Same-day discharge following catheter ablation and venous closure with VASCADE MVP: A postmarket registry.

INTRODUCTION: Early and safe ambulation can facilitate same-day discharge (SDD) following catheter ablation, which can reduce resource utilization and healthcare costs and improve patient satisfaction. This study evaluated procedure success and safety of the VASCADE MVP venous vascular closure system in patients with atrial fibrillation (AF). METHODS: The AMBULATE SDD Registry is a two-stage series of postmarket studies in patients with paroxysmal or persistent AF undergoing catheter ablation followed by femoral venous access-site closure with VASCADE MVP. Efficacy endpoints included SDD success, defined as the proportion of patients discharged the same day who did not require next-day hospital intervention for procedure/access site-related complications, and access site sustained success within 15 days of the procedure. RESULTS: Overall, 354 patients were included in the pooled study population, 151 (42.7%) treated for paroxysmal AF and 203 (57.3%) for persistent AF. SDD was achieved in 323 patients (91.2%) and, of these, 320 (99.1%) did not require subsequent hospital intervention based on all study performance outcomes. Nearly all patients (350 of 354; 98.9%) achieved total study success, with no subsequent hospital intervention required. No major access-site complications were recorded. Patients who had SDD were more likely to report procedure satisfaction than patients who stayed overnight. CONCLUSION: In this study, 99.7% of patients achieving SDD required no additional hospital intervention for access site-related complications during follow-up. SDD appears feasible and safe for eligible patients after catheter ablation for paroxysmal or persistent AF in which the VASCADE MVP is used for venous access-site closure.

Three-dimensional intracardiac echocardiography for left atrial appendage sizing and percutaneous occlusion guidance.

AIMS: Left atrial appendage (LAA) imaging is critical during percutaneous occlusion procedures. 3D-intracardiac echocardiography (ICE) features direct visualization of LAA from multiple cross-sectional planes at a time. We aimed at reporting procedural success of 3D-ICE-guided LAA occlusion and the correlation between pre-procedural transoesophageal echocardiography (TEE) and intraprocedural 3D-ICE for LAA sizing. METHODS AND RESULTS: Among 274 patients undergoing left atrial appendage occlusion (LAAO) with a Watchman FLX, periprocedural ICE guidance was achieved via a commercially available 2D-ICE catheter (220 patients) or a novel (NUVISION™) 3D-ICE one (54 patients). Primary endpoint was a composite of procedural success and LAA sealing at follow-up TEE. Secondary endpoint was a composite of periprocedural device recapture/resizing plus presence of leaks ≥ 3 mm at follow-up TEE. 3D-ICE measurements of maximum landing zone correlated highly with pre-procedural TEE reference values [Pearson's: 0.94; P < 0.001; bias: -0.06 (-2.39, 2.27)]. The agreement between 3D-ICE-based device selection and final device size was 96.3% vs. 79.1% with 2D-ICE (P = 0.005). The incidence of the primary endpoint was 98.1% with 3D-ICE and 97.3% with 2D-ICE (P = 0.99). 2D-ICE patients had a trend towards a higher incidence of periprocedural device recapture/redeployment (31.5% vs. 44.5%; P = 0.09). The secondary endpoint occurred in 31.5% of 3D-ICE patients vs. 45.9% of 2D-ICE ones (P = 0.065). CONCLUSION: Intracardiac echocardiography-guided LAAO showed a very high success, with no major adverse events. A very high level of agreement for LAA sizing was found between pre-procedural TEE and periprocedural 3D-ICE. 3D-ICE performed significantly better than 2D-ICE for FLX size selection and may provide better guidance during device deployment.

Intracardiac echocardiography- versus transesophageal echocardiography-guided left atrial appendage occlusion with Watchman FLX.

INTRODUCTION: Watchman FLX has been recently approved for left atrial appendage occlusion (LAAO) in the US. Intracardiac echocardiography (ICE) - which is already commonly used to guide trans-septal access - can serve as an alternative to TEE, simplifying the procedure and reducing associated costs. Herein, we report our experience with ICE-guided LAAO with Watchman FLX. METHODS AND RESULTS: This cohort study included the first 190 consecutive patients who underwent LAAO with Watchman FLX in our center. LAAO was successful in all patients without significant peri-procedural, device-related complications in either group. Compared to TEE, we observed a significant reduction in procedural times when using ICE. In addition, there was a potentially clinically relevant reduction in fluoroscopy dose, mainly secondary to fewer cine acquisition runs. At follow-up, no cases of device embolism were noted, whereas the rate of device-related thrombosis and peri-device leaks were comparable between groups. CONCLUSION: ICE-guided LAAO with Watchman FLX is safe and feasible, with a significant reduction in procedural time and potential reduction in fluoroscopy dose when compared to TEE.

