ABSTRACT
INTRODUCTION: In patients with symptomatic permanent atrial fibrillation (PEAF) and narrow QRS, atrio-ventricular junction ablation (AVJA) plus cardiac resynchronization therapy (CRT) is superior to medical therapy in reducing heart failure (HF) hospitalization and all-cause mortality. To compare the mortality of a population of patients with HF, reduced EF (rEF), and PEAF treated with AVJA plus CRT with that of a contemporary cohort of patients in sinus rhythm (SR) with similar baseline characteristics. METHODS AND RESULTS: In this prospective, multicentre, observational study, all-cause mortality in a group of consecutive patients undergoing AVJA and implantable cardioverter-defibrillator (ICD) combined with CRT implantation for HFrEF, narrow QRS, and PEAF with uncontrolled ventricular rate was compared with that of a contemporary cohort of patients in SR undergoing ICD implantation (not combined with CRT) for HFrEF and narrow QRS. Individual 1:1 propensity matching of baseline characteristics was performed. A total of 824 patients were enrolled. Propensity matching yielded 107 matched pairs. After a median follow-up of 52 months, all-cause mortality was similar in patients treated with AVJA plus CRT and in the control group (p = .434). In AVJA plus CRT patients, mortality was significantly lower than in control group patients with a history of paroxysmal/persistent AF (n = 45, p = .020), and similar to that of patients without a history of AF (n = 62, p = .459). CONCLUSIONS: After adjustment for patient characteristics, the long-term prognosis of patients with HFrEF, narrow QRS, and PEAF who underwent AVJA plus CRT was similar to that of a population of patients in SR with similar characteristics.
Subject(s)
Atrial Fibrillation , Cardiac Resynchronization Therapy , Heart Failure , Ventricular Dysfunction, Left , Humans , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Heart Failure/diagnosis , Heart Failure/therapy , Heart Failure/etiology , Prospective Studies , Stroke Volume , Treatment Outcome , Ventricular Dysfunction, Left/therapyABSTRACT
INTRODUCTION: Comparison data on management of device-related complications and their impact on patient outcome and healthcare utilization between subcutaneous implantable cardioverter-defibrillator (S-ICD) and transvenous ICD (TV-ICD) are lacking. We designed this prospective, multicentre, observational registry to compare the rate, nature, and impact of long-term device-related complications requiring surgical revision on patient outcome and healthcare utilization between patients undergoing S-ICD or TV-ICD implantation. METHODS AND RESULTS: A total of 1099 consecutive patients who underwent S-ICD or TV-ICD implantation were enrolled. Propensity matching for baseline characteristics yielded 169 matched pairs. Rate, nature, management, and impact on patient outcome of device-related complications were analyzed and compared between two groups. During a mean follow-up of 30 months, device-related complications requiring surgical revision were observed in 20 patients: 3 in S-ICD group (1.8%) and 17 in TV-ICD group (10.1%; p = .002). Compared with TV-ICD patients, S-ICD patients showed a significantly lower risk of lead-related complications (0% vs. 5.9%; p = .002) and a similar risk of pocket-related complications (0.6 vs. 2.4; p = .215) and device infection (0.6% vs. 1.2%; p = 1.000). Complications observed in S-ICD patients resulted in a significantly lower number of complications-related rehospitalizations (median 0 vs. 1; p = .013) and additional hospital treatment days (1.0 ± 1.0 vs. 6.5 ± 4.4 days; p = .048) compared with TV-ICD patients. CONCLUSIONS: Compared with TV-ICD, S-ICD is associated with a lower risk of complications, mainly due to a lower risk of lead-related complications. The management of S-ICD complications requires fewer and shorter rehospitalizations.
