Recent clinical trials in atrial fibrillation.

PURPOSE OF REVIEW: Management of atrial fibrillation can be overwhelming with the amount of information and treatment options available today. This review discusses landmark and other clinically relevant trials published in the last 18 months. RECENT FINDINGS: There have been several recent key clinical trials and subanalyses in the field of atrial fibrillation. Early rhythm control with ablation or antiarrhythmic medications has upended the previous practice of rate control for patients with atrial fibrillation. Vein of Marshall alcohol ablation in combination with endocardial mitral annular ablation and a hybrid epicardial/endocardial approach has shown promising results in the fight against persistent atrial fibrillation. Early ablation with cryoballoon therapy vs. antiarrhythmic therapy gives further evidence for early ablation in patients with symptomatic paroxysmal atrial fibrillation. SUMMARY: The rapid development in technology and medications to treat atrial fibrillation, prevent stroke and improve quality of life for patients has created a vast amount of information for physicians to process. The present review will focus on the recent (within 2 years) clinical trials in atrial fibrillation and the impact they may have on your practice.

Severity of Ischemic Stroke After Left Atrial Appendage Closure vs Nonwarfarin Oral Anticoagulants.

BACKGROUND: Strokes after left atrial appendage closure (LAAC) prophylaxis are generally less severe than those after warfarin prophylaxis-thought to be secondary to more hemorrhagic strokes with warfarin. Hemorrhagic strokes are similarly infrequent with direct oral anticoagulant (DOAC) prophylaxis, so the primary subtype after either LAAC or DOAC prophylaxis is ischemic stroke (IS). OBJECTIVES: The purpose of this study was to compare the severity of IS using the modified Rankin Scale in atrial fibrillation patients receiving prophylaxis with DOACs vs LAAC. METHODS: A retrospective analysis was performed of consecutive patients undergoing LAAC at 8 centers who developed an IS (ISLAAC) compared with contemporaneous consecutive patients who developed IS during treatment with DOACs (ISDOAC). The primary outcome was disabling/fatal stroke (modified Rankin Scale 3-5) at discharge and 3 months later. RESULTS: Compared with ISDOAC patients (n = 322), ISLAAC patients (n = 125) were older (age 77.2 ± 13.4 years vs 73.1 ± 11.9 years; P = 0.002), with higher HAS-BLED scores (3.0 vs 2.0; P = 0.004) and more frequent prior bleeding events (54.4% vs 23.6%; P < 0.001), but similar CHA2DS2-VASc scores (5.0 vs 5.0; P = 0.28). Strokes were less frequently disabling/fatal with ISLAAC than ISDOAC at both hospital discharge (38.3% vs 70.3%; P < 0.001) and 3 months later (33.3% vs 56.2%; P < 0.001). Differences in stroke severity persisted after propensity score matching. By multivariate regression analysis, ISLAAC was independently associated with fewer disabling/fatal strokes at discharge (OR: 0.22; 95% CI: 0.13-0.39; P < 0.001) and 3 months (OR: 0.25; 95% CI: 0.12-0.50; P < 0.001), and fewer deaths at 3 months (OR: 0.28; 95% CI: 0.12-0.64; P < 0.001). CONCLUSIONS: Ischemic strokes in patients with atrial fibrillation are less often disabling or fatal with LAAC than DOAC prophylaxis.

Retrograde Coronary Venous Ethanol Infusion for Ablation of Refractory Left Ventricular Summit Arrhythmias.

Chemical ablation using the transcoronary arterial system has a lengthy but arduous history. Although it has shown to be efficacious in controlling ventricular arrhythmias, safety concerns from cannulation of the coronary arterial system to unwanted ethanol downstream effects have limited transcoronary ethanol ablation (TCEA)'s use. Retrograde coronary venous ethanol ablation (RCVEA) has shown promising results. Although it appears to be in its infancy, RCVEA appears to be the future of chemical ablation in comparison to TCEA due to its increased safety and efficacy. Prospective randomized trial data is needed for this adjunctive treatment to radiofrequency ablation.

Persistent and Recurrent Device-Related Thrombus After Left Atrial Appendage Closure: Incidence, Predictors, and Outcomes.

BACKGROUND: Scarce data exist on the evolution of device-related thrombus (DRT) after left atrial appendage closure (LAAC). OBJECTIVES: This study sought to assess the incidence, predictors, and clinical impact of persistent and recurrent DRT in LAAC recipients. METHODS: Data were obtained from an international multicenter registry including 237 patients diagnosed with DRT after LAAC. Of these, 214 patients with a subsequent imaging examination after the initial diagnosis of DRT were included. Unfavorable evolution of DRT was defined as either persisting or recurrent DRT. RESULTS: DRT resolved in 153 (71.5%) cases and persisted in 61 (28.5%) cases. Larger DRT size (OR per 1-mm increase: 1.08; 95% CI: 1.02-1.15; P = 0.009) and female (OR: 2.44; 95% CI: 1.12-5.26; P = 0.02) were independently associated with persistent DRT. After DRT resolution, 82 (53.6%) of 153 patients had repeated device imaging, with 14 (17.1%) cases diagnosed with recurrent DRT. Overall, 75 (35.0%) patients had unfavorable evolution of DRT, and the sole predictor was average thrombus size at initial diagnosis (OR per 1-mm increase: 1.09; 95% CI: 1.03-1.16; P = 0.003), with an optimal cutoff size of 7 mm (OR: 2.51; 95% CI: 1.39-4.52; P = 0.002). Unfavorable evolution of DRT was associated with a higher rate of thromboembolic events compared with resolved DRT (26.7% vs 15.1%; HR: 2.13; 95% CI: 1.15-3.94; P = 0.02). CONCLUSIONS: About one-third of DRT events had an unfavorable evolution (either persisting or recurring), with a larger initial thrombus size (particularly >7 mm) portending an increased risk. Unfavorable evolution of DRT was associated with a 2-fold higher risk of thromboembolic events compared with resolved DRT.

