Transcatheter, Subvalvular Delivery of Millimeter-Scale, Self-Powered, Bioresorbable Pacemaker for Left Bundle Branch Pacing and Resynchronization Therapy
Abstract Body (Do not enter title and authors here): Background We have engineered the world’s smallest pacemaker, a self-powered, leadless “milli-pacemaker” that is smaller than a single grain of rice. It is 1.8 mm × 3.5 mm × 1.0 mm and able to fit in the lumen of a small-diameter introducer, enabling transcatheter delivery.
Aim We are developing the means of delivering the smallest pacemaker in the world for resynchronization therapy. In this study, we sought to optimize this delivery system for left bundle branch pacing in beating hearts.
Methods The prototype system was iteratively developed through ex vivo experiments on perfused, paced, human hearts declined for transplant. The catheter-based system delivers the milli-pacemaker below the aortic valve to the left ventricular septum. A transcatheter mechanical fixation system facilitates milli-pacemaker attachment to the endocardium. Optical stimulation by a light emitting diode triggers milli-pacemaker activity. Pacing threshold testing was performed. Electrocardiogram confirmed left bundle branch capture.
Results Iterative prototyping was performed through ex vivo testing on perfused, paced, human hearts declined for transplantation (n=3). A satisfactory pacing threshold of 0.6 V with 4 ms 2 Hz pulses was achieved. Electrocardiogram confirmed left bundle branch capture in each heart.
Conclusions We have tested a transcatheter delivery system for the smallest pacemaker in the world. It delivers the milli-pacemaker to the left ventricular side of the interventricular septum for resynchronization therapy. Pacing the left ventricular endocardial surface limits septum penetration and facilitates left bundle branch capture. It is also more in-line with physiologic cardiac conduction. Our delivery system makes the milli-pacemaker a feasible option for minimally invasive resynchronization therapy.
Stark, Charles
( Northwestern University
, Chicago
, Illinois
, United States
)
Rogers, John
( Northwestern University
, Chicago
, Illinois
, United States
)
Efimov, Igor
( Northwestern University
, Chicago
, Illinois
, United States
)
Rytkin, Eric
( Northwestern University
, Chicago
, Illinois
, United States
)
Bhat, Pavan
( Northwestern University
, Chicago
, Illinois
, United States
)
Tang, Lichao
( Northwestern University
, Chicago
, Illinois
, United States
)
Saleem, Noor
( Northwestern University
, Chicago
, Illinois
, United States
)
Saba, Peter
( Northwestern University
, Chicago
, Illinois
, United States
)
Zeng, Liangsong
( Northwestern University
, Chicago
, Illinois
, United States
)
Zhang, Yamin
( Northwestern University
, Chicago
, Illinois
, United States
)
Pfenniger, Anna
( Northwestern University
, Chicago
, Illinois
, United States
)
Author Disclosures:
Charles Stark:DO NOT have relevant financial relationships
| John Rogers:DO NOT have relevant financial relationships
| Igor Efimov:DO have relevant financial relationships
;
Ownership Interest:NuSera Biosystems:Active (exists now)
| Eric Rytkin:DO have relevant financial relationships
;
Individual Stocks/Stock Options:NuSera Biosystems Inc.:Active (exists now)
| Pavan Bhat:DO NOT have relevant financial relationships
| Lichao Tang:No Answer
| Noor Saleem:No Answer
| Peter Saba:No Answer
| Liangsong Zeng:DO NOT have relevant financial relationships
| YAMIN ZHANG:DO NOT have relevant financial relationships
| Anna Pfenniger:DO NOT have relevant financial relationships