Arrhythmia monitoring and outcome after myocardial infarction (BIO|GUARD-MI): a randomized trial.

Objectives: Cardiac arrhythmias predict poor outcome after myocardial infarction (MI). We studied if arrhythmia monitoring with an insertable cardiac monitor (ICM) can improve treatment and outcome. Design: BIO|GUARD-MI was a randomized, international open-label study with blinded outcome assessment. Setting: Tertiary care facilities monitored the arrhythmias, while the follow-up remained with primary care physicians. Participants: Patients after ST-elevation (STEMI) or non-ST-elevation MI with an ejection fraction >35% and a CHA2DS2-VASc score ≥4 (men) or ≥5 (women). Interventions: Patients were randomly assigned to receive or not receive an ICM in addition to standard post-MI treatment. Device-detected arrhythmias triggered immediate guideline recommended therapy changes via remote monitoring. Main outcome measures: MACE, defined as a composite of cardiovascular death or acute unscheduled hospitalization for cardiovascular causes. Results: 790 patients (mean age 71 years, 72% male, 51% non-STEMI) of planned 1,400 pts were enrolled and followed for a median of 31.6 months. At 2 years, 39.4% of the device group and 6.7% of the control group had their therapy adapted for an arrhythmia [hazard ratio (HR) = 5.9, P < 0.0001]. Most frequent arrhythmias were atrial fibrillation, pauses and bradycardia. The use of an ICM did not improve outcome in the entire cohort (HR = 0.84, 95%-CI: 0.65-1.10; P = 0.21). In secondary analysis, a statistically significant interaction of the type of infarction suggests a benefit in the pre-specified non-STEMI subgroup. Risk factor analysis indicates that this may be connected to the higher incidence of MACE in patients with non-STEMI. Conclusions: The burden of asymptomatic but actionable arrhythmias is large in post-infarction patients. However, arrhythmia monitoring with an ICM did not improve outcome in the entire cohort. Post-hoc analysis suggests that it may be beneficial in non-STEMI patients or other high-risk subgroups. Clinical Trial Registration: [https://www.clinicaltrials.gov/ct2/show/NCT02341534], NCT02341534.

Incidence and patterns of atrial fibrillation after catheter ablation of typical atrial flutter-the FLUTFIB study.

AIMS: In patients with atrial flutter (AFL), ablation of the cavotricuspid isthmus (CTI) is a highly effective procedure to prevent AFL recurrence, but atrial fibrillation (AF) may occur during follow-up. The presented FLUTFIB study was designed to identify the exact incidence, duration, timely occurrence, and associated symptoms of AF after CTI ablation using continuous cardiac monitoring via implantable loop recorders. METHODS AND RESULTS: One hundred patients with AFL without prior AF diagnosis were included after CTI ablation (mean age 69.7 ± 9.7 years, 18% female) and received an implantable loop recorder for AF detection. After a median follow-up of 24 months 77 patients (77%) were diagnosed with AF episodes. Median time to first AF occurrence was 180 (43-298) days. Episodes lasted longer than 1 h in most patients (45/77, 58%). Forty patients (52%) had AF-associated symptoms.Patients with and without AF development showed similar baseline characteristics and neither HATCH- nor CHA2DS2-VASc scores were predictive of future AF episodes. Oral anticoagulation (OAC) was stopped during FU in 32 patients (32%) and was re-initiated after AF detection in 15 patients (15%). No strokes or transient ischaemic attack episodes were observed during follow-up. CONCLUSION: This study represents the largest investigation using implantable loop recorders (ILRs) to detect AF after AFL ablation and shows a high incidence of AF episodes, most of them being asymptomatic and lasting longer than 1 h. In anticipation of trials determining the duration of AF episodes that should trigger OAC initiation, these results will help to guide anticoagulation management after CTI ablation.

Risk of occurrence of electromagnetic interference from the application of transcutaneous electrical nerve stimulation on the sensing function of implantable defibrillators.

