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Biomedical subjects

M Brignole

Publications and source records attributed to M Brignole.

At least 55 records · Page 3Linked to original sources
PubMed2000

[The tilt test enhanced with oral nitroglycerin in patients with unexplained syncope: the Italian Protocol. The Working Group on Syncope of the Associazione Italiana di Aritmologia e Cardiostimolazione--the Arrhythmia Area of the Associazione Nazionale Medici Cardiologi Ospedalieri].

The head-up tilt testing potentiated with oral nitroglycerin, devised by an Italian group, is a simple, safe and powerful, but still not a standardized, diagnostic tool. In fact, owing to its rapid diffusion, the original protocol received, often arbitrarily, subsequent modifications. Thus a task force of experienced cardiologists defined the best methodology for the test on strictly evidence-based criteria. Particular attention was reserved to some controversial topics, such as the tilting angle, the duration of the passive and pharmacological stages of the test, the type and dosage of the drug utilized. We hope that the enclosed protocol, named by us as "The Italian Protocol", will be accepted as the standard methodology of the head-up tilt testing potentiated with oral nitrates.

Administration, Oral↗
PubMed1999

Effect of etilefrine in preventing syncopal recurrence in patients with vasovagal syncope: a double-blind, randomized, placebo-controlled trial. The Vasovagal Syncope International Study.

BACKGROUND: Etilefrine is an alpha-agonist agent with a potent vasoconstrictor effect, which is potentially useful in preventing vasovagal syncope by reducing venous pooling and/or by counteracting reflex arteriolar vasodilatation. The present multicenter, randomized, placebo-controlled study was designed to evaluate the efficacy of this drug for the long-term management of patients with recurrent vasovagal syncope. METHODS AND RESULTS: In the 20 participating centers, 126 patients with recurrent vasovagal syncope (at least 3 episodes in the last 2 years) and a positive baseline head-up tilt response were randomly assigned to placebo (63 patients) or etilefrine at a dosage of 75 mg/d (63 patients) and were followed up for 1 year or until syncope recurred. The primary end-point of the study was the first recurrence of syncope. There were no differences between the 2 study groups in the patients' baseline characteristics. During follow-up, the group treated with etilefrine had a similar incidence of first syncopal recurrence to that of placebo group both in the intention-to-treat analysis (24% versus 24%) and in on- treatment analysis (26% versus 24%). Moreover, the median time to the first syncopal recurrence did not significantly differ between the 2 study groups (106 days in the etilefrine arm and 112 days in the placebo arm). CONCLUSIONS: Oral etilefrine is not superior to placebo in preventing spontaneous episodes of vasovagal syncope. Randomized controlled studies are essential to assess the real usefulness of any proposed therapy for patients with vasovagal syncope.

Adrenergic alpha-Agonists↗
PubMed1999

Which strategy is "best" after myocardial infarction? The Beta-blocker Strategy plus Implantable Cardioverter Defibrillator Trial: rationale and study design.

The Beta-blocker Strategy plus Implantable Cardioverter Defibrillator (BEST-ICD) Trial is a multicenter prospective randomized trial that started in June 1998, in 95 centers in Italy and Germany. The trial will test the hypothesis whether, in high-risk post myocardial infarction (MI) patients already treated with beta blockers, electrophysiologic study (EPS)-guided therapy (including the prophylactic implantation of implantable cardioverter defibrillator [ICD] in inducible patients) will improve survival compared with conventional therapy. Patients eligible for the study are survivors of recent MI (> or = 5 and < or = 21 days), aged < or = 80 years, with left ventricular ejection fraction < or = 35% and > or = 1 of the following additional risk factors: (1) ventricular premature beats > or = 10/hour; (2) decreased heart rate variability (standard deviation of unusual RR intervals < 70 msec); and (3) presence of ventricular late potentials. Furthermore, all enrolled patients must be able to tolerate at least 25 mg of metoprolol per day. These patients constitute about 9% of all patients with recent MI and are expected to have a 2-year all-cause mortality > 25% of which 50% is anticipated to be from sudden death. The main criteria of exclusion from the study are (1) a history of sustained ventricular arrhythmia; (2) documentation of nonsustained ventricular tachycardia during the screening phase; and (3) the need for myocardial revascularization and contraindications or intolerance to beta-blocker therapy. Eligible patients will be randomized to 2 different therapeutic strategies: conventional strategy or EPS/ICD strategy. Patients allocated to the EPS/ICD strategy will undergo further risk stratification, and electrophysiologically inducible patients (approximately 35%) will receive prophylactic ICDs, in addition to the conventional therapy, whereas noninducible patients will be only conventionally treated. The primary endpoint of the study will be death from all causes. By hypothesizing a 30% reduction in the 2-year mortality (from 20% to 14%) in the EPS/ICD group compared with conventionally treated patients, 1,200 patients will have to be included. A triangular, 2-sided sequential design with preset boundaries, for a 5% significance level and 90% power to detect a reduction in 2-year mortality from 20% to 14%, will be used to permit early termination of the trial if the strategy is found to be efficacious, no difference, or inefficacious.

