Remote magnetic navigation ablation via the right jugular vein approach in patient with interruption of the inferior vena cava and incessant left atrial flutter.

Remote magnetic navigation (RMN) can be safely and effectively utilized in patients with difficult cardiac arrhythmias and complex anatomy. Interruption of the inferior vena cava (IVC) is a rare congenital abnormality that results in the inability to use conventional femoral access in patients that require interventional procedures. The present case demonstrates the feasibility of left atrial flutter ablation using RMN via jugular approach in a patient with interruption of IVC.

Comparative Safety and Efficacy of Left Atrial Appendage Occlusion with the Watchman Device and Amplatzer Cardiac Plug: Results of the Russian National Registry.

PURPOSE: This multicenter, prospective registry evaluated the comparative safety and efficacy of left atrial appendage occlusion (LAAO) using the Watchman device (WD) and the Amplatzer Cardiac Plug (ACP) in patients with nonvalvular atrial fibrillation (NVAF) in real-world clinical practice in Russia. METHODS: The study included data from 200 consecutive NVAF patients (66.8 ± 7.8 years, 44.5% female, median CHA2DS2VASc 4, median HAS-BLED 3) who had undergone LAAO implantation using WD (n = 108) or ACP (n = 92) from September 2015 to December 2017 in 5 medical centers in Russia. The primary safety endpoint was the procedure-related major adverse events, and the primary efficacy endpoint was the composite of thromboembolic events, device thrombosis, hemorrhagic events, and unexplained death during the 12-month follow-up. RESULTS: Successful LAAO was performed in all 92 (100%) patients with ACP and 105 (97.2%) with WD (p = 0.053). At 12 months, primary safety endpoint occurred in 6.5% of patients in the ACP group with no events in the WD group (6.5% vs. 0%, p = 0.008). During the 12-month follow-up, the primary efficacy endpoint has occurred in 8.3% of patients in the WD group (n = 9) and 1.1% of patients in the ACP group (n = 1) (p = 0.016). CONCLUSIONS: In this multicenter prospective registry, LAA closure with the WD was associated with significantly higher thromboembolic events rate in NVAF patients. Patients, receiving the ACP, had more procedure-related major adverse events. However, further multicenter studies are necessary to evaluate these findings.

Pulmonary Artery Denervation for Patients With Residual Pulmonary Hypertension After Pulmonary Endarterectomy.

BACKGROUND: Pulmonary artery denervation (PADN) procedure has not been applied to patients with residual chronic thromboembolic pulmonary hypertension (CTEPH) after pulmonary endarterectomy (PEA). OBJECTIVES: This study sought to assess the safety and efficacy of PADN using remote magnetic navigation in patients with residual CTEPH after PEA. METHODS: Fifty patients with residual CTEPH despite medical therapy at least 6 months after PEA, who had mean pulmonary artery pressure ≥25 mm Hg or pulmonary vascular resistance (PVR) > 400 dyn‧s‧cm-5 based on right heart catheterization were randomized to treatment with PADN (PADN group; n = 25) using remote magnetic navigation for ablation or medical therapy with riociguat (MED group; n = 25). In the MED group, a sham procedure with mapping but no ablation was performed. The primary endpoint was PVR at 12 months after randomization. Key secondary endpoint included 6-min walk test. RESULTS: After PADN procedure, 2 patients (1 in each group) developed groin hematoma that resolved without any consequences. At 12 months, mean PVR reduction was 258 ± 135 dyn‧s‧cm-5 in the PADN group versus 149 ± 73 dyn‧s‧cm-5 in the MED group, mean between-group difference was 109 dyn‧s‧cm-5 (95% confidence interval: 45 to 171; p = 0.001). The 6-min walk test distance was significantly increased in the PADN group as compared to distance in the MED group (470 ± 84 m vs. 399 ± 116 m, respectively; p = 0.03). CONCLUSIONS: PADN in patients with residual CTEPH resulted in substantial reduction of PVR at 12 months of follow-up, accompanied by improved 6-min walk test.

Effect of Renal Denervation and Catheter Ablation vs Catheter Ablation Alone on Atrial Fibrillation Recurrence Among Patients With Paroxysmal Atrial Fibrillation and Hypertension: The ERADICATE-AF Randomized Clinical Trial.

