Impact of intracardiac echocardiography usage on the safety of cryoballoon atrial fibrillation ablation: Subanalysis of the prospective FREEZE cluster cohort study.

INTRODUCTION: Cryoballoon ablation (CBA) aiming at pulmonary vein isolation (PVI) became a standardized atrial fibrillation (AF) ablation procedure. Life-threatening complications like cardiac tamponade exist. Intracardiac echocardiography (ICE) usage is associated with superior safety in radiofrequency ablation. It is unclear if ICE has an impact on safety of CBA. METHODS: The FREEZE Cohort (NCT01360008) subanalysis included patients undergoing "PVI only" CBA. Patients with intraprocedural transesophageal echocardiography were excluded. Group A comprises conventional, group B ICE-guided CBA. Periprocedural results were compared. RESULTS: From 2011 to 2016, a total of 4189 patients were enrolled, and 1906 (45.5%) were included in this subanalysis, split up in two groups (A: 1066 [55.9%], B: 840 [44.1%]). Group A was younger (60.6 ± 10.8 vs. 62.4 ± 10.5 years, p < .001), with smaller left atria (41 vs. 43 mm, p < .001), and less persistent AF (23.1 vs. 38.1%, p < .001). Procedure, left atrial, and fluoroscopy times were shorter in group A as compared to group B. Dose area product was significantly higher in group A (2911 vs. 2072 cGyxcm2 , p < .001). In-hospital major adverse cerebrovascular and cardiac event rates including two deaths in group A were not different between groups (0.5% vs. 0.1%, p = .18). The rate of total procedural (10.4% vs. 5.1%, p < .001) and major complications (3.2% vs. 1.3%, p < .001) was significantly higher in group A. Cardiac tamponade occurred significantly more frequently in group A (8 [0.8%] vs. 1 [0.1%], p = .046). Independent predictors for major complications were female sex (odds ratio [OR] 2.03, p = .03) and non-ICE usage (OR 2.38, p = .02). No differences were observed for persistent phrenic nerve palsy, nor for groin complications. CONCLUSION: CBA was significantly safer and required less radiation if ICE was used, although the procedures were more complex. The risk of groin complications was not increased with ICE usage. Non-ICE usage was the only modifiable independent predictor of major complications.

Baroreflex activation therapy in advanced heart failure therapy: insights from a real-world scenario.

AIMS: Baroreflex activation therapy (BAT) is an innovative treatment option for advanced heart failure (HFrEF). We analysed patients' BAT acceptance and the outcome of BAT patients compared with HFrEF patients solely treated with a guideline-directed medical therapy (GDMT) and studied effects of sacubitril/valsartan (ARNI). METHODS: In this prospective study, 40 HFrEF patients (71 ± 3 years, 20% female) answered a questionnaire on the acceptance of BAT. Follow-up visits were performed after 3, 6, and 12 months. Primary efficacy endpoints included an improvement in QoL, NYHA class, LVEF, HF hospitalization, NT-proBNP levels, and 6MHWD. RESULTS: Twenty-nine patients (73%) showed interest in BAT. Ten patients (25%) opted for implantation. BAT and BAT + ARNI patients developed an increase in LVEF (BAT +10%, P-value (P) = 0.005*; BAT + ARNI +9%, P = 0.049*), an improved NYHA class (BAT -88%, P = 0.014*, BAT + ARNI -90%, P = 0.037*), QoL (BAT +21%, P = 0.020*, BAT + ARNI +22%, P = 0.012*), and reduced NT-proBNP levels (BAT -24%, P = 0.297, BAT + ARNI -37%, P = 0.297). BAT HF hospitalization rates were lower (50%) compared with control group patients (83%) (P = 0.020*). CONCLUSIONS: Although BAT has generated considerable interest, acceptance appears to be ambivalent. BAT improves outcome with regard to LVEF, NYHA class, QoL, NT-proBNP levels, and HF hospitalization rates. BAT + ARNI resulted in more pronounced effects than ARNI alone.

Randomized evaluation of redo ablation procedures of atrial fibrillation with focal impulse and rotor modulation-guided procedures: the REDO-FIRM study.

