BACKGROUND: Early detection of cardiovascular disease is a global public health priority. Artificial intelligence (AI)-enabled stethoscopes offer robust performance characteristics in point-of-care detection of heart failure, atrial fibrillation, and valvular heart disease (VHD). We conducted a pragmatic, cluster-randomised controlled implementation trial to determine the real-world effect and implementation challenges of AI-stethoscopes.
METHODS: UK primary care practices were cluster randomised 1:1 to intervention (training and implementation in use of AI-stethoscopes in routine care) or control (routine care). Given the nature of the intervention, masking of participants (practices, clinicians, and patients) was not feasible. During cardiac examinations, the AI stethoscope recorded 15 s of single-lead electrocardiogram and phonocardiogram signals for input to three AI algorithms that returned binary predictions for the presence or absence of reduced left ventricular ejection fraction (=40%), atrial fibrillation, and VHD (all with regulatory approval). The primary endpoint was incidence of any newly coded diagnosis of heart failure (all subtypes), expressed per 1000 patient-years (incidence rate ratio [IRR]), derived from a UK National Health Service Secure Data Environment. A coprimary endpoint stratified detection of heart failure by place of diagnosis (community-based vs via hospital admission). Secondary endpoints included atrial fibrillation and VHD detection rates, performance characteristics of the AI-stethoscope, use rates, and clinician-reported implementation barriers and enablers.
FINDINGS: Between Oct 30, 2023, and May 22, 2024, 205 practices were randomly assigned (96 to the intervention arm [701 933 registered patients] and 109 to the control arm [851 242 registered patients]). Intervention practices recorded 12 725 patient examinations with the AI-stethoscope, across 972 clinical users. Intention-to-treat analysis found heart failure detection did not differ between groups (IRR 0·94 [95% CI 0·86-1·02]); with no difference in community-based or hospital-based diagnoses (p>0·05).
INTERPRETATION: Implementation of an AI stethoscope in routine primary care did not significantly increase detection of heart failure or increase community-based diagnosis after 12 months of implementation. AI stethoscope use was independently associated with significantly higher detection rates of heart failure, as well as atrial fibrillation and VHD. This randomised controlled implementation trial establishes a pragmatic design with randomisation that generates real-world data essential for understanding and overcoming the barriers to implementation of innovation in health care.
FUNDING: National Institute for Health and Care Research, British Heart Foundation, and Imperial Health Charity.
| Discipline Area | Score |
|---|---|
| Family Medicine (FM)/General Practice (GP) |  |
| General Internal Medicine-Primary Care(US) | |
| Public Health | |
| Internal Medicine | Coming Soon... |
| Cardiology | Coming Soon... |
The conclusion contradicts itself. A typo? AI stethoscopes offered no HF detection advantage but apparently AF detection, which raises serious concerns regarding the skills and competence of those who used normal stethoscopes and didn't detect AF.
An important 'negative' study. New technology is constantly appearing. We need to know whether it makes clinically significant improvements in diagnosis and outcomes.
In the current environment in Medicine, all things related to AI are pertinent and should be evaluated as AI seems to moving quickly. The outcomes were not unexpected, and the explanation in the interpretation section was very ambiguous.
This is interesting with respect to the LVEF finding. The utility of this for AF detection is probably already superseded or will be superseded by watches and other wearables; however, the LVEF finding is interesting. I suspect that POC US may end up replacing this pretty quickly, and I don't know about the generalizability of RCT evidence for treatments for reduced LVEF detected via echo (presumably the vast majority of which had some symptoms, hence the echo) to this situation where reduced LVEF is being detected in someone who is mostly or entirely asymptomatic. Still, it is interesting.