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.

Rhythm-symptom correlation in patients on continuous monitoring after catheter ablation of atrial fibrillation.

INTRODUCTION: Correlation between symptoms and atrial fibrillation (AF) episodes after catheter ablation may have clinical relevance, especially for anticoagulation usage. The aim of our project was to analyze the relationship between symptoms and AF recurrences in unselected patients following AF catheter ablation during long-term follow-up. METHODS AND RESULTS: One hundred and forty-three consecutive patients (mean age 59 ± 9 years, 85% male) were implanted with a continuous cardiac monitor (RevealXT, Medtronic Inc., Minneapolis, MN, USA) following first pulmonary vein ablation procedure. Device data were downloaded every 3 months and correlated to patients' symptom diary. AF was paroxysmal in 55% and persistent in 45%. At a mean follow-up of 14 ± 6 months, 98/143 (69%) patients had at least one AF recurrence. Among these, 53 (54%) reported AF-related symptoms while 45 (46%) were totally asymptomatic. Conversely, 13 (29%) out of 45 patients without AF recurrences reported symptoms. Globally, a significant reduction of symptoms (from 82% at baseline to 44% at last follow-up; P < 0.0001) was observed. SF-12 questionnaire showed a significant improvement of physical and mental functioning (respectively 44.5 ± 8.5 vs 51.0 ± 6.7, and 45.7 ± 9.3 vs 49.2 ± 6.1, P < 0.05 baseline vs last follow-up). At the 12-month follow-up, 80% and 77% of patients were on AAD and anticoagulant drugs, respectively. There were not differences in AAD usage in symptomatic and asymptomatic patients. CONCLUSIONS: Continuous ECG monitoring is a valuable tool for long-term follow-up after AF catheter ablation facilitating reliable assessment of symptomatic and asymptomatic AF episodes. This may have clinical implications with regards to anticoagulation therapy in high-risk patients.

Defibrillation testing at the time of implantation of cardioverter defibrillator in the clinical practice: a nation-wide survey.

AIMS: Despite an effective defibrillation testing (DT) is considered mandatory to be consistent with the rules of good clinical practice, some physicians are concerned about the risk of complications related to the induction test, and in real world clinical practice, several implant procedures are performed without any induction test. We conducted a systematic nation-wide retrospective survey in order to determine the DT rate and its complications. METHODS AND RESULTS: An ad hoc questionnaire was sent to all 343 Italian implanting centres and the data from the 229 (67%) centres that answered were analysed. During the year 2005, a total of 7857 patients underwent a first implantation of cardioverter defibrillator (ICD), 38% of which with cardiac resynchronization therapy (CRT). Of these, 2356 (30%) were implanted without any induction test. In 35 (15%) centres, the induction test was performed in < 25% of the patients, whereas in 136 (59%) centres, it was performed in > 75% of the patients. At multivariable analysis, performed in a subset of 1206 patients from 107 centres, CRT device (OR = 1.82) and primary prevention (OR = 1.47) were independent predictors of the decision to not perform DT. However, altogether, the clinical variables accounted only for 35% of the total variance, whereas the remaining 65% was probably unrelated to clinical factors. There was a total of 22 (0.4%) life-threatening complications as a consequence of the induction test: 4 deaths (0.07%), 8 cardiopulmonary arrests requiring resuscitation manoeuvres (0.15%), 6 cardiogenic shocks (0.11%), 3 strokes (0.05%), and 1 pulmonary embolism (0.02%). CONCLUSION: In real world practice, DT is not performed in a substantial number of patients, most of these in the absence of legitimate reasons. The clinical impact of DT vs. no DT remains unclear until the not negligible complication rate is compared against the long-term potential benefit.

Dose to cardiologists in haemodynamic and electrophysiology cardiac interventional procedures.

Interventional cardiac procedures can be complex and involve extensive use of low dose rate fluoroscopy and high dose rate in image acquisition mode; hence, staff may receive significant radiation exposure. Radiation exposure to operators was assessed in 173 procedures. Fluoroscopy time, number of acquired images and dose-area product were recorded and occupational dose assessed with thermoluminescence dosemeters. The effective dose to the operator was compared with relevant literature data: values found were generally lower than those reported for other interventional cardiology laboratories. This is probably because of the strict radiation protection policy in our centre. Higher effective doses were found for defibrillator implantation and percutaneous transluminal coronary angiography procedures; for other cardiac procedures, effective dose was lower. Yearly extrapolated occupational doses to cardiologists are lower than the regulatory dose limit and in the lower band of doses reported in the literature.

Patient skin dosimetry in haemodynamic and electrophysiology interventional cardiology.

