Effect of Left Atrial Ablation on the Quality of Life in Patients With Atrial Fibrillation

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1 Circ J 08; 72: Effect of Left Atrial Ablation on the Quality of Life in Patients With Atrial Fibrillation Shinsuke Miyazaki, MD; Taishi Kuwahara, MD; Atsushi Takahashi, MD; Atsushi Kobori, MD; Yoshihide Takahashi, MD; Toshihiro Nozato, MD; Hiroyuki Hikita, MD; Akira Sato, MD; Kazutaka Aonuma, MD; Kenzo Hirao, MD; Mitsuaki Isobe, MD Background The current study aimed to investigate the effect of ablation therapy on the quality of life (QOL) in patients with atrial fibrillation (AF) by using a questionnaire specific for AF. Methods and Results A total of 86 patients (paroxysmal/chronic, 61/25) with drug-resistant AF undergoing extensive pulmonary vein isolation were recruited for the study. The QOL was quantitatively assessed by the Atrial Fibrillation Quality of Life Questionnaire at baseline, and 1, 3 and 6 months after the ablation. Sinus rhythm was maintained in 48/61 (79%) of the paroxysmal AF group, and /25 (60%) of those in the chronic AF group during 6 months after the initial ablation procedure. Among the patients without any AF recurrences, patients with chronic AF exhibited a substantial improvement in the QOL at 1 month after the procedure, and it remained unchanged until the end of the follow-up period. However, in the patients with paroxysmal AF, the QOL level gradually increased over a 6-month period. The patients with recurrent AF exhibited no improvement in the QOL. Conclusion Although the clinical course of the QOL improvement was different, both paroxysmal and chronic AF patients gained better QOL to maintain sinus rhythm by means of catheter ablation. (Circ J 08; 72: ) Key Words: Ablation; Atrial fibrillation; Quality of life Atrial fibrillation (AF) is one of the most common arrhythmias. 1 It can significantly impair the quality of life (QOL) in a variety of ways, 2 which can be manifested as a decreased exercise tolerance, sensation of a heartbeat irregularity, or side-effects of the medications used to treat the arrhythmia. Catheter ablation (CA) of AF has evolved rapidly and has become one of the therapeutic modalities for curing AF. 3 8 Using the Short-Form-36 questionnaire (SF-36), some previous reports showed a significant improvement in the QOL following the CA in patients with AF. 9,10 In this study, we used a questionnaire specific for AF, and assessed the clinical course of the QOL after the CA over a 6-month follow-up period in patients with both paroxysmal and chronic AF. Methods Study Population This study consisted of 92 patients with drug-refractory paroxysmal or chronic AF who underwent left atrial (LA) ablation in our hospital. Six patients who could not (Received July, 07; revised manuscript received November, 07; accepted December 3, 07) Cardiovascular Center, Yokosuka Kyosai Hospital, Yokosuka, Department of Cardiology, University of Tsukuba Graduate School, Tsukuba and Department of Cardiovascular Medicine, Tokyo Medical and Dental University, Tokyo, Japan Mailing address: Shinsuke Miyazaki, MD, Cardiovascular Center, Yokosuka Kyosai Hospital, 1- Yonegahamadori, Yokosuka , Japan. mshinsuke@k3.dion.ne.jp All rights are reserved to the Japanese Circulation Society. For permissions, please cj@j-circ.or.jp complete all the questionnaires over 6 months were excluded, and the rest of the 86 patients were analyzed in this study. Chronic AF was defined as AF lasting more than 6 months despite the administration of any type of antiarrhythmic drugs (AAD), and paroxysmal AF was as AF spontaneously converting to sinus rhythm with or without administration of AAD. All patients gave their written informed consent to participate in the study. Extensive Pulmonary Vein (PV) Isolation All AAD were discontinued more than 7 days before the ablation procedure. All patients were effectively anticoagulated for >1 month, and transesophageal echocardiography was performed to exclude any atrial thrombi before the ablation. The surface electrocardiogram (ECG) and bipolar intracardiac electrograms were continuously monitored and stored on a computer-based digital recorder system Cardiolab system (Prucka Engineering, Houston, TX, USA). The bipolar electrograms were filtered from 30 to 500 Hz. After