-
Something wrong with this record ?
Efficacy and Safety of Appropriate Shocks and Antitachycardia Pacing in Transvenous and Subcutaneous Implantable Defibrillators: Analysis of All Appropriate Therapy in the PRAETORIAN Trial
RE. Knops, W. van der Stuijt, PPHM. Delnoy, LVA. Boersma, J. Kuschyk, MF. El-Chami, H. Bonnemeier, ER. Behr, TF. Brouwer, S. Kääb, S. Mittal, ABE. Quast, L. Smeding, JGP. Tijssen, NR. Bijsterveld, S. Richter, MA. Brouwer, JR. de Groot, KM....
Language English Country United States
Document type Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
NLK
Free Medical Journals
from 1950 to 1 year ago
Open Access Digital Library
from 1950-01-01
Open Access Digital Library
from 1950-01-01
- MeSH
- Defibrillators, Implantable standards MeSH
- Middle Aged MeSH
- Humans MeSH
- Prospective Studies MeSH
- Aged MeSH
- Arrhythmias, Cardiac diagnosis therapy MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
BACKGROUND: The PRAETORIAN trial (A Prospective, Randomized Comparison of Subcutaneous and Transvenous Implantable Cardioverter Defibrillator Therapy) showed noninferiority of subcutaneous implantable cardioverter defibrillator (S-ICD) compared with transvenous implantable cardioverter defibrillator (TV-ICD) with regard to inappropriate shocks and complications. In contrast to TV-ICD, S-ICD cannot provide antitachycardia pacing for monomorphic ventricular tachycardia. This prespecified secondary analysis evaluates appropriate therapy and whether antitachycardia pacing reduces the number of appropriate shocks. METHODS: The PRAETORIAN trial was an international, investigator-initiated randomized trial that included patients with an indication for implantable cardioverter defibrillator (ICD) therapy. Patients with previous ventricular tachycardia <170 bpm or refractory recurrent monomorphic ventricular tachycardia were excluded. In 39 centers, 849 patients were randomized to receive an S-ICD (n=426) or TV-ICD (n=423) and were followed for a median of 49.1 months. ICD programming was mandated by protocol. Appropriate ICD therapy was defined as therapy for ventricular arrhythmias. Arrhythmias were classified as discrete episodes and storm episodes (≥3 episodes within 24 hours). Analyses were performed in the modified intention-to-treat population. RESULTS: In the S-ICD group, 86 of 426 patients received appropriate therapy, versus 78 of 423 patients in the TV-ICD group, during a median follow-up of 52 months (48-month Kaplan-Meier estimates 19.4% and 17.5%; P=0.45). In the S-ICD group, 83 patients received at least 1 shock, versus 57 patients in the TV-ICD group (48-month Kaplan-Meier estimates 19.2% and 11.5%; P=0.02). Patients in the S-ICD group had a total of 254 shocks, compared with 228 shocks in the TV-ICD group (P=0.68). First shock efficacy was 93.8% in the S-ICD group and 91.6% in the TV-ICD group (P=0.40). The first antitachycardia pacing attempt successfully terminated 46% of all monomorphic ventricular tachycardias, but accelerated the arrhythmia in 9.4%. Ten patients with S-ICD experienced 13 electrical storms, versus 18 patients with TV-ICD with 19 electrical storms. Patients with appropriate therapy had an almost 2-fold increased relative risk of electrical storms in the TV-ICD group compared with the S-ICD group (P=0.05). CONCLUSIONS: In this trial, no difference was observed in shock efficacy of S-ICD compared with TV-ICD. Although patients in the S-ICD group were more likely to receive an ICD shock, the total number of appropriate shocks was not different between the 2 groups. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01296022.
