Abstract：
BACKGROUND: The autonomic nervous system plays an important role in atrial fibrillation (AF) and hypertension. Renal denervation (RDN) lowers blood pressure (BP), but its role in AF is poorly understood.
OBJECTIVE: The purpose of this study was to investigate whether RDN reduces AF recurrence after pulmonary vein isolation (PVI).
METHODS: This study randomized patients from 8 centers (United States, Germany) with drug-refractory AF for treatment with PVI+RDN vs PVI alone. A multielectrode radiofrequency Spyral catheter system was used for RDN. Insertable cardiac monitors were used for continuous rhythm monitoring. The primary efficacy endpoint was ≥2 minutes of AF recurrence or repeat ablation during all follow-up. The secondary endpoints included atrial arrhythmia (AA) burden, discontinuation of class I/III antiarrhythmic drugs, and BP changes from baseline.
RESULTS: A total of 70 patients with AF (52 paroxysmal, 18 persistent) and uncontrolled hypertension were randomized (RDN+PVI, n = 34; PVI, n = 36). At 3.5 years, 26.2% and 21.4% of patients in RDN+PVI and PVI groups, respectively, were free from the primary efficacy endpoint (log rank P = 0.73). Patients with mean ≥1 h/d AA had less daily AA burden after RDN+PVI vs PVI (4.1 hours vs 9.2 hours; P = 0.016). More patients discontinued class I/III antiarrhythmic drugs after RDN+PVI vs PVI (45% vs 14%; P = 0.040). At 1 year, systolic BP changed by -17.8 ± 12.8 mm Hg and -13.7 ± 18.8 mm Hg after RDN+PVI and PVI, respectively (P = 0.43). The composite safety endpoint was not significantly different between groups.
CONCLUSIONS: In patients with AF and uncontrolled BP, RDN+PVI did not prevent AF recurrence more than PVI alone. However, RDN+PVI may reduce AF burden and antiarrhythmic drug usage, but this needs further prospective validation.
OBJECTIVE: The purpose of this study was to investigate whether RDN reduces AF recurrence after pulmonary vein isolation (PVI).
METHODS: This study randomized patients from 8 centers (United States, Germany) with drug-refractory AF for treatment with PVI+RDN vs PVI alone. A multielectrode radiofrequency Spyral catheter system was used for RDN. Insertable cardiac monitors were used for continuous rhythm monitoring. The primary efficacy endpoint was ≥2 minutes of AF recurrence or repeat ablation during all follow-up. The secondary endpoints included atrial arrhythmia (AA) burden, discontinuation of class I/III antiarrhythmic drugs, and BP changes from baseline.
RESULTS: A total of 70 patients with AF (52 paroxysmal, 18 persistent) and uncontrolled hypertension were randomized (RDN+PVI, n = 34; PVI, n = 36). At 3.5 years, 26.2% and 21.4% of patients in RDN+PVI and PVI groups, respectively, were free from the primary efficacy endpoint (log rank P = 0.73). Patients with mean ≥1 h/d AA had less daily AA burden after RDN+PVI vs PVI (4.1 hours vs 9.2 hours; P = 0.016). More patients discontinued class I/III antiarrhythmic drugs after RDN+PVI vs PVI (45% vs 14%; P = 0.040). At 1 year, systolic BP changed by -17.8 ± 12.8 mm Hg and -13.7 ± 18.8 mm Hg after RDN+PVI and PVI, respectively (P = 0.43). The composite safety endpoint was not significantly different between groups.
CONCLUSIONS: In patients with AF and uncontrolled BP, RDN+PVI did not prevent AF recurrence more than PVI alone. However, RDN+PVI may reduce AF burden and antiarrhythmic drug usage, but this needs further prospective validation.
摘要：
背景：自主神经系统在心房颤动（AF）和高血压中起重要作用。去肾神经（RDN）降低血压（BP），但对其在房颤中的作用知之甚少。
目的：本研究的目的是探讨RDN是否能降低肺静脉隔离术后房颤复发。
方法：本研究将来自8个中心的患者随机分组(美国，德国)用PVI+RDN与单独PVI治疗的药物难治性AF。多电极射频Spyral导管系统用于RDN。可插入心脏监护仪用于连续节律监测。主要疗效终点为所有随访期间房颤复发或重复消融≥2分钟。次要终点包括房性心律失常（AA）负担，停止I/III类抗心律失常药物，和BP相对于基线的变化。
结果：共有70例房颤患者（52例阵发性，18持续性)和未控制的高血压被随机分组(RDN+PVI，n=34；PVI，n=36）。在3.5年，RDN+PVI和PVI组中分别有26.2%和21.4%的患者，分别,均无主要疗效终点（对数秩P=0.73）。平均≥1h/dAA的患者在RDN+PVI和PVI后每日AA负荷较少(4.1小时vs9.2小时;P=0.016)。更多的患者在RDN+PVI和PVI后停用I/III类抗心律失常药物(45%和14%;P=0.040)。在1年,RDN+PVI和PVI后收缩压变化-17.8±12.8mmHg和-13.7±18.8mmHg，分别为(P=0.43)。组间的复合安全终点没有显著差异。
结论：在房颤和血压失控的患者中，RDN+PVI不能比单独的PVI更能预防AF复发。然而,RDN+PVI可以减少房颤负担和抗心律失常药物的使用，但这需要进一步的前瞻性验证。
目的：本研究的目的是探讨RDN是否能降低肺静脉隔离术后房颤复发。
方法：本研究将来自8个中心的患者随机分组(美国，德国)用PVI+RDN与单独PVI治疗的药物难治性AF。多电极射频Spyral导管系统用于RDN。可插入心脏监护仪用于连续节律监测。主要疗效终点为所有随访期间房颤复发或重复消融≥2分钟。次要终点包括房性心律失常（AA）负担，停止I/III类抗心律失常药物，和BP相对于基线的变化。
结果：共有70例房颤患者（52例阵发性，18持续性)和未控制的高血压被随机分组(RDN+PVI，n=34；PVI，n=36）。在3.5年，RDN+PVI和PVI组中分别有26.2%和21.4%的患者，分别,均无主要疗效终点（对数秩P=0.73）。平均≥1h/dAA的患者在RDN+PVI和PVI后每日AA负荷较少(4.1小时vs9.2小时;P=0.016)。更多的患者在RDN+PVI和PVI后停用I/III类抗心律失常药物(45%和14%;P=0.040)。在1年,RDN+PVI和PVI后收缩压变化-17.8±12.8mmHg和-13.7±18.8mmHg，分别为(P=0.43)。组间的复合安全终点没有显著差异。
结论：在房颤和血压失控的患者中，RDN+PVI不能比单独的PVI更能预防AF复发。然而,RDN+PVI可以减少房颤负担和抗心律失常药物的使用，但这需要进一步的前瞻性验证。