Clinical presentation, diagnosis, and treatment of atrioesophageal fistula resulting from atrial fibrillation ablation.

BACKGROUND: Atrioesophageal fistula (AEF) is a worrisome complication of atrial fibrillation (AF) ablation. Its clinical manifestations and time course are unpredictable and may contribute to diagnostic and treatment delays. We conducted a systematic review of all available cases of AEF, aiming at characterizing clinical presentation, time course, diagnostic pitfalls, and outcomes. METHODS: The digital search retrieved 150 studies containing 257 cases, 238 (92.6%) of which with a confirmed diagnosis of AEF and 19 (7.4%) of pericardioesophageal fistula. RESULTS: The median time from ablation to symptom onset was 21 days (interquartile range [IQR]: 11-28). Neurological abnormalities were documented in 75% of patients. Compared to patients seen by a specialist, those evaluated at a walk-in clinic or community hospital had a significantly greater delay between symptom onset and hospital admission (median: 2.5 day [IQR: 1-8] vs. 1 day [IQR: 1-5); p = .03). Overall, 198 patients underwent a chest scan (computed tomography [CT]: 192 patients and magnetic resonance imaging [MRI]: 6 patients), 48 (24.2%; 46 CT and 2 MRI) of whom had normal/unremarkable findings. Time from hospital admission to diagnostic confirmation was significantly longer in patients with a first normal/unremarkable chest scan (p < .001). Overall mortality rate was 59.3% and 26.0% survivors had residual neurological deficits at the time of discharge. CONCLUSIONS: Since healthcare professionals of any specialty might be involved in treating AEF patients, awareness of the clinical manifestations, diagnostic pitfalls, and time course, as well as an early contact with the treating electrophysiologist for a coordinated interdisciplinary medical effort, are pivotal to prevent diagnostic delays and reduce mortality.

Half-normal saline versus normal saline for irrigation of open-irrigated radiofrequency catheters in atrial fibrillation ablation.

BACKGROUND: The creation of effective and permanent lesions is a crucial factor in determining the success rate of atrial fibrillation (AF) ablation. By increasing the efficacy of radiofrequency (RF) energy-mediated lesion formation, half-normal saline (HNS) as an irrigant for open-irrigated ablation catheters has the potential to reduce procedural times and improve acute and long-term outcomes. METHODS: This is a double-blind randomized clinical trial of 99 patients undergoing first-time RF catheter ablation for AF. Patients enrolled were randomly assigned in a 1:1 fashion to perform ablation using HNS or normal saline (NS) as an irrigant for the ablation catheter. RESULTS: The use of HNS is associated with shorter RF times (26 vs. 33 min; p = .02) with comparable procedure times (104 vs. 104 min). The rate of acute pulmonary vein reconnections (16% vs. 18%) was comparable, with a median of 1 vein reconnection in the HNS arm versus 2 in the NS arm. There was no difference in procedure-related complications, including the incidence of postprocedural hyponatremia when using HNS. Over the 1-year follow-up, there is no significant difference between the HNS and NS with respect to the recurrence of any atrial arrhythmia (off antiarrhythmic drugs [AAD]: 47% vs. 52%; hazard ratio [HR]: 1.17, 95% confidence interval [CI]: 0.66-2.06; off/on AAD: 66% vs. 66%, HR: 1.06, 95% CI: 0.53-2.12), with a potential benefit of using HNS when considering the paroxysmal AF cohort (on/off AAD 73% vs. 62%, HR: 0.72, 95% CI: 0.19-2.70). CONCLUSIONS: In a mixed cohort of patients undergoing first-time AF ablation, irrigation of open-irrigated RF ablation catheters with HNS is associated with shorter RF times, with a comparably low rate of procedure-related complications. In the long term, there is no significant difference with respect to the recurrence of any atrial arrhythmia. Larger studies with a more homogeneous population are necessary to determine whether HNS improves clinical outcomes.

