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Objective: Prolonged mechanical ventilation after cardiac surgery significantly increases morbidity and mortality. The aim of this study is to establish the role of diaphragmatic pacing to decrease mechanical ventilation burden in high-risk patients undergoing cardiac surgery. Methods: This is a prospective, randomized trial of temporary diaphragmatic pacing electrode use in patients undergoing cardiac surgery (NCT04899856). Prognostic enrichment strategy was used to identify patients at higher risk of prolonged mechanical ventilation by having inclusion criteria of prior open cardiac surgery, left ventricular ejection fraction less than 30%, history of stroke, intra-aortic balloon pump, or history of chronic obstructive pulmonary disease. Two electrodes were placed in each hemidiaphragm intraoperatively. On arrival to the intensive care unit, patients were randomized to immediate diaphragmatic pacing or standard of care. Results: Forty patients received implants, with 19 in the treatment group and 21 in the standard of care group. Only 1 patient in the treatment group was on mechanical ventilation at 24 hours versus 4 patients in the standard of care group, resulting in a relative risk reduction of 71% being on mechanical ventilation at 24 hours postoperatively. Predictive enrichment strategy was used to identify patients most likely to respond to therapy of diaphragmatic pacing. In this analysis, median time on mechanical ventilation was 17.7 hours (interquartile range, 8.3-23.4) for the 15 patients in the standard of care group and 9.4 hours (interquartile range, 7.14-12.5) for the 13 patients in the treatment group, for an improvement of 8 hours with diaphragm pacing (P

Objective: We performed a post hoc analysis of the Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial to determine the effect an on-versus off-pump strategy had on outcomes when compared with percutaneous coronary intervention. Methods: All randomized patients in EXCEL (n = 1905) were included. The outcomes of interest were the primary end point composite of death from any cause, stroke, or myocardial infarction; the composite study end point or ischemia-driven revascularization; and the rate of death from any cause at 5 years. Event rates were based on Kaplan–Meier estimates in time-to-first-event analyses. Results: Propensity matching resulted in groups of 1142 patients (571 each) for on-pump coronary artery bypass grafting versus percutaneous coronary intervention and 472 patients (236 each) for off-pump coronary artery bypass grafting versus percutaneous coronary intervention. In the on-pump coronary artery bypass grafting versus percutaneous coronary intervention matched groups, the composite end point was similar (18.0% vs 22.1%, P = .19) and the composite end point or ischemia-driven revascularization (23.3% vs 31.0%, P = .01) was lower, and mortality (7.6% vs 11.8%, P = .025) was lower in the on-pump coronary artery bypass grafting group at 5 years. In the off-pump coronary artery bypass grafting versus percutaneous coronary intervention matched groups, the composite end point (19.4% vs 22.2%, P = .47), composite end point or ischemia-driven revascularization (25.9% vs 34.2%, P = .07), and mortality (12.5% vs 14.2%, P = .59) were similar at 5 years. Conclusions: In the EXCEL trial, on-pump coronary artery bypass grafting was associated with a decreased 5-year rate of the composite outcome of death, stroke, myocardial infarction, or ischemia-driven revascularization, and decreased mortality when compared with percutaneous coronary intervention, whereas outcomes of off-pump coronary artery bypass grafting were similar to percutaneous coronary intervention.

Therapeutic Area: ASCVD/CVD Risk Reduction Background: Increased place-based social deprivation is known to be associated with higher cardiovascular mortality (CVM) rates. While CVM rates in the US have been declining overall, our study evaluated whether this holds true for areas with increased social deprivation. Methods: In this cross-sectional study, we used county-level CVM rates between 2000 and 2019 and linked it to the CDC Social Vulnerability Index (SVI), and analyzed data from 3052 counties nationwide. We grouped counties as per their SVI (Group I 0 - 0.2, Group II 0.21 - 0.4, Group III 0.41 - 0.6, Group IV 0.61 - 0.8,and Group V 0.81 – 1) and obtained the relative change in the age adjusted CVM between 2000-2003 and 2016-2019. We studied the temporal change in CVM across SVI groups, overall and separately according to race (white vs black), sex (men vs women) and county location (metro vs non-metro). We used adjusted linear regression analyses to explore the association between increasing SVI and the relative change in CVM. Results: The median county-level age-adjusted CVM (aa-CVM) rate (per 100,000) overall was 272.6 [IQR: 237.5, 311.7]. Men (315.6 [IQR: 273.4, 363.9]) had higher aa-CVM rates than women (221.3 [IQR: 189.6, 256.7]), and blacks (347.2 [IQR: 301.1, 391.1]) had higher aa-CVM rates than whites (258.9 [IQR: 226, 299.1], p < 0.001). The aa-CVM for SVI I (233.6 [IQR: 214.8, 257.0]) was significantly higher than group V (323.6 [IQR: 277.2, 359.2], p < 0.001). The relative reduction in CVM was significantly higher for SVI group I (32.2% [IQR: 24.2%, 38.4%]) than SVI group V (27.2% [IQR: 19%, 34.1%]) counties. An increasing SVI index was associated with lower relative percent decline in the age-adjusted CVM (model coefficient -6.01 [0.73], p < 0.001). Conclusions: We observed higher age-adjusted CVM in more socially deprived counties in the US. While the overall age-adjusted CVM has declined in the past 20 years, this improvement is substantially lesser in more socially deprived counties.

Therapeutic Area: ASCVD/CVD Risk Factors Background: Particulate matter (PM2.5) air pollution is a global health problem associated with adverse cardiovascular outcomes. With the use of fossil fuels and ambient air pollution levels many-fold over the air quality standards, air pollution is a significant concern in the South Asia region (SAR). We, therefore, sought to examine the effect of particulate matter on cardiovascular disease (CVD) burden in the SAR from 1990 to 2019. Methods: We used the 1990–2019 global burden of disease methodology to calculate the total PM2.5, ambient PM2.5, and household PM2.5-related CVD deaths and years of life lost (YLL) in SAR (India, Pakistan, Bangladesh, Bhutan and Nepal). We additionally tracked population-weighted ambient PM2.5 and household air pollution (HAP) use (proportion of population) over the study period using the State of the Global Air repository. Results: The average annual population-weighted ambient PM2.5 exposure in SAR increased from 68 μg/m3 [95% confidence interval (CI): 34.5-120] in 1990 to 78.2 μg/m3 [95% CI: 71.9–85] in 2019. This is contrasted with a reduction in the proportion of HAP exposure proportion from 86% (95% CI: 85-87) in 1990 to 61% (95% CI: 58-63) in 2019. In 2019, particulate matter pollution contributed to 27.6% (95% CI: 25.7-29.5%) of deaths and 31.4% (95% CI: 29.3–33.4%) of YLL due to CVD in the SAR. From 1990 to 2019, the age-standardized rate of PM2.5-attributable CVD death decreased by 52 per 100,000 due to HAP and increased by 23 per 100,000 due to ambient PM2.5. Similarly, the age standardized rate of YLL attributed to HAP decreased by 63.4% while that attributed to ambient PM2.5 increased by 107.2% from 1990 to 2019. Conclusions: Despite the decrease in HAP exposure, ambient PM2.5 increased in SAR over the past 3 decades. Overall PM2.5 air pollution continues to have significant contribution to overall CVD mortality, accounting for one quarter of CVD deaths. Societal and personal interventions are urgently needed to curb the CVD pandemic in SAR.