Background Recent animal and human studies have shown antiarrhythmic effects inhibiting inducibility of atrial fibrillation through low-level transcutaneous electrical stimulation at the auricular branch of the vagus nerve (ABVN). Objective The present study investigated effects of acupuncture at the ABVN on the autonomic cardiac nervous system in humans through analysis of heart rate and heart rate variability (HRV) parameters. Methods We enrolled 24 healthy male volunteers and compared acupuncture at the ABVN to placebo-acupuncture performed at the Ma-35 point (an acupuncture point used in traditional Chinese medicine to treat pain caused by gonarthrosis). An additional measurement without acupuncture served as control. We analyzed the following heart rate and HRV parameters: standard deviation of normal-to-normal intervals (SDNN), root mean square of successive R-R interval differences (RMSSD), high frequency (HF), low frequency (LF), LF/HF ratio. Results In comparison to placebo acupuncture, acupuncture at the ABVN led to a significant reduction in heart rate (approximately 4%–6%, P < .05) and an increase in overall HRV demonstrated by SDNN (approximately 19%, P < .05). RMSSD and power spectral density parameters (HF, LF, LF/HF) showed statistical trends ( P < .1) induced by auricular acupuncture in favor of vagal tone. No relevant difference was shown between control and placebo group. Conclusion Acupuncture of the region innervated by the ABVN may activate the parasympathetic nervous system, as suggested by reduction in heart rate and increase in SDNN. However, given the lack of clear significant changes in other HRV parameters, this effect seems modest and its evaluation requires further investigation.

(1) Background: Cryoballoon pulmonary vein isolation (cryoPVI) is established for symptomatic paroxysmal atrial fibrillation (AF) treatment, but its value in persistent AF is less clear. In particular, limited data are available on its efficacy in elderly patients (≥75 years) with persistent AF. Age is an important modifier of AF progression and represents a risk-factor for AF recurrence. (2) Methods: Prospective, single-center observational study to evaluate the impact of age on efficacy and safety of cryoPVI in elderly patients. Primary efficacy endpoint was symptomatic AF recurrence after 90-day blanking period. Primary safety endpoints were death from any cause, procedure-associated complications or stroke/transient ischemic attack. Median follow-up was 17 months (range 3–24). (3) Results: We included 268 patients with persistent AF (94 ≥ 75 years of age). Multivariate Cox regression analysis identified age as the only independent factor influencing AF recurrence in the overall cohort (p = 0.006). To minimize confounding bias in efficacy and safety analysis of cryoPVI, we matched younger and elderly patients with respect to baseline characteristics. At 24 months, primary efficacy endpoint occurred in 13/69 patients <75 years and 31/69 patients ≥75 years of age (24 months Kaplan–Meier event-rate estimates, HR 0.34; 95% CI, 0.19 to 0.62; log-rank p = 0.0004). No differences were observed in the occurrence of safety end points. (4) Conclusions: Elderly (≥75 years) patients with persistent AF undergoing cryoPVI had an approximately threefold higher risk of symptomatic AF recurrence than matched younger patients. Accordingly, other treatment modalities may be evaluated in this population.

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Background Atrial fibrillation (AF) and heart failure (HF) are of growing prevalence and increasing mortality. Radiofrequency ablation is safe and effective for patients with AF and HF. Prognosis might be improved in patients treated. However, there is no prospective trial investigating efficacy and safety of cryoballon ablation in patients with AF and HF. Objective To prospectively compare cryoballoon ablation in patients with and without HF (defined as LVEF ≤40%) in terms of safety and efficacy. Methods Ongoing POLAR-HF trial is a prospective, investigator-initiated, single-center, non-inferiority, open-label study. We analyzed 244 consecutive patients who underwent cryoballoon ablation. Of these 217 had normal LVEF (age 68.1±9.6 years, CHA2DS2-VASc Score 2.5±1.3, 55.3% male) while 27 patients (11%) suffered from HF (age 70.4±8.6 years, CHA2DS2-VASc Score 3±1.2, 70.4% male). Follow-up was performed at 3, 6 and 12 months after ablation. Kaplan-Meier method was used to calculate 12-month event-rate estimates. Log-Rank Test to estimate hazard ratios in the primary analysis. Endpoints were: symptomatic AF relapse for efficacy and bleeding, stroke or death for safety. Results Analysis showed no difference in AF-free survival rate between patients with and without HF (81% vs. 76.3%, Log-Rank-Test P=0.81, Figure). Primary safety end point occurred in 5 patients with normal LVEF (2.3%) and none in the HF-group. No deaths were observed. Conclusion Results of POLAR-HF indicate that cryoballoon ablation is an effective ablation method for patients suffering from AF and HF. Event-Free Survival (Efficacy Endpoint) Funding Acknowledgement Type of funding source: None

Aims In the light of an increasing prevalence of atrial fibrillation (AF) and growing evidence for the superiority of early invasive rhythm control, the demand for ablation therapy is rising. Accordingly, ablation centres will have to maximize their capacity by either adding electrophysiology laboratory resources or optimizing process management. In order to optimize process management, we applied “Lean Six Sigma” method to a single ablation center. We compared procedural parameters, acute efficacy and safety of cryoballoon pulmonary vein isolation (cryoPVI) before and after modifications. Methods and results Patients (n = 713) undergoing cryoPVI (108 before and 605 after process optimization) were analysed. Within 3 years of process optimization, electrophysiology laboratory occupancy time (150.7 ± 44.4 vs. 94 ± 22.1 min, P &lt; 0.001), procedure time (84.5 ± 21–47.4 ± 12 min, P &lt; 0.001), left-atrial dwell time (53.9 ± 18.4–31.9 ± 9.9 min, P &lt; 0.001), and fluoroscopy time (15.8 ± 5.1 vs. 6.2 ± 2.8 min, P &lt; 0.001) decreased. Contrast dye use (116 ± 35 vs. 27 ± 15 mL, P &lt; 0.001) and radiation dose (893 ± 1078 vs. 253 ± 249 cGy cm2, P &lt; 0.001) were reduced by ∼77 and ∼72%, respectively. There was no difference in safety endpoint occurrence (3.7 vs. 1.5%, P = 0.11). Conclusion The process optimization of cryoPVI for AF therapy using the ‘Lean Six Sigma’ method significantly increases efficiency without compromising patient safety.

ZusammenfassungDerzeit wird über den Stellenwert primärprophylaktisch implantierter Kardioverter-Defibrillatoren (ICD) bei Patienten mit nicht ischämischer dilatativer Kardiomyopathie (NIDCM) diskutiert. Frühere Studien (DEFINITE, SCD-HeFT) schlossen Patienten ein, die nach heutigem Standard nicht optimal medikamentös und ohne kardiale Resynchronisation (CRT) therapiert wurden. Diese Studien bilden die Grundlage für die Empfehlung der ICD zur Primärprophylaxe des plötzlichen Herztods. Die DANISH-Studie (an der Patienten mit kontemporärer optimaler medikamentöser Therapie sowie hohem Prozentsatz von CRT teilnahmen) zeigte einen Effekt des ICD auf die kardiovaskuläre Sterblichkeit, jedoch ohne Nutzen in Bezug auf Gesamtletalität. Einige Faktoren wie Alter, Komorbiditäten oder Rechtsventrikeldysfunktion fordern Aufmerksamkeit. Insgesamt besteht die Leitlinienempfehlung fort, primärprophylaktische ICD bei NIDCM zu implantieren, wenn eine optimale medikamentöse Therapie und eine Lebenserwartung > 5 Jahren bestehen.

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