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.