BACKGROUND: Transcutaneous electrical nerve stimulation (TENS) is an established method for pain relief. But electrical TENS currents are also a source of electromagnetic interference (EMI). Thus, TENS is considered to be contraindicated in implantable cardioverter-defibrillator (ICD) patients. However, data might be outdated due to considerable advances in ICD and cardiac resynchronization therapy (CRT) filtering and noise protection algorithm technologies. The aim of this pilot safety study was to re-evaluate the safety of TENS in patients with modern ICDs. METHODS AND RESULTS: One hundred and seven patients equipped with 55 different models of ICD/CRT with defibrillators from 4 manufacturers underwent a standardized test protocol including TENS at the cervical spine and the thorax, at 2 stimulation modes-high-frequency TENS (80 Hz) and burst-mode TENS (2 Hz). Potential interference monitoring included continuous documentation of ECG Lead II, intracardiac electrograms and the marker channel. Electromagnetic interference was detected in 17 of 107 patients (15.9%). Most frequent were: interpretations as a premature ventricular beats (VS/S) in 15 patients (14%), noise reversion in 5 (4.6%) which resulted in temporary asynchronous pacing in 3 (2.8%), interpretation as ventricular tachycardia/ventricular fibrillation in 2 (1.9%), and premature atrial beat in 2 (1.9%) patients. Electromagnetic interference occurrence was influenced by position (chest, P < 0.01), higher current intensity (P < 0.01), and manufacturer (P = 0.012). CONCLUSION: Overall, only intermittent and minor EMI were detected. Prior to the use of TENS in patients with ICDs, they should undergo testing under the supervision of a cardiac device specialist.

Safety and Healthcare Resource Utilization in Patients Undergoing Left Atrial Appendage Closure-A Nationwide Analysis.

Percutaneous left atrial appendage closure (LAAC) has emerged as a non-pharmacological alternative for stroke prevention in patients with atrial fibrillation (AF) not suitable for anticoagulation therapy. Real-world data on peri-procedural outcomes are limited. The aim of this study was to analyze outcomes of peri-procedural safety and healthcare resource utilization in 11,240 adult patients undergoing LAAC in the United States between 2016 and 2019. Primary outcomes (safety) were in-hospital ischemic stroke or systemic embolism (SE), pericardial effusion (PE), major bleeding, device embolization and mortality. Secondary outcomes (resource utilization) were adverse discharge disposition, hospital length of stay (LOS) and costs. Logistic and Poisson regression models were used to analyze outcomes by adjusting for 10 confounders. SE decreased by 97% between 2016 and 2019 [95% Confidence Interval (CI) 0-0.24] (p = 0.003), while a trend to lower numbers of other peri-procedural complications was determined. In-hospital mortality (0.14%) remained stable. Hospital LOS decreased by 17% (0.78-0.87, p < 0.001) and adverse discharge rate by 41% (95% CI 0.41-0.86, p = 0.005) between 2016 and 2019, while hospital costs did not significantly change (p = 0.2). Female patients had a higher risk of PE (OR 2.86 [95% CI 2.41-6.39]) and SE (OR 5.0 [95% CI 1.28-43.6]) while multi-morbid patients had higher risks of major bleeding (p < 0.001) and mortality (p = 0.031), longer hospital LOS (p < 0.001) and increased treatment costs (p = 0.073). Significant differences in all outcomes were observed between male and female patients across US regions. In conclusion, LAAC has become a safer and more efficient procedure. Significant sex differences existed across US regions. Careful considerations should be taken when performing LAAC in female and comorbid patients.

P-wave detection performance of the BioMonitor III, Confirm Rx and Reveal Linq implantable loop recorders.

