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Biomedical subjects

Michele Brignole

Publications and source records attributed to Michele Brignole.

At least 19 recordsLinked to original sources

Left ventricular electromechanical delay in patients with heart failure and normal QRS duration and in patients with right and left bundle branch block.

AIMS: We sought to define the reference values of intra-left ventricular (LV) electromechanical delay (EMD), and to assess the prevalence (and pattern) of intra-LV dyssynchrony in patients with heart failure (HF) and normal QRS and in patients with right and left bundle branch block. METHODS AND RESULTS: We used tissue Doppler imaging echocardiography and a six-LV wall model to study LV EMD in 103 patients [41 with HF and normal QRS, 22 with right bundle branch block (RBBB), and 40 with left bundle branch block (LBBB)], and in 59 controls. In controls, the median intra-LV EMD was 17 ms, (inter-quartile range 13-30); 95% of controls had a value < or =41 ms. Patients showed a longer intra-LV EMD than controls: 33 ms (20-57) in patients with normal QRS, 32 ms (23-50) in RBBB patients, and 50 ms (30-94) in LBBB patients. Intra-LV dyssynchrony (defined as intra-LV EMD >41 ms) was present in 39, 36, and 60% of the patients, respectively. On average, HF patients showed the same pattern of activation as controls, from the septum to the posterior wall, but activation times were significantly prolonged. In RBBB patients the activation sequence was directed from inferior to anterior and in LBBB from anterior to inferior wall. CONCLUSIONS: Left ventricular dyssynchrony was present in several patients with HF and normal QRS, and in patients with RBBB; conversely, 40% of LBBB patients showed values of LV EMD within the normal range. Left ventricular activation sequence was different between groups. Assessment of LV synchronicity by means of imaging techniques may be more important than QRS duration or morphology in selecting patients for cardiac resynchronization treatment.

Aged↗

Effectiveness of physical counterpressure maneuvers in preventing vasovagal syncope: the Physical Counterpressure Manoeuvres Trial (PC-Trial).

OBJECTIVES: In this study, we assessed the effectiveness of physical counterpressure maneuvers (PCM) in daily life. BACKGROUND: There is presently no evidence-based therapy for vasovagal syncope. Current treatment consists of explanation and life-style advice. Physical counterpressure maneuvers have been shown to raise blood pressure and to control or abort vasovagal episodes in laboratory conditions. METHODS: We performed a multicenter, prospective, randomized clinical trial, which included 223 patients age 38.6 (+/-15.4) years with recurrent vasovagal syncope and recognizable prodromal symptoms. One hundred and seventeen patients were randomized to standardized conventional therapy alone, and 106 patients received conventional therapy plus training in PCM. RESULTS: The median yearly syncope burden during follow-up was significantly lower in the group trained in PCM than in the control group (p = 0.004). During a mean follow-up period of 14 months, overall 50.9% of the patients with conventional treatment and 31.6% of the patients trained in PCM experienced a syncopal recurrence (p = 0.005). Actuarial recurrence-free survival was better in the treatment group (log-rank p = 0.018), resulting in a relative risk reduction of 39% (95% confidence interval, 11% to 53%). No adverse events were reported. CONCLUSIONS: Physical counterpressure maneuvers are a risk-free, effective, and low-cost treatment method in patients with vasovagal syncope and recognizable prodromal symptoms, and should be advised as first-line treatment in patients presenting with vasovagal syncope with prodromal symptoms. (The PC-Trial; http://www.controlled-trials.com/isrctn/trial/45146526/0/45146526.html; ISRCTN45146526).

Actuarial Analysis↗

Lower limb and abdominal compression bandages prevent progressive orthostatic hypotension in elderly persons: a randomized single-blind controlled study.

