Pulsed field versus cryoballoon ablation for atrial fibrillation: a real-world observational study on procedural outcomes and efficacy.

INTRODUCTION: Atrial fibrillation often necessitates catheter ablation when antiarrhythmic drug therapy fails. Single-shot technologies using thermal energy, such as cryoballoon ablation, are commonly used, but pulsed field ablation (PFA), an innovative non-thermal ablation technique, is a potential alternative. This retrospective observational study aimed to compare the safety and efficacy of cryoballoon ablation and PFA in patients undergoing their first pulmonary vein isolation (PVI) procedure for atrial fibrillation treatment. METHODS: We utilised real-world data from patients who underwent PVI using cryoballoon ablation or PFA. The primary outcome encompassed procedural complications, including phrenic nerve palsy, cardiac tamponade, thromboembolic complications, bleeding complications and mortality. Secondary outcomes were procedural characteristics including procedure duration, length of hospital admission, and re-do ablation rates within 6 months. RESULTS: A total of 1714 procedures were analysed: 1241 in the cryoballoon group and 473 in the PFA group. Gender distribution (p = 0.03) and estimated glomerular filtration rate (p = 0.01) differed significantly. With regard to the primary outcome, the cryoballoon group demonstrated a higher incidence of phrenic nerve palsy compared with the PFA group (15 vs 0; p = 0.02). The procedure duration was shorter in the PFA group, even after adjusting for baseline characteristics (95.0 vs 74.0 min; p < 0.001). After adjustment for baseline characteristics, admission duration differed between the groups as well (p = 0.04). CONCLUSION: The study results supported the safety and efficacy of PFA over cryoballoon ablation for PVI, highlighting advantages such as shorter procedure duration and absence of phrenic nerve palsy.

Results of systematic patient outcome monitoring: Does post-dilatation during angiography-guided percutaneous coronary intervention improve clinical outcomes?

OBJECTIVES: This study evaluates clinical outcomes after implementing a liberal post-dilatation strategy during PCI. BACKGROUND: Post-dilatation after percutaneous coronary intervention (PCI) is performed to achieve optimal stent expansion and reduce complications. However, its prognostic effects are unclear and conflicting. METHODS: This study is a pre-post-intervention analysis of two cohorts, before (2015-2017) and after (2018-2020) implementation of a liberal post-dilatation strategy. The primary end point consisted of major adverse cardiovascular events (MACE) at 30 days. Secondary end points consisted of the individual components of the primary end point as well as 1 year mortality and target vessel revascularization. RESULTS: A total of 10,153 patients were included: 5,383 in the pre-cohort and 4,770 in the post-cohort. The 30-day MACE was 5.00% in the pre-cohort and 4.09% in the post-cohort (p = 0.008; OR 0.75 (CI 0.61-0.93)). There was a significant difference between the pre- and post-cohort in 30-day mortality, respectively, 2.91% and 2.25% (p = .01; OR 0.70 (CI 0.53-0.93)), and MI at 30 days, 1.17% versus 0.59% (p = .003; OR 0.49 (CI 0.31-0.78)). At 1 year, there was a significant difference in mortality between the pre-cohort, 5.84%, and post-cohort, 5.19% (p = .02; OR 0.79 (CI 0.66-0.96)). CONCLUSIONS: A liberal post-dilatation strategy after PCI was associated with a significant decrease in 30-day MACE, 30-day MI, 30-day mortality, and 1-year mortality. Future studies are warranted to validate the causality between post-dilatation and improvement of clinical outcomes.

Introduction of a New Method to Monitor Patient-Relevant Outcomes and Costs: Using a Quality Improvement Project in Transcatheter Aortic Valve Implantation Care as an Example.

BACKGROUND AND OBJECTIVE: Routine outcome monitoring is becoming standard in care evaluations, but costs are still underrepresented in these efforts. The primary aim of this study was therefore to assess if patient-relevant cost drivers can be used alongside clinical outcomes to evaluate an improvement project and to provide insight into (remaining) areas for improvement. METHODS: Data from patients who underwent transcatheter aortic valve implantation (TAVI) between 2013 and 2018 at a single center in the Netherlands were used. A quality improvement strategy was implemented in October 2015, and pre- (A) and post-quality improvement cohorts (B) were distinguished. For each cohort, clinical outcomes, quality of life (QoL), and cost drivers were collected from the national cardiac registry and hospital registration data. The most appropriate cost drivers in TAVI care were selected from hospital registration data using a novel stepwise approach with an expert panel of physicians, managers, and patient representatives. A radar chart was used to visualize the clinical outcomes, QoL and the selected costs drivers. RESULTS: We included 81 patients in cohort A and 136 patients in cohort B. All-cause mortality at 30 days was borderline significantly lower in cohort B than in cohort A (1.5% vs 7.4%, P = .055). QoL improved after TAVI for both cohorts. The stepwise approach resulted in 21 patient-relevant cost drivers. Costs for pre-procedural outpatient clinic visits (€535, interquartile range [IQR] = 321-675, vs €650, IQR = 512-890, P < .001), costs for the procedure (€1354, IQR = 1236-1686, vs €1474, IQR = 1372-1620, P < .001), and imaging during admission (€318, IQR = 174-441, vs €329, IQR = 267-682, P = .002) were significantly lower in cohort B than in cohort A. Possible improvement potential was seen in 30-day pacemaker implantation and 120-day readmission. CONCLUSION: A selection of patient-relevant cost drivers is a valuable addition to clinical outcomes for use in evaluation of improvement projects and identification of room for further improvement.

Improving outcomes of AF ablation by integrated personalized lifestyle interventions: rationale and design of the prevention to improve outcomes of PVI (POP) trial.

Progression of atrial fibrillation (AF) and outcomes of ablation therapy are strongly affected by modifiable risk factors. Although previous studies show beneficial effects of modifying single risk factors, there is lack of evidence from randomized controlled trials on the effects of integrated AF lifestyle programmes. The POP trial is designed to evaluate the clinical outcomes of a dedicated nurse-led AF lifestyle outpatient clinic in patients with symptomatic AF. This study is a prospective, 1:1 randomized, single centre, investigator-initiated clinical trial in 150 patients with paroxysmal or persistent AF referred for a first pulmonary vein isolation (PVI). Prior to the ablation, patients in the intervention group receive a personalized risk factor treatment programme in a specialized, protocolized, nurse-led outpatient clinic. Patient education and durable lifestyle management is promoted with an e-health platform. Patients in the control group receive standard care by cardiologists before ablation. The primary endpoint is the number of hospitalizations for re-ablation and cardioversion, with a follow-up of 12 months after ablation. Secondary endpoints include mortality, number of acute ischemic events, stroke or hospitalizations for heart failure, quality of life, number of ablations cancelled because of symptom reduction, and ablation success rate at 12 months. Determinants of patient and staff experience are explored and a cost-effectiveness analysis is included. The POP trial will help ascertain the efficacy and cost-effectiveness of an integrated technology-supported lifestyle therapy in patients with symptomatic AF. The trial is funded by the Netherlands Organisation for Health Research and Development [10070012010001]. Home sleep apnoea testing devices were provided by Itamar Medical, Ltd.ClinicalTrials.gov Identifier NCT05148338. AF atrial fibrillation, OSA obstructive sleep apnoea, PFA pulsed field ablation, PVI pulmonary vein isolation.