Biodegradable-polymer-based, paclitaxel-eluting Infinnium stent: 9-Month clinical and angiographic follow-up results from the SIMPLE II prospective multi-centre registry study.

BACKGROUND: SIMPLE II was a multi-centre, prospective registry study aimed at investigating the safety and efficacy of the Infinnium (Sahajanand Medical Technologies Pvt. Ltd, India) paclitaxel-eluting stent for the treatment of single de novo lesions in the native coronary arteries. METHODS: One hundred and three patients with symptomatic coronary artery disease were treated for single de novo native coronary artery lesions using the Infinnium stent (paclitaxel concentration 1.4 mcg/mm2 released over 48 days) in a multi-centre, prospective study performed on 3 continents (Asia, Europe and South America). The primary safety endpoint was major adverse cardiac events at 30 days (MACE 30d) and efficacy was assessed by in-stent binary restenosis as measured by quantitative coronary angiography (QCA) at six-month follow-up. A clinical follow-up was scheduled at nine months. RESULTS: The mean patient age was 58.5 years; 70.9% were males; 43.7% had unstable angina and 38.8% previous myocardial infarction. Risk factors included hypertension in 62.1%, hypercholesterolemia in 52.4%, current smoking in 32.0% and diabetes in 28.2%. Stent implantation was successful in all patients, with more than one stent being implanted in 9 patients (8.7%). Hierarchical MACE 30d was 2.9%. At nine months, 101 patients had clinical follow-up (1 patient had died and 1 refused). There was one death (1.0%), one Q-wave myocardial infarction (Q MI) (1.0%), three non-Q MIs (2.9%), one clinically-driven target lesion Coronary Artery Bypass Grafting (CABG) (1.0%), and one clinically-driven target lesion repeat percutaneous coronary intervention (re-PCI) (1.0%). The overall event-free rate at nine months was 93.2%. QCA revealed in-stent and in-segment late loss of 0.38+/-0.49 mm and 0.18+/-0.46 mm, resulting in binary restenosis rates of 7.3% and 8.3%, respectively. There was one case of late stent thrombosis in the patient experiencing the Q MI and subsequent re-PCI. CONCLUSIONS: The Infinnium paclitaxel-eluting stent appears to be safe and efficacious for the treatment of single de novo lesions in coronary arteries in a patient population with symptomatic coronary artery disease (CAD).

Left heart bypass in the pig with a centrifugal pump using cannulae prepared for percutaneous placement.

A rapid and efficient circulatory support system may save a patient in cardiogenic shock. Left heart bypass with percutaneous and trans-septal placement of the aspiration cannula simplifies the circuit and eliminates the need for an oxygenator. In this pre-clinical study we assessed left heart bypass support with a centrifugal pump using new cannulae prepared for percutaneous placement (14 F arterial catheter and 16 F left atrial aspiration line) in 5 anaesthetized pigs. Animals were supported for two hours at a mean flow of 3.2 l/min (4,033 rpm), a mean haematocrit of 29% and low heparinisation (ACT double baseline). Hemodynamic measurements and blood samples were taken at baseline (A), 10 minutes (B), one hour (C) and 2 hours (D) on support. Results show maintenance of hemodynamic parameters throughout the 2 hour support period. Only systolic arterial and left ventricular pressure decreased by 12% and 20% respectively from baseline to the end of the support period with a 13% increase in cardiac output. When the pump was turned on (0-3 l/min) there was usually a decrease in heart rate, systolic pressure and left ventricular pressure, with unchanged cardiac output (non failing model). Potassium increased from 3.9 to 4.2 mmol/l (ns), and plasma hemoglobin from 6.0 to 18.2 mg/dl (p<0.05). Thrombocytes decreased from 187 to 155 10(9)/l (ns). In conclusion, this preclinical study demonstrated the feasibility of an efficient left heart bypass of short duration with a centrifugal pump using cannulae prepared for percutaneous placement. Left heart bypass was well tolerated hemodynamically and no significant laboratory change occurred within the two hours of support. This opens several possibilities for the short term support of patients in cardiogenic shock and eventually also for patients submitted to minimally invasive cardiac surgery.

Effect of pre-treatment with transdermal glyceryl trinitrate on myocardial ischaemia during coronary angioplasty.

