The Design of the Understanding Outcomes with the S‐ICD in Primary Prevention Patients with Low EF Study (UNTOUCHED)

Gold, Michael R.; Knops, Reinoud E.; Burke, Martin C.; Lambiase, Pier D.; Russo, Andrea M.; Bongiorni, Maria Grazia; Deharo, Jean‐Claude; Aasbo, Johan D.; El‐Chami, Mikhael F.; Husby, Michael; Carter, Nathan; Boersma, Lucas V.A.

doi:10.1111/pace.12994

Cited by 40 publications

(67 citation statements)

References 32 publications

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“…Patients with a left ventricular ejection fraction (LVEF) 35% and a primary prevention indication (primary prevention 35%) were underrepresented in most registries, although the early registries showed equally good performance in this cohort. [1][2][3][4][5][6] The UNTOUCHED study was designed specifically to evaluate patients undergoing S-ICD implantation for the most common indication for ICD therapy, primary prevention 35%, to compare inappropriate shock rates in this population 7 with those in the MADIT-RIT study. 7,8 With a contemporary version of the S-ICD device and algorithms, the periprocedural performance and safety are presented here.…”

Section: Introductionmentioning

confidence: 99%

Understanding Outcomes with the EMBLEM S-ICD in Primary Prevention Patients with Low EF Study (UNTOUCHED): Clinical characteristics and perioperative results

et al. 2019

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BACKGROUND The subcutaneous implantable cardioverterdefibrillator (S-ICD) has shown favorable outcomes in large registries with broad inclusion criteria. The cohorts reported had less heart disease and fewer comorbidities than standard ICD populations.OBJECTIVE The purpose of this study is to characterize acute performance for primary prevention patients with a left ventricular ejection fraction (LVEF) 35% (primary prevention 35%).METHODS Primary prevention 35% patients with no prior documented sustained ventricular tachycardia (VT), pacing indication, end-stage heart failure, or advanced renal failure were prospectively enrolled. Analyses included descriptive statistics, Kaplan-Meier time to event, and multivariable linear and logistic regression. RESULTSIn 1112 of 1116 patients, an S-ICD was successfully implanted (99.6%). Predictors for longer procedure time included 3-incision technique, higher body mass index (BMI), performing defibrillation testing (DFT), imaging, younger age, black race, and European vs North American centers. Patients undergoing DFT (82%) were successfully converted (99.2%; 93.5% converting at 65 J). Higher BMI was predictive of failing DFT at 65 J. The rate of 30-day freedom Disclosures: Drs Lambiase, Dinerman, and Barr report no disclosures. Dr Boersma serves as a consultant and receives research grants from Boston Scientific and Medtronic. Dr El-Chami receives honoraria for Boston Scientific and Medtronic. Dr Bongiorni receives honoraria from Abbott Medical Italia S.p.a., Biotronik, Boston Scientific, and Medtronic. Dr Burke is a consultant and receives honoraria from Boston Scientific; receives research grants from Boston Scientific; and has equity in AtaCor Medical. Dr Knops reports honoraria for consulting and speaking, and research grants from Boston Scientific. Dr Aasbo reports Boston Scientific and Biotronik consulting fees. Dr Deharo receives research grants, travel grants, and honoraria for lectures/consulting from Medtronic, Boston Scientific, Abbott, Microport, and Biotronik. Dr Russo reports research grants from Boston Scientific, serves on steering Committees for Boston Scientific and Apple, and receives royalties from Up-to-Date. Dr Shaik receives honoraria for consulting, research, and speaking from Boston Scientific, Abbott, Biotronik, and Biosense Webster. Ms Appl, Mr Carter, Dr Brisben, and Dr Stein are all employees and shareholders of Boston Scientific. Dr Gold receives honoraria and research grants from Boston Scientific and Medtronic. Funding: The UNTOUCHED study was funded entirely by Boston Scientific Corporation.

