First-in-human clinical series of a novel conformable large-lattice pulsed field ablation catheter for pulmonary vein isolation.

AIMS: Pulsed field ablation (PFA) has significant advantages over conventional thermal ablation of atrial fibrillation (AF). This first-in-human, single-arm trial to treat paroxysmal AF (PAF) assessed the efficiency, safety, pulmonary vein isolation (PVI) durability and one-year clinical effectiveness of an 8 Fr, large-lattice, conformable single-shot PFA catheter together with a dedicated electroanatomical mapping system. METHODS AND RESULTS: After rendering the PV anatomy, the PFA catheter delivered monopolar, biphasic pulse trains (5-6 s per application; ∼4 applications per PV). Three waveforms were tested: PULSE1, PULSE2, and PULSE3. Follow-up included ECGs, Holters at 6 and 12 months, and symptomatic and scheduled transtelephonic monitoring. The primary and secondary efficacy endpoints were acute PVI and post-blanking atrial arrhythmia recurrence, respectively. Invasive remapping was conducted ∼75 days post-ablation. At three centres, PVI was performed by five operators in 85 patients using PULSE1 (n = 30), PULSE2 (n = 20), and PULSE3 (n = 35). Acute PVI was achieved in 100% of PVs using 3.9 ± 1.4 PFA applications per PV. Overall procedure, transpired ablation, PFA catheter dwell and fluoroscopy times were 56.5 ± 21.6, 10.0 ± 6.0, 19.1 ± 9.3, and 5.7 ± 3.9 min, respectively. No pre-defined primary safety events occurred. Upon remapping, PVI durability was 90% and 99% on a per-vein basis for the total and PULSE3 cohort, respectively. The Kaplan-Meier estimate of one-year freedom from atrial arrhythmias was 81.8% (95% CI 70.2-89.2%) for the total, and 100% (95% CI 80.6-100%) for the PULSE3 cohort. CONCLUSION: Pulmonary vein isolation (PVI) utilizing a conformable single-shot PFA catheter to treat PAF was efficient, safe, and effective, with durable lesions demonstrated upon remapping.

Results of a 4-Year Follow Up of Patients with Paroxysmal and Persistent Atrial Fibrillation after Cryoablation.

Background and Objectives: Cryoablation is an established treatment method for atrial fibrillation (AF). We present the long-term results of cryoablation in 94 patients with paroxysmal and persistent AF treated in our center. Materials and Methods: This was an observational, retrospective study of 94 patients who underwent a cryoablation procedure for paroxysmal or persistent AF from 2015 to 2017. The follow up was 51 ± 3 months. The absence of arrhythmia was checked at 6, 12, 24, and 48 months after the procedure with 24 h Holter monitoring. We evaluated echocardiography parameters before and 48 months after cryoablation. The quality of life was assessed by calculating EHRA scores at each visit. Results: The mean history of pre-procedural AF duration was 55.3 ± 8.6 months. Paroxysmal AF was present in 42% of patients and persistent AF in 58%. Comparing the EHRA classes, a statistically significant difference was observed between the score assessed before the procedure and the score after one year, as well as when comparing the rates before the procedure and four years after the procedure (p < 0.000). The recurrence of AF was observed in 22.3% of patients 1 year after the procedure, in 26.6% of patients 2 years after the procedure, and in 34% of patients 4 years after the procedure; 9.3% of them were left in permanent AF. During the observation period, 28% of patients underwent a repeated pulmonary vein isolation procedure, and 6% of patients had a permanent pacemaker implanted. Five hematomas (5%) and one instance of phrenic nerve palsy (1%) were observed during the procedure. Conclusions: The rate of arrhythmia recurrence increased every year after cryoablation. Quality of life improved after the procedure, despite the recurrence of AF. A quarter of patients had to undergo a repeat pulmonary vein isolation procedure.

Aborted Cardiac Arrest in LQT2 Related to Novel KCNH2 (hERG) Variant Identified in One Lithuanian Family.

