CLINICAL RESEARCH
Europace (2010) 12, 331–336 doi:10.1093/europace/eup428
Ablation for Atrial Fibrillation
Persistent iatrogenic atrial septal defect after a single-puncture, double-transseptal approach for pulmonary vein isolation using a remote robotic navigation system: results from a prospective study Andreas Rillig*, Udo Meyerfeldt, Markus Kunze, Ralf Birkemeyer, Tomislav Miljak, Sebastian Ja¨ckle, Bajram Hajredini, Fabian Treusch, and Werner Jung Department of Cardiology, Schwarzwald-Baar-Klinikum Villingen-Schwenningen, Academic Hospital of the University of Freiburg Vo¨hrenbacherstr, 23, Villingen-Schwenningen, Germany Received 21 September 2009; accepted after revision 7 December 2009; online publish-ahead-of-print 15 January 2010
Persistent iatrogenic atrial septal defect (iASD) after transseptal puncture for pulmonary vein isolation (PVI) has been described recently as a complication of PVI. No data exists evaluating systematically the incidence and clinical implications of iASDs after PVI using a remote robotic navigation system (RNS) with sheaths with a distinct larger outer diameter. ..................................................................................................................................................................................... Methods In this prospective study, 40 patients with either paroxysmal (n ¼ 22, 55%) or persistent symptomatic atrial fibrillation were treated with circumferential PVI using an RNS. In all patients, a single-puncture, double-transseptal and results approach was used to access the left atrium. Transoesophageal echocardiography was performed before and the day after PVI as well as after a 3 and 6 months follow-up (FU). The day after ablation an iASD was detected in 38 of 40 (95%) patients with a mean diameter of 3.45 + 1.5 mm. At 6-month FU, the iASDs were closed in 30 of 39 (78.9%) patients. During the 6-month FU period, no patient died or suffered from cerebral or cardiac embolism. ..................................................................................................................................................................................... Conclusion After a single-puncture, double-transseptal approach for PVI using the RNS, iASDs show a high spontaneous closure rate of 78.9% after a 6-month FU period. Persistent iASDs following PVI with the RNS are not associated with an increased rate of paradoxical embolism or with relevant shunting.
----------------------------------------------------------------------------------------------------------------------------------------------------------Keywords
Atrial fibrillation † Catheter ablation † Atrial septal defect † Transseptal puncture † Left to right-shunting † Complication
Introduction In the past decade, pulmonary vein isolation (PVI) has been established as a curative modality for the treatment of symptomatic drug-resistant atrial fibrillation1 with good procedural outcomes and long-term results. Mapping and ablation have traditionally been performed manually and therefore placement and control of diagnostic and ablation catheters remained technically challenging requiring high experience and skills of the ablationist. Recently,
a remote robotic navigation system (RNS, Sensei Robotic Catheter System, Hansen Medical, Inc., Mountain View, CA, USA) has become available to facilitate precise catheter movement and positioning in the cardiac chambers. To gain access to the left atrium for encircling the pulmonary veins, a transseptal puncture is necessary unless a persistent foramen ovale exists. Despite the development of alternative tools for transseptal puncture such as radiofrequency current application2 or excimer laser,3 access with the Brockenbrough needle remains the most common
* Corresponding author. Tel: þ49 7721 93 3064; fax: þ49 7721 93 3099. Email:
[email protected] Published on behalf of the European Society of Cardiology. All rights reserved. & The Author 2010. For permissions please email:
[email protected].