Subject(s)
Defibrillators, Implantable , Defibrillators, Implantable/adverse effects , Humans , Patient Acceptance of Health Care , Prospective Studies , Reoperation , Treatment OutcomeABSTRACT
AIMS: To evaluate the risk of syncopal recurrences after pacemaker implantation in a population of patients with syncope of suspected bradyarrhythmic aetiology. METHODS AND RESULTS: Prospective, multicentre, observational registry enrolling 1364 consecutive patients undergoing pacemaker implantation for syncope of bradyarrhythmic aetiology (proven or presumed). Before pacemaker implantation, all patients underwent a cardiac work-up in order to establish the bradyarrhythmic aetiology of syncope. According to the results of the diagnostic work-up, patients were divided into three groups: Group A, patients in whom a syncope-electrocardiogram (ECG) correlation was established (n = 329, 24.1%); Group B, those in whom clinically significant bradyarrhythmias were detected without a documented syncope-ECG correlation (n = 877, 64.3%); and Group C, those in whom bradyarrhythmias were not detected and the bradyarrhythmic origin of syncope remained presumptive (n = 158, 11.6%). During a median follow-up of 50 months, 213 patients (15.6%) reported at least one syncopal recurrence. Patients in Groups B and C showed a significantly higher risk of syncopal recurrences than those in Group A [hazard ratios (HRs): 1.60 and 2.66, respectively, P < 0.05]. Failure to establish a syncope-ECG correlation during diagnostic work-up before pacemaker implantation was an independent predictor of syncopal recurrence on multivariate analysis (HR: 1.90; P = 0.002). CONCLUSION: In selecting patients with syncope of suspected bradyarrhythmic aetiology for pacemaker implantation, establishing a correlation between syncope and bradyarrhythmias maximizes the efficacy of pacing and reduces the risk of syncopal recurrences.
Subject(s)
Pacemaker, Artificial , Syncope, Vasovagal , Bradycardia/diagnosis , Bradycardia/therapy , Cardiac Pacing, Artificial , Electrocardiography , Follow-Up Studies , Humans , Prospective Studies , Recurrence , Syncope/diagnosis , Syncope/etiology , Syncope/therapy , Syncope, Vasovagal/therapy , Tilt-Table Test , Treatment OutcomeABSTRACT
AIMS: The aim of this study was to determine the long-term effects and determinants of success of cardiac pacing in patients affected by reflex syncope enrolled in the Syncope Unit Project 2 (SUP 2) study. Initial results have validated the effectiveness of a standardized guideline-based algorithm which can be used in clinical practice in order to select suitable candidates for cardiac pacing. METHODS AND RESULTS: In this prospective, multicentre, observational study, patients aged >40 years, affected by severe unpredictable recurrent reflex syncope, underwent carotid sinus massage (CSM), followed by tilt testing (TT) if CSM was negative, followed by implantation of an implantable loop recorder (ILR) if TT was negative. Those who had an asystolic response to one of these tests received a dual-chamber pacemaker. Of 281 patients who met the inclusion criteria, 137 (49%) received a pacemaker and were followed up for a mean of 26 ± 11 months: syncope recurred in 25 (18%) of them. At 3 years, the actuarial syncope recurrence rate was 20% [95% confidence interval (CI) 12-30] and was significantly lower than in 142 patients who did not receive a pacemaker and were observed by means of an ILR [43% (95% CI 29-57), P = 0.01]. The 3-year recurrence rate was not different among 78 CSM+, 38 TT+, and 21 ILR+ patients, whereas it was lower in 20 patients with negative TT [5% (95% CI 0-15)] than in 61 patients with positive TT [24% (95% CI 10-38)]. CONCLUSION: The benefit of cardiac pacing is maintained at 3 years, irrespective of the index diagnostic test, and is maximum in patients with negative TT. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01509534.
Subject(s)
Algorithms , Cardiac Pacing, Artificial/methods , Carotid Sinus/innervation , Pacemaker, Artificial , Reflex , Syncope, Vasovagal/therapy , Aged , Aged, 80 and over , Cardiac Pacing, Artificial/adverse effects , Equipment Design , Female , Humans , Italy , Male , Middle Aged , Patient Selection , Predictive Value of Tests , Prospective Studies , Recurrence , Severity of Illness Index , Syncope, Vasovagal/diagnosis , Syncope, Vasovagal/etiology , Syncope, Vasovagal/physiopathology , Tilt-Table Test , Time Factors , Treatment OutcomeABSTRACT
AIMS: Opinions differ regarding the effectiveness of cardiac pacing in patients affected by reflex syncope. We assessed a standardized guideline-based algorithm in different forms of reflex syncope. METHODS AND RESULTS: In this prospective, multi-centre, observational study, patients aged >40 years, affected by severe unpredictable recurrent reflex syncopes, underwent carotid sinus massage (CSM), followed by tilt testing (TT) if CSM was negative, followed by implantation of an implantable loop recorder (ILR) if TT was negative. Those who had an asystolic response to one of these tests received a dual-chamber pacemaker. POPULATION: 253 patients, mean age 70 ± 12 years, median 4 (3-6) syncopes, 89% without or with short prodromes. Of these patients, 120 (47%) received a pacemaker and 106 were followed up for a mean of 13 ± 7 months: syncope recurred in 10 (9%). The recurrence rate was similar in 61 CSM+ (11%), 30 TT+ (7%), and 15 ILR+ (7%) patients. The actuarial total syncope recurrence rate was 9% (95% confidence interval (CI), 6-12) at 1 year and 15% (95% CI, 10-20) at 2 years and was significantly lower than that observed in the group of 124 patients with non-diagnostic tests who had received an ILR: i.e. 22% (95% CI, 18-26) at 1 year and 37% (95% CI, 30-43) at 2 years (P = 0.004). CONCLUSION: About half of older patients with severe recurrent syncopes without prodromes have an asystolic reflex for which cardiac pacing goes along with a low recurrence rate. The study supports the clinical utility of the algorithm for the selection of candidates to cardiac pacing in everyday clinical practice. CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov. Unique identifier: NCT01509534.
