Findings of an observational investigation of pure remote follow-up of pacemaker patients: is the in-clinic device check still needed?

BACKGROUND: Device follow-up is mandatory in the care of patients with a pacemaker. However, in most cases, device checks appear to be mere technical, time-consuming procedures. The aim of this research is to evaluate whether remote follow-up can replace in-clinic device checks by assessing clinical outcomes for pacemaker patients followed only via remote follow-up. METHODS AND RESULTS: Consecutive pacemaker patients followed with remote monitoring were prospectively included by 6 Italian cardiology centers in an observational investigation. The workflow for remote monitoring included an initial assessment by nursing staff and, when necessary, by a responsible physician for medical decisions. No in-person visits were scheduled after the start of remote monitoring. One-thousand and two-hundred and fifty one patients (30% female, 75±11years old) were followed for a median observation period of 15months. Out of 4965 remote transmissions, 1882 (38%) had at least one clinically relevant event to be investigated further, but, only after 137 transmissions (2.8%), the patients were contacted for an in-clinic visit or hospitalization. Sixty-nine patients died and 124 were hospitalized for various reasons. Atrial fibrillation episodes were the most common clinical events discovered by remote transmissions, occurring in 1339 (26%) transmissions and 471 (38%) patients. CONCLUSIONS: Our experience shows that remote monitoring in a pacemaker population can safely replace in-clinic follow-up, avoiding unnecessary in-hospital device follow-up.

Psychological profile in children and adolescents with severe course Juvenile Idiopathic Arthritis.

OBJECTIVE: Juvenile Idiopathic Arthritis (JIA) is the most common chronic pediatric rheumatic disease. It is recognized that only reliance on clinical signs of disease outcome is inadequate for understanding the impact of illness and its treatment on child's life and functioning. There is a need for a multidisciplinary and holistic approach to children with arthritis which considers both physical and emotional functioning. This study investigated the psychosocial functioning of children and adolescent with JIA and the disease-related changes in their family. METHODS: The sample consisted of 33 hospitalized patients, aged 6-16 years. Both parents and the children were given a number of questionnaire to fill out. Clinical information was extracted from the interviews. RESULTS: Self-reported psychological functioning (depression, anxiety, and behavior) was not different from the normal population; however significant psychological suffering was detected by the clinical interview. CONCLUSIONS: Children and adolescents with JIA do not show overt psychopathology by structured assessment; nevertheless a more clinically oriented holistic approach confirms JIA as a disrupting event causing relevant changes in the quality of life of the affected families.

Rem sleep brady-arrhythmias: an indication to pacemaker implantation?

OBJECTIVES: Important adjustments in the autonomic nervous system occur during sleep. Bradycardia, due to increased vagal tone, and hypotension, caused by reduction of sympathetic activity, may occur during non rapid eye movement (REM) sleep (NREM). Increased sympathetic activity, causing increased heart rate, is conversely a feature of phasic REM sleep. During REM sleep, sinus arrests and atrioventricular (AV) blocks unrelated to apnea or hypopnea have been described. These arrhythmias are very rare and only a few cases have been reported in the literature. PATIENTS/METHODS: Following an ECG performed for other reasons, two patients with no history of sleep complaints nor symptoms of heart failure or heart attack were referred to our center for nocturnal brady-arrhythmias. RESULTS: 24h ECG Holter recorded several episodes of brady-arrhythmia with sinus arrest in the first patients and brady-arrhythmias with complete AV block in the second patient. In both patients, episodes of brady-arrhythmia were prevalent in the second part of the night. Nocturnal polysomnography (PSG) demonstrated that episodes occurred only during REM sleep, particularly during phasic events. Treatment with pacemaker was considered only for the patient with complete AV blocks. CONCLUSIONS: These types of brady-arrhythmias are usually detected accidentally due to their lack of symptoms. It has been suggested that in some patients they may lead to sudden unexpected death. Thus, the identification of predisposing factors is mandatory in order to prevent potentially dangerous arrhythmic events.

Indications for dual-chamber cardioverter defibrillators at implant and at 1 year follow-up: a retrospective analysis in the single-chamber defibrillator era.

