| Coverage Policy Manual | |
| Policy #: | 2004028 |
| Category: | Medicine |
| Initiated: | August 2004 |
| Last Review: | August 2023 |
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| Ablation Therapy for Atrial Fibrillation (Pulmonary Venous Isolation, Radiofrequency, Cryoablation, AV Node Ablation) | |
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| Description: |
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, with a prevalence estimated at 0.4% of the population, increasing with age. The underlying mechanism of AF involves an interplay between electrical triggering events and the myocardial substrate that permits propagation and maintenance of the aberrant electrical circuit. The most common focal trigger of AF appears to be located within the cardiac muscle that extends into the pulmonary veins.
AF can be subdivided into 3 types: paroxysmal (self terminating), persistent (non-self terminating) or permanent. AF accounts for approximately one-third of hospitalizations for cardiac rhythm disturbances. Symptoms of AF (eg, palpitations, decreased exercise tolerance, dyspnea) are primarily related to poorly controlled or irregular heart rate. The loss of atrioventricular synchrony results in a decreased cardiac output, which can be significant in patients with compromised cardiac function. Also, patients with AF are at higher risk for stroke, with anticoagulation typically recommended. AF is also associated with other cardiac conditions, such as valvular heart disease, heart failure, hypertension, and diabetes. Although episodes of AF can be converted to normal sinus rhythm using pharmacologic or electroshock conversion, the natural history of AF is that of recurrence, thought to be related to fibrillation-induced anatomic and electrical remodeling of the atria.
Treatment strategies can be broadly subdivided into rate control, in which only the ventricular rate is controlled and the atria are allowed to fibrillate, or rhythm control, in which there is an attempt to reestablish and maintain normal sinus rhythm. Rhythm control has long been considered an important treatment goal for AF management, although it should be noted that its primacy has recently been challenged by the results of two several randomized trials, both of which reported that pharmacologically maintained rhythm control offered no improvement in mortality compared to rate control.
However, rhythm control is not curative. A variety of ablative procedures have been investigated as potentially curative approaches, or perhaps modifying the arrhythmia such that drug therapy becomes more effective. Ablative approaches focus on interruption of the electrical pathways that contribute to AF, through modifying the triggers of AF and/or the myocardial substrate that maintains the aberrant rhythm. The Maze procedure, an open surgical procedure often combined with other cardiac surgeries (i.e. valve repair) is an ablative procedure involving sequential atriotomy incisions designed to create electrical barriers that prevent the maintenance of AF. Because of the highly invasive nature of this procedure, it is currently, mainly reserved for patients undergoing open heart surgery for other reasons (eg, valve repair, coronary artery bypass grafting).
Radiofrequency ablation using a percutaneous catheter-based approach is a widely used technique for a variety of supraventricular arrhythmias where intracardiac mapping identifies a discrete arrhythmogenic focus that is the target of ablation. The situation is more complex for atrial fibrillation because there may be no single arrhythmogenic focus. AF most frequently arises from an abnormal focus at or near the junction of the pulmonary veins and the left atrium, thus leading to the feasibility of more focused, percutaneous ablation techniques. Strategies that have emerged for focal ablation within the pulmonary veins originally involved segmental ostial ablation guided by pulmonary vein potential (electrical approach) but currently more typically involve circumferential pulmonary vein ablation (anatomic approach). Circumferential pulmonary vein ablation using radiofrequency energy is the most common approach at present.
Research into specific ablation and pulmonary vein isolation techniques is ongoing.
Use of current radiofrequency catheters for AF has a steep learning curve because they require extensive guiding to multiple ablation points. The procedure can also be done using cryoablation technology. One of the potential advantages of cryoablation is that cryoablation catheters have a circular or shaped endpoint, permitting a "one-shot" ablation.
Repeat procedures following initial radiofrequency ablation are commonly performed if AF recurs or if atrial flutter develops post procedure. The need for repeat procedures may, in part, depend on the clinical characteristics of the patient (eg, age, persistent vs paroxysmal AF, atrial dilatation), and the type of ablation initially performed. Repeat procedures are generally more limited in scope than the initial procedure. Additional clinical factors associated with the need for a second procedure include the length of AF, permanent AF, left atrial size, and left ventricular ejection fraction.
Regulatory Status
In February 2009, the NAVISTAR® THERMOCOOL® Irrigated Deflectable Diagnostic/Ablation Catheter and EZ Steer ThermoCool NAV Catheter (Biosense Webster Inc.) were approved by the U.S. Food and Drug Administration (FDA) through the pre-market approval (PMA) process for radiofrequency ablation to treat drug refractory recurrent symptomatic paroxysmal AF. FDA product code: OAD.
Devices using laser or cryoablation techniques for substrate ablation have been approved by the FDA through the premarket approval process for AF (FDA product code: OAE). They include:
Also, numerous catheter ablation systems have been approved by the FDA for other ablation therapy for arrhythmias such as supraventricular tachycardia, atrial flutter, and ventricular tachycardia. FDA product code: LPB.
Coding
Beginning in 2013, there is a new CPT code specific to pulmonary vein ablation:
93656: Comprehensive electrophysiologic evaluation including transseptal catheterizations, insertion and repositioning of multiple electrode catheters with induction or attempted induction of an arrhythmia with atrial recording and pacing, when possible, right ventricular pacing and recording, His bundle recording with intracardiac catheter ablation of arrhythmogenic focus, with treatment of atrial fibrillation by ablation by pulmonary vein isolation.
This new combination code is not to be used with any of the following CPT codes: 93279-93284, 93286-93289, 93462, 93600, 93602, 93603, 93610, 93612, 93618, 93619, 93620, 93621, 93653, or 93654.
There is also a CPT add-on code for additional atrial fibrillation therapy after the pulmonary vein isolation procedure:
93657: Additional linear or focal intracardiac catheter ablation of the left or right atrium for treatment of atrial fibrillation remaining after completion of pulmonary vein isolation (List separately in addition to code for primary procedure)
Prior to 2013, there was no specific CPT code for pulmonary vein ablation. CPT code 93651 would have been used. Code 93651 included ablation of an intra-atrial arrhythmogenic focus as treatment of a supraventricular tachycardia. Circumferential ablation of the pulmonary vein might be considered basically intra-arterial in location due to its close proximity to the pulmonary os and atria. Supraventricular tachycardias typically describe arrhythmias due to accessory pathways within the atria, such as Wolff-Parkinson-White syndrome or atrioventricular nodal reentry arrhythmias. Although not consistently associated with tachycardia, strictly speaking, atrial fibrillation could be considered a type of supraventricular tachycardia.
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Policy/ Coverage: |
EFFECTIVE AUGUST 2015
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Transcatheter radiofrequency ablation or cryoablation meets member benefit certificate primary coverage criteria as a treatment for atrial fibrillation in:
Repeat radiofrequency ablation or cryoablation meets member benefit certificate primary coverage in patients with recurrence of atrial fibrillation and/or development of atrial flutter following the initial procedure.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Any other use of catheter-based techniques for treatment of atrial fibrillation does not meet Primary Coverage Criteria that there be scientific evidence of effectiveness.
For contracts without Primary Coverage Criteria, any other use of these procedures is considered investigational and is not covered. Investigational services are an exclusion in the member benefit certificate.
EFFECTIVE PRIOR TO AUGUST 2015
Pulmonary-vein ablation/isolation meets Primary Coverage Criteria that there be scientific evidence of effectiveness for the treatment of atrial fibrillation under the following conditions.
Catheter Ablation or modification of the AV node for treatment of rapid atrial fibrillation meets Primary Coverage Criteria that there be scientific evidence of effectiveness for patients who remain symptomatic despite a reasonable trial of medical therapy.
