantation. All patients were receiving cyclosporine and methylprednisolone orally. At early catheterization, right heart pressures as well as pulmonary capillary wedge pressure still remained above normal values in the majority of patients. Systemic arterial hypertension was already present in 29% of the patients and cardiac index was usually in the normal range, without any inotropic support. Results of late catheterization showed continuing improvement with return of right heart pressures to normal values in most but not all patients. Systemic arterial hypertension was noted in nearly all patients and is likely to be the result of hypervolemia secondary to cyclosporine-induced sodium retention. The increase in cardiac index, which was above normal values in 39% of the patients, was also consistent with hypervolemia in the setting of cardiac denervation. Thus, cardiac function at rest is satisfactory at short- and long-term assessment after cardiac transplantation, but the development and persistence of systemic arterial hypertension associated with cyclosporine use are a matter of concern in such patients.