Impact of Cerebral Embolic Protection Devices on Disabling Stroke after Transcatheter Aortic Valve Replacement: Updated Results from the STS/ACC TVT Registry.

Background: Cerebral embolic protection devices (EPDs) were developed to mitigate the risk of stroke during transcatheter aortic valve replacement (TAVR), but their benefit remains unproven. In the PROTECTED-TAVR trial, EPD use did not reduce periprocedural stroke (primary study outcome) but led to a 62% reduction in the secondary endpoint of disabling stroke. Given these results, the impact of EPDs during TAVR remains unclear. Methods: We used STS/ACC TVT registry data to examine the association between EPD use and a proxy for disabling stroke among transfemoral TAVR patients between 1/2018-6/2023. The primary outcome was in-hospital disabling stroke-defined as stroke associated with either in-hospital death or discharge to a non-home location. We evaluated the association between EPD use and disabling stroke using instrumental variable (IV) analysis with site-level preference for EPD use as the instrument-a quasi-experimental approach that can support causal inference. In addition, we performed a propensity-score based comparison using overlap weighting as a secondary analysis. Results: The study population consisted of 414,649 patients of whom 53,389 (12.9%) received an EPD. The unadjusted rate of in-hospital disabling stroke was 0.7% among the EPD group and 0.9% in the no EPD group. EPD use was associated with a reduction in disabling stroke in both IV analysis (RR 0.87; 95% CI: 0.73-1.00) and propensity-weighted (PW) analysis (OR 0.79; 95% CI: 0.70-0.90) but was not associated with a reduction in non-disabling stroke. In subgroup analyses, the benefit of EPD was greater among those with versus without prior stroke (interaction p<0.05 for IV and PW). Conclusions: In the largest study to date, among patients undergoing TAVR, EPD use was associated with a small, borderline significant reduction in stroke associated with death or a discharge to a non-home location (a proxy for disabling stroke) that is likely to be causal in nature. Taken together with previous mechanistic and clinical studies, these findings provide credible evidence that EPDs benefit patients undergoing TAVR.

The effects of oxygenation on acute vasodilator challenge in pulmonary arterial hypertension.

Identification of long-term calcium channel blocker (CCB) responders with acute vasodilator challenge is critical in the evaluation of patients with pulmonary arterial hypertension. Currently there is no standardized approach for use of supplemental oxygen during acute vasodilator challenge. In this retrospective analysis of patients identified as acute vasoresponders, treated with CCBs, all patients had hemodynamic measurements in three steps: (1) at baseline; (2) with 100% fractional inspired oxygen; and (3) with 100% fractional inspired oxygen plus inhaled nitric oxide (iNO). Those meeting the definition of acute vasoresponsiveness only after first normalizing for the effects of oxygen in step 2 were labeled "iNO Responders." Those who met the definition of acute vasoresponsiveness from a combination of the effects of 100% FiO2 and iNO were labeled "oxygen responders." Survival, hospitalization for decompensated right heart failure, duration of CCB monotherapy, and functional data were collected. iNO responders, when compared to oxygen responders, had superior survival (100% vs. 50.1% 5-year survival, respectively), fewer hospitalizations for acute decompensated right heart failure (0% vs. 30.4% at 1 year, respectively), longer duration of CCB monotherapy (80% vs. 52% at 1 year, respectively), and superior 6-min walk distance. Current guidelines for acute vasodilator testing do not standardize oxygen coadministration with iNO. This study demonstrates that adjusting for the effects of supplemental oxygen before assessing for acute vasoresponsiveness identifies a cohort with superior functional status, tolerance of CCB monotherapy, and survival while on long-term CCB therapy.

Temporal trends in outcomes following inpatient transcatheter aortic valve replacement.