Importance: Renal denervation can reduce cardiac sympathetic activity that may result in an antiarrhythmic effect on atrial fibrillation. Objective: To determine whether renal denervation when added to pulmonary vein isolation enhances long-term antiarrhythmic efficacy. Design, Setting, and Participants: The Evaluate Renal Denervation in Addition to Catheter Ablation to Eliminate Atrial Fibrillation (ERADICATE-AF) trial was an investigator-initiated, multicenter, single-blind, randomized clinical trial conducted at 5 referral centers for catheter ablation of atrial fibrillation in the Russian Federation, Poland, and Germany. A total of 302 patients with hypertension despite taking at least 1 antihypertensive medication, paroxysmal atrial fibrillation, and plans for ablation were enrolled from April 2013 to March 2018. Follow-up concluded in March 2019. Interventions: Patients were randomized to either pulmonary vein isolation alone (n = 148) or pulmonary vein isolation plus renal denervation (n = 154). Complete pulmonary vein isolation to v an end point of elimination of all pulmonary vein potentials; renal denervation using an irrigated-tip ablation catheter delivering radiofrequency energy to discrete sites in a spiral pattern from distal to proximal in both renal arteries. Main Outcomes and Measures: The primary end point was freedom from atrial fibrillation, atrial flutter, or atrial tachycardia at 12 months. Secondary end points included procedural complications within 30 days and blood pressure control at 6 and 12 months. Results: Of the 302 randomized patients (median age, 60 years [interquartile range, 55-65 years]; 182 men [60.3%]), 283 (93.7%) completed the trial. All successfully underwent their assigned procedures. Freedom from atrial fibrillation, flutter, or tachycardia at 12 months was observed in 84 of 148 (56.5%) of those undergoing pulmonary vein isolation alone and in 111 of 154 (72.1%) of those undergoing pulmonary vein isolation plus renal denervation (hazard ratio, 0.57; 95% CI, 0.38 to 0.85; P = .006). Of 5 prespecified secondary end points, 4 are reported and 3 differed between groups. Mean systolic blood pressure from baseline to 12 months decreased from 151 mm Hg to 147 mm Hg in the isolation-only group and from 150 mm Hg to 135 mm Hg in the renal denervation group (between-group difference, -13 mm Hg; 95% CI, -15 to -11 mm Hg; P < .001). Procedural complications occurred in 7 patients (4.7%) in the isolation-only group and 7 (4.5%) of the renal denervation group. Conclusions and Relevance: Among patients with paroxysmal atrial fibrillation and hypertension, renal denervation added to catheter ablation, compared with catheter ablation alone, significantly increased the likelihood of freedom from atrial fibrillation at 12 months. The lack of a formal sham-control renal denervation procedure should be considered in interpreting the results of this trial. Trial Registration: ClinicalTrials.gov Identifier: NCT01873352.

Long-term suppression of atrial fibrillation by botulinum toxin injection into epicardial fat pads in patients undergoing cardiac surgery: Three-year follow-up of a randomized study.

BACKGROUND: Botulinum toxin (BTX) injections into epicardial fat pads in patients undergoing coronary artery bypass grafting (CABG) has resulted in suppression of atrial fibrillation (AF) during the early postoperative period through 1-year of follow-up in a pilot program. OBJECTIVE: The purpose of this study was to report 3-year AF patterns by the use of implantable cardiac monitors (ICMs). METHODS: Sixty patients with a history of paroxysmal AF and indications for CABG were randomized 1:1 to either BTX or placebo injections into 4 posterior epicardial fat pads. All patients received an ICM with regular follow-up for 3 years after surgery. The primary end point of the extended follow-up period was incidence of any atrial tachyarrhythmia after 30 days of procedure until 36 months on no antiarrhythmic drugs. The secondary end points included clinical events and AF burden. RESULTS: At the end of 36 months, the incidence of any atrial tachyarrhythmia was 23.3% in the BTX group vs 50% in the placebo group (hazard ratio 0.36; 95% confidence interval 0.14-0.88; P = .02). AF burden at 12, 24, and 36 months was significantly lower in the BTX group than in the placebo group: 0.22% vs 1.88% (P = .003), 1.6% vs 9.5% (P < .001), and 1.3% vs 6.9% (P = .007), respectively. In the BTX group, 2 patients (7%) were hospitalized during follow-up compared with 10 (33%) in the placebo group (P = .02). CONCLUSION: Injection of BTX into epicardial fat pads in patients undergoing CABG resulted in a sustained and substantial reduction in atrial tachyarrhythmia incidence and burden during 3-year follow-up, accompanied by reduction in hospitalizations.