INTRODUCTION: Rhythm interpretation of EGMs recorded by implantable loop recorders (ILRs) is facilitated in cases when p-waves are visible. The three most commonly used ILRs (BioMonitor III, Confirm RX and Reveal Linq) vary in size, electrode placement and filter algorithms. Therefore, p-wave visibility and amplitude on EGM may vary according to the implanted device. MATERIAL AND METHODS: Consecutive patients were included after ILR implantation. P-wave visibility and amplitude were evaluated in sinus rhythm on 30-s EGMs with standard resolution (25 mm/mV for Biotronik and St. Jude, 30 mm/mV for Medtronic) and after maximum magnification. Additionally, baseline characteristics and p-wave amplitude in lead II on the surface-ECG were documented. RESULTS: 148 patients with either BioMonitor III (n = 48), Confirm Rx (n = 51) or Reveal Linq (n = 49) ILRs were included. With standard resolution, p-waves were visible in 40 patients (83%) implanted with BioMonitor III, 36 patients (71%) with Confirm Rx and in 35 patients (71%) with Reveal Linq ILRs (p = 0.267). After maximum magnification, p-waves could not be identified in 6 patients with Confirm Rx ILR (12%) and 1 patient in both BioMonitor III and Reveal Linq ILR (2%; p = 0.051). The Biomonitor III showed higher p-wave amplitudes compared to the Confirm Rx (0.050 mV (0.040-0.070) vs. 0.030 mV (0.020-0.040); p < 0.001) and the Reveal Linq ILR (0.050 mV (0.040-0.070) vs. 0.030 mV (0.020-0.040); p < 0.001). CONCLUSION: P-wave amplitudes were higher in patients with Biomonitor III. This did not lead to higher p-wave visibility compared to the Confirm RX ILR or the Reveal Linq ILR.

Benefit of a wearable cardioverter defibrillator for detection and therapy of arrhythmias in patients with myocarditis.

AIMS: Myocarditis may lead to malignant arrhythmias and sudden cardiac death. As of today, there are no reliable predictors to identify individuals at risk for these catastrophic events. The aim of this study was to evaluate if a wearable cardioverter defibrillator (WCD) may detect and treat such arrhythmias adequately in the peracute setting of myocarditis. METHODS AND RESULTS: In this observational, retrospective, single centre study, we reviewed patients presenting to the Charité Hospital from 2009 to 2017, who were provided with a WCD for the diagnosis of myocarditis with reduced ejection fraction (<50%) and/or arrhythmias. Amongst 259 patients receiving a WCD, 59 patients (23%) were diagnosed with myocarditis by histology. The mean age was 46 ± 14 years, and 11 patients were women (19%). The mean WCD wearing time was 86 ± 63 days, and the mean daily use was 20 ± 5 h. During that time, two patients (3%) had episodes of sustained ventricular tachycardia (VT; four total) corresponding to a rate of 28 sustained VT episodes per 100 patient-years. Consequently, one of these patients underwent rhythm stabilization through intravenous amiodarone, while the other patient received an implantable cardioverter defibrillator. Two patients (3.4%) were found to have non-sustained VT. CONCLUSIONS: Using a WCD after acute myocarditis led to the detection of sustained VT in 2/59 patients (3%). While a WCD may prevent sudden cardiac death after myocarditis, our data suggest that WCD may have impact on clinical management through monitoring and arrhythmia detection.

The use of a high-power (50 W), ablation index-guided protocol for ablation of the cavotricuspid isthmus.

BACKGROUND: High-power (HP) ablation protocols are increasingly used for ablation procedures to shorten procedural times and improve short- and long-term success. The ablation index (AI) combines contact force, power settings, and ablation time. It can be used in combination with HP protocols to guide operators toward standardized lesions. The purpose of this study was to evaluate both a HP and AI-guided strategy for ablation of the cavotricuspid isthmus (CTI) in patients with typical atrial flutter (AFL). METHODS: In this single-center study, consecutive patients with typical AFL (n = 52, mean age 68.7 ± 8.3 years, 21/52 [40.4%] female) underwent AI-guided HP radiofrequency (RF) ablation of the CTI. Ablation was performed with 50 W and AI target values of 550 with a maximum ablation duration of 25 seconds per lesion. Target interlesion distance was ≤6 mm. Ablation was performed with a 3.5 mm porous tip Smarttouch SF catheter. RESULTS: Acute CTI block was achieved in 52 of 52 patients (100%), and first-pass conduction block was achieved in 41 of 52 patients (80.4%). Spontaneous reconduction after 30 minutes waiting time occurred in 1 of 52 (1.9%) patient. Average ablation time until CTI block was 3:51 ± 1:40; 2:33 ± 1:01 minutes of bonus ablation pulses were applied after CTI block. An audible steam pop was noted in one patient (1.9%). No major complications occurred. After a mean follow-up of 193.7 ± 152.2 days, no patient showed recurrence of typical AFL. CONCLUSION: In this pilot study, AI-guided HP ablation of the CTI was fast, safe, and effective.

Reduction of mapping time in pulmonary vein isolation using atrial pacing during left atrial voltage map acquisition.

