Evgeny Pokushalov

A Randomized Comparison of Pulmonary Vein Isolation With Versus Without Concomitant Renal Artery Denervation in Patients With Refractory Symptomatic Atrial Fibrillation and Resistant Hypertension

OBJECTIVES The aim of this prospective randomized study was to assess the impact of renal artery denervation in patients with a history of refractory atrial fibrillation (AF) and drug-resistant hypertension who were referred for pulmonary vein isolation (PVI). BACKGROUND Hypertension is the most common cardiovascular condition responsible for the development and maintenance of AF. Treating drug-resistant hypertension with renal denervation has been reported to control blood pressure, but any effect on AF is unknown. METHODS Patients with a history of symptomatic paroxysmal or persistent AF refractory to ≥2 antiarrhythmic drugs and drug-resistant hypertension (systolic blood pressure >160 mm Hg despite triple drug therapy) were eligible for enrolment. Consenting patients were randomized to PVI only or PVI with renal artery denervation. All patients were followed ≥1 year to assess maintenance of sinus rhythm and to monitor changes in blood pressure. RESULTS Twenty-seven patients were enrolled, and 14 were randomized to PVI only, and 13 were randomized to PVI with renal artery denervation. At the end of the follow-up, significant reductions in systolic (from 181 ± 7 to 156 ± 5, p < 0.001) and diastolic blood pressure (from 97 ± 6 to 87 ± 4, p < 0.001) were observed in patients treated with PVI with renal denervation without significant change in the PVI only group. Nine of the 13 patients (69%) treated with PVI with renal denervation were AF-free at the 12-month post-ablation follow-up examination versus 4 (29%) of the 14 patients in the PVI-only group (p = 0.033). CONCLUSIONS Renal artery denervation reduces systolic and diastolic blood pressure in patients with drug-resistant hypertension and reduces AF recurrences when combined with PVI.