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Section: Introductionmentioning

confidence: 99%

Understanding Outcomes with the EMBLEM S-ICD in Primary Prevention Patients with Low EF Study (UNTOUCHED): Clinical characteristics and perioperative results

et al. 2019

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“…14,26 This is being studied in even more detail in the UNTOUCHED trial of primary prevention patients with a reduced ejection fraction. 41 Though direct randomized comparisons between the two systems are currently unavailable, the Prospective, Randomized Comparison of Subcutaneous and Transvenous Implantable Cardioverter-Defibrillator Therapy (PRAETORIAN) trial is ongoing. 42 In selected patients, and arguably most, who qualify for ICD therapy without an indication for pacing, CRT, or ATP, the subcutaneous ICD system should be considered.…”

Section: Resultsmentioning

confidence: 99%

The Subcutaneous Implantable Cardioverter-Defibrillator: New Insights and Expanding Populations

Turnage¹,

Kpaeyeh²,

Gold³

2018

US Cardiology Review

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Implantable cardioverter defibrillators (ICDs) have become a mainstay of treatment in patients at risk for sudden cardiac death. The majority of contemporary ICDs are implanted transvenously; however, this approach carries acute procedural and long-term risks. The subcutaneous ICD (S-ICD) was developed, in part, to circumvent some of these adverse events or as an alternative option in patients unable to undergo transvenous implantation. Early promising trials evaluating the S-ICD were small and focused on niche populations. More recently, larger trials included broader populations with worse heart failure and co-morbidities that may be more representative of typical ICD recipients. These studies have consistently demonstrated positive results. This review describes the S-ICD system, implantation, and the safety and efficacy of the device.

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“…34 Importantly, UNTOUCHED was confined to patients with a reduced EF and a primary prevention ICD indication and hence excluded patients with purely electrical disease such as long-QT and particularly Brugada syndrome. 35 While these may numerically represent a minority of potentially S-ICD eligible patients, the risk of inappropriate shocks in this subgroup has been reported to be higher than in those with primary prevention heart failure indication. 36 However, contemporary data including new generation S-ICDs, adequate screening, and programming are scarce; indeed some data indicate that the contemporary rates of inadequate therapies in this context may be lower than previously reported.…”

Section: Safety and Efficacy Of The S-icd-the Prospective Multicentermentioning

confidence: 98%

The subcutaneous ICD for prevention of sudden cardiac death: Current evidence and future directions

Steffel¹

2020

Pacing Clinical Electrophis

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Despite major advances in medical therapy, sudden cardiac death remains an important cause of cardiovascular mortality. In order to improve the risk‐benefit balance of transvenous implantable cardioverter‐defibrillator (ICD) systems, a totally subcutaneous ICD (S‐ICD) system was developed and approved for use in Europe in 2009. The currently available S‐ICD system has undergone several important hardware‐ and software‐related modifications and improvements over the last 10 years aimed at further improving its efficacy and safety. The results of the PRAETORIAN trial, that is, the first randomized comparison of S‐ICD versus transvenous ICDs, of the prospective UNTOUCHED study, and the overall consistent observational data underline that current generation S‐ICD systems may be a valid alternative in patients with an ICD indication in whom bradycardia pacing or cardiac resynchronization therapy is not required due to a lower risk of system‐related problems. This review summarizes the key differences between the two systems, improvements in hardware components and algorithms over time, as well as most recent clinical evidence regarding the efficacy and safety of the S‐ICD.

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The Design of the Understanding Outcomes with the S‐ICD in Primary Prevention Patients with Low EF Study (UNTOUCHED)

Abstract: This trial will provide important data regarding the rates of inappropriate and appropriate shock therapy in real-world use of the S-ICD in the most common group of patients receiving ICDs.

Cited by 40 publications

References 32 publications

Understanding Outcomes with the EMBLEM S-ICD in Primary Prevention Patients with Low EF Study (UNTOUCHED): Clinical characteristics and perioperative results

Understanding Outcomes with the EMBLEM S-ICD in Primary Prevention Patients with Low EF Study (UNTOUCHED): Clinical characteristics and perioperative results

The Subcutaneous Implantable Cardioverter-Defibrillator: New Insights and Expanding Populations

The subcutaneous ICD for prevention of sudden cardiac death: Current evidence and future directions

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