Subcutaneous ICD (S-ICD), which overcomes the disadvantages of transvenous-ICD (TV-ICD), which requires electrode wires to be inserted into the blood vessels and heart, is establishing itself as a next-generation runner.
With the accumulation of Rewall World Data (RWD) following comparative clinical trials with various TV-ICDs, evidence is being established that it is no inferior to ‘standard status’.
Even in the largest post-approval study in which 1637 patients were enrolled, it received a passing score in terms of the incidence of complications and the shock effect of eliminating ventricular fibrillation over a period of 5 years.
The clinical results of S-ICD PAS, which observed the complications of S-ICD and the efficacy of electric shock for 5 years, were published in the August issue of the Journal of the American College of Cardiology (JCC) (doi.org/10.1016/j.jacc.2023.05.034).
TV-ICD has been the defibrillator standard for 40 years. The problem is that due to the nature of electrode wires being inserted into blood vessels and the heart, they are not free from side effects such as infection or electrode wire defects when they remain in the blood vessels for a long time.
The currently commercialized S-ICD is the only emblem developed by Boston Scientific.
On the other hand, S-ICD overcomes the disadvantages of existing ICDs by adopting a method in which electrode lines are located outside the heart to avoid direct contact with the heart and blood vessels.
Since S-ICD is a relatively new technology, various verifications in the medical world are continuing.
Clinical studies such as PRAETORIAN, ATLAS, and EFFORTLESS focused on ‘comparison’ of the incidence rate of complications and incidence of inappropriate electric shock between the two groups of S-ICD and TV-ICD, while recent studies are ‘comparison’ that examines long-term clinical efficacy and safety in the field after commercialization. RWD rationale’ is focused on.
Both the EHRA 22 clinical trial published in 2021 and the ELISIR clinical trial published in 2022 analyzed the actual effects of S-ICD in heart failure patients. The S-ICD PAS clinical trial, which was released this month, was followed up for five years on efficacy and safety, including shock efficacy and complications and complications related to the transplant procedure, at 86 medical institutions in the United States.
In an analysis of a total of 1643 patients, the mean shock efficacy for individual occurrences of ventricular tachycardia or ventricular fibrillation was 98.4%, which remained similar during the follow-up period.
The rates without S-ICD-related complications and electrode-related complications were 93.4% and 99.3%, respectively.
Only 1.6% of patients had their device replaced with a TV-ICD as needed, with a cumulative all-cause mortality rate of 21.7% and an inappropriate shock rate of 15.8%, similar shock rates to TV-ICD.
“This study is the largest in terms of scale among prospective studies on S-ICD that have been conducted so far,” said Michael R. Gold of the University of South Carolina Medical School, USA. It proves safety and efficacy.”
As S-ICD entered the insurance benefit right in Korea in 2019, efforts to upgrade the recommended grade in the guidelines and calculate RWD are currently in progress.
Professor A of Cardiovascular Internal Medicine at Seoul National University Hospital said, “Since the S-ICD insertion was performed, we have been monitoring patients in the hospital.” Complications definitely tend to be less,” he said.
As the international guidelines recommend the use of S-ICD for high-risk patients such as infections and chronic diseases, the Korean Heart Failure Society also added a new implantable cardioversion defibrillator item last year and said, “subcutaneous cardioversion defibrillators are difficult to access to blood vessels or have previously been It is useful in patients who have had an infection from a defibrillator.”
2023-08-21 20:30:00
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