Publications

BACKGROUND AND AIMS: Valvular heart disease (VHD) is a significant source of morbidity and mortality, though early intervention can improve outcomes. This study aims to develop artificial intelligence-enhanced electrocardiography (AI-ECG) models to diagnose and predict future moderate or severe regurgitant VHDs (rVHDs), including mitral regurgitation (MR), tricuspid regurgitation (TR), and aortic regurgitation (AR).

METHODS: The AI-ECG models were developed in a data set of 988 618 ECG and transthoracic echocardiogram pairs from 400 882 patients from Zhongshan Hospital, Shanghai, China. The AI-ECG models used a residual convolutional neural network with a discrete-time survival loss function. External evaluation was performed in outpatients from a secondary care data set from Beth Israel Deaconess Medical Center, Boston, USA, consisting of 34 214 patients with linked echocardiography.

RESULTS: In the internal test set, the AI-ECG models accurately predicted future significant MR [C-index 0.774, 95% confidence interval (CI) 0.753-0.792], AR (0.691, 95% CI 0.657-0.720), and TR (0.793, 95% CI 0.777-0.808). In age- and sex-adjusted Cox models, the highest risk quartile had a hazard ratio (HR) of 7.6 (95% CI 5.8-9.9, P < .0001) for risk of future significant MR, compared with the lowest risk quartile. For future AR and TR, the equivalent HRs were 3.8 (95% CI 2.7-5.5) and 9.9 (95% CI 7.5-13.0), respectively. These findings were confirmed in the transnational external test set. Imaging association analyses demonstrated AI-ECG predictions were associated with subclinical chamber remodelling.

CONCLUSIONS: This study developed AI-ECG models to diagnose and predict rVHDs and validated the models in a transnational and ethnically distinct cohort. The AI-ECG models could be utilized to guide surveillance echocardiography in patients at risk of future rVHDs, to facilitate early detection and intervention.

BACKGROUND: Cardiac magnetic resonance imaging (CMR) contributes to the diagnostic evaluation of cardiomyopathy and procedural planning. Many patients referred for clinical CMR have cardiac implantable electrical devices (CIEDs). Few studies have described the feasibility of CMR at 3T in patients with CIED.

OBJECTIVE: This study aimed to assess the safety and quality of CMR at 3T field strength in patients with conditional CIEDs.

METHODS: We implemented an abbreviated CMR protocol including cardiac cine and late gadolinium enhancement (LGE) sequences. We identified patients with magnetic resonance imaging-conditional CIEDs at 3T referred for a clinical CMR from September 2020 to February 2024. CIED function was assessed after each scan. Cardiac cine and LGE sequences were evaluated for quality and artifacts affecting interpretation.

RESULTS: We evaluated 87 patients (22 women, 66 ± 11.7 years) who underwent 90 scans. No adverse events were observed during any scan. No changes in battery voltage or lead parameters required device reprogramming; 82 scans (91%) were diagnostic. In 50 cine sequences (59%) and 49 LGE sequences (58%), the quality was determined to be good or good/intermediate. In 73 cine (86%) and 47 LGE sequences (55%), there was agreement that there were no artifacts affecting interpretation.

CONCLUSION: Our single-center real-world experience confirms the safety of CIED-CMR at 3T for appropriately labeled CIEDs, with no adverse events or changes to device parameters requiring reprogramming. Although images may be suboptimal owing to artifacts, more than 90% of scans were diagnostic.

Endovascular renal denervation (RDN) is a catheter-based, procedural therapy for the treatment of hypertension that was approved by the US Food and Drug Administration (FDA) in November 2023. Early studies suggest that endovascular RDN reduces blood pressure (BP) in patients with hypertension. However, BP response to RDN is highly variable, optimal patient selection remains uncertain, and the procedure's high cost remains a significant challenge. The purpose of this review is to comprehensively examine the literature regarding the mechanism by which endovascular RDN reduces BP and the safety and effectiveness of RDN, and to discuss key considerations for selecting appropriate patients for endovascular RDN. Relevant studies in the field were identified from PubMed using search terms including 'renal denervation' and 'renal denervation for hypertension.' In conclusion, clinical trials have demonstrated a statistically significant BP-lowering effect of endovascular RDN, which based on multiple trials with long-term follow-up, appears to persist over several years with low complication rates. More research is needed to understand which patients benefit most from endovascular RDN and to evaluate the long-term outcomes, including the impact of endovascular RDN on cardiovascular events.

