News
A Restrictive Benzodiazepine Strategy During Cardiac Surgery Does Not Reduce Post-Operative Delirium
Key Points:
- Benzodiazepine use contributes to delirium before and after cardiac surgery, but intra-operative benzodiazepine use has not been well-studied.
- In B-Free, a restrictive intraoperative benzodiazepine strategy was compared with a liberal benzodiazepine strategy in the reduction of post-operative delirium.
- In the primary intention-to-treat analysis, the restrictive benzodiazepine strategy did not result in a significant reduction in post-operative delirium. However, this endpoint was significantly reduced in the restrictive arm using either an on-policy analysis approach or after excluding patients receiving pre-operative benzodiazepines.
TRAVERSE: Transseptal approach to LV ablation results in fewer cerebral emboli compared to retrograde aortic approach
Key Points:
- Among patients who undergo endocardial ablation for left ventricular arrythmias, it is uncertain whether the number of imaging-detected cerebral emboli differs based on the anatomical approach.
- In this randomized trial, participants who were assigned to a transseptal approach had significantly lower rates of imaging-detected cerebral emboli compared to those assigned to a retrograde aortic approach.
FFR-Guided Complete Revascularization in STEMI did not reduce MACE vs Culprit-lesion only PCI: The FULL REVASC Trial
Key Points
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- Researchers compared outcomes in patients with STEMI or very-high-risk non-STEMI (NSTEMI) and multivessel disease who were undergoing primary percutaneous coronary intervention (PCI) of the culprit lesion to receive either FFR-guided complete revascularization of nonculprit lesions or no further revascularization.
- There was no significant difference in the composite primary outcome of death, myocardial infarction or unplanned revascularization, between patients randomized to culprit lesion only PCI versus FFR-guided complete revascularization
PREVENT: PCI of non-flow-limiting vulnerable plaques reduced MACE compared to medical therapy alone
Key Points:
- Vulnerable plaques can lead to acute coronary syndromes, but it is unknown whether performing PCI on these lesions improves outcomes.
- In this RCT, patients with at least one non-flow limiting vulnerable plaque who received PCI plus OMT had significantly lower rates of target-vessel failure compared to OMT alone at a median follow up of 4.4 years.
EMBO-ABL: Cryoballoon non-inferior to radiofrequency catheter ablation for AF for silent cerebral events
Key Points:
- Among AF patients undergoing catheter ablation, cryoballoon was non-inferior compared to radiofrequency for the primary endpoint of silent cerebral embolic events detected on MRI.
RELIEVE HF: Inter-Atrial Shunting Does Not Reduce Symptoms or Improve Prognosis in HF
Key Points:
- Inter-atrial shunting (IAS) may provide a useful opportunity to dynamically regulate left atrial pressure in heart failure.
- In the RELIEVE-HF study, IAS was compared with placebo in patients with at least a 6-month history of HF, across all LVEF categories and HF etiologies. The primary endpoint was a hierarchical composite of all-cause death, transplant or LVAD placement, all HF hospitalizations, and change in KCCQ score from baseline to 12 months; the primary safety endpoint was a composite of major adverse cardiac or neurologic events over 30 days.
- IAS was well-tolerated with zero adverse safety events, but it did not result in a significant reduction in the primary endpoint. However, in exploratory pre-specified stratified analyses by LVEF, IAS appeared to cause harm in patients with HFpEF and confer benefit in HFrEF.
SHASTA 2: Novel RNAi Therapeutic Plozasiran Results in Sustained Reduction In Triglycerides in Severe Hypertriglyceridemia
Key Points:
- Severe hypertriglyceridemia portends high risk of both CVD and acute pancreatitis, but there are limited effective treatment options.
- A novel RNA interference (RNAi) therapeutic plozasiran can reduce APOC3, a mediator of triglyceride elevation.
- In the Phase 2B trial SHASTA-2, two doses of plozasiran were compared with placebo in long-term (24 and 48 week) reduction of triglycerides and other cholesterol pathway mediators.
