Author + information
- Received March 21, 2017
- Revision received April 24, 2017
- Accepted April 26, 2017
- Published online May 12, 2017.
- Fleur V.Y. Tjong, MD∗∗ (, )
- Tom F. Brouwer, MD∗,
- Brendan Koop, PhD‡,
- Brian Soltis, MSc‡,
- Allan Shuros, MSc‡,
- Brian Schmidt, MSc‡,
- Bryan Swackhamer, MSc‡,
- Anne-Floor Quast, MD∗,
- Arthur A.M. Wilde, MD, PhD∗,
- Martin C. Burke, DO∗∗ and
- Reinoud E. Knops, MD∗
- ∗Academic Medical center, Amsterdam, The Netherlands
- ‡Boston Scientific Corporation, St. Paul, MN, USA
- ∗∗CorVita Science Foundation, Chicago, IL, USA
- ↵∗Corresponding Author: Fleur V. Y. Tjong, MD AMC Heart Center, Department of Clinical and Experimental Cardiology, Academic Medical Center, Meibergdreef 9, 1105 AZ, Room F3-240 Amsterdam, the Netherlands Phone: +31-20-5669111; Fax: +31-20-6969704.
Background Transvenous pacemakers and ICDs have considerable rates of lead complications. We examine the next step in multi-component leadless cardiac rhythm management: feasibility of pacing, including anti-tachycardia pacing (ATP), by a leadless pacemaker (LP), commanded by an implanted subcutaneous implantable cardioverter defibrillator (S-ICD) through wireless, intra-body, device-device communication. The primary objective is the acute and 3-month performance of the modular ATP-enabled LP and S-ICD system, particularly device-device communication and ATP delivery.
Methods The combined modular cardiac rhythm management therapy system of LP and S-ICD prototypes was evaluated in three animal models (ovine, porcine and canine) both in acute and chronic (90 days) experiments. LP performance, S-ICD to LP communication, S-ICD and LP rhythm discrimination, and ATP delivery triggered by the S-ICD were tested.
Results The LP and S-ICD were successfully implanted in 98% of the animals (n=39/40). 23 out of the 39 animals were followed up for 90 days post-implant. LP performance was adequate and demonstrated appropriate VVI behavior during 90 days of follow-up in all tested animals. Unidirectional communication between the S-ICD and LP was successful in 99% (n=398/401) attempts resulting in 100% ATP delivery by the LP (10 beats at 81% of coupling interval). Adequate S-ICD sensing was observed during normal sinus rhythm, LP pacing, and VT/VF.
Conclusion We present the preclinical acute and chronic performance of the combined function of an ATP-enabled LP and S-ICD. We demonstrated appropriate VVI functionality, successful wireless device-device communication and ATP delivery by the LP. Clinical studies on safety and performance are needed.
Disclosures: Dr. Tjong reports consulting fees from Boston Scientific Corporation, Inc. and St. Jude Medical. Dr. Burke reports consulting fees, research grants and honoraria for Boston Scientific, research grants with Medtronic and St. Jude Medical, and consulting fees and equity for AtaCor Medical. Dr. Knops reports consulting fees, research grants and honoraria for Boston Scientific, consulting fees research grants with Medtronic and St. Jude Medical. Prof. Wilde is a member of the Scientific Advisory Board of LivaNova. Mr. Koop, Mr. Soltis, Mr. Shuros, Mr. Schmidt, and Mr. Swackhamer are employees of Boston Scientific Corporation, Inc. The remaining authors have nothing to declare. Part of this study was funded by Boston Scientific Corp.
- Received March 21, 2017.
- Revision received April 24, 2017.
- Accepted April 26, 2017.
- 2017 American College of Cardiology Foundation