Chemical Ablation of Ventricular Tachycardia Using Coronary Arterial and Venous Systems.

Radiofrequency catheter ablation (RFCA) is the first-line therapy for treatment of drug refractory ventricular arrhythmias (VAs), however, creating a safe, transmural lesion can be difficult. Ethanol in the arterial system has been used as an adjunctive therapy to RFCA since 1986, but with limited use due to technical and efficacy limitations. Venous ethanol is emerging as powerful alternative.

Advanced Techniques for Ethanol Ablation of Left Ventricular Summit Region Arrhythmias.

BACKGROUND: Coronary venous ethanol ablation (VEA) can be used as a strategy to treat ventricular arrhythmias arising from the left ventricular summit, but collateral flow and technical challenges cannulating intramural veins in complex venous anatomies can limit its use. Advanced techniques for VEA can capitalize on collateral vessels between target and nontarget sites to improve success. METHODS: Of 55 patients with left ventricular summit ventricular arrhythmia, advanced techniques were used in 15 after initial left ventricular summit intramural vein mapping failed to show suitable targets for single vein, single-balloon VEA. All patients had previous radiofrequency ablation attempts. Techniques included: double-balloon for distal protection to block distal flow and target the proximal portion of a large intramural vein where best signal was proximal (n=6); balloons in 2 different left ventricular summit veins for a cross-fire multivein VEA (n=4); intramural collateral vein-to-vein cannulation to reach of targeted vein via collateral with antegrade ethanol and proximal balloon block (n=2); prolonged ethanol dwell time for vein sclerosis of large intramural vein and subsequent VEA (n=3); and intramural collateral VEA (n=1). RESULTS: Fifteen (8 females) patients (age 60.6±17.6 years) required advanced techniques. Procedure time was 210±49.9 minutes, fluoroscopy time was 25.3±14.1 minutes, and 113±17.9 cc of contrast was utilized. A median of 7 cc of ethanol was delivered (range, 4-15 cc). Intraprocedural radiofrequency ablation was delivered before ethanol in 9 out of 15 patients but failed. Ethanol achieved acute success in all 15 patients. Ethanol was used as the sole treatment in two patients. At a median follow-up of 194 days, one patient experienced recurrence. CONCLUSIONS: Advanced techniques capitalizing on venous anatomy can enable successful VEA and selective targeting of arrhythmogenic sites, by blocking distal flow, utilization of collaterals between nontarget and target veins and multivein VEA. Understanding individual anatomy is critical for VEA success.

PET-Driven, Voltage-Guided Atrial Endomyocardial Biopsy Clinches the Diagnosis of Cardiac Sarcoidosis.

Endomyocardial biopsy (EMB) is used in diagnosing infiltrative and other suspected cardiomyopathies. We present a case in which positron emission tomography- and electroanatomic mapping-guided EMB of the atrial septum confirmed the diagnosis of cardiac sarcoidosis in a patient with negative findings on ventricular and lymph node biopsy. (Level of Difficulty: Advanced.).

Predictors of Device-Related Thrombus Following Percutaneous Left Atrial Appendage Occlusion.

BACKGROUND: Device-related thrombus (DRT) has been considered an Achilles' heel of left atrial appendage occlusion (LAAO). However, data on DRT prediction remain limited. OBJECTIVES: This study constructed a DRT registry via a multicenter collaboration aimed to assess outcomes and predictors of DRT. METHODS: Thirty-seven international centers contributed LAAO cases with and without DRT (device-matched and temporally related to the DRT cases). This study described the management patterns and mid-term outcomes of DRT and assessed patient and procedural predictors of DRT. RESULTS: A total of 711 patients (237 with and 474 without DRT) were included. Follow-up duration was similar in the DRT and no-DRT groups, median 1.8 years (interquartile range: 0.9-3.0 years) versus 1.6 years (interquartile range: 1.0-2.9 years), respectively (P = 0.76). DRTs were detected between days 0 to 45, 45 to 180, 180 to 365, and >365 in 24.9%, 38.8%, 16.0%, and 20.3% of patients. DRT presence was associated with a higher risk of the composite endpoint of death, ischemic stroke, or systemic embolization (HR: 2.37; 95% CI, 1.58-3.56; P < 0.001) driven by ischemic stroke (HR: 3.49; 95% CI: 1.35-9.00; P = 0.01). At last known follow-up, 25.3% of patients had DRT. Discharge medications after LAAO did not have an impact on DRT. Multivariable analysis identified 5 DRT risk factors: hypercoagulability disorder (odds ratio [OR]: 17.50; 95% CI: 3.39-90.45), pericardial effusion (OR: 13.45; 95% CI: 1.46-123.52), renal insufficiency (OR: 4.02; 95% CI: 1.22-13.25), implantation depth >10 mm from the pulmonary vein limbus (OR: 2.41; 95% CI: 1.57-3.69), and non-paroxysmal atrial fibrillation (OR: 1.90; 95% CI: 1.22-2.97). Following conversion to risk factor points, patients with ≥2 risk points for DRT had a 2.1-fold increased risk of DRT compared with those without any risk factors. CONCLUSIONS: DRT after LAAO is associated with ischemic events. Patient- and procedure-specific factors are associated with the risk of DRT and may aid in risk stratification of patients referred for LAAO.