Why the study?
Although an RF transseptal device may be faster and more often successful than a conventional mechanical needle, increased equipment costs may dissuade routine use.
Does a radiofrequency transseptal device improve cost-effectiveness and 30-day survival compared to a conventional mechanical needle during pulmonary vein isolation?
Does a radiofrequency transseptal device improve cost-effectiveness and 30-day survival compared to a conventional mechanical needle during pulmonary vein isolation?
Despite higher initial equipment costs, the radiofrequency transseptal device is more cost-effective and provides better 30-day effectiveness than the conventional mechanical needle.
RF device may offer marginal effectiveness and cost advantages in transseptal puncture; leaves open need for randomized confirmation in PVI.
INTRODUCTION: Transseptal puncture is an integral step in various catheter-based cardiac procedures and can be performed with either the conventional mechanical needle or an FDA-cleared device utilizing radiofrequency (RF) energy. Although a previous randomized trial suggested that the RF transseptal device may be faster and more often successful, the increased equipment costs may dissuade operators from routine use. This analysis compares the cost-effectiveness of the mechanical needle to the RF device during pulmonary vein isolation. METHODS: The rates of successful transseptal punctures for each device and transseptal-related complications were determined from the peer-reviewed medical literature. Procedural, equipment, and complication costs were obtained from peer-reviewed medical literature and the Healthcare Cost and Utilization Project. The effectiveness was defined as the probability of 30-day survival following a successful transseptal puncture. Monte Carlo probabilistic analyses tested variable effects of costs and complication rates on the incremental cost-effectiveness ratio. RESULTS: The 30-day effectiveness of the RF device vs the mechanical needle was 99.7% and 98.8%, respectively. After accounting for all costs of performing a single transseptal puncture, the cost at 30 days associated with the RF device was $41 less than the mechanical needle ($21 096 vs $21 137). The RF device was similarly dominant to the mechanical needle in double transseptal puncture scenarios. Finally, the RF device was more cost-effective than the mechanical needle at any willingness-to-pay in Monte Carlo probabilistic sensitivity analyses. CONCLUSIONS: Despite greater equipment costs, the RF device costs less and provides better effectiveness at 30 days than the conventional mechanical needle.
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Sánchez et al. (2020) studied this question.
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