OBJECTIVE: Despite advances in the management of chronic limb-threatening ischemia (CLTI), a large proportion of these patients are not candidates for traditional revascularization and may be destined for major amputation. Given this medically complex and no-option patient population, deep venous arterialization (DVA) has been recently revitalized as a limb salvage technique, whereby an arteriovenous fistula in the lower leg is created to supply more oxygenated blood via the venous system to the foot. Recently, PROMISE II (Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia) demonstrated a 6-month amputation-free survival (AFS) rate of 66% after DVA. With this trial in mind, our study aimed to evaluate the real-world outcomes of this procedure.

METHODS: The study population included all patients undergoing a DVA from January 1, 2021, through December 31, 2023 among fee-for-service beneficiaries identified in the Medicare Fee-for-Service Carrier Claims file. DVA procedures were identified using Current Procedural Terminology code 0620T. Outcomes included limb salvage, freedom from major adverse limb events (defined as major amputation or ipsilateral reintervention), survival, and AFS. Cumulative incidences for outcomes that include death were estimated from traditional Kaplan-Meier methods; for non-death end points, outcomes were estimated from the cumulative incidence function, accounting for the competing risk of death.

RESULTS: Between 2021 and 2023, 134 patients underwent a DVA for CLTI. Among these, the median age was 70 years and the majority of patients were male (66%), White (63%), and had tissue loss (72%), hypertension (99%), hyperlipidemia (96%), chronic kidney disease (89%), and diabetes (83%). After a DVA for CLTI, the 6-month and 1-year AFS incidences were 42% and 33%, respectively. One-year incidences of limb salvage, freedom from major adverse limb events, and survival were 53%, 36%, and 65%, respectively.

CONCLUSIONS: Among patients with no traditional options for revascularization, our data demonstrate that DVA is a procedure that is, by its nature, performed on high-risk individuals who continue to have a high risk of limb loss and mortality. Importantly, AFS in our analysis was notably worse than that reported in PROMISE II and, as such, raises questions about the generalizability of this procedure in real world practice. Further investigation is needed regarding patient selection criteria for and the clinical usefulness of the DVA procedure.

The day-to-day regularity of sleep-wake timing refers to time-varying patterns of behavioral cycles, which co-occur with temporally associated environmental exposures and circadian rhythms. Introduced in 2017, the Sleep Regularity Index (SRI) has enabled rigorous study of the health and performance implications of the day-to-day regularity of sleep-wake timing. Since its introduction, multiple open-source calculators have been published to facilitate SRI scoring from timestamped sleep-wake data; however, the comparability of these calculators had not previously been evaluated. Here, we sought to (1) estimate SRI usage and method of calculation in peer-reviewed studies published since its establishment; (2) compare SRI scores calculated by two widely used SRI calculators, sleepreg and GGIR; (3) compare results from prospective assessments of the relationship between sleepreg SRI scores versus GGIR SRI scores and previously examined health outcomes. We found that amidst increasing use of the SRI, non-disclosure and heterogeneity in the method of SRI calculation are common. Additionally, among more than 70 000 adults with accelerometer-derived sleep-wake data, SRI scores calculated by two widely used open-source packages differed markedly, both in absolute and relative values. Applied to prospective clinical outcome models for all-cause mortality, incident type 2 diabetes, and incident atrial fibrillation or atrial flutter, the method of calculation alone meaningfully changed results and interpretations. In light of these findings, we developed and introduced a 14-item RIRI statement (Reporting Items for Regularity Indices) to standardize reporting and promote reproducibility in research involving the SRI or complementary regularity indices.

OBJECTIVE: Routine imaging surveillance following endovascular aortic aneurysm repair (EVAR) for abdominal aortic aneurysm (AAA) is critical for the timely diagnosis of late postoperative complications. Compliance with recommended EVAR surveillance is variable, and disparities in post-EVAR surveillance remain unclear. This study examines variability in EVAR surveillance and emergency health service use across several sociodemographic populations.

