[Epidural spinal stimulation in the treatment of refractory angina pectoris. Its clinical efficacy, complications and long-term mortality. An Italian multicenter retrospective study]. / La stimolazione spinale epidurale nel trattamento dell'angina pectoris refrattaria. Efficacia clinica, complicanze e mortalità a lungo termine. Studio retrospettivo multicentrico Italiano.

BACKGROUND: Spinal cord stimulation has been used for many years in the treatment of refractory angina pectoris. Its anti-anginal and anti-ischemic effect has been well documented in several studies, but the long-term efficacy, safety and survival rate are not well known. The aim of this study was to carry out a retrospective analysis of a series of patients from the Italian Multicenter Registry, the data of which were collected in five centers, by means of a questionnaire. METHODS: One hundred and thirty patients (83 males, 47 females, mean age 74.8 +/- 9.8 years) were submitted to spinal cord stimulator implantation for refractory angina pectoris in the period 1988-1995 and controlled during a mean follow-up of 31.4 +/- 25.9 months. A previous myocardial infarction had already occurred in 69.3% of patients, whereas in 67.6% multivessel coronary artery disease was documented. A left ventricular dysfunction (ejection fraction < 0.40) was present in 34% of patients; bypass surgery and coronary angioplasty were performed in 49.6% and in 27% of patients respectively. In 96.3% of cases revascularization procedures were not advisable. RESULTS: A complete follow-up of 116 patients (89.2%) was available. The spinal cord stimulator induced a significant reduction in NYHA functional class from 2.5 +/- 1.2 to 1.5 +/- 0.9 (p < 0.01). During the follow-up 41 patients (35.3%) died, and in 14.2% a new acute myocardial infarction developed. The total percentage of minor spinal cord stimulation-related complications was 6.8%. No major complications occurred. The annual total mortality rate was 6.5%, whereas the cardiac mortality rate was 5%. Compared to the survivors, patients who died showed a higher incidence of left ventricular dysfunction, previous myocardial infarction and bypass surgery at implantation. CONCLUSIONS: In our experience, spinal cord stimulation is an effective therapy in patients affected by refractory angina pectoris and who cannot undergo revascularization procedure. The complication rate is low, with the total and cardiac mortality showing a trend as that reported for patients with similar coronary disease.

Calcium antagonist antihypertensive treatment of non-insulin-dependent diabetics: efficacy and safety of lacidipine versus nifedipine SR.

Arterial hypertension is a chronic condition regarded as one of the main risk factors for development of coronary atherosclerosis. As dyslipidemia and reduced glucose tolerance are also risk factors for coronary disease, it is considered important to use antihypertensive drugs having no negative effects on lipid and glucose metabolism when diabetic patients are treated for hypertension. Lacidipine, a new dihydropyridine-like calcium antagonist, has been shown in in vivo and in vitro preclinical studies to possess potent, long-lasting antihypertensive activity. The present study compared the efficacy and safety of once-daily treatment with lacidipine versus nifedipine SR given twice-daily in non-insulin-dependent diabetic patients. Results have shown a similar efficacy of the two treatments: 6 months later, both drugs had reduced blood pressure values [lacidipine from 184.8/105.2 mm Hg to 144.4/87.1 mm Hg; nifedipine slow-release (SR) from 182.3/106.8 mm Hg to 143.6/89.4 mmHg]. However, lacidipine exhibited a lower incidence of adverse events (particularly ankle edema and tachycardia) than nifedipine SR. Finally, both treatments showed no negative effect on metabolic parameters (total cholesterol, high-density lipoprotein cholesterol, triglycerides, and blood glucose).

Amlodipine versus nifedipine retard in the treatment of chronic ischemic heart disease.

