Subcutaneous versus transvenous implantable defibrillator in patients with hypertrophic cardiomyopathy

Jankelson, Lior; Garber, Leonid; Sherrid, Mark V.; Massera, Daniele; Jones, Paul; Barbhaiya, Chirag R.; Holmes, Douglas; Bernstein, Scott; Spinelli, Michael; Park, David; Aizer, Anthony; Chinitz, Larry A.

doi:10.1016/j.hrthm.2022.01.013

Cited by 14 publications

(13 citation statements)

References 25 publications

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“…Based on this evidence, the choice to implant an ATP-capable ICD should not exclusively be based on the ischemic or non-ischemic cardiomyopathy, but it should have applied a patient's centered tailoring approach which takes into account the potential mechanisms of ventricular arrhythmias and other patient factors such as susceptibility to systemic infections. Our study population included a large cohort of patients with HCM who were more likely treated with S-ICD; this preferred choice may be justified by the low rate of ATP therapies experienced by patients with HCM, with no difference in the rate of shock therapy compared to those with TV-ICD ( 20 ). However, the choice to implant an S-ICD should take into account the clinical features of patients with HCM since older age and symptomatic patients seem to be more likely to benefit from T-ICD pacing for the high incidence of symptomatic bradycardia and conduction disturbances in need of pacing, together with monomorphic ventricular tachycardia, as the predominant rhythm triggering successful ATP therapy ( 21 ).…”

Section: Discussionmentioning

confidence: 99%

Device-Related Complications and Inappropriate Therapies Among Subcutaneous vs. Transvenous Implantable Defibrillator Recipients: Insight Monaldi Rhythm Registry

Russo

Rago

Ruggiero

et al. 2022

Front. Cardiovasc. Med.

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IntroductionIn the context of randomized clinical trials, subcutaneous implantable cardiac defibrillators (S-ICDs) are non-inferior to transvenous ICDs (T-ICDs) concerning device-related complications or inappropriate shocks in patients with an indication for defibrillator therapy and not in need of pacing. We aimed at describing the clinical features of patients who underwent S-ICD implantation in our clinical practice, as well as the ICD-related complications and the inappropriate therapies among S-ICD vs. T-ICD recipients during a long-term follow-up.Materials and MethodsAll patients undergoing ICD, both S-ICD and TV-ICD, at Monaldi Hospital from January 1, 2015 to January 1, 2019 and followed up at our institution were included in the present analysis. The clinical variables associated with S-ICD implantation were evaluated by logistic regression analyses. We collected the ICD inappropriate therapies, ICD-related complications (including both pulse generator and lead-related complications), ICD-related infections, appropriate ICD therapies, and overall mortality. Kaplan-Meier (KM) analyses were performed to assess the risk of clinical outcome events between the two subgroups. A time-dependent Cox regression analysis was performed to adjust the results.ResultsTotal 607 consecutive patients (mean age 53.8 ± 16.8, male 77.8%) with both TV-ICD (n: 290, 47.8%) and S-ICD (n: 317, 52.2%), implanted and followed at our center for a mean follow-up of 1614 ± 1018 days, were included in the study. At multivariate logistic regression analysis, an independent association between S-ICD implantation and ionic channel disease [OR: 6.01 (2.26–15.87); p < 0.0001] and ischemic cardiomyopathy [OR: 0.20 (0.12–0.35); p < 0.0001] was shown. The KM analysis did not show a significantly different risk of the inappropriate ICD therapies (log rank p = 0.64) between the two subgroups; conversely, a significant increase in the risk of ICD-related complications (log rank p = 0.02) and infections (log rank p = 0.02) in TV-ICD group was shown. The adjusted risk for ICD-related infections [OR: 0.07 (0.009–0.55), p = 0.01] and complications [0.31 (0.12–0.81), p = 0.01] was significantly lower among patients with S-ICD.ConclusionsThe choice to implant S-ICD was mainly driven by younger age and the presence of ionic channel disease; conversely ischemic cardiomyopathy reduces the probability to use this technology. No significant differences in inappropriate ICD therapies were shown among S-ICD vs. TV-ICD group; moreover, S-ICD is characterized by a lower rate of infectious and non-infectious complications leading to surgical revision or extraction.

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Section: Discussionmentioning

confidence: 99%

Device-Related Complications and Inappropriate Therapies Among Subcutaneous vs. Transvenous Implantable Defibrillator Recipients: Insight Monaldi Rhythm Registry

Russo

Rago

Ruggiero

et al. 2022

Front. Cardiovasc. Med.

