Intravascular Imaging-Guided Versus Coronary Angiography-Guided Complex PCI: A Meta-analysis of Randomized Controlled Trials.

INTRODUCTION: Trials evaluating the role of intravascular imaging in percutaneous coronary intervention (PCI) for complex coronary artery disease have yielded mixed results. This study aimed to compare the outcomes of intravascular imaging specifically intravascular ultrasound (IVUS) with those from conventional coronary angiography in complex PCI. METHODS: Comprehensive electronic search of MEDLINE, EMBASE, and Cochrane databases was performed until March 2023 for randomized clinical trials (RCTs) comparing intravascular imaging with coronary angiography in patients undergoing complex PCI. Complex PCI was defined per each study, and included PCI for American College of Cardiology/American Heart Association (ACC/AHA) type B2/C lesions, unprotected left main coronary artery disease, or multivessel stenting. The primary study outcome was major adverse clinical events (MACE). RESULTS: The meta-analysis included 10 RCTs with a total of 6615 patients (3576 in the intravascular imaging group and 3039 in the coronary angiography group). The weighted mean-follow up was 28.9 months. Compared with coronary angiography, intravascular imaging reduced MACE (8% vs. 13.3%; relative risk [RR] 0.63; 95% confidence interval [CI] 0.54-0.73), cardiac death (RR 0.47; 95% CI 0.31-0.73), definite/probable stent thrombosis (RR 0.48; 95% CI 0.24-0.97), target vessel revascularization (RR 0.62; 95% CI 0.46-0.83), and target lesion revascularization (RR 0.61; 95% CI 0.47-0.79). There was no difference between both groups in all-cause death (RR 0.79; 95% CI 0.53-1.18) and myocardial infarction (RR 0.80; 95% CI 0.61-1.04). CONCLUSION: In patients undergoing complex PCI, intravascular imaging-specifically IVUS-reduced MACE by decreasing the incidence of cardiac death, stent thrombosis, and target vessel and target lesion revascularization.

Burden of Ischemic and Hemorrhagic Stroke Across the US From 1990 to 2019.

Importance: Stroke is a leading cause of death and disability in the US. Accurate and updated measures of stroke burden are needed to guide public health policies. Objective: To present burden estimates of ischemic and hemorrhagic stroke in the US in 2019 and describe trends from 1990 to 2019 by age, sex, and geographic location. Design, Setting, and Participants: An in-depth cross-sectional analysis of the 2019 Global Burden of Disease study was conducted. The setting included the time period of 1990 to 2019 in the US. The study encompassed estimates for various types of strokes, including all strokes, ischemic strokes, intracerebral hemorrhages (ICHs), and subarachnoid hemorrhages (SAHs). The 2019 Global Burden of Disease results were released on October 20, 2020. Exposures: In this study, no particular exposure was specifically targeted. Main Outcomes and Measures: The primary focus of this analysis centered on both overall and age-standardized estimates, stroke incidence, prevalence, mortality, and DALYs per 100 000 individuals. Results: In 2019, the US recorded 7.09 million prevalent strokes (4.07 million women [57.4%]; 3.02 million men [42.6%]), with 5.87 million being ischemic strokes (82.7%). Prevalence also included 0.66 million ICHs and 0.85 million SAHs. Although the absolute numbers of stroke cases, mortality, and DALYs surged from 1990 to 2019, the age-standardized rates either declined or remained steady. Notably, hemorrhagic strokes manifested a substantial increase, especially in mortality, compared with ischemic strokes (incidence of ischemic stroke increased by 13% [95% uncertainty interval (UI), 14.2%-11.9%]; incidence of ICH increased by 39.8% [95% UI, 38.9%-39.7%]; incidence of SAH increased by 50.9% [95% UI, 49.2%-52.6%]). The downturn in stroke mortality plateaued in the recent decade. There was a discernible heterogeneity in stroke burden trends, with older adults (50-74 years) experiencing a decrease in incidence in coastal areas (decreases up to 3.9% in Vermont), in contrast to an uptick observed in younger demographics (15-49 years) in the South and Midwest US (with increases up to 8.4% in Minnesota). Conclusions and Relevance: In this cross-sectional study, the declining age-standardized stroke rates over the past 3 decades suggest progress in managing stroke-related outcomes. However, the increasing absolute burden of stroke, coupled with a notable rise in hemorrhagic stroke, suggests an evolving and substantial public health challenge in the US. Moreover, the significant disparities in stroke burden trends across different age groups and geographic locations underscore the necessity for region- and demography-specific interventions and policies to effectively mitigate the multifaceted and escalating burden of stroke in the country.