AIM: This retrospective four-centre study assessed the current indications for dual-chamber implantable cardioverter defibrillators (ICDs) at implant and during a medium-term follow-up period in a group of patients treated by single-chamber ICD in the pre dual-chamber ICD era. METHODS AND RESULTS: The study population consisted of 153 consecutive patients (127 males, mean age 58 +/- 6 years) treated by single-chamber ICD for ventricular tachycardia and/or ventricular fibrillation. Definite indications for having a dual-chamber ICD included the presence of sinus node dysfunction and of second- or third-degree atrioventricular (AV) block, while possible indications were represented by paroxysmal atrial fibrillation or flutter and first-degree AV block. At implant, dual-chamber ICD would appear definitely indicated in 10.5% of cases, and possibly indicated in an additional 17.5% of cases. During 12 +/- 10 months follow-up, such percentages remained stable (11 and 19.5%, respectively). Inappropriate ICD intervention was documented in five of 13 patients (38%), with episodes of paroxysmal atrial fibrillation or flutter. CONCLUSION: In this non-selected study population, a dual-chamber ICD would have potentially benefited approximately 30% of the patients. During medium-term follow-up, there was no progression towards increasing dual-chamber ICD indications. The 15% cumulative incidence of paroxysmal atrial tachyarrhythmias justifies the activation of dedicated detection algorithms.

Safety of pacemaker implantation prior to radiofrequency ablation of atrioventricular junction in a single session procedure.

RF current delivery may cause acute and chronic dysfunction of previously implanted pacemakers. The aim of this study was to assess prospectively the effects of RF energy on Thera I and Kappa pacemakers in 70 consecutive patients (mean age 70 +/- 11 years, mean left ventricular ejection fraction 48 +/- 15%) who underwent RF ablation of the AV junction for antiarrhythmic drug refractory atrial fibrillation (permanent in 42 patients, paroxysmal in 28). These pacing systems incorporate protection elements to avoid electromagnetic interference. The pacemakers (Thera DR 7960 I in 20 patients, Thera SR 8960 I in 30, Kappa DR 600-601 in 8, Kappa SR 700-701 in 12) were implanted prior to RF ablation in a single session procedure and were transiently programmed to VVI mode at a rate of 30 beats/min. Capsure SP and Z unibipolar leads were used. During RF application there was continuous monitoring of three ECG leads, endocavitary electrograms, and event markers. Complete AV block was achieved in all cases after 3.6 +/- 2.9 RF pulses and 100 +/- 75 seconds of RF energy delivery. The mean time of pacemaker implantation and RF ablation was 60 +/- 20 minutes. Transient or permanent pacemaker dysfunction including under/oversensing, reversion to a "noise-mode" pacing, pacing inhibition, reprogramming, or recycling were not observed. Leads impedance, sensing, and pacing thresholds remained in the normal range in the acute and long-term phase (average follow-up 18 +/- 12 months). In conclusion, Thera I and Kappa pacemakers exhibit excellent protection against interference produced by RF current. The functional integrity of the pacemakers and Capsure leads was observed in the acute and chronic phases. Thus, the implantation of these pacing systems prior to RF ablation of the AV junction can be recommended.

Radiofrequency ablation of atrioventricular junction and pacemaker implantation versus modulation of atrioventricular conduction in drug refractory atrial fibrillation.

Modulation of atrioventricular (AV) node conduction and radiofrequency ablation of AV junction are alternative approaches to control ventricular rate in drug refractory atrial fibrillation (AF). In 2 centers, 120 patients were treated either with AV junction ablation (center 1, group 1, 60 patients [30 men, aged 64 +/- 11 years], paroxysmal AF in 24 patients) or with modulation (group 2, 60 patients [32 men, aged 58 +/- 12 years], paroxysmal AF in 43 patients). In group 1, complete AV block was achieved in all patients. In group 2, the procedure was performed in sinus rhythm (30 patients), prolonging the Wenckebach cycle length from 328 +/- 85 to 466 +/- 80 ms (p <0.01) or during AF (30 patients), decreasing ventricular rate from 178 +/- 35 to 96 +/- 35 beats/min (p <0.01), and to <100 beats/min in 17 patients (61%). Complete AV block was induced in 9 of 60 patients (15%). In groups 1 and 2, at a follow-up of 27 +/- 7 and 26 +/- 6 months, there were 2 deaths (1 cardiac, 1 sudden death) and 1 death for end-stage heart failure, respectively. Hospital readmissions decreased from 3.2 to 0.2 and from 4.2 to 0.2/year; late AF recurrences at of >120 beats/min were documented in 6% and 12%, respectively. Symptom score analysis including effort and rest dyspnea, exercise intolerance, weakness, and palpitation showed a significant improvement in both treatment groups, when acutely effective, in patients with paroxysmal and/or chronic AF. In conclusion, ablation of the AV junction shows a higher acute success rate compared with modulation of the AV node conduction in patients with drug refractory AF. Depending on the acute success, both approaches therefore were similarly effective in achieving long-term ventricular rate control and symptom score improvement.

Asymptomatic superior vena caval occlusion: a complication of nonthoracotomy implantation of cardioverter defibrillator.

