Fabrizio Ammirati

Development and prospective validation of a risk stratification system for patients with syncope in the emergency department: the OESIL risk score

AIMS Aim of the present study was the development and the subsequent validation of a simple risk classification system for patients presenting with syncope to the emergency departments. METHODS AND RESULTS A group of 270 consecutive patients (145 females, mean age 59.5 years) presenting with syncope to the emergency departments of six community hospitals of the Lazio region of Italy was used as a derivation cohort for the development of the risk classification system. Data from the baseline clinical history, physical examination and electrocardiogram were used to identify independent predictors of total mortality within the first 12 months after the initial evaluation. Multivariate analysis allowed the recognition of the following predictors of mortality: (1) age >65 years; (2) cardiovascular disease in clinical history; (3) syncope without prodromes; and (4) abnormal electrocardiogram. The OESIL (Osservatorio Epidemiologico sulla Sincope nel Lazio) score was calculated by the simple arithmetic sum of the number of predictors present in every single patient. Mortality increased significantly as the score increased in the derivation cohort (0% for a score of 0, 0.8% for 1 point; 19.6% for 2 points; 34.7% for 3 points; 57.1% for 4 points; p<0,0001 for trend). A similar pattern of increasing mortality with increasing score was prospectively confirmed in a second validation cohort of 328 consecutive patients (178 females; mean age, 57.5 years). CONCLUSIONS Clinical and electrocardiographic data available at presentation to the emergency department can be used for the risk stratification of patients with syncope. The OESIL risk score may represent a simple prognostication tool that could be usefully employed for the triage and management of patients with syncope in emergency departments.

Permanent Cardiac Pacing Versus Medical Treatment for the Prevention of Recurrent Vasovagal Syncope A Multicenter, Randomized, Controlled Trial

Background—This clinical investigation was performed to compare the effects of permanent dual-chamber cardiac pacing with pharmacological therapy in patients with recurrent vasovagal syncope. Methods and Results—Patients from 14 centers were randomized to receive either a DDD pacemaker provided with rate-drop response function or the &bgr;-blocker atenolol at the dosage of 100 mg once a day. Inclusion criteria were age >35 years, ≥3 syncopal spells in the preceding 2 years, and positive response to tilt table testing with syncope occurring in association with relative bradycardia. The primary outcome was the first recurrence of syncope after randomization. Enrollment was started in December 1997, and the first formal interim analysis was performed on July 30, 2000. By that time, 93 patients (38 men and 55 women; mean age, 58.1±14.3 years) had been enrolled and randomized, although follow-up data were available for all patients (46 patients in the pacemaker arm, 47 patients in the pharmacological arm). The interim analysis showed a significant effect in favor of permanent cardiac pacing (recurrence of syncope in 2 patients [4.3%] after a median of 390 days) compared with medical treatment (recurrence of syncope in 12 patients [25.5%] after a median of 135 days; OR, 0.133; 95% CI, 0.028 to 0.632;P =0.004). Consequently, enrollment and follow-up were terminated. Conclusions—DDD pacing with rate-drop response function is more effective than &bgr;-blockade for the prevention of syncopal recurrences in highly symptomatic vasovagal fainters with relative bradycardia during tilt-induced syncope.

Do European GSM Mobile Cellular Phones Pose a Potential Risk to Pacemaker Patients

BARBARO, V., et al.: Do European GSM Mobile Cellular Phones Pose a Potential Risk to Pacemaker Patients? A series of in vivo trials were carried out in order to verify whether the electromagnetic field radiated by GSM (Groupe Systemes Mobiles) mobile cellular phones might affect implanted pacemakers. Two European GSM phones of 2‐watt power were tested and trials conducted on 101 pacemaker implanted outpatients attending day hospital for routine check‐up, who volunteered for trials. Forty‐three pacemaker models from 11 manufacturers were tested in all. When the sensing threshold of the pacemakers was set at a minimum and the antenna of the phone was in direct contact with the patients chest, interference was detected for 26 implanted pacemakers. Specifically, pulse inhibition in 10 of 101 cases, ventricular triggering in 9 of 46 DDD‐VDD pacemakers, and asynchronous pacing in 4 of 52 devices. Pulse inhibition was also observed combined with asynchronous pacing in 1 of 52 cases and with ventricular triggering in 2 of 46 cases. Minimum effect duration was ca. 3 seconds but in 6 cases effects continued as long as the interfering GSM signal was on. No permanent malfunctioning or changes in the programmed parameters were detected. Whenever interference was detected, trials were repeated to determine the maximum sensing threshold at which interference persisted (with the antenna in contact with the skin over the pacemaker). Then maximum distance between antenna and pacemaker at which interference occurred was determined at pacemaker maximum and minimum sensing threshold. Under our experimental conditions electromagnetic interference effects were detected at a maximum distance of 10 cm with the pacemaker programmed at its minimum sensing threshold. When the phone antenna was in direct contact with patients skin over the implant, electromagnetic interference effects occurred at maximum ventricular and atrial sensing thresholds of 4 mV and 2.5 mV, respectively.

