Detail
Článek
Článek online
FT
Medvik - BMČ
  • Je něco špatně v tomto záznamu ?

Implant and Midterm Outcomes of the Subcutaneous Implantable Cardioverter-Defibrillator Registry: The EFFORTLESS Study

L. Boersma, C. Barr, R. Knops, D. Theuns, L. Eckardt, P. Neuzil, M. Scholten, M. Hood, J. Kuschyk, P. Jones, E. Duffy, M. Husby, K. Stein, PD. Lambiase, . ,

. 2017 ; 70 (7) : 830-841.

Jazyk angličtina Země Spojené státy americké

Typ dokumentu časopisecké články, multicentrická studie, pozorovací studie

Perzistentní odkaz   https://www.medvik.cz/link/bmc17030650

BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (S-ICD) was developed to defibrillate ventricular arrhythmias, avoiding drawbacks of transvenous leads. The global EFFORTLESS S-ICD (Evaluation oF FactORs ImpacTing CLinical Outcome and Cost EffectiveneSS of the S-ICD) registry is collecting outcomes in 985 patients during a 5-year follow-up. OBJECTIVES: The primary goal of the EFFORTLESS registry is to determine the safety of the S-ICD by evaluating complications and inappropriate shock rate. METHODS: This is the first report on the full patient cohort and study endpoints with follow-up ≥1 year. The predefined endpoints are 30- and 360-day complications, and shocks for atrial fibrillation or supraventricular tachycardia. RESULTS: Patients were followed for 3.1 ± 1.5 years and 82 completed the study protocol 5-year visit. Average age was 48 years, 28% were women, ejection fraction was 43 ± 18%, and 65% had a primary prevention indication. The S-ICD system and procedure complication rate was 4.1% at 30 days and 8.4% at 360 days. The 1-year complication rate trended toward improvement from the first to last quartile of enrollment (11.3% [quartile 1]) to 7.8% [quartile 2], 6.6% [quartile 3], and 7.4% [quartile 4]; quartile 1 vs. quartiles 2 to 4; p = 0.06). Few device extractions occurred due to need for antitachycardia (n = 5), or biventricular (n = 4) or bradycardia pacing (n = 1). Inappropriate shocks occurred in 8.1% at 1 year and 11.7% after 3.1 years. At implant, 99.5% of patients had a successful conversion of induced ventricular tachycardia or ventricular fibrillation. The 1- and 5-year rates of appropriate shock were 5.8% and 13.5%, respectively. Conversion success for discrete spontaneous episodes was 97.4% overall. CONCLUSIONS: This registry demonstrates that the S-ICD fulfills predefined endpoints for safety and efficacy. Midterm performance rates on complications, inappropriate shocks, and conversion efficacy were comparable to rates observed in transvenous implantable cardioverter-defibrillator studies. (Evaluation oF Factors ImpacTing CLinical Outcome and Cost EffectiveneSS of the S-ICD [The EFFORTLESS S-ICD Registry]; NCT01085435).

