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(Circulation. 2000;101:1138.)
© 2000 American Heart Association, Inc.

Clinical Investigation and Reports

Clinical Outcomes After Ablation and Pacing Therapy for Atrial Fibrillation

A Meta-Analysis

Mark A. Wood, MD; Chris Brown-Mahoney, PhD; G. Neal Kay, MD; Kenneth A. Ellenbogen, MD

From Virginia Commonwealth University/Medical College of Virginia (M.A.W., K.A.E.); the University of Minnesota, Minneapolis (C.B.-M.); and the University of Alabama, Birmingham (G.N.K.).

Correspondence to Mark A. Wood, MD, Medical College of Virginia, PO Box 980053, Richmond, VA 23298-0053.

	Abstract

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Background—Radiofrequency ablation of the atrioventricular node and permanent pacing are used for symptomatic relief in patients with medically refractory atrial fibrillation. In this study, meta-analysis was used to clarify clinical outcomes and survival after ablation and pacing therapy using data from the published literature.

Methods and Results—We used 21 studies with a total of 1181 patients in the meta-analysis. All patients had medically refractory atrial tachyarrhythmias, primarily atrial fibrillation (97%). Nineteen measures of clinical outcome, encompassing quality of life, ventricular function, exercise duration, and healthcare use, were derived from the studies. The meta-analysis demonstrated significant improvement after ablation and pacing therapy in all outcome measures except fractional shortening, which demonstrated a trend toward improvement (P=0.08). Ejection fraction did show significant improvement (P<0.001). The calculated 1-year total and sudden death mortality rates after ablation and pacing therapy were 6.3% and 2.0%, respectively.

Conclusions—Ablation and pacing therapy improves a broad range of clinical outcomes for patients with medically refractory atrial fibrillation. The calculated 1-year mortality rates after this therapy are low and comparable with medical therapy.

Key Words: ablation • pacing • fibrillation • clinical trials • survival

	Introduction

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Atrial fibrillation affects >2 million people in the United States alone.¹ It is estimated that 12% of patients with atrial fibrillation are refractory to medical therapy.² These patients may suffer intractable symptoms and a severely diminished quality of life.³ Radiofrequency catheter ablation of the atrioventricular (AV) node to produce complete heart block followed by permanent pacemaker implantation (ablation and pacing therapy) is a recognized treatment to alleviate symptoms in medically refractory patients.⁴ Data supporting the use of this procedure are derived from numerous, small, uncontrolled clinical trials, however. The clinical response after ablation and pacing therapy varies considerably.^{5 6 7 8 9} In addition, reports of sudden death after ablation and pacing have raised concerns regarding excessive mortality that is directly attributable to the procedure.¹⁰ The clinical evaluation of ablation and pacing therapy is complicated by the multiple, small, uncontrolled clinical studies; the use of differing instruments to measure outcomes; and the variable outcome results. Currently, very limited data have been derived from randomized, controlled studies to clarify these findings.^{5 11}

When properly applied, meta-analysis can increase the statistical power of primary end points, clarify disagreement among studies, and estimate effect sizes to quantify outcomes from a collection of individual reports.^{12 13 14 15 16 17 18} The purpose of this study was to quantify the effects of ablation and pacing therapy on measures of clinical outcome and survival using meta-analysis.

	Methods

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Search Strategy
A literature search for all published outcome studies of radiofrequency ablation and pacing therapy was performed for the period from January 1989 through June 1998. The search strategy included the authors’ knowledge of the literature, a review of bibliographies of published reports, manual library searches, and computerized MEDLINE searches. Criteria for inclusion in the analyses were as follows: (1) peer-reviewed, full-length articles published in English, (2) the use of radiofrequency catheter ablation to produce complete heart block in the setting of medically refractory atrial tachyarrhythmia or explicit separation of radiofrequency ablation data from direct-current catheter ablation in comparative studies, and (3) numeric representation of measures of clinical outcome before and after ablation and pacing and/or explicit data on sudden death or total mortality presented with follow-up duration. Abstracts, studies using only direct-current ablation, and studies examining only AV nodal modification for ventricular rate slowing rather than complete AV junctional ablation were excluded from the meta-analysis. Because only 2 randomized trials were found during the search, their data were included in the analysis with the nonrandomized trials.^{5 11}