Any other use of catheter-based techniques for treatment of atrial fibrillation does not meet Primary Coverage Criteria that there be scientific evidence of effectiveness.
For contracts without Primary Coverage Criteria, any other use of these procedures is considered investigational and is not covered. Investigational services are an exclusion in the member benefit certificate.
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| Rationale: |
“Due to the detail of the rationale, the complete document is not online. If you would like a hardcopy print, please email: codespecificinquiry@arkbluecross.com”
The use of catheter ablation for treatment of supraventricular arrhythmias other than atrial fibrillation is discussed in Arkansas BCBS policy 1998045.
Use of catheter ablation for limited categories of patients with atrial fibrillation is becoming more frequent, but the role of this treatment is not as established and coverage is limited to specific types of, and in specific patient situations associated with, atrial fibrillation. The majority of the following information is taken from the 2007 Heart Rhythm Society/European Heart Rhythm Association/European Cardiac Arrhythmia Society (in collaboration with the American College of Cardiology, American Heart Association, and Society of Thoracic Surgeons) Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation Recommendations for Personnel; Policy, Procedures and Follow-up; and the results from the AFFIRM and RACE randomized controlled trials.
The concensus document adopted the atrial fibrillation classification system developed in 2006 by the ACC/AHA/ESC and published as Guidelines for Management of Patients with Atrial Fibrillation. Paroxysmal AF is defined as recurrent AF (≥ 2 episodes) that terminate spontaneously within 7 days. Persistent AF is defined as AF which is sustained beyond 7 days, or lasting less than 7 days necessitating pharmacologic or electrical cardioversion. Included within the category of persistent AF is “longstanding persistent AF” which is defined as continuous AF of greater than one year duration. The term permanent AF is not appropriate in the context of patients undergoing catheter and/or surgical ablation of AF as it refers to a group of patients where a decision has been made not to pursue restoration of sinus rhythm by any means, including catheter or surgical ablation. These definitions apply only to AF episodes which are of at least 30 seconds’ duration and do not have a reversible cause such as acute pulmonary disease and hyperthyroidism.
Catheter ablation of AF should not be considered as first line therapy. The primary indication for catheter AF ablation is the presence of symptomatic AF refractory or intolerant to at least one Class 1 or 3 antiarrhythmic medication. The HRS/EHRA/ECAS Consensus Paper recommended that catheter ablation is appropriate for selected symptomatic patients with heart failure and/or reduced ejection fraction (vide infra regarding ejection fraction criteria).
The HRS/EHRA/ECAS Consensus Paper stated, "A patient's desire to eliminate the need for ong-term anticoagulation by itself should not be considered an appropriate selection criterion."
Historically, most therapy for treatment of atrial fibrillation has been directed at control of the cardiac rate rather than control of cardiac rhythm by reversion from AF to sinus rhythm. Controversy over the effectiveness of catheter ablation has occurred because of safety concerns, and because of lack of, or conflicting evidence that controlling the cardiac rhythm improves survival, reduces the risk of stroke or embolic disease, lowers risk of adverse drug effects, reduces hospitalization, or improves quality of life. Based on this variance of evidence, some have recommended pharmacological control of rate is preferable to control of rhythm. However, there is also concern that the benefits of sinus rhythm have been negated by the deleterious effects of antiarrhythmic drugs, and therefore the control of rhythm without drugs may shift the current balance between rate- and rhythm-control strategies.
In patients with a mitral valve prosthesis, there has been concern about injuring the valve or getting the cathether trapped with the valve mechanism. In a study comparing ablation in 26 patients with mitral valve prostheses vs. 52 patients with no prosthesis, the procedure was as safe and the success rate (maintenance of sinus rhythm) was the same, but there was a higher rate of post-procedure atrial tachycardia in the patients with the prostheses (Lang, 2005).
A major trial of circumferential pulmonary-vein ablation for chronic AF (Oral, 2006) limited enrollment to patients with an ejection fraction >= 30% and a left atrial diameter <= 55 mm. This trial demonstrated that sinus rhythm could be maintained long term in the majority of patients treated with ablation. With maintenance of sinus rhythm, both symptoms and left atrial diameter decreased. However, two consecutive study studies (Hsu, 2004; Chen, 2004) have demonstrated that patients with significant left ventricular dysfunction tolerate pulmonary vein isolation and in fact demonstrate improvements in left ventricular function, symptoms, exercise capacity, and quality; however, these were not randomized trials. The long-term success rate in HF patients was 75% in the Chen study, somewhat less than in non-HF patients.
The published literature on pulmonary vein ablation reflects its evolving nature, dominated by reports of the technical capability of different mapping and ablation strategies. For example, catheters with different arrays of electrodes have been specifically developed for pulmonary vein ablation and various authors have described different ablation parameters. Published studies consist of single institution case series; some studies included only patients with paroxysmal AF, while others included both paroxysmal and persistent AF. Only one study attempted to compare outcomes with alternative pharmacologic treatment. Pappone and colleagues reported the outcomes of a nonrandomized long-term study in which 589 patients with symptomatic AF were treated with circumferential pulmonary vein ablation compared to 582 patients who received pharmacologic therapy for rhythm control. The report did not indicate whether the patients had paroxysmal, persistent or permanent AF, and the treatment choice was left to the discretion of the treating physician. In general, patients had two or more ineffective trials with antiarrhythmic drugs, greater than 2 AF related hospital admissions during the 2 years before entering the study or two or more years of antiarrhythmic drug treatment. The median follow up was 904 days. A Kaplan-Meter analysis showed that observed survival for those treated with ablation was significantly longer than those treated medically and not different from that expected for healthy persons of the same gender and age. The lower mortality in the ablation group was entirely due to a lower rate of cardiovascular deaths, such as heart failure, stroke and sudden death. AF recurrence rates were significantly lower among those receiving ablation. The improvement in quality of life measures was also greater in the ablation group. The incidence of adverse side effects in the ablation group was low and considered acceptable.
Post procedure pulmonary vein stenosis has been reported as a serious complication in other series, but was not reported in this series, perhaps due to the fact that the circumferential ablation was further removed from the pulmonary os. While this study reports promising results of pulmonary vein ablation as an alternative to drug therapy, the lack of detail provided regarding the patient selection criteria and the non-randomized nature of this study limit its interpretation and questions still remain regarding the role of pulmonary ablation in different groups of patients with AF. This study essentially compares the results of pharmacologic vs. ablation rhythm control. The superiority of the ablation approach challenges the results of randomized trials of drug therapy, which report equivalent results of rate vs. rhythm control. It is logical that restoration of sinus rhythm should provide benefit, if achieved with minimal complications. Confirmation of the results of Pappone in a multi-institutional controlled study may create a new paradigm for the treatment of AF.
In 2002 Oral et al published a report of 70 patients, 58 with paroxysmal atrial fibrillation. Satisfactory results were achieved in more than 80% of the patients using a segmental isolation approach targeting at least 3 pulmonary veins. The clinical efficacy of pulmonary vein isolation is much lower when AF is persistent.
In 2006 Oral and colleagues published results of a randomized, controlled trial of circumferential pulmonary-vein ablation for the treatment of chronic atrial fibrillation. Of 77 patients who underwent circumferential pulmonary-vein ablation (CPVA) the procedure was repeated in 26% with recurrent atrial fibrillation and 6% who had atypical atrial flutter. Among the 69 patients in the control group, 53 crossed over to undergo CPVA for recurrent atrial fibrillation by one year. At the end of one year 57 (74%) of 77 patients in the CPVA group were in sinus rhythm without amiodarone. At the same time period, in the control group of 49, 40 (58%) were in sinus rhythm without amiodarone, 37 (54%) were in sinus rhythm after CPVA, and 3 (4%) were in sinus rhythm without amiodarone or CPVA.