2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation

During the past three decades, catheter and surgical ablation of atrial fibrillation (AF) have evolved from investigational procedures to their current role as effective treatment options for patients with AF. Surgical ablation of AF, using either standard, minimally invasive, or hybrid techniques, is available in most major hospitals throughout the world. Catheter ablation of AF is even more widely available, and is now the most commonly performed catheter ablation procedure. In 2007, an initial Consensus Statement on Catheter and Surgical AF Ablation was developed as a joint effort of the Heart Rhythm Society (HRS), the European Heart Rhythm Association (EHRA), and the European Cardiac Arrhythmia Society (ECAS).1 The 2007 document was also developed in collaboration with the Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC). This Consensus Statement on Catheter and Surgical AF Ablation was rewritten in 2012 to reflect the many advances in AF ablation that had occurred in the interim.2 The rate of advancement in the tools, techniques, and outcomes of AF ablation continue to increase as enormous research efforts are focused on the mechanisms, outcomes, and treatment of AF. For this reason, the HRS initiated an effort to rewrite and update this Consensus Statement. Reflecting both the worldwide importance of AF, as well as the worldwide performance of AF ablation, this document is the result of a joint partnership between the HRS, EHRA, ECAS, the Asia Pacific Heart Rhythm Society (APHRS), and the Latin American Society of Cardiac Stimulation and Electrophysiology (Sociedad Latinoamericana de Estimulacion Cardiaca y Electrofisiologia [SOLAECE]). The purpose of this 2017 Consensus Statement is to provide a state-of-the-art review of the field of catheter and surgical ablation of AF and to report the findings of a writing group, convened by these five international societies. The writing group is charged with defining the indications, techniques, and outcomes of AF ablation procedures. Included within this document are recommendations pertinent to the design of clinical trials in the field of AF ablation and the reporting of outcomes, including definitions relevant to this topic. The writing group is composed of 60 experts representing 11 organizations: HRS, EHRA, ECAS, APHRS, SOLAECE, STS, ACC, American Heart Association (AHA), Canadian Heart Rhythm Society (CHRS), Japanese Heart Rhythm Society (JHRS), and Brazilian Society of Cardiac Arrhythmias (Sociedade Brasileira de Arritmias Cardiacas [SOBRAC]). All the members of the writing group, as well as peer reviewers of the document, have provided disclosure statements for all relationships that might be perceived as real or potential conflicts of interest. All author and peer reviewer disclosure information is provided in Appendix A and Appendix B. In writing a consensus document, it is recognized that consensus does not mean that there was complete agreement among all the writing group members. Surveys of the entire writing group were used to identify areas of consensus concerning performance of AF ablation procedures and to develop recommendations concerning the indications for catheter and surgical AF ablation. These recommendations were systematically balloted by the 60 writing group members and were approved by a minimum of 80% of these members. The recommendations were also subject to a 1-month public comment period. Each partnering and collaborating organization then officially reviewed, commented on, edited, and endorsed the final document and recommendations. The grading system for indication of class of evidence level was adapted based on that used by the ACC and the AHA.3,4 It is important to state, however, that this document is not a guideline. The indications for catheter and surgical ablation of AF, as well as recommendations for procedure performance, are presented with a Class and Level of Evidence (LOE) to be consistent with what the reader is familiar with seeing in guideline statements. A Class I recommendation means that the benefits of the AF ablation procedure markedly exceed the risks, and that AF ablation should be performed; a Class IIa recommendation means that the benefits of an AF ablation procedure exceed the risks, and that it is reasonable to perform AF ablation; a Class IIb recommendation means that the benefit of AF ablation is greater or equal to the risks, and that AF ablation may be considered; and a Class III recommendation means that AF ablation is of no proven benefit and is not recommended. The writing group reviewed and ranked evidence supporting current recommendations with the weight of evidence ranked as Level A if the data were derived from high-quality evidence from more than one randomized clinical trial, meta-analyses of high-quality randomized clinical trials, or one or more randomized clinical trials corroborated by high-quality registry studies. The writing group ranked available evidence as Level B-R when there was moderate-quality evidence from one or more randomized clinical trials, or meta-analyses of moderate-quality randomized clinical trials. Level B-NR was used to denote moderate-quality evidence from one or more well-designed, well-executed nonrandomized studies, observational studies, or registry studies. This designation was also used to denote moderate-quality evidence from meta-analyses of such studies. Evidence was ranked as Level C-LD when the primary source of the recommendation was randomized or nonrandomized observational or registry studies with limitations of design or execution, meta-analyses of such studies, or physiological or mechanistic studies of human subjects. Level C-EO was defined as expert opinion based on the clinical experience of the writing group. Despite a large number of authors, the participation of several societies and professional organizations, and the attempts of the group to reflect the current knowledge in the field adequately, this document is not intended as a guideline. Rather, the group would like to refer to the current guidelines on AF management for the purpose of guiding overall AF management strategies.5,6 This consensus document is specifically focused on catheter and surgical ablation of AF, and summarizes the opinion of the writing group members based on an extensive literature review as well as their own experience. It is directed to all health care professionals who are involved in the care of patients with AF, particularly those who are caring for patients who are undergoing, or are being considered for, catheter or surgical ablation procedures for AF, and those involved in research in the field of AF ablation. This statement is not intended to recommend or promote catheter or surgical ablation of AF. Rather, the ultimate judgment regarding care of a particular patient must be made by the health care provider and the patient in light of all the circumstances presented by that patient. The main objective of this document is to improve patient care by providing a foundation of knowledge for those involved with catheter ablation of AF. A second major objective is to provide recommendations for designing clinical trials and reporting outcomes of clinical trials of AF ablation. It is recognized that this field continues to evolve rapidly. As this document was being prepared, further clinical trials of catheter and surgical ablation of AF were under way.

Selective ganglionated plexi ablation for paroxysmal atrial fibrillation.

BACKGROUND Selective ganglionated plexi (GP) ablation guided by high-frequency stimulation has been proposed for the treatment of paroxysmal atrial fibrillation (AF), but the efficacy of the method is not established. OBJECTIVE This study sought to compare selective ablation of GP identified by high-frequency stimulation with extensive regional ablation targeting the anatomic areas of GP in patients with paroxysmal AF. METHODS Eighty patients with paroxysmal AF (age 53 +/- 9 years) were randomized to undergo selective GP ablation or regional left atrial ablation at the anatomic sites of GP. For selective GP ablation (n = 40), ablation targets were the sites where vagal reflexes were evoked by high-frequency stimulation. Vagal reflexes were defined as prolongation of the R-R interval by >50% and a concomitant decrease in blood pressure (>20 mm Hg) during AF. The end point of the procedure was failure to reproduce vagal reflexes with repeated high-frequency stimulation. For anatomic ablation, lesions were delivered at the sites of GP clustering. RESULTS At 13.1 +/- 1.9 months, 42.5% of patients with selective GP and 77.5% of patients with anatomic ablation were free of symptomatic paroxysmal AF (PAF) (P = .02). Parasympathetic denervation was more prominent in patients with anatomic than selective GP ablation, and in patients free of AF compared to these with AF recurrence immediately after ablation, but this trend was abolished at 6 months. CONCLUSION Selective GP ablation directed by high-frequency stimulation does not eliminate paroxysmal AF in the majority of patients. An anatomic approach for regional ablation at the sites of GP confers better results.

