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Biomedical subjects

M Brignole

Publications and source records attributed to M Brignole.

At least 37 records · Page 2Linked to original sources
PubMed2001

The vasovagal Syncope and pacing (Synpace) trial: rationale and study design.

BACKGROUND: Though vasovagal syncope probably does not directly cause death, it is often associated with severe trauma and, when recurrent, significantly impairs the patient's quality of life. While drug therapy for vasovagal syncope is still controversial, recently two randomized studies revealed the efficacy of dual-chamber pacemaker implantation in decreasing recurrences in very symptomatic patients. However, since both studies were not placebo-controlled, the benefits observed might have been due to the placebo effect of the pacemaker. AIM OF THE STUDY: The aim of the vasovagal Syncope and pacing (Synpace) trial, a multicentre, prospective, randomized, double-blind, placebo-controlled trial, is to ascertain whether, in patients suffering from recurrent vasovagal syncope, the implantation of a dual-chamber pacemaker with rate drop response algorithm programmed to ON, will reduce syncope relapses compared with the implantation of a pacemaker programmed to OFF. Moreover, in order to evaluate the role of the haemodynamic response during tilt-induced syncope in identifying those patients who will benefit most from pacemaker implantation, enrolled patients will be divided into two groups on the basis of their haemodynamic behaviour during tilt-induced syncope: group 1, asystolic response (development of asystole >3 s), and group 2, mixed response (development of bradycardia <60 bpm, without asystole >3 s). The head-up tilt testing protocol will consist of 20 min at 60 degrees without drug potentiation, followed by 15 min at the same inclination after 400 microg of sublingual nitroglycerin. Results from the two groups will be analysed both separately and globally. The primary clinical endpoint of the study will be syncope. INCLUSION AND EXCLUSION CRITERIA: To be enrolled, patients will have to meet the following criteria: at least six syncopal episodes in the patient's lifetime; positive head-up tilt testing with asystolic or mixed response; at least one syncope recurrence following a positive head-up tilt test. The following constitute exclusion criteria: non-vasovagal syncope; other indications for pacing. SAMPLE SIZE: We hypothesize a risk of syncope recurrence of 70% after one year, and we estimate that--owing to the placebo effect alone--pacemaker will produce a 20% decrease in risk, which corresponds to a 50% risk of recurrence after one year, in those patients randomized to 'pacemaker OFF'. We calculate conservatively a risk decrease of 60% in patients with 'pacemaker ON'. This implies a 10% incidence of syncope recurrence after one year, vs 50% in patients with 'pacemaker OFF'. Fifty patients will need to be enrolled in the study: 25 patients for each group.

Databases as Topic↗
PubMed2001

[Comparison of clinical and electrophysiologic characteristics of patients with occult and manifest atrioventricular accessory pathway].