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“…A graphical representation of QAREL scores for all papers separated by modality can be found in online Supporting Information (Table S4 The Netherlands) [13,[17][18][19][20][21][22][23]; SensiumVitals (The Surgical Company, Oxford, UK) [13,[24][25][26]; Respirasense (PMD, Cork, Ireland) [27]; Philips Healthdot [28] (Koninklijke Philips N.V); CoVA (Tosense, San Diego, CA, USA) [29]; Biostamp (MC10, Lexington, KY, USA) [30]; Respiheart (Respiheart, Link€ oping, Sweden) [31]; Zephyr (Medtronic, Minneapolis, MN, USA) [32,33]; and Multisense (RDS, Strasbourg,…”

Section: Resultsmentioning

confidence: 99%

“…There were seven studies assessing under-mattress sensors, three of which were with a commercially available device (Earlysense, Earlysense Inc, Woburn, MA, USA) [13,44,45]. One study [42] All but one wearable device study [29] reported a mean heart rate bias of < 5 beats.min -1 (Fig. 3).…”

Section: Resultsmentioning

confidence: 99%

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Novel wearable and contactless heart rate, respiratory rate, and oxygen saturation monitoring devices: a systematic review and meta‐analysis

et al. 2022

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We performed a systematic review and meta-analysis to identify, classify and evaluate the body of evidence on novel wearable and contactless devices that measure heart rate, respiratory rate and oxygen saturations in the clinical setting. We included any studies of hospital inpatients, including sleep study clinics. Eighty-four studies were included in the final review. There were 56 studies of wearable devices and 29 of contactless devices. One study assessed both types of device. A high risk of patient selection and rater bias was present in proportionally more studies assessing contactless devices compared with studies assessing wearable devices (p = 0.023 and p < 0.0001, respectively). There was high but equivalent likelihood of blinding bias between the two types of studies (p = 0.076). Wearable device studies were commercially available devices validated in acute clinical settings by clinical staff and had more real-time data analysis (p = 0.04). Contactless devices were more experimental, and data were analysed post-hoc. Pooled estimates of mean (95%CI) heart rate and respiratory rate bias in wearable devices were 1.25 (À0.31-2.82) beats.min -1 (pooled 95% limits of agreement À9.36-10.08) and 0.68 (0.05-1.32) breaths.min -1 (pooled 95% limits of agreement À5.65-6.85). The pooled estimate for mean (95%CI) heart rate and respiratory rate bias in contactless devices was 2.18 (3.31-7.66) beats.min -1 (pooled limits of agreement À6.71-10.88) and 0.30 (À0.26-0.87) breaths.min -1 (pooled 95% limits of agreement À3. 94-4.29). Only two studies of wearable devices measured S p O 2 ; these reported mean measurement biases of 3.54% (limits of agreement À5.65-11.45%) and 2.9% (À7.4-1.7%). Heterogeneity was observed across studies, but absent when devices were grouped by measurement modality and reference standard. We conclude that, while studies of wearable devices were of slightly better quality than contactless devices, in general all studies of novel devices were of low quality, with small (< 100) patient datasets, typically not blinded and often using inappropriate statistical techniques. Both types of devices were statistically equivalent in accuracy and precision, but wearable devices demonstrated less measurement bias and more precision at extreme vital signs. The statistical variability in precision and accuracy between studies is partially explained by differences in reference standards.

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“…The difference was mainly driven by a significantly higher ATP therapy rate in the TV-ICD group, suggesting that ATP therapy is very likely to be unnecessary in HCM patients. 30 Some aspects of the S-ICD system hold me back from proposing the S-ICD as the first choice in every patient in the need of an ICD. These include the need for conscious sedation or, in some cases, even the support of an anaesthesiologist during the implantation procedure, along with the relatively shorter battery life of 7-9 years and the larger size of the S-ICD compared with the TV-ICD.…”

Section: Tv-icd Study or Subgroupmentioning

confidence: 99%

The ATLAS Randomised Clinical Trial: What do the Superiority Results Mean for Subcutaneous ICD Therapy and Sudden Cardiac Death Prevention as a Whole?

Rordorf

2022

Arrhythm Electrophysiol Rev

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This review sets out the key evidence comparing subcutaneous ICDs (S-ICDs) and transvenous ICDs and uses it to empower clinical cardiologists and those who implant ICDs to make optimum patient selections for S-ICD use. The evidence demonstrates that clinical trials performed until recently have proven the performance of S-ICDs. However, the latest data now available from the ATLAS randomised controlled trial have added new insights to this body of evidence. ATLAS demonstrates the superiority of S-ICDs over transvenous ICDs regarding lead-related complications, findings that point to promising opportunities for patients who are at risk of sudden cardiac death.

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Subcutaneous versus transvenous implantable defibrillator in patients with hypertrophic cardiomyopathy

Cited by 14 publications

References 25 publications

Device-Related Complications and Inappropriate Therapies Among Subcutaneous vs. Transvenous Implantable Defibrillator Recipients: Insight Monaldi Rhythm Registry

Device-Related Complications and Inappropriate Therapies Among Subcutaneous vs. Transvenous Implantable Defibrillator Recipients: Insight Monaldi Rhythm Registry

Novel wearable and contactless heart rate, respiratory rate, and oxygen saturation monitoring devices: a systematic review and meta‐analysis

The ATLAS Randomised Clinical Trial: What do the Superiority Results Mean for Subcutaneous ICD Therapy and Sudden Cardiac Death Prevention as a Whole?

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