Congenital long QT syndrome (LQTS) is a hereditary ion channelopathy associated with ventricular arrhythmia and sudden cardiac death starting from young age due to prolonged cardiac repolarization, which is represented by QT interval changes in electrocardiogram (ECG). Mutations in human ether-à-go-go related gene (KCNH2 (7q36.1), formerly named hERG) are responsible for Long QT syndrome type 2 (LQT2). LQT2 is the second most common type of LQTS. A resuscitated 31-year-old male with the diagnosis of LQT2 and his family are described. Sequencing analysis of their genomic DNA was performed. Amino acid alteration p.(Ser631Pro) in KCNH2 gene was found. This variant had not been previously described in literature, and it was found in three nuclear family members with different clinical course of the disease. Better understanding of genetic alterations and genotype-phenotype correlations aids in risk stratification and more effective management of these patients, especially when employing a trigger-specific approach to risk-assessment and individually tailored therapy.

Authorship: from credit to accountability. Reflections from the Editors' Network.

The Editors' Network of the European Society of Cardiology provides a dynamic forum for editorial discussions and endorses the recommendations of the International Committee of Medical Journal Editors (ICMJE) to improve the scientific quality of biomedical journals. Authorship confers credit and important academic rewards. Recently, however, the ICMJE emphasized that authorship also requires responsibility and accountability. These issues are now covered by the new (fourth) criterion for authorship. Authors should agree to be accountable and ensure that questions regarding the accuracy and integrity of the entire work will be appropriately addressed. This review discusses the implications of this paradigm shift on authorship requirements with the aim of increasing awareness on good scientific and editorial practices.

Cardiac resynchronization therapy pacemaker or cardiac resynchronization therapy defibrillator: what determines the choice?-findings from the ESC CRT Survey II.

AIMS: The decision to implant a cardiac resynchronization therapy pacemaker (CRT-P) or a cardiac resynchronization therapy defibrillator (CRT-D) may be challenging. There are no clear guideline recommendations as no randomized study of cardiac resynchronization therapy (CRT) has been designed to compare the effects of CRT-P with those of CRT-D on patients' outcomes. In the CRT Survey II, we studied patient and implantation centre characteristics associated with the choice of CRT-P vs. CRT-D. METHODS AND RESULTS: Clinical practice data from 10 692 patients undergoing CRT implantation of whom 7467 (70%) patients received a CRT-D and 3225 (30%) received a CRT-P across 42 ESC countries were collected and analysed between October 2015 and January 2017. Factors favouring the selection of CRT-P implantation included age >75 years, female gender, non-ischaemic heart failure (HF) aetiology, New York Heart Association functional Class III/IV symptoms, left ventricular ejection fraction >25%, atrial fibrillation, atrioventricular (AV) block II/III, and implantation in a university hospital. CONCLUSION: In a large cohort from the CRT Survey II, we found that patients allocated to receive CRT-P exhibited particular phenotypes with more symptomatic HF, more frequent comorbidities, advanced age, female gender, non-ischaemic HF aetiology, atrial fibrillation, and evidence of AV block. There were substantial differences in the proportion of patients allocated to receive CRT-P vs. CRT-D between countries.

Is Abdominal Aortic Aneurysm Behavior after Endovascular Repair Associated with Aneurysm Wall Density on Computed Tomography Angiography?

Background and objectives: Abdominal aortic aneurysm (AAA) growth is unpredictable after the endovascular aneurysm repair (EVAR). Continuing aortic wall degradation and weakening due to hypoxia may have a role in post-EVAR aneurysm sac growth. We aimed to assess the association of aortic wall density on computed tomography angiography (CTA) with aneurysm growth following EVAR. Materials and Methods: A total of 78 patients were included in the study. The control group consisted of 39 randomly assigned patients without aortic pathology. Post-EVAR aneurysm sac volumes on CTA were measured twice during the follow-up period to estimate aneurysm sac behavior. A maximum AAA sac diameter, aortic wall and lumen densities in Hounsfield units (HU) on CTA were measured. A relative aortic wall density (the ratio of aortic wall to lumen densities) was calculated. A statistical data analysis was performed using standard methods. Results: An increase in the AAA sac volume was observed in 12 (30.8%) cases. Median relative aortic wall density on CTA scores in both the patient and the control group at the level of the diaphragm were similar: 0.15 (interquartile range (IQR), 0.11-0.18) and 0.16 (IQR 0.11-0.18), p = 0.5378, respectively. The median (IQR) relative aortic wall density score at the level of the maximum AAA diameter in the patient group was lower than at the level below renal arteries in the control group: 0.10 (0.07-0.12) and 0.17 (0.12-0.23), p < 0.0001, respectively. The median (IQR) relative growing AAA sac wall density score was lower than a relative stable/shrinking AAA sac wall density score: 0.09 (0.06-0.10) and 0.11 (0.09-0.13), p = 0.0096, respectively. Conclusions: A lower aortic aneurysm wall density on CTA may be associated with AAA growth after EVAR.