BACKGROUND: It is current opinion that concealed and manifest accessory pathways (APs) are indistinguishable with respect to their location and contribution to orthodromic reciprocating tachycardias. The aim of this study was to compare clinical and electrophysiological characteristics of two groups of patients. METHODS: Between January 1999 and June 2000, 42 consecutive patients underwent radiofrequency catheter ablation for paroxysmal atrioventricular reciprocating tachycardia attributable to a concealed AP. Their clinical and electrophysiological characteristics were compared with a group of 48 consecutive patients with manifest AP and supraventricular tachyarrhythmias. RESULTS: There were no differences regarding gender, the prevalence of heart disease and the age of onset of symptomatic tachycardias between the two groups. Compared to those with a manifest AP, the patients presenting with a tachyarrhythmia due to a concealed AP were older (48 +/- 15 vs 40 +/- 16 years, p < 0.05) and had a longer history of tachyarrhythmias (22 +/- 16 vs 13 +/- 13 years, p < 0.05). Atrial fibrillation was more frequent in patients with a manifest AP than in patients with a concealed AP (50 vs 9.5% respectively, p = 0.02). Atrioventricular reciprocating tachycardia was a cause of more hospitalizations (76 vs 35%, p = 0.01) and episodes of pre-syncope (47 vs 22%, p < 0.05) in the group of patients with a concealed AP. The anatomical site of concealed and manifest APs was significantly different: concealed APs were more frequently localized in the left side (93% left, 7% right), while manifest APs were seen in the left side in 64% of cases, in the right side in 29% and in the posteroseptal left + right region in 7% of cases. The retrograde electrophysiological properties and the inducibility of other types of reentrant arrhythmias were similar. Catheter ablation was similarly successful regardless of whether the AP was concealed or manifest, the rates of success being 91 and 88% respectively at the first attempt and with a similar number of energy applications (7 +/- 7 vs 10 +/- 9, p = NS). At a second attempt, the procedure was successful in 100 and 98% of cases respectively. Periprocedural complications occurred in 5% of patients with a concealed (1 ventricular fibrillation, 1 cerebral transient ischemic attack) and in 8% of patients with a manifest AP (2 pericardial effusion, 1 transient atrioventricular block, 1 anginal attack with spontaneous recovery) (p = NS). Complications occurred only for left-sided APs and were independent of the approach (transseptal or retrograde). Relapse of AP conduction was more frequent in the group of patients with a manifest than in those with a concealed AP (12 vs 5%), though not significantly. There were no late complications. CONCLUSIONS: Those patients presenting with a tachyarrhythmia due to a concealed AP, compared to those with a manifest AP, were older and had a longer history of tachyarrhythmia. Atrial fibrillation was more frequent in patients with manifest AP. Atrioventricular reciprocating tachycardia episodes were longer-lasting and caused more hospitalizations and more frequently pre-syncope in the group of patients with a concealed AP. Almost all concealed APs were localized in the left side. The retrograde electrophysiological properties were similar. The results of radiofrequency catheter ablation were comparable in both groups.

Adult↗
PubMed2001

[Variables of arrhythmia risk in relation to pacemaker and implantable defibrillator].

Patients suffering from heart failure are at high risk of arrhythmic death. Conventional pacemakers have not shown to affect mortality in patients with chronic heart failure and sick sinus syndrome, while this issue is established in patients with III degree or advanced atrioventricular block. Biventricular pacing has recently been introduced in clinical practice and the experience is limited; to date, only an improvement in symptoms and quality of life has been shown. Biventricular pacing with implantable cardioverter-defibrillator back-up is promising. The implantable cardioverter-defibrillator is able to reduce total and sudden mortality in high risk patients, as clearly demonstrated by several randomized clinical trials.

Anti-Arrhythmia Agents↗
PubMed2000

Effects of left ventricular pacing on cardiac performance and on quality of life in patients with drug refractory heart failure.

We assessed the effects of left ventricular pacing on echocardiographic and clinical parameters in 13 consecutive patients with heart failure and bundle branch block by means of a controlled acute and medium-term evaluation. Left ventricular pacing induced a significant improvement in left ventricular ejection fraction, Minnesota Living with Heart Failure Questionnaire score, New York Heart Association class, and 6-minute walking test compared with sinus rhythm or right ventricular pacing.

Aged↗
PubMed2000

Clinical and genetic heterogeneity of right bundle branch block and ST-segment elevation syndrome: A prospective evaluation of 52 families.

BACKGROUND: The ECG pattern of right bundle branch block and ST-segment elevation in leads V(1) to V(3) (Brugada syndrome) is associated with high risk of sudden death in patients with a normal heart. Current management and prognosis are based on a single study suggesting a high mortality risk within 3 years for symptomatic and asymptomatic patients alike. As a consequence, aggressive management (implantable cardioverter defibrillator) is recommended for both groups. METHODS AND RESULTS: Sixty patients (45 males aged 40+/-15 years) with the typical ECG pattern were clinically evaluated. Events at follow-up were analyzed for patients with at least one episode of aborted sudden death or syncope of unknown origin before recognition of the syndrome (30 symptomatic patients) and for patients without previous history of events (30 asymptomatic patients). Prevalence of mutations of the cardiac sodium channel was 15%, demonstrating genetic heterogeneity. During a mean follow-up of 33+/-38 months, ventricular fibrillation occurred in 5 (16%) of 30 symptomatic patients and in none of the 30 asymptomatic patients. Programmed electrical stimulation was of limited value in identifying patients at risk (positive predictive value 50%, negative predictive value 46%). Pharmacological challenge with sodium channel blockers was unable to unmask most silent gene carriers (positive predictive value 35%). CONCLUSIONS: At variance with current views, asymptomatic patients are at lower risk for sudden death. Programmed electrical stimulation identifies only a fraction of individuals at risk, and sodium channel blockade fails to unmask most silent gene carriers. This novel evidence mandates a reappraisal of therapeutic management.