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Aims
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practice in most laboratories worldwide. For circumferential PVI, usually one or two transseptal sheaths are necessary for positioning the mapping and ablation catheter in the left atrium using either a double-puncture approach4,5 or a single-puncture, doubletransseptal manoeuvre.5,6 Persistent iatrogenic atrial septal defect (iASD) after transseptal puncture for PVI has been described recently;4,5 to the best of our knowledge no data exists regarding the incidence, size, and closure rates of iASDs after PVI using an RNS. For ablation with the RNS, the artisan sheath, consisting of an inner (outer diameter 11.5 F) and an outer sheath (outer diameter 14 F), is used for carrying the ablation catheter. As it is not possible to introduce a Brockenbrough needle into the artisan sheath for transseptal puncture, a single-puncture, doubletransseptal approach was chosen in this study, as commonly used by most investigators.7,8 However, the single-puncture, double-transseptal approach might result in larger iASDs, when both a conventional transseptal sheath and the artisan sheath are introduced into the left atrium via the same puncture site. This prospective study aims to evaluate the incidence, size, and clinical implications of iASDs after a single-puncture, doubletransseptal approach for PVI with an RNS.
Patients Between August 2008 and February 2009, 40 patients [17 (42.5%) women, mean age ¼ 60.3 + 9.4 years] with either paroxysmal (n ¼ 22; 55%) or persistent (n ¼ 18; 45%) symptomatic drug-resistant atrial fibrillation were included in this prospective study. All patients were treated with at least one anti-arrhythmic drug before the ablation procedure. Patient characteristics are displayed in Table 1. Exclusion criteria were previously performed transseptal puncture, an inability to undergo transoesophageal echocardiography (TEE) or a pre-existing atrial septal defect. All patients gave written informed consent. Anticoagulation with phenprocoumon was discontinued at least 5 days before the ablation procedure until international normalized
Echocardiographic parameters Before the ablation procedure, valve abnormalities, significant right ventricular dysfunction, or significantly elevated pulmonary artery pressure was ruled out by transthoracic echocardiography. In all patients, TEE was performed before PVI, the day after the ablation procedure as well as at 3 and 6 months follow-up (FU) for the evaluation of persistent iASD or pulmonary vein stenosis. Comprehensive 2D and Doppler echocardiography assessment was performed in all patients using the model GE Vivid 7 with a 7 MHz probe (GE Medical Systems, Milwaukee, WI, USA). Atrial morphology was determined with TEE from the mid to upper oesophagus at angles ranging between 0 and 1208. In addition to standard views, careful scanning of the atrial septum in as many planes as possible was performed. Echocardiographic parameters were optimized for maximal temporal resolution. Colour Doppler imaging was used for the evaluation of the iASD. Contrast medium was not used on a regular basis.
Ablation procedure In all patients, a circumferential isolation of the ipsilateral pulmonary veins using an RNS was performed. In patients with persistent atrial fibrillation, additional lines as mitral-isthmus line or roof-line was performed at the descretion of the operator. Pulmonary vein isolation was performed using a remote RNS consisting of a physician workstation with the instinctive motion controller and the remote catheter manipulator carrying the artisan sheath (Artisan Catheter, Hansen Medical, Figure 1) that consists of an inner (outer diameter 11.5 F) and an outer sheath (outer diameter 14 F) incorporating the ablation catheter (Thermocool Navistar 3.5 mm, Biosense Webster, Diamond Bar, CA, USA).
Transseptal puncture First, a pigtail catheter was placed in the aortic root (Cordis, Johnson and Johnson, Miami, FL, USA) to determine the location of the aorta and prevent aortic puncture and a Josephson catheter (Supreme, JSN, 6F, St Jude Medical, Minnetonka, MN, USA) was positioned in
Table 1 Characteristics of patients with and without iatrogenic atrial septal defect the day after pulmonary vein isolation Patients with iASD the day after the procedure (n 5 38)
Patients without iASD the day after the procedure (n 5 2)
P-value
Age (years) Female, n (%)
59.9 + 9.5 22 (57.9)
65.5 + 7.8 1 (50)
0.43 1.0
Paroxysmal atrial fibrillation, n (%)
22 (57.9)
0 (0)
0.19
Hypertension, n (%) Diabetes mellitus, n (%)
22 (57.9) 5 (13.2)
0 (0) 0 (0)
0.19 1.0
Coronary heart disease, n (%)
4 (10.5)
0 (0)
1.0
Hyperlipidaemia, n (%) Body mass index
9 (23.7) 29.1 + 5.0
0 (0) 24.1 + 0.7
1.0 0.17
Left atrial diameter (mm)
45.4 + 7.3
45.6 + 1.8
0.98
Left atrial pressure (mmHg) Procedure time (min)a
12.9+5.1 186.1 + 52.1
12.3 + 0.4 249.5 + 140.7
0.88 0.13
...............................................................................................................................................................................