Wood and Ellenbogen, in an editorial in the same journal which published Oral’s study, stated:
“Ablation procedures are not yet widely used for chronic atrial fibrillation and are still rapidly evolving. Further technical advances are being made that are likely to improved procedural outcomes. Catheter ablation is not first-line therapy for chronic atrial fibrillation. Physicians considering this therapy for their patients should refer them to experienced centers and recognize that the elderly and those with severe structural heart disease may not be good candidates for ablation.”
The policy was updated with a literature search using MEDLINE through May 2007. Stabile reported on the 12-month follow-up of patients with paroxysmal and persistent AF who were intolerant of or who had failed at least 2 pharmacologic regimens (Stabile, 2006). In this study, 137 patients were randomized to drug therapy (N=69) or drug therapy with pulmonary vein ablation (N=68). During 1 year of follow-up, after a 1-month blanking period, 91% (63 of 69) of the control (pharmacologic) group had at least one recurrence of AF compared to 44% (30/68) of those who also received ablation (p<0.001). There were 3 (4.4%) major complications in the PVI group including a stroke, transient phrenic nerve paralysis, and pericardial effusion requiring treatment. The authors also commented that the rate of AF noted in this study was higher than has been reported in some studies, and may reflect daily telephonic monitoring during the 3 months following the procedure. This study did not report on additional relevant clinical outcomes such as overall cardiovascular events or quality of life.
Pappone also reported the 12-month follow-up on patients with paroxysmal AF who had failed drug therapy and who were randomized to pulmonary vein ablation (N=99) or additional drug therapy (N=99) (Pappone, 2006). At 1 year, 93% of the pulmonary venous isolation group and 35% of the drug therapy group were free of atrial tachycardia. One transient ischemic attack and 1 pericardial effusion (not requiring pericardiocentesis) were noted in the PVI group. This study also did not report on a full-range of cardiovascular outcomes or quality of life for the two groups. The authors noted that 24 cardiovascular hospital admissions occurred in the PVI group compared to 167 in the drug therapy group (p < 0.001); however, no further detail was provided.
2011 Update
A literature search was performed for the period of January 2009 through February 2011. This topic remains an active area of research, with many reports published during this period. Much of the research focused on technical aspects of the procedure, such as testing new types of catheters or novel methods of electroanatomic mapping. Research studies that included important evidence on the outcomes of catheter ablation include new randomized, controlled trials comparing catheter ablation with medications, studies reporting long-term follow-up of patients treated with ablation, and studies reporting rates of complications following ablation. There have also been an increasing number of published studies addressing the use of cryoablation, rather than radiofrequency ablation, as the energy source in catheter ablation.
Two randomized, controlled trials were identified that compared radiofrequency catheter ablation to antiarrhythmic drug therapy. Wilber et al. (2010) enrolled 167 patients who had failed at least one antiarrhythmic medication and had at least 3 atrial fibrillation episodes in the prior 6 months. Patients were randomly assigned to either catheter ablation or continued drug therapy and followed for 9 months. At the end of follow-up, 66% of patients in the ablation group were free of recurrent atrial fibrillation compared to 16% of patients in the medication group. Adverse events related to treatment occurred in 4.9% (5/103) of patients treated with ablation and in 8.8% (5/57) of patients treated with medications.
Forleo et al. (2009) randomly assigned 70 patients with type 2 diabetes and atrial fibrillation to either radiofrequency ablation or an antiarrhythmic medication. Follow-up was for 1 year, with the primary outcome being recurrence of atrial fibrillation. At the end of the trial, 42.9% of patients in the medication group were free of atrial fibrillation compared to 80% of patients in the ablation group. There was also a significant improvement in QOL for patients in the ablation group. Adverse events from medications occurred in 17.2% (6/35) patients, whereas complications from ablation occurred in 2.9% (1/35).
Complications of catheter ablation were reported in a large cohort of 1,000 patients undergoing ablation at a high-volume center in Europe (Dagres, 2009). There were no deaths definitely attributable to the procedure, but there were 2 deaths of uncertain cause within the first 30 days following ablation. Overall, 3.9% of patients had a major complication resulting from the procedure. Tamponade was the most serious life-threatening complication, occurring in 1.3% of patients. Major vascular complications occurred in 1.1%. Thromboembolism, cerebrovascular accident/transient ischemic attack, atrio-esophageal fistula, and endocarditis were all reported complications that occurred at a rate of less than 1%.
Cappato et al. (2009) performed a multicenter, retrospective case series to estimate the overall mortality rate following ablation. Data were collected on 32,569 patients from 162 clinical centers worldwide. There were 32 deaths reported, for a mortality rate of 0.98 per 1,000 patients. The most common causes of death were tamponade (n=8), stroke (n=5), atrio-esophageal fistula (n=5), and pneumonia (n=2).
Longer-term outcomes, i.e., longer than the 1-year follow-up reported in most randomized, controlled trials, were reported by several authors. Tzou et al. (2010) reported long-term follow-up for 123 patients who had a previous successful ablation, defined as free of atrial fibrillation at 1 year. At 3 years of follow-up, 85% of patients were still free of atrial fibrillation and off of all medications, and at 5 years, 71% remained free of atrial fibrillation. The authors estimated a late recurrence rate of approximately 7% per year for patients with an initial successful procedure. In a similar study, Bertaglia et al. (2010) reported outcomes after 6 years of follow-up for 229 patients who had a single, successful ablation. At 1-year follow-up, 77% of patients (177/229) were free of atrial fibrillation and off of all medications. After a mean additional follow-up of 49.7 +/- 13.3 months for these 177 patients, 58% remained free of atrial fibrillation. Sawhney et al. (2009) reported 5-year success rates in 71 patients who underwent ablation in 2002 or 2003. Freedom from symptomatic atrial fibrillation off medications was achieved in 86% of patients at 1 year, 79% at 2 years, and 56% at 5 years. A substantial minority of patients (22.5%) had recurrence at times greater than 2 years post-ablation.
A number of studies reported outcomes of ablation using cryoablation. These were mainly case series (Chun, 2009) (Paylos, 2009) reporting success rates in the range of that reported for radiofrequency ablation. One small matched analysis compared 20 patients undergoing cryoablation with 20 patients undergoing radiofrequency ablation, matched for age, gender, left ventricular ejection fraction and atrial fibrillation history (Linhart, 2009). Freedom from atrial fibrillation at 6 months was 55% for the cryoablation group, compared to 45% for the radiofrequency ablation group, a difference that was not significantly different.
Results of the STOP-AF trial, a randomized, controlled trial of cryoablation versus antiarrhythmic medications, were presented at the March 2010 American College of Cardiology meeting, but results have not yet been published in the peer-reviewed literature (O’Riordan, 2010). This study enrolled 245 patients with paroxysmal atrial fibrillation who had failed a median of 1.2 medications. At 1-year follow-up, 69.9% of patients in the ablation group were free of atrial fibrillation versus 7.3% in the medication group. There was also a significantly greater reduction in symptoms for the ablation group. Serious adverse events were reported in 3.1% of ablation patients. Phrenic nerve injury occurred at a rate of 13.5%, with 86% resolved at 12 months. The FreezeAF trial (Luik, 2010) is a randomized, controlled trial directly comparing radiofrequency ablation with cryoablation for patients with paroxysmal atrial fibrillation. This trial is in the early stages of enrollment, and results are not expected for several years.
