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IMPORTANCE Quality of life is not a standard primary outcome in ablation trials, even though symptoms drive the indication. OBJECTIVE To assess quality of life with catheter ablation vs antiarrhythmic medication at 12 months in patients with atrial fibrillation. DESIGN, SETTING, AND PARTICIPANTS Randomized clinical trial at 4 university hospitals in Sweden and 1 in Finland of 155 patients aged 30-70 years with more than 6 months of atrial fibrillation and treatment failure with 1 antiarrhythmic drug or beta-blocker, with 4-year follow-up. Study dateswere July 2008-September 2017. Major exclusionswere ejection fraction <35%, left atrial diameter > 60 mm, ventricular pacing dependency, and previous ablation. INTERVENTIONS Pulmonary vein isolation ablation (n= 79) or previously untested antiarrhythmic drugs (n= 76). MAIN OUTCOMES AND MEASURES Primary outcomewas the General Health subscale score (Medical Outcomes Study 36-Item Short-Form Health Survey) at baseline and 12 months, assessed unblinded (range, 0 [worst] to 100 [best]). There were 26 secondary outcomes, including atrial fibrillation burden (% of time) from baseline to 12 months, measured by implantable cardiac monitors. The first 3 months were excluded from rhythm analysis. RESULTS Among 155 randomized patients (mean age, 56.1 years; 22.6% women), 97% completed the trial. Of 79 patients randomized to receive ablation, 75 underwent ablation, including 2 who crossed over to medication and 14 who underwent repeated ablation procedures. Of 76 patients randomized to receive antiarrhythmic medication, 74 received it, including 8 who crossed over to ablation and 43 for whom the first drug used failed. General Health score increased from 61.8 to 73.9 points in the ablation group vs 62.7 to 65.4 points in the medication group (between-group difference, 8.9 points; 95% CI, 3.1-14.7; P=.003). Of 26 secondary end points, 5 were analyzed; 2 were null and 2 were statistically significant, including decrease in atrial

Aims: Catheter ablation is considered the treatment of choice for many tachyarrhythmias, but convincing 'real-world' data on efficacy and safety are lacking. Using Swedish national registry data, the ablation spectrum, procedural characteristics, as well as ablation efficacy and reported adverse events are reported. Methods and Results: Consecutive patients (≥18 years of age) undergoing catheter ablation in Sweden between 01 January 2006 and 31 December 2015 were included in the study. Follow-up (repeat ablation and vital status) was collected through 31 December 2016. A total of 26 642 patients (57 ± 15 years, 62% men), undergoing a total of 34 428 ablation procedures were included in the study. In total, 4034 accessory pathway/Wolff-Parkinson-White syndrome (12%), 7358 AV-nodal re-entrant tachycardia (21%), 1813 atrial tachycardia (5.2%), 5481 typical atrial flutter (16%), 11 916 atrial fibrillation (AF, 35%), 2415 AV-nodal (7.0%), 581 premature ventricular contraction (PVC, 1.7%), and 964 ventricular tachycardia (VT) ablations (2.8%) were performed. Median follow-up time was 4.7 years (interquartile range 2.7-7.0). The spectrum of treated arrhythmias changed over time, with a gradual increase in AF, VT, and PVC ablation (P < 0.001). Decreasing procedural times and utilization of fluoroscopy with time, were seen for all arrhythmia types. The rates of repeat ablation differed between ablation types, with the highest repeat ablation seen in AF (41% within 3 years). The rate of reported adverse events was low (n = 595, 1.7%). Death in the immediate period following ablation was rare (n = 116, 0.34%). Conclusion: Catheter ablations have shifted towards more complex procedures over the past decade. Fluoroscopy time has markedly decreased and the efficacy of catheter ablation seems to improve for AF.

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 ± 0.8, p < 0.0001), symptom severity score (SSQ) (−5.0 ± 4.2, p < 0.0001) and EQ5D-5 L global score (+10.4 ± 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 ± 37.4 versus 113 ± 31.2 min (p = 0.129), application time, 1605 ± 659 versus 1521 ± 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.

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.

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±0.8, p<0.0001), symptom severity score (SSQ) (-5.0±4.2, p<0.0001) and EQ5D-5L global score (+10.4±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±37.4 versus 113±31.2 minutes (p=0.129), application time, 1605±659 versus 1521±557 seconds (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.