Aortic sac enlargement after endovascular aneurysm repair: volume-related changes and the impact of intraluminal thrombus.

PURPOSE: Abdominal aortic aneurysm (AAA) growth after endovascular aneurysm repair (EVAR) is still unpredictable. The issue of optimal frequency of computed tomography angiography for surveillance and its measurement method accuracy remain unclear. We aimed to assess the value of abdominal aneurysm sac volume measurement for detecting expansions and the association of preprocedural intraluminal thrombus (ILT) volume with aneurysm sac growth following EVAR. MATERIAL AND METHODS: A total of 107 patients underwent elective EVAR. Inclusion criteria provided a cohort of 39 patients. Changes of postoperative maximum aneurysm sac diameter and AAA volume were calculated. Volumetric AAA changes and demographic data of the cases with clinically irrelevant AAA diameter enlargement were evaluated. Preoperative ILT volumes were collected. ILT and AAA sac volume ratio was calculated. Statistical data analysis was performed using standard methods. RESULTS: The mean changes of maximum AAA diameter and volume in percentage after EVAR were -5.08 ± 8.20 mm and -13.39 ± 23.32%, respectively. A moderate positive linear correlation between those changes was found (R 2 = 0.731; p < 0.0001). The mean relative AAA volume increase in cases without clinically relevant diameter enlargement was 11.50 ± 8.27%. The means of ILT and AAA sac ratios were 0.59 ± 0.17 and 0.52 ± 1.8 in growing AAA sac and in stable or shrinking AAA sac groups, respectively (p = 0.308). CONCLUSIONS: Volumetric AAA measurement may be useful as an additional method to diameter measurement after EVAR to identify clinically relevant sac growth. Preoperative volume of ILT may not significantly affect the growth rate of AAA after EVAR.

Management of patients with ventricular arrhythmias and prevention of sudden cardiac death-translating guidelines into practice: results of the European Heart Rhythm Association survey.

Prevention of sudden cardiac death (SCD) remains a partly unsolved task in cardiology. The European Society of Cardiology (ESC) guidelines on management of patients with ventricular arrhythmias and prevention of SCD published in 2015 considered the new insights of the natural history of diseases predisposing to SCD. The guidelines improved strategies for management of patients at risk of SCD and included both drug and device therapies. The intention of this survey was to evaluate the extent of the disparities between daily clinical practice and the 2015 SCD ESC guidelines among electrophysiology centres in Europe. The results suggest that the adherence to guidelines is reasonably high and strategies for the management of ischaemic disease are well-established. Implantable cardioverter-defibrillator indications for primary prevention are a difficult topic, particularly in non-ischaemic dilated cardiomyopathy. Disparities in the use of genetic testing are probably due to differences in local availability.

Auscultatory versus oscillometric blood pressure measurement in patients with atrial fibrillation and arterial hypertension.

BACKGROUND: The aim of our study was to investigate the reliability of automated oscillometric blood pressure (BP) monitoring in the presence and absence of atrial fibrillation (AF) in hypertensive patients. METHODS: BP was measured and compared in 71 randomly selected patients with AF and arterial hypertension diagnosis, 4 times each by auscultatory and oscillometric (Microlife BP A6 PC with AF detection system) methods. RESULTS: Study included 71 patients: 36 males (mean age 67.4 years) and 35 females (70.2 years). At the time of BP measuring procedure, 36 patients were in sinus rhythm (SR) and 35 in AF. In SR patients mean systolic blood pressure (SBP) was 132 ± 17.9 mmHg with auscultatory method (AM), 137.4 ± 19.4 mmHg with oscillometric method (OM); mean diastolic BP was 77.1 ± 10.9 mmHg (AM), 78.5 ± 12.2 mmHg (OM), in AF patients mean SBP was 127.5 ± 15.1 mmHg (AM), 133.6 ± 17.4 mmHg (OM); mean diastolic BP was 81.4 ± 9.9 mmHg (AM), 83.5 ± 11.8 mmHg (OM), p = 0.037. The averages of differences for SBP and DBP in sinus rhythm group were (-5.3 mmHg (95% limits of agreement -27.2 - 16.6)) and (-1.4 mmHg (95% limits of agreement -12.8 - 10.0)), respectively. In patients with AF the averages of differences for SBP and DBP were (-6.1 mmHg (95% limits of agreement -23.9 - 11.7)) and (-2.1 mmHg (95% limits of agreement -12.9 - 8.7)), respectively. CONCLUSIONS: The oscillometric device validated for patients with AF on average gives 5.3 mmHg higher systolic BP values for patients with SR and 6.3 mmHg higher BP values for patients with AF. However, the limits of agreement between two methods reveal wide range of random error rates which is a questionable topic in clinical practice, as it could possibly affect the treatment of arterial hypertension in patients with AF.