a single transseptal puncture, a long sheath (SR0, St. Jude Medical, AF Division, Minnetonka, MN, USA) and Mullins transseptal sheath (Medtronic, Corp, Minneapolis, MN, USA) were introduced into the left superior and inferior PV, respectively. A 5,000-U dose of heparin was administered intravenously followed by a continuous heparin infusion at 1,000-U/h to maintain an activated clotting time of 0 to 300 s. Left pulmonary venography by an injection of contrast medium via the 2 long sheaths and esophagraphy were simultaneously performed to obtain the anatomical relationship between the area around the PV ostia and the esophagus. Right pulmonary venography was similarly performed. Double circular mapping catheters (Lasso, Biosense Circulation Journal Vol.72, April 08

2 LA Ablation on the QOL in Patients With AF 583 Table 1 Patient Clinical Characteristics Paroxysmal AF Chronic AF p value n Age (years) 59.5± ±10.2 NS Sex (M/F) 47/ /4 NS Structural heart disease 9 (.8%) 4 (.0%) NS Ischemic heart disease 4 2 Valvular heart disease 2 0 Cardiomyopathy 3 1 Duration of AF (months) 40.3± ±60.4 NS Ineffective AAD (n) 1.8± ±1.5 NS LAD (mm) 37.6± ±5.1 LVEF (%) 66.5± ±9.1 AF, atrial fibrillation; AAD, antiarrhythmic drugs; LAD, left atrial diameter; LVEF, left ventricular ejection fraction. Webster, Inc, Diamond Bar, CA, USA) were placed in the superior and inferior PV, respectively, and the left-sided and right-sided ipsilateral PV were circumferentially and extensively ablated, respectively, under fluoroscopic and electrophysiologic guidance. The LA posterior wall, at a distance of 1 2 cm from the left- or right-sided ostia of the PV, was anatomically ablated to include an extensive region of the LA posterior wall within the isolation area. Furthermore, at the anterior aspect of the PV, the distal edges of the PV with early PV potentials or continuous PV and LA potentials were targeted for ablation. Isolation of the left-sided PV was performed during coronary sinus distal pacing and isolation of the right sided PV was during sinus rhythm. Radiofrequency (RF) current applications were applied with an 8-mm tip ablation catheter (Japan Lifeline, Inc, Tokyo, Japan) during an intravenous isoproterenol infusion (0.33 g/min). The power settings consisted of a temperature control mode, with a target temperature of 55 C and maximum power of 35W at the LA posterior wall and 40W at the anterior aspect of PV. A steerable 4-mm tip ablation catheter, connected to a thermocouple thermometer (Delta Ohm, Padova, Italy), was appropriated for a temperature probe. It was advanced into the esophagus via an endogastric tube, and was maneuvered during the ablation procedure to be placed as close as possible to the ablation electrode under fluoroscopic guidance. The RF energy deliveries were basically applied for 60 s; however, when the esophageal temperature reached 42 C, the delivery of the RF energy was stopped. After the esophageal temperature returned to the control, we re-started the RF application at the same site. The endpoint of the ablation was the elimination of all PV potentials. After completing the extensive PV isolation (EPVI), the cavo-tricuspid isthmus (CTI) was also ablated to create bi-directional conduction block. In patients with chronic AF, we restored sinus rhythm by internal cardioversion before ablation and performed the EPVI and CTI ablation as described above. If the cardioversion failed to restore sinus rhythm, we started the ablation during ongoing AF and after completing the EPVI, we performed a repeated cardioversion to achieve sinus rhythm. Following the EPVI and CTI ablation, if burst pacing from the high right atrium could induce sustained AF lasting over 5min, an LA roof line 5 joining the left-sided and right-sided PV isolation circles was added, and the mitral isthmus 4 between the left inferior PV and mitral annulus was also ablated to create bi-directional conduction block. If frequent atrial premature contractions (APC) occurred, we performed focal ablation to cure the APC. The superior vena cava was also isolated if it was associated with frequent APC. Assessment of the QOL In the present study, the QOL was quantitatively assessed by using a QOL questionnaire specific for AF (AFQLQ) invented by the Japanese Society of Electrocardiology. It consisted