OBJECTIVE: In the light of the reported inconsistent anti-ischaemic and antianginal effects of transdermal glyceryl trinitrate, its efficacy and influence on the effects of intracoronary glyceryl trinitrate were examined during coronary angioplasty, which provides a model of controlled, reversible ischaemia. DESIGN: Double blind, randomised study of the effect of transdermal and intracoronary glyceryl trinitrate on ischaemia during coronary angioplasty. PATIENTS: 40 patients with isolated severe stenosis of the left anterior descending coronary artery. INTERVENTIONS: Patients were randomised (double blind) to transdermal glyceryl trinitrate (10 mg per day) and placebo, starting four to six hours before angioplasty. After 4 one-minute balloon inflations intracoronary glyceryl trinitrate was injected (0.2 mg) and then 4 further one-minute inflations were performed. MAIN OUTCOME MEASURES: The time to angina and the time to > 0.2 mV ST shift on surface electrocardiogram (ECG) or intracoronary ECG during the individual inflations. RESULTS: These times did not significantly differ during initial inflations between transdermal glyceryl trinitrate (27 (11), 25 (9), and 19 (9) s, respectively) and placebo (34 (11), 30 (8), and 21 (7) s. After intracoronary glyceryl trinitrate, they were significantly prolonged compared with the initial values, without differences between patients with transdermal glyceryl trinitrate (37 (10), 30 (8), and 23 (8) s, respectively) or placebo (39 (15), 36 (11), and 28 (12) s). Ischaemic preconditioning was not seen. CONCLUSIONS: Transdermal glyceryl trinitrate (10 mg per day), unlike intracoronary glyceryl trinitrate, did not alleviate the myocardial ischaemia produced by balloon inflation during coronary angioplasty.

Use of the reversed button device to treat an atrial septal aneurysm associated with a patent foramen ovale.

An atrial septal aneurysm may be associated with a patent foramen ovale. When paradoxical emboli result, the shunt must be closed and the atrial septal aneurysm excised. A reversed buttoned occluder device was successfully used for the transcatheter treatment of this condition.

Stenting with the half (disarticulated) Palmaz-Schatz stent.

A total of 110 half (disarticulated) Palmaz-Schatz coronary stents were implanted in 102 patients. Procedural success rate was 98%. Elective stenting was performed in five patients. The others received half stents for bail-out situations, including short dissections, relapsing stenoses, dissections not adequately covered by a full stent, ostial stenoses, and thrombus containing lesions. Seventeen patients received no anticoagulation except aspirin. Complications included one procedural death, three acute occlusions (resulting in one Q and two non-Q wave myocardial infarctions), and one non-Q wave infarction related to side branch closure. Stenting with the half Plamaz-Schatz coronary stent is an effective technique. It allows stenting in situations where a full stent may not be ideally suited. Use of only half a stent reduces thrombogenicity and halves costs.

Coronary stenting without anticoagulation.

Stents are useful bail-out devices in coronary angioplasty. They are also used electively for situations associated with poor angioplasty results (e.g., restenotic lesions, venous grafts) and may reduce restenosis rates. However, the significant incidence of stent thrombosis necessitated aggressive anticoagulation with associated hemorrhagic complications. This remains a major limitation of stenting. We present our experience of stenting with half (disarticulated) Palmaz-Schatz coronary stents in eight consecutive patients, managed with aspirin alone. No patient experienced acute or subacute stent thrombosis.

Preharvest aflatoxin contamination of groundnuts subjected to terminal drought stress in postrainy season.

Groundnuts grown in the postrainy season under terminal drought stress imposed by withholding irrigation, or under a water-deficit gradient created by line-source sprinkler irrigation, were examined for preharvest aflatoxin contamination. High levels of aflatoxin B1 were found in damaged seeds in both situations. When grown under continuous drought-stress, toxin levels in damaged seed samples ranged from 1480 to 2467 [Symbol: see text]g/kg in the 1990/91, and 1.3 to 2000 [Symbol: see text]g/kg in the 1991/92 postrainy seasons. Aflatoxin B1 contamination in all damaged seed samples increased with increasing water deficit; toxin levels ranged from 26 to 850 [Symbol: see text]g/kg across the water deficit gradient. Aflatoxin was either absent or almost negligible (1-2 [Symbol: see text]g/kg) in apparently undamaged seed samples. Low risk of aflatoxin contamination in apparently undamaged seeds of groundnuts grown in postrainy seasons is indicated, even when there is terminal drought stress.