Rapid pulmonary vein isolation combined with autonomic ganglia modification: A randomized study

BACKGROUND Evidence indicates that the combination of left atrial ganglionated plexi (GP) ablation and pulmonary vein (PV) isolation is beneficial for treatment of paroxysmal atrial fibrillation (AF). OBJECTIVE The purpose of this study was to compare GP and PV ablation with PV isolation alone for treatment of paroxysmal AF. METHODS Sixty-seven patients with paroxysmal AF were randomized to either PV isolation using a circular catheter suitable for both mapping and ablation (PV group) or anatomic GP modification followed by PV isolation (GP+PV group). Patients were seen at monthly visits, and 48-hour ambulatory ECG recordings were obtained every 3 months for a predefined follow-up period of 12 months. Primary endpoint was freedom from AF or other sustained atrial arrhythmia recurrence 3 to 12 months postablation after one or two procedures, without antiarrhythmic medications. RESULTS Recurrence of arrhythmia was documented in 18 (54.5%) patients in the PV group 4.7 ± 1.0 months after ablation, and repeat PV isolation was performed in 7 (21.2%) of these patients 5.1 ± 1.1 months after the first procedure. Recurrence of arrhythmia was documented in 9 (26.5%) patients in the GP+PV group 5.0 ± 1.3 months after ablation, and repeat ablation was performed in 6 (17.6%) of these patients 4.3 ± 0.5 months after the first procedure. At the end of follow-up, 20 (60.6%) patients in the PV group and 29 (85.3%) patients in the GP+PV group remained arrhythmia-free (log rank test, P = .019). CONCLUSION Addition of anatomic GP modification to PV isolation confers significantly better outcomes than PV isolation alone during a follow-up period of 12 months.

Implant success and safety of left atrial appendage closure with the WATCHMAN device: peri-procedural outcomes from the EWOLUTION registry

Abstract Aims  Left atrial appendage closure is a non-pharmacological alternative for stroke prevention in high-risk patients with non-valvular atrial fibrillation. The objective of the multicentre EWOLUTION registry was to obtain clinical data on procedural success and complications, and long-term patient outcomes, including bleeding and incidence of stroke/transient ischaemic attack (TIA). Here, we report on the peri-procedural outcomes of up to 30 days. Methods and results  Baseline/implant data are available for 1021 subjects. Subjects in the study were at high risk of stroke (average CHADS 2 score: 2.8 ± 1.3, CHA 2 DS 2 -VASc: 4.5 ± 1.6) and moderate-to-high risk of bleeding (average HAS-BLED score: 2.3 ± 1.2). Almost half of the subjects (45.4%) had a history of TIA, ischaemic stroke, or haemorrhagic stroke; 62% of patients were deemed unsuitable for novel oral anticoagulant by their physician. The device was successfully deployed in 98.5% of patients with no flow or minimal residual flow achieved in 99.3% of implanted patients. Twenty-eight subjects experienced 31 serious adverse events (SAEs) within 1 day of the procedure. The overall 30-day mortality rate was 0.7%. The most common SAE occurring within 30 days of the procedure was major bleeding requiring transfusion. Incidence of SAEs within 30 days was significantly lower for subjects deemed to be ineligible for oral anticoagulation therapy (OAT) compared with those eligible for OAT (6.5 vs. 10.2%, P = 0.042). Conclusion  Left atrial appendage closure with the WATCHMAN device has a high success rate in complete LAAC with low peri-procedural risk, even in a population with a higher risk of stroke and bleeding, and multiple co-morbidities. Improvement in implantation techniques has led to a reduction of peri-procedural complications previously limiting the net clinical benefit of the procedure.

Catheter Ablation for Atrial Fibrillation with Heart Failure

Background Mortality and morbidity are higher among patients with atrial fibrillation and heart failure than among those with heart failure alone. Catheter ablation for atrial fibrillation has been proposed as a means of improving outcomes among patients with heart failure who are otherwise receiving appropriate treatment. Methods We randomly assigned patients with symptomatic paroxysmal or persistent atrial fibrillation who did not have a response to antiarrhythmic drugs, had unacceptable side effects, or were unwilling to take these drugs to undergo either catheter ablation (179 patients) or medical therapy (rate or rhythm control) (184 patients) for atrial fibrillation in addition to guidelines‐based therapy for heart failure. All the patients had New York Heart Association class II, III, or IV heart failure, a left ventricular ejection fraction of 35% or less, and an implanted defibrillator. The primary end point was a composite of death from any cause or hospitalization for worsening heart failure. Results After a median follow‐up of 37.8 months, the primary composite end point occurred in significantly fewer patients in the ablation group than in the medical‐therapy group (51 patients [28.5%] vs. 82 patients [44.6%]; hazard ratio, 0.62; 95% confidence interval [CI], 0.43 to 0.87; P=0.007). Significantly fewer patients in the ablation group died from any cause (24 [13.4%] vs. 46 [25.0%]; hazard ratio, 0.53; 95% CI, 0.32 to 0.86; P=0.01), were hospitalized for worsening heart failure (37 [20.7%] vs. 66 [35.9%]; hazard ratio, 0.56; 95% CI, 0.37 to 0.83; P=0.004), or died from cardiovascular causes (20 [11.2%] vs. 41 [22.3%]; hazard ratio, 0.49; 95% CI, 0.29 to 0.84; P=0.009). Conclusions Catheter ablation for atrial fibrillation in patients with heart failure was associated with a significantly lower rate of a composite end point of death from any cause or hospitalization for worsening heart failure than was medical therapy. (Funded by Biotronik; CASTLE‐AF ClinicalTrials.gov number, NCT00643188.)

