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.