Subject(s)
Algorithms , Cardiac Pacing, Artificial , Syncope/therapy , Aged , Electrocardiography, Ambulatory/instrumentation , Female , Humans , Male , Massage/methods , Prospective Studies , Secondary Prevention , Syncope/etiology , Syncope/prevention & control , Tilt-Table Test , Treatment OutcomeABSTRACT
AIMS: Little is known regarding the overall prevalence of syncope in a population of workers and the risk of occurrence during working time. METHODS AND RESULTS: A total of 452 consecutive workers (mean age: 46 ± 9 years) were invited to answer an anonymous questionnaire. They had been employed for 22 ± 10 years for a total of 9765 years worked. In the cohort, 160 subjects (35%) reported a total of 465 episodes of syncope during their lives; 64 (14%) suffered a syncopal episode after the start of employment, but only 26 (5.7%) reported syncope at work, 7 (1.5%) having had 2 episodes, and 1 (0.2%) 3 episodes (total: 36 episodes). The risk of syncope during work was 4.6 times higher for those who had a prior history of syncope [18 of 138 (13%)] than for those who did not [8 of 314 (3%), P = 0.001]. The occurrence of syncope during work for the patients with a history of syncope was one syncopal episode in every 99 years worked and for those who had already had an episode during work, one episode in every 16 years worked. Only one patient experienced minor trauma as a consequence of syncope during work and three were referred to the emergency department. All patients continued their employment without any problems. CONCLUSION: The prevalence of syncope during work is low and its impact is benign. The probability of syncope during work is higher for subjects with a history of syncope.
Subject(s)
Occupational Diseases/epidemiology , Syncope/epidemiology , Adult , Cross-Sectional Studies , Female , Health Surveys , Humans , Incidence , Italy/epidemiology , Male , Middle Aged , Occupational Diseases/diagnosis , Occupational Health , Prevalence , Risk Assessment , Risk Factors , Surveys and Questionnaires , Syncope/diagnosis , Time FactorsABSTRACT
BACKGROUND: Cardiac resynchronization therapy (CRT) with biventricular pacing (BVP) is a well-established therapy in patients with reduced left ventricular ejection fraction, heart failure, and left bundle branch block. Left bundle branch area pacing (LBBAP) has recently been shown to be a feasible and effective alternative to BVP. Comparative data on the risk of complications between LBBAP and BVP among patients undergoing CRT are lacking. OBJECTIVE: The aim of this study was to compare the long-term risk of procedure-related complications between LBBAP and BVP in a cohort of patients undergoing CRT. METHODS: This prospective, multicenter, observational study enrolled 668 consecutive patients (mean age 71.2 ± 10.0 years; 52.2% male; 59.4% with New York Heart Association class III-IV heart failure symptoms) with left ventricular ejection fraction 33.4% ± 4.3% who underwent BVP (n = 561) or LBBAP (n = 107) for a class I or II indication for CRT. Propensity score matching for baseline characteristics yielded 93 matched pairs. The rate and nature of intraprocedural and long-term post-procedural complications occurring during follow-up were prospectively collected and compared between the 2 groups. RESULTS: During a mean follow-up of 18 months, procedure-related complications were observed in 16 patients: 12 in BVP (12.9%) and 4 in LBBAP (4.3%) (P = .036). Compared with patients who underwent LBBAP, those who underwent BVP showed a lower complication-free survival (P = .032). In multivariate analysis, BVP resulted an independent predictive factor associated with a higher risk of complications (hazard ratio 3.234; P = .042). Complications related to the coronary sinus lead were most frequently observed in patients who underwent BVP (50.0% of all complications). CONCLUSION: LBBAP was associated with a lower long-term risk of device-related complications compared with BVP in patients with an indication for CRT.
