Added value of transoesophageal echocardiography during transseptal puncture performed by inexperienced operators

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1 Europace (2012) 14, doi: /europace/eur366 CLINICAL RESEARCH Ablation for Atrial Fibrillation Added value of transoesophageal echocardiography during transseptal puncture performed by inexperienced operators Fatih Bayrak*, Gian-Battista Chierchia, Mehdi Namdar, Yoshinao Yazaki, Andrea Sarkozy, Carlo de Asmundis, Stephan Andreas Muller-Burri, Jayakeerthi Rao, Danilo Ricciardi, Antonio Sorgente, and Pedro Brugada Heart Rhythm Management Center, UZ Brussels-VUB, Laarbeeklaan 101, Brussel 1090, Belgium Received 11 September 2011; accepted after revision 24 October 2011; online publish-ahead-of-print 23 November 2011 Aims Transseptal puncture (TP) appears to be safe in experienced hands; however, it can be associated with life-threatening complications. The aim of our study was to demonstrate the added value of routine use of transoesophageal echocardiography (TEE) for the correct positioning of the transseptal system in the fossa ovalis, thus potentially preventing complications during fluoroscopy-guided TP performed by inexperienced operators.... Methods Two hundred and five patients undergoing pulmonary vein isolation procedure (PVI) for drug-resistant paroxysmal or and results persistent atrial fibrillation were prospectively included. When the operator (initially blinded to TEE) assumed that the transseptal system was in a correct position according to fluoroscopical landmarks, the latter was then checked with TEE unblinding the physician. If necessary, further refinement of the catheter position was performed. Refinement.10 mm, or in case of catheter pointing directly at the aortic root or posterior wall were considered as major repositioning. Thirty-four patients required major repositioning. Regression analysis revealed age (P: , Wald: 12.9, 95% confidence interval: ), left atrial diameter (P: 0.01, Wald: 6.6, 95% confidence interval: ), previous PVI (P: 0.01, Wald: 6.3, 95% confidence interval: ), and atrial septal thickness (P: 0.03, Wald: 4.5, 95% confidence interval: ) as independent predictors of major revision with TEE.... Conclusion Routine 2D TEE in addition to traditional fluoroscopic TP appears to be very useful to guide the TP assembly in a correct puncture position and thus, to avoid TP-related complications. However, further randomized prospective comparative studies are necessary to support these suggestions Keywords Ablation Atrial fibrillation Echocardiography Transseptal puncture Background Atrial fibrillation (AF) is the most common supraventricular arrhythmia characterized by rapid and irregular atrial activation with consequent deterioration of the chamber s mechanical function. Although traditionally treated medically, the recent discovery of the role of pulmonary vein (PV) potentials in the genesis of this arrhythmia 1,2 has led to pulmonary vein isolation (PVI) with ablation techniques. Pulmonary vein isolation is a left-sided procedure that requires transseptal access through the interatrial septum. Transseptal puncture (TP) is usually safe in experienced hands. 3,4 However, it can be associated with life-threatening complications. 5 As a successful performance of TP is mandatory for ablation procedure, this technique remains challenging particularly in inexperienced hands, especially when facing difficult anatomies or during repeat AF ablation procedures. 6 9 Transoesophageal echocardiography (TEE) is a cardiac imaging technique that gives precise information on cardiac anatomy. To date, no randomized trial comparing clinical outcomes and success rates between TEE-guided and traditional fluoroscopic TP is available. Many studies conclude that cardiac imaging may * Corresponding author. Tel: ; fax: , dfatihbayrak@yahoo.com Published on behalf of the European Society of Cardiology. All rights reserved. & The Author For permissions please journals.permissions@oup.com.

