Transesophageal Echocardiography Improves Precision in Transseptal Puncture Compared to Fluoroscopy in Left Atrial Electrophysiological Procedures.

Background: Complex arrhythmias often arise from the left side of the heart, necessitating established electrophysiological (EP) procedures like 3D-mapping-assisted radiofrequency (RF) ablations or pulmonary vein isolation (PVI). These procedures typically require transseptal access, emphasizing the critical role of achieving an optimal catheter position through a precise transseptal puncture (TSP). Commonly employed imaging methods for TSP guidance include fluoroscopy and interventional echocardiography. Despite their routine use, there is limited evidence on which imaging modality offers superior catheter positioning for EP procedures, and safety concerns regarding transseptal punctures with imaging remain underexplored. This study aims to systematically evaluate the feasibility, safety, and accuracy of echo-guided TSP compared to fluoroscopy-guided TSP. Methods: In this prospective study, 150 consecutive patients undergoing left atrial EP procedures were enrolled between October 2023 and February 2024 at the Ulm University Heart Center. Following optimal fluoroscopy-guided transseptal needle positioning at the interatrial septum, the catheter placement was further verified using transesophageal echocardiography (TEE). Adjustments were made in cases of suboptimal needle positioning observed in TEE. The fluoroscopically achieved septal positions were categorized based on TEE images as optimal, suboptimal, poor, or dangerous. Results: Among the 150 patients included (58.0% male), fluoroscopy achieved optimal, suboptimal, and poor/dangerous positions in 32.7%, 43.3%, and 24.0%, respectively. After TEE-guided adjustments, optimal and suboptimal positions were achieved in 59.3% and 40.7% of patients, respectively. No instances of poor or dangerous transseptal needle positions were observed under TEE guidance. Conclusions: TEE-guided TSP emerges as a feasible, more accurate, and safer imaging method for transseptal punctures in EP procedures.

Pulmonary Vein Isolation with a Novel Size-Adjustable Cryo-Balloon Catheter: A Tailored Ablation Protocol.

Background: Pulmonary vein isolation (PVI) is a common therapeutic approach for symptomatic atrial fibrillation (AF). Among various techniques, cryo-balloon (CB) PVI is widely adopted, but, to date, established CB systems have had fixed balloon sizes. A novel size-adjustable CB, allowing balloon size adjustments during ablation, lacks sufficient data on optimal utilization in patient care. This study aims to systematically investigate this feature with a tailored ablation protocol. Methods: Our single-center prospective study included patients with paroxysmal or persistent atrial fibrillation undergoing first-time PVI with the size-adjustable CB from July 2023 to February 2024. Ablation was performed using the balloon size that provided better occlusion. The ablation protocol involved an initial occlusion test with the small balloon size (28 mm). If optimal occlusion (occlusion level 4) could not be achieved, an attempt with the larger balloon (31 mm) was initiated. Ablation was conducted using the balloon configuration that provided better occlusion of the pulmonary vein ostium. Results: Our prospective study includes 50 patients (median age [interquartile range, IQR]: 72 [65; 79] years, 24 [48.0%] females, and 35 [70.0%] patients with paroxysmal AF). The median procedure duration (IQR) was 77 (65; 96) minutes, and the median fluoroscopy time (IQR) was 17.7 (12.5; 22.0) min. PVI was successfully accomplished in each treated pulmonary vein (PV), with 87.4% of PVs isolated during the first freeze. The large balloon configuration was used to isolate 16.8% of PVs. Conclusions: The utilization of the size-adjustable CB, combined with the presented tailored ablation workflow, appears to facilitate effective and efficient pulmonary vein isolation. The use of a larger balloon configuration appears beneficial in isolating a significant proportion of the PVs.

Comparison between a Novel Radiofrequency-Balloon and a Standard Cryo-Balloon in Pulmonary Vein Isolation: A Propensity-Score-Matched Analysis.