Subject(s)
Bundle-Branch Block , Cardiac Resynchronization Therapy , Heart Failure , Propensity Score , Registries , Stroke Volume , Humans , Male , Female , Aged , Cardiac Resynchronization Therapy/methods , Cardiac Resynchronization Therapy/adverse effects , Heart Failure/therapy , Heart Failure/physiopathology , Prospective Studies , Bundle-Branch Block/therapy , Bundle-Branch Block/physiopathology , Stroke Volume/physiology , Treatment Outcome , Bundle of His/physiopathology , Follow-Up Studies , Ventricular Function, Left/physiologyABSTRACT
BACKGROUND: In Italy, the adoption of a total lockdown has generated almost total suspension of outpatient visits except for emergencies. Even after lockdown, the pandemic fear created additional barriers to access the health services. The aim of our study is to evaluate the economic impact of the lockdown for COVID-19 on public health in Italy, focusing on its effects on diabetic population. MATERIALS AND METHODS: We analyzed the impact of the lockdown on excess mortality and morbidity in the Italian diabetic population during 2020. The analysis was divided into several steps: a quantification of specialist visit reduction, the calculation of excess mortality in the diabetic population, the economic evaluation of the slowdown in the use of innovative diabetic therapies. Furthermore, the impact of the lockdown on the reduction of procedures and follow-up visits in diabetic population was evaluated. The overall impact of the pandemic and lockdown effects on costs and quality of life was then calculated. RESULTS: During 2020, a drop of 28% in patient access has been observed. Diabetic patients recorded a twice higher mortality value compared to general population (20.4% vs 10.2%). The analysis of market data revealed a slowdown in consumption of new antidiabetic therapies (-14%, 27% vs 41%). We estimated an expense of 26.6 million for NHS and a loss of 257 utilities in diabetic population due to the missed benefits related to slowdown in innovative antidiabetic drugs use and non-optimal follow-up and control of diabetes complications. In simulation scenarios, we also estimated an overall expenditure ranging from 38.7 to 94.0 million and a loss of 294-836 utilities. CONCLUSION: Diabetic population paid a high tribute to pandemic and lockdown, both in terms of number of deaths and burden of diabetic complications, together with an overall deterioration of quality of life.
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BACKGROUND: Few studies have examined the causes of syncope/collapse recurrences in patients with a previously implanted pacemaker for bradyarrhythmic syncope. OBJECTIVE: The purpose of this study was to assess the causes of syncope/collapse recurrences after pacemaker implantation for bradyarrhythmic syncope in a large patient population. METHODS: The SYNCOpal recurrences in patients treated with permanent PACing for bradyarrhythmic syncope (SYNCOPACED) registry was a prospective multicenter observational registry enrolling 1364 consecutive patients undergoing pacemaker implantation for bradyarrhythmic syncope. During follow-up, the time to the first syncope/collapse recurrence was recorded. Patients with syncope/collapse recurrences underwent a predefined diagnostic workup aimed at establishing the mechanism of syncope/collapse. RESULTS: During a median follow-up of 50 months, 213 patients (15.6%) reported at least 1 syncope/collapse recurrence. The risk of syncope/collapse recurrence was highest in patients who underwent implantation for cardioinhibitory vasovagal syncope (26.4%), followed by unexplained syncope and chronic bifascicular block (21.5%), cardioinhibitory carotid sinus syndrome (17.2%), atrial fibrillation needing pacing (15.5%), atrioventricular block (13.6%), and sinus node disease (12.5%) (P = .017). The most frequent cause of syncope/collapse recurrence was reflex syncope (27.7%), followed by orthostatic hypotension (26.3%), pacemaker or lead malfunction (5.6%), structural cardiac disease (5.2%), and atrial and ventricular tachyarrhythmias (4.7% and 3.8%, respectively). In 26.8% of cases, the mechanism of syncope/collapse remained unexplained. CONCLUSION: In patients receiving a pacemaker for bradyarrhythmic syncope, reflex syncope and orthostatic hypotension are the most frequent mechanisms of syncope/collapse recurrence after implantation. Pacing system malfunction, structural cardiac diseases, and tachyarrhythmias are rare mechanisms. The mechanism remains unexplained in >25% of patients.