INTRODUCTION: Despite the growing adoption of transcatheter aortic valve replacement (TAVR), there remains a lack of clinical data evaluating procedural safety and discharge practices. AIMS: This study aims to investigate if there have been improvements in postoperative clinical outcomes following TAVR. METHODS: In this large-scale, retrospective cohort study, patients who underwent TAVR as an inpatient were identified from 2016 to 2020 using the National Readmissions Database. The primary outcome was temporal trends in the rates of discharge to home. Secondary endpoints assessed annual discharge survival rates, 30-day readmissions, length of stay, and periprocedural cardiac arrest rates. RESULTS: Over the 5-year study period, a total of 31,621 inpatient TAVR procedures were identified. Of these, 79.2 % of patients were successfully discharged home with home disposition increasing year-over-year from 74.5 % in 2016 to 85.9 % in 2020 (Odds ratio: 2.01; 95 % CI 1.62-2.48, p < 0.001). The mean annual discharge survival rate was 97.7 % which did not change significantly over the 5-year study period (p = 0.551). From 2016 to 2020, 30-day readmissions decreased from 14.0 % to 10.3 %, respectively (p = 0.028). Perioperative cardiac arrest occurred in 1.8 % (n = 579) of cases with rates remaining unchanged during the study (p = 0.674). CONCLUSION: Most TAVR patients are successfully discharged alive and home, with decreasing 30-day readmissions observed over recent years. This data suggests potential improvements in preoperative planning, procedural safety, and postoperative care. Despite perioperative cardiac arrest being associated with high mortality, it remains a relatively rare complication of TAVR.

Implementation of a Multidimensional Strategy to Reduce Post-PCI Bleeding Risk.

BACKGROUND: The American College of Cardiology Reduce the Risk: PCI Bleed Campaign was a hospital-based quality improvement campaign designed to reduce post-percutaneous coronary intervention (PCI) bleeding events. The aim of the campaign was to provide actionable evidence-based tools for participants to review, adapt, and adopt, depending upon hospital resources and engagement. METHODS: We used data from 8 757 737 procedures in the National Cardiovascular Data Registry between 2015 and 2021 to compare patient and hospital characteristics and bleeding outcomes among campaign participants (n=195 hospitals) and noncampaign participants (n=1384). Post-PCI bleeding risk was compared before and after campaign participation. Multivariable hierarchical logistic regression was used to determine the adjusted association between campaign participation and post-PCI bleeding events. Prespecified subgroups were examined. RESULTS: Campaign hospitals were more often higher volume teaching facilities located in urban or suburban locations. After adjustment, campaign participation was associated with a significant reduction in the rate of bleeding (bleeding: adjusted odds ratio, 0.61 [95% CI, 0.53-0.71]). Campaign hospitals had a greater decrease in bleeding events than noncampaign hospitals. In a subgroup analysis, the reduction in bleeding was noted in non-ST-segment-elevation acute coronary syndrome and ST-segment-elevation myocardial infarction patients, but no significant reduction was seen in patients without acute coronary syndrome. CONCLUSIONS: Participation in the American College of Cardiology Reduce the Risk: PCI Bleed Campaign was associated with a significant reduction in post-PCI bleeding. Our results underscore that national quality improvement efforts can be associated with a significant impact on PCI outcomes.

Transcatheter closure of a large coronary cameral fistula presenting as a calcified cystic right atrial mass.

A 51-year-old patient with progressive right heart dysfunction was found to have a large calcified right atrial mass on echocardiography. As part of the work up for an intracardiac mass he had a cardiac computed tomogram which detailed a large coronary cameral fistula from the circumflex coronary artery to the right atrium associated with a spherical calcific pseudo-aneurysmal sac. Transcatheter occlusion of the exit point into the atrium with a vascular plug was performed directly from a right atrial approach without the need for an arteriovenous wire loop. This case details a unique presentation of a coronary cameral fistula to an unusual position within the right atrium which facilitated the rare ability to occlude the fistula from a venous approach without creating an arteriovenous wire rail.

Dynamic Coronary Roadmap versus standard angiography for percutaneous coronary intervention: the randomised, multicentre DCR4Contrast trial.