Repeat procedures
Repeated procedures for recurrent atrial fibrillation or atrial flutter were commonly performed in most of the clinical trials included in this policy statement. Of the 7 randomized, controlled trials reviewed, only 2 (Wazni, 2005) (Forleo, 2009) did not include repeated procedures. In the other 5 studies, one or more repeated procedures were allowed, and success rates reported generally incorporated the results of up to 3 procedures. In 3 studies that reported these data, repeated procedures were performed in 9% (Pappone, 2006), 20% (Khan, 2008), and 32% (Oral, 2006) of patients randomized to ablation. Stabile et al.did not report specifics on how many patients actually underwent repeated procedures, but limited data in the publication indicated that up to 30% of treated patients were eligible for repeated procedures. In the Jais et al. study, patients underwent a mean of 1.8 procedures per patient and a median of 2 procedures per patient, indicating that approximately 50% of patients in the ablation group underwent at least one repeated procedure.
Because of this high rate of repeated procedures, the results reported in these studies do not reflect the success of a single procedure. Rather, they more accurately estimate the success of an ablation strategy that includes repeated procedures for recurrences that occur within the first year of treatment.
Nonrandomized evidence suggests that early reablation increases the success of the procedure, when defined as maintenance of sinus rhythm at one year (Leflouche, 2008). There is variability in the protocol for when repeated procedures should be performed. There is also uncertainty concerning other details on repeated procedures, such as how soon after the initial procedure it should be done, the threshold of atrial fibrillation recurrence that should prompt a repeat, and whether medications should be tried prior to a repeated procedure (Leflouche, 2008).
2012 Update
This policy is being updated with a literature search through January 2012. There was no new information identified that would prompt a change in the coverage statement.
2013 Update
This policy is being updated with a literature search conducted through February 2013. There was no new information identified that would prompt a change in the coverage statement. The following is a summary of the key identified literature.
A Cochrane Review on catheter ablation for paroxysmal and persistent atrial fibrillation was published in 2012 (Chen, 2012). This review included 7 RCTs of catheter ablation versus medical therapy. Main conclusions were that catheter ablation was superior at reducing the recurrence of atrial fibrillation (RR 0.27, 95% CI 0.18-0.41), but that there were no differences in mortality (RR 0.50, 95% CI 0.04-5.65), embolic complications (RR 1.01, 95% CI 0.18-5.68), or death from thromboembolism (RR 3.04, 95% CI 0.13-73.4).
Nielsen et al. published an RCT of RFA ablation as the initial therapy for paroxysmal atrial fibrillation in 2012 (Cosedis, 2012). A total of 294 patients were randomized to initial treatment with catheter ablation or pharmacologic therapy. Patients were followed for up to 24 months for the primary outcomes of burden of atrial fibrillation (percent of time in atrial fibrillation on holter monitor) at each time point and cumulative burden of atrial fibrillation over all time points. For the individual time points, the burden of atrial fibrillation was lower in the catheter ablation group at 24 months (9% versus 18%, p=0.007), but not at other time points. The cumulative burden did not differ significantly for the catheter ablation group compared to pharmacologic therapy (90th percentile of cumulative burden, 13% versus 19%, p=0.10). The secondary outcome of percent of patients free from atrial fibrillation at 24 months was greater for the catheter ablation group (85% vs. 71%, p=0.004), as was the secondary outcome of freedom from symptomatic atrial fibrillation (93% vs. 84%, p=0.01). There was one death in the ablation group due to a procedural-related stroke, and there were 3 patients in the ablation group who developed cardiac tamponade following the procedure.
Waldo et al. reported the results of an FDA-directed post-marketing safety study involving 1275 patients from six prospective, multicenter studies of RFA ablation using an open-irrigated catheter (Waldo, 2012). A total of 4.9% (63/1275) of patients experienced any acute serious complication within seven days of the procedure. Vascular access complications were most common, ranging from 0.5% to 4.7% across the six studies. Exacerbations of heart failure occurred in 1.5% of patients and two patients experienced cardiac tamponade. There were no strokes or TIA’s reported post-procedure.
An expert consensus document on catheter and surgical catheter ablation for atrial fibrillation was developed jointly by seven cardiac specialty societies (HRS, EHRA, ECAS, ACC, AHA, APHRS, STS) in 2012 (Calkins, 2012). The following recommendations were made concerning indications for catheter ablation:
2014 Update
Radiofrequency Ablation for Atrial Fibrillation
In 2013, Ganesan et al. published results from a systematic review and meta-analysis of studies reporting long-term outcomes after percutaneous catheter ablation for paroxysmal and nonparoxysmal atrial fibrillation (Ganesan, 2013). The authors included 19 studies (RCTs, case-control and cohort studies, and case series) that reported catheter ablation outcomes at greater than or equal to 3 years after the index ablation procedures. Sample sizes in these studies ranged from 39 to 1404, with a total of 6167 patients included overall. For a single procedure, the pooled overall success rate at 12 months post-procedure was 64.2% (95% CI 57.5% to 70.3%). At late follow-up, the overall single-procedure success, defined as freedom from atrial arrhythmia at latest follow-up, was 53.1% (95% CI 46.2% to 60.0%). The pooled overall multiple-procedure long-term success rate was 79.8% (95% CI 75.0% to 83.8%). The analysis was unable to identify any predictors of short- or long-term recurrence. Reporting of periprocedural complications was heterogeneous across the studies, but complication rates were generally low.
Mont et al. conducted an RCT comparing radiofrequency catheter ablation to antiarrhythmic drug therapy among 146 patients with symptomatic persistent atrial fibrillation (Mont, 2013). Patients were randomized in a 2:1 fashion to catheter ablation (n=98) or antiarrhythmic drug therapy (N=48). Although the study was terminated before the planned sample size of 208 was met due to lower than expected enrollment, at 12 months of follow up, the proportion of patients who were free of sustained episodes of atrial fibrillation was higher in the catheter ablation group than the antiarrhythmic drug therapy group (70.4% vs. 43.7%, P=0.002). Quality of life scores did not significantly differ between the groups. Longer term outcomes were not reported.
Several studies have compared catheter ablation to medical therapy for atrial fibrillation in the setting of heart failure. Hunter et al. conducted an RCT comparing catheter ablation to medical rate control for patients with persistent atrial fibrillation and symptomatic heart failure, with adequate rate control at the time of enrollment (Hunter, 2014). The study’s primary end point was difference between groups in left ventricular ejection fraction (LVEF) at 6 months post-procedure. Fifty patients were randomized, 26 to catheter ablation and 24 to medical management. At 6 months, 81% of the catheter ablation group was free from recurrent atrial fibrillation off antiarrhythmic drugs. LVEF at 6 months post-procedure was 40% (±12%) in the catheter ablation group, compared to 31% (±13%, P=0.015). Catheter ablation was also associated with improvements in health-related quality of life. Jones et al. reported result from an RCT comparing catheter ablation to medical rate control for patients with symptomatic heart failure, left ventricular ejection fraction less than or equal to 35%, and persistent atrial fibrillation (Jones, 2013). Fifty-two patients were randomized, 26 each to catheter ablation or medical rate control. At 12 months post-procedure, sinus rhythm was maintained in 88% of the catheter ablation group, with a single-procedure success rate of 68%. For the study’s primary outcome, peak oxygen consumption at 12 months post-procedure, there was a significant increase in the catheter ablation group compared with the medical management group (+3.07 mL/kg/min, 95% CI 0.56 to 5.59, P=0.018).
Longer-term outcomes
The available RCTs mainly report on short-term outcomes up to 1 year and, therefore, do not evaluate the rate of late recurrences after 1 year. Longer-term outcomes have been reported by several authors. These studies generally report rates of early recurrence in the range of 20-30%, requiring repeat ablations. Rates of longer-term recurrence are lower if early recurrence does not occur, in the range of 1-2% per year.