INTRODUCTION: 3D mapping systems are used during radiofrequency (RF) pulmonary vein isolation (PVI) to facilitate catheter navigation and to provide additional electroanatomical information as a surrogate marker for the presence and location of fibrotic atrial myocardium. Electric voltage information can only be measured when the myocardium is depolarized. Low heart rates or frequent premature atrial beats can significantly prolong creation of detailed left atrial voltage maps. This study was designed to evaluate the potential advantage of voltage information collection during atrial pacing instead of acquisition during sinus rhythm. METHODS AND RESULTS: A total of 40 patients were included in the study, in 20 consecutive patients voltage mapping was performed during sinus rhythm, and in the following 20 patients during atrial pacing. The average age of the included patients was 69.5 ± 9.4, 17 of 40 patients (43%) were male. All procedures were performed using the Carto 3D Mapping system. For LA voltage mapping, a multipolar circular mapping catheter was used. The atrium was paced via the proximal coronary sinus catheter electrodes with a fixed cycle length of 600 ms. By mapping during atrial pacing mapping time was reduced by 35% (441 s. (±141) vs. 683 s. (±203) p = 0.029) while a higher number of total mapping points were acquired (908 ± 560 vs. 581 ± 150, p = 0.008). CONCLUSION: Acquiring left atrial low voltage maps during atrial pacing significantly reduces mapping time. As pacing also improves comparability of left atrial electroanatomical maps we suggest that this approach may be considered as a standard during these procedures.

[Update on radiation exposure in catheter ablation of atrial fibrillation]. / Update zum Strahlenschutz bei der Katheterablation von Vorhofflimmern.

The rising number of catheter ablations of atrial fibrillation increases radiation exposure for both patients and surgeons. Fortunately, this trend is counteracted by the development of measures to reduce total fluoroscopy time using non-fluoroscopic catheter visualization. Since even low-dose radiation can cause serious injury, all options to reduce radiation burden must be utilized (ALARA, "as low as reasonably achievable"). Dose reduction protocols with low-dose settings, which include reduced framerates, pulse duration, detector entrance dose and increased beam hardening, play a decisive role in this regard. This review provides a state-of-the-art summary of non-fluoroscopic catheter visualization and dose reduction protocols for catheter ablation of atrial fibrillation.

Correlation of P-wave properties with the size of left atrial low voltage areas in patients with atrial fibrillation.

BACKGROUND: Left atrial low voltage areas (LVA) are associated with increased recurrence rates of atrial fibrillation (AF) after catheter ablation and can be a potential ablation target during the procedure. Therefore, noninvasive prediction of the presence and the distribution of LVA may help physicians to predict ablation outcomes and to guide antiarrhythmic management. MATERIAL AND METHODS: Seventy-three consecutive patients with atrial fibrillation undergoing first time left atrial ablation for paroxysmal or persistent AF were enrolled. P-wave properties (amplitude and duration) were measured in all limb and precordial leads in pre-interventional sinus rhythm surface ECGs and correlated with total LVA size. LVA were detected via high density low voltage maps of the left atrium in sinus rhythm. LVA were then manually encircled, their total size was calculated and given as a percentage of the total LA surface area. RESULTS: A significant, inverse correlation with LVA size was shown for P-wave amplitude for leads I, II, aVR, aVF, V1, V4, V5 and V6. Additionally, a significant positive correlation between LVA size and P-wave duration was shown for leads V1, V2 and V3. As the strongest correlation was shown for the amplitude in lead I (R = -0.578), this lead was used to find a potential cutoff for LVA prediction. The best cut-off for a P-wave amplitude in lead I to predict severe scarring (defined as LVA size >35%, according to UTAH stadium IV) was 0.062 mV with an area-under-the receiver-operating-characteristic curve of 0.935, a sensitivity of 85% and a specificity of 88%. CONCLUSIONS: P-wave duration and amplitude show significant correlations with LVA size and may be used as a noninvasive tool to predict severe scarring. Amplitudes in lead I smaller than 0.062 mV were found to be predictive of LVA >35%.

Heart rate variability in patients with agoraphobia with or without panic disorder remains stable during CBT but increases following in-vivo exposure.