A patient with ischemic dilated cardiomyopathy and history of ventricular fibrillation received an implantable cardioverter defibrillator by the nonthoracotomy approach. Four years later, during elective replacement of an exhausted pulse generator, a superior vena caval thrombotic occlusion with collateral circulation through the azygos and emiazygos vein systems was documented. This occlusion occurred despite an anticoagulant treatment in the standard therapeutic range. We speculate that thrombotic occlusion might be secondary to a mechanical vessel injury.

[Recurrent ventricular fibrillation, right bundle-branch block and persistent ST segment elevation in V1-V3: a new arrhythmia syndrome? A clinical case report]. / Fibrillazione ventricolare recidivante, blocco di branca destra, persistente sopraslivellamento del tratto ST in V1-V3: una nuova sindrome aritmica? Descrizione di un caso clinico.

In this report we describe a patient with a rare arrhythmic syndrome, recently reported and characterized by aborted sudden death, right bundle branch block and persistent ST segment elevation in precordial leads. The patient is a 65-year-old man, who had survived recurrent episodes of ventricular fibrillation (VF). The ECG during sinus rhythm revealed the coexistence of right bundle branch block and persistent ST segment elevation (1-4 mm) in leads V1-V3. The clinical and laboratory investigations, including echocardiography, cardiac catheterization and right endomyocardial biopsy, could not identify any significant morphological and functional cardiac abnormalities. The presence of late potentials (high gain ECG), and the inducibility of VF during the electrophysiological study, suggest a functional reentry as arrhythmogenic substratum. During a 60-month follow-up period, high-dose amiodarone per os, and subsequent AICD therapy successfully treated recurrent VF episodes. This clinical case confirms the existence of a new idiopathic malignant arrhythmic syndrome. Aggressive antiarrhythmic therapy seems fundamental in this type of patients.

Risk stratification and prognosis of patients treated with amiodarone for malignant ventricular tachyarrhythmias after myocardial infarction.

Seventy-seven consecutive patients (mean age 62 years) with episodes of sustained ventricular tachycardia (VT) or ventricular fibrillation (VF) after acute myocardial infarction (AMI) were evaluated to assess the long-term efficacy of first-line amiodarone treatment and to identify clinical and laboratory factors associated with a high risk of death or arrhythmia recurrence. The presenting arrhythmia was VT in 41 cases (53%) and VF in 36 (47%). VT or VF occurred between the 4th and 90th day after AMI in 45 cases (58%) and later (more than 90 days) in the remaining 32 (42%). The mean number of arrhythmic episodes was 4.2. Forty patients (52%) were in New York Heart Association (NYHA) class I or II, and 37 (48%) were in class III or IV. Mean left ventricular ejection fraction was 32%; ventricular aneurysm was present in 41 subjects. Most patients had multivessel coronary artery disease. Amiodarone was administered as a first-choice drug in all patients, in combination with other antiarrhythmic drugs in 14. By ventricular stimulation after loading doses of amiodarone, sustained VT was inducible in 46 (62%) and noninducible in 28 (38%). During a mean follow-up of 28 months the incidence of cardiac mortality at 1, 3, and 5 years was 21%, 37%, and 47%; of sudden death was 7%, 19%, and 23%; of nonfatal VT recurrence was 13%, 13%, and 24%, respectively. The overall incidence of amiodarone side effects was 35%.2+ was a weak predictor only by univariate analysis (p = 0.05).(ABSTRACT TRUNCATED AT 250 WORDS)

[Malignant ventricular arrhythmias in the subacute and late phases of myocardial infarction. Clinical arrhythmological characteristics and prognostic value]. / Contributo allo studio delle aritmie ventricolari maligne nella fase subacuta e tardiva dell'infarto miocardico. Caratteristiche clinico-aritmologiche e significato prognostico.