Adult↗
PubMed2000

Ablate and pace: palliating the symptoms?

Atrioventricular (AV) junction ablation (producing AV block) followed by pacemaker implantation is the most common nonpharmacologic treatment for patients affected by atrial fibrillation (AF) not controlled by antiarrhythmic drugs. In expert hands, the efficacy of producing complete AV block is usually >95% if a sequential right- and left-side approach is used; regression of AV block late after ablation (which requires a second procedure on a different day) occurs in <5% of cases. The clinical efficacy of ablate and pace therapy in controlling arrhythmic symptoms and improving overall quality of life is well established for patients with paroxysmal AF, although not yet for patients with persistent and permanent AF, owing to the lack of sufficient clinical studies. Ablation and pacing is clinically unsuccessful in a minority of cases. There have been little data available on long-term effects of this treatment on cardiac performance, morbidity, and survival. Although concern has arisen from some case reports, no evidence of adverse effect has ever been shown in controlled trials. Ablation and pacing does not seem to increase thromboembolic risk. We estimate that in Europe, about 396,000 patients with paroxysmal AF not controlled by drug therapy could therefore be candidates for ablate and pace therapy. Permanent forms of AF are even more frequent, but it is unknown how many are refractory to drug therapy. The recommended pacing mode is DDDR with mode switching for paroxysmal/persistent AF and VVIR for permanent AF.

Atrial Fibrillation↗
PubMed2000

Dual-chamber pacing in the treatment of neurally mediated tilt-positive cardioinhibitory syncope : pacemaker versus no therapy: a multicenter randomized study. The Vasovagal Syncope International Study (VASIS) Investigators.

BACKGROUND-This study was performed to compare implantation of a DDI pacemaker with rate hysteresis with no implant in respect to syncopal recurrences in patients with severe cardioinhibitory tilt-positive neurally mediated syncope. METHODS AND RESULTS-Forty-two patients from 18 European centers were randomized to receive a DDI pacemaker programmed to 80 bpm with hysteresis of 45 bpm (19 patients) or no pacemaker (23 patients). Inclusion criteria were >/=3 syncopes over the last 2 years and a positive cardioinhibitory (Vasovagal Syncope International Study types 2A and 2B) response to tilt testing. The median number of previous syncopal episodes was 6; asystolic response to tilt testing was present in 36 patients (86%) (mean asystole, 13.9+/-10.2 seconds). All patients were followed up for a minimum of 1.0 years and a maximum of 6.7 years (mean, 3.7+/-2.2). One patient (5%) in the pacemaker arm experienced recurrence of syncope compared with 14 patients (61%) in the no-pacemaker arm (P=0.0006). In the no-pacemaker arm, the median time to first syncopal recurrence was 5 months, with a rate of 0.44 per year. On repeated tilt testing performed within 15 days after enrollment, positive responses were observed in 59% of patients with pacemakers and in 61% of patients without pacemakers (P=NS). CONCLUSIONS-In a limited, select group of patients with tilt-positive cardioinhibitory syncope, DDI pacing with hysteresis reduced the likelihood of syncope. The benefit of the therapy was maintained over the long term. Even in untreated patients, the syncopal recurrence burden was low. A negative result of tilt testing was not a useful means to evaluate therapy efficacy.

Aged↗
PubMed2000

Comparison of diagnostic accuracy of sublingual nitroglycerin test and low-dose isoproterenol test in patients with unexplained syncope.