The low efficacy rates reported for conventional catheter ablation of longstanding persistent atrial fibrillation (LPAF) have led to the development of alternative techniques such as minimal invasive surgical ablation, aiming for durable and contiguous transmural lesions. The aim was to evaluate the efficacy and safety of total thoracoscopic epicardial left atrial ablation (TELA-AF) procedures in a prospective study of severely symptomatic patients with either drug-resistant AF and/or failed attempts of catheter ablation. The TELA-AF surgical technique includes pulmonary vein isolation, left atrial (LA) 'box lesion', and partial vagal denervation. The LA appendage was excluded if deemed safe. Patients were followed with clinical evaluations and 12-lead electrocardiograms at 3, 6, and 12 months after the surgical intervention, complemented with a 7-day Holter monitoring after 6 and 12 months. Sixty patients, of whom 38 (63%) suffered from LPAF, underwent TELA-AF between November 2008 and December 2010. One patient with LPAF was lost to follow-up. At 12-month follow-up, 55/59 patients (93%) were free from atrial fibrillation (AF), while 7/59 patients (12%) suffered from recurrent LA tachycardia. Among patients with LPAF, 32/37 (86%) maintained sinus rhythm after 12 months. Adverse events included four perioperative bleedings requiring conversion to sternotomy in three cases, two ischaemic strokes and one transient ischaemic attack. The total thoracoscopic surgical ablation procedure is highly effective even in patients with LPAF, and it seems safe. The high rate of iatrogenic LA re-entrant tachycardia, however, warrants further improvement of the technique.

Catheter based pulmonary vein isolation (PVI), is the recommended therapy for drug-refractory atrial fibrillation (AF) [1]. The procedure may be technically challenging, can be time consuming and highly dependent on operators skill. In order to improve the efficacy of PV isolation, shorten the procedure time and learning curve of operators; new specially designed catheters for pulmonary vein isolation have been developed [2-4]. One of these catheters is the Pulmonary Vein Ablation Catheter (PVAC) (Medtronic; Minneapolis, USA), which is a 10-pole circular, over the wire catheter used in combination with a multi-channel, duty-cycled radiofrequency generator (GENius; Medtronic) [2]. The feasibility of the PVAC has been demonstrated in a number of studies and randomized clinical studies have reported similar clinical results compared to point-by-point ablation around the pulmonary veins [2,5-9]. The energy can be delivered in a unipolar or bipolar setting or combined in various ratios. A higher proportion of unipolar energy will give deeper lesions but less energy between the poles possibly leading to non-continuous lines [12]. Although certain energy settings have been recommended for PV isolation there are no randomized studies that have compared the different settings for this purpose. The aim of this study was therefore to compare the efficacy and safety of PV isolation using a 4:1 versus a 2:1 unipolar/bipolar energy setting with the PVAC. Our hypothesis was that the 2:1 setting, delivering more unipolar energy, would result in deeper and more transmural lesions for pulmonary vein isolation leading to fewer applications and thus shorter procedure times.

BACKGROUND: Cox Maze surgery for atrial fibrillation (AF) has been found to have high efficacy in maintaining sinus rhythm and has been shown to improve quality of life early after surgery, but reports on long-term effects in this respect are lacking. This study was therefore undertaken to evaluate the effect of the Maze procedure on health-related quality of life in the long term. METHODS: Patients with drug-refractory AF undergoing the 'cut and sew' Maze III procedure without any modification were assessed with the SF-36 Health Survey regarding quality of life at baseline and late after surgery. Totally 61 patients, mean age 55 years (range: 29-74 years), were evaluated. At the time of surgery, 34 patients (56%) had paroxysmal or persistent AF and the remainder had permanent AF. RESULTS: At late follow-up, at a mean of 55+/-12 months, 54 patients (89%) were free from AF recurrences and another five patients (8%) had experienced only one or a few AF episodes. All eight scales on the SF-36 Health Survey were significantly improved at long-term follow-up compared to baseline. The quality-of-life improvement was seen both in patients with paroxysmal/persistent AF and in those with permanent AF. At long-term follow-up, the quality-of-life scores were comparable with those of the general population. CONCLUSIONS: The Cox Maze III procedure has good long-term efficacy for rhythm control in patients with medically refractory AF, resulting in a quality-of-life improvement, which is maintained late after surgery.