2 662 F. Bayrak et al. be better than fluoroscopy for guiding TP, 10,11 especially in less experienced hands, but the advantages of routine use of imaging modalities have not yet been demonstrated. The aim of our study was to assess the added value of routine use of 2D TEE for the correct positioning of the transseptal system in the fossa ovalis (FO), thus potentially preventing complications during traditional fluoroscopy-guided TP in a training centre where the TP is performed by electrophysiology fellows with limited experience under the guidance of experienced electrophysiologists. Patients and methods Two hundred and thirteen consecutive patients with drug-resistant paroxysmal or persistent AF (.18 years old) who were planned to undergo PVI with 3D electroanatomical mapping (Carto 3, Biosense Webster, Diamond Bar, CA, USA) at our institution between February 2010 and July 2011 were prospectively included. Patients with thrombus material at 2D TEE in the left atrial appendage,24 h before ablation (seven patients) and with contraindication to TEE (one patient with oesophageal diverticula) were excluded. The remaining 205 patients represented the study population. Written informed consent was obtained from every patient according to our institutional guidelines. Clinical parameters such as age, gender, risk factors, cardiovascular history, underlying structural heart disease, type of AF (paroxysmal, persistent), duration of AF, and previous ablations were recorded for all patients. Transseptal puncture procedure The TP procedure was performed under general anaesthesia. A 6 F quadripolar diagnostic catheter (Biosense Webster) was placed in the His bundle-region and a 8 F steerable decapolar catheter (Biosense Webster) was inserted in the coronary sinus via the right jugular vein in all cases. The TP sheath and dilator were advanced into the superior vena cava (SVC) over a guidewire via the femoral vein. After removing the guidewire and aspirating and flushing the dilator, the Brockenbrough needle (BRK-1, St Jude Medical, Minneapolis, MN, USA) was inserted in the dilator. Thereafter, the sheath/dilator/needle assembly was slowly withdrawn together while monitoring mono or biplane fluoroscopy. Under fluoroscopic guidance (antero-posterior projection), during gradual sheath/dilator/needle withdrawal oriented between 3:30 and 5:30 o clock handle position, the FO was engaged, indicated by a sudden displacement of the sheath tip and/or tenting of the septum. The septal localization was also confirmed by contrast injection through the needle and demonstration of tenting of the septum in both antero-posterior and left-lateral fluoroscopic projections. Until this point the operator was blinded to TEE (GE TEE probe and VIVID-I echocardiography machine, GE Vingmed Ultrasound AS, Horten, Norway). When the operator assumed that the transseptal needle was in a correct position for TP according to fluoroscopical landmarks, the latter was then checked with TEE unblinding the physician. If necessary, further refinement of the catheter position was performed at mid-oesophageal 45 and Correction of the orientation.10 mm, or in the case of catheter pointing directly at the aortic root or posterior wall were considered as major repositioning. Refinement of position of,10 mm was considered as minor repositioning. In any case, repositioning was targeted to perform the TP in the mid or midposterior portion of the FO (Figure 1). All 2D TEE images were stored digitally. For the transseptal puncture, the tenting before and after access into the left atrium (LA) at mid-oesophageal 45 and 1208 were stored. During tenting and after puncture, distances between the puncture site to LA posterior wall and aortic wall at 458 were noted. Echocardiographic parameters such as left ventricle (LV) dimensions as well as ejection fraction, eventual valvular diseases, detailed evaluation of LA dimensions, and any presence of LA thrombus were recorded for all patients. After refinement of the catheter position with TEE guidance, LA access was obtained by passing the needle extended through the dilator. Once the needle was removed, the guidewire was advanced in the left superior PV. The sheath was advanced over the dilator and positioned in the LA, after which the dilator was removed. After gaining LA access a 70 UI/kg heparin intravenous bolus was given. Activated clotting time (ACT) was maintained 250 s during the procedure. Success rate was evaluated in terms of number of puncture attempts to gain access to the LA. Procedural time was quantified as the time from catheter positioning in SVC to time of LA access. Safety was evaluated in terms of complications (mild pericardial effusion noted on echocardiogram related to TP, major systemic arterial embolization, cardiac tamponade, accidental puncture of aortic root and right atrium, cardiac death related to TP). Comparison of the data between patients with and without major repositioning of catheter following TEE and also between patients with and without complications was made. Transseptal punctures are performed by four operators all of whom had limited experience (.20 and,40 TP performed as primary operator with guidance of experienced operators) in the field. Statistical analysis Data were analysed using SPSS for Windows (version 15.0, SPSS Inc., Chicago, IL, USA). Continuous variables are expressed as mean + SD. Comparisons were made using Student s t-test, Mann Whitney U test, Fisher s exact test, or x 2 test, as appropriate. Multivariate Cox regression analysis was performed to detect independent predictors of major repositioning with TEE. We examined the sensitivity and specificity of various cut-off values of age and LA diameter for major repositioning with TEE and created receiver-operating characteristic curves. Results Mean age of the patients was years (150 males, 73%), 137 patients (66%) presented