DISCUSSION
This study reports the first-in-human experience with the Swift Sync temporary pacing catheter, a novel device implanted via the internal jugular vein approach to provide temporary atrioventricular synchronous pacing. We demonstrated the feasibility and initial safety of the study device in patients undergoing elective cardiac catheterization procedures. The catheter was successfully delivered and retrieved in all patients and achieved adequate pacing thresholds in all patients, although it required one patient higher MA to pace atrium. . There were no deaths, major adverse cardiac events, or device-related adverse events.
Impaired electromechanical coupling at any level (atrioventricular, interventricular, and intraventricular) can worsen cardiac performance and heart failure symptoms. Conversely, improving electromechanical dyssynchrony and restoring the physiologic AV relationship results in improved myocardial performance, reduced severity of mitral regurgitation, and ultimately increased cardiac output (1). These hemodynamics benefits are desirable in patients needing temporary pacing, particularly those with impaired hemodynamics, such as cardiogenic shock, myocardial infarction with right ventricular involvement, left ventricular hypertrophy, or decompensated heart failure.
Nearly all temporary pacing is done trans-venously with a single bipolar catheter, which is floated or advanced into the right ventricle (5). This only allows ventricular pacing without atrial pacing and tracking or AV synchrony. Furthermore, these catheters displace easily. Even with active fixation, there can be complications such as loss of pacing capture or potential ventricular perforation(6). We believe TAVSP catheter design with multiple unipolar expanding leads will improve endocardial contact and catheter stability.
AV synchrony is obtained during cardiac surgery by directly suturing temporary transcutaneous leads to the epicardium(7). These leads are then connected to an external cardiac pacer box, and AV synchrony can be achieved. However, these leads are not without potential complications. There are reports of infections, myocardial damage, ventricular arrhythmia, and cardiac perforations with these leads(8). In addition, removing the leads can be complicated, as highlighted by the published tragic case of Neal Armstrong (the first astronaut to walk on the Moon), who died of cardiac tamponade immediately following the removal of his epicardial transcutaneous leads. There were no device-related adverse events in our study. The atraumatic round tip of the lead was designed to minimize chamber perforation and erosion. The profile size of the TAVPS is comparable with some of the commercially available temporary pacing venous catheters.
This acute first in man study has limitations. This early feasibility study aimed to gather information on the device’s ease of deployment and performance. We did not compare TAVPS to any other standard temporary pacing catheters with a single-arm design. Furthermore, we did not measure the hemodynamics effects of atrioventricular pacing using our device. Additionally, this initial experience was performed in patients with no need for temporary pacing. TAVPS still needs to be evaluated in patients with indications for temporary pacing and varied hemodynamic conditions. Although we did not observe any adverse device-related event, definitive conclusions about safety cannot be drawn due to the small number of patients.