Adrenergic beta-Antagonists↗
PubMed1999

Prospective, randomized study of atrioventricular ablation and mode-switching, dual chamber pacemaker implantation versus medical therapy in drug-resistant paroxysmal atrial fibrillation. The PAF study. Paroxysmal Atrial Fibrillation.

We performed a prospective randomized 6-month evaluation of the clinical effects of atrioventricular junctional ablation together with placement of a DDDR mode-switching pacemaker vs pharmacological treatment in 43 patients with intolerable paroxysmal atrial fibrillation not controlled with antiarrhythmic drugs. Ablation and pacemaker treatment were highly effective and superior to drug therapy in controlling symptoms and improving quality of life. However, discontinuation of drug therapy exposed patients to further recurrences of paroxysmal atrial fibrillation and the risk of developing permanent atrial fibrillation.

Anti-Arrhythmia Agents↗
PubMed1999

Determinants of development of permanent atrial fibrillation and its treatment.

We evaluated the rate of progression of permanent atrial fibrillation (AF) and identified clinical factors that predict this event in 63 consecutive patients who had undergone AV junctional ablation and DDDR pacemaker implantation for drug-refractory paroxysmal atrial fibrillation/ flutter. Immediately after ablation, anti-arrhythmic drugs were discontinued in all cases. Permanent AF was considered to have developed if AF was present on two consecutive 6-monthly examinations with no interim documented sinus rhythm. During a mean follow-up of 23 +/- 16 months, 22 (35%) of the 63 patients developed permanent AF. The actuarial estimate of progression of permanent AF was 22%, 40% and 56%, respectively, 1, 2 and 3 years after ablation. Age and underlying heart disease were independent predictors of progression of permanent AF. Only one (6%) of 16 patients with idiopathic AF had permanent AF (low risk group). Among the 47 patients with structural heart disease, permanent AF developed in 18 (62%) of the 29 who were aged >75 years or had >12 arrhythmic episodes per year and a symptom duration >4 years (high risk group), but only in three (17%) of the remaining 18 patients who did not (intermediate risk group). In conclusion, during a 3-year follow-up period, about half of the patients with a history of drug-refractory paroxysmal AF did not develop permanent AF after AV junctional ablation and dual-chamber pacemaker implantation, even in the absence of anti-arrhythmic drug therapy. Moreover, subgroups of patients whose risk of permanent AF progression differed were identified on the basis of simple baseline clinical variables. The results of this study form the necessary background for the correct management of patients after AV junction ablation and for the planning of future trials in this field.

Actuarial Analysis↗
PubMed1999

Report of a study group on ablate and pace therapy for paroxysmal atrial fibrillation. Barcelona Discussion Group. Working Group on Arrhythmias of the European Society of Cardiology.

Atrioventricular junctional (AVJ) catheter ablation followed by pacemaker implantation is now widely accepted for patients affected by paroxysmal atrial fibrillation (PAF) not controlled by antiarrhythmic drugs. However, few data exist on its indications, optimal methodology and complications. Therefore a study group examined current practice in Europe and North America, using a questionnaire, followed by a Study Group Meeting to discuss the results. Based upon this, class I, class II and class III indications were proposed. Class I indications (for which general agreement existed) include drug-refractory PAF, correlating with important symptoms, the bradycardia tachycardia syndrome already treated with a pacemaker, and continued PAF. Large differences exist in the current methodology, but consensus was reached on the technical approaches of right and left-sided AVJ ablation, and on the timing of pacemaker implant in relation to ablation. No complete agreement was reached on technical features such as catheter choice and heparin use. The recommended pacing mode was DDDR with mode switching.

Atrial Fibrillation↗
PubMed1999

Head-up tilt testing potentiated with oral nitroglycerin: a randomized trial of the contribution of a drug-free phase and a nitroglycerin phase in the diagnosis of neurally mediated syncope.