Findings of transoesophageal echocardiogram in appropriately anticoagulated patients with persistent atrial fibrillation prior to planned cardioversion.

BACKGROUND: To evaluate a diagnostic value of transoesophageal echocardiogram (TEE) in appropriately anticoagulated patients with a non-valvular atrial fibrillation (AF) and to establish possible additional indications for TEE; to evaluate the incidence of left atrial (LA) thrombi in appropriately anticoagulated patients in daily clinical practice. METHODS: This retrospective study analyses data of 432 patients who had been anticoagulated by means of oral anticoagulants (OACs) prior to planned cardioversion during the period from 2012 to 2015. Thromboembolic (TE) and bleeding risks were assessed using CHA2DS2-VASc and HAS-BLED scores. Transthoracic and transoesophageal echocardiograms were evaluated. TE complications during 30 days after discharge were assessed. RESULTS: 432 patients were selected, aged from 22 to 89 years (mean 65.0 ±11.5), 277 (64.1%) males and 155 (35.9%) females, 306 (70.8%) on warfarin and 126 (29.2%) on non-vitamin K antagonist oral anticoagulants (NOAC). Mean CHA2DS2-VASc score was 3.5 ±1.5. TEE was performed for 120 (27.8%) patients, more frequently for patients on NOACs and for ones with III° LA enlargement. TEE revealed LA thrombi in seven (5.8%) of the patients. In warfarin and NOACs groups thrombi were revealed in five (7.0%) and two (4.1%) patients, respectively. TEE did not reveal any thrombi in patients with normal left ventricular (LV) function; however, thrombi were found in two (6.1%) patients with slightly decreased LV function, and in five (17.9%) patients with markedly decreased LV function. In patients with decreased left ventricular ejection fraction (LVEF) thrombi in LA were found more frequently than in patients with normal and slightly decreased LVEF (17.9% vs 2.2%, p=0.008). CHA2DS2-VASc score of all 7 patients was ≥5. None of the patients after cardioversion had TE complications 30 days after discharge. CONCLUSIONS: The risk of LA thrombi in patients prepared for scheduled cardioversion in line with the guidelines is low. Higher risk of thrombi was present in patients with decreased LVEF (≤40%), CHA2DS2-VASc ≥5. In order to assess more accurately indications to perform TEE for appropriately anticoagulated patients prior to scheduled cardioversion a study with larger number of patients is required.

Evaluation of atrial fibrillation management and cardiovascular risk profile in atrial fibrillation patients: A cross-sectional survey.

OBJECTIVE: The aim of this study to investigate the most frequent risk factors of atrial fibrillation (AF), co-morbidities, complications associated with AF and the use of anticoagulants and other medications in patients who were referred to university hospitals in Lithuania. MATERIALS AND METHODS: This cross-sectional study enrolled consecutive inpatients and outpatients with AF presenting to cardiologists in the two biggest Lithuanian university hospitals from November 2013 to May 2014. AF diagnosis was confirmed by a 12-lead ECG or 24-h Holter with an episode duration of >30s. RESULTS: A total number of 575 patients were recruited, and complete data on clinical subtype were available for 515 patients (mean age of 70.7 years; 48.5% of women). Permanent AF was the most frequent type of AF (46.6%). Common comorbidities were hypertension (85.8%), heart failure (77.9%) and coronary artery disease (51.8%). Amiodarone was the most common antiarrhythmic agent used in 14.6% of the patients, while beta-blockers and digoxin were the most often used rate control drugs (59.6% and 10.7%, respectively). Oral anticoagulants were used by 53.3% of the patients; of them, 95.6% used vitamin K antagonists, while non-vitamin K antagonist were used by only 4.4%. The INR within a therapeutic range (2.0-3.0) was documented in 19.2% of the patients. Other antithrombotic drugs such as aspirin and clopidogrel were used in 13.7% and 2.0% of the patients, respectively; dual antiplatelet treatment was administered in 6.2% of the patients. Of the entire cohort, the mean CHA2DS2-VASc score was 3.97±1.6 and the mean HAS-BLED score was 2.25±1.0. CONCLUSIONS: Compliance with the treatment guidelines remains suboptimal and further patient education is needed.