Despite the widespread use of head-up tilt testing as a means for diagnosing vasovagal syncope, standardization of test methodology remains a controversial issue. The aim of this study was to compare the diagnostic value of head-up tilt testing potentiated with sublingual nitroglycerin with that of head-up tilt testing potentiated with low-dose isoproterenol. For this purpose, 71 patients with unexplained syncope (mean age 43 years) and 30 asymptomatic controls were studied. All underwent the sublingual nitroglycerin and low-dose isoproterenol tests on separate days in a randomized fashion. The protocol of the 2 tests was similar and consisted of 2 phases. Initially, subjects were tilted at 60 degrees for 20 minutes without medication; then, if syncope did not occur, patients and controls received sublingual nitroglycerin (300 microg) or low-dose intravenous isoproterenol (mean infusion rate 1.3 +/- 0.5 microg/min) and continued to be tilted at 60 degrees for a further 20 minutes. During the sublingual nitroglycerin test, a positive response (syncope associated with sudden hypotension and bradycardia) occurred in 35 patients (49%), a negative response in 36 (51%), and drug intolerance in none (0%). During the low-dose isoproterenol test, these percentages were 41%, 59%, and 6%, respectively. A concordant response was observed in 53 cases (75%). Among controls, 3 subjects (10%) had a positive response to the sublingual nitroglycerin test and 4 (13%) to the low-dose isoproterenol test. It is concluded that sublingual nitroglycerin and low-dose isoproterenol are equivalent tests for evaluating patients with unexplained syncope. The sublingual nitroglycerin test, however, is simpler, better tolerated, and safer than the low-dose isoproterenol test and, thus, more suitable for routine clinical use.

Administration, Sublingual↗
PubMed2000

New classification of haemodynamics of vasovagal syncope: beyond the VASIS classification. Analysis of the pre-syncopal phase of the tilt test without and with nitroglycerin challenge. Vasovagal Syncope International Study.

We believe that the pattern of blood pressure response to tilt during the time preceding the development of the vasovagal reaction may provide adjunctive diagnostic information. A group of 101 consecutive patients affected by syncope of uncertain origin underwent passive tilt testing for 45 min at 60 degrees followed, if negative, by oral (sublingual) trinitroglycerin (TNG) 0.4 microg with continuation of the test for 20 min. Three main patterns were observed: the classic (vasovagal) syncope pattern was observed in 36 patients who, during the preparatory phase, had a rapid and full compensatory reflex adaptation to upright position, resulting in stabilization of their blood pressure values until abrupt onset of the vasovagal reaction; the dysautonomic (vasovagal) syncope pattern was observed in 47 patients in whom steady-state adaptation to upright position was not possible. There was thus a progressive fall in their blood pressure until the occurrence of a typical vasovagal reaction; the orthostatic intolerance pattern was observed in 18 patients in whom there was a progressive fall in blood pressure, similar to that of the dysautonomic group, but this was not followed by a clear vasovagal reaction. Compared with the classic, the dysautonomic patients were older, had a higher prevalence of co-morbidities, a very much shorter history of syncopal episodes, and a prevalence of mixed and vasodepressor forms of the VASIS classification. The patients with orthostatic intolerance had clinical characteristics similar to the dysautonmic group but they could not be classified according to the VASIS classification. In conclusion, in patients with syncope, a variety of abnormal responses is observed during tilt testing, suggesting that different syndromes can be diagnosed by the test. A more detailed, although still arbitrary, classification may form the basis of a number of future drug and pacemaker trials, as well as help towards a greater understanding of the different mechanisms of tilt-induced syncope.

Autonomic Nervous System↗
PubMed2000

'The Italian Protocol': a simplified head-up tilt testing potentiated with oral nitroglycerin to assess patients with unexplained syncope.

