Influence of body mass index on quality of life in atrial fibrillation patients undergoing catheter ablation

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1 Influence of body mass index on quality of life in atrial fibrillation patients undergoing catheter ablation Sanghamitra Mohanty, MD,* Prasant Mohanty, MBBS, MPH,* Luigi Di Biase, MD, PhD, FHRS,* Rong Bai, MD, FHRS,* Amy Dixon,* David Burkhardt, MD, FHRS,* Joseph G. Gallinghouse, MD,* Rodney Horton, MD,* Javier E. Sanchez, MD,* Shane Bailey, MD,* Jason Zagrodzky, MD,* Andrea Natale, MD, FACC, FESC, FHRS* # From *St. David s Medical Center, Texas Cardiac Arrhythmia Institute, Austin, Texas; School of Biological Sciences, University of Texas at Austin, Texas; Department of Cardiology, University of Foggia, Foggia, Italy; Department of Biomedical Engineering, University of Texas at Austin, Texas; Department of Internal Medicine, Tong-Ji Hospital, Tong- Ji Medical College, Huazhong University of Science and Technology, Wuhan, China; Interventional Electrophysiology, Scripps Clinic, San Diego, California; # Division of Cardiology, Stanford University, Palo Alto, California. BACKGROUND Obesity increases the risk of atrial fibrillation (AF), and AF seriously impairs the quality of life (QoL). However, it is not known whether body mass index (BMI) has any direct influence on QoL in AF. OBJECTIVE To study the association between baseline BMI and QoL improvement in patients with AF following catheter ablation. METHODS Six hundred sixty patients with AF (62 10 years, male 69%, paroxysmal AF 27%, persistent AF 31%, long-standing persistent AF 42%) made up the study population. On the basis of the baseline BMI, patients were categorized into 2 groups: normal (BMI 25) and overweight/obese (BMI 25). The QoL survey was done at baseline and at 12-month postablation by using the Medical Outcomes Study Short Form-36 (SF-36), Beck Depression Inventory (BDI), Hospital Anxiety and Depression (HAD) scale, and State-Trait Anxiety Inventory (STAI). RESULTS At baseline, dyslipidemia, hypertension, diabetes, coronary artery disease, and large left atrium had higher prevalence in the overweight/obese population. In addition, the preprocedure QoL scores on the SF-36, HAD scale, and STAI were significantly lower in this group than in the normal-bmi group. At the 12-month postablation assessment, no significant improvement in QoL score was noted in the normal-bmi group. However, in the overweight/obese group, QoL scores improved significantly in all scales, except the physical functioning and bodily pain categories of SF-36. Long-term ablation success was not different across the groups (69% normal BMI, 63% high BMI, log-rank P.109). Patients with successful ablation showed significant improvement in QoL scores compared with those who failed. The multivariable analysis revealed the baseline QoL score and BMI 25 to be independent predictors of QoL improvement. CONCLUSION Obese patients with AF tend to have a better postablation QoL outcome than do their nonobese counterparts. KEYWORDS Body mass index; Atrial fibrillation; Catheter ablation; Quality of life; SF-36; BDI; HAD; STAI ABBREVIATIONS AADs anti-arrhythmic drugs; AF atrial fibrillation; AT atrial tachycardia; BDI Beck Depression Inventory; BMI body mass index; BP bodily pain; GH general health; HAD Hospital Anxiety and Depression; MCS mental component summary; SF-36 Medical Outcomes Study Short Form- 36; MH mental health; PAF paroxysmal AF; PCS physical component summary; PF physical functioning; PV pulmonary vein; QoL quality of life; RE role limitations due to emotional problem; RP role limitations due to physical health; SF social functioning; STAI State-Trait Anxiety Inventory; VT vitality (Heart Rhythm 2011;8: ) 2011 Heart Rhythm Society. All rights reserved. Address for reprints and correspondence: Dr Andrea Natale, MD, Texas Cardiac Arrhythmia Institute at St. David s Medical Center, 3000 N I-35, Suite 720, Austin, TX address: dr.natale@gmail.com. (Received May 4, 2011; accepted July 2, 2011.) Introduction Obesity is a fast growing health problem in the United States, with more than 70% of adults classified as overweight or obese. 1 It is associated with increased cardiovascular risk and could be responsible for nearly 60% of the increase in the incidence of atrial fibrillation (AF). AF is the commonest rhythm disorder encountered in clinical practice, and its prevalence is predicted to increase 7-fold in the coming decades. 2 These data clearly demonstrate the severity of these 2 interlinked epidemics and necessitate an indepth study of the impact that they have on one another. Quality of life (QoL) is a subjective phenomenon being conceptualized by many as a combination of symptoms, functional status, and patient s health perceptions. It has many domains that are measured by using standardized questionnaires. Prior studies have reported an approximately 4% increase in new-onset AF with each unit increase in body mass index (BMI), when BMI is investigated as a continu /$ -see front matter 2011 Heart Rhythm Society. All rights reserved. doi: /j.hrthm