Targeting non-pulmonary vein triggers in persistent atrial fibrillation: results from a prospective, multicentre, observational registry.

AIMS: We evaluated the efficacy of an ablation strategy empirically targeting pulmonary veins (PVs) and posterior wall (PW) and the prevalence and clinical impact of extrapulmonary trigger inducibility and ablation in a large cohort of patients with persistent atrial fibrillation (PerAF). METHODS AND RESULTS: A total of 1803 PerAF patients were prospectively enrolled. All patients underwent pulmonary vein antrum isolation (PVAI) extended to the entire PW. A standardized protocol was performed to confirm persistent PVAI and elicit any triggers originating from non-PV sites. All non-PV triggers initiating sustained atrial tachyarrhythmias were ablated. Ablation of non-PV sites triggering non-sustained runs (<30 s) of atrial tachyarrhythmias or promoting frequent premature atrial complexes (≥10/min) was left to operator's discretion. Overall, 1319 (73.2%) patients had documented triggers from non-PV areas. After 17.4 ± 8.5 months of follow-up, the cumulative freedom from atrial tachyarrhythmias among patients without inducible non-PV triggers (n = 484) was 70.2%. Patients with ablation of induced non-PV triggers had a significantly higher arrhythmia control than those whose triggers were not ablated (67.9% vs. 39.4%, respectively; P < 0.001). After adjusting for clinically relevant variables, patients in whom non-PV triggers were documented but not ablated had an increased risk of arrhythmia relapse (hazard ratio: 2.39; 95% confidence interval: 2.01-2.83; P < 0.001). CONCLUSION: Pulmonary vein antrum isolation extended to the entire PW might provide acceptable long-term arrhythmia-free survival in PerAF patients without inducible non-PV triggers. In our population of PerAF patients, non-PV triggers could be elicited in ∼70% of PerAF patients and their elimination significantly improved outcomes.

Association between prolonged P wave duration and left atrial scarring in patients with paroxysmal atrial fibrillation.

BACKGROUND: We evaluated the association of P wave duration (PWD) with left atrial scar (LAS) in patients with paroxysmal atrial fibrillation (PAF). METHODS: Consecutive patients with PAF undergoing their first catheter ablation were screened and only those in sinus rhythm at baseline were included in the analysis. A standard 12-lead electrocardiogram (ECG) was performed in all and three-dimensional voltage mapping of the left atrium was generated for identification of low-voltage areas (≤0.2 mV) before the procedure. RESULTS: In total, 411 patients with PAF were included in this study of which 181 had LASs (scar group), while 230 had no scar (nonscar group). In the scar group, patients were older (65.5 ± 8.8 vs 59.7 ± 11.7 years; P < .001), the proportion of female was higher (47.5% vs 37.4%; P = .04) and left atrial (LA) diameter (4.1 ± 0.6 vs 3.9 ± 0.6 cm; P < .001) was larger compared with the nonscar group. There was no significant difference in terms of hypertension, sleep apnea, and diabetes between the two groups. When comparing ECG characteristics between the two groups, PWD was significantly longer in the scar group (122.9 ± 18.5 and 116.9 ± 28.0 ms; P = .01). A multivariate analysis was performed, after adjustment of age, sex, LA diameter, PWD ≥ 120 ms was found to be an independent predictor of LA scarring (OR: 1.69, p-value: 0.02). CONCLUSION: In the current series, prolonged PWD was found to be independently associated with LA scarring in PAF, even after adjustment for age, sex, and LA diameter.

Thromboembolic events and need for anticoagulation therapy following left atrial appendage occlusion in patients with electrical isolation of the appendage.