BACKGROUND: Since the pharmacological challenge with nitroglycerin (NTG) follows the initial drug-free phase in current tilt testing protocols, the effects of nitroglycerin alone and the appropriate duration of the basal phase are unknown. METHODS: To optimize the test, a randomized intra-patient comparison of two protocols was undertaken: a conventional nitroglycerin test (cHUT) consisting of passive upright posture at 60 degrees for 45 min followed, if negative, by sublingual NTG 0.4 mg spray, with the test continued for 20 min; and, accelerated nitroglycerin test (aHUT) consisting of passive upright posture at 60 degrees for 5 min--to rule out orthostatic hypotension--followed by sublingual NTG 0.4 mg spray, with the test continued for 20 min. Eighty-four consecutive patients (33 males; mean age 55+/-22) with unexplained syncope underwent both cHUT and aHUT in a randomized sequence with a 24-72 h interval between them. Additionally, 25 age-matched control subjects underwent aHUT. RESULTS: In the drug-free phase, cHUT was positive in 15/84 patients (18%) and aHUT in 1/84 patients (1%). After NTG, cHUT and aHUT showed the same positivity rate of 33% (28/84 patients). The overall positivity rate was therefore higher with cHUT than with aHUT (51% vs 35%, P=0.04). Times to syncope were 29+/-12 min, (range 2-44) for cHUT drug-free phase, 5+/-2 min (range 2-9) for cHUT NTG phase, and 5+/-2 min (range 2-9) for aHUT. Only one (4%) of the control subjects had a positive response to aHUT. CONCLUSIONS: The contribution of NTG to the diagnosis is independent of the presence of an unmedicated phase. The appropriate duration of the NTG phase is 10 min. aHUT has good specificity, but a positivity rate lower than cHUT; thus a drug-free phase is necessary to increase the sensitivity of the test.

Administration, Oral↗
PubMed1999

Modification of antegrade slow pathway is not crucial for successful catheter ablation of common atrioventricular nodal reentrant tachycardia.

We tested the hypothesis that in some patients affected by typical AVNRT, successful catheter ablation treatment may be achieved independently of specific measurable electrophysiological modifications of antegrade AV node conducting properties. Standard electrophysiological parameters and comparable antegrade AV node function curves were obtained, before and after successful ablation, in 104 patients (mean age 52 +/- 16 years; 69 women and 35 men) affected by the common form of AVNRT. The end point of the ablation procedure was noninducibility of AVNRT and of no more than one echo beat. For the purpose of this study, AV node duality was defined as an increase of > or = 50 ms in the A2H2 interval in response to a 10 ms decrease of the A1A2 coupling interval. Before ablation, AV node duality was present in 65 patients (62%) and absent in 39 patients (37%). Ablation caused measurable modifications of electrophysiological properties of the AV node in most patients with elicited AV node duality, but not in most patients without demonstrable AV node duality. After ablation, AV node duality persisted in 20 patients who had it before, whereas a new duality that could not be elicited before appeared in 5 patients. During 19 +/- 6 months of follow-up, clinical AVNRT recurred in 1 of 45 patients who had disappearance of AV node duality after ablation, in 1 of 34 patients who did not show AV node duality before and after ablation, and in 1 of 20 patients who had persistence of AV node duality after ablation. In conclusion, modifications of antegrade conduction properties of the AV node are not crucial for the cure of AVNRT in many patients.

Atrioventricular Node↗
PubMed1999

Thromboembolism after atrioventricular node ablation and pacing: long term follow up.

OBJECTIVE: To assess the incidence of arterial embolic events in patients with high rate, drug resistant, severely symptomatic paroxysmal and chronic atrial fibrillation who have undergone atrioventricular (AV) node ablation and permanent pacing. DESIGN: Multicentre retrospective cohort study. PATIENTS AND MANAGEMENT: From May 1987 to January 1997, AV node ablation was performed in 585 severely symptomatic patients (mean (SD) age 66 (11) years) with high rate, drug resistant paroxysmal atrial fibrillation (308) or chronic atrial fibrillation (277). Lone atrial fibrillation was present in 133 patients, while the remaining 452 suffered from dilated, ischaemic, or valvar heart disease. Patients underwent VVIR (454) or DDDR (131) pacemaker implantation, after AV node ablation. Antiplatelet agents were given to 202 patients, warfarin to 187 patients. RESULTS: During a follow up of 33.6 (24.2) months, thromboembolic events were observed in 17 patients (3%); the actuarial occurrence rates of thromboembolism were 1.1%, 3%, 4.2%, and 7.4% after one, three, five, and seven years, respectively. Among five variables, univariate analysis showed that only the presence of chronic atrial fibrillation at the time of ablation (relative risk (RR) = 1.8, 95% confidence interval (CI) = 1.02 to 3. 20, p = 0.04) and the need for warfarin treatment (RR = 1.6, 95% CI 1.00 to 2.71, p = 0.048) were associated with a significantly higher risk of occurrence of thromboembolic events. On multivariate analysis the only predictor of embolic events during the follow up was the presence of chronic atrial fibrillation. CONCLUSIONS: Data from this large cohort of patients indicate a fairly low incidence (1.04% per year) of thromboembolic events after AV node ablation and pacing for drug refractory, high rate atrial fibrillation.