OBJECTIVES: This study sought to assess the efficacy of compression bandage of legs and abdomen in preventing hypotension and symptoms. BACKGROUND: Progressive orthostatic hypotension can occur in elderly people during standing. METHODS: Twenty-one patients (70 +/- 11 years) affected by symptomatic progressive orthostatic hypotension underwent 2 tilt-test procedures, with and without elastic bandage of the legs (compression pressure 40 to 60 mm Hg) and of the abdomen (compression pressure 20 to 30 mm Hg) in a randomized crossover fashion. Leg bandage was administered for 10 min and was followed by an additional abdominal bandage for a further 10 min. Symptoms were evaluated by a 7-item Specific Symptom Score (SSS) questionnaire before and after 1 month of therapy with elastic compression stockings of the legs (prescribed in all patients irrespective of the results of the tilt study). RESULTS: In the control arm, systolic blood pressure decreased from 125 +/- 18 mm Hg immediately after tilting to 112 +/- 25 mm Hg after 10 min of sham leg bandage and to 106 +/- 25 mm Hg after 20 min despite the addition of sham abdominal bandage. The corresponding values with active therapy were 129 +/- 19 mm Hg, 127 +/- 17 mm Hg (p = 0.003 vs. control), and 127 +/- 21 mm Hg (p = 0.002 vs. control). In the active arm, 90% of patients remained asymptomatic, versus 53% in the control arm (p = 0.02). During the month before evaluation, the mean SSS score was 35.2 +/- 12.1 with dizziness, weakness, and palpitations accounting for 64% of the total score. The SSS score decreased to 22.5 +/- 11.3 after 1 month of therapy (p = 0.01). CONCLUSIONS: Lower limb compression bandage is effective in avoiding orthostatic systolic blood pressure decrease and in reducing symptoms in elderly patients affected by progressive orthostatic hypotension.

Abdomen↗

Lack of correlation between the responses to tilt testing and adenosine triphosphate test and the mechanism of spontaneous neurally mediated syncope.

AIMS: We prospectively correlated the results of tilt testing (TT) and adenosine triphosphate test (ATP) with the findings observed during a spontaneous syncopal relapse by means of an implantable loop recorder (ILR) in patients with a clinical diagnosis of neurally mediated syncope. METHODS AND RESULTS: We included patients with three or more clinically severe syncopal episodes in the last 2 years without significant electrocardiographic and cardiac abnormalities. Patients with orthostatic hypotension and carotid sinus syncope were excluded. After ILR implantation, patients were followed until the first documented syncope. Among 392 enrolled patients, 343 underwent TT, which was positive in 164 (48%), and 180 ATP test, which was positive in 53 (29%). Syncope was documented by ILR in 106 (26%) patients after a median of 3 months. Patients with positive and negative TT had similar baseline characteristics, syncopal recurrence rate, and mechanism of syncope, but those with positive TT had more frequently no or slight rhythm variations during spontaneous syncope (45 vs. 21%, P=0.02). An asystolic pause was more frequently found during spontaneous syncope than during TT (45 vs. 21%, P=0.02), but there was a trend for those with an asystolic response during TT also to have an asystolic response during spontaneous syncope (75 vs. 37%, P=0.1). Patients with positive ATP test responses showed syncopal recurrence rates and mechanism of syncope similar to those with negative ATP tests. CONCLUSION: In patients with neurally mediated syncope, clinical characteristics, outcome, and mechanism of syncope are poorly correlated and not predicted by the results of TT and ATP test. Therefore, these tests are of little or no value in guiding specific therapy.

Adenosine Triphosphate↗

Effects of right ventricular pacing on intra-left ventricular electromechanical activation in patients with native narrow QRS.

Some patients with right ventricular (RV) apical pacing show contractile asynchrony of the left ventricle. Whether the asynchrony is due to RV pacing or was a preexistimg condition remains unknown. The aim of this study was to evaluate how much pacing from the RV apex affects left ventricular (LV) electromechanical activation and to assess whether the extent of LV asynchrony during RV pacing can be predicted by clinical, electrocardiographic, or echocardiographic findings obtained during spontaneous rhythm. We evaluated 56 patients with narrow QRS and preserved atrioventricular conduction who received permanent backup RV pacing. Intra-LV electromechanical activation was assessed during spontaneous rhythm and during pacing using tissue Doppler echocardiography. An abnormal intra-LV electromechanical delay (EMD) (defined as a >41-ms difference between the faster and slower activated LV wall) was found in 15 patients (27%) during spontaneous rhythm and 28 patients (50%) during RV pacing (p<0.001). Of the 9 baseline variables (age, gender, history of heart failure, QRS duration in spontaneous rhythm and during pacing, LV end-diastolic and end-systolic diameters, LV ejection fraction, and intra-LV EMD in spontaneous rhythm), an abnormal baseline intra-LV EMD and QRS duration of >85 ms were independent predictors of an abnormal intra-LV delay during RV pacing. RV apical pacing induces asynchrony of LV contractions in a substantial percentage of patients but not in all. Although normal baseline intra-LV electromechanical activation cannot exclude the development of significant asynchrony during RV pacing, the presence of preimplant LV asynchrony predicts for a worsening of this detrimental effect.

Aged↗

Early application of an implantable loop recorder allows effective specific therapy in patients with recurrent suspected neurally mediated syncope.