Sex differences in the outcomes after transcatheter aortic valve replacement with newer generation devices: A meta-analysis.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is a reasonable therapeutic approach among patients with symptomatic severe aortic stenosis irrespective of surgical risk. Data regarding sex-specific differences in the outcomes with newer generation valves are limited. METHODS: Electronic databases were searched for studies assessing sex differences in the outcomes of patients undergoing TAVR with newer generation valves (SAPIEN 3 or Evolut). Random effects model was constructed for summary estimates. RESULTS: Four observational studies with 4522 patients (44.8% women) were included in the meta-analysis. Women were older and had a lower prevalence of coronary artery disease and mean EuroScore. Women had a higher incidence of short-term mortality (up to 30 days) (risk ratio [RR]: 1.60, 95% confidence interval [CI]: 1.14-2.25), but no difference in 1-year mortality (RR: 0.92, 95% CI: 0.72-1.17). There was no significant difference in the incidence of major bleeding (RR: 1.16, 95% CI: 0.86-1.57), permanent pacemaker (PPM) (RR: 0.80, 95% CI: 0.62-1.04), or disabling stroke (RR: 1.16, 95% CI: 0.54-2.45). CONCLUSION: In this meta-analysis, we found that women undergoing TAVR with newer-generation devices were older but had a lower prevalence of comorbidities. Women had a higher incidence of short-term mortality but no difference in the 1-year mortality, bleeding, PPM, or stroke compared with men. Future studies are required to confirm these findings.

Association Between Clinical Trial Participation Status and Outcomes With Mitral Transcatheter Edge-to-Edge Repair.

BACKGROUND: Clinical trials have demonstrated the efficacy and safety of mitral transcatheter edge-to-edge repair (M-TEER) for selected patients with severe mitral regurgitation. However, the generalizability of trial results to real-world patients remains uncertain. OBJECTIVES: The authors aimed to compare baseline characteristics and in-hospital outcomes among trial participants with nonparticipants undergoing M-TEER. METHODS: Using the National Inpatient Sample database years 2016-2020, M-TEER admissions were identified and categorized into trial participants vs none. We also identified a cohort of trial noneligible patients based on clinical exclusion criteria from pivotal trials. Multivariate regression analysis was performed to compare in-hospital outcomes. The primary outcome was in-hospital mortality, and secondary outcomes included in-hospital complications, length of stay, and hospitalization cost. RESULTS: Among 38,770 M-TEER admissions from 2016 to 2020, 11,450 (29.5%) were trial participants, 22,975 (59.3%) were eligible nonparticipants, and 2,960 (7.6%) were noneligible. Baseline characteristics and comorbidity profiles were mostly similar between trial participants vs eligible nonparticipants. In-hospital mortality (adjusted OR [aOR]: 0.98; 95% CI: 0.60-1.62), cardiogenic shock (aOR: 1.06; 95% CI: 0.80-1.42), mechanical circulatory support (aOR: 0.91; 95% CI: 0.58-1.41), mechanical ventilation (aOR: 1.03; 95% CI: 0.74-1.42), and conversion to mitral valve surgery (aOR: 1.08; 95% CI: 0.57-2.03) were not different between both groups. Conversely, M-TEER for noneligible patients was associated with higher rates of mortality (aOR: 6.27; 95% CI: 3.75-10.45) and complications. CONCLUSIONS: The majority of real-world M-TEER patients would have been eligible for clinical trial participation and had comparable clinical profiles and in-hospital outcomes to trial participants. However, noneligible patients had worse in-hospital outcomes compared with trial participants.

