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.
| Original language | English |
|---|---|
| Pages (from-to) | 186-196 |
| Number of pages | 11 |
| Journal | JACC: Clinical Electrophysiology |
| Volume | 5 |
| Issue number | 2 |
| DOIs | |
| Publication status | Published - Feb 1 2019 |
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Keywords
- anterior mediastinum
- defibrillation lead
- extravascular
- implantable cardioverter-defibrillator
- substernal
- tachyarrhythmia
ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine
- Physiology (medical)
Cite this
Therapy From a Novel Substernal Lead : The ASD2 Study. / Boersma, Lucas V.A.; Merkely, B.; Neuzil, Petr; Crozier, Ian G.; Akula, Devender N.; Timmers, Liesbeth; Kalarus, Zbigniew; Sherfesee, Lou; DeGroot, Paul J.; Thompson, Amy E.; Lexcen, Daniel R.; Knight, Bradley P.
In: JACC: Clinical Electrophysiology, Vol. 5, No. 2, 01.02.2019, p. 186-196.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Therapy From a Novel Substernal Lead
T2 - The ASD2 Study
AU - Boersma, Lucas V.A.
AU - Merkely, B.
AU - Neuzil, Petr
AU - Crozier, Ian G.
AU - Akula, Devender N.
AU - Timmers, Liesbeth
AU - Kalarus, Zbigniew
AU - Sherfesee, Lou
AU - DeGroot, Paul J.
AU - Thompson, Amy E.
AU - Lexcen, Daniel R.
AU - Knight, Bradley P.
PY - 2019/2/1
Y1 - 2019/2/1
N2 - 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.
AB - 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.
KW - anterior mediastinum
KW - defibrillation lead
KW - extravascular
KW - implantable cardioverter-defibrillator
KW - substernal
KW - tachyarrhythmia
UR - http://www.scopus.com/inward/record.url?scp=85061124512&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85061124512&partnerID=8YFLogxK
U2 - 10.1016/j.jacep.2018.11.003
DO - 10.1016/j.jacep.2018.11.003
M3 - Article
C2 - 30784689
AN - SCOPUS:85061124512
VL - 5
SP - 186
EP - 196
JO - JACC: Clinical Electrophysiology
JF - JACC: Clinical Electrophysiology
SN - 2405-5018
IS - 2
ER -