AIMS: This prospective multicentre observational study assessed the efficacy of specific therapy based on implantable loop recorder (ILR) diagnostic observations in patients with recurrent suspected neurally mediated syncope (NMS). METHODS AND RESULTS: Patients with three or more clinically severe syncopal episodes in the last 2 years without significant electrocardiographic and cardiac abnormalities were included. Orthostatic hypotension and carotid sinus syncope were excluded. After ILR implantation, patients were followed until the first documented syncope (Phase I). The ILR documentation of this episode determined the subsequent therapy and commenced Phase II follow-up. Among 392 patients, the 1-year recurrence rate of syncope during Phase I was 33%. One hundred and three patients had a documented episode and entered Phase II: 53 patients received specific therapy [47 a pacemaker because of asystole of a median 11.5 s duration and six anti-tachyarrhythmia therapy (catheter ablation: four, implantable defibrillator: one, anti-arrhythmic drug: one)] and the remaining 50 patients did not receive specific therapy. The 1-year recurrence rate in 53 patients assigned to a specific therapy was 10% (burden 0.07 +/- 0.2 episodes per patient/year) compared with 41% (burden 0.83 +/- 1.57 episodes per patient/year) in the patients without specific therapy (80% relative risk reduction for patients, P = 0.002, and 92% for burden, P = 0.002). The 1-year recurrence rate in patients with pacemakers was 5% (burden 0.05 +/- 0.15 episodes per patient/year). Severe trauma secondary to syncope relapse occurred in 2% and mild trauma in 4% of the patients. CONCLUSION: A strategy based on early diagnostic ILR application, with therapy delayed until documentation of syncope allows a safe, specific, and effective therapy in patients with NMS.

Adult↗

Standardized-care pathway vs. usual management of syncope patients presenting as emergencies at general hospitals.

AIMS: The study hypothesis was that a decision-making approach improves diagnostic yield and reduces resource consumption for patients with syncope who present as emergencies at general hospitals. METHODS AND RESULTS: This was a prospective, controlled, multi-centre study. Patients referred from 5 November to 7 December 2001 were managed according to usual practice, whereas those referred from 4 October to 5 November 2004 were managed according to a standardized-care pathway in strict adherence to the recommendations of the guidelines of the European Society of Cardiology. In order to maximize its application, a decision-making guideline-based software was used and trained core medical personnel were designated-both locally in each hospital and centrally-to verify adherence to the diagnostic pathway and give advice on its correct application. The 'usual-care' group comprised 929 patients and the 'standardized-care' group 745 patients. The baseline characteristics of the two study populations were similar. At the end of the evaluation, the standardized-care group was seen to have a lower hospitalization rate (39 vs. 47%, P=0.001), shorter in-hospital stay (7.2+/-5.7 vs. 8.1+/-5.9 days, P=0.04), and fewer tests performed per patient (median 2.6 vs. 3.4, P=0.001) than the usual-care group. More standardized-care patients had a diagnosis of neurally mediated (65 vs. 46%, P=0.001) and orthostatic syncope (10 vs. 6%, P=0.002), whereas fewer had a diagnosis of pseudo-syncope (6 vs. 13%, P=0.001) or unexplained syncope (5 vs. 20%, P=0.001). The mean cost per patient and the mean cost per diagnosis were 19 and 29% lower in the standardized-care group (P=0.001). CONCLUSION: A standardized-care pathway significantly improved diagnostic yield and reduced hospital admissions, resource consumption, and overall costs.

Aged↗

Seven-year follow-up after catheter ablation of atrioventricular nodal re-entrant tachycardia.

BACKGROUND: Radiofrequency catheter ablation is considered to be a curative therapy for patients with atrioventricular nodal re-entrant tachycardia (AVNRT). Nevertheless, there is little information available with respect to long-term results and the consequences of catheter ablation. The present study aimed to assess the long-term results (a minimum of 5 years) and clinical events. PATIENTS AND METHODS: The recurrence rate of AVNRT, the development of late atrioventricular block and the presence of other arrhythmias (atrial flutter and fibrillation) were assessed in 131 consecutive patients who were undergoing catheter ablation between January 1992 and December 1998. RESULTS: During a mean follow-up of 7.2 +/- 2.5 years, tachycardia recurred in 13 patients (10%) after a median time of 6 months (interquartile range 4-24 months) and a second procedure was perfomed. Atrioventricular block occurred in two patients (1.5%) after 1 and 13 months. Atrial fibrillation recurred in seven (44%) of 16 patients in whom atrial fibrillation or flutter was present before ablation after a median of 12 months (interquartile range 9-15 months). Overall, all these events occurred after a median of 9 months (interquartile range 4-17 months). Subsequently, no event related to the arrhythmia or to the procedure was observed. A new onset atrial fibrillation, probably not related to AVNRT, occurred late in the follow-up in a further three patients. CONCLUSIONS: Arrhythmic events are not infrequent after catheter ablation of AVNRT during the early years after ablation, but they are unlikely during the subsequent long-term follow-up.

