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. 2022 Jan;111(1):114-123.
doi: 10.1007/s00392-021-01959-z. Epub 2021 Oct 28.

Patients' attitude towards a sham-controlled trial on pulmonary vein isolation in atrial fibrillation

Tobias Uhe #  1 , Samira Beimel #  2   3 , Romy Langhammer  2 , Tina Stegmann  2 , Gerhard Hindricks  3 , Ulrich Laufs  2 , Nikolaos Dagres  3 , Rolf Wachter  2
Affiliations

Patients' attitude towards a sham-controlled trial on pulmonary vein isolation in atrial fibrillation

Tobias Uhe et al. Clin Res Cardiol. 2022 Jan.

Abstract

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 has been questioned. We aimed to assess the attitude of potential participants regarding a sham-controlled trial in a common AF-patient population planned for PVI.

Methods: Patients in two tertiary care centres planned for PVI were asked for their current AF symptoms using the Atrial Fibrillation Effect on QualiTy of Life (AFEQT) questionnaire 1 day before catheter ablation. Subsequently, the study design of a hypothetical sham-controlled PVI-study was introduced, and patients were asked for their agreement in participation. Telephone follow-up of the AFEQT questionnaire was conducted 3 months after PVI.

Results: One hundred and ninety-six patients (mean age 64 ± 11 years, 63% male) were included. Seventy-nine (40%) patients expressed their agreement to participate in the hypothetical sham-controlled trial. An additional 7% agreed to participate if a cross-over option after three months was offered. Agreement rate was similar in patients with first and Redo-PVI and minimal, moderate or severe symptoms. Mean overall AFEQT at baseline was 55 ± 19 and improved by 25 ± 20 points after 3 months (p < 0.001 versus baseline).

Conclusion: With a participation rate of 40% in potential study participants, a sham-controlled trial for pulmonary vein isolation seems feasible. Patient-reported symptom relief after pulmonary vein isolation is in accordance with previous randomized open studies. The benefit of PVI should be rigorously evaluated in a sham-controlled trial.

Keywords: Atrial fibrillation; Catheter ablation; Pulmonary vein isolation; Sham-controlled trial.

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Conflict of interest statement

None.

Figures

Fig. 1
Fig. 1
Study flowchart. PVI pulmonary vein isolation; FU follow-up. All participants lost to follow-up declined to be interviewed again by phone after 3 months
Fig. 2
Fig. 2
Rate of hypothetical participation in a sham-controlled pulmonary vein isolation (PVI) trial overall, in patients undergoing their first PVI, patients undergoing a Redo-PVI and in different symptom severity groups assessed by AFEQT score. AFEQT Atrial Fibrillation Effect on QualiTy of Life questionnaire
Fig. 3
Fig. 3
Mean AFEQT score overall and AFEQT score subscales at baseline (blue columns) compared to 3 months post-PVI (orange columns). Differences were calculated using ANOVA. AFEQT Atrial Fibrillation Effect on QualiTy of Life questionnaire, PVI pulmonary vein isolation
Fig. 4
Fig. 4
Changes in overall AFEQT symptom severity groups from baseline to 3 months. AFEQT Atrial Fibrillation Effect on QualiTy of Life questionnaire
Fig. 5
Fig. 5
Change in AFEQT overall three months post PVI compared to baseline for individual patients. AFEQT Atrial Fibrillation Effect on QualiTy of Life (AFEQT) questionnaire, PVI pulmonary vein isolation
See this image and copyright information in PMC

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