Background/Objectives: Single-shot devices are important tools for efficient pulmonary vein isolation (PVI) in atrial fibrillation (AF). In addition to the standard cryo-balloon (CB) catheter, a novel multi-electrode radiofrequency balloon-catheter (RFB, Heliostar, Biosense Webster, Irvine, CA, USA) with 3D-mapping-integration is available. Currently, there is no evidence allowing for a direct comparison between RFB-PVI and CB-PVI in a matched population. The study aimed to assess the procedural data, safety profiles, and outcomes of RFB-PVI versus CB-PVI. Methods: In this prospective registry study, symptomatic AF patients undergoing first-time PVI from January 2019 to April 2023, using RFB or CB, were included, with patients matched in a 1:2 ratio to reduce potential confounders. Results: The results from 171 consecutive RFB patients and 342 matched CB patients showed comparable recurrence-free survival after 12 months (81.3% RFB vs. 76.8% CB, p = 0.359). The RFB group had a longer procedure duration (88 vs. 73 min, p < 0.001) and longer fluoroscopy time (18.9 vs. 14.5 min, p < 0.001). Conclusions: In conclusion, the novel RFB system enables efficient and safe PVI, which is broadly comparable to the established CB system. However, the 3D-mapping integration in RFB did not reduce fluoroscopy time compared to CB.

Atrial Fibrillation Ablation with a Novel Fully 3D-Mapping-Integrated Multi-Electrode Radiofrequency Balloon Catheter.

Pulmonary vein isolation (PVI), as the cornerstone of atrial fibrillation (AF) ablation, has emerged a widely used therapy for patients suffering from AF. To improve PVI efficiency, single-shot catheters (SSCs) have been developed. Regrettably, SSCs are not integrated into 3D-mapping technology. In that regard, a novel radiofrequency balloon catheter (RFBC, Heliostar, Biosense Webster) with full integration into 3D-mapping technology has been developed. The aim of this study was to assess operative and follow-up outcomes of the RFBC in AF patients. In this monocentric prospective registry, patients with a first-time PVI using the RFBC were included. Follow-up visits were scheduled 3, 6, 12 and 24 months after ablation and in case of symptoms. A total of 171 patients (36.8% female) were included, with a mean age of 68.5 ± 10.2 years. Among them, 63 patients (36.8%) presented with persistent AF. Notably, no major periprocedural complications were observed. The mean follow-up period was 287 ± 157 days. In the Kaplan-Meier analysis, the estimated recurrence-free survival after 12 months was 81.8%. Based on our data, PVI with the fully 3D-mapping-integrated RFBC seems to be safe and effective and to have a favorable 12-month outcome in patients with paroxysmal and persistent AF.

Incidence of Long-Term Pulmonary Vein Reconnection after a 2-Minute Cryoballoon Freeze for Pulmonary Vein Isolation-Invasive Insights of TTI-Dependent Cryoenergy Titration.

INTRODUCTION: The optimal freeze duration in cryoballoon pulmonary vein isolation (PVI) is unknown. TTI-based titration of cryoenergy allows individualized freeze duration and has emerged as a favorable ablation strategy in PV cryoablation. In a recent study, we demonstrated that omission of a bonus freeze and reduction in freeze duration to a minimum of 2 min in the case of short TTI led to comparable arrhythmia recurrence rates. Whereas clinical outcome seems to be comparable to fixed freeze duration, evidence of long-term PV reconnection rates in patients undergoing TTI-based cryoballoon ablation is sparse. AIM OF THE STUDY: To evaluate the procedural efficacy of a single 2-min freeze for PVI, we assessed PV conduction recovery after cryoballoon PVI with a TTI-guided titration of freeze duration compared to a fixed ablation protocol. METHODS AND RESULTS: We included consecutive patients with atrial fibrillation (AF) recurrence undergoing a second ablation procedure after the initial cryoballoon procedure. The second AF ablation procedure was performed by the 3D-mapping system and radiofrequency ablation technique. A total of 219 patients (age: 66.2 ± 10.8 years, 53% female, paroxysmal AF: 53%) treated with the TTI-guided protocol (174 patients, 685 PV) or fixed protocol (45 patients, 179 PV) showed comparable total reconnection rates (TTI: 36.9% vs. fixed: 31.8%, p = 0.21). The PV reconnection rate was not statistically different for PVs treated with a 2-min freeze in case of short TTI, compared to longer freeze duration. Interestingly, the PV reconnection rate was lower in LIPVs treated with the fixed protocol (13% vs. 31%, p = 0.029). In the TTI group, 17 out of 127 patients (15%) had durable isolation of all PVs, whereas in 8 out of 40 patients (20%) in the fixed group, all PVs were still isolated (p = 0.31). CONCLUSIONS: overall reconnection rate was not different using a TTI-guided ablation protocol compared to a fixed ablation protocol, whereas the LIPV reconnection rate was significantly lower in patients treated with a fixed ablation protocol.