BACKGROUND: Decreasing the amount of iodinated contrast is an important safety aspect of percutaneous coronary interventions (PCI), particularly in patients with a high risk of contrast-induced acute kidney injury (CI-AKI). Dynamic Coronary Roadmap (DCR) is a PCI navigation support tool projecting a motion-compensated virtual coronary roadmap overlay on fluoroscopy, potentially limiting the need for contrast during PCI. AIMS: This study investigates the contrast-sparing potential of DCR in PCI, compared to standard angiographic guidance. METHODS: The Dynamic Coronary Roadmap for Contrast Reduction (DCR4Contrast) trial is a multicentre, international, prospective, unblinded, stratified 1:1 randomised controlled trial. Patients were randomised to either DCR-guided PCI or to conventional angiography-guided PCI. The primary endpoint was the total volume of iodinated contrast administered, and the secondary endpoint was the number of cineangiography runs during PCI. RESULTS: The study population included 356 randomised patients (179 in DCR and 177 in control groups, respectively). There were no differences in patient demographics, angiographic characteristics or estimated glomerular filtration rate (eGFR) between the two groups. The total contrast volume used during PCI was significantly lower with DCR guidance compared with conventional angiographic guidance (64.6±44.4 ml vs 90.8±55.4 ml, respectively; p<0.001). The total number of cineangiography runs was also significantly reduced in the DCR group (8.7±4.7 vs 11.7±7.6 in the control group; p<0.001). CONCLUSIONS: Compared to conventional angiography-guided PCI, DCR guidance was associated with a significant reduction in both contrast volume and the number of cineangiography runs during PCI. (ClinicalTrials.gov: NCT04085614).

Pulmonary Artery Catheter Use and Outcomes in Patients With ST-Elevation Myocardial Infarction and Cardiogenic Shock Treated With Impella (a Nationwide Analysis from the United States).

The role of continuous hemodynamic assessment with pulmonary artery (PA) catheter placement in cardiogenic shock (CS) remains debated. We aimed to assess the association between PA catheter placement and clinical outcomes in patients with CS secondary to ST-elevation myocardial infarction (STEMI) treated with an intravascular microaxial flow pump. We identified patients hospitalized with STEMI complicated by CS on mechanical circulatory support with an intravascular microaxial flow pump (Impella, Abiomed, Danvers, Massachusetts) using the National Inpatient Sample database and compared the outcomes in those treated with and without PA catheters. The primary outcome was in-hospital mortality. The secondary outcomes included in-hospital complications, hospital length of stay, inpatient costs, and temporal trends. The total cohort included 14,635 hospitalizations for STEMI complicated by CS treated with Impella between 2016 and 2020, of whom 5,505 (37.6%) received PA catheters. Over the study period, the use of PA catheters increased significantly from 25.9% to 41.8% (ptrend <0.01). Similarly, the use of Impella increased from 9.9% to 18.9% (ptrend <0.01). After adjustment for baseline characteristics using a multivariate logistic regression analysis, PA catheter use was associated with lower in-hospital mortality (adjusted odds ratio 0.80, 95% confidence interval 0.67 to 0.96, p = 0.01) and similar cardiovascular, neurologic, renal, and hematologic complications; length of stay; and inpatient costs compared with no PA catheter use. In conclusion, PA catheter use in patients with STEMI complicated by CS treated with Impella is associated with reduced in-hospital mortality and similar complication rates. Given the mortality benefit, further research is necessary to optimize PA catheter use in patients with STEMI with CS.

Interaction of COVID-19 With Common Cardiovascular Disorders.