Use of half (disarticulated) Palmaz-Schatz stents for thrombus-containing coronary lesions.

Coronary stenoses associated with thrombus can lead to poor angioplasty results and increased procedural complications. Stenting in the presence of thrombus is associated with an increased risk of stent thrombosis. We report eight patients in whom half a Palmaz-Schatz stent was implanted for inadequate angioplasty results owing to thrombus. Stenting resulted in improved angioplasty results; no stent thrombosis occurred.

Coronary angioplasty in the young: procedural results and late outcome.

Procedural outcome of coronary angioplasty in 89 patients < or = 40 years was compared to an older group of 1,916 patients > 40 years. Young patients were more often male (98% vs. 81%), smokers (89% vs. 70%), and more stressed (subjectively) (29% vs. 15%) compared to the older group. Other coronary risk factors were less common in the younger group: diabetes (5% vs. 13%), and hypertension (19% vs. 40%). Left ventricular function, number of diseased vessels, and the number and location of sites dilated were similar in the two groups. Procedural success rates were similar in the two groups (90% in young, 86% in old; p = NS). Younger patients suffered no major complications of the procedure, in contrast to a myocardial infarction rate of 5%, and urgent bypass surgery and mortality rates of 1% each in the older group. Young patients were followed up for a mean of 30 +/- 26 months after the procedure, with an actuarial 5-year survival of 100%. Four patients (5%) required elective coronary bypass surgery: two due to a failed angioplasty attempt (failure to cross), the other two for progressive multivessel disease. A total of 28 patients (34%) required re-angioplasty (restenosis: 13%, progression elsewhere: 12%, both: 9%). All re-angioplasty procedures were angiographically and clinically successful, with no major complications. For young patients, coronary angioplasty is a safe and effective procedure. If technically feasible, angioplasty should be considered the initial therapeutic option without neglecting risk factor modification.

Coronary angioplasty for isolated non-dominant left circumflex coronary artery disease.

The study describes the clinical findings and results of coronary balloon angioplasty in 134 patients with non-dominant left circumflex coronary artery disease. The immediate angiographic success rate was 97% versus 95% for left anterior descending (P = NS), and 90% for right coronary lesions (P < 0.002). There was no hospital mortality in the circumflex group versus 1.2% in the left anterior descending (P < 0.01), and 0.4% in the right coronary artery group (P = NS). Major non-fatal cardiac complications were significantly lower in the non-dominant left circumflex coronary artery patients (no new Q-wave versus 3% in the left anterior descending, P < 0.0002, and 3% in the right coronary artery group, P < 0.01; no urgent coronary artery bypass grafting versus 2% in the left anterior descending, P < 0.001, and 1% in the right coronary artery group, P = NS). The freedom from chest pain was 63% in 112 patients (84%) with follow-up data available at 24 +/- 18 months, and mean angina class diminished to 0.7 +/- 1.3 (P < 0.001). Consumption of antianginal and other cardiac drugs was diminished during follow-up, and the number of patients on no such drugs increased from 5 to 32% (P < 0.001). Restenosis was found in 19 of 32 patients with repeat coronary angiography (59%). Repeat angioplasty was required in 22 patients during follow-up and in 4 of them (18%) it was done for new lesions. Angioplasty for isolated non-dominant left circumflex coronary artery disease yields excellent immediate and long-term results.

Interventional cardiology: state of the art.