Head-up tilt testing potentiated by sublingual nitroglycerin (NTG), advocated by an Italian group, is a simple and safe but still not a standardized, diagnostic tool for the investigation of syncope. In fact, owing to its rapid spread, the original protocol received, often arbitrarily, many subsequent modifications. We now define the best methodology of the test on strictly evidence-based criteria as: stabilization phase of 5 min in the supine position; passive phase of 20 min at a tilt angle of 60 degrees; provocation phase of further 15 min after 400 micrograms NTG sublingual spray. Test interruption is made when the protocol is completed in the absence of symptoms, or there is occurrence of syncope, or occurrence of progressive (> 5 min) orthostatic hypotension. We intend that this protocol, named by us as 'The Italian Protocol', will be accepted as the standard methodology of the tilt test potentiated by sublingual nitrates.

Administration, Oral↗
PubMed2000

Long-term follow-up after atrioventricular nodal ablation and pacing: low incidence of sudden cardiac death.

Sudden cardiac death (SCD) has been reported in patients with drug refractory AF who underwent AV nodal ablation and pacing. However, whether SCD in these patients is related to the underlying heart disease or to the ablating and pacing procedure remains uncertain. Between May 1987 and January 1997, AV nodal ablation was performed in 585 patients (mean age 66 +/- 11 years) with drug-resistant, paroxysmal (n = 308) or chronic (n = 277) AF in 12 Italian centers. Lone AF was present in 133 patients. After AV junction ablation, patients underwent VVIR (454 patients) or DDDR (131 patients) pacemaker implantation. At a follow-up of 33.6 +/- 24.2 months, 80 (13.7%) deaths were recorded: 40 noncardiac, 23 nonsudden, and 17 sudden cardiac death (3%, 1.04% per year). Among five variables, including age. NYHA functional class, presence of heart disease, paroxysmal or chronic AF, previous embolic events, and LVEF, the presence of heart disease (P = 0.007) and a LVEF < 0.45, (P = 0.003) were associated with a higher risk of SCD. Analysis of SCD-free survival by log-rank test showed a higher incidence of SCD in patients with LVEF < 0.45 (P = 0.0001) and with coronary artery disease (P = 0.005). In this large cohort, a low incidence of long-term SCD after AV nodal ablation and pacing for drug-refractory AF was observed. The presence of underlying heart disease and the extent of baseline LV dysfunction were associated with an increased likelihood of SCD.

Aged↗
PubMed2000

Clinical features of adenosine sensitive syncope and tilt induced vasovagal syncope.

AIM: To evaluate the possible relation between adenosine sensitive syncope and tilt induced vasovagal syncope. METHODS: An ATP test and a head up tilt test were performed in 175 consecutive patients with syncope of uncertain origin. The ATP test consisted of the rapid intravenous injection of 20 mg of ATP; a positive response was defined as the induction of a ventricular pause (maximum RR interval) >/= 6000 ms. The head up tilt test was performed at 60 degrees for 45 minutes; if negative, 0.4 mg oral glyceryl trinitrate spray was given and the test continued for a further 20 minutes; a positive response was defined as induction of syncope in the presence of bradycardia, hypotension, or both. RESULTS: Of the 121 patients with a positive response, 77 (64%) had a positive head up tilt alone, 18 (15%) had a positive ATP test alone, and in 26 (21%) both ATP and head up tilt were positive. Compared with the patients with isolated positive head up tilt, those with isolated positive ATP were older (mean (SD) age, 68 (10) v 45 (20) years), had a lower median number of syncopal episodes (2 v 3), a shorter median duration of syncopal episodes (4 v 36 months), a lower prevalence of situational, vasovagal, or triggering factors (11% v 64%), a lower prevalence of warning symptoms (44% v 71%), and a higher prevalence of systemic hypertension (22% v 5%) and ECG abnormalities (28% v 9%). The patients with a positive response to both tests had intermediate features. Of the 44 positive responses to the ATP test, atrioventricular block was the cause of the ventricular pause in 43; of the 29 positive cardioinhibitory responses to head up tilt, sinus arrest was present in 23 cases and atrioventricular block in six. CONCLUSIONS: ATP and head up tilt tests identify different populations of patients affected by syncope; these have different general clinical features, different histories of syncopal episodes, and different mechanism sites of action. Therefore, adenosine sensitive syncope and tilt induced vasovagal syncope are two distinct clinical entities.

Adenosine Triphosphate↗