AIMS: REDO-FIRM evaluated safety and effectiveness of conventional vs. focal impulse and rotor modulation (FIRM)-guided ablation of recurrent persistent or paroxysmal atrial fibrillation (AF) after an initial AF ablation procedure. METHODS AND RESULTS: This prospective, multicentre, randomized study included patients with a single prior AF ablation, but with recurrent AF and reconnected pulmonary veins (PVs). Conventional ablation generally included PV re-isolation; however, additional ablation was permitted per physician discretion. In the FIRM arm, beyond PV re-isolation, basket catheter-based FIRM mapping created dynamic animations of putative rotors, which were targeted for ablation. Between May 2016 and July 2019, 269 subjects were randomized, with 243 subjects completing 12-month follow-up. Ablation beyond re-pulmonary vein isolation, the FIRM vs. Conventional arms did not differ significantly: cavo-tricuspid isthmus -9.0% vs. 15.3%, caval vein isolation -1.5% vs. 0.8%, non-PV trigger -2.2% vs. 3.8%, other -11.9% vs. 13.0%. Single procedure 12-month freedom from AF/atrial tachycardia/atrial flutter-recurrence was 63.3% (76/120) vs. 59.0% (72/122) in the FIRM and Conventional arms (P = 0.3503). Efficacy was similar in the paroxysmal and persistent AF subgroups (P = 0.22 and P = 0.48). The 10-day and 12-month safety endpoints were achieved in 93.3% vs. 93.8% (P = 0.89) and 88.4% vs. 93.4% (P = 0.22) in the FIRM and Conventional arms, respectively. CONCLUSIONS: In REDO-FIRM, as compared to standard ablation, FIRM-guided ablation did not provide additional efficacy in redo ablation procedures, but FIRM-guided ablation was equally safe. Additional studies are necessary to identify any potential population able to benefit from FIRM-guided ablation.

[A taste of honey : Rare cause of syncope associated with junctional rhythm]. / A taste of honey : Ungewöhnliche Ursache einer Synkope bei junktionalem Ersatzrhythmus.

We present a rare reversible cause of bradycardia. A 49-year-old man who suffered from syncope was administered to our emergency department. In preclinical ECG recordings, a sinus node arrest was documented. All following examinations documented normal sinus node function. Finally, grayanotoxin poisoning, which can be present in honey from the Black Sea region, was proven. A pacemaker implantation could be avoided in this reversible cause of bradyarrhythmia.

Impact of pulmonary vein variant anatomy and cross-sectional orifice area on freedom from atrial fibrillation recurrence after cryothermal single-shot guided pulmonary vein isolation.

BACKGROUND: Cryoballoon (CB)-guided pulmonary vein isolation (PVI) is an established treatment for atrial fibrillation (AF). This study aimed to evaluate ablation efficacy and freedom from arrhythmia recurrence using the novel POLARx compared to the Arctic Front Advance Pro (AFA) CB system including the analysis of individual PV characteristics. METHODS: A total of 687 patients underwent CB-guided ablation for AF. Arrhythmia recurrence was defined as an ECG documented episode of any AF/atrial tachycardia (AT) > 30 s. Anatomical characteristics were assessed using magnetic resonance imaging (MRI). For each PV, the cross-sectional orifice area (CSOA) was determined. Follow-up examinations were scheduled after 3, 6, and 12 months. RESULTS: Acute PVI was achieved in all patients. Twelve-month AF-free survival was similar between the groups (POLARx 43/86 (50%) vs. AFA 318/601 (53%), Log-rank (LR) p = 0.346). MRI found a comparable percentage of patients with normal PV anatomy (POLARx 71/86 (83%) vs. AFA 530/601 (85%), p = 0.162). Patients with variant PV characteristics presented with a significantly impaired 12-month AF-free survival (normal PVs 326/585 (56%) vs. variant PVs 27/102 (27%), LR p < 0.001) independent of the applied CB ablation system. PAF patients with AF recurrence presented with significantly larger CSOA of the left-sided PVs and the right superior PVs (LSPV: p < 0.001; LIPV: p < 0.001; RSPV: p < 0.001). In PERS AF, no association between CSOA and ablation outcome was observed. Multivariate analyses identified PERS AF (hazard ratio (HR) 2.504, confidence interval (CI), 1.900-3.299, p < 0.001) and variant PV anatomy (HR 2.124, CI 1.608-2.805, p < 0.001) as independent predictors for AF recurrence. CONCLUSIONS: Both CB ablation systems are associated with comparable 12-month AF-free survival rates. Variant PV anatomy seems to be predictive for AF recurrence. An association between CSOA and the outcome after CB-guided PVI was demonstrated for PAF.

