Long-Term Changes in Atrial Arrhythmia Burden After Renal Denervation Combined With Pulmonary Vein Isolation: SYMPLICITY-AF.

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. OBJECTIVES: 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.

Posterior wall isolation using the cryoballoon in conjunction with pulmonary vein ablation is superior to pulmonary vein isolation alone in patients with persistent atrial fibrillation: A multicenter experience.

BACKGROUND: Pulmonary vein isolation (PVI) in conjunction with isolation of the posterior left atrial wall (PVI+PWI) is associated with improved clinical outcomes in certain patients with atrial fibrillation (AF). OBJECTIVE: The purpose of this multicenter study was to evaluate the acute and long-term outcomes of PVI+PWI vs PVI alone performed using cryoballoon ablation in patients with persistent AF (persAF). METHODS: We examined the procedural safety and efficacy and short- and long-term outcomes in 390 consecutive patients with persAF who underwent a first-time cryoballoon ablation procedure using PVI+PWI (n = 222 [56.9%]) vs PVI alone (n = 168 [43.1%]). RESULTS: Acute isolation was achieved in 99.7% of all pulmonary veins (PVI+PWI = 99.8% vs PVI alone = 99.3%; P = .23) using 6.3 ± 1.4 applications and 17 ± 2 minutes of cryoablation. PWI was achieved using 13.7 ± 3.2 applications and 34 ± 10 minutes of cryoablation. Adjunct radiofrequency ablation was required in 1.8% of patients to complete PVI (4 ± 2 minutes) and in 32.4% to complete PWI (5 ± 2 minutes). PVI+PWI yielded significantly greater posterior wall (77.2% ± 6.4% vs 40.6% ± 4.9%; P < .001) and total left atrial (53.3% ± 4.2% vs 36.3% ± 3.8%; P < .001) isolation. In addition, PVI+PWI was associated with greater AF termination (19.8% vs 8.9%; P = .003) and conversion to atrial flutters (12.2% vs 5.4%; P = .02). Adverse events were similar in both groups, whereas recurrence of AF and all atrial arrhythmias was lower with PVI+PWI at 12 months of follow-up. Moreover, in a Cox regression analysis, PVI+PWI emerged as a significant predictor of freedom from recurrent atrial arrhythmias (hazard ratio: 2.04; 95% confidence interval: 1.15-3.61; P = .015). CONCLUSION: PVI+PWI can be achieved safely and effectively using the cryoballoon. This approach appears superior to PVI alone in patients with persAF.

Association between incomplete surgical ligation of left atrial appendage and stroke and systemic embolization.

BACKGROUND: Surgical exclusion of the left atrial appendage (LAA) can frequently yield incomplete closure. OBJECTIVE: We evaluated the ischemic stroke/systemic embolization (SSE) risk in patients with atrial fibrillation (AF) and complete LAA closure (cLAA) vs incompletely surgically ligated LAA (ISLL) and LAA stump after surgical suture ligation. METHODS: Seventy-two patients (CHA2DS2-VASc score 4.1 ± 1.9) underwent surgical LAA ligation in conjunction with mitral valve/AF surgery and postoperative LAA evaluation using computerized tomographic angiography. RESULTS: Overall, cLAA was detected in 46 of 72 patients (64%), ISLL in 17 patients (24%), and LAA stump in 9 patients (12%). The incidences of oral anticoagulation (OAC) and recurrent AF were similar among the 3 groups during 44 ± 19 months of follow-up. SSE occurred in 2% of patients with cLAA vs 24% with ISLL and 0% with LAA stump (P = .006). None of the patients with SSE were receiving OAC, and all had recurrent AF during follow-up. Additionally, patients with SSE exhibited a significantly smaller ISLL neck diameter (2.8 ± 1.0 vs 7.1 ± 2.1 mm; P = .002). The annualized SSE risk was 1.9% (entire cohort), 6.5% (ISLL patients), 14.4% (ISLL patients not receiving OAC), and 19.0% (ISLL neck diameter ≤5.0 mm) per 100 patient-years of follow-up. The latter risk was nearly 5 times greater than predicted by conventional risk-stratification schemes. Moreover, ISLL emerged as an independent predictor of SSE in univariate analyses and as the sole predictor of SSE in a multivariate analysis. CONCLUSION: In patients with AF, ISLL is a predictor of SSE, independent of conventional risk stratification schemes. Consequently, OAC should be strongly considered in this high-risk cohort.

