DOI DOI https://doi.org/10.1007/s00392-021-01843-w
Background:
The interpretation of recent trials on pulmonary vein ablation (PVI) for the treatment of atrial fibrillation (AF) is hampered by the lack of blinding and sham controls. The feasibility of a sham-controlled trial regarding patients’ willingness has been questioned. We therefore assessed the willingness for participation in such a trial in a common AF-patient population planned for PVI.
The interpretation of recent trials on pulmonary vein ablation (PVI) for the treatment of atrial fibrillation (AF) is hampered by the lack of blinding and sham controls. The feasibility of a sham-controlled trial regarding patients’ willingness has been questioned. We therefore assessed the willingness for participation in such a trial in a common AF-patient population planned for PVI.
Methods:
Patients in two tertiary care centers planned for PVI were asked for their current AF symptoms using the Atrial Fibrillation Effect on QualiTy of Life (AFEQT) questionnaire. Subsequently, the study design of a hypothetical sham-controlled PVI-study was introduced in detail and patients were asked for agreement in participation. Telephone follow-up including AFEQT and participation-questionnaire of the hypothetical study was conducted after three months.
Patients in two tertiary care centers planned for PVI were asked for their current AF symptoms using the Atrial Fibrillation Effect on QualiTy of Life (AFEQT) questionnaire. Subsequently, the study design of a hypothetical sham-controlled PVI-study was introduced in detail and patients were asked for agreement in participation. Telephone follow-up including AFEQT and participation-questionnaire of the hypothetical study was conducted after three months.
Results:
One hundred and ninety-six patients (mean age 64 ± 11 years, 63 % male) were included and mean overall AFEQT at baseline was 55.5 ± 19.3. Seventy-nine (40.3 %) patients expressed their agreement to participate in the hypothetical sham-controlled trial. Figure 1 shows participation rate (left panel) and reasons to refuse participation (right panel). AFEQT improved by 24.9 ± 19.9 points after three months (p < 0.001 versus baseline).
One hundred and ninety-six patients (mean age 64 ± 11 years, 63 % male) were included and mean overall AFEQT at baseline was 55.5 ± 19.3. Seventy-nine (40.3 %) patients expressed their agreement to participate in the hypothetical sham-controlled trial. Figure 1 shows participation rate (left panel) and reasons to refuse participation (right panel). AFEQT improved by 24.9 ± 19.9 points after three months (p < 0.001 versus baseline).
Figure 1: Proportion of patients willing to participate in a sham-controlled PVI trial and reasons to refuse participation
Conclusion:
With a participation rate up to 40%, a sham-controlled trial for PVI seems feasible. Symptomatic benefit of PVI in these patients is in accordance with previously randomized open studies (e.g. CABANA trial). The true symptomatic benefit of PVI should be rigorously evaluated in a sham-controlled trial.
With a participation rate up to 40%, a sham-controlled trial for PVI seems feasible. Symptomatic benefit of PVI in these patients is in accordance with previously randomized open studies (e.g. CABANA trial). The true symptomatic benefit of PVI should be rigorously evaluated in a sham-controlled trial.
Key words:
Atrial fibrillation, catheter ablation, pulmonary vein isolation, sham procedure
Atrial fibrillation, catheter ablation, pulmonary vein isolation, sham procedure
https://dgk.org/kongress_programme/jt2021/aP982.html