INTRODUCTION: Electrical isolation of the left atrial appendage (LAA) is an important adjunctive ablation strategy in patients with nonparoxysmal atrial fibrillation (AF). Patients who have impaired LAA contractility following isolation may require long-term oral anticoagulant (OAC) therapy irrespective of their CHADS2 -VASc score. Percutaneous LAA occlusion (LAAO) is a potential alternative to life-long OAC therapy. We aimed to assess the rate of OAC discontinuation and thromboembolic (TE) events following percutaneous LAAO in patients who underwent LAA electrical isolation (LAAI). METHODS: This is a retrospective two-center study of patients who underwent percutaneous LAAO following LAAI. Patients with at least 3-month follow-up were included in the study. The antithrombotic therapy and TE events at the time of the last follow-up were noted. RESULTS: The LAA was successfully occluded in 162 (with Watchman device in 140 [86.4%] and Lariat in 22 [13.6%]). A total of 32 patients had leaks detected on the 45-day transesophageal echocardiogram (TEE); 21 (15%) Watchman and 11 (50%) Lariat cases (P = 0.0001). Two (one Watchman and one Lariat) of the 32 leaks were more than 5 mm. After the 45-day TEE, 150 (92.6%) patients were off-OAC. No TE events were reported in the 150 patients who stopped the anticoagulants. Four (2.47%) patients experienced stroke following the LAAO (three Watchman and one Lariat) procedure while on-OAC, two of which were fatal. At the median follow-up of 18.5 months, 159 (98.15%) patients were off-anticoagulant. CONCLUSION: Up to 98% of patients with LAAI could safely discontinue OAC after undergoing the appendage closure procedure.

Impact of rotor ablation in non-paroxysmal AF patients: Findings from the per-protocol population of the OASIS trial at long-term follow-up.

The objective of this study was to evaluate the long-term efficacy of FIRM ablation with PVAI vs PVAI plus posterior wall isolation (PWI) and non-PV trigger ablation in persistent (PeAF) and long-standing persistent AF (LSPAF) patients. The procedure time was recorded to be 180.6 ±â€¯35.9 and 124.03 ±â€¯45.4 minutes in the FIRM+PVI and PVI + PWI + non-PV trigger ablation group respectively. At 24-month follow-up, 24% (95% CI 8.7%-37.8%) in the FIRM-ablation group and 48% (95% CI 27.6-63.3%) in the non-PV trigger ablation group remained arrhythmia-free off-antiarrhythmic drugs after a single procedure. Clinical Trial Registration:ClinicalTrials.gov (Identifier: NCT02533843).

Long-term outcomes of catheter ablation in patients with longstanding persistent atrial fibrillation lasting less than 2 years.

INTRODUCTION: Outcome data after catheter ablation (CA) for longstanding persistent atrial fibrillation (LSPAF) lasting less than 2 years are limited and highly variable with different ablation approaches. We aimed to assess the long-term outcomes in patients with LSPAF lasting less than 2 years undergoing extended pulmonary vein antrum isolation (PVAI) versus those with additional non-pulmonary vein (PV) trigger ablation. METHODS AND RESULTS: In this prospective analysis, 381 consecutive patients with LSPAF lasting less than 2 years (age: 64 ± 9 years, 76% male, atrial fibrillation duration: 19 ± 5 months) undergoing their first CA were classified into two groups: Group 1 (n = 104) received PVAI extended to PW plus isolation of superior vena cava (SVC) and Group 2 ( n = 277) received PVAI + PW + SVC + non-PV-trigger ablation. All patients were followed-up for at least 2 years. In case of recurrence, repeat procedure was offered and non-PV triggers were targeted for ablation in all. After a single procedure, 26 (25%) patients in Group 1 and 172 (62.1%) in Group 2 remained arrhythmia-free (P < 0.001). A second procedure was performed in 58 of 78 (74.4%) patients in Group 1 and 77 of 105 (73.3%) patients in Group 2. Non-PV triggers were identified in 52 (89.6%) and 54 (70.1%) patients in Groups 1 and 2, respectively, and targeted for ablation. Overall, 72 (69.2%) patients in Group 1 and 238 (86%) in Group 2 remained arrhythmia-free ( P < 0.001). CONCLUSION: In patients with LSPAF lasting less than 2 years, extended PVAI plus SVC isolation was less likely to achieve long-term sinus rhythm. In the majority of patients, recurrence was due to non-PV triggers and ablation of those resulted in better outcome.

Impact of weight loss on ablation outcome in obese patients with longstanding persistent atrial fibrillation.