of 3 subscales: questions 1 6 reflected the variety and (0 24 points); questions 7, the (0 points); and questions, the limitations of daily and special activities and the related to AF (0 56 points). A higher score in each subscale indicated a good health status. The patients completed the AFQLQ before, and 1, 3 and 6 months after the ablation procedure. Follow-up After 3 to 6 months, in the absence of any AF recurrences, the anticoagulant treatment was discontinued unless other major risk factors were present. No AAD were prescribed in the patients with paroxysmal AF, but were in the patients with chronic AF for 3 months following the ablation. If the patients with paroxysmal AF had palpitations because of frequent APC, AAD were allowed to be prescribed. All patients were scheduled to visit our clinic at 2, 6, 10, and 24 weeks after discharge. A recurrence of AF was defined according to the patient s symptoms, ECG and Holter ECG recordings. A multi-detector row CT examined the morphological changes in the PV 3 months after the ablation procedure. Statistical Analysis The analyses were performed with a commercially available statistical package (SPSS.0J). The continuous variables are expressed as the mean ± SD. The continuous and categorical variables were compared with the Student s t-test and chi-square test, respectively. The time-course patterns of the QOL score were compared with 2-way layout ANOVA between the patients with and without AF recurrence. Sequential data measurements in each group were analyzed by repeated-measures analysis of variance (repeated measures ANOVA), and furthermore each data was analyzed with Dunnett s and Bonferoni s multiple comparison. A probability value of p<0.05 indicated statistical significance. Results Study Population The characteristics of the study population are described in Table 1. Patients with chronic AF had a larger LA and lower left ventricular systolic function than those with paroxysmal AF. Circulation Journal Vol.72, April 08

3 584 MIYAZAKI S et al. Table 2 Ablation Sites Table 3 Antiarrhythmic Drugs Used Before and 1 Month After EPVI Paroxysmal AF Chronic AF n EPVI 61 (100%) 25 (100%) CTI line 61 (100%) 25 (100%) LA roof line 1 (2%) 3 (%) Mitral isthmus line 0 (0%) (56%) SVC isolation 3 (5%) 7 (28%) Focal ablation 3 (5%) 2 (8%) EPVI, extensive pulmonary vein isolation; CTI, cavo-tricuspid isthmus; LA, left atrium; SVC, superior vena cave. Other abbreviation see in Table 1. Procedural Results A successful PV isolation (PVI) and bi-directional CTI conduction block were achieved in all patients. The ablation sites are presented in Table 2. A complication of a cardiac tamponade was observed in 1 patient with paroxysmal AF. No patients experienced a thromboembolism, PV stenosis or any other major complications. Follow-up The AAD used before and after the ablation procedure are shown in Table 3. Because of palpitations due to APC, % of the patients with paroxysmal AF were prescribed Class I AAD 1 month after the ablation procedure. AF recurred in of the 61 patients (%) in the paroxysmal AF group and 10 of the 25 patients (40%) in the chronic AF group after the first ablation procedure. Time to AF recurrence was within 1 month of the ablation procedure in all patients, except for 1 patient who had the recurrence 2 months later. Most of the patients with AF recurrence received repeated procedure more than 3 months after the initial procedure. Before After Paroxysmal AF group (n=61) Class I 39 (64%) (%) Class III 2 (3%) 0 (0%) Bepridil (%) 0 (0%) -blocker (%) 10 (%) Verapamil 8 (%) 6 (10%) Digitalis 4 (7%) 1 (2%) Chronic AF group (n=25) Class I 9 (36%) (60%) Class III 0 (0%) 1 (4%) Bepridil 3 (%) 6 (24%) -blocker 7 (28%) 7 (28%) Verapamil 4 (%) 3 (%) Digitalis 3 (%) 0 (0%) Abbreviations see in Tables 1,2. Table 4 Baseline Quality of Life Questionnaire Specific for AF Scores Paroxysmal AF Chronic AF p value n Frequency of symptoms.7±6.3.7±6.5 NS Severity of symptoms.0±4.4.1±4.4 p<0.05 Mental anxiety 32.4± ±10.9 NS Abbreviation see in Table 1. QOL Assessment The baseline AFQLQ scores are presented in Table 4. The patients with chronic AF had a higher QOL than did those with paroxysmal AF in the subscale. The clinical course of the AFQLQ score during 3 months following the initial procedure in the patients with paroxysmal and chronic AF is shown in Fig 1. The QOL score at 6 months after the procedure is not presented, because the A B Fig 1. Clinical course of the quality of life (QOL) questionnaire specific for atrial fibrillation (AF) scores for each subscale over 3 months (A; paroxysmal AF group, B; chronic AF group). Each QOL score improved in both groups. The QOL score at 6 months after the procedure is not presented, because the patients with AF recurrence received repeated procedure within 6 months after the initial procedure. compared with the baseline; compared with 1 month. Circulation Journal Vol.72, April 08