Patients with anxiety disorders have a lower heart rate variability (HRV) than healthy controls. Low HRV is associated with cardiovascular disease and dysfunction of the autonomic nervous system (ANS). The aim of the present study was to investigate if HRV in patients with agoraphobia with or without panic disorder can be influenced by cognitive behavioral therapy (CBT). 73 patients with agoraphobia with or without panic disorder were included in the study. Heart rate (HR) and HRV were recorded at rest before and after CBT and during in-vivo exposure. No changes in HR and HRV were observed throughout therapy. During in-vivo exposure HRV increased significantly and HR exhibited a tendency to decrease. Despite clinical improvement of anxiety symptoms, ANS activity at rest did not seem to be influenced by CBT. However, during in-vivo exposure, HRV changed significantly, indicating a higher parasympathetic activity at the end of exposure.

Velocity characteristics of atrial fibrillation sources determined by electrographic flow mapping before and after catheter ablation.

BACKGROUND: Electrographic-Flow-(EGF)-Mapping is a novel method to identify Atrial Fibrillation (AF) drivers. Sources of excitation during AF can be characterized and monitored. OBJECTIVE: The aim of this study was to evaluate the correlation between velocity of EGF around a respective AF source and its spatial variability (SV) and stability (SST). METHODS: 25 patients with AF were included in this study (persistent: n = 24, long-standing persistent: n = 1; mean age 70 ±â€¯8.3 years, male: n = 17). Focal impulse and Rotor-Mapping (FIRM) was performed in addition to pulmonary vein isolation. One-minute epochs of unipolar electrograms recorded via a 64-pole basket catheter in both atria were re-analyzed with EGF-Mapping. SST was calculated as the percentage of time in which a source was detected. RESULTS: AF sources identified with EGF-Mapping show a wide range of SV during 1 min covering between 0.12% and 38% of the recorded basket-catheter surface. The 12 atria where the sources showed highest temporal stability (TS; between 34% and 97% of 1 min recorded) and those 12 with the lowest TS (between 11 and 20%) differed significantly in their velocities (17.8 el/s vs 12.2 el/s; p < 0.01). In 11 atria ablation caused an average decrease of TS by 47% and of velocity by 27% while SV more than doubled. CONCLUSION: Less stable AF-sources with high spatial variability showed reduced excitation propagation velocity while stable AF sources displayed a high average velocity in their vicinity. Importantly, catheter ablation reduced stability of sources and velocity suggesting a role of these parameters in guidance of ablation. CONDENSED ABSTRACT: Electrographic Flow (EGF)-Mapping is a novel method to identify Atrial Fibrillation (AF) drivers based on modeling of an electrical potential surface and subsequent flow analysis. Sources of excitation during AF can be characterized and monitored. The aim of this study was to evaluate the correlation between velocity of EGF around a respective AF source and its spatial variability and stability. Less stable AF sources with high spatial variability showed reduced excitation propagation velocity while very stable AF sources displayed a high average velocity in their vicinity. Catheter ablation reduced stability of sources and velocity.

A combination of rare complications 3 years after a dual-chamber pacemaker implantation.

Late perforation of the atrial wall after pacemaker implantation frequently remains asymptomatic but may cause chest pain, dyspnea or syncope. Perforation can also lead to rarer complications such as hemoptysis and pneumopericardium. We present the case of a patient who developed progressive hemoptysis 3 years after a dual-chamber pacemaker implantation. Pacemaker interrogation showed stable impedance of the right atrial lead and stable pacing threshold values. CT revealed perforation of the right atrial wall by the RA-lead with consecutive pneumopericardium and diffuse lung bleeding of the right middle lobe. The patient was hemodynamically stable at all times. The right atrial lead was transvenously extracted and replaced without any further complications.

Cryoballoon ablation in the elderly: one year outcome and safety of the second-generation 28mm cryoballoon in patients over 75 years old.