2 1848 Heart Rhythm, Vol 8, No 12, December 2011 ous variable. 1 3 In this study, we examined the association between BMI and the change in QoL between the pre- and the postablation period in a sizeable group of patients with AF by using multiple measurement tools. Material and methods Patient population Seven hundred twenty consecutive patients with AF undergoing radiofrequency catheter ablation were prospectively enrolled in this study. For each patient, complete clinical history, procedural data, and follow-up information were prospectively collected and entered into our Afib Registry at St. David s Medical Center, Austin, Texas. On the basis of the baseline BMI, patients were categorized into 2 groups: lean or normal (BMI 25) and overweight and obese (BMI 25). 2,4,5 Patients were asked to participate in a set of QoL surveys before and 12 months after the procedure. At the end of the study, follow-up survey was not available for 60 patients. Six hundred sixty patients (62 10 years, male 69%, paroxysmal AF [PAF] 27%, persistent AF 31%, long-standing persistent AF 42%) with both pre- and postprocedure survey made up the study population. Assessment of QoL QoL survey was done for all patients before and 12 months after ablation by using 4 questionnaires: Beck Depression Inventory (BDI), Medical Outcome Study Short Form-36 (SF-36), Hospital Anxiety and Depression (HAD) scale, and State-Trait Anxiety Inventory (STAI). SF-36 The SF-36 survey assesses 8 aspects of health status, namely, physical functioning (PF), role limitations due to physical health (RP), mental health (MH), role limitations due to emotional problem (RE), social functioning (SF), bodily pain (BP), general health (GH), and vitality (VT). Two composite scores physical component summary (PCS) and mental component summary (MCS) were computed from the SF-36 subscales (PCS included PF, RP, BP, and GH, and MCS included VT, SF, RE, and MH). All responses were scored on a scale from 0 to 100, with 100 representing the best possible functioning status. SF-36 subscales were used to examine any connection between the objective evidence of AF (duration, frequency, and intensity of AF) and the subjective perception of illness and QoL. BDI BDI is the most widely used ( gold standard ) multiplechoice self-report inventory for measuring the severity of depression. The survey consists of 21 questions; lower score indicates lesser depression and better QoL. HAD scale The HAD scale is a frequently used 14-item self-rating instrument for anxiety and depression in nonpsychiatric hospital patients. It includes subscales for the measurement of anxiety and depression separately. A lower score translates to better QoL. STAI STAI is a definitive tool for measuring anxiety in adults. It has two 20-item scales to measure short-term anxiety in a specific situation (state anxiety) and anxiety as a general trait (trait anxiety). Higher score represents poorer QoL. BDI, HAD scale, and STAI questionnaires were used to assess the prevalence and persistence of anxiety and depression in preand postablation patients with AF. The self-administered mode was adopted as the method of survey assessment. Ablation procedure Details of the electrophysiology study and the ablation procedure along with anticoagulation therapy have been described in earlier publications from our group. 6,7 Briefly stating, anti-arrhythmic drugs (AADs) were discontinued 4 to 5 half-lives before ablation. A circular mapping catheter (Lasso, Biosense Webster, Diamond Bar, CA) and a 3.5-mm open-irrigation tip catheter (Thermocool, Biosense Webster) were used for ablation. In patients with PAF, the pulmonary vein (PV) antrum, the posterior wall between the PVs, and the area anterior to the right PV along the left atrial septum were ablated by using radiofrequency energy. The superior vena cava was also isolated if PV-like potential was recorded in that region. In patients with non-paf, the PV antrum, the posterior wall down to the coronary sinus, and the left septal wall were isolated by using radiofrequency energy. In addition, left and right atria were mapped to identify complex fractionated atrial electrograms, which were ablated as well. Complex fractionated atrial electrograms were defined as electrograms composed of 2 or more deflections, having continuous baseline activity, or both or electrograms with a cycle length of 120 ms. After ablation, isoproterenol (up to 30 mcg/min) challenge was performed in all patients to locate any non-pv triggers any firing sites outside the PV antrum or to ensure electrical disconnection. All sites showing firings were ablated. Endpoint Long-term procedural success and improvement in QoL were 2 primary endpoints for this study. Procedural success is defined as freedom from atrial flutter, AF, or atrial tachycardia (AT) of 30- second duration in the absence of AADs at follow-up. 7 Episodes that occurred during the first 3 months (blanking period) after the procedure were not considered as recurrences. 6 Follow-up Patients were discharged after overnight observation following ablation. They were discharged on their previously ineffective AADs that were continued during the blanking period (12 weeks). After the blanking period, AADs were discontinued. In the case of recurrence after the blanking period, patients were given previously ineffective AADs. All patients were followed up for 15 3 months postablation. Follow-up was performed at 3, 6, 9, and 12 months after the procedure, with a cardiology evaluation, a 12-lead electrocardiogram, and 7-day holter monitoring.

