Long term clinical outcomes and cost-effectiveness of catheter vs thoracoscopic surgical ablation in long-standing persistent atrial fibrillation using continuous cardiac monitoring: CASA-AF randomised controlled trial.

BACKGROUND: Long-term clinical outcomes of catheter ablation (CA) compared to thoracoscopic surgical ablation (SA) to treat patients with long-standing persistent atrial fibrillation (LSPAF) are not known. OBJECTIVES: To compare long-term (36-months) clinical efficacy, quality of life and cost-effectiveness of SA and CA in LSPAF. METHODS: Participants were followed up for 3 years using implantable loop recorder (ILR) and questionnaires to assess change in quality of life. Intention-to-treat analyses were used to report the findings. RESULTS: Of 115 LSPAF patients treated, 104 (90.4%) completed 36-months follow-up (CA=57, SA=47). Following a single procedure without anti-arrhythmic drugs (AAD) 7 (12%) patients in the CA arm and 5 (11%) in the SA arm (HR 1.22, 95% CI 0.81 to 1.83, p = 0.41) were free from AF/AT ≥30 sec at 36 months. Thirty-three patients (58%) in the CA arm and 26 (55%) in the SA arm (HR 1.04, 95% CI 0.57 to 1.88, p = 0.91) had their AF/AT burden reduced by ≥75%. The overall impact on health-related quality of life was similar, with mean QALY estimates of 2.45 (95% CI 2.31 to 2.59) for CA and 2.32 (2.13 to 2.52) for SA. Estimated costs were higher for SA (mean £24,682, 95% CI £21,746 to £27,618) than for CA (mean £18,002, 95% CI £15,422 to £20,581). CONCLUSION: In symptomatic LSPAF, CA and SA were equally effective at achieving arrhythmia outcomes (freedom from AF/AT ≥30s and ≥75% burden reduction) following a single-procedure without AADs. However, SA is significantly more costly than catheter ablation.

Catheter ablation vs. thoracoscopic surgical ablation in long-standing persistent atrial fibrillation: CASA-AF randomized controlled trial.

AIMS: Long-standing persistent atrial fibrillation (LSPAF) is challenging to treat with suboptimal catheter ablation (CA) outcomes. Thoracoscopic surgical ablation (SA) has shown promising efficacy in atrial fibrillation (AF). This multicentre randomized controlled trial tested whether SA was superior to CA as the first interventional strategy in de novo LSPAF. METHODS AND RESULTS: We randomized 120 LSPAF patients to SA or CA. All patients underwent predetermined lesion sets and implantable loop recorder insertion. Primary outcome was single procedure freedom from AF/atrial tachycardia (AT) ≥30 s without anti-arrhythmic drugs at 12 months. Secondary outcomes included clinical success (≥75% reduction in AF/AT burden); procedure-related serious adverse events; changes in patients' symptoms and quality-of-life scores; and cost-effectiveness. At 12 months, freedom from AF/AT was recorded in 26% (14/54) of patients in SA vs. 28% (17/60) in the CA group [OR 1.128, 95% CI (0.46-2.83), P = 0.83]. Reduction in AF/AT burden ≥75% was recorded in 67% (36/54) vs. 77% (46/60) [OR 1.13, 95% CI (0.67-4.08), P = 0.3] in SA and CA groups, respectively. Procedure-related serious adverse events within 30 days of intervention were reported in 15% (8/55) of patients in SA vs. 10% (6/60) in CA, P = 0.46. One death was reported after SA. Improvements in AF symptoms were greater following CA. Over 12 months, SA was more expensive and provided fewer quality-adjusted life-years (QALYs) compared with CA (0.78 vs. 0.85, P = 0.02). CONCLUSION: Single procedure thoracoscopic SA is not superior to CA in treating LSPAF. Catheter ablation provided greater improvements in symptoms and accrued significantly more QALYs during follow-up than SA. CLINICAL TRIAL REGISTRATION: ISRCTN18250790 and ClinicalTrials.gov: NCT02755688.

Catheter Ablation versus Thoracoscopic Surgical Ablation in Long Standing Persistent Atrial Fibrillation (CASA-AF): study protocol for a randomised controlled trial.

