Use of a novel integrated dilator-needle system in cryoballoon procedures: a zero-exchange approach

Abstract

Background Recently, a novel integrated dilator-needle system (AcQCross Qx, Acutus Medical) was introduced to reduce the number of exchanges for a transseptal access. This system can be used in combination with large bore sheaths. In this pilot study, we evaluated the safety and efficacy of a zero-exchange approach with the AcQCross system in cryoballoon procedures. Methods In this retrospective single-center study, we included 40 patients (AcQCross: n = 20; control group: n = 20) who underwent a cryoballoon procedure for the treatment of atrial fibrillation. In the AcQCross and control group, patients underwent ablation with POLARx (Boston Scientific) and Arctic Front Advance Pro (AFA-Pro, Medtronic) in equal numbers (n = 10). In the AcQCross group, the AcQGuide Max sheath (Acutus Medical) was used in all POLARx cases. Results The baseline characteristics of the study population were comparable between groups. In the AcQCross group, there was a reduction in procedure time (49.7 ± 9.0 min vs. 59.6 ± 8.1 min, P < 0.001) and time from puncture until balloon delivery (15.5 ± 6.8 min vs. 21.5 ± 7.4 min, P = 0.01) in comparison with the control group. The balloon in body time, fluoroscopy time, number of cryoapplications, and biophysical parameters were similar between groups. There was one temporary phrenic nerve injury in the AcQCross group. Importantly, no signs of air embolism were noted with the AcQGuide Max sheath. Conclusions The use of the novel AcQCross system improves procedural efficacy in cryoballoon procedures by reducing the number of exchanges.

A zero‐exchange approach for left atrial access in pulmonary vein isolation with pulsed field ablation

“…For instance, in the setting of cryoballoon PVIs an integrated dilator-needle system has been described. 6 The authors found a significant reduction in procedure time, as well as time from puncture to balloon delivery when using the integrated dilator-needle system. This reflects also the inherent time-saving potential of our technique with an additional advantage of saving costs.…”

“…9 The technique described is safe, feasible, and saves costs in comparison with other workflows or zero-exchange systems. 6,10 A true costeffectiveness of our workflow needs to be further assessed after studying the patient outcomes.…”

“…There is only scarce literature regarding zero‐exchange approaches for LA access. For instance, in the setting of cryoballoon PVIs an integrated dilator‐needle system has been described 6 . The authors found a significant reduction in procedure time, as well as time from puncture to balloon delivery when using the integrated dilator‐needle system.…”

Eliminating transseptal sheath exchange for pulsed field ablation procedures using a direct over-the-needle transseptal access with the Faradrive sheath

“…For cryoballoon procedures, streamlined workflows for direct TSP have been suggested. 3 , 4 For the PFA system, this is the first description of a workflow for direct TSP using the 16.8 Fr PFA sheath. The long tapering of the dilator makes the sheath particularly suitable for both groin access and TSP without pre-dilation.…”

“…While we used an over-the-needle approach, it is conceivable that an over-the-wire approach could work similarly well. 4 , 5 While additional imaging (predominantly intracardiac echocardiography) is routinely used to guide TSP in the USA and Canada, the majority of European Centers performs TSP guided by fluoroscopy. 6 Our TSP workflow was guided by fluoroscopy only, and we believe that it can be safely used without additional imaging.…”