Hussein et al. (Hussein, 2014) reported on 831 patients who were treated in 2005, with a median follow-up of 55 months. During the first year following ablation, 23.8% had a recurrence of atrial fibrillation. During the remaining follow-up, recurrences occurred in 8.9% additional patients. The overall rate of arrhythmia-free and off drugs was 79.4% at 55 months. An additional 10.5% of patients were arrhythmia-free on drugs, for a total rate of 89.9% clinical improvement.
In 2013, Bunch et al. reported results from a prospective cohort study comparing risk of stroke between patients with atrial fibrillation who had undergone catheter ablation, patients with atrial fibrillation who did not undergo ablation, and patients without a history of atrial fibrillation (Bunch, 2013). A total of 4212 patients with atrial fibrillation who had undergone catheter ablation were age/sex matched in a 1:4 ratio to 16, 848 subjects in each of the other groups. The mean follow up time was 3.9 years. At 1 year post-procedure, significantly more patients with atrial fibrillation who did not undergo ablation had a stroke (3.5%) than those with atrial fibrillation who underwent ablation (1.4%) or had no history of atrial fibrillation (1.4%; P for trend <0.001). During the follow up period, for all ages and CHADS2 profiles, patients with atrial fibrillation who had ablation had a lower stroke risk than those with atrial fibrillation without ablation.
A 2013 study by Anselmino et al. followed 196 patients who underwent radiofrequency catheter ablation for paroxysmal or persistent atrial fibrillation and had left ventricular ejection fraction less than or equal to 50% for a mean of 46.2 months (Anselmino, 2013). During follow up, 29.6% of patients required repeat ablation procedures. At the end of follow up, 37.8% had at least one episode of atrial fibrillation, atrial flutter, or ectopic atrial tachycardia.
Cryoablation of the pulmonary veins
In 2013, Packer et al. reported results of the STOP-AF trial, an RCT of cryoablation versus antiarrhythmic medications (Packer, 2013). This study enrolled 245 patients with paroxysmal atrial fibrillation who had failed at least 1 ( median 1.2 ) membrane-active antiarrhythmic medications. Patients were randomized in 2:1 fashion to either cryoballon ablation (n=163) or drug therapy (n=82). At 1-year follow-up, 69.9% of patients in the ablation group were free of atrial fibrillation versus 7.3% in the medication group. The single-procedure success rate was 57.7%. There was also a significantly greater reduction in symptoms for the ablation group. Seventy-nine percent of the drug treatment group crossed over to cryoablation during 12 months of study follow up because of recurrent, persistent atrial fibrillation. Cryoablation procedure-related adverse events occurred in 5 patients (3.1%); major atrial fibrillation events occurred in 3.1% of the cryoablation group compared to 8.5% of the drug-treatment group (noninferiority P<0.001). Phrenic nerve injury occurred at a rate of 13.5%, with 86% resolved at 12 months.
The Mesh Ablator versus Cryoballoon Pulmonary Vein Ablation of Symptomatic Paroxysmal Atrial Fibrillation (MACPAF) study was a single-center RCT comparing cryoablation to radiofrequency ablation with the HD Mesh Ablator Catheter (Bard®, purchased by Boston Scientific in 2013) for atrial fibrillation. The HD Mesh Ablator Catheter, which is not cleared for use in the U.S., is a multielectrode radiofrequency catheter that involves a mesh electrode that is designed to delivery radiofrequency energy to multiple points of contact. Primary short-term results for MACPAF were reported by
Koch et al. in 2013 (Koch, 2012). The study randomized symptomatic paroxysmal atrial fibrillation to catheter ablation with the Arctic Front® cryoablation catheter or the HD Mesh Ablator. The study’s primary endpoint was complete isolation of the pulmonary veins at the end of the procedure. Enrollment was initially planned for 108 with symptomatic paroxysmal atrial fibrillation that was inadequately controlled with antiarrhythmic drug treatment. However, at interim analysis, the HD Mesh Ablator demonstrated a lack of efficacy for the primary endpoint and the study’s data safety monitoring board prematurely terminated the subject. Forty-four patients with drug resistant paroxysmal atrial fibrillation were randomized at the time the study was terminated and comprise the intention-to-treat analysis cohort. The per-protocol analysis cohort included 32 patients. Three patients withdrew before the catheter procedure; 9 additional patents were excluded from analysis due to use of a study non-compliant catheter (n=2), identification of a trigger arrhythmia which was subsequently ablated (n=1), failure of transseptal puncture (n=1), or ablation occurring after the interim analysis (n=5). For the primary endpoint, by intention-to-treat analysis, complete pulmonary vein isolation was achieved in 13/23 (56.5%) of patients in the cryoablation group, compared with 2/21 (9.5%) of patients in the mesh ablator group (P=0.001). In the per-protocol cryoablation group, 76.5% of subjects had complete pulmonary vein isolation. Major complications included 1 case of retroperitoneal hematoma in the cryoablation group and 1 case of pericardial tamponade requiring drainage in the mesh ablator group.
Malmborg et al. reported results from an RCT comparing cryoablation with the Arctic Front® cryoballoon catheter to radiofrequency ablation with the Pulmonary Vein Ablation Catheter® (Malmborg, 2013). One hundred ten patients with paroxysmal or persistent atrial fibrillation were randomized, 54 to the cryoablation group and 56 to the radiofrequency ablation group. Complete pulmonary vein isolation was achieved in 98% of the cryoablation group, compared with 93% of the radiofrequency ablation group (P=0.37). At 6 month follow up, freedom from atrial fibrillation (absence of symptoms and no atrial fibrillation episodes on 7-day Holter monitoring or 12-lead ECG) without antiarrhythmic drug treatment was achieved in 52% of the cryoablation group and 38% of the radiofrequency ablation group (P=0.13).
Schmidt et al. used data from a prospective German registry of catheter ablation procedures to compare radiofrequency to cryoablation for paroxysmal atrial fibrillation (Schmidt, 2014). The cohort included 905 patients who underwent cryoablation and 2870 patients who underwent radiofrequency ablation who were enrolled from January 2007 to August 2011. The two groups were generally similar, with the exception that patients who underwent radiofrequency ablation were significantly more likely to have valve disease (8.1% vs. 3.0%, P<0.0001) and an ejection fraction less than or equal to 40% (2.4% vs. 1.2%, P<0.05). Rates of acute success were similar for the two groups (97.5% for cryoablation vs. 97.6% for radiofrequency ablation, P=0.92), as were rates of major procedure-related adverse cardiac and cerebrovascular events (0.4% for cryoablation vs. 0.2% for radiofrequency ablation, P=0.15). The overall procedural complication rates were similar for the two groups (4.6% for each group, P=1.0); the rate of post-procedural phrenic nerve palsy was significantly higher for the cryoablation group (2.1% for cryoablation vs. 0% for radiofrequency ablation, P=0.15). Long term follow rates are not reported.
A meta-analysis of studies of cryoablation was published in 2011 (Andrade, 2011). This analysis included the STOP-AF results in abstract form and a total of 22 other non-randomized studies, primarily case series. Procedural success was reported in over 98% of cases. At 1 year, the rates of success, as defined by no recurrent atrial fibrillation, were 73% (95% CI: 69-77%) for paroxysmal atrial fibrillation and 60% (95% CI: 54-66%) for persistent atrial fibrillation. Complications were inconsistently reported among the available studies. The most common complication reported was phrenic nerve palsy, which occurred in 6.4% of patients. Other rates of reported complications were pericardial effusion or tamponade (1.5%), groin complications at insertion site (1.8%), stroke (0.3%), and pulmonic stenosis (0.9%).
