Unexpected large device related thrombus at 12 months follow-up after left atrial appendage closure.

An 89-year-old woman underwent left atrial appendage (LAA) closure (LAAC) in our hospital because of recurrent gastrointestinal bleedings. The first transesophageal echocardiography (TEE) follow-up at six weeks revealed a complete sealing of the LAA and no device related thrombus. In a TEE follow-up at one year after the LAA closure, a large device related thrombus (6 × 3 cm) was found. Treated with oral anticoagulation (apixaban) the thrombus showed a partial resolution one year later.

Percutaneous left atrial appendage closure in the presence of thrombus: A feasibility report.

BACKGROUND: Patients with a left atrial appendage thrombus (LAAT) despite oral anticoagulation (OAC) are at high risk of thromboembolism (TE) and a relevant proportion of LAAT do not resolve under continued OAC. Left atrial appendage closure (LAAC) in the presence of LAAT was anecdotally described as a therapeutic option to prevent TE in the patients. OBJECTIVE: To describe the feasibility of LAAC despite LAAT in consecutive patients. METHODS: We searched the LAAC database of our center to identify patients in whom a LAAC was performed despite evidence of a thrombus in the LAA. All procedures were performed under transesophageal echocardiography guidance, no angiographies were performed to avoid LAAT dislocation. An Amulet Occluder device was preferred to allow proximal implantation and sealing of the LAA. RESULTS: Nine patients were identified. The mean age was 68.1 ± 10.7 years, four were female, mean CHADSVASC and HASBLED were 3.6 ± 1.7 and 3.0 ± 1.0. Eight of nine patients were on OAC, one patient was under lone aspirin therapy because of bleeding. The mean distance between the LAAT and the estimated landing zone was 18 ± 6 mm, the minimal distance was 11 mm. The mean landing zone was 21 ± 3 mm, devices with a mean size of 25 ± 4 mm were chosen for implantation. All implantation succeeded, only two patients required an intraprocedural replacement. No procedural complication nor short term thromboembolic complication during a follow up of 138 ± 149 days were recorded. CONCLUSION: In the presented series a percutaneous LAAC despite a LAAT resulted to be feasible and safe.

What Is the Acute Antral Lesion Size After Pulmonary Vein Isolation Using Different Balloon Ablation Technologies?

BACKGROUND: Clinical outcome after pulmonary vein isolation (PVI) may be linked to both durability of PVI and the antral lesion size. Data on balloon-guided technologies are scarce. We investigated the size of the isolated surface area (ISA) acutely after PVI achieved by cryoballoon (CB) or laser balloon (LB), both using voltage mapping.Methods and Results:In 40 patients (73% male, mean age 66±9 years), a bipolar voltage map before and after PVI in sinus rhythm was acquired to delineate the isolated antral surface area (IASA, contiguous area of low voltage <0.5 mV) and the ISA (relative size of the low-voltage area in relation to the whole antral surface area including the posterior wall). IASA (CB: 57±14 cm2vs. LB: 42±15 cm2; P=0.002) as well as ISA (65±8% vs. 54±10%; P=0.001) were significantly larger in the CB than in the LB group. No periprocedural complications occurred. During a mean follow-up of 326±142 days, 4/20 and 5/20 patients experienced an AF/AT recurrence in the CB and LB groups, respectively. No differences in clinical outcome were observed between patients with a large (≥55%) or small (<55%) ISA. CONCLUSIONS: Balloon-guided PVI is associated with antral lesion formation. CB-guided PVI is associated with the largest ISA as compared with LB procedures. ISA size did not correlate with clinical outcome after a single procedure in the present study population.

How to learn pulmonary vein isolation with a novel ablation device: learning curve effects using the endoscopic ablation system.

INTRODUCTION: Novel ablation devices for pulmonary vein isolation (PVI) need a careful evaluation of its efficacy and safety beyond clinical studies in a real world situation. The endoscopic ablation system (EAS) was recently approved for PVI in Europe. We sought to determine the safety, efficacy, and learning curve effects of EAS-PVI in a large volume single center. METHODS AND RESULTS: Between June 2010 and March 2013, all EAS guided PVI procedures were analyzed and 150 consecutive patients were divided in tertiles (T). Clinical follow-up of 12 months assessed freedom from atrial fibrillation (AF) using 72 hour-Holter ECG recordings. In total, 497 of 583 PVs (85%) were isolated by visual guidance only. In T 2 and T 3, visually guided PVI rates increased from 73% to 91% (P < 0.001). After gap mapping, 96% and 99% of all PVs were isolated in T 1-3, respectively (P = 0.018). Total procedure and fluoroscopy time significantly declined over time. All major periprocedural complications occurred in the first T. In 3 patients (2 in 1st and 1 in 2nd T), phrenic nerve palsy was observed (2%). At 12-months follow-up, 103 of 133 patients (77%) remained in stable sinus rhythm without significant differences between Ts. CONCLUSION: With EAS even first time users may achieve acute PVI in a high number of patients with favorable clinical outcomes after 1 year. Yet, acute procedural efficacy and safety are further improved after passing a learning curve of 50 patients.

