Europace Advance Access originally published online on August 1, 2007
Europace 2007 9(9):805-811; doi:10.1093/europace/eum152
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PACING FOR ATRIAL FIBRILLATION
A novel method of multisite atrial pacing, incorporating Bachmann’s bundle area and coronary sinus ostium, for electrical atrial resynchronization in patients with recurrent atrial fibrillation
browska-Kugacka1
ski2
Zago
don3
1 Department of Cardiology and Electrotherapy, Medical University of Gdask, ul. D
binki 7, 80-211 Gdask, Poland;
2 Department of Cardiology, Medical University of Lublin, Lublin, Poland;
3 Department of Hygiene and Epidemiology, Medical University of Gdask, ul. Dbinki 7, 80-211 Gdask, Poland
Manuscript submitted 19 April 2007. Accepted after revision 4 July 2007.
* Corresponding author. Tel: +48 58 349 39 10; fax: +48 58 349 39 20. E-mail address: elew{at}amg.gda.pl
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Abstract |
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Aims The aim of the study was to assess efficacy and safety of a novel method of multisite atrial pacing, incorporating Bachmann’s bundle (BB) and coronary sinus (CS) ostium pacing, which was implemented for the first time in atrial fibrillation (AF) patients with intra-atrial conduction delay.
Methods and results This follow-up study included 97 patients with drug refractory symptomatic AF, sinus node dysfunction, sinus P-wave 
120 ms, and normal atrioventricular conduction. Pacing efficacy was assessed on the basis of two main endpoints: successful rhythm control and the absence of documented or symptomatic AF. During the mean 2.3 ± 0.7 years of follow-up, the survival rate was 99%, pacing maintenance rate 97%, and the need for re-operation 5%. Rhythm control efficacy was 90%, and 14 patients had no evidence of recurrent AF. After implantation, the mean number of anti-arrhythmic drugs used (P < 0.0001), the need for cardioversion (P < 0.01), and the incidence (P < 0.0001) and duration (P < 0.001) of AF-related hospitalizations decreased. P-wave duration with multisite atrial pacing was shorter than during sinus rhythm, BB, and CS pacing (P < 0.0001).
Conclusion A novel method of multisite atrial pacing is safe, provides effective long-term rhythm control, and decreases the necessity for adjunctive therapies in patients with refractory AF and intra-atrial conduction delay.
Key Words: Atrial fibrillation, Atrial septum, Bachmann’s bundle, Coronary sinus, Pacing, Hybrid therapy
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Introduction |
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It has been reported that atrial pacing prevents atrial fibrillation (AF) in patients referred for cardiac pacing, mainly with AF and sinus node dysfunction.1
The mechanism of AF prevention by atrial pacing is multifactorial, by targeting both the substrate of arrhythmia and initiating factors, such as bradycardia or premature atrial beats. The rationale for multisite atrial pacing is derived from the fundamental premise that abnormal atrial conduction-promoting re-entrant arrhythmias2,3 is an important factor in the development and/or maintenance of AF. Thus, multifocal atrial pacing, which improves global atrial electrical activation, may be beneficial in AF patients with conventional pacing indications who manifest inter- and intra-atrial conduction delays.
Daubert et al.4 and Saksena and co-workers5 reported a favourable effect of bi-atrial or dual-site right atrial (RA) pacing on preventing atrial arrhythmias. These methods of multisite atrial pacing incorporated one electrode at RA appendage (RAA) or high RA, and the other at coronary sinus (CS) ostium (dual-site RA) or in the mid or distal CS (bi-atrial pacing). More recently, it has been shown that pacing at the inter-atrial septum, either at the triangle of Koch or at Bachmann’s bundle (BB), is more successful in AF prevention in comparison with RAA pacing.6,7 As one theorized, AF mechanism is of the multiple re-entrant wavelets; all these site-specific atrial pacing methods might be successful in preventing AF by similar mechanisms: shortening of global atrial activation time, reduction of the dispersion of atrial refractoriness, and pre-exciting zones that are critical for the initiation of sustained atrial arrhythmias owing to specific conduction delays to and within this region.8,9
The issue of choice of the optimal site(s) of preventive atrial pacing remains unresolved. One may expect that in patients with major inter-atrial conduction block, multisite pacing might be superior to a single-site pacing because it better compensates for the anatomic and functional sites of conduction delay. Thus we aimed to explore the hypothesis that electrical resynchronization of the atria obtained by pacing at two sites that are critical for the initiation and maintenance of AF, the BB area and the CS ostium, can prevent AF recurrence. In the present study, we assessed anti-arrhythmic efficacy and safety of this new method of multisite atrial pacing that was implemented for the first time in patients with a history of recurrent AF, sinus node dysfunction, and intra-atrial conduction delay manifested by the P-wave prolongation during sinus rhythm.