News from the Cold Chamber: Clinical Experiences of POLARx versus Arctic Front Advance for Single-Shot Pulmonary Vein Isolation.

Cryoballoon (CB)-guided pulmonary vein isolation (PVI) represents a cornerstone in the treatment of atrial fibrillation (AF). Recently, a novel balloon-guided single shot device (POLARx, Boston Scientific) was designed. Our study aimed to compare the efficacy, safety and characteristics of the novel CB system with the established one (Arctic Front Advance (Pro), AFA, Medtronic). A total number of 596 patients undergoing CB-guided ablation for AF were included. 65 patients (65.0 ± 11.6, 31% female) undergoing PVI with the POLARx were compared to a cohort of 531 consecutive patients (63.0 ± 27.9, 25% female) treated with AFA. Acute PVI was achieved in all patients (n = 596, 100%). Total procedure duration (POLARx 113.3 ± 23.2 min, AFA 100.9 ± 21.3 min; p < 0.001) and fluoroscopy time (POLARx 10.5 ± 5.9 min, AFA 4.8 ± 3.6 min; p < 0.001) were significantly longer in the POLARx group. The POLARx balloon achieved significantly lower nadir temperatures (POLARx -57.7 ± 0.9 °C, AFA -45.1 ± 2.6 °C; p < 0.001) and a significantly higher percentage of pulmonary veins successfully isolated with the first freeze (p = 0.027 *). One major complication occurred in the POLARx (2%) and three (1%) in the AFA group. Both ablation systems are comparably safe and effective. AF ablation utilizing the POLARx system is associated with longer procedure and fluoroscopy times as well as lower nadir temperatures.

Impact of lockdown during COVID-19 pandemic on physical activity and arrhythmia burden in heart failure patients.

BACKGROUND: Restricted outdoor activity during COVID-19 related lockdown may accelerate heart failure (HF) progression and thereby increase cardiac arrhythmias. We analyzed the impact of March/April 2020 lockdown on physical activity and arrhythmia burden in HF patients treated with cardiac resynchronization therapy (CRT) devices with daily, automatic remote monitoring (RM) function. METHODS: The study cohort included 405 HF patients enrolled in Observation of Clinical Routine Care for Heart Failure Patients Implanted with BIOTRONIK CRT Devices (BIO|STREAM.HF) registry in 16 countries, who had left ventricular ejection fraction (LVEF) ≤40% (mean 28.2 ± 6.6%) and NYHA class II/III/IV (47.9%/49.6%/2.5%) before CRT pacemaker/defibrillator implantation. The analyzed RM data comprised physical activity detected by accelerometer, mean heart rate and nocturnal rate, PP variability, percentage of biventricular pacing, atrial high rate episode (AHRE) burden, ventricular extrasystoles and tachyarrhythmias, defibrillator shocks, and number of implant interrogations (i.e., follow-ups). Intraindividual differences in RM parameters before (4-week period) versus during (4-week period) lockdown were tested for statistical significance and independent predictors were identified. RESULTS: There was a significant relative change in activity (mean -6.5%, p < .001), AHRE burden (+17%, p = .013), and follow-up rate (-75%, p < .001) during lockdown, with no significant changes in other RM parameters. Activity decreased by ≥8 min/day in 46.5% of patients; predictors were higher LVEF, lower NYHA class, no defibrillator indication, and more activity before lockdown. AHRE burden increased by ≥17 min/day in 4.7% of patients; predictors were history of atrial fibrillation, higher LVEF, higher body mass index, and activity decrease during lockdown. CONCLUSION: Unfavorable changes in physical activity, AHRE burden, and follow-up rate were observed during lockdown, but not in ventricular arrhythmia.