Pulsed Field Ablation for Atrial Fibrillation.

Catheter ablation is a widely used, effective and safe treatment for AF. Pulsed field ablation (PFA), as a novel energy source for cardiac ablation, has been shown to be tissue selective and is expected to decrease damage to non-cardiac tissue while providing high efficacy in pulmonary vein isolation. The FARAPULSE ablation system (Boston Scientific) follows the idea of single-shot ablation and is the first device approved for clinical use in Europe. Since its approval, multiple high-volume centres have performed increasing numbers of PFA procedures in patients with AF and have published their experiences. This review summarises the current clinical experience regarding the use of PFA for AF using the FARAPULSE system. It provides an overview of its efficacy and safety.

Single transseptal big Cryoballoon pulmonary vein isolation using an inner lumen mapping catheter.

BACKGROUND: The single big cryoballon technique for pulmonary vein isolation (PVI) has been limited by the need for two transseptal punctures (TP). We therefore investigated feasibility and safety of a simplified approach using a single TP and a novel circumferential mapping catheter (CMC). METHODS: Patients underwent 28-mm cryoballoon PVI using a single TP. The CMC (Achieve(©) Medtronic Inc., Minneapolis, MN, USA) served as (1) guidewire and (2) as a PV mapping tool. Primary endpoint was PVI without switching to a regular guidewire. Secondary endpoints included: (1) PV signal quality during freezing, (2) time to PVI, (3) classification of successful ablation technique, (4) complications, and (5) procedural data. RESULTS: A total of 32 patients (126 PVs) were studied (mean age: 62 ± 11 years, 24 males, left atrium: 40 ± 4 mm). The primary endpoint was achieved in 29/32 patients (91%) and 123/126 PVs (98%) with a procedure and fluoroscopy time of 126 ± 26 minutes and 18.9 ± 7.5 minutes, respectively. Real-time visualization of PVI could be observed in 61/126 (48%) PVs. Time to sustained PVI versus nonsustained PVI was 66 ± 56 seconds versus 129 ± 76 seconds (P < 0.001). One phrenic nerve palsy was observed. After a follow-up of 250 ± 84 days 23/32 patients (72%) remained in sinus rhythm. CONCLUSION: The "simplified single big cryoballoon" PVI strategy appears to be safe and feasible. However, real-time PV recording was achieved in <50% of PVs. Therefore, further catheter refinements are warranted. (PACE 2012; 35:1304-1311).

Validation of lesion durability following pulmonary vein isolation using the new third-generation laser balloon catheter in patients with recurrent atrial fibrillation.

BACKGROUND: The second- and third-generation endoscopic ablation systems (EAS2 and EAS3) have been launched in recent years. We aimed to assess the lesion durability as well as gap localization using the multigenerational novel technologies in patients with recurrent atrial fibrillation (AF). METHODS: Consecutive patients who underwent second ablation for recurrent AF following the initial pulmonary vein isolation (PVI) with EAS2 or EAS3 were retrospectively investigated. The persistent durability of PVI, gap localization at the second procedure, and procedural/anatomical features of durable PVI were analyzed. RESULTS: Among 225 patients treated with EAS3 (N = 125) and EAS2 (N = 100), 34 patients (EAS3: 13 patients, 50 PVs, EAS2: 21 patients, 82 PVs) underwent a second procedure because of recurrent AF mean 11.9 ± 9.3 months after the initial procedure. Persistent isolation of all four PVs was recorded in 6 (46.2%) patients in EAS3 group and 4 (19.1%) patients in EAS2 group (p = 0.130). Ninety-one out of 132 (68.9%) PVs were persistently isolated with a higher rate in EAS3 group (82.0% vs. EAS2 group: 61.0%, p = 0.0113). A total of 45 gaps were recorded in 41 PVs. Right superior PV (RSPV) was the predominantly common reconnected vein (15 gaps, 14 PVs) irrespective of generations (EAS3: 4 gaps in 3 PVs and EAS2: 12 gaps in 11 PVs). Logistic multivariate regression analysis revealed ablation without reduced energy dose (5.5-7 W) as an independent predictor of durable PVI [adjusted OR: 3.70, 95% CI (1.408-10.003)], p = 0.008]. CONCLUSION: The technical innovation resulted in a higher lesion durability in EAS3-guided PVI in patients with recurrent AF. The most common gap location was found at RSPV in successor EASs. Ablation without reduced energy was a predictor of durable PVI in successor EASs.

