000130123 001__ 130123
000130123 005__ 20240122171020.0
000130123 0247_ $$2doi$$a10.1161/circulationaha.120.048728
000130123 0248_ $$2sideral$$a136272
000130123 037__ $$aART-2021-136272
000130123 041__ $$aeng
000130123 100__ $$aGold, Michael R.
000130123 245__ $$aPrimary Results From the Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction (UNTOUCHED) Trial.
000130123 260__ $$c2021
000130123 5060_ $$aAccess copy available to the general public$$fUnrestricted
000130123 5203_ $$aBackground:
The subcutaneous (S) implantable cardioverter-defibrillator (ICD) is safe and effective for sudden cardiac death prevention. However, patients in previous S-ICD studies had fewer comorbidities, had less left ventricular dysfunction, and received more inappropriate shocks (IAS) than in typical transvenous ICD trials. The UNTOUCHED trial (Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction) was designed to evaluate the IAS rate in a more typical, contemporary ICD patient population implanted with the S-ICD using standardized programming and enhanced discrimination algorithms.
Methods:
Primary prevention patients with left ventricular ejection fraction ≤35% and no pacing indications were included. Generation 2 or 3 S-ICD devices were implanted and programmed with rate-based therapy delivery for rates ≥250 beats per minute and morphology discrimination for rates ≥200 and <250 beats per minute. Patients were followed for 18 months. The primary end point was the IAS-free rate compared with a 91.6% performance goal, derived from the results for the ICD-only patients in the MADIT-RIT study (Multicenter Automatic Defibrillator Implantation Trial–Reduce Inappropriate Therapy). Kaplan-Meier analyses were performed to evaluate event-free rates for IAS, all-cause shock, and complications. Multivariable proportional hazard analysis was performed to determine predictors of end points.
Results:
S-ICD implant was attempted in 1116 patients, and 1111 patients were included in postimplant follow-up analysis. The cohort had a mean age of 55.8±12.4 years, 25.6% were women, 23.4% were Black, 53.5% had ischemic heart disease, 87.7% had symptomatic heart failure, and the mean left ventricular ejection fraction was 26.4±5.8%. Eighteen-month freedom from IAS was 95.9% (lower confidence limit, 94.8%). Predictors of reduced incidence of IAS were implanting the most recent generation of device, using the 3-incision technique, no history of atrial fibrillation, and ischemic cause. The 18-month all-cause shock-free rate was 90.6% (lower confidence limit, 89.0%), meeting the prespecified performance goal of 85.8%. Conversion success rate for appropriate, discrete episodes was 98.4%. Complication-free rate at 18 months was 92.7%.
Conclusions:
This study demonstrates high efficacy and safety with contemporary S-ICD devices and programming despite the relatively high incidence of comorbidities in comparison with earlier S-ICD trials. The inappropriate shock rate (3.1% at 1 year) is the lowest reported for the S-ICD and lower than many transvenous ICD studies using contemporary programming to reduce IAS.
000130123 540__ $$9info:eu-repo/semantics/openAccess$$aby-nc-nd$$uhttp://creativecommons.org/licenses/by-nc-nd/3.0/es/
000130123 590__ $$a39.922$$b2021
000130123 591__ $$aPERIPHERAL VASCULAR DISEASE$$b1 / 67 = 0.015$$c2021$$dQ1$$eT1
000130123 591__ $$aCARDIAC & CARDIOVASCULAR SYSTEMS$$b2 / 143 = 0.014$$c2021$$dQ1$$eT1
000130123 592__ $$a8.281$$b2021
000130123 593__ $$aPhysiology (medical)$$c2021$$dQ1
000130123 593__ $$aCardiology and Cardiovascular Medicine$$c2021$$dQ1
000130123 594__ $$a40.5$$b2021
000130123 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion
000130123 700__ $$aLambiase, Pier D.
000130123 700__ $$aEl-Chami, Mikhael F.
000130123 700__ $$aKnops, Reinoud E.
000130123 700__ $$aAasbo, Johan D.
000130123 700__ $$aBongiorni, Maria Grazia
000130123 700__ $$aRusso, Andrea M.
000130123 700__ $$aDeharo, Jean-Claude
000130123 700__ $$aBurke, Martin C.
000130123 700__ $$aDinerman, Jay
000130123 700__ $$aBarr, Craig S.
000130123 700__ $$aShaik, Naushad
000130123 700__ $$aCarter, Nathan
000130123 700__ $$aStoltz, Thomas
000130123 700__ $$aStein, Kenneth M.
000130123 700__ $$aBrisben, Amy J.
000130123 700__ $$aBoersma, Lucas V.A.