3 Mohanty et al High BMI Correlates With Better QoL in Postablation AF 1849 After ablation, the patients were given an event recorder for 5 months and were asked to transmit their rhythm every time they had symptoms compatible with arrhythmias and at least twice a week even if asymptomatic. Any episode of AF/AT longer than 30 seconds was considered as a recurrence. QoL surveys were conducted before ablation (baseline) and at 12-month follow-up. Statistical analysis Continuous data are described as mean standard deviation and as counts and percentage if categorical. Student s t-test, 1-way analysis of variance, chi-square test, and Fisher s exact test were used to compare groups. Paired t-tests were used to compare QoL scores at baseline and at 12- month follow-up. The Pearson linear correlation coefficient (r) and Spearman rank correlation coefficient ( ) were calculated to assess the correlation between individual scales. The multivariate general linear model was used for identifying significant predictors of QoL improvement while controlling for clinically relevant covariates (age, gender, comorbidities, type of AF, baseline ejection fraction, left atrium diameter, and preprocedure medications). Potential confounders were entered into the model based on known or expected clinical relevance, regardless of their statistical significance. All tests were 2 sided and a P value of.05 was considered statistically significant. Analyses were performed by using SAS (SAS Institute, Inc, Cary, NC). Results A total of 660 consecutive patients (62 10 years, male 69%, PAF 27%, persistent AF 31%, long-standing persistent AF 42%) undergoing catheter ablation for AF, who had the baseline and 12-month postprocedure QoL survey available, were included in the study. According to the baseline BMI value, the study cohort was grouped into 2 categories: normal BMI (BMI 25, n 139, 21%) and high BMI (BMI 25, n 521, 79%). Compared with patients in the normal-bmi group, patients in high-bmi group had significantly higher prevalence of dyslipidemia, hypertension, diabetes, and coronary artery diseases and had larger left atrium diameter. No difference was noted for age, gender, AF type, left ventricular ejection fraction, and preprocedure drug use. The clinical characteristics at baseline are presented in Table 1. Table 2 presents information relating to QoL scores at the 2 points of assessment baseline and 12-month followup. Baseline QoL scores were generally higher among the patients with normal BMI. As expected from the higher comorbidities, the baseline QoL for the high-bmi group was significantly low in 5 of 8 SF-36 subscales (PF, RP, RE, VT, and GH) and in HAD and STAI anxiety. Non-PV triggers were more prevalent in the high-bmi group compared with the normal-bmi group (336 [64%] vs 31 [22%], P.001). At the end of the procedure, persistence of AF/AT was observed in 18 patients (12.7%) in the normal-bmi group and 49 patients (9.5%) in the high-bmi Table 1 Baseline clinical characteristics BMI 25 (n 139, 21%) BMI 25 (n 521, 79%) P value Age (y) Male 90 (65%) 370 (71%).15 AF Type PAF 44 (32%) 135 (26%).176 PER 39 (28%) 162 (31%).489 LSP 56 (40%) 224 (43%).566 AF Duration (mo) BMI Dyslipidemia 56 (41%) 272 (52%).013 Hypertension 68 (49%) 318 (61%).01 CHF 7 (5%) 47 (9%).128 Diabetes 11 (8%) 89 (17%).007 Prior stroke/tia 8 (6%) 26 (5%).717 CAD 22 (16%) 132 (25%).019 OSA 15 (11%) 73 (14%).321 LA Diameter (mm) LV EF (%) Follow-up (mo) Pacemaker 10 (7%) 26 (5%).309 ACE inhibitor 44 (32%) 193 (37%).239 Beta blocker 53 (38%) 219 (42%).406 Aspirin 33 (24%) 141 (27%).43 Lipid-lowering therapy 39 (28%) 156 (30%).665 INR at baseline Fluoroscopic time (min) RF time (min) Procedure time (min) Failed AADs Number of prior 48 (35%) 238 (46%).018 cardioversions Prior surgical ablations 5 (3.6%) 21 (4.0%).815 Preablation TEE 11 (8%) 53 (10%).423 Preablation TTE 139 (100%) 521 (100%) AADs anti-arrhythmic drugs; ACE angiotensin-converting enzyme; AF atrial fibrillation; BMI body mass index; CAD coronary artery disease; CHF congestive heart failure; INR international normalized ratio; LA left atrium; LSP long-standing persistent; LV EF left ventricular ejection fraction; OSA obstructive sleep apnea; PAF paroxysmal AF; PER persistent AF; RF Time radiofrequency time; TEE transesophageal echocardiogram; TIA transient ischemic attack; TTE transthoracic echocardiogram. group (P.305). Sinus rhythm was achieved in these patients by cardioversion. QoL at follow-up by BMI groups In the normal-bmi group, no significant improvement was observed at the 12-month postablation assessment. Lack of improvement was more evident in the physical composite of SF-36; PF and BP became worse, there was only a 0.1% increase in RP, and although the GH improved 4.6%, it did not reach statistical significance. Similarly, the drop in anxiety and depression levels in the HAD scale, BDI, and STAI was far from being statistically significant (Table 2, Figure 1). On the other hand, in the high-bmi group, the 12-month postablation QoL scores improved significantly in all measures, except for PF and BP. The change in PF was very close to statistical significance (P.08), and an improve-

4 1850 Heart Rhythm, Vol 8, No 12, December 2011 Table 2 QoL scores by BMI category BMI 25 (n 139, 21%) % P BMI 25 (n 521, 79%) % P P value from paired t-test comparing baseline (BMI 25 vs BMI 25) and PRE POST change value PRE POST change value postprocedure QoL PF RP RE VT MH SF BP GH HAD: anxiety HAD: depression BDI score T-anxiety score S-anxiety score BDI Beck Depression Inventory; BP bodily pain; GH general health; HAD Hospital Anxiety and Depression; MH mental health; PF physical function; POST postprocedure follow-up; PRE preprocedure; RE role limitations due to emotional problem; RP role limitations due to physical health; S-anxiety State-anxiety; SF social functioning; T-anxiety trait anxiety; VT vitality. ment of 7.8% was considerably high compared with 1% worsening in the normal-bmi group. Among SF-36 subscales, maximum improvement (27%) was observed in RP, while RE and VT showed an increase of more than 20%. The HAD scale and BDI scores also reported substantial reduction with about 25% decrease in the mean score. As regard to STAI, while the T-anxiety score did not change, the S-anxiety score was significantly lower (9.5% decrease) at follow-up (Table 2, Figure 1). QoL at follow-up by ablation success At the end of follow-up, 424 of 660 patients (64%) were AF/AT free (96 [69%] in the normal-bmi group and 328 [63%] in the high-bmi group, log-rank P.109). On an average, the normal-bmi and high-bmi groups had 1.3 and 1.4 procedures, respectively. Compared with patients who failed, those with successful ablation experienced significantly higher improvement in SF-36 PCS (increment from baseline was [P.144] and [P.001], respectively]. While MCS scores improved across the board, procedure success did not show any substantial impact on the degree of improvement. The decrease in HAD scale and BDI scores was larger with ablation success compared with failed procedures; change in HAD anxiety score was (P.003) and (P.131); change in HAD depression score was (P.001) and (P.415), and change in BDI score was (P.024) and (P.642) for successful and failed ablation, respectively. STAI scores did not show any association with ablation success. A subanalysis was performed to assess the magnitude of QoL change after successful ablation among both the BMI groups. Successful ablation resulted in significant QoL change in the high-bmi group (change in PCS score was [P.006], change in HAD anxiety score was [P.001], change in HAD depression score was [P.001], and change in BDI score was [p.015]), whereas although some improvement occurred in the normal-bmi group, it did not reach statistical significance ( PCS [P.059], change in HAD anxiety score was [P.103], change in HAD depression score was [P.085], and change in BDI score was [P.115]). Predictor of QoL improvement The predictive role of baseline risk factors in the change in QoL score was assessed in a multivariable regression analysis using a general linear model. The covariates in the model are described in the Statistical Analysis section. After adjusting for important confounders, baseline QoL score and high BMI (BMI 25) were found to be independent predictors of QoL improvement. Every unit increase in baseline PCS and MCS scores predicted 1.4 units less improvement in the PCS score (95% CI 2.13 to 0.63, P.005) and 1.7 units less improvement in the MCS score (95% CI 2.4 to 1.059, P.001) at followup. In the case of the HAD scale and BDI, higher baseline depression was associated with larger improvement, regression coefficient 1.9 (95% CI , P.001) and 1.29 (95% CI , P.001), respectively. On the other hand, high BMI (BMI 25 at baseline) predicted larger improvement in the PCS score (coefficient 3.5, 95% CI , P.008), MCS score (coefficient 2.1, 95% CI , P.009), HAD scale score (coefficient 1.66, 95% CI , P.004), and BDI score (coefficient 0.78, 95% CI , P.012) at follow-up. Complications During ablation, 1 (0.7%) patient with normal BMI and 4 (0.8%) patients with high BMI (P 1.00) had pericardial effusions requiring pericardiocentesis. None of the patients

