Novel streamlined technique for left atrial appendage closure using a radiofrequency wire-based large access system.

INTRODUCTION: Transseptal puncture (TSP) to allow for large delivery sheath left atrial (LA) access remains a challenging aspect of LA appendage closure (LAAC) in patients with prior history of TSP, thick or lipomatous septum, atrial septal aneurysms, or other complex cardiac anatomies. This study investigates the use of the VersaCross large access (VLA) system (Baylis Medical/Boston Scientific) to improve procedural efficiency of LAAC compared to the standard needle workflow. METHODS AND RESULTS: Fifty LAAC procedures using WATCHMAN FLX between November 2021 and September 2022 were retrospectively analyzed comparing the VLA workflow (n = 25) to the standard needle workflow (n = 25). Study primary endpoint was time to procedural efficiency, and secondary endpoints included TSP time, acute LAAC success, fluoroscopy use, device recaptures, and periprocedural complications. Acute LAAC was successfully completed in all cases with no intraprocedural complications. TSP time was faster, but not significant, using the VLA workflow compared to the standard RF needle workflow (2.6 ± 1.1 min vs. 3.0 ± 1.8 min, p = 0.38). Time to WATCHMAN sheath in LA from TSP was 27% faster (1.5 ± 0.8 min vs. 2.1 ± 0.9 min; p = 0.03), and time to WATCHMAN release from TSP was 19% faster (10.5. ± 2.5 min vs. 13.0 ± 3.7 min; p = 0.01) with the VLA workflow. Overall procedure time was 15% faster (30.4 ± 5.1 min vs. 36.0 ± 6.6 min; p = 0.003) using VLA. Fluoroscopy time was 25% lower (4.0 ± 2.2 min vs. 5.5 ± 2.3 min; p = 0.003) and fluoroscopy dose was 60% lower (97.0 ± 91.7 mGy vs. 241.8 ± 240.6 mGy; p = 0.01) and more consistent [F-test, p ˂ 0.0001] using the VLA workflow compared to the needle workflow. CONCLUSION: The VLA system streamlines LAAC procedures, improving LAAC efficiency and reducing fluoroscopy use by allowing for de novo dilation of the septum for large-bore delivery sheaths, and reducing device exchanges and delivery sheath manipulation.

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.

Hybrid Convergent Procedure for the Treatment of Persistent and Long-Standing Persistent Atrial Fibrillation: Results of CONVERGE Clinical Trial.

BACKGROUND: The limited effectiveness of endocardial catheter ablation (CA) for persistent and long-standing persistent atrial fibrillation (AF) treatment led to the development of a minimally invasive epicardial/endocardial ablation approach (Hybrid Convergent) to achieve a more comprehensive lesion set with durable transmural lesions. The multicenter randomized controlled CONVERGE trial (Convergence of Epicardial and Endocardial Ablation for the Treatment of Symptomatic Persistent AF) evaluated the safety of Hybrid Convergent and compared its effectiveness to CA for persistent and long-standing persistent AF treatment. METHODS: One-hundred fifty-three patients were randomized 2:1 to Hybrid Convergent versus CA. Primary effectiveness was freedom from AF/atrial flutter/atrial tachycardia absent new/increased dosage of previously failed/intolerant class I/III antiarrhythmic drugs through 12 months. Primary safety was major adverse events through 30 days. CONVERGE permitted left atrium size up to 6 cm and imposed no limits on AF duration, making it the only ablation trial to substantially include long-standing persistent-AF, that is, 42% patients with long-standing persistent-AF. RESULTS: Of 149 evaluable patients at 12 months, primary effectiveness was achieved in 67.7% (67/99) patients with Hybrid Convergent and 50.0% (25/50) with CA (P=0.036) on/off previously failed antiarrhythmic drugs and in 53.5% (53/99) versus 32.0% (16/50; P=0.0128) respectively off antiarrhythmic drugs. At 18 months using 7-day Holter, 74.0% (53/72) Hybrid Convergent and 55% (23/42) CA patients experienced ≥90% AF burden reduction. A total of 2.9% (3/102) patients had primary safety events within 7 days, and 4.9% (5/102) between 8 and 30 days postprocedure. No deaths, cardiac perforations, or atrioesophageal fistulas occurred. All but one primary safety event resolved. CONCLUSIONS: The Hybrid Convergent procedure has superior effectiveness compared to the CA for the treatment of persistent and long-standing persistent atrial fibrillation. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01984346.