Substrate-based ablation of atypical atrial flutter in patients with atrial cardiomyopathy.

Background: Standard therapy of atypical atrial flutter (AFL) aims at deploying ablation lines between two non-conducting anatomical structures, thereby creating a line of block within the re-entry circuit. We have developed an ablation strategy, where we incorporate voltage information as a surrogate for atrial fibrosis from the electro-anatomical map (EAM) during AFL ablation procedures to create individualized, substrate-based ablation lines along the area of most pronounced low-voltage within the reentry-circuit. Objective: The aim of this study was to evaluate acute procedural success and long-term outcome of a substrate-based ablation (SBA) strategy in comparison to a standard anatomically based ablation (ABA) strategy for the ablation of atypical AFL. Methods: Patients that underwent ablation for AFL at our institution were included. SBA procedures were compared to ABA procedures. Endpoints were acute termination of AFL and recurrence of the index AFL or any other AFL during follow-up. Results: We included 47 patients, 24 individuals (51.1%) in the SBA group and 23 patients (48.9%) in the ABA group. Most patients had signs of atrial cardiomyopathy, namely enlarged left atrial diameter (LAD) and extended amount of left atrial low-voltage areas (LVA). Termination of AFL occurred in 27 of 29 (93.1%) AFL in the SBA group and in 28 of 31 (90.3%) AFL in the ABA group (p = 0.99). Freedom from recurrence of any atypical AFL after 2.5 years was 21.5% in the ABA group compared to 48.8% in the SBA group (p = 0.047). Conclusion: Substrate-based ablation is as effective as an anatomically-based ablation in the acute termination of AFL but yields better rhythm outcome with less recurrence of AFL in patients with atrial cardiomyopathy.

Predicting Phrenic Nerve Palsy in Patients Undergoing Atrial Fibrillation Ablation With the Cryoballoon-Does Sex Matter?

Background: Phrenicus nerve palsy (PNP) is a typical complication during pulmonary vein isolation (PVI) using the cryoballoon with the ominous potential to counteract the clinical benefit of restored sinus rhythm. According to current evidence incidence of PNP is about 5-10% of patients undergoing Cryo-PVI and is more frequent during ablation of the RSPV compared to the RIPV. However, information on patient specific characteristics predicting PNP and long-term outcome of patients suffering from this adverse event is sparse. Aim of the Study: To evaluate procedural and clinical characteristics of AF patients with PNP during cryoballoon PVI compared to patients without PNP. Methods and Results: Between 2013 and 2019 we included 632 consecutive AF patients undergoing PVI with the cryoballoon in our study. 84/632 (13.3%) patients experienced a total number of 89 PNP during the ablation procedure. 75/89 (84%) cryothermal induced PNP recovered until the end of the procedure (transient PNP, tPNP), whereas 14/89 (16%) PNP hold beyond the end of the procedure (non-transient PNP, ntPNP). Using multivariate logistic regression, we found that sex and BMI are strong and independent predictors of cryothermal induced non-transient PNP during cryoballoon PVI with an odds ratio of 3.9 (CI: 95%, 1.1-14.8, p = 0.04) for female gender. Interestingly, all patients (14/14, 100%) with a non-transient PNP experienced complete PNP resolution after a mean recovery time of 68 ± 79 days. Conclusion: Our data indicate for the first time, that female sex and lower BMI are independent predictors for non-transient PNP caused by cryoballoon PVI. Fortunately, during follow up all PNP patients resolved completely with a median recovery time of 35 days.