Adult↗

[Comparative study of results of catheter ablation in ventricular tachycardia of different etiologies].

BACKGROUND: The aim of this study was to assess long-term results and adverse events in patients with ventricular tachycardia from different etiologies. METHODS: The recurrence rate of tachycardia, consequent further therapies (other catheter ablation procedures, drug therapy and implantable defibrillator) and clinical events have been assessed in 60 consecutive patients undergoing ventricular tachycardia catheter ablation between January 2000 and December 2004. RESULTS: During a median follow-up of 20 months (interquartile range 13-36 months), tachycardia recurred in 27 patients (45%) after a median of 3 months (interquartile range 1-12 months). A second procedure was performed in 11 patients; it was successful in 8 patients. Four patients underwent pharmacological therapy which was successful in all cases. Overall, after ablation (> or =1 procedures) and pharmacological therapy, tachycardia was cured in 75% of cases. All the 20 patients without structural heart disease were cured with ablation vs. 62% of patients with heart disease (p = 0.001). Patients with dilated cardiomyopathy reported worst results (33% success, p = 0.03). Recurrences were predicted by acute failure of procedure (p = 0.05), presence of heart disease (p = 0.006) and history of atrial arrhythmias (p = 0.02). On a multivariate analysis, only structural heart disease continued to be an independent predictor of ventricular tachycardia recurrence. CONCLUSIONS: Catheter ablation of ventricular tachycardia has a high percentage of recurrences in patients with heart disease, whereas is curative in subjects without structural heart disease.

Adult↗

A new management of syncope: prospective systematic guideline-based evaluation of patients referred urgently to general hospitals.

AIMS: The guidelines of the European Society of Cardiology (ESC) define the current standard for the management of syncope, but are still incompletely applied in the clinical setting. METHODS AND RESULTS: Prospective systematic evaluation, on strict adherence to the guidelines, of consecutive patients referred for syncope to the emergency departments of 11 general hospitals. In order to maximize the application, a decision-making guideline-based software was used and trained core medical personnel were designated-both locally in each hospital and centrally-to verify adherence to the diagnostic pathway and give advice on its correction. A diagnostic work-up consistent with the guidelines was completed in 465/541 patients (86%). A definite diagnosis was established in 98% (unexplained in 2%): neurally mediated syncope accounted for 66% of diagnosis, orthostatic hypotension 10%, primary arrhythmias 11%, structural cardiac or cardiopulmonary disease 5%, and non-syncopal attacks 6%, respectively. The initial evaluation (consisting of history, physical examination, and standard electrocardiogram) established a diagnosis in 50% of cases. Hospitalization for the management of syncope was appropriate in 25% and was required for other reasons in a further 13% of cases. The median in-hospital stay was 5.5 days (interquartile range, 3-9). Apart from the initial evaluation, a mean of 1.9+/-1.1 appropriate tests per patient was performed in 193 patients and led to a final diagnosis in 182 of these (94%). CONCLUSION: The results of this study assess the current standard for the management of syncope on the basis of a rigorous adherence to guidelines of the ESC and provide a frame of reference for daily activity when dealing with syncope.

Aged↗

Relation of clinical presentation of syncope to the age of patients.

The aim of the study was to evaluate the effect of patient age on the clinical presentation of syncope and to establish the diagnostic value of clinical history in older patients. A total of 485 consecutive patients with unexplained syncope referred to secondary and tertiary hospitals were divided into 2 predefined age groups: 224 patients <65 years and 261 patients > or =65 years. The diagnostic criteria for the cause of syncope were developed before the beginning of the study. The clinical features of syncope were analyzed using a standard 46-item form. A cardiac cause of syncope was established in 27 younger (12%) and 89 older (34%) patients. A neurally mediated cause was established in 154 younger (68%) and 142 older (54%) patients. In patients > or =65 years, the clinical features of cardiac and neurally mediated syncope were very similar. The diagnosis of the cause of syncope was possible on the basis of the history alone in 26% younger and 5% older patients (p <0.0001). Myoclonic movements, effort syncope, and supine position during loss of consciousness were the most specific (97%, 99%, and 99%, respectively) diagnostic criteria for a cardiac cause of syncope in older patients, but, all together, they accounted for only 14% of patients. In conclusion, compared with younger patients, the medical history has a limited value in the diagnosis of the cause of syncope in older patients. The specificity of some features is high but these can be observed in only a minority of patients.