Prospective multicentre systematic guideline-based management of patients referred to the Syncope Units of general hospitals

AIMS Although an organizational model for syncope management facilities was proposed in the 2004 guidelines of the European Society of Cardiology (ESC), its implementation in clinical practice and its effectiveness are largely unknown. METHODS AND RESULTS This prospective study enrolled 941 consecutive patients referred to the Syncope Units of nine general hospitals from 15 March 2008 to 15 September 2008. A median of 15 patients per month were examined in each unit, but the five older units had a two-fold higher volume of activity than the four newer ones (instituted <1 year before): 23 vs. 12, P = 0.02. These figures give an estimated volume of 163 and 60 patients per 100,000 inhabitants per year, respectively. Referrals: 60% from out-of-hospital services, 11% immediate and 13% delayed referrals from the Emergency Department, and 16% hospitalized patients. A diagnosis was established on initial evaluation in 191 (21%) patients and early by means of 2.9 +/- 1.6 tests in 541 (61%) patients. A likely reflex cause was established in 67%, orthostatic hypotension in 4%, cardiac in 6% and non-syncopal in 5% of the cases. The cause of syncope remained unexplained in 159 (18%) patients, despite a mean of 3.5 +/- 1.8 tests per patient. These latter patients were older, more frequently had structural heart disease or electrocardiographic abnormalities, unpredictable onset of syncope due to the lack of prodromes, and higher OESIL and EGSIS risk scores than the other groups of patients. The mean costs of diagnostic evaluation was 209 euro per outpatient and 1073 euro per inpatient. The median cost of hospital stay was 2990 euro per patient. CONCLUSION We documented the current practice of syncope management in specialized facilities that have adopted the management model proposed by the ESC. The results are useful for those who wish to replicate this model in other hospitals. Syncope remains unexplained during in-hospital evaluation in more complex cases at higher risk.

Head-up tilt testing potentiated with low-dose sublingual isosorbide dinitrate : a simplified time-saving approach for the evaluation of unexplained syncope

BACKGROUND Head-up tilt testing is widely used in the clinical assessment of patients with unexplained syncope. However, the lack of a standard methodology and the conflicting results concerning sensitivity and specificity of the procedure have prompted further studies to define a more cost-effective approach for tilt testing. OBJECTIVES Our clinical investigation was undertaken to assess the diagnostic value in unexplained syncope of a simple and time-saving protocol for head-up tilt testing, including low-dose sublingual isosorbide dinitrate administration. PATIENTS AND METHODS A group of 73 consecutive patients (43 women and 30 men, mean age 39.6+/-21.8 years) with unexplained syncope despite conventional clinical cardiovascular and neurologic assessment and 10 asymptomatic control subjects underwent head-up tilt testing with isosorbide dinitrate challenge. Participants were tilted at 60 degrees for 30 minutes without medication; if no symptoms occurred, 1.25 mg of isosorbide dinitrate was administered sublingually and tilting was continued for an additional 15 minutes. RESULTS During the drug-free phase of the test 14 (19.2%) patients had syncope. After isosorbide dinitrate administration syncope occurred in another 28 patients (38.3%); minor symptoms in association with hypotension developed in 10 (13.7%) patients. The test result was negative in all control subjects. The positive rate and specificity of head-up tilt testing with isosorbide dinitrate provocation were 57.5% and 100%, respectively. CONCLUSIONS This new practical diagnostic procedure was found to be fairly sensitive and clearly specific in inducing a vasovagal reflex in patients with syncope of uncertain origin. Consequently, such approach could give a significant contribution in the diagnostic workup of these patients.

