Safety and Efficacy of a Novel Radiofrequency Wire-Based Transseptal Puncture System

Transseptal puncture (TSP) is a key component of cardiac ablation and structural interventional procedures. Procedural efficacy and safety of the VersaCross TSP platform, a novel blunt radiofrequency (RF)-wire based system, was compared with conventional equipment.

Consecutive patients undergoing TSP with VersaCross or a control group using conventional equipment were studied. Procedures were carried out using fluoroscopy alone or with additional transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE) guidance. Procedural metrics including TSP and fluoroscopy times were recorded. Complications, both acute and up to a month post procedure, were included.

Two hundred and fifty procedures were included (150 VersaCross, 100 control) in the registry. Of these, 100 consecutive cases (75 VersaCross, 25 control) had prospective data collected for procedural metrics. Between the VersaCross and control cases, there was no difference between echocardiographic use (50 vs. 52%, p = 0.8) or conscious sedation use (53 vs. 55%, p = 0.56). AF ablations predominated in both groups (81% vs. 90%). There was no difference between median TSP or fluoroscopy times for either single or double transseptal access between groups. There were five minor (one momentary AV-block and four acute pericardial effusions not requiring intervention) and two major (cardiac tamponade and hemothorax) complications in the VersaCross group, with two major (cardiac tamponade) complications in the control group.

The VersaCross TSP system can be used in a variety of ablation procedures with or without TEE/ICE guidance under conscious sedation or general anesthesia. Compared with conventional TSP technologies, there is no increase in major complications, TSP or fluoroscopy times.