4 LA Ablation on the QOL in Patients With AF 585 A No recurrence p< No recurrence No recurrence B No recurrence No recurrence No recurrence 10 p< Fig 2. Clinical course of the quality of life questionnaire specific for atrial fibrillation (AFQLQ) scores for each subscale over 3 months in the patients with and without atrial fibrillation (AF) recurrences (A, paroxysmal AF group; B, chronic AF group). There were significant differences in the clinical course of the AFQLQ scores between the patients with and without AF recurrence (2-way layout analysis of variance). A B Months 10 6 Months Months 6 Months 6 Months 35 6 Months Fig 3. Clinical course of the quality of life (QOL) questionnaire specific for atrial fibrillation (AF) scores for each subscale over 6 months in the patients without AF recurrences (A, paroxysmal AF group; B, chronic AF group). The QOL in the paroxysmal AF patients gradually improved over the 6 months, in contrast to the substantial improvement in the QOL 1 month after the procedure in the patients with chronic AF. compared with the baseline; compared with 1 month; compared with 3 months (repeated measures analysis of variance). patients with AF recurrence received repeated ablation session within 6 months after the initial procedure. Each group showed improvement of the QOL score in each scale following the ablation. The comparison of clinical course of AFQLQ score between the patients with and without AF recurrence is shown in Fig 2. There were significant differences in clinical course between both groups. The patients with AF recurrences had no significant difference in each subscale of the AFQLQ score between before and after the procedure in Circulation Journal Vol.72, April 08

5 586 MIYAZAKI S et al. both paroxysmal and chronic AF groups. Fig 3 shows the AFQLQ score changes during 6 months following the initial procedure in the patients without any AF recurrences. In the patients with paroxysmal AF, the QOL gradually improved over a 6-month follow-up period, whereas in the patients with chronic AF it improved at 1 month, and did not change anytime later up to the end of the follow-up period. Discussion Major Findings In this study, 79% of the patients with paroxysmal AF and 60% of those with chronic AF were AF free following the first ablation procedure during a 6-month follow-up period. The EPVI-based CA for AF resulted in a significant improvement in the QOL, not only in the paroxysmal but also in the chronic AF patients. Furthermore, the time course of the QOL improvement differed between the paroxysmal and chronic AF patients. The QOL in the chronic AF patients improved sooner than that in the paroxysmal AF patients. AFQLQ The SF-36, which has been widely applied in the assessment of the QOL, is a standardized and generic healthrelated QOL measurement instrument. However, it might not really be suitable for the assessment of the QOL in patients with AF, because the SF-36 does not reflect the specific health problems related to AF. Thus, a QOL assessment of the AF patients needed to be newly developed, and the Japanese Society of Electrocardiology invented a QOL questionnaire specifically for AF, and was called the AFQLQ. In this study, we used the AFQLQ and were able to appropriately evaluate the clinical course of the QOL after the AF ablation. Comparison With Previous Studies Tada et al described that 3 PV isolation procedures could ultimately maintain sinus rhythm in 28 of 50 patients with paroxysmal AF, and with additional drug treatment for the 22 patients with AF recurrence, the QOL score for both the physical and mental parameters showed a significant improvement after the ablation. 