Per Insulander

Aims: This study evaluates the incidence of procedural complications related to catheter ablation of atrial fibrillation (AF) to assess the potential feasibility and safety of same‐day discharge in a large cohort.Methods: We performed an analysis of prospectively collected data of complications of all patients staying overnight after undergoing AF ablation between 2001 and 2020 at a tertiary center. Using medical records, we analyzed complications occurring intraprocedurally until 6 h postablation and between 6 h postablation and discharge the day after the ablation procedure.Results: In 5414 AF ablations, we identified a total of 108 (2.0%) major complications occurring intraprocedural or before discharge. Most major complications occurred intraprocedurally or within 6 h after the procedure (n = 96, 1.8%). Twelve (0.2%) major complications occurred between 6 h Postablation and discharge. The most common of these major complications were congestive heart failure (n = 6) and transient ischemic attack (TIA, n = 4). During this time span, 61 (1.1%) minor complications occurred. Factors independently associated with major complications intraprocedurally and until discharge were body mass index (BMI) ≥ 30 kg/m² (p = .009), significant valvular disease (p = .001), cardiomyopathy (p < .001), prior stroke or TIA (p = .014), first‐time procedure versus repeat procedure (p = .013), cryoablation versus radiofrequency (p < .001), and procedure duration (p < .001).Conclusion: After AF ablation, very few complications occurred between 6 h postprocedure and discharge the next day. Therefore, same‐day discharge is a safe option for a majority of patients.

Palpitations, particularly common in women, are generally considered benign symptoms rarely caused by clinically important arrhythmias. Nevertheless, palpitations may cause anxiety, depression, and decreased health-related quality of life (HRQOL). This study investigates to what degree palpitations cause symptoms such as anxiety and depression and affect HRQOL in women and whether direct feedback of underlying heart rhythm during palpitations decrease anxiety and depression and increase HRQOL in women. The study included 821 women, age 21–88 years (mean 57 ± 11 years), with symptomatic palpitations recruited using social media. For 60 days, the participants used a handheld electrocardiogram (ECG)-recording device (Coala Heart Monitor) connected to their smartphones. ECG was recorded twice a day and when symptoms were present and was automatically algorithm-interpreted with immediate response to the user. Non-benign arrhythmias were also analysed manually. Questionnaires addressing anxiety and depression—Hospital Anxiety and Depression Scale (HADS), Generalized Anxiety Disorder (GAD-7), HRQOL (RAND-36), and Symptoms Checklist: Frequency and Severity (SCL)—were analysed before and after the data were collected. A total of 101 804 ECG recordings were automatically analysed. In 94%, sinus rhythm or premature atrial/ventricular contraction were recorded; in 6%, atrial fibrillation or supraventricular tachycardia were recorded. Apart from premature ventricular contractions, no ventricular arrhythmias were documented. Anxiety and depression (HADS and GAD-7) decreased (P < 0.001) as did frequency and severity of symptoms, and HRQOL increased in all domains (P < 0.001) at the 2-month follow-up. Instant analysis of the ECG with direct response during palpitations decreases symptoms, anxiety, and depression and increases HRQOL in women.

Background: In general, most clinical studies have long recruitment periods. Signing the informed consent is particularly time-consuming when the participant must meet physically with the researchers. Therefore, introducing fully web-based techniques with the use of eAuthentication (BankID) and new digital electrocardiogram (ECG) monitoring could speed up inclusion time, increase adherence, and also reach out to more remote regions. Objective: The objectives of this study were to explore whether inclusion of a large number of participants could be realized quickly by using a total digital approach both for information and signing of informed consent, along with ECG monitoring and instant feedback on a mobile device. We also explored whether this approach can increase adherence in registration of ECG recordings and answering questionnaires, and if it would result in a more geographically uniform distribution of participants covering a wide age span. Methods: Women with palpitations were intensively studied over 2 months by means of a handheld ECG monitoring device (Coala Heart Monitor). The device connects to a smartphone or tablet, which allows the participants to obtain the results immediately. Recruitment, study information, and signing the informed consent form with the help of BankID were performed in a completely digital manner. Results: Between March and May 2018, 2424 women indicated their interest in participating in the study. On June 19, 2018, presumptive participants were invited to log in and register. After 25 days, 1082 women were included in the study; among these, 1020 women fulfilled the inclusion criteria, 913 of whom completed all phases of the study: recording ECG using the handheld device, completion of the prestudy questionnaires, and completion of the poststudy questionnaires 2 months after the ECG recordings. The dropout rate was 9%. In total, 101,804 ECG recordings were made. The mean age was 56 (SD 11) years (range 21-88 years) and 35 participants were 75 years or older. The participants were evenly distributed between living in the countryside and in cities. Conclusions: Total digital inclusion recruitment of 1082 participants was achieved in only 25 days, and resulted in a good geographical distribution, excellent adherence, and ability to reach a vast age span, including elderly women. Studies using a total digital design would be particularly appealing during a pandemic since physical contact should be avoided as much as possible. Trial Registration: ISRCTN Registry ISRCTN22495299; http://www.isrctn.com/ISRCTN22495299

Very late recurrences after ablation of AVNRT have been reported. Age related alterations of nodal tissues caused by fibrous and fatty tissue infiltration and changes of the sympathovagal influence on the AV node, in turn altering AV nodal conduction and refractoriness, could set the stage for a previously not present substrate for AVNRT. Consequently, the occurrence of AVNRT many years after an ablation procedure may perhaps not always implicate a recurrence but instead an arrhythmia caused by a new substrate.