Prophylactic pulmonary vein isolation during isthmus ablation for atrial flutter: Three-year outcomes of the PREVENT AF I study.

INTRODUCTION: The PREVENT AF I study demonstrated that prophylactic pulmonary vein isolation (PVI) in patients with pure typical atrial flutter (AFL) resulted in substantial reduction of new-onset atrial fibrillation (AF) during 1-year follow-up as assessed by continuous implantable cardiac monitor (ICM). The objective of this study was to assess 3-year outcomes. METHODS AND RESULTS: Fifty patients with documented AFL were randomized to either cavotricuspid isthmus (CTI) ablation alone (n = 25) or CTI with concomitant PVI (n = 25). The primary endpoint of the study was the occurrence of any atrial tachyarrhythmia with the monthly burden exceeding 0.5% on the ICM. At the end of 3 years, freedom from any atrial tachyarrhythmia was 48% (95% confidence interval [CI]: 32-72%) in the CTI plus PVI group as compared to 20% (95% CI: 9-44%) in the CTI-only group (P = 0.01). Freedom from redo procedures was also higher: 92% (95% CI: 82-100%) versus 68% (95% CI: 52-89%), respectively (P = 0.027). The 3-year AF burden favored the combined ablation group: 6.2% versus 16.8% (P = 0.03). In the CTI-only group, 12 (48%) patients were hospitalized compared to 4 (16%) in the PVI + CTI group (P = 0.03). Two patients in the CTI-only group developed stroke with no serious adverse events in the PVI + CTI group. CONCLUSION: Prophylactic PVI in patients with only typical AFL resulted in a significant reduction of new-onset AF and burden during long-term follow-up as assessed by ICM, with consequent reduction in hospitalizations and need to perform repeat ablation for AF.

Incidence of atrial fibrillation detected by continuous rhythm monitoring after acute myocardial infarction in patients with preserved left ventricular ejection fraction: results of the ARREST study.

Aims: Cardiac arrhythmias following acute myocardial infarction (AMI) can be associated with major adverse cardiovascular events. Data on the "real incidence" of post-MI arrhythmias are limited. We aimed to determine the rate and burden of cardiac arrhythmias by the use of insertable cardiac monitors (ICM) in patients with preserved left ventricular ejection fraction (LVEF) after AMI. Methods and results: In this prospective observational study, patients with LVEF ≥40% who underwent PCI within 7 days following AMI were enrolled to receive an ICM. Primary outcome was the incidence of new-onset atrial fibrillation (AF) measured by the ICM during a follow-up of 2 years; results: Of 165 consecutive patients with AMI, 50 (30.3%) eligible patients were recruited (mean age 57.8 ± 8.3, 88% male). During follow-up, AF was the most frequently detected arrhythmia. Twenty-nine (58%, 95% CI: 42-70%) patients developed new-onset AF, with a cumulative rate of all detected arrhythmias of 65%. Median time to the first detected AF episode was 4.8 months and the peak cumulative AF burden was detected between 3 and 6 months. Twenty-seven (93%) out of 29 patients with AF were asymptomatic. Cox regression analysis found that baseline troponin level (hazard ratio [HR] for 1 ng/mL increment: 1.03, 95% CI: 1.01-1.06, P = 0.01) and CHA2DS2-VASc score of 4 (HR: 11.42, 95% CI: 1.01-129.06, P = 0.04) were independent risk factors of new-onset AF post-AMI. Conclusion: AF is a frequent but largely underestimated cardiac arrhythmia after AMI. More rigorous monitoring strategies resulting in crucial medical interventions (e.g. implementation of oral anti-coagulation) are needed. Clinical Trial Registration: http://www.clinicaltrials.gov. Unique identifier: NCT02492243.