Statistical Analysis
Results from 19 measures of clinical outcome were extracted from the studies (Table 1). These included measures of exercise duration, symptoms, quality of life, cardiac function, and healthcare use. The estimate of the effect size was defined as the mean difference in a measure before and after radiofrequency ablation and pacing. All measures reported on Likert-type scales were standardized to proportions to be combined across studies. For each of the 19 measures, effect size and variance were calculated using the maximum likelihood method (Fastpro software, Academic Press, Inc). Estimates of the effect size and 95% confidence intervals (CIs) were made by comparing measures before and after ablation within each study and then combining these measures across studies using the random-effects model.¹⁷

View this table: [in this window] [in a new window]   Table 1. Measures of Clinical Outcomes

The survival analysis used a Kaplan-Meier model adjusted for time to control for different follow-up durations among studies. The combined 1-year mortality rates with 95% CIs were calculated by the DerSimonian and Laird method.^{17 18} Because of the broad distribution of follow-up durations (10 studies had durations 1 year and 11 studies had durations <1 year), 1-year mortality rates were calculated from studies with 1 year of follow-up and monthly mortality rates were calculated from studies with <1 year of follow-up.

	Results

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On the basis of key search words, the search strategy produced >400 studies. A total of 21 studies containing a total of 1181 patients met the inclusion criteria. The patient characteristics for each study are summarized in Table 2. The outcome and survival findings from each study are summarized in Table 3. All studies included only patients with highly symptomatic, medically refractory atrial fibrillation (97%), atrial flutter,^{3 9 10 25 27} or atrial tachycardia (3%).^{18 19 30 31}

View this table: [in this window] [in a new window]   Table 2. Summary of Patient Characteristics From the 21 Studies Included in the Meta-Analysis

View this table: [in this window] [in a new window]   Table 3. Summary of Findings From the 21 Studies Included in the Meta-Analysis

The outcomes analysis included 642 patients in 15 studies (median patients per study, 25; range, 10 to 156).¹ The average duration of follow-up ranged from 48 days to 2.3 years. Thirteen studies were nonrandomized trials, and 2 compared ablation and pacing therapy with pharmacological therapy or radiofrequency modification of AV nodal conduction.^{5 11} Data on 1073 patients from 16 studies (median patients per study, 30; range, 11 to 235) was included in the mortality analysis.² The average duration of follow-up ranged from 3 months to 2.3 years.

Clinical Outcomes
The effect sizes and 95% confidence intervals for each of the 19 outcome measures are illustrated in Figures 1 through 3 and listed in Table 4. All measures showed significant improvement except for fractional shortening, which showed a trend toward improvement (P=0.08). Cardiac symptom scores, quality-of-life measures, and healthcare use showed improvement in all individual studies. Among individual studies, exercise duration and ejection fraction were unchanged by ablation and pacing therapy in 4 of 7 and 5 of 11 studies, respectively (Table 3). The meta-analysis results showed significant improvement in both of these measures. Fractional shortening was improved in 2 of 3 studies.^{9 28 29}

View larger version (10K): [in this window] [in a new window]   Figure 1. Graphic representation of effect sizes (•) and 95% CIs (error bars) for measures of exercise duration, heart rate, and percentage of patients who improved after AV junctional ablation and pacing. Units for effect sizes are shown and explained in Table 1. Worsened indicates an unfavorable change in clinical outcome measure, and improved, a favorable change in clinical outcome measure. P<0.05 for all effect sizes (Table 4).

View larger version (9K): [in this window] [in a new window]   Figure 2. Graphic representation of effect sizes and 95% CIs for measures of left ventricular function, healthcare use, and New York Heart Association (NYHA) functional classification after AV functional ablation and pacing. Graph format and abbreviations as in Figure 1. Units for effect sizes are shown and explained in Table 1. P0.001 for all effect sizes except fractional shortening, which is P=0.08 (Table 4).