a
Measured from transseptal puncture to the end of ablation.
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Methods
ratio (INR) was ,2, and continued 2 days after the intervention. To assure ongoing sufficient anticoagulation, enoxaparin was applied twice daily until the INR was .2. Phenprocoumon therapy was continued for at least 3 months after the ablation procedure.
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iASD after transseptal puncture for PVI
Figure 1 Artisan sheath (inner and outer sheath) incorporating the ablation catheter.
Statistical analysis All values are expressed as mean + SD or median (range). Continuous data were compared using Student t-test and categorical variables
Figure 2 Fluoroscopic view of both the conventional transseptal sheath and the artisan sheath after introduction into the left atrium. CS catheter, coronary sinus catheter; RNS, robotic navigation system.
using x2 analysis. Pearson’s correlation coefficient was calculated and multivariate analysis was used to evaluate the presence of associated variables in the relationship between various parameters. A P-value ,0.05 was considered statistically significant. Statistics were calculated with the Statistical Package for the Social Sciences (SPSS software version 11.0, Chicago, IL, USA).
Results Forty patients underwent PVI with the single-puncture, doubletransseptal approach. The day after ablation an iASD was detected in 38 of 40 (95%) patients with a mean diameter of 3.45 + 1.5 (range 1–6 mm) mm (Figure 3). In 24 of 38 (63.2%) of the patients with iASDs, there was seen an intermittent left to right shunting; in 14 of 38 (36.8%) of the patients, we found a continuous left to right shunting. A spontaneous right to left shunting could not be documented in any of the patients. Comparing the patients with or without iASD the day after the procedure, there were no significant differences with regard to age, body mass index (BMI), hypertension, diabetes mellitus, coronary heart disease, hyperlipidaemia, atrial fibrillation type, left atrial diameter, left atrial pressure, and procedure time (after transseptal puncture) (Table 1). At the 3-month FU, an iASD was found in 19 of 38 (50%) patients with an average size of 2.1 + 1.22 mm (range 1– 4 mm). There were no significant differences with regard to cardiovascular risk factors, age, left atrial size, left atrial pressure and time of ablation between patients with or without iASD at 3-month FU. Notably, the initial size of the iASD, the day after ablation, was significantly larger in patients with a persistent iASD after 3 months
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the coronary sinus (CS) for the demarcation of the lateral border of the left atrium as well as for defining intrathoracic rotation. For a more stable catheter position, a subclavian approach for positioning the CS catheter was chosen. After uncomplicated placement of the aforementioned catheters, a bolus of 3000 IU heparin was administered intravenously before the transseptal puncture (Figure 2). Transseptal access was obtained using a needle sheath assembly existing of a BRK-1 shaped Brockenbrough needle (St Jude Medical, St Paul, MN, USA) and an 8.5 F transseptal sheath (Swartz, SL 0, length 63 cm, St Jude Medical) under biplane fluoroscopy imaging (RAO 308 and LAO 908 view) via a right femoral vein access. The needle and sheath assembly was slowly withdrawn from the superior caval vein to the right atrium. The superior limbus of the fossa ovalis was identified by a significant leftward jump of the assembly tip, indicating the approach of the assembly from the muscular to the fibrous septum. After the transseptal sheath with the dilator was advanced into the left atrium, a guidewire replaced the transseptal needle and was positioned into the left superior pulmonary vein. Once transseptal puncture was successful, the sheath was aspirated to prevent thrombus formation due to tissue or air, left atrial pressure was measured and injection of contrast confirmed the left atrial position of the sheath. Patients received 5000 IU heparin intravenously and activated clotting time (ACT) was monitored each 30 min, maintaining an ACT .300 s throughout the procedure. Accordingly, the artisan sheath with the ablation catheter inside was inserted via a 14 F sheath in the right groin and introduced in the right atrium under fluoroscopic guidance. Having pulled back the transseptal sheath with the guidewire left in the left superior pulmonary vein, the artisan sheath was introduced manually into the left atrium across the same puncture site until both, the inner and outer sheath crossed the interatrial septum. Finally, the transseptal sheath was advanced again into the left atrium over the guidewire. The transseptal sheaths were continuously flushed with saline during the ablation procedure to prevent thromboembolism. Ablation was performed under conscious sedation with midazolam and fentanyl. Sheath removal was performed at least 3 h after termination of the ablation procedure and low molecular heparin was started directly after sheath removal. Phenprocoumon therapy was commenced 2 days after PVI.