With the increase in number and complexity of interventional cardiology (IC) procedures, it is important to monitor skin dose in order to decrease skin injuries. This study investigated radiation doses for patients undergoing IC procedures, compare results with the literature and define a local dose-area product trigger level for operators to identify situations likely to exceed the threshold for transient skin erythema of 2 Gy. Dosimetric data were collected for 77 haemodynamic and 90 electrophysiological procedures. Mean maximum local skin doses (MSDs) were 0.28 Gy for coronary angiography, 1.03 Gy for percutaneous transluminal coronary angioplasty (PTCA), 0.03 Gy for pacemaker insertion, 0.17 Gy for radiofrequency ablation for nodal tachycardia, 0.10 Gy for WPW and 0.22 Gy for atrial flutter. Since MSD values for the other procedures were well below the deterministic effect limit, a trigger level of 140 Gy cm2 was derived for PTCA procedures alone.

Long term follow up of radiofrequency catheter ablation of atrial flutter: clinical course and predictors of atrial fibrillation occurrence.

OBJECTIVES: To evaluate the time to onset and the predictors of atrial fibrillation (AF) during long term follow up of patients with typical atrial flutter (AFL) treated with transisthmic ablation. DESIGN: Prospective multicentre study. METHODS AND RESULTS: 383 patients (75.4% men, mean (SD) age 61.7 (11.1) years) who underwent transisthmic ablation for typical AFL were investigated. In 239 patients (62.4%) AF was present before ablation. Ablation proved successful in 367 patients (95.8%). During a mean (SD) follow up of 20.5 (12.4) months, 41.5% of patients reported AF. The cumulative probability of postablation AF increased continuously as time passed: it was 22% at six months, 36% at one year, 50% at two years, 58% at three years, and 63% at four years. CONCLUSIONS: AF occurred in a large proportion of patients after transisthmic catheter ablation of typical AFL. The occurrence of AF was progressive during follow up. Preablation AF, age < 65 years, and left atrial size > 50 mm are associated with postablation AF occurrence.

Management of patients with syncope referred urgently to general hospitals.

OBJECTIVE: To evaluate the incidence and the strategy of management of syncope admitted urgently to a general hospital. BACKGROUND: The management of patients with syncope is not standardized. METHODS: The study was a prospective observational registry from a sample of 28 general hospitals in Italy and enroled all consecutive patients referred to their emergency rooms from November 5th 2001 to December 7th 2001 who were affected by transient loss of consciousness as the principal symptom. RESULTS: The incidence of syncope was 0.95% (996 of 105,173 patients attending). Forty-six percent were hospitalized, mostly in the Department of Internal Medicine. The mean in-hospital stay was 8.1+/-5.9 days. A mean of 3.48 tests was performed per patient. A definite diagnosis was made in 80% of cases, neurally-mediated syncope being the most frequent. The findings of each of the 28 hospitals participating in the survey were separately evaluated. We observed great inter-hospital and inter-department heterogeneity regarding the incidence of emergency admission, in-hospital pathways, most of the examinations performed and the final assigned diagnosis. For example, the execution of carotid sinus massage ranged from 0% in one hospital to 58% in another (median 12.5%); tilt testing ranged from 0 to 50% (median 5.8%); the final diagnosis of neurally-mediated syncope ranged from 10 to 78.6% (median 43.3%). CONCLUSION: Great inter-hospital and inter-department heterogeneity in the incidence and management of syncope was observed in general hospitals. As a consequence, we were unable to describe a uniform strategy for the management of syncope in everyday practice.

Randomized crossover comparison of right atrial appendage pacing versus interatrial septum pacing for prevention of paroxysmal atrial fibrillation in patients with sinus bradycardia.

BACKGROUND: New atrial pacing techniques and overdrive pacing algorithms have been introduced to prevent atrial fibrillation. This study was designed to test the hypotheses that (1) interatrial septum pacing (IASP) at the triangle of Koch would be more effective than right atrial appendage pacing (RAAP) in preventing paroxysmal atrial fibrillation (PAF) in patients with sinus bradycardia and (2) an algorithm (CAP) designed to achieve constant atrial capture would increase the efficacy of rate-responsive atrial pacing. METHODS: We studied 46 patients with PAF and sinus bradycardia implanted with a DDD(R) (Medtronic Thera) pacemaker. Twenty-four patients (6.0 +/- 10.1 PAF episodes/month within 3 months before study) were randomized to RAAP and 22 patients (5.4 +/- 7.1, not significant) to IASP. Within each arm 2 randomized crossover periods of CAP-OFF and CAP-ON function were programed. RESULTS: The PAF episodes per month significantly decreased in the RAAP (CAP-OFF: 2.1 +/- 4.2, P <.05; CAP-ON: 1.9 +/- 3.8, P <.05) and in the IASP group (CAP-OFF: 0.2 +/- 0.5, P <.05; CAP-ON: 0.2 +/- 0.5, P <.05). Values were significantly lower in the IASP group than in the RAAP group in both CAP-OFF (0.2 +/- 0.5 vs 2.1 +/- 4.2, P <.05) and CAP-ON (0.2 +/- 0.5 vs 1.9 +/- 3.8, P <.05) conditions. PAF burden was significantly lower in the IASP than in the RAAP group in CAP-OFF (47 +/- 84 min/d vs 140 +/- 217, P <.05) and in CAP-ON (41 +/- 72 vs 193 +/- 266, P <.05) conditions. No differences were observed within each arm in PAF burden between the 2 crossover CAP programing periods. CONCLUSIONS: Rate-adaptive IASP at the triangle of Koch is more effective than RAAP in preventing PAF in patients with sinus bradycardia. In our sample of patients no additional clinical benefit is furnished by the CAP algorithm.

