Efficacy and Safety of an Extravascular Implantable Cardioverter-Defibrillator.
Journal
The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562
Informations de publication
Date de publication:
06 10 2022
06 10 2022
Historique:
pubmed:
30
8
2022
medline:
12
10
2022
entrez:
29
8
2022
Statut:
ppublish
Résumé
The extravascular implantable cardioverter-defibrillator (ICD) has a single lead implanted substernally to enable pause-prevention pacing, antitachycardia pacing, and defibrillation energy similar to that of transvenous ICDs. The safety and efficacy of extravascular ICDs are not yet known. We conducted a prospective, single-group, nonrandomized, premarket global clinical study involving patients with a class I or IIa indication for an ICD, all of whom received an extravascular ICD system. The primary efficacy end point was successful defibrillation at implantation. The efficacy objective would be met if the lower boundary of the one-sided 97.5% confidence interval for the percentage of patients with successful defibrillation was greater than 88%. The primary safety end point was freedom from major system- or procedure-related complications at 6 months. The safety objective would be met if the lower boundary of the one-sided 97.5% confidence interval for the percentage of patients free from such complications was greater than 79%. A total of 356 patients were enrolled, 316 of whom had an implantation attempt. Among the 302 patients in whom ventricular arrhythmia could be induced and who completed the defibrillation testing protocol, the percentage of patients with successful defibrillation was 98.7% (lower boundary of the one-sided 97.5% confidence interval [CI], 96.6%; P<0.001 for the comparison with the performance goal of 88%); 299 of 316 patients (94.6%) were discharged with a working ICD system. The Kaplan-Meier estimate of the percentage of patients free from major system- or procedure-related complications at 6 months was 92.6% (lower boundary of the one-sided 97.5% CI, 89.0%; P<0.001 for the comparison with the performance goal of 79%). No major intraprocedural complications were reported. At 6 months, 25 major complications were observed, in 23 of 316 patients (7.3%). The success rate of antitachycardia pacing, as assessed with generalized estimating equations, was 50.8% (95% CI, 23.3 to 77.8). A total of 29 patients received 118 inappropriate shocks for 81 arrhythmic episodes. Eight systems were explanted without extravascular ICD replacement over the 10.6-month mean follow-up period. In this prospective global study, we found that extravascular ICDs were implanted safely and were able to detect and terminate induced ventricular arrhythmias at the time of implantation. (Funded by Medtronic; ClinicalTrials.gov number, NCT04060680.).
Sections du résumé
BACKGROUND
The extravascular implantable cardioverter-defibrillator (ICD) has a single lead implanted substernally to enable pause-prevention pacing, antitachycardia pacing, and defibrillation energy similar to that of transvenous ICDs. The safety and efficacy of extravascular ICDs are not yet known.
METHODS
We conducted a prospective, single-group, nonrandomized, premarket global clinical study involving patients with a class I or IIa indication for an ICD, all of whom received an extravascular ICD system. The primary efficacy end point was successful defibrillation at implantation. The efficacy objective would be met if the lower boundary of the one-sided 97.5% confidence interval for the percentage of patients with successful defibrillation was greater than 88%. The primary safety end point was freedom from major system- or procedure-related complications at 6 months. The safety objective would be met if the lower boundary of the one-sided 97.5% confidence interval for the percentage of patients free from such complications was greater than 79%.
RESULTS
A total of 356 patients were enrolled, 316 of whom had an implantation attempt. Among the 302 patients in whom ventricular arrhythmia could be induced and who completed the defibrillation testing protocol, the percentage of patients with successful defibrillation was 98.7% (lower boundary of the one-sided 97.5% confidence interval [CI], 96.6%; P<0.001 for the comparison with the performance goal of 88%); 299 of 316 patients (94.6%) were discharged with a working ICD system. The Kaplan-Meier estimate of the percentage of patients free from major system- or procedure-related complications at 6 months was 92.6% (lower boundary of the one-sided 97.5% CI, 89.0%; P<0.001 for the comparison with the performance goal of 79%). No major intraprocedural complications were reported. At 6 months, 25 major complications were observed, in 23 of 316 patients (7.3%). The success rate of antitachycardia pacing, as assessed with generalized estimating equations, was 50.8% (95% CI, 23.3 to 77.8). A total of 29 patients received 118 inappropriate shocks for 81 arrhythmic episodes. Eight systems were explanted without extravascular ICD replacement over the 10.6-month mean follow-up period.
CONCLUSIONS
In this prospective global study, we found that extravascular ICDs were implanted safely and were able to detect and terminate induced ventricular arrhythmias at the time of implantation. (Funded by Medtronic; ClinicalTrials.gov number, NCT04060680.).
Identifiants
pubmed: 36036522
doi: 10.1056/NEJMoa2206485
doi:
Banques de données
ClinicalTrials.gov
['NCT04060680']
Types de publication
Clinical Trial
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1292-1302Subventions
Organisme : Medtronic
ID : ClinicalTrial.gov NCT04060680
Investigateurs
Emily Kotschet
(E)
Prashanthan Sanders
(P)
Gopal Sivagangabalan
(G)
Andrew Teh
(A)
Clemens Steinwender
(C)
Jaimie Manlucu
(J)
Francois Philippon
(F)
Jens Brock Johansen
(JB)
Nicolas Clémenty
(N)
Christophe Leclercq
(C)
Joseph Yat
(J)
Sun Chan
(S)
Béla Peter Merkely
(BP)
Mauro Biffi
(M)
Lucas V A Boersma
(LVA)
Peter Paul
(P)
Henri Marie Delnoy
(HM)
Reinoud Elwin Knops
(RE)
Ian George Crozier
(IG)
Erik Kongsgård
(E)
Maciej Sterliński
(M)
Ahmad Hersi
(A)
Ignacio Muñoz Carvajal
(I)
Jan Steffel
(J)
Francis David Murgatroyd
(FD)
Richard Abben
(R)
Anish Amin
(A)
Ulrika Maria Birgersdotter-Green
(UM)
Yong-Mei Cha
(YM)
Jim Cheung
(J)
Greg Engel
(G)
Laurence Epstein
(L)
Charles Gornick
(C)
Troy Hounshell
(T)
Michael Katz
(M)
Sung Lee
(S)
Robert Lewis
(R)
Albert Lin
(A)
Thomas Mattioni
(T)
Brian Ramza
(B)
Melissa Robinson
(M)
Henri Roukoz
(H)
Venkata Sagi
(V)
Naushad Shaik
(N)
Mark Shen
(M)
Darius Sholevar
(D)
Khaldoun Tarakji
(K)
Sergio Thal
(S)
Commentaires et corrections
Type : CommentIn
Informations de copyright
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