The Effect of Diabetes Mellitus on the Recurrence of Atrial Fibrillation after Ablation.

Diabetes mellitus (DM) plays a crucial role in the regulation of atrial fibrillation (AF). This study aimed to evaluate the outcome of pulmonary vein isolation (PVI) using a single-shot device in patients with AF and DM. A total of 531 consecutive patients undergoing initial cryoballoon (CB)-guided PVI were evaluated. Two hundred eighty-one patients (53%) suffered from paroxysmal AF (PAF; mean age 51 ± 23.2 years, 26% female), 250 patients (48%) from persistent AF (PERS; 64 ± 10.0 years old, 30% female) and 80 patients (15%) were diagnosed with coincidental DM (68 ± 19.6 years old, 30% female). Follow-up visits were performed at 3, 6 and 12 months including 7-day Holter ECGs. Primary endpoint was the first documented recurrence of atrial tachyarrhythmia. AF recurrence occurred in 26% (140 patients). PAF patients with DM presented with a significantly higher risk for arrhythmia recurrence (Kaplan Meier analysis; Log rank p < 0.001 *). Multivariate analyses found DM to be an independent predictor (IP) for AF recurrence (p = 0.009 *, hazard ratio (HR) 4.363, confidence interval (CI) 1.456-13.074). In PERS, DM was associated with a 43% increase in AF recurrence (p = 0.320, HR 1.427, CI 0.707-2.879). DM has relevant effects on AF recurrence after PVI-only ablation approaches for AF. Major differences were observed in PAF as DM seems to favor the development of individual arrhythmia substrate, which is usually not yet present in PAF. In PERS, DM effects are less pronounced as individual fibrosis has already developed. Thus, personalized paths addressing individual arrhythmia substrates are needed in this specific cohort of patients.

Long-Term Efficacy and Impact on Mortality of Remote Magnetic Navigation Guided Catheter Ablation of Ventricular Arrhythmias.

Remote magnetic navigation (RMN) facilitates ventricular arrhythmia (VA) ablation. This study aimed to evaluate the long-term efficacy of RMN-guided ablation for ventricular tachycardia (VT) and premature ventricular contractions (PVC). A total of 176 consecutive patients (mean age 53.23 ± 17.55 years, 37% female) underwent VA ablation for PVC (132 patients, 75%) or VT (44 patients, 25%). The cohort consisted of 119 patients (68%) with idiopathic VA, 31 (18%) with ischemic (ICM), and 26 (15%) with dilated cardiomyopathy (DCM). VA recurrence was observed in 69 patients (39%, mean age 51.71 ± 19.91 years, 23% female) during a follow-up period of 5.48 years (first quartile 770.50 days, second quartile 1101.50 days, third quartile 1615.50 days). Left ventricular ejection fraction <40% lead to a significantly increased risk for VA (p = 0.031*). Multivariate analyses found DCM to be an independent predictor (IP) for VA recurrence (p < 0.001*, hazard ratio (HR) 3.74, confidence interval (CI) 1.58-8.88). ICM resulted in a lower increase in VA recurrence (p = 0.221, HR 1.49, CI 0.79-2.81). Class I/III/IV antiarrhythmic drug therapy (AADs) was also identified as IP for recurrence (p = 0.030*, HR 2.48, CI 1.11-5.68). A total of 16 patients (9%) died within the observational period. RMN-guided ablation of VA lead to acceptable long-term results. An impaired LV function, DCM, and AADs were associated with a significant risk for VA recurrence. Personalized paths are needed to improve efficacy and outcome.

Cool enough? Lessons learned from cryoballoon-guided catheter ablation for atrial fibrillation in young adults.