- All doses of plozasiran was well-tolerated and resulted in sustained reduction in triglycerides, APOC3, and remnant cholesterol with increased HDL-C by 24 weeks, with a still-significant but attenuated effect at 48 weeks.
DanGer Shock: Impella Reduces All-Cause Mortality in STEMI Cardiogenic Shock
Key Points:
- Cardiogenic shock (CS) mortality remains high despite increased utilization of mechanical circulatory support. Specifically, no randomized data has supported the use of Impella CP in CS.
- In DanGer Shock, routine use of Impella CP was compared with standard of care in selected individuals with cardiogenic shock after STEMI.
- Impella CP use was associated with a 13% reduction in 6-month all-cause-mortality but increased rates of both ischemic and hemorrhagic adverse events.
AT-001, a potent aldose reductase inhibitor, did not improve exercise capacity in diabetic cardiomyopathy with impaired exercise capacity
Key Points:
- The ARISE-HF trial evaluates the use of AT-001, a potent aldose reductase inhibitor, to reduce the risk of diabetic cardiomyopathy among patients with Type II diabetes.
- The trial did not find a significant difference in its primary outcome, change in a patient’s peak VO2 consumption, or secondary outcomes, including risk of progression to overt heart failure, between patients who received the higher dose of AT-001 (1500 mg) compared to placebo.
- In a pre-specified secondary analysis of patients who were not receiving either a GLP1 agonist or an SGLT2 inhibitor, there was a statistically significant difference in VO2 consumption after 15 months between patients receiving AT-001 1500 mg and those receiving placebo.
TAVR non-inferior to SAVR in Low to Intermediate Risk Patients With Severe Aortic Stenosis: DEDICATE-DZHK6 Trial
Key Points
- In the DEDICATE-DZHK6 trial, patients with a history of severe aortic stenosis who were ≥ 65 years old and low to intermediate risk for surgery were randomized to receive TAVR versus SAVR.
- TAVR was noninferior to SAVR with respect to death from any cause or stroke at 1 year.
- Patients who received a TAVR had improved secondary outcomes including lower rates of disabling stroke, cardiovascular death, bleeding and new-onset atrial fibrillation compared to those who received a SAVR
ORBITA COSMIC: Coronary sinus reducer did not improve transmural myocardial perfusion but angina symptoms
Key Points
– Coronary sinus reduction (CSR) is a potential therapeutic device for patients with refractory angina
– In this first-of-its-kind randomized, placebo-controlled, double-blind trial, participants underwent CSR implantation or a placebo procedure, with pre- and post-trial CMR and daily angina reporting
-Participants who received a CSR reported fewer episodes of angina, but CMR did not demonstrate improved blood flow
TARGET BP I: Alcohol-mediated renal artery denervation reduced SBP in treatment-resistant hypertension at 3 months compared to sham control
Key Points:
- Achieving hypertension control has remained an elusive goal in the US and globally, and procedural treatments like renal denervation have gained traction as a means to successfully overcome non-adherence to traditional lifestyle and medical treatment for hypertension.
- The TARGET BP I investigated a novel percutaneous device, capable of injecting a small amount of alcohol into the renal artery perivascular space, to achieve a circumferential and confluent (yet self-limited) arc of ablation of the sympathetic nervous system.
- Between 2019 and 2023, 301 patients with hypertension despite treatment with 2-5 medications were randomized 1:1 to renal denervation or sham control. At 3 months of follow-up, there was a modest but statistically significant reduction in 24-hour ambulatory systolic blood pressure (-10.0 ± 14.2 mm Hg versus -6.8 ± 12.1 mm Hg, i.e. a delta of -3.2 mm Hg with 95%CI -6.3 to 0.0, P=0.049), but no reduction in office systolic blood pressure, nor office or ambulatory diastolic blood pressure. This was in the context of an alarmingly high rate of medication non-adherence in both arms (50-60%).