5 Mohanty et al High BMI Correlates With Better QoL in Postablation AF 1851 Figure 1 A: Quality of life (QoL) at baseline and at 12-month follow-up in patients with normal body mass index (BMI). B: QoL at baseline and 12-month follow-up in patients with high BMI. P represents the P value from paired t-test comparing baseline and postprocedure QoL. required surgery. All patients were discharged after a median hospitalization of 1 day. No other major complications were observed in any of the groups. Discussion In this study, 79% of the population was overweight or obese and interestingly they reported significant improvement in all domains of QoL during postablation follow-up whereas no substantial improvement was observed in patients with normal BMI. In other words, although obesity is a well-known risk factor for AF, our findings demonstrated that it predicts better ablation outcome in terms of QoL. Similar obesity paradoxes have been observed in the elderly population as well as in patients with chronic obstructive pulmonary disease, advanced cancers, rheumatoid arthritis, acquired immune deficiency syndrome, hypertension, and coronary artery disease. 1,8 In an earlier study, Cha et al 4 reported substantial QoL improvement in postablation patients with AF across all BMI classes: lean, overweight, and obese. We observed significant improvement in QoL among overweight and obese patients only and not in the lean population. This difference can be explained by 3 possible factors: the lean population for Cha et al was (1) younger ([55 12 years] compared with ours [63 12 years]) and (2) predominantly composed of patients with PAF (68% vs 32% in our study). Several published researches have demonstrated younger age and shorter AF duration with low symptom burden as well as absence of adverse drug effects and improved rhythm control to be the causal factors behind better QoL after successful catheter ablation in PAF. 3,9 11 The third factor influencing QoL assessment could be the mode of questionnaire administration. It is not clear whether Cha et al used a self-administered or interviewer-administered mode to measure QoL. However, it is well known that usually patients are reluctant to answer or prefer to give socially favorable responses to sensitive questions during interviewer-administered surveys while willing to respond more truthfully to self-administered questionnaires. In our study, patients were given the opportunity to answer the survey questions in the privacy of their homes without any interference from the physicians or other health care professionals. By strict adherence to the self-administration mode, we possibly achieved an unbiased assessment of QoL in our study population. Wokhlu et al 12 measured QoL in 502 patients with AF by using the SF-36 scale and reported a less robust QoL improvement in patients with a higher baseline score. Our findings were in agreement with theirs. In our study populations, patients with BMI 25 had higher baseline scores in almost all the subscales of SF-36, BDI, HAD scale, and STAI. Postablation scores for these patients showed a very small and nonsignificant change. In contrast, patients with BMI 25 started with a lower baseline score but had a significant positive change in almost all scales at 12-month follow-up. Lower baseline scores represented a lower feeling of well-being because of the symptom burden of AF, extended and difficult treatment history, and associated physical and mental limitations causing greater hardship in the daily activities in the high-bmi group. After ablation, these patients had a much better perception and appreciation of QoL improvement not only because of the elimination of AF symptoms but also because of the riddance of frequent utilization of health care resources. Patients with normal BMI are usually health conscious and tend to consult their doctors earlier in the course of AF for primary ablation or ablation immediately after the failure of the first AAD. Therefore, they usually have a less difficult AF course with fewer cardioversions and prior ablations, which helps in maintaining an almost normal QoL. In our lean population, possibly for the same reason (AAD failed vs , prior cardioversions 35% vs 46%, Table 1), QoL was affected very little at baseline, and thus the postablation score failed to reflect a significant improvement. Several nonrandomized studies on QoL following catheter ablation in AF have documented positive improvement