INTRODUCTION: Cryoballoon (CB)-guided ablation of atrial fibrillation (AF) is established in symptomatic AF patients. This study sought to determine the safety and efficacy of CB pulmonary vein isolation (PVI) in young adults. METHODS AND RESULTS: A total of 93 consecutive patients aged <45 years referred to our center for AF ablation were included in this observational study. All patients received CB-guided PVI according to a standardized institutional protocol. Follow-up was performed in our outpatient clinic using 72-h Holter monitoring and periodic telephone interview. Recurrence was defined as any AF/atrial tachycardia (AT) episode >30 s following a 3-month blanking period. A propensity matched control group consisting of patients older than 45 years were used for further evaluation. Mean age was 35 ± 7 years, 22% suffered from persistent AF, 85% were male. Mean follow-up was 2.6 ± 2 years. At the end of the observational period, 83% of patients were free of any AF/AT episodes. There was an excellent overall 12-month success rate of 92%. In comparison to a matched group the overall recurrence rate was noticeably lower in the young group (15% vs. 27%). Increasing age was associated with a hazard ratio of 1.16 for recurrence. In a multivariate analysis model, left atrial diameter remained as significant predictor of AF/AT recurrence. The complication rate was low, no permanent phrenic nerve palsy was observed. CONCLUSION: CB-guided PVI in young adults is safe and effective with favorable long-term results. It may be considered as first-line therapy in this relatively healthy population.

Long-term development of radiation exposure, fluoroscopy time and contrast media use in daily routine in cryoballoon ablations after implementation of intracardiac echocardiography and other radioprotective measures: experiences from a large single-centre cohort.

PURPOSE: The concern of higher radiation exposure during cryoballoon ablation (CBA) compared with radiofrequency ablation for atrial fibrillation (AF) was raised before. Previously, we compared CBA plus intracardiac echocardiography (ICE) to our former standard approach without ICE. A substantial reduction of radiation exposure without compromising safety or outcome was observed. We now investigate if at all and possibly to which amount radiation reduction can be achieved with growing experience. METHODS: We retrospectively analysed procedure time, dose area product (DAP), fluoroscopy time (FT) and contrast media (CM) use for all patients receiving CBA between 2013 and 2017 for AF. RESULTS: In 1131 procedures, procedure time decreased significantly between 2013 and 2017 (2013 111 ± 26 min, 2017 99 ± 25 min, p = 0.005). DAP halved between 2013 and 2014 without further significant decline (2013 1428 ± 1276 cGycm2, 2014 725 ± 551 cGycm2, p < 0.001). FT demonstrated a constant decrease from 2013 to 2017 (2013 11.7 ± 5.5 min, 2017 5.1 ± 3.5 min, p < 0.001). CM use did not show a significant reduction comparing 2013 to 2017 (2013 62 ± 19 ml, 2017 59 ± 18 ml, 2013/2017 p = 0.584). CONCLUSION: Given the imminent negative effects of radiation, every effort should be undertaken for its reduction. Feasible protocols can be kept simple by technical changes as reducing frame rates and basic radiation reduction strategies such as collimation, but ICE might add additional benefit. With growing experience and awareness of radioprotection, DAP and FT as low as or lower than in radiofrequency ablations seem possible.

Interventional techniques to increase implantation success of transvenous phrenic nerve stimulation for central sleep apnea treatment.

PURPOSE: Central sleep apnea (CSA) is a highly common comorbidity in heart failure (HF) patients and is known to deteriorate quality of life and prognosis. Effective treatment options are scarce. Transvenous phrenic nerve stimulation (PNS) has been shown to be effective and safe in CSA treatment in HF. However, lead implantation may be difficult or fail due to anatomical or technical challenges. We report novel and innovative approaches applying different interventional techniques to enhance PNS implantation success, allowing otherwise missing CSA treatment. METHODS: Twenty-seven consecutive HF patients (86% male, mean age: 69 ± 11 years; reduced left ventricular ejection fraction in 16 patients (57%)) were included in this study who were unable to tolerate or had contraindications for mask-based therapy. We evaluated PNS total implantation success, procedural characteristics, and feasibility and success rates of intravascular interventions to facilitate PNS lead implantation in otherwise ineffective procedures. RESULTS: Seven lead implantation attempts (24%) required additional intravascular interventional action to facilitate successful implantation, mainly consisting of balloon angioplasties to allow optimal PNS lead placement. Two procedures remained unsuccessful and two patients underwent a second procedure due to stimulation side effects and lead fracture respectively. All over, no complications resulted from application of interventional techniques to achieve a 93% implantation success rate. CONCLUSION: Transvenous PNS lead placement for CSA treatment can be difficult and challenging. However, interventional intravascular techniques markedly increase implantation success and thereby allow application of this therapy for effective CSA treatment in most patients without additional complications.