Aims: The efficacy of the second-generation cryoballoon (CB) ablation in patients with atrial fibrillation (AF) has been demonstrated previously. Data on the efficacy of CB ablation in elderly patients is missing. The aim of this study was to evaluate the long-term success rate of pulmonary vein isolation (PVI) in patients ≥75 years vs. <75 years using the second-generation 28mm CB. Methods and results: Eighty patients [n = 40 ≥75 years (Group 1); n = 40 <75 years (Group 2)] with paroxysmal [n = 37 (46%) or persistent (n = 43 (54%)] AF were included. Median follow-up was 12 [6;18] months (Group 1 vs. 13 [6;27]) months (Group 2; P = 0.8). PVI was performed in all patients using cryoablation. Follow-up was obtained using 24h-Holter monitoring or via an implanted loop recorder or pacemaker. CHA2DS2VASc-Score (Group 1: 4 [4;5] vs. Group 2: 2 [1;3], P < 0.001) and HASBLED-Score (Group 1: 2 [2;3] and Group 2: 2 [1;3], (P = 0.009)) differed significantly between the two groups. Mean fluoroscopy time was 22.9 [16.3;31.9] in Group 1 and 24.5 [19.1;30.6] in Group 2 (P = 0.75), and mean procedure time was 125 min [105;151] in Group 1 and 130.5 min [117.5;147.3] in Group 2 (P = 0.66). Arrhythmia recurrence was similar in Group 1 and Group 2 (12/40 (30%) vs. 10/40 (25%) (P = 0.62). One transient ischaemic attack occurred in Group 2. No further major complications were documented in this patients cohort. Conclusion: CB ablation in patients ≥75 years has favourable success rates and similar complication rates compared with patients <75 years.

Identification of active atrial fibrillation sources and their discrimination from passive rotors using electrographical flow mapping.

BACKGROUND: The optimal ablation approach for the treatment of persistent atrial fibrillation (AF) is still under debate; however, the identification and elimination of AF sources is thought to play a key role. Currently available technologies for the identification of AF sources are not able to differentiate between active rotors or focal impulse (FI) and passive circular turbulences as generated by the interaction of a wave front with a functional obstacle such as fibrotic tissue. OBJECTIVES: This study introduces electrographic flow (EGF) mapping as a novel technology for the identification and characterization of AF sources in humans. METHODS: Twenty-five patients with AF (persistent: n = 24, long-standing persistent: n = 1; mean age 70.0 ± 8.3 years, male: n = 17) were included in this prospective study. Focal impulse and Rotor-Mapping (FIRM) was performed in addition to pulmonary vein isolation using radiofrequency in conjunction with a 3D-mapping-system. One-minute epochs were exported from the EP-recording-system and re-analyzed using EGF mapping after the procedure. RESULTS: 44 potential AF sources (43 rotors and one FI) were identified with FIRM and 39 of these rotors were targeted for ablation. EGF mapping verified 40 of these patterns and identified 24/40 (60%) as active sources while 16/40 (40%) were classified as passive circular turbulences. Four rotors were not identified by EGF mapping. CONCLUSION: EGF is the first method to identify active AF sources during AF ablation procedures in humans and discriminate them from passive rotational phenomena, which occur if the excitation wavefront passes conduction bariers. EGF mapping may allow improved guidance of AF ablation procedures.

Prospective randomized study evaluating the effects of PerClot® (Polysaccharide Hemostatic System) application in patients with high bleeding risk undergoing cardiac rhythm device implantation.

BACKGROUND: Thus far, the topic hemostatic agent PerClot® is used for surgical procedures. Data about the use of PerClot® for cardiac-rhythm-devices (CRD) implantation are missing. The aim of this study was to evaluate the safety and efficacy of PerClot® in patients with high bleeding risk. METHODS AND RESULTS: In this prospective randomized study we planned to include 150 patients admitted for CRD-Implantation receiving anticoagulation and/or dual-antiplatelet-therapy. Participants were randomized to receive PerClot® versus standard-of-care. The primary endpoint was the incidence of pocket hematoma. Safety endpoint was pocket infection. After a planned safety-interim-analysis the study was terminated early because of safety concerns. 51 patients were included. The two groups were comparable with regard to age (73±11years vs. 74±10years; p=0.71), CHA2DS2VASc (3.6±1.5 vs. 4.0±1.5; p=0.27) and HASBLED-Score (2.4±1.1 vs. 2.5±1.0; p=0.98), CRD or procedure type, anticoagulant or anti-platelet therapy. The use of PerClot® resulted in a higher incidence of postoperative fever (7 (28%) vs. 0 (0%); p=0.004), higher C-Reactive Protein (66.1±50.5mg/l vs. 25.9±22.5mg/l; p=0.002); and higher postoperative white blood cell count (13.5±4.3/nl vs. 8.8±2.6/nl; p<0.001). Hematoma formation did not differ significantly (p=0.14). Reoperation was not necessary in any patient. CONCLUSION: This first randomized controlled study for the topical use of the hemostatic agent PerClot® in CRD implantation was terminated early by the safety monitoring board because of an augmented rate of fever and inflammatory markers in the PerClot® group. The addition of PerClot® does not suggest a benefit with regard to the frequency of pocket hematoma.

