Optimizing beta-blocker dosage in female patients using the wearable cardioverter defibrillator: the OPT-BB Women interventional study
V Kutyifa, A Burch, A Russo, C Beck, A Cuneo, N Bianco, D Bonderman, C Perings, D Duncker, E Winzer, A Hain, B Assmus, J ErathAbstract
Background
Approximately half of female patients with newly diagnosed heart failure and low ejection fraction (EF) do not achieve adequate heart rate (HR) control during beta blocker (BB) therapy optimization.
Purpose
In the OPT-BB Women trial, we aimed to assess the use of continuous HR data from the wearable cardioverter defibrillator (WCD) to achieve HR control in female patients.
Methods
the OPT-BB Women trial was a prospective, interventional, non-randomized study, with 24 enrolling sites. Adult female patients with newly diagnosed cardiomyopathy and a low EF, eligible for an FDA-approved WCD were consented, and started a 2-week "run-in" phase to assess compliance. Those with≥105 hours of WCD wear per week were entered into the "study phase". Healthcare providers received a biweekly report on daily HR trends and HR control alerts if the HR exceeded a pre-determined threshold for 3 days (Figure 1). Based on HR data and alerts, clinicians were instructed to follow guideline-directed medical therapy to add or titrate medication. The primary endpoint was the percentage of female patients with adequate HR control, defined as average nighttime HR <70 bpm by the end of WCD use.
Results
A total of 224 females were screened from 24 sites in the United States and the EU, 214 patients entered the screening phase, and 196 progressed to the study phase. A total of 121 females completed the study with the prespecified amount of HR data for analysis. The median age was 62 years (IQR 55-70). The median nighttime HR was 68.7 bpm (IQR 60.7-76.3) at the beginning of WCD use (BOU) and decreased to 61.3 bpm (IQR 56.7-67.7) at the end of WCD use (EOU) (p<0.001). At the beginning of WCD use, 45% of patients had insufficient HR control (resting HR ≥ 70 bpm) compared to 59% in a historical control. At the end of WCD use, the percentage of patients with inadequate HR control dropped to 20%, compared to 43% in the historical control (p<0.001). Adequate HR control was achieved in 80%, with a 25% absolute improvement in HR control by end of use, exceeding the goal of 70% (Figure 2). Fifty-one patients (42%) had at least one HR alert that led to 49 medication changes in 28 (23%) of patients.
Conclusions
In the OPT-BB Women trial, continuous HR monitoring and HR alerts by the WCD appropriately identified female patients with inadequate HR control, leading to frequent medication changes, that resulted in a 25% absolute increase in female patients achieving adequate HR control by the end of WCD use. Utilizing the WCD to optimize beta-blocker treatment seems to be a useful and practical approach in females with heart failure.For image description, please refer to the figure legend and surrounding text.For image description, please refer to the figure legend and surrounding text.