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compared with patients without a persistent iASD after 3 months (Table 2). At the 6-month FU, the iASDs were closed in 30 of 38 (78.9%) patients (Table 3). The mean size of the persistent iASDs at 6-month FU was 1.3 + 0.6 mm (range 0.5 –2 mm). During the 6-month FU period, no patient died or suffered from cerebral or cardiac embolism.
Correlation analysis The initial size of the iASD correlated with the persistence and the size of the iASD at 3-month FU (r 2 ¼ 0.334, P ¼ 0.040 and r 2 ¼ 0.768, P , 0.001, respectively). The size of the iASD at 3-month FU correlated with female gender (r 2 ¼ 20.499, P ¼ 0.029) and diabetes mellitus (r 2 ¼ 0.519, P ¼ 0.023).
Multivariate analysis There was no association of left atrial diameter, left atrial pressure, age, BMI, and duration of the ablation procedure with the incidence of iASD the day after the ablation procedure. There was no association of left atrial diameter, left atrial pressure, age, duration of the ablation procedure, the initial size of the iASD, and cardiovascular risk factors with the persistence of iASDs at 3- and 6-months FU. The size of the iASDs at 3-month FU was associated with the incidence of a persistent iASD at 6-month FU (r 2 ¼ 0.408, P ¼ 0.025).
Discussion Data regarding the incidence of iASDs after PVI are limited. To the best of our knowledge, this is the first prospective study evaluating the incidence, size, and clinical implication of iASDs with TEE 1 day after the ablation procedure, as well as after a 3 and 6 months FU period in patients with a single-puncture, doubletransseptal approach for PVI. Moreover, this is the first study describing iASDs in patients when a remote RNS (Sensei Robotic Catheter System, Hansen Medical, Inc.) with the artisan sheath (with a distinct larger outer diameter) is used for PVI.
Figure 3 Large iatrogenic atrial septal defect (6 mm) with left to right shunting detected in TEE. LA, left atrium; RA, right atrium.
There are several important findings of this study. First, as expected, iASDs in this study using the RNS were much larger the day after ablation (mean size of 3.45 mm) when compared with a double-puncture, double-transseptal approach4 but were smaller at 6-month FU when compared with a manual singlepuncture, double-transseptal approach for PVI, although sheaths with a distinct larger outer diameter were used (14 þ 8.5 F compared with 8 þ 8 F). Second, iASDs after a single-puncture, double-transseptal approach for PVI using the RNS with the artisan sheath show a high spontaneous closure rate of 78.9% after a 6 months FU period.