Outcomes With Malignancy-Associated High-Risk Pulmonary Embolism: A Nationwide Analysis.

OBJECTIVE: To examine the characteristics and outcomes among patients with high-risk pulmonary embolism (PE) and malignancy. PATIENTS AND METHODS: The Nationwide Readmissions Database was used to identify hospitalizations with high-risk PE from January 1, 2016, to December 31, 2019. The main outcome was the difference in all-cause in-hospital mortality. RESULTS: Among 28,547 weighted hospitalizations with high-risk PE, 4,825 (16.9%) had malignancy. Admissions with malignancy had a lower prevalence of other comorbid conditions except for anemia and coagulopathy. The use of systemic thrombolysis, catheter-directed interventions, and surgical embolectomy was less common among admissions with malignancy, whereas the use of inferior vena cava filter was more common among those with malignancy. All-cause in-hospital mortality was higher among admissions with malignancy even after adjustment (adjusted odds ratio, 1.91; 95% CI, 1.72 to 2.11; P<.001). Metastatic genitourinary, gastrointestinal (other than colorectal), and lung malignancies were associated with the highest incidence of in-hospital mortality. The incidence of intracranial hemorrhage (3.9% vs 3.1%; P=.056) and the composite of non-intracranial hemorrhage bleeding (21.9% vs 20.6%; P=.185) was not different between admissions with and without malignancy. However, admissions with malignancy had higher incidence of gastrointestinal bleeding. CONCLUSION: In this nationwide analysis of patients admitted with high-risk PE, malignancy was independently associated with an increased risk of in-hospital mortality. The risk was highest among patients with metastatic genitourinary, gastrointestinal, and lung malignancies. Advanced therapies were less frequently used among patients with malignancy.

Cardiovascular Risk in Patients with Hematological Malignancies: A Systematic Review and Meta-Analysis.

Patients with hematologic malignancies (HMs) are at risk of future cardiovascular (CV) events. We therefore conducted a systematic review and meta-analysis to quantify their risk of future CV events. We searched Medline and EMBASE databases from inception until January 31, 2023 for relevant articles using a combination of keywords and medical subject headings. Studies examining CV outcomes in patients with HM versus controls without HM were included. The outcomes of interest included acute myocardial infarction (AMI), heart failure (HF), and stroke. The outcomes were expressed as hazard ratios (HRs) and their 95% confidence intervals (CIs). This study is registered with PROSPERO at CRD42022307814. A total of 15 studies involving 1,960,144 cases (178,602 patients with HM and 1,781,212 controls) were included in the quantitative analysis. A total of 10 studies examined the risk of AMI, 5 examined HF, and 11 examined stroke. Compared with the control group, the HRs for HM for AMI, HF, and stroke were 1.65 (95% CI 1.29 to 2.09, p <0.001), 4.82 (95% CI 3.72 to 6.25, p <0.001), and 1.60 (95% CI 1.30 to 1.97, p <0.001), respectively. The sensitivity analysis of stroke risk based on lymphoma type showed an increased risk of stroke in patients with non-Hodgkin lymphoma compared with controls (HR 1.31, 95% CI 1.04 to 1.64, p = 0.03) but no significant difference for Hodgkin lymphoma (HR 1.67, 95% CI 0.86 to 3.23, p = 0.08). Patients with HM are at increased risk of future AMI, HF, and stroke, and these findings suggest that CV care of patients with HM should be considered as a growing priority.

Antithrombotic Management for Transcatheter Aortic Valve Implantation.

