The results of health-related quality of life assessment depend on the prevailing rhythm at the assessment: Experience from the CAPTAF trial (Catheter Ablation Compared with Pharmacological Therapy for Atrial Fibrillation).

AIMS: To assess whether the prevailing rhythm at the time of replying to symptom and health-related quality of life (HR-QoL) questionnaires impacts the findings. METHOD: A total of 150 patients from the randomized Catheter Ablation Compared with Pharmacological Therapy for Atrial Fibrillation-trial, comparing atrial fibrillation (AF) ablation versus drugs, were included. The effect of the prevailing rhythm on the outcome results of the HR-QoL 36-Item Short-Form Health Survey, the symptom severity questionnaire (SSQ), and the European Heart Rhythm Association (EHRA) score for classification of AF-related symptoms was assessed. RESULTS: AF as the prevailing rhythm was independently associated with a significantly lower Vitality score; 18.4 points lower (95% confidence interval -32.7 to -4.1, p = .01) compared with sinus rhythm when adjusted for AF burden, median duration of episode, number of episodes, beta-blocker use, type of AF, and sex. The presence of AF did not affect the General Health score compared with sinus rhythm, nor did it influence symptoms assessed by the SSQ or EHRA score. CONCLUSION: The observation that the presence of AF versus sinus rhythm when conducting HR-QoL tests had a negative impact on its outcome, leaving symptom-related questionnaires unaffected, implies that the prevailing rhythm should be taken into account when results of HR-QoL questionnaires are interpreted.

Acute and long-term efficacy and safety with a single cryoballoon application as compared with the standard dual application strategy: a prospective randomized study using the second-generation cryoballoon for pulmonary vein isolation in patients with symptomatic atrial fibrillation.

Aims: A single cryoballoon (CB) application per vein for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF) could save time and was therefore compared to the standard approach of two consecutive CB applications for acute and long-term efficacy and safety. Methods and results: Patients with symptomatic AF were randomized to a single CB application per vein guided by an Achieve® catheter (Single cryo-arm) or to two CB applications using a standard guidewire (Routine cryo-arm). The primary endpoint was the rate of acute complete PVI. Secondary endpoints were freedom from AF evaluated by electrocardiogram and 7 days Holter at 6 and 12 months, symptoms by Symptom Severity Questionnaires and EHRA score and quality of life (QoL) by EQ5D-5L at 12 months. Among 140 patients included, PVI was achieved in 271 (100%) veins in the Single cryo-arm and in 269/271 (99.3%) veins in the Routine cryo-arm, P = 0.25. The procedure time was shorter in the Single cryo-arm, mean ± standard deviation 99.4 ± 33.3 min vs. 118.4 ± 34.3 min, P = 0.0015. Freedom from AF after one procedure at 12 months did not differ; 73.9.0% (Single cryo) vs. 71.4% (Routine), P = 0.74. Symptoms and QoL did also not differ between the two groups. There was a lower complication rate in the Single cryo-group, 2.9% vs. 12.9%, P = 0.03. Conclusion: A single CB application shortens the procedure time without affecting acute or long-term efficacy, as compared to the routine two-application strategy, which with the lower complication rates has important implications when defining standards for PVI.

Atrial fibrillation burden, episode duration and frequency in relation to quality of life in patients with implantable cardiac monitor.

AIMS: To assess the relation between atrial fibrillation (AF) characteristics and health-related quality of life (QoL), and which AF characteristic had the greatest impact. METHOD: The AF characteristics burden (percentage of time in AF), duration and number of AF episodes/month were obtained from implantable cardiac monitors during the 2-month run-in period in 150 patients included in the randomized CAPTAF trial comparing early ablation and antiarrhythmic drug therapy. The QoL was measured by the General Health and Vitality dimensions of the 36-Item Short-Form Health Survey. AF characteristics were analysed continuously and in quartiles (Q1-Q4). RESULTS: Greater AF burden (p = 0.003) and longer AF episodes (p = 0.013) were associated with impaired QoL (Vitality score only) in simple linear regression analyses. Greater AF burden was, however, the only AF characteristic associated with lower QoL, when adjusted for sex, type of AF, hypertension, heart rate above 110 beats per minute during AF, and beta-blocker use in multiple linear regression analyses. For every 10% increase in AF burden there was a 1.34-point decrease of Vitality score (95% confidence interval (CI) -2.67 to -0.02, p = 0.047). The Vitality score was 12 points lower (95% CI -22.73 to -1.27, p = 0.03) in patients with an AF burden > 33% (Q4) versus those with < 0.45% (Q1), but only in unadjusted analysis. CONCLUSION: AF burden had a greater impact on QoL (Vitality), than the duration and number of AF episodes, corroborating that AF burden may be the preferred outcome measure of rhythm control in trials including relatively healthy AF populations.

Clinical outcome of the 2nd generation cryoballoon for pulmonary vein isolation in patients with persistent atrial fibrillation - A sub-study of the randomized trial evaluating single versus dual cryoballoon applications.

AIMS: To assess the efficacy of the 2nd generation Cryoballoon for pulmonary vein isolation (PVI) in patients with persistent atrial fibrillation (PersAF), and to compare it to patients with paroxysmal atrial fibrillation (PAF). METHODS: The outcome (arrhythmia recurrence at 12 months) was prospectively assessed in patients with PersAF(n = 77) and compared to that in patients with PAF(n = 62), who underwent PVI within a randomized trial evaluating single versus dual applications with the 2nd generation cryoballoon. Other endpoints included symptoms of AF, quality of life, procedure related characteristics, redo ablation rates and adverse events. Variables predicting recurrences were studied including all patients. RESULTS: Freedom from arrhythmia recurrence was 64.9% after a single ablation and 68.8% after one or more procedures, which was significantly lower compared to PAF patients; 82.2% (p = 0.029) and 83.9% (p = 0.048) respectively, at 12 months. The improvements in EHRA score (-1.3 ±â€¯0.8, p < 0.0001), symptom severity score (SSQ) (-5.0 ±â€¯4.2, p < 0.0001) and EQ5D-5 L global score (+10.4 ±â€¯20.3, p = 0.0002) after ablation was significant compared to baseline. The re-ablation rate was 7/77 (9.1%) which did not differ from that in PAF patients, 9/62 (14.5%), p = 0.42. Procedure duration, 104.8 ±â€¯37.4 versus 113 ±â€¯31.2 min (p = 0.129), application time, 1605 ±â€¯659 versus 1521 ±â€¯557 s (p = 0.103) and total adverse events after 12 months, 8/77 (10.4%) versus 5/62 (8.1%) (p = 0.77) did not differ in PersAF versus PAF patients. CONCLUSION: Both symptoms and QoL improved significantly in patients with PersAF after ablation. Freedom from AF was clinically significant but lower than in PAF patients. The cryoballoon seems an effective technique also in patients with persistent AF.