Subcutaneous implantable cardioverter-defibrillator Post-Approval Study: Clinical characteristics and perioperative results

Gold, Michael R.; Aasbo, Johan D.; El‐Chami, Mikhael F.; Niebauer, Mark; Herre, John M.; Prutkin, Jordan M.; Knight, Bradley P.; Kutalek, Steven P.; Hsu, Kevin; Weiss, Raul; Bass, Eric B.; Husby, Michael; Stivland, Timothy M.; Burke, Martin C.

doi:10.1016/j.hrthm.2017.05.016

Cited by 140 publications

(131 citation statements)

References 36 publications

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“…Relatively little is known regarding the outcomes of ARVC patients who have a subcutaneous ICD implanted 41, 44 . Among the 312 ARVC patients described in the recent large report of the outcomes of ICD therapy in ARVC patients, 7 had a subcutaneous ICD implanted 41 .…”

Section: Risk Stratification In Patients With Arvcmentioning

confidence: 99%

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Risk Stratification in Arrhythmogenic Right Ventricular Cardiomyopathy

2017

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Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) is an inherited cardiomyopathy that is characterized by ventricular arrhythmias, and an increased risk of sudden death (SCD). Although structural abnormalities of the right ventricle predominate, it is well recognized that left ventricular involvement is common particularly in advanced disease, and that left dominant forms occur. The pathologic characteristic of ARVC/D is myocyte loss with fibrofatty replacement. Since the first detailed clinical description of the disorder in 1982, significant advances have been made in understanding this disease. Once the diagnosis of ARVC is established, the single most important clinical decision is whether a particular patient’s SCD risk is sufficient to justify placement of an implantable cardioverter defibrillator (ICD). The importance of this decision reflects the fact that ARVC is a common cause of sudden death in young people, and that sudden cardiac death may be the first manifestation of the disease. This decision is particularly important since these are often young patients who are expected to live for many years. While an ICD can save lives in individuals with this disease, it is also well recognized that ICD therapy is associated with both short and long term complications. Decisions regarding placement of an ICD are based on an estimate of a patient’s risk of SCD, as well as their preferences and values. The primary purpose of this article is to provide a review of literature that concerns risk stratification in patients with ARVC and to place this literature into the framework of the three authors considerable lifetime experiences in caring for patients with ARVC. The most important parameters to consider when determining arrhythmic risk include: 1) electrical instability including frequency of PVC’s and sustained VA, 2) proband status, 3) extent of structural disease, 4) cardiac syncope, 5) male gender, 6) the presence of multiple mutations or a mutation in TMEM 43, and 7) the patient’s willingness to restrict exercise and eliminate participation in competitive or endurance exercise.

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Section: Risk Stratification In Patients With Arvcmentioning

confidence: 99%

“…Similarly, 15 of the 1637 patients (0.9%) who were included in the recently published post approval study of the subcutaneous ICD had ARVC. The outcomes of this small subset of patients have not been separately reported 44 .…”

Section: Risk Stratification In Patients With Arvcmentioning

confidence: 99%

Risk Stratification in Arrhythmogenic Right Ventricular Cardiomyopathy

2017

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“…Besides the above described possible predictors such as ejection fraction, also factors such as time to therapy, cardiac substrate, patient history, and implanting characteristics such as the shock vector could be contributing to the DFT in individual patients. Several of these factors have previously been defined as predictors of a high DFT and could contribute to the prediction of outliers . Larger studies with more heterogeneous patient characteristics should be performed to identify all contributing factors and may even expand the PRAETORIAN score in the future in a similar way as the CHADS score's evolution into the CHADS VASC score.…”

Section: Discussionmentioning

confidence: 99%

“…Three of the major components are the amount of fat tissue underneath the coil, the amount of fat tissue under the can and the placement of the S‐ICD generator towards anterior on the thoracic wall. Multivariable analysis showed a high body mass index (BMI) as the only predictor for failing a DFT test . With this knowledge implanting physicians have improved their technique of implantation and are taking these factors into consideration.…”

Section: Introductionmentioning

confidence: 99%

Minimal defibrillation thresholds and the correlation with implant position in subcutaneous implantable‐defibrillator patients