Laser balloon in pulmonary vein isolation for atrial fibrillation: current status and future prospects.

INTRODUCTION: Visually guided laser balloon (LB) catheter has been an established modality dedicated for pulmonary vein (PV) isolation in patients with atrial fibrillation. The newly updated version of this novel device has technically evolved recent years. AREAS COVERED: This review will summarize the contemporary technical evolution of LB catheter. Available efficacy outcomes and the historical change of ablation style will be evaluated. Furthermore, the future perspectives for clinical practice are discussed. EXPERT COMMENTARY: The initial LB ablation system provided comparable clinical results in PV isolation with other technologies, but with a unique strategical concept enabling the direct visualization of the tissue to cauterize. With multigenerational development, the LB catheter has been equipped with more compliant balloon for favorable PV occlusion and a robotically motor driven continuous ablation mode (RAPID mode). These technical innovations changed the concept of the ablation strategy using LB catheter as 'point-by-point' into 'single-shot' fashion. The remaining tasks are further improvements such as equipping with real-time recording system of intracardiac electrogram, durable structured balloon and the instrument for visualizing the cauterization area in a 360-degree panoramic view, which includes potential possibilities to develop this novel device to the more optimal device for PV isolation.

Focal atrial tachycardia originating from the right atrial appendage: first successful cryoballoon isolation.

Focal atrial tachycardias (AT) can arise from the right atrial appendage (RAA). However, conventional catheter mapping and radiofrequency (RF) ablation inside the RAA is associated with the risk of cardiac perforation. The cryoballoon catheter represents a novel ablation device that was originally developed to facilitate pulmonary vein isolation. This report describes the first successful RAA isolation using a cryoballoon in a patient with an incessant focal RAA AT despite previous irrigated tip endo- and epicardial ablation attempts. Further, cryoballoon ablation targets beyond pulmonary veins may evolve.

Complications From Left Atrial Appendage Exclusion Devices.

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and has been identified as an independent risk factor for stroke. Prevention of thromboembolic events has been based on oral anticoagulation (OAC) using Vitamin K antagonists (VKA). However, long-term OAC medication is limited by an increased bleeding risk and a low patient compliance. Relying on the observation that the majority of cardiac thrombi originate from the left atrial appendage (LAA) different devices aiming for LAA closure have been proposed. This review will discuss contemporary LAA closure devices with special emphasis on procedure related complications.

Catheter-ablation of ventricular tachycardia in patients with coronary artery disease: influence of the endocardial substrate size on clinical outcome.

Ablation of symptomatic ventricular tachycardia (VT) in patients with coronary artery disease is frequently performed using the three dimensional mapping system CARTO. In the amplitude map, bipolar potentials of <1.5 mV are considered abnormal and represent damaged myocardium due to previous infarction. This pathological electrical area can be arrhythmogenic, serving as the substrate for reentrant VT. The purpose of this study was to correlate the size of the endocardial substrate with the success of VT catheter ablation. Included in this retrospective analysis were 69 consecutive patients with coronary artery disease who underwent ablation for symptomatic clinical VT using CARTO. The voltage maps were analyzed and the area with abnormal bipolar electrograms (<1.5 mV) was determined using geometric approximation models. The area of abnormal electrograms was divided into three sizes: small (or=100 cm(2); 8 patients). Patient characteristics were not different between the three substrate groups in regard to age, tachycardia cycle length, or number of radiofrequency applications, however differed significantly between the small, medium and large group in regard to left ventricular ejection fraction (44 +/- 12% vs. 32 +/- 9% vs. 21 +/- 7%, respectively; P = 0.001). Overall, there was a significant correlation between myocardial infarction locations and endocardial substrate sizes (P = 0.031), such that 73% of small substrates were found after inferior myocardial infarctions, and 100% of large substrates after anterior and multiple myocardial infarctions (P = 0.003). After ablation, inducibility of ventricular arrhythmias was more rare in patients with small substrates compared to patients with medium or large substrates (small substrates: 9%, medium and large substrates: 43%, P = 0.043). Although during follow-up of 25 +/- 17 months (1 day to 72 months) there was no significant difference between endocardial substrate sizes in regard to recurrence rates (small: 27%, medium: 38%, large: 50%, P = 0.588), patients with a small substrate did not have fast VT or ventricular fibrillation (VF), in contrast to 30% and 38% of patients with medium and large substrates, respectively. We conclude that in patients with coronary artery disease a small area of low amplitude bipolar potentials (