Data Sharing: A New Editorial Initiative of the International Committee of Medical Journal Editors. Implications for the Editors' Network.

The International Committee of Medical Journal Editors (ICMJE) provides recommendations to improve the editorial standards and scientific quality of biomedical journals. These recommendations range from uniform technical requirements to more complex and elusive editorial issues including ethical aspects of the scientific process. Recently, registration of clinical trials, conflicts of interest disclosure, and new criteria for authorship- emphasizing the importance of responsibility and accountability-, have been proposed. Last year, a new editorial initiative to foster sharing of clinical trial data was launched. This review discusses this novel initiative with the aim of increasing awareness among readers, investigators, authors and editors belonging to the Editors' Network of the European Society of Cardiology.

Imaging techniques in electrophysiology and implantable device procedures: results of the European Heart Rhythm Association survey.

The purpose of this European Heart Rhythm Association (EHRA) survey is to assess the implementation and use of imaging techniques in cardiac electrophysiology (EP) and device procedures across European cardiovascular centres. Forty European centres, all members of the EHRA EP research network, responded to this survey. Thirty-one centres (88%) use transthoracic echocardiography (TTE) to evaluate left atrial size and/or volume before atrial fibrillation (AF) ablation. Sixteen centres (46%) perform delayed-enhancement cardiac magnetic resonance imaging (MRI) to guide ventricular tachycardia ablation. Electroanatomical mapping (EAM) systems are available in >65% of responding centres and the use of robotic catheter and remote magnetic navigation systems is limited to <10%. Fusion of EAM data with cardiac computed tomography (CT) and/or MRI is performed in up to 43% of AF ablation procedures. Seventeen out of 35 (49%) responding centres also perform TTE to predict a favourable response to cardiac resynchronization therapy (CRT). Imaging of the cardiac venous system with CT and identification of myocardial scar using CT or MRI, is not routinely performed in the majority of centres [32 (91%) and 26 (75%) centres, respectively) prior to CRT. This EHRA survey shows that several imaging techniques are used to guide catheter ablation and CRT procedures in European centres. Echocardiographic imaging, EAM techniques, and cardiac CT/MRI are commonly used.

Current practice in Europe: how do we manage patients with ventricular tachycardia? European Heart Rhythm Association survey.

The purpose of the EP wire is to examine the clinical practice in the management of sustained ventricular tachycardia (VT), with special focus on diagnostic and therapeutic strategies. Forty-five European centres, all members of the EHRA-EP Research network completed the questions of the survey. There was an equal distribution of centres with high, medium, and low volume of activity. The most common aetiologies were: post-myocardial infarction ischaemic heart disease (55%), followed by idiopathic dilated cardiomyopathy (18%), and idiopathic VT (11%) and others (12%). Cardiac magnetic resonance imaging was performed in more than 50% of patients in 24 centres (62.2%). Invasive electrophysiological study was performed in more than 70% of patients in 16 centres (35.6%), between 51 and 70% in 9 (20%), below 50% in 20 (44.5%). In 39 centres (86.7%), implantable cardioverter defibrillator implantation was considered in all patients with structural heart disease and left ventricular ejection fraction <35%. In the setting of secondary prevention, early radiofrequency ablation of the VT was performed in more than 50% of the patients in only five centres (11.4%). Sequential endo-epicardial approach was reported in 52.2% of centres.

Preferred tools and techniques for implantation of cardiac electronic devices in Europe: results of the European Heart Rhythm Association survey.