Pulmonary vein isolation and beyond: Predictive value of vagal reactions in second-generation cryoballoon ablation for the outcome of persistent atrial fibrillation.

BACKGROUND: Cryoballoon ablation (CBA) is gaining increasing acceptance in the treatment of persistent (per) atrial fibrillation (AF). The cardiac autonomic nervous system plays a pivotal role in the regulation of AF. OBJECTIVE: We evaluated the impact of vagal reactions (VRs), as a surrogate marker for autonomic nervous system modulation, on the outcome of CBA in patients (pts) with perAF. METHODS: A total of 250 consecutive pts (mean age 63.9 ± 10.0 years; 175 pts, 70% male) undergoing primary second-generation CBA for perAF were studied. VRs were defined as bradycardia <40 beats/min, asystole, or higher-degree atrioventricular block. Follow-up visits at 3, 6, and 12 months included 7-day Holter electrocardiograms. RESULTS: VRs were recorded in 61 pts (24%). These pts showed a significantly reduced recurrence rate of AF (5%) than did those without VRs (log-rank, P < .01). Univariate Cox regression analyses confirmed VRs as a strong predictor of AF-free survival (hazard ratio [HR] 0.10; P < .01). Female sex (HR 1.71; P = .02), preprocedural tachycardia (HR 1.01; P = .01), and AF (HR 1.75; P = .01) before CBA at admission were revealed as predictors of AF recurrence. Multivariate regression model calculation solely identified VRs (HR 0.11; 95% confidence interval 0.03-0.34; P < .01) and male sex (HR 0.57; 95% confidence interval 0.36-0.89; P = .01) as independent predictors of AF-free survival. CONCLUSION: VR is an independent predictor of AF-free survival after CBA for perAF.

Internal Versus External Electrical Cardioversion of Atrial Arrhythmia in Patients With Implantable Cardioverter-Defibrillator: A Randomized Clinical Trial.

BACKGROUND: Atrial arrhythmias are common in patients with implantable cardioverter-defibrillator (ICD). External shocks and internal cardioversion through commanded ICD shock for electrical cardioversion are used for rhythm-control. However, there is a paucity of data on efficacy of external versus internal cardioversion and on the risk of lead and device malfunction. We hypothesized that external cardioversion is noninferior to internal cardioversion for safety, and superior for successful restoration of sinus rhythm. METHODS: Consecutive patients with ICD undergoing elective cardioversion for atrial arrhythmias at 13 centers were randomized in 1:1 fashion to either internal or external cardioversion. The primary safety end point was a composite of surrogate events of lead or device malfunction. Conversion of atrial arrhythmia to sinus rhythm was the primary efficacy end point. Myocardial damage was studied by measuring troponin release in both groups. RESULTS: N=230 patients were randomized. Shock efficacy was 93% in the external cardioversion group and 65% in the internal cardioversion group (P<0.001). Clinically relevant adverse events caused by external or internal cardioversion were not observed. Three cases of pre-existing silent lead malfunction were unmasked by internal shock, resulting in lead failure. Troponin release did not differ between groups. CONCLUSIONS: This is the first randomized trial on external vs internal cardioversion in patients with ICDs. External cardioversion was superior for the restoration of sinus rhythm. The unmasking of silent lead malfunction in the internal cardioversion group suggests that an internal shock attempt may be reasonable in selected ICD patients presenting for electrical cardioversion. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03247738.

Clinical evaluation of a small implantable cardiac monitor with a long sensing vector.