- While encouraging, these results require confirmation via longer follow-up beyond 3 months, in order to understand whether alcohol-mediated renal denervation will demonstrate persistent reduction in blood pressure and perhaps show a larger advantage of the sham control arm, which may be expected to further worsen in hypertension control over time.
Hózhó: Phone-based GDMT Initiation and Uptitration Feasible and Effective among HFrEF patients in Navajo Nation
Key Points:
- GDMT utilization is suboptimal among American Indian patients with HFrEF in Navajo Nation.
- In this pragmatic, stepped-wedge, randomized clinical trial, a telehealth intervention using telephone calls and remote BP monitoring was significantly more effective than usual care in rapid GDMT optimization.
HUDDLE: Cross-sectional study finds large gap between hypertension prevalence and awareness among former NFL athletes
Key Points:
- Little is known about the prevalence of cardiovascular risk factors or disease in former professional athletes. Gaps may exist between the awareness and prevalence of CVD in this population.
- This cross-sectional study of National Football League (NFL) alumni who participated in cardiovascular screening events found that 90% had HTN, 46% had an abnormal EKG, and 62% had structural abnormalities on TTE. Overall, 84% were found to have an elevated BP but only 38% had a self-reported a history of HTN.
- There may be a significant knowledge gap between self-awareness of CVD and actual CVD prevalence among retired NFL athletes.
Health 360x: Medical assistants more likely to complete training and remain in clinical research in community practices
Key Points:
- Research coordinators embedded in community-based practices can help ensure that underrepresented and underserved patients have equitable point-of-care access to decentralized clinical trials.
- This study evaluated a need-based protocol-specific workshop to train medical assistants at Health360x practices in research coordination, and compared them to enrollees in a formal didactic Clinical Research Coordinator Certificate program.
- Medical assistants enrolled in the Health360x needs-based, protocol-specific training program were more likely to complete the training and remain engaged in research activities.
- This flexible training approach can be used to build sustainable, equitable research infrastructure in community-based practices over time.
HeLP: Behavioral interventions improve cardiac rehabilitation attendance among recently hospitalized patients with lower SES
Key Points:
- Low-SES patients are less likely to attend CR following hospitalization for a major cardiovascular event and are more likely to be readmitted compared to those with higher SES.
- The HeLP study found that low-SES adults who were randomized to weekly calls from a case manager, financial incentives, or both had higher rates of post-discharge CR attendance compared to usual care.
MINT subgroup analysis: Among patients with acute MI and anemia, a restrictive transfusion strategy was associated with higher rates of death and MI at 30 days
Key Points:
- The MINT trial found that among patients with acute MI and anemia, those randomized to a liberal transfusion strategy had lower rates death or MI at 30 days compared to a restrictive strategy; this result approached but did not reach statistical significance.
- This prespecified subgroup analysis found that the restrictive strategy resulted in a higher rate of death or MI in patients with Type 1 but not Type 2 MI, however the p-value for interaction was not significant.
- Further research is needed, as this analysis was likely underpowered to detect a clinically significant differential response to transfusion strategy based on MI type.
Routine Assessment of Patient-Reported Health Status in Academic Clinics Did Not Improve Patient-Reported Health-Status: The PRO-HF Trial
Key Points:
- The latest AHA/ACC Heart Failure (HF) guidelines recommend routine assessment of patient-reported health status, but no randomized trials have analyzed its possible impact on routine HF care.
- This study compared routine health status assessment with the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) with usual care among HF clinic patients.
- Primary outcome was patient-reported health status at 1 year while secondary outcomes included therapy patterns, testing, and care utilization.
- The study did not show significant differences in patient-reported health status between the KCCQ-12 arm and the usual care arm, nor differences in therapy patterns, testing, and care utilization.
A Spirituality-Based Intervention Improves Blood Pressure Control and Central Hemodynamics: The FEEL Trial
Key Points:
- HTN is a leading cause of cardiovascular (CV) morbidity and mortality worldwide, but blood pressures remain uncontrolled worldwide.