Vogt et al. reported longer-term follow up for 605 patients who underwent cryoablation for symptomatic, paroxysmal or persistent atrial fibrillation (Vogt, 2013). Follow up data beyond 12 months were available for 451 patients (median follow up 30 months). Of those with follow up available, 278 (61.6%) were free of atrial fibrillation recurrence with no need for repeat procedures after a 3 month blanking period. After 1, 2, and 3 repeat procedures, rates of freedom from atrial fibrillation were 74.9%, 76.2%, and 76.9%, respectively. Phrenic nerve palsy was the most common adverse event, occurring in 2% of patients, all of which resolved within 3-9 months. There were two periprocedural strokes, and one case each of periprocedural pericardial tamponade and pericardial effusion.
Repeat procedures
Pokushalov et al. reported results of an RCT comparing repeat catheter ablation to antiarrhythmic drug therapy for patients with paroxysmal atrial fibrillation who had failed an initial pulmonary vein isolation procedure (Pokushalov, 2013). After an initial post-ablation blanking period, 154 patients with symptomatic atrial fibrillation recurrence were randomized to drug therapy (n=77) or repeat ablation (n=77). Patients were followed for 3 years with an implanted cardiac monitor. At the 3-year follow up, 58% (45/77) of the repeat ablation group were free from atrial fibrillation or atrial tachycardia on no antiarrhythmic drugs, compared to 12% (9/77) of the antiarrhythmic therapy group (P<0.01). In the antiarrhythmic drug group, 43 patients (56%) crossed over to receive repeat ablation; in the repeat ablation group, 21 patients (27%) required antiarrhythmic drug therapy. By intention to treat analysis, 65% (50/77) of the repeat ablation group and 45% (35/77) of the drug therapy group were free from atrial fibrillation or atrial tachycardia (P=0.02).
2015 Update
A literature search conducted through January 2015 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
Recent systematic reviews have assessed the effect of RFA on a variety of AF-related outcomes. Zhuang and colleagues conducted a systematic review to evaluate the effect of RFA on left atrial (LA) volume and function in patients with AF (Shuang, 2014). In a summary of data from 26 studies enrolling 1821 patients, RFA was associated in improvements in LA volume measurements compared with pre-ablation: for example, for LA diameter, the weighted mean difference was -1.52 mm (955 CI -2.57 to -0.47). There were no significant improvements in LA function.
RFA as First-Line Therapy for AF
Several studies have evaluated RFA ablation as first-line therapy for AF. Morillo and colleagues published results of the RAAFT-2 trial, an RCT to compare RFA with antiarrhythmic drug therapy as first-line therapy for paroxysmal AF (Morillo, 2014). Eligible patients had symptomatic recurrent paroxysmal AF lasting more than 30 seconds, with 4 or fewer episodes in the prior 6 months, and had no previous antiarrhythmic drug treatment. The study enrolled 127 patients at 16 centers; 66 were randomized to RFA and 61 to antiarrhythmic drug therapy, at the discretion of the treating physician. In the ablation group, 63 underwent ablation; during follow up, 9 underwent reablation and 6 crossed over to receive antiarrhythmic drug therapy. In the drug therapy group, 26 crossed over to undergo ablation and 24 discontinued antiarrhythmic drug therapy. Analysis was intention-to-treat. Patients were followed with biweekly scheduled trans-telephonic monitor recordings and symptomatic recordings through the 24 month follow up period. For the study’s primary outcome, recurrence of any atrial tachyarrhythmia lasting longer than 30 seconds occurred in 72.1% (n=44) in the antiarrhythmic drug group, compared with 54.5% (n=36) in the ablation group (HR 0.56; 95% CI 0.35 to 0.90; P=0.02). Fewer patients in the RFA group had recurrence of symptomatic AF, atrial flutter, or atrial tachycardia (47% vs 59%; HR 0.56, 95% CI 0.33 to 0.95; P=0.03) or recurrence of symptomatic AF (415 vs 57%; HR 0.52, 95% CI 0.3 to 0.89; P=0.02). Quality of life measures did not differ significantly between groups.
Takigawa and colleagues reported long-term follow up for 1220 patients who underwent RFA for symptomatic paroxysmal AF (Takigawa, 2014). AF recurrence-free survival probabilities at 5 years were 59.4% after the initial procedure and 81.1% after the final ablation procedure, with an average of 1.3 procedures per patient.
In 2014, Andrade et al published a follow-up analysis of the STOP-AF trial results to evaluate the incidence and significance of early recurrence of AF after ablation (Andrade, 2014). Of the 163 subjects randomized to cryoablation, 84 patients (51.5%) experienced early recurrence of AF, defined as any recurrence of AF lasting more than 30 seconds between 3 and 12 months post-ablation. The presence of early AF recurrence was associated with late AF recurrence: late AF recurrence occurred in 41 patients (25.1%), and was more likely in those with early recurrence (55.6% in those with early recurrence vs 12.7% in those without early recurrence; P<0.001).
Results of the Cryo vs RFA trial (A Randomized Study Comparing Pulmonary Vein Isolation Using the Occluding Cryoballoon, Conventional Radiofrequency Energy, or Both in the Treatment of Atrial Fibrillation; NCT01038115), which was an RCT comparing cryoablation with RFA or a hybrid approach among 237 patients with paroxysmal AF, have been presented in abstract form (Hunter, 2014). Single-procedure success rates at 1 year were higher for cryoablation than for RFA (67% vs 47%; P=0.015). There are ongoing trials of cryoablation versus RFA for AF. The FreezeAF trial (PV-Isolation With the Cryoballoon Versus RF: a Randomized Controlled Prospective Non-inferiority Trial) is a non-inferiority RCT comparing cryoablation with RFA for patients with paroxysmal AF. Enrollment of 244 patients is planned, and patients will be followed for at least 1 year. The primary outcome is freedom from AF off all drugs. Secondary outcomes include longer-term success rates, procedural data, and cost-effectiveness. The Fire and Ice trial is another ongoing RCT comparing cryoablation with RFA for patient with symptomatic paroxysmal AF.
Ongoing and Unpublished Clinical Trials
A search of ClinicalTrials.gov February 2015 identified a large number of randomized comparative studies evaluating catheter ablation for AF that are currently enrolling patients. A sample of some of the representative studies are as follows:
2016 Update
A literature search conducted through July 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
In 2015, Vaidya and colleagues reported results of a systematic review and meta-analysis of RCTs comparing pulmonary vein isolation, pharmacologic rate control, atrioventricular (AV) junction ablation with pacemaker insertion for AF (Vaidya, 2015). Subgroup analyses focused on patients with congestive cardiac failure. The review identified 7 RCTs, 2 comparing AV junction ablation and pacemaker insertion with pharmacologic rate control, 1 comparing AV junction ablation with pacemaker insertion with pharmacologic rate control and pacemaker insertion, 1 comparing pulmonary vein isolation with AV junction ablation and biventricular pacing, and 3 comparing pulmonary vein isolation with pharmacologic rate control. Studies ranged in size from 36 to 99 patients, with 425 patients in total across the 7 studies. When pulmonary vein isolation was compared with pharmacologic rate control, based on 3 RCTs, pulmonary vein isolation-treated patients had higher increases in left ventricular ejection fraction (LVEF; weighted mean difference [WMD] +6.5; 95% confidence interval [CI], 0.6 to 12.5; p=0.03). When pulmonary vein isolation was compared with AV junction ablation and pacemaker insertion, based on 1 RCT, pulmonary vein isolation-treated patients had higher increases in LVEF (WMD = +9.0; 95% CI, 6.3 to 11.7; p<0.01). Patients treated with pulmonary vein isolation had greater improvements in heart failure symptoms, measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ) compared with pharmacologic rate control, in 3 RCTs that included only patients with congestive cardiac failure (WMD = -11.0; 95% CI, -19.4 to -2.6; p=0.01). MLHFQ score was also improved when pulmonary vein isolation was compared with AV junction ablation with pacemaker insertion.