1st Department of Medicine University Medical Center Mannheim Germany
Cardiac Electrophysiology Division Department of Medicine Englewood Hospital and Medical Center NJ
CorVita Science Foundation Chicago IL
Department of Cardiology Amphia Hospital Breda The Netherlands
Department of Cardiology Flevoziekenhuis Almere The Netherlands
Department of Cardiology Homolka Hospital Prague Czech Republic
Department of Cardiology Isala Heart Centre Zwolle The Netherlands
Department of Cardiology OLVG Amsterdam The Netherlands
Department of Cardiology Radboud University Medical Center Nijmegen The Netherlands
Department of Cardiology St Antonius Hospital Nieuwegein The Netherlands
Department of Cardiology Tergooi MC Blaricum The Netherlands
Department of Cardiology The Heart Centre Rigshospitalet University of Copenhagen Denmark
Department of Electrophysiology Catharina Hospital Eindhoven The Netherlands
Department of Electrophysiology Heart Center at University of Leipzig Germany
Department of Internal Medicine 1 Jena University Hospital Germany
Department of Medicine 1 Ludwig Maximillians University Hospital München Germany
Department of Medicine Cardiology Columbia University Irving Medical Center New York
Division of Cardiology Northwestern Memorial Hospital Northwestern University Chicago IL
Division of Cardiology Section of Electrophysiology Emory University Atlanta GA
Division of Cardiovascular Medicine College of Medicine The Ohio State University Columbus
European Reference Network for Rare Low Prevalence and Complex Diseases of the Heart ERN GUARD Heart
German Center for Cardiovascular Research Munich Heart Alliance Germany
German Center for Cardiovascular Research Partner Site Heidelberg Mannheim Germany
Icahn School of Medicine at Mount Sinai Mount Sinai Hospital New York
Liverpool Heart and Chest Hospital United Kingdom
Medical Spectrum Twente Enschede The Netherlands
Medisch Centrum Leeuwarden Leeuwarden The Netherlands
National Heart and Lung Institute Imperial College London United Kingdom
Oxford Biomedical Research Centre Oxford University Hospitals NHS Trust United Kingdom
St George's University Hospitals NHS Foundation Trust London United Kingdom
St George's University of London United Kingdom
The Valley Health System Ridgewood NJ
University and University Hospital Würzburg Germany
Werkgroep Cardiologische Centra Nederland Utrecht The Netherlands
References provided by Crossref.org
- 000
- 00000naa a2200000 a 4500
- 001
- bmc22011110
- 003
- CZ-PrNML
- 005
- 20220506125831.0
- 007
- ta
- 008
- 220425s2022 xxu f 000 0|eng||
- 009
- AR
- 024 7_
- $a 10.1161/CIRCULATIONAHA.121.057816 $2 doi
- 035 __
- $a (PubMed)34779221
- 040 __
- $a ABA008 $b cze $d ABA008 $e AACR2
- 041 0_
- $a eng
- 044 __
- $a xxu
- 100 1_
- $a Knops, Reinoud E $u Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, location AMC, The Netherlands (R.E.K., W.v.d.S., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., J.G.P.T., J.R.d.G., K.M.K., A.d.W., A.A.M.W., L.R.A.O.N.) $1 https://orcid.org/0000000207723573
- 245 10
- $a Efficacy and Safety of Appropriate Shocks and Antitachycardia Pacing in Transvenous and Subcutaneous Implantable Defibrillators: Analysis of All Appropriate Therapy in the PRAETORIAN Trial / $c RE. Knops, W. van der Stuijt, PPHM. Delnoy, LVA. Boersma, J. Kuschyk, MF. El-Chami, H. Bonnemeier, ER. Behr, TF. Brouwer, S. Kääb, S. Mittal, ABE. Quast, L. Smeding, JGP. Tijssen, NR. Bijsterveld, S. Richter, MA. Brouwer, JR. de Groot, KM. Kooiman, PD. Lambiase, P. Neuzil, K. Vernooy, M. Alings, TR. Betts, FALE. Bracke, MC. Burke, JSSG. de Jong, DJ. Wright, WPJ. Jansen, ZI. Whinnet, P. Nordbeck, M. Knaut, BT. Philbert, JM. van Opstal, AB. Chicos, CP. Allaart, AE. Borger van der Burg, JF. Clancy, JM. Dizon, MA. Miller, D. Nemirovsky, R. Surber, GA. Upadhyay, R. Weiss, A. de Weger, AAM. Wilde, LRA. Olde Nordkamp, PRAETORIAN Investigators‡
- 520 9_