Catheter ablation for atrial fibrillation in HFpEF patients-A propensity-score-matched analysis.

BACKGROUND: Heart failure with preserved ejection fraction (HFpEF) and atrial fibrillation (AF) are both common conditions associated with high morbidity and mortality, especially if they coexist. Catheter ablation (CA) for AF has been shown recently to induce reverse remodeling and improve symptoms in HFpEF patients. The aim of this study was to compare outcomes of AF patients with HFpEF, who either underwent CA for AF or received medical therapy only. METHODS AND RESULTS: We included all AF patients with HFpEF according to current guidelines treated at our hospital between 2013 and 2018. Out of 6614 AF patients, we identified 127 with confirmed HFpEF. After applying propensity score matching to balance patient groups, 43 patients treated by CA and 43 patients receiving medical treatment were compared. Patients in the CA group underwent a mean of 1.5 ± 0.8 ablation procedures. Arrhythmia recurrence occurred significantly less frequently in the CA group (hazard ratio [HR]: 0.47; 95% CI: 0.25-0.87; p = .016). The primary endpoint, a composite of heart failure hospitalization and death, was reduced significantly by CA compared to medical therapy (HR: 0.30; 95% CI: 0.13-0.67; p = .003). This was driven by a decrease in heart failure hospitalization. Clinical and echocardiographic parameters of HFpEF improved significantly only after CA. Remarkably, reassessment of diagnostic HFpEF criteria at the end of follow-up demonstrated HFpEF resolution in 15 out of 43 patients (35%) treated by CA and only 4 out of 43 patients (9%) treated medically (p = .008). CONCLUSION: Catheter ablation for AF in HFpEF patients in comparison to medical therapy decreases heart failure hospitalization, heart failure symptoms, and improves diastolic function. AF ablation should be considered in patients with HFpEF and concomitant AF.

Impact of re-definition of paroxysmal and persistent atrial fibrillation in the 2012 and 2016 European Society of Cardiology atrial fibrillation guidelines on outcomes after pulmonary vein isolation.

PURPOSE: In the 2016 European Society of Cardiology (ESC) guidelines for the management of atrial fibrillation (AF), the definition of AF type has been modified compared with the 2010 guidelines and its 2012 focused update. We compared the difference of single procedure outcomes using the definitions before and after 2016 on a cohort of patients with AF undergoing AF ablation. METHODS: Consecutive AF ablation patients with paroxysmal or persistent AF were retrospectively reclassified applying the 2010, 2012, and 2016 ESC definitions on AF type. RESULTS: We included a total of 628 patients. Applying the 2010 ESC AF guidelines definition, 68% of patients were paroxysmal while according to the 2016 ESC AF guidelines, the proportion increased to 87%. Applying the 2010 ESC guidelines definition, recurrence rates of paroxysmal and persistent AF patients differ significantly (log-rank p < 0.001). Applying the 2012 focused update and the 2016 ESC AF guidelines, recurrence rates do not differ significantly. In a cox regression model applying the 2010 guidelines, persistent AF is the only independent predictor of AF recurrence in our cohort. However, when applying the 2016 guidelines, persistent AF is no longer a predictor of AF recurrence. CONCLUSIONS: The revised definition of AF types in the 2016 ESC AF guidelines leads to a marked shift from persistent to paroxysmal AF. It appears that the old definition provided a better separator to predict rhythm outcome after AF ablation.

Safety of conscious sedation in electroanatomical mapping procedures and cryoballoon pulmonary vein isolation.