9 The study population only consisted of paroxysmal AF patients. Meanwhile, the QOL in 109 patients with AF undergoing circumferential PV ablation was estimated by Pappone et al. 10 They reported that the ablated patient s QOL, differing from those patients treated medically, reached normative levels at 6 months and remained unchanged at 1 year. The participants were both paroxysmal and chronic AF patients. Although the outcome of the current study was basically compatible to that of the previous 2 articles, the questionnaire in this study was an AF-specific one and we analyzed the QOL separately in the patients with paroxysmal and chronic AF, and the patients with AF recurrence did not show any improvement in the QOL after the ablation. Compared to the previous report, the baseline AFQLQ score is lower in this study. It could be explained by the difference of subject. They evaluated the QOL of stable AF patients, meanwhile our subject consisted of the patients with drug-resistant AF. Drug Effects on the QOL Various effects of drugs should be taken into consideration, when we evaluate the patient s QOL. In our study design, the patients with chronic AF were supposed to take AAD for 3 months after the ablation. We presumed it would partly decrease their QOL especially in the subscale of limitations of daily and special activities and ; however, the AFQLQ including that subscale demonstrated improvements in the patients without any AF recurrence after the ablation. Moreover, the AAD effects, rather than the ablation, on avoiding AF recurrence, might have increased the QOL. In the present study, after the discontinuation of the AAD by 3 months, the AF recurrences did not increase and the improvement in the QOL did not change all the way up to the end of the follow-up period. AAD were less likely to be associated with the clinical course of the QOL, and the maintenance of sinus rhythm itself seemed to be very important for improving the QOL in the patients with AF. Different Clinical Courses of the QOL Between the Paroxysmal and Chronic AF Patients Because symptoms in the patients with chronic AF were masked due to the long-term clinical course, they might gain better QOL soon after the ablation therapy. The patients with paroxysmal AF did not always feel symptoms related to AF. They felt symptoms only during AF attacks. It might require some time to confirm if the patients were free of AF after the ablation, which could result in a longer time for the QOL to improve than in the chronic AF patients. Recent studies have shown that sinus rhythm could be maintained for long periods in the majority of patients with chronic AF by means of the CA. 6 Many patients with chronic AF are expected to improve their QOL by the CA. Study Limitations Participants who underwent an invasive procedure might report improvements in the QOL simply as a result of being part of a treatment group. It seemed to be one of the major limitations to assess the effect of the invasive procedure on the change of the QOL. A further study to compare the QOL between the ablated patients and medically treated patients is needed to determine the precise effect of the CA on the clinical course of the QOL. Other limitations involved our relatively small sample size, especially in the chronic AF group. However, most of the patients without any AF recurrences had a similar tendency toward a QOL improvement after the ablation. Therefore, we speculated that even with a larger sample size, the outcome would point in the same direction. The third limitation was the follow-up period of 6 months. Longer follow-up periods of more than 6 months might reveal an additional improvement in the QOL, nevertheless, the improvement in the QOL reported by Pappone et al stopped at 6 months after the ablation. Six follow-up periods might be adequate to assess any change in the QOL following the ablation. Conclusions Maintenance of sinus rhythm could provide a better QOL to the patients with not only paroxysmal but also chronic AF by means of LA ablation. The clinical course of the QOL was different between those patients. Although the QOL of the paroxysmal AF exhibited a gradual improvement, those in chronic AF improved soon after the ablation therapy. Circulation Journal Vol.72, April 08

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