- $a BACKGROUND: The PRAETORIAN trial (A Prospective, Randomized Comparison of Subcutaneous and Transvenous Implantable Cardioverter Defibrillator Therapy) showed noninferiority of subcutaneous implantable cardioverter defibrillator (S-ICD) compared with transvenous implantable cardioverter defibrillator (TV-ICD) with regard to inappropriate shocks and complications. In contrast to TV-ICD, S-ICD cannot provide antitachycardia pacing for monomorphic ventricular tachycardia. This prespecified secondary analysis evaluates appropriate therapy and whether antitachycardia pacing reduces the number of appropriate shocks. METHODS: The PRAETORIAN trial was an international, investigator-initiated randomized trial that included patients with an indication for implantable cardioverter defibrillator (ICD) therapy. Patients with previous ventricular tachycardia <170 bpm or refractory recurrent monomorphic ventricular tachycardia were excluded. In 39 centers, 849 patients were randomized to receive an S-ICD (n=426) or TV-ICD (n=423) and were followed for a median of 49.1 months. ICD programming was mandated by protocol. Appropriate ICD therapy was defined as therapy for ventricular arrhythmias. Arrhythmias were classified as discrete episodes and storm episodes (≥3 episodes within 24 hours). Analyses were performed in the modified intention-to-treat population. RESULTS: In the S-ICD group, 86 of 426 patients received appropriate therapy, versus 78 of 423 patients in the TV-ICD group, during a median follow-up of 52 months (48-month Kaplan-Meier estimates 19.4% and 17.5%; P=0.45). In the S-ICD group, 83 patients received at least 1 shock, versus 57 patients in the TV-ICD group (48-month Kaplan-Meier estimates 19.2% and 11.5%; P=0.02). Patients in the S-ICD group had a total of 254 shocks, compared with 228 shocks in the TV-ICD group (P=0.68). First shock efficacy was 93.8% in the S-ICD group and 91.6% in the TV-ICD group (P=0.40). The first antitachycardia pacing attempt successfully terminated 46% of all monomorphic ventricular tachycardias, but accelerated the arrhythmia in 9.4%. Ten patients with S-ICD experienced 13 electrical storms, versus 18 patients with TV-ICD with 19 electrical storms. Patients with appropriate therapy had an almost 2-fold increased relative risk of electrical storms in the TV-ICD group compared with the S-ICD group (P=0.05). CONCLUSIONS: In this trial, no difference was observed in shock efficacy of S-ICD compared with TV-ICD. Although patients in the S-ICD group were more likely to receive an ICD shock, the total number of appropriate shocks was not different between the 2 groups. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01296022.
- 650 _2
- $a senioři $7 D000368
- 650 _2
- $a srdeční arytmie $x diagnóza $x terapie $7 D001145
- 650 _2
- $a defibrilátory implantabilní $x normy $7 D017147
- 650 _2
- $a ženské pohlaví $7 D005260
- 650 _2
- $a lidé $7 D006801
- 650 _2
- $a mužské pohlaví $7 D008297
- 650 _2
- $a lidé středního věku $7 D008875
- 650 _2
- $a prospektivní studie $7 D011446
- 650 _2
- $a výsledek terapie $7 D016896
- 655 _2
- $a časopisecké články $7 D016428
- 655 _2
- $a randomizované kontrolované studie $7 D016449
- 655 _2
- $a práce podpořená grantem $7 D013485
- 700 1_
- $a van der Stuijt, Willeke $u Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, location AMC, The Netherlands (R.E.K., W.v.d.S., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., J.G.P.T., J.R.d.G., K.M.K., A.d.W., A.A.M.W., L.R.A.O.N.) $1 https://orcid.org/0000000222363983
- 700 1_
- $a Delnoy, Peter Paul H M $u Department of Cardiology, Isala Heart Centre, Zwolle, The Netherlands (P.P.H.M.D.)
- 700 1_
- $a Boersma, Lucas V A $u Department of Cardiology, St Antonius Hospital, Nieuwegein, The Netherlands (L.V.A.B.) $1 https://orcid.org/0000000345914220
- 700 1_
- $a Kuschyk, Juergen $u First Department of Medicine, University Medical Center Mannheim, Germany (J.K.) $u German Center for Cardiovascular Research Partner Site Heidelberg, Mannheim, Germany (J.K.)
- 700 1_
- $a El-Chami, Mikhael F $u Division of Cardiology Section of Electrophysiology, Emory University, Atlanta, GA (M.F.E.-C.)
- 700 1_
- $a Bonnemeier, Hendrik $u Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Germany (H.B.)
