Transseptal puncture device integrated with 3D mapping visualizable streerable sheet: a feasibility study

A novel transseptal crossing device combines the vessel dilator and transseptal needle into a single component. The needle lumen accepts a 0.32 inch guidewire. Inside the transseptal crossing device, the needle is affixed to a spring-tensioned actuator that prevents needle extension until the operator purposely advances the needle via a slider button located on the outer surface of the handle. The handle is also fitted with an electrical connector in order to monitor an EGM from the needle, utilising the EGM adapter cable, and/or to apply RF current from an electrosurgical generator. [1]

We aimed to evaluate the performace in transeptal puncture (TSP) of this novel transseptal crossing device integrated with 3D mapping visualizable streerable sheet.

We retrospectively evaluated 20 patients (12 males, mean age 67.4± 11.1 years), indicated to supraventricular left sided tachyarrhythmia ablation, underwent TSP using transseptal crossing device integrated with 3D mapping visualizable streerable sheet. We compared the results to a control cohort of twenty patients (10 males, mean age 65.5 ± 10.1 years) underwent TSP using the traditional system.

The novel TSP device led to a successful and safe access to the left atrium in all the study group. The mean transseptal time, defined as the time occurring between the groin puncture and the advancing of the guidewire into the left superior pulmonary vein (PV), was 3 min 26 s ± 51 s as compared to 7 min 5 s ± 36 s in the control cohort. Notably the TSP X-Ray time was 2 min 20 s±58 s and dose area product was 27,9±46 µGY*m2 which coincided also with total procedure ones, since the 3d mapping system visualizable streerable sheet allowed us to perform near zero-X-ray procedure in all the study cohort. No acute complications related to the TSP were noted in both cohorts.

TSP performed with dedicated device integrated with 3D mapping visualizable streerable sheet is feasible and safe. It is significantly faster as compared to the traditional system, also aiming to perform near-zero-X-Ray procedure according to ALARA principle.

Technique