The aim of this European Heart Rhythm Association (EHRA) survey was to assess clinical practice in relation to the tools and techniques used for cardiac implantable electronic devices procedures in the European countries. Responses to the questionnaire were received from 62 members of the EHRA research network. The survey involved high-, medium-, and low-volume implanting centres, performing, respectively, more than 200, 100-199 and under 100 implants per year. The following topics were explored: the side approach for implantation, surgical techniques for pocket incision, first venous access for lead implantation, preference of lead fixation, preferred coil number for implantable cardioverter-defibrillator (ICD) leads, right ventricular pacing site, generator placement site, subcutaneous ICD implantation, specific tools and techniques for cardiac resynchronization therapy (CRT), lead implantation sequence in CRT, coronary sinus cannulation technique, target site for left ventricular lead placement, strategy in left ventricular lead implant failure, mean CRT implantation time, optimization of the atrioventricular (AV) and ventriculo-ventricular intervals, CRT implants in patients with permanent atrial fibrillation, AV node ablation in patients with permanent AF. This panoramic view allows us to find out the operator preferences regarding the techniques and tools for device implantation in Europe. The results showed different practices in all the fields we investigated, nevertheless the survey also outlines a good adherence to the common standards and recommendations.

X-ray exposure hazards for physicians performing ablation procedures and device implantation: results of the European Heart Rhythm Association survey.

The purpose of the survey was to evaluate physician's and authorities policies and clinical practices when using occupational X-ray during ablation procedures and device implantation. This survey shows infrequent use of lead gloves, radiation absorbing pads, and lead glass cabins, but increasing use of three-dimensional mapping systems to decrease X-ray radiation hazards. Digital fluoroscopy with decreased frame rate is not used by approximately one-third of responding centres.

Current strategy for treatment of patients with Wolff-Parkinson-White syndrome and asymptomatic preexcitation in Europe: European Heart Rhythm Association survey.

The aims of this survey was to provide insight into treatment activity, the strategy of treatment, and risk stratification of patients with asymptomatic and symptomatic ventricular pre-excitation across Europe. Fifty-eight centres, members of the European Heart Rhythm Association EP research network, covering 20 countries answered the survey questions. All centres were high-volume ablation centres. A younger person with asymptomatic Wolff-Parkinson-White (WPW) pattern has a higher likelihood of being risk-stratified or receiving ablation therapy compared with an older subject. Two-thirds of centres report that they have observed a decline in the number of patients ablated for an accessory pathway during the last 10 years. Pre-excited atrial fibrillation is rarely seen. Discontinuation of a scheduled WPW ablation due to close vicinity of the accessory pathway to the AV node happens very rarely. Patients with a first episode of pre-excited atrial fibrillation would immediately be referred for catheter ablation to be performed within weeks by 80.4% of the centres. A significant proportion of responders (50.9%) would use electrical cardioversion to restore sinus rhythm in a patient with pre-excited atrial fibrillation. With respect to the choice of antiarrhythmic medication for a patient with pre-excited AF, the majority (80.0%) would choose class 1C antiarrhytmic drugs while waiting for a catheter ablation. A patient seen in the emergency room with a second episode of orthodromic atrioventricular reentry tachycardia would be referred for immediate ablation by 79.2-90.6% of centres depending on the presence of pre-excitation. The volume of paediatric ablations performed on children younger than 12 years was low (46.4%: 0 patients per year; 46.4%: 1-9 patients per year). The majority of responding centres (61-69%) report that their country lack national guidelines dealing with clinical strategies related to WPW. There is a need for national guidelines dealing with clinical strategy in patients with WPW syndrome. Older individuals with asymptomatic WPW pattern have a higher risk of not receiving risk stratification or curative therapy with ablation compared with younger patients, despite the higher risk of developing atrial fibrillation.

Anticoagulant therapy during cardiovascular implantable electronic device procedures.