View larger version (15K): [in this window] [in a new window]   Figure 3. Graphic representation of effect sizes and 95% CIs for measures of quality of life and symptoms after AV junctional ablation and pacing. Graph format and abbreviations as in Figure 1. These normalized effect size values have no units. QOL indicates quality of life, and Sx, symptoms. P0.005 for all effect sizes (Table 4).

View this table: [in this window] [in a new window]   Table 4. Measures of Clinical Outcome After Treatment

Mortality
The calculated monthly and 1-year total mortality rates were 1.4% (95% CI, 0.04% to 2.4%) and 6.3% (95% CI, 5.5% to 7.2%), respectively. The range of total mortality rates for studies with 1 year of follow-up was 0% to 23%; it was 0% to 18% for studies with <1 year follow up.

The calculated monthly and 1-year sudden death rates were 0.7% (95% CI, 0.01% to 1.2%) and 2.0% (95% CI, 1.5% to 2.6%), respectively. The range of sudden death rates for studies with 1 year of follow-up was 0% to 9% and, for studies with <1 year follow-up, 0% to 6%.

	Discussion

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The major findings of this study are as follows: (1) in patients with refractory atrial tachyarrhythmia, ablation and pacing therapy significantly reduces cardiac symptoms and healthcare use while improving exercise duration, quality of life, and ejection fraction, and (2) the 1-year total and sudden death mortality rates after ablation and pacing therapy are estimated to be 6.3% and 2.0%, respectively.

The long-term management of atrial fibrillation is often unsatisfactory, despite the availability of numerous pharmacological and nonpharmacological therapies. The ability of ablation and pacing therapy to provide relief to the most highly symptomatic patients meets a large and growing challenge in clinical practice. In this study, the improvement in symptoms, quality of life, and healthcare use after ablation and pacing therapy was uniform across studies and highly significant for the combined data. The variable effects on exercise duration and ventricular function reported among individual studies may result from the small sample sizes and patient selection biases. The mechanism of improved exercise duration is probably related to the salutary effects of strict heart-rate control on ventricular systolic function, diastolic function, filling time, and cardiac output.^{24 32 33}

The improved left ventricular ejection fraction noted in these studies is an important feature of this therapy. In studies stratifying patients by ejection fraction before therapy, mean left ventricular function improved significantly in those patients with baseline impairment, but it remained unchanged or decreased slightly in those with normal ventricular function.^{6 28} Improved ventricular function after ablation and pacing may be attributed to enhanced diastolic filling times, improved cardiac mechanics, the withdrawal of negative inotropic drugs, and the reversal of tachycardia-induced cardiomyopathy.³⁴

The mortality rates in some reports have raised concerns about excess deaths that are directly attributable to ablation and pacing therapy.^{10 19 31} In addition to a risk of pacing-system failure, a specific risk for sudden death due to polymorphic ventricular tachycardia after ablation and pacing has been identified.^{10 35} This complication seems to be minimized by programming to high baseline pacing rates (80 to 90 bpm) for 1 to 2 months after ablation.¹⁰ Previous mortality estimates may have been influenced by the early experience with direct-current catheter ablation and before the recognition of the risk for polymorphic ventricular arrhythmias.^{10 36}

Recent studies using high-rate pacing have reported no sudden deaths at up to 25 months of follow up.^{5 11 31} The populations undergoing ablation and pacing have a high prevalence of structural heart disease and heart failure, which are associated with an intrinsic risk of mortality. The total mortality and arrhythmic death rates in the 1330 patients with atrial fibrillation who were followed in the Stroke Prevention in Atrial Fibrillation Trial were 6.7% and 2.4%, respectively, at 1.3 years of follow up.³⁷ This meta-analysis describes very comparable mortality rates that do not seem to be disproportionate for the characteristics of the study group. Reports of sudden death in the absence of structural heart disease mandate careful consideration of the risks of this procedure in each individual patient, however.¹⁰

Limitations
The limitations of meta-analysis are well recognized.³⁸ The design excluded studies with data presented in noncombinable formats. Also excluded were studies not published in English, including European trials. The results of studies from the European literature, however, are consistent with the findings of this meta-analysis.³⁹ This analysis includes primarily small, uncontrolled studies. The potential for a placebo effect in patients undergoing invasive procedures could not be assessed without control groups.⁴⁰