Quast

Baalman

Stuijt

et al. 2019

Cardiovasc electrophysiol

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Background Since the introduction of the subcutaneous implantable‐defibrillator (S‐ICD) knowledge of factors elevating the defibrillation threshold (DFT), have increased. Optimal device positioning most likely results in a decrease in DFT. The PRAETORIAN score is a tool to systematically evaluate S‐ICD implant position and predict conversion success by estimating the DFT on a chest X‐ray. The objective of this study is to determine DFT in de novo S‐ICD patients. Methods De novo S‐ICD patients were enrolled with DFT testing using a single 30 J shock or a prespecified step‐down protocol. Chest X‐rays were obtained and implant position was evaluated using the PRAETORIAN score. Results Fifteen patients, age 47 (±18) years and body mass index (BMI) 25(±3) kg/m2, underwent conversion testing with a single 30 J shock. Fourteen patients (93%) converted successfully. Implant position was optimal in all patients, PRAETORIAN score of 30 (100%). Twelve patients were available for analysis in the step‐down DFT cohort, age 46 years (±15), left ventricular ejection fraction 50% (±15%) and a median BMI of 25.7 kg/m2 (range 23.8‐29.1 kg/m2). No complications occurred during DFT testing. Mean DFT was 29 J (±12 J). Time to shock was 11 seconds (±2 seconds) for a 20 J shock compared with 17 seconds in case of a 70 J shock output. Nearly all patients were implanted with optimal device positioning with the lowest possible PRAETORIAN score of 30 (92%). Conclusion DFT in S‐ICD patients with optimal device positioning is lower than previously reported. Conversion testing using a low shock output reduced time to therapy by 6 seconds on average.

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“…A subcutaneous implantable cardioverter‐defibrillator (S‐ICD) has been adopted as an alternative to transvenous (TV)‐ICD . S‐ICD does not require placement of leads directly into the heart transvenously; hence these devices could avoid the complications related to the use of TV‐ICD leads .…”

Section: Introductionmentioning

confidence: 99%

Patient characteristics and in‐hospital complications of subcutaneous implantable cardioverter‐defibrillator for Brugada syndrome in Japan

Kawamura

Nakajima

Kitamura

et al. 2019

Journal of Arrhythmia

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BackgroundClinical features and complications of subcutaneous implantable cardioverter‐defibrillator (S‐ICD) implantation for Brugada syndrome have not been well studied.MethodsWe used the Japanese Diagnosis Procedure Combination database to retrospectively investigate patients who had undergone ICD implantation between April 2016 and March 2017. We compared the characteristics and in‐hospital complications of patients with Brugada syndrome implanted with S‐ICD or transvenous (TV)‐ICD.ResultsWe extracted 3090 patients who received ICD implantation. Among them, we identified 278 Brugada patients. The mean age was 43 ± 14.4 years and 262 (94%) were male. Of these 278 patients, 136 (49%) received S‐ICD and 142 (51%) received TV‐ICD. TV‐ICD recipients had a history of atrial fibrillation more frequently compared with S‐ICD recipients. The median (interquartile range) of length of hospital stay was not significantly different between patients with S‐ICD and TV‐ICD (13 days [10‐20.5] vs 12 days [10‐18], respectively). The prevalence of in‐hospital complications after ICD implantation was similar between the two groups. There were no patients with cardiac tamponade, hemothorax, pneumothorax, cardiovascular event, stroke, and death following the procedure during hospitalization in either group.ConclusionsShort‐term safety of S‐ICD implantation may be identical to that of TV‐ICD. Large prospective studies are warranted to compare the effects and long‐term safety of S‐ICD compared with TV‐ICD.

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Subcutaneous implantable cardioverter-defibrillator Post-Approval Study: Clinical characteristics and perioperative results

Abstract: Contemporary US patients with S-ICD have more comorbidities than do previous cohorts with S-ICD, but they are younger with more end-stage renal disease than do patients with transvenous ICD. Implantation success is high, and short-term complication rates are acceptable.

Cited by 140 publications

References 36 publications

Risk Stratification in Arrhythmogenic Right Ventricular Cardiomyopathy

Risk Stratification in Arrhythmogenic Right Ventricular Cardiomyopathy

Minimal defibrillation thresholds and the correlation with implant position in subcutaneous implantable‐defibrillator patients

Patient characteristics and in‐hospital complications of subcutaneous implantable cardioverter‐defibrillator for Brugada syndrome in Japan

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