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.

Impact of consistent atrial pacing algorithm on premature atrial complexe number and paroxysmal atrial fibrillation recurrences in brady-tachy syndrome: a randomized prospective cross over study.

AIM OF THE STUDY: The Consistent Atrial Pacing (CAP) algorithm has been designed to achieve a high percentage of atrial pacing to suppress paroxysmal atrial fibrillation. The aim of our study was to compare the impact of DDDR+CAP versus DDDR pacing on paroxysmal atrial fibrillation recurrences and triggers in patients with Brady-Tachy Syndrome. METHODS: 61 patients, 23 M and 38 F, mean age 75+/-9 y, affected by Brady-Tachy Syndrome, implanted with a DDDR pacemaker, were randomized to DDDR or DDDR+CAP pacing with cross over of pacing modality after 1 month. RESULTS: 78 % of patients in DDDR pacing and 73 % in DDDR + CAP pacing (p=n.s.) were free from symptomatic paroxysmal atrial fibrillation recurrences. During DDDR+CAP pacing, the atrial pacing percentage increased from 77+/-29 % to 96+/-7 % (p<0.0001). Automatic mode switch episodes/day were 0.73+/-1.09 in DDDR and 0.79+/-1.14 (p=n.s.) in DDDR+CAP. In patients with less than 50 % of atrial pacing during DDDR, automaticmode switch episodes/day decreased during DDDR+CAP from 1.13+/-1.59 to 0.23+/-0.32 (p<0.05) and in patients with less than 90 % from 1.23+/-1.27 to 0.75+/-1.10 (p<0.001). The number of premature atrial complexes per day decreased during DDDR + CAP from 2665+/-4468 to 556+/-704 (p<0.02). CONCLUSION: CAP algorithm allowed continuous overdrive atrial pacing without major side effects. Triggers of paroxysmal atrial fibrillation induction, such as premature atrial complexes, were critically decreased. Paroxysmal atrial fibrillation episodes were reduced in patients with atrial pacing percentage lower than 90 % during DDDR pacing.

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.

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

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

Thromboembolism after atrioventricular node ablation and pacing: long term follow up.

OBJECTIVE: To assess the incidence of arterial embolic events in patients with high rate, drug resistant, severely symptomatic paroxysmal and chronic atrial fibrillation who have undergone atrioventricular (AV) node ablation and permanent pacing. DESIGN: Multicentre retrospective cohort study. PATIENTS AND MANAGEMENT: From May 1987 to January 1997, AV node ablation was performed in 585 severely symptomatic patients (mean (SD) age 66 (11) years) with high rate, drug resistant paroxysmal atrial fibrillation (308) or chronic atrial fibrillation (277). Lone atrial fibrillation was present in 133 patients, while the remaining 452 suffered from dilated, ischaemic, or valvar heart disease. Patients underwent VVIR (454) or DDDR (131) pacemaker implantation, after AV node ablation. Antiplatelet agents were given to 202 patients, warfarin to 187 patients. RESULTS: During a follow up of 33.6 (24.2) months, thromboembolic events were observed in 17 patients (3%); the actuarial occurrence rates of thromboembolism were 1.1%, 3%, 4.2%, and 7.4% after one, three, five, and seven years, respectively. Among five variables, univariate analysis showed that only the presence of chronic atrial fibrillation at the time of ablation (relative risk (RR) = 1.8, 95% confidence interval (CI) = 1.02 to 3. 20, p = 0.04) and the need for warfarin treatment (RR = 1.6, 95% CI 1.00 to 2.71, p = 0.048) were associated with a significantly higher risk of occurrence of thromboembolic events. On multivariate analysis the only predictor of embolic events during the follow up was the presence of chronic atrial fibrillation. CONCLUSIONS: Data from this large cohort of patients indicate a fairly low incidence (1.04% per year) of thromboembolic events after AV node ablation and pacing for drug refractory, high rate atrial fibrillation.

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.

Idiopathic left ventricular aneurysm: an unusual substrate of ventricular fibrillation and ventricular tachycardia.

Idiopathic left ventricular aneurysm (LVA) is a very rare clinical condition. This article describes a patient with idiopathic LVA associated with episodes of ventricular tachycardia and ventricular fibrillation. Clinical and instrumental examinations did not reveal the pathogenesis of the aneurysm. The malignant clinical course suggests that an aggressive antiarrhythmic treatment, including ICD implantation, may be warranted.