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 β-blocker, with 4-year follow-up. Study dates were July 2008–September 2017. Major exclusions were 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 outcome was 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 fibrillation burden (from 24.9% to 5.5% in the ablation group vs 23.3% to 11.5% in the medication group; difference –6.8% 95% CI, –12.9% to –0.7%; P = .03). Of the Health Survey subscales, 5 of 7 improved significantly. Most common adverse events were urosepsis (5.1%) in the ablation group and atrial tachycardia (3.9%) in the medication group. CONCLUSIONS AND RELEVANCE: Among patients with symptomatic atrial fibrillation despite use of antiarrhythmic medication, the improvement in quality of life at 12 months was greater for those treated with catheter ablation compared with antiarrhythmic medication. Although the study was limited by absence of blinding, catheter ablation may offer an advantage for quality of life. TRIAL REGISTRATION: clinicaltrialsregister.eu Identifier: 2008-001384-11
Abstract
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.
Thrombo-embolic events are one of the most feared complications related to atrial fibrillation (AF) ablation. Since radiofrequency (RF) energy is thought to be associated with a higher risk of ...thrombus formation than cryoenergy, the purpose of this study was to assess if the degree of activation of coagulation and inflammatory markers differed between ablation procedures performed with a cryoballoon catheter vs. a RF energy-based pulmonary vein ablation catheter (PVAC), respectively.
Thirty patients referred for AF ablation were randomized to pulmonary vein isolation with either the cryoballoon or the PVAC. Biomarkers were studied for endothelial damage (von Willebrand factor antigen), platelet activation (soluble P-selectin), and coagulation activity prothrombin fragment 1 + 2 (F1 + 2) and D-dimer at five different time points during the procedure. Troponin I (Trop I) and C-reactive protein were analysed to reflect myocardial destruction and inflammatory activity. Markers of endothelial damage and platelet activation increased after ablation in both the cryo and the RF group. Similarly, the D-dimer levels increased significantly (P = 0.001) in both groups, whereas the F1 + 2 levels increased after the transseptal puncture only (P = 0.001). The overall activation of the coagulation system was, however, comparable between the groups. The cryoballoon was associated with higher Trop I compared with the PVAC (P < 0.001), but the ratios between biomarkers and Trop I were higher with the PVAC than with the cryoballoon.
Even though the cryoballoon causes a higher degree of myocardial destruction than the PVAC, markers of coagulation, endothelial damage, and inflammation were comparable between the two techniques.
Aims Cardiac dyssynchrony is common in patients with heart failure, whether or not they have ischaemic heart disease (IHD). The effect of the underlying cause of cardiac dysfunction on the response ...to cardiac resynchronization therapy (CRT) is unknown. This issue was addressed using data from the CARE-HF trial. Methods and results Patients (n = 813) were grouped by heart failure aetiology (IHD n = 339 vs. non-IHD n = 473), and the primary composite (all-cause mortality or unplanned hospitalization for a major cardiovascular event) and principal secondary (all-cause mortality) endpoints analysed. Heart failure severity and the degree of dyssynchrony were compared between the groups by analysing baseline clinical and echocardiographic variables. Patients with IHD were more likely to be in NYHA class IV (7.5 vs. 4.0%; P = 0.03) and to have higher NT-proBNP levels (2182 vs. 1725 pg/L), indicating more advanced heart failure. The degree of dyssynchrony was more pronounced in patients without IHD (assessed using mean QRS duration, interventricular mechanical delay, and aorta-pulmonary pre-ejection time). Left ventricular ejection fraction and left ventricular end-systolic volume improved to a lesser extent in the IHD group (4.53 vs. 8.50% and −35.68 vs. –58.52 cm3). Despite these differences, CRT improved all-cause mortality, NYHA class, and hospitalization rates to a similar extent in patients with or without IHD. Conclusion The benefits of CRT in patients with or without IHD were similar in relative terms in the CARE-HF study but as patients with IHD had a worse prognosis, the benefit in absolute terms may be greater.
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 cm2 , 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 cm2 , 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.
Maze surgery for atrial fibrillation (AF) is a curative therapy, but its effect on health-related quality of life has not been studied.
Maze operations were performed in 48 patients with ...drug-refractory AF. The majority of patients (80%) had lone AF, and the primary indication for surgery in all patients was AF. The SF-36 Health Survey was used to assess quality of life before operation and at 6 months and 1 year after surgery. Twenty-five patients were available for the 1-year follow-up and completed all questionnaires. Before maze surgery, the SF-36 scores were significantly lower than in the general Swedish population, reflecting significant impairment in well-being, physical and social functioning, and mental health. After maze surgery, the quality of life was significantly improved at 6 months and at 1 year on all scales except for bodily pain, which, however, was not significantly decreased before surgery. At both 6 months and 1 year after maze surgery, quality of life, measured by the SF-36, reached the levels of the general Swedish population.