Acute procedural and cryoballoon characteristics from cryoablation of atrial fibrillation using the first- and second-generation cryoballoon: a retrospective comparative study with follow-up outcomes.

PURPOSE: There is limited data available on the safety and efficacy of the second-generation cryoballoon (CB-2) for cryoablation of atrial fibrillation (Cryo-AF). We evaluated the procedural, biophysical, and clinical outcomes of Cryo-AF in a large patient cohort using CB-2 as compared with the first-generation cryoballoon (CB-1). METHODS: Three-hundred and forty consecutive patients undergoing Cryo-AF with CB-1 (n = 140) and CB-2 (n = 200) were retrospectively evaluated. RESULTS: Paroxysmal AF was more prevalent in CB-1 (86%) versus CB-2 (72%) (p = 0.001). During Cryo-AF, the mean balloon temperature was lower with CB-2 at 30 s (8 versus -4°C; p < 0.001) and 60 s (-26 versus -32°C; p < 0.001) with equivalent nadir temperatures (both at -50°C; p = 0.542). With CB-2, time-to-nadir temperature was shorter (232 versus 209 s; p < 0.001) and thaw times were longer (47 versus 53 s; p < 0.001). Acute pulmonary vein (PV) isolation rate was higher with CB-2 (92 versus 98%; p = 0.036) despite reduced cryoablation time (61 versus 47 min; p < 0.001) and freeze area-under-the-curve (-155,044 versus -116,740 s°C; p < 0.001). With CB-2, procedure time (209 versus 154 min; p < 0.001) and fluoroscopy time (42 versus 27 min; p < 0.001) were shorter, with similar acute/long-term adverse events (AEs) and freedom from AF at 6, 9, and 12 months (89, 86, and 82%) during 16 ± 8 months of follow-up. However, CB-2 was associated with lower PV reconnection rates at redo ablation (30 versus 13%; p = 0.037). CONCLUSIONS: With CB-2, acute and long-term PV isolation rates were higher despite shorter ablations, faster balloon cooling, and longer thaw times, with similar AE rates and freedom from AF.

Shock on T versus direct current voltage for induction of ventricular fibrillation: a randomized prospective comparison.

VF is induced during ICD implantation to determine efficacy of therapy. Establishing the best clinical method of induction of VF would potentially be beneficial in reducing the number of induction attempts and reducing the frequency of inadvertent induction of VT. Commonly used methods to induce VF include shock in the T wave vulnerable period (T shock) and high frequency stimulation. This study compared the efficacy of T shock with a new induction method using a 9-V DC pulse. The study was a randomized, prospective, case crossover trial in patients receiving ICDs. VF was induced by T shock and DC in a randomized sequence during an ICD implant. VF was induced at least four times in each patient (two T shocks and two DC inductions) and with each induction; attempts were continued with modifications until successful. A paired evaluation between the T shock/DC induction was performed in 37 patients (28 men, age 64 +/- 12 years) with a left ventricular ejection fraction of 0.40 +/- 0.20. Arrhythmia indications were VT (n = 23), VF (n = 10), and VT/VF (n = 4). Drug therapy included amiodarone (n = 10), metoprolol (n = 6), digoxin (n = 1), and lidocaine (n = 1). The average T shock voltage was 207.0 +/- 16.1 V. The S1 cycle drive length was consistently 400 ms, and the mean S2 coupling interval was 317.8 +/- 19.6 ms. The length of time DC applied averaged 3.8 +/- 1.4 seconds. A total of 148 episodes of VF were included in the analysis. T shock induced VF with a cycle length of 213.5 +/- 35.1 ms, and DC induced VF with a cycle length of 214.6 +/- 34.5 ms (P = 0.86). Although VF was eventually induced for each randomization, the number of attempts required were dependent on the method of induction. The successful DC first attempt VF induction rate was 96%, with three patients requiring two attempts during one of the DC inductions. T shock had a 68% first attempt success rate with 21 patients requiring multiple T shocks to induce VF. All nine female patients had at least one unsuccessful first attempt T shock, which contributed to an overall unsuccessful first attempt induction rate significantly higher in women then men (36.1% vs 12.5%, P = 0.001). A constant DC voltage induction of VF may be more effective than T shock for induction of VF in a clinical setting because it reduces the number of attempts required to induce VF. By either method, VF appears to be more difficult to induce in women. DC induction has the advantage of simple programming of only duration of stimulation. These findings have implications particularly for ICD implantation with conscious sedation.