AIMS: This study investigated the impact of weight loss in longstanding persistent (LSPAF) patients undergoing catheter ablation (CA). METHODS: Ninety consecutive obese LSPAF patients were approached; 58 volunteered to try weight loss interventions for up to 1 year (group 1), while 32 patients declined weight loss interventions and were included as a control (group 2). Both groups remained on antiarrhythmic drugs. If they continued to experience AF, CA was performed. Body weight was measured at 6-month intervals and arrhythmia status was assessed by event recorder, electrocardiogram (ECG), and Holter monitoring. Symptom severity and quality of life (QoL) were evaluated by AFSS and SF-36 survey, respectively. A scoring algorithm with two summary measures, physical component score (PCS) and mental component score (MCS), was prepared for QoL analysis. RESULTS: Significant reduction in body weight (median -24.9 (IQR -19.1 to -56.7) kg, P < 0.001) was observed in the group 1 patients, while no such change was seen in group 2. The PCS and MCS scores improved significantly in group 1 only, with a change from baseline of 8.4 ± 3 (P = 0.013) and 12.8 ± 8.2 (P < 0.02). However, AF symptom severity remained unchanged from baseline in both groups (P = 0.84). All 90 patients eventually underwent CA and received PVAI+ posterior wall+ non-PV triggers ablation. At 1-year follow-up after single procedure, 37 (63.8%) in group 1 and 19 (59.3%) patients in group 2 remained arrhythmia-free off AAD (P = 0.68). CONCLUSION: In this prospective analysis, in LSPAF patients weight loss improved QoL but had no impact on symptom severity and long-term ablation outcome.

Isolation of the superior vena cava from the right atrial posterior wall: a novel ablation approach.

Aims: Superior vena cava (SVC) isolation might be difficult to achieve because of the vicinity of the phrenic nerve (PN) and sinus node. Based on its embryogenesis, we hypothesized the presence of preferential conduction from the right atrial (RA) posterior wall, making it possible to isolate the SVC antrally, sparing its anterior and lateral aspect. Methods and results: This is a descriptive cohort study of 105 consecutive patients in which SVC isolation was obtained with radiofrequency ablation, starting in the septal aspect of the SVC-RA junction and continued posteriorly and inferiorly targeting sites of early activation until electrical isolation was obtained. Acute SVC isolation was achieved in 103 (98%) patients; the mean distance between the site of SVC isolation and the SVC-RA junction was 19.9 ± 5.3 (range 9.7-33.7) mm. During follow-up, 2 (2%) patients developed symptomatic diaphragmatic paralysis due to transient right PN injury; 13 patients underwent a repeat ablation: SVC reconnection was observed in 5 patients, and re-isolation was easily achieved by targeting the corresponding sites of early activation. Conclusion: Superior vena cava isolation can be completed by targeting its septal segment and sites of early activation in the posterior SVC-RA junction and RA posterior wall; this is a feasible alternative ablation strategy in patients in which SVC isolation cannot be completed with the standard approach. The risk of sinus node injury or SVC stenosis are eliminated; PN injury is still possible but can easily be prevented with high-output pacing to exclude a true posterior course of the PN.

Glenoid component loosening associated with increased critical shoulder angle at midterm follow-up.

BACKGROUND: Glenoid component loosening is a common failure mode of total shoulder arthroplasty (TSA). A larger critical shoulder angle (CSA) may cause superior glenoid component loading and more rapid component loosening. The purpose of this study was to define the relationship between the CSA and glenoid component loosening in midterm follow-up after TSA. METHODS: We conducted a retrospective study of 61 primary TSAs for osteoarthritis with an average follow-up of 5.0 ± 2.2 years without surgical revision. Standard true anteroposterior radiographs postoperatively and at longest follow-up were graded in a blinded and repetitive nature for pegged glenoid radiolucent lines and measured for the CSA. An "at-risk" glenoid was defined as grade 3 or higher lucency. RESULTS: The average CSA was 32° ± 5°, median midterm lucency grade was 2 (range, 0-5), and median progression of lucency grade was 1 (range, -1 to 4). At midterm follow-up, 20% of TSAs were grade 3 or higher mean glenoid lucency, with an average CSA of 36°. There was a statistically significant correlation between CSA and both glenoid lucency grade (odds ratio, 1.20 per degree CSA) and progression of lucency grade (odds ratio, 1.24). An increase in CSA of 10° was associated with a 6.2-fold increased odds of having an at-risk glenoid. CONCLUSION: This study identifies the CSA as a risk factor for glenoid component loosening after TSA. Our findings suggest that the CSA may be a modifiable factor during surgery to improve glenoid component outcomes.

Procedural findings and ablation outcome in patients with atrial fibrillation referred after two or more failed catheter ablations.