Table 2 Characteristics of patients with iatrogenic atrial septal defect at 3-month follow-up Patients with iASD after 3-month FU (n 5 19)
Patients without iASD after 3-month FU (n 5 19)
P-value
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a
Age (years)
59.4 + 9.6
60.5 + 9.7
0.75
Female, n (%) Paroxysmal atrial fibrillation, n (%)
8 (42.1) 10 (52.6)
8 (42.1) 12 (63.2)
1.0 0.51
Hypertension, n (%)
2 (10.5)
2 (10.5)
1.0
Diabetes mellitus, n (%) Hyperlipidaemia, n (%)
4 (21) 4 (21)
1 (5.3) 5 (23.8)
0.34 1.0
Body mass index
29.5 + 5.2
28.7 + 5.0
0.63
Coronary heart disease, n (%) Left atrial diameter (mm)
10 (52.6) 46.2 + 6.2
12 (63.2) 43.9 + 9.0
0.51 0.46
Left atrial pressure (mmHg)
12.5 + 5.2
13.5 + 5.3
0.67
Size of iASD the day after ablation Procedure time (min)a
3.9 + 1.2 178.4 + 52.3
2.9 + 1.7 195.3 + 52.1
0.040 0.35
Measured from transseptal puncture to the end of ablation.
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Main findings
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Table 3 Characteristics of patients with iatrogenic atrial septal defect at 6-month follow-up Patients with iASD after 6-month FU (n 5 8)
Patients without iASD after 6-month FU (n 5 30)
P-value
0.64
............................................................................................................................................................................... Age (years)
58.4 + 7.4
60.3 + 10.0
Hypertension, n (%)
5 (62.5)
17 (56.6)
1.0
Diabetes mellitus, n (%) Coronary heart disease, n (%)
2 (25) 1 (12.5)
3 (10) 3 (10)
1.0 1.0
Hyperlipidaemia, n (%)
1 (12.5)
8 (26.6)
0.65
Body mass index Left atrial diameter (mm)
29.9 + 5.6 45.9 + 7.8
28.9 + 4.9 45.2 + 7.2
0.62 0.75
Left atrial pressure (mmHg)
12.4 + 5.2
13.1 + 5.2
0.78
Procedure time (min)a Size of iASD the day after ablation
212.3 + 44.3 4.0 + 1.4
178.4 + 52.5 3.2 + 1.6
0.11 0.21
Size of iASD at 3-month follow-up
2.8 + 1.2
1.5 + 1.0
0.029
a
Measured from transseptal puncture to the end of ablation.
Third, in this study, there was no spontaneous right to left shunting found in TEE, and only continuous or intermittent spontaneous left to right shunting was observed without haemodynamic compromise.
The incidence of iASDs the day after a single-puncture, doubletransseptal approach has not been evaluated yet. Interestingly, when using the RNS, the incidence of iASDs after the procedure is not higher with a single-puncture, double-transseptal approach even when compared with manual ablation with a doublepuncture, double-transseptal approach.4 However, the reported closure rate in the FU varies and iASDs after a double-transseptal approach are usually closed after a 3-month FU period, whereas iASDs after a single-puncture, double-transseptal approach for manually performed PVI were detected after 9 months with an incidence of 29.6%.5 In the present study, only 21.1% persistent iASDs were detected in TEE after a 6-month FU period. Therefore, the spontaneous closure rate after single-puncture double-transseptal with the RNS is high and the persistence of iASDs is lower at 6-month FU when compared with the 9-month FU of patients with manual ablation.5 To date, the size of atrial septal defects the day after a singlepuncture, double-transseptal approach using the RNS has not been evaluated. The mean size of atrial septal defects detected by TEE 1 day after the ablation procedure in this study was 3.45 mm with a maximum size of 6 mm and therefore is much larger than the size of iASDs reported for patients with a doublepuncture approach.4 As one can learn from this study, the size of the iASDs declines continuously with a mean size of 2.1 mm at 3-month FU and a mean size of 1.3 + 0.6 mm (maximum size 2 mm) at 6-month FU. When compared with iASDs after a doublepuncture approach where the size is small and the spontaneous closure rate is high after a 3-month period, the size of iASDs
