Dataset Information

An Overview of Clinical Outcomes in Transvenous and Subcutaneous ICD Patients.

ABSTRACT: PURPOSE OF REVIEW:Clear guidelines on when to select a subcutaneous ICD (S-ICD) over a transvenous ICD (TV-ICD) are lacking. This review will provide an overview of the most recent clinical data on S-ICD and TV-ICD therapy by pooling comparison studies in order to aid clinical decision making. RECENT FINDINGS:Pooling of observational-matched studies demonstrated an incidence rate ratio (IRR) for device-related complication of 0.90 (95% CI 0.58-1.42) and IRR for lead-related complications of 0.15 (95% CI 0.06-0.39) in favor of S-ICD. The IRR for device infections was 2.00 (95% CI 0.95-4.22) in favor of TV-ICD. Both appropriate shocks (IRR 0.67 (95% CI 0.42-1.06)) and inappropriate shocks (IRR 1.17 (95% CI 0.77-1.79)) did not differ significantly between both groups. With randomized data underway, the observational data demonstrate that the S-ICD is associated with reduced lead complications, but this has not yet resulted in a significant reduction in total number of complications compared to TV-ICDs. New technologies are expected to make the S-ICD a more attractive alternative.

SUBMITTER: Baalman SWE

PROVIDER: S-EPMC6061190 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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An Overview of Clinical Outcomes in Transvenous and Subcutaneous ICD Patients.

Baalman S W E SWE Quast A B E ABE Brouwer T F TF Knops R E RE

Current cardiology reports 20180710 9

<h4>Purpose of review</h4>Clear guidelines on when to select a subcutaneous ICD (S-ICD) over a transvenous ICD (TV-ICD) are lacking. This review will provide an overview of the most recent clinical data on S-ICD and TV-ICD therapy by pooling comparison studies in order to aid clinical decision making.<h4>Recent findings</h4>Pooling of observational-matched studies demonstrated an incidence rate ratio (IRR) for device-related complication of 0.90 (95% CI 0.58-1.42) and IRR for lead-related compli ...[more]

PMID: 29992422

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Project description:The subcutaneous implantable cardioverter-defibrillator (S-ICD) system is an established therapy for prevention of sudden cardiac death (SCD) and an alternative to a transvenous implantable cardioverter-defibrillator (ICD) system in selected patients. Since introduction of S-ICD in 2010, the device has undergone further development. Based on the unique feature of an entirely extracardiac implantation, S-ICD is able to reduce the known common perioperative and long-term complications of conventional transvenous implanted ICD systems. Especially for patients with a complex anatomy and no option of an endovascular lead implantation, the S-ICD offers a potential alternative. Initial uncertainty existed, questioning whether this ICD approach would be reliable in detecting and terminating ventricular arrhythmias. Multiple clinical studies, however, provided evidence for an effective treatment. Based on obvious advantages compared to conventional ICD systems, the question arises whether the S-ICD should actually be the first choice in the majority of all primary prevention patients in the future. Recent data from large registries show that S-ICD indications are also expanding in secondary prevention patients. As a consequence, the S-ICD was listed in the 2015 ESC guidelines as an alternative therapeutic option with a class-IIa recommendation in patients with an ICD indication not requiring pacing for bradycardia, cardiac resynchronization therapy or anti-tachycardia pacing (ATP). In addition, the American Heart Association guidelines refer to class-I recommendation for patients with a complex anatomy and venous access problems or at a high risk for infections who need ICD therapy. Limitations with respect to the not available pacing option of S-ICD might be also overcome by a potential combination with a leadless pacemaker in the near future. This article provides an overview of recent developments of S-ICD and reviews the most recent literature and ongoing studies.

Project description:BACKGROUND:Cardiovascular magnetic resonance (CMR) studies in patients with implanted cardioverter/defibrillators (ICD) are increasingly required in daily clinical practice. However, the clinical experience regarding the feasibility as well as clinical value of CMR studies in patients with subcutaneous ICD (S-ICD) is still limited. Besides safety issues, image quality and analysis can be impaired primarily due the presence of image artefacts associated with the generator. METHODS:Twenty-three patients with an implanted S-ICD (EMBLEM, Boston Scientific, Marlborough, Massachusetts, USA; MR-conditional) with suspected cardiomyopathy and/or myocarditis underwent multi-parametric CMR imaging. Studies were performed on a 1.5 T CMR scanner after device interrogation and comprised standard a) balanced steady state free precession cine, b) T2 weighted-edema, c) velocity-encoded cine flow, d) myocardial perfusion, e) late-gadolinium-enhancement (LGE)-imaging and f) 3D-CMR angiography of the aorta. In case of substantial artefacts, alternative CMR techniques such as spoiled gradient-echo cine-sequences and wide-band inversion-recovery LGE (wb-LGE) sequences were applied. RESULTS:Successful CMR studies could be performed in all patients without any case of unexpected early termination or relevant technical complication other than permanent loss of the S-ICD system beeper volume in 52% of our patients. Assessment of cine-CMR images was predominantly impaired in the left ventricular (LV) anterior, lateral and inferior wall segments and a switch to spoiled gradient echo-based cine-CMR allowed an accurate assessment of cine-images in N?=?17 (74%) patients with only limited artefacts. Hyperintensity artefacts in conventional LGE-images were predominantly observed in the LV anterior, lateral and inferior wall segments and image optimisation by use of the wb-LGE was helpful in 15 (65%) cases. Aortic flow measurements and 3D-CMR angiography were assessable in all patients Perfusion imaging artefacts precluded a meaningful assessment in at least one half of the patients. A benefit in clinical-decision making was documented in 17 (74%) patients in the present study. CONCLUSION:Safe 1.5?T CMR imaging was possible in all patients with an S-ICD, though the majority had permanent loss of the S-ICD beeper volume. Achieving good image quality may be challenging in some patients - particularly for perfusion imaging. Using spoiled gradient echo-based cine-sequences and wb-LGE sequences may help to reduce the extent of artefacts, thereby allowing accurate cardiac assessment. Thus, 1.5?T CMR studies should not be withhold in patients with S-ICD for safety concerns and/or fear of extensive imaging artefacts precluding successful image analysis.

Dataset Information

An Overview of Clinical Outcomes in Transvenous and Subcutaneous ICD Patients.

Publications

An Overview of Clinical Outcomes in Transvenous and Subcutaneous ICD Patients.

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