Shi and colleagues reported results of a meta-analysis of RCTs comparing catheter ablation with antiarrhythmic drug therapy for AF (Shi, 2015). The meta-analysis included 11 trials (total N=1763 patients), of which 4 included only patients with paroxysmal AF, 2 included only patients with persistent AF, and 5 included patients with paroxysmal or persistent AF. Eight RCTs included only patients who were drug-refractory or drug-intolerant, and the remaining 3 included patients treated with catheter ablation as first-line therapy. Catheter ablation-treated patients had lower rates of AF recurrence than antiarrhythmic drug therapy-treated patients (RR 0.47; 95% CI, 0.38 to 0.58; p<0.001; I2=62%, p=0.003).
In 2015, Hakalathi and colleagues reported on a systematic review and meta-analysis of RCTs comparing RFA with antiarrhythmic drug therapy as first-line therapy for symptomatic AF which included 3 trials (total N=491 patients) (Hakalahti, 2015). Included were the RAAFT-234 and MANTRA-PAF35 trials (described below) and the earlier RAAFT-1 trial. RAAFT-2 and MANTRA-PAF were considered to be at low risk of bias. RFA was associated with lower risk of recurrence of AF (risk ratio, 0.63; 95% CI, 0.44 to 0.92; p=0.02; I2=38%).
RFA for AF in the Setting of Heart Failure
In 2016, Anselmino and colleagues reported on a systematic review of available observational studies and RCTs evaluating catheter ablation for AF in patients with chronic heart failure or structural cardiomyopathies (Anselmino, 2016). For the population of patients with chronic heart failure, the authors identified 17 observational studies, 4 RCTs, and 4 meta-analyses. In the 4 RCTs, 1 compared catheter ablation with AV node ablation and biventricular pacemaker insertion and 3 compared catheter ablation with optimal medical therapy and rate control. In pooled analysis, the mean efficacy of catheter ablation in maintaining sinus rhythm was 59% after a single procedure, increasing to 77% after patients who underwent a repeat procedure were included.
Comparisons of RFA Techniques
In 2015, Reddy and colleagues reported results of a noninferiority RCT comparing a contact force-sensing RFA catheter with a standard (noncontact force-sensing) catheter in 300 patients with treatment-refractory paroxysmal AF (Reddy, 2015). The study’s primary effectiveness end point was a composite end point of acute ablation success and long term ablation success (freedom from symptomatic AF, atrial tachycardia, or atrial flutter at 12 months off antiarrhythmic drugs, after a 3-month blanking period). In the modified intention-to-treat population, patients in the contact force-sensing catcheter group (n=149) were noninferior to control catheter group patients (n=141; 67.8% vs 69.4%, respectively; absolute difference, -1.6%; lower limit of 1-sided 95% CI; -10.7; p=0.007 for noninferiority.)
A 2015 systematic review and meta-analysis by Afzal and colleagues, which included 9 studies (1 RCT) but not the Reddy RCT, also compared RFA with contact force-sensing or noncontact force-sensing catheters (Afzal, 2015). At 12-month follow-up, contact force-sensing catheter-treated patients had lower AF recurrence at 12 months compared with standard catheter-treated patients (relative risk, [RR] 0.63; 95% CI, 0.44 to 0.91; p=0.01).
Systematic Reviews
In 2015, Cheng and colleagues reported on a meta-analysis of RCTs and observational studies comparing cryoablation and RFA for AF (Cheng, 2015). The meta-analysis included 11 studies (3 RCTs, 11 observational studies) with a total of 1216 patients. One RCT included only patients undergoing repeat treatment after an initial failed ablation procedure. In pooled analysis, 66.9% of those treated with cryoablation and 65.1% of those treated with RFA were free of AF after a mean 16.5 months follow up (RR=1.01; 95% CI, 0.94 to 1.07; p=0.87; I2=5%, p=0.39).
In 2014, Xu and colleagues reported on a meta-analysis of studies comparing cryoablation and RFA for AF, which included 14 studies (total N=1104 patients) (Xu, 2014). Two RCTs were included in the analysis, although in 1 cryoablation was compared with laser ablation, so may not be representative of RFA studies. In pooled analysis, there were no significant differences between RFA and cryoablation in terms of ablation success rates (odds ratio [OR], 1.34; 95% CI, 0.53 to 3.36; p=0.538; I2=74.8%, p=0.003) or AF recurrence (OR=0.75; 95% CI, 0.3 to 1.88; p=0.538; I2=74.8%, p=0.003)
Cryoablation Compared With RFA
In 2016, Kuck and colleagues reported results of the FIRE AND ICE Trial, a multicenter RCT with a non-inferiority design and blinded end point assessment, which compared RFA with cryoablation in individuals with symptomatic, treatment-refractory paroxysmal AF (Kuck, 2016). The study enrolled 769 patients, of whom 750 were randomized and included in a modified intention-to-treat analysis (n=376 in the RFA group, n=374 in the cryoablation group). The study’s tested the hypothesis that the cryoballoon would be non-inferior to RFA in terms of a prespecified efficacy end point, which was time to the first documented clinical failure occurring more than 90 days after the index ablation period (“blanking period”). The study defied clinical failure as recurrence of AF or occurrence of atrial flutter or atrial tachycardia on ECT or 24-hour Holter monitoring, prescription of class I or III antiarrhythmic drugs, or repeat ablation. After 90 days, the primary efficacy end point occurred in 138 cryoablation group patients and in 143 RFA group patients (1-year Kaplan-Meier event rate estimates, 34.6% and 35.9%, respectively; HR=0.96; 95% CI, 0.76 to 1.22; p<0.001 for noninferiority). Cryoablation group patients had shorter total procedure time (124 minutes vs 141 minutes, p<0.001) and left atrial dwell time (92 minutes vs 109 minutes, p<0.001), but longer fluoroscopy time (22 minutes vs 17 minutes, p<0.001). The study’s primary safety end point , a composite of death from any cause, stroke or transient ischemic attack form any cause, and serious adverse events, occurred in 40 patients in the cryoablation group and 51 patients in the RFA group (1-year Kaplan-Meier event rate estimates, 10.2% and 12.8%, respectively; HR=0.78; 95% CI, 0.52 to 1.18; p=0.024). In the cryoablation group, phrenic nerve injury was the most common adverse event reported (2.7%).
In 2015, Luik and colleagues reported results of the FreezeAF trial, an RCT with a noninferiority design which compared RFA with an irrigated catheter with cryoablation in individuals with treatment-refractory paroxysmal AF (Luik, 2015). The study included 315 patients with paroxysmal AF refractory to treatment with at least 1 antiarrhythmic drug, who were randomized to RFA (n=159) or cryoablation (n=156). The study tested the null hypothesis that cryoablation was non-inferiority to RFA in terms of a coprimary endpoint: the absence of AF in combination with absence of persistent complications at 6- and 12-month follow-ups. The coprimary end point was reached in 63.1% and in 64.1% of the RFA and cryoablation groups, respectively, at 6 months, and in and 73.6% and 73 % of the RFA and cryoablation groups, respectively, at 12 months. At 12 months postablation, the null hypothesis was rejected (null hypothesis risk difference, ≤ -0.15; risk difference, 0.029; 95% CI, -0.074 to 0.132; p<0.001).