Factors influencing the incidence of iatrogenic atrial septal defects Procedure time might play a role in the size and the persistence of an iASD due to more extensive sheath manipulation during long ablation procedures. In our study, procedure time (measured from transseptal puncture to the end of the ablation procedure) was not associated with larger diameters of iASDs or with persistence of iASDs at 6-month FU. Also the left atrial diameter or left atrial pressure could influence the size and closure rate of iASDs after PVI. In this study, there was no correlation between left atrial size or left atrial pressure with the incidence or size of iASDs. Importantly, in patients with persistence of iASDs after
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Incidence of iatrogenic atrial septal defects after different transseptal approaches
after a single-puncture double-transseptal approach is usually higher. Hammerstingl et al. reported iASDs with an average defect diameter of 0.4 mm at 9-month FU. When compared with their findings, the iASDs at 6-month FU in this study were much smaller, although the ablation procedure was performed with larger sheaths and the FU was performed earlier.5 An explanation for that finding might be that the position of the outer artisan sheath (although, in part, advanced into the left atrium) remains rather stable throughout the procedure as mainly the inner sheath is used for catheter navigation. During the manual approach, the ablation catheter, which is introduced in the left atrium (often without a sheath) usually, is more often manipulated into different directions and therefore the shear stress might be higher, resulting in longer persisting iASDs with larger size. Severe right to left shunting has been described in 22.2% of patients after manual PVI using the single-transseptal, doublepuncture approach.5 In this study, there was no spontaneous right to left shunting found in TEE either the day after the procedure or at 3 or 6 months FU; only continuous or intermittent left to right shunting was observed without haemodynamic compromise. Therefore, the use of larger transseptal sheaths necessary for ablation with the RNS is not associated with haemodynamically relevant iASDs.
336 the 3-month FU, the size of the iASD 1 day after the ablation procedure was larger and diabetes mellitus and female gender were correlated with the size at 3-month FU. Therefore, patients with large iASDs the day after the procedure or at 3-month FU as well as female patients and patients with diabetes mellitus might be at higher risk for persistence of the iASD, particularly when the RNS is used. In patients with persistent iASD at 6-month FU, the iASD at the day after ablation (not significant) as well as the size of the iASD at 3-month FU was larger compared with patients without iASD.
Clinical implications
Study limitations One limitation of the present study is that there exists no control group with patients in whom double-transseptal puncture has been performed using the RNS for PVI. In this respect, the incidence of iASDs after double-transseptal puncture for PVI with the RNS remains unclear. Further, the question remains, if doubletransseptal puncture or single-puncture, double-transseptal is the
most optimal approach for PVI with the RNS. Prospective randomized studies are necessary to solve this question.
Conclusion This prospective study shows that after PVI with a single-puncture, double-transseptal approach using the RNS, the iASDs show a high spontaneous closure rate of 78.9% after 6 months. Persistent iASDs following circular PVI with the RNS are not associated with an increased rate of clinically apparent paradoxical embolism or with haemodynamic relevant shunting. Conflict of interest: none declared.