The maze operation can significantly improve the health-related quality of life in selected groups of patients with both paroxysmal and chronic AF refractory to antiarrhythmic therapy.
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).
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.
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.
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.
•Symptoms and QoL improved in persistent AF and did not differ from paroxysmal AF patients after cryoballoon ablation•Freedom from AF 12 months after a single ablation was clinically significant at 64.9%, but lower than in paroxysmal AF•Cryoballoon ablation seems to be a feasible and effective technique in persistent AF
The urge to facilitate the atrial fibrillation (AF) ablation procedure has led to the development of new ablation catheters specifically designed as 'one-shot tools' for pulmonary vein isolation ...(PVI). The purpose of this study was to compare the efficacy, safety, and procedure times for two such catheters using different energy sources.
One hundred and ten patients, referred for ablation of paroxysmal or persistent AF, were randomized to treatment with either the cryoballoon or the circular multipolar duty-cycled radiofrequency-based pulmonary vein ablation catheter (PVAC). Complete PVI was achieved in 98 vs. 93% patients in the cryoballoon and PVAC group, respectively, with complication rates of 8 vs. 2% (P = 0.2). Complete freedom from AF, without antiarrhythmic drugs, after one single ablation procedure was seen in 46% in the cryoballoon vs. 34% after 12 months (P = 0.2). Procedure times were comparable, but fluoroscopy time was shorter for the cryoballoon (32 ± 16 min) than for the PVAC procedures (47 ± 17 min) (P < 0.001). A significant improvement of quality of life (QoL) and arrhythmia-related symptoms was seen in both groups after ablation.
Both catheters proved comparably effective and safe in achieving acute PVI, apart from the shorter fluoroscopy times achieved with the cryoballoon. At follow-up, there was no statistically significant difference between the groups regarding freedom from AF and clinical success. The QoL increased to the same levels as for the general Swedish population in both groups.
Background. The Maze procedure is a curative surgical therapy for atrial fibrillation, restoring sinus rhythm and improving quality of life. Because the procedure results in tissue scarring, the ...atrial transport function is most likely affected.
Methods. Seventeen patients with paroxysmal atrial fibrillation underwent the Maze III procedure without any concomitant valve operation. Atrial size and transport function were measured before and at 2, 6, and 24 months after operations with two-dimensional echocardiography and pulsed-wave Doppler.
Results. Fifteen patients (88%) had signs of left atrial contractions as shown by the presence of a transmitral atrial filling wave on Doppler echocardiography at 6 months follow-up. The transmitral early filling wave and atrial filling wave were measured to calculate the early filling/atrial filling wave ratio, which increased from 1.2 before to 1.9 at 2 months after the Maze procedure (nonsignificant), and further to 2.8 at 24 months (
p = 0.02). A decrease in the right and left atrial size was seen at 2 months after an operation, but no further decrease occurred.
Conclusions. In patients with paroxysmal atrial fibrillation, there is a progressive increase in the transmitral early filling/atrial filling wave ratio after the Maze procedure, consistent with a gradual decrease in the left atrial transport function.
Purpose
Epicardial pulmonary vein isolation has become an increasingly used therapy for medically resistant atrial fibrillation. The purpose of the present study was therefore to evaluate if ...epicardial pulmonary vein isolation combined with ganglionated plexi ablation affects the size and mechanical function of the left atrium, and whether the effects are dependent on the extensiveness of the ablation applications.
Methods
A total of 42 patients underwent an echocardiographic examination prior to and 6 months after a minimal invasive epicardial pulmonary vein isolation procedure for the assessment of the effects on left atrial size and function. In 27 patients, who had sinus rhythm both at baseline and follow-up, was a comparison of atrial size and function possible at these time intervals. Fractional area changes were obtained from the left atrial end-systolic and end-diastolic areas in the apical four-chamber view. Pulsed-Doppler was used to assess the transmitral flow velocities to evaluate mechanical function.
Results
Left atrial size and function at 6-month follow-up had not changed significantly from those at baseline as indicated by left atrial maximal area (17.1 ± 4.6 vs. 18.7 ± 5.3,
p
= 0.118), minimal area (12.5 ± 3.8 vs. 13.4 ± 4.7,
p
= 0.248), fractional area change (27.4 ± 8.2 vs. 28.7 ± 10.6,
p
= 0.670), and E/A ratio (1.49 ± 0.47 vs. 1.54 ± 0.67,
p
= 0.855).
Conclusions
Radiofrequency ablation for epicardial pulmonary vein isolation combined with ganglionated plexi ablation has no major effects on atrial function or size. A preserved atrial function for those maintaining sinus rhythm may have important implications for thromboembolic risk after surgery, but warrants confirmation in larger trials.
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