Citace poskytuje Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc17030650
003      
CZ-PrNML
005      
20171025122714.0
007      
ta
008      
171025s2017 xxu f 000 0|eng||
009      
AR
024    7_
$a 10.1016/j.jacc.2017.06.040 $2 doi
035    __
$a (PubMed)28797351
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a xxu
100    1_
$a Boersma, Lucas $u St. Antonius Ziekenhuis, Nieuwegein, the Netherlands; Academic Medical Center, Amsterdam, the Netherlands. Electronic address: l.boersma@antoniusziekenhuis.nl.
245    10
$a Implant and Midterm Outcomes of the Subcutaneous Implantable Cardioverter-Defibrillator Registry: The EFFORTLESS Study / $c L. Boersma, C. Barr, R. Knops, D. Theuns, L. Eckardt, P. Neuzil, M. Scholten, M. Hood, J. Kuschyk, P. Jones, E. Duffy, M. Husby, K. Stein, PD. Lambiase, . ,
520    9_
$a BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (S-ICD) was developed to defibrillate ventricular arrhythmias, avoiding drawbacks of transvenous leads. The global EFFORTLESS S-ICD (Evaluation oF FactORs ImpacTing CLinical Outcome and Cost EffectiveneSS of the S-ICD) registry is collecting outcomes in 985 patients during a 5-year follow-up. OBJECTIVES: The primary goal of the EFFORTLESS registry is to determine the safety of the S-ICD by evaluating complications and inappropriate shock rate. METHODS: This is the first report on the full patient cohort and study endpoints with follow-up ≥1 year. The predefined endpoints are 30- and 360-day complications, and shocks for atrial fibrillation or supraventricular tachycardia. RESULTS: Patients were followed for 3.1 ± 1.5 years and 82 completed the study protocol 5-year visit. Average age was 48 years, 28% were women, ejection fraction was 43 ± 18%, and 65% had a primary prevention indication. The S-ICD system and procedure complication rate was 4.1% at 30 days and 8.4% at 360 days. The 1-year complication rate trended toward improvement from the first to last quartile of enrollment (11.3% [quartile 1]) to 7.8% [quartile 2], 6.6% [quartile 3], and 7.4% [quartile 4]; quartile 1 vs. quartiles 2 to 4; p = 0.06). Few device extractions occurred due to need for antitachycardia (n = 5), or biventricular (n = 4) or bradycardia pacing (n = 1). Inappropriate shocks occurred in 8.1% at 1 year and 11.7% after 3.1 years. At implant, 99.5% of patients had a successful conversion of induced ventricular tachycardia or ventricular fibrillation. The 1- and 5-year rates of appropriate shock were 5.8% and 13.5%, respectively. Conversion success for discrete spontaneous episodes was 97.4% overall. CONCLUSIONS: This registry demonstrates that the S-ICD fulfills predefined endpoints for safety and efficacy. Midterm performance rates on complications, inappropriate shocks, and conversion efficacy were comparable to rates observed in transvenous implantable cardioverter-defibrillator studies. (Evaluation oF Factors ImpacTing CLinical Outcome and Cost EffectiveneSS of the S-ICD [The EFFORTLESS S-ICD Registry]; NCT01085435).
650    12
$a defibrilátory implantabilní $7 D017147
650    _2
$a ženské pohlaví $7 D005260
650    _2
$a následné studie $7 D005500
650    _2
$a lidé $7 D006801
650    _2
$a mužské pohlaví $7 D008297
650    _2
$a lidé středního věku $7 D008875
650    12
$a registrace $7 D012042
650    _2
$a komorová tachykardie $x terapie $7 D017180
650    _2
$a časové faktory $7 D013997
650    _2
$a výsledek terapie $7 D016896
655    _2
$a časopisecké články $7 D016428
655    _2
$a multicentrická studie $7 D016448
655    _2
$a pozorovací studie $7 D064888
700    1_
$a Barr, Craig $u Russells Hall Hospital, Dudley, United Kingdom.
700    1_
$a Knops, Reinoud $u Academic Medical Center, Amsterdam, the Netherlands.
700    1_
$a Theuns, Dominic $u Erasmus Medical Center, Rotterdam, the Netherlands.
700    1_
$a Eckardt, Lars $u Division of Electrophysiology, University Hospital, Münster, Germany.
700    1_
$a Neuzil, Petr $u Heart Center Homolka Hospital, Prague, Czech Republic.
700    1_
$a Scholten, Marcoen $u Medisch Spectrum Twente, Enschede, the Netherlands.
700    1_
$a Hood, Margaret $u Auckland City Hospital, Auckland, New Zealand.
700    1_
$a Kuschyk, Juergen $u First Department of Medicine, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany; DZHK (German Center for Cardiovascular Research), Partner Site Heidelberg-Mannheim, Mannheim, Germany.
700    1_
$a Jones, Paul $u Boston Scientific, St. Paul, Minnesota.
700    1_
$a Duffy, Elizabeth $u Boston Scientific, St. Paul, Minnesota.
700    1_
$a Husby, Michael $u Boston Scientific, St. Paul, Minnesota.
700    1_
$a Stein, Kenneth $u Boston Scientific, St. Paul, Minnesota.
700    1_
$a Lambiase, Pier D $u Heart Hospital, London, United Kingdom.
700    1_
$a ,
773    0_
$w MED00002964 $t Journal of the American College of Cardiology $x 1558-3597 $g Roč. 70, č. 7 (2017), s. 830-841
856    41
$u https://pubmed.ncbi.nlm.nih.gov/28797351 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y a $z 0
990    __
$a 20171025 $b ABA008
991    __
$a 20171025122756 $b ABA008
999    __
$a ok $b bmc $g 1254243 $s 991677
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2017 $b 70 $c 7 $d 830-841 $i 1558-3597 $m Journal of the American College of Cardiology $n J. Am. Coll. Cardiol. $x MED00002964
LZP    __
$a Pubmed-20171025
Zpět

Najít záznam

Citační ukazatele

Možnosti archivace