Adult↗

Proposed electrocardiographic classification of spontaneous syncope documented by an implantable loop recorder.

Uniform data from the literature show that the mechanism of syncope recorded by implantable loop recorder is extremely heterogeneous and a wide variety of rhythm disturbances is recorded at the time of syncope. Therefore, the proposed classification aims to group the observations into homogeneous patterns in order to define an acceptable standard useful for future studies and clinical practice.

Electrocardiography, Ambulatory↗

The usage and diagnostic yield of the implantable loop-recorder in detection of the mechanism of syncope and in guiding effective antiarrhythmic therapy in older people.

OBJECTIVES: To evaluate the usage and diagnostic yield of the implantable loop-recorder (ILR) in detection of the mechanism of syncope and in guiding therapy in patients aged >/=65 years and comparing them with those <65 years. DESIGN: This was a two-hospital, observational, prospective study in consecutive patients with unexplained syncope who underwent an ILR implantation. Between November 1997 and December 2002, a total of 2052 patients with syncope were evaluated (local population of 590,000 inhabitants). The diagnosis remained unexplained in 371 (18%). Of these, 103 patients (5% of the total, 28% of those with unexplained syncope) received an ILR. RESULTS: There were 70 (76%) patients aged >/=65 years and 25 (24%) <65 years. ILR implantation was 110 and 9 per million inhabitants per year, respectively. During a mean follow-up of 14+/-10 months, syncope was recorded in 52 patients. Compared with younger patients those older had a 2.7 higher syncope recurrence rate (56% vs 32%, P=0.03); arrhythmias were 3.1 times more likely to be responsible for syncope (44% vs 20%, P=0.03). More patients >/=65 years finally received ILR-guided therapy (42% vs 20%, P=0.04). Among the 29 patients (25 of those >/=65 years) who received specific antiarrhythmic therapy, only one (3%), had recurrence of syncope during the subsequent follow-up of 40+/-18 months. CONCLUSIONS: In patients referred for investigation of unexplained syncope, the older subjects are more likely to have an indication for ILR implantation than those younger, ILR has a higher diagnostic value, an arrhythmia is more likely to be detected and successfully treated.

Aged↗

Early EPS/ICD strategy in survivors of acute myocardial infarction with severe left ventricular dysfunction on optimal beta-blocker treatment. The BEta-blocker STrategy plus ICD trial.

AIMS: This multicentre prospective randomised trial was undertaken to evaluate the usefulness of an electrophysiological study (EPS)-guided/implantable cardioverter defibrillator (ICD) strategy in patients at high risk of sudden death (SD) early after myocardial infarction (MI). Previous studies have shown the benefits of such a strategy only in high-risk patients late after MI. METHODS AND RESULTS: We enrolled 143 survivors of acute MI (<1 month) with left ventricular ejection fraction < or = 35% and either frequent (> or =10/h) premature ventricular complexes (PVCs), or depressed heart rate variability (SDNN < 70 ms) or abnormal signal-averaged ECG, who were able to tolerate optimised beta-blocker therapy (68 +/- 40 mg/day of metoprolol). Of these, 138 were randomised, in a 2:3 ratio, to two therapeutic strategies: conventional (CONV) strategy (n = 59) or EPS-guided/ICD strategy (n = 79). The latter resulted in ICD implantation in 24 inducible patients and in CONV therapy in the remaining 55. During a mean follow-up of 540 +/- 378 days, 26 patients (19%) died: nine (6.5%) SD, nine (6.5%) non-SD, and four (3%) non-cardiac death; in four patients (3%) the cause of death was unknown. The actuarial overall mortality for the CONV and EPS-guided/ICD arms was 18% vs 14% after 1 year and 29.5% vs 20% after 2 years, respectively (P = 0.3 and 0.2). CONCLUSIONS: Despite optimal therapy, mortality remains significant in high-risk patients following MI. Although there is a trend in favour of EPS-guided/ICD, our data are insufficient to demonstrate a survival benefit of this strategy early after MI.

Adrenergic beta-Antagonists↗