Since the advent of percutaneous transluminal coronary angioplasty (PCTA) in 1977, a new breed of cardiologists was born "Interventional Cardiologists". To date, a wide range of new interventions have been developed including percutaneous closure of atrial septal defects and balloon dilatation of the pulmonary valve and mitral valvuloplasty among others. In 1994, the final position of interventional cardiology is not fully defined but indicates what can be expected in the near future. Conventional coronary angioplasty presently accounts for over 90% of all coronary interventions and is likely to remain the cornerstone of coronary interventions. New techniques include stents which have been shown to be effective in acute and threatening occlusions as part of the armamentarium against restenosis. The Rotablator is a technique which uses an olive-shaped high-speed burr coated with diamond chips used for debulking lesions though to represent a high risk/low success rate for balloon angioplasty. Directional coronary atherectomy, transluminal extraction catheters, and Rotacs (a low-speed rotator) have also been developed. Laser angioplasty, which initially created great enthusiasm, probably will be of limited use. Mitral balloon valvuloplasty has emerged as the most common balloon valvuloplasty performed world-wide. It can be performed with or without fluoroscopy, particularly useful in pregnant women. Balloon valvuloplasty is also the treatment of choice in cases of pulmonary stenosis and balloon dilatation of the aortic valve, initially developed for children is now indicated in adults with the exception of elderly patients with calcified valves for whom valve replacement is indicated. Other interventions currently performed include balloon angioplasty for aortic coarctation following surgical repair and transcatheter closure of shunts. Patent ductus arteriosus, atrial septal defect and ventricular septal defect are choice indications. Certain congenital heart diseases including the creation of atrial septal defects in neonates whose survival depends on such a shunt and the treatment of pulmonary branch stenosis, venous obstructions, discrete subaortic stenoses and dilatation of the infundibular stenosis. Coil embolization of arteriovenous fistulae has also been developed. Finally, ablative techniques of invasive electrophysiology have further widened the indications of interventional techniques in cardiology which will continue to develop as an important pole of research and clinical applications in the future.

Coronary angioplasty through 4 French diagnostic catheters.

In 50 consecutive patients subjected to coronary angioplasty immediately following a 4 French (F) diagnostic study, the technical feasibility and economical aspects of angioplasty through 4F catheters of 54 lesions were assessed. The patients were selected, but multiple, eccentric, and long lesions were not a priori excluded. 4F diagnostic catheters (Cordis), and fixed-wire dilatation catheters (Ace, Scimed) were used in all cases. The procedure was successful in 43 lesions (80%) using 4F catheters. For 11 stenoses (20%), a change over to a larger French size was required. Two of these lesions could not be crossed with the balloon despite the larger sized guiding catheter. The final overall success rate was 96%, and there were no major complications. The use of diagnostic 4F catheters for angioplasty in these 50 patients resulted in the saving of 39 guiding catheters and 19 introducer sheaths. For 12 lesions (22%), an additional 4F catheter became necessary since the shape used for the diagnostic study was inadequate for angioplasty. In 7 cases, more than 1 balloon was used, but 5 of these balloon exchanges were independent of the use of 4F catheters. Three exchanges were performed through the 4F catheter (1 for need of a larger balloon to improve on an unsatisfactory angiographic result and 2 for a crimped guide wire tip of the Ace balloon). In the remaining 4, a larger catheter was used; in 2 of them, angioplasty eventually failed (failure to cross lesion) and in the remaining 2, a Monorail system solved the problem, which is incompatible with 4F catheters.(ABSTRACT TRUNCATED AT 250 WORDS)

Balloon recanalisation of a chronically occluded left internal mammary artery graft.

A patient in whom balloon recanalisation of a chronically occluded left internal mammary artery graft was successful is described. A Magnum-Magnarail system was used, and a four month follow up showed no restenosis.

Conventional coronary angioplasty.

Coronary angioplasty has come a long way since its inception 16 years ago. Although several new devices have shown promise, none, with the exception of the stent, has significantly changed results, and the "simple" balloon remains the backbone of coronary angioplasty. Increased operator experience and advanced guidewire and balloon technology have expanded indications for the procedure to include multivessel angioplasty, angioplasty of chronic occlusions and grafts, angioplasty in the setting of acute myocardial infarction, and supported, high-risk angioplasty. However, single-vessel angioplasty remains by far the most common form of this procedure. Restenosis continues to be an unsolved problem. Results of several trials comparing angioplasty and surgery are expected soon, but they will not answer the question of which method of revascularization is best for the individual patient.

Left main coronary angioplasty in a 10-year-old boy with homozygous familial hypercholesterolemia.

Homozygous familial hypercholesterolemia is a rare cause of premature coronary artery disease. A young boy with this disorder who underwent successful coronary angioplasty for left main stem stenosis is presented.

Coronary stenting through 6 French guiding catheters.

Most stent implantation procedures currently require the use of large-diameter guiding catheters. We describe our preliminary successful experience with 6 French guiding catheters to deliver balloon-expandable Palmaz-Schatz stents to the coronary arteries.