16-27: Percutaneous Left Atrial Appendage Closure with WATCHMAN device: results from the TRAPS Registry

EP Europace, Jun 2016

Purpose of the study: The WATCHMAN device for Left Atrial Appendage occlusion (LAAO) has been found effective and non-inferior to the oral anticoagulation (OAC) in patients with atrial fibrillation, and is now adopted in clinical practice.

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16-27: Percutaneous Left Atrial Appendage Closure with WATCHMAN device: results from the TRAPS Registry

Steven Williams 1 3 4 5 7 8 Henry Chubb 1 3 4 5 7 8 James Harrison 1 3 4 5 7 8 Nick Linton 1 3 4 5 7 8 John Whitaker 1 3 4 5 7 8 Radoslaw Kiedrowicz 1 2 3 5 7 8 Jaswinder Gill 1 3 4 5 7 8 Michael Cooklin 1 3 4 5 7 8 Christopher Aldo Rinaldi 1 3 4 5 7 8 Steven Niederer 1 3 4 5 7 8 Reza Razavi 1 3 4 5 7 8 Matthew Wright 1 3 4 5 7 8 Mark O'Neill 1 3 4 5 7 8 0 P.O. Riunito-Ospedale Civile , Cirie` (TO) , Italy 1 Patrizio Mazzone 2 Szczecin , Poland 3 Frankfurt am Main , Germany 4 London , United Kingdom 5 Stefano Bordignon , Laura Perrotta, Daniela Dugo, Fabrizio Bologna, Alexander Fu ̈ rnkranz, Julian Chun, and Boris Schmidt 6 Mirano Hospital , Mirano (VE) , Italy 7 Zabrze , Poland 8 Katarzyna Mitrega , Witold Streb, Magdalena Szymala, Tomasz Podolecki, and Zbigniew Kalarus - Introduction: Left atrial fibrosis is thought to be associated with outcome after pulmonary vein isolation (PVI) in atrial fibrillation (AF) patients. Aim of this study is to determine (1) the incidence of bipolar left atrial (LA) electroanatomical scar (EA-S) in patients with AF undergoing PVI and (2) its correlation with LA conduction delay. Methods: Consecutive AF patients referred for PVI using an electroanatomical 3D mapping system were enrolled. The map was acquired during SR. Patients in which SR could not be restored after 2 DC cardioversion were excluded. After double transseptal puncture “time to LAA” was determined (TTLAA: P wave begin to first intracardiac LAA activation measured with a circumferential mapping catheter (CMC)). EA-S was defined as an area with a bipolar amplitude ,0.5 mV. Two groups were defined: group A, without EA-S, and group B, with presence of left atrial EA-S. Results: One hundred patients (61 male, 69 + 9 years, 41 paroxysmal AF (PAF), 59 persistent AF ( persAF)) were enrolled, 49/100 had no EA-S, group A, 51/100 presented an EA-S, group B. In group B patients were significantly older (74 + 6 vs. 64 + 9 years; p , 0.001), were mostly female (29/51 (57%) vs. 10/49 (20%), p , 0.001) and had a history of arterial hypertension (44/51 (86%) vs 30/49 (61%), p , 0.001). EA-S were localized in the left atrial anterior wall in 48/51 patients (94%), while EA-S in the lateral wall were rare (6/51 pts, 11,8%). Septal, posterior, roof and inferior EA-S were identified in the 65%, 39%, 39% and 22% of patients of group B, respectively. TTLAA was significantly longer in patients with LAEA-S (122 + 43 vs. 84 + 22 ms, group B and group A, respectively p , 0.001). P wave duration was longer in group B (133 + 28 vs. 119 + 18 ms, p ¼ 0.009). PVI was achieved in all patients without major complications. Follow up is ongoing to clarify the clinical role after a PVI procedure of EA-S and interatrial conduction delay. Conclusion: Age, female sex and hypertension are risk factors for EA-S. Sinus rhythm conduction time to LAA is significantly longer in patients presenting with left atrial EA-S. Conflict of interest: none Purpose of the study: The WATCHMAN device for Left Atrial Appendage occlusion (LAAO) has been found effective and non-inferior to the oral anticoagulation (OAC) in patients with atrial fibrillation, and is now adopted in clinical practice. Method used: The TRAPS registry is an observational, multicenter registry involving 4 Italian centers. Patients who underwent LAAO with WATCHMAN device were enrolled, and clinical, demographic and procedural data were collected. Summary of results: In this analysis we included 148 patients. Mean age was 73 + 8 years, 57% of patients were male, 22% had heart failure, 10% had a history of transient ischemic attack, 23% a history of ischemic stroke and 72% a history of bleeding. The baseline CHADS2 score was 2.4 + 1.3, the CHADsVASc score was 3.9 + 2.8 and the HAS-BLED score was 3.3 + 1.1. 