Clinical Implications
This study supports the use of ablation and pacing therapy to benefit patients with highly symptomatic, medically refractory atrial fibrillation. The results of 5 small, randomized trials comparing ablation and pacing therapy with pharmacologic management, AV nodal modification, or pacemaker implantation alone have also demonstrated the superiority of ablation and pacing for symptomatic relief.^{5 9 11 20 41} Thus, it may be argued that further outcome studies, randomized or not, using this most recalcitrant population are not warranted.⁴² Until sinus rhythm can be maintained in these patients, ablation and pacing therapy can serve as a valuable palliative therapy.

The greater question about ablation and pacing therapy now concerns its role in the much larger population of patients with less symptomatic atrial fibrillation. The benefits of pharmacological rate control compared with the maintenance of sinus rhythm are under evaluation in the Atrial Fibrillation Follow-up Investigation of Rhythm Management, which is studying a general population of patients with recent-onset atrial fibrillation.⁴³ The potential benefits of ablation and pacing therapy in this population include absolute heart rate control, diminished drug burden, improved ventricular function, and freedom from drug side effects. In broadening the indications for ablation and pacing, many questions still exist regarding patient selection, appropriate level of symptoms, requisite number of pharmacological trials, cost effectiveness and, above all, risk of morbidity and mortality related to the therapy. The findings of this meta-analysis with effect sizes for clinical outcomes may facilitate the design of future trials to address these issues.

	Acknowledgments

 
This study was supported in part by Medtronic, Inc, Minneapolis, Minn.

	Footnotes

 
Dr. Brown-Mahoney received limited financial support from Medtronic, Inc, for the statistical analysis, and Drs. Ellenbogen and Wood are consultant speakers and clinical investigators for Medtronic, Inc. Medtronic, Inc partially supported this study.

¹ References 3, 5–9, 11, 18, 21, 23–25, 28, 29, 31.

² References 5–7, 9–11, 18–21, 24–27, 30, 31.

Received April 13, 1999; revision received September 21, 1999; accepted October 8, 1999.

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				V. Fuster, L. E. Ryden, D. S. Cannom, H. J. Crijns, A. B. Curtis, K. A. Ellenbogen, J. L. Halperin, J.-Y. Le Heuzey, G. N. Kay, J. E. Lowe, et al. ACC/AHA/ESC 2006 Guidelines for the Management of Patients With Atrial Fibrillation--Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation) Developed in Collaboration With the European Heart Rhythm Association and the Heart Rhythm Society J. Am. Coll. Cardiol., August 15, 2006; 48(4): 854 - 906. [Full Text] [PDF]

				V. Fuster, L. E. Ryden, D. S. Cannom, H. J. Crijns, A. B. Curtis, K. A. Ellenbogen, J. L. Halperin, J.-Y. Le Heuzey, G. N. Kay, J. E. Lowe, et al. ACC/AHA/ESC 2006 Guidelines for the Management of Patients With Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation) Developed in Collaboration With the European Heart Rhythm Association and the Heart Rhythm Society J. Am. Coll. Cardiol., August 15, 2006; 48(4): e149 - e246. [Full Text] [PDF]

				J. S. Steinberg Desperately Seeking a Randomized Clinical Trial of Resynchronization Therapy for Patients With Heart Failure and Atrial Fibrillation J. Am. Coll. Cardiol., August 15, 2006; 48(4): 744 - 746. [Full Text] [PDF]

				V. Fuster, L. E. Ryden, D. S. Cannom, H. J. Crijns, A. B. Curtis, K. A. Ellenbogen, J. L. Halperin, J.-Y. Le Heuzey, G. N. Kay, J. E. Lowe, et al. ACC/AHA/ESC 2006 Guidelines for the Management of Patients With Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation): Developed in Collaboration With the European Heart Rhythm Association and the Heart Rhythm Society Circulation, August 15, 2006; 114(7): e257 - e354. [Full Text] [PDF]