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Methods |
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Study design
This was an observational study that included patients with at least 1 year of follow-up completed.
Patient selection
The study included consecutive patients meeting all the following criteria: (i) symptomatic documented recurrent AF (paroxysmal or persistent); (ii) with a class I or II indications for pacing due to sinus node dysfunction; (iii) patients with signs of advanced intra- and inter-atrial conduction delay: the sinus P-wave duration 120 ms on the surface ECG; (iv) no evidence of second- or third-degree atrio-ventricular block.
The following data regarding AF history were collected in each patient: (i) the frequency of symptomatic AF recurrences during 6 months before implantation. Symptomatic AF paroxysms were qualified as: occasional AF—if they were reported less than one episode per month; recurrent AF—if they occurred within the range of one episode per week to one episode per month, and frequent—if patients reported more than one AF episode per week; (ii) the number of all ECG-documented AF episodes within the last 3 months before implantation; (iii) the number of in-hospital cardioversions, both pharmacological and direct current, that were performed during the last year; (iv) the number and the duration of all AF-related hospitalizations that occurred during the last year before implantation. A hospitalization was qualified as AF-related if it was caused by arrhythmic symptoms or aggravation of the underlying cardiovascular disease by AF, owing to a need for cardioversion, a change in concomitant anti-arrhythmic therapy, or for the introduction of anticoagulation; (v) anti-arrhythmic drugs that were administered for AF symptoms in past patients’ history. The study was approved by appropriate Ethical Committee, and all patients gave their informed consent.
Pacemaker implantation
A single bipolar screw-in lead was fixed in the BB region. The lead was first placed in the RAA, which served as the reference position, before it was moved to the BB area. The target region to implant the BB lead was a confluence of the RA roof and the inter-atrial septum. The implantation of the BB lead was based on the following criteria: (i) fluoroscopic position in the posterior–anterior (PA) view: the tip of the lead slightly above the RAA location, and moved cranially as far as possible in the left anterior oblique view; (ii) PA view: minimal, only ‘up-and-down’ movements of the lead tip were accepted; (iii) paced P-wave positive in leads I, II, and III, starting immediately with the pacing spike, and shorter than the sinus P-wave (Figure 1). The second atrial pacing lead was placed in the proximity of the CS ostium. Bipolar screw-in leads were preferred; however, in the first nine patients, unipolar leads designed specifically for CS pacing (V447Y, CXLA65, or CXLAH; Biotronik GmbH, Berlin, Germany) were implanted in the proximal CS, 1–3 cm from the CS orifice. The ostial CS pacing was confirmed on the ECG by negative P-waves in the inferior limb leads. The BB lead was connected to the atrial port and the CS lead to the ventricular port of standard dual-chamber pacemaker (Axios DR, Philos DR, or Logos DC; Biotronik GmbH, Berlin, Germany). The pacemaker was programmed with a basic rate between 65 and 85 bpm to a DDD mode or DDDR in patients with chronotropic incompetence. In Axios and Philos pacemakers, the shortest available delay of 15 ms between the paced/sensed event at BB and the paced CS was programmed, and in Logos DS, a value of 0 ms was set. Patients underwent careful examination to ensure appropriate pacing and sensing at both sites, with no evidence of far-field R-wave oversensing. P-wave duration during sinus rhythm was measured in lead II at a recording speed of 100 mm/s on pacemaker electrograms obtained with the use of the programmer.