with paroxysmal AF, 47 (22%) underwent PVI as a repeat procedure, mean duration of AF was years, mean LA diameter mm, and mean LV ejection fraction %. Overall successful transseptal access was achieved in 204 of 205 patients (99%). The mean procedural time was s (range, s) and mean fluoroscopy time was s (range, s). In 21 of 30 patients (70%) with patent foramen ovale (PFO), the puncture was performed at a more posterior region without passing through the PFO. In 7 of 10 patients (70%) with iatrogenic atrial septal defect secondary to previous TP, it was possible to pass the septum through the latter under the guidance of TEE. Three patients experienced complications (two pericardial effusion without tamponade, one cardiac tamponade handled with subxiphoidal pericardial puncture and drainage) during TP under TEE guidance. Patients with complications were older (P: 0.05),

3 Echocardiography during transseptal puncture 663 Figure 1 Transoesophageal echocardiography images demonstrating a major repositioning. (A) Baseline mid-oesophageal 458 transoesophageal echocardiography image showing aorta, posterior left atrial wall, and interatrial septum. (B) Transoesophageal echocardiography image showing anteriorly oriented transseptal system pointing aorta (arrow indicating the tip of the transseptal system) before repositioning with transoesophageal echocardiography. (C) Transoesophageal echocardiography image showing transseptal system in the mid-part of atrial septum during tenting after major repositioning. (D) Transoesophageal echocardiography image showing transseptal system over the septum after transseptal puncture. had larger LA diameters (P: 0.01) and also had a significantly higher probability of major repositioning (P: 0.01) under TEE guidance. The patient with cardiac tamponade was a 52-year-old male, underwent a re-do PVI due to persistent AF (4 years), and had a LA diameter of 49 mm. Most probably, the underlying cause for the complication was a floppy interatrial septum and a prominent jump of the catheter towards lateral free wall of the LA. Thrombus material at the tip of transseptal sheath before puncture was detected in three patients. In all patients the sheaths were retracted back with successful aspiration of the material. Of the 205 patients included, 34 required major repositioning (2 patients with the catheter pointing to the aortic root, 1 patient with the catheter pointing towards the posterior LA wall, and 31 cases of repositioning of.10 mm), 61 required minor repositioning of the catheter following TEE (110 patients without repositioning). In the last 3 months of the study inclusion period, only four major revisions were performed which demonstrates the progressive improvement in the performance of the operators, and a possible decrease in the need for routine TEE over the time in concordance with increased experience. Comparison of baseline clinical, echocardiographical, and fluoroscopical characteristics of the patients with and without major repositioning is demonstrated in Table 1. Patients with major repositioning were significantly older, had a higher prevalence of persistent AF and a previous PVI, longer duration of AF, lower LV EF, larger LA diameter, thicker interatrial septum, longer fluoroscopy times, and higher incidence of complications even after major repositioning with TEE. Regression analysis revealed age (P: , Wald: 12.9, 95% confidence interval: ), LA diameter (P: 0.01, Wald: 6.6, 95% confidence interval: ), previous PVI procedure (P: 0.01, Wald: 6.3, 95% confidence interval: ), and atrial septal thickness (P: 0.03, Wald: 4.5, 95% confidence interval: ) as independent predictors of major revision with TEE. We examined the sensitivity and specificity of various cut-off values of age and LA diameter for predicting major repositioning with TEE and created receiver operating characteristic curves. The best value of age with the highest sensitivity (82%) and specificity (63%) was 55 years (area under the curve 0.75), and the best value of LA diameter with the highest sensitivity (79%) and specificity (77%) was 44 mm (area under the curve 0.79) (Figure 2). Discussion Our findings demonstrate that a high percentage of patients (16%) undergoing a TP by an inexperienced operator still require a major catheter repositioning to potentially avoid possible complications

4 664 F. Bayrak et al. Table 1 Comparison of patients with and without major revision of catheter position after transoesophageal echocardiography Variable Patients Patients with P without MR MR n n Female gender 46 (26%) 9 (29%) NS Age (years) Hypertension 59 (34%) 14 (41%) NS Diabetes mellitus 17 (9%) 3 (8%) NS Coronary artery 11 (6%) 5 (14%) NS disease CVA 11 (6%) 3 (8%) NS Paroxysmal AF 120 (70%) 17 (50%) 0.02 Duration of AF (years) Previous PVI 28 (16%) 19 (55%) Fluoroscopical second 110 (64%) 16 (47%) NS jump Number of puncture attempts Fluoroscopy time (s) LA diameter (mm) LV ejection fraction (%) Septal thickness (mm) Complications 1 (0.5%) 2 (5%) 0.01 Hypertension, systolic blood pressure 140 mmhg and/or diastolic blood pressure 90 mmhg and/or the use of any antihypertensive medication; CAD, atherosclerotic coronary artery disease; CVA, cerebrovascular accident; AF, atrial fibrillation; LA, left atrial diameter; PVI, pulmonary vein isolation procedure; MR, major revision. Figure 2 Receiver-operating characteristic curves of age and left atrial diameter for predicting major repositioning with transoesophageal echocardiography. P: for age, P: for left atrial diameter. after traditional fluoroscopical positioning of the TP system according to His and coronary sinus catheter landmarks by the stepwise implementation of TEE. Three possible major complications might have been avoided with the help of TEE imaging (two aortic punctures and one posterior wall puncture). A major complication occurred even after a major