Clinical Evidence / Publications / Clinical
Cerclage Parahisian Septal Pacing through the Septal Perforator Branch of the Great Cardiac Vein: Bedside-to-Bench Development of a Novel Technique and Lead
Min Soo Cho et al.
Heart Rhythm · 2019
Summary
This study tested "cerclage pacing": placing a pacemaker lead inside the septum near the heart's conduction system by going through a vein on the heart surface. Lead implantation succeeded in all five patients, and the experience led to a purpose-built lead prototype.
Part of Tau Medical’s electrophysiology research program.
Key results
5/5
successful lead implantation
4/5
intraseptal pacing achieved
0.8V
median pacing threshold
227min
median procedure time
Background
Why this study
Standard right ventricular pacing can weaken the heart over time, and His-bundle pacing can be hard to achieve and keep stable. Cerclage pacing uses the same vein path as mitral cerclage to reach the septum from the coronary sinus.
Methods
What was done
- Seven patients screened at two hospitals (2016–2018); two were excluded because the septal vein was not visible.
- Five patients underwent lead placement through the coronary sinus into a septal perforator vein, guided toward the His bundle.
- Findings were used to design and test a dedicated lead prototype.
Findings
What was found
- Lead implantation and pacing worked in all five patients; four achieved true intraseptal pacing.
- Paced QRS width was near normal or narrower than baseline in all but the first patient.
- Procedures were long (median 227 minutes), and one lead dislodged the day after implantation; for these reasons the clinical protocol was stopped.
- Left ventricular function was preserved or improved at 12 months in the three patients with follow-up.
Interpretation
What it means
Authors’ conclusion
Cerclage parahisian septal pacing is a feasible route to physiological pacing. Commercial leads were ill-suited, so a dedicated lead was developed for further study.
Limitations
- Five patients
- Long procedure and fluoroscopy times
- Off-the-shelf leads
- Clinical protocol stopped early
Overview
Study at a glance
- Type
- Early clinical series and device development
- Patients
- 5
- Route
- Coronary sinus → septal perforator vein
- Goal
- Physiological pacing near the His bundle
Summary written by Tau Medical from the published article. Results come from a small study without a control group. Tau Medical devices described here are investigational, and their safety and effectiveness have not been established.