Management of syncope: clinical and economic impact of a Syncope Unit

AIMS Aim of this observational study is to evaluate the clinical performance of a Syncope Unit, in order to assess whether the implemented organization really improves syncope management. METHODS AND RESULTS The study enrolled patients with unexplained syncope who were consecutively referred to our Syncope Unit, either as outpatients or during hospitalization, in a 2-month period. The design of this observational study consists in three phases: a retrospective analysis of their clinical management in the 9 months prior to the first attendance at the Syncope Unit (phase one), their subsequent clinical management in the Syncope Unit (phase two) and a 9-month follow-up (phase three). The retrospective analysis of phase one showed that 25% of patients had already been hospitalized without diagnosis. After Syncope Unit evaluation, diagnosis was obtained in 82% of patients, with 15% of patients indicated to pacing. In the follow-up, 23% of patients experienced a syncopal recurrence. Our analysis indicated an 85% reduction of hospital costs in the follow-up period. CONCLUSION The clinical and economic analysis of the three phases of our study demonstrates that a Syncope Unit allows an improved management of patients with syncope.

Transthoracic DC Shock May Represent a Serious Hazard in Pacemaker Dependent Patients

External defibrillation is widely used for the termination of various atrial and ventricular tachyarrhythmias, including pacemaker patients. Our study was intended to evaluate the effects of DC shocks in 36 patients with unipolar pacemakers implanted in the right pectoral region (25 DDD, 10 VVI, 3 AAI). The shocks were delivered with paddles on the anterior surface of the thorax, as far as possible away from the pacemaker. The pacing output was programmed at 0.5 msec and 5 V (25 patients), 4 V (1 patient), and 2.5 V (10 patients). Transient loss of capture occurred in 18 patients (50%). These patients, compared with those without capture failure, received higher peak and cumulative shock energies, respectively, 216 ± 99 versus 123 ± 50 joules (P < 0.002) and 352 ± 62 versus 147 ± 98 joules (P < 0.004) and had a lower pacemaker pulse amplitude (4.0 ± 1.2 vs 4.6 ± 1.0 V, P = 0.11). Failure to capture lasted from 5 seconds to 30 minutes (mean 157 sec). In 15 patients the ventricular stimulation threshold was measured before and serially after cardioversion. A six‐fold threshold increase was observed 3 minutes after the shock (P < 0.004) with gradual recovery to nearly baseline values at 24 hours. Transient sensing failure occurred in 7 of the 17 patients in whom it could be evaluated (41%). Furthermore, three cases of shock induced pacemaker malfunctions were observed requiring replacement of the stimulator in two patients. In conclusion, the incidence of loss of capture in pacemaker patients subjected to electrical cardioversion/defibrillation is high. The phenomenon is due to an abrupt rise in stimulation threshold, caused by the electrical shock, and may represent a serious hazard in pacemaker dependent patients. The risk of pacing failure could be reduced by utilizing low shock energies when possible, and by programming the pacemaker at its maximal output before cardioversion.

Diagnosis, management, and outcomes of patients with syncope and bundle branch block

Aims Although patients with syncope and bundle branch block (BBB) are at high risk of developing atrio-ventricular block, syncope may be due to other aetiologies. We performed a prospective, observational study of the clinical outcomes of patients with syncope and BBB following a systematic diagnostic approach. Methods and results Patients with ≥1 syncope in the last 6 months, with QRS duration ≥120 ms, were prospectively studied following a three-phase diagnostic strategy: Phase I, initial evaluation; Phase II, electrophysiological study (EPS); and Phase III, insertion of an implantable loop recorder (ILR). Overall, 323 patients (left ventricular ejection fraction 56 ± 12%) were studied. The aetiological diagnosis was established in 267 (82.7%) patients (102 at initial evaluation, 113 upon EPS, and 52 upon ILR) with the following aetiologies: bradyarrhythmia (202), carotid sinus syndrome (20), ventricular tachycardia (18), neurally mediated (9), orthostatic hypotension (4), drug-induced (3), secondary to cardiopulmonary disease (2), supraventricular tachycardia (1), bradycardia–tachycardia (1), and non-arrhythmic (7). A pacemaker was implanted in 220 (68.1%), an implantable cardioverter defibrillator in 19 (5.8%), and radiofrequency catheter ablation was performed in 3 patients. Twenty patients (6%) had died at an average follow-up of 19.2 ± 8.2 months. Conclusion In patients with syncope, BBB, and mean left ventricular ejection fraction of 56 ± 12%, a systematic diagnostic approach achieves a high rate of aetiological diagnosis and allows to select specific treatment.