Aim: The objective of the study is to systematically evaluate the safety and efficacy of peri-procedural utilization of anticoagulation therapy during cardiovascular implantable electronic device procedures. Material and methods: The review materials were based on comprehensive retrieval of randomized controlled trials and observational studies published until April 2023. Studies which compared different management strategies of long-term anticoagulation therapy during peri-procedural cardiac rhythm device implantation and compared the complications of bleeding and/or thromboembolic events were selected and reviewed. Results: Studies analysing non-vitamin K oral anticoagulants interruption versus continuation during peri-procedural implantable cardiac device surgery found no statistically significant difference in bleeding or thromboembolic complications between these strategies. Studies comparing non-vitamin K oral anticoagulants with vitamin K antagonists also showed no statistically significant difference. One study comparing uninterrupted warfarin with interrupted warfarin with heparin bridging reported a reduced incidence of clinically significant device pocket haematoma in patients with continued warfarin treatment (relative risk = 0.19; 95% confidence interval: 0.10 to 0.36; p < 0.001). A sub-analysis of one study comparing dabigatran versus warfarin with heparin bridging and without bridging reported a lower risk of pocket haematoma with dabigatran when compared to warfarin with heparin bridging (risk difference: -8.62%, 95% confidence interval: -24.15 to -0.51%; p = 0.034). Both bleeding and thromboembolic complications were rare. Conclusions: The traditional method of vitamin K antagonists interruption with heparin bridging is less safe than continuing vitamin K antagonists at therapeutic levels. Both continuation and interruption strategies of non-vitamin K anticoagulants during cardiac device surgery seem to be safe and appropriate.

A Focal Ablation Catheter Toggling Between Radiofrequency and Pulsed Field Energy to Treat Atrial Fibrillation.

BACKGROUND: Because of its safety, "single-shot" pulsed field ablation (PFA) catheters have been developed for pulmonary vein isolation (PVI). However, most atrial fibrillation (AF) ablation procedures are performed with focal catheters to permit flexibility of lesion sets beyond PVI. OBJECTIVES: This study sought to determine the safety and efficacy of a focal ablation catheter able to toggle between radiofrequency ablation (RFA) or PFA to treat paroxysmal or persistent AF. METHODS: In a first-in-human study, a focal 9-mm lattice tip catheter was used for PFA posteriorly and either irrigated RFA (RF/PF) or PFA (PF/PF) anteriorly. Protocol-driven remapping was at ∼3 months postablation. The remapping data prompted PFA waveform evolution: PULSE1 (n = 76), PULSE2 (n = 47), and the optimized PULSE3 (n = 55). RESULTS: The study included 178 patients (paroxysmal/persistent AF = 70/108). Linear lesions, either PFA or RFA, included 78 mitral, 121 cavotricuspid isthmus, and 130 left atrial roof lines. All lesion sets (100%) were acutely successful. Invasive remapping of 122 patients revealed improvement of PVI durability with waveform evolution: PULSE1: 51%; PULSE2: 87%; and PULSE3: 97%. After 348 ± 652 days of follow-up, the 1-year Kaplan-Meier estimates for freedom from atrial arrhythmias were 78.3% ± 5.0% and 77.9% ± 4.1% for paroxysmal and persistent AF, respectively, and 84.8% ± 4.9% for the subset of persistent AF patients receiving the PULSE3 waveform. There was 1 primary adverse event-inflammatory pericardial effusion not requiring intervention. CONCLUSIONS: AF ablation with a focal RF/PF catheter allows efficient procedures, chronic lesion durability, and good freedom from atrial arrhythmias-for both paroxysmal and persistent AF. (Safety and Performance Assessment of the Sphere-9 Catheter and the Affera Mapping and RF/PF Ablation System to Treat Atrial Fibrillation; NCT04141007 and NCT04194307).

Performing magnetic resonance imaging in patients with implantable pacemakers and defibrillators: results of a European Heart Rhythm Association survey.

The purpose of our survey was to evaluate the experience, current practice and attitudes of performing magnetic resonance imaging (MRI) studies in patients with cardiac implantable electronic devices. Fifty-one centre-members of European Heart Rhythm Association Research network have responded to the survey. According to the obtained data, 55.2% of responding centres do not perform MRI scans in patients with non-MRI-certified pacemakers and 65.8% in patients with such implantable cardioverter defibrillators (ICDs). Reported complication rate in patients with non-MRI-certified devices is low and conforms to the literature data. Experience with newer MRI-compatible pacemakers and ICDs is limited to single cases in most centres. This survey shows limited experience with performing MRI studies in patients with implanted pacemakers and ICDs. In concordance with available guidelines, most centres limit MRI scans in patients with non-MRI-certified devices. The implant numbers for MRI-certified devices and experience with performing MRI scans in these patients are still low.