Pulmonary vein isolation with concomitant renal artery denervation is associated with reduction in both arterial blood pressure and atrial fibrillation burden: Data from implantable cardiac monitor.

BACKGROUND: Renal artery denervation (RDN) has provided incremental atrial fibrillation (AF) suppression after pulmonary vein isolation (PVI) in patients with AF in the setting of drug-resistant hypertension. OBJECTIVE: To assess the relationship between changes of mean blood pressure (BP) and AF recurrences/AF burden after PVI combined with RDN. METHODS: All patients from two randomized studies with symptomatic paroxysmal AF and/or persistent AF and resistant hypertension who underwent PVI-only (n=37) or PVI with RDN (n=39), and implantable cardiac monitor (ICM) implantation were eligible for this study. Mixed-effects linear models were used to investigate the effect of RDN on mean BP and mean AF burden and associations between the two during the 12-month follow-up. RESULTS: Concomitant RDN was associated with a significant reduction in both mean AF burden (2.43 [95% CI: 1.76-3.09] % vs 6.95 [95% CI: 5.44-8.45] %) and mean BP (104 [95% CI: 103-106] mm Hg vs 112 [95% CI: 110-113] mm Hg). Decrease in mean BP was positively correlated with decline in mean AF burden: reduction of 5-10 mm Hg was accompanied by a 7.0% decreased mean AF burden, with greater reduction (up to 20 mm Hg) associated with on average 17.7% lower mean AF burden. CONCLUSIONS: Renal artery denervation when added to PVI decreases AF recurrences, AF burden, and mean BP. Reduction in mean BP is associated with both AF burden and recurrences. Further large-scale studies are needed to define the mechanistic pathway(s) of the antiarrhythmic effects of RDN.

Effect of left atrial appendage excision on procedure outcome in patients with persistent atrial fibrillation undergoing surgical ablation.

BACKGROUND: Catheter ablation is less successful for treatment of persistent atrial fibrillation (PersAF) than for paroxysmal atrial fibrillation. Some studies suggest that left atrial appendage (LAA) isolation in addition to pulmonary vein isolation (PVI) is required to maximize the benefits for PersAF after ablation. OBJECTIVE: The purpose of this study was to compare the efficacy and safety of 2 surgical ablation approaches for PersAF via video-assisted thoracoscopy: PVI + box lesion and PVI + box lesion + LAA excision. METHODS: We randomly assigned 176 patients with PersAF to video-assisted thoracoscopic surgical ablation with PVI + box lesion (88 patients) or PVI + box lesion + LAA excision (88 patients). The primary endpoint was freedom from any documented atrial arrhythmia lasting >30 seconds after a single ablation procedure without antiarrhythmic drug (AAD). RESULTS: After 18 months of follow-up, 61 of 86 patients (70.9%) assigned to PVI + box lesion were free from recurrent atrial fibrillation compared to 64 of 87 patients (73.6%) assigned to PVI + box lesion + LAA excision after a single ablation procedure without AAD (P = .73). Freedom from any atrial arrhythmia after a single procedure with or without AAD was also nonsignificant (70.9% vs 74.7%, respectively). There were no significant differences between groups with regard to adverse events, including death, transient ischemic attack, stroke, pneumothorax, and hydrothorax. CONCLUSION: Among patients with PersAF, no reduction in the rate of recurrent atrial fibrillation was found when LAA excision was performed in addition to PVI and box lesion during surgical ablation.

Cardiac resynchronization therapy combined with coronary artery bypass grafting in ischaemic heart failure patients: long-term results of the RESCUE study.

