Lucas V A Boersma1, Béla Merkely2, Petr Neuzil3, Ian G Crozier4, Devender N Akula5, Liesbeth Timmers6, Zbigniew Kalarus7, Lou Sherfesee8, Paul J DeGroot8, Amy E Thompson8, Daniel R Lexcen8, Bradley P Knight9. 1. Department of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands; Academic Medical Center (AMC), University of Amsterdam, Amsterdam, the Netherlands. Electronic address: l.boersma@antoniusziekenhuis.nl. 2. Semmelweis University, Heart and Vascular Center, Budapest, Hungary. 3. Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic. 4. Department of Cardiology, Christchurch Hospital, Christchurch, New Zealand. 5. Lourdes Cardiology Center, Voorhees, New Jersey. 6. Department of Cardiology, Ghent University Hospital, Ghent, Belgium. 7. SMDZ, Zabrze, Poland, Medical University of Silesia, Katowice, Poland; Department of Cardiology, Silesian Center for Heart Diseases, Zabrze, Poland. 8. Medtronic, Minneapolis, Minnesota. 9. Northwestern University, Feinberg School of Medicine, Chicago, Illinois.
Abstract
OBJECTIVES: The ASD2 (Acute Extravascular Defibrillation, Pacing, and Electrogram) study evaluated the ability to adequately sense, pace, and defibrillate patients with a novel implantable cardioverter-defibrillator (ICD) lead implanted in the substernal space. BACKGROUND: Subcutaneous ICDs are an alternative to a transvenous defibrillator system when transvenous implantation is not possible or desired. An alternative extravascular system placing a lead under the sternum has the potential to reduce defibrillation energy and the ability to deliver pacing therapies. METHODS: An investigational lead was inserted into the substernal space via a minimally invasive subxiphoid access, and a cutaneous defibrillation patch or subcutaneous active can emulator was placed on the left mid-axillary line. Pacing thresholds and extracardiac stimulation were evaluated. Up to 2 episodes of ventricular fibrillation were induced to test defibrillation efficacy. RESULTS: The substernal lead was implanted in 79 patients, with a median implantation time of 12.0 ± 9.0 min. Ventricular pacing was successful in at least 1 vector in 76 of 78 patients (97.4%), and 72 of 78 (92.3%) patients had capture in ≥1 vector with no extracardiac stimulation. A 30-J shock successfully terminated 104 of 128 episodes (81.3%) of ventricular fibrillation in 69 patients. There were 7 adverse events in 6 patients causally (n = 5) or possibly (n = 2) related to the ASD2 procedure. CONCLUSIONS: The ASD2 study demonstrated the ability to pace, sense, and defibrillate using a lead designed specifically for the substernal space.
OBJECTIVES: The ASD2 (Acute Extravascular Defibrillation, Pacing, and Electrogram) study evaluated the ability to adequately sense, pace, and defibrillate patients with a novel implantable cardioverter-defibrillator (ICD) lead implanted in the substernal space. BACKGROUND: Subcutaneous ICDs are an alternative to a transvenous defibrillator system when transvenous implantation is not possible or desired. An alternative extravascular system placing a lead under the sternum has the potential to reduce defibrillation energy and the ability to deliver pacing therapies. METHODS: An investigational lead was inserted into the substernal space via a minimally invasive subxiphoid access, and a cutaneous defibrillation patch or subcutaneous active can emulator was placed on the left mid-axillary line. Pacing thresholds and extracardiac stimulation were evaluated. Up to 2 episodes of ventricular fibrillation were induced to test defibrillation efficacy. RESULTS: The substernal lead was implanted in 79 patients, with a median implantation time of 12.0 ± 9.0 min. Ventricular pacing was successful in at least 1 vector in 76 of 78 patients (97.4%), and 72 of 78 (92.3%) patients had capture in ≥1 vector with no extracardiac stimulation. A 30-J shock successfully terminated 104 of 128 episodes (81.3%) of ventricular fibrillation in 69 patients. There were 7 adverse events in 6 patients causally (n = 5) or possibly (n = 2) related to the ASD2 procedure. CONCLUSIONS: The ASD2 study demonstrated the ability to pace, sense, and defibrillate using a lead designed specifically for the substernal space.
Authors: Levente Molnár; Ian Crozier; Haris Haqqani; David O'Donnell; Emily Kotschet; Jeffrey Alison; Amy E Thompson; Varun A Bhatia; Roland Papp; Endre Zima; Ádám Jermendy; Astrid Apor; Béla Merkely Journal: Europace Date: 2022-05-03 Impact factor: 5.486
Authors: Amy E Thompson; Brett Atwater; Lucas Boersma; Ian Crozier; Gregory Engel; Paul Friedman; J Rod Gimbel; Bradley P Knight; Jaimie Manlucu; Francis Murgatroyd; David O'Donnell; Juergen Kuschyk; Paul DeGroot Journal: J Cardiovasc Electrophysiol Date: 2022-05-08 Impact factor: 2.942
Authors: Christoph Schukro; David Santer; Günther Prenner; Markus Stühlinger; Martin Martinek; Alexander Teubl; Deddo Moertl; Stefan Schwarz; Michael Nürnberg; Lukas Fiedler; Robert Hatala; Cesar Khazen Journal: Clin Cardiol Date: 2020-08-14 Impact factor: 2.882
Authors: Ian Crozier; David O'Donnell; Lucas Boersma; Francis Murgatroyd; Jaimie Manlucu; Bradley P Knight; Ulrika Maria Birgersdotter-Green; Christophe Leclercq; Amy Thompson; Robert Sawchuk; Sarah Willey; Christopher Wiggenhorn; Paul Friedman Journal: J Cardiovasc Electrophysiol Date: 2021-08-05 Impact factor: 2.942