Immobilization of patients during electrophysiological procedures, to avoid complications by patients' unexpected bodily motion, is achieved by moderate to deep conscious sedation using benzodiazepines and propofol for sedation and opioids for analgesia. Our aim was to compare respiratory and hemodynamic safety endpoints of cryoballoon pulmonary vein isolation (PVI) and electroanatomical mapping (EAM) procedures. Included patients underwent either cryoballoon PVI or EAM procedures. Sedation monitoring included non-invasive blood pressure measurements, transcutaneous oxygen saturation (tSpO2) and transcutaneous carbon-dioxide (tpCO2) measurements. We enrolled 125 consecutive patients, 67 patients underwent cryoballoon atrial fibrillation ablation and 58 patients had an EAM and radiofrequency ablation procedure. Mean procedure duration of EAM procedures was significantly longer (p < 0.001) and propofol doses as well as morphine equivalent doses of administered opioids were significantly higher in EAM patients compared to cryoballoon patients (p < 0.001). Cryoballoon patients display higher tpCO2 levels compared to EAM patients at 30 min (cryoballoon: 51.1 ± 7.0 mmHg vs. EAM: 48.6 ± 6.2 mmHg, p = 0.009) and at 60 min (cryoballoon: 51.4 ± 7.3 mmHg vs. EAM: 48.9 ± 6.6 mmHg, p = 0.07) procedure duration. Mean arterial pressure was significantly higher after 60 min (cryoballoon: 84.7 ± 16.7 mmHg vs. EAM: 76.7 ± 13.3 mmHg, p = 0.017) in cryoballoon PVI compared to EAM procedures. Regarding respiratory and hemodynamic safety endpoints, no significant difference was detected regarding hypercapnia, hypoxia and episodes of hypotension. Despite longer procedure duration and deeper sedation requirement, conscious sedation in EAM procedures appears to be as safe as conscious sedation in cryoballoon ablation procedures regarding hemodynamic and respiratory safety endpoints.

Continuous transcutaneous carbon-dioxide monitoring to avoid hypercapnia in complex catheter ablations under conscious sedation.

BACKGROUND: Ablation of complex cardiac arrhythmias requires an immobilized patient. For a successful and safe intervention and for patient comfort, this can be achieved by conscious sedation. Administered sedatives and analgesics have respiratory depressant side effects and require close monitoring. We investigated the feasibility and accuracy of additional, continuous transcutaneous carbon-dioxide partial pressure (tpCO2) measurement during conscious sedation in complex electrophysiological catheter ablation procedures. METHOD: We evaluated the accuracy and additional value of continuous tpCO2 detection by application of a Severinghaus electrode in comparison to arterial and venous blood gas analyses. RESULTS: We included 110 patients in this prospective observational study. Arterial pCO2 (paCO2) and tpCO2 showed good correlation throughout the procedures (r = 0.60-0.87, p < 0.005). Venous pCO2 (pvCO2) were also well correlated to transcutaneous values (r = 0.65-0.85, p < 0.0001). Analyses of the difference of pvCO2 and tpCO2 measurements showed a tolerance within <10 mmHg in up to 96-98% of patients. Hypercapnia (pCO2 < 70 mmHg) was detected more likely and earlier by continuous tpCO2 monitoring compared to half-hourly pvCO2 measurements. CONCLUSION: Continuous tpCO2 monitoring is feasible and precise with good correlation to arterial and venous blood gas carbon-dioxide analysis during complex catheter ablations under conscious sedation and may contribute to additional safety.

Pulmonary vein isolation with the cryoballoon in obese atrial fibrillation patients - Does weight have an impact on procedural parameters and clinical outcome?