BACKGROUND: There have been significant changes in the optimal antithrombotic regimen post transcatheter aortic valve implantation (TAVI) after the results of major clinical trials in the past few years. Given the clinical importance of the optimal antithrombotic therapy post TAVI, we performed a narrative description of the major clinical trials behind the scientific evidence supporting these changes, as well the current guideline recommendations and knowledge gaps. METHODS: We performed a narrative description of the major clinical trials behind the scientific evidence supporting these changes. We used PubMed as a major source to collect the major clinical trials including the following key words: "transcatheter aortic valve replacement", "transcatheter aortic valve implantation", "antithrombotic", "antiplatelet" and "anticoagulation". We selected the major clinical trials on this topic. This is not a systematic review or meta-analysis. RESULTS: We describe the results of the major clinical trials on antithrombotic therapy post TAVI: POPULAR-TAVI A, POPULAR-TAVI B, ENVISAGE-TAVI AF, GALILEO, ATLANTIS and ADAPT-TAVR trials. Based on the results of these trials, single antiplatelet therapy is recommended post TAVI in patients without concomitant indication for oral anticoagulation or dual antiplatelet therapy, especially in elderly patients. In younger patients, it is advised to evaluate the patient's bleeding and thrombotic risk, and dual antiplatelet therapy may be reasonable in patients with a high thrombotic risk and low bleeding risk. In patients with a concurrent indication for oral anticoagulation or dual antiplatelet therapy, it is recommended to continue oral anticoagulation or dual antiplatelet therapy post TAVI. CONCLUSION: In most patients without concomitant indication for oral anticoagulation, single antiplatelet therapy is recommended post TAVI.

Temporal trends in the utilization of advanced therapies among patients with acute pulmonary embolism: insights from a national database.

There is a paucity of data regarding the contemporary temporal trends in the adoption of advanced pulmonary embolism (PE) therapies in the United States as well as the parallel trends in outcomes of patients with acute PE. Therefore, we queried the Nationwide Readmissions Database (years 2016-2020) to report the temporal trends in utilization of advanced PE therapies. Our final analysis included 920 770 hospitalizations with acute PE. We demonstrated an increase in the proportion of patients diagnosed with high-risk PE during the study years. Overall, there was an increase in the use of advanced PE therapies, which was mainly due to the increase in the utilization of systemic thrombolytics, and catheter-directed therapies. Also, extracorporeal membrane oxygenation cannulation showed an incremental increase over the study years. The use of inferior vena cava filter has declined, while the use of surgical embolectomy did not change during the study years. The use of advanced therapies has increased among urban teaching, but not among urban non-teaching hospitals. During the study years, there was no change in unadjusted or adjusted in-hospital mortality rates among patients with acute PE, while the 90-day unplanned readmission rate has declined.

Outcomes of Transcatheter Aortic Valve Replacement With and Without Index Chronic Total Occlusion of Coronary Artery: A Propensity Matched Analysis.

Transcatheter aortic valve replacement (TAVR) utilization is increasing, along with procedural success. Coronary angiography is frequently performed before the TAVR procedure for coronary artery disease workup. Chronic total occlusion (CTO) of the coronary artery shares common risk factors with aortic stenosis and could be challenging, especially in terms of procedural safety. The outcomes of TAVR among patients with concomitant CTO are not extensively studied. We analyzed the National Inpatient Sample database between October 2015 and December 2020 to evaluate the clinical characteristics, procedural safety, and outcomes among patients who underwent TAVR who had concomitant CTO lesions. A total of 304,330 TAVRs were performed between 2015 and 2020, 5,235 of which (1.72%) were in patients with TAVR-CTO and 299,095 (98.28%) in those with TAVR-no CTO. After propensity matching, there was no difference in the odds of in-hospital mortality (adjusted odds ratio [aOR] 1.28, 95% confidence interval [CI] 0.94 to 1.75, p = 0.11). However, TAVR-CTO was associated with an increased incidence of acute myocardial infarction (aOR 1.27, 95% CI 1.05 to 1.53, p = 0.01), cardiac arrest (aOR, 2.60, 95% CI 1.64 to 4.11, p <0.0001), and need for mechanical circulatory support (aOR 2.6, 95% CI 1.88 to 3.59, p <0.0001). There was no difference in the incidence of stroke, major bleeding, complete heart block, or requirement for permanent pacemaker between the 2 groups. However, the TAVR-CTO cohort had a slightly greater length of stay and total hospitalization cost. TAVR is a relatively safe procedure among those with concomitant CTO lesions; however, it is associated with a greater incidence of acute myocardial infarction, cardiac arrest, and requirement for mechanical circulatory support.