Subject(s)
Cardiac Pacing, Artificial/methods , Heart Rate/physiology , Registries , Syncope/epidemiology , Aged , Chronic Disease , Female , Follow-Up Studies , Humans , Incidence , Italy/epidemiology , Male , Prospective Studies , Recurrence , Syncope/physiopathology , Syncope/therapyABSTRACT
OBJECTIVES: This study aimed to determine how CIED-related complications affect all-cause and cardiovascular mortality over a long-term follow-up. BACKGROUND: Although complications related to implantable electronic device (CIED) implantation are steadily increasing in Europe, little is known about the impact of complications other than device infection on mortality. METHODS: The POINTED (Impact on Patient Outcome and health care utilization of cardiac ImplaNTable Electronic Device complications) registry was a prospective, multicenter, observational study designed to collect data on complications in patients undergoing de novo CIED implantation (NCT03612635). All consecutive patients were enrolled in 6 high-volume centers between January 2010 and December 2012 and followed up for at least 3 years. A complication was defined as any CIED-related adverse event requiring surgical revision after implantation. RESULTS: During follow-up (median 56.9 months), we observed 283 complications in 263 of 2811 consecutive patients (71 ± 14 years of age, 66.7% men). Early complications (≤30 days) were associated with significantly lower cumulative survival from cardiovascular death in comparison with late complications and with freedom from complications. On multivariate analysis, early complication, pneumothorax, and pocket hematoma were significantly associated with a higher risk of all-cause death, while device infection remained the only complication significantly associated with a higher risk of cardiovascular death. CONCLUSIONS: All CIED-related complications are associated with an increased risk of cardiovascular mortality, and early complications are associated with an increased risk of all-cause mortality. These data underline the importance of specific measures aimed at reducing CIED complications and improving their management.
Subject(s)
Defibrillators, Implantable , Heart Diseases , Aged , Defibrillators, Implantable/adverse effects , Electronics , Female , Humans , Male , Prospective Studies , Registries , Treatment OutcomeABSTRACT
We aimed to assess the prevalence of and factors associated with anti- severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) positivity in a large population of adult volunteers from five administrative departments of the Liguria and Lombardia regions. A total of 3609 individuals were included in this analysis. Participants were tested for anti-SARS-CoV-2 antibodies [Immunoglobulin G (IgG) and M (IgM) class antibodies] at three private laboratories (Istituto Diganostico Varelli, Medical Center, and Casa della Salute di Genova). Demographic data, occupational or private exposure to SARS-CoV-2-infected patients, and prior medical history consistent with SARS-CoV-2 infection were collected according to a preplanned analysis. The overall seroprevalence of anti-SARS-CoV-2 antibodies (IgG and/or IgM) was 11.0% [398/3609; confidence interval (CI) 10.0%-12.1%]. Seroprevalence was higher in female inmates than in male inmates (12.5% vs. 9.2%, respectively, p = 0.002), with the highest rate observed among adults aged >55 years (13.2%). A generalized estimating equations model showed that the main risk factors associated with SARS-CoV-2 seroprevalence were the following: an occupational exposure to the virus [Odd ratio (OR) = 2.36; 95% CI 1.59-3.50, p = 0.001], being a long-term care facility resident (OR = 4.53; 95% CI 3.19-6.45, p = 0.001), and reporting previous symptoms of influenza-like illness (OR = 4.86; 95% CI 3.75-6.30, p = 0.001) or loss of sense of smell or taste (OR = 41.00; 95% CI 18.94-88.71, p = 0.001). In conclusion, we found a high prevalence (11.0%) of SARS-CoV-2 infection that is significantly associated with residing in long-term care facilities or occupational exposure to the virus. These findings warrant further investigation into SARS-CoV-2 antibody prevalence among the Italian population.