6 1852 Heart Rhythm, Vol 8, No 12, December 2011 in all or nearly all subscales of SF-36 after successful curative ablation. 10,13 16 We observed a similar trend in our study population. Although obesity is a known risk factor for AF, we saw a comparable procedural success rate in both groups (BMI 25 and BMI 25) at follow-up. Obese patients tend to have a higher prevalence of non-pv triggers and the success rate in that group could have been lower if the non-pv triggers were not targeted for ablation. In a prior study published by our group, we reported higher BMI to be an independent predictor of AF recurrence after catheter ablation among females. 7 However, in that study we did not observe any significant association of BMI with procedural success in the overall population, which is in agreement with the current study. In our study population, comorbidities such as dyslipidemia, hypertension, diabetes, and coronary artery disease were more prevalent in the overweight and obese group. Earlier studies have reported that as the obese patients frequently benefit from the cardioprotective effects of antihypertensive (angiotensin-converting enzyme inhibitor, beta blockers) and cholesterol-lowering statin drugs 1,17,18 before and after ablation. It is worth mentioning that as QoL is a subjective perception of disease intrusion, anything that makes the disease burden lighter would also contribute to a better sense of well-being. Limitations Certain limitations of this study need to be acknowledged. (1) The questionnaires that were used in this study are considered as generic tools. These do not take into account some of the specific clinical and demographic characteristics of the AF population. In that case, an AF-specific questionnaire could have been a better choice. However, the wealth of data and extensive validation that come with these generic tools cannot be ignored. (2) Measures of inflammation and metabolic stress were not incurred to check whether there was any direct association between these markers, BMI, and QoL improvement. Conclusion Our study is the first prospective observational study that used 4 assessment tools to measure QoL in patients with AF undergoing catheter ablation and examined the association between BMI and improvement in QoL scores following ablation. Our data demonstrate a clear association between BMI and QoL outcome in patients with AF and state that obese patients tend to have a better QoL than do nonobese patients after catheter ablation. However, as it is beyond the capacity of this observational study to establish the exact mechanism of this observation, it seems necessary to use disease-specific QoL tools in a larger population to confirm this result References 1. Badheka A, Rathod A, Kizilbash MA, et al. 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Obesity and hypertension, heart failure, and coronary heart disease risk factor, paradox, and recommendations for weight loss. Ochsner J 2009;9: Erdogan A, Carlsson J, Neumann T, et al. Quality-of-life in patients with paroxysmal atrial fibrillation after catheter ablation: results of long-term followup. Pacing Clin Electrophysiol 2003;26: Reynolds MR, Lavelle T, Vidal Essebag, et al. Influence of age, gender, and AF recurrence on quality of life outcomes in a population of new-onset AF patients: the FRACTAL Registry. Am Heart J 2006; 152: Wilber DJ, Pappone C, Neuzil P, et al, for the ThermoCool AF Trial Investigators. Comparison of antiarrhythmic drug therapy and radiofrequency catheter ablation in patients with paroxysmal atrial fibrillation: a randomized controlled trial. JAMA 2010;303: Wokhlu A, Monahan KM, Hodge DO, et al. Long-term quality of life after ablation of atrial fibrillation: the impact of recurrence, symptom relief, and placebo effect. 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