INTRODUCTION: This study reports the procedural findings and ablation outcome in AF patients referred after ≥2 failed PV isolation (PVI). METHODS: Three hundred and five consecutive AF patients referred after ≥2 PVI were included in the analysis. High-dose isoproterenol challenge was used to identify PV reconnection and non-PV triggers; the latter were ablated based on the operator's discretion during the index procedure. At the repeat procedure, non-PV triggers were ablated in all. Empirical isolation of LA appendage (LAA) and coronary sinus (CS) was performed if the PVs were silent and no non-PV triggers were detected. RESULTS: PV reconnection was detected in 226 and non-PV triggers were identified or empirically isolated in 285 patients during the index procedure. At follow-up, 182 (60%) patients were recurrence-free off-AAD; the success rate with and without non-PV ablation was 81% vs. 8% (P < 0.0001). 104 patients underwent repeat procedure with non-PV trigger ablation in all. At 1 year, 90% were arrhythmia free off-AAD in non-PV ablation group, and 72% who did not receive non-PV triggers ablation at the index procedure (P = 0.035). The success rate of empirical LAA and CS isolation was 78.5% and 82% after the index and repeat procedure, respectively. CONCLUSION: In patients experiencing AF recurrence after multiple failed PVI, despite PV reconnection, non-PV triggers were found to be responsible for AF maintenance in the majority and ablating those triggers increased ablation success. Additionally, in the presence of permanent PVI and no non-PV triggers on isoproterenol, empirical isolation of LAA and CS provided high rate of arrhythmia-free survival.

Long-term follow-up of patients with paroxysmal atrial fibrillation and severe left atrial scarring: comparison between pulmonary vein antrum isolation only or pulmonary vein isolation combined with either scar homogenization or trigger ablation.

AIMS: Left atrial (LA) scarring, a consequence of cardiac fibrosis is a powerful predictor of procedure-outcome in atrial fibrillation (AF) patients undergoing catheter ablation. We sought to compare the long-term outcome in patients with paroxysmal AF (PAF) and severe LA scarring identified by 3D mapping, undergoing pulmonary vein isolation (PVAI) only or PVAI and the entire scar areas (scar homogenization) or PVAI+ ablation of the non-PV triggers. METHODS AND RESULTS: Totally, 177 consecutive patients with PAF and severe LA scarring were included. Patients underwent PVAI only (n = 45, Group 1), PVAI+ scar homogenization (n = 66, Group 2) or PVAI+ ablation of non-PV triggers (n = 66, Group 3) based on operator's choice. Baseline characteristics were similar across the groups. After first procedure, all patients were followed-up for a minimum of 2 years. The success rate at the end of the follow-up was 18% (8 pts), 21% (14 pts), and 61% (40 pts) in Groups 1, 2, and 3, respectively. Cumulative probability of AF-free survival was significantly higher in Group 3 (overall log-rank P <0.01, pairwise comparison 1 vs. 3 and 2 vs. 3 P < 0.01). During repeat procedures, non-PV triggers were ablated in all. After average 1.5 procedures, the success rates were 28 (62%), 41 (62%), and 56 (85%) in Groups 1, 2, and 3, respectively (log-rank P< 0.001). CONCLUSIONS: In patients with PAF and severe LA scarring, PVAI+ ablation of non-PV triggers is associated with significantly better long-term outcome than PVAI alone or PVAI+ scar homogenization.

Hybrid Procedure (Endo/Epicardial) versus Standard Manual Ablation in Patients Undergoing Ablation of Longstanding Persistent Atrial Fibrillation: Results from a Single Center.