INTRODUCTION: Obesity is a known risk factor for the incidence and prevalence of atrial fibrillation (AF). Pulmonary vein isolation (PVI) is an established therapeutic option for AF patients, however clinical benefit of AF ablation remains controversial in overweight and obese patients. We investigated the impact of overweight and obesity in AF patients undergoing cryoballoon PVI on procedural characteristics and clinical outcome. METHODS: We included consecutive patients undergoing cryoballoon PVI at Ulm University Medical center. Normal weight was defined as a body mass index (BMI) of 18.5-24.9 kg/m2, overweight as a BMI of 25.0-29.9 kg/m2 and obesity as a BMI of ≥30.0 kg/m2. RESULTS: Evaluating 600 patients, mean age was 66.3±10.8 years and 43% patients were female. 41% of the patients were classified as overweight and 34% as obese. Regarding procedural characteristics, overweight and obese patients had longer fluoroscopy area dose product (p<0.001) and obese patients a higher fluoroscopy time (p<0.05). Analyses of ablation related procedural characteristics revealed no relevant differences regarding number and duration of ablation, time to isolation and nadir temperature. Importantly, recurrence of atrial arrhythmia was statistically not different comparing normal weight, overweight and obese patients. CONCLUSION: Besides higher radiation exposure, cryoballoon PVI in overweight and obese patients is as safe and efficient as in normal weight patients. It is reasonable to proceed with cryoballoon PVI on overweight and obese patients as would be done in normal weight patients, since this might encourage overweight and obese patients to exercise.

Atrial fibrillation ablation in heart failure patients: improved systolic function after cryoballoon pulmonary vein isolation.

AIMS: Atrial fibrillation (AF) and heart failure (HF) are the most common cardiac diseases and often coexist leading to increased mortality and morbidity compared with AF patients without HF. As shown previously, AF ablation using radio frequency (RF) in HF patients leads to a reduction of AF burden, an increase of left ventricular ejection fraction (LVEF) and consequently to reduced hospitalization and mortality. Previous AF ablation studies on HF patients have been liberal about additional targets beyond pulmonary vein isolation (PVI). Thus, the aim of this study was to assess systematically the impact of a straightforward PVI-only strategy on LVEF, NYHA functional class, and cardiovascular hospitalization rate in HF patients. METHODS AND RESULTS: Out of 414 consecutive patients undergoing PVI, only with the cryoballoon 113 patients with reduced LVEF [mean: 38.4 ± 10.8%, reduced ejection fraction (rEF) group] and 301 patients with normal LVEF (>55%) at baseline were identified [normal ejection fraction (nEF) group]. Remarkably, even though freedom from arrhythmia recurrence after 1 year was significantly lower in the rEF group (64.9%) compared with the nEF group (71.2%, P = 0.036), mean LVEF improved from 38.4 ± 10.8% to 52.5 ± 17.2% (P < 0.001) after cryoballoon ablation in the rEF group. Accordingly, HF-related symptoms as well as hospitalization rate declined significantly in the rEF group during follow-up compared with baseline. CONCLUSIONS: The results of the present study suggest that catheter ablation restricted to a straightforward PVI-only strategy using the cryoballoon leads to improved left ventricular ejection fraction as well as improvement of NYHA functional class and increased freedom from cardiovascular rehospitalization.

Restoration of sinus rhythm by pulmonary vein isolation improves heart failure with preserved ejection fraction in atrial fibrillation patients.

AIMS: Atrial fibrillation (AF) in patients suffering from heart failure with preserved ejection fraction (HFpEF) is associated with increased symptoms and higher morbidity and mortality. Effective treatment strategies for this patient population have not yet been established. METHODS AND RESULTS: We analysed clinical outcomes and echocardiographic parameters of patients with AF and HFpEF who underwent pulmonary vein isolation (PVI). Out of 374 PVI patients, we identified 35 patients suffering from concomitant HFpEF. Freedom from atrial tachyarrhythmia (AT) after 1 year was 80%. Heart failure symptoms assessed by New York Heart Association class significantly improved from 2.7 ± 0.7 to 1.7 ± 0.9 (P < 0.001). We observed regression of diastolic dysfunction by echocardiography 12 months after the index procedure. Moreover, 15 patients (42.9%) experienced complete resolution of HFpEF after a single ablation procedure. Multivariate logistic regression revealed absence of AT recurrence as an independent predictor of recovery from HFpEF (hazard ratio 11.37, 95% confidence interval 1.70-75.84, P = 0.009). Furthermore, resolution of HFpEF by achieving freedom from AT recurrence by PVI, including multiple procedures, led to a significant reduction of hospitalizations. CONCLUSION: Our results suggest that restoration of sinus rhythm by PVI in HFpEF patients with concomitant AF induces reverse remodelling, improvement of symptoms, resolution of HFpEF and subsequently decrease of hospitalizations. Randomized controlled trials are warranted to confirm our results.