INTRODUCTION: We conducted this study to show the safety and efficacy of a new implantable cardiac monitor (ICM), the BioMonitor 2 (Biotronik SE & Co. KG; Berlin, Germany), and to describe the arrhythmia detection performance. METHODS: The BioMonitor 2 has an extended sensing vector and is implanted close to the heart. It can transmit up to six subcutaneous electrocardiogram strips by Home Monitoring each day. We enrolled 92 patients with a standard device indication for an ICM in a single-arm, multicenter prospective trial. Patients were followed for 3 months, and 48-h Holter recordings were used to evaluate the arrhythmia detection performance. RESULTS: One patient withdrew consent and in one patient, the implantation failed. Two study device-related serious adverse events were reported, satisfying the primary safety hypothesis. Implantations took 7.4 ± 4.4 min from skin cut to suture. At 1 week, the R-wave amplitude was 0.75 ± 0.53 mV. In the 82 patients with completed Holter recordings, all patients with arrhythmias were correctly identified. False positive detections of arrhythmia were mostly irregular rhythms wrongly detected as atrial fibrillation (episode-based positive predictive value 72.5%). Daily Home Monitoring transmission was 94.9% successful. CONCLUSION: Safety and efficacy of the new device has been demonstrated. The detected R-wave amplitudes are large, leading to a low level of inappropriate detections due to over- or undersensing.

Silent cerebral lesions and cognitive function after pulmonary vein isolation with an irrigated gold-tip catheter: REDUCE-TE Pilot study.

INTRODUCTION: Stroke is one of the most feared complications during catheter ablation of atrial fibrillation (AF). While symptomatic thromboembolic events are rare, magnetic resonance imaging (MRI) may identify asymptomatic (ie, silent) cerebral lesions (SCLs) following pulmonary vein isolation (PVI) procedures. METHODS AND RESULTS: The REDUCE-TE Pilot was a prospective multicenter, single-arm observational study investigating the incidence of SCL in patients with symptomatic paroxysmal AF undergoing PVI with a novel gold-tip, externally irrigated ablation catheter. After ablation, cerebral diffusion-weighted MRI and a postablation follow-up were performed at 1 to 3 days after the ablation procedure. A neurocognitive test was done before and after ablation. The primary study endpoint was the occurrence of one or more new SCLs. Secondary study endpoints included neurocognitive status, procedural success rate, and periprocedural complications including symptomatic thromboembolic events. A total of 104 patients were enrolled (69% male, mean age: 61.5 ± 9.7 years, mean CHA2 DS 2 -VASc score: 1.7 ± 1.2). Postprocedural MRI examination was performed in 97 patients, and in nine of them (9.3%; 95% CI: 4.3-16.9%) a total of 11 SCLs were detected. Univariate analyses did not reveal any significant predictor for new SCLs. Nonsignificant trends were observed for low activated clotting time during ablation and for international normalized ratio value outside the range of 2 to 3 at ablation. There was no evidence of significant deterioration of neurocognitive function after PVI. In four patients, a pericardial tamponade was noted but all patients fully recovered during follow-up. CONCLUSIONS: Ablation of AF using a novel gold-tip, externally irrigated ablation catheter, resulted in SCLs in approximately one out of 10 patients without a measurable effect on neurocognitive function.

Hemoptysis as a side effect of cryoballoon pulmonary vein isolation in atrial fibrillation: a retrospective case-control study.

PURPOSE: Hemoptysis and pulmonary hemorrhage are rarely described as complications of cryoballoon ablation for pulmonary vein isolation (CB PVI). This study evaluated a large cohort to determine the frequency and risk factors for manifestation of these complications and assess the clinical relevance of hemoptysis after CB PVI. METHODS: Seven hundred fifteen consecutive patients (351 female) from a single-center database were evaluated to identify those who developed hemoptysis after CB PVI. RESULTS: A total of 31 patients with hemoptysis (4.3%; 2 female, age 60.5 ± 11.5 years) were matched with a control group (n = 31). Hemoptysis developed within 72 h after CB PVI. Cases versus controls had significantly lower ablation temperatures in the right inferior pulmonary vein (PV) (- 56.2 ± 26.6 vs - 49.1 ± 13.2 °C; p = 0.004) and left inferior PV (- 56.4 ± 11.9 vs - 47.2 ± 7.6 °C; p = 0.001). A trend to lower temperatures not reaching the level of significance was also found for the superior PV. All other procedural parameters were not significantly different between cases and controls. Although pre-procedural hemoglobin levels were comparable, post-procedural hemoglobin was lower in cases versus controls (12.9 ± 1.6 vs 13.7 ± 1.5 g/dL; p < 0.05). Twenty-six patients presenting with hemoptysis underwent chest CT scan, which showed perivenous infiltration at either the right (n = 23) or left inferior PV (n = 2) or no infiltrate (n = 1). No negative long-term effects were reported after 3, 6, and 12 months' follow-up. CONCLUSIONS: Post-procedural hemoptysis after CB PVI is a relatively frequent finding and was associated with low freezing temperatures and pulmonary tissue infiltration predominantly located at the right inferior PV. Hemoptysis resolved without long-term sequelae.

