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.