Cryoballoon Pulmonary Vein Isolation as First-Line Treatment for Typical Atrial Flutter.

OBJECTIVE: We aimed to compare cryoballoon pulmonary vein isolation (PVI) with standard radiofrequency cavotricuspid isthmus (CTI) ablation as first-line treatment for typical atrial flutter (AFL). METHODS: Cryoballoon Pulmonary Vein Isolation as First-Line Treatment for Typical Atrial Flutter was an international, multicentre, open with blinded assessment trial. Patients with CTI-dependent AFL and no documented atrial fibrillation (AF) were randomised to either cryoballoon PVI alone or radiofrequency CTI ablation. Primary efficacy outcome was time to first recurrence of sustained (>30 s) symptomatic atrial arrhythmia (AF/AFL/atrial tachycardia) at 12 months as assessed by continuous monitoring with an implantable loop recorder. Primary safety outcome was a composite of death, stroke, tamponade requiring drainage, atrio-oesophageal fistula, pacemaker implantation, serious vascular complications or persistent phrenic nerve palsy. RESULTS: Trial recruitment was halted at 113 of the target 130 patients because of the SARS-CoV-2 pandemic (PVI, n=59; CTI ablation, n=54). Median age was 66 (IQR 61-71) years, with 98 (86.7%) men. At 12 months, the primary outcome occurred in 11 (18.6%) patients in the PVI group and 9 (16.7%) patients in the CTI group. There was no significant difference in the primary efficacy outcome between the groups (HR 1.11, 95% CI 0.46 to 2.67). AFL recurred in six (10.2%) patients in the PVI arm and one (1.9%) patient in the CTI arm (p=0.116). Time to occurrence of AF of ≥2 min was significantly reduced with cryoballoon PVI (HR 0.46, 95% CI 0.25 to 0.85). The composite safety outcome occurred in four patients in the PVI arm and three patients in the CTI arm (p=1.000). CONCLUSION: Cryoballoon PVI as first-line treatment for AFL is equally effective compared with standard CTI ablation for preventing recurrence of atrial arrhythmia and better at preventing new-onset AF. TRIAL REGISTRATION NUMBER: NCT03401099.

Impact of COVID-19 pandemic on cardiac rhythm management services: Views from the United Kingdom.

Background: Effects of the COVID-19 pandemic on cardiac rhythm management (CRM) services remain poorly quantified. Objective: To describe the impact of COVID-19 on specialist CRM centers in the United Kingdom (UK). Methods: Two-center study involving the Liverpool Heart and Chest Hospital NHS Foundation Trust and Royal Papworth Hospital NHS Foundation Trust. The first nationwide lockdown lasted from April to July 2020 and the second from December 2020 to March 2021. Results: Compared to the pre-pandemic period, pandemic 1 (April-July 2020) was associated with a 52.2% reduction in electrophysiology (EP) procedures (P = .083), 32.7% reduction in device procedures (P = .003), and 36.8% decrease in CRM referrals (P < .001). There was also a 13.4% increase in the use of conscious sedation (CS) (P < .001) and day-case procedures for EP (P = .003), with no change in day-case device procedures (P = .555). Corresponding numbers for pandemic 2 (August-November 2020) were a 0.7% increase in EP procedures (P = .925), 7.9% reduction in device procedures (P = .232), 13.9% decrease in referrals (P = .014), 5.5% increase in CS for EP (P = .009), 7.1% increase in day-case EP procedures (P < .001), and no change in day-case device procedures (P = .537). Corresponding numbers for pandemic 3 (December 2020-March 2021) were a 31.6% reduction in EP procedures (P = .001), 22.3% reduction in device procedures (P = .006), 8.4% decrease in referrals (P = .094), 11.0% increase in CS for EP (P < .001), 7.6% increase in day-case EP procedures (P = .003), and no change in day-case device procedures (P = .146). By the end of March 2021, the CRM waiting list was 167.8% pre-pandemic levels. Conclusion: During the COVID-19 pandemic, specialist centers in the UK were affected such that the number of procedures performed was greatly reduced in the initial period with latter improvements as better coping strategies were developed.

Impact of COVID-19 on patients awaiting ablation for atrial fibrillation.