catheter repositioning. Number of necessary major revisions decreased by time (only four major revisions during the last 3 months) which demonstrates the progressive improvement in the performance of the operators, and a possible decrease in the need for routine TEE over the time in concordance with increased experience. A major repositioning with TEE is more probable in older patients with persistent AF, re-do PVI, longer duration of AF, lower LV EF, larger LA diameter, and a thicker interatrial septum. Advanced age, larger LA diameter, previous PVI procedure, and atrial septal thickness were independent predictors of a major repositioning with TEE. Importantly, patients with complications were significantly older, had larger LA diameters and had significantly higher rate of major repositioning when compared with patients without complications. Thus, these findings suggest that a major repositioning is more likely in patients with a higher general procedural risk of complications. Transseptal puncture performed under fluoroscopic guidance appears to be safe in experienced hands, but can be associated with major complications such as aortic root puncture or left posterior wall injury with consequent pericardial effusion or in worst cases, cardiac tamponade (1.31%), and can lead to death (0.15%). 5 A recent large multicentre Italian survey (5520 TP procedures) reported severe complications (including one death), although the overall complication rate was low (0.79% in 2003 and 0.74% in the previous years), 12 Of note, patients in whom echocardiography guidance was used were also included in this survey. Furthermore, 6 8 A substantial number of patients require a second left atrial procedure after ablation of AF. Compared with the first procedure, the repeat transseptal catheterization after the ablation for AF might be more challenging and potentially associated with more complications. 9 To reduce the incidence of complications and to overcome difficult septal anatomies, TP can be done under TEE or intracardiac echocardiography (ICE) guidance that allow direct visualization of the tip of the TP needle within the FO and thus, a safe TP in almost all patients. 10,11,13 15 All of these studies suggest indirectly that the use of echocardiography may increase the safety of the procedure, but to date there is no data to prove this directly. Although TEE requires a high level of sedation and is sometimes poorly tolerated, ICE requires an additional expertise, significantly increases the cost of the procedure, increases the risk of puncture site complications 16, and is not available in most centres. The echocardiographic guidance also enables a selective site puncture within the FO. A lower and more posterior puncture is favoured for ablation of AF. Although it is difficult to quantify the benefit of such a selective site puncture, Knecht et al. 17 have clearly demonstrated that isolation of the PVs performed via a PFO is more difficult for both the left- and right-sided PVs and takes significantly longer time. As demonstrated by our data, it was possible to avoid an LA access through the PFO in 70% of the cases with TEE guidance.

5 Echocardiography during transseptal puncture 665 One of the usually neglected advantages of echocardiographic guidance during the TP is the possibility of detecting a silent thrombus on TP catheters. In AF patients, the risk of thrombus formation is high despite the anticoagulation to an ACT of 250 s. 18 In our study, it was possible to aspirate a silent catheter thrombus in three cases without further complications. Even though our study is not a randomized comparison of classical fluoroscopical TP and TEE-guided TP, it demonstrates the added value and also the limitations of TEE with respect to TP safety, which to our knowledge has never been done before. The decision whether to use routine TEE or not should be individualized based on the experience of the operator as well as the challenges encountered in each patient. Accordingly, it might be conceivable to use the TEE as a standard practice for safety reasons particularly for inexperienced operators, whereas experienced operators exhibiting a relatively low overall complication rate (,0.1%) may keep the TEE as an additional help for especially challenging cases, such as older patients with persistent AF, re-do PVI, longer duration of AF, lower LV EF, larger LA diameter, thicker interatrial septum. Conclusion Routine 2D TEE in addition to traditional fluoroscopic TP appears to be very useful to guide the TP assembly in a correct puncture position for inexperienced operators and, thus, to considerably avoid otherwise difficult to anticipate major procedure-related complications. However, further studies with direct comparison of TP guided by TEE with fluoroscopic approach are necessary to support these suggestions. Conflict of interest: P.B. discloses that his institution has received research grants and himself speaker fees from Medtronic, Boston Scientific, St Jude Medical, Biosense Webster, and Biotronik. Funding None. References 1. Chen YJ, Chen SA. Electrophysiology of the pulmonary veins. J Cardiovasc Electrophysiol 2006;17: Haïssaguerre M, Jaïs P, Shah DC, Takahashi A, Hocini M, Quiniou G et al. Spontaneous initiation of atrial fibrillation by ectopic beats originating in the pulmonary veins. N Engl J Med 1998;339: Fagundes RL, Mantica M, De Luca L, Forleo G, Pappalardo A, Avella A et al. Safety of single transseptal puncture for ablation of atrial fibrillation: retrospective study from a large cohort of patients. J Cardiovasc Electrophysiol 2007;18: Hanaoka T, Suyama K, Taguchi A, Shimizu W, Kurita T, Aihara N et al. Shifting of puncture site in the fossa ovalis during radiofrequency catheter ablation: intracardiac echocardiography guided transseptal left heart catheterization. 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