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BACKGROUND: In-hospital administration of flecainide and propafenone in a single oral loading dose has been shown to be effective and superior to placebo in terminating atrial fibrillation. We evaluated the feasibility and the safety of self-administered oral loading of flecainide and propafenone in terminating atrial fibrillation of recent onset outside the hospital. METHODS: We administered either flecainide or propafenone orally to restore sinus rhythm in 268 patients with mild heart disease or none who came to the emergency room with atrial fibrillation of recent onset that was hemodynamically well tolerated. Of these patients, 58 (22 percent) were excluded from the study because of treatment failure or side effects. Out-of-hospital self-administration of flecainide or propafenone--the "pill-in-the-pocket" approach--after the onset of heart palpitations was evaluated in the remaining 210 patients (mean age [+/-SD], 59+/-11 years). RESULTS: During a mean follow-up of 15+/-5 months, 165 patients (79 percent) had a total of 618 episodes of arrhythmia; of those episodes, 569 (92 percent) were treated 36+/-93 minutes after the onset of symptoms. Treatment was successful in 534 episodes (94 percent); the time to resolution of symptoms was 113+/-84 minutes. Among the 165 patients with recurrences, the drug was effective during all the arrhythmic episodes in 139 patients (84 percent). Adverse effects were reported during one or more arrhythmic episodes by 12 patients (7 percent), including atrial flutter at a rapid ventricular rate in 1 patient and noncardiac side effects in 11 patients. The numbers of monthly visits to the emergency room and hospitalizations were significantly lower during follow-up than during the year before the target episode (P<0.001 for both comparisons). CONCLUSIONS: In a selected, risk-stratified population of patients with recurrent atrial fibrillation, pill-in-the-pocket treatment is feasible and safe, with a high rate of compliance by patients, a low rate of adverse events, and a marked reduction in emergency room visits and hospital admissions.
Subject(s)
Anti-Arrhythmia Agents/therapeutic use , Atrial Fibrillation/drug therapy , Flecainide/therapeutic use , Heart Failure/complications , Propafenone/therapeutic use , Administration, Oral , Ambulatory Care , Anti-Arrhythmia Agents/administration & dosage , Anti-Arrhythmia Agents/adverse effects , Atrial Fibrillation/complications , Feasibility Studies , Female , Flecainide/administration & dosage , Flecainide/adverse effects , Follow-Up Studies , Heart Failure/physiopathology , Humans , Male , Middle Aged , Propafenone/administration & dosage , Propafenone/adverse effects , Prospective Studies , Self Administration , Stroke VolumeABSTRACT
OBJECTIVES: Most elderly patients affected by reflex vasodepressor syncope take one or more hypotensive drugs. The role of these drugs in causing syncope has not yet been established. We hypothesised that recurrence of syncope and presyncope can be reduced by discontinuing/reducing vasoactive therapy without increasing the risk of cardiovascular and neurological events. METHODS: This randomised, parallel, prospective, trial was conducted from January 2014 to March 2016 in four general hospitals. Of 328 initially screened participants, 58 patients (mean (SD) age 74±11â years) affected by vasodepressor reflex syncope, which was reproduced by tilt testing (n=54) or carotid sinus massage (n=4), were randomised to stop/reduce vasoactive therapy or to continue it. Primary end point was recurrence of syncope, presyncope or adverse events (defined as stroke, cerebral transient ischaemic attacks, worsening heart failure, myocardial infarction). RESULTS: Of 58 patients who were randomised, 55 completed the trial. After 1â month, systolic blood pressure was significantly higher in the 'stop/reduce' group than in the 'continue' group, in both supine (141±13â mmâ Hg vs 128±14â mmâ Hg; p=0.004) and standing (133±13â mmâ Hg vs 122±15â mmâ Hg; p=0.02) positions. During a mean follow-up of 13±7â months, the primary combined end point occurred in seven 'stop/reduce' patients (23%): three had syncope, three had presyncope and one had heart failure. Conversely, it occurred in 13 'continue' patients (54%): 10 had syncope, 2 had presyncope and 1 had cerebral transient ischaemic attack. The log-rank p value was 0.02 and the HR was 0.37 (95% CI 0.15 to 0.91). CONCLUSIONS: Recurrence of syncope and presyncope can be reduced by discontinuing/reducing vasoactive therapy in most elderly patients affected by reflex vasodepressor syncope. TRIAL REGISTRATION NUMBER: NCT01509534; EudraCT2013-004364-63; Results.