INTRODUCTION: Ablation of longstanding persistent atrial fibrillation (LSPAF) is the most challenging procedure in the treatment of AF, either by surgical or by percutaneous approach. OBJECTIVE: We investigated the difference in success and complication rates between combined surgical epicardial and endocardial catheter ablation procedure and our standard endocardial ablation procedure. METHODS AND RESULTS: Twenty-four consecutive patients (group 1) with LSPAF and enlarged left atrium (>4.5 cm) underwent a combined procedure, consisting of surgical, closed-chest, epicardial, radiofrequency ablation (nContact, NC, USA) via pericardial access, and concomitant endocardial ablation (hybrid procedure). Procedural complications and long-term outcomes were compared to those of 35 consecutive patients who refused the hybrid procedure and underwent standard endocardial only ablation (group 2). Baseline characteristics were comparable. In group 1, 1 patient (4.2%) developed post-procedural cardio-embolic stroke and 3 (12.5%) died (1 atrio-esophageal fistula, 1 fatal stroke, 1 of unknown cause in early follow-up), while no strokes or deaths occurred in group 2. Overall complication rates were higher for group 1 (P = 0.036). At 24-month follow-up, 4 (19%) patients in group 1 and 19 (54.3%) in group 2 were arrhythmia-free after a single procedure, on or off antiarrhythmic drugs (P<0.001). Total procedural time (276.9 ± 63.5 vs. 203.15 ± 67.3 minutes) and length of hospital stay (5 [IQR 3-8] vs. 1 [IQR 1-3] days were significantly shorter for group 2 (P <0.001). CONCLUSIONS: In patients with LSPAF and enlarged left atrium, a concomitant combined surgical/endocardial ablation approach increases complication rate and does not improve outcomes when compared to extensive endocardial ablation only.

Management of Periprocedural and Early Pericardial Effusions With Tamponade Following Ablation of Atrial Fibrillation With Uninterrupted Factor Xa Inhibitors: A Case Series.

INTRODUCTION: Because of the absence of a dedicated reversal agent, the outcome of pericardial effusion (PE) following procedures performed with uninterrupted apixaban or rivaroxaban is unknown. We report the characteristics of PEs presenting with tamponade in patients undergoing AF ablation with uninterrupted factor Xa inhibition (FXaI) to understand their management and prognosis. METHODS AND RESULTS: We performed a multicenter cross-sectional survey in 10 centers across the United States. Patient data were obtained by chart review. In all patients the procedure was performed with uninterrupted FXaI. A total of 16 PEs requiring intervention were reported from 5 centers. Two patients were on apixaban 5 mg BD, the remaining on rivaroxaban 20 mg OD. Eleven PEs occurred in the periprocedural setting, and 5 PEs occurred from 1 to 28 days after the procedure. Pericardiocentesis and drainage were performed in all cases. Protamine and 4-factor prothrombin complex concentrate (4F-PCC) were given in all periprocedural cases. Two patients required surgery: in one case coagulation of the pericardial blood prevented effective drainage, and in the other bleeding was secondary to a steam pop-induced atrial tear. None of the postprocedural cases required FXaI reversal and the dose of rivaroxaban was temporarily reduced. No fatal outcomes or thromboembolic events were reported. CONCLUSION: Pericardiocentesis and drainage with FXaI reversal proved effective in the management of acute PEs with tamponade occurring periprocedurally in patients undergoing AF ablation with uninterrupted FXaI. Early postprocedural effusions can be treated with pericardiocentesis without the need of a reversal agent.

Periprocedural stroke and bleeding complications in patients undergoing catheter ablation of atrial fibrillation with different anticoagulation management: results from the Role of Coumadin in Preventing Thromboembolism in Atrial Fibrillation (AF) Patients Undergoing Catheter Ablation (COMPARE) randomized trial.

BACKGROUND: Periprocedural thromboembolic and hemorrhagic events are worrisome complications of catheter ablation for atrial fibrillation (AF). The periprocedural anticoagulation management could play a role in the incidence of these complications. Although ablation procedures performed without warfarin discontinuation seem to be associated with lower thromboembolic risk, no randomized study exists. METHODS AND RESULTS: This was a prospective, open-label, randomized, parallel-group, multicenter study assessing the role of continuous warfarin therapy in preventing periprocedural thromboembolic and hemorrhagic events after radiofrequency catheter ablation. Patients with CHADS2 score ≥1 were included. Patients were randomly assigned in a 1:1 ratio to the off-warfarin or on-warfarin arm. The incidence of thromboembolic events in the 48 hours after ablation was the primary end point of the study. The study enrolled 1584 patients: 790 assigned to discontinue warfarin (group 1) and 794 assigned to continuous warfarin (group 2). No statistical difference in baseline characteristics was observed. There were 39 thromboembolic events (3.7% strokes [n=29] and 1.3% transient ischemic attacks [n=10]) in group 1: two events (0.87%) in patients with paroxysmal AF, 4 (2.3%) in patients with persistent AF, and 33 (8.5%) in patients with long-standing persistent AF. Only 2 strokes (0.25%) in patients with long-standing persistent AF were observed in group 2 (P<0.001). Warfarin discontinuation emerged as a strong predictor of periprocedural thromboembolism (odds ratio, 13; 95% confidence interval, 3.1-55.6; P<0.001). CONCLUSION: This is the first randomized study showing that performing catheter ablation of AF without warfarin discontinuation reduces the occurrence of periprocedural stroke and minor bleeding complications compared with bridging with low-molecular-weight heparin. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01006876.