000130123 700__ $$aPhelan, Timothy
000130123 700__ $$aAl-Ameri, Hazim
000130123 700__ $$aAlbirini, Abdulhay
000130123 700__ $$aAlimohammad, Rizwan
000130123 700__ $$aArias, Miguel
000130123 700__ $$aBadenco, Nicolas
000130123 700__ $$aBertaux, Geraldine
000130123 700__ $$aBhakta, Deepak
000130123 700__ $$aBindra, Sanjay
000130123 700__ $$aBlangy, Hugues
000130123 700__ $$aBoveda, Serge
000130123 700__ $$aBrock, Johansen
000130123 700__ $$aBusch, Mathias
000130123 700__ $$0(orcid)0000-0002-1889-3746$$aCalvo, Naiara$$uUniversidad de Zaragoza
000130123 700__ $$aCassidy, Christopher
000130123 700__ $$aChauvin, Michel
000130123 700__ $$aMarzak, Halim
000130123 700__ $$aChinitz, Jason
000130123 700__ $$aCiuffo, Allen
000130123 700__ $$aClancy, Jude
000130123 700__ $$aCrossen, Karl
000130123 700__ $$aDe Filippo, Paolo
000130123 700__ $$aDevecchi, Fausto
000130123 700__ $$aKaranam, Sreekanth
000130123 700__ $$aDoshi, Rahul
000130123 700__ $$aEckardt, Lars
000130123 700__ $$aFedor, Matthew
000130123 700__ $$aFreedman, Roger
000130123 700__ $$aGehi, Anil
000130123 700__ $$aGoethals, Peter
000130123 700__ $$aGosau, Nils
000130123 700__ $$aGottlieb, Charles
000130123 700__ $$aGranrud, Gregory
000130123 700__ $$aGreenstein, Radmira
000130123 700__ $$aHamdan, Firas
000130123 700__ $$aHanon, Sam
000130123 700__ $$aHassankhani, Alborz
000130123 700__ $$aHenderson, Rick
000130123 700__ $$aHohnloser, Stefan
000130123 700__ $$aHuang, David
000130123 700__ $$aIrles, Didier
000130123 700__ $$aKalahasty, Gautham
000130123 700__ $$aKazemian, Pedram
000130123 700__ $$aKhairallah, Farhat
000130123 700__ $$aKim, Brian
000130123 700__ $$aKim, Edward
000130123 700__ $$aKlein, Christoph
000130123 700__ $$aKnight, Bradley
000130123 700__ $$aKoide, Niuton
000130123 700__ $$aKuk, Richard
000130123 700__ $$aLeclercq, Christophe
000130123 700__ $$aLee, Michael
000130123 700__ $$aLee, Shang-Chiun
000130123 700__ $$aLenz, Corinna
000130123 700__ $$aLewis, Nigel
000130123 700__ $$aLewis, Robert
000130123 700__ $$aMark, George
000130123 700__ $$aMarquie, Christelle
000130123 700__ $$aMcDonnell, Kelly
000130123 700__ $$aMckenzie, John
000130123 700__ $$aMerchant, Faisal
000130123 700__ $$aMobarek, Sameh
000130123 700__ $$aMoccetti, Tiziano
000130123 700__ $$aMolin, Franck
000130123 700__ $$aPhilliopon, Francois
000130123 700__ $$aMorani, Giovanni
000130123 700__ $$aMorin, Daniel
000130123 700__ $$aNg, G.
000130123 700__ $$aNsah, Emmanuel
000130123 700__ $$aPanday, Manoj
000130123 700__ $$aPasquie, Jean-Luc
000130123 700__ $$aCastellano Perez, Nicasio
000130123 700__ $$aPerez-Gil, Francisco
000130123 700__ $$aPtaszynski, Pawel
000130123 700__ $$aRajendra, Anil
000130123 700__ $$aRhodes, Troy
000130123 700__ $$aRoberts, Paul
000130123 700__ $$aRowe, Steven
000130123 700__ $$aSaba, Samir
000130123 700__ $$aSagi, Venkata
000130123 700__ $$aSarter, Brian
000130123 700__ $$aSchoenhard, John
000130123 700__ $$aSchutzman, John
000130123 700__ $$aScott, Luis
000130123 700__ $$aSegerson, Nathan
000130123 700__ $$aShakir, Ali
000130123 700__ $$aSmelley, Matthew
000130123 700__ $$aSteffel, Jan
000130123 700__ $$aSturdivant, J. Lacy
000130123 700__ $$aTabbal, Ghiyath
000130123 700__ $$aTendler, Drory
000130123 700__ $$aTheuns, Dominic
000130123 700__ $$aTimmers, Liesbeth
000130123 700__ $$aTrojan, Matthew
000130123 700__ $$aTsai, Shane
000130123 700__ $$aUpadhyay, Gaurav
000130123 700__ $$aVarkey, Santosh
000130123 700__ $$aViani, Stefano
000130123 700__ $$aWeiner, Stanislav
000130123 700__ $$aWeiss, Raul
000130123 700__ $$aWiggins, Sherman
000130123 700__ $$aWright, David
000130123 700__ $$aZadeh, Andrew
000130123 700__ $$aZitron, Edgar
000130123 7102_ $$11007$$2610$$aUniversidad de Zaragoza$$bDpto. Medicina, Psiqu. y Derm.$$cArea Medicina
000130123 773__ $$g143, 1 (2021), 7-17$$pCirculation$$tCirculation$$x0009-7322
000130123 8564_ $$s775929$$uhttps://zaguan.unizar.es/record/130123/files/texto_completo.pdf$$yVersión publicada
000130123 8564_ $$s2829407$$uhttps://zaguan.unizar.es/record/130123/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada
000130123 909CO $$ooai:zaguan.unizar.es:130123$$particulos$$pdriver
000130123 951__ $$a2024-01-22-15:28:14
000130123 980__ $$aARTICLE