57% of the patients were on OAC at the time of implantation. The device was successfully positioned in all patients with no or minimal (, 5mm) leakage, assessed by peri-procedural transesophageal echo. Following intra-procedural complications were reported: 2 pericardial effusions treated with pericardiocentesis, 1 device-associated thrombus formation treated with aspiration, and 1 vascular access dissection. Moreover, device embolization was reported in 1 patient early after the implantation and the device was successfully snared in the iliac bifurcation. The overall rate of adverse events within 7 days was therefore (5/148 ¼ 3.3%). In the present experience, device size was chosen 20% greater than the LAA diameter in 68% of patients. Comparing the first half with the second half of the study cohort, the procedure duration decreased from 89min to 64min ( p , 0.0001). Conclusion: The success rate in LAAO with WATCHMAN was high, and the rate of adverse events was low. We reported an experience-related improvement in procedural duration. Conflict of interest: none PERCUTANEOUS LEFT ATRIAL APPENDAGE CLOSURE WITH WATCHMAN DEVICE: RESULTS FROM THE TRAPS REGISTRY RESIDUAL LEAKS AFTER LEFT ATRIAL APPENDAGE CLOSURE IN CORRELATION TO THE SHAPE OF OSTIUM AND LENDING ZONE ELECTRICAL REMODELING DOES NOT REPRODUCIBLY MIRROR STRUCTURAL CHANGE ON ATRIAL MRI Purpose of the Study: Left atrial (LA) late gadolinium enhancement (LGE) CMR has been proposed to guide ablation therapy and predict procedure outcome. AF electrical and structural remodeling are known to occur to varying extents in patients with AF. The extent to which pre-procedural LGE CMR reflects LA electrophysiological remodeling is unknown. Methods Used: Intracardiac contact mapping during programmed stimulation was used to characterize conduction delay, activation dispersion, electrogram morphology and AF vulnerability in 8 patients undergoing first-time pulmonary vein isolation. Pre-procedural LGE CMR imaging was performed and quantified by LGE signal intensity (SI; image intensity ratio, IIR), % LGE area and LA sphericity indices. Summary of Results: Although electrogram voltage was significantly reduced at areas of high SI (IIR . 0.97 0.9mV vs 1.3mV P ¼ 0.049), IIR showed no relationship with electrogram duration (17.7ms vs 18.3ms, P ¼ 0.673), conduction delay (322ms vs 316ms, P ¼ 0.3939) or conduction block (262ms vs. 262ms, P ¼ 0.8667). There was no relationship between % LGE area or sphericity and any of the LA remodeling parameters (all P . 0.05). LA extrastimulus conduction curves showed significant variation between patients with similar LGE CMR findings (Figure). Conclusions: Although these results confirm that electrogram voltage may be significantly reduced at areas of high LGE signal intensity, other markers of LA remodeling showed significant variation between patients with similar LGE appearances. These findings may have important implications for patient-tailored ablation strategies guided by the integration of electrical and structural information. Conflict of interest: none Age [years] Male HASBLED CHA2DS2VASc HA [n] DM t.2 [n] CHD [n] AF paroxysmal [n] Residual leak Device thrombosis Pericardial effusion Background: Left atrial appendage occlusion is a method of stroke prevention in atrial fibrillation patients. The protective effect of LAA elimination may be deteriorated by periocclcuder leakage. Inadequate occlude sizing is a known risk factor for a leak occurrence, however additional factors may be important. Aim: The current study was aimed to assess the relation between morphology of left atrial appendage ostium and the shape of landing zone chosen for occluder implantation, and the residual leak incidence. Methods: 40 consecutive patients (79 + 8 years; 57% male) underwent LAA occlusion with Amplatzer Cardic Plug or Amplatzer Amulet. During LAA occlusion the patients were anesthetized and the transesophageal echocardiography (TOE) was performed. The shape of ostium and lending zone was assessed based on two perpendicular measurements (r1, r2) of each using 3-D TOE. The patients were divided to group with elliptic shape of LAA ostium and lending zone (r1 - r2 . 4 mm) or the regular one (r1 - r2 4 mm). Statistical analysis was performed using Yates x2 test. Results: Mean values of LAA ostium diameters measured in two perpendicular axis using 3-D TOE were 29.6 + 5.3 and 24.8 + 4.5 mm. Mean values of LAA lending zone dimensions also measured in two perpendicular axis were 21.4 + 3.8 and 17.1 + 4.1 mm. In patients with elliptic shape of LAA ostium (n ¼ 18; 45%) 27% (n ¼ 5) had residual leak in TOE, whereas in patients with regular shape of LAA ostium none residual leak was observed. The elliptic shape of LAA lending zone was found in 19 patients (47.5%) and 26% of those patients had diagnosed residual leak. Patients with regular shape of lending zone had no residual leak. The comparison of different shapes of LAA ostium or lending zone and residual leak incidence showed the significant differences for the elliptic and regular shape (P ¼ 0.03, P ¼ 0.04 respectively). Conclusions: In patients with regular shape of LAA ostium or lending zone statistically less residual leaks were observed.Table 1Group characteristic HA – atrial hypertension; DM t.2 – diabetes mellitus type 2; CHD – coronary heart disease; AF – atrial fibrillation Conflict of interest: none 70 + 8

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Mazzone, Patrizio, Angelo, Giuseppe D, Regazzoli, Damiano, Molon, Giulio, Senatore, Gaetano, Saccà, Salvatore, Canali, Guido, Amellone, Claudia, Turri, Riccardo, Bella, Paolo Della. 16-27: Percutaneous Left Atrial Appendage Closure with WATCHMAN device: results from the TRAPS Registry, EP Europace, 2016, i7, DOI: 10.1093/europace/18.suppl_1.i7b