Ventricular tachycardia originating from the septal papillary muscle of the right ventricle: electrocardiographic and electrophysiological characteristics.

INTRODUCTION: Premature ventricular complexes (PVCs) and ventricular tachycardia (VT) arising from papillary muscles of both ventricles have recently been described. There is a lack of data on VT originating from the right ventricular papillary (RV PAP) muscles. There have been no prior studies focused on the electrocardiogram (ECG) features and ablation of PVC/VT arising from the septal papillary muscle of the right ventricle. METHODS: Among 155 consecutive patients with normal structural heart who underwent catheter ablation of PVC/VT, 8 patients with PVC/VT from the septal RV PAP muscle were identified. The site of origin of the arrhythmias was identified through activation/pace mapping and intracardiac echocardiography. All patients underwent radiofrequency ablation of the arrhythmia. RESULTS: Data on 8 consecutive patients (2 men, age 42 ± 13 years old) were collected. All patients had a preserved ejection fraction (60 ± 4%). Septal RV PAP arrhythmias had a left superior axis and negative concordance or late R-wave transition in precordial leads. PVCs were spontaneous in 5 cases, were induced by isoprotenerol in 2 cases and by isoproterenol plus phenylephrine in another one. PVCs were never induced with calcium bolus and only rarely with burst pacing. Adenosine never terminated VT or suppressed the VT/PVCs. Radiofrequency, fluoroscopic, and procedural time were, respectively, 10.3 ± 3, 36.4 ±11.3, and 76.3 ± 27.5 minutes. During a mean follow-up of 8 ± 4 months, mean PVC burden was reduced from 14 ± 3% preablation to 0.1 ± 0.2% postablation. CONCLUSION: PVCs and VT originating from septal RV papillary muscle could have a typical ECG pattern due to the site of the muscle involved. Radiofrequency ablation of this anatomic area is feasible and effective.

Pulmonary Vein Isolation to Reduce Future Risk of Atrial Fibrillation in Patients Undergoing Typical Flutter Ablation: Results from a Randomized Pilot Study (REDUCE AF).

BACKGROUND: This study examined incidence of AF following cavotricuspid isthmus (CTI) ablation alone or CTI plus prophylactic pulmonary vein isolation (PVI) in patients presenting with isolated atrial flutter (AFL) with no history of AF. METHODS AND RESULTS: We enrolled 216 patients with isolated typical atrial flutter and randomized them to CTI alone (group 1, n = 108, 61.2 ± 9.7 year, 75% male) or CTI+PVI ablation (group 2, n = 108, 62.4 ± 9.3 year, 73% male). Insertible loop recorder (ILR) was implanted in 21 and 19 patients from groups 1 and 2, respectively. Remaining patients were monitored with event recorders, ECG, 7-day Holter. Follow-up period was for 18 ± 6 months. Compared to group 1, group 2 had significantly longer procedural duration (75.9 ± 33 min vs. 161 ± 48 min [P < 0.001]) and fluoroscopy time (15.9 ± 12.3 min vs. 56.4+21 min [P < 0.001]). At the end of follow-up, 65 (60.2%) in group 1 and 77 (71.3%) in group 2 were arrhythmia free off-AAD (log-rank P = 0.044). A subgroup analysis was performed with 55 year age cut-off. In the <55 age group the CTI only population had similar success as in CTI+PVI, (21 of 24 [83.3%] vs. 19 of 22 [86.4%], respectively, log-rank P = 0.74). In the ≥55 group, having CTI+PVI showed significantly higher success compared to CTI only; 45 of 84 (53.6%) were AF/AT free in CTI only group versus 58 of 86 (67.4%) with CTI+PVI (log-rank P = 0.029). CONCLUSION: Prophylactic PVI reduced new-onset AF in patients with lone atrial flutter.