Aim: To investigate the association of sinus heart rate pre- and post-ablation and recurrence rates in patients undergoing catheter ablation for atrial fibrillation. Methods: Between January 2012 and December 2017, data of 482 patients undergoing their first pulmonary vein isolation (PVI) were included. All patients were followed-up for 12 months and were screened for any atrial tachyarrhythmia. Sinus heart rate measurements were recorded before (PRE), directly post ablation (POST) and 3 months post ablation (3M). Results: In the total study population, the mean resting sinus heart rate at PRE (mean 57.9 bpm (95% CI, 57.1–58.7 bpm)) increased by over 10 bpm to POST (mean 69.4 bpm (95% CI, 68.5–70.3 bpm); p<0.001) followed by a slight decrease at 3M (mean 67.3 bpm (95% CI, 66.4–68.2 bpm)) but still remaining higher compared to PRE (p<0.001). This pattern was observed in patients with and without recurrences at PRE, POST and 3M respectively (both p<0.001). However, only at 3M, there was a significant difference in mean heart rate being lower in patients with compared to patients without recurrences (p=0.031). In this regard, patients with a heart rate ≥60 bpm at 3M and a heart rate change ≥11 bpm (PRE to 3M) had a favorable outcome in terms of recurrences compared to the remaining patients (HR 0.61 (95% CI, 0.44–0.84), p=0.002 and HR 0.55 (95% CI, 0.40–0.76), p<0.001, respectively). These variables remained independently associated in multivariable analysis. Conclusion: Our study confirms the impact of PVI on cardiac autonomic function with a significant heart increase post-ablation. A heart rate ≥60bpm at 3M and a heart rate change ≥11 bpm (PRE to 3M) are associated with a favorable outcome in terms of recurrences. Funding Acknowledgement: Type of funding source: Foundation. Main funding source(s): German Research Foundation

Background: Cryoablation (CRYO) of cavotricuspid isthmus (CTI)-dependent atrial flutter (AFL) has been shown to be non-inferior to radiofrequency ablation (RF) in terms of ablation success and is associated with less pain. However, procedural time has been significantly longer with CRYO compared to RF. A possible explanation for this could be that operators had less experience with CRYO than with RF. The purpose of this study was to test the hypothesis that in the hands of experienced operators, cryoablation of CTI-dependent AFL is effective with procedure-time similar to what is reported for RF. Methods: This prospective 2-center study included 184 patients with CTI-dependent AFL – median age 66 years (range 28–83), 159 men (86%). Cryoablation was performed using a 9 F, 8 mm tip catheter (Freezor MAX, Medtronic, Inc, MN, USA). Ablation endpoint was bidirectional CTI-block. Pain was evaluated with a visual analogue scale (VAS 0–10). All operators had experience of at least 25 previous CTI-ablations with CRYO. Results: The acute success rate was 89%. Procedural time including an observation period of 30 min, was 115 ± 36 min which is similar to procedural times for RF in previous studies. Fluoroscopy time was 11 ± 9 min. Cryoablation was perceived as almost pain- free by the patients, VAS (mean) 1.8 ± 1.2. Success rate at 12-month follow-up (FU) was 88% in patients with primary success. No major adverse events occurred. Conclusions: Cryoablation of CTI-dependent AFL is effective, with a low level of procedure-related pain. In experienced hands, the procedure time in this prospective non-randomised trial seems to be in the level of reported procedure times for RF. The long-term relapse rate appears to be higher than for RF.

BACKGROUND In general, most clinical studies have long recruitment periods. Signing the informed consent is particularly time-consuming when the participant must meet physically with the researchers. Therefore, introducing fully web-based techniques with the use of eAuthentication (BankID) and new digital electrocardiogram (ECG) monitoring could speed up inclusion time, increase adherence, and also reach out to more remote regions. OBJECTIVE The objectives of this study were to explore whether inclusion of a large number of participants could be realized quickly by using a total digital approach both for information and signing of informed consent, along with ECG monitoring and instant feedback on a mobile device. We also explored whether this approach can increase adherence in registration of ECG recordings and answering questionnaires, and if it would result in a more geographically uniform distribution of participants covering a wide age span. METHODS Women with palpitations were intensively studied over 2 months by means of a handheld ECG monitoring device (Coala Heart Monitor). The device connects to a smartphone or tablet, which allows the participants to obtain the results immediately. Recruitment, study information, and signing the informed consent form with the help of BankID were performed in a completely digital manner. RESULTS Between March and May 2018, 2424 women indicated their interest in participating in the study. On June 19, 2018, presumptive participants were invited to log in and register. After 25 days, 1082 women were included in the study; among these, 1020 women fulfilled the inclusion criteria, 913 of whom completed all phases of the study: recording ECG using the handheld device, completion of the prestudy questionnaires, and completion of the poststudy questionnaires 2 months after the ECG recordings. The dropout rate was 9%. In total, 101,804 ECG recordings were made. The mean age was 56 (SD 11) years (range 21-88 years) and 35 participants were 75 years or older. The participants were evenly distributed between living in the countryside and in cities. CONCLUSIONS Total digital inclusion recruitment of 1082 participants was achieved in only 25 days, and resulted in a good geographical distribution, excellent adherence, and ability to reach a vast age span, including elderly women. Studies using a total digital design would be particularly appealing during a pandemic since physical contact should be avoided as much as possible. CLINICALTRIAL ISRCTN Registry ISRCTN22495299; http://www.isrctn.com/ISRCTN22495299