Impact of atrial rhythm on pulmonary vein signals in cryoballoon ablation - Sinus rhythm predicts real-time observation of pulmonary vein isolation.

PURPOSE: Real-time observation of pulmonary vein (PV) potentials with a spiral mapping catheter has emerged as a key electrogram-based procedural parameter to estimate lesion quality and titrate cryoenergy application during PV isolation (PVI) with the cryoballoon. Whether correct PV electrogram interpretation and thus PVI real-time observation rate depends on atrial rhythm during cryoballoon PVI is unknown. We compared observation rates of time-to PV isolation (TTI) during sinus rhythm (SR group) and during atrial fibrillation (AFib group) in cryoballoon PVI. METHODS: We prospectively included 157 consecutive patients undergoing cryoballoon PVI and compared the incidence of PVI real-time recording of each pulmonary vein during SR and in AFib. RESULTS: Overall PVI real-time observation rate was 82.1% (491/598 PV) with significantly higher TTI observation rate in the SR group (315/365 PV, 86.3%) compared to the AFib group (176/233 PV, 75.5%; p < 0.001). Per vein analysis demonstrated that only TTI observation rate in the left superior pulmonary vein (LSPV) was significantly higher during SR (85/92, 92.4%) compared to AFib (37/54, 68.5%; p < 0.001). Regression analysis revealed that atrial rhythm is a strong and independent predictor of PVI real-time observation in the LSPV with an odds ratio of 4.98 (95%-CI: 1.86-13.34, p = 0.001) to detect TTI during SR. CONCLUSIONS: Our results demonstrate that correct interpretation of PV electrograms and thus PVI real-time observation is more likely in SR than in AFib. Hence, cardioversion of patients in AFib at the beginning of the procedure should be considered to yield higher PVI real-time observation rates facilitating TTI guided cryoenergy titration.

Novel spiral mapping catheter facilitates observation of the time-to-pulmonary vein isolation during cryoballoon ablation.

Observation of the time-to-pulmonary vein isolation (TTI) by a spiral mapping catheter has emerged as a valuable procedural parameter in cryoballoon pulmonary vein isolation (PVI). The 1st generation spiral mapping catheter (Achieve, SMC1) has been available as an 8-polar catheter with a distal loop diameter of 15 or 20 mm. The novel spiral mapping catheter (Achieve Advance, SMC2) was designed as a true guidewire and is available, in addition to the sizes of the SMC1, as a 10-polar mapping catheter with a distal loop diameter of 25 mm. Whether these novel features of SMC2 influence procedural characteristics of Cryo-PVI in comparison to SMC1 has not been reported. In this prospective cohort study 158 patients (age 65.1 ± 12.4 years, female 39%, paroxysmal AF 60%) undergoing PVI with the 2nd generation cryoballoon were included. SMC1 was used in 57 patients (36%), whereas 101 patients (64%) underwent Cryo-PVI with the SMC2. All PVs (623/623, 100%) were isolated successfully. Mean procedure duration was 72.0 ± 18.9 min in the SMC1 group and 74.4 ± 19.1 min in the SMC2 group (p = 0.432). Mean fluoroscopy time was also not different between both study groups (SMC1 15.7 ± 6.6 min, SMC2 15.7 ± 7.3 min, p = 0.593). TTI was observed in 68.6% of pulmonary veins in the SMC1 group, whereas TTI observation rate was 82.6% in the SMC2 group (p < 0.001). Number of freezes (5.5 ± 1.5 vs. 6.5 ± 1.9; p = 0.001) and total freeze duration (14.1 ± 4.5 vs. 17.6 ± 5.6; p < 0.001) were increased in the SMC2 group. SMC2 significantly increases TTI observation rate during Cryo-PVI. Procedure duration and fluoroscopy time are similar and number of freezes and total freeze duration are increased compared to PVI with SMC1 due to decreased stability and maneuverability of SMC2.