BACKGROUND: The aim of this study was to investigate the cost-effectiveness of cardiac resynchronization therapy (CRT) in Denmark, Finland and Sweden. The analysis was based on the CARE-HF trial, a randomised clinical trial investigating the efficacy of adding CRT (n=409) to optimal pharmacological treatment (n=404) in patients with moderate to severe heart failure with markers of cardiac dyssynchrony. The average follow-up time was 29.4 months. METHODS: The health effects were measured in terms of quality-adjusted life years (QALYs) gained. Data on health care resource consumption from CARE-HF was combined with costs for CRT implantation and hospitalisation from university hospitals in Denmark, Finland and Sweden. Calculations were based on patients' expected life time. The expected device lifetime (6 years) was used for CRT, and no additional gains in clinical effects were assumed after the 6 years. RESULTS: The cost-effectiveness ratio per QALY gained was 4800 euros in Denmark, 3600 euros in Finland and 6700 euros in Sweden. The 95% confidence intervals for the cost per QALY gained varied between a lower limit of 1169 euros in Finland to an upper limit of 17,482 euros in Sweden. These values were all below the threshold for being cost-effective in Denmark, Finland and Sweden. CONCLUSIONS: The study indicates that CRT is a cost-effective treatment in Scandinavian health care settings compared to traditional pharmacological therapy and can therefore be recommended for routine use in patients with moderate to severe heart failure and markers of dyssynchrony.

Background. The Maze procedure is effective in restoring sinus rhythm, but the extensive procedure may have negative effects on atrial mechanical function. Decreased atrial contractility has been observed early after the Maze procedure. The purpose of this study was to determine the long-term effect of the Maze procedure on atrial size and mechanical function. Methods. Fifty-two patients with symptomatic atrial fibrillation, without structural heart or valvular disease, underwent the Cox Maze III procedure. Atrial size and mechanical function were assessed by echocardiographic examination at baseline and postoperatively at a mean +/- SD of 6 +/- 1 and 56 +/- 12 months. Results. The left atrial area was decreased 6 months after the procedure compared with baseline (mean, 15.4 +/- 3.3 vs 17.6 +/- 3.2 cm(2), p < 0.01). By 56 months, however, the left atrial area had increased compared with the 6-month follow-up (19.5 +/- 3.9 vs 15.4 +/- 3.3 cm(2), p < 0.001), resulting in no difference in left atrial size compared with the baseline values. The left atrial contractility, measured as fractional area change, was significantly reduced at 6 and 56 months of follow-up (0.20 +/- 0.09 and 0.19 +/- 0.07 vs baseline 0.36 +/- 0.09), as was the transmitral A-wave velocity (30 +/- 12 and 28 +/- 8 cm/s vs baseline 40 +/- 15). The same pattern was seen for the right atrium. Conclusions. This study shows that the Maze procedure results in a sustained decrease in atrial contractility. The initial reduction in atrial size is later reversed. These findings contradict late improvements in atrial mechanical function after Maze surgery and may have important implications for the risk of thromboembolic complications.

The Maze III procedure is a surgical operation for curative treatment of AF. The procedure is extensive, however, with multiple incisions in both atria, and its effects on autonomic regulation of the heart rhythm are not known. This study comprises 17 patients, 10 with paroxysmal AF and 7 with chronic AF, who had no concurrent cardiac disease known to affect heart rate variability (HRV). A 24-hour Holter recording was performed preoperatively and 2 months (early) and 7 months (late) after surgery, for analysis of HRV in the time and frequency domains. Early after the Maze procedure all HRV components were markedly reduced compared to baseline (mean +/- 1 SD): SDNN 73 +/- 13 versus 148 +/- 50 (ms), total power 168 +/- 126 versus 560 +/- 1567 (ms2), low frequency (LF) power 47 +/- 67 versus 826 +/- 677 (ms2), high frequency (HF) power 47 +/- 40 versus 678 +/- 666 (ms2), and LF:HF 1.22 +/- 0.9 versus 2.55 +/- 1.4. Late after the Maze procedure all variables were still reduced. Only total power increased significantly between early and late follow-up (168 +/- 126 vs 496 +/- 435 ms2). Late after Maze surgery, values of the different HRV components did not differ between the patients with paroxysmal AF and chronic AF. Early after the Maze procedure there is a marked decrease of all HRV components, which is maintained 7 months after surgery, a pattern consistent with denervation of the heart., NR 20140805