Ganglionated plexi ablation for longstanding persistent atrial fibrillation

AIMS To study the potential efficacy of ganglionated plexi (GP) ablation in the setting of longstanding persistent atrial fibrillation (AF). METHODS AND RESULTS Anatomic ablation at the areas of GP in the left atrium was performed in 89 patients with symptomatic, drug-refractory, persistent AF (71 men, 56 +/- 7 years of age). In 29 patients, a second procedure by means of circumferential pulmonary vein (PV) isolation was performed, and 5 of them were subjected to a third circumferential ablation. At 16 +/- 7 months after the final ablation procedure, 53 (59.6%) of the 89 patients were in sinus rhythm in the absence of antiarrhythmic drug therapy, 5 (5.6%) patients had permanent AF, and 31 (34.8%) patients had paroxysmal AF. The long-term success rate for patients who underwent a single ablation procedure with only GP ablation was 38.2% over a follow-up of 24 +/- 3 months. Independent predictors of later arrhythmia recurrences were left atrial diameter [HR 1.039 (1.00-1.07), P = 0.028] and duration of AF prior to ablation [HR 1.116 (1.02-1.22), P = 0.008]. CONCLUSION Ganglionated plexi ablation in chronic AF results in long-term maintenance of sinus rhythm in 38.2% of cases. Repeat procedures with circumferential isolation of all PV offer a success rate of 59.6% over a follow-up of 16 +/- 7 months.

Ablation of paroxysmal and persistent atrial fibrillation: 1-year follow-up through continuous subcutaneous monitoring.

Ablation of Paroxysmal and Persistent Atrial Fibrillation. Background: The aim of this prospective observational study was to identify responders to ablation through continuous subcutaneous monitoring for 1 year after ablation in patients with paroxysmal atrial fibrillation (PAF) or persistent AF (PersAF).

Ganglionated plexus ablation vs linear ablation in patients undergoing pulmonary vein isolation for persistent/long-standing persistent atrial fibrillation: a randomized comparison.

BACKGROUND The optimal ablation technique for persistent and long-standing persistent atrial fibrillation (AF) is unclear. Both linear lesion (LL) and ganglionated plexus (GP) ablation have been used in addition to pulmonary vein isolation (PVI), but no direct comparison of the 2 methods exists. OBJECTIVE The aim of this study is to assess the comparative safety and efficacy of 2 different ablation strategies-PVI+LL vs PVI+GP ablation -in patients with persistent or long-standing persistent AF. METHODS Two hundred sixty-four consecutive patients with persistent/long-standing persistent AF were randomly assigned to 2 different ablation schemes: PVI+LL (n = 132) and PVI+GP (n = 132) ablation. Consistent sinus rhythm (SR) off antiarrhythmic drug was assessed after follow-up of at least 3 years with the use of an implanted monitoring device. RESULTS All procedural end points were acutely achieved. At 12 months after a single procedure, 47% of the patients treated with PVI+LL were in SR compared to 54% of the patients treated with PVI+GP (P = .29). At 3 years, 34% of the patients with PVI+LL and 49% of the patients with PVI+GP maintained SR (P = .035). Atrial flutter was more frequent in the PVI+LL group than in PVI+GP group (18% vs 6%; P = .002). After a second procedure in 78 patients of the PVI+LL group and 55 patients of the PVI+GP group, the long-term overall success rate was 52% and 68%, respectively (P = .006). CONCLUSIONS PVI+GP ablation confers superior clinical results with less ablation-related left atrial flutter and reduced AF recurrence compared to PVI+LL ablation at 3 years of follow-up.

Left Atrial Ablation at the Anatomic Areas of Ganglionated Plexi for Paroxysmal Atrial Fibrillation

Background:  Modification of left atrial ganglionated plexi (GP) is a promising technique for the treatment of paroxysmal atrial fibrillation (AF) but its therapeutic efficacy is not established. This study aimed at evaluating the effectiveness of anatomic GP modification by means of an implantable arrhythmia monitoring device.