#1 “[SCD-PROTECT] is a very important trial, and that will help us moving forward in the field… It was arguably the best GDMT related study in terms of following sudden cardiac death that we've seen in modern times.”
SCD-PROTECT was designed to address an evidence gap in the era of modern 4-pillar GDMT. Authors enrolled nearly 20,000 consecutive LifeVest® WCD patients in Germany and measured their SCA treatment rates using data captured by LifeVest.
Study Design Note: Patients in SCD-PROTECT used only the LifeVest® WCD. There are notable differences in the design, algorithm, and treatment thresholds of available WCDs, so SCD-PROTECT results should only be applied to LifeVest.
#2 “[SCD-PROTECT] enrolled a very high volume of patients. And a large percentage of them had probably the best amount of GDMT that we've seen in a sort of modern-day study.”
Achieving the level of care exhibited in the SCD-PROTECT study is a significant challenge in routine practice, as optimal GDMT requires the careful and sequential titration of 4-pillar GDMT over a period of several months and can be complicated by numerous patient-specific factors.
Reinforced by Dr. Butler, “Whatever data that we are going to see now, if anything may be an under representation of the real risk of what we might expect in the US because our background medical therapy is not as good.”
#3 “[SCD risk] was significantly higher than I thought it would be, especially given how well they did with GDMT.”
Despite the high utilization of 4-pillar GDMT, the rate of SCD per 100 patient-years in SCD-PROTECT exceeded rates reported in long-term ICD trials. As Dr. D’Souza shared during the presentation, “I think it's just important to recognize that even with newer, better drugs and modern day, you know, approaches to revascularization, we still have a pretty significant risk of sudden cardiac death.”
#4 – “Clearly, we know that the LifeVest saves patients’ lives. And it is, you know, a very important part of the treatment for these patients”
Dr. D’Souza shared that arrhythmic risk is the highest in the early phases of GDMT optimization, and “so that's when you need to mitigate that risk and protect these patients from sudden cardiac death.”
Dr. Butler added, “The data that we are seeing is that, if you have a wearable cardioverter defibrillator, then this risk, initial risk is mitigated because all of these patients that are getting these arrhythmias are protected against a sudden cardiac death. And that's at least one strategy during this vulnerable phase.”
In SCD-PROTECT, authors also observed high LifeVest WCD compliance of 23.4+ hours/day (median) over a duration of 62 days (median), with a low rate of inappropriate treatment (0.5% of patients).
#5 – “When you educate patients on the actual risk, it’s pretty surprising if they decide to not be protected from sudden cardiac death.”
The SCD-PROTECT study indicates that, despite modern, contemporary GDMT, the early risk of sudden cardiac death remains high for patients with newly diagnosed reduced LVEF. Dr. D’Souza believes that, “it is important to be able to quote that risk to patients... so that they are educated about what about what their risk of sudden cardiac death is.”
Together, this crucial emphasis on shared decision making, combined with high residual risk, strongly supports the use of LifeVest during the vulnerable GDMT optimization period.