OBJECTIVE: Atrial fibrillation (AF) ablation services were significantly affected by the COVID-19 pandemic. We aimed to evaluate a symptom-based clinician prioritisation scheme for waiting list management compared with patient-completed quality of life (QoL) scores. We also sought to understand factors influencing QoL, particularly the impact of COVID-19, on patients awaiting AF ablation, via a bespoke questionnaire. METHODS: Patients awaiting AF ablation were sent two QoL questionnaires (Atrial Fibrillation Effect on QualiTy of Life (AFEQT) and EuroQol 5D (EQ5D-5L)) and the bespoke questionnaire. At a separate time point, patients were categorised as C1-urgent, C2-priority or C3-routine by their cardiologist based on review of clinic letters. RESULTS: There were 118 patients included with priority categorisation available for 86 patients. Median AFEQT scores were lower in C2 (30.4; 17.2-51.9) vs C3 patients (56.5; 32.1-74.1; p<0.01). Unplanned admission occurred in 3 patients in C3 with AFEQT scores of <40. Although 65 patients had AF symptoms during the pandemic, 43.1% did not seek help where they ordinarily would have. An exercise frequency of ≥3-4 times a week was associated with higher AFEQT (56.5; 41.2-74.1; p<0.001) and EQ5D (0.84; 0.74-0.88; p<0.0001) scores. CONCLUSION: The QoL of patients awaiting AF ablation is impaired and AFEQT helps to identify patients at risk of admission, over and above physician assessment. COVID-19 influenced patients seeking medical attention with symptomatic AF when they normally would. Regular exercise is associated with better QoL in patients awaiting AF ablation.

The European TeleCheck-AF project on remote app-based management of atrial fibrillation during the COVID-19 pandemic: centre and patient experiences.

AIMS: TeleCheck-AF is a multicentre international project initiated to maintain care delivery for patients with atrial fibrillation (AF) during COVID-19 through teleconsultations supported by an on-demand photoplethysmography-based heart rate and rhythm monitoring app (FibriCheck®). We describe the characteristics, inclusion rates, and experiences from participating centres according the TeleCheck-AF infrastructure as well as characteristics and experiences from recruited patients. METHODS AND RESULTS: Three surveys exploring centre characteristics (n = 25), centre experiences (n = 23), and patient experiences (n = 826) were completed. Self-reported patient characteristics were obtained from the app. Most centres were academic (64%) and specialized public cardiology/district hospitals (36%). Majority of the centres had AF outpatient clinics (64%) and only 36% had AF ablation clinics. The time required to start patient inclusion and total number of included patients in the project was comparable for centres experienced (56%) or inexperienced in mHealth use. Within 28 weeks, 1930 AF patients were recruited, mainly for remote AF control (31% of patients) and AF ablation follow-up (42%). Average inclusion rate was highest during the lockdown restrictions and reached a steady state at a lower level after easing the restrictions (188 vs. 52 weekly recruited patients). Majority (>80%) of the centres reported no problems during the implementation of the TeleCheck-AF approach. Recruited patients [median age 64 (55-71), 62% male] agreed that the FibriCheck® app was easy to use (94%). CONCLUSION: Despite different health care settings and mobile health experiences, the TeleCheck-AF approach could be set up within an extremely short time and easily used in different European centres during COVID-19.

On-demand mobile health infrastructures to allow comprehensive remote atrial fibrillation and risk factor management through teleconsultation.

BACKGROUND: Although novel teleconsultation solutions can deliver remote situations that are relatively similar to face-to-face interaction, remote assessment of heart rate and rhythm as well as risk factors remains challenging in patients with atrial fibrillation (AF). HYPOTHESIS: Mobile health (mHealth) solutions can support remote AF management. METHODS: Herein, we discuss available mHealth tools and strategies on how to incorporate the remote assessment of heart rate, rhythm and risk factors to allow comprehensive AF management through teleconsultation. RESULTS: Particularly, in the light of the coronavirus disease 2019 (COVID-19) pandemic, there is decreased capacity to see patients in the outpatient clinic and mHealth has become an important component of many AF outpatient clinics. Several validated mHealth solutions are available for remote heart rate and rhythm monitoring as well as for risk factor assessment. mHealth technologies can be used for (semi-)continuous longitudinal monitoring or for short-term on-demand monitoring, dependent on the respective requirements and clinical scenarios. As a possible solution to improve remote AF care through teleconsultation, we introduce the on-demand TeleCheck-AF mHealth approach that allows remote app-based assessment of heart rate and rhythm around teleconsultations, which has been developed and implemented during the COVID-19 pandemic in Europe. CONCLUSION: Large scale international mHealth projects, such as TeleCheck-AF, will provide insight into the additional value and potential limitations of mHealth strategies to remotely manage AF patients. Such mHealth infrastructures may be well suited within an integrated AF-clinic, which may require redesign of practice and reform of health care systems.