Surgical and concomitant epicardial-endocardial (hybrid) ablation of persistent and long-standing persistent atrial fibrillation.

Catheter ablation of atrial fibrillation (AF) has been shown to be effective for paroxysmal AF. However, for patients with persistent or longstanding persistent AF, the success rates for catheter ablation is low. The Cox-Maze procedure is the most effective non-pharmacological treatment of AF. However, due to the need for open-heart surgery and the morbidity associated with the surgical Cox-Maze procedure, minimally invasive and epicardial-endocardial (hybrid) ablation procedures have been developed. This article will review the main surgical and hybrid approaches used for the treatment of persistent and long-standing persistent AF.

Randomized comparison of encircling and nonencircling left atrial ablation for chronic atrial fibrillation.

BACKGROUND: Left atrial (LA) circumferential ablation has been reported to eliminate atrial fibrillation (AF). Whether an ablation without encirclement of the pulmonary veins (PVs) is as effective as LA circumferential ablation is not clear. OBJECTIVES: The purpose of this study was to compare the efficacy of LA circumferential ablation and nonencircling linear ablation in patients with chronic AF. METHODS: Eighty patients with chronic AF were randomized to undergo LA circumferential ablation (n = 40) or nonencircling linear ablation (n = 40). In LA circumferential ablation, the PVs were encircled, with additional lines made in the mitral isthmus and posterior wall or roof. In nonencircling linear ablation, 4 +/- 1 ablation lines were created through areas of complex electrograms, with lines in the roof (38), anterior wall (36), septum (40), mitral isthmus (32), and posterior annulus (6). The endpoint of LA circumferential ablation and nonencircling linear ablation was voltage abatement. RESULTS: LA flutter occurred in 15% after LA circumferential ablation and in 18% after nonencircling linear ablation (P = .8). A repeat ablation procedure was performed for recurrent AF in 7 and 11 patients or for atrial flutter in 6 and 4 patients after LA circumferential ablation and nonencircling linear ablation, respectively (P = .8). At 9 +/- 4 months, the prevalence of AF was 28% in the LA circumferential ablation and 25% in the nonencircling linear ablation group (P = .8). Sixty-eight percent and 60% of patients were in sinus rhythm and free of AF and atrial flutter in the absence of antiarrhythmic drug therapy after LA circumferential ablation and nonencircling linear ablation, respectively (P = .5). There were no complications. CONCLUSION: Nonencircling linear ablation and LA circumferential ablation are equally efficacious in eliminating chronic AF. However, the advantage of nonencircling linear ablation is that it eliminates the need for ablation along the posterior wall of the LA. Therefore, nonencircling linear ablation may avoid the small but real risk of atrioesophageal fistula formation associated with LA circumferential ablation.

Optimizing the detection of bidirectional block across the flutter isthmus for patients with typical isthmus-dependent atrial flutter.

The purpose of this study was to show that multipolar electrographic recordings along the subeustachian isthmus (SI) can better differentiate slow conduction from complete isthmus block after atrial flutter ablation, leading to a lower incidence of recurrent atrial flutter (Afl). Despite the presence of various techniques to identify bidirectional conduction block (BDB) after isthmus ablation for typical Afl, several studies, including a report from a national registry, suggest that radiofrequency ablation is still associated with a 15% recurrence rate. Thus, techniques that can distinguish slow conduction from complete isthmus block have the potential for reducing long-term recurrences. We evaluated patients who underwent radiofrequency ablation for typical isthmus-dependent Afl. Patients were separated into 2 groups. Group A underwent assessment of BDB with conventional methods. In group B, BDB was assessed by placing a multipolar catheter along the floor of the SI, pacing adjacent to the line of radiofrequency application, and assessing electrographic activation on either side. One hundred thirty-one cases of Afl ablation were analyzed (86 in group A, 45 in group B). Over a mean follow-up period of 17 months, recurrence rates of Afl were 16.5% in group A and 4.3% in group B (p = 0.043). Thus, assessment of BDB by placement of a multipolar catheter across the SI after ablation of typical Afl is associated with a significant reduction in long-term recurrence of Afl.