Aged↗
PubMed1998

The natural course of untreated sick sinus syndrome and identification of the variables predictive of unfavorable outcome.

We performed a prospective study in 35 untreated patients aged > or = 45 years, who had a mean sinus rate at rest of < or = 50 beats/min and/or intermittent sinoatrial block, and symptoms attributable to sinus node dysfunction. The patients were followed up for up to 4 years (mean 17 +/- 15 months). During follow-up, 20 patients (57%) had cardiovascular events that required treatment: 8 had syncope (23%); 6 had overt heart failure (17%); 4 patients had chronic atrial fibrillation (11%); and 2 patients had poorly tolerated episodes of paroxysmal tachyarrhythmias (6%). Actuarial rates of occurrence of all events were 35%, 49%, and 63%, respectively, after 1, 2, and 4 years. At univariate analysis, age > or = 65 years, end-systolic left ventricular diameter > or = 30 mm, end-diastolic left ventricular diameter > or = 52 mm, and ejection fraction < 55% were predictors of cardiovascular events. At multivariate analysis, age, end-diastolic diameter, and ejection fraction remained independent predictors of events. Actuarial rates of occurrence of syncope were 16%, 31%, and 31%, respectively, after 1, 2, and 4 years. Both univariate and multivariate predictors of syncope were history of syncope and corrected sinus node recovery > or = 800 ms. A favorable outcome was observed in the remaining 43% of patients. Thus, clinical cardiovascular events occur in most untreated sick sinus syndrome patients during long-term follow-up, even though a favorable course can be expected in 43% of patients. The outcome can be partly predicted on initial evaluation. In the patients with a favorable outcome, treatment can safely be delayed.

Actuarial Analysis↗
PubMed1998

Assessment of atrioventricular junction ablation and VVIR pacemaker versus pharmacological treatment in patients with heart failure and chronic atrial fibrillation: a randomized, controlled study.

BACKGROUND: Uncontrolled studies have suggested that atrioventricular junction ablation and pacemaker implantation have beneficial effects on quality of life in patients with chronic atrial fibrillation (AF). METHODS AND RESULTS: We performed a multicenter, controlled, randomized, 12-month evaluation of the clinical effects of atrioventricular junction ablation and VVIR pacemaker (Abl+Pm) versus pharmacological (drug) treatment in 66 patients with chronic (lasting >6 months) AF who had clinically manifest heart failure and heart rate >90 bpm on 3 standard ECGs recorded at rest during stable clinical conditions on different days. Before completion of the study, withdrawals occurred in 8 patients of the drug group and in 4 patients of the Abl+Pm group. At the end of the 12 months, the 28 Abl+Pm patients who completed the study showed lower scores in palpitations (-78%; P=0.000) and effort dyspnea (-22%; P=0.05) than the 26 of the drug group. Lower scores, although not significant, were also observed for exercise intolerance (-20%), easy fatigue (-17%), chest discomfort (-50%), Living with Heart Failure Questionnaire (-14%), New York Heart Association functional classification (-4%), and Activity scale (-12%). The intrapatient comparison between enrollment and month 12 showed that in the Abl+Pm group, all variables except easy fatigue improved significantly from 14% to 82%. However, because an improvement was also observed in the drug group, the difference between the 2 groups was significant only for palpitations (P=0.000), effort dyspnea (P=0.01), exercise intolerance (P=0.005), easy fatigue (P=0.02), and chest discomfort (P=0.02). Cardiac performance, evaluated by means of standard echocardiogram and exercise test, did not differ significantly between the 2 groups and remained stable over time. CONCLUSIONS: In patients with heart failure and chronic AF, Abl+Pm treatment is effective and superior to drug therapy in controlling symptoms, although its efficacy appears to be less than that observed in uncontrolled studies because some improvement can also be expected in medically treated patients. Cardiac performance is not modified by the treatment.

Aged↗
PubMed1998

Progression of permanent atrial fibrillation after atrioventricular junction ablation and dual-chamber pacemaker implantation in patients with paroxysmal atrial tachyarrhythmias.

Among 63 patients affected by symptomatic drug refractory paroxysmal atrial fibrillation who had undergone atrioventricular junction ablation and dual-chamber pacemaker implantation, the actuarial estimate of progression of permanent atrial fibrillation was 22%, 40%, and 56% respectively, 1, 2, and 3 years after ablation. A stratification of the risk of development of permanent atrial fibrillation was obtained on the basis of several clinical variables.

Aged↗