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Follow-up
Clinic visits were scheduled at 1, 3, and 6 months post-implantation, and thereafter every 6 months to assess arrhythmia control and device performance. At each clinic visit, measurements of atrial pacing and sensing thresholds, as well as the interrogation of the pacemaker data logs were performed. Patients were asked to go to hospital in case of arrhythmia symptoms. Symptomatic AF was documented using standard ECG or pacemaker-derived electrograms. During the follow-up, survival and stroke events were evaluated. Changes in anti-arrhythmic drug therapy, the need for cardioversion (pharmacological or direct current), and AF-related hospitalizations were noted.
Clinical efficacy of multisite atrial pacing was assessed on the basis of the two main endpoints: successful rhythm control, defined as the absence of permanent AF at the end of follow-up, and the absence of documented or symptomatic AF episodes. All ECG-recorded AF episodes and those lasting >30 min in pacemaker data logs or on the Holter monitoring (if it was clinically indicated) were taken into account. Moreover, the frequency of symptomatic AF recurrences, the administration of adjunctive therapies (anti-arrhythmic drugs and cardioversion), and hospitalizations due to AF were evaluated and compared with the data regarding the pre-implantation period. Early and late complications were analysed to assess the safety of the pacing therapy. Complications were defined as early if they occurred within the first 30 days after implantation, and late if they occurred thereafter. After at least 1 year of pacing, the P-wave duration was measured in lead II on the pacemaker-derived electrograms during sinus rhythm, BB, CS, and multisite atrial pacing at 70 or 75 bpm (at a recording speed of 100 mm/s). At the final visit, the frequency of symptomatic AF recurrences during the last 6 months of pacing was assessed and compared with the data regarding the pre-implantation period.
Statistical methods
Baseline clinical characteristics are presented as mean values and standard deviations or median, and quartile range, where appropriate. Differences between cumulative incidence of cardioversions were analysed using Fisher's exact test. Cumulative incidence was calculated as a ratio of patients who had at least one cardioversion in a specified period of time and a number of patients observed. Incidence density counted multiple events per patient. Differences between incidence density rates of cardioversions and hospitalizations were analysed using 
2 test. A 2 test was also used to compare categorical variables. Analysis of variance (ANOVA) with repeated measurements was used to test statistical significance of the differences in P-wave duration during sinus rhythm and different pacing modes. When ANOVA results suggested significant differences, post hoc analysis with Newman–Keul's test was performed. If variables were not normally distributed, as in the case of the number of hospitalization days, ANOVA Friedman test for repeated measurements and STATISTICA software (StatSoft, Inc., Tulsa, USA) were used. P < 0.05 was considered statistically significant.
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Results |
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Study population
Ninety-seven patients, who underwent pacemaker implantation between September 2003 and October 2005, were included in the study. Patient characteristics are presented in Table 1. Eighty-eight patients (90%) had concomitant cardiovascular disease, but left ventricular ejection fraction was normal in 89% of patients. Implantation of two atrial leads was successful in all patients. Eleven patients were implanted with Logos DS, and 86 patients received Axios or Philos dual-chamber pacemaker. The chest X-ray films demonstrating pacing lead positions are presented in Figure 2. The mean follow-up was 2.3 ± 0.7 years (1.4–3.7 years).
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Patient survival
One patient died of colon cancer 1.5 years after pacemaker implantation. Four patients experienced strokes, among whom three declined anti-thrombotic treatment.
Adjunctive therapy
At hospital discharge, anti-arrhythmic therapy was administered to 92% of patients, with a mean of 1.5 ± 0.7 anti-arrhythmic drugs prescribed (some patients were treated with two drugs simultaneously). During the follow-up in 55% of patients, the pharmacotherapy was modified, with an increased usage of class I and class III anti-arrhythmics (Table 2). Finally, a mean of 2.3 ± 1.1 anti-arrhythmic drugs were administered, and this number was reduced in comparison with the pre-implantation history (3.2 ± 1.8 drugs; P < 0.0001). At last control visit, 97% of patients received anti-arrhythmic agents, and the mean number of the medications was similar to that at hospital discharge (1.5 ± 0.6 drugs, P = 0.7).