Apixaban, rivaroxaban, and dabigatran use in patients undergoing catheter ablation for atrial fibrillation using the second-generation cryoballoon.

BACKGROUND: Data are limited on the safety of periprocedural anticoagulation with novel oral anticoagulants (NOACs) in patients undergoing pulmonary vein isolation (PVI) using the second-generation cryoballoon (CB) for the treatment of atrial fibrillation. HYPOTHESIS: We hypothesized that the incidence of acute periprocedural complications in patients undergoing PVI do not differ between patients treated with VKA compared to NOACs. METHODS: In 200 consecutive patients (mean age, 64.3 _ 10.6 years; female, n = 83) with symptomatic atrial fibrillation, PVI using the second-generation 28-mm CB was performed. In patients treated with NOACs, the medication was stopped the day of the procedure and continued the evening after the procedure with a reduced dosage. Patients treated with phenprocoumon were continued on uninterrupted phenprocoumon with a target INR of 2 to 3. If INR was <2, bridging with low-molecular-weight heparin was performed. RESULTS: Forty-seven of 200 patients (23.5%) were treated with a vitamin K antagonist (VKA) and 55 (27.5%) were treated with apixaban, 67 (33.5%) with rivaroxaban, and 31 (15.5%) with dabigatran. Seven (3.5%) major complications occurred in the overall population. Major bleeding complications did not differ significantly between the 2 groups (P = 0.23). One patient taking VKA had a pericardial tamponade at the end of the procedure; 2 patients treated with apixaban developed a groin hematoma requiring surgical intervention. Transient ischemic attack occurred in 1 patient of the apixaban and rivaroxaban group. CONCLUSIONS: Apixaban, rivaroxaban, and dabigatran, compared with uninterrupted VKA, did not show a higher risk for major bleeding or ischemic complications in patients undergoing PVI using the second-generation CB.

Two years outcome in patients with persistent atrial fibrillation after pulmonary vein isolation using the second-generation 28-mm cryoballoon.

BACKGROUND: The efficacy of the second-generation cryoballoon (CB) in patients with paroxysmal atrial fibrillation (AF) has been demonstrated previously. Data on the efficacy of CB ablation in patients with persistent AF are sparse. OBJECTIVE: The aim of this study was to evaluate the 2-year success rate of pulmonary vein isolation in patients with persistent AF using the second-generation CB. METHODS: Fifty consecutive patients (mean age 64.6 ± 9.9 years; 19 women [38%]) with persistent AF were included in this analysis. The mean follow-up period was 22 ± 11 months. All patients were ablated using the second-generation 28-mm CB. Isolation of the pulmonary veins was confirmed using a spiral mapping catheter. In all patients, follow-up was obtained using 24-hour Holter monitoring or via interrogation of an implanted loop recorder or pacemaker. RESULTS: The mean left atrial diameter was 43.6 ± 5.6 mm, the mean CHA2DS2-VASc score was 2.8 ± 1.5, and the mean HAS-BLED score was 2.1 ± 1.2. The mean fluoroscopy time was 25.8 ± 9 minutes, and the mean procedural time was 146.4 ± 37.8 minutes. After 22 ± 11 months, the frequency of arrhythmia recurrence was 22 of 50 (44%) in the overall group (paroxysmal AF 6 of 22 [27%]; persistent AF 16 of 22 [73%]). No major complications occurred. Aneurysma spurium not requiring surgical intervention occurred in 1 (2%) patient. No phrenic nerve palsy was observed. CONCLUSION: Two years' results after pulmonary vein isolation using the second-generation CB in patients with persistent AF are promising. The clinical success rate appears to be similar to the reported success rates of radiofrequency ablation for the treatment of persistent AF.