BACKGROUND: Atrial fibrillation is the commonest arrhythmia which raises the risk of heart failure, thromboembolic stroke, morbidity and death. Pharmacological treatments of this condition are focused on heart rate control, rhythm control and reduction in risk of stroke. Selective ablation of cardiac tissues resulting in isolation of areas causing atrial fibrillation is another treatment strategy which can be delivered by two minimally invasive interventions: percutaneous catheter ablation and thoracoscopic surgical ablation. The main purpose of this trial is to compare the effectiveness and safety of these two interventions. METHODS/DESIGN: Catheter Ablation versus Thoracoscopic Surgical Ablation in Long Standing Persistent Atrial Fibrillation (CASA-AF) is a prospective, multi-centre, randomised controlled trial within three NHS tertiary cardiovascular centres specialising in treatment of atrial fibrillation. Eligible adults (n = 120) with symptomatic, long-standing, persistent atrial fibrillation will be randomly allocated to either catheter ablation or thoracoscopic ablation in a 1:1 ratio. Pre-determined lesion sets will be delivered in each treatment arm with confirmation of appropriate conduction block. All patients will have an implantable loop recorder (ILR) inserted subcutaneously immediately following ablation to enable continuous heart rhythm monitoring for at least 12 months. The devices will be programmed to detect episodes of atrial fibrillation and atrial tachycardia ≥ 30 s in duration. The patients will be followed for 12 months, completing appropriate clinical assessments and questionnaires every 3 months. The ILR data will be wirelessly transmitted daily and evaluated every month for the duration of the follow-up. The primary endpoint in the study is freedom from atrial fibrillation and atrial tachycardia at the end of the follow-up period. DISCUSSION: The CASA-AF Trial is a National Institute for Health Research-funded study that will provide first-class evidence on the comparative efficacy, safety and cost-effectiveness of thoracoscopic surgical ablation and conventional percutaneous catheter ablation for long-standing persistent atrial fibrillation. In addition, the results of the trial will provide information on the effects on patients' quality of life. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN18250790 . Registered on 24 April 2015.

Propofol sedation administered by cardiologists without assisted ventilation for long cardiac interventions: an assessment of 1000 consecutive patients undergoing atrial fibrillation ablation.

AIMS: Patients can expect a cure from atrial fibrillation (AF) with ablation. Procedural safety and success depend on patient comfort, compliance, and immobility. This is difficult to achieve with benzodiazepine and opiate boluses that are the mainstay of current practice. We sought to determine the safety and efficacy of propofol infusion sedation administered to patients without assisted ventilation for AF ablation. METHODS AND RESULTS: Procedural data from 1000 consecutive patients undergoing AF ablation were analysed. Sedation with 2% propofol was used in all procedures without assisted ventilation and was administered, monitored, and controlled by electrophysiologists. Primary outcome measures were adverse sedative affects including (i) respiratory depression (SpO(2)< 90% for >20 s) and (ii) persistent hypotension [systolic blood pressure (SBP)<90 mmHg at minimum sedation level]. Secondary endpoints included full recovery within 60 min and procedural complications. Of 1000 ablations, 506 ablations were performed for persistent and 494 for paroxysmal AF. Average patient age was 60.1 ± 11.3 years (72.3% male). Propofol was commenced in all patients at a mean infusion rate of 18.5 ± 4.8 mL/h with a mean baseline SBP of 140.3 ± 19.9 mmHg. Mean procedure time was 148.7 ± 57.7 min. Adverse sedative effects necessitating cessation of propofol and switch to midazolam bolus sedation occurred in 15.6% of patients (13.6% due to persistent hypotension, 1.9% due to respiratory depression, and 0.1% due to hypersalivation). Patients who had persistent hypotension were older (62.9 ± 11.2 vs. 60.0 ± 11.4 years, P= 0.011) and more likely to be female (39.5 vs. 23.7%, P< 0.001) than those who tolerated propofol. Patient age correlated to maximum blood pressure drop with propofol (R(2)= 0.101, P< 0.001) and inversely correlated to mean propofol infusion rate (R(2)= 0.066, P< 0.001). No procedures were abandoned due to adverse effects of sedation. All patients recovered within 60 min. Serious procedural complications, unrelated to sedation, occurred in 0.5%, all of whom had pericardial tamponade successfully treated with percutaneous pericardiocentesis. CONCLUSIONS: Sedation with 2% propofol infusion administered by cardiologists without assisted ventilation is safe, effective, and practical for use in AF ablation without serious or residual complications. In this setting, persistent hypotension is the most common acute adverse effect requiring cessation of propofol in ∼14%.