DDD Pacing with Rate Drop Response Function Versus DDI with Rate Hysteresis Pacing for Cardioinhibitory Vasovagal Syncope

Background: The effectiveness of cardiac pacing in preventing vasovagal syncope remains controversial. However, DDI pacing with rate hysteresis has been reported to prevent the recurrence of Cardioinhibitory vasovagal syncope in up to 35% of affected subjects and to reduce the overall incidence of syncopal episodes in the others. Recently, DDD pacing with a new promising rate drop response function (Medtronic Thera‐I model 7960) has become available in clinical practice. Aim of the study: The aim of the present open trial was to test the effectiveness of this new pacing modality in patients with Cardioinhibitory vasovagal syncope. Study population and methods: The study population included 20 patients (12 males and 8 females; mean age 61.1 ± 14 yrs) with recurrent syncope (mean number of prior episode = 6.8, range 5–11) and Cardioinhibitory responses during two head‐up tilt tests: the first diagnostic and the second during drug therapy with either β‐blockade or etilephrine. The study patients were randomized to receive either DDI pacing with rate hysteresis (8 patients) or DDD pacing with rate drop response function (11 patients). The head‐up tilt test performed 1 month after pacemaker implantation was positive in 3 of 12 patients (25%) with DDD pacing with rate drop response function and in 5 of 8 patients (62.5%) with DDI pacing with rate hysteresis. The mean duration of follow‐up was 17.7 ± 7.4 months. During follow‐up no patients with a DDD pacemaker with rate drop response function had syncope, while 3 of 8 patients with a DDI pacemaker with rate hysteresis had recurrence of syncope (P < 0.05). Conclusions: These data suggest that DDD pacing with rate drop response function is effective in Cardioinhibitory vasovagal syncope and may be preferable to DDI pacing with rate hysteresis.

Local Capture by Atrial Pacing in Spontaneous Chronic Atrial Fibrillation

BACKGROUND Atrial fibrillation (AF) is considered to be maintained by multiple reentrant circuits without or with a very short excitable gap. However, the possibility of local atrial capture has been shown recently in experimental AF or induced AF in humans. METHODS AND RESULTS This study was undertaken to evaluate the feasibility of atrial capture-suggestive of an excitable gap-in spontaneous chronic AF. Decremental pacing was performed in 47 right atrial sites in 14 patients with chronic AF, not taking antiarrhythmic drugs. A Franz catheter (for pacing and monophasic action potential recording) and a recording quadripolar catheter positioned about 10 mm apart were used. Local capture was achieved in 41 (87.2%) sites for a total of 100 captures. In 71 episodes the capture was lost within 15 seconds, while in the remaining 29, pacing was stopped after 15 seconds of stable capture. AF types immediately before capture were type 1 in 83 and type 2 in 17 episodes. Type 3 AF was never captured. Pacing cycle at capture was 175.7 +/- 20.9 ms. The baseline atrial interval (FF) was 185.4 +/- 24.5, significantly longer than the FF recorded during pacing immediately before capture (176.0 +/- 19.8 ms) (P < .02). CONCLUSIONS During spontaneous chronic AF in humans, (1) local capture by atrial pacing is possible up to at least 15 mm from the pacing site, (2) regional entrainment is possible during type 1 and type 2 AF but not type 3 AF, and (3) pacing before capture accelerates AF, probably by transient or local capture. These findings suggest that an excitable gap is present in chronic AF, therefore supporting the hypothesis that leading circle reentry is not the unique electrophysiological mechanism maintaining the arrhythmia.