Vera Baranova

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.

Renal denervation for improving outcomes of catheter ablation in patients with atrial fibrillation and hypertension: Early experience

BACKGROUND The potential role of renal denervation (RD) in patients with AF and less severe hypertension is unknown. OBJECTIVE The purpose of this study was to assess the potential role of RD as an adjunct to pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF) and moderate resistant or severe resistant hypertension. METHODS The data for this study were obtained from 2 different prospective randomized studies, analyzed by meta-analysis. Patients with paroxysmal AF or persistent AF and moderate resistant hypertension (office blood pressure BP ≥140/90 mm Hg and <160/100 mm Hg; first study; n = 48) or severe resistant hypertension (≥160/100 mm Hg; second study; n = 38) were randomized to PVI or PVI with RD. RESULTS At 12 months, 26 of the 41 PVI with RD patients (63%) were AF-free vs 16 of the 39 patients (41%) in the PVI-only group (P = .014). In patients with severe hypertension, 11 of the 18 PVI with RD patients (61%) vs 5 of the 18 PVI-only patients (28%) were AF-free (P = .03). For moderate hypertension, the differences were less dramatic: 11 of 21 (52%) vs 15 of 23 (65%) when RD added (P = .19). The superior efficacy of adding RD was most apparent in persistent AF and severe hypertension (hazard ratio 0.25, confidence interval 0.09-0.72, P = .01). Duration of the procedure and fluoroscopy were nonsignificantly longer in the RD group. CONCLUSION RD may improve the results of PVI in patients with persistent AF and/or severe resistant hypertension.

Cryoballoon Versus Radiofrequency for Pulmonary Vein Re-Isolation After a Failed Initial Ablation Procedure in Patients with Paroxysmal Atrial Fibrillation

Cryoballoon versus Radiofrequency Ablation. Aim: Catheter ablation of paroxysmal atrial fibrillation (PAF) is associated with an important risk of early and late recurrence, necessitating repeat ablation procedures. The aim of this prospective randomized patient‐blind study was to compare the efficacy and safety of cryoballoon (Cryo) versus radiofrequency (RF) ablation of PAF after failed initial RF ablation procedure.

Progression of atrial fibrillation after a failed initial ablation procedure in patients with paroxysmal atrial fibrillation: a randomized comparison of drug therapy versus reablation.

Background—The aim of this prospective randomized study was to assess whether an early reablation was superior to antiarrhythmic drug (AAD) therapy in patients with previous failed pulmonary vein isolation. Methods and Results—Patients with paroxysmal atrial fibrillation (AF) eligible for AAD therapy or reablation after a previously failed initial pulmonary vein isolation procedure were eligible for this study and were followed up for 3 years to assess rhythm by means of an implanted cardiac monitor. After the blanking period postablation, 154 patients had symptomatic AF recurrences and were randomized to AAD (n=77) or repulmonary vein isolation (n=77). At the end of follow-up, 61 (79%) patients in the AAD group and 19 (25%) patients in the reablation group demonstrated AF% progression (P<0.01). The AF% at 36 months was significantly greater in the AAD group compared with patients in the reablation group (18.8±11.4% versus 5.6±9.5%, respectively; P<0.01). In addition, 18 (23%) patients in the AAD group and 3 (4%) patients in the reablation group progressed to persistent AF (P<0.01). Furthermore, 45 (58%) of the 77 reablation group patients were free of AF/atrial tachycardia on no AADs; in contrast, in the AAD group, only 9 (12%) of the 77 patients were free of AF/atrial tachycardia (P<0.01) throughout follow-up. Conclusions—Redo AF ablation was substantially more effective than AAD in reducing the progression and prevalence of AF after the failure of an initial ablation. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT01709682.

RELATIONSHIP BETWEEN REDUCTION OF SYSTOLIC BLOOD PRESSURE AND ATRIAL FIBRILLATION BURDEN AFTER RENAL DENERVATION AND PULMONARY VEIN ISOLATION

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, but the antiarrhythmic mechanism by which RND functions is unknown. All patients from two randomized

Reply: first-in-humans randomized clinical trial of renal denervation for atrial arrhythmia raises concern.

We appreciate the interest that Dr. Staessen and colleagues have expressed regarding our recently published study [(1)][1]. We have addressed each of the issues. The study was initially registered with a larger estimated sample size, formally anticipating correction or revision as the study

Progression of Atrial Fibrillation After a Failed Initial Ablation Procedure in Patients With Paroxysmal Atrial FibrillationClinical Perspective

Background—The aim of this prospective randomized study was to assess whether an early reablation was superior to antiarrhythmic drug (AAD) therapy in patients with previous failed pulmonary vein isolation. Methods and Results—Patients with paroxysmal atrial fibrillation (AF) eligible for AAD therapy or reablation after a previously failed initial pulmonary vein isolation procedure were eligible for this study and were followed up for 3 years to assess rhythm by means of an implanted cardiac monitor. After the blanking period postablation, 154 patients had symptomatic AF recurrences and were randomized to AAD (n=77) or repulmonary vein isolation (n=77). At the end of follow-up, 61 (79%) patients in the AAD group and 19 (25%) patients in the reablation group demonstrated AF% progression (P<0.01). The AF% at 36 months was significantly greater in the AAD group compared with patients in the reablation group (18.8±11.4% versus 5.6±9.5%, respectively; P<0.01). In addition, 18 (23%) patients in the AAD group and 3 (4%) patients in the reablation group progressed to persistent AF (P<0.01). Furthermore, 45 (58%) of the 77 reablation group patients were free of AF/atrial tachycardia on no AADs; in contrast, in the AAD group, only 9 (12%) of the 77 patients were free of AF/atrial tachycardia (P<0.01) throughout follow-up. Conclusions—Redo AF ablation was substantially more effective than AAD in reducing the progression and prevalence of AF after the failure of an initial ablation. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT01709682.

Progression of Atrial Fibrillation After a Failed Initial Ablation Procedure in Patients With Paroxysmal Atrial FibrillationClinical Perspective: A Randomized Comparison of Drug Therapy Versus Reablation

Background—The aim of this prospective randomized study was to assess whether an early reablation was superior to antiarrhythmic drug (AAD) therapy in patients with previous failed pulmonary vein isolation. Methods and Results—Patients with paroxysmal atrial fibrillation (AF) eligible for AAD therapy or reablation after a previously failed initial pulmonary vein isolation procedure were eligible for this study and were followed up for 3 years to assess rhythm by means of an implanted cardiac monitor. After the blanking period postablation, 154 patients had symptomatic AF recurrences and were randomized to AAD (n=77) or repulmonary vein isolation (n=77). At the end of follow-up, 61 (79%) patients in the AAD group and 19 (25%) patients in the reablation group demonstrated AF% progression (P<0.01). The AF% at 36 months was significantly greater in the AAD group compared with patients in the reablation group (18.8±11.4% versus 5.6±9.5%, respectively; P<0.01). In addition, 18 (23%) patients in the AAD group and 3 (4%) patients in the reablation group progressed to persistent AF (P<0.01). Furthermore, 45 (58%) of the 77 reablation group patients were free of AF/atrial tachycardia on no AADs; in contrast, in the AAD group, only 9 (12%) of the 77 patients were free of AF/atrial tachycardia (P<0.01) throughout follow-up. Conclusions—Redo AF ablation was substantially more effective than AAD in reducing the progression and prevalence of AF after the failure of an initial ablation. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT01709682.