Apixaban in patients at risk of stroke undergoing atrial fibrillation ablation.

Aims: It is recommended to perform atrial fibrillation ablation with continuous anticoagulation. Continuous apixaban has not been tested. Methods and results: We compared continuous apixaban (5 mg b.i.d.) to vitamin K antagonists (VKA, international normalized ratio 2-3) in atrial fibrillation patients at risk of stroke a prospective, open, multi-centre study with blinded outcome assessment. Primary outcome was a composite of death, stroke, or bleeding (Bleeding Academic Research Consortium 2-5). A high-resolution brain magnetic resonance imaging (MRI) sub-study quantified acute brain lesions. Cognitive function was assessed by Montreal Cognitive Assessment (MoCA) at baseline and at end of follow-up. Overall, 674 patients (median age 64 years, 33% female, 42% non-paroxysmal atrial fibrillation, 49 sites) were randomized; 633 received study drug and underwent ablation; 335 undertook MRI (25 sites, 323 analysable scans). The primary outcome was observed in 22/318 patients randomized to apixaban, and in 23/315 randomized to VKA {difference -0.38% [90% confidence interval (CI) -4.0%, 3.3%], non-inferiority P = 0.0002 at the pre-specified absolute margin of 0.075}, including 2 (0.3%) deaths, 2 (0.3%) strokes, and 24 (3.8%) ISTH major bleeds. Acute small brain lesions were found in a similar number of patients in each arm [apixaban 44/162 (27.2%); VKA 40/161 (24.8%); P = 0.64]. Cognitive function increased at the end of follow-up (median 1 MoCA unit; P = 0.005) without differences between study groups. Conclusions: Continuous apixaban is safe and effective in patients undergoing atrial fibrillation ablation at risk of stroke with respect to bleeding, stroke, and cognitive function. Further research is needed to reduce ablation-related acute brain lesions.

Second generation cryoballoon ablation for persistent atrial fibrillation: an updated meta-analysis.

BACKGROUND: Catheter ablation is an established treatment option for patients with symptomatic atrial fibrillation (AF). The cornerstone of AF ablation is pulmonary vein isolation (PVI). The second-generation cryoballoon (2G-CB) has shown non-inferiority to radiofrequency (RF) ablation in paroxysmal AF in several trials. Growing evidence suggests that 2G-CB is also effective in patients with persistent AF (perAF). The aim of this study was to summarize and analyze available data on safety and mid-term (≥ 12 months) efficacy of PVI using 2G-CB in patients with perAF. METHODS: We did a search in PubMed, Web of Science, Cochrane Library, and clinicaltrials.gov in December 2016 for studies of 2G-CB ablation for perAF. Studies reporting clinical success rates at a follow-up (FU) of ≥ 12 months were included. Success was defined as freedom from any atrial arrhythmia lasting > 30 s after an initial blanking period of 3 months. Acute success and complication rates were also assessed. Data were analyzed applying random-effects model. RESULTS: A total of 917 patients from 11 studies meeting study inclusion criteria were analyzed. After a mean FU of 16.7 ± 3.0 months, 68.9% were free from recurrences [95% confidence interval (CI) 63.4-74.7%]. Overall acute success rate was 99.7% (95% CI 99.2-100%). Complications occurred in 5.5% (95% CI 2.4-9.6%). Vascular access complications were the most frequent 3.3% (95% CI 1.5-5.6%). The rate of phrenic nerve palsy/injury was 2.09% (95% CI 0.8-3.9%). No death, stroke or myocardial infarction was reported. CONCLUSION: The 2G-CB seems to be safe and effective in the treatment of perAF in the mid-term.