- 700 1_
- $a Behr, Elijah R $u St George's University of London, United Kingdom (E.R.B.) $u St George's University Hospitals NHS Foundation Trust, London, United Kingdom (E.R.B.) $1 https://orcid.org/0000000287312853
- 700 1_
- $a Brouwer, Tom F $u Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, location AMC, The Netherlands (R.E.K., W.v.d.S., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., J.G.P.T., J.R.d.G., K.M.K., A.d.W., A.A.M.W., L.R.A.O.N.)
- 700 1_
- $a Kääb, Stefan $u Department of Medicine I, Ludwig-Maximillians University Hospital, München, Germany (S.K.) $u German Center for Cardiovascular Research, Munich Heart Alliance, Germany (S.K.) $1 https://orcid.org/0000000188243581
- 700 1_
- $a Mittal, Suneet $u The Valley Health System, Ridgewood, NJ (S.M.) $1 https://orcid.org/0000000280037254
- 700 1_
- $a Quast, Anne-Floor B E $u Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, location AMC, The Netherlands (R.E.K., W.v.d.S., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., J.G.P.T., J.R.d.G., K.M.K., A.d.W., A.A.M.W., L.R.A.O.N.)
- 700 1_
- $a Smeding, Lonneke $u Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, location AMC, The Netherlands (R.E.K., W.v.d.S., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., J.G.P.T., J.R.d.G., K.M.K., A.d.W., A.A.M.W., L.R.A.O.N.) $1 https://orcid.org/0000000275589011
- 700 1_
- $a Tijssen, Jan G P $u Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, location AMC, The Netherlands (R.E.K., W.v.d.S., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., J.G.P.T., J.R.d.G., K.M.K., A.d.W., A.A.M.W., L.R.A.O.N.)
- 700 1_
- $a Bijsterveld, Nick R $u Department of Cardiology, Flevoziekenhuis, Almere, The Netherlands (N.R.B.)
- 700 1_
- $a Richter, Sergio $u Department of Electrophysiology, Heart Center at University of Leipzig, Germany (S.R.) $1 https://orcid.org/0000000171286411
- 700 1_
- $a Brouwer, Marc A $u Department of Cardiology, Radboud University Medical Center, Nijmegen, The Netherlands (M.A.B.)
- 700 1_
- $a de Groot, Joris R $u Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, location AMC, The Netherlands (R.E.K., W.v.d.S., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., J.G.P.T., J.R.d.G., K.M.K., A.d.W., A.A.M.W., L.R.A.O.N.) $1 https://orcid.org/0000000281227017
- 700 1_
- $a Kooiman, Kirsten M $u Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, location AMC, The Netherlands (R.E.K., W.v.d.S., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., J.G.P.T., J.R.d.G., K.M.K., A.d.W., A.A.M.W., L.R.A.O.N.)
- 700 1_
- $a Lambiase, Pier D $u Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre, United Kingdom (P.D.L.) $u European Reference Network for Rare, Low Prevalence and Complex Diseases of the Heart: ERN GUARD-Heart (P.D.L., A.A.M.W.) $1 https://orcid.org/0000000290559267
- 700 1_
- $a Neuzil, Petr $u Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P. Neuzil) $1 https://orcid.org/0000000343348165
- 700 1_
- $a Vernooy, Kevin $u Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, The Netherlands (K.V.) $1 https://orcid.org/0000000288185964
- 700 1_
- $a Alings, Marco $u Department of Cardiology, Amphia Hospital, Breda, The Netherlands (M.A.) $u Werkgroep Cardiologische Centra Nederland, Utrecht, The Netherlands (M.A.)
- 700 1_
- $a Betts, Timothy R $u Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, United Kingdom (T.R.B.) $1 https://orcid.org/0000000190639905
- 700 1_
- $a Bracke, Frank A L E $u Department of Electrophysiology, Catharina Hospital Eindhoven, The Netherlands (F.A.L.E.B.)
- 700 1_
- $a Burke, Martin C $u CorVita Science Foundation, Chicago, IL (M.C.B.)
- 700 1_
- $a de Jong, Jonas S S G $u Department of Cardiology, OLVG, Amsterdam, The Netherlands (J.S.S.G.d.J.) $1 https://orcid.org/0000000325445279
- 700 1_
- $a Wright, David J $u Liverpool Heart and Chest Hospital, United Kingdom (D.J.W.)
- 700 1_
- $a Jansen, Ward P J $u Department of Cardiology, Tergooi MC, Blaricum, The Netherlands (W.P.J.J.)