METHODS: All Medicare fee-for-service beneficiaries who underwent infrarenal EVAR for intact abdominal aortic aneurysm between January 2011 and December 2019 were included. Patients were stratified by several sociodemographic characteristics: age category (66-74, 75-84, >85 years), sex (male, female), race (White, Black, Asian, other), dual enrollment in Medicare and Medicaid (dual enrolled, Medicare only), and distressed communities index (distressed >80th percentile, nondistressed ≤80th percentile). The following postoperative health care use metrics were assessed: EVAR-related office visits, imaging studies, emergency department (ED) visits, and hospital readmissions. Annual incidence rates were calculated for each health care use metric at 2 and 5 years after EVAR and compared across groups using Poisson regression models, adjusting for sociodemographic and hospital characteristics and comorbidities.

RESULTS: In 111,381 Medicare beneficiaries who underwent EVAR, postoperative health care use varied substantially across sociodemographic groups. After adjustment, annual incidence rates of EVAR-related office visits at 2 years post EVAR were lower in patients who were >85 years vs 66-75 years (adjusted rate ratio [aRR], 0.95; 95% confidence interval [CI], 0.93-0.97), female vs male (aRR, 0.94; 95% CI, 0.93-0.95), dual enrolled vs Medicare only (aRR, 0.83; 95% CI, 0.81-0.85), and residing in distressed vs nondistressed communities (aRR, 0.95; 95% CI, 0.93-0.96). Rates of imaging studies were lower in patients who were >85 years (aRR, 0.98; 95% CI, 0.96-0.99), dual enrolled (0.97; 95% CI, 0.95-0.98), and residing in distressed communities (aRR, 0.97; 95% CI, 0.96-0.98). There was higher use of hospital services in patients who were >85 years (ED: aRR, 1.37; 95% CI, 1.33-1.41; readmission: aRR, 1.23; 95% CI,1.19, 1.28), female (ED: aRR, 1.19; 95% CI, 1.16-1.22; readmission: aRR, 1.15; 95% CI, 1.12-1.19), Black (ED: aRR, 1.10; 95% CI, 1.05-1.15; readmission: aRR, 1.15; 95% CI, 1.09-1.22), dual-enrolled (ED: 1.29; aRR, 95% CI, 1.26-1.33; readmission: aRR, 1.14; 95% CI, 1.09-1.18), and residing in distressed communities (ED: aRR, 1.03; 95% CI, 1.01-1.06; readmission: aRR, 1.02; 95% CI, 0.99-1.05). At 5 years post EVAR, similar trends across sociodemographic groups were observed, with the added finding of lower rates of EVAR-related office visits in Black vs White patients.

CONCLUSIONS: Significant variation in post-EVAR health care use exists among Medicare beneficiaries. Patients who were older age, of female sex, of Black race, or socioeconomically disadvantaged had lower rates of EVAR-specific follow-up and higher use of emergency health service. Barriers in access to care are apparent, underscoring the need for targeted interventions to enhance post-EVAR surveillance and improve outcomes in these populations.

BACKGROUND: Symptomatic peripheral artery disease (PAD) is prevalent and guideline-recommended therapies include optimal medical therapy (OMT), supervised exercise therapy (SET), and revascularization (stenting). The Claudication: Exercise Versus Endoluminal Revascularization (CLEVER) trial examined longitudinal patient-reported outcomes to assess response to OMT, SET, and stenting. The predictors of symptomatic improvement have not been fully assessed.

METHODS: This is a secondary analysis of the CLEVER trial, which randomized patients with claudication to OMT alone, OMT plus SET, or OMT plus stenting. The primary outcome was a change in the Peripheral Artery Questionnaire (PAQ) summary score by 10 points or more from baseline to 6 and 18 months. Multivariate logistic regression was used to identify predictors of response.

RESULTS: Of the 103 participants (66 men, median age 63 years), 65 (63%) had a response to therapy at 6 months. Of 98 participants who completed the 18-month PAQ, 52 (53%) had a symptomatic response. On binary logistic regression, when compared to OMT, SET (6 months: odds ratio [OR] 4.25, 95% CI: 1.33-13.58; 18 months: OR 3.92, 95% CI: 1.04-14.70) and ST (6 months: OR 5.19, 95% CI: 1.58-17.03; 18 months: OR 11.50, 95% CI: 2.89-45.72) were associated with an increase in PAQ at 6 and 18 months.

CONCLUSION: Among randomized patients in the CLEVER trial, treatment with either SET or stenting was predictive of clinically meaningful change in the PAQ summary score from baseline to 6 and 18 months. These interventions, with a prioritization of SET, should be more widely available to patients with PAD. This study adds to the findings of the CLEVER trial by denoting that SET and stenting are beneficial in patients with PAD, independent of comorbidities.