The onset and widespread dissemination of the severe acute respiratory syndrome coronavirus-2 in late 2019 impacted the world in a way not seen since the 1918 H1N1 pandemic, colloquially known as the Spanish Flu. Much like the Spanish Flu, which was observed to disproportionately impact young adults, it became clear in the early days of the coronavirus disease 2019 (COVID-19) pandemic that certain groups appeared to be at higher risk for severe illness once infected. One such group that immediately came to the forefront and garnered international attention was patients with preexisting cardiovascular disease. Here, we examine the available literature describing the interaction of COVID-19 with a myriad of cardiovascular conditions and diseases, paying particular attention to patients diagnosed with arrythmias, heart failure, and coronary artery disease. We further discuss the association of acute COVID-19 with de novo cardiovascular disease, including myocardial infarction due to coronary thrombosis, myocarditis, and new onset arrhythmias. We will evaluate various biochemical theories to explain these findings, including possible mechanisms of direct myocardial injury caused by the severe acute respiratory syndrome coronavirus-2 virus at the cellular level. Finally, we will discuss the strategies employed by numerous groups and governing bodies within the cardiovascular disease community to address the unprecedented challenges posed to the care of our most vulnerable patients, including heart transplant recipients, end-stage heart failure patients, and patients suffering from acute coronary syndromes, during the early days and height of the COVID-19 pandemic.

Rationale and design of the Dynamic Coronary Roadmap for Contrast Reduction (DCR4Contrast) in PCI randomized controlled trial.

BACKGROUND: The clinical and anatomic complexity of patients undergoing percutaneous coronary interventions (PCI) has increased significantly over the past 2 decades. Contrast induced nephropathy (CIN) significantly impacts prognosis after PCI, therefore minimizing the risk of CIN is important in improving clinical outcomes. Dynamic Coronary Roadmap (DCR) is a PCI navigation support tool which may decrease CIN by projecting a motion-compensated virtual coronary roadmap overlay on fluoroscopy, potentially reducing iodinated contrast volume during PCI. STUDY DESIGN AND OBJECTIVES: The Dynamic Coronary Roadmap for Contrast Reduction trial (DCR4Contrast) is a multi-center, prospective, unblinded, stratified 1:1 randomized controlled trial investigating if DCR use reduces the total contrast volume administered during PCI compared to PCI performed without DCR guidance. DCR4Contrast aims to recruit 394 patients undergoing PCI. The primary end point is the total undiluted iodinated contrast volume administered during the PCI, performed with or without DCR. As of November 14, 2022, 346 subjects have been enrolled. CONCLUSIONS: The DCR4Contrast study will investigate the potential contrast-sparing effect of the DCR navigation support tool in patients undergoing PCI. By reducing iodinated contrast administration, DCR has the potential to contribute to reduced risk of CIN and thus increase PCI safety. CLINICAL TRIAL REGISTRATION URL: https://clinicaltrials.gov/ct2/show/NCT04085614.

Magnitude of troponin elevation in patients with biomarker evidence of myocardial injury: relative frequency and outcomes in a cohort study across a large healthcare system.

BACKGROUND: Serum troponin levels correlate with the extent of myocyte necrosis in acute myocardial infarction (AMI) and predict adverse outcomes. However, thresholds of cardiac troponin elevation that could portend to poor outcomes have not been established. METHODS: In this cohort study, we characterized all cardiac troponin elevations > 0.04 ng/mL (upper limit of normal [ULN]) from patients hospitalized with an ICD-9/10 diagnosis of AMI across our health system from 2012-2019. We grouped events into exponential categories of peak cardiac troponin and evaluated the association of these troponin categories with all-cause mortality, heart transplants, or durable left ventricular assist devices (LVAD). Patients with cardiac troponin > 10,000 × ULN were manually chart reviewed and described. RESULTS: There were 18,194 AMI hospitalizations with elevated cardiac troponin. Peak troponin was 1-10 × ULN in 21.1%, 10-100 × ULN in 34.8%, 100-1,000 × ULN in 30.1%, 1,000-10,000 × ULN in 13.1%, and > 10,000 × ULN in 0.9% of patients. One-year mortality was 17-21% across groups, except in > 10,000 × ULN group where it was 33% (adjusted hazard ratio (99%CI) for > 10,000 × ULN group compared to all others: 1.86 (1.21, 2.86)). Hazards of one-year transplant and MCS were also significantly elevated in the > 10,000 × ULN group. CONCLUSIONS: Elevation in cardiac troponin levels post AMI that are > 10,000 × ULN was rare but identified patients at particularly high risk of adverse events. These patients may benefit from clarification of goals of care and early referral for advanced heart failure therapies. These data have implications for conversion to newer high-sensitivity cardiac troponin assays whose maximum assay limit is often lower than traditional assays.