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Arrhythmia history prior to implantation
All patients suffered from symptomatic (palpitations, dyspnoea, dizziness, hypotension) paroxysmal or persistent AF recurrences, and the duration from the onset of attacks of documented AF varied from 0.4 to 28 years (Table 1). The frequency of symptomatic AF episodes during 6 months preceding implantation is presented in Table 3. During the 3-month pre-implantation period, a median of ECG-documented AF episodes was 2 per patient. Within the last year, preceding pacemaker insertion, 79 patients required pharmacological or electrical cardioversion (Table 4).
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Arrhythmia recurrence and rhythm control in the follow-up
During the follow-up, 10 patients developed permanent AF, after a mean of 1.4 ± 0.7 years after implantation (2 months–2.6 years). Thus, an overall rhythm control rate was 90%. There were no differences between patients who developed permanent AF and those who did not, regarding the history of paroxysmal AF (P = 0.11) and the frequency of symptomatic AF recurrences before pacemaker implantation (P = 0.93), or the programmed delay of 0 or 15 ms after implantation (P = 0.88).
During the follow-up in 14 patients (14%), there was no evidence of AF paroxysms when symptoms, ECG, and pacemaker-retrieved data were considered. Regarding symptomatic AF episodes after implantation, 37 patients became free of any AF-related symptoms, 18 patients noticed symptomatic improvement, and 5 patients reported more frequent episodes; in 29 patients, there were no changes in the AF frequency (Table 3). During the follow-up, 56 patients required cardioversion, pharmacological in 39%, and direct current in 43% of patients. A significant decrease in number of all cardioversions was noted during the first year of pacing, when compared with data from the year preceding pacemaker implantation (Table 4). This reduction persisted up to year 3, and one patient required cardioversion within the fourth year of pacing (among 10 patients studied).
Complications
Early complications included postoperative pneumothorax in one patient and pacemaker pocket haematoma in another patient, who recovered without any surgical intervention. In the perioperative period, two patients had dislodgement of the BB lead, and in other two patients, an excessive increase in pacing threshold at BB area was observed. In all these patients, a successful repositioning of the BB lead was performed. Late complications included persistent pacing failure of the BB lead (exit block) in two patients (after 2 and 7 months, respectively) and pacemaker pocket infection in one patient, requiring device removal (after 9 months). Thus, during the long-term follow-up, 94 patients (97%) maintained successful multisite atrial pacing.
Hospitalizations
The number and duration of AF-related hospitalizations that occurred during the last year preceding implantation and during the follow-up period are presented in Table 4. When compared with the last year before implantation, the incidence of AF-related hospitalizations decreased during the consecutive years of follow-up. A significant reduction in the hospital treatment duration was also noted.
Electrocardiography
In 77 patients, P-wave duration during sinus rhythm and atrial pacing was measured on a control visit after at least 1 year of pacing (1.4 ± 0.4 years). During multisite atrial pacing, the P-wave duration was shorter (P < 0.0001) than during sinus rhythm, the BB, and the CS pacing (Table 5). It was reduced during the BB pacing when compared with the CS pacing (P < 0.01) (Figure 3).
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Discussion |
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Implementing for the first time a novel method of multisite atrial pacing in AF patients, which incorporated the BB and the CS ostium, the two sites critical for the initiation of AF, we achieved rhythm control in 90% of patients, with significant alleviation of symptoms during the follow-up exceeding 1 year. Moreover, it reduced the need for adjunctive therapies, as the number of anti-arrhythmic drugs and cardioversion procedures, both pharmacological and direct current, was lower in comparison with the pre-implantation period. Reduction in AF-related hospitalizations with multisite atrial pacing was also observed, and duration of these hospitalizations was significantly lower. We confirmed that the insertion of the two leads at atrial septum was safe and showed acceptable stability. It resulted in the improvement of global atrial electrical activation, as indicated by significant shortening of the P-wave during multisite pacing.