				V. Fuster, L. E. Ryden, D. S. Cannom, H. J. Crijns, A. B. Curtis, K. A. Ellenbogen, J. L. Halperin, J.-Y. Le Heuzey, G. N. Kay, J. E. Lowe, et al. ACC/AHA/ESC 2006 Guidelines for the Management of Patients With Atrial Fibrillation--Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation): Developed in Collaboration With the European Heart Rhythm Association and the Heart Rhythm Society Circulation, August 15, 2006; 114(7): 700 - 752. [Full Text] [PDF]

				Authors/Task Force Members, V. Fuster, L. E. Ryden, D. S. Cannom, H. J. Crijns, A. B. Curtis, K. A. Ellenbogen, J. L. Halperin, J.-Y. Le Heuzey, G. N. Kay, et al. ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation executive summary: A report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients with Atrial Fibrillation) Developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society Eur. Heart J., August 2, 2006; 27(16): 1979 - 2030. [Full Text] [PDF]

				G. Y H Lip and A. Tello-Montoliu Management of atrial fibrillation. Heart, August 1, 2006; 92(8): 1177 - 1182. [Full Text] [PDF]

				K. F. Kwaku Cell Therapy for Rate Control in Atrial Fibrillation: A New Approach to an Old Problem Circulation, May 30, 2006; 113(21): 2474 - 2476. [Full Text] [PDF]

				T. J. Bunch, S. Mahapatra, G. K. Bruce, S. B. Johnson, D. V. Miller, B. D. Horne, X.-L. Wang, H.-C. Lee, N. M. Caplice, and D. L. Packer Impact of Transforming Growth Factor-{beta}1 on Atrioventricular Node Conduction Modification by Injected Autologous Fibroblasts in the Canine Heart Circulation, May 30, 2006; 113(21): 2485 - 2494. [Abstract] [Full Text] [PDF]

				T. Szili-Torok, M. Bountioukos, A. J.Q.M. Muskens, D. A.M.J. Theuns, D. Poldermans, J. R.T.C. Roelandt, and L. J. Jordaens The presence of contractile reserve has no predictive value for the evolution of left ventricular function following atrio-ventricular node ablation in patients with permanent atrial fibrillation Eur J Echocardiogr, October 1, 2005; 6(5): 344 - 350. [Abstract] [Full Text] [PDF]

				G. V. Naccarelli Antiadrenergic Therapy in the Control of Atrial Fibrillation Journal of Cardiovascular Pharmacology and Therapeutics, October 1, 2005; 10(4_suppl): S33 - S43. [Abstract] [PDF]

				R. H. Falk Rate Control Is Preferable to Rhythm Control in the Majority of Patients With Atrial Fibrillation Circulation, June 14, 2005; 111(23): 3141 - 3150. [Full Text] [PDF]

				M. Brignole, M. Gammage, E. Puggioni, P. Alboni, A. Raviele, R. Sutton, P. Vardas, M.G. Bongiorni, L. Bergfeldt, C. Menozzi, et al. Comparative assessment of right, left, and biventricular pacing in patients with permanent atrial fibrillation Eur. Heart J., April 1, 2005; 26(7): 712 - 722. [Abstract] [Full Text] [PDF]

				O. S. Satish, K.-H. Yeh, M.-S. Wen, and C.-C. Wang Cardiac resynchronisation therapy versus dual site right ventricular pacing in a patient with permanent pacemaker and congestive heart failure Europace, January 1, 2005; 7(4): 380 - 384. [Abstract] [Full Text] [PDF]

				L.-F. Hsu, P. Jais, P. Sanders, S. Garrigue, M. Hocini, F. Sacher, Y. Takahashi, M. Rotter, J.-L. Pasquie, C. Scavee, et al. Catheter Ablation for Atrial Fibrillation in Congestive Heart Failure N. Engl. J. Med., December 2, 2004; 351(23): 2373 - 2383. [Abstract] [Full Text] [PDF]

				P. Dorian, I. Mangat, A. Pinter, and V. Korley The Burden of Atrial Fibrillation: Should We Abandon Antiarrhythmic Drug Therapy? Journal of Cardiovascular Pharmacology and Therapeutics, October 1, 2004; 9(4): 257 - 262. [Abstract] [PDF]