The efficacy of amlodipine, a long half-life dihydropyridine calcium antagonist, at the dosage of 5-10 mg/day in a single daily administration, has been compared with that of nifedipine R, a short half-life dihydropyridine, at the dosage of 20-40 mg b.i.d. in 29 patients with chronic ischemic heart disease. After a one week placebo period, patients were assigned to the treatment with amlodipine or nifedipine R, according to a randomized sequence and a cross-over, single-blind design, for two control periods of four weeks and without a wash-out interval between these two phases. During the stress test, a significant increase from baseline in test duration and in time to onset of ischemia and of angina have been obtained with both treatments; moreover amlodipine increased significantly the time to onset of ST segment deviation (-1 mm) and the time to maximum ST segment deviation compared with nifedipine R changes. Also with Holter monitoring and in the angina diary there was a significant reduction of anginal episodes. As regards safety profile, amlodipine treatment was associated with a significantly lower incidence of side effects compared with nifedipine R. This is probably due to the particular pharmacokinetics of amlodipine which, besides the long half-life which allows a single daily administration, shows a retarded peak (between the 6th and the 12th hour) with consequent reduction of phenomena connected with fast and excessive peripheral vasodilatation. In conclusion, amlodipine was as effective in reducing the signs of ischemia as nifedipine R, but compliance was better due to the single daily administration and so was tolerability.

[3 cases of gingival hyperplasia during nifedipine therapy]. / Su tre casi di iperplasia gengivale in corso di terapia con Nifedipina.

The authors report the cases of three male patients, aged 36, 54 and 52 years, who developed gingival hypertrophy during treatment with nifedipine at a dose of 40 mg/daily. Hypertrophy was the same as that observed in patients treated with anti-convulsive or cytostatic drugs, and may probably be due to interference with calcium ions and local factors. Full recovery was achieved by suspending nifedipine treatment in all patients.

[Necrosis of the pouch due to nontraumatic rupture of the pile during permanent endocardial electrostimulation]. / Necrosi della tasca per rottura non traumatica di pile in corso di elettrostimolazione endocardica permanente.

Necrosis of the pouch containing the generator, due to non-traumatic breakage of the batteries, was observed in a patient with a permanent pacemaker, followed by rapid ingravescence. The cause of this complication is discussed. Chemical inflammation was noted soon after the pacemaker ceased to function. Initially this was similar to the not uncommon bacterial inflammation noted in such patients. Here, of course, the pacemaker usually continues to work, and its replacement is optional, whereas in the reported case is an emergency matter. In situations where tissue distress in the pouch is accompanied by inflammation, therefore, thought should be given to the possibility that, even if the batteries are still working, the cause may be chemical or electrochemical rather than septic, and than sudden breakdown of the generator may be expected.

[Radiological picture in the diagnosis of various complications of permanent endocardial electrostimulation]. / L'indagine radiologica nella diagnostica di alcune complicanze dell'elettrostimolazione endocardica permanente.

The close links between the implantation of permanent pacemakers and radiological examination are described with particular reference to position of the the right ventricle. Here radiological examination offers the best chance of diagnosis. The need for close cooperation between specialists is emphasised.

[Permanent endocardiac electrostimulation. Considerations on 511 implantations and reimplantations in 7 years of practice]. / L'elettrostimolazione endocardica permanente. Considerazioni su 511 impianti e reimpianti in sette anni di attività.

Permanent pacemakers were implanted and reimplanted in a total of 511 patients (mostly men) during a period of about 7 yr. Mean age was 67.9 yr. The cephalic route was used in nearly every case, with subclavicular implantation of the generator. Mean hospital stay was 7.6 days. Ventricular inhibition pacemakers were used in over 84% and fixed-frequency models in 7%. Mean pacemaker life was 24.1 months, with longer periods in the last months of the period of observation. The evaluation of battery run-down and recent and long-term complications is discussed, together with a particular type of decubitus of electrolytic origin. Hospital mortality was 2%. Survival was 91% at 1 yr and 54% at 6 yr. Emphasis is placed on the fact that subjects continue to be heart patients. Their well-being depends on psychological and general medical care, together with help from their, families and society, quite apart from cardiological attention.