Myocardial Injury and Altered Gene Expression Associated With SARS-CoV-2 Infection or mRNA Vaccination.

SARS CoV-2 enters host cells via its Spike protein moiety binding to the essential cardiac enzyme angiotensin-converting enzyme (ACE) 2, followed by internalization. COVID-19 mRNA vaccines are RNA sequences that are translated into Spike protein, which follows the same ACE2-binding route as the intact virion. In model systems, isolated Spike protein can produce cell damage and altered gene expression, and myocardial injury or myocarditis can occur during COVID-19 or after mRNA vaccination. We investigated 7 COVID-19 and 6 post-mRNA vaccination patients with myocardial injury and found nearly identical alterations in gene expression that would predispose to inflammation, coagulopathy, and myocardial dysfunction.

Transradial versus transfemoral approach for percutaneous coronary intervention in patients with ST-elevation myocardial infarction complicated by cardiogenic shock: a systematic review and meta-analysis.

BACKGROUND: In ST-elevation myocardial infarction (STEMI), transradial access (TRA) for percutaneous coronary intervention (PCI) is associated with less bleeding and mortality than transfemoral access (TFA). However, patients in cardiogenic shock (CS) are more often treated via TFA. The aim of this meta-analysis is to compare the safety and efficacy of TRA vs. TFA in CS. METHODS: Systematic review was performed querying PubMed, Google Scholar, Cochrane, and clinicaltrials.gov for studies comparing TRA to TFA in PCI for CS. Outcomes included in-hospital, 30-day and ≥1-year mortality, major and access site bleeding, TIMI3 (thrombolytics in myocardial infarction) flow, procedural success, fluoroscopy time, and contrast volume. Risk ratios (RRs) and 95% confidence intervals (CIs) were calculated using random effects models. RESULTS: Six prospective and eight retrospective studies (TRA, n = 8032; TFA, n = 23 031) were identified. TRA was associated with lower in-hospital (RR 0.59, 95% CI 0.52-0.66, P < 0.0001), 30-day and ≥1-year mortality, as well as less in-hospital major (RR 0.41, 0.31-0.56, P < 0.001) and access site bleeding (RR 0.42, 0.23-0.77, P = 0.005). There were no statistically significant differences in post-PCI coronary flow grade, procedural success, fluoroscopy time, and contrast volume between TRA vs. TFA. CONCLUSIONS: In PCI for STEMI with CS, TRA is associated with significantly lower mortality and bleeding complications than TFA while achieving similar TIMI3 flow and procedural success rates.

Readmission After ACS: Burden, Epidemiology, and Mitigation.

PURPOSE OF REVIEW: The past decade has brought increased efforts to better understand causes for ACS readmissions and strategies to minimize them. This review seeks to provide a critical appraisal of this rapidly growing body of literature. RECENT FINDINGS: Prior to 2010, readmission rates for patients suffering from ACS remained relatively constant. More recently, several strategies have been implemented to mitigate this including improved risk assessment models, transition care bundles, and development of targeted programs by federal organizations and professional societies. These strategies have been associated with a significant reduction in ACS readmission rates in more recent years. With this, improvements in 30-day post-discharge mortality rates are also being appreciated. As we continue to expand our knowledge on independent risk factors for ACS readmissions, further strategies targeting at-risk populations may further decrease the rate of readmissions. Efforts to understand and reduce 30-day ACS readmission rates have resulted in overall improved quality of care for patients.

Hospital Characteristics and Early Enrollment Trends in the American College of Cardiology Voluntary Public Reporting Program.