Lead Cap Use in Interventional Cardiology: Time to Protect Our Head in the Cardiac Catheterisation Laboratory?

Background: Radiation exposure is an occupational hazard for interventional cardiologists and cardiac catheterisation laboratory staff that can manifest with serious long-term health consequences. Personal protective equipment, including lead jackets and glasses, is common, but the use of radiation protective lead caps is inconsistent. Methods: A systematic review qualitative assessment of five observational studies using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines protocol was performed. Results: It was concluded that lead caps significantly reduce radiation exposure to the head, even when a ceiling-mounted lead shield was present. Conclusion: Although newer protective systems are being studied and introduced, tools, such as lead caps, need to be strongly considered and employed in the catheterisation laboratory as mainstay personal protective equipment.

Predictors and Outcomes of Extracorporeal Membrane Oxygenation in COVID-19 Patients With ARDS: A Propensity-Matched Analysis of National Inpatient Sample.

Extracorporeal membrane oxygenation (ECMO) is a significant treatment modality for COVID-19 patients on ventilators. The current data is limited for understanding the indicators and outcomes of ECMO in COVID-19 patients with acute respiratory distress syndrome (ARDS). The National Inpatient Sample (NIS) database from 2020 was queried in this study. Among 1,666,960 patients admitted with COVID-19, 99,785 (5.98%) patients developed ARDS, and 60,114 (60.2%) were placed on mechanical ventilation. Of these mechanically ventilated COVID-ARDS patients, 2580 (4.3%) were placed on ECMO. Patients with ECMO intervention had higher adjusted odds (aOR) of blood loss anemia (aOR 9.1, 95% CI: 6.16-13.5, propensity score-matched (PSM) 42% vs 5.4%, P < 0.001), major bleeding (aOR 3.79, 95% CI: 2.5-5.6, PSM 19.9% vs 5.9%, P < 0.001) and acute liver injury (aOR 1.7, 95% CI: 1.14-2.6 PSM 14% vs 6%, P = 0.009) compared to patients without ECMO intervention. However, in-hospital mortality, acute kidney injury, transfusions, acute MI, and cardiac arrest were insignificant. On subgroup analysis, patients placed on veno-arterial ECMO had higher odds of cardiogenic shock (aOR 13.4, CI 3.95-46, P < 0.0001), cardiac arrest (aOR 3.5, CI 1.45-8.47, P = 0.0057), acute congestive heart failure (aOR 4.18, CI 1.05-16.5, P = 0.042) and lower odds of major bleeding (aOR 0.26, CI 0.07-0.92). However, there was no significant difference in mortality, intracranial hemorrhage, and acute MI. Further studies are needed before considering COVID-19 ARDS patients for placement on ECMO.

Intracoronary Imaging and Physiology to Guide PCI: Are We Ready for a Class I Guideline Recommendation?

PURPOSE OF REVIEW: Over the last decade, there has been a plethora of evidence to support the utilization of intravascular coronary imaging and physiological assessment to guide percutaneous coronary interventions (PCI). While there is a class I recommendation for the use of coronary physiology to guide PCI, the use of intravascular coronary imaging remains a class IIa recommendation. Herein, we aimed to review the recent scientific evidence from major trials highlighting the consideration for a future class I guideline recommendation for the use of intracoronary imaging. RECENT FINDINGS: The benefits of intravascular ultrasound (IVUS) and optical coherence tomography (OCT) to guide and optimize PCI have been demonstrated in several large trials. These trials have demonstrated that IVUS reduces major adverse cardiovascular events. Similarly, intracoronary physiology has been demonstrated to be an important tool to guide revascularization decision-making and been associated with a lower incidence of death, non-fatal myocardial infarction, and repeat revascularization compared with angiography alone. With existing clinical outcomes data on the benefit of intracoronary physiology and imaging-guided PCI as well as forthcoming data from ongoing trials regarding the use of these modalities, the interventional cardiology community is bound to transition from routine PCI to precision-, image-, and physiology-guided PCI.

