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Published on: April 21, 2013
Utility of a guiding catheter for conduction system pacing: An early multicenter experience
Jan De Pooter1, Alan Bulava2, Daniel Gras3
1University Hospital Ghent, Ghent, Belgium.
Insights
The new Selectra 3D catheter facilitates conduction system pacing (CSP) with high success rates and no early serious adverse device effects. This tool supports both His bundle pacing (HBP) and left bundle branch area pacing (LBBAP) for improved patient outcomes.
Area of Science:
- Cardiology
- Medical Devices
- Electrophysiology
Background:
- Conduction system pacing (CSP), encompassing His bundle pacing (HBP) and left bundle branch area pacing (LBBAP), presents a potentially superior alternative to traditional right ventricular pacing.
- The efficacy and safety of CSP techniques are areas of ongoing research and clinical interest.
Purpose of the Study:
- To evaluate the acute performance of the Biotronik Selectra 3D guiding catheter and Solia S lead for CSP implantations.
- To assess the safety and feasibility of using this new system in a clinical setting.
Main Methods:
- Prospective, international, nonrandomized study (BIO|MASTER.Selectra 3D).
- Primary endpoint: freedom from catheter-related serious adverse device effects (SADEs) within 7 days of implantation.
- Enrolled 157 patients, assessing implantation success, procedure time, and catheter handling.
Main Results:
- CSP was successfully achieved in 147 patients (93.6%), with no SADEs within the first week.
- Implantation success approached 99% when both HBP and LBBAP approaches were considered.
- Mean procedure and fluoroscopy times were approximately 50 and 6 minutes, respectively, with most cases requiring only one catheter.
- QRS duration narrowed in patients with bundle branch block and widened slightly in those without, indicating electrical effects of CSP.
Conclusions:
- The Selectra 3D catheter is effective for HBP and LBBAP lead implantations.
- High success rates (∼99%) were observed when both pacing strategies were considered, highlighting the value of procedural flexibility.
- The catheter demonstrated positive handling characteristics and a favorable safety profile for CSP procedures.
Background:
Conduction system pacing (CSP), either as His bundle pacing (HBP) or as left bundle branch area pacing (LBBAP), may be superior to right ventricular apical or septal pacing.
Objective:
The study sought to present acute results for a new guiding catheter (Biotronik Selectra 3D) designed for CSP implantations of a retractable screw-in lead (Biotronik Solia S).
Methods:
The primary endpoint of the prospective, international nonrandomized BIO|MASTER.Selectra 3D study was freedom from catheter-related serious adverse device effects (SADEs) within 1 week of lead implantation.
Results:
Of 157 enrolled patients, CSP was achieved in 147 (93.6%) patients. No SADEs occurred within 7 days. LBBAP was achieved in 82 patients (45 as crossover from an HBP attempt) and HBP in 65 (44.2%) patients. In centers considering both HBP and LBBAP, the CSP implantation success approached 99%. Successful CSP implantations lasted on average ∼50 minutes (fluoroscopy ∼6 minutes). Most procedures (87.9%) needed only 1 catheter, even after switch from HBP to LBBAP. The catheter's handling was rated largely positive. In patients without bundle branch block, mean QRS duration increased from 106 ms (intrinsic) to 122 ms (CSP) (P = .001). In patients with bundle branch block, mean QRS duration decreased from 151 ms (intrinsic) to 137 ms (CSP) (P = .004).
Conclusion:
The Selectra 3D catheter is a valuable tool for HBP and LBBAP implantations of the stylet-supported pacemaker leads. When implanters considered both HBP and LBBAP, the success rate was ∼99%. Flexibility to change between different approaches may be advisable in heterogeneous and challenging areas, such as CSP implantations.
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