An additional RCT published in 2015 compared point-by-point RFA with cryoablation, but in one comparison group pulmonary vein isolation could be achieved with RFA if cryoablation was unsuccessful, and in the second comparison group a hybrid procedure (cryoablation following RFA) was used, which makes isolating the relative efficacy of cryoablation difficult (Hunter, 2015).
Nonrandomized Studies
Aryana and colleagues compared ablation with a second-generation cryoballoon with RFA in a retrospective cohort of 1196 patients with paroxysmal and persistent AF (Aryana, 2015). Of the overall study population, 76% had paroxysmal AF; 773 were treated with cryoablation and 423 with RFA. Procedural success and complication rates did not differ significantly between groups. For the study’s primary end point, freedom from AF or atrial flutter or tachycardia at 12 months following a single ablation procedure without the use of antiarrhythmic medications was significantly higher for cryoablation-treated patients (76.6% vs 60.4%, p<0.001).
Schmidt and colleagues compared 1-year outcomes for patients treated with RFA or cryoablation in the German registry described above (Schmidt, 2016). This cohort included 2306 patients with symptomatic paroxysmal AF who underwent ablation from January 2007 to January 2010 (n=607 cryoblation; n=1699 RFA). The groups did not differ significantly in rates of reduction of symptomatic AF at 1 year (77.7% in RFA patients vs 79.5% in cryoablation patients; p=0.42). At 1 year, fewer cryoablation-treated patients were taking an antiarrhythmic drug (27.5% vs 32.1%, p<0.05). Rates of major clinical adverse events did not differ significantly between groups at 1 year, with the exception of phrenic nerve paralysis, which was more common in cryoablation patients (1.1% vs 0.3%, p<0.05).
Some studies have reported on comparisons between newer and older generations of devices, including 2 nonrandomized studies comparing cryoablation with a second generation device with RFA with a contact-force sensing catheter (Jourda, 2015; Squara, 2015). One smaller nonrandomized study reported lower rates of atrial tachycardias after cryoablation than after RFA, but with greater magnitude of effect with cryoablation with a second generation device (Julia, 2015).
2017 Update
A literature search conducted through July 2017 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
Nyong and colleagues reported on a Cochrane review of ablation for individuals with nonparoxysmal AF, which included RCTs comparing RF catheter or surgical ablation with antiarrhythmic drugs for persistent or long-standing persistent AF (Nyong, 2016). Reviewers selected 3 RCTs (total N=261 subjects; (Forleo, 2009; Stabile, 2006 , Mont 2014) not discussed in detail herein, all comparing catheter RFA (n=159) to antiarrhythmic drugs (n=102) at 12 months. The trials were assessed to have low or unclear risk of bias.
Morillo and colleagues published results of the RAAFT-2 trial, an RCT comparing RFA to antiarrhythmic drug therapy as first-line therapy for paroxysmal AF (Morillo, 2014). Eligible patients had symptomatic recurrent paroxysmal AF lasting more than 30 seconds, with 4 or fewer episodes in the prior 6 months, and had no previous antiarrhythmic drug treatment. The study enrolled 127 patients at 16 centers; 66 were randomized to RFA and 61 to antiarrhythmic drug therapy, at the discretion of the treating physician. In the RFA group, 63 underwent ablation; during follow-up, 9 underwent reablation and 6 crossed over to receive antiarrhythmic drug therapy. In the drug therapy group, 26 crossed over to undergo ablation and 24 discontinued antiarrhythmic drug therapy but continued in the trial. Analysis was intention-to-treat (ITT). Patients were followed with biweekly scheduled transtelephonic monitor recordings and symptomatic recordings through the 24-month follow-up period. The trial’s primary outcome (recurrence of any atrial tachyarrhythmia lasting >30 seconds) occurred in 72.1% (n=44) in the antiarrhythmic drug group compared with 54.5% (n=36) in the ablation group (hazard ratio [HR], 0.56; 95% CI, 0.35 to 0.90; p=0.02). Fewer patients in the RFA group had recurrence of symptomatic AF, atrial flutter, or atrial tachycardia (47% vs 59%; HR=0.56; 95% CI, 0.33 to 0.95; p=0.03) or recurrence of symptomatic AF (41% vs 57%; HR=0.52; 95% CI, 0.3 to 0.89; p=0.02). QOL measures did not differ significantly between groups.
Cosedis and colleagues published a random control trial of RFA as initial therapy for paroxysmal AF (Cosedis, 2012). A total of 294 patients were randomized to initial treatment with catheter ablation or pharmacologic therapy. Patients were followed up to 24 months for the primary outcomes of burden of AF (percentage of time in AF on Holter monitor) at each time point and cumulative burden of AF over all time points. For the individual time points, the burden of AF was lower in the catheter RFA group at 24 months (9% vs 18%, p=0.007), but not at other time points. The 90th percentile cumulative burden did not differ significantly between groups (13% vs 19%; p=0.10). The secondary outcome of percent of patients free from AF at 24 months was greater for the catheter ablation group (85% vs 71%, p=0.004), as was the secondary outcome of freedom from symptomatic AF (93% vs 84%, p=0.01). There was 1 death in the ablation group (due to a procedural-related stroke) and 3 patients in the ablation group developed cardiac tamponade following the procedure.
Nielsen and colleagues published a five-year follow-up from MANTRA-PAF (Nielsen, 2017) Follow-up was available for 245 (83%) of 294 patients, of whom 227 had Holter recordings. The randomized groups did not differ significantly in terms their availability for follow-up. In ITT analysis, significantly more patients in the RFA group were free from any AF (126/146 [86%]) than those in the pharmacologic therapy group (105/148 [71%]; RR=0.82; 95% CI, 0.73 to 0.93; p=0.001). Symptomatic AF burden was also significantly lower in the RFA group, although quality of life was not.
In 2016, Zhu and colleagues reported on a systematic review and meta-analysis of RCTs comparing catheter ablation to medical rate control in patients with persistent AF and heart failure (Zhu, 2016). Three trials (total N=143 subjects; range, 41-52 subjects) met reviewers inclusion criteria, all of which used blinded outcome assessment and were considered to have low risk of bias. For the meta-analysis’s primary end point, compared with medical rate control, catheter ablation was associated with larger improvements in left ventricular end diastolic fraction (mean difference, 6.22%; 95% CI, 0.7% to 11.74%; I2=63%). Measures of peak oxygen capacity, New York Heart Association functional class, and quality of life scores were also significantly improved in the catheter RFA-treated groups.
Andrade and colleagues published a follow-up analysis of the STOP AF trial to evaluate the incidence and significance of early recurrence of AF after ablation (*Andrade, 2014). Of the 163 subjects randomized to cryoablation, 84 (51.5%) patients experienced early recurrence of AF, defined as any recurrence of AF lasting more than 30 seconds between 3 and 12 months postablation. The presence of early AF recurrence was associated with late AF recurrence: late AF recurrence occurred in 41 (25.1%) patients, and was more likely in those with early recurrence (55.6% in those with early recurrence vs 12.7% in those without early recurrence; p<0.001).
Kuck and colleagues reported on rehospitalization, repeat ablation, and quality of life outcomes during 1000 days of follow-up (Kuck, 2016). Cryoablation group patients had fewer hospitalizations (122 patients) than RFA-treated patients (156 patients; HR=0.72; 95% CI, 0.57 to 0.91; p=0.01). In addition, they had fewer repeat ablations (44 patients vs 66 patients; HR=0.65; 95% CI, 0.45 to 0.95; p=0.03). Patients in both groups had improvements in quality of life scores from preablation through 12 months postablation, but there were no significant differences in change in quality of life between groups.
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Nyong J, Amit G, Adler AJ, et al.
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