- Spirituality, a comprehensive concept encompassing both personal and interpersonal factors, has been previously studied as a protective factor against CV disease.
- The authors conducted a randomized non-inferiority trial comparing intervention with a daily WhatsApp message, encouraging forgiveness, gratitude, optimism or life purpose, versus usual care for 12 weeks on peripheral and central BP.
- The intervention group demonstrated a significant improvement in both peripheral (7.6 mmHg; p<0.001) and central BP compared to the control group, suggesting evidence of BP improvement with a spirituality intervention on par with many anti-hypertensive medications.
Advancing Acute MI Care in Densely Populated LMICs: Innovative Standalone Chest Pain Units for Expedited Triage and Timely Management – A Role Model for Global Healthcare Systems
Key Points:
- The burden of coronary artery disease (CAD) is high in South Asia, but challenges are present with time-sensitive cardiac care, as evidenced within Karachi, Pakistan (population: >23 million)
- This study deployed portable chest pain units (CPUs) across Karachi to enhance access to primary percutaneous coronary intervention (PCI) to evaluate CPUs’ effect on primary PCI access
- CPUs (complete with cardiologist, crash cart, and prompt evaluation and ECG) coincided with substantial annual increase (16-20%) in primary PCI volume with significantly reduced ischemic time
- Results from this positive study of standalone CPUs may have ramifications for acute MI care in densely populated LMICs, given CPUs’ demonstrable scalability and cost-effectiveness
South Asia has the highest burden of CAD globally with high rates of acute MI (AMI), even occurring in individuals younger than 40 years old. Within South Asia, Pakistan has the highest rate of ischemic heart disease (IHD) mortality and disability adjusted life-years (DALYs). One significant factor contributing to this epidemic is limitations on timely access to primary PCI. Notably, the Government of Sindh approved a program in 2016 offering free primary PCI, doubling the rate of primary PCI from 1500 per year prior to more than 4000 cases in 2016. Access to primary PCI is very challenging in this setting given major traffic issues and emergency room overcrowding. In Karachi, Pakistan, a city of over 23 million, efforts were made to establish stand-alone portable chest pain units (CPUs) across the city in order to expedite evaluation and referral of AMI patients to the local National Institute of Cardiovascular Diseases (NICVD), currently the world’s largest primary PCI center.
Multiple CPUs were strategically deployed throughout Karachi based on population density. From 2017 to 2023, 915,564 patients were evaluated for chest pain. 33.5% (306,794) were found to have a primary cardiac etiology (vs non-cardiac), 24% (223,120) were referred for primary PCI, and 2% of all evaluated (19,580) were found to have a STEMI. Among the STEMI patients, 81% were male, median age was 56 years old (IQR 50-65), and cardiogenic shock (Killip class III or IV) was observed in 1108 patients (5.66% of the STEMI cohort).
Regarding ischemic time outcomes, median first medical contact to device time was 100 minutes (IQR 80-135), median door to balloon time was 84 minutes (IQR 60-125) for patients presenting directly to NICVD ED, and median total ischemic time (TIT) was 232 minutes (IQR 172-315). The presence of CPUs (3 PCUs in 2017 to 18 PCUs in 2023) coincided with the increased caseload of primary PCI with an annual growth rate ranging from 16% to 20% and total primary PCI volume over 9000 by 2023.
The authors present a novel model of acute chest pain and MI care in a densely populated LMIC. These units were strategically available in areas where road access was difficult, removing barriers to swift diagnosis and triage. Given the substantial area covered and large population served, these results demonstrate scalability and may be instructive for other densely populated LMICs where acute cardiac care is challenging. Furthermore, the geographical distribution of CPUs ensures each region is within 120 minutes of a primary PCI facility, thereby promoting equitable healthcare access. With such an approach serving as a possible model of cardiac care within resource constraints, the authors conclude that such an approach requires collaboration between public bodies, healthcare professionals, and the local community in order to improve global healthcare systems.