References 1. O’Neill MD, Jaı¨s P, Hocini M, Sacher F, Klein GJ, Cle´menty J et al. Catheter ablation for atrial fibrillation. Circulation 2007;116:1515 –23. 2. Bidart C, Vaseghi M, Cesario DA, Mahajan A, Fujimura O, Boyle NG et al. Radiofrequency current delivery via transseptal needle to facilitate septal puncture. Heart Rhythm 2007;4:1573 – 6. 3. Elagha AA, Kocaturk O, Guttman MA, Ozturk C, Kim AH, Burton GW et al. Blunt atrial transseptal puncture using excimer laser in swine. J Vasc Interv Radiol 2008; 19:1347 –53. 4. Rillig A, Meyerfeldt U, Birkemeyer R, Treusch F, Kunze M, Jung W. Persistent iatrogenic atrial septal defect after pulmonary vein isolation: incidence and clinical implications. J Interv Card Electrophysiol 2008;22:177–81. 5. Hammerstingl C, Lickfett L, Jeong KM, Troatz C, Wedekind JA, Tiemann K et al. Persistence of iatrogenic atrial septal defect after pulmonary vein isolation—an underestimated risk? Am Heart J 2006;152:362.e1 –365. 6. Yamada T, McElderry HT, Epstein AE, Plumb VJ, Kay GN. One-puncture, doubletransseptal catheterization manoeuvre in the catheter ablation of atrial fibrillation. Europace 2007;9:487–9. 7. DI Biase L, Wang Y, Horton R, Gallinghouse GJ, Mohanty P, Sanchez J et al. Ablation of atrial fibrillation utilizing robotic catheter navigation in comparison to manual navigation and ablation: single-center experience. J Cardiovasc Electrophysiol 2009;20:1328 –35. 8. Schmidt B, Tilz R, Kars Neven K, Chun KR, Fuernkranz A, Ouyang F. Remote robotic navigation and electroanatomical mapping for ablation of atrial fibrillation. considerations for navigation and impact on procedural outcome. Circ Arrhythmia Electrophysiol 2009;2:120 – 8. 9. Homma S, Sacco RL. Patent foramen ovale and stroke. Circulation 2005;112: 1063 –72. 10. Lechat P, Mas JL, Lascault G, Loron P, Theard M, Klimczac M et al. Prevalence of patent foramen ovale in patients with stroke. New England. J Med 1988;318: 1148 –52. 11. Obel O, Mansour M, Picard M, Ruskin J, Keane D. Persistence of septal defects after transeptal puncture for pulmonary vein isolation procedures. Pacing Clin Electrophysiol 2004;27:1411 – 4. 12. Fuster V, Ryde´n LE, Cannom DS, Crijns HJ, Curtis AB, Ellenbogen KA et al. American College of Cardiology/American Heart Association Task Force on Practice Guidelines; European Society of Cardiology Committee for Practice Guidelines; European Heart Rhythm Association; Heart Rhythm Society. ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation): Developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. Circulation 2006;114:e257 –354. 13. Chilukuri K, Sinha S, Berger R, Marine JE, Cheng A, Nazarian S et al. Association of transseptal punctures with isolated migraine aura in patients undergoing catheter ablation of cardiac arrhythmias. J Cardiovasc Electrophysiol 2009;20:1227 –30.
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The risk for paradoxical thromboembolic events such as transient cerebral ischaemia or stroke in the presence of persistent foramen ovale (PFO) has been shown in several studies.9,10 To date, the thromboembolic risk associated with persistent iASDs has not yet been well defined,11 but seems to be low.4 Usually, anticoagulation is recommended for at least 3 months after PVI and often warfarin therapy is recommended for up to 6 months or even longer.12 In this study, patients received anticoagulation treatment for 3–6 months after the ablation procedure. As the risk for paradoxical thrombembolism is small in patients with PFO, thromboembolic events in patients with iASDs treated with phenprocoumon might be substantially low. Therefore, the size of this study population is not adequate to assess the risk of thromboembolic events such as paradoxical embolism. During the FU period, no patient from this study population reported symptoms indicative of transient cerebral ischaemia or stroke. Larger studies are necessary to answer the clinical relevance of iASDs with regard to cerebrovascular events. Larger sheaths with resulting larger iASDs raise the question if interatrial shunting might reach the level of haemodynamic relevance. Iatrogenic atrial septal defects with a diameter of up to 6 mm and intermittent or continuous left to right shunting have been shown in this study. Though the iASDs detected in this study were large in size, no patient suffered from symptoms or complications due to haemodynamic relevant interatrial shunting. Migraine aura with reversible visual symptoms has been reported in patients with iASDs after PVI.13 None of the patients in this study reported symptoms consistent with migraine aura.
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