Feasibility and safety of same day subcutaneous defibrillator implantation and send home (DASH) strategy

Okabe, Toshimasa; Miller, Adrianne; Koppert, Tanner; Cavalcanti, Rafael; Alcivar-Franco, Diego; Osei, Jemina; Kahaly, Omar; Afzal, Muhammad R.; Tyler, Jaret; Kalbfleisch, Steven J.; Weiss, Raul; Houmsse, Mahmoud; Augostini, Ralph; Daoud, Emile G.; Andritsos, Michael; Bhandary, Sujatha; Dimitrova, Galina; Fiorini, Kasey; Elsayed‐Awad, Hamdy; Flores, Antolin; Gorelik, Leonid; Iyer, Manoj H.; Saklayen, Samiya; Stein, Erica; Turner, Katja; Pérez, William; Hummel, John D.; Essandoh, Michael

doi:10.1007/s10840-019-00673-1

Cited by 8 publications

(6 citation statements)

References 20 publications

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“…Okabe et al 30 also demonstrated the suitability of the same-day discharge of S-ICD patients and mentioned that device-related pain can be severe in the first 3 days, which is true for our patients as well; however, most patients did well with analgesics with only one patient had an unplanned visit at 1 week due to severe pain, but no signs of infection or bleeding were noted and it responded with opioid analgesics.…”

Section: Baselinesupporting

confidence: 62%

A real‐world experience of subcutaneous and transvenous implantable cardiac defibrillators—comparison with the PRAETORIAN study

Khanra

Hamid

Patel

et al. 2022

Journal of Arrhythmia

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Background: PRAETORIAN is the first randomized controlled trial that demonstrated the noninferiority of subcutaneous ICD (S-ICD) in comparison with transvenous ICD (TV-ICD). We retrospectively reviewed electronic records of patients with ICD implanted over the past 6 years, with the primary objective to compare our real-world single tertiary center experience with the randomized data from the PRAETORIAN study.Methods: Seventy S-ICD patients were compared with 197 TV-ICD patients, from July 2014 to June 2020 retrospectively, over a median period of 1304 days (296-2451 days). Primary composite endpoints included inappropriate shocks and devicerelated malfunctions.Results: Patients with S-ICD implantation were younger than those who received TV-ICD (mean, 49.7 years vs 63.9 years, p < .001). About 31.4% of S-ICDs were implanted for secondary prevention, and 58.6% of S-ICD patients had ischemic cardiomyopathy (ICM) with a median left ventricular ejection fraction of 32.5% (range: 10-67%). S-ICDs and TV-ICD had statistically similar inappropriate shocks (4.3% vs 4.6%, p = .78), device-related complications (11.4% vs 9.1%, p = .93), and the overall primary endpoints (15.7% vs 13.7%, p = .68). The findings remained the same even after age and gender adjustments and time-dependent analysis. Conclusion:Although single-center experience with a small number of S-ICD patients, results of the PRAETORIAN study has been replicated in our real-world experience of S-ICD and TV-ICD implantations across diverse etiologies, indications, and age groups confirming the comparable performance of S-ICD and TV-ICD when implanted in selected patients.

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Section: Baselinesupporting

confidence: 62%

A real‐world experience of subcutaneous and transvenous implantable cardiac defibrillators—comparison with the PRAETORIAN study

Khanra

Hamid

Patel

et al. 2022

Journal of Arrhythmia

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“…15 A decrease in operative pain realized by complex analgesia protocol has been correlated with the expedited recovery, such as the possibility of same-day discharge. 16 However, such alternative method involves human resources and carries a risk of treatmentrelated complication. Thus, our study suggests that IV-PCA is not only effective but also advantageous over other measures in terms of simplicity.…”

Section: Discussionmentioning

confidence: 99%

Postoperative intravenous patient‐controlled analgesia improves pain management after subcutaneous implantable defibrillator implantation

Tsutsui,

Terazaki,

Kanai

et al. 2024

Journal of Arrhythmia

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ObjectivePostoperative pain is a major issue with subcutaneous implantable cardioverter defibrillators (S‐ICD). In 2020, we introduced intravenous patient‐controlled analgesia (IV‐PCA) in addition to the conventional, request‐based analgesia for postoperative pain control in S‐ICD. To determine the effect and safety, we quantitatively assessed the effect of IV‐PCA after S‐ICD surgery over conventional methods.MethodsDuring the study period, a total of 113 consecutive patients (age, 50.1 ± 15.5 years: males, 101) underwent a de novo S‐ICD implantation under general anesthesia. While the postoperative pain was addressed with either request‐based analgesia (by nonsteroid anti‐inflammatory drugs, N = 68, dubbed as “PCA absent”) or fentanyl‐based IV‐PCA in addition to the standard care (N = 45, dubbed as “PCA present”). The degree of postoperative pain from immediately after surgery to 1 week were retrospectively investigated by the numerical rating scale (NRS) divided into four groups at rest and during activity (0: no pain, 1–3: mild pain, 4–6: moderate pain, 7–10: severe pain).ResultsAlthough IV‐PCA was removed on Day 1, it was associated with continued better pain control compared to PCA absent group. At rest, the proportion of patients expressing pain (mild or more) was significantly lower in the PCA present group from Day 0 to Day 4. In contrast to at rest, a better pain control continued through the entire study period of 7 days. No serious adverse events were observed. A few patients experienced nausea in both groups and the inter‐group difference was not found significant.ConclusionIV‐PCA suppresses postoperative pain in S‐ICD without major safety concerns.

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“…[ 20 , 25 , 26 , 36 ] Lastly, the implementation of specific analgesic protocols and telephone follow-up for early device-related pain enables successful same-day discharges after outpatient implantation of S-ICDs which is an area of attention in the modern era of high-value healthcare. [ 52 ]…”

Section: Discussionmentioning

confidence: 99%

The Subcutaneous ICD: A Review of the UNTOUCHED and PRAETORIAN Trials

Karimianpour

John

Gold

2021

Arrhythm Electrophysiol Rev

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The ICD is an important part of the treatment and prevention of sudden cardiac death in many high-risk populations. Traditional transvenous ICDs (TV-ICDs) are associated with certain short- and long- term risks. The subcutaneous ICD (S-ICD) was developed in order to avoid these risks and complications. However, this system is associated with its own set of limitations and complications. First, patient selection is important, as S-ICDs do not provide pacing therapy currently. Second, pre-procedural screening is important to minimise T wave and myopotential oversensing. Finally, until recently, the S-ICD was primarily used in younger patients with fewer co-morbidities and less structural heart disease, limiting the general applicability of the device. S-ICDs achieve excellent rates of arrhythmia conversion and have demonstrated noninferiority to TV-ICDs in terms of complication rates in real-world studies. The objective of this review is to discuss the latest literature, including the UNTOUCHED and PRAETORIAN trials, and to address the risk of inappropriate shocks.

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Feasibility and safety of same day subcutaneous defibrillator implantation and send home (DASH) strategy

Cited by 8 publications

References 20 publications

A real‐world experience of subcutaneous and transvenous implantable cardiac defibrillators—comparison with the PRAETORIAN study

A real‐world experience of subcutaneous and transvenous implantable cardiac defibrillators—comparison with the PRAETORIAN study

Postoperative intravenous patient‐controlled analgesia improves pain management after subcutaneous implantable defibrillator implantation

The Subcutaneous ICD: A Review of the UNTOUCHED and PRAETORIAN Trials

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