Intravenous iron therapy among patients with heart failure and iron deficiency: An updated meta-analysis of randomized controlled trials.

Background: Randomized clinical trials (RCTs) evaluating the role of intravenous (IV) iron administration in patients with heart failure (HF) and iron deficiency (ID) have yielded inconsistent results. Methods: Electronic search of MEDLINE, EMBASE and OVID databases was performed until November 2022 for RCTs that evaluated the role of IV iron administration in patients with HF and ID. The main study outcomes were the composite of HF hospitalization or cardiovascular mortality, and individual outcome of HF hospitalization. Summary estimates were evaluated using random effects model. Results: The final analysis included 12 RCTs with 3,492 patients (1,831 patients in the IV iron group and 1,661 patients in the control group). The mean follow-up was 8.3 months. IV iron was associated with a lower incidence in the composite of HF hospitalization or cardiovascular mortality (31.9% vs. 45.3%; relative risk [RR] 0.72; 95% confidence interval [CI] 0.59-0.88) and individual outcome of HF hospitalization (28.4% vs. 42.2; RR 0.69; 95% CI 0.57-0.85). There was no significant difference between both groups in cardiovascular mortality (RR 0.88; 95% CI 0.75-1.04) and all-cause mortality (RR 0.95; 95% CI 0.83-1.09). IV iron was associated with lower New York Heart Association class and higher left ventricular ejection fraction (LVEF). Meta-regression analyses showed no effect modification for the main outcomes based on age, hemoglobin level, ferritin level or LVEF. Conclusion: Among patients with HF and ID, IV iron administration was associated with reduction in the composite of HF hospitalization or cardiovascular mortality and driven by a reduction in HF hospitalization.

Outcomes and Institutional Variation in Arterial Access Among Patients With AMI and Cardiogenic Shock Undergoing PCI.

BACKGROUND: Contemporary data comparing the outcomes of transradial access (TRA) vs transfemoral access (TFA) among patients presenting with acute myocardial infarction and cardiogenic shock (AMI-CS) undergoing percutaneous coronary intervention (PCI) are limited. OBJECTIVES: This study examines in-hospital outcomes and institutional variation among patients with AMI-CS undergoing TRA-PCI vs TFA-PCI. METHODS: Patients admitted with AMI-CS from the NCDR CathPCI registry between April 2018 and June 2021 were included. Multivariable logistic regression and inverse probability weighting models were used to assess the association between access site and in-hospital outcomes. A falsification analysis using non-access site-related bleeding was performed. RESULTS: Among 35,944 patients with AMI-CS undergoing PCI, 25.6% were performed with TRA. The proportion of TRA-PCI increased over the study period (22.0% in the second quarter of 2018 vs 29.1% in the second quarter of 2021; P-trend <0.001). Significant institutional-level variability in the use of TRA-PCI was also observed: 20.9% of all sites using TRA in <2% of PCIs (low utilization) vs 1.9% of all sites using TRA in >80% of PCIs (high utilization). Patients undergoing TRA-PCI had a significantly lower adjusted incidence of major bleeding (odds ratio [OR]: 0.71; 95% confidence interval [CI]: 0.67-0.76), mortality (OR: 0.73; 95% CI: 0.69-0.78), vascular complications (OR: 0.67; 95% CI: 0.54-0.84), and new dialysis (OR: 0.86; 95% CI: 0.77-0.97). There was no difference in non-access site related bleeding (OR: 0.93; 95% CI: 0.84-1.03). Sensitivity analyses revealed similar benefit with TRA-PCI among patients without arterial cross-over. There were no significant interactions observed between TRA-PCI with mechanical circulatory support and in-hospital outcomes. CONCLUSIONS: In this large nationwide contemporary analysis of patients with AMI-CS, about quarter of PCIs were performed via TRA with wide variability across US institutions. TRA-PCI was associated with significantly lower incidence of in-hospital major bleeding, mortality, vascular complications, and new dialysis. This benefit was observed irrespective of mechanical circulatory support use.