The purposes of this study are as follows: 1) to describe the clinical and arrhythmological characteristics of 30 patients (23 male, 7 female, mean age: 61 years) who suffered from episodes of ventricular tachycardia and/or ventricular fibrillation between the 7th and the 90th day following acute myocardial infarction; 2) to evaluate the effectiveness of treatment with amiodarone also taking into account the results of electrophysiologic study; 3) to correlate our results with data from previous studies. The site of the acute myocardial infarction was anterior in 16 patients, inferior in 12, and anterior and inferior in 2. Twenty patients had early post-acute myocardial infarction complications (67%) such as cardiac failure (16), bundle branch blocks (9) and ventricular fibrillation in the first 48 hours (6). The mean ejection fraction was 33 +/- 8% and a left ventricular aneurysmatic evolution was observed in 13 patients (43%). The first episodes of spontaneous ventricular arrhythmias occurred after a mean interval of 32 +/- 24 days following acute myocardial infarction. These occurred in the form of ventricular fibrillation in 19 patients (63%) and of ventricular tachycardia in the other 11 (37%). The patients experienced 5.6 +/- 5 episodes of ventricular fibrillation or ventricular tachycardia. Of the 30 patients, 28 received amiodarone, 1 procainamide and 1 propafenone. Five of the 28 patients treated with amiodarone were also given either procainamide or propafenone due to the early recurrence of ventricular tachycardia or fibrillation. One patient underwent early left ventricular aneurysmatic resection due to refractory ventricular fibrillation. Two groups of patients were distinguished on the basis of the electrophysiologic study results obtained during anti-arrhythmic treatment: group A consisted of 17 cases in which a sustained ventricular tachycardia was inducible (57%), group B consisted of 13 cases in which a sustained ventricular tachycardia was not inducible (43%). During a mean follow-up period of 31.6 +/- 26 months the total mortality rate was 23% in group A and 46% in group B (p = ns), the incidence of sudden death was 17% in group A and 23% in group B (p = ns), the incidence of non fatal ventricular tachycardia or ventricular fibrillation recurrences was 24% in group A and 0% in group B (0.05 less than p less than 0.1). One group A patient successfully underwent a heart transplant. The negative predictive value of ventricular stimulation in relation to sudden death and to non-fatal arrhythmic recurrences was 77% and 100%; the positive predictive value was 17 and 28%.(ABSTRACT TRUNCATED AT 400 WORDS)

[Syncope of unknown origin after electrophysiologic study: is the treatment with pacemaker useful?]. / Sincope di incerta origine dopo studio elettrofisiologico: è utile il trattamento con pacemaker?

The usefulness of pacemaker treatment appears doubtful in patients suffering from syncope of unknown origin after a complete diagnostic evaluation, which includes electrophysiological study. To better assess the effectiveness of this therapy, 24 patients with syncope of unknown origin and negative electrophysiological study were prospectively and alternatively assigned to treatment with pacemaker (group A) vs treatment without pacemaker (group B). Group A included 12 patients (7 males, 5 females) with a mean age of 64 +/- 10 years. No heart disease was present in 7 cases (58%); 3 cases had chronic ischaemic heart disease (25%) and 2 had hypertensive heart disease (17%). The standard ECG was normal in 7 patients, while various conduction abnormalities were observed in the other 5. The mean number of syncopal episodes was 4.8 +/- 3.9 per patient, and the mean between the onset of symptoms and the beginning of this study was 32 +/- 42 months. In these 12 cases a VVI-M pacemaker was implanted, at a programmed rate of 50 or 60 bpm; in three subjects, the pacemaker was of the diagnostic type ("bradycardia event counter"). Group B included 12 patients (8 females, 4 males) with a mean age of 56 +/- 11 years. Organic heart disease was absent in 7 cases (58%); 4 patients showed hypertensive heart disease (33%) and 1 had mitral prolapse (9%). The ECG was normal in 9 subjects. The mean number of syncopes was 3.2 +/- 1.5 per patient; the mean interval since the onset of symptoms was 18 +/- 19 months.(ABSTRACT TRUNCATED AT 250 WORDS)

[Diagnostic value of Q wave changes during the exercise test. Review of the literature and personal experience]. / Il valore diagnostico delle modificazioni dell'onda Q durante test ergometrico. Revisione della letteratura ed esperienza personale.

UNLABELLED: To test if a low Q wave voltage and its faulty increase after exercise is an additional sign of myocardial ischemia, 64 pts with no previous myocardial infarction, bundle branch block or left ventricular hypertrophy were studied by a treadmill test and coronary angiography. Nineteen had single vessel disease (SVD), 21 double vessel disease (DVD), 4 triple vessel disease (TVD) and 20 normal coronary arteries. Sensitivity (SENS), specificity (SPEC) and predictive value (P) of Q wave changes have resulted as follows: 84%, 55%, 80.4%, respectively, compared to 79.5%, 75%, 87.5% of ST modifications associated or not with angina. The SENS of Q wave changes was 72% in SVD and 92% in multivessel disease (p less than 0.05). In 68% of our pts ST and Q wave changes gave concordant results and their combination increased SENS, SPEC, PV to 90.1%, 80%, 90.3%. IN CONCLUSION: Q wave analysis can provide further evidence of myocardial ischemia and can increase SENS, SPEC of stress test. In our experience Q wave is a more sensitive finding than ST depression in multivessel disease.