RA appendage or high lateral RA wall had been conventional lead positions for atrial pacing until early 1990 when a bi-atrial pacing was introduced as a method aimed to prevent atrial arrhythmias. In the first study by Daubert et al.,4 simultaneous pacing at the RAA and the left atrium from the distal CS resulted in significant arrhythmia suppression in patients with advanced inter-atrial conduction delay. These observations led to further studies that assessed anti-arrhythmic properties of different atrial sites and pacing configurations: dual-site RA5,9 or bi-atrial.10,11 However, results of observational,10,12 and randomized prospective studies9,11 were inconsistent. Moreover, it was reported that pacing from alternative single site, the inter-atrial septum, or the left atrium through a lead placed in the CS was effective to prevent AF.6,7,13,14 A number of unresolved issues remain, such as the selection of the optimal atrial pacing site and the number of pacing sites necessary to obtain the most beneficial anti-arrhythmic effect.
Pacing at the optimal site results in pre-excitation of the abnormal substrate—the area where conduction block occurs as a result of local differences in refractory periods or anisotropy. Pre-excitation at this region subsequently increases the coupling interval of its activation by premature beat and thus prevents the initiation of re-entrant arrhythmia. It may be successful also in patients with AF initiated by atrial foci from the pulmonary veins, in whom conduction delays would help maintain the arrhythmia. Reports from experimental and electrophysiological studies suggested that the inter-atrial septum was the region of critical conduction, as it incorporated the BB area and the triangle of Koch, both of long atrial refractoriness, preferential conduction delay, and non-uniform anisotropy.15,16 It was shown by O’Donnel et al.17 that, compared with controls, patients with AF had prolonged effective refractory periods in the BB region and the CS ostium, greater dispersion of refractoriness, and increased conduction times when premature pulmonary vein impulses were applied. In the goat model of AF, Duytschaever et al.18 showed that pacing at BB prevented AF initiation by single premature beats originating from the left atrium. Other studies indicate that posterior triangle of Koch, with site-specific conduction delay to and within this region, may be responsible for AF initiation.19 Pacing the area of the CS orifice prevented the initiation of AF paroxysms triggered by single-RA premature beats.17,18 In the study by Roithinger et al.,20 when mapping of RA activation during distal CS pacing was performed, it demonstrated that the earliest activation was found near the CS ostium and the BB insertion, indicating that these regions play an important role in the inter-atrial impulse propagation.
The efficacy of pacing at the triangle of Koch was documented by Padeletti et al.,6 who showed that it was more successful in reducing AF episodes in patients with sinus bradycardia than RAA pacing. Similar results were reported later in a study by Manolis et al.13 In another study, Bailin et al.7 showed that pacing in the BB region in patients with recurrent AF and bradycardia significantly reduced the progression to permanent AF, when compared with RAA pacing. Whether the triangle of Koch or the BB area should be preferred for atrial pacing remains unclear.
The application of multisite atrial pacing has not been widely accepted so far owing to mixed results of previous studies. However, they were performed in various patient populations, with or without pacing indications, with different follow-up durations, and various main endpoints. Moreover, the presence of intra-atrial conduction delay was not considered an inclusion criterion in the majority of these studies. In addition, dynamic development of ablation techniques and its application in AF patients have dominated the concept of this arrhythmia treatment. Nowadays, catheter ablation is the treatment of choice in patients with AF initiated by ‘triggers’ that mainly originate from the pulmonary veins. However, also in these patients, conduction delays may play an important role in the maintenance of AF.
The choice of atrial pacing site(s) may play a crucial role in arrhythmia prevention in AF patients with abnormal atrial conduction and permanent pacing indications. Thus, we aimed to explore the hypothesis that, in these patients, pacing at two regions critical for AF, the CS ostium and the BB area, would improve clinical outcome. Moreover, only patients with abnormal atrial conduction, as documented by P-wave 120 ms during sinus rhythm, were qualified for this new pacing method, as the presence of these disturbances may predict multisite atrial pacing efficacy.
