Publications

2025

Maher, Timothy, Nathan Kong, Ryan Spray, Sophie Lee, Sofia Gurgel, Jonathan Waks, Daniel B Kramer, Kenneth A Ellenbogen, Peter Zimetbaum, and Andre D’Avila. (2025) 2025. “Safety and Behavior of Implantable Electronic Devices During Cremation.”. Heart Rhythm 22 (4): 1073-79. https://doi.org/10.1016/j.hrthm.2024.08.031.

BACKGROUND: The current standard of practice for cremating patients with cardiac implantable electronic devices (CIEDs) is surgical explantation before cremation to mitigate the risk of device explosion. This surgery may conflict with patient or family beliefs, whereas cremation of CIEDs may create occupational hazards.

OBJECTIVE: This study sought to establish an ex vivo model for screening CIED behavior during cremation.

METHODS: Seven CIEDs underwent testing including projectile/sound testing, impact testing, and gas analysis. In the projectile test, devices were heated until thermal failure (explosion) and filmed with a high-speed camera and microphone. For impact testing, brick structures were built to assess damage after explosion. Gas chromatography-mass spectrometry identified released gases. Findings were compared with occupational health standards, where available.

RESULTS: The implantable loop recorder and leadless pacemaker produced minimal kinetic energy and impact risk with thermal failure. The remaining devices demonstrated explosive disintegration at thermal temperatures <500°C. The pacemakers and implantable cardiac defibrillators produced sound levels >120 dB and resulted in damage to brick structures. Small quantities of benzene and hydrogen fluoride were produced but at quantities within acceptable occupational exposure limits in a cremation chamber.

CONCLUSION: All tested CIEDs experienced explosion at temperatures below crematorium standards. The smallest devices produced minimal risk of damage or injury, suggesting that they may safely remain in situ during cremation, whereas the larger devices produced more kinetic energy, testing chamber damage, and louder explosions, suggesting potential risk with cremation. Cadaveric testing in full-sized cremation chambers is required to determine real-world risk.

Amyar, Amine, Danah Al-Deiri, Jakub Sroubek, Alan Kiang, Fahime Ghanbari, Shiro Nakamori, Jennifer Rodriguez, et al. (2025) 2025. “Radiomic Cardiac MRI Signatures For Predicting Ventricular Arrhythmias In Patients With Nonischemic Dilated Cardiomyopathy.”. JACC. Advances 4 (4): 101684. https://doi.org/10.1016/j.jacadv.2025.101684.

BACKGROUND: Risk stratification in patients with nonischemic dilated cardiomyopathy (DCM) remains challenging. Although late gadolinium enhancement (LGE) cardiovascular magnetic resonance is recognized as a major risk factor for ventricular tachycardia/ventricular fibrillation (VT/VF), the prognostic value of LGE radiomics is unknown.

OBJECTIVES: The purpose of this study was to investigate if radiomic analysis of LGE images can improve arrhythmia risk stratification in patients with DCM beyond current clinical and imaging markers.

METHODS: In a 2-center retrospective study, patients with DCM were identified among those who received primary prevention implantable cardioverter-defibrillators (ICDs) according to the clinical guidelines and had a cardiovascular magnetic resonance before ICD implantation. The study included patients with DCM from the Cleveland Clinic Foundation for model development and patients with DCM from Beth Israel Deaconess Medical Center for external validation. Left ventricular myocardial radiomic features were extracted from LGE images. The primary outcome was appropriate ICD intervention defined as shock or antitachycardia pacing for VT/VF. Consensus clustering and pairwise correlation were used to identify the radiomic signature. To assess the prognostic value of LGE radiomics, we built 2 logistic regression models using the development data: 1) model 1, including clinical risk factors and scar presence and 2) model 2, which combines model 1 and LGE radiomics.

RESULTS: In total, 270 patients with DCM (61% male, age 58 ± 13 years) in development data and 113 patients with DCM (71% male, age 55 ± 14 years) in external validation were included. VT/VF occurred in 40 (15%) patients in development and 16 (15%) in external validation cohorts over a median follow-up period of 4.0 (IQR: 2.5-6.1) and 2.6 (IQR: 1.2-4.1) years, respectively. Consensus clustering and pairwise correlation revealed 3 distinct radiomic features. Model 2 showed a higher C-statistic than model 1 (0.71 [95% CI: 0.62-0.80] vs 0.61 [95% CI: 0.53-0.71]; P = 0.028 in development and 0.70 [95% CI: 0.59-0.85] vs 0.61 [95% CI: 0.46-0.77]; P = 0.025 in external validation). This also significantly improved risk stratification with a continuous net reclassification index of 0.60 [95% CI: 0.29-0.91; P < 0.001] in development and of 0.29 [95% CI: 0.26-0.56; P = 0.03] in external validation. Additionally, 1 radiomic feature, namely the gray level co-occurrence matrix autocorrelation, was an independent predictor of VT/VF in both development (HR: 1.45 [95% CI: 1.10-1.91]; P = 0.01) and in external validation (HR: 2.38 [95% CI: 1.28-4.42]; P = 0.01).

