Table 1.
Probabilities and expected number of occurrences per patient in BAT + GDT vs. GDT alone groups: Treatment, events, and serious adverse events
| Parameter | 6 Month | 1 Year | 2 Year | 3 Year | ||||
|---|---|---|---|---|---|---|---|---|
| BAT + GDT | GDT Alone | BAT + GDT | GDT Alone | BAT + GDT | GDT Alone | BAT + GDT | GDT Alone | |
| Heart failure medications (a, b) | ||||||||
| ACE/ARB (c) | 0.97 | 1.07 | 1.95 | 2.13 | 3.90 | 4.44 | 5.85 | 6.84 |
| Beta blocker | 1.83 | 1.89 | 3.67 | 3.79 | 7.34 | 7.89 | 11.01 | 12.15 |
| Digitalis | 0.22 | 0.25 | 0.43 | 0.50 | 0.86 | 1.04 | 1.30 | 1.60 |
| Diuretics | 2.71 | 2.78 | 5.42 | 5.57 | 10.83 | 11.59 | 16.25 | 17.86 |
| ARNI (d) | 0.60 | 0.73 | 1.21 | 1.46 | 1.98 | 3.24 | 2.60 | 5.18 |
| Ivabradine | 0.07 | 0.07 | 0.13 | 0.14 | 0.26 | 0.30 | 0.39 | 0.46 |
| MRA (e) | 0.62 | 0.63 | 1.24 | 1.26 | 2.47 | 2.63 | 3.71 | 4.05 |
| Other HF meds | 1.05 | 1.31 | 2.09 | 2.61 | 4.18 | 5.44 | 6.27 | 8.38 |
| Cardiovascular Hospitalization (non-HF) Rate, Relative Reduction = 25% (f) | 0.08 | 0.10 | 0.15 | 0.20 | 0.3 | 0.40 | 0.45 | 0.60 |
| Heart failure hospitalizations, relative reduction = 25% (f) | 0.13 | 0.18 | 0.26 | 0.35 | 0.53 | 0.70 | 0.79 | 1.05 |
| LVAD (g) | 0.00% | 1.64% | 0.50% | 3.25% | 0.50% | 6.40% | 0.50% | 9.44% |
| Heart transplant | 0.00% | 0.50% | 0.50% | 1.00% | 0.50% | 1.99% | 0.50% | 2.97% |
| BAT-specific serious adverse events | ||||||||
| Infections | 2.61% | |||||||
| Other (h) | 0.87% | |||||||
Notes and sources: (a) HF medication usage based on BeAT-HF clinical trial data, values are expressed as the expected number of medications for patients within the given time frame; (b) Assumes medication use in BAT + GDT is proportional over time, while GDT alone usage increases an additional rate of 4% per year; (c) ACE = angiotensin converting enzyme inhibitors, ARB = angiotensin receptor blockers; (d) ARNI use in GDT alone is assumed to increase at a faster rate than that of other medication usage in GDT alone; (e) MRA = mineralocorticoid receptor antagonist; (f) estimates based on NTproBNP levels (see text); (g) Assumes that left ventricular assist device (LVAD) implantations do not increase in BAT cohort, but probability of LVAD in GDT cohort increases nearly linearly (see text); (h) “Other” includes the following BAT-specific serious adverse events, each of which occurred at a rate of 0.87%: Prolonged Intubation (requiring overnight stay); Antibiotic Allergic Reaction (BAT implanted at a later date); HF Exacerbation; Prolonged Stay due to Dizziness; Acute Respiratory Failure (consequence of anesthesia); Pneumonia Resulting in Intubation; Ischemic Stroke; Cranial Nerve Stimulation for Localized Neck Pain (341 days post implant)