Division of Cardiology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.
Cardiovascular Institute, North Shore University Health System, Evanston, Illinois, USA.
J Cardiovasc Electrophysiol. 2024 Jan;35(1):16-24. doi: 10.1111/jce.16111. Epub 2023 Oct 27.
Mechanical force to achieve transseptal puncture (TSP) using a standard needle may lead to overshooting and injury, and can potentially be avoided using a radiofrequency (RF)-powered needle or wire. Applying electrocautery to needles and guidewires as an alternative to purpose-built RF systems has been associated with safety risks, such as tissue coring and thermal damage. The commercially available AcQCross needle-dilator system (Medtronic) features a sharp open-ended needle for mechanical puncture, as well as a built-in connector to enable energy delivery for RF puncture. This investigation compares the safety and efficacy of the AcQCross needle to the dedicated VersaCross RF wire system and generator (Baylis Medical/Boston Scientific).
In an ex vivo porcine model, VersaCross wire punctures were performed using 1 s, constant mode (approx. 10 W) with maximum two attempts. AcQCross punctures were performed by applying energy for 2 s using a standard electrosurgical generator at 10 W (max. five attempts), 20 W (max. two attempts), and 30 W (max. two attempts). Efficacy was assessed in terms of puncture success and a number of energy applications required for TSP. Safety was assessed quantitatively as force required for TSP, energy required to puncture, and incidence of tissue coring, as well as by qualitative assessment of puncture sites. Additional qualitative observation of tissue cores and debris were obtained from TSP performed in live swine.
RF TSP was 100% successful using the VersaCross wire with 1.0 ± 0.0 attempts. When power was used with the AcQCross needle, it failed to puncture at low (10 and 20 W) power settings; TSP was achieved with 30 W of energy with 91% success using 1.53 ± 0.51 attempts (p < .05 vs. VC) with greater variability (F = 9223.5, p < .0001). Compared to RF puncture using the VersaCross system, mechanical puncture, alone, using the AcQcross needle required six times more force (8 mm additional forward device displacement) to perforate the septum. Qualitative assessment of puncture sites revealed larger defects and more tissue charring with the AcQCross needle at 30 W compared to punctures with VersaCross wire. Tissue coring with the open-ended AcQCross needle was observed in vivo and measured to occur in 57% of punctures using the ex vivo model; no coring was observed with the closed-tip VersaCross wire.
The AcQCross needle frequently required higher energy of 30 W to achieve RF TSP and was associated with tissue coring and charring, which have been, previously, reported when electrifying a standard open-ended mechanical needle or guidewire. These findings may limit safety and effectiveness compared to the VersaCross system.
使用标准针进行经间隔穿刺（TSP）的机械力可能导致过度穿刺和损伤，使用射频（RF）动力针或导丝可以避免这种情况。将电灼用于针和导丝作为专用 RF 系统的替代方案与组织芯和热损伤等安全风险相关联。市售的 AcQCross 针扩张器系统（美敦力）具有用于机械穿刺的锋利的开放式末端针，以及用于 RF 穿刺的内置连接器。这项研究比较了 AcQCross 针与专用 VersaCross RF 线系统和发生器（Baylis Medical/Boston Scientific）的安全性和有效性。
在离体猪模型中，使用 VersaCross 线进行 1s、恒模（约 10W），最多尝试两次。AcQCross 穿刺通过在标准电外科发生器上以 10W（最大 5 次尝试）、20W（最大 2 次尝试）和 30W（最大 2 次尝试）施加能量进行 2s 的穿刺。以 TSP 所需的穿刺成功率和能量应用次数来评估疗效。安全性通过 TSP 所需的力、穿刺所需的能量以及组织芯的发生率进行定量评估，并通过穿刺部位的定性评估进行评估。还从活体猪中进行的 TSP 中获得了组织芯和碎片的额外定性观察。
使用 VersaCross 线进行 RF TSP 成功率为 100%，尝试次数为 1.0±0.0。当使用 AcQCross 针施加功率时，在低功率设置（10 和 20W）下未能穿刺；使用 30W 能量，成功率为 91%，尝试次数为 1.53±0.51（p<.05 与 VC 相比），变异性更大（F=9223.5，p<.0001）。与使用 VersaCross 系统进行 RF 穿刺相比，单独使用 AcQcross 针进行机械穿刺需要施加 6 倍的力（装置向前移动 8mm）才能穿透间隔。与 VersaCross 线穿刺相比，30W 时 AcQCross 针穿刺部位的定性评估显示出更大的缺陷和更多的组织焦化。在体内观察到开放式 AcQCross 针的组织芯，并在使用离体模型进行的 57%的穿刺中进行了测量；未观察到闭合尖端 VersaCross 线的芯。
AcQCross 针经常需要更高的 30W 能量才能实现 RF TSP，并且与组织芯和焦化有关，这在以前使用标准开放式机械针或导丝通电时已经报道过。与 VersaCross 系统相比，这些发现可能会限制安全性和有效性。