CONCLUSIONS: In this proof-of-concept study, radiomic analysis of LGE images provides additional prognostic value beyond LGE presence in predicting arrhythmia in patients with DCM.

Kelshiker, Mihir A, Patrik Bachtiger, Josephine Mansell, Daniel B Kramer, Saloni Nakhare, Melanie T Almonte, Abdullah Alrumayh, et al. (2025) 2025. “Triple Cardiovascular Disease Detection With an Artificial Intelligence-Enabled Stethoscope (TRICORDER): Design and Rationale for a Decentralised, Real-World Cluster-Randomised Controlled Trial and Implementation Study.”. BMJ Open 15 (5): e098030. https://doi.org/10.1136/bmjopen-2024-098030.

INTRODUCTION: Early detection of cardiovascular disease in primary care is a public health priority, for which the clinical and cost-effectiveness of an artificial intelligence-enabled stethoscope that detects left ventricular systolic dysfunction, atrial fibrillation and cardiac murmurs is unproven but potentially transformative.

METHODS AND ANALYSIS: TRICORDER is a pragmatic, two-arm, multi-centre (decentralised), cluster-randomised controlled trial and implementation study. Up to 200 primary care practices in urban North West London and rural North Wales, UK, will be randomised to usual care or to have artificial intelligence-enabled stethoscopes available for use. Primary care clinicians will use the artificial intelligence-enabled stethoscopes at their own discretion, without patient-level inclusion or exclusion criteria. They will be supported to do so by a clinical guideline developed and approved by the regional health system executive board. Patient and outcome data will be captured from pooled primary and secondary care records, supplemented by qualitative and quantitative clinician surveys. The coprimary endpoints are (i) difference in the coded incidence (detection) of heart failure and (ii) difference in the ratio of coded incidence of heart failure via hospital admission versus community-based diagnostic pathways. Secondary endpoints include difference in the incidence of atrial fibrillation and valvular heart disease, cost-consequence differential, and prescription of guideline-directed medical therapy.

ETHICS AND DISSEMINATION: This trial has ethical approval from the UK Health Research Authority (23/LO/0051). Findings from this trial will be disseminated through publication of peer-reviewed manuscripts, presentations at scientific meetings and conferences with local and national stakeholders.

TRIAL REGISTRATION NUMBER: NCT05987670.

Chiang, Cho-Han, Junmin Song, Yu-Cheng Chang, Soravis Osataphan, Yu-Che Lee, Ko-Yun Chang, Kuan-Yu Chi, et al. (2025) 2025. “Glucagon-Like Peptide 1 Receptor Agonists and Venous Thromboembolism in Type 2 Diabetes: A Target Trial Emulation.”. Blood Advances 9 (10): 2410-18. https://doi.org/10.1182/bloodadvances.2025015871.

Glucagon-like peptide 1 receptor agonists (GLP1-RA) are antidiabetic agents recently approved for weight loss. Obesity is an established risk factor for venous thromboembolism (VTE). Moreover, preclinical studies have shown that GLP1-RA may attenuate thromboxane-induced platelet activation. Therefore, we hypothesized that GLP1-RA use may reduce the risk of VTE. We performed a target trial emulation (TTE) using a population-based database of electronic health records to evaluate whether GLP1-RA use is associated with a reduction in VTE in patients with type 2 diabetes mellitus (T2DM) compared with dipeptidyl peptidase-4 inhibitors (DPP4i). Patients who were newly initiated on GLP1-RA were propensity score matched to patients who were newly initiated on DPP4i. We evaluated the primary outcome, composite VTE, identified using ICD-10 (International Classification of Diseases, Tenth Revision) codes, within 12 months of the initiation of GLP1-RA or DPP4i. The study cohort comprised 540 258 patients with 270 129 individuals receiving either GLP1-RA or DPP4i. Over 12 months of follow-up, patients who received GLP1-RA had a lower incidence of VTE compared with patients who received DPP4i (6.1 vs 7.6 events per 1000 patient-years; hazard ratio [HR], 0.78; 95% confidence interval [CI], 0.73-0.83). This was similar for pulmonary embolism (2.9 vs 3.8 events per 1000 patient-years; HR, 0.74; 95% CI, 0.68-0.82) and deep vein thrombosis (3.9 vs 4.7 events per 1000 patient-years; HR, 0.81; 95% CI, 0.75-0.88). In this propensity score-matched, TTE study, patients with T2DM who received a GLP1-RA had a lower risk of VTE at 1 year compared with patients who received DPP4i.