- 700 1_
- $a Whinnet, Zachary I $u National Heart and Lung Institute, Imperial College London, United Kingdom (Z.I.W.) $1 https://orcid.org/0000000227755126
- 700 1_
- $a Nordbeck, Peter $u University and University Hospital Würzburg, Germany (P. Nordbeck) $1 https://orcid.org/0000000225604068
- 700 1_
- $a Knaut, Michael $u Heart Surgery, Heart Center Dresden, Carl Gustav Carus Medical Faculty, Dresden University of Technology, Germany (M.K.)
- 700 1_
- $a Philbert, Berit T $u Department of Cardiology, The Heart Centre, Rigshospitalet, University of Copenhagen, Denmark (B.T.P.) $1 https://orcid.org/0000000194797601
- 700 1_
- $a van Opstal, Jurren M $u Medical Spectrum Twente, Enschede, The Netherlands (J.M.v.O.) $1 https://orcid.org/0000000234921807
- 700 1_
- $a Chicos, Alexandru B $u Division of Cardiology, Northwestern Memorial Hospital, Northwestern University, Chicago, IL (A.B.C.) $1 https://orcid.org/0000000202914434
- 700 1_
- $a Allaart, Cornelis P $u Department of Cardiology, and Amsterdam Cardiovascular Sciences, Amsterdam UMC, Location VUMC, Amsterdam, The Netherlands (C.P.A.) $1 https://orcid.org/0000000205069512
- 700 1_
- $a Borger van der Burg, Alida E $u Medisch Centrum Leeuwarden, Leeuwarden, The Netherlands (A.E.B.v.d.B.)
- 700 1_
- $a Clancy, Jude F $u Department of Internal Medicine, Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, CT (J.F.C.)
- 700 1_
- $a Dizon, Jose M $u Department of Medicine-Cardiology, Columbia University Irving Medical Center, New York (J.M.D.)
- 700 1_
- $a Miller, Marc A $u Icahn School of Medicine at Mount Sinai, Mount Sinai Hospital, New York (M.A.M.)
- 700 1_
- $a Nemirovsky, Dmitry $u Cardiac Electrophysiology Division, Department of Medicine, Englewood Hospital and Medical Center, NJ (D.N.)
- 700 1_
- $a Surber, Ralf $u Department of Internal Medicine I, Jena University Hospital, Germany (R.S.)
- 700 1_
- $a Upadhyay, Gaurav A $u Center for Arrhythmia Care, Heart and Vascular Institute, University of Chicago Pritzker School of Medicine, IL (G.A.U.)
- 700 1_
- $a Weiss, Raul $u Division of Cardiovascular Medicine, College of Medicine, The Ohio State University, Columbus (R.W.)
- 700 1_
- $a de Weger, Anouk $u Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, location AMC, The Netherlands (R.E.K., W.v.d.S., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., J.G.P.T., J.R.d.G., K.M.K., A.d.W., A.A.M.W., L.R.A.O.N.)
- 700 1_
- $a Wilde, Arthur A M $u European Reference Network for Rare, Low Prevalence and Complex Diseases of the Heart: ERN GUARD-Heart (P.D.L., A.A.M.W.) $1 https://orcid.org/0000000205280852
- 700 1_
- $a Olde Nordkamp, Louise R A $u Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, location AMC, The Netherlands (R.E.K., W.v.d.S., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., J.G.P.T., J.R.d.G., K.M.K., A.d.W., A.A.M.W., L.R.A.O.N.)
- 710 2_
- $a PRAETORIAN Investigators‡
- 773 0_
- $w MED00001091 $t Circulation $x 1524-4539 $g Roč. 145, č. 5 (2022), s. 321-329
- 856 41
- $u https://pubmed.ncbi.nlm.nih.gov/34779221 $y Pubmed
- 910 __
- $a ABA008 $b sig $c sign $y p $z 0
- 990 __
- $a 20220425 $b ABA008
- 991 __
- $a 20220506125823 $b ABA008
- 999 __
- $a ok $b bmc $g 1788946 $s 1162308
- BAS __
- $a 3
- BAS __
- $a PreBMC
- BMC __
- $a 2022 $b 145 $c 5 $d 321-329 $e 20211114 $i 1524-4539 $m Circulation (New York, N.Y.) $n Circulation (New York) $x MED00001091
- LZP __
- $a Pubmed-20220425