Clinical outcome of 2nd generation cryoballoon pulmonary vein isolation in patients over 75 years of age.

BACKGROUND: Pulmonary vein isolation is an established therapy for symptomatic atrial fibrillation. Despite the fact that incidence and prevalence of atrial fibrillation increases with age, patients over 75 years of age have been excluded in all major atrial fibrillation ablation trials. Pulmonary vein isolation with the cryoballoon has been shown to be equally effective compared to irrigated radiofrequency catheter ablation, but patients over 75 years have also been excluded. The 2nd generation cryoballoon has shown superior efficacy compared to the 1st generation cryoballoon. The aim of the study was to assess the efficacy of pulmonary vein isolation with the 2nd generation cryoballoon for symptomatic atrial fibrillation in elderly patients over 75 years. METHODS: Patients over 75 years of age presenting with symptomatic paroxysmal or persistent atrial fibrillation refractory or intolerant to at least one class I or class III antiarrhythmic drug who underwent pulmonary vein isolation with the 2nd generation cryoballoon were included in this single-center observational study. RESULTS: A total of 40 patients with a mean age of 78.3±2.7 years with paroxysmal (n=31; 77.5%) or persistent (n=9; 22.5%) atrial fibrillation were identified. All patients had a successful pulmonary vein isolation procedure with 100% of veins isolated. After a 3-month blanking period during a mean follow-up of 15.1±8.2 months there were 9 (22.5%) arrhythmia recurrences, while 31 patients (77.5%) maintained stable sinus rhythm. Freedom from arrhythmia recurrence was 86.4% at 12 months and 80.2% at 24 months. CONCLUSIONS: Pulmonary vein isolation with the 2nd generation cryoballoon appears to be an effective treatment for symptomatic atrial fibrillation also in patients over 75 years of age.

Efficacy and safety of percutaneous left atrial appendage closure to prevent thromboembolic events in atrial fibrillation patients with high stroke and bleeding risk.

AIMS: The randomized PROTECT AF trial demonstrated non-inferiority of left atrial appendage (LAA) closure to oral anticoagulation with warfarin. Current guidelines give a class IIb recommendation for LAA closure. We evaluated the efficacy and safety of LAA closure in a consecutive series of non-valvular atrial fibrillation patients with contraindications to long-term oral anticoagulation or at high bleeding risk. METHODS AND RESULTS: 101 consecutive non-valvular atrial fibrillation patients (age 74.7 ± 7.5 years) at high risk for stroke (CHA2DS2-VASc Score 4.4 ± 1.6) and high bleeding risk (HAS-BLED Score 4.2 ± 1.3) received LAA closure with either the Watchman closure device (n = 38) or the Amplatzer cardiac plug (n = 63). Dual antiplatelet therapy with aspirin and clopidogrel was recommended for 3-6 months after device implantation, followed by long-term antiplatelet therapy with aspirin. No anticoagulation was given after device implantation. Mean follow-up was 400 days. One patient (1 %) experienced a transient ischemic attack, and two patients (2 %) suffered from ischemic stroke. While on recommended antiplatelet therapy, bleeding occurred in 12/101 patients (12 %). Bleeding was significantly reduced with 3 compared with 6 months dual antiplatelet therapy (3.0 vs. 16.2 %, p < 0.05) while ischemic or thrombotic events were similar. CONCLUSION: Left atrial appendage closure in patients with non-valvular atrial fibrillation and high risk for stroke and bleeding events effectively prevented stroke and reduced cerebral ischemic events compared to expected stroke rate according to CHA2DS2-VASc Score. Dual antiplatelet therapy for 3 months reduced the rate of bleeding events compared to 6 months therapy with no increase of thrombotic events.