OBJECTIVES: Totally epicardial cardiac resynchronization therapy (CRT) is a novel treatment modality for patients with heart failure (HF) and systolic dyssynchrony undergoing coronary artery bypass grafting (CABG). In this study, we have prospectively evaluated the long-term outcomes of totally epicardial CRT. METHODS: Between September 2007 and June 2009, one hundred and seventy-eight patients were randomly assigned to the CABG alone group (n = 87) and CABG with concomitant epicardial CRT implantation (n = 91). The primary end-point of the study was all-cause mortality in the two groups between the day of surgery and 13 August 2013 (common closing date). The secondary outcomes included mode of death, adverse cardiac events and lead performance. RESULTS: The mean follow-up was 55 ± 10.7 months. According to per-protocol analysis with treatment as a time-dependent variable to account for conversion from CABG to CABG + CRT, there were 24 deaths (35.8%) in the CABG group and 17 deaths (15.3%) in the CABG + CRT group. When compared with CABG alone, concomitant CRT was associated with reduced risk of both all-cause mortality [hazard ratio (HR) 0.43, 95% confidence interval (CI) 0.23-0.84, P = 0.012] and cardiac death (HR 0.39, 95% CI 0.21-0.72, P = 0.002). Eleven (12.6%) sudden deaths were observed in the CABG group in comparison with 4 (4.4%) in the CABG + CRT group (P = 0.048). Hospital readmission was required for 9 (9.9%) patients in CABG + CRT group and for 25 (28.7%) patients in the CABG group (P = 0.001). There were 4 (1.5%) epicardial lead failures. CONCLUSIONS: The results of our study suggest that the procedure of CABG and totally epicardial CRT system implantation is safe and significantly improves the survival of patients with HF and dyssynchrony during long-term follow-up. CLINICAL TRIAL REGISTRATION: NCT 00846001 (http://www.clinicaltrials.gov).

Outcomes of Cryoballoon Ablation in High- and Low-Volume Atrial Fibrillation Ablation Centres: A Russian Pilot Survey.

PURPOSE: The results of cryoballoon ablation (CBA) procedure have been mainly derived from studies conducted in experienced atrial fibrillation (AF) ablation centres. Here, we report on CBA efficacy and complications resulting from real practice of this procedure at both high- and low-volume centres. METHODS: Among 62 Russian centres performing AF ablation, 15 (24%) used CBA technology for pulmonary vein isolation. The centres were asked to provide a detailed description of all CBA procedures performed and complications, if encountered. RESULTS: Thirteen sites completed interviews on all CBAs in their centres (>95% of CBAs in Russia). Six sites were high-volume AF ablation (>100 AF cases/year) centres, and 7 were low-volume AF ablation. There was no statistical difference in arrhythmia-free rates between high- and low-volume centres (64.6 versus 60.8% at 6 months). Major complications developed in 1.5% of patients and were equally distributed between high- and low-volume centres. Minor procedure-related events were encountered in 8% of patients and were more prevalent in high-volume centres. Total event and vascular access site event rates were higher in women than in men. CONCLUSIONS: CBA has an acceptable efficacy profile in real practice. In less experienced AF ablation centres, the major complication rate is equal to that in high-volume centres.

Prophylactic pulmonary vein isolation during isthmus ablation for atrial flutter: the PReVENT AF Study I.

BACKGROUND: Although catheter ablation of isthmus-dependent atrial flutter (AFL) is successful at eliminating the target arrhythmia, many patients subsequently experience new-onset atrial fibrillation (AF). OBJECTIVE: The aim of this study was to determine whether AF can be prevented by prophylactic pulmonary vein ablation in patients with AFL. METHODS: A prospective, single-blind, randomized clinical trial in patients whose sole arrhythmia was AFL without AF was conducted. Patients were randomized to cavotricuspid isthmus ablation alone or with concomitant pulmonary vein isolation. All patients received an implantable cardiac monitor. RESULTS: Fifty patients completed the trial, and patients were well matched. Isthmus ablation was successful in all patients; pulmonary vein isolation was successful in 25 (100%) randomized patients. Procedure (P < .0001) and fluoroscopy (P < .0001) times were longer in the combined ablation group. More patients in the isthmus ablation-only group experienced new-onset AF during follow-up (52% vs. 12%; P = .003). The 1-year AF burden also favored the combined ablation group compared with the isthmus ablation-only group (8.3% vs. 4.0%; P = .034). In the isthmus ablation-only group, 8 (32%) patients subsequently underwent another ablation for AF. The performance of pulmonary vein isolation and male sex were independent predictors of freedom from AF. CONCLUSION: In the PREVENT-AF Study I randomized clinical trial of patients in whom only typical AFL had been observed clinically, the addition of pulmonary vein isolation to cavotricuspid isthmus ablation resulted in a marked reduction of new-onset AF during clinical follow-up as assessed with a continuous implantable cardiac monitor.