Subject(s)
Blood Pressure/drug effects , Cardiovascular System/innervation , Reflex/drug effects , Syncope, Vasovagal/prevention & control , Vasoconstrictor Agents/administration & dosage , Vasoconstrictor Agents/adverse effects , Aged , Aged, 80 and over , Drug Administration Schedule , Female , Hospitals, General , Humans , Italy , Male , Middle Aged , Posture , Prospective Studies , Recurrence , Syncope, Vasovagal/chemically induced , Syncope, Vasovagal/diagnosis , Syncope, Vasovagal/physiopathology , Tilt-Table Test , Treatment OutcomeABSTRACT
BACKGROUND: Syncope in patients with bifascicular block (BFB) is a common event whose causes might be difficult to assess. METHODS AND RESULTS: Prevention of syncope through permanent cardiac pacing in patients with bifascicular block (PRESS) is a multicenter, prospective, randomized, single-blinded study designed to demonstrate a reduction in symptomatic events in patients with bifascicular block and syncope of undetermined origin implanted with permanent pacemaker. Device programming mode (NASPE/BPEG code) at DDD with a lower rate of 60 ppm is compared with backup pacing at DDI with a lower rate of 30 ppm. The end point consisted of (1) syncope, (2) symptomatic presyncopal episodes associated with a device intervention (ventricular pacing), and (3) symptomatic episodes associated with intermittent or permanent atrioventricular block (any degree). One hundred one patients were enrolled and randomized. Primary end point events at 2 years were observed in 23 patients, with a significant lower incidence in the study group (hazard ratio, 0.32; 95% confidence interval [CI], 0.10-0.96; P=0.042). Reduction of any symptoms, associated or not with device intervention, was superior in DDD60 compared with DDI30 (hazard ratio, 0.4; 95% confidence interval, 0.25-0.78; P=0.0053). Fourteen patients developed other rhythm diseases and met class I indication for pacing. The annual incidence of rhythm disease development was 7.4%. CONCLUSIONS: In patients with bifascicular block and syncope of undetermined origin, the use of a dual chamber pacemaker programmed to DDD60 led to a significant reduction of syncope or symptomatic events associated with a cardioinhibitory origin, compared with DDI30 programming. Symptoms associated with a new onset of rhythm disease were found in 15% of the population at 2 years.
Subject(s)
Cardiac Pacing, Artificial/methods , Heart Block/therapy , Syncope/prevention & control , Aged , Aged, 80 and over , Cardiac Pacing, Artificial/adverse effects , Cardiac Pacing, Artificial/mortality , Equipment Design , Female , Heart Block/complications , Heart Block/diagnosis , Heart Block/mortality , Heart Block/physiopathology , Humans , Italy , Kaplan-Meier Estimate , Male , Pacemaker, Artificial , Proportional Hazards Models , Prospective Studies , Single-Blind Method , Syncope/diagnosis , Syncope/etiology , Syncope/mortality , Syncope/physiopathology , Time Factors , Treatment OutcomeABSTRACT
Recurrent neurally mediated syncope represents a common clinical event and a therapeutic challenge. Recently tilt training has been proposed for the treatment of recurrent neurally mediated syncope. To evaluate the efficacy of tilt training in preventing tilt-induced syncope and its feasibility, this controlled, randomized study was undertaken. Sixty-eight consenting patients (25 males and 43 females, mean age 40 +/- 19) with recurrent neurally mediated syncope and 2 consecutive positive nitroglycerin-potentiated head-up tilt tests were randomized to tilt training (35 patients) or no treatment (controls, 33 patients). The tilt training programme consisted of daily 30-min sessions of upright standing against a vertical wall 6 days a week for at least 3 weeks, until a reevaluation tilt test (3 patients of both groups dropped out). On this third head-up tilt test, 19 (59%) of 32 tilt trained patients and 18 (60%) of 30 controls still had a positive test. Treated patients performed a mean number of 15 +/- 7 sessions (median 16) and only 11 patients (34%) did all the programmed sessions. Only 1 patient (3%) discontinued treatment because of intolerance, while all other patients did not perform tilt training adequately, because of poor compliance. Thus, in our study tilt training was not effective in reducing tilt testing positivity rate in patients with neurally mediated syncope. Because of poor compliance, tilt training appears to be a feasible treatment only for highly motivated patients, but not for the majority of patients with recurrent neurally mediated syncope.