Authors' objectives:

The objective of this assessment is to determine whether pulmonary vein isolation (PVI) improves health outcomes when used as an alternative to pharmacologic treatment for patients with atrial fibrillation (AF).

Authors' results and conclusions: Numerous clinical series of PVI treatment have been published that report primarily on success in maintaining sinus rhythm following PVI. However, these reports provide little evidence on the true efficacy of PVI in maintaining sinus rhythm apart from the natural history of the disorder and/or the impact of ancillary treatment measures. These uncontrolled series also do not provide relevant data on the comparative efficacy of PVI vs. pharmacologic treatment. Three controlled trials met the inclusion criteria and were reviewed in-depth for this Assessment. One trial was a randomized, controlled trial (RCT) (n=146) that compared PVI plus ancillary treatments (i.e., short-term amiodarone, cardioversion) with ancillary treatments alone for patients with chronic AF. The second trial was a smaller RCT (n=70) that randomized patients with new-onset, paroxysmal AF to PVI or antiarrhythmic drug therapy. The final study was a nonrandomized comparative study (n=1,171) that included patients with symptomatic AF refractory to prior antiarrhythmic drug treatment, and compared outcomes of PVI vs. continued antiarrhythmic drug treatment. All 3 trials reported improvements in outcomes that favored the PVI group. In the RCT of PVI plus ancillary treatment vs. ancillary treatment alone, maintenance of sinus rhythm was higher in the PVI group, with 74% of patients in the PVI group in sinus rhythm at 1 year, compared to only 4% of patients in the control group who maintained sinus rhythm following ancillary treatment alone. Two of the 3 trials compared PVI to pharmacologic treatment. The smaller RCT reported a lower incidence of AF recurrence in the PVI group compared to the antiarrhythmic drug group (13% vs. 63%, p<0.001). This study also included quality of life outcomes, with a greater improvement on 5 of 8 subscales of the SF-36 reported for the PVI group. The larger nonrandomized trial corroborated the findings of the smaller RCT of lower recurrence of AF following PVI, with an incidence at 1 year of 20% in the PVI group vs. 58% in the medical treatment group (p<0.001). This nonrandomized study also reported on mortality and AF-related morbidities. The PVI group had improved survival at 3 years (92% vs. 86%, p<0.001) and a reduced likelihood of cardiovascular morbidities (hazard ratio [HR] 0.45; 95% CI: 0.31-0.64). Adverse events from the procedure can occur, including pulmonary vein stenosis, tamponade, thromboembolism, and perforation of the esophageal wall. The rates of these complications cannot be determined accurately from the available data. The rates of complications in the available studies reflect the specific procedures performed and may not be generalizable to variations on the procedure. There have been numerous modifications to the original PVI technique, mainly with the intention of reducing pulmonary vein stenosis and other complications, and currently there is no standardization of the procedure across medical centers.

Authors' recommendations: Based on the available evidence, the Blue Cross and Blue Shield Association Medical Advisory Panel made the following judgments about whether PVI as a treatment for atrial fibrillation meets the Blue Cross and Blue Shield Association Technology Evaluation Center (TEC) criteria: 1. The technology must have final approval from the appropriate governmental regulatory bodies. PVI is a percutaneous procedure, and as such is not itself subject to U.S. Food and Drug Administration (FDA) approval. However, the devices used for PVI are subject to FDA approval. The FDA has granted approval to numerous catheter ablation systems under the premarket approval process. Indications for use of these catheters include ablation therapy for arrhythmias such as supraventricular tachycardia, atrial flutter, and ventricular tachycardia. Some of the catheter systems also have approval for treatment of refractory atrial fibrillation. 2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes. The evidence is not sufficient to permit conclusions on the effect of PVI on outcomes of atrial fibrillation. The available evidence includes 3 controlled trials that met the inclusion criteria for this Assessment: 2 RCTs and 1 larger nonrandomized controlled study. One RCT does not compare PVI to pharmacologic management. The second RCT is small and does not report on the full range of clinical outcomes. The third study is a larger, nonrandomized study that is prone to selection bias. While the results of the available trials are suggestive that PVI may lead to health outcome benefits, larger RCTs are needed that enroll the appropriate population(s) and that include the most relevant comparison groups before conclusions can be made on the efficacy of this treatment. 3. The technology must improve the net health outcome; and 4. The technology must be as beneficial as any established alternatives The evidence does not permit conclusions as to whether PVI improves health outcomes or is as beneficial as established alternatives. 5. The improvement must be attainable outside the investigational settings. Whether PVI improves the net health outcome has not been established in the investigational settings. Based on the above, PVI as a treatment for atrial fibrillation does not meet the TEC criteria.

Authors' methods: Review

Project Status: Completed

URL for project: http://www.bcbs.com/blueresources/tec/contact-tec.html

Year Published: 2006

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: United States

Organisation Name: BlueCross BlueShield Association

Contact Address: BlueCross BlueShield Association, Technology Evaluation Center, 225 North Michigan Ave, Chicago, Illinois, USA. Tel: 888 832 4321

Contact Name: tec@bcbsa.com

Contact Email: tec@bcbsa.com

Copyright: BlueCross BlueShield Association (BCBS)