In our patients, insertion of the two atrial leads at the inter-atrial septum had acceptable safety and stability. Implantation was successfully performed in all patients, and adverse event rate was even less than that reported in studies with implementation of alternative atrial pacing site(s).9
Pacing at the BB area and the CS ostium resulted in significant clinical improvement in our study. After a mean of 2.3 ± 0.7 years of pacing, 90% of patients were free from permanent AF, and the majority of patients derived significant benefit of AF symptom alleviation. In addition, with multisite atrial pacing, the need for in-hospital cardioversions was reduced in comparison with pre-implantation period. In the study by Madan and Saksena,21 the long-term efficacy of a combination therapy strategy was evaluated, incorporating dual-site RA pacing, anti-arrhythmic drugs, and RA ablation for rhythm control in 113 patients with recurrent symptomatic AF and pacing indications. With this approach at 3 years of follow-up, 90% of patients had successful rhythm control that persisted up to year 5. However, 30% of patients required cardioversion during the study period, and the cumulative probability of receiving cardioversion increased during follow-up from 25% at 1 year to 45.4% at 5 years. In our study, 43% of patients required electrical cardioversion during the follow-up, and the need for cardioversion tended to decrease with the time of pacing.
In our patients, a combination therapy was incorporated, as anti-arrhythmic drugs were administered to almost all patients. This is in agreement with studies that evaluated effects of bi-atrial, multisite, or alternative single-site pacing with the use of concomitant anti-arrhythmic agents in 88–93% of patients, mostly the same that had been prescribed during the pre-implantation period.9,21 There are a lot of literature data on the efficacy of different anti-arrhythmic agents used for acute AF conversion or maintenance of sinus rhythm. However, the value of the pharmacological and pacing therapy is underestimated in terms of research activities and was not assessed in prospective clinical studies. Several studies reported the usefulness of class I or III anti-arrhythmic drugs. In a study by Madan and Saksena,21 which revealed the long-term efficacy of combined therapy incorporating dual-site RA pacing, 78% of patients received class III drugs. In the DAPPAF trial, dual-site RA pacing significantly increased AF-free survival in the subgroup of patients who experienced less than or equal to one episode of symptomatic AF per week and received class I or III anti-arrhythmic drugs.9 In our patients, the mean number of anti-arrhythmic drugs was significantly reduced with pacing, when compared with AF pre-implantation treatment history, and mainly class I or III anti-arrhythmic drugs were prescribed after implantation. An issue of pharmacotherapy in pacemaker population needs further investigation to establish its value and efficacy in this special subset of patients.
The clinical benefit of pacing at the BB area and the CS ostium in our patients was accompanied by a significant reduction of the paced P-wave duration, when compared with spontaneous sinus rhythm. Bailin14 reported that pacing at the BB region resulted in a significant reduction of P-wave duration, from 10 to 20 ms, compared with sinus rhythm. A significant decrease in P-wave duration was also observed during pacing at the CS orifice area13 and with multisite or bi-atrial pacing.10,12 As the sinus P-wave may be related to abnormal atrial conduction, P-wave shortening is considered to reflect electrical resynchronization of the atria and improvement in global atrial conduction with pacing. Moreover, in some studies, haemodynamics during different atrial pacing modes was evaluated,22 and recent studies have shown beneficial effects of pacing at the BB region.23,24 Thus, haemodynamic improvement obtained with pacing may support its ‘electrical’ effect.
Study limitations
The main limitation is the absence of a single-site control or crossover multisite pacing control. However, it was designed as an observational study, mainly to test a new pacing therapy. Further studies are needed to document the value of this novel method of atrial pacing in prospective randomized trials. Another point is that the P-wave duration was measured only in lead II; however, recent studies suggest that it would be better to measure the longest P-wave, taking into consideration all leads measurements.
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Conclusions |
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A novel method of multisite atrial pacing with two leads implanted at atrial septum is safe and provides effective long-term rhythm control in patients with refractory AF and abnormal atrial conduction. It reduces the need for adjunctive therapies with anti-arrhythmic drugs and cardioversion and the necessity for AF-related hospitalizations. This technique can be implemented in a broad spectrum of patients with refractory AF and intra-atrial conduction delay referred for permanent cardiac pacing.
Conflict of interest: none declared.
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References |
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