Importance: Limited data exist regarding the characteristics of hospitals that do and do not participate in voluntary public reporting programs. Objective: To describe hospital characteristics and trends associated with early participation in the American College of Cardiology (ACC) voluntary reporting program for cardiac catheterization-percutaneous coronary intervention (CathPCI) and implantable cardioverter-defibrillator (ICD) registries. Design, Setting, and Participants: This cross-sectional study analyzed enrollment trends and characteristics of hospitals that did and did not participate in the ACC voluntary public reporting program. All hospitals reporting procedure data to the National Cardiovascular Data Registry (NCDR) CathPCI or ICD registries that were eligible for the public reporting program from July 2014 (ie, program launch date) to May 2017 were included. Stepwise logistic regression was used to identify hospital characteristics associated with voluntary participation. Enrollment trends were evaluated considering the date US News & World Report (USNWR) announced that it would credit participating hospitals. Data analysis was performed from March 2017 to January 2018. Main Outcomes and Measures: Hospital characteristics and participation in the public reporting program. Results: By May 2017, 561 of 1747 eligible hospitals (32.1%) had opted to participate in the program. Enrollment increased from 240 to 376 hospitals (56.7%) 1 month after the USNWR announcement that program participation would be considered as a component of national hospital rankings. Compared with hospitals that did not enroll, program participants had increased median (IQR) procedural volumes for PCI (481 [280-764] procedures vs 332 [186-569] procedures; P < .001) and ICD (114 [56-220] procedures vs 62 [25-124] procedures; P < .001). Compared with nonparticipating hospitals, an increased mean (SD) proportion of participating hospitals adhered to composite discharge medications after PCI (0.96 [0.03] vs 0.92 [0.07]; P < .001) and ICD (0.88 [0.10] vs 0.81 [0.12]; P < .001). Hospital factors associated with enrollment included participation in 5 or more NCDR registries (odds ratio [OR],1.98; 95% CI, 1.24-3.19; P = .005), membership in a larger hospital system (ie, 3-20 hospitals vs ≤2 hospitals in the system: OR, 2.29; 95% CI, 1.65-3.17; P = .001), participation in an NCDR pilot public reporting program of PCI 30-day readmissions (OR, 2.93; 95% CI, 2.19-3.91; P < .001), university affiliation (vs government affiliation: OR, 3.85, 95% CI, 1.03-14.29; P = .045; vs private affiliation: OR, 2.22; 95% CI, 1.35-3.57; P < .001), Midwest location (vs South: OR, 1.47; 95% CI, 1.06-2.08; P = .02), and increased comprehensive quality ranking (4 vs 1-2 performance stars in CathPCI: OR, 8.08; 95% CI, 5.07-12.87; P < .001; 4 vs 1 performance star in ICD: OR, 2.26; 95% CI, 1.48-3.44; P < .001) (C statistic = 0.829). Conclusions and Relevance: This study found that one-third of eligible hospitals participated in the ACC voluntary public reporting program and that enrollment increased after the announcement that program participation would be considered by USNWR for hospital rankings. Several hospital characteristics, experience with public reporting, and quality of care were associated with increased odds of participation.

Mechanical Complications of Transcatheter Aortic Valve Replacement.

Mechanical complications after transcatheter aortic valve replacement are fortunately rare with the current generation of devices. Unfortunately, life-threatening complications will occur and it is the responsibility of operators to be familiar with strategies to prevent and manage these challenging scenarios. Because these cases will not occur often, it is important for us to highlight and talk about those that do occur, to learn best practices in how to manage and prevent them going forward. We can learn much from each other's good crash landings.

Transcatheter Closure of Left Ventricle to Coronary Sinus Fistula Post-MVR and Septal Myectomy.

This paper describes the case of a patient who developed refractory heart failure due to a fistula from the left ventricle to the coronary sinus that was unintentionally created after a surgical myectomy and mitral valve replacement. Advanced image guidance with a pre-procedure 3-dimensional physical